Docstoc

PSAT

Document Sample
PSAT Powered By Docstoc
					Patient Safety Assessment Too
          Version 2009
ssessment Tool (PSAT)
on 2009
 Patient Safety Assessmen
     Administration Elemen
Element 1
    Management and Leadership

Element 2
    Patient Safety Program Management

Element 3
    JCAHO (CAM-H)

Element 4
    Procurement and Equipment Management

Element 5
    Recalls and VA Alerts & Advisories

Element 6
    Patient Safety Policies, Tools & Aids
 essment Tool
n Elements



ent




agement


s


ds
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                                            Not
                                                                                                                      Met       Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                      (1)        Met (2)    (3)   possible root causes
            Leadership/Support                                                                                                                                                         START             1.1
1.1.1       Does a non-punitive environment        Interview leadership and staff. Review of SPOT
            exist that promotes reporting of       data to evaluate if a systems approach is
            errors and mistakes?                   consistently used. Ask leaders or PSM about
                                                   Patient Safety Culture Survey Results and
                                                   related action plan for dimensions that showed
                                                   non-favorable results.
                                                   JC- CAMH LD-03-01-01.pdf
            Mandatory;Priority A                   VHA Handbook 1050 01 PSI.pdf /A Page=3                                                                                              END
            Leadership/Support                                                                                                                                                         START             1.1
1.1.2       Are staff made available to serve on   Review RCA's looking for a mix of staff
            RCA teams including physicians,        participation and interview Patient Safety
            pharmacists and employees on off-      Managers and upper management. Employees
            tours when needed?                     who work on second and third shifts and
                                                   weekends should be documented in the RCA's.
                                                   The PSM should keep management abreast of
                                                   the participation status. RCA Team membership
                                                   appropriateness should be supported by
                                                   management and facilitated by staff.

                                                   JC- CAMH LD-03-05-01.pdf
            Mandatory;Priority A                   VHA Handbook 1050 01 PSI.pdf /A Page=6                                                                                              END
            Leadership/Support                                                                                                                                                         START             1.1
1.1.3       Is the Patient Safety Manager          Interview PSM and management. The PSM or
            permitted to charter RCA teams         other individuals trained on using the SAC
            based upon the SAC score without       matrix should be the authority for determining
            approval from his/her supervisor or    which cases become individual RCAs. Although
            top management?                        top management approval is ultimately needed
                                                   to begin an RCA, the PSM should be the
                                                   primary decision-maker.
            Recommended; Priority A                JC- CAMH LD-03-01-01.pdf                                                                                                            END




        Mgt Ldr - 1                                                                         Mgt Ldr - 1 - Version: 01.30.2009                                                                5 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                                             Not
                                                                                                                       Met       Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                      (1)        Met (2)    (3)   possible root causes
            Leadership/Support                                                                                                                                                          START             1.1
1.1.4       Do RCA teams meet with top              Interview PSM and management. Evidence
            management to discuss their             should show management interaction with the
            findings and recommendations?           teams, including suggestions/recommendations
                                                    made. Reports should not be without
                                                    justification for actions not approved.

                                                    JC- CAMH LD-03-01-01.pdf
            Mandatory;Priority A                    VHA Handbook 1050 01 PSI.pdf /A Page=6                                                                                              END
            Leadership/Support                                                                                                                                                          START             1.1
1.1.5       Are close call reports being            Review SPOT for potential SAC scores of 1and
            received?                               2 to determine if Safety Reports are being
                                                    entered. Have PSM show specific examples of
                                                    close calls including events that have become
                                                    RCAs.
                                                    JC- CAMH LD-03-06-01.pdf
            Mandatory;Priority A                    VHA Handbook 1050 01 PSI.pdf                                                                                                        END
            Leadership/Support                                                                                                                                                          START             1.1
1.1.6       Are lessons learned from RCAs and Show reports made to VISN, or others that have
            best practices shared with the    been shared. Methods for sharing information
            Network?                          could include: meetings, conference calls, e-
                                              mail correspondence, summaries done by PSO,
                                              etc.
                                                    JC- CAMH LD-03-04-01.pdf
            Recommended; Priority C                 VHA Handbook 1050 01 PSI.pdf                                                                                                        END
            Leadership/Support                                                                                                                                                          START             1.1
1.1.7       When criminal or intentionally          Verify via interviews with key personal (PSM,
            unsafe acts are identified during the   Director, RCA team members). If systems
            RCA process, is the RCA stopped,        issues are identified a new RCA team may be
            the record sealed and top               chartered to complete the RCA following
            management notified without             completion of the ABI.
            revealing team findings and
            conclusions?
            Mandatory;Priority A                    VHA Handbook 1050 01 PSI.pdf /A Page=9                                                                                              END




        Mgt Ldr - 1                                                                          Mgt Ldr - 1 - Version: 01.30.2009                                                                6 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                                                Not
                                                                                                                          Met       Partially   Met   If score other than 'met' what are
              Question:                             Rationale/Assessment Methods:                                         (1)        Met (2)    (3)   possible root causes
              Leadership/Support                                                                                                                                                           START             1.1
1.1.8         Are confidentiality rules complied    Conduct interviews, review how records are
              with in the Patient Safety RCA        managed (e.g., locked office, record access,
              Process?                              etc.). Leadership should possess general
                                                    knowledge of 5705 protection for patient safety
                                                    data and PSMs should have in-depth knowledge
                                                    of all 5705 confidentiality rules related to sharing
                                                    data collected. If de-identified, tables 18 and 19
                                                    of the RCA are appropriate for sharing.

                                                    202 Briefing.ppt
                                                    Confidentiality 5705 Cognitive Aid.pdf
              Mandatory;Priority A                  JC- CAMH IM-02-01-03.pdf                                                                                                               END
              Leadership/Support                                                                                                                                                           START             1.1
1.1.9         Are RCA reports de-identified         Review a random sample of submitted RCAs in
              thoroughly prior to submission to     the SPOT database for identifiers. Reviewing
              NCPS?                                 the reports received though the NCPS Facility
                                                    Report Process is another way to analyze
                                                    compliance to de-identification.
                                                    5705.pdf
                                                    Code of Federal Regulations_part 17.pdf
              Mandatory;Priority A                  JC- CAMH IM-02-01-03.pdf                                                                                                               END
              Staffing                                                                                                                                                                     START             1.2
1.2.1         Is there a full time Patient Safety   The Patient Safety program requirements
              Manager?                              should be met before other collateral duties are
                                                    assigned to the PSM.
                                                    Supporting the Patient Safety Program Memo.pdf
                                                    JC- CAMH LD-03-06-01.pdf
              Mandatory;Priority A                  USH memo PSM Job Jar (2).pdf                                                                                                           END
              Staffing                                                                                                                                                                     START             1.2
1.2.1.1       Is clerical support personnel         Depending on facility size, a rigorous work load
              provided if deemed necessary by       of RCA inputting, maintenance, and follow up
              the PSM or PSO?                       can keep the PSM from being able to perform
                                                    other duties, therefore clerical support, if
                                                    justified, should be provided.
              Recommended; Priority B                                                                                                                                                      END




          Mgt Ldr - 1                                                                           Mgt Ldr - 1 - Version: 01.30.2009                                                                7 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                                                Not
                                                                                                                          Met       Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                                       (1)        Met (2)    (3)   possible root causes
              Staffing                                                                                                                                                                     START             1.2
1.2.2         Does the Patient Safety Manager         VA Memorandum to Network Directors specifies
              report directly to the Medical Center   that "facility Patient Safety Managers be
              Director or Chief of Staff?             organizationally aligned to report directly to top
                                                      management (i.e., Director or COS)."

                                                      Supporting the Patient Safety Program Memo.pdf
                                                      JC- CAMH LD-03-06-01.pdf
              Mandatory; Priority A                   USH memo PSM Job Jar (2).pdf                                                                                                         END
              Resources                                                                                                                                                                    START             1.3
1.3.1         Does management support patient       Verify via training certificates, training records,
              safety staff by funding attendance at etc.
              patient safety training/conferences?

              Recommended; Priority C                 JC- CAMH LD-03-05-01.pdf                                                                                                             END
              Resources                                                                                                                                                                    START             1.3
1.3.1.1       If needed, is specific training being   A memorandum was sent out by the Assistant
              provided for the PSM to meet job        Deputy Under Secretary for Health (10N) in
              responsibilities listed in the          December of 2001 that provided a list of PSM
              guidance distributed by the             job responsibilities to assist in establishing the
              Assistant Deputy Under Secretary        PSM positions. The list captures the
              for Health (in 12-2001) to enhance      fundamental activities that must be in place to
              qualifications?                         run the program. On-going training should be
                                                      sought and provided to PSMs to meet the list
                                                      criteria. See NCPS web site for memo and list
                                                      at vaww.ncps.med.va.gov/

                                                      JC- CAMH LD-03-06-01.pdf
              Recommended; Priority A                 USH memo PSM Job Jar (2).pdf                                                                                                         END
              Resources                                                                                                                                                                    START             1.3
1.3.2         Is there dedicated space and            Private work space should be provided to the
              equipment for the Patient Safety        PSM when needed to help to comply with
              Program including an appropriate        confidentiality guidelines of 5705. A dedicated
              meeting space, a portable notebook      work space or room for RCA teams should also
              computer, and an LCD projector?         be provided for team meetings. LCD projector
                                                      and notebook should be made available to
                                                      teams upon request.
              Recommended; Priority B                 JC- CAMH LD-03-02-01.pdf                                                                                                             END




          Mgt Ldr - 1                                                                           Mgt Ldr - 1 - Version: 01.30.2009                                                                8 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                                             Not
                                                                                                                       Met       Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                                         (1)        Met (2)    (3)   possible root causes
            Resources                                                                                                                                                                   START             1.3
1.3.3       Is Information Technology support    IT staff is often needed for SPOT help or for
            personnel provided to assist the     patient safety related upgrades to software such
            patient safety program to complete   as CPRS.
            related tasks?
            Recommended; Priority B              http://vaww.ncps.med.va.gov/Tools/SPOT/installation.html                                                                               END




        Mgt Ldr - 1                                                                          Mgt Ldr - 1 - Version: 01.30.2009                                                                9 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          10 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          11 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          12 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          13 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          14 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          15 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          16 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          17 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          18 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          19 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          20 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          21 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          22 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          23 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          24 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          25 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          26 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          27 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          28 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
          Question:                     Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          29 of 1656
                                                NCPS Patient Safety Assessment Tool

                                                             Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
                                                                                                                  Not
                                                                                            Met       Partially   Met   If score other than 'met' what are
           Question:                    Rationale/Assessment Methods:                       (1)        Met (2)    (3)   possible root causes




      65




      Mgt Ldr - 1                                                 Mgt Ldr - 1 - Version: 01.30.2009                                                          30 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative


                         Leadership/Support




                         Leadership/Support




                         Leadership/Support




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   31 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative


                         Leadership/Support




                         Leadership/Support




                         Leadership/Support




                         Leadership/Support




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   32 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative


                         Leadership/Support




                         Leadership/Support




                         Staffing




                         Staffing




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   33 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative


                         Staffing




                         Resources




                         Resources




                         Resources




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   34 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative


                         Resources




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   35 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   36 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   37 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   38 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   39 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   40 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   41 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   42 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   43 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   44 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   45 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   46 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   47 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   48 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   49 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   50 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   51 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   52 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   53 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   54 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   55 of 1656
              NCPS Patient Safety Assessment Tool

                     Part I Adminstrative




Mgt Ldr - 1             Mgt Ldr - 1 - Version: 01.30.2009   56 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                                             Not
                                                                                                                     Met         Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                      (1)          Met (2)    (3)   possible root causes
             Root Cause Analysis Activities                                                                                                                                             START              2.1
2.1.1        Are questions 1-7 consistently       The SPOT database should be used to enter
             completed in SPOT to assess all      Safety Reports (i.e., items 1-7 in SPOT).
             reported patient safety events,
             including close calls?
                                                  JCAHO_CAMH.pdf /A Page=294
             Mandatory; Priority A                JC- CAMH PI-01-01-01.pdf                                                                                                              END
             Root Cause Analysis Activities                                                                                                                                             START              2.1
2.1.1.1      Are RCAs completed as dictated by    Incidents where the Safety Report indicates an
             SAC scoring?                         actual or potential SAC score of 3 should have a
                                                  RCA team chartered. Other incidents that score
                                                  lower than 3 can receive an RCA based on a
                                                  local/network decision.
             Mandatory; Priority A                VHA Handbook 1050 01 PSI.pdf /A Page=16                                                                                               END
             Root Cause Analysis Activities                                                                                                                                             START              2.1
2.1.1.2      Are Medication, Para-Suicide/Out-    Actual SAC score of 3 requires an individual
             Patient Suicides, Falls and          RCA to be done. All others of these event types
             Elopement adverse events and         can included in an aggregated review (twice or
             close calls with a SAC potential     four times per FY depending on which event
             score of 3 addressed via the         type) focusing on fixing related processes
             Aggregated Review Process?           (NOTE: Any event can receive an individual
                                                  RCA, even if it meets the criteria for an inclusion
                                                  in an aggregate report). Facility-wide logs
                                                  should be kept in the facility SPOT database or
                                                  other database. The incident data captured
                                                  should follow guidelines in Appendix C of the
                                                  NCPS Handbook (each event type has unique
                                                  criteria). Assessor should review logs and
                                                  aggregate reports to verify process is being
                                                  followed.
                                                  AggReviewSchedule 09 & 10 11x17.pdf
                                                  Guidanceon New Standards for VHA Patient Safety Program.pdf
             Mandatory; Priority A                ISMP_Book.pdf                                                                                                                         END
             Root Cause Analysis Activities                                                                                                                                             START              2.1
2.1.2        Has the Patient Safety Manager       Show certificate(s) of completion from attendees.
             attended the NCPS three day
             Patient Safety Improvement training?

             Recommended; Priority A              JC- CAMH LD-03-06-01.pdf                                                                                                              END




          PS Prgm Mgt - 2                                                                PS Prgm Mgt - 2 - Version: 01.30.2009                                                                57 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                                           Not
                                                                                                                   Met         Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                    (1)          Met (2)    (3)   possible root causes
             Root Cause Analysis Activities                                                                                                                                           START              2.1
2.1.2.1      If individuals other than the PSMs   The appropriate training would be considered
             serve as advisors on RCA teams       the three day Patient Safety Improvement
             have they been appropriately         Course offered by NCPS, or the equivalent
             trained?                             given by a trained PSO or PSM.
             Recommended; Priority A                                                                                                                                                  END
             Root Cause Analysis Activities                                                                                                                                           START              2.1
2.1.3        Are RCA teams orientated to the      PSM to show presentation materials of what is
             Patient Safety Process prior to      reviewed with all new team members. Interview
             participating on a RCA team?         team members, and/or review training records.

                                                  Charter Memo.pdf
                                                  RCATeamProcess.pdf
             Recommended; Priority A              JC- CAMH LD-03-05-01.pdf                                                                                                            END
             Root Cause Analysis Activities                                                                                                                                           START              2.1
2.1.4        Is RCA team membership               Review a minimum of 4 RCA's to determine if
             appropriate for the adverse event    appropriate personal participate based on
             being evaluated?                     relevance to RCA content. Team members'
                                                  titles/qualifications should be documented in the
                                                  RCA (SPOT database).
                                                  JC- CAMH LD-03-06-01.pdf
             Mandatory; Priority A                VHA Handbook 1050 01 PSI.pdf /A Page=6                                                                                              END
             Root Cause Analysis Activities                                                                                                                                           START              2.1
2.1.4.1      Does the PSM direct and advise the   Review a minimum of 4 RCA's and interview
             RCA/Aggregate Review teams as        selective team members and the PSM. RCA
             necessary to produce the desired     documentation should include defined root
             outcomes?                            cause statements, actions that address the root
                                                  causes, and outcome measures that measure
                                                  the actions.
             Mandatory; Priority A                                                                                                                                                    END
             Root Cause Analysis Activities                                                                                                                                           START              2.1
2.1.4.2      Does the PSM serve as an advisor     Review a minimum of 4 RCA's and interview
             and not as the leader, recorder or   team members and the PSM. Review RCA
             team member on RCAs?                 charter memos to determine PSM role in each
                                                  RCA reviewed.
                                                  Charter Memo.pdf
             Recommended; Priority B              USH memo PSM Job Jar (2).pdf /A Page=2                                                                                              END




          PS Prgm Mgt - 2                                                              PS Prgm Mgt - 2 - Version: 01.30.2009                                                                58 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                                                Not
                                                                                                                        Met         Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                      (1)          Met (2)    (3)   possible root causes
             Root Cause Analysis Activities                                                                                                                                                START              2.1
2.1.5        Is a follow-up and review process for   Show RCA updates, SPOT follow up table,
             RCA Actions and Outcome                 SPOT action dates, or other tracking methods.
             Measures being used within SPOT?        If action and outcome tracking is reviewed at
                                                     committee meetings, the meeting minutes may
                                                     qualify as proof as well.
                                                     JC- CAMH PI-02-01-01.pdf
             Mandatory; Priority A                   VHA Handbook 1050 01 PSI.pdf /A Page=14                                                                                               END
             Root Cause Analysis Activities                                                                                                                                                START              2.1
2.1.6        Are the RCA Actions completed with Review a minimum of 4 RCA's to evaluate time
             the specified time frame?          frames, have PSM show results and show
                                                tracking items to completion with dates.
                                                Changes may also be observed on the units in
                                                lieu of reviewing documentation.
             Recommended; Priority B                 JC- CAMH PI-03-01-01.pdf                                                                                                              END
             Root Cause Analysis Activities                                                                                                                                                START              2.1
2.1.6.1      Are Action completion and follow up Review a minimum of 4 RCA's looking for time
             dates reasonable?                   frames and action completion rates. In some
                                                 cases it is necessary to implement actions
                                                 immediately to prevent another occurrence.

             Recommended; Priority B                                                                                                                                                       END
             Root Cause Analysis Activities                                                                                                                                                START              2.1
2.1.7        Are Root Cause Contributing             Review 10 % of yearly (minimum of 4) RCA's for
             Factors in the RCA reports              context.
             consistently written to meet the five
             rules of causation?
                                                     CognitiveAids_TriageQuestions.pdf /A Page=12
             Recommended; Priority A                 VHA Handbook 1050 01 PSI.pdf                                                                                                          END
             Root Cause Analysis Activities                                                                                                                                                START              2.1
2.1.8        Do the RCA reports identify             Review a minimum of 4 RCA's for context.
             pertinent Root Cause Contributing       RC/CFs should be appropriate for RCA event.
             Factors?                                For instance, evaluate if the event descriptions
                                                     match the root cause statements developed
                                                     within the same RCA.
             Recommended; Priority A                 JC- CAMH PI-02-01-01.pdf                                                                                                              END




          PS Prgm Mgt - 2                                                                   PS Prgm Mgt - 2 - Version: 01.30.2009                                                                59 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                                             Not
                                                                                                                     Met         Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                    (1)          Met (2)    (3)   possible root causes
            Root Cause Analysis Activities                                                                                                                                              START              2.1
2.1.9       Do Actions in RCA reports target        Review 10% of yearly (minimum of 4) RCA's.
            and address the Root Cause              Also review Actions and assess if they are
            Contributing Factors?                   appropriate (e.g., if the root cause is about
                                                    training then the action(s) should be about
                                                    training as well to address the root cause).
            Recommended; Priority A                                                                                                                                                     END
            Root Cause Analysis Activities                                                                                                                                              START              2.1
2.1.10      Do the Outcome Measures in the      Review 10% of yearly (minimum of 4) RCA's.
            RCA reports effectively measure the Look for relation to Action and for numerators,
            Actions?                            denominators, and thresholds. The NCPS
                                                Facility Reports provided as feedback to each
                                                station often address outcome measures and
                                                show relevant examples and rewrites.

            Recommended; Priority A                 JC- CAMH LD-03-01-01.pdf                                                                                                            END
            Root Cause Analysis Activities                                                                                                                                              START              2.1
2.1.11      Are RCA reports completed within        Review 10% of yearly (minimum of 4) RCA's. If
            45-days of the facility becoming        reports are not competed, Actions cannot be
            aware that an RCA is required?          implemented. Reminder: Coroner dates or peer
                                                    review dates are the 'date aware' on RCAs.

            Mandatory; Priority A                   VHA Handbook 1050 01 PSI.pdf /A Page=13                                                                                             END
            Root Cause Analysis Activities                                                                                                                                              START              2.1
2.1.12      Are at least 4 individual RCAs being    The minimum requirement guidance was set
            completed each fiscal year in           forth in December 2006 by NCPS that each
            addition to the required 4              facility will complete a minimum of 4 individual
            Aggregated Reviews? Note: Zero          RCAs per year (exception: 1/1/07 - 9/30/07 only
            event Aggregated Reviews do not         3 are due.)
            count towards the minimum number
            of reviews. Additional individual
            RCAs or Wild Card Aggregated
            Reviews must be completed to
            reach the required level of 8 reviews
            per year.
            Mandatory; Priority A                   VHA Handbook 1050 01 PSI.pdf /A Page=16                                                                                             END




         PS Prgm Mgt - 2                                                                 PS Prgm Mgt - 2 - Version: 01.30.2009                                                                60 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                                          Not
                                                                                                                  Met         Partially   Met   If score other than 'met' what are
           Question:                             Rationale/Assessment Methods:                                    (1)          Met (2)    (3)   possible root causes
           Patient Safety Reporting System                                                                                                                                           START              2.2
2.2.1      Has the Patient Safety Reporting      Confirm that the PSRS program been
           System (PSRS) program been            communicated adequately, such as with all new
           instituted at the facility?           employees, and regularly there after. Inquire if
                                                 forms are provided in the facility where clinicians
                                                 will use and see them such as lounges and
                                                 office areas.
           Recommended; Priority B               NASA_VA_agree.pdf                                                                                                                   END
           General Programmatic Functions                                                                                                                                            START              2.3
2.3.1      Does the PSM collaborate with other   Interview Engineering, Safety/IH, and/or
           entities, such as Biomedical          Infection Control. Documentation should be
           Engineering staff, Occupational       shown such as JCAHO projects, and
           Safety Officer and/or Industrial      participation of these disciplines on RCA and
           Hygienist, & Infection Control?       HFMEA teams.
           Recommended; Priority A               USH memo PSM Job Jar (2).pdf                                                                                                        END
           General Programmatic Functions                                                                                                                                            START              2.3
2.3.2      Does the patient safety information   Review committee structure to determine if
           discussed in committee meetings       adequate information is flowing up through the
           reach top management for their        organization (such committees as EOC, QI, PS,
           consideration and action?             etc.). Have PSM show how action and outcome
                                                 measure tracking is presented at committees. A
                                                 general idea of how patient safety issues are
                                                 channeled should be evident.

                                                 JC- CAMH PI-03-01-01.pdf
           Mandatory; Priority A                 VHA Handbook 1050 01 PSI.pdf /A Page=7                                                                                              END
           General Programmatic Functions                                                                                                                                            START              2.3
2.3.3      Is the PSM involved in the Patient    Show examples of Alerts/Advisories from facility,
           Safety Alerts/Advisories process,     and documentation from tracking. Interview
           including tracking issues to          PSM. (Note: PSMs should not be involved in the
           resolution?                           Recall process)
           Recommended; Priority A                                                                                                                                                   END
           General Programmatic Functions                                                                                                                                            START              2.3
2.3.4      Are Patient Safety Program            Check documentation from town meeting
           successes publicized within the       agenda/minutes, postings, newsletters, e-mails,
           facility?                             or other.
           Recommended; Priority B                                                                                                                                                   END




        PS Prgm Mgt - 2                                                               PS Prgm Mgt - 2 - Version: 01.30.2009                                                                61 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                                               Not
                                                                                                                    Met        Partially       Met   If score other than 'met' what are
           Question:                           Rationale/Assessment Methods:                                        (1)         Met (2)        (3)   possible root causes
           General Programmatic Functions                                                                                                                                                 START              2.3
2.3.5      Is the topic of Patient Safety      Verify NEO process and materials. Criteria that
           covered in New Employee             should be covered is: background information
           Orientation?                        on patient safety (presentations such as 'Why
                                               Bother?' and 'Beyond Blame'), existence of
                                               NCPS, employee's responsibilities for patient
                                               safety (such as reporting and training), overview
                                               of RCA process, PSRS, etc.

                                               WhyBother.ppt
                                               http://vaww.ncps.med.va.gov/education.html#neo http://vaww.ncps.med.va.gov/education.html#neo
           Recommended; Priority A             JC- CAMH HR-01-04-01.pdf                                                                                                                   END
           General Programmatic Functions                                                                                                                                                 START              2.3
2.3.6      Is continuing education being       Review training methods used. Not all
           provided for employees on Patient   employees will require the same level of
           Safety topics?                      continuing education on Patient Safety. Review
                                               examples from the past 12 months and
                                               determine if training was proved based on the
                                               assessed needs.
           Mandatory; Priority A               JC- CAMH HR-01-05-03.pdf                                                                                                                   END
           General Programmatic Functions                                                                                                                                                 START              2.3
2.3.7      Does the PSM consult with experts   Intervention with, NCPS, JCAHO, ASRAM,
           within or outside the VA when       ASHE, ISMP, ECRI, IHI, etc. The referencing of
           needed?                             written resources as well as telephone contact
                                               is appropriate.
           Recommended; Priority C             USH memo PSM Job Jar (2).pdf                                                                                                               END
           General Programmatic Functions                                                                                                                                                 START              2.3
2.3.8      Is at least one HFMEA (or proactive PSM should initiate evaluations and/or advise
           risk analysis) been completed for    personnel involved with the evaluations.
           each JCAHO accredited program or Assessor should review completed reports.
           has a single analysis been done that
           covers all programs?

                                               HFMEA.pdf
                                               NCPS HFMEA Critique Sheet.pdf
           Mandatory; Priority A               JC- CAMH LD-04-04-05.pdf                                                                                                                   END




        PS Prgm Mgt - 2                                                                PS Prgm Mgt - 2 - Version: 01.30.2009                                                                    62 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                                            Not
                                                                                                                    Met         Partially   Met   If score other than 'met' what are
           Question:                               Rationale/Assessment Methods:                                    (1)          Met (2)    (3)   possible root causes
           General Programmatic Functions                                                                                                                                              START              2.3
2.3.9      Does a system exist, and is it used,    Prompt feedback to those reporting adverse
           to give feedback to staff that report   events has been credited in other reporting
           adverse event and close call            systems with being one of the cornerstones that
           incidents that result in an RCA?        establishes trust in the system. It demonstrates
                                                   the seriousness and

                                                   commitment on the part of the organization to
                                                   the importance of the reporting effort. Reporters
                                                   are to be made acutely aware that their effort of
                                                   reporting was not just a paperwork drill.




                                                   Verify via feedback documentation and interview
                                                   facility personnel. It is required to give feedback
                                                   to employees who report events which become
                                                   RCAs (of the actions and outcome measures).
                                                   However, other feedback of all events reported
                                                   (safety reports and aggregate log entries) are
                                                   helpful as well when communicated in facility
                                                   publications (i.e., web or newsletters) or when
                                                   given in a report to each Service Location as an
                                                   overall analysis.


           Mandatory; Priority A                   VHA Handbook 1050 01 PSI.pdf /A Page=11                                                                                             END




        PS Prgm Mgt - 2                                                                 PS Prgm Mgt - 2 - Version: 01.30.2009                                                                63 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          64 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          65 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          66 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          67 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          68 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          69 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          70 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          71 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          72 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          73 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          74 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          75 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          76 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          77 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          78 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          79 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          80 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          81 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          82 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
         Question:                   Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          83 of 1656
                                             NCPS Patient Safety Assessment Tool

                                                          Part I Adminstrative
PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
                                                                                                                 Not
                                                                                         Met         Partially   Met   If score other than 'met' what are
           Question:                 Rationale/Assessment Methods:                       (1)          Met (2)    (3)   possible root causes


     101




      PS Prgm Mgt - 2                                        PS Prgm Mgt - 2 - Version: 01.30.2009                                                          84 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative


                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




PS Prgm Mgt - 2             PS Prgm Mgt - 2 - Version: 01.30.2009   85 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative


                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




PS Prgm Mgt - 2             PS Prgm Mgt - 2 - Version: 01.30.2009   86 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative


                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




PS Prgm Mgt - 2             PS Prgm Mgt - 2 - Version: 01.30.2009   87 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative


                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




                          Root Cause Analysis Activities




PS Prgm Mgt - 2             PS Prgm Mgt - 2 - Version: 01.30.2009   88 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative


                          Patient Safety Reporting System




                          General Programmatic Functions




                          General Programmatic Functions




                          General Programmatic Functions




                          General Programmatic Functions




PS Prgm Mgt - 2             PS Prgm Mgt - 2 - Version: 01.30.2009   89 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative


                          General Programmatic Functions




                          General Programmatic Functions




                          General Programmatic Functions




                          General Programmatic Functions




PS Prgm Mgt - 2             PS Prgm Mgt - 2 - Version: 01.30.2009   90 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative


                          General Programmatic Functions




PS Prgm Mgt - 2             PS Prgm Mgt - 2 - Version: 01.30.2009   91 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   92 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   93 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   94 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   95 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   96 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   97 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   98 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   99 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   100 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   101 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   102 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   103 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   104 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   105 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   106 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   107 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   108 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   109 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   110 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   111 of 1656
                  NCPS Patient Safety Assessment Tool

                         Part I Adminstrative




PS Prgm Mgt - 2            PS Prgm Mgt - 2 - Version: 01.30.2009   112 of 1656
                                                      NCPS Patient Safety Assessment Tool

                                                                   Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                     Not
                                                                                                  Met    Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                       (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                           START            3.9
3.9.1       Goal 1: Improve the Accuracy of
            Patient Identification
            HOSP, LTC, BHC, HC, AMC & Lab                                                                                                                       END




        JC - 3                                                            JC - 3 - Version: 01.30.2009                                                             113 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                     Not
                                                                                                                  Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                     (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                         START            3.9
3.9.1.1       NPSG.01.01.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              Use at least two patient identifiers
              when providing care, treatment, and 1) Prior to any specimen collection, medication
              services.                                 administration, transfusion, or treatment, the
                                                        hospital actively involves the patient and, as
                                                        needed, the family in the identification and
                                                        matching process. When active patient
              Wrong-patient errors occur in             involvement is not possible or the patient’s
              virtually all stages of diagnosis and reliability is in question, the hospital will
              treatment. The intent for this goal is designate the caregiver responsible for identity
              two-fold: first, to reliably identify the verification.
              individual as the person for whom
              the service or treatment is intended; Note: The involvement of a single caregiver is
              second, to match the service or           acceptable as long as the other components of
              treatment to that individual.             patient identification are satisfied.




                                                     2) Two patient identifiers are used when
                                                     administering medications, blood, or blood
                                                     components.




                                                     3) Two patient identifiers are used when
                                                     collecting blood samples and other specimens
                                                     for clinical testing.


                                                     2009 NPSGs Chart TIPS (2).pdf
                                                     The Joint Commission NPSG.01.01.01
              HOSP, LTC, BHC, HC, AMC & Lab          TIPS Jan Feb 09                                                                                                            END




          JC - 3                                                                          JC - 3 - Version: 01.30.2009                                                             114 of 1656
                                                                        NCPS Patient Safety Assessment Tool

                                                                                            Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                                 Not
                                                                                                                              Met    Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                                                   (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                                       START
3.9.1.1     (continued)... NPSG.01.01.01      ...(continued) other specimens are labeled in the
(continued)                                   presence of the patient.


              Use at least two patient identifiers
              when providing care, treatment, and
              services.



              Wrong-patient errors occur in
              virtually all stages of diagnosis and
              treatment. The intent for this goal is
              two-fold: first, to reliably identify the
              individual as the person for whom
              the service or treatment is intended;
              second, to match the service or
              treatment to that individual.

                                                          2009 NPSGs Chart TIPS (2).pdf
                                                          The Joint Commission NPSG.01.01.01
              HOSP, LTC, BHC, HC, AMC & Lab               TIPS Jan Feb 09                                                                                                                   END
              The Joint Commission Patient Safety Goals                                                                                                                                     START            3.9
3.9.1.2       NPSG.01.02.01                     This standard comes under the Universal
                                                Protocal for Hospitals and Ambulatory Care
                                                Accrediation Programs.

              Conduct a verification process
              before starting invasive/surgical
              procedures.                                 Elements of Performace for other Accredication
                                                          Programs unavailable in PSAT.
                                                          2009 NPSGs Chart TIPS (2).pdf
              HOSP & AMC                                  TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




          JC - 3                                                                                      JC - 3 - Version: 01.30.2009                                                             115 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                            Not
                                                                                                                         Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                            (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                                START            3.9
3.9.1.3       NPSG.01.03.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              Eliminate transfusion errors related
              to patient misidentification.          1) Before initiating a blood or blood component
                                                     transfusion, the patient is objectively matched to
                                                     the blood or blood component during a two-
                                                     person bedside or chair-side verification
                                                     process. At least two unique identifiers are used
                                                     in the process, and it is conducted after the
                                                     blood or blood component that matches the
                                                     order has been issued or dispensed. Note: If
                                                     two individuals are not available, an automated
                                                     identification technology (for example, bar
                                                     coding) may be used in place of one of the
                                                     individuals.




                                                     2) When using a two-person bedside or chair-
                                                     side verification process, one individual
                                                     conducting the identification verification must be
                                                     the qualified transfusionist who will administer
                                                     the blood or blood component to the patient




                                                     3) When using a two-person bedside or chair-
                                                     side verification process, the second individual
                                                     conducting the identification verification must be
                                                     qualified to participate in the process.
                                                     2009 NPSGs Chart TIPS (2).pdf
                                                     JC- NPSG-01-03-01.pdf
              HOSP & AMC                             TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




          JC - 3                                                                                 JC - 3 - Version: 01.30.2009                                                             116 of 1656
                                                        NCPS Patient Safety Assessment Tool

                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                        Not
                                                                                                     Met    Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                       (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                              START            3.9
3.9.2       Goal 2: Improve the Effectiveness of
            Communication Among Caregivers

            HOSP, LTC, BHC, HC, AMC & LAB                                                                                                                          END




        JC - 3                                                               JC - 3 - Version: 01.30.2009                                                             117 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                             Not
                                                                                                                          Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                             (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                                 START            3.9
3.9.2.1       NPSG.02.01.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              For verbal or telephone orders or for
              telephone reporting of critical test    1 The individual receiving the information writes
              results, the individual giving the      down the complete order or test result or enters
              order or test result verifies the       it into a computer.
              complete order or test result by
              having the person receiving the
              information record and "read back"
              the complete order or test result.      2 The individual receiving the information reads
                                                      back the complete order or test result.


              Ineffective communication is the
              most frequently cited root cause for    3 The hospital defines the acceptable length of
              sentinel events. Effective              time for reporting the results of routine tests with
              communication that is timely,           critical abnormal values or findings.
              accurate, complete, unambiguous,
              and understood by the recipient
              reduces error and results in
              improved patient safety.                4 The hospital defines the acceptable length of
                                                      time between the availability of critical tests and
                                                      critical results and values and receipt by the
                                                      responsible licensed caregiver.




                                                      3 The individual who gave the order or test
                                                      2009 NPSGs Chart TIPS (2).pdf
                                                      JC- NPSG-02-01-01.pdf
              HOSP, LTC, BHC, HC, AMC & LAB           TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




          JC - 3                                                                                  JC - 3 - Version: 01.30.2009                                                             118 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                    Not
                                                                                                                 Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                    (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                        START            3.9
3.9.2.2       NPSG.02.02.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              There is a standardized list of
              abbreviations, acronyms, symbols,     1 The hospital develops a standardized list of
              and dose designations that are not    abbreviations, acronyms, symbols, and dose
              to be used throughout the hospital.   designations that are not to be used throughout
                                                    the hospital.




                                                    2 The current list of abbreviations, acronyms,
                                                    symbols, and dose designations not to be used
                                                    includes the following:

                                                    - U,u

                                                    - IU

                                                    - Q.D., QD, q.d., qd

                                                    - Q.O.D., QOD, q.o.d, qod

                                                    - Trailing zero (X.0 mg)

                                                    - Lack of leading zero (.X mg)

                                                    - MS

                                                    - MSO4
                                                    2009 NPSGs Chart TIPS (2).pdf
                                                    The Joint Commission NPSG.02.02.01
              HOSP, LTC, BHC, HC, AMC & LAB         TIPS Jan Feb 09                                                                                                            END




          JC - 3                                                                         JC - 3 - Version: 01.30.2009                                                             119 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                  Not
                                                                                                               Met    Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                                    (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                        START
3.9.2.2     (continued)... NPSG.02.02.01      ...(continued) entered as free text into a
(continued)                                   computer.


            There is a standardized list of
            abbreviations, acronyms, symbols,     4 The hospital does not include any
            and dose designations that are not    abbreviations, acronyms, symbols, and dose
            to be used throughout the hospital.   designations identified as not to be used on
                                                  preprinted forms.
                                                  2009 NPSGs Chart TIPS (2).pdf
                                                  The Joint Commission NPSG.02.02.01
            HOSP, LTC, BHC, HC, AMC & LAB         TIPS Jan Feb 09                                                                                                            END




        JC - 3                                                                         JC - 3 - Version: 01.30.2009                                                             120 of 1656
                                                                     NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                        Not
                                                                                                                     Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                        (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                            START            3.9
3.9.2.3       NPSG.02.03.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              The hospital measures, assesses,
              and, if needed, takes action to           1 The hospital defines critical tests and critical
              improve the timeliness of reporting       results and values.
              and the timeliness of receipt of
              critical tests and critical results and
              values by the responsible licensed
              caregiver.                                2 The hospital defines the acceptable length of
                                                        time between the ordering of critical tests and
                                                        reporting the results of these tests, whether
                                                        normal or abnormal.




                                                        3 The hospital defines the acceptable length of
                                                        time for reporting the results of routine tests with
                                                        critical abnormal values or findings.




                                                        4 The hospital defines the acceptable length of
                                                        time between the availability of critical tests and
                                                        critical results and values and receipt by the
                                                        responsible licensed caregiver.




                                                        5 The hospital collects data on the timeliness of
                                                        reporting critical test results and critical results
                                                        2009 NPSGs Chart TIPS (2).pdf
                                                        The Joint Commission NPSG.02.03.01
              HOSP, LTC, BHC, HC, AMC & Lab             TIPS Jan Feb 09                                                                                                            END




          JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             121 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                     Not
                                                                                                                  Met    Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                           START
3.9.2.3     (continued)... NPSG.02.03.01            ...(continued) action to improve the timeliness of
(continued)                                         reporting critical test results and critical results
                                                    and values from routine tests and measures the
                                                    effectiveness of those actions.
            The hospital measures, assesses,
            and, if needed, takes action to
            improve the timeliness of reporting
            and the timeliness of receipt of
            critical tests and critical results and
            values by the responsible licensed
            caregiver.
                                                     2009 NPSGs Chart TIPS (2).pdf
                                                     The Joint Commission NPSG.02.03.01
             HOSP, LTC, BHC, HC, AMC & Lab           TIPS Jan Feb 09                                                                                                            END




         JC - 3                                                                           JC - 3 - Version: 01.30.2009                                                             122 of 1656
                                                                     NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                        Not
                                                                                                                     Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                        (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                            START            3.9
3.9.2.4       NPSG.02.05.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              The hospital implements a
              standardized approach to hand-off         1 The hospital’s process for effective hand-off
              communications, including an              communication includes the following:
              opportunity to ask and respond to         Interactive communication that allows for the
              questions.                                opportunity for questioning between the giver
                                                        and receiver of patient information.


              Health care has numerous types of
              patient hand-offs, including, but not     2 The hospital's process for effective hand-off
              limited to, nursing shift changes;        communication includes the following: Up-to-
              physician transfer of complete            date information regarding the patient’s
              responsibility for a patient; physician   condition, care, treatment, medications,
              transfer of on-call responsibility;       services, and any recent or anticipated changes.
              acceptance of temporary                   (See also NPSG.08.01.01, EP 4)
              responsibility for staff leaving the
              unit for a short time;
              anesthesiologist report to post-
              anesthesia recovery room nurse;           3 The hospital’s process for effective hand-off
              nursing and physician hand-off from       communication includes the following: A method
              the emergency department to               to verify the received information, including
              inpatient units, different hospitals,     repeat-back or read-back techniques.
              nursing homes, and home health
              care; and critical laboratory and
              radiology results sent to physician
              offices. The primary objective of a       4 The hospital’s process for effective hand-off
              hand-off is to provide accurate           communication includes the following: An
              information about a patient's care,       opportunity for the receiver of the hand-off
              treatment, and services; current          2009 NPSGs Chart TIPS (2).pdf
                                                        The Joint Commission NPSG.02.05.01
              HOSP, LTC, BHC, HC, AMC & LAB             TIPS Jan Feb 09                                                                                                            END




          JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             123 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                      Not
                                                                                                                   Met    Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                                        (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                            START
3.9.2.4     (continued)... NPSG.02.05.01      ...(continued) during hand-offs are limited to
(continued)                                   minimize the possibility that information fails to
                                              be conveyed or is forgotten.

            The hospital implements a
            standardized approach to hand-off
            communications, including an
            opportunity to ask and respond to
            questions.



            Health care has numerous types of
            patient hand-offs, including, but not
            limited to, nursing shift changes;
            physician transfer of complete
            responsibility for a patient; physician
            transfer of on-call responsibility;
            acceptance of temporary
            responsibility for staff leaving the
            unit for a short time;
            anesthesiologist report to post-
            anesthesia recovery room nurse;
            nursing and physician hand-off from
            the emergency department to
            inpatient units, different hospitals,
            nursing homes, and home health
            care; and critical laboratory and
            radiology results sent to physician
            offices. The primary objective of a
            hand-off is to provide accurate
            information about a patient's care,
            treatment, and services; current          2009 NPSGs Chart TIPS (2).pdf
                                                      The Joint Commission NPSG.02.05.01
            HOSP, LTC, BHC, HC, AMC & LAB             TIPS Jan Feb 09                                                                                                            END




        JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             124 of 1656
                                                                     NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                              Not
                                                                                                                           Met    Partially   Met   If score other than 'met' what are
              Question:                           Rationale/Assessment Methods:                                            (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                                  START            3.9
3.9.3         Goal 3: Improve the Safety of Using
              Medication
              HOSP, LTC, BHC, HC & AMC                                                                                                                                                   END
              The Joint Commission Patient Safety Goals                                                                                                                                  START            3.9
3.9.3.1       NPSG.03.03.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              The hospital identifies and, at a
              minimum, annually reviews a list of      1 The hospital identifies a list of look-
              look-alike/sound-alike medications       alike/sound-alike medications used by the
              used by the hospital and takes           hospital. The list includes a minimum of 10 look-
              action to prevent errors involving the   alike/sound-alike medication combinations
              interchange of these medications.        selected from the tables of look-alike/sound-
                                                       alike medications posted on The Joint
                                                       Commission Web site at
                                                       http://www.jointcommission.org.




                                                       2 The hospital reviews the list of look-
                                                       alike/sound-alike medications at least annually.




                                                       3 The hospital takes action to prevent errors
                                                       involving the interchange of the medications on
                                                       the list of look-alike/sound-alike medications.


                                                       2009 NPSGs Chart TIPS (2).pdf
                                                       JC- NPSG-03-03-01.pdf
              HOSP, LTC, BHC, HC & AMC                 TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




          JC - 3                                                                                   JC - 3 - Version: 01.30.2009                                                             125 of 1656
                                                                     NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                        Not
                                                                                                                     Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                        (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                            START            3.9
3.9.3.2       NPSG.03.04.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              Label all medications, medication
              containers (for example, syringes,        1 Medications and solutions both on and off the
              medicine cups, basins), or other          sterile field are labeled even if there is only one
              solutions on and off the sterile field.   medication being used.



              Medications or other solutions in         2 Labeling occurs when any medication or
              unlabeled containers are                  solution is transferred from the original
              unidentifiable. Errors, sometimes         packaging to another container.
              tragic, have resulted from
              medications and other solutions
              removed from their original
              containers and placed into                3 Medication or solution labels include the
              unlabeled containers. This unsafe         medication name, strength, amount (if not
              practice neglects basic principles of     apparent from the container), expiration date
              medication management safety yet          when not used within 24 hours, and expiration
              has been routine in many                  time when expiration occurs in less than 24
              organizations.                            hours.



              The labeling of all medications,          4 All medication or solution labels are verified
              medication containers, and                both verbally and visually by two qualified
              solutions is a risk reduction activity    individuals whenever the person preparing the
              consistent with safe medication           medication or solution is not the person who will
              practices. This practice addresses a      be administering it.
              recognized risk point in the safe
              administration of medications in          2009 NPSGs Chart TIPS (2).pdf
                                                        The Joint Commission NPSG.03.04.01
              HOSP & AMC                                TIPS Jan Feb 09                                                                                                            END




          JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             126 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                      Not
                                                                                                                   Met    Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                                        (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                            START
3.9.3.2     (continued)... NPSG.03.04.01      ...(continued) reference in the perioperative or
(continued)                                   procedural area until the conclusion of the
                                              procedure.

            Label all medications, medication
            containers (for example, syringes,
            medicine cups, basins), or other           8 All labeled containers on the sterile field are
            solutions on and off the sterile field.   discarded at the conclusion of the procedure.



            Medications or other solutions in          9 At shift change or break relief, all
            unlabeled containers are                  medications and solutions both on and off the
            unidentifiable. Errors, sometimes         sterile field and their labels are reviewed by
            tragic, have resulted from                entering and exiting personnel.
            medications and other solutions
            removed from their original
            containers and placed into
            unlabeled containers. This unsafe
            practice neglects basic principles of
            medication management safety yet
            has been routine in many
            organizations.



            The labeling of all medications,
            medication containers, and
            solutions is a risk reduction activity
            consistent with safe medication
            practices. This practice addresses a
            recognized risk point in the safe
            administration of medications in          2009 NPSGs Chart TIPS (2).pdf
                                                      The Joint Commission NPSG.03.04.01
            HOSP & AMC                                TIPS Jan Feb 09                                                                                                            END




        JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             127 of 1656
                                                                     NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                        Not
                                                                                                                     Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                        (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                            START            3.9
3.9.3.3       NPSG.03.05.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              Reduce the likelihood of patient
              harm associated with the use of           1 The hospital implements a defined
              anticoagulant therapy.                    anticoagulation management program to
                                                        individualize the care provided to each patient
                                                        receiving anticoagulant therapy.

              Note: This requirement applies only
              to hospitals that provide
              anticoagulant therapy and/or long-        2 To reduce compounding and labeling errors,
              term anticoagulation prophylaxis (for     the hospital uses only oral unit dose products,
              example, atrial fibrillation) where the   pre-filled syringes, or pre-mixed infusion bags
              clinical expectation is that the          when these types of products are available.
              patient’s laboratory values for           Note: For pediatric patients, pre-loaded syringe
              coagulation will remain outside           products should only be used if specifically
              normal values. This requirement           designed for children.
              does not apply to routine situations
              in which short-term prophylactic
              anticoagulation is used for venous
              thrombo-embolism prevention (for          3 The hospital uses approved protocols for the
              example, related to procedures or         initiation and maintenance of anticoagulant
              hospitalization) and the clinical         therapy appropriate to the medication used, to
              expectation is that the patient’s         the condition being treated, and to the potential
              laboratory values for coagulation will    for medication interactions.
              remain within, or close to, normal
              values.

                                                        4 For patients starting on warfarin, a baseline
                                                        International Normalized Ratio (INR) is
              Anticoagulation therapy poses risks       2009 NPSGs Chart TIPS (2).pdf
                                                        The Joint Commission NPSG.03.05.01
              HOSP, LTC, HC & AMC                       TIPS Jan Feb 09                                                                                                            END




          JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             128 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                   Not
                                                                                                                Met    Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                               (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                         START
3.9.3.3     (continued)... NPSG.03.05.01            ...(continued) services are provided by the
(continued)                                         hospital, the service is notified of all patients
                                                    receiving warfarin and responds according to its
                                                    established food/medication interaction program.
            Reduce the likelihood of patient
            harm associated with the use of
            anticoagulant therapy.
                                                    6 When heparin is administered intravenously
                                                    and continuously, the hospital uses
                                                    programmable infusion pumps in order to
            Note: This requirement applies only provide consistent and accurate dosing.
            to hospitals that provide
            anticoagulant therapy and/or long-
            term anticoagulation prophylaxis (for
            example, atrial fibrillation) where the 7 The hospital has a written policy that
            clinical expectation is that the        addresses baseline and ongoing laboratory
            patient’s laboratory values for         tests that are required for heparin and low
            coagulation will remain outside         molecular weight heparin therapies.
            normal values. This requirement
            does not apply to routine situations
            in which short-term prophylactic
            anticoagulation is used for venous      8 The hospital provides education regarding
            thrombo-embolism prevention (for        anticoagulant therapy to prescribers, staff,
            example, related to procedures or       patients, and families. Note: Patient/family
            hospitalization) and the clinical       education includes the importance of follow-up
            expectation is that the patient’s       monitoring, compliance issues, dietary
            laboratory values for coagulation will restrictions, and potential for adverse drug
            remain within, or close to, normal      reactions and interactions.
            values.



                                                   9 The hospital evaluates its anticoagulation
             Anticoagulation therapy poses risks   2009 NPSGs Chart TIPS (2).pdf
                                                   The Joint Commission NPSG.03.05.01
             HOSP, LTC, HC & AMC                   TIPS Jan Feb 09                                                                                                            END




         JC - 3                                                                         JC - 3 - Version: 01.30.2009                                                             129 of 1656
                                                           NCPS Patient Safety Assessment Tool

                                                                          Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                             Not
                                                                                                          Met    Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                            (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                   START            3.9
3.9.4       Goal 4: RETIRED - As of 2005 this    a) Use a pre-op verification process, such as a
            goal is now surveyed under the       checklist, to confirm appropriate documents are
            Universal Protocol: Eliminate wrong- available.
            site, wrong-patient, wrong-
            procedure.                           b) Implement a process to mark the surgical
                                                 site and involve the patient in the process.
            RETIRED                                                                                                                                                     END
            The Joint Commission Patient Safety Goals                                                                                                                   START            3.9
3.9.5       Goal 5: RETIRED - improve the     Ensure free-flow protection on all general-use
            safety of using infusion pumps.   and PCA (patient controlled analgesia)
                                              intravenous infusion pumps used in the
                                              organization
            RETIRED                                                                                                                                                     END
            The Joint Commission Patient Safety Goals                                                                                                                   START            3.9
3.9.6       Goal 6: RETIRED - As of 2005 this a) Implement regular preventive maintenance
            goal is now surveyed under EC     and testing of alarm systems.
            standards: Improve the
            effectiveness of clinical alarm   b) Assure that alarms are activated with
            systems.                          appropriate settings and are sufficiently audible
                                              with respect to distances and competing noise
                                              within the unit.
            RETIRED                                                                                                                                                     END
            The Joint Commission Patient Safety Goals                                                                                                                   START            3.9
3.9.7       Goal 7: Reduce the Risk of Health
            Care-Associated Infections
            HOSP, LTC, BHC, HC, AMC & LAB                                                                                                                               END




        JC - 3                                                                    JC - 3 - Version: 01.30.2009                                                             130 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                     Not
                                                                                                                  Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                     (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                         START            3.9
3.9.7.1       NPSG.07.01.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              Comply with current World Health
              Organization (WHO) hand hygiene         1 The hospital complies with current World
              guidelines or Centers for Disease       Health Organization (WHO) or Centers for
              Control and Prevention (CDC) hand       Disease Control and Prevention (CDC) hand
              hygiene guidelines.                     hygiene guidelines. Note: Hospitals are required
                                                      to comply with 1A, 1B, and 1C of the WHO or
                                                      CDC guidelines.

              Compliance with the WHO or CDC
              hand hygiene guidelines will reduce
              the transmission by staff to patients
              of infectious agents, thereby
              decreasing the incidence of health
              care–associated infections.

                                                      CDC Hand Hygiene.pdf
                                                      2009 NPSGs Chart TIPS (2).pdf
              HOSP, LTC, BHC, HC, AMC & LAB           JC- NPSG-07-01-01.pdf                                                                                                     END




          JC - 3                                                                          JC - 3 - Version: 01.30.2009                                                             131 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                          Not
                                                                                                                       Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                          (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                              START            3.9
3.9.7.2       NPSG.07.02.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              Manage as sentinel events all
              identified cases of unanticipated    1 The hospital manages all identified cases of
              death or major permanent loss of     unanticipated death or major permanent loss of
              function related to a health         function associated with a health
              care–associated infection.           care–associated infection as sentinel events
                                                   (that is, the hospital conducts a root cause
                                                   analysis).

              A significant percentage of patients
              who unexpectedly die or suffer
              major permanent loss of function     2 The root cause analysis addresses the
              have health care–associated          management of the patient before and after the
              infections. These unanticipated      identification of infection.
              deaths and injuries meet the
              definition of a sentinel event and,
              therefore, are required to undergo a
              root cause analysis. The root cause
              analysis should attempt to answer
              the following questions: Why did the
              patient acquire an infection? Why
              did the patient die or suffer
              permanent loss of function?

                                                   2009 NPSGs Chart TIPS (2).pdf
                                                   JC- NPSG-07-02-01.pdf
              HOSP, LTC, BHC, HC, AMC & LAB        TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




          JC - 3                                                                               JC - 3 - Version: 01.30.2009                                                             132 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                     Not
                                                                                                                  Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                     (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                         START            3.9
3.9.7.3       NPSG.07.03.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              Implement evidence-based
              practices to prevent health            1 As of April 1, 2009, the hospital’s leadership
              care–associated infections due to      has assigned responsibility for oversight and
              multidrug-resistant organisms in       coordination of the development, testing, and
              acute care hospitals.                  implementation of NPSG.07.03.01.



              Note 1: This requirement applies to,   2 As of July 1, 2009, an implementation work
              but is not limited to,                 plan is in place that identifies adequate
              epidemiologically important            resources, assigned accountabilities, and a time
              organisms such as methicillin-         line for full implementation of NPSG.07.03.01 by
              resistant Staphylococcus aureus        January 1, 2010.
              (MRSA), Clostridium difficile (CDI),
              vancomycin-resistant Enterococci
              (VRE), and multiple drug-resistant
              gram negative bacteria.                3 As of October 1, 2009, pilot testing in at least
                                                     one clinical unit is under way, for the
                                                     requirements in NPSG.07.03.01.

              Note 2: This requirement has a one-
              year phase-in period that includes
              defined expectations for planning,    4 As of January 1, 2010, the elements of
              development, and testing              performance in NPSG.07.03.01 are fully
              (milestones) at three, six, and nine  implemented across the hospital.
              months in 2009, with the
              expectation of full implementation by
              January 1, 2010.
                                                     2009 NPSGs Chart TIPS (2).pdf
                                                     The Joint Commission NPSG 07.03.01
              HOSP                                   TIPS Jan Feb 09                                                                                                            END




          JC - 3                                                                          JC - 3 - Version: 01.30.2009                                                             133 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                    Not
                                                                                                                 Met    Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                                      (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                          START
3.9.7.3     (continued)... NPSG.07.03.01      ...(continued) health care–associated infections,
(continued)                                   multidrug-resistant organisms, and prevention
                                              strategies at hire and annually thereafter. Note:
                                              The education provided recognizes the diverse
            Implement evidence-based          roles of staff and licensed independent
            practices to prevent health       practitioners and is consistent with their roles
            care–associated infections due to within the hospital. (See also HR.01.05.03, EP 4)
            multidrug-resistant organisms in
            acute care hospitals.

                                                    7 As of January 1, 2010, the hospital educates
                                                    patients, and their families as needed, who are
            Note 1: This requirement applies to,    infected or colonized with a multidrug-resistant
            but is not limited to,                  organism about health care–associated infection
            epidemiologically important             strategies.
            organisms such as methicillin-
            resistant Staphylococcus aureus
            (MRSA), Clostridium difficile (CDI),
            vancomycin-resistant Enterococci        8 As of January 1, 2010, the hospital
            (VRE), and multiple drug-resistant      implements a surveillance program for multidrug-
            gram negative bacteria.                 resistant organisms based on the risk
                                                    assessment.


            Note 2: This requirement has a one-
            year phase-in period that includes      9 As of January 1, 2010, the hospital measures
            defined expectations for planning,      and monitors multidrug-resistant organism
            development, and testing                prevention processes and outcomes including
            (milestones) at three, six, and nine    the following:
            months in 2009, with the
            expectation of full implementation by   - Multidrug-resistant organism infection rates
            January 1, 2010.                        using evidence-based metrics
                                                    2009 NPSGs Chart TIPS (2).pdf
                                                    The Joint Commission NPSG 07.03.01
            HOSP                                    TIPS Jan Feb 09                                                                                                            END




        JC - 3                                                                           JC - 3 - Version: 01.30.2009                                                             134 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                     Not
                                                                                                                  Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                     (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                         START            3.9
3.9.7.4       NPSG.07.04.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              Implement best practices or
              evidence-based guidelines to           1 As of April 1, 2009, the hospital’s leadership
              prevent central line–associated        has assigned responsibility for oversight and
              bloodstream infections.                coordination of the development, testing, and
                                                     implementation of NPSG.07.04.01.


              Note 1: This requirement covers
              short- and long-term central venous    2 As of July 1, 2009, an implementation work
              catheters and peripherally inserted    plan is in place that identifies adequate
              central catheter (PICC) lines.         resources, assigned accountabilities, and a time
                                                     line for full implementation of NPSG.07.04.01 by
                                                     January 1, 2010.

              Note 2: This requirement has a one-
              year phase-in period that includes
              defined expectations for planning,     3 As of October 1, 2009, pilot testing in at least
              development, and testing               one clinical unit is under way for the
              (“milestones”) at three, six, and nine requirements in NPSG.07.04.01.
              months in 2009, with the
              expectation of full implementation by
              January 1, 2010.
                                                     4 As of January 1, 2010, the elements of
                                                     performance in NPSG.07.04.01 are fully
                                                     implemented across the hospital.



                                                     2009 NPSGs Chart TIPS (2).pdf
                                                     The Joint Commission NPSG.07.04.01
              HOSP, LTC, HC & AMC                    TIPS Jan Feb 09                                                                                                            END




          JC - 3                                                                          JC - 3 - Version: 01.30.2009                                                             135 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                  Not
                                                                                                               Met    Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                                    (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                        START
3.9.7.4     (continued)... NPSG.07.04.01      ...(continued) procedures is added to an
(continued)                                   individual’s job responsibilities.


            Implement best practices or
            evidence-based guidelines to          6 As of January 1, 2010, prior to insertion of a
            prevent central line–associated       central venous catheter, the hospital educates
            bloodstream infections.               patients and, as needed, their families about
                                                  central line–associated bloodstream infection
                                                  prevention.

            Note 1: This requirement covers
            short- and long-term central venous
            catheters and peripherally inserted    7 As of January 1, 2010, the hospital
            central catheter (PICC) lines.         implements policies and practices aimed at
                                                   reducing the risk of central line–associated
                                                   bloodstream infections that meet regulatory
                                                   requirements and are aligned with evidence-
            Note 2: This requirement has a one- based standards (for example, the Centers for
            year phase-in period that includes     Disease Control and Prevention (CDC) and/or
            defined expectations for planning,     professional organization guidelines)
            development, and testing
            (“milestones”) at three, six, and nine
            months in 2009, with the
            expectation of full implementation by 8 As of January 1, 2010, the hospital conducts
            January 1, 2010.                       periodic risk assessments for surgical site
                                                  infections, measures central line–associated
                                                  bloodstream infection rates, monitors
                                                  compliance with best practices or evidence-
                                                  based guidelines, and evaluates the
                                                  effectiveness of prevention efforts.
                                                  2009 NPSGs Chart TIPS (2).pdf
                                                  The Joint Commission NPSG.07.04.01
            HOSP, LTC, HC & AMC                   TIPS Jan Feb 09                                                                                                            END




        JC - 3                                                                         JC - 3 - Version: 01.30.2009                                                             136 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                       Not
                                                                                                                    Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                       (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                           START            3.9
3.9.7.5       NPSG.07.05.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              Implement best practices for
              preventing surgical site infections.     1 As of April 1, 2009, the hospital’s leadership
                                                       has assigned responsibility for oversight and
                                                       coordination of the development, testing, and
                                                       implementation of NPSG.07.05.01.
              Note: This requirement has a one-
              year phase-in period that includes
              defined expectations for planning,
              development, and testing                 2 As of July 1, 2009, an implementation work
              (“milestones”) at three, six, and nine   plan is in place that identifies adequate
              months in 2009, with the                 resources, assigned accountabilities, and a time
              expectation of full implementation by    line for full implementation of NPSG.07.05.01 by
              January 1, 2010.                         January 1, 2010.




                                                       3 As of October 1, 2009, pilot testing in at least
                                                       one clinical unit is under way, for the
                                                       requirements in NPSG.07.05.01.




                                                       4 As of January 1, 2010, the elements of
                                                       performance in NPSG.07.05.01 are fully
                                                       implemented across the hospital.



                                                       2009 NPSGs Chart TIPS (2).pdf
                                                       The Joint Commission NPSG.07.05.01
              HOSP & AMC                               TIPS Jan Feb 09                                                                                                            END




          JC - 3                                                                            JC - 3 - Version: 01.30.2009                                                             137 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                       Not
                                                                                                                    Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                       (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                           START
3.9.7.5       (continued)... NPSG.07.05.01      ...(continued) an individual’s job responsibilities.
(continued)



              Implement best practices for             6 As of January 1, 2010, prior to all surgical
              preventing surgical site infections.     procedures, the hospital educates patients, and
                                                       their families as needed, who are undergoing a
                                                       surgical procedure about surgical site infection
                                                       prevention.
              Note: This requirement has a one-
              year phase-in period that includes
              defined expectations for planning,
              development, and testing                 7 As of January 1, 2010, the hospital
              (“milestones”) at three, six, and nine   implements policies and practices aimed at
              months in 2009, with the                 reducing the risk of surgical site infections that
              expectation of full implementation by    meet regulatory requirements and are aligned
              January 1, 2010.                         with evidence-based standards (for example,
                                                       the Centers for Disease Control and Prevention
                                                       (CDC) and/or professional organization
                                                       guidelines). (See also UP.01.03.01, EP 5)




                                                       8 As of January 1, 2010, the hospital conducts
                                                       periodic risk assessments for surgical site
                                                       infections, selects surgical site infection
                                                       measures using best practices or evidence-
                                                       based guidelines, monitors compliance with best
                                                       practices or evidence-based guidelines, and
                                                       evaluates the effectiveness of prevention efforts.


                                                       2009 NPSGs Chart TIPS (2).pdf
                                                       The Joint Commission NPSG.07.05.01
              HOSP & AMC                               TIPS Jan Feb 09                                                                                                            END




         JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             138 of 1656
                                                          NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                   Not
                                                                                                                Met    Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                                     (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                         START            3.9
3.9.8       Goal 8: Accurately and Completely
            Reconcile Medication Across the
            Continuum of Care
                                            2009 NPSGs Chart TIPS (2).pdf
                                            TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




        JC - 3                                                                          JC - 3 - Version: 01.30.2009                                                             139 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                    Not
                                                                                                                 Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                    (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                        START            3.9
3.9.8.1       NPSG.08.01.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              A process exists for comparing the
              patient’s current medications with    1 At the time the patient enters the hospital or is
              those ordered for the patient while   admitted, a complete list of the medications the
              under the care of the hospital.       patient is taking at home (including dose, route,
                                                    and frequency) is created and documented. The
                                                    patient and, as needed, the family are involved
                                                    in creating this list.




                                                    2 The medications ordered for the patient while
                                                    under the care of the hospital are compared to
                                                    those on the list created at the time of entry to
                                                    the hospital or admission.




                                                    3 Any discrepancies (that is, omissions,
                                                    duplications, adjustments, deletions, additions)
                                                    are reconciled and documented while the
                                                    patient is under the care of the hospital.




                                                    4 When the patient’s care is transferred within
                                                    the hospital (for example, from the ICU to a
                                                    floor), the current provider(s) informs the
                                                    receiving provider(s) about the up-to-date
                                                    2009 NPSGs Chart TIPS (2).pdf
                                                    The Joint Commission NPSG.08.01.01
              HOSP, LTC, BHC, HC & AMC              TIPS Jan Feb 09                                                                                                            END




          JC - 3                                                                         JC - 3 - Version: 01.30.2009                                                             140 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                  Not
                                                                                                               Met    Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                                    (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                        START
3.9.8.1     (continued)... NPSG.08.01.01      ...(continued) patient’s medications is also an
(continued)                                   important component of all patient care hand-
                                              offs.

            A process exists for comparing the
            patient’s current medications with
            those ordered for the patient while
            under the care of the hospital.

                                                  2009 NPSGs Chart TIPS (2).pdf
                                                  The Joint Commission NPSG.08.01.01
            HOSP, LTC, BHC, HC & AMC              TIPS Jan Feb 09                                                                                                            END




        JC - 3                                                                         JC - 3 - Version: 01.30.2009                                                             141 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                             Not
                                                                                                                          Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                             (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                                 START            3.9
3.9.8.2       NPSG.08.02.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              When a patient is referred to or
              transferred from one hospital to        1 The patient’s most current reconciled
              another, the complete and               medication list is communicated to the next
              reconciled list of medications is       provider of service, either within or outside the
              communicated to the next provider       hospital. The communication between providers
              of service, and the communication is    is documented.
              documented. Alternatively, when a
              patient leaves the hospital’s care to
              go directly to his or her home, the
              complete and reconciled list of         2 At the time of transfer, the transferring
              medications is provided to the          hospital informs the next provider of service how
              patient’s known primary care            to obtain clarification on the list of reconciled
              provider, the original referring        medications.
              provider, or a known next provider of
              service.



              Note: When the next provider of
              service is unknown or when no
              known formal relationship is planned
              with a next provider, giving the
              patient and, as needed, the family
              the list of reconciled medications is
              sufficient.



              The accurate communication of a         2009 NPSGs Chart TIPS (2).pdf
                                                      JC- NPSG-08-02-01.pdf
              HOSP, LTC, BHC, HC & AMC                TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




          JC - 3                                                                                  JC - 3 - Version: 01.30.2009                                                             142 of 1656
                                                                     NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                              Not
                                                                                                                           Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                              (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                                  START            3.9
3.9.8.3       NPSG.08.03.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              When a patient leaves the hospital’s
              care, a complete and reconciled list     1 When the patient leaves the hospital’s care,
              of the patient’s medications is          the current list of reconciled medications is
              provided directly to the patient and,    provided and explained to the patient and, as
              as needed, the family, and the list is   needed, the family. This interaction is
              explained to the patient and/or          documented. Note: Patients and families are
              family.                                  reminded to discard old lists and to update any
                                                       records with all medication providers or retail
                                                       pharmacies.

              The accurate communication of the
              patient’s medication list to the
              patient and, as needed, the family,
              reduces the risk of transition-related
              adverse drug events. A thorough
              knowledge of the patient’s
              medications is essential for the
              patient’s primary care provider or
              next provider of service to manage
              the subsequent stages of care for
              the patient.
                                                       2009 NPSGs Chart TIPS (2).pdf
                                                       JC- NPSG-08-03-01.pdf
              HOSP, LTC, BHC, HC & AMC                 TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




          JC - 3                                                                                   JC - 3 - Version: 01.30.2009                                                             143 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                             Not
                                                                                                                          Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                             (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                                 START            3.9
3.9.8.4       NPSG.08.04.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              In settings where medications are
              used minimally, or prescribed for a     1 The hospital obtains and documents an
              short duration, modified medication     accurate list of the patient’s current medications
              reconciliation processes are            and known allergies in order to safely prescribe
              performed.                              any setting-specific medications (for example,
                                                      intravenous contrast media, local anesthesia,
                                                      antibiotics) and to assess for potential allergic or
                                                      adverse drug reactions.
              Note: This requirement does not
              apply to hospitals that do not
              administer medications. It may be
              important for health care               2 When only short-term medications (for
              organizations to know which types       example, a preprocedure medication or a short-
              of medications their patients are       term course of an antibiotic) will be prescribed
              taking because these medications        and no changes are made to the patient's
              could affect the care, treatment, and   current medication list, the patient and, as
              services provided.                      needed, the family are provided with a list
                                                      containing the short term medication additions
                                                      that the patient will continue after leaving the
                                                      hospital. Note: This list of new short term
                                                      medications is not considered to be part of the
                                                      original, known, and current medication list.
                                                      When patients leave these settings, a list of the
                                                      original, known, and current medications does
                                                      not need to be (continued)...


                                                      2009 NPSGs Chart TIPS (2).pdf
                                                      The Joint Commission NPSG.08.04.01
              HOSP, LTC, BHC, HC & AMC                TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




          JC - 3                                                                                  JC - 3 - Version: 01.30.2009                                                             144 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                          Not
                                                                                                                       Met    Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                        (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                                START
3.9.8.4     (continued)... NPSG.08.04.01          ...(continued) provided, unless the patient is
(continued)                                       assessed to be confused or unable to
                                                  comprehend adequately. In this case, the
                                                  patient’s family is provided both medication lists
            In settings where medications are     and the circumstances are documented.
            used minimally, or prescribed for a
            short duration, modified medication
            reconciliation processes are
            performed.                            3 In these settings, a complete, documented
                                                  medication reconciliation process is used when:
                                                  Any new long-term (chronic) medications are
                                                  prescribed.
            Note: This requirement does not
            apply to hospitals that do not
            administer medications. It may be
            important for health care             4 In these settings, a complete, documented
            organizations to know which types     medication reconciliation process is used when:
            of medications their patients are     There is a prescription change for any of the
            taking because these medications      patient’s current, known long-term medications.
            could affect the care, treatment, and
            services provided.

                                                   5 In these settings, a complete, documented
                                                   medication reconciliation process is used when:
                                                   The patient is required to be subsequently
                                                   admitted to an organization from these settings
                                                   for ongoing care.




                                                   6 When a complete, documented, medication
                                                   reconciliation is required in any of these
                                                   2009 NPSGs Chart TIPS (2).pdf
                                                   The Joint Commission NPSG.08.04.01
             HOSP, LTC, BHC, HC & AMC              TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




         JC - 3                                                                                JC - 3 - Version: 01.30.2009                                                             145 of 1656
                                                           NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                    Not
                                                                                                                 Met    Partially   Met   If score other than 'met' what are
            Question:                          Rationale/Assessment Methods:                                     (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                          START            3.9
3.9.9       Goal 9: Reduce the Risk of Patient
            Harm Resulting for Falls
                                             2009 NPSGs Chart TIPS (2).pdf
            HOSP, LTC & HC                   TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




        JC - 3                                                                           JC - 3 - Version: 01.30.2009                                                             146 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                          Not
                                                                                                                       Met    Partially   Met   If score other than 'met' what are
              Question:                         Rationale/Assessment Methods:                                          (1)     Met (2)    (3)   possible root causes
              The Joint Commission Patient Safety Goals                                                                                                                              START            3.9
3.9.9.1       NPSG.09.02.01                     Elements of Performance as doucumented for
                                                the Hospital Progam


              The hospital implements a fall
              reduction program that includes an   1 The hospital establishes a fall reduction
              evaluation of the effectiveness of   program.
              the program.


                                                   2 The fall reduction program includes an
                                                   evaluation appropriate to the patient population,
                                                   settings, and services provided.




                                                   3 The fall reduction program includes
                                                   interventions to reduce the patient’s fall risk
                                                   factors.




                                                   4 Staff receive education and training for the fall
                                                   reduction program.




                                                   5 The hospital educates the patient and, as
                                                   needed, the family on the fall reduction program
                                                   and any individualized fall reduction strategies.


                                                   2009 NPSGs Chart TIPS (2).pdf
                                                   JC- NPSG-09-01-01.pdf
              HOSP, LTC & HC                       TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




          JC - 3                                                                               JC - 3 - Version: 01.30.2009                                                             147 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                          Not
                                                                                                                       Met    Partially   Met   If score other than 'met' what are
               Question:                          Rationale/Assessment Methods:                                        (1)     Met (2)    (3)   possible root causes
               The Joint Commission Patient Safety Goals                                                                                                                             START            3.9
3.9.10         Goal 10: Reduce the Risk of
               Influenza and Pneumococcal
               Disease in Institutionalized Older
               Adults
               LTC                                                                                                                                                                   END
               The Joint Commission Patient Safety Goals                                                                                                                             START            3.9
3.9.10.1       NPSG.10.01.01                     Elements of Performance listed in JC resource
                                                 "Meeting the 2009 NPSGs"


               Develop and implement a protocol
               for administration and              1 Appropriate protocols are developed to
               documentation of the flu vaccine.   determine whether to administer the flu vaccine
                                                   to a patient.




                                                   2 There is evidence that protocols were
                                                   implement for residents identified as high risk.




                                                   JC Reference for this Goal is unavailable in
                                                   PSAT
                                                   2009 NPSGs Chart TIPS (2).pdf
               LTC                                 TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




           JC - 3                                                                              JC - 3 - Version: 01.30.2009                                                             148 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                         Not
                                                                                                                      Met    Partially   Met   If score other than 'met' what are
               Question:                         Rationale/Assessment Methods:                                        (1)     Met (2)    (3)   possible root causes
               The Joint Commission Patient Safety Goals                                                                                                                            START            3.9
3.9.10.2       NPSG.10.02.01                     Elements of Performance listed in JC resource
                                                 "Meeting the 2009 NPSGs"


               Develop and implement a protocol
               for administration and             1 Appropriate protocols are developed to
               documentation of the               determine whether to administer the
               pneumococcus vaccine.              pneunnococcus vaccine to a patient.




                                                  2 There is evidence that protocols were
                                                  implemented to for patients identified as high
                                                  risk.




                                                  JC Reference for this Goal is unavailable in
                                                  PSAT
                                                  2009 NPSGs Chart TIPS (2).pdf
               LTC                                TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




           JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             149 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                           Not
                                                                                                                        Met    Partially   Met   If score other than 'met' what are
               Question:                         Rationale/Assessment Methods:                                          (1)     Met (2)    (3)   possible root causes
               The Joint Commission Patient Safety Goals                                                                                                                              START            3.9
3.9.10.3       NPSG.10.03.01                     Elements of Performance listed in JC resource
                                                 "Meeting the 2009 NPSGs"


               Develop and implement a protocol
               to identify new cases of influenza   1 Protocols are developed to identify cases of
               and to manage an outbreak.           influenza and to manage an outbreak.




                                                    2 There is evidence that the protocols are
                                                    followed for patients displaying signs and
                                                    symptoms of influenza.




                                                    JC Reference for this Goal is unavailable in
                                                    PSAT
                                                    2009 NPSGs Chart TIPS (2).pdf
               LTC                                  TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END
               The Joint Commission Patient Safety Goals                                                                                                                              START            3.9
3.9.11         Goal 11: Reduce the Risk of
               Surgical Fires
               AMC                                                                                                                                                                    END




           JC - 3                                                                               JC - 3 - Version: 01.30.2009                                                             150 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                            Not
                                                                                                                         Met    Partially   Met   If score other than 'met' what are
               Question:                         Rationale/Assessment Methods:                                           (1)     Met (2)    (3)   possible root causes
               The Joint Commission Patient Safety Goals                                                                                                                               START            3.9
3.9.11.1       NPSG.11.01.01                     Elements of Performance listed in JC resource
                                                 "Meeting the 2009 NPSGs"


               Educate staff, including operating
               licensed independent practitioners  1 Organizations asses the risk for surgical fires
               and anesthesia providers, on how to based on equipment and procedures used.
               control heat sources and manage
               fuels, and establish guidelines to
               minimize oxygen concentration
               under drapes.                       2 The organization establishes guidelines to
                                                   minimize oxygen concentration under drapes.




                                                     3 Organizations that identify themselves as at
                                                     risk provide staff training on the methods to
                                                     minimize oxygen concentration under drapes.




                                                     4 Organizations that identify themselves as at
                                                     risk provide staff training on methods to avoid
                                                     the use of flammable solutions and materials.
                                                     2009 NPSGs Chart TIPS (2).pdf
               AMC                                   TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END
               The Joint Commission Patient Safety Goals                                                                                                                               START            3.9
3.9.12         Goal 12: NOT APPLICIABLE -         Inform and encourage components and
               Implementation of applicable       practitioner sites to implement the applicable
               National Patient Safety Goals and  National Patient Safety Goals and associated
               associated requirements by         requirements.
               components and practitioner sites.
               NA                                                                                                                                                                      END




           JC - 3                                                                                JC - 3 - Version: 01.30.2009                                                             151 of 1656
                                                       NCPS Patient Safety Assessment Tool

                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                       Not
                                                                                                    Met    Partially   Met   If score other than 'met' what are
             Question:                          Rationale/Assessment Methods:                       (1)     Met (2)    (3)   possible root causes
             The Joint Commission Patient Safety Goals                                                                                                            START            3.9
3.9.13       Goal 13: Encourage the Active
             Involvement of Patients and Their
             Families in the Patient’s Own Care
             as a Patient Safety Strategy
             HOSP, LTC, BHC, HC, AMC & Lab                                                                                                                        END




         JC - 3                                                             JC - 3 - Version: 01.30.2009                                                             152 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                       Not
                                                                                                                    Met    Partially   Met   If score other than 'met' what are
               Question:                         Rationale/Assessment Methods:                                      (1)     Met (2)    (3)   possible root causes
               The Joint Commission Patient Safety Goals                                                                                                                          START            3.9
3.9.13.1       NPSG.13.01.01                     Elements of Performance as doucumented for
                                                 the Hospital Progam


               Identify the ways in which the
               patient and his or her family can       1 The patient and family are educated on
               report concerns about safety and        available reporting methods for concerns related
               encourage them to do so.                to care, treatment, and services and patient
                                                       safety issues.


               Communication with the patient and
               family about all aspects of care,       2 The hospital provides the patient with
               treatment, and services is an           information regarding infection control measures
               important characteristic of a culture   for hand hygiene practices, respiratory hygiene
               of safety. When the patient knows       practices, and contact precautions according to
               what to expect, he or she is more       the patient’s condition. The information is
               aware of possible errors and            discussed with the patient and his or her family
               choices. The patient can also be an     members on the day the patient enters the
               important source of information         hospital or as soon as possible (for example,
               about potential adverse events and      within 24–48 hours). The patient’s
               hazardous conditions.                   understanding of this information is evaluated
                                                       and documented. (See also PC.02.03.01, EP 25)

                                                       Note: The information provided to the patient
                                                       may be in any form of media.




                                                       3 For surgical patients, the hospital describes
                                                       the measures that will be taken to prevent
                                                       adverse events in surgery. Examples include,
                                                       2009 NPSGs Chart TIPS (2).pdf
                                                       The Joint Commission NPSG.13.01.01
               HOSP, LTC, BHC, HC, AMC & LAB           TIPS Jan Feb 09                                                                                                            END




           JC - 3                                                                           JC - 3 - Version: 01.30.2009                                                             153 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                     Not
                                                                                                                  Met    Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                                       (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                           START
3.9.13.1    (continued)... NPSG.13.01.01      ...(continued) prevention of surgical infections,
(continued)                                   and marking of the procedure sites. The
                                              patient’s understanding is evaluated and
                                              documented. (See also PC.02.03.01, EP 25).
            Identify the ways in which the    Note: The information provided to the patient
            patient and his or her family can may be in any form of media.
            report concerns about safety and
            encourage them to do so.

                                                     4 The hospital encourages patients and their
                                                     families to report concerns about safety.
             Communication with the patient and
             family about all aspects of care,
             treatment, and services is an
             important characteristic of a culture
             of safety. When the patient knows
             what to expect, he or she is more
             aware of possible errors and
             choices. The patient can also be an
             important source of information
             about potential adverse events and
             hazardous conditions.

                                                     2009 NPSGs Chart TIPS (2).pdf
                                                     The Joint Commission NPSG.13.01.01
             HOSP, LTC, BHC, HC, AMC & LAB           TIPS Jan Feb 09                                                                                                            END
             The Joint Commission Patient Safety Goals                                                                                                                          START            3.9
3.9.14       Goal 14: Prevent Health Care-
             Associated Pressure Ulcers
             (Decubitus Ulcers)
             LTC                                                                                                                                                                END




         JC - 3                                                                           JC - 3 - Version: 01.30.2009                                                             154 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                             Not
                                                                                                                          Met    Partially   Met   If score other than 'met' what are
               Question:                         Rationale/Assessment Methods:                                            (1)     Met (2)    (3)   possible root causes
               The Joint Commission Patient Safety Goals                                                                                                                                START            3.9
3.9.14.1       NPSG.14.01.01                     Elements of Performance listed in JC resource
                                                 "Meeting the 2009 NPSGs"


               Assess and periodically reassess
               each patient's risk for developing a   1 There is a plan for the prediction, prevention,
               pressure ulcer and take action to      and early treatment of pressure ulcers, which
               address any identified risks.          addresses the following:

                                                      -Identifying individuals at risk and the specific
                                                      factors that place them at risk.

                                                      -Maintaining and improving tissue tolerance to
                                                      pressure in order to prevent injury.

                                                      -Protecting against the adverse effects of
                                                      external mechanical forces.

                                                      -Reducing the incidence of pressure ulcers
                                                      through staff educational programs.




                                                      2 Initial assessments are performed at
                                                      admission.




                                                      3 A systematic resk assessment is conducted
                                                      using a vaildated risk assesment tool such as
                                                      the Braden Scale or Norton Scale.
                                                      2009 NPSGs Chart TIPS (2).pdf
               LTC                                    TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




           JC - 3                                                                                 JC - 3 - Version: 01.30.2009                                                             155 of 1656
                                                                     NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                              Not
                                                                                                                           Met    Partially   Met   If score other than 'met' what are
               Question:                            Rationale/Assessment Methods:                                          (1)     Met (2)    (3)   possible root causes
               The Joint Commission Patient Safety Goals                                                                                                                                 START            3.9
3.9.15         Goal 15: The Organization Identifies
               Safety Risks Inherent In Its Patient
               Population
               HOSP, BHC & HC                                                                                                                                                            END
               The Joint Commission Patient Safety Goals                                                                                                                                 START            3.9
3.9.15.1       NPSG.15.01.01                     Elements of Performance as doucumented for
                                                 the Hospital Progam


               The hospital identifies patients at
               risk for suicide.                       1 The risk assessment includes identification of
                                                       specific patient factors and environmental
                                                       features that may increase or decrease the risk
                                                       for suicide.
               Note: This requirement only applies
               to psychiatric hospitals and patients
               being treated for emotional or
               behavioral disorders in general         2 The hospital addresses the patient’s
               hospitals.                              immediate safety needs and most appropriate
                                                       setting for treatment.


               Suicide of a care recipient while in a
               staffed, round-the-clock care setting 3 The hospital provides information such as a
               is a frequently reported type of       crisis hotline to individuals at risk for suicide and
               sentinel event. Identification of      their family members
               individuals at risk for suicide while
               under the care of or following
               discharge from a health care
               organization is an important step in
               protecting these at-risk individuals.

                                                       2009 NPSGs Chart TIPS (2).pdf
                                                       JC- NPSG-15-01-01.pdf
               HOSP & BHC                              TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END




           JC - 3                                                                                  JC - 3 - Version: 01.30.2009                                                             156 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                          Not
                                                                                                                       Met    Partially   Met   If score other than 'met' what are
               Question:                         Rationale/Assessment Methods:                                         (1)     Met (2)    (3)   possible root causes
               The Joint Commission Patient Safety Goals                                                                                                                             START            3.9
3.9.15.2       NPSG.15.02.01                     Elements of Performance listed in JC resource
                                                 "Meeting the 2009 NPSGs"


               The organization identifies risks
               associated with long-term oxygen    1 The home safety risk assessment includes
               therapy, such as home fires.        presence or absence and working order of
                                                   smoke detectors, fire extinguishers, and fire
                                                   safety plans and review of all medical
                                                   equipment.




                                                   2 The organization provides education to the
                                                   patient and family regarding the findings of the
                                                   home safety risk assessment, possible
                                                   interventions, causes of fire and fire prevention
                                                   activities.
                                                   2009 NPSGs Chart TIPS (2).pdf
               HC                                  TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf                                                                                         END
               The Joint Commission Patient Safety Goals                                                                                                                             START            3.9
3.9.16         Goal 16: Improve Recognition and
               Response to Changes in a Patient's
               Condition
               HOSP                                                                                                                                                                  END




           JC - 3                                                                              JC - 3 - Version: 01.30.2009                                                             157 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                     Not
                                                                                                                  Met    Partially   Met   If score other than 'met' what are
               Question:                         Rationale/Assessment Methods:                                    (1)     Met (2)    (3)   possible root causes
               The Joint Commission Patient Safety Goals                                                                                                                        START            3.9
3.9.16.1       NPSG.16.01.01                     Elements of Performance as doucumented for
                                                 the Hospital Progam


               The hospital selects a suitable
               method that enables health care       1 The hospital selects an early recognition and
               staff members to directly request     response method most suitable for its needs
               additional assistance from a          and resources.
               specially trained individual(s) when
               the patient’s condition appears to be
               worsening.
                                                     2 The hospital develops criteria for calling
                                                     additional assistance to respond to a change in
                                                     the patient’s condition or a perception of change
                significant number of critical       by the staff, the patient, and/or family.
               inpatient events are preceded by
               warning signs prior to the event. A
               majority of patients who have
               cardiopulmonary or respiratory        3 Based on the hospital’s criteria, staff seek
               arrest demonstrate clinical           additional assistance when they have concerns
               deterioration in advance. Early       about a patient’s condition.
               response to changes in a patient’s
               condition by a specially trained
               individual(s) may reduce
               cardiopulmonary arrests and patient 4 The hospital encourages the patient and
               mortality.                            family to seek assistance when the patient’s
                                                     condition worsens.


               A significant number of critical
               inpatient events are preceded by      5 Formal education for urgent response policies
               warning signs prior to the event. A   and practices is conducted with the staff and
               majority of patients who have         2009 NPSGs Chart TIPS (2).pdf
                                                     The Joint Commission NPSG.16.01.01
               HOSP                                  TIPS Jan Feb 09                                                                                                            END




           JC - 3                                                                         JC - 3 - Version: 01.30.2009                                                             158 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                   Not
                                                                                                                Met    Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                 (1)     Met (2)    (3)   possible root causes
            The Joint Commission Patient Safety Goals                                                                                                                         START
3.9.16.1    (continued)... NPSG.16.01.01          ...(continued) intervention program and any
(continued)                                       underlying organizational system issues, takes
                                                  appropriate action to improve its intervention
                                                  system, and measures the effectiveness of
            The hospital selects a suitable       those actions on a regular basis. Note: Hospitals
            method that enables health care       are not required to create “rapid response
            staff members to directly request     teams” or “medical emergency teams” in order
            additional assistance from a          to meet this goal. The existence of these types
            specially trained individual(s) when of teams does not mean that all of the elements
            the patient’s condition appears to be of performance are automatically achieved.
            worsening.



              significant number of critical
             inpatient events are preceded by
             warning signs prior to the event. A
             majority of patients who have
             cardiopulmonary or respiratory
             arrest demonstrate clinical
             deterioration in advance. Early
             response to changes in a patient’s
             condition by a specially trained
             individual(s) may reduce
             cardiopulmonary arrests and patient
             mortality.



             A significant number of critical
             inpatient events are preceded by
             warning signs prior to the event. A
             majority of patients who have         2009 NPSGs Chart TIPS (2).pdf
                                                   The Joint Commission NPSG.16.01.01
             HOSP                                  TIPS Jan Feb 09                                                                                                            END




         JC - 3                                                                         JC - 3 - Version: 01.30.2009                                                             159 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                       Not
                                                                                                                    Met    Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                  (1)     Met (2)    (3)   possible root causes
             Universal Protocol                                                                                                                                                   START            3.1
3.10.1       UP.01.01.01: Conduct a                  Elements of Performance as doucumented for
             preprocedure verification process.      the Hospital Progam



             The preprocedure verification is an     1 Verification of the correct person, correct site,
             ongoing process of information          and correct procedure occurs at the following
             gathering and verification, beginning   times:
             with the decision to perform a
             procedure, continuing through all       - At the time the procedure is scheduled
             settings and interventions involved
             in the preprocedure preparation of      - At the time of preadmission testing and
             the patient, up to and including the    assessment
             time-out just before the start of the
             procedure.                              - At the time of admission or entry into the
                                                     facility for a procedure, whether elective or
                                                     emergent

             The purpose of the preprocedure       - Before the patient leaves the preprocedure
             verification process is to make sure area or enters the procedure room
             that all relevant documents and
             related information or equipment are: - Anytime the responsibility for care of the
                                                   patient is transferred to another member of the
             - Available prior to the start of the procedural care team, (including the anesthesia
             procedure.                            providers) at the time of, and during, the
                                                   procedure
             - Correctly identified, labeled, and
             matched to the patient’s identifiers. - With the patient involved, awake and aware, if
                                                     possible
             - Reviewed and are consistent with
             the patient’s expectations and with
             the team’s understanding of the
             intended patient, procedure, and        2009 NPSGs Chart TIPS (2).pdf
                                                     The Joint Commission UP.01.01.01
             HOSP & AMC                              TIPS Jan Feb 09                                                                                                              END




         JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             160 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                      Not
                                                                                                                   Met    Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                  (1)     Met (2)    (3)   possible root causes
            Universal Protocol                                                                                                                                                   START
3.10.1      (continued)... UP.01.01.01:             ...(continued) matched to the patient:
(continued) Conduct a preprocedure verification
            process.                                - Relevant documentation (for example, history
                                                    and physical, nursing assessment, and pre-
                                                    anesthesia assessment)

            The preprocedure verification is an     - Accurately completed, and signed, procedure
            ongoing process of information          consent form
            gathering and verification, beginning
            with the decision to perform a          - Correct diagnostic and radiology test results
            procedure, continuing through all       (for example, radiology images and scans, or
            settings and interventions involved     pathology and biopsy reports) that are properly
            in the preprocedure preparation of      labeled
            the patient, up to and including the
            time-out just before the start of the   - Any required blood products, implants,
            procedure.                              devices, and/or special equipment for the
                                                    procedure


            The purpose of the preprocedure
            verification process is to make sure
            that all relevant documents and
            related information or equipment are:

            - Available prior to the start of the
            procedure.

            - Correctly identified, labeled, and
            matched to the patient’s identifiers.

            - Reviewed and are consistent with
            the patient’s expectations and with
            the team’s understanding of the         2009 NPSGs Chart TIPS (2).pdf
                                                    The Joint Commission UP.01.01.01
            HOSP & AMC                              TIPS Jan Feb 09                                                                                                              END




        JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             161 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                       Not
                                                                                                                    Met    Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                  (1)     Met (2)    (3)   possible root causes
             Universal Protocol                                                                                                                                                   START            3.1
3.10.2       UP.01.02.01: Mark the procedure         Elements of Performance as doucumented for
             site.                                   the Hospital Progam



             Marking the procedure site allows       1 For all procedures involving incision or
             staff to identify without ambiguity the percutaneous puncture or insertion, the
             intended site for the procedure.        intended procedure site is marked. The marking
                                                     takes into consideration laterality, the surface
                                                     (flexor, extensor), the level (spine), or specific
                                                     digit or lesion to be treated. Note: For
                                                     procedures that involve laterality of organs, but
                                                     the incision(s) or approaches may be from the
                                                     midline or from a natural orifice, the site is still
                                                     marked and the laterality noted.




                                                     2 The procedure site is initially marked before
                                                     the patient is moved to the location where the
                                                     procedure will be performed and takes place
                                                     with the patient involved, awake and aware, if
                                                     possible.




                                                     3 The procedure site is marked by a licensed
                                                     independent practitioner or other provider who is
                                                     privileged or permitted by the hospital to perform
                                                     the intended surgical or nonsurgical invasive
                                                     procedure. This individual will be involved
                                                     directly in the procedure and will be
                                                     2009 NPSGs Chart TIPS (2).pdf
                                                     The Joint Commission UP.01.02.01
             HOSP & AMC                              TIPS Jan Feb 09                                                                                                              END




         JC - 3                                                                             JC - 3 - Version: 01.30.2009                                                             162 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                    Not
                                                                                                                 Met    Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                  (1)     Met (2)    (3)   possible root causes
            Universal Protocol                                                                                                                                                 START
3.10.2      (continued)... UP.01.02.01: Mark      ...(continued) present at the time the procedure
(continued) the procedure site.                   is performed. Note: Final confirmation and
                                                  verification of the site mark takes place during
                                                  the time-out.

            Marking the procedure site allows
            staff to identify without ambiguity the
            intended site for the procedure.        4 The method of marking the site and the type
                                                    of mark is unambiguous and is used
                                                    consistently throughout the hospital.




                                                  5 The site marking has the following
                                                  characteristics:

                                                  - It is made at or near the procedure site or the
                                                  incision site. Other nonprocedure site(s) are not
                                                  marked unless necessary for some other aspect
                                                  of care.

                                                  - It includes, preferably, the surgeon’s or
                                                  proceduralist’s initials, with or without a line
                                                  representing the proposed incision.

                                                  - It is made using a marker that is sufficiently
                                                  permanent to remain visible after completion of
                                                  the skin prep and sterile draping. Adhesive site
                                                  markers are not to be used as the sole means of
                                                  marking the site.

                                                  - It is positioned to be visible after the patient
                                                  2009 NPSGs Chart TIPS (2).pdf
                                                  The Joint Commission UP.01.02.01
            HOSP & AMC                            TIPS Jan Feb 09                                                                                                              END




        JC - 3                                                                           JC - 3 - Version: 01.30.2009                                                             163 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                         Not
                                                                                                                      Met    Partially   Met   If score other than 'met' what are
             Question:                                 Rationale/Assessment Methods:                                  (1)     Met (2)    (3)   possible root causes
             Universal Protocol                                                                                                                                                     START            3.1
3.10.3       UP.01.03.01: A time-out is                Elements of Performance as doucumented for
             performed immediately prior to            the Hospital Progam
             starting procedures.


                                                       1 The time-out is conducted prior to starting the
             The purpose of the time-out               procedure and, ideally, prior to the introduction
             immediately before starting the           of the anesthesia process (including
             procedure is to conduct a final           general/regional anesthesia, local anesthesia,
             assessment that the correct patient,      and spinal anesthesia), unless contraindicated.
             site, positioning, and procedure are
             identified and that, as applicable, all
             relevant documents, related
             information, and necessary                2 The time-out has the following characteristics:
             equipment are available.
                                                       - It is standardized (as defined by the hospital).

                                                       - It is initiated by a designated member of the
             The time-out is consistently initiated    team.
             by a designated member of the
             team and includes active                  - It involves the immediate members of the
             communication among all relevant          procedure team including the proceduralist(s),
             members of the procedure team. It         the anesthesia providers, the circulating nurse,
             is conducted in a standardized fail-      the operating room technician, and other active
             safe mode (that is, the procedure is      participants as appropriate for the procedure,
             not started until all questions or        who will be participating in the procedure at its
             concerns are resolved).                   inception.

                                                       - It involves interactive verbal communication
                                                       between all team members, and any team
                                                       member is able to express concerns about the
                                                       procedure verification.
                                                       2009 NPSGs Chart TIPS (2).pdf
                                                       The Joint Commission UP.01.03.01
             HOSP & AMC                                TIPS Jan Feb 09                                                                                                              END




         JC - 3                                                                               JC - 3 - Version: 01.30.2009                                                             164 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                                        Not
                                                                                                                     Met    Partially   Met   If score other than 'met' what are
            Question:                                 Rationale/Assessment Methods:                                  (1)     Met (2)    (3)   possible root causes
            Universal Protocol                                                                                                                                                     START
3.10.3      (continued)... UP.01.03.01: A time-       ...(continued) During the time-out, other
(continued) out is performed immediately prior        activities are suspended, to the extent possible
            to starting procedures.                   without compromising patient safety, so that all
                                                      relevant members of the team are focused on
                                                      the active confirmation of the correct patient,
                                                      procedure, site, and other critical elements.
            The purpose of the time-out
            immediately before starting the
            procedure is to conduct a final
            assessment that the correct patient,      4 When two or more procedures are being
            site, positioning, and procedure are      performed on the same patient, a time-out is
            identified and that, as applicable, all   performed to confirm each subsequent
            relevant documents, related               procedure before it is initiated.
            information, and necessary
            equipment are available.

                                                      5 The time-out addresses the following:

            The time-out is consistently initiated    - Correct patient identity
            by a designated member of the
            team and includes active                  - Confirmation that the correct side and site are
            communication among all relevant          marked
            members of the procedure team. It
            is conducted in a standardized fail-      - An accurate procedure consent form
            safe mode (that is, the procedure is
            not started until all questions or        - Agreement on the procedure to be done
            concerns are resolved).
                                                      - Correct patient position

                                                      - Relevant images and results are properly
                                                      labeled and appropriately displayed
                                                      2009 NPSGs Chart TIPS (2).pdf
                                                      The Joint Commission UP.01.03.01
            HOSP & AMC                                TIPS Jan Feb 09                                                                                                              END




        JC - 3                                                                               JC - 3 - Version: 01.30.2009                                                             165 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          166 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          167 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          168 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          169 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          170 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          171 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          172 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          173 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          174 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          175 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          176 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          177 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          178 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          179 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          180 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
           Question:                       Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          181 of 1656
                                                    NCPS Patient Safety Assessment Tool

                                                                 Part I Adminstrative
JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
                                                                                                                   Not
                                                                                                Met    Partially   Met   If score other than 'met' what are
            Question:                      Rationale/Assessment Methods:                        (1)     Met (2)    (3)   possible root causes


      286




       JC - 3                                                           JC - 3 - Version: 01.30.2009                                                          182 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     183 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     184 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative




              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     185 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     186 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     187 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     188 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     189 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   190 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     191 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   192 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     193 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   194 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals



              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     195 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     196 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   197 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     198 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   199 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




              The Joint Commission Patient Safety Goals




              The Joint Commission Patient Safety Goals




              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     200 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     201 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     202 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     203 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   204 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     205 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   206 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     207 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   208 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     209 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     210 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   211 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     212 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     213 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     214 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   215 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     216 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     217 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     218 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     219 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     220 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     221 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     222 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     223 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative




              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     224 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     225 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     226 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     227 of 1656
         NCPS Patient Safety Assessment Tool

                 Part I Adminstrative


              The Joint Commission Patient Safety Goals




JC - 3                   JC - 3 - Version: 01.30.2009     228 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   229 of 1656
         NCPS Patient Safety Assessment Tool

                  Part I Adminstrative


              Universal Protocol




JC - 3                   JC - 3 - Version: 01.30.2009   230 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   231 of 1656
         NCPS Patient Safety Assessment Tool

                  Part I Adminstrative


              Universal Protocol




JC - 3                   JC - 3 - Version: 01.30.2009   232 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   233 of 1656
         NCPS Patient Safety Assessment Tool

                  Part I Adminstrative


              Universal Protocol




JC - 3                   JC - 3 - Version: 01.30.2009   234 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   235 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   236 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   237 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   238 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   239 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   240 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   241 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   242 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   243 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   244 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   245 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   246 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   247 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   248 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   249 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   250 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   251 of 1656
         NCPS Patient Safety Assessment Tool

                Part I Adminstrative




JC - 3              JC - 3 - Version: 01.30.2009   252 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                                    Not
                                                                                                             Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                              (1)         Met (2)    (3)   possible root causes
            Procurement and Equipment                                                                                                                                          START            4.1
4.1.1       Are Human Factors Engineering         The medical devices are evaluated for ease of
            principals considered when            use; feedback to the user (verbal and visual);
            purchasing medical devices?           level of knowledge transfer from existing
                                                  equipment; and the impact of slips or mistakes
                                                  on providing patient care. The use of informal
                                                  usability groups to test the devices is
                                                  recommended.
                                                  Copyrighted Refs.doc
            Mandatory; Priority A                 JC- CAMH EC-02-04-01.pdf                                                                                                     END
            Procurement and Equipment                                                                                                                                          START            4.1
4.1.2       Is equipment assessed for usability   Internal and external failure rates or other past
            and maintainability prior to          history reports should be considered when
            procurement?                          purchasing or replacing new equipment. Look
                                                  for evidence of a usability testing process (via
                                                  an evaluation addressing such things as: Does
                                                  the equipment prominently display the mode to
                                                  the user?; Are buttons spaced far enough apart
                                                  to prevent inadvertent activation?; Is the readout
                                                  clear and unambiguous?; Will parallax be an
                                                  issue?)

                                                  Copyrighted Refs.doc
                                                  Copyrighted Refs.doc
            Mandatory; Priority A                 JC- CAMH EC-02-04-01.pdf                                                                                                     END
            Procurement and Equipment                                                                                                                                          START            4.1
4.1.3       Is equipment inspection scope and     Show evidence of the PM inspection
            frequency modified based on           modifications. Interview Biomedical Service
            inspection results or user input?     personnel have them show evidence of tracking
                                                  and modification if applicable.
            Recommended; Priority A               JC- CAMH EC-02-04-01.pdf                                                                                                     END
            Procurement and Equipment                                                                                                                                          START            4.1
4.1.4       Are users and maintenance             Verify training requirements are included in
            personnel trained on new equipment procurement contract; and interview BME and
            prior to it being introduced into the Clinician users.
            hospital?
            Recommended; Priority A                                                                                                                                            END




        Procure Equip mgt - 4                                                 Procure Equip mgt - 4 - Version: 01.30.2009                                                         253 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                              (1)         Met (2)    (3)   possible root causes
              Procurement and Equipment                                                                                                                                            START            4.1
4.1.4.1       Is the effectiveness of this training   Not only should training occur, but the
              assessed?                               competency testing or other measures of
                                                      effectiveness should be applied.
              Recommended; Priority A                                                                                                                                              END
              Procurement and Equipment                                                                                                                                            START            4.1
4.1.5         When feasible, is equipment             Limiting the number of systems/equipment
              standardized by manufacturer and        clinicians and maintenance staff are required to
              model?                                  operate/maintain will reduce latent errors in the
                                                      system. Interview personnel, review examples.

              Recommended; Priority A                                                                                                                                              END
              Procurement and Equipment                                                                                                                                            START            4.1
4.1.5.1       Are you in compliance with VISN or      A standardization group has previously
              National BPAs (Blanket Purchase         evaluated equipment and has placed them on
              Agreements)?                            the BPA list. The evaluations have considered
                                                      safety and human factors. Talk with AMM&S
                                                      personnel to verify which equipment has been
                                                      purchased under the BPA.

              Recommended; Priority B                                                                                                                                              END
              Procurement and Equipment                                                                                                                                            START            4.1
4.1.6         When errors are identified that are  Review documentation or log of these
              unable to be duplicated or repeated, inspections or evaluations. While proficiency
              are appropriate actions taken?       with the equipment is important, actions should
                                                   be focused on the equipment and environment
                                                   with appropriate follow-up to the users. Looking
                                                   at "unable to repeat" events provides insight into
                                                   equipment design/usability issues.

              Recommended; Priority A                                                                                                                                              END
              Procurement and Equipment                                                                                                                                            START            4.1
4.1.7         Is there a procurement process or  Essential Medical back up equipment should be
              plan to acquire an adequate amount available in all areas, or accessible as needed
              of back up equipment.              when primary equipment fails.
              Mandatory; Priority A                   JC- CAMH EC-02-04-01.pdf                                                                                                     END




          Procure Equip mgt - 4                                                   Procure Equip mgt - 4 - Version: 01.30.2009                                                         254 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      255 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      256 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      257 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      258 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      259 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      260 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      261 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      262 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      263 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      264 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      265 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      266 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      267 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      268 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      269 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      270 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      271 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      272 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      273 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      274 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
          Question:                 Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      275 of 1656
                                            NCPS Patient Safety Assessment Tool

                                                         Part I Adminstrative
PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
                                                                                                                 Not
                                                                                          Met        Partially   Met   If score other than 'met' what are
           Question:                Rationale/Assessment Methods:                         (1)         Met (2)    (3)   possible root causes




      33




      Procure Equip mgt - 4                                Procure Equip mgt - 4 - Version: 01.30.2009                                                      276 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative


                                Procurement and Equipment




                                Procurement and Equipment




                                Procurement and Equipment




                                Procurement and Equipment




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   277 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative


                                Procurement and Equipment




                                Procurement and Equipment




                                Procurement and Equipment




                                Procurement and Equipment




                                Procurement and Equipment




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   278 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   279 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   280 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   281 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   282 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   283 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   284 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   285 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   286 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   287 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   288 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   289 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   290 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   291 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   292 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   293 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   294 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   295 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   296 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   297 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   298 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   299 of 1656
                        NCPS Patient Safety Assessment Tool

                               Part I Adminstrative




Procure Equip mgt - 4           Procure Equip mgt - 4 - Version: 01.30.2009   300 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
            Question:                           Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
            Recalls and VA Patient Safety Alerts & Advisories                                                                                                                            START            5.1
5.1.1       Has the Facility implemented a      At minimum the program must cover:
            product recall program in
            accordance with the requirements of
            VHA Directive 2008-080, “Recall of
            Defective Medical Devices and       (1) Ensuring recalled medical devices or
            Medical Products, including Food    medical products are not used at any facility.
            and Food Products?”


                                                 (2) Designating a FRC and back-up FRC(s).




                                                 (3) Ensuring all recalls are completed by the due
                                                 date specified on the VHA Alert and Recall
                                                 Management System Web site.




                                                 (4) Designating FDASs, and alternates, for all
                                                 categories identified in Attachment B of the Alert.




                                                 (5) Ensuring that action status or
                                                 recommendations of Recalls, VHA Patient
                                                 Safety Alerts, and Patient Safety Advisories are
                                                 implemented and documented on the VHA Alert
                                                 and Recall Management System Web site.



            Mandatory; Priority A                VHA Directive 2008-080 recalls.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        301 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
            Question:                           Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
            Recalls and VA Patient Safety Alerts & Advisories                                                                                                                            START
5.1.1       (continued)... Has the Facility     ...(continued) implanted in VA patients at non-
(continued) implemented a product recall        VA facilities, including affiliates or private
            program in accordance with the      institutions.
            requirements of VHA Directive 2008-
            080, “Recall of Defective Medical
            Devices and Medical Products,
            including Food and Food Products?” (8) Ensuring that facility-initiated contracts
                                                require vendors to notify the Facility Contracting
                                                Officer of any recalls or important product safety
                                                issues as described in subparagraph 4j(2).

             Mandatory; Priority A               VHA Directive 2008-080 recalls.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                     Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        302 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
              Question:                            Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
              Recalls and VA Patient Safety Alerts & Advisories                                                                                                                             START            5.1
5.1.1.1       At minimum do the responsibilities   (1) Coordinating and disseminating logistics-
              of the Facility Recall Coordinator   related recall information to the Facility
              (FRC) include items 1-7 as stated in Designated Area Specialists (FDASs), and
              the rationale?                       verifying and reporting that recall actions are
                                                   completed within the facility by the due date.




                                                    (2) Working with the facility Contracting Officer
                                                    to obtain recalls or important product safety
                                                    issues received from facility-initiated contracts,
                                                    including information described in subparagraph
                                                    4d(4).




                                                    (3) Maintaining an up-to-date list of the FDASs
                                                    including name, email address, and phone
                                                    numbers and providing this list to the Network
                                                    Recall Coordinator.




                                                    (4) Verifying that the appropriate action has
                                                    been taken, e.g., identifying numbers and
                                                    locations of medical devices and products;
                                                    removing, sequestering, and returning the
                                                    products for credit; and providing suitable
                                                    alternate products so that essential activities are
                                                    not adversely impacted.


              Mandatory; Priority A                 VHA Directive 2008-080 recalls.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        303 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
            Recalls and VA Patient Safety Alerts & Advisories                                                                                                                               START
5.1.1.1     (continued)... At minimum do the        ...(continued) for maintaining records that details
(continued) responsibilities of the Facility Recall the steps taken to resolve recalls, such as:
            Coordinator (FRC) include items 1-7 distribution lists, response times, number of
            as stated in the rationale?             items identified, final disposition of affected
                                                    items, and date resolved.




                                                    (7) Contacting the PRO (10X) and the NRC with
                                                    any recalls or important product safety issues
                                                    received from facility-initiated contracts or
                                                    locally-identified product or device issues
                                                    potentially impacting product or patient safety
                                                    (e.g., recall letter sent from supplier to OR or
                                                    Chief of Supply, Processing and Distribution
                                                    (SPD)), including information described in
                                                    subparagraph 4d(4).
             Mandatory; Priority A                  VHA Directive 2008-080 recalls.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        304 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
              Question:                           Rationale/Assessment Methods:                                            (1)         Met (2)    (3)   possible root causes
              Recalls and VA Patient Safety Alerts & Advisories                                                                                                                              START            5.1
5.1.1.2       At minimum do the responsibilities  (1) Providing technical expertise on completing
              of the Facility Designated Area     recalls in coordination with the FRC.
              Specialists include items 1-4 as
              stated in the rationale?

                                                   (2) Serving as the subject matter expert and
                                                   investigator on internally-identified hazards
                                                   within their area of expertise or specialty.




                                                   (3) Communicating recall information to their
                                                   respective Designated Service Area Specialists
                                                   in VACO, when national notification may be
                                                   appropriate, including the described in
                                                   subparagraph 4d(4).




                                                   (4) Implementing actions specified by the FRC
                                                   by the due date, and reporting back to the FRC
                                                   when those actions have been completed.


              Mandatory; Priority A                VHA Directive 2008-080 recalls.pdf                                                                                                        END
              Recalls and VA Patient Safety Alerts & Advisories                                                                                                                              START            5.1
5.1.2         Are VA Patient Safety Alert and     Check the VHA Alert and Recall Management
              Advisory actions and                System at
              recommendations implemented and http://vaww.nbc.med.va.gov/visn/recalls/ to see
              tracked until completed?            if Alerts and Advisories are being addressed
                                                  appropriately.




                                                   Interview PSM to review local process that
                                                   tracks completion of recommendations.
                                                   http://vaww.nbc.med.va.gov/visn/recalls/
              Mandatory; Priority A                JC- CAMH EC-02-04-01.pdf                                                                                                                  END




          Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        305 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                      Not
                                                                                                               Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            1998 Alerts & Advisories                                                                                                                                             START            5.2
5.2.1       Patient Burns from Hot Water, 6/98    1. Carefully review VHA Directive 97-027 to
                                                  ensure your policies and procedures are
                                                  compliant.

                                                  2. Your local policies and procedures must also
                                                  emphasize situations where partial immersion
                                                  takes place away from fixed tubs.

                                                  3. At 120 F, which is the exit temperature at the
                                                  faucet, serious burns can occur in seconds. It is
                                                  essential to measure water temperature with a
                                                  thermometer.

                                                  4. Make sure clinical staff is trained and aware
                                                  that temperature must be measured before any
                                                  immersion and the only acceptable method of
                                                  taking temperature is with an accurate
                                                  instrument.
            Mandatory; Priority A                 ScaldAlert.pdf                                                                                                                 END
            1998 Alerts & Advisories                                                                                                                                             START            5.2
5.2.2       COBE® CENTURYSYSTEM® 3                1. Identify blood tubing sets and cease their use.
            Blood Tubing Sets, 6/98
                                                  2. Quarantine any inventory and arrange return
                                                  to GAMBRO Healthcare.

            Blood tubing sets may be              3. Special instructions are available for clinics,
            associated with incidents of          which must provide treatment before
            hemolysis. A total of four patient    replacements arrive and for which the only
            deaths have been reported following   blood tubing sets available are those subject to
            dialysis treatment, none in VA. All   the recall. Call GAMBRO Healthcare (800) 456-
            lot numbers of catalog numbers:       7339 (24 HOUR) for these instructions.
            003109-400, 003109-410, 003110-
            500, 003111-500, 003112-500,          4. Contact GAMBRO Healthcare for further
            003113-500, 003114-500, 003210-       questions, Tim Schoenberg at (800) 525-2623
            500, 003212-500 003101-000,           x4010.
            003212-515.
            Mandatory; Priority A                 COBE.pdf                                                                                                                       END




        Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        306 of 1656
                                                             NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                     Not
                                                                                                              Met        Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            1998 Alerts & Advisories                                                                                                                                            START            5.2
5.2.3       Truncation of Viral Loads in Network 1. IRM sections should fix data fields in NHE to
            Health Exchange, 7/98                allow the full (which may include “< or >”
                                                 characters) value to be entered. Two VISNs
                                                 have collaborated and developed a routine that
                                                 has been shared with their counterparts in other
            The NHE viral load value field only  VISN facilities. This is an interim measure. A
            allowed for a 4 digit value to be    national patch should be made available no later
            transmitted, when in fact, the value than 7/31/98.
            is often 6 digits long.
                                                 2. A National Online Information Sharing (NOIS)
                                                 (CIN-0698-41578) has been submitted to the
                                                 national developers of the NHE alerting them to
                                                 this matter.

                                                 3. Facilities should undertake a review of
                                                 whether clinicians have looked up viral load
                                                 results using NHE. And whether clinical
                                                 judgements were based on these values rather
                                                 than looking up the results in VistA directly. If
                                                 this has happened then it must be determined
                                                 whether patients’ treatment protocol is accurate
                                                 and that the laboratory values were not
                                                 truncated which may have resulted in
                                                 inappropriate treatment. Corrective actions
                                                 should be taken immediately.
            Mandatory; Priority A                Trunc.pdf                                                                                                                      END




        Recalls Alerts Advis - 5                                             Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        307 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            1998 Alerts & Advisories                                                                                                                                               START            5.2
5.2.4       Boston Scientific/SCIMED NIR            1. Facilities will immediately discontinue use of
            ON™ RANGER™ With SOX™                   the product. These device failures may result in
            Premounted Stent, 10/98                 emergency interventions, including coronary
                                                    bypass surgery.

                                                    2. Return all unused product to the
            The balloon portion of the delivery     manufacturer, Boston Scientific/SCIMED (Maple
            catheter can develop pinhole leaks      Grove, MN) who will replace them with the NIR
            and rupture at inflation pressures as   ON™ RANGER™ Without SOX™ at no cost.
            low as 3 ATM. This problem
            manifests during the stent              3. For further information regarding the product
            deployment procedure.                   recall and exchange program, call the SCIMED
                                                    customer service line at 1-888-724-6334.


            Mandatory; Priority A                   Ranger.pdf                                                                                                                     END
            1998 Alerts & Advisories                                                                                                                                               START            5.2
5.2.5       Blakemore tube 3-lumen, X-ray           1. VHA Medical Facilities that have received
            opaque, 2 balloon catheter, 21          these catalog numbers of catheters are to
            French, 36" long, by Rusch Int'nat'l,   immediately cease using them.
            10/98
                                                    2. Quarantine any inventory and arrange their
                                                    return to Rusch International for a no cost
                                                    exchange.
            Blakemore tube – 21 Fr, 36 inches
            long, Model Number – 2300-21,       3. Contact Rusch International for exchange,
            Batch Number – E343601, Sterilized Derek Monjure (800) 553-5214.
            by EtO – 01/95, Use By” – 01/2000,
            In pre-use testing, they discovered
            the balloons were deteriorated
            beyond use.

            Mandatory; Priority A                   BlakeTube.pdf                                                                                                                  END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        308 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            1998 Alerts & Advisories                                                                                                                                               START            5.2
5.2.6       Invivo Research Inc.'s Milennia        1. Determine if facility contains any monitors
            3500 multiparameter patient            manufactured before December 1998.
            monitor, 12/98
                                                   2. The manufacturer advises the problem will
                                                   not occur if the clock is neither tested nor reset
                                                   on December 31 - January 1. Invivo has a
            The FDA has issued an advisory for     software upgrade to fix the problem that is now
            this patient monitor. It has a         available.
            potential New Year’s Eve problem
            on every year including 1998-1999.     3. Contact Invivo Research Inc at 407-275-3220
                                                   and ask for customer service.
            Mandatory; Priority A                  PtMonitor.pdf                                                                                                                   END
            1998 Alerts & Advisories                                                                                                                                               START            5.2
5.2.7       Hewlett-Packard Defibrillator, model 1. Device will defibrillate properly but will not
            43100a/43200a, 12/98                 print out the month, day, hour, and minute.

                                               2. The manufacturer advises it should be reset
                                               to 1998 (not 1999) after which the unit will work
            They will experience a minor date  properly for the year 1999 (because the event
            change problem upon the start of   record does not print the year, only the month,
            the New Year, January 1, 1999. The day, etc.).
            Hewlett-Packard 43100a/43200a will
            defibrillate properly.             3. "At the end of 1999 it will need to be reset
                                               again, from 1998 to year 2000, after which it
                                               should work properly. Thirty-nine thousand of
                                               these defibrillators were sold worldwide between
                                               1985 and 1992. Hewlett-Packard’s website is:
                                               www.hp.com
                                               "
            Mandatory; Priority A                  Defib.pdf                                                                                                                       END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        309 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                     Not
                                                                                                              Met        Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            1999 Alerts & Advisories                                                                                                                                            START            5.3
5.3.1       GE/Marquette Clinical Information    1. Do not use the APEX pulse oximeter while it
            Center (V1.4 and all previous        is connected to the APEX S telemetry
            software revisions), 4/99            transmitter.

                                                 2. The APEX pulse oximeter may continue to be
                                                 used as a standalone device. In this case, the
            Versions used with the APEX S        interface cables between the pulse oximeter and
            telemetry transmitter and APEX       the telemetry transmitter (PN. 412926-001, -002,
            pulse oximeter. 4/99                 -003) should be removed from patient use.

                                                 3. GE/Marquette will provide a software update
                                                 for your CIC upon completion of testing and
            The “ALL ALARMS OFF” visual          validation. A GE-Marquette service
            message on the CIC waveform          representative will then contact you to schedule
            window disappears and the alarms     updates. Once your CIC software is updated,
            remain off when the following        you may again use your APEX Pulse Oximeter
            conditions are met: 1.The user turns while it is connected to your APEX S
            off alarms on the CIC, THEN          transmitters.

            2. A. The APEX pulse oximeter is     4. If you have any questions concerning this
            turned on or turned off while        safety alert, please contact Tom Lower,
            connected to the APEX S telemetry    GE/Marquette's Telemetry Product Manager
            transmitter OR B. The APEX pulse     (414) 362-2572.
            oximeter is connected to or
            disconnected from the APEX S
            telemetry transmitter.

            Mandatory; Priority A                Telemetry.pdf                                                                                                                  END




        Recalls Alerts Advis - 5                                             Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        310 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                      Not
                                                                                                               Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            1999 Alerts & Advisories                                                                                                                                             START            5.3
5.3.2       Boston Scientific/SCIMED;             1. VA medical facilities will immediately either
            Discovery Catheters catalog           replace the Discovery catheter with the
            numbers C3020 and C3005 (All          UltraCross intravascular ultrasound catheter or
            lots); 6/99                           discontinue use of the product.

                                                  2. Return all unused products to the
                                                  manufacturer, Boston Scientific/SCIMED (Maple
            The distal segment of the sheath of   Grove, MN) who will replace them with the
            Discovery catheters may separate      UltraCross intravascular ultrasound catheter at
            from the proximal segment. The        no cost or credit your account.
            separations have led to surgical
            intervention in some cases where      3. For further information regarding the product
            the separation occurred in vivo.      recall and exchange program, call SCIMED at 1-
                                                  800-862-1284 from 8:30 a.m. to 5 p.m. (EDT).

            Mandatory; Priority A                 Catheter.pdf                                                                                                                   END




        Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        311 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            1999 Alerts & Advisories                                                                                                                                                START            5.3
5.3.3       Hoyer Power Lift Actuators              1. "Verify if you have any affected units in use.
            Manufactured by Sunrise Medical         If so, there are two options to remedy the
            used on all serial numbers of:          problem: Option 1: Order and install no-cost
            (Descriptions), 8/99                    upgrade kits. Option 2: Send in affected
                                                    actuators (NOT the entire lift) for a no cost
                                                    upgrade.

            Retro-fit Power, Retro-fit Power        2. You can use the form enclosed in the
            Conversion Kit 59105, Power             attached manufacturer's notice to report affected
            Partner Lifter 53005, Power Partner     actuators to Sunrise Medical. Contact Sunrise
            Stand-Assist Lifter 53006, Power        Medical at (800) 556-5438 to arrange for
            Chrome Hoyer Lifter, Scanac             delivery of the kit or upgrading the actuator.
            Actuator 400-2543, Scanac Actuator
            400-2546, Replacement Battery
            Pack 400-2384, Affected units have
            a BLACK motor cover. Unaffected
            units have a GRAY motor cover.

            After extended use and wear, an
            electronic short can occur inside the
            battery and motor housing. This
            short can damage the batteries,
            drive motor and housing resulting in
            loss of power and lift functions.
            Additionally, the short can cause
            smoke and fumes.

            Mandatory; Priority A                   Hoyer.pdf                                                                                                                       END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        312 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
            Question:                                 Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            1999 Alerts & Advisories                                                                                                                                                  START            5.3
5.3.4       OEC Medical Systems' UroView,             1. If you have an affected system, contact the
            8/99                                      regional service manager (information attached)
                                                      for your area to schedule the no-cost upgrade.

                                                      2. "Until the modification is complete you can
            Model 2600, Model 2500, and Model         safely use the 30” or 36” Leg Extension if you
            2000 urologic Xray systems, with          take the following precautions:
            30" and 36" Leg Extensions, all           1. When the Leg Extension is installed, the
            serial numbers. 8/99. The 30” and         operator should confirm that the locks positively
            36” Leg Extension accessory               engage and “snap” back to the lock position.
            utilized in conjunction with the          2. From the foot end of the Leg Extension, lift
            UroView X-ray imaging system may          the platform up from side to side to ensure that
            not properly engage and lock in           the accessory is firmly secured.
            place and can potentially disengage       "
            when the UroView is tilted beyond
            70 degrees reverse Trendelenberg,         3. If the locks do not “snap” back or if the table
            potentially resulting in patient injury   accessory rails or Leg Extension side rails are
            or equipment damage.                      loose, call your local OEC Field Service office
                                                      for service support.


            Mandatory; Priority A                     UroView.pdf                                                                                                                     END




        Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        313 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                    Not
                                                                                                             Met        Partially   Met   If score other than 'met' what are
            Question:                           Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            1999 Alerts & Advisories                                                                                                                                           START            5.3
5.3.5       Nellcor Puritan Bennett Pulse       1. To verify proper operation of the affected
            Oximeters manufactured by           units, perform the following test: 1. With the
            Mallinckrodt Medical, 9/99          pulse oximeter ""OFF"", connect an approved
                                                Nellcor sensor to the NPB 190 or NPB 195
                                                pulse oximeter. 2. Turn the pulse oximeter
                                                ""ON"" 3. Verify that the ""%Sp02"" and ""BPM""
            Models NPB-190 and NPB-195, all     displays both show ""0"" after a short audible
            units manufactured before October   tone.
            9 1998. The manufacturer has
            received reports of the affected    2. If the pulse oximeter performs as indicated
            pulse oximeters failing to alarm    above, no further action is required.
            when the sensor is disconnected
            from the patient.                   3. However, if the pulse oximeter displays
                                                alternating ""--"" and ""00"" (dashes and
                                                zeroes), it may be susceptible to the
                                                aforementioned problem. If your pulse oximeter
                                                is affected: 1. Remove it from clinical service
                                                immediately. 2. Contact Mallinckrodt Technical
                                                Service at 1-800-635-5267, and select Option 3.
                                                3. Provide Mallinckrodt with the pulse oximeters'
                                                serial number(s) to arrange returning the unit to
                                                them for service. Note: DO NOT return the
                                                pulse oximeter without first obtaining a Returned
                                                Goods Authorization (RGA) Number.
            Mandatory; Priority A               PulseOx.pdf                                                                                                                    END




        Recalls Alerts Advis - 5                                            Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        314 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2000 Alerts & Advisories                                                                                                                                               START            5.4
5.4.1       Patient Ventilators (all               1. Unless recommended by the equipment
            makes/models) used with flow           manufacturer, attach the ventilator directly to the
            meters, 1/00                           supply outlet on the patient panel. In most
                                                   cases, there are two outlets available. If the
                                                   patient requires more than two supplies, branch
                                                   off the outlet NOT used by the ventilator. If you
            A VA Medical recently experienced      must attach a second device to the same outlet,
            a “Low Flow” alarm on a patient        as the ventilator, test the output of the branching
            ventilator attached to the oxygen      device with a flow analyzer to ensure sufficient
            wall outlet via a “T” adapter on the   flow to the ventilator.
            supply side of the flowmeter.

            Mandatory; Priority A                  Vent.pdf                                                                                                                        END
            2000 Alerts & Advisories                                                                                                                                               START            5.4
5.4.2       The Clinipad Corporation is recalling 1. Recall of sterile and non-sterile products
            Sterile and Non-sterile products,     including: Sterile Povidone Iodine, Tincture of
            12/00                                 Iodine, Benzoin Tincture, Acetone Alcohol, and
                                                  Alcohol Antiseptic Products, Sterile Cliniguard
                                                  Protective Dressing, and Specified Lots of
                                                  Nonsterile Products. The products (swabsticks,
            The company has confirmed             prep pads, towelettes, ointments and pouches,
            microbial contamination in some lots as well as protective dressings) are distributed
            of its “sterile” products, including  under the names: Cliniswab, Clinipad, Clinidine,
            one lot with Pseudomonas              Cliniguard, EZ Prep, Cooper Instrument Corp.,
            aeruginosa, Stenotrophomonas          Moore Medical Corp., and Rauscher.
            maltophilia, and Coagulase
            Negative Staphylococcus which was
            recalled in December 1999.

            Mandatory; Priority A                  Clinipad.pdf                                                                                                                    END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        315 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                       Not
                                                                                                                Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2000 Alerts & Advisories                                                                                                                                              START            5.4
5.4.3       Medtronic Dual Chamber Temporary 1. Immediately affix a warning label to these
            Pacemaker Model 5388, 8/00             pacemakers that show steps to clear 0004 error.
                                                    Label: WARNING: If error code 0004 appears
                                                   immediately release battery door. REMOVE
                                                   battery until error message clears. REINSTALL
            Model may become inactive if a         battery.
            button is touched while it is in "self
            test" mode.                            2. Verify and document that all staff who utilize
                                                   or come in contact have been trained on how to
                                                   clear the 0004 error code.

                                                   3. Report identical or similar design related
                                                   events to the FDA and through appropriate
                                                   channels within the VA.
            Recommended; Priority A                Pacemaker.pdf                                                                                                                  END
            2001 Alerts & Advisories                                                                                                                                              START            5.5
5.5.1       Magnetic Resonance Imaging (MRI) 1. Purchase "sand bags" for patient care that do
            Systems, all, 2/01.              not contain iron and properly label the bags.

                                                   2. If facility uses bags that contain iron, these
                                                   bags should be labeled "Contains Iron: DO NOT
            A “sand bag” attached to a patient’s   expose to MRI."
            arm undergoing an MRI exam
            contained iron pellets (unknown to     3. Patients should disrobe and wear clothing
            staff) encased in heavy vinyl; brand   tested for your MRI environment.
            name “North West”. When the
            patient was being moved into the       4. DO NOT verify that a "sand bag" is
            MRI bore, the iron-filled bag flew     compatible by testing it with the MRI magnet -
            into the magnet and pinned the         this could have catastropic consequences.
            patient’s forearm to the side of the
            magnet.                                5. Staff should consider all items to be unsafe
                                                   for the MRI environment until proven otherwise.


            Mandatory; Priority A                  MRIgenalert.pdf                                                                                                                END




        Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        316 of 1656
                                                                      NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                   Not
                                                                                                                            Met        Partially   Met   If score other than 'met' what are
            Question:                                 Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
            2001 Alerts & Advisories                                                                                                                                                          START            5.5
5.5.2       Bed Rail Entrapment, 7/01.                1. Within 120 days of alert, complete inventory
                                                      of all existing beds and identify those that do not
                                                      meet the dimensions specified in this Alert
                                                      (≥60mm for bed gaps, ≥120mm for bed rail
            A patient experienced a close call        openings).
            event when his head became
            wedged in the bed rail opening while      2. Within 120 days of alert, permanently mark all
            having a coughing episode. The            non-complying bed assemblies using a method
            patient was found by the nursing          that clearly communicates the bed entrapment
            staff with a partially obstructed         risk to staff.
            airway and was released without
            injury. This alert patient with a right   3. Immediately fill gaps created between the
            side CVA (cerebrovascular                 mattress and bedrail that are equal to or wider
            accident) was trapped while laying        than 60mm used for high risk patients ( frail,
            on his left side.                         elderly, confused, physically impaired) with
                                                      suitable materials (e.g. high density fire
                                                      retardant foam wedges) to reduce risk of
                                                      entrapment.

                                                      4. Immediately reduce the openings within the
                                                      bed rails to less than 120mm in size for beds
                                                      used for high risk patients (frail, elderly,
                                                      confused, physically impaired). Depending
                                                      upon the bed side rail type this opening may
                                                      exist between horizontal bars (bars parallel to
                                                      mattress) or vertical bars (bars perpendicular to
                                                      the mattress). Materials include bed rail
                                                      (continued)...
                                                      BedEntrap.pdf
            Mandatory; Priority A                     VHA Patient Safety Alert on Bed Rail Entrapment 2001.doc                                                                                END




        Recalls Alerts Advis - 5                                                           Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        317 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
            Question:                           Rationale/Assessment Methods:                                            (1)         Met (2)    (3)   possible root causes
            2001 Alerts & Advisories                                                                                                                                                       START
5.5.2       (continued)... Bed Rail Entrapment, ...(continued) netting or clear padding or bed rail
(continued) 7/01.                               retrofit kits.

                                                     5. When new bed assemblies or replacement
                                                     mattresses are purchased openings within the
             A patient experienced a close call      bed side rails and gaps between the mattress
             event when his head became              and the side rail shall not exceed the
             wedged in the bed rail opening while dimensions specified in this Alert.
             having a coughing episode. The
             patient was found by the nursing
             staff with a partially obstructed
             airway and was released without
             injury. This alert patient with a right
             side CVA (cerebrovascular
             accident) was trapped while laying
             on his left side.

                                                   BedEntrap.pdf
             Mandatory; Priority A                 VHA Patient Safety Alert on Bed Rail Entrapment 2001.doc                                                                                END
             2001 Alerts & Advisories                                                                                                                                                      START            5.5
5.5.3        General Electric Advantage            1. Identify the affected workstations; affected
             Windows workstation, models           models contain all iteration of software version
             2273156-2 and 2273220-2, 7/01         AW4.0_02. Other software versions are not
                                                   affected.

                                                   2. If affected, contact your local GE field
             The ROI (Region Of Interest)          engineer, schedule the upgrade to version
             function on the workstation can       AW4.0_03 and ask if you are on the effectivity
             change value, depending upon the      list. If so, you should receive the software at no
             display mode selected (i.e.; moving   cost.
             from 1 on 1 to 4 on 1 views, etc.).
             Users have had ROIs displayed with
             incorrect CT#. This can lead to
             misinterpretation of tissue mass
             characteristics.

             Mandatory; Priority A                 GEWorksta.pdf                                                                                                                           END




         Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        318 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                     Not
                                                                                                              Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                               (1)         Met (2)    (3)   possible root causes
            2001 Alerts & Advisories                                                                                                                                            START            5.5
5.5.4       Corruption of VistA Imaging           1. Facility directors must immediately consult
            files,8/01                            with the Chief of IRM to determine if part of the
                                                  routine system management includes moving
                                                  globals. While moving data from one volume to
                                                  another if your facility is using DICOM image
            Patient images and audio fax files    gateway or MUMPS AudioFax system or any
            may become miss-associated when other satellite system that uses DDP to access
            the repacking utility is run and all  data you are at risk and must implement the
            “globals” are not properly shutdown. guidance contained in Office of Information alert
             This means that clinical information #AXP 123. This OI Alert may be found at
            could appear in a patients record     http://vaww.va.gov/custsvc/cssupp/axp/axp123.h
            which is incorrect and the care giver tm
            would have no way of knowing that
            the information is invalid.           2. Also do not move data from one volume to
                                                  another without coordinating the move with the
                                                  other satellite that uses DDP to access VistA
                                                  data. In any case all facility directors must
                                                  respond to oialert@med.va.gov with copies to
                                                  Gerry.Barry@med.va.gov and
                                                  Debbie.Channell@med.va.gov (to ensure
                                                  receipt of this message) by close of business
                                                  August 21, 2001 and report whether this alert
                                                  applies to their operation and if applicable that
                                                  the appropriate procedures are being executed.
                                                  Negative replies are required.
            Mandatory; Priority A                 PACS1.pdf                                                                                                                     END




        Recalls Alerts Advis - 5                                             Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        319 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                      Not
                                                                                                               Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2001 Alerts & Advisories                                                                                                                                             START            5.5
5.5.5       Clinician Awareness of Corruption of 1. Facility Directors must ensure that: All
            VistA Imaging files, 8/01             clinicians are sensitive to and aware of this
                                                  potenital problem. Any clinical concerns related
                                                  to images should be immediately pursued in
                                                  consultation with the Chief IRM.
            Patient images and audio fax files
            may become miss-associated when
            the repacking utility is run and all
            “globals” are not properly shutdown.
             This means that clinical information
            could appear in a patients record
            which is incorrect and the care giver
            would have no way of knowing that
            the information is invalid.

            Mandatory; Priority A                 PACS2.pdf                                                                                                                      END
            2001 Alerts & Advisories                                                                                                                                             START            5.5
5.5.6       Pharmacy Package - Synonym            Interim 1. Review all drug entries in the
            Lookup Resulted in Wrong              Pharmacy Package drug and synonym files to
            Medication Being Displayed or         ensure that there is consistent use of upper and
            Selected, 1/01                        lower case letters.

                                                  Interim 2. Notify all pharmacy personnel that the
                                                  Pharmacy Package drug lookup feature is case
                                                  sensitive. Post reminders in Pharmacy and all
                                                  satellite Pharmacy's.

                                                  Solution: Pharmacy service in conjunction with
                                                  the Offuce of Information Management will
                                                  update the Pharmacy Package lookup feature to
                                                  eliminate case sensitivity. If a single match is
                                                  found, users will be prompted to verify the match
                                                  is correct. These updates will be provided by
                                                  Inpatient Medications patch PSJ*5*55 and
                                                  Outpatient Pharmacy patch PSO*7*54.

            Recommended; Priority A               DrugSyn.pdf                                                                                                                    END




        Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        320 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                      Not
                                                                                                               Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2001 Alerts & Advisories                                                                                                                                             START            5.5
5.5.7       Computerized Medical Record 'List     1. Review the records of patents with identifier
            Manager Version', 7/01                NW to determine if orders have been
                                                  erroneously entered and take appropriate action.

                                                  2. Notify staff of the potential for error if the
            Inadvertent access to medical         correct prompt if not visible when entering new
            record with patient identifier “NW”   orders. Orders are entered at the "Action"
            when attempting to access the NW      prompt rather than the "Patient" prompt.
            (new order) prompt resulting in
            wrong orders for patient NW           3. If your facility has the List Manager version,
                                                  switch to GUI version as soon as possible.
                                                  Remember that complete implementation to the
                                                  GUI verson is required by 12/31/2001.



            Recommended; Priority A               CPRSManager.pdf                                                                                                                END




        Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        321 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                     Not
                                                                                                              Met        Partially   Met   If score other than 'met' what are
            Question:                           Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2001 Alerts & Advisories                                                                                                                                            START            5.5
5.5.8       Risperidone oral medication syringe 1. Consider using oral tablets.
            (pipette), 8/01
                                                2. For those inpatients that cannot tolerate
                                                tablets, have pharmacy prepackage unit dose
                                                liquid.
            Graduated markings on the
            risperidone syringe (pipette) that  3. Advise the caregiver to use USA standard,
            comes in the medication box are     oral syringe by replacing the pipette that comes
            opposite of the markings on         in the box with an oral syringe.
            syringes we use in USA. Nurse
            almost administered the wrong       4. Alert staff that passes medication that devices
            dosage.                             that come in the box for liquid risperidone are
                                                considered pipettes by the company, although
                                                would normally be thought of as syringes by our
                                                frontline users. The markings are opposite of
                                                the syringes we are used to, and the are on the
                                                plunger of the pipettes. If possible, DO NOT
                                                USE THEM.

                                                 5. We are working to encourage the company to
                                                 provide a new pipette that meets USA
                                                 standards. Replace your liquid risperidone
                                                 stock when the new pipettes come out.
            Recommended; Priority A              Pipette.pdf                                                                                                                    END




        Recalls Alerts Advis - 5                                             Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        322 of 1656
                                                             NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                     Not
                                                                                                              Met        Partially   Met   If score other than 'met' what are
            Question:                           Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2001 Alerts & Advisories                                                                                                                                            START            5.5
5.5.9       Hemodialysis Catheters: Ash Split   1. Do not use Alcohol, Acetone, Hydrogen
            and Vaxcel, 8/01                    Peroxide, and other ointments on these
                                                catheters. If these agents are not necessary in
                                                the unit, remove them from the premises.

            These long-term indwelling          2. Prior to insertion/installation in patients:
            catheters may crack and/or form     Inspect each catheter for small blisters (blebs),
            small blisters (blebs), if wrong    cracks and defects as you remove them from
            disinfectants and/or cleaning       the sterile packaging. If any defect is found prior
            solutions are used.                 to installation, stop and sequester the catheter
                                                and its packaging and call your risk manager
                                                and/or patient safety officer.

                                                3. During use site care: a) Inspect the catheter
                                                at each patient's visit and b) Use only
                                                manufacturer's recommended Iodine based
                                                antiseptic soltions.

                                                4. During use monitor patient's symptoms:
                                                Inspect catheters for cracks and blisters of
                                                patients who present with complaints of nausea,
                                                vomiting, and shortness of breath.
            Recommended; Priority A             HemodiCatheterAdv.pdf                                                                                                           END




        Recalls Alerts Advis - 5                                             Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        323 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2002 Alerts & Advisories                                                                                                                                                START            5.6
5.6.1       Zoll M Series defibrillators and M      1. Immediately (within 24 hours) upon receiving
            Series AEDs with software versions      this alert, arrange for Biomedical Engineering to
            below 30.00, 1/02                       confirm whether or not your units are affected
                                                    via the serial number and software version.

                                                    2. If affected:a) M Series Advisory defibrillators
            Specific defibrillators: T98F00046 to   and AEDs with manual operation option -
            T01K27762, AEDs: T98F00092 to           Disable the auto charge configuarion and
            T01J27533, In the auto-charge           contact your local Zoll representative to obtain
            mode, the charging circuit may          the corrective software. You can continue to
            generate an artifact on the             use the defibrillatr in the manual configuration.
            electrocardiograph (ECG) signal         b) Fully Automatic AEDs - Remove the affected
            that can lead the units to display      units from service and contact your local Zoll
            "No Shock Advised" even during          representative for the corrective software. Do
            shockable ventricular fibrillation.     Not use the units until the software has been
                                                    upgraded. Assure that you identify a loaner unit
                                                    to provide coverage for the removed unit.


            Mandatory; Priority A                   ZollDefib.pdf                                                                                                                   END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        324 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                     Not
                                                                                                              Met        Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2002 Alerts & Advisories                                                                                                                                            START            5.6
5.6.2       Bronchoscopes manufactured by        1. Immediately identify all units affected.
            Olympus America, Inc., per           Remove them from service and test them for a
            manufacturer's letter, 3/02          loose portal following Olympus procedure.

                                                  2. If you detect any looseness in the biopsy
                                                  channel port, discontinue using the affected
            Affected models: BF-40, BF-40, BF - bronchoscope, notify Olympus via fax and return
            P40, BF-1T40, BF-3C40, BF -XP40, it to Olympus per their directions for immediate
            BF -XT40, BF –240, BF -P240, BF- upgrade.
            1T240, BF-6C240, BF-160, BF-
            P160, BF-1T160, BF-3C160, BF -        3. If the unit is not affected, it can be used.
            XT160, per manufacturer’s letter, A However, Olympus requests it be returned for a
            loose biopsy port can trap bacteria   biopsy port housing upgrade when practical.
            in a spot that the usual disinfecting
            process may not reach.                4. Finally, if you have affected units, review
            Epidemiologists traced the problem relevant patient records to determine if there is a
            to the Olympus bronchoscopes,         pattern of increased pseudomonas infections
            which were picking up bacteria from associated with the use of these bronchoscopes
            one patient, shielding them from the and report positive findings to Dr. Gary Roselle,
            disinfectants and transferring them   VAMC Cincinnati.
            to the next patient exposed to the
            scope.


            Mandatory; Priority A                BronchOlympusMar02.pdf                                                                                                         END




        Recalls Alerts Advis - 5                                             Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        325 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2002 Alerts & Advisories                                                                                                                                                START            5.6
5.6.3       Baxter Colleague infusion pumps,        1. If you have not arlready received and
            all units may be affected, 5/02         responded to this notice, immediately (within 24
                                                    hours) identify all units affected by this alert and
                                                    contact Baxter at 1-800-843-7867, select 2 (for
                                                    Technical Assistance) then 1 (for Colleague) to
            Product codes 2M8151, 2M8151R,          either arrange modification or obtain the
            2M8153, 2M8153R, If fluid enters        insulators for installation by Biomedical
            the pump body (usually during           Engineering.
            cleaning), there is a risk of a short
            circuit later causing the pump to       2. If a pump us exposed to excessive fluids or
            rapidly cycle on and off. This can      starts cycling on and off, remove it and contact
            happen without any alarms; if this      Biomedical Engineering to arrange for service.
            happens during use, therapy
            delivery may be interrupted.            3. Copy, post, and follow Baxter’s recommended
                                                    cleaning procedures.

                                                    4. As recommended by the manufacturer’s letter
                                                    use the panel lockout feature during infusions as
                                                    standard procedure. This disables the on-off
                                                    switch, preventing the potential on-off cycling
                                                    and allows uninterrupted therapy. Panel lockout
                                                    is engaged and disengaged by pressing the
                                                    black lockout button on the back of the pump.
                                                    Remember to disengage panel lockout to
                                                    change pump settings.


            Mandatory; Priority A                   BaxterColleagueMay02.pdf                                                                                                        END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        326 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2002 Alerts & Advisories                                                                                                                                                START            5.6
5.6.4       Phillips/Agilent/Hewlett Packard        1. If you have the affected units and did not
            Viridia information centers; 5/02.      already receive and respond to Phillips Medical
                                                    Systems letter, immediately check your central
                                                    station monitoring serial numbers against the list
                                                    in the attached letter from Phillips Medical.
            Central station monitors using the
            Hewlett Packard Vectra VL400           2. If affected, contact Phillips Medical at (800)
            personal computer. This PC is used 548-8833 to arrange replacement of the hard
            in models M3150A, M3151A,              drives.
            M3153A and M3150AU#A01 central
            station monitors. All units shipped
            between Feb 1, 2001 and Feb 21,
            2000 are affected. Bedside monitors
            are NOT affected., The hard disk
            drive installed in the units may fail,
            causing loss of central station
            monitoring and alarming. Bedside
            monitoring and alarms are not
            affected.

                                                   PhilipsViridia1.pdf
            Mandatory; Priority A                  PhilipsViridia.pdf                                                                                                               END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        327 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2002 Alerts & Advisories                                                                                                                                                START            5.6
5.6.5       Inadvertent deletion of text from       1. On August 20, 2002, the emergency patch
            CPRS progress notes, 8/02.              OR*3*155 was released; nearly all stations have
                                                    already installed this patch. Within 24 hours of
                                                    this alert, ensure that your facility has installed
                                                    the patch. (This patch removes the spell
            Four VA medical facilities report       checking option on CPRS only. A permanent fix
            random deletion of progress note        is scheduled to be released first week of
            text after running Microsoft Word       October 2002.)
            spell checker while using CPRS GUI.
                                                    2. Patient Safety Managers need to verify that
                                                    clinicians are aware of this issue. In addition,
                                                    clinicians should report any unusual incidents
                                                    they notice relating to the functionality of
                                                    progress notes and associated tools to the
                                                    Office of Information Help Desk at 1-888-596-
                                                    4357 and others per medical center local policy.

            Mandatory; Priority A                   SpellCheckThin.pdf                                                                                                              END
            2002 Alerts & Advisories                                                                                                                                                START            5.6
5.6.6       Recall of the Pocket Guide "VA/DoD      1. Retrieve and destroy all existing Pocket
            Clinical Practice Guideline for         Guides for the “VA/DoD Clinical Practice
            Management of Postoperative             Guideline for Management of Postoperative
            Pain", 9/02.                            Pain.” The guide is white, quad-folded,
                                                    laminated and contains the Equianalgesic Table.


            These printed version units were
            distributed mid-July 2002. There is a
            typographical error in some of the
            pocket guides. The column “Dosage
            forms available” may be printed
            incorrectly in the Equianalgesic
            Table for Fentanyl (IV). The table

            (micrograms/ml)” not “Injection: 50
            mg/ml (milligrams/ml).”

            Mandatory; Priority A                   PocketGuideRecall.pdf                                                                                                           END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        328 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                      Not
                                                                                                               Met        Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2002 Alerts & Advisories                                                                                                                                             START            5.6
5.6.7       MEDISYSTEMS Corp., blood tubing 1. Check your inventory for the affected
            for dialysis, 9/02                   products, Medisystems Product code D3-
                                                 9694/9793 or K3-9694/9793, Baxter Product
                                                 code 5M9694. Contact the manufacturer for
                                                 alternative blood tubing products so that you will
            Product Code D3-9694/9793 or         not compromise needed dialysis treatments.
            K39694/9793, Baxter Code 5M9694, Immediately (within 24 hours) remove affected
            There are reports outside the VA     tubing from service in a manner that does not
            healthcare system that this blood    compromise the provision of necessary dialysis
            tubing may be linked to deaths and treatment.
            injuries when used with the Meridian
            model of dialysis machines
            manufactured by Baxter Healthcare
            Corporation.
            Mandatory; Priority A                 BaxterTubingSept02[1].pdf                                                                                                      END




        Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        329 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
            2002 Alerts & Advisories                                                                                                                                                 START            5.6
5.6.8       4341B Thoracentesis Catheters in        1. Remove all stock with the identified lot
            Thoracentesis Trays distributed by      numbers from the inventory.
            Allegiance Healthcare Corp., 11/02
                                                    2. Follow product return instructions.


            Lot Numbers: L1J035X, L1J088,
            L1K042, L1K058, L1K070,
            L1L057X, L1N018, L1N031,
            L1N039X, L1N094, L1P017,
            L1P045, L1S015, L2A012, L2A021,
            L2A048, L2A075, L2B039, L2B047,
            L2B073, L2C012, L2C038, L2C083,
            L2D041, L2D067, L2E036, The
            catheters may be brittle creating the
            potential for breakage during use.
            These catheters, which are used to
            aspirate fluid from the lungs, are
            only exposed after they are inserted
            into the patient; therefore they
            cannot be examined for flexibility or
            strength prior to insertion.


            Mandatory; Priority A                   AllegianceThoraCatheter.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        330 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2002 Alerts & Advisories                                                                                                                                               START            5.6
5.6.9       Power cords used with GE Dinamap        1. Check the medical equipment inventory to
            Vital Signs Monitors, all models        determine if the specified monitors are in use at
            distributed btwn June 2001 & Oct        the facility.
            2002, 11/02
                                                    2. Immediately replace any cords with a broken
                                                    ground pin with another spare power cord that is
                                                    not affected by this notice.
            A VA medical center reported
            ground pins breaking on the power       3. Determine the total number of power cords
            cords used with GE Dinamap Vital        affected by this notice, whether they show
            Signs Monitors. This compromises        broken ground pins or not. They can be
            one of the safety features designed     identified by their manufacture date code as
            to limit patients' risk of electrical   follows. Two numbers are imprinted on the hot
            shock, should an electrical fault       and neutral blades; one is the week and the
            occur in the equipment. Unless the      other is the year of manufacture. Blades made
            pin has broken, patient safety is not   between (week - year) 09 - 01 and 16 - 02 are
            compromised.                            affected.

                                                    4. Contact General Electric to replace all the
                                                    power cords affected by this notice. The contact
                                                    at GE is Erik Granby; he can be contacted at
                                                    (813) 887-2545 or via e-mail at
                                                    erik.granby@med.ge.com.

                                                    5. When new cords are installed, return the
                                                    affected cords to GE for disposal.
            Mandatory; Priority A                   GEDinamapCord.pdf                                                                                                              END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        331 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                            Not
                                                                                                                     Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                    (1)         Met (2)    (3)   possible root causes
             2002 Alerts & Advisories                                                                                                                                                  START            5.6
5.6.10       Potential for incorrectly attaching    1. Use only standardized irrigation kits identified
             Allegiance Irrigation Kit caps to      by the Medical/Surgical Users Group; acquire
             Foley catheters, 2/02.                 from LSL Industries purchased under (BPA)
                                                    Blanket Purchase Agreement # VANAC90NP-00-
                                                    035 with Foley catheters.

             The tubing cap (Catalog #3T4121)       2. Check with Materials Management to
             of the Allegiance irrigation kit is    determine if Allegiance Irrigation kits are present
             small enough to fit into a Foley       in your facility. If so, alert all clinical staff of this
             catheter, resulting in an obstructed   possible problem and the manufacturer’s
             Foley catheter.                        intended use and design of the cap. Make
                                                    copies of the attached WARNING sheet and
                                                    distribute with Allegiance irrigation kits. Place
                                                    signs in areas where this product is used to
                                                    remind staff to remove cap from urinary bag
                                                    tubing (if it is their practice to cap the bag
                                                    tubing), prior to reinsertion to Foley catheter.


             Recommended; Priority A                Foleycath.pdf                                                                                                                      END




         Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        332 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                    Not
                                                                                                             Met        Partially   Met   If score other than 'met' what are
             Question:                           Rationale/Assessment Methods:                               (1)         Met (2)    (3)   possible root causes
             2002 Alerts & Advisories                                                                                                                                          START            5.6
5.6.11       Confusion between Oxygen &          1. Purchase clear adaptors and avoid green-
             Compressed Air Wall Outlet, 3/02    yellow confusion.

                                                2. When appropriate, purchase compressed air
                                                tubing that does not require "Christmas Tree"
             Close calls have occurred when low adapters, so adapters are not needed for air.
             oxygen saturation on pulse
             oximeters revealed that patients   3. Consider removing air flowmeters when not in
             who inadvertently had their oxygen use; this may require addressing informal norms
             tubing hooked up to air regulators through training, incentives.
             with green adapters instead of
             oxygen.                            4. More prominently label air and oxygen outlets.

                                                 5. Respiratory Therapy, Nursing, and Pharmacy
                                                 must work together for the smoothest
                                                 implementation of any redesign or training.



             Recommended; Priority A             Air_O2WallInlet.pdf                                                                                                           END




         Recalls Alerts Advis - 5                                           Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        333 of 1656
                                                                       NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
             Question:                                Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
             2002 Alerts & Advisories                                                                                                                                                START            5.6
5.6.12       Addendum to Patient Safety               1. The National Center for Patient Safety and
             Advisory Issued on February 27,          the VA Medical/Surgical Users’ Group are
             2002 Concerning Allegiance               working with the VA National Acquisition Center
             Irrigation Kits, 5/02                    and vendors to modify the configuration of the
                                                      caps so that inadvertent insertion is effectively
                                                      precluded. Until we can find a vendor who is
                                                      willing to modify the configuration, continue to
             It has come to our attention that        remind caregivers that blockage/obstruction
             even the larger size caps of the         could occur. Use the attached WARNING sheet
             standardized product we suggested        to distribute with the products.
             in the previous advisory have been
             incorrectly inserted into the drainage
             port of larger Foley catheters. The
             tubing cap of the standardized LSL
             urinary drainage bag was
             inadvertently left on and inserted
             into the drainage port of a Foley
             catheter. This obstructed the flow of
             urine from a patient.
             Recommended; Priority A                  AllegIrrig.pdf                                                                                                                 END




         Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        334 of 1656
                                                             NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                     Not
                                                                                                              Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                               (1)         Met (2)    (3)   possible root causes
             2002 Alerts & Advisories                                                                                                                                           START            5.6
5.6.13       SSCOR Inc, Suction Pumps, Models    1. Check the medical equipment inventory to
             2314, 2314B, and 2315, all units,   determine if you have the specified pumps.
             7/02                                Model numbers for the SSCOR suction units
                                                 can be found on a silver label on the back of the
                                                 units. Ensure any units on hand are being used
                                                 as intended, and not placed in areas where they
             These pumps are designed for short- can be used for long term or continuous suction.
             term suction, primarily during
             resuscitation efforts, yet one      2. Refer to the revised page 3 of the operator
             medical center used them for        and service manuals (attached), copy and insert
             extended procedures, use of these the revised pages in all SSCOR 2314, 2314B
             pumps for extended high             and 2315 operator and service manuals. If
             vacuum/high occlusion can lead to   manuals are not available they can be obtained
             overheating and premature pump      from the manufacturer or from the Center for
             failure, making the equipment       Engineering and Occupational Safety & Health
             unavailable for use and limiting    (CEOSH) at (314) 543-6700 or at
             needed suction.                     http://vaww.ceosh.med.va.gov.

                                                  3. Label pumps to reflect intended use:
                                                  “CAUTION: Not for continuous suction; for short
                                                  term use only.”

                                                  4. Train users on the intended use of these
                                                  pumps and the possible risk associated with use
                                                  beyond the equipment’s design. If necessary,
                                                  purchase appropriate suction systems for
                                                  wound or procedural drainage.


             Recommended; Priority A              SSCOR7_02.pdf                                                                                                                 END




         Recalls Alerts Advis - 5                                            Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        335 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
             2002 Alerts & Advisories                                                                                                                                               START            5.6
5.6.14       CPRS & Inpatient Complex                For Providers authorized to enter orders:
             Medication Orders, 8/02
                                                     1. When entering a complex medication orders,
                                                     keep a written list of all your complex orders and
                                                     at renewal time, reference the list and enter
             When renewing an automatically          complex orders first.
             stopped medication order of a
             tapering dose, or editing an existing   2. Notify pharmacy of all your complex orders
             order of a single dose the start/stop   when you initiate them by including a statement
             dates will be changed and overlap       in the Provider Comments on CPRS such as
             the current order. This could result    “TAPERING ORDER” or “PART OF COMPLEX
             in a patient receiving multiple doses   ORDER”.
             in one day, if the provider didn’t
             notice the shift in start dates.        3. When editing or renewing orders, review the
                                                     displayed start/stop dates in CPRS and be
                                                     aware that a new order might be inadvertently
                                                     created and that new order’s start/stop dates will
                                                     be changed and overlap the current order.

                                                     For Pharmacy staff:

                                                     1. Pay particular attention to tapering orders.
                                                     Devise a method or process to alert others in
                                                     the pharmacy as tapering orders are received.
                                                     For Example: Include a statement in the Special
                                                     Instructions such as “TAPERING ORDER” or
                                                     “PART OF COMPLEX ORDER”.

                                                     2. Review the BCMA last action displayed on
                                                     renewed order when verifying within inpatient
                                                     meds.
             Recommended; Priority A                 CPRScomplexorders.pdf                                                                                                          END




         Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        336 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2002 Alerts & Advisories                                                                                                                                               START
5.6.14      (continued)... CPRS & Inpatient         ...(continued) Providers authorized to administer
(continued) Complex Medication Orders, 8/02         medication:

                                                    1. Before administering medications double
                                                    check against the electronic MAR to make sure
            When renewing an automatically          that this is part of a complex order and proper
            stopped medication order of a           start date and time. Be aware of cases where
            tapering dose, or editing an existing   multiple doses are due on the same date.
            order of a single dose the start/stop
            dates will be changed and overlap       2. Review the last action for that medication
            the current order. This could result    displayed within BCMA before administering a
            in a patient receiving multiple doses   medication.
            in one day, if the provider didn’t
            notice the shift in start dates.

            Recommended; Priority A                 CPRScomplexorders.pdf                                                                                                          END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        337 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
             2002 Alerts & Advisories                                                                                                                                              START            5.6
5.6.15       Cochlear Implant Recipients may be   1. "The FDA advised that cochlear implant
             at increased risk for bacterial      candidates, as well as those already implanted,
             meningitis, 9/02                     may benefit from vaccinations against
                                                  organisms commonly associated with bacterial
                                                  meningitis, particularly S. pneumoniae and H.
                                                  influenzae (ACIP recommends 23valent
             The FDA has determined that, over    pneumococcal vaccines [Pnu-ImuneR 23 and
             the past 14 years, 52 cases of       PneumovaxR]] for adults with increased risk of
             meningitis have been reported        invasive pneumococcal disease). Therefore, all
             worldwide, out of which 12 known     veterans who are candidates for cochlear
             deaths have resulted from these      implant (s) should be ascertained of their
             cases. It was identified that 24     immunization status prior to surgery as well as
             cases (of the 52 worldwide cases)    all patients with existing implants received from
             were in North America.               VA and non-VA facilities. Previously
                                                  unvaccinated adults with a high-risk condition
                                                  (functional or anatomic aspleina,
                                                  immunodeficiency, [particularly, persons with
                                                  IgG2 subclass deficiency], immunosuppression
                                                  from cancer chemotherapy, and infection with
                                                  human immunodeficiency virus) should be given
                                                  at least one dose of any licensed Hib conjugate
                                                  vaccine. As neither FDA nor CDC specifically
                                                  notes the use of Hib vaccine in (continued)...


             Recommended; Priority A              CochlearImplantAdvisory.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        338 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
            2002 Alerts & Advisories                                                                                                                                               START
5.6.15      (continued)... Cochlear Implant       ...(continued) adults related to cochlear
(continued) Recipients may be at increased risk   implants, the use of Hib vaccine in this scenario
            for bacterial meningitis, 9/02        would be based on theoretical risk.
                                                  For additional info on immunizations refer to the
                                                  following websites.
                                                  http://www.cdc.gov/nip/publications/pink/
            The FDA has determined that, over
            the past 14 years, 52 cases of        http://www.cdc.gov/mmwr/preview/mmwrrhtml/00
            meningitis have been reported         025228
            worldwide, out of which 12 known      http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf
            deaths have resulted from these       "
            cases. It was identified that 24
            cases (of the 52 worldwide cases)     2. In some of the reported cases, patients may
            were in North America.                have had overt or sub-clinical otitis media prior
                                                  to surgery or before meningitis developed.
                                                  Physicians are encouraged to consider
                                                  appropriate prophylactic perioperative antibiotic
                                                  treatment, and to diagnose and treat otitis media
                                                  promptly in patients with cochlear implants.

                                                  3. Patient Safety Managers, please make sure
                                                  that Primary Care Physicians, EENT specialists
                                                  (on Surgery service) and Audiologists are aware
                                                  of this. Follow FDA MedWatch reporting
                                                  instructions to report cases of meningitis in
                                                  cochlear implant recipients.


            Recommended; Priority A               CochlearImplantAdvisory.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        339 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
             Question:                             Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
             2002 Alerts & Advisories                                                                                                                                                    START            5.6
5.6.16       Inpatient Medications Version 5.0     1. Install CPRS/BCMA PSJ*5*94 and PSB*2*13
             and BCMA Version 2 (PSJ*5*94 and      when they are released. These patches are
             PSB*2*13), 11/02                      currently undergoing testing and are scheduled
                                                   for release by November 30, 2002.

                                                   2. In the interim when pharmacists renew IV
             Original IV continuous orders do not continuous orders, indicate the start date as
             appear on the Virtual Due List        "now."
             (VDL), if a renewal order is entered
             with a future date/time. The original
             order and the renewed order will not
             display on the VDL until the start
             date/time of the renewed order is
             reached. This could lead to a
             missed IV administration.

             Recommended; Priority A               BCMA_VDL_Advisory.pdf                                                                                                                 END
             2002 Alerts & Advisories                                                                                                                                                    START            5.6
5.6.17       CPRS consultant note amendments 1. Patient Safety Managers should check with
             are not printing and displaying after the Chief MIS and others who are authorized to
             changes are entered 12/02             amend consultant notes, to ensure that all
                                                   documents are manually LINK under ‘Consults
                                                   hierarchy’ when documents are amended.
                                                   Authorized amenders should also verify that the
             Specifics are: TIU version 1.0,       amended document is listed under the related
             Consults version 3.0, A VA Medical document hierarchy. There should be two
             Center reported that amended          documents, the amended document and the
             consult notes did not print with      retracted document.
             updated information after authorized
             personnel entered them. While the     2. Notes that have been previously amended
             electronic record displays the        should be reviewed against the electronic data
             corrected information, the printed    to verify accuracy and manually linked if
             copy does not. This may result in     necessary.
             incorrect information being relied
             upon when making clinical decisions.


             Recommended; Priority A               CPRSConsultantNoteAmendments.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                     Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        340 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2003 Alerts & Advisories                                                                                                                                               START            5.7
5.7.1       Connection tubing set used with        1. Notify staff to observe for normal inflation on
            Sequential Compression Device          the SCD sleeves when first applied to a patient.
            (SCD) 1/03                             In particular, activate the cooling button for 30
                                                   seconds to ensure that no observable over-
                                                   inflation occurs.

            Models 6235, 7325, 5320 and 5325       2. Inspect all Kendall SCD tubing sets to confirm
            manufactured by Kendall (Tyco          that none of the recalled sets remain on site
            Healthcare). The recalled tubing       (identification instructions are attached). Either
            sets have a reversed connector and     positively identify “blank” (no lot number label)
            pose a serious hazard. Underr this     tubing sets for proper connectors or treat them
            condition the SCD becomes a            as suspect.
            tourniquet applying up to 200 mmHg
            pressure around the extremity. This    3. Contact Kendall to obtain replacement
            condition can persist even after the   connection tubing sets. The contact at Kendall
            machine is turned off and in a pain-   is Karen Tabaczynski; she can be contacted at
            controlled patient, could go           (508) 261-8037.
            unnoticed for several hours, leading
            to permanent tissue damage.


            Mandatory; Priority A                  KendallConnectTubing.pdf                                                                                                        END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        341 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2003 Alerts & Advisories                                                                                                                                                START            5.7
5.7.2       Zoll AED Plus, Public Access            1. Immediately identify all affected units.
            Defibrillator (PAD) distributed before
            Dec 8 2002, 2/03                        2. For AEDs awaiting updating, determine which
                                                    of the following work around procedures is best
                                                    suited for your application: a) If the error
                                                    condition is activated, turn the AED off for 10
            Serial numbers X02K000812 to            seconds, then restart; or b) Attach the pads to
            X02K0077486. While handling             the patient prior to turning the AED on.
            electrodes prior to attaching them to
            a patient, communication between        3. Place the appropriate work around
            the unit’s internal ECG and Safety      instructions with each affected defibrillator and
            Monitoring functions can lead to an train potential users on the work around.
            error condition. This error condition Remember to schedule training again after the
            will cause the defibrillator to issue a software upgrade is installed.
            "Shock Advised" message,
            immediately followed by "No
            Treatment Delivered" and "Change
            Batteries" messages.

            Mandatory; Priority A                  ZollDefibFeb2003.pdf                                                                                                             END
            2003 Alerts & Advisories                                                                                                                                                START            5.7
5.7.3       Counterfeit drugs labeled as           1. Follow this link for details on identifying the
            PROCRIT® (Epoetin alfa) 40,000         counterfeit products and directions:
            units/mL; 3/03                         http://www.procrit.com/counterfeit/letter.html

                                                   2. Inspect your stock and immediately remove
                                                   all affected product.
            Lot numbers: P007645, expiration
            10/2004; P004677, expiration           3. Notify the physician in charge if follow-up of
            02/2004; and P004839, expiration       patient(s) is indicated.
            02/2004. FDA testing of the
            counterfeit products indicates they
            are contaminated with bacteria and
            some counterfeit products contain
            no active ingredient.
            Mandatory; Priority A                  Procritcounterfeit.pdf                                                                                                           END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        342 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2003 Alerts & Advisories                                                                                                                                               START            5.7
5.7.4       ACCU-CHEK® Comfort Curve® and           1. For inpatient and clinic areas: Within the next
            Advantage® test strips                  72 hours, inspect the inventory and check the
            manufactured by Roche Diagnostics       bottom of any unused or currently in-use vials
            Corp; 5/03                              for cracks. Make sure that the lot specific code
                                                    key inside each strip box is kept associated with
                                                    the correct vial as you conduct this inspection.
                                                    Also, as a standard practice, inspect each vial
            The bottom of the vial may be           for cracks before each use. If you find cracked
            cracked which may cause                 vials, do not use the strips and call 1-800-440-
            inaccurate blood glucose results        3638 to arrange for a replacement product.
            due to changes in humidity. This
            product correction refers to all lots   2. Patients at home: The Pharmacy Benefits
            currently available of the ACCU-        Management (PBM) is notifying outpatients.
            CHEK® Comfort Curve® test strips,
            part numbers 2030420, 2030365,
            2030373, 2030381, 3000133,
            3000141 and the ACCU-CHEK®
            Advantage® test strips, part
            numbers 336, 553, 787, and 966.

            Mandatory; Priority A                   AccuChek.pdf                                                                                                                   END
            2003 Alerts & Advisories                                                                                                                                               START            5.7
5.7.5       In-line air filter requirement for      1. If you use these pumps immediately acquire
            Abbott Pumps, 6/03                      IV administration sets from the manufacturer
                                                    that are configured with the required air
                                                    elimination filters or IV extension sets configured
                                                    with the required air elimination filters for the
            A new manufacturer requirement for pumps listed.
            air elimination filters and air-in-line
            detection tests for Intravenous         2. Immediately review and revise operating and
                                                    maintenance procedures to incorporate air-in-
            Plus, APMTM, APMII, and                 line tests per manufacturer instructions for the
            ANNETM, manufactured by Abbott          pumps listed.
            Laboratories Hospital Product
            Division.
            Mandatory; Priority A                   AbbottPumpsAir_Line.pdf                                                                                                        END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        343 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                    (1)         Met (2)    (3)   possible root causes
            2003 Alerts & Advisories                                                                                                                                                  START            5.7
5.7.6       Decimal point display issue with       1. Check to see if you have these pumps at you
            Abbott APM II pump, 6/03               facility. If these pumps are not used, then no
                                                   further action is required.

                                                   2. If you have these pumps review the analgesic
            The APM II Pump will not display a     formulary to determine if your facility uses
            decimal point on the screen when       Fentanyl or other analgesics that are
            entering values in the tenths of       administered via a PCA pump in the microgram
            micrograms per milliliter (mcg/mL).    per milliliter concentration range. If these
            However, the decimal point is          medications are not used no further action is
            displayed when the value entered is    required.
            in the milligrams/milliliter (mg/mL)
            range.                                 3. If the pumps are present and used to
                                                   administer Fentanyl or other analgesics ensure
                                                   that there is a facility guideline for use of these
                                                   drugs with PCA pumps. a. Guidelines must
                                                   cover all aspects of medication ordering,
                                                   dispensing, administration and monitoring. b.
                                                   Make sure that a standard dose in whole
                                                   numbers is ordered. Use only whole numbers
                                                   without a decimal. c. Make sure that a standard
                                                   solution is dispensed to the patient at a
                                                   concentration that is compatible with PCA
                                                   pumps. Only use whole numbers without
                                                   decimals. d. Have Pharmacy review all PCA
                                                   medication orders for accuracy, to (continued)...


            Mandatory; Priority A                  AbbottPumpsDecimalReadout.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        344 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                                      (1)         Met (2)    (3)   possible root causes
            2003 Alerts & Advisories                                                                                                                                                  START
5.7.6       (continued)... Decimal point display ...(continued) make sure medication orders and
(continued) issue with Abbott APM II pump, 6/03 dispensing meets your facility’s guidelines and
                                                 are in whole number before sending to the
                                                 patient care unit for administration.

            The APM II Pump will not display a
            decimal point on the screen when
            entering values in the tenths of
            micrograms per milliliter (mcg/mL).
            However, the decimal point is
            displayed when the value entered is
            in the milligrams/milliliter (mg/mL)
            range.

            Mandatory; Priority A                  AbbottPumpsDecimalReadout.pdf                                                                                                      END
            2003 Alerts & Advisories                                                                                                                                                  START            5.7
5.7.7       Power cords for Hill-Rom Century+      1. Check the medical equipment inventory to
            electric beds, distributed between     determine if you have Hill-Rom, Century +
            Jan 1 1999 and July 1 2002; 7/03       electric beds and inspect the power cords for
                                                   beds that fall within the affected range.

                                                   2. Determine the number of power cords
            Power cord ground pins on some         affected by this notice. Affected cords are
            portable monitors broke off. This      identified by their manufacture date with codes
            fracture compromises one of the        as follows: 09 - 01 through 16 - 02 (week - year)
            safety features designed to limit      is imprinted on the hot and neutral cord blades.
            patients' risk of electrical shock.    Immediately replace any cords with a broken
            Unless the pin has broken, patient     ground pin with a spare and schedule
            safety is not compromised.             replacement of other cords with an imprinted
                                                   date that falls within the affected range.

                                                   3. Contact Hill-Rom technical support at 800-
                                                   445-3720 for replacement power cords. We
                                                   also suggest you provide them with updated
                                                   contact information for future notices.

            Mandatory; Priority A                  HillRomPower.pdf                                                                                                                   END




        Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        345 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2003 Alerts & Advisories                                                                                                                                                START            5.7
5.7.8       Soft Skin™ protective sleeve            1. If this product is present in any areas you
            manufactured by Span America to         consider to be high risk for self-harm, remove
            cover Geo-Matt® seat cushions and       the plastic cover.
            mattresses, 7/03
                                                    2. Remove any other plastic covers, sleeves,
                                                    wraps, liners, or bags that are accessible to the
                                                    patient from areas classified as high risk for self
            A patient in locked psychiatric ward    harm.
            used a plastic cover on a Geo-
            Matt® wheelchair cushion to commit
            suicide. The patient removed the
            protective sleeve/covering on the
            cushion and placed it over their
            head/face resulting in suffocation.
            The wheelchair seat cushion was
            purchased with the plastic cover in
            place for incontinence protection. It
            is worth restating that plastic
            trashcan liners, sleeves, wraps, dry
            cleaning bags, etc., present similar
            suffocation hazards.

            Mandatory; Priority A                   SoftskinAlert.pdf                                                                                                               END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        346 of 1656
                                                             NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                     Not
                                                                                                              Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                               (1)         Met (2)    (3)   possible root causes
            2003 Alerts & Advisories                                                                                                                                            START            5.7
5.7.9       J&J/Cordis Cypher™ Sirolimus-         1. Interventional Cardiologist: In addition to
            Eluting Coronary Stent, 11/03         following the manufacturer’s recommendation
                                                  (see attached letter from Cordis dated July 7,
                                                  2003), coordinate with the post-stent care
                                                  physicians to ensure that the required
            Informing Physicians of sub-acute     antiplatelet therapy regimen is continued post-
            thromboses (SAT) and                  stenting.
            hypersensitivity reactions with the
            use of the Cordis CypherTM drug       2. Post-stent care Physicians: As recommended
            eluting Coronary Stent.               by Cordis
                                                  http://www.fda.gov/bbs/topics/news/cordis_ltr.pdf
                                                   and referred to by the FDA “Administration of
                                                  continued antiplatelet therapy for three (3)
                                                  months post-stenting is considered critical.”

                                                  3. Report all adverse events to Cordis at 1 800
                                                  327 7714 and FDA via MedWatch.

            Mandatory; Priority A                 CYPHER_DES.pdf                                                                                                                END




        Recalls Alerts Advis - 5                                             Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        347 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
             2003 Alerts & Advisories                                                                                                                                               START            5.7
5.7.10       Roche Diagnostics Corp.                 1. Inspect all CoaguChek PT test-strip foil
             CoaguCheck PT Test Strips, 11/03        pouches before use to verify pouch integrity,
                                                     regardless of the lot number. Refer to the
                                                     attached photographs to help identify defective
                                                     packages.
             Catalog # 3116247 (professional
             use), Catalog # 3116239 (patient        2. If the foil pouches appear to be compromised
             self test), Catalog # 1937642           do not use the test strips and notify Roche
             (packaged 48 strips per box),           Diagnostics Point of Care Technical Service at
             Catalog # 1937634 (packaged 12          (800) 428-4674 within the U.S., or visit the
             strips per box), Lot #s 591, 619, 600   CoaguChek Web site at http://www.coaguchek-
             and 583. Extended to all lots with an   usa.com. To receive replacement product, fax
             expiration date of on or before         the replacement request form to Roche
             March 1, 2005., A packaging defect      Diagnostics at (800) 722-7222 within the U.S.
             involved the opening scoremark
             intruding into the sealed pouch         3. If the foil pouches appear to be intact run
             containing the product. This defect     duplicate tests, is the test strip lot number is
             may allow air and moisture to enter     lower that lot 670 . Duplicate test results should
             the sealed pouch causing erroneous      be within +/-1.0 international normalized ratio
             readings when the strips are used.      (INR) of each other for values less than 4.5 INR.
                                                     If values are greater than +/-1.0 INR or greater
                                                     than 4.5 INR, consult with the physician or
                                                     pathologist at your facility.


             Mandatory; Priority A                   CoaguChekClassIrecall.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        348 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
             2003 Alerts & Advisories                                                                                                                                               START            5.7
5.7.11       Counterfeit PROLENE                    1. Physicians, nurses, and all other healthcare
             Polypropylene Mesh, 11/03              professionals must carefully examine all
                                                    PROLENE flat mesh (3”x6”) before use. Do not
                                                    use any product that is suspected to be
                                                    counterfeit. If counterfeit mesh is found contact
             Product code PMII bearing lot          the distributor to discuss refund/replacement of
             numbers RBE609 (expiration date        the product(s). Refer to the attached
             1/07) and RJJ130 (expiration date      photographs for information on how to identify
             7/07). Prolene flat mesh 3" x 6",      counterfeit PROLENE mesh.
             Physicians, nurses and all other
             healthcare professionals should        2. Review surgical records for patients to
             carefully examine all PROLENE flat     determine if they are recipients of the counterfeit
             mesh product before using it to        mesh. Involve your regional counsel when
             determine if it is counterfeit based   communicating with affected patients. We are
             upon photographs provided by           waiting for the FDA to issue additional
             Ethicon.                               information regarding the mechanical properties,
                                                    biocompatibility or sterility of the material. This
                                                    additional information may be used as needed
                                                    when communicating with patients who have
                                                    received this mesh.


             Mandatory; Priority A                  CounterfeitProlene.pdf                                                                                                          END




         Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        349 of 1656
                                                             NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                     Not
                                                                                                              Met        Partially   Met   If score other than 'met' what are
             Question:                         Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
             2003 Alerts & Advisories                                                                                                                                           START            5.7
5.7.12       Olympus Cystoscopes, models CYF- 1. Check inventory for affected cystoscopes.
             4/4A and CYF-240/240A with MAJ-
             891 Forceps/Irrigation Plug, 2/03 2. Inspect the MAJ-891 plug (refer to the photo
                                               in the attached Olympus notice). Earlier
                                               production, affected plugs have a black rubber
                                               locking ring; later production, replacement plugs
             Earlier production MAJ-891 plugs  have a gray rubber locking ring.
             can bind when connected to the
             aforementioned cystoscopes. This 3. Contact Olympus immediately if you have the
             binding can lead the operator to  affected plug. Refer to attachment for more
             apply excessive force when        information.
             removing the plug, thus damaging
             the cystoscope and rendering it   4. Contact Paul Sherman at CEOSH via e-mail
             unusable.                         at paul.sherman@med.va.gov if you have the
                                               affected plug and did not receive the letter from
                                               Olympus.

             Recommended; Priority A             OlympusCYF.pdf                                                                                                                 END
             2003 Alerts & Advisories                                                                                                                                           START            5.7
5.7.13       Olympus EXERA Gastrointestinal      1. Follow manufacturer instructions.
             Endoscopes, 3/03
                                                 2. All channels of all endoscopes must be
                                                 reprocessed during each reprocessing cycle
                                                 even if the channels were not utilized during the
             Models: CF-Q160L, CF-Q160I, CF-     preceding patient procedure.
             160S, CF-Q160AL, CF-Q160AI and
             GIF-2T160, The manufacturer
             issued a safety notice to remind
             users that the auxiliary water
             channel must be reprocessed each
             time the endoscope is used.
             Recommended; Priority A             OlympusEXERA.pdf                                                                                                               END




         Recalls Alerts Advis - 5                                            Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        350 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
             Question:                                Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
             2003 Alerts & Advisories                                                                                                                                                 START            5.7
5.7.14       Adverse Reaction/Allergy database        1. Information Resource Management (IRM) at
             of CPRS GUI v20 Allergy Reaction         VAMCs should monitor the VistA M error trap, at
             Tracking v4.0; 4/03                      least on a daily basis (until a patch is released)
                                                      to determine if the data has been recorded
                                                      properly in file 120.8. If the data is not recorded
                                                      on file 120.8, then the data will need to be re-
             Allergy information does not get         entered.
             recorded in the database if the
             correct letter is not entered in the
             “Enter Allergy Information” dialog
             box, the allergy entry will appear on
             the Orders Tab as an unreleased
             order and the data is not sent to the
             Allergy/Adverse Reaction Tracking
             application. Therefore, the
             information is not posted and will not
             trigger allergy alerts.


             Recommended; Priority A                  CPRSAllergy.pdf                                                                                                                 END




         Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        351 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
             Question:                             Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
             2003 Alerts & Advisories                                                                                                                                              START            5.7
5.7.15       The Ancure ® Endograft System         1. Because the Ancure ® device will no longer
             made by EndoVascular                  be supported in the near future other
             Technologies, Inc.will no longer be   procedures and FDA approved devices should
             sold. 6/03                            be considered for cases requiring endovascular
                                                   repair.


             Endo Vascular Technologies, Inc. of
             Menlo Park, CA, is a subsidiary of
             Indianapolis-based Guidant
             Corporation. Ancure ® is the
             registered name for a device used
             to treat abdominal aortic aneurysm
             without tradional surgical
             techniques. This device will no
             longer be supported in the near
             future. Other procedures and FDA
             approved devices should be
             considered for cases requiring
             endovascular repair.
             Recommended; Priority A               Ancure.pdf                                                                                                                      END
             2003 Alerts & Advisories                                                                                                                                              START            5.7
5.7.16       METFORMIN Orders on CPRS V3.0 1. Mark metformin in the facility drug file as “Not
             GUI v22; 9/03                 Renewable” until the order check function in
                                           CPRS is upgraded with patch OR*3*190
                                           currently being developed.

             A patient’s order for metformin was   2. In the interim, if you wish to continue the
             renewed three times although the      same order, use the COPY feature.
             serum creatinine values before
             renewal were above 1.5mg/dL.          3. Review patients that are currently receiving
                                                   metformin with serum creatinine values higher
                                                   than normal and take appropriate interventions.

             Recommended; Priority A               Metformin9_03.pdf                                                                                                               END




         Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        352 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                                START            5.8
5.8.1       Proper Connectors for Sterlization of    1. By March 5, 2004 conduct in-service training
            all Gastrointestinal Fiberoptic          at all sites including VA medical centers and
            Endoscopes, 2/04                         CBOCs for personnel tasked with reprocessing
                                                     gastrointestinal fiberoptic endoscopes. The in-
                                                     service training must address manufacturer
                                                     instructions for proper reprocessing of specific
            Using an incorrect connector to link     models of gastrointestinal fiberoptic endoscopes
            sterilizing solution to endoscopes       for consistency with local work procedures. All
            during reprocessing (cleaning and        third party (other than the endoscope
            sterilizing) procedures. A dual-port     manufacturer) tools and materials used for
            or “Y” connector designed to             reprocessing must also be covered during the in-
            connect to endoscopes                    service training.
            incorporating dual ports was
            connected to endoscopes with             2. Validate that appropriate reprocessing
            single ports. Under this condition an    connectors are being utilized with each model of
            indeterminate amount of sterilizing      endoscope. Some manufacturers provide
            solution may have been directed to       cognitive aids such as instruction placards and
            the unconnected port, possibly           these must be available and intact where
            leading to inadequate sterilization of   provided.
            the endoscope.
                                                     3. Incorporate knowledge of proper handling
                                                     and reprocessing of gastrointestinal fiberoptic
                                                     endoscopes into JCAHO competency
                                                     assessment requirements for individuals tasked
                                                     with this assignment.

                                                     4. Facility Patient Safety Managers will monitor
                                                     (continued)...
            Mandatory; Priority A                    EndoscopeCleaning_all.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        353 of 1656
                                                                     NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
            Question:                                  Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                                  START
5.8.1       (continued)... Proper Connectors           ...(continued) the in-service training requirement
(continued) for Sterlization of all Gastrointestinal   and report completion to the VISN Patient
            Fiberoptic Endoscopes, 2/04                Safety Officer. Reporting instructions for the
                                                       VISN PSO will be provided in a separate
                                                       communication from the office of the Deputy
                                                       Under Secretary for Health for Operations and
             Using an incorrect connector to link      Management.
             sterilizing solution to endoscopes
             during reprocessing (cleaning and      5. Scheduled procedures may continue while
             sterilizing) procedures. A dual-port   the above actions are undertaken.
             or “Y” connector designed to
             connect to endoscopes
             incorporating dual ports was
             connected to endoscopes with
             single ports. Under this condition an
             indeterminate amount of sterilizing
             solution may have been directed to
             the unconnected port, possibly
             leading to inadequate sterilization of
             the endoscope.


             Mandatory; Priority A                     EndoscopeCleaning_all.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        354 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                       Not
                                                                                                                Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                              START            5.8
5.8.2       Potential bacterial contamination of   1. Immediately remove and quarantine the
            Twice-A-Day Nasal Spray                affected nasal spray bottles from inventory.
            manufactured by Propharma Inc.,
            3/04



            Product with Lot Number K4496,
            generic name is Oxymetazoline HCl
            0.05% with the following additional
            identifiers: NDC# 0904-5217-35 and
            0904-5217-30, Lot number K4496,
            expiration date 10/06.

            Mandatory; Priority A                  PropharmaNasalSpray.pdf                                                                                                        END




        Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        355 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                                        START            5.8
5.8.3       Oxygen Utility System, 4/04             1. Conduct alarm-set point verification through
                                                    the use of a qualified third party expert. The set
                                                    points must be code compliant and this action
                                                    documented. (see NFPA-99 5.1.3.4.11.6, 2002
            Two VA Medical Centers reported a       Edition)
            loss of service in the Oxygen Utility
            System. In both incidents the alarm     2. Ensure that a minimum of two, independent
            on the main tank did not sound until    24/7 and constantly attended monitoring
            reaching near or completely empty       stations are provided for all alarm conditions
            and both sites did not meet the         related to the Oxygen Utility System. Test all
            NFPA-99 requirement for two,            alarm conditions to ensure the alarm
            independent 24/7 supervised areas       annunciation is working.
            where mandatory alarm conditions
            for the Oxygen Utility System are       3. If either of the conditions in 1. or 2. above
            annunciated                             cannot be met, the Medical Center must publish,
                                                    over the Director’s signature, a comprehensive
                                                    Interim Life Safety Measure that fully addresses
                                                    and compensates for the non-compliant
                                                    condition. The ILSM must remain in effect until
                                                    the code requirements are met. In addition
                                                    appropriate staff must be trained on the ILSM
                                                    requirements, and this training needs to be
                                                    documented.

                                                    4. Review the oxygen delivery contract and
                                                    verify the delivery schedule meets current
                                                    demands to ensure an adequate supply of
                                                    Oxygen (continued)...
            Mandatory; Priority A                   OxygenUtilitySystemAlert040504.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        356 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                                         START
5.8.3       (continued)... Oxygen Utility            ...(continued) so alarm conditions are not
(continued) System, 4/04                             triggered between refills.

                                                     5. Ensure qualified and trained technical staff
                                                     such as a Biomedical Engineering Technician,
             Two VA Medical Centers reported a       SPD Technician or Pipe Fitter monitors tank
             loss of service in the Oxygen Utility   refilling procedures.
             System. In both incidents the alarm
             on the main tank did not sound until    6. Ensure an adequate supply of portable
             reaching near or completely empty       oxygen with an appropriate mixture of tanks is
             and both sites did not meet the         available for deployment at point of health care
             NFPA-99 requirement for two,            delivery in the event of total Oxygen Utility
             independent 24/7 supervised areas       System failure. All tanks must be properly stored.
             where mandatory alarm conditions
             for the Oxygen Utility System are       7. Set, maintain, and document appropriate
             annunciated                             Oxygen Utility System preventive maintenance
                                                     and testing protocols.

                                                     8. Review Medical Center Utility Shutdown
                                                     Policy, as required by JCAHO to assure
                                                     appropriate safeguards are in place in the event
                                                     of unplanned utility shutdowns.
             Mandatory; Priority A                   OxygenUtilitySystemAlert040504.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        357 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                               Not
                                                                                                                        Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                                      START            5.8
5.8.4       Implantable Cardioverter              1. Immediately check patient records in CPRS to
            Defibrillator (ICD), 4/04             identify patients with the ICD implants
                                                  described in this notification.

                                                  2. Contact your local Medtronic sales
            Models Micro-Jewell II 7223Cx and     representative (or Medtronic Technical
            GEM DR 7271; Medtronic,               Services, listed in the Contact section of this
            implanted in 1997 and 1998, During    notification if you cannot reach the local
            a cardiac event requiring             representative) for assistance with determining
            cardioversion or defibrillation,      whether the identified implant requires follow-up
            internal capacitors may take longer   action as identified by Medtronic.
            to charge and can cause a delay or
            non-delivery of appropriate shock     3. If follow-up action is necessary, see the
            therapy.                              attached letter from Medtronic describing
                                                  required actions.

            Mandatory; Priority A                 MedtronicICDAlert042804.pdf                                                                                                             END
            2004 Alerts & Advisories                                                                                                                                                      START            5.8
5.8.5       Class I recall of Medtronic MiniMed   1.If you still have any of the above mentioned
            Paradigm® Quick-set® Plus             product in inventory, immediately stop
            Infusion Sets, 5/04                   distributing them to your patients.

                                                  2. Please complete the enclosed Distributor
                                                  Response Form indicating how you will proceed
            Model MMT-359S6, MMT-359S9,           with this mandatory notification and return it by
            MMT-359L6 and MMT-359L9,              fax as soon as possible to the manufacturer.
            Problems with the infusion sets can
            interrupt insulin flow resulting in   3. Please also complete the enclosed Exchange
            serious injury.                       Request Form so that arrangements can be
                                                  made to return all affected product to the
                                                  manufacturer for disposal and send you the
                                                  replacement products of your choice.


            Mandatory; Priority A                 MedtronicMiniMedInsulinSetAlert051904.pdf                                                                                               END




        Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        358 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                      Not
                                                                                                               Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                             START            5.8
5.8.6       Minor Surgery/Exam lights:            1. Review Burton Medical’s notice (attached and
            CoolSpot™ and Outpatient®             available on-line at
            Fleximount™, 6/04                     http://www.burtonmedical.com/safetyNote.htm).

                                                  2. Identify and inspect all units affected by this
                                                  alert for cracked pivot supports, and complete
            Single Ceiling and Track Mount with Burton Medical's form to obtain new pivot
            Single Trolley manufactured by        supports and arms.
            Burton Medical before August 2000.
             Model numbers: 0100540,              3. For identified lamps with cracked pivot
            0100740, 0100580, 0102180 and         supports- If possible, remove them from service.
            0102540, Due to an inherent           a. Users: Inspect each light daily before use for
            weakness in the original              normal movement and stability. If the light
            composition of the pivot support      appears loose or unstable, contact Engineering
            casting, the pivot joint can fail and to have it checked. b. Engineering: Inspect
            the light may fall onto a patient.    identified lights every two weeks until new
                                                  components are installed.


            Mandatory; Priority A                 BurtonLightsJune04.pdf                                                                                                         END




        Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        359 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                                 START            5.8
5.8.7       CPRS Text Integration Utility (TIU)     1. Run patch TIU*1*174 for all patient records
            v1.0 documents, 6/04                    created after January 1, 2004 and at least daily
                                                    thereafter until permanent solutions are
                                                    implemented. Review all records identified by
                                                    this patch to determine if text has been deleted
            Reported and confirmed that text        or truncated.
            stored in Text Integration Utility
            (TIU) document file 8925 may be         2. When records with missing or truncated text
            deleted or truncated automatically      are identified:(a) Refer them to the author for
            without the author being made           review of the note and to add an addendum if
            aware that this occurred when the       needed (b) If the author is no longer available or
            document is signed. The Office of       is unable to remember what information is
            Information (OI) has developed a        missing a disclaimer, similar to the following,
            patch that may be used to identify      should be added to the file “DISCLAIMER: This
            potentially affected patient records.   completed document may have text that was
                                                    electronically deleted in error. (c) If the note is of
                                                    significant concern, and the author is no longer
                                                    available, the record should be referred to the
                                                    site medical record committee or other
                                                    functional group that processes records that are
                                                    suspected as being incomplete. The committee
                                                    may decide to forward the note to the service
                                                    chief or equivalent to either complete the note or
                                                     (continued)...
            Mandatory; Priority A                   CPRS_TIUJune04.pdf                                                                                                               END




        Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        360 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                                START
5.8.7       (continued)... CPRS Text                 ...(continued) allow the disclaimer to be added.
(continued) Integration Utility (TIU) v1.0
            documents, 6/04



             Reported and confirmed that text
             stored in Text Integration Utility
             (TIU) document file 8925 may be
             deleted or truncated automatically
             without the author being made
             aware that this occurred when the
             document is signed. The Office of
             Information (OI) has developed a
             patch that may be used to identify
             potentially affected patient records.
             Mandatory; Priority A                   CPRS_TIUJune04.pdf                                                                                                             END




         Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        361 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                               START            5.8
5.8.8       DeRoyal ReliaFlex™ Suction             1. Review the attached letter from DeRoyal and
            Canisters with Liners, 6/04            sequester all affected models and lot numbers.
                                                   a) 71-9101, canister liner, 1300cc, Lot numbers
                                                   lower than 5951 b) 71-9201, canister liner,
                                                   1800cc, Lot numbers lower than 5949 c) 71-
            DeRoyal suction canisters that are     9301, canister liner, 3200cc, Lot numbers lower
            used with the ReliaFlexTM suction      than 6096
            liner system have violently
            discharged blood and body fluids       2. With the help of your Logistics office or your
            when the full liners were removed by   material management service, contact your local
            clinical staff from the hard outer     DeRoyal sales representative or distributor to
            shell. Unsecured caps on the           make sure that you have an adequate supply of
            tandem port and pour spouts along      the redesigned ReliaFlexTM suction liners
            with slight pressure on the flexible   (those with lot numbers higher than 1a-c) before
            suction liner precipitated the         you ship the affected units back to DeRoyal for
            discharge.                             free replacement. DeRoyal has agreed to accept
                                                   returns on partial cases.

                                                   3. In lieu of continuing to use the ReliaFlexTM
                                                   suction liner system, you may elect to use the
                                                   DeRoyal CrystalineTM Disposable Canister
                                                   System.
            Mandatory; Priority A                  DeRoyalSuctionCanister.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        362 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                                START            5.8
5.8.9       Failure of medical alarm systems         1. Determine if your facility uses a medical alarm
            using paging technology to notify        paging technology and confirm that alarm
            clinical staff, 7/04                     protocols classify the paging component as a
                                                     secondary (or back-up) notificaiton method and
                                                     that it is not used as the primary alarm or
                                                     communication method.
            Reports documenting the failure of
            medical alarm systems using paging       2. Verify that staff is assigned to monitor and
            technology to notify clinical staff of   manage physiologic monitoring systems and
            alarms or other critical clinical        other clinically significant primary alarms when
            information.                             patients are being monitored.

                                                     3. Evaluate the physical layout of your patient
                                                     care areas to determine where monitoring staff
                                                     (monitor watcher) is needed. Perform this
                                                     assessment as though you did not have an
                                                     alarm paging system. Note: If you use a medical
                                                     alarm system using paging technology to
                                                     comply with JCAHO Patient Safety Goal No. 6b
                                                     compliance must be reassessed without the use
                                                     of the paging system.

                                                     4. If a medical system using paging technology
                                                     is used as a component of the clinical staff
                                                     notification process (i.e., secondary or back-up)
                                                     there must be positive feedback to the initiator
                                                     of (continued)...
            Mandatory; Priority A                    AlarmPagingJuly04.pdf                                                                                                          END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        363 of 1656
                                                                     NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                      Not
                                                                                                                               Met        Partially   Met   If score other than 'met' what are
            Question:                                 Rationale/Assessment Methods:                                            (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                                             START
5.8.9       (continued)... Failure of medical         ...(continued) the page that the message was
(continued) alarm systems using paging                received and responded to in a timely manner.
            technology to notify clinical staff,      This allows appropriate action to be taken to
            7/04                                      deliver clinical care if the page was not
                                                      acknowledged.


             Reports documenting the failure of
             medical alarm systems using paging
             technology to notify clinical staff of
             alarms or other critical clinical
             information.
             Mandatory; Priority A                    AlarmPagingJuly04.pdf                                                                                                                      END
             2004 Alerts & Advisories                                                                                                                                                            START            5.8
5.8.10       Boston Scientific Stent System           1. Confirm that your facility received the
             Recall, 7/04                             manufacturer’s recall letter dated 7/21/2004.
                                                      (Letters were sent to Director of Cardiac
                                                      Catheterization Labs and Risk Manager). If not
                                                      contact Boston Scientific at (800) 832-7822.
             Models: 1) Taxus Express 2
             Monorail (MR) Paclitaxel-Eluting 2)      2. By close of business July 30, 2004, ensure
             Taxus Express 2 Over-the-wire            you have on site replacements from FDA
             (OTW) Paclitaxel-Eluting 3) Express      approved stent suppliers, for existing, affected
             2 Monorail (MR) bare-metal 4)            models (“recalled stents”) of Boston Scientific
             Express 2 Over-the Wire (OTW)            stent systems. Do not sequester the “recalled
             bare-metal. The FDA and the              stents” from use until you have replacements on
             manufacturer received reports 43         hand.
             confirmed “no deflation” (failure of
             the balloon to deflate within one        3. Contact your local Boston Scientific sales
             minute after deployment of the           representative to exchange the affected stents
             stent) complaints related to the         one for one with their replacements.
             Taxus Express 2 device system.
             Mandatory; Priority A                    BostonScientificStentRecallJuly04.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                             Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        364 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
             2004 Alerts & Advisories                                                                                                                                               START            5.8
5.8.11       Shiley Tracheosoft XLT Extended        1. Patients with the affected models (see below)
             Length Tracheostomy Tube and           should be contacted and arrangements made to
             Cannula FDA Class I Recall, 8/04       exchange the equipment.

                                                    2. If you have the affected devices in stock work
                                                    with your materials management (AMMS) to
             The outer cannula may separate         make sure that a recall package has been
             from the hub and neck flange           received. Follow the instructions in the package
             allowing the outer cannula to travel   to receive credit for the recalled products.
             farther into the patient’s airway
             leading to obstruction of the airway   3. If you have these devices in stock and did not
             and significantly interfering with     receive a recall package from the company,
             breathing and ventilation.             contact Nellcor/Tyco Technical Services
                                                    Department at 1-800-635-5267.


             Mandatory; Priority A                  ShileyTracheosoftAug04.pdf                                                                                                      END
             2004 Alerts & Advisories                                                                                                                                               START            5.8
5.8.12       Automated External Defibrillators      1. Immediately check your inventory to
             (AED) manufactured by Access           determine if you have any Access
             Cardiosystems, Inc., operation         Cardiosystems AEDs and remove units from
             failure, 11/04                         service affected by items 1 and 2 above.

                                                    2. Other Access Cardiosystems units can
                                                    remain in service only as long as you have
             Units with serial numbers ranging      consumables on hand to support them or until
             from 075690 to 077140 may              February 1, 2005, then they must be removed
             experience a malfunction in the        from service and replaced with AEDs from other
             shock delivery circuit and fail to     manufacturers.
             deliver therapeutic shocks.
                                                    3. If you are affected, plan for emergency
                                                    replacement of any Access Cardiosystems
                                                    defibrillators in stock.
             Mandatory; Priority A                  AccessAEDsNov04.pdf                                                                                                             END




         Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        365 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
             Question:                           Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
             2004 Alerts & Advisories                                                                                                                                                START            5.8
5.8.13       Renewal prompts for "one-time only" 1. Check the attachment to determine if you are
             medication orders, 12/04            one of the sites that has already installed CPRS
                                                 test patch PSJ*5*127.

                                                     2. If your site is NOT listed on the attachment
             After installation of CPRS patch        and you have installed patch PSJ*5*110, then
             PSJ*5*110, several close call           install test patch PSJ*5*127.
             reports of providers being prompted
             to "renew" an expiring medication
             order when they logged into CPRS.
             These orders had been previously
             processed as one-time orders and
             by definition should not be eligible
             for renewal. The potential exists for
             one-time orders to be renewed in
             CPRS resulting in harm to the
             patient.
             Mandatory; Priority A                   RenewalofOnetimeOrders.pdf                                                                                                      END
             2004 Alerts & Advisories                                                                                                                                                START            5.8
5.8.14       Drug File view from CPRS, 4/04          1. Facility pharmacy staff should review the
                                                     CPRS drug file listings to identify products that
                                                     are inappropriate for clinical use, and then work
                                                     with IRM to RESTRICT these products on a
             Facility drug files may contain         case by case basis, from view of the providers.
             entries that are for pharmacy use       Restricting the products in CPRS file 101.43
             only. Some of these entries may be      prevents providers from seeing them but will
             inappropriate or harmful for patient    permit pharmacy staff access to them through
             administration. In addition, some       the back door CHUI interface.
             items are in the drug file for
             inventory management purposes           2. If a restricted product is needed for clinical
             only.                                   patient use, incorporate the item in a quick order
                                                     instead, thus removing the potential of mis-
                                                     prescribing.

             Recommended; Priority A                 CPRSDrugFile042804.pdf                                                                                                          END




         Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        366 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                            Not
                                                                                                                     Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                    (1)         Met (2)    (3)   possible root causes
             2004 Alerts & Advisories                                                                                                                                                  START            5.8
5.8.15       Tubing separation of Edwards           1. Caregivers should always inspect disposable
             Lifesciences VAMP Plus®                products for obvious defects before use.
             Disposable Pressure Transducers
             Monitoring Kits, 7/04                  2. Follow directions for use and, ensure all
                                                    connections are secure and finger tight during
                                                    set-up of pressure monitoring systems.

             Relative to tubing disconnects that    3. Be vigilant of any blood leaks or dampened
             may result in blood leaks and          blood pressure waveforms when using this
             potential for exsanguinations. The     transducer.
             complaint rate is presently about 1%
             and disconnects have not been          4. Contact your local representatives to
             specific to one lot.                   exchange, free of charge, all defective, Edwards
                                                    Lifesciences transducer devices.

             Recommended; Priority A                EdwardsVAMPXducerJul04.pdf                                                                                                         END
             2004 Alerts & Advisories                                                                                                                                                  START            5.8
5.8.16       ALARIS (IMED) Gemini Infusion          1. DO NOT use medication pumps, or other
             Pumps, 10/04                           medical devices that are in need of repair.

                                                  2. As a standard practice, operators of medical
                                                  devices should inspect and conduct operational
             Pump provides automatic free flow    checks, as specified in the manufacturers
             protection via the medication        operations manual, on all equipment and
             administration set and the exterior  medical devices before use. If the device is
             door. If the door latch is broken it found to be in need of repair, it should be
             may not properly activate the free   removed from service and sent to biomedical
             flow protection mechanism on the IV engineering for service.
             set, and free flow of medication may
             occur if other methods of free flow  3. Assure that there are an adequate number of
             protection are not employed.         pumps available to adjust for peak utilizations
                                                  and/or maintenance cycles.
             Recommended; Priority A                ALARISGeminiInfusionPumps.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        367 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                    Not
                                                                                                             Met        Partially   Met   If score other than 'met' what are
             Question:                             Rationale/Assessment Methods:                             (1)         Met (2)    (3)   possible root causes
             2004 Alerts & Advisories                                                                                                                                          START            5.8
5.8.17       Electro-magnetic Interference (EMI) 1. Check to see if you have current policy
             from the use of two-way hand held   addressing EMI risks including
             radios/walkie-talkies, 11/04        recommendations for areas where wireless
                                                 communication devices are restricted. For two-
                                                 way radios, 20 feet from medical equipment is a
                                                 minimum recommended distance (ECRI Health
             When operated in close proximity to Devices 2003 Mar; 32(3):118-21).
             medical devices. Oxygen
             concentrators in the nursing home   2. Refer to your EMI policy and modify to
             unit alarmed and sometimes shut     improve if necessary.
             down, requiring a reset when two-
             way radios were keyed to transmit   3. Train radio users (generally Engineering,
             from approximately 10 feet away.    Safety and Police personnel) to maintain
             Distance and transmitter            appropriate distances from medical equipment
             management are the most             when using radios.
             controllable and effective.

             Recommended; Priority A               EMIAdvisoryNov04.pdf                                                                                                        END




         Recalls Alerts Advis - 5                                           Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        368 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
             2004 Alerts & Advisories                                                                                                                                                    START            5.8
5.8.18                                         During surgery at a VA medical facility the
             Power supplies for flat panel patient
             monitor, Model 91415-A            power supply for the flat panel patient monitor
                                               degraded to the point where the audio circuit
             manufactured by Spacelabs Medical stopped working, affecting the alarm function.
             between January 2000 and          This was unknown to the operator and when the
                                               patient experienced a cardiovascular event, the
             December 2001. 11/03.             alarm was not heard resulting in a patient
                                               incident.




                                                     Action:




                                                     1. Immediately (within 24 hours) identify all units
                                                     affected according to the instructions in the
                                                     attached Recall from Spacelabs Medical.




                                                     Note: these power supplies are only used with
                                                     flat panel patient monitors; CRT patient monitors
                                                     are not affected.




                                                     2. Request replacement supplies as per the
                                                     attached Recall from

                                                     Spacelabs Medical.
             Mandatory; Priority A                   Spacelabs Display Nov 2003.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                     Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        369 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
            2004 Alerts & Advisories                                                                                                                                                 START
5.8.18      (continued)... Power supplies for    ...(continued) audio prior to each procedure or
(continued) flat panel patient monitor, Model    with
            91415-A
                                               each shift change, whichever is most frequent. If
             manufactured by Spacelabs Medical the audio test
             between January 2000 and
                                               fails, immediately switch to another system or
             December 2001. 11/03.             enable the patient

                                                 monitoring system’s audio and notify Biomedical
                                                 Engineering.

                                                 c.) Place a warning label on the flat panel
                                                 patient monitor

                                                 informing the user about required testing prior to
                                                 each procedure

                                                 or with each shift change, whichever is more
                                                 frequent.
             Mandatory; Priority A               Spacelabs Display Nov 2003.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        370 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                START            5.9
5.9.1       Fire Response and Planning, 1/05          1. Facilities Management or Engineering Service
                                                      personnel will initiate immediate replacement of
                                                      the recalled Central O-ring sprinklers if any are
                                                      still present in the facility and complete
            A fire in a VA hospital caused by the replacement by March 15, 2005. If this cannot
            improper use of smoking materials, be accomplished the facility director must
            combined with the presence of             contact Mr. Ken Faulstich, Chief, Fire Protection
            oxygen completed the fire triangle        Engineering (10NB) (202) 273-5869 to arrive at
            and resulted in the death of a            an acceptable solution.
            patient, In the room of fire origin, the
            fire sprinkler closest to the fire failed 2. Clinical management staff will ensure that
            to operate. This was an O-ring type staff understand and enforce the existing
            fire sprinkler manufactured by            program to control smoking materials, especially
            Central Sprinkler Company (Model          when 100% oxygen is in use.
            GB). These O-ring sprinklers, along
            with other models, were recalled by 3. Occupational Safety and Health or VA Fire
            the manufacturer in 2001 and were Department personnel will review the fire plan
            scheduled for replacement.                to: A) There will be an adequate number of staff,
                                                      including clinical staff, immediately responding
                                                      to the fire area regardless of the day of the week
                                                      or time of day, to assist in patient relocation to
                                                      the next smoke zone should it become
                                                      necessary. The number of responders needed
                                                      is dependent upon the number of patients in the
                                                      (continued)...
            Mandatory; Priority A                   FireResponseAlert.pdf                                                                                                           END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        371 of 1656
                                                                      NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
            Question:                                   Rationale/Assessment Methods:                               (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                  START
5.9.1       (continued)... Fire Response and            ...(continued) impacted smoke zone and the
(continued) Planning, 1/05                              acuity level of the patients. Based upon past
                                                        fire events, the minimum recommended staff
                                                        response (not counting Fire Department
                                                        Personnel) is: 1) For patient care buildings with
            A fire in a VA hospital caused by the       overnight stay that are not fully sprinkler
            improper use of smoking materials,          protected: One responder for every two non-
            combined with the presence of               ambulatory patients. If this response ratio
            oxygen completed the fire triangle          cannot be met, consider installing sprinkler
            and resulted in the death of a              protection, modifying the number (mix) of non-
            patient, In the room of fire origin, the    ambulatory to ambulatory patients in the smoke
            fire sprinkler closest to the fire failed   zone, reducing the size of the smoke zone(s) or
            to operate. This was an O-ring type         a combination of these actions. 2) For fully
            fire sprinkler manufactured by              sprinkler protected patient care buildings with
            Central Sprinkler Company (Model            overnight stay: One responder for every four
            GB). These O-ring sprinklers, along         non-ambulatory patients. If this response ratio
            with other models, were recalled by         cannot be met conduct a risk assessment to
            the manufacturer in 2001 and were           determine if an appropriate level of safety is
            scheduled for replacement.                  being provided. For the purposes of this Alert
                                                        non-ambulatory patients shall include individuals
                                                        with cognitive or behavioral impairments that
                                                        need assistance when relocating to an adjacent
                                                        smoke zone. B) The fire plan clearly identifies
                                                        the individual in the unit/area responsible for
                                                        turning off the room or zone oxygen shut off
                                                        control valve should it be necessary. This is
                                                        especially important in surgery and ICU areas.
                                                        (Note: Preventing fires in surgical areas is a
                                                        JCAHO 2005 Patient Safety goal for AHC. See
                                                        Goal #11; “Reduce the risk of surgical fires.”
                                                        Additional information on this goal may be found
            Mandatory; Priority A                       FireResponseAlert.pdf                                                                                                         END




        Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        372 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
            Question:                                 Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                 START            5.9
5.9.2       Nellcor pulse oximeters,                  1. Immediately (within the next 48 hours)
            manufacturered after November 8,          determine and identify all affected units. Only
            2001, 1/05                                units manufactured after November 8, 2001
                                                      (after S/N G01844386) are affected.

                                                      2. Until the speaker assemblies are replaced,
            Model 595 and limited quantities of       users should routinely test speaker functions by:
            models 395, 295, and 290. Affected        a. Listening for the tone emitted during the
            units were manufactured after             Power On Test. b. Activating audio pulse tones
            November 8 2001. Nellcor notified         while monitoring patients to hear patient’s pulse
            known affected customers by letter        to provide positive confirmation of speaker
            dates October 18 2004, Alarm              function; volume can be set low to minimize
            speakers and other audio                  disturbing patients.
            notifications are reported to fail at a
            higher rate than expected which           3. Ensure user and Biomedical Engineering
            could result in serious patient injury.   inspections include alarm testing according to
                                                      manufacturer recommendations.

                                                      4. If the speaker fails, immediately remove the
                                                      unit from service and replace with another unit,
                                                      making sure the speaker is functioning on the
                                                      replacement unit. Contact Nellcor at the phone
                                                      numbers listed below and see the attached for
                                                      replacement speakers and/or service.
            Mandatory; Priority A                     Nellcor595Jan05.pdf                                                                                                            END




        Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        373 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                   (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                 START            5.9
5.9.3       Medtronic (ICD) and (CRT-D)           1. Within two weeks, identify all affected patients
            manufactured between 4/01 and         by using all steps a - e: a) The manufacturer’s
            12/03, see list., 2/05.               letter available from the local Medtronic
                                                  representative b) List obtained from Medtronic
                                                  available from Dr. Ed Keung, Director of VA
                                                  National ICD Surveillance Center (see attached
            Medtronic Implantable Cardioverter- letter from VA National ICD Surveillance Center)
            Defibrillator (ICD) and Cardiac       c) VA National ICD Surveillance Center Registry
            Resynchronization Therapy             at https://icd.sanfrancisco.med.va.gov d) VA
            Defibrillator (CRT-D), Models and     National registry for ICD implants Washington
            batteries manufactured between        VAMC e) Your patient records.
            April 2001 and December 2003,
            Model 7230 Marquis VR, Model          2. Replace entire device in first priority group
            7274 Marquis DR, Model 7232           patients (see item B of attached letter from VA
            Maximo VR,Model 7278 Maximo           National ICD Surveillance Center).
            DR, Model 7277 InSync Marquis,
            Model7289 InSync II Marquis, Model 3. Follow one of three options for those patients
            7279 InSync III Marquis,Model 7285 who are not on the first–priority group. (see
            In Sync III Protect (not implanted in attached letter from VA National ICD
            US), a potential battery shorting     Surveillance Center).
            mechanism (embedded in the
            device) that may occur in a subset
            of ICDs and CRT-Ds. If shorting
            occurs, battery depletion can occur
            within a few hours to a few days,
            after which there is loss of device
            function.

            Mandatory; Priority A                  MedtronicICDsCRT-DsFeb05.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        374 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                       Not
                                                                                                                Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                              START            5.9
5.9.4       Spacelabs Medical Monitor, model      1. Immediately identify and locate all monitors
            90385 Universal Clinical              affected by this notice.
            Workstation (UCW), 2/05, (
                                                  2. Inspect the monitors to see if they have been
                                                  upgraded by: a. Looking for a label on the
                                                  bottom of the monitor that reads either “Part No.
            Affected units were manufactured      010-0681-00 Rev. N” or “FEB 0509” or b.
            between 1994 and 1997, units          Inspecting the bottom of the pedestal for a
            purchased after, or serviced by       screw in the center (See photos in attached
            Spacelabs Medical after March 18      Spacelabs Medical notice for more detail) If
            1997 are not affected, The monitor    neither a nor b is present, the bases need
            base becomes fatigued and             upgrading.
            separates from the monitor display.
            In that case, gravity is all that keeps 3. If units have not been upgraded contact
            the monitor together and movement Spacelabs Medical Monitoring Technical
            can cause the monitor to fall, risking Support at (800) 522-7025 to arrange upgrades.
            patient or caregiver injury.
                                                    4. Until the bases are upgraded, notify users of
                                                    affected monitors of this issue and the risks.
                                                    Users should examine units for noticeable wear
                                                    or cracked bases, and if present, contact
                                                    Biomedical Engineering. Biomedical
                                                    Engineering can determine whether the unit is
                                                    safe for continued use.
            Mandatory; Priority A                 SpacelabsUCWAlertFeb05.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        375 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                   (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                  START            5.9
5.9.5       Louvered heating, ventilating, and      1. Survey all locked Behavioral Health Units to
            air conditioning (HVAC) grilles in      determine if louvered grilles are present that
            locked Behavioral Health Units, 2/05    may be used as an anchor point.
            (AL05-06)
                                                    2. If louvered grilles are present in these
                                                    Behavioral Health Units upgrade them by
                                                    installing a woven wire cloth grille or replace
            Louvered grilles covering HVAC          them with a suitable grille that cannot be used
            openings located in locked mental       as an anchor point. Breakaway grilles should
            health units may be used as an          not be used as the broken parts may be used
            anchor point for a noose made from      for other purposes.
            clothing or other flexible material.

            Mandatory; Priority A                   LouveredHVACGrilleFeb28.pdf                                                                                                       END
            2005 Alerts & Advisories                                                                                                                                                  START            5.9
5.9.6       LIFEPAK 12 Defibrillator/Monitors       1. Within 48 hours, identify all LIFEPAK 12
            with Adaptive Biphasic technology,      biphasic defibrillators deployed at your facility.
            all units, man'f'd by Medtronic, 3/05
            (AL05-07)                               2. Check user settings to verify they are
                                                    configured for what your facility protocol
                                                    requires: Step–by–step directions, Basic
                                                    directions are included in the enclosed notice
            Units that have undergone a             from Medtronic, Detailed directions are included
            software upgrade or reinstallation      in the user’s manual.
            may revert to a default energy
            setting of 125 Joules, rather than      3. If the settings have changed or do not match
            the setting selected by the             those required for your protocol, correct them
            customer. The setting may not be        per the directions.
            noticed until use, resulting in
            inappropriate energy delivery.          4. Record all defibrillator serial numbers and
                                                    settings that have changed, plus your contact
                                                    information and call Medtronic Technical
                                                    Support at (877) 873-7630 to provide this
                                                    information.

            Mandatory; Priority A                   LP12BiphasicAlertMarch05.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        376 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                            Not
                                                                                                                     Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                   (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                   START            5.9
5.9.7       CPRS National Drug File V 4.0            1. Check with your IT/computer service (IRM) to
            Adverse Reaction Tracking, 3/05          determine if your facility is affected -- Data
            (AL05-08)                                Updates PSN*4*95 and PSN*4*97 installed.

                                                     2. If your facility is affected, notify all clinical
                                                     users (e.g. clinicians, pharmacists) that the
            Clinicians at facilities that recently   allergy tracking software is not functional and
            installed National Drug File (NDF)       requires providers to assure that new orders
            Data Updates PSN*4*95 and                entered for patients are checked manually
            PSN*4*97 may not be notified of          against the current allergy history until this is
            drug allergies and will be unaware       resolved.
            that the allergy check was not
            completed.                               3. Do not uninstall these Data Updates or it may
                                                     adversely affect other programs in the system.

                                                     4. If your facility has not installed Patches
                                                     PSN*4*95 and PSN*4*97 do not install until
                                                     further guidance is issued from the Office of
                                                     Information.

            Mandatory; Priority A                    NationalDrugFile031105.pdf                                                                                                        END




        Recalls Alerts Advis - 5                                                    Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        377 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                      Not
                                                                                                               Met        Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                             START            5.9
5.9.8       Enclosed Bed systems                 1. VA facilities may continue to use Vail
            manufactured by Vail Products Inc,   enclosed beds on a case by case basis only
            3/05 (AL05-09)                       when there is a clinical determination that this is
                                                 in the best interest of patient care. Vail
                                                 enclosed beds, similar to all enclosed bed
                                                 systems, may be considered in the continuum of
            Models: 500, 1000, and 2000, FDA     care for certain types of patients and disease
            issued recommendations for users     states. In certain instances, use of enclosed
            based on cited safety problems.      beds provides the most humane and least
                                                 restrictive care modality.

                                                 2. By close of business (COB) March 31 2005:
                                                 a) Visually ensure that Vail enclosed beds meet
                                                 the requirement for mattress gaps as spelled out
                                                 in the VHA Patient Safety Alert on bed
                                                 entrapment risk from 2001:
                                                 http://vaww.ncps.med.va.gov/alerts/BedEntrap.d
                                                 oc Accomplish this by pushing the mattress to
                                                 one side with the side rails in the up and latched
                                                 position. Also, measure the gaps at the foot and
                                                 head of the bed with the mattress pushed to one
                                                 end and the head and foot rails in the up and
                                                 latched position. The gaps must be less than 2
                                                 and 3/8 inch (60 mm) (continued)...


            Mandatory; Priority A                VailBedMarch2005.pdf                                                                                                            END




        Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        378 of 1656
                                                            NCPS Patient Safety Assessment Tool

                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                   Not
                                                                                                            Met        Partially   Met   If score other than 'met' what are
            Question:                          Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                          START
5.9.8       (continued)... Enclosed Bed        ...(continued) horizontal distance at the widest
(continued) systems manufactured by Vail       spot. b) If using a Vail enclosed bed with side
            Products Inc, 3/05 (AL05-09)       rails visually confirm that the side rails and the
                                               bolsters at the head and foot are up and
                                               properly latched, except when patient is entering
                                               or exiting the bed, or if the caregiver needs
            Models: 500, 1000, and 2000, FDA   access to the patient. (Side rails should be up
            issued recommendations for users   at all other times as a patient can get their head
            based on cited safety problems.    between the mattress and the bottom vinyl cover
                                               presenting a suffocation hazard.) c) Visually
                                               inspect Vail enclosed beds for any defects and
                                               repair or replace as soon as is practical with
                                               patient safety as the deciding factor. Inspect for
                                               broken welds at the joint on the frames and
                                               visually inspect the sleeping surface and
                                               components such as, but not limited to, zippers,
                                               netting, and Velcro connection points for proper
                                               attachment and function. d) Ensure that Vail
                                               enclosed beds with a high-low adjustable
                                               mechanism such as the Vail 1000 are not left in
                                               the up position when the patient is unattended.
                                               Additional hazards are created by the bed left in
                                               this position.e) Ensure that you are using only
                                               the mattress recommended by Vail and the gap
                                               complies with the criteria from action (a) above.
                                               f) If using other enclosed beds, follow actions a)
                                               through e) as applicable.
            Mandatory; Priority A              VailBedMarch2005.pdf                                                                                                           END




        Recalls Alerts Advis - 5                                           Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        379 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                       START            5.9
5.9.9        VistA Imaging v3.0 versions             1. Advise clinicians who view EKGs to verify that
             released since 10/1/03 patch            the “Show MUSE EKGs” option under Options >
             MAG*3.0*24, 4/05 (AL05-10)              View Preferences is enabled (the box is
                                                     checked), and that they should not disable it.

                                                   2. Advice clinicians to check the patient’s name
             In certain situations, the VistA      on an EKG viewed via the VistA Imaging Display
             Imaging Display EKG viewer window application to be sure that the name and EKG
             will not update properly when a       correspond to the current patient in CPRS.
             clinician views an EKG. Rather than
             showing the current patient, the
             EKG viewer window will continue to
             show the previous patient, it is
             possible that the clinician will miss
             this information and proceed to
             reading and acting on the EKG for
             the wrong patient.
             Mandatory; Priority A                   VistAImagingDisplayEKGApril05.pdf                                                                                                      END
             2005 Alerts & Advisories                                                                                                                                                       START            5.9
5.9.10       CM 100-Heartstart Adapter Cable         1. Immediately (within the next 24 hours)
             man'f'd by Laerdal Medical Corp,        remove CM 100-Heartstart Adapter Cable from
             5/05, (AL05-10).                        service and inventory.

                                                     2. Assure replacement cable from another
                                                     source is available for each defirillator where the
             This product is designed for use        cable was removed.
             with various make/model
             defibrillators. Laerdal Medical Corp
             catalogue no. 920650, wires within
             this adapter cable are susceptible to
             breakage. The vendor reports failure
             to deliver defibrillation shocks when
             there is breakage in this cable.

             Mandatory; Priority A                   LaerdalAdapterCables.pdf                                                                                                               END




         Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        380 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                      START            5.9
5.9.11       Blood glucose meters, models            1. Diabetes educators, outpatient pharmacists,
             OneTouch, Ultra, InDuo, and             and other cliniciansinvolved in diabetes
             OneTouch FastTake man'f'd by            management must be notified about the design
             LifeScan, Inc., 5/05 (AL05-11).         vulnerabilities of LifeScan devices.

                                                     2. Clinicians with diabetes patients using
                                                     LifeScan must: a) No later than the next visit,
             LifeScan has received reports of        confirm with all diabetes patients that their
             adverse events related to the device glucose meter is properly set up with mg/dL,
             inadvertently set to the incorrect unit NOT mmol/L. b) Understand the importance of
             of measure: milligram per deciliter     training the patient on the complex device set-
             (mg/dL) and milli-mole per liter        up and calibration.
             (mmol/L). In the United States, it is
             mg/dL. However the units of             3. Acceptable alternative blood glucose meters
             measure can be unintentionally          are available that do not exhibit this vulnerability
             changed during the task of setting      and facilities should consider providing those
             the date and time.                      devices instead.

             Mandatory; Priority A                   LifeScanOneTouchAlertMay2005.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        381 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                START            5.9
5.9.12       Guidant Model 1861 Ventak Prizm 2        1. Within two weeks,
             DR, ICDs manufactured before             electrophysiology/cardiology staff or other
             November 2002, 6/05, (AL05-013)          appropriate parties must identify all affected
                                                      patients by implementing each of the following
                                                      steps a through d. It is important that ALL
                                                      INFORMATION sources be reviewed to insure
             An unpredictable breach of an            that patients will not be missed, as they may be
             insulator in the device. This insulator found on one list and not on another. a) Review
             defect could result in at least partial the manufacturer's letter. b) Review the patient
             diversion of current in the high-        list posted on the VA National ICD Surveillance
             voltage output circuitry, thereby        Center intranet website
             preventing the device from               (https://icd.sanfrancisco.med.va.gov). This list,
             delivering high-voltage shock            provided by Guidant, consists of all the VA
             therapy when ventricular                 patients in the company’s database that have an
             tachycardia or fibrillation is detected. implanted model 1861 ICD which had been
                                                      manufactured prior to November 13, 2002 and
                                                      VA patients having this implant that are being
                                                      followed at a VA facility. c) Review the VA
                                                      National registry for ICD implants Washington
                                                      VAMC, point of contact is
                                                      Ronald.Jones1@va.gov. d) Review your patient
                                                      records for all patients with implanted Guidant
                                                      model 1861Ventak Prizm 2 DR, ICD devices.

                                                    2. (continued)...


             Mandatory; Priority A                  GuidantICDAlertJune2005.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        382 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                               Not
                                                                                                                        Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                      (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                      START
5.9.12      (continued)... Guidant Model 1861         ...(continued) Within the next 45 calendar days,
(continued) Ventak Prizm 2 DR, ICDs                   interrogate all Guidant Model 1861 ICDs for “no
            manufactured before November              telemetry” or “warning screen” conditions. These
            2002, 6/05, (AL05-013)                    conditions indicate that the ICD may be
                                                      inoperative. If one of these conditions is present,
                                                      replace with a suitable new device. a) If the
                                                      interrogation of the Guidant model 1861 ICD
             An unpredictable breach of an            does not reveal a problem, the patient should be
             insulator in the device. This insulator followed at the manufacturer’s recommended
             defect could result in at least partial intervals of every 3 months. However patients
             diversion of current in the high-        should be instructed to return immediately for
             voltage output circuitry, thereby        device interrogation following any shock
             preventing the device from               delivery, and ICD replacement should be
             delivering high-voltage shock            considered at that time.
             therapy when ventricular
             tachycardia or fibrillation is detected. 3. Follow the actions contained in Attachment 2.
                                                      This guidance was prepared by Dr. Edmund
                                                      Keung of the VA National ICD Surveillance
                                                      Center as the best course of action for your
                                                      patients.

             Mandatory; Priority A                   GuidantICDAlertJune2005.pdf                                                                                                          END
             2005 Alerts & Advisories                                                                                                                                                     START            5.9
5.9.13       Smiths Medical, Fast Flow Fluid       1. Promptly (within one week) check local
             Warmer Models 250, 500 and 1000, inventory to identify all units affected by this
             6/05 (AL05-14)                        Alert and institute recommended practices to
                                                   minimize risk (attached) for all users of Smiths
                                                   Medical Fast Flow Fluid Warmers, models 250,
                                                   500 and 1000.
             Hospitals in Australia report serious
             patient injury from intravascular air 2. Procure and install the Smiths Medical
             embolisms introduced while using      accessory Air Detector/Clamp, model H-31 that
             the Smiths Medical fluid warmers      is designed to reduce the risk of air embolism
             identified in this Alert.             introduction while using the Smiths Medical Fast
                                                   Flow Fluid Warmers, models 250, 500 and 1000.

             Mandatory; Priority A                   SmithsMedicalFluidWarmerJune2005.pdf                                                                                                 END




         Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        383 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
             Question:                                 Rationale/Assessment Methods:                                      (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                       START            5.9
5.9.14       Guidant Corporation recalls               1.Within two weeks,
             additional models (update to PS           electrophysiology/cardiology staff or other
             Alert AL05-013 dated 6/8/05), 7/05        appropriate caregivers must identify all affected
             (AL05-15)                                 patients by implementing each of the following
                                                       steps a through d. It is important that ALL
                                                       INFORMATION sources be reviewed to insure
                                                       that patients will not be missed, as they may be
             Additional models of Implantable          found on one list and not on another.
             Cardioverter-Defibrillators (ICD),
             and has added Cardiac                     a) Review the manufacturers letters (See Links
             Resynchronization Therapy                 below).
             Defibrillators (CRT-D) to the recall
             list. These devices can develop an        b) Review the patient list posted on the VA
             internal short circuit without warning,   National ICD Surveillance Center intranet
             resulting in failure to deliver a shock   website (https://icd.sanfrancisco.med.va.gov).
             when needed. In addition, Guidant         This list, provided by Guidant, consists of all VA
             sent letters to physicians notifying      patients in the company’s database that have an
             them that identified models of Atrial     implanted Guidant device affected by this recall.
             Therapy devices (AVT) and CRT-D           Double check by providing name of your facility
             devices will require reprogramming.       and implant physician’s name. (See attachment
                                                       2)
             ICDs (FDA Class I Recall) Guidant
             Ventak Prizm 2 DR, Model 1861,            c) Review the VA National registry for ICDs and
             Implantable Cardioverter-                 CRT-R implants, Washington VAMC, point of
             Defibrillators (ICDs) manufactured        contact is Ronald.Jones1@va.gov.
             before April 16, 2002,CRT-Ds (FDA
             Class I Recall) Guidant Contak            d) Review your patient records for all patients
             Renewal, Model H135, Cardiac              with implanted Guidant devices affected by this
             Resynchronization Therapy                 (continued)...
             Defibrillators (CRT-D) manufactured
             on or before August 26,
             2004,Guidant Contak Renewal 2,
             Mandatory; Priority Cardiac
             Model H155, A                             GuidantICDsCRTsUpdateJuly05.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        384 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
            Question:                                  Rationale/Assessment Methods:                                      (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                        START
5.9.14      (continued)... Guidant Corporation         ...(continued) recall.
(continued) recalls additional models (update to
            PS Alert AL05-013 dated 6/8/05),           2.Within the next 45 calendar days, interrogate
            7/05 (AL05-15)                             all affected ICDs and CRT-Ds devices for:

                                                       a) Loss of telemetry/programming/interrogation.

             Additional models of Implantable          b) Loss of tachyarrhythmia detection and
             Cardioverter-Defibrillators (ICD),        therapy delivery
             and has added Cardiac
             Resynchronization Therapy                 c) Loss of pacing therapy.
             Defibrillators (CRT-D) to the recall
             list. These devices can develop an        d) Programmer display of a red warning screen
             internal short circuit without warning,   upon attempted device interrogation.
             resulting in failure to deliver a shock
             when needed. In addition, Guidant         e) Programmer display of yellow warning screen
             sent letters to physicians notifying      indicating out of range shocking impedance.
             them that identified models of Atrial
             Therapy devices (AVT) and CRT-D           f) Corrective reprogramming in the appropriate
             devices will require reprogramming.       models.

             ICDs (FDA Class I Recall) Guidant         Conditions a) to e) indicate that the affected
             Ventak Prizm 2 DR, Model 1861,            device may be inoperative. If one or more of
             Implantable Cardioverter-                 these conditions is present, replace with a
             Defibrillators (ICDs) manufactured        suitable new device.
             before April 16, 2002,CRT-Ds (FDA
             Class I Recall) Guidant Contak            3. If If the interrogation of the affected device
             Renewal, Model H135, Cardiac              does not reveal a problem, the patient should be
             Resynchronization Therapy                 followed at the manufacturer’s recommended
             Defibrillators (CRT-D) manufactured       intervals of every 3 months. However, patients
             on or before August 26,                   should be instructed to return immediately for
             2004,Guidant Contak Renewal 2,            device interrogation following any shock
             Mandatory; Priority Cardiac
             Model H155, A                             GuidantICDsCRTsUpdateJuly05.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        385 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                            Not
                                                                                                                     Met        Partially   Met   If score other than 'met' what are
             Question:                           Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                  START            5.9
5.9.15       Depression Screening for Veteran    1. All clinical and administrative services that
             Patients Recently Separated from    may be involved with treating recently separated
             Active Military Duty, 1/05          veterans should review the current policy, or
                                                 standard operating procedure (SOP) addressing
                                                 depression or suicide prevention screening for
                                                 Veterans recently separated from active military
             Depression screening for recently   duty. (If this policy or SOP does not exist it
             separated Veterans may increase     should be developed.)
             early identification of possible
             psychiatric problems and/or         2. Refer to the websites, information letter and
             suicidality.                        video identified in this advisory, then provide
                                                 pertinent information to any and all interested
                                                 inpatient and outpatient clinical and
                                                 administrative services.

                                                 3. Ensure that discharge planning for patients
                                                 treated for depression and/or suicidality includes
                                                 information - - or direct referral, as needed - - to
                                                 mental health services available in or near their
                                                 home community (e.g., address, phone number,
                                                 point of contact, fee arrangements, etc.).

             Recommended; Priority A             DepressionScreeningAdvisoryJan05.pdf                                                                                                  END




         Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        386 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                               Not
                                                                                                                        Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                     START            5.9
5.9.16       CPRS - Transferring Outpatient         Notify all users, when transferring medications
             Medication Orders to Inpatient         from Outpatient to Inpatient, using the
             Medication Orders, 6/05 (AD05-14)      Medication Screen in CPRS; they need to scroll
                                                    down, whenever text appears in the first line of
                                                    the information box, until the patch is installed.

             When the “Transfer to” function,
             located in the Medications Tab in
             CPRS, is used to transfer existing
             outpatient mediation orders to
             inpatient orders, it can present
             clinicians with an order dialog that
             does not display dosing information.
              There are limited visual clues to
             direct the user to the fact that
             additional critical information is
             available.

             Recommended; Priority A                CPRSAdvisoryOutpatientMedstoInpatientMeds.pdf                                                                                         END




         Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        387 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                             Not
                                                                                                                      Met        Partially   Met   If score other than 'met' what are
             Question:                           Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                   START            5.9
5.9.17       Olympus 180 series endoscopes       Olympus model CFQ180AL scopes were being
             and Steris Quick Connects, 10/05,   reprocessed in a Steris System 1 when it was
             (AL06-01).                          discovered the attached Quick Connect
                                                 cognitive aid (placard) did not list it for use with
                                                 the CF!180AL. The Steris Quick Connect QLC
                                                 1676, which is compatible with the Olympus
                                                 CFQ160AL colonoscope, is not intended to be
                                                 used with the Olympus CFQ180AL colonoscope.




                                                 1) Effective immediately do not use the Steris
                                                 System 1 to reprocess Olympus 180 series
                                                 endoscopes.

                                                 2) Immediately begin to follow manufacturer’s
                                                 (Olympus) recommended instructions to
                                                 manually clean and sterilize the 180 series
                                                 scopes. Refer to Olympus Reprocessing
                                                 Manual, Instructions for Evis Exera II
                                                 Gastrointestinal Videoscope and
                                                 Colonovideoscope Type 180 series.

                                                 3) By close of business October 14, 2005, tag or
                                                 label Olympus 180 series endoscopes to remind
                                                 staff not to use the Steris System 1 for
                                                 reprocessing this model until a quick connect
                                                 harness for this scope is available.
             Mandatory; Priority A               SterisQuickConnectOlympusAlert Oct 10 05.pdf                                                                                           END




         Recalls Alerts Advis - 5                                                    Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        388 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
             Question:                           Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                START            5.9
5.9.18       MEDRAD Stellant CT Injector         Heat maintainers for Stellant CT Injector
             Systems, 11/05, (AL06-04).          Systems, manufactured by MEDRAD, Inc. Part
                                                 numbers for the heat maintainers are 3007871,
                                                 3007872, 3009707 and 3009708. (Note: Part
                                                 numbers for the Stellant injector systems are
             The manufacturer reports the heat   3007301, 3010432, 3007300 and 3010091.)
             maintainers used on the Stellant
             injector systems may malfunction
             and overheat the syringe and
             contrast media.                     Action: Respond to MEDRAD's letter dated
                                                 10/12/05 to determine if you have the affected
                                                 heat maintainer.

             Mandatory; Priority A               MEDRADStellantCT Nov 01 05.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        389 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                      START            5.9
5.9.19       Injector connector relays on patient    The manufacturer reports failures of Injector
             tables, 12/05, (AL06-06)                connector relays for the table models listed,
                                                     although none are reported in VA. If a relay fails,
                                                     high voltage can be present on a pin of the
                                                     exposed injector connectors, placing patients
             Tables manufactured by Philips          and employees at risk. Philips will be upgrading
             Medical, table models AD5 and AD6 affected systemsas parts are available, to be
             used with the Integris, Integris Allura completed by mid-2006. Philips Medical
             and Allura                              hasidentified 42 VA medical facilities affected by
                                                     this Alert.
             Xper x-ray systems.


                                                     If affected and you have not already done so:

                                                     1. Within one week, identify affected tables, and
                                                     until the tables are

                                                     upgraded,

                                                     2. Cover the connectors (diagrams in attached
                                                     Philips notification) with

                                                     nonconductive material, and

                                                     3. Inform users to exercise caution when
                                                     connecting/disconnecting the

                                                     injector connector from the table and when
                                                     cleaning near the connector.
             Mandatory; Priority A                  PhilipsTableAL06-06 Dec 21 05.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        390 of 1656
                                                                     NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
             Question:                                 Rationale/Assessment Methods:                                   (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                    START            5.9
5.9.20       LEDI III Lab Electronic Data              1. The Laboratory ADPAC or other qualified
             Interchange, 8/05, (AL05-016).            individuals must review the laboratory test
                                                       setups to identify those tests using "set of
                                                       codes."

             VistA Laboratory Package, patch
             LR*5.2*286
                                                       2. By close of business (COB) Tuesday, August
                                                       30, 2005: If any lab test used "set of codes" and
                                                       the site recognizes that they now need to modify
             A VHA facility recently reported that     the set up, they should make the modifications
             critical flags were not being set for     or seek assistance by logging a Remedy ticket
             positive tests of hemocult. As a          with National Help Desk.
             result, over 200 positive tests for
             hemocult did not trigger a flag to
             alert providers. Although the site
             has made the proper modifications         3. By COB Friday, September 9, 2005: Once
             and taken necessary actions, this         modifications/corrections have been made, the
             Patient Safety Alert is issued to alert   site needs to review the historical data from the
             other sites that may be affected.         time the patch was installed (January 2005, or
                                                       eariler if you were a test site) to present date to
                                                       determine potential critical flag omissions. If
                                                       there were critical flag omissions in the historical
                                                       data, the site needs to review the comment field
                                                       to see if the critical value was recognized and
                                                       called to the attention of the provider as required
                                                       by the College of American Pathologists and
                                                       VHA Directive 2003-043.




                                                       4. If critical flag (continued)...
             Mandatory; Priority A                     LEDI-IIIPatch Aug 26 05.pdf                                                                                                       END




         Recalls Alerts Advis - 5                                                     Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        391 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                 START
5.9.20      (continued)... LEDI III Lab             ...(continued) omissions were identified and it
(continued) Electronic Data Interchange, 8/05,      was determined that the provider was not
            (AL05-016).                             notified, report the situation to the provider
                                                    immediately. If the provider is no longer with the
                                                    facility, then notification should be given to the
                                                    Chief of Service.
             VistA Laboratory Package, patch
             LR*5.2*286

                                                     5. By COB Monday, September 12, 2005:
                                                     Identify and report, to the Patient Safety
             A VHA facility recently reported that Manager, the number of patients that were not
             critical flags were not being set for   notified of positive test results since
             positive tests of hemocult. As a        implementing the patch, along with the date all
             result, over 200 positive tests for     patients will be notified. If your facility is not
             hemocult did not trigger a flag to      impacted, submit a negative report. The Patient
             alert providers. Although the site      Safety Manager should report this information to
             has made the proper modifications       the Network Patient Safety Officer who will
             and taken necessary actions, this       report this information to the National Center for
             Patient Safety Alert is issued to alert Patient Safety, attention Joe DeRosier/Lori King.
             other sites that may be affected.

             Mandatory; Priority A                  LEDI-IIIPatch Aug 26 05.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        392 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                 START            5.9
5.9.21       Sulfa Allergy Order Checks, 12/05,   By close of business (COB) 12/28/05, the
             (AL06-07)                            Pharmacy ADPAC (or designee) must edit the
                                                  Message filed in the Drug file (50) to display the
                                                  following message for each of the drugs shown
                                                  in Attachment #1:
             VistA allergy file (120.8) - Certain
             drug classes are not currently
             generating order checks for patients
             with a documented allergy.           MESSAGE: "SULFA cross drug classes may
                                                  NOT trigger an ORDER CHECK" (refer to
                                                  screen shot below).




                                                  This message is intended to alert clinicians that
                                                  a drug-allergy order check for "SULFAS" may
                                                  not trigger appropriately, and that they must
                                                  manually check for allergies for these products.
                                                  Other appropriate messages may be added to
                                                  address other identified products (e.g., iodine,
                                                  aspirin, erythromycin, food); however, because
                                                  of their prevalence, "sulfa" must be addressed.
             Mandatory; Priority A                SulfaOrderChecks Dec 23 05.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        393 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
             Question:                                Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                        START            5.9
5.9.22       Hospira LifeCare PCA3 Infustion          1. Notify clinicians of this programming
             Pumps List No: 12384-04, 11/05,          vulnerability and include this information in all
             (AD06-02).                               training sessions (e.g., in-service, orientation)
                                                      conducted on this PCA infusion pump.


             Hospira Inc. has identified two
             potential scenarios that may lead to     2. Also, clinicians must use the clear key "CLR"
             incorrect medication flow rates          prior to changing a value, and use the
             being entered into this model of         confirmation screen to assure that values that
             PCA pump that could result in an         have been entered in fact have been accepted
             adverse medication event. To date,       by the device.
             there have been no reported
             adverse events associated with
             either scenario.



             Scenario 1: Enter a number for
             dose, dose limit, rate or
             concentration, without pressing
             "ENTER" to accept the value; Press
             either the "History" key or
             "Silence/Volume" key, scroll through
             history or silence/volume and
             reenter the programming screen;
             Press a number key to change the
             value previously entered for dose,
             dose limit, rate or concentration.
             NOTE: Taking these steps will not
             overwrite the original value of dose,
             dose limit, rate or concentration, but
             Recommended;increase the original
             rather, will Priority A                  HospiraPCA3Advisory Nov 29 05.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        394 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
             Question:                             Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                      START            5.9
5.9.23       VA Drug Class Allergy Entry, 11/05,   1. Clinical staff should be reminded NOT to
             (AD06-01).                            select the ingredient file from CPRS GUI allergy
                                                   entry process or directly through VistA CHUI
                                                   interface, unless there is a specific reason to
                                                   use an ingredient level entry. A cognitive aid
             VistA package allergy file (120.8)    could help clinical staff to remember this when
             may have allergy entries that have    entering allergens.
             been accidentally entered without a
             VA drug class - when a drug class
             entry was appropriate.
                                                  2. Medication administration records and
                                                  patient charts can be used to review allergy
                                                  information until this issue is resolved (see Addl.
             A patient had a drug allergy entered Information below).
             into VistA in 1997 prior to
             implementing CPRS. The allergen
             cephradine was selected as being
             an ingredient of a product, versus a 3. In the interim, any specific concerns should
             drug, and therefore no VA drug       be addressed to the OI National Help Desk, who
             class was assigned to that entry.    will set up a remedy ticket to assist you with any
             Years later, a provider ordered      issue.
             cefazolin - a drug in the same drug
             class as cephradine, but not the
             exact ingredient as cephradine. No
             allergy warning occurred because
             ingredient level warnings only occur
             if there is an exact item match. The
             patient received the cefazolin.

             Recommended; Priority A               DrugClassIngredientAllergies Nov 17 05.pdf                                                                                              END




         Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        395 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
             Question:                             Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                              START            5.9
5.9.24       St. Jude Medical Implantable         1. By the close of business (COB) Monday,
             Cardioverter Defibrillators, 11/05,  November 28, 2005:
             (AL06-05)                            electrophysiology/cardiology staff or other
                                                  appropriate parties must identify all affected
                                                  patients by implementing each of the following
                                                  steps a through c. It is important that ALL
             Temporary loss of pacing function    INFORMATION sources be reviewed to insure
             and permanent loss of tachycardia    that patients will not be overlooked, as affected
             detection may occur in selected      patients may be found on one list and not on
             Photon DR (Model V-230HV) and all another. Your local SJM representative may
             Photon Micro VR/DR (Model V-         have a list of patients with you or your
             194/V-232) and Atlas VR/DR           colleagues as the follow-up physician.
             (Models V-199/V-240) units. St.
             Jude Medical (SJM) reported 60       A. Review the manufacturer's letter (See Links
             failures out of 36,000 devices       below).
             (0.167%) with no serious patient
             injuries or death. The cause of this B. Review the patient list posted on the VA ICD
             failure mode has been identified as Surveillance Center intranet website
             cosmic radiation damage to a         (https://ICD.sanfrancisco.med.va.gov). It
             vendor-supplied static random        consists of a list of VA patients provided by
             access memory (SRAM) chip in         SJM. The SJM list is made up of all the VA
             these ICDs.                          patients in the company's databse that have an
                                                  SJM device implanted at a VA facility and are
                                                  affected by this recall. (See Attachment 2)

                                                   C. Review your patient records for all patients
                                                   with implanted SJM devices (continued)...
             Mandatory; Priority A                 SJM_ICDAlert Nov 15 05.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        396 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                START
5.9.24      (continued)... St. Jude Medical        ...(continued) affected by this recall.
(continued) Implantable Cardioverter
            Defibrillators, 11/05, (AL06-05)

                                                  2. By COB Wednesday, December 15, 2005:
                                                  interrogate all affected devices for: Hardware
             Temporary loss of pacing function    Reset Mode. If the device is in the Hardware
             and permanent loss of tachycardia    Reset Mode, acing at VVI at 60 ppm and no
             detection may occur in selected      tachycardia detection and theraphy, replace the
             Photon DR (Model V-230HV) and all device with a suitable new device immediately.
             Photon Micro VR/DR (Model V-
             194/V-232) and Atlas VR/DR
             (Models V-199/V-240) units. St.
             Jude Medical (SJM) reported 60       3. Follow the actions contained in Attachment
             failures out of 36,000 devices       1. This guidance was prepared by Dr. Edmund
             (0.167%) with no serious patient     Keung, Director of the VA ICD Surveillance
             injuries or death. The cause of this Center, and details the best course of action for
             failure mode has been identified as your patients.
             cosmic radiation damage to a
             vendor-supplied static random
             access memory (SRAM) chip in
             these ICDs.
             Mandatory; Priority A                 SJM_ICDAlert Nov 15 05.pdf                                                                                                       END




         Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        397 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                               Not
                                                                                                                        Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                     START            5.9
5.9.25       Insignia and Nexus Implantable         1. By close of business (COB) Monday,
             Cardiac Pacemakers manufactured        November 7, 2005: electrophysiology/cardiology
             by Guidant Corp, 10/05, (AL06-03)      staff or other appropriate parties must identify all
                                                    affected patients by implementing each of the
                                                    following steps a through d. It is important that
                                                    ALL INFORMATION sources be reviewed to
             Guidant Corporation is voluntarily     insure that patients will not be overlooked, as
             advising physicians, by letter about   affected patients may be found on one list and
             two separate failure modes within      not on another.
             the INSIGNIA and NEXUS families
             of cardiac pacemakers. One or          A. Review the manufactuer's letters (See Links
             more of the following malfunctions     below).
             may occur:
                                                    B. Review the patient list posted on the VA
             - Intermittent or permanent loss of    Western Pacemaker Surveillance Center
             pacing output without warning;         intranet website
                                                    (https://pacemaker.sanfrancisco.med.va.gov).
              - Intermittent or permanent loss of   This list combines the patients with the affected
             telemetry;                             devices that are already being followed via TTM
                                                    by the VA Western Pacemaker Surveillance
             - Reversion of VVI mode or             Center with a list of VA patients provided by
             appearance of a reset warning          Guidant. The Guidant list consists of all the VA
             message upon interrogation             patients in the company's database that have a
                                                    Guidant device implanted at the VA facility and
                                                    is affected by this recall. (See Attachment 2)

             First Failure Mode: May occur in       C. Review the VA National (continued)...
             selected Insignia and Nexus
             implanted units. Guidant reported
             36 failures out of 49,500 devices
             (0.073%). Seven (7) of these
             devices were found to exhibit no
             output during the implant
             Mandatory; Priority A                  GuidantInsigniaNexusPacemakers Oct 24 05.pdf                                                                                          END




         Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        398 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
            2005 Alerts & Advisories                                                                                                                                                     START
5.9.25      (continued)... Insignia and Nexus      ...(continued) registry for pacemaker implants
(continued) Implantable Cardiac Pacemakers         and the VA Eastern Pacemaker Surveillance
            manufactured by Guidant Corp,          Center, Washington DC VAMC, point of contact
            10/05, (AL06-03)                       is Ronald.Jones1@va.gov.

                                                   D. Review your patient records for all patients
                                                   with implanted Guidant devices affected by this
            Guidant Corporation is voluntarily     recall.
            advising physicians, by letter about
            two separate failure modes within
            the INSIGNIA and NEXUS families
            of cardiac pacemakers. One or          2. For first Failure Mode only: By COB Friday,
            more of the following malfunctions     November 25, 2005: interrogate all affected
            may occur:                             devices for:

            - Intermittent or permanent loss of    A. Intermittent or permanent loss of pacing
            pacing output without warning;         output without warning;

             - Intermittent or permanent loss of   B. Intermittent or permanent loss of telemetry;
            telemetry;
                                                   C. Reversion to VVI mode or appearance of a
            - Reversion of VVI mode or             reset warning message upon interrogation with
            appearance of a reset warning          a programmer.
            message upon interrogation
                                                   If one or more of these conditions are present,
                                                   replace the device with a suitable new device
                                                   immediately.
            First Failure Mode: May occur in
            selected Insignia and Nexus
            implanted units. Guidant reported
            36 failures out of 49,500 devices      3. Follow the actinos contained in Attachment
            (0.073%). Seven (7) of these           1. This guidance was prepared by Dr. Edmund
            devices were found to exhibit no
            Mandatory; Priority A                  GuidantInsigniaNexusPacemakers Oct 24 05.pdf                                                                                          END




        Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        399 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                               Not
                                                                                                                        Met        Partially   Met   If score other than 'met' what are
             Question:                             Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
             2005 Alerts & Advisories                                                                                                                                                     START            5.9
5.9.26       Use of Batch Data Entry Option          1. By close of business (COB) Friday, October
             Does Not Execute Delta Checks,          14, 2005, the Laboratory ADPAC or other
             10/05, (AL06-02)                        qualified individual must place the Batch Data
                                                     Entry [LRSTUF] option OUT OF ORDER until
                                                     VistA patch LR*5.2*347 is released and
                                                     installed. Acceptable alternate methods for data
             Positive Hepatitis C (HCV) reports      entry are EL Enter/verify data (Load list)
             did not generate a critical value alert [LRVRW2] or EM Enter/verify/modify data
             to the provider (as normally            (manual) [LRENTER].
             expected) when the test results
             were entered using the Batch Data
             Entry option [LRSTUF]. Test results
             entered using the                       2. By COB Friday, October 28, 2005: Review
             Enter/Verify/Modify Data (Manual)       the past 12 months of data to determine if any
             [LRENTER] option generated the          tests capable of being batch-entered and
             appropriate critical alerts.            containing a delta check did not generate a
                                                     critical value flag.




                                                   3. By COB Friday, November 4, 2005: Notify
                                                   providers of any critical flag omissions that were
                                                   identified, provided the patient has not already
                                                   had subsequent follo up. If the provider is no
                                                   longer with the facility, then notification should
                                                   be given to the Chief of Service. Affected
                                                   patients should be notified of positive test
                                                   results as soon as possible.
             Mandatory; Priority A                 VistABatchDataEntryDeltaChecks Oct 11 05.pdf                                                                                           END




         Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        400 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
             2006 Alerts & Advisories                                                                                                                                                 START            5.1
5.10.1       Physician Advisory issued by         Medtronic is reporting 19 failures out of 38000
             Medtronic Inc. on the Sigma Series   devices (0.05%) due to: loss of rate response;
             single and dual chamber              premature battery depletion; intermittent or total
             pacemakers, 1/06. (AL06-08).         loss of telemetry; or loss of pacing output in the
                                                  identified Sigma pacemaker units. The cause of
                                                  the failure has been identified as separation of
                                                  (i.e. loss of contact) redundant interconnection
             The Sigma Series single and dual     wires from the hybrid block in the pacemaker
             chamber pacemakers include:          circuit.
             SD203, SD303, SDR203, SDR303,
             SDR306, SVDD303, SS103, SS106,
             SS203, SS303, SSR203, SSR303,
             SSR306, SVVI103.

             Recommended; Priority A              MedtronicSigmaAL Jan 09 06.pdf                                                                                                      END
             2006 Alerts & Advisories                                                                                                                                                 START            5.1
5.10.2       Patient Pump Pain Management         Baxter reports incidents of unrequested patient
             Systems manufactured by Baxter       doses delivered due to the following:
             Healthcare Corp, 01/06, (AD06-03).
                                                  Damaged PCA patient cord/button;

                                                  Partial button sticking; and
             Products include Ipump Pain Mgmt
             System, APII Infusion Pump and       Fluid in the pump or PCA button.
             PCA II Infusion Pump.
                                                  The unrequested bolus doses do not exceed the
                                                  programmed total prescription limits.

                                                  Although Baxter has identified approximately 50
                                                  VAMCs affected by this notice, none of the
                                                  reported incidents are in VHA.
             Recommended; Priority A              BaxterPCAAD06-03 Jan 10 06.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        401 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
             Question:                           Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
             2006 Alerts & Advisories                                                                                                                                                    START            5.1
5.10.3       Cessation of Topical Spray          Affected products include, but are not limited to:
             Benzocaine Usage in topical
             anesthetization, 2/06, (AL06-09).   Hurricaine®Spray (benzocaine 20%)

                                                 Cetacaine®Spray (benzocaine 14% butyl
                                                 aminobenzoate 2% and tetracaine 2%)
             Specific use of Topical Spray
             Benzocaine to Anesthetize the       Topex® Spray (benzocaine 20%)
             Surfaces of the Nasopharynx,
             Oropharynx, Laryngotracheal
             Region and Airway.
                                                 Several cases have been reported where
                                                 benzocaine used as a topical anesthetic on the
                                                 surfaces of the nasopharynx, oropharynx,
                                                 laryngotracheal region, and airway has resulted
                                                 in severe, and in some cases fatal,
                                                 methemoglobinemia (MHb).

             Mandatory; Priority A               Benzocaine-WWW Feb 08 06.pdf                                                                                                            END
             2006 Alerts & Advisories                                                                                                                                                    START            5.1
5.10.4       Alaris IV Tubing sets, mfd by       Several VA facilities report failures when loading
             Cardinal Health, Alaris Products,   administration sets in Alaris Signature series
             3/06. (AL06-10).                    infusion pumps. The sets are difficult to load,
                                                 and, when they do load, may malfunction or
                                                 become occluded.

             This includes commonly used
             72023E and 72033E sets.
                                                 Production runs from the latter part of the
                                                 calendar year 2005 into January 2006 of all
                                                 Alaris tubing sets, including 72023E and
                                                 72033E (commonly used in VA), for Alaris
                                                 Signature infusion pumps, may be affected by
                                                 this problem.
             Mandatory; Priority A               CardinalAlarisIVTubingSets Mar 06 06.pdf                                                                                                END




         Recalls Alerts Advis - 5                                                     Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        402 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                    Not
                                                                                                                             Met        Partially   Met   If score other than 'met' what are
             Question:                                Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
             2006 Alerts & Advisories                                                                                                                                                          START            5.1
5.10.5       Mix-up (wrong route of                   Since 2001, VA facilities have reported five
             administration) of bladder irrigation    cases of accidental infusion into an IV line or
             with intravenous (IV) infusions, 4/06,   PICC line. Amphotericin B (See Attachment #1,
             (AL06-012).                              Patient Safety Alert AL06-012) was given
                                                      intravenously when it was intended for irrigation
                                                      of the bladder via a catheter. The same
                                                      adverse event could occurr with Glycine.
                                                      Amphotericin B and Glycine are both
                                                      contraindicated in patients with kidney or liver
                                                      disease and when Amphotericin B is infused via
                                                      IV line, it can induce serious complications (e.g.,
                                                      kidney failure.)
             Mandatory; Priority A                    AmphoBladderIrrigationAlert Apr 06 06.pdf                                                                                                END
             2006 Alerts & Advisories                                                                                                                                                          START            5.1
5.10.6       Transrectal ultrasound transducer  During patient safety rounds in the Urology
             assembly, manufactured by B-K      Clinic at the reporting facility, the lumen of a
             Medical Systems, Inc., 4/06 (AL06- needle guide of a reprocessed (i.e., ready to be
             011)                               used for a procedure) reusable B-K Medical
                                                transrectal ultrasound transducer assembly was
                                                found to be soiled. Upon investigation, it was
                                                discovered that brushes were not being used to
             Specific models are 8808 and 8551, clean the lumen of the needle guide.
             and are manufactured by B-K
             Medical Systems, Inc., Wilmington,
             MA.
             Mandatory; Priority A                    B-KMedicalTransducerAlert06-011 Apr 03 06.pdf                                                                                            END




         Recalls Alerts Advis - 5                                                           Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        403 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                      Not
                                                                                                               Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
             2006 Alerts & Advisories                                                                                                                                            START            5.1
5.10.7       Transfilling liquid oxygen from a    Specific Incident: A VA facility reports a fire
             liquid oxygen Dewar to a portable    erupted during the transfilling of liquid oxygen
             oxygen container., 03/06 (AD06-04)   from a Dewar to a portable container resulting in
                                                  property damage and the unscheduled
                                                  relocation of several patients; there were no
                                                  injuries.




                                                  General Information: Liquid oxygen stored in
                                                  Dewars can be transferred to smaller portable
                                                  containers for use by patients as a matter of
                                                  convenience. Patients can have smaller
                                                  portable oxygen containers filled at the
                                                  healthcare facility enabling them carry up to an
                                                  eight-hour supply of oxygen. The process of
                                                  transferring the liquid oxygen from the Dewar to
                                                  fill the portable oxygen container is commonly
                                                  referred to as transfilling. The

                                                  transfilling of liquid oxygen from one container to
                                                  another presents a potential hazard due to the
                                                  oxygen enriched atmosphere in the vicinity that
                                                  makes it easier for flammable material to ignite
                                                  and burn more vigorously. Materials not
                                                  normally considered combustible might burn in
                                                  an oxygen enriched atmosphere.
             Recommended; Priority A              O2TransfillingAD06-04.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                             Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        404 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
             2006 Alerts & Advisories                                                                                                                                               START            5.1
5.10.8       Oxygen Regulator Fires Resulting        1. Never use plastic crush gaskets.
             from Incorrect Use of CGA 870
             Seals., 05/06, (AD06-05)                2. Instead always use the sealing washer
                                                     specified by the

                                                     regulator manufacturer.
             Specific Incident: FDA has received
             12 reports in which regulators used     (Note: While FDA accepts using crush gaskets,
             with oxygen cylinders have burned       VHA believes the
             or exploded due to suspected
             improper use of gaskets/washers.        fire risk of reusing them outweighs the additional
             None of these reports involve VA        expense of using sealing washers.)
             facilities. The incidents are related
             to the reuse of single-use gaskets.     3. Always “crack” cylinder valves (open the
                                                     valve just enough to

                                                     allow gas to escape for a very short time) before
             General Information: Two types of       attaching regulators in order to expel foreign
             washers, or CGA 870 seals, are          matter from the outlet port of
             commonly used to create the seal at
             the cylinder valve / regulator          the valve.
             interface. The type required by
             many regulator manufacturers is a       4. Always inspect the regulator and CGA 870
             metal-bound elastomeric sealing         seal before
             washer that is designed for multiple
             use applications. The other common      attaching it to the valve to insure that the
             type, often supplied free-of-charge     regulator and seal are in good condition and the
             with refilled oxygen cylinders, is a    regulator is equipped with only one integral
             plastic crush gasket suitable for       metal and rubber seal that is in good condition.
             single use applications.
                                                     5. Tighten the T-handle firmly by hand, but do
                                                     not use wrenches
             Recommended; Priority A                 O2SealsAD06-05.pdf                                                                                                             END




         Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        405 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                       Not
                                                                                                                Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
             2006 Alerts & Advisories                                                                                                                                             START            5.1
5.10.9       Renewing medications using           Specific Incident: After installing OR*3*215
             Computerized Records System          (CPRS GUIv26) a VA medical center reports
             (CPRS), version 26., 05/06, (AL06-   that providers noticed renewed medications are
             13).                                 not showing up on their signature list. It’s been
                                                  discovered CPRS v26 contains a change to the
                                                  default action for completing the Outpatient
                                                  Medication and Inpatient Medication ordering
                                                  dialogs. In v25, the “OK” button is the default
                                                  choice. In

                                                  v26, “CANCEL” is the default choice. Pressing
                                                  the “Enter” or "Space” keys activates the default
                                                  choice. Providers, who are accustomed to
                                                  pressing the “Enter” key to close the dialog, may
                                                  not notice that the renewal medication order is
                                                  canceled rather than being renewed. Providers
                                                  need to click the “OK” button to accept the
                                                  renewal, or press tab or an arrow key to cause
                                                  the “OK” button to respond to an “Enter” key
                                                  press.




                                                  Actions: 1. Do not install CPRS version 26
                                                  (OR*3*215) until this issue is corrected.

                                                  2. If patch OR*3*215 is already installed,
                                                  implement the following immediately to assure
                                                  medications are (continued)...
                                                  CPRSv26MedrenewAL06-13.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        406 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
            2006 Alerts & Advisories                                                                                                                                                        START
5.10.9      (continued)... Renewing                 ...(continued) properly renewed.
(continued) medications using Computerized
            Records System (CPRS), version          a. Providers must review the medications being
            26., 05/06, (AL06-13).                  renewed and validate they are displayed upon
                                                    electronic signature.

                                                    b. For Inpatient medication orders, run the
                                                    ‘Inpatient Stop Order

                                                    Notices’ [PSJ EXP] that provides information of
                                                    expired medication orders and/or medication
                                                    orders nearing expiration. This VistA option is
                                                    available within the Unit Dose Medications menu.

                                                    c. Do not uninstall patch OR*3*215 (CPRS
                                                    GUIv26), if your facility has already installed.

                                                    CPRSv26MedrenewAL06-13.pdf                                                                                                              END
              2006 Alerts & Advisories                                                                                                                                                      START            5.1
5.10.10       Boston Scientific Corp (AL06-14),     These products are manufactured by the
              recalling a subset of devices that    Company's Cardiac Rhythm Management
              includes INSIGNIA and NEXUS           (CRM) Group, formerly Guidant's CRM
              pacemakers 06/06                      business. Boston Scientific acquired Guidant on
                                                    April 21, 2006.


              Also includes CONTAK RENEWAL
              TR/TR2 cardiac resynchronization      Boston Scientific/Guidant has recently
              therapy (CRT) pacemakes, and          confirmed five (5) reports of device malfunction
              VENTAK PRIZM 2 VITALITY and           associated with the failure of a low voltage
              VITALITY 2 implantable cardioverter   capacitor. This may lead to a device
              defibrillators (ICDs.)                malfunction, including intermittent or permanent
                                                    loss of therapy, or premature battery depletion.

              Mandatory; Priority A                 BostonScientificImplantableAL06-14.pdf                                                                                                  END




          Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        407 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
              Question:                             Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
              2006 Alerts & Advisories                                                                                                                                                       START            5.1
5.10.11       Sealed Lead-Acid Batteries for        A VA medical center reports multiple external
              External Defibrillators (AL06-15)     defibrillators not functioning properly on battery
                                                    mode after a limited number of discharges
                                                    although the internal batteries were fully
                                                    charged. Upon further investigation it was
              Sealed, lead-acid batteries for       discovered that the second source batteries
              external defibrillators supplied by   contain internal thermal breakers and heat
              non-OEM (Original Equipment           generated by the battery
              Manufacturer) or second source
              suppliers. Second source suppliers    after a limited number of discharges can trip the
              include Alpha Source, Anybattery,     thermal breaker, temporarily disabling the
              R&D Batteries and Unipower,           defibrillator until the battery cools.
              among others.


                                                    Actions:




                                                    1. By close of business July 25, 2006 identify
                                                    external defibrillators in your facility powered by
                                                    second source batteries and contact the battery
                                                    supplier to determine if internal thermal breakers
                                                    are incorporated into the battery.




                                                    2. If the defibrillator battery incorporates an
                                                    internal thermal breaker, replace it with a battery
                                                    acquired directly from the defibrillator

                                                    manufacturer (OEM), or if a second source
              Mandatory; Priority A                 Defibrillator Batteries AL06-15.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        408 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
            2006 Alerts & Advisories                                                                                                                                                         START
5.10.11     (continued)... Sealed Lead-Acid         ...(continued) a replacement battery is not
(continued) Batteries for External Defibrillators   available:
            (AL06-15)
                                                    (a) Instruct users and code response teams to
                                                    plug in the defibrillator during a code if the
                                                    defibrillator appears to fail to charge and
             Sealed, lead-acid batteries for        discharge normally (temporary signage can
             external defibrillators supplied by    assist).
             non-OEM (Original Equipment
             Manufacturer) or second source         (b) Assure code team defibrillators are equipped
             suppliers. Second source suppliers     with a fully charged spare battery.
             include Alpha Source, Anybattery,
             R&D Batteries and Unipower,
             among others.
             Mandatory; Priority A                  Defibrillator Batteries AL06-15.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        409 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
              Question:                             Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
              2006 Alerts & Advisories                                                                                                                                             START            5.1
5.10.12       Shutdown of Donor Referral            At this time it has been determined that tissue
              Services (DRS) Tissue Harvesting      from DRS was sold or distributed to:
              Co by FDA (AD06-06)


                                                    • Alamo Tissue Services of San Antonio, Texas
              FDA issued an order to Donor
              Referral Services (DRS) of Raleigh,   • Bonebank Allographs, San Antonio, TX
              North Carolina, to “cease
              manufacturing and to retain human     • DCI, Nashville, TN
              cells, tissues, and cellular and
              tissue-based products (HCT/Ps)",      • Global Orthopedic, Ellisville, MS
              due to violations of Good
              Manufacturing Practices (GMP).        • Lost Mountain Bank of Kennesaw, Georgia

                                                    • Neuro Tec, Marietta, GA

                                                    • US Tissue (AlloSource) of Cincinnati, Ohio and
                                                    Salt Lake City, Utah

                                                    • Tissue Management Solutions, Scottsdale, AZ

                                                    • Tissue Net of Orlando, Florida (may have
                                                    received from US Tissue (AlloSource) of
                                                    Cincinnati)

                                                    • West Coast Medical, Seattle, WA




                                                    Recommendations:
              Recommended; Priority A               DRS tissue AD06-06.pdf                                                                                                         END




          Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        410 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                       Not
                                                                                                                Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2006 Alerts & Advisories                                                                                                                                              START
5.10.12     (continued)... Shutdown of Donor      ...(continued) sources to replace the affected
(continued) Referral Services (DRS) Tissue        products.
            Harvesting Co by FDA (AD06-06)
                                                  d) If alternative sources are not immediately
                                                  available, the physicians should assess the
                                                  impact of denying use of this product against the
            FDA issued an order to Donor          patient’s medical outcome.
            Referral Services (DRS) of Raleigh,
            North Carolina, to “cease             e) Individuals who have received this material
            manufacturing and to retain human     will likely need notification and patient call back
            cells, tissues, and cellular and      for testing once it is determined that they have
            tissue-based products (HCT/Ps)",      received the recalled material. Refer to VHA
            due to violations of Good             Directive 2005-049 “Disclosure of Adverse
            Manufacturing Practices (GMP).        Events to Patients.”

            Recommended; Priority A               DRS tissue AD06-06.pdf                                                                                                          END




        Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        411 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                             Not
                                                                                                                      Met        Partially   Met   If score other than 'met' what are
              Question:                             Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
              2006 Alerts & Advisories                                                                                                                                                  START            5.1
5.10.13       Alaris® SE infusion pumps (AL06-      On August 15, 2006 Cardinal Health initiated a
              16)                                   voluntary field corrective action to address
                                                    concerns about the sensitivity of the keypad that
                                                    can lead to ‘key bounce,’ with a potential to
                                                    result in over infusion. Key bounce occurs when
              All models of Alaris® SE infusion     a keyboard entry registers twice while pressing
              pumps - formerly the Signature        the key once. For example, an infusion rate
                                                    intended to be 4.0 mL/hr where a key bounce
              Edition® Infusion System. Alaris is a occurs, results in an entry of 44.0 mL/hr.
              subsidiary of Cardinal Health, Inc.


                                                    Subsequently, on August 28, 2006 Cardinal
                                                    Health suspended

                                                    manufacturing and distribution of the Alaris® SE
                                                    infusion pumps

                                                    resultant from FDA actions.




                                                    Actions: If your facility has an affected pump
                                                    please assure the following:




                                                    1. Your facility has received the letters and
                                                    warning labels sent by

                                                    Cardinal Health for the Alaris® SE infusion
                                                    pumps, and that the warning labels have been
              Mandatory; Priority A                 Alaris SE Keyboard AL06-16.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        412 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                    (1)         Met (2)    (3)   possible root causes
            2006 Alerts & Advisories                                                                                                                                                  START
5.10.13     (continued)... Alaris® SE infusion     ...(continued) your Alaris infusion pumps do not
(continued) pumps (AL06-16)                        have the Guardrails®

                                                   software, consider acquiring the software and
                                                   implementing in locations where high risk
             All models of Alaris® SE infusion     medications are used.
             pumps - formerly the Signature
                                                   4. Assure that clinical staffs who program these
             Edition® Infusion System. Alaris is a pumps or any
             subsidiary of Cardinal Health, Inc.
                                                   programmable medical device visually verify the
                                                   intended device setting before beginning
                                                   treatment and leaving the area.
             Mandatory; Priority A                Alaris SE Keyboard AL06-16.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        413 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                             Not
                                                                                                                      Met        Partially   Met   If score other than 'met' what are
              Question:                           Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
              2006 Alerts & Advisories                                                                                                                                                  START            5.1
5.10.14       BCMA v3.0 Patch PSB*3.0*13          Four facilities report that BCMA scanners are
              (AL06-17)                           producing an audible sound when nurses scan
                                                  certain medications, as expected, but the status
                                                  of the medication doesn’t update to “G” (given)
                                                  on the BCMA screen. No adverse events
              BCMA scanners are producing an      occurred since nurses noticed the Virtual Due
              audible sound when nurses scan      List (VDL) did not update and took corrective
              certain medications, as expected,   action; however, had they not taken corrective
              but the status of the               action, another caregiver could believe the
                                                  medication wasn’t provided and
              medication doesn’t update to “G”
              (given) on the BCMA screen.         administer it again.




                                                  General Information: As identified by the Office
                                                  of Information Patient Safety Office this problem
                                                  is linked to the installation of BCMA v3.0 Patch
                                                  PSB*3.0*13. When using the patch, BCMA will
                                                  not update the medication status in the VDL to
                                                  “G” (given) following administration of a
                                                  medication that (1) has been renewed

                                                  and (2) has had special instructions (inserted by
                                                  the provider) removed prior to the order being
                                                  accepted by Pharmacy. When the status of the
                                                  medication is not updated to “G” in the VDL, the
                                                  medication will show up (continued)...



              Mandatory; Priority A               BCMA patch PSB-30-13 AL06-17.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        414 of 1656
                                                             NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
            Question:                           Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
            2006 Alerts & Advisories                                                                                                                                                  START
5.10.14     (continued)... BCMA v3.0 Patch      ...(continued) on the missed medication report.
(continued) PSB*3.0*13 (AL06-17)                Hence, the possibility exists that another
                                                caregiver could administer the medication again
                                                and overdose the patient.

            BCMA scanners are producing an
            audible sound when nurses scan
            certain medications, as expected,   Action: By COB September 14, 2006:
            but the status of the

            medication doesn’t update to “G”
            (given) on the BCMA screen.         1. For sites that have not installed BCMA v3.0
                                                Patch PSB*3.0*13 (i.e., those sites who do not
                                                appear on the list shown in Attachment A), the
                                                IRM (or designee) must IMMEDIATELY take
                                                steps to ensure that the patch is NOT installed.
                                                Once completed, there are no further actions for
                                                these sites and sites will be notified when it is
                                                okay to administer the patch.

                                                2. For sites that have already installed BCMA
                                                v3.0 Patch PSB*3.0*13 (i.e., those sites who
                                                appear on Attachment A), DO NOT uninstall the
                                                patch.




                                                Instead, the following actions are to be taken to
                                                minimize the risk to patients while a permanent
                                                solution is developed.


            Mandatory; Priority A               BCMA patch PSB-30-13 AL06-17.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        415 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
             Question:                        Rationale/Assessment Methods:                                                (1)         Met (2)    (3)   possible root causes
             2007 Alerts & Advisors                                                                                                                                                          START            5.11
5.11.1       VistA Imaging Patch MAG*3*18 -   This Patient Safety Alert only affects those
             VistARad Enhancements (AL07-01). facilities that read MRI images using MAG*3*18.
                                              This problem occurs if these conditions are
                                              present:

             A Radiologist reviewing a series of
             images from a MRI study discovered
             the software presented an              1) The Site is using an MRI device that allows
             incomplete set of images (missing a    for the creation of a scout (localizer) image
             slice) for review. The missing slice   using the Referenced Image Sequence field
             almost resulted in a spinal tumor      (0008,1140)
             being missed. The facility was
             using VistA Imaging Patch              2) The operator performing the imaging
             MAG*3*18 (released on June 16,         procedure chooses to generate a referenced
             2006) to read the images.              image sequence (done at the MRI console).




                                                    If these conditions are present when the exam is
                                                    opened using VistARad Patch MAG*3*18, the
                                                    image that serves as the scout (localizer) in the
                                                    referenced image series is moved out of its
                                                    original series in the Viewer window and placed
                                                    into the VistARad “Scout Image” window. The
                                                    radiologist needs to recognize that the image is
                                                    missing and then go to the Scout Image window
                                                    to view the image that was removed from the
                                                    original series.

                                                    This removal of scout images became a known
                                                    problem with Patch
             Mandatory; Priority A                  VistA Rad Patch MAG 318 AL07-01.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        416 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                          START
5.11.1      (continued)... VistA Imaging Patch     ...(continued) field. Therefore the problem was
(continued) MAG*3*18 - VistARad                    included in the ReadMe.txt file as PROBLEM 7:
            Enhancements (AL07-01).                “Scout Image problem on MRI exams.”



            A Radiologist reviewing a series of    Action:
            images from a MRI study discovered
            the software presented an
            incomplete set of images (missing a
            slice) for review. The missing slice   1. If you are NOT currently using VistA Imaging
            almost resulted in a spinal tumor      Patch MAG*3*18 to view MRI images do not
            being missed. The facility was         begin to do so until this sequencing problem is
            using VistA Imaging Patch              corrected.
            MAG*3*18 (released on June 16,
            2006) to read the images.              2. If VistA Imaging Patch MAG*3*18 is being
                                                   used to read MR images complete the following:

                                                   a. By close of business (COB) 10/6/2006, make
                                                   sure that all radiologists who review MRI studies
                                                   read and understand ReadMe.txt file Problem 7
                                                   that is included with the Patch.

                                                   b. By COB 10/20/2006 assess whether any MRI
                                                   studies read using Patch 18 need further
                                                   analysis. Clinical judgment must be used in
                                                   prioritizing and scheduling studies that need to
                                                   be re-read.


            Mandatory; Priority A                  VistA Rad Patch MAG 318 AL07-01.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        417 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
             Question:                             Rationale/Assessment Methods:                                   (1)         Met (2)    (3)   possible root causes
             2007 Alerts & Advisors                                                                                                                                                  START            5.11
5.11.2       Incorrect electronic chart associated This problem is not specific to CPRS v26 and
             with patient name in CPRS (AL07-      BCMA; it was
             03).
                                                   introduced with CPRS v22.16 (released
                                                   December of 2003) and

             Clinical orders (e.g. medications,       continued with later versions (current version is
             progress notes) and other clinical       26.68), and any
             data may be inadvertently entered
             into VistA for the incorrect patient     patient context CCOW-enabled application. The
             when the following conditions are        BCMA CCOWenabled version (PSB*3*13
             present:                                 released August 2006) increased the probability
                                                      of this occurring in CPRS.
             1) CPRS v26 and BCMA (post
             install PSB*3*13) are both open and Action: By close of business (COB) on Monday,
                                                  November 27, 2006:
             displaying information for the same
             patient (e.g., Patient A), and       1. The facility IT support must edit the BCMA
                                                  desktop shortcut
             2) an action is pending in BCMA
             (e.g., critical unviewed information parameters on all applicable workstations to
             on the IVP/IVPB tab) for Patient A,, include “/noccow” (without quotes) which will
             and                                  disable CCOW, and then notify the facility
                                                      BCMA Coordinator of this action. (The following
             3) a user attempts to process a          is an example of the BCMA desktop shortcut
             notification for another patient (e.g.   parameter setting with CCOW disabled
             Patient B) via the CPRS “File/Select     “C:\Program Files\vista\BCMA\BCMA.exe"
             Patient” patient selection               /noccow) AL07-03 November 21, 2006

             screen pathway, and

             4) the user selects “Break Link” from Note 1: This action will result in loss of patient
             the “Problem Changing
             Mandatory; Priority A   Clinical      CPRS CCOW AL07-03.pdf                                                                                                             END




         Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        418 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                  START
5.11.2      (continued)... Incorrect electronic     ...(continued) installation of Patch
(continued) chart associated with patient name
            in CPRS (AL07-03).                      PSB*3*13. All non-CCOW related changes
                                                    included in PSB*3*13

                                                    will remain active.
             Clinical orders (e.g. medications,
             progress notes) and other clinical
             data may be inadvertently entered
             into VistA for the incorrect patient   Note 2: While this CCOW issue is not
             when the following conditions are      associated with BCMA,
             present:
                                                  disabling CCOW in BCMA will reduce the
             1) CPRS v26 and BCMA (post           probability of sites
             install PSB*3*13) are both open and
                                                  encountering this problem in CPRS and have
             displaying information for the same minimal impact to
             patient (e.g., Patient A), and
                                                  patient synchronization across all other CCOW
             2) an action is pending in BCMA      enabled
             (e.g., critical unviewed information
             on the IVP/IVPB tab) for Patient A,, applications
             and

             3) a user attempts to process a
             notification for another patient (e.g. 2. Once Action 1 has been completed, the
             Patient B) via the CPRS “File/Select facility BCMA Coordinator must advise BCMA
             Patient” patient selection             users that CCOW is disabled.

             screen pathway, and                   3. Clinical Application Coordinators (CACs) or
                                                   designee must inform clinical users to select
             4) the user selects “Break Link” from “Cancel” instead of “Break Link,” if prompted by
             the “Problem Changing Clinical
             Mandatory; Priority A                 CPRS CCOW AL07-03.pdf                                                                                                            END




         Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        419 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                           Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                   Not
                                                                                                                            Met        Partially   Met   If score other than 'met' what are
             Question:                                Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
             2007 Alerts & Advisors                                                                                                                                                           START            5.11
5.11.3       Gemini PC series infusion pumps          Recommendations:
             manufactured by Alaris, formerly
             IMED, (AD07-01).                         1. DO NOT use medication pumps, or other
                                                      medical devices that

                                                      are in need of repair.
             A VA medical facility reported a
             Gemini PC series infusion pump

             exhibiting free flow while connected     2. As standard practice, operators of medical
             to a patient. Upon                       devices should inspect and conduct operational
                                                      checks consistent with manufacturer
             examination it was discovered that       recommendations on all medical devices before
             the free-flow protection latch           use. If the device is found to be in need of
                                                      repair, it should be labeled as defective,
             was broken. Discussions with other       removed from service, and sent to biomedical
             VA medical facilities confirm            engineering for service.

             that the free-flow protection latch on
             the Gemini PC series infusion
                                                      3. For sites using the Gemini PC series referred
             pump is prone to breaking and            to in this Advisory,
             therefore commonly inspected
                                                      include inspection of the free-flow protection
             before each use.                         latch in maintenance

                                                      and operational checks. A sample inspection
                                                      protocol developed by a VA medical facility is
                                                      attached to this Advisory as Attachment 1.



             Recommended; Priority A                  Alaris Gemini PC Latch AD07-01.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                          Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        420 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
             2007 Alerts & Advisors                                                                                                                                                 START            5.11
5.11.4       VistA Pharmacy Package: use of         VA facilities have the flexibility for entering
             alpha characters in “Infusion Rate”    information into the VistA field titled “Infusion
             field, (AD 07-02).                     Rate” that can lead to misunderstanding of the
                                                    infusion rate information. The capability to add
                                                    this nomenclature (text followed by @0) has
                                                    been available in the VistA system since 1994.
             A VA facility pharmacist entered
             T@0 in the “Infusion Rate” field to

             instruct the pharmacy printer not to   Recommendations: Implementation of all the
             print labels for an IV morphine        following is recommended:
             infusion. Caregivers believed that
             this abbreviation, which displays on
             the BCMA screen, meant that the
             medication could be titrated. This     1. Avoid the use of non-standardized
             misinterpretation resulted in a        abbreviations or nomenclature (e.g. “T”@0) prior
             medication misadministration and       to the @ symbol.
             inaccurate documentation.


                                                    2. In the situation where there is a desire to
                                                    prevent labels from being printed, use full text
                                                    (e.g. “No labels@0”, check with caregivers or
                                                    providers to ensure that the full text is not prone
                                                    to misinterpretation) so that communication
                                                    between pharmacy and other caregivers or
                                                    providers is complete, clear, accurate and
                                                    consistent.




                                                    3. If the medication order specifies an infusion
             Recommended; Priority A                VistaCPRSBCMATOAD07-02.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        421 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                 START
5.11.4      (continued)... VistA Pharmacy          ...(continued) administration of a medication
(continued) Package: use of alpha characters in    order is based on a titration, FULL instructions
            “Infusion Rate” field, (AD 07-02).     (e.g. Titrate@0) AND parameters for titration
                                                   (e.g. Infuse at 1ml/hr. May titrate as per protocol
                                                   to 2ml/hr.) should be included in the “Other
                                                   print:” information field (see Attachment A).
            A VA facility pharmacist entered
            T@0 in the “Infusion Rate” field to

            instruct the pharmacy printer not to
            print labels for an IV morphine
            infusion. Caregivers believed that
            this abbreviation, which displays on
            the BCMA screen, meant that the
            medication could be titrated. This
            misinterpretation resulted in a
            medication misadministration and
            inaccurate documentation.
            Recommended; Priority A                VistaCPRSBCMATOAD07-02.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        422 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                             Not
                                                                                                                      Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
             2007 Alerts & Advisors                                                                                                                                                     START            5.11
5.11.5       Reprocessing of resectoscope         During their SPD Healthcare Failure Mode and
             system’s working elements (used in   Effects Analysis
             urology) (AD 07-03)
                                                  (HFMEA™) on rigid cystoscopes, a VA Medical
                                                  Center identified they were improperly
                                                  reprocessing Karl Storz model 27050E
                                                  resectoscope working elements. The device
                                                  manufacturer’s instructions indicate the working
                                                  element cannot be sterilized in a STERRAD®
                                                  sterilization system, which was currently being
                                                  used for sterilization.




                                                  A contributing factor to the improper sterilization
                                                  of the resectoscope system’s working element is
                                                  the manufacturer’s reprocessing instructions
                                                  that may be open to misinterpretation. The
                                                  manufacturer’s instructions indicate sterilization
                                                  using a STERRAD® sterilization system can be
                                                  used for sterilization of Karl Storz’s
                                                  resectoscope working elements; however, an
                                                  asterisk (*) – which could be easily overlooked –
                                                  indicates that STERRAD® sterilization system
                                                  cannot be used for the 27050 series of Karl
                                                  Storz resectoscope working elements.




                                                  Reliance on instructions provided with
                                                  reprocessor’s (continued)...
             Recommended; Priority A              Resectoscope Working Element Reprocessing.pdf                                                                                         END




         Recalls Alerts Advis - 5                                                    Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        423 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                            Not
                                                                                                                     Met        Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                     START
5.11.5      (continued)... Reprocessing of       ...(continued) (sterilization)
(continued) resectoscope system’s working
            elements (used in urology) (AD 07-   equipment – to determine if a device can be
            03)                                  reprocessed using their reprocessing equipment
                                                 – could also contribute to improper
                                                 reprocessing. For example, the resectoscope
                                                 working element discussed in this Patient Safety
                                                 Advisory has multiple lumens and holes having
                                                 different inside diameters that are constructed
                                                 from different materials (e.g., stainless steel,
                                                 Teflon). Without a thorough knowledge of all of
                                                 the lumens and holes that

                                                 exist (some of which are not obvious and easily
                                                 overlooked – see

                                                 Attachment 2), a facility could easily come to the
                                                 incorrect conclusion (based on reprocessing
                                                 information from STERRAD®) that sterilization
                                                 using a STERRAD® sterilization system would
                                                 be acceptable for the Karl Storz resectoscope
                                                 working element 27050E.




                                                 Resectoscope working elements are part of
                                                 resectoscope systems and are used in Urology
                                                 in the transurethral resection of tissue; including
                                                 the ablation or cutting of prostate tissue (as in
                                                 transurethral resection of the prostate [TURP])
                                                 and superficial bladder tumors, and to cauterize
                                                 minor bleeding in the prostate and bladder. An
            Recommended; Priority A              Resectoscope Working Element Reprocessing.pdf                                                                                         END




        Recalls Alerts Advis - 5                                                    Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        424 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
             Question:                               Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
             2007 Alerts & Advisors                                                                                                                                                   START            5.11
5.11.6       Privacy curtains and privacy curtain    Locked mental health unit sleeping rooms -
             support structures (e.g., track and     provided with privacy
             track supports) in locked mental
             health units. (AL07-04).                curtains to meet patient privacy needs - conflict
                                                     with the need to

                                                     keep patients safe from self harm. Patient
             A VAMC reported that a patient          privacy is important;
             used a privacy curtain (and its
                                                     however, patient safety must come first. Privacy
             support) in a sleeping room located     curtains and their
             in a locked mental health unit to
             commit suicide by hanging. The          components are not appropriate in this
             patient used the privacy curtain as a   protected environment.
             noose - knotting it to make it more
             rope-like while it remained attached    A review of inpatient suicide and parasuicide
             to the curtain support structure. The   events in VHA over the past 5 years reveals that
             entire system supported the full        approximately 54% of the reported
             weight of the patient.
                                                     suicide/parasuicide events have occurred in
                                                     locked inpatient

                                                     psychiatric and detox units. 70% of the reported
                                                     events involved

                                                     hanging, drug overdose, or cutting with a sharp
                                                     object. The majority of items used for nooses for
                                                     suicides include bedding or clothing (including
                                                     belts and shoelaces). Various items have been
                                                     used for anchors in the suicide and parasuicides
                                                     including, but not limited to, doors, wardrobe
                                                     cabinets, bed rails, shower fixtures, bathroom
             Mandatory; Priority A                   Privacy Curtain AL07-04.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        425 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                    START
5.11.6      (continued)... Privacy curtains and      ...(continued) business (COB) Friday, February
(continued) privacy curtain support structures       23, 2007
            (e.g., track and track supports) in
            locked mental health units. (AL07-       identify every location accessible to patients in
            04).                                     your locked mental

                                                     health units that have privacy curtains and/or
                                                     support systems for
             A VAMC reported that a patient
             used a privacy curtain (and its         the curtains and remove the curtains.

             support) in a sleeping room located
             in a locked mental health unit to
             commit suicide by hanging. The          2. By COB Friday, March 9, 2007 remove any
             patient used the privacy curtain as a   privacy curtain
             noose - knotting it to make it more
             rope-like while it remained attached    supportive structures (e.g. tracks and track
             to the curtain support structure. The   supports) that could be used as an anchor for
             entire system supported the full        suicide by hanging.
             weight of the patient.

             Mandatory; Priority A                   Privacy Curtain AL07-04.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        426 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
             2007 Alerts & Advisors                                                                                                                                                   START            5.11
5.11.7       Medtronic Vitatron dual chamber      Medtronic Corporation is voluntarily advising
             cardiac pacemakers T-series and C-   physicians, by letter, about problems that might
             series, (AL07-05).                   occur, under certain conditions, within the
                                                  Vitatron dual chamber cardiac pacemakers T-
                                                  series and C-series.

             Device Name             Model
             Numbers
                                                  Specific Incident: A software anomaly can cause
             C50 D                   C50A1,       the pacemakers to present clinically as a reset
             C50A2, C50A3                         of the pacemaker or inhibition of pacing, if these
                                                  devices are programmed to specific parameters
             C60 DR                  C60A1,       and if the patient’s intrinsic heart rate falls below
             C60A2, C60A3                         the programmed lower heart rate.

             C70 DR                  C70A3

             T60 DR                  T60A1        Actions:

             T70 DR                  T70A1

                                                  1. By close of business (COB) Monday March
                                                  12, 2007, electrophysiology/cardiology staff or
                                                  other appropriate parties must identify all
                                                  affected patients by implementing each of the
                                                  following steps a through c. It is important that
                                                  ALL INFORMATION sources be reviewed to
                                                  insure that patients will not be overlooked, as
                                                  affected patients may be found on one list and
                                                  not on another.

                                                  a) Review the manufacturer’s letter (See
             Mandatory; Priority A                Medtronic Vitatron AL07-05.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        427 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                           Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                  START
5.11.7      (continued)... Medtronic Vitatron   ...(continued) Pacemaker Surveillance Center
(continued) dual chamber cardiac pacemakers     intranet website
            T-series and C-series, (AL07-05).   (https://pacemaker.sanfrancisco.med.va.gov).
                                                (See Attachment

                                                2.) This list combines the patients with the
            Device Name             Model       affected devices that are already being followed
            Numbers                             via Trans Telephonic Monitoring (TTM) by the
                                                VA Eastern and Western Pacemaker
            C50 D                   C50A1,      Surveillance Centers with a list of VA patients
            C50A2, C50A3                        provided by Medtronic. The Medtronic list
                                                consists of all the VA patients in the company’s
            C60 DR                  C60A1,      databases that have had a Medtronic device
            C60A2, C60A3                        implanted at a VA facility and are affected by
                                                this.
            C70 DR                  C70A3
                                                c) Review your patient records for all patients
            T60 DR                  T60A1       with implanted Medtronic devices affected by
                                                this notification.
            T70 DR                  T70A1



                                                2. By close of business (COB) March 23, 2007,
                                                follow the recommendations contained in
                                                Attachment 2. This guidance was prepared by
                                                Dr. Edmund Keung, Director of the VA Western
                                                Pacemaker Surveillance Center, and details the
                                                best course of action for your patients.
            Mandatory; Priority A               Medtronic Vitatron AL07-05.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        428 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                       Not
                                                                                                                Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
             2007 Alerts & Advisors                                                                                                                                               START            5.11
5.11.8       Tonometer Tips, (AL07-06)             The 120 day extension, previously issued by
                                                   The Acting Principal Deputy Under Secretary for
                                                   Health, for the Tonometer Tips Reprocessing
                                                   Patient Safety Alert (AL07-02) required that
             Reprocessing instructions for Haag- Action #2 be completed by March 7, 2007. The
             Streit reusable tips (prisms) used to extension was granted to provide sufficient time
             measure intraocular pressure.         to determine a reprocessing procedure for U.S.
                                                   customers to use for Haag-Streit reusable
                                                   tonometer tips.
                                                   http://vaww.ncps.med.va.gov/Dialogue/pslog/vie
                                                   w.asp?eid=94

                                                  Proposed reprocessing instructions were sent to
                                                  all VHA facilities at the end of January, 2007, for
                                                  review and comment. This Alert provides the
                                                  final instructions to be used for reprocessing
                                                  Haag-Streit reusable tonometer tips in the U.S.
                                                  These instructions have been provided to VA by
                                                  the manufacturer; the need to follow
                                                  reprocessing instructions as provided by the
                                                  manufacturer

                                                  complies with VA Handbook 7176, Part 6, 610.




                                                  Action:




                                                  By close of business Friday, March 30, 2007,
                                                  use the instructions
             Mandatory; Priority A                Tonometer Tips AL07-06.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        429 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                  START
5.11.8      (continued)... Tonometer Tips,          ...(continued) reusable tonometer tips in the U.S.
(continued) (AL07-06)




            Reprocessing instructions for Haag-
            Streit reusable tips (prisms) used to
            measure intraocular pressure.

            Mandatory; Priority A                   Tonometer Tips AL07-06.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        430 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                      (1)         Met (2)    (3)   possible root causes
             2007 Alerts & Advisors                                                                                                                                                      START            5.11
5.11.9       Boston Scientific Corporation’s        The following Guidant ICD and CRT-D device
             Cardiac Rhythm Management              models have low-voltage capacitors that may be
             Division (previously called Guidant)   subject to degradation and may cause
             recall of Implantable Cardiac          accelerated battery depletion.
             Defibrillators (ICDs) and Cardiac
             Resynchronization Therapy
             Defibrillators (CRT-Ds), (AL07-07).
                                                    Device Name                Model Numbers

                                                    Vitality DS DR/VR           T125/T135

                                                    Vitality EL DR              T127

                                                    Vitality AVT               A155

                                                    Vitality 2 DR/VR            T165/T175

                                                    Vitality 2 EL DR/VR          T167/T177

                                                    Vitality DR HE              T180

                                                    Contak Renewal 3            H170/H175

                                                    Contak Renewal 3            HE H177/H179

                                                    Contak Renewal 4            H190/H195

                                                    Contak Renewal 4            HE H197/H199

                                                    Contak Renewal 3            RF H210/H215

                                                    Contak Renewal 3            RF HE H217/H219
             Mandatory; Priority A                  Guidant BSCI-ICDs CRTs AlertAL07-07 -VAWW.pdf                                                                                        END




         Recalls Alerts Advis - 5                                                     Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        431 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                      (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                       START
5.11.9      (continued)... Boston Scientific        ...(continued) a through c. It is important that
(continued) Corporation’s Cardiac Rhythm            ALL INFORMATION sources be reviewed to
            Management Division (previously         insure that patients will not be missed, as they
            called Guidant) recall of Implantable   may be found on one list and not on another. a)
            Cardiac Defibrillators (ICDs) and       Review the manufacturers letters (see the links
            Cardiac Resynchronization Therapy       under Additional Information). b) Retrieve and
            Defibrillators (CRT-Ds), (AL07-07).     review a list of your patients with the affected
                                                    devices (ICDs and CRT-Ds) on the VA National
                                                    ICD Surveillance Center intranet website
                                                    (https://icd.sanfrancisco.med.va.gov, see
                                                    Attachment 2 for instructions). This list consists
                                                    of all the patients in Guidant’s database that
                                                    have implanted devices affected by this and
                                                    previous recalls (some devices are affected by
                                                    more than one recall). c) Review your patient
                                                    records for all patients with implanted Guidant
                                                    devices affected by this recall.




                                                    2. Within the next 30 calendar days, follow the
                                                    actions contained in Attachment 1. This
                                                    guidance was prepared by Dr. Edmund Keung,
                                                    Director of the VA National ICD Surveillance
                                                    Center, as the best course of action for your
                                                    patients.


             Mandatory; Priority A                  Guidant BSCI-ICDs CRTs AlertAL07-07 -VAWW.pdf                                                                                        END




         Recalls Alerts Advis - 5                                                     Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        432 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
              Question:                              Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                        START            5.11
5.11.10       Shelhigh, Inc. implantable medical     FDA states that the company’s deficiencies
              products, (AL07-08).                   could compromise the safety and effectiveness
                                                     of the products. The affected products include
                                                     heart valves, conduits, surgical patches, dural
                                                     patches (to aid in tissue recovery after
              On April 17, 2007, the FDA seized      neurosurgery), annuloplasty rings to repair heart
              all implantable medical products       valves, and arterial grafts.
              from Shelhigh, Inc. and on May 2,
              2007, the FDA issued a press
              release disclosing a formal request
              to Shelhigh, Inc., of Union, New       These products have been issued under
              Jersey “to recall all of its medical   supplier names of Shelhigh, Inc., Integra
              products remaining in the              NeuroSciences, and Integra LifeSciences Corp.
              marketplace including hospital
              inventories, because of sterility
              concerns.” Shelhigh, Inc. does not
              agree with the FDA                     Actions:

              position and consequently is not       1. By COB May 21, 2007 determine if you have
              implementing the requested recall.     any of the affected medical products listed in
                                                     Attachment A, remove them from inventory and
                                                     sequester.




                                                     2. Immediate action should be taken to
                                                     purchase alternative medical products from
                                                     other suppliers to replace the affected items.




                                                     3. By close of business (COB) May 25, 2007,
              Mandatory; Priority A                  Shelhigh Implantables AL07-08.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        433 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                               Not
                                                                                                                        Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                        START
5.11.10     (continued)... Shelhigh, Inc.          ...(continued) that these physicians are aware of
(continued) implantable medical products,          this issue, especially if patients under their care
            (AL07-08).                             have already received one of the implants.



            On April 17, 2007, the FDA seized      a) Retrieve and review a list of your patients
            all implantable medical products       with the affected
            from Shelhigh, Inc. and on May 2,
            2007, the FDA issued a press           products, sent to your facility Patient Safety
            release disclosing a formal request    Manager under
            to Shelhigh, Inc., of Union, New
            Jersey “to recall all of its medical   separate cover by secured FedEx. This list
            products remaining in the              includes all the
            marketplace including hospital
            inventories, because of sterility      patients in the VHA Prosthetics database that
            concerns.” Shelhigh, Inc. does not     have implanted
            agree with the FDA
                                                   products that are the subject of this notification.
            position and consequently is not       As this list may
            implementing the requested recall.
                                                   not be complete also complete action 3.b) below.




                                                   b) Review your patient records for all patients
                                                   with implanted

                                                   Shelhigh, Inc., Integra NeuroSciences, and
                                                   Integra LifeSciences

                                                   Corp products to identify those implanted with
            Mandatory; Priority A                  Shelhigh Implantables AL07-08.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        434 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                         START            5.11
5.11.11       BCMA Double Scans Alert (AL 07-         A VAMC discovered an inappropriate 4 digit
              09).                                    number as the unit of

                                                      administration in the medication administration
                                                      log for a patient
              Incorrect units of administration can
              be documented when scanning             receiving Morphine. At another facility, a
              variable dose medications in BCMA       provider reported viewing “743” as the unit of
                                                      administration for a regular Insulin order. These
                                                      inappropriate entries become part of the
                                                      patient’s medical record, can be misinterpreted
                                                      as the dose the patient received, and may
                                                      consequently be used by physicians to plan
                                                      future treatments.




                                                      General Information: After scanning a
                                                      medication in BCMA, there are instances where
                                                      the user is presented with a pop-up dialog box
                                                      for free-text entry; BCMA is expecting the user
                                                      to enter the units of administration of the
                                                      scanned medication into the pop-up box. If the
                                                      user doesn’t notice the pop-up box and doesn’t
                                                      enter the expected text into it – either because
                                                      the user inadvertently double scanned the same
                                                      medication or proceeded to scan another
                                                      medication - the internal entry number (IEN) or
                                                      synonym of the scanned (continued)...
              Mandatory; Priority A                   BCMA Double Scans Alert 07-09.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        435 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                         START
5.11.11     (continued)... BCMA Double Scans        ...(continued) medication is automatically
(continued) Alert (AL 07-09).                       entered into the free-text pop-up box. This
                                                    number is stored in the Medication History
                                                    Report as the units of administration for the first
                                                    scanned medication.
            Incorrect units of administration can
            be documented when scanning
            variable dose medications in BCMA
                                                    Examples: if a variable dose medication
                                                    (Medication 1) is

                                                    inadvertently scanned twice, the IEN of
                                                    Medication 1 would appear

                                                    as the units of administration for Medication 1 in
                                                    the Medication

                                                    History Report. Similarly, if Medication 2 was
                                                    scanned (and no text

                                                    was entered into the pop-up box that appeared)
                                                    and then Medication 3 was subsequently
                                                    scanned, the IEN for Medication 3 would be
                                                    entered as the units of administration for
                                                    Medication 2 in the Medication History Report.




                                                    Actions:



            Mandatory; Priority A                   BCMA Double Scans Alert 07-09.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        436 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                      Not
                                                                                                               Met        Partially   Met   If score other than 'met' what are
              Question:                            Rationale/Assessment Methods:                               (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                             START            5.11
5.11.12       Daylight Saving Time (DST)          In general, this change does not affect basic
              changes, (AD07-04)                  medical device operation, but could lead to
                                                  discrepancies for some record keeping activity.
                                                  Manufacturers are expected to provide formal
                                                  communications to customers shortly and the
              With the passage of the Energy      FDA is likewise preparing information on this
              Policy Act of 2005 the start of DST subject. Aside from general cautions regarding
              is changed from the first Sunday in devices that communicate with each other,
              April to the second Sunday in March where each device includes a separate clock,
              and the end of DST is changed from there are no indications for direct impact on
              the last Sunday in October to the   patient care other than minimal risk associated
              first Sunday of November beginning with time stamp issues.
              this year, 2007.


                                                   Recommendation: Managing a practical
                                                   approach to addressing DST changes includes
                                                   the following important steps:

                                                   1. Awareness – describe and communicate the
                                                   scope of the DST change to facility staff using
                                                   newsletters, daily bulletins and other normal
                                                   communication mechanisms.




                                                   2. Assessment – using available technical
                                                   documentation, identify the inventory of devices
                                                   with internal clocks that track date and time.



              Recommended; Priority A              DST_AD07-04.pdf                                                                                                               END




          Recalls Alerts Advis - 5                                            Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        437 of 1656
                                                              NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                       Not
                                                                                                                Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                START
5.11.12     (continued)... Daylight Saving Time   ...(continued) patches made available by
(continued) (DST) changes, (AD07-04)              medical equipment manufacturers to address
                                                  DST.


            With the passage of the Energy
            Policy Act of 2005 the start of DST   Note: Software patches from sources other than
            is changed from the first Sunday in   the medical device manufacturer cannot be
            April to the second Sunday in March   installed on medical devices without the explicit
            and the end of DST is changed from    consent of the medical device manufacturer.
            the last Sunday in October to the
            first Sunday of November beginning
            this year, 2007.
                                                  3. Prioritize – assign priority to devices requiring
                                                  action and address the following at minimum:

                                                  - life support, examples include defibrillators,
                                                  ventilators

                                                  - critical patient monitoring, examples include
                                                  ICU, vital signs monitors

                                                  - synchronization between devices/systems
                                                  using real-time clocks such

                                                  as BCMA laptops communicating with VistA

                                                  - diagnostic devices such as imaging, ECG, and
                                                  laboratory analyzers

                                                  - other devices such as sterilizers/reprocessing
                                                  equipment
            Recommended; Priority A               DST_AD07-04.pdf                                                                                                                 END




        Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        438 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
              Question:                              Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                 START            5.11
5.11.13       Ceiling collapse in exterior           By close of business (COB) on Friday, August
              connecting corridor between            31, 2007:
              buildings. (AL07-10)


                                                    1. Survey all plaster lathe ceiling systems in
              An approximately twenty foot          exterior connecting corridors between buildings
              section of a plaster ceiling over an  for bulging or cracking that may indicate the
                                                    ceiling system is unsound. If the plaster lathe
              exterior connecting corridor between ceiling system is obscured by a lower
              buildings collapsed and fell through suspended ceiling, inspect the plaster lathe
              an existing suspended ceiling,        system at approximately 8 foot intervals down
              injuring two patients. The exterior   the length of the exterior connecting corridor.
              connecting corridor roof system was
              approximately 57 years old and did
              not have ridge or soffit vents. There
              was no evidence that moisture from 2. Take immediate action to shore up any
              recent rains was a factor; however, plaster ceiling that is showing signs of
              the wire lathe and fasteners          deterioration and/or damage and prevent
              securing the ceiling to the wood      patients, staff or visitors from using the exterior
              rafters and ties showed advanced      connecting corridor between buildings until it is
              deterioration.                        safe to do so. Initiate a project to permanently
                                                    shore up the ceiling system or remove the
                                                    plaster lathe assembly.




                                                     NOTE: Plaster lathe ceilings may be an integral
                                                     component of the

                                                     connecting corridors fire rated assembly.
                                                     Consult with your Network Safety Manager
              Mandatory; Priority A                  NCPS Alert AL07-10.pdf                                                                                                          END




          Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        439 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                  START
5.11.13     (continued)... Ceiling collapse in      ...(continued) system in place is not properly
(continued) exterior connecting corridor between    vented and is to remain in place, initiate a
            buildings. (AL07-10)                    project to install vents in the exterior connecting
                                                    corridors between buildings. Facilities must
                                                    develop station level or NRM project plans.
                                                    NRM projects plans should be incorporated into
            An approximately twenty foot            the VISN NRM 2008 operating plans. VISNs
            section of a plaster ceiling over an    should target correcting these deficiencies by
                                                    September 30, 2008.
            exterior connecting corridor between
            buildings collapsed and fell through
            an existing suspended ceiling,
            injuring two patients. The exterior
            connecting corridor roof system was
            approximately 57 years old and did
            not have ridge or soffit vents. There
            was no evidence that moisture from
            recent rains was a factor; however,
            the wire lathe and fasteners
            securing the ceiling to the wood
            rafters and ties showed advanced
            deterioration.

            Mandatory; Priority A                   NCPS Alert AL07-10.pdf                                                                                                          END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        440 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                  START            5.11
5.11.14       VistAWeb may display a different        This problem is specific to the use of
              patient’s data than other open          TeleReader along with the VistAWeb
              desktop applications when using         application. TeleReader is primarily used in VHA
              TeleReader (AL07-11).                   for telereading of retinal images, but is also
                                                      used at some sites for teledermatology and
                                                      teledentistry.

              A VA Medical Center reported that
              VistA Imaging patient data (retinal
              images) from one patient were           Action:
              displayed with a different patient’s
              VistAWeb electronic chart when the      By close of business (COB) on Thursday,
              following conditions were met: 1.       September 13, 2007, inform optometrists,
              CCOW-enabled applications of            dentists, dermatologists, and other clinicians
              TeleReader, VistAWeb, CPRS GUI,         using TeleReader of this problem and instruct
              and VistA Imaging were all open on      them to immediately discontinue use of
              the same workstation and displaying     VistAWeb if it is being used on the same
              information for the same patient,       workstation as TeleReader (until the national
              AND THEN 2. A patient selection         patch is available to fix this problem). Users will
              change was initiated from within        need to set CPRS to use Remote Data Views
              TeleReader. While the newly             (RDV) as the default viewer for remote patient
              selected patient’s image was            data. See Figure 1 (on the following page) for
              displayed in Vista Imaging,             instructions for selecting RDV to view remote
              VistAWeb was unable to change to        data in CPRS. If you have any issues selecting
              the newly selected patient’s data.      RDV to view remote data, contact your Clinical
              Therefore, providers did not have       Application Coordinator (CAC) for help.
              access to the correct historical data
              (VistAWeb electronic chart data)        NOTE: We discourage readers who have the
              when viewing patient data (e.g.,        option of using a second workstation to set up
              progress notes, lab results, images)    (continued)...
              in other applications. This can lead
              to a delay in follow-up care and
              subsequent disease progression.
              Mandatory; Priority A                   TelereaderAL07-11.pdf                                                                                                           END




          Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        441 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                       Not
                                                                                                                Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                               (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                START
5.11.14     (continued)... VistAWeb may             ...(continued) VistAWeb (without TeleReader) on
(continued) display a different patient’s data      the second workstation. This puts the onus on
            than other open desktop                 the user to switch to a new patient on the
            applications when using TeleReader      second workstation each time a patient change
            (AL07-11).                              is made in TeleReader (on the first workstation)
                                                    and presents the same potential error that exists
                                                    with the current use of VistAWeb with
                                                    TeleReader.
            A VA Medical Center reported that
            VistA Imaging patient data (retinal
            images) from one patient were
            displayed with a different patient’s
            VistAWeb electronic chart when the
            following conditions were met: 1.
            CCOW-enabled applications of
            TeleReader, VistAWeb, CPRS GUI,
            and VistA Imaging were all open on
            the same workstation and displaying
            information for the same patient,
            AND THEN 2. A patient selection
            change was initiated from within
            TeleReader. While the newly
            selected patient’s image was
            displayed in Vista Imaging,
            VistAWeb was unable to change to
            the newly selected patient’s data.
            Therefore, providers did not have
            access to the correct historical data
            (VistAWeb electronic chart data)
            when viewing patient data (e.g.,
            progress notes, lab results, images)
            in other applications. This can lead
            Mandatory; Priorityfollow-up care and
            to a delay in A                         TelereaderAL07-11.pdf                                                                                                         END




        Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        442 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                            Not
                                                                                                                     Met        Partially   Met   If score other than 'met' what are
              Question:                           Rationale/Assessment Methods:                                      (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                   START            5.11
5.11.15       Medtronic SynchroMed EL             As of June 15, 2007, Medtronic received 354
              implantable infusion pump (AL08-01) inquiries/complaints from health care
                                                  professionals worldwide, regarding gear shaft
                                                  wear on the SynchroMed EL implantable drug
                                                  infusion pumps. Medtronic estimates that
              Models: 8626-10, 8626L-10, 8626-    approximately 52,000 of these pumps, that may
              18, 8626L-18, 8627-10, 8627L-10,    experience gear shaft wear, are still implanted in
              8627-18, 8627L-18                   patients worldwide. If a pump motor stall occurs,
                                                  drug delivery will stop abruptly without warning
                                                  and result in loss of therapy. Drug withdrawal
                                                  from Intrathecal Baclofen (ITB) therapy can be
              Medtronic issued an Urgent Medical fatal if not treated properly and effectively.
              Device Correction “SynchroMed EL
              Pump Motor Stall Due to gear Shaft
              Wear” in August 2007.
                                                  Actions:

                                                   1. If you have these devices in stock do not use
                                                   them.

                                                   2. By close of business (COB) Friday, October
                                                   26, 2007 identify all affected

                                                   patients by implementing each of the following
                                                   steps a through c.

                                                   It is important that ALL INFORMATION sources
                                                   be reviewed to insure that

                                                   patients will not be overlooked, as affected
                                                   patients may be found on one list and not on
                                                   another.
              Mandatory; Priority A                MedtronicSynchroMedAL08-01.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        443 of 1656
                                                            NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                          Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                 START
5.11.15     (continued)... Medtronic           ...(continued) Review the VA
(continued) SynchroMed EL implantable          physician/caregiver list and their associated
            infusion pump (AL08-01)            patients with an affected device available from
                                               your Network (VISN) Patient Safety Officer
                                               (PSO) and contact the physician/caregiver to
                                               implement action 3 below.
            Models: 8626-10, 8626L-10, 8626-
            18, 8626L-18, 8627-10, 8627L-10,   c) Review patient records for all other patients
            8627-18, 8627L-18                  with implanted Medtronic

                                               SynchroMed EL devices affected by this recall
                                               that might have been
            Medtronic issued an Urgent Medical
            Device Correction “SynchroMed EL implanted at a non-VA facility and have their VA
            Pump Motor Stall Due to gear Shaft physician/caregiver
            Wear” in August 2007.
                                               implement action 3 below.

                                               3. By close of business (COB) Friday,
                                               November 30, 2007 physicians/caregivers must
                                               follow Patient Management Recommendations
                                               #1 through #4 contained in the manufacturer’s
                                               letters (Alert Attachments 1 and 2) and
                                               reproduced below:




                                               Patient Management Recommendation #1

                                               If a patient presents symptoms of underinfusion
                                               or withdrawal, a clinician can confirm a pump
                                               motor stall through a drug refill volume
            Mandatory; Priority A              MedtronicSynchroMedAL08-01.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        444 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                         START            5.11
5.11.16       Sprint Fidelis® Defibrillation Leads,   The Sprint Fidelis® leads are used to deliver
              manufactured by Medtronic (AL08-        therapy in defibrillators, including Implantable
              02)                                     Cardioverter Defibrillators (ICD) and Cardiac
                                                      Resynchronization Therapy - Defibrillators (CRT-
                                                      D). More than 268,000 of the leads have been
                                                      implanted worldwide, and Medtronic and the
              Medtronic issued a recall of its        FDA estimate that fractures have occurred in
              Sprint Fidelis® leads, models 6930,     less than 1 percent of the leads. Medtronic
              6931, 6948, and 6949 due to a           reports that lead fractures may have contributed
              potential for fracture.                 to five deaths.




                                                      Actions:

                                                      1. By close of business (COB) Friday, October
                                                      26, 2007, materials management or cardiology
                                                      staff must remove affected leads from stock;
                                                      these leads should not be used.




                                                      2. By COB Friday, November 9, 2007,
                                                      electrophysiology/cardiology staff or other
                                                      appropriate parties must identify all affected
                                                      patients by implementing each of the following
                                                      steps a through c and then implement action 3
                                                      below. It is important that ALL INFORMATION
                                                      sources be reviewed to insure that patients will
                                                      not be overlooked, as affected patients may be
                                                      found on one list and (continued)...
              Mandatory; Priority A                   MedtronicSprintFidelisAL08-02.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        445 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                       START
5.11.16     (continued)... Sprint Fidelis®        ...(continued) not on another.
(continued) Defibrillation Leads, manufactured
            by Medtronic (AL08-02)                a) Review the manufacturer’s letter (See Alert
                                                  Attachment 1).

                                                  b) Review the patient list posted on the VA
            Medtronic issued a recall of its      National ICD Surveillance Center intranet
            Sprint Fidelis® leads, models 6930,   website
            6931, 6948, and 6949 due to a         (https://ICDPM.sanfrancisco.med.va.gov). (See
            potential for fracture.               Alert Attachment 2.) This list combines patients
                                                  with affected leads who are already in the
                                                  Center’s database with a list of VA patients
                                                  provided by Medtronic.

                                                  c) Review your patient records for all patients
                                                  with implanted Medtronic leads affected by this
                                                  notification that might have been implanted at a
                                                  non-VA facility.




                                                  3. By COB Friday, December 28, 2007, follow
                                                  the recommendations contained in Alert
                                                  Attachment 2. This guidance was prepared by
                                                  Dr. Edmund Keung, Director of the VA National
                                                  Surveillance Center, and details the best course
                                                  of action for your patients.
            Mandatory; Priority A                 MedtronicSprintFidelisAL08-02.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        446 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
              Question:                             Rationale/Assessment Methods:                                      (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                     START            5.11
5.11.17       Updated Haag-Streit reusable          Haag-Streit has revised their reprocessing
              tonometer tip (prism) reprocessing    instructions for their reusable tonometer tips to
              instructions for U.S. customers (AL   also permit disinfection with a 10% aqueous
              08-03) ADDENDUM TO PATIENT            solution of sodium hypochlorite (household
              SAFETY ALERTS AL07-06 and             bleach). The new instructions may be found in
              AL07-02                               Attachment 1 and at
                                                    http://www.newsmaker.ch/upload/customers/haa
                                                    gstreit/Disinfect_in_the_USA.pdf.

              AL07-06 (ISSUED ON MARCH 7,           Haag-Streit has also revised the rinsing step in
              2007)                                 their new instructions. Supplemental VHA
                                                    reprocessing instructions are also provided in
              AL07-08 (ISSUED OCTOBER 26,           Alert Attachment 2.
              2006)



              CONCERNING REPROCESSING
              OF REUSABLE TONOMETER TIPS
              (PRISMS) USED TO MEASURE
              INTRAOCULAR PRESSURE

              Mandatory; Priority A                 TonometerTipsReprocessingAL08-03.pdf                                                                                                 END




          Recalls Alerts Advis - 5                                                    Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        447 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                            Not
                                                                                                                     Met        Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                   START            5.11
5.11.18       Model 8100 infusion pump modules     The springs can be missing, bent or broken,
              shipped before September 27,         risking medication over-infusion. Cardinal Health
              2007; a component of the Alaris      identified 5,560 units of the model 8100 module
              Medley infusion pump system,         at 30 VA Medical Centers and sent notices to
              distributed by Cardinal Health (AL08-Biomedical Engineering, Materials Management,
              04)                                  Nursing and Risk Management via certified
                                                   letter. Cardinal Health is establishing teams to
                                                   visit each hospital and arrange for definitive
                                                   testing of all modules that is expected to be
              Cardinal Health reports that some of completed over the next several months. The
              the 8100 pump modules may have       only definitive test is an x-ray of each module to
              misassembled occluder springs.       examine the occluder springs.




                                                      Actions:




                                                      1. By close of business (COB) on Friday,
                                                      December 7, 2007:

                                                      a. If you have Alaris Medley pumps and have
                                                      not received notification from

                                                      Cardinal Health, check Attachment 1 to see if
                                                      your facility is affected.

                                                      b. If your facility is affected and did not receive
                                                      Cardinal Health’s customer

                                                      letter (Attachment 2), contact Cardinal Health at
              Mandatory; Priority A                   Alaris8100AL08-04.pdf                                                                                                            END




          Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        448 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                      Not
                                                                                                               Met        Partially   Met   If score other than 'met' what are
            Question:                            Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                               START
5.11.18     (continued)... Model 8100 infusion   ...(continued) possible, arrange to send modules
(continued) pump modules shipped before          not currently in use to Cardinal Health for x-ray
            September 27, 2007; a component      testing. Cardinal Health will bear the cost of
            of the Alaris Medley infusion pump   shipping and testing. Ensure you have enough
            system, distributed by Cardinal      infusion pumps and modules on hand for use
            Health (AL08-04)                     before sending modules to Cardinal Health for x-
                                                 ray.


            Cardinal Health reports that some of
            the 8100 pump modules may have       3. Monitor the modules impacted by this
            misassembled occluder springs.       notification for potential inaccurate

                                                 flow. If you suspect inaccurate flow with a
                                                 particular device, remove the

                                                 device from service and contact Cardinal Health
                                                 at (800) 854-7128 (select

                                                 option 3) to arrange for a device failure
                                                 investigation.
            Mandatory; Priority A                Alaris8100AL08-04.pdf                                                                                                           END




        Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        449 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
              Question:                              Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                  START            5.11
5.11.19       Positive displacement, needle-free     Recent published literature suggests the
              intravascular connector valves (AD-    possibility of increased BSI
              08-01)
                                                     rates associated with some positive
                                                     displacement, needle-free

              A VAMC reports their blood stream      intravascular connector valves. (See Addl.
              infection (BSI) rates increased in     Information below.)

              2005 and 2006 when compared to
              their BSI rates before 2005. The
                                                     Suggestions:
              increase coincides with use of luer-
              activated mechanical valves and        1) If you are considering a switch to positive
                                                     displacement, needlefree
              positive displacement, needle-free
              intravascular connector valves.        intravascular connector valves for central
                                                     venous catheters or

                                                     PICC (Peripherally Inserted Central Catheter)
                                                     lines, please consider

                                                     the published literature cited below in the Addl.
                                                     Information section

                                                     before making a decision.

                                                     2) If you have already begun to use positive
                                                     displacement, needlefree

                                                     intravascular connector valves for central
                                                     venous catheters or
              Recommended; Priority A                NeedlelessValvesAD08-01.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        450 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                  START
5.11.19     (continued)... Positive                ...(continued) (734) 930-5890 or via email at
(continued) displacement, needle-free
            intravascular connector valves (AD-    Judith.Anderson4@va.gov.
            08-01)
                                                   3) Always follow manufacturer’s latest
                                                   instructions on the safe use of

            A VAMC reports their blood stream      their devices; ensure that training has occurred,
            infection (BSI) rates increased in     and there is

            2005 and 2006 when compared to         demonstrated competency.
            their BSI rates before 2005. The

            increase coincides with use of luer-
            activated mechanical valves and

            positive displacement, needle-free
            intravascular connector valves.

            Recommended; Priority A                NeedlelessValvesAD08-01.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        451 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
              Question:                              Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                START            5.11
5.11.20       Potential for medication errors due    Both problems can occur when a pharmacist is
              to VistA Patch PSJ*5.0*175             processing orders for a

                                                     patient currently receiving multiple medications
                                                     within the same drug class.
              Two patient safety vulnerabilities
              were identified following the          The processing pharmacist will receive a
              installation of                        “Duplicate drug class” order

              VistA Pharmacy patch PSJ*5.0*175       check message. The pharmacist is prompted to
              released on October 25, 2007.          discontinue one or more
              These
                                                     of the possible duplicate medications (see Alert
              vulnerabilities can occur when a       Attachment A). If the
              Pharmacist is processing a
              medication                             pharmacist enters “YES” to the prompt, instead
                                                     of accepting the defaulted
              order.
                                                  “NO” value, then for the first problem above, the
              1. Two VA Medical centers report    medication dispensed may not be the same as
              that a Unit Dose dispensed drug did the medication prescribed.
              not

              match the Unit Dose ordered drug.
              This problem is not easily detected.   Actions:

              It can result in drug “B” being        1. Immediately notify pharmacists of this Patient
              dispensed when drug “A” was            Safety Alert and advise
              ordered, if
                                                     them to reply “NO” to the prompt “Do you wish to
              the patient has both drug “A” and      DISCONTINUE any of
              drug “B” as current orders and both
              Mandatory; Priority A                  VistAPatchPSJAL08-05.pdf                                                                                                       END




          Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        452 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                 (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                 START
5.11.20     (continued)... Potential for           ...(continued) Immediately notify Information
(continued) medication errors due to VistA         Technology (IT) service to:
            Patch PSJ*5.0*175
                                                   a. Do NOT back out VistA patch PSJ*5.0*175.
                                                   Emergency patch

            Two patient safety vulnerabilities     PSJ*5.0*201 is planned for release the week of
            were identified following the          December 10,
            installation of
                                                   2007, to restore pre-PSJ*5.0*175 state. This
            VistA Pharmacy patch PSJ*5.0*175       emergency patch
            released on October 25, 2007.
            These                                  must be installed immediately upon release.

            vulnerabilities can occur when a       b. Identify the source of your facility’s Bar Code
            Pharmacist is processing a             Medication
            medication
                                                   Administration (BCMA) backup contingency
            order.                                 software. If the

            1. Two VA Medical centers report    software is NOT the nationally released
            that a Unit Dose dispensed drug did BarCodeBackUp
            not
                                                   (BCBU), notify BCMA users that the Medication
            match the Unit Dose ordered drug.      Administration
            This problem is not easily detected.
                                                   Record (MAR) and/or Medication Administration
            It can result in drug “B” being        History (MAH)
            dispensed when drug “A” was
            ordered, if                            may not be complete.

            the patient has both drug “A” and
            drug “B” as current orders and both
            Mandatory; Priority A                  VistAPatchPSJAL08-05.pdf                                                                                                        END




        Recalls Alerts Advis - 5                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        453 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                             Not
                                                                                                                      Met        Partially   Met   If score other than 'met' what are
              Question:                              Rationale/Assessment Methods:                                    (1)         Met (2)    (3)   possible root causes
              2007 Alerts & Advisors                                                                                                                                                    START            5.11
5.11.21       FDA CLASS II recall of Boston          Actions:
              Scientific Corporation’s Cardiac
              Rhythm Management Division
              (previously called Guidant)
              Implantable Cardiac Defibrillators     1.Within 14 calendar days of the issuance of this
              (ICDs) and Cardiac                     Alert, electrophysiology/cardiology staff or other
              Resynchronization Therapy              appropriate caregivers must identify all affected
              Defibrillators (CRT-Ds). (AL08-06)     patients by implementing both of the following
                                                     steps a and b. It is important that ALL
                                                     INFORMATION sources be reviewed to insure
                                                     that patients will not be missed, as they may be
              NOTE: Some models addressed in         found on one list and not on another.
              this Alert also appear in Patient
              Safety Alert AL07-07 issued on Aprila) Retrieve and review a list of your patients
              18, 2007. This Alert provides new   with the affected devices (ICDs and CRT-Ds) on
              information addressing a new        the VA National ICD Surveillance Center
              battery problem.                    intranet website
                                                  (https://icdpm.sanfrancisco.med.va.gov, see
                                                  Attachment 3 for instructions). This list consists
                                                  of all the patients in Guidant’s database that
              A subset of the following Guidant   have implanted devices affected by this and
              ICD and CRT-D device models have previous recalls (some devices are affected by
              a buildup of internal battery       more than one recall).
              impedance that may lengthen ICD
              and CRT-D charge times and          b) Review your patient records for all patients
              display the Elective Replacement    with implanted Guidant devices affected by this
              Indicator (ERI) or End of Life      recall.
              Indicator (EOL) even though battery
              voltage and capacity remain
              available. This issue can result in
              delayed delivery of shock therapy.  2. Within the next 90 calendar days of the
                                                     issuance of this Alert, follow the actions
              Mandatory; Priority A                  GuidantBSCI-ICDsCRTsAlert-AL08-06-VAWW.pdf                                                                                         END




          Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        454 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                            Not
                                                                                                                     Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                    (1)         Met (2)    (3)   possible root causes
            2007 Alerts & Advisors                                                                                                                                                     START
5.11.21     (continued)... FDA CLASS II recall      ...(continued) Attachment 2. This guidance was
(continued) of Boston Scientific Corporation’s      prepared by Dr. Edmund Keung, Director of the
            Cardiac Rhythm Management               VA National ICD Surveillance Center, as the
            Division (previously called Guidant)    best course of action for your patients.
            Implantable Cardiac Defibrillators
            (ICDs) and Cardiac
            Resynchronization Therapy
            Defibrillators (CRT-Ds). (AL08-06)      NOTE: Because the incidence rate is very low
                                                    and prolongation of charge time and ERI/EOL
                                                    can be identified by close monitoring (see
                                                    information contained within the Attachments
             NOTE: Some models addressed in         below), prophylactic replacement of the devices
             this Alert also appear in Patient      is not recommended.
             Safety Alert AL07-07 issued on April
             18, 2007. This Alert provides new
             information addressing a new
             battery problem.



             A subset of the following Guidant
             ICD and CRT-D device models have
             a buildup of internal battery
             impedance that may lengthen ICD
             and CRT-D charge times and
             display the Elective Replacement
             Indicator (ERI) or End of Life
             Indicator (EOL) even though battery
             voltage and capacity remain
             available. This issue can result in
             delayed delivery of shock therapy.

             Mandatory; Priority A                  GuidantBSCI-ICDsCRTsAlert-AL08-06-VAWW.pdf                                                                                         END




         Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        455 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
             Question:                                 Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
             2008 Alerts & Advisories                                                                                                                                                      START            5.12
5.12.1       Implant orientation of Implantable        Actions:
             Cardioverter Defibrillators (ICDs)
             and Cardiac Resynchronization
             Therapy Devices (CRT-Ds)
             manufactured by Boston Scientific         1. By Close of Business (COB) April 30, 2008,
             Corporation’s Cardiac Rhythm              electrophysiology and/or
             Management Division, previously
             under the name Guidant (AL08-08)          cardiology staff or other appropriate caregivers
                                                       must identify all affected

                                                 patients by implementing steps a, b, c and step
             A subset of the following Guidant   d if indicated. It is important that ALL
             ICDs and CRT-Ds models implanted INFORMATION sources be reviewed to insure
             in a                                that patients will not be missed, as they may be
                                                 found on one list and not on another.
             specific location and in an
             uncommon orientation - beneath the a) Retrieve and review a list of your patients
             pectoral muscle with the serial     with the affected devices
             number facing the ribs - may be
             subject to component damage and     (ICDs) on the VA National ICD Surveillance
             device malfunction. This can impact Center intranet website
             the device’s ability to deliver
             appropriate shock therapy.          (https://icdpm.sanfrancisco.med.va.gov, see
                                                       Attachment 3 for instructions.
             May 12, 2006 Poplation
                                                       This list includes all the patients in Guidant’s
             Device Model Name                         database that have implanted
             Model Numbers
                                                       devices affected by this and previous recalls
             Contak Renewal 3 & 3 HE                   (some devices are affected by
             H170/H173/H175/H177/H179
                                                       more than one recall).
             Mandatory; Renewal
             Contak Priority A      3 AVT & 3 AVT HE   GuidantBSCIICDsCRTsAlertAL08-07.pdf                                                                                                 END




         Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        456 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                             Not
                                                                                                                      Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                    START
5.12.1      (continued)... Implant orientation of   ...(continued) identified in steps a and b above,
(continued) Implantable Cardioverter                to determine if device’s location and orientation
            Defibrillators (ICDs) and Cardiac       are verifiable. If device
            Resynchronization Therapy Devices
            (CRT-Ds) manufactured by Boston         location or orientation is not verifiable or a post-
            Scientific Corporation’s Cardiac        implant CXR is not
            Rhythm Management Division,
            previously under the name Guidant       available then proceed to step d. If device
            (AL08-08)                               orientation is verified as beneath the pectoral
                                                    muscle with the serial number facing the ribs
                                                    then proceed to Action 2 below.

             A subset of the following Guidant   d) Contact the patients identified at step c above
             ICDs and CRT-Ds models implanted (those with device
             in a
                                                 orientation or location not verifiable) to have an
             specific location and in an         Anterior/Posterior (AP)
             uncommon orientation - beneath the
             pectoral muscle with the serial     Chest x-ray to determine/verify specific device
             number facing the ribs - may be     orientation or to have a
             subject to component damage and
             device malfunction. This can impact physical examination of the implant area to best
             the device’s ability to deliver     determine the location of
             appropriate shock therapy.
                                                    the device.
             May 12, 2006 Poplation

             Device Model Name
             Model Numbers                          2. Review and plan appropriate action as
                                                    discussed in Attachment 2 prepared by Dr.
             Contak Renewal 3 & 3 HE                Edmund Keung, Director of the VA National ICD
             H170/H173/H175/H177/H179               Surveillance Center.
             Mandatory; Priority A                  GuidantBSCIICDsCRTsAlertAL08-07.pdf                                                                                                 END




         Recalls Alerts Advis - 5                                                    Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        457 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
             Question:                             Rationale/Assessment Methods:                                   (1)         Met (2)    (3)   possible root causes
             2008 Alerts & Advisories                                                                                                                                                START            5.12
5.12.2       VistA Anesthesia and Nurse            VistA patch TIU*1*236 was subsequently
             Interoperative Report patch           released on November
             TIU*1.0*215, released June 28,
             2007. (AL08-08)                       15, 2007 to restore the VistA Surgical Notes and
                                                   addendum

                                                   function to the pre-TIU*1*215 state. As of
             A VHA VISN reports that VistA         November 20, 2007, all
             patch TIU*1.0*215 has not been
                                                   VA Medical Facilities have installed TIU*1*236.
             creating addendums when either the
             Anesthesia or Nurse

             Intraoperative Report is edited via   Actions:
             Surgery case editors [e.g. OSS

             Operation (Short Screen)]. If
             changes were made by Surgery          1. By Close of Business (COB) February 15,
                                                   2008 review
             personnel to surgical data via the
             Surgery case editor, such as          Attachment 1, the list of facilities that installed
                                                   VistA patch
             ESU Coagulation Range or
             coagulation therapy changes,          TIU*1*215.

             addended data is not available for    a. If your facility/healthcare system is listed in
             viewing via the Surgery tab in        Attachment 1,

             CPRS, resulting in inaccurate         execute Actions 2, 3 and 4.
             surgery information.
                                                   b. If your facility/healthcare system is not on the
                                                   list, execute
             Mandatory; Priority A                 VistAPatchTIU1215AL08-08.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        458 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                   (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                START
5.12.2      (continued)... VistA Anesthesia and   ...(continued) (or their designees) in a formal
(continued) Nurse Interoperative Report patch     letter (see
            TIU*1.0*215, released June 28,
            2007. (AL08-08)                       sample letter in Alert Attachment 2).



            A VHA VISN reports that VistA         4. By COB April 30, 2008, the Chief of
            patch TIU*1.0*215 has not been        Anesthesia (or their

            creating addendums when either the designee) and the Operating Room Supervisor
            Anesthesia or Nurse                (or their designee)

            Intraoperative Report is edited via   must compare Anesthesia notes and Nurse
            Surgery case editors [e.g. OSS        Intraoperative Reports

            Operation (Short Screen)]. If         respectively, with CPRS Surgical Note(s). VistA
            changes were made by Surgery          patch TIU*1*231

            personnel to surgical data via the    provides software tools to assist with the
            Surgery case editor, such as          process. If the

            ESU Coagulation Range or              discrepancy contains significant clinical data,
            coagulation therapy changes,          facilities must

            addended data is not available for    reconcile the information and follow
            viewing via the Surgery tab in        documentation provided within

            CPRS, resulting in inaccurate         the TIU*1*231 patch description to correct the
            surgery information.                  missing addendums.

                                                  If the discrepancy was caused by VistA patch
            Mandatory; Priority A                 VistAPatchTIU1215AL08-08.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        459 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
             2008 Alerts & Advisories                                                                                                                                              START            5.12
5.12.3       Baxter - Allergic Reactions to          A possible link to severe allergic reactions has
             Heparin Sodium (AL08-09)                been associated with the use of Baxter multiple
                                                     dose heparin vials and single dose vials. 40% of
                                                     the cases are estimated as serious, based on
                                                     preliminary and ongoing review. The number of
             The Food and Drug Administration        reports seen in the past two months is a marked
             (FDA) announced on February 11,         increase from the number of reports associated
             2008, that since December 2007,         with heparin use normally received. Since the
             Baxter and FDA have received 350 January 17, 2008, recall, Baxter has also
             reports of adverse reactions to         received similar reports of adverse patient
             heparin dispensed from Baxter multi reactions occurring in other lots of 1,000
             dose vials. On January 17, 2008,        units/ml, 10 ml and 30 ml multi-dose vials, 5,000
             Baxter issued a recall of 9 specific    units/ml and 10,000 units/ml multi-dose vials
             heparin lots (see affected lots listed and 5,000 units/ml single-dose vials when single
             under Action 1 below). The increase doses were combined to create a larger bolus
             in adverse events was reported in       dose. The increase in reported adverse
             patients receiving high bolus doses reactions has primarily occurred when used in
             of heparin. Adverse events reported the following clinical settings:
             include: allergic or hypersensitivity-
             type reactions, with symptoms of        • Hemodialysis
             oral swelling, nausea, vomiting,
             sweating, shortness of breath, and      • Invasive cardiovascular procedures (cardiac
             cases of severe hypotension             valvular surgery,
             requiring treatment. Most events
             develop within minutes of heparin       coronary artery bypass graft (CABG) surgery,
             initiation, although the possibility of carotid
             a delayed response has not been
             excluded.                               endarterectomy and cardiac catheterization);

                                                    • (continued)...
             Mandatory; Priority A                  HeparinAlert08-09.pdf                                                                                                          END




         Recalls Alerts Advis - 5                                               Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        460 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
            Question:                          Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                 START
5.12.3      (continued)... Baxter - Allergic   ...(continued) Apheresis procedures (photo and
(continued) Reactions to Heparin Sodium (AL08- plasma)
            09)


                                                      There have been isolated reports of reactions
            The Food and Drug Administration          with other forms of heparin including premixed
            (FDA) announced on February 11,           bags.
            2008, that since December 2007,
            Baxter and FDA have received 350
            reports of adverse reactions to
            heparin dispensed from Baxter multi       Actions:
            dose vials. On January 17, 2008,
            Baxter issued a recall of 9 specific      1. By close of business (COB) February 20,
            heparin lots (see affected lots listed    2008, Pharmacy Chiefs will assure that the
            under Action 1 below). The increase       following 9 lots of Baxter multi-dose heparin
            in adverse events was reported in         vials are removed from inventory, segregated
            patients receiving high bolus doses       and returned. Use the following link for
            of heparin. Adverse events reported       information on returning affected product.
            include: allergic or hypersensitivity-
            type reactions, with symptoms of
            oral swelling, nausea, vomiting,
            sweating, shortness of breath, and        Recall Update - Baxter HealthCare - Heparin
            cases of severe hypotension               Inj.doc
            requiring treatment. Most events
            develop within minutes of heparin
            initiation, although the possibility of
            a delayed response has not been           See Attached Alert for affected vials and lot
            excluded.                                 numbers.



            Mandatory; Priority A                     HeparinAlert08-09.pdf                                                                                                          END




        Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        461 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
             Question:                                Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
             2008 Alerts & Advisories                                                                                                                                                       START            5.12
5.12.4       Expanded Recall of Baxter Heparin        This Patient Safety Alert supplements Patient
             Products, AL08-10                        Safety Alert AL08-09 (PSAT question 5.12.3).
                                                      Any future updates relating to the original or
                                                      expanded Baxter heparin recalls will be
                                                      communicated through the National Center for
             Baxter initially recalled nine lots of   Patient Safety’s Patient Safety Log.
             multi-dose heparin sodium injection
             products (e.g., vials, syringes) on
             January 17, 2008. This recall has
             now been expanded to include the         Actions:
             following products:

             • all remaining lots of Baxter multi-
             dose heparin sodium injection            By close of business Saturday March 1, 2008:
             products,
                                                      1. Implement the Actions in Patient Safety Alert
             • all lots of Baxter single-dose         AL08-09, if not already completed.
             heparin sodium injection products,
             and

             • all lots of Baxter heparin flush       2. Pharmacy Chiefs (or designee) must assure
             products.                                that the following products are removed from
                                                      inventory, segregated and returned to the
                                                      supplier:

             NOTE: This recall does not involve       a) all remaining lots of Baxter multi-dose heparin
             Baxter's heparin pre-mix IV              sodium injection
             solutions in bags (heparin sodium in
             5% dextrose injection and heparin        products
             sodium in 0.9% sodium chloride
             injection).                              b) all lots of Baxter single-dose heparin sodium
             Mandatory; Priority A                    ExpandedBaxterHeparinAL08-10.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        462 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                    (1)         Met (2)    (3)   possible root causes
             2008 Alerts & Advisories                                                                                                                                                START            5.12
5.12.5       STERIS C1160 Universal Flexible      STERIS identified this issue internally during
             Processing Trays used with the       quality control procedures; STERIS indicated
             STERIS System 1 Sterile              there have been no adverse incidents reported
             Processing Systems (AL08-11)         from facilities regarding this issue. It is possible,
                                                  however, that devices (e.g., endoscopes,
                                                  esophageal dilators) sterilized in the STERIS
                                                  System 1 with C1160 trays may not have been
             STERIS Corporation issued an         adequately sterilized. Additional diagnostic
             Urgent Recall Notice about the       cycles recommended by STERIS will ensure the
             design/operation of the C1160        processor is operating within acceptable limits.
             universal flexible processing tray
             that may compromise the ability of
             the STERIS System 1 Sterile
             Processor to provide an effective    Prior to STERIS’ Urgent Recall Notice, STERIS’
             sterilization cycle when the C1160   operating instructions indicated that a diagnostic
             tray is used.                        cycle is only required to be run once every 24
                                                  hours. Since the discovery that the C1160 tray
                                                  may compromise the ability of the STERIS
                                                  System 1 to provide an effective sterilization
             NOTE: This Patient Safety Alert      cycle when the C1160 tray is used, STERIS is
             applies to all STERIS System 1       now indicating that, in addition, diagnostic
             models and                           cycles be run after each C1160 tray is
                                                  processed in the STERIS System 1.
             all serial numbers of C1160 trays.
             This Patient Safety Alert does not
             apply
                                                  Actions:
             to C1200, C1220, or C1140 trays.
                                                  Chief of SPD (or designee) will ensure the
                                                  following actions are carried out (continued)...


             Mandatory; Priority A                SterisSystemIAlertAL08-11.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        463 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                    (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                 START
5.12.5      (continued)... STERIS C1160           ...(continued) by close of business Friday,
(continued) Universal Flexible Processing Trays   March 14, 2008:
            used with the STERIS System 1
            Sterile Processing Systems (AL08-
            11)
                                                  1. Reprocessing personnel who utilize the
                                                  STERIS System 1 must read this

            STERIS Corporation issued an          Patient Safety Alert and the attachments.
            Urgent Recall Notice about the
            design/operation of the C1160         NOTE: Be sure to identify all areas in your
            universal flexible processing tray    facility that have STERIS
            that may compromise the ability of
            the STERIS System 1 Sterile           System 1 Processing Systems that may include,
            Processor to provide an effective     but are not limited
            sterilization cycle when the C1160
            tray is used.                         to the following: Ambulatory Surgery,
                                                  Endoscopy, GI, GU, OR,

                                                  Respiratory, SPD, and Urology.
            NOTE: This Patient Safety Alert
            applies to all STERIS System 1
            models and
                                                  2. If possible, discontinue the use of STERIS
            all serial numbers of C1160 trays.    C1160 trays with the STERIS
            This Patient Safety Alert does not
            apply                                 System 1 until STERIS is able to correct the
                                                  problem at your facility. (STERIS began field
            to C1200, C1220, or C1140 trays.      correction on March 7, 2008.) Use alternative
                                                  trays in the meantime to sterilize your devices.

                                                  NOTE: The alternative trays must be suitable for
            Mandatory; Priority A                 SterisSystemIAlertAL08-11.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        464 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
             Question:                              Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
             2008 Alerts & Advisories                                                                                                                                                      START            5.12
5.12.6       Free-text patient allergy entries in   Earlier versions (prior to December 2003) of the
             the Computerized Patient Record        VistA Adverse Reaction
             System (CPRS) (AL08-12)
                                                    Tracking (ART) and CPRS software allowed
                                                    users to enter free-text patient

             Free-text allergy entries in CPRS do allergies. Since 2003, ART and CPRS no longer
             not generate automatic drug-allergy permit entry of free-text

             order checks necessary for effective allergies. In June 2007, a software utility
             medication management. Patients      (GMRA*4*29) was provided to
             with
                                                  automate mapping of existing free-text patient
             a known allergy may be               allergy entries to standard
             administered a medication or served
             a food product for which they could entries. Remaining free text allergy entries were
             have a severe reaction.              either too ambiguous to be reliably mapped, or
                                                  may contain multiple reactants.




                                                    Actions:

                                                    1. By close of business (COB), March 26, 2008,
                                                    pharmacy ADPACs (or

                                                    designees) must:

                                                    a) run the VistA option ‘Allergy clean up utility‘
                                                    within the VistA

                                                    Adverse Reaction Tracking Manager’s menu to
             Mandatory; Priority A                  FreeTextAllergiesAlertAL08-12.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        465 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                        START
5.12.6      (continued)... Free-text patient         ...(continued) facilities must submit an initial
(continued) allergy entries in the Computerized      report - even those
            Patient Record System (CPRS)
            (AL08-12)                                with negative reports (i.e., those facilities with
                                                     zero free-text

                                                  allergy entries). If your facility’s report is
             Free-text allergy entries in CPRS do negative, no further
             not generate automatic drug-allergy
                                                  action is required after submitting your negative
             order checks necessary for effective report. If your
             medication management. Patients
             with                                 facility’s report is positive (i.e., contains free-text
                                                  allergy
             a known allergy may be
             administered a medication or served entries), then proceed to actions 2 and 3 after
             a food product for which they could submitting your
             have a severe reaction.
                                                  positive report.




                                                     2. By COB, June 20, 2008, Pharmacy ADPACs
                                                     (or designees) must ensure

                                                     all remaining free text allergy entries are
                                                     resolved. See Attachment 2 for

                                                     detailed instructions for resolving free-text
                                                     allergy entries. ADPACS (if

                                                     they are not Pharmacists) will need to work with
             Mandatory; Priority A                   FreeTextAllergiesAlertAL08-12.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        466 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
             Question:                             Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
             2008 Alerts & Advisories                                                                                                                                                    START            5.12
5.12.7       Improper reprocessing of flexible     The caps of the semi-disposable biopsy valves
             endoscope biopsy valves (AL08-13) were not opened up (see the figures in Alert
                                                   Attachment 1), and hence were not cleaned,
                                                   brushed, and disinfected or sterilized according
                                                   to the manufacturer’s instructions. This resulted
             A VA medical center noted that their in the presence of bioburden on the
             semi-disposable (i.e., reusable to an semidisposable
             extent; limited use) biopsy valves
             (Olympus part number MB-358) for biopsy valves. The facility has since switched to
             their colonoscopes (Olympus Model use of disposable biopsy
             CF-180AL) and esophago-gastro-
             duodeno (EGD) scopes (Olympus         valves for their flexible endoscopes.
             Model GIF-H180) were not being
             reprocessed properly.

                                                   NOTE: While the Specific Incident section
                                                   references a specific

                                                   manufacturer’s flexible endoscopes and biopsy
                                                   valves, THIS PATIENT

                                                   SAFETY ALERT APPLIES TO ALL
                                                   COLONOSCOPES, EGD, AND

                                                   ULTRASOUND SCOPES THAT HAVE BIOPSY
                                                   VALVES,

                                                   REGARDLESS OF MANUFACTURER OR
                                                   MODEL.



             Mandatory; Priority A                 FlexibleEndoscopeBiopsyValvesAL08-13.pdf                                                                                              END




         Recalls Alerts Advis - 5                                                     Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        467 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                               Not
                                                                                                                        Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                      START
5.12.7      (continued)... Improper                 ...(continued) biopsy valves. The reusable
(continued) reprocessing of flexible endoscope      biopsy valves must be opened up for cleaning
            biopsy valves (AL08-13)                 and reprocessed according to the flexible
                                                    endoscope manufacturer’s instructions.


            A VA medical center noted that their
            semi-disposable (i.e., reusable to an   Actions:
            extent; limited use) biopsy valves
            (Olympus part number MB-358) for        Chief of SPD (or designee) must ensure the
            their colonoscopes (Olympus Model       following actions are carried out by close of
            CF-180AL) and esophago-gastro-          business Tuesday, April 8, 2008:
            duodeno (EGD) scopes (Olympus
            Model GIF-H180) were not being
            reprocessed properly.
                                                    1. All personnel who reprocess flexible
                                                    endoscopes have read this Patient

                                                    Safety Alert and the attachment.

                                                    NOTE: Ensure you have identified all areas in
                                                    your facility that

                                                    reprocess flexible endoscopes, which may
                                                    include, but are not

                                                    limited to the following: Ambulatory Surgery,
                                                    Endoscopy, GI,

                                                    GU, OR, Respiratory, SPD, Urology, and Clinics
                                                    to include
            Mandatory; Priority A                   FlexibleEndoscopeBiopsyValvesAL08-13.pdf                                                                                              END




        Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        468 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                               Not
                                                                                                                        Met        Partially   Met   If score other than 'met' what are
             Question:                            Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
             2008 Alerts & Advisories                                                                                                                                                     START            5.12
5.12.8       Collimator screws on x-ray systems   The manufacturer issued an Urgent Device
             manufactured by Philips Medical,     Correction
             collimator models 9896 010 00612,
             9896 010 00614, and 9896 010         (Alert Attachment 1) about collimator screws
             00615 used on the Bucky Diagnot,     securing the collimator to
             Digital Diagnost, Easy Diagnost,
             and Thorovision x-ray systems.       the stand in the models listed above where they
             (AL08-14)                            may become

                                                  loose and fall out. If the screws fall out, there is
                                                  a small chance

                                                  the collimator could fall from the x-ray stand,
                                                  placing patients and

                                                  employees at risk, although no incidents of this
                                                  type have been

                                                  reported.




                                                  Philips Medical is upgrading affected systems
                                                  as quickly as

                                                  possible, to be completed by October 2008.




                                                  Actions:


             Mandatory; Priority A                PhilipsCollimatorScrewsAL08-14.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        469 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
             Question:                                Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
             2008 Alerts & Advisories                                                                                                                                                START            5.12
5.12.9       Topcon IMAGEnet DICOM Interface          This can happen when the local Topcon hard
             2 Retinal Image Acquisition              drive is filled to capacity
             Systems distributed by Topcon
             Medical Systems. (AL08-15)               with imaging studies, and the operator uses
                                                      Microsoft Windows Explorer instead of the
                                                      IMAGEnet “copy/delete” window to manage
                                                      images. Deleting images with Windows
             VA sites report patient identification   Explorer, rather than using the Topcon
             errors during image transmission         IMAGEnet “copy/delete”, can result in incorrect
             from                                     association between patient retinal images and
                                                      patient demographics. Incorrect information will
             Topcon IMAGEnet DICOM interface          be displayed in CPRS/VistA Imaging viewers.
             2 Retinal Imaging Workstations to
             VistA

             Imaging.                                 Actions:




                                                      All Topcon operators will immediately employ
                                                      the following standard operating procedures:

                                                      1. Topcon IMAGEnet tools will be used at all
                                                      times to manage images on Topcon systems;
                                                      Windows Explorer may not be used.




                                                      2. All images will be deleted from local Topcon
                                                      hard drives once verification of successful
                                                      DICOM transmission to VistA Imaging occurs.
             Mandatory; Priority A                    TopconImagenetAL08-15.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        470 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                         Not
                                                                                                                  Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                START
5.12.9      (continued)... Topcon IMAGEnet           ...(continued) failure that prevents transmission
(continued) DICOM Interface 2 Retinal Image
            Acquisition Systems distributed by       of images from the local Topcon IMAGEnet
            Topcon Medical Systems. (AL08-15)        Workstation to the VistA

                                                     Imaging gateway, images may reside on the
                                                     local Topcon workstation
            VA sites report patient identification
            errors during image transmission         temporarily. Once transmission ability is
            from                                     restored, images must be

            Topcon IMAGEnet DICOM interface          transmitted and deleted. Under no circumstance
            2 Retinal Imaging Workstations to        should images greater
            VistA
                                                     than seven days old remain on the Topcon
            Imaging.                                 Workstation.




                                                     3. All Topcon IMAGEnet devices must be
                                                     upgraded to version 2.11 as soon as the
                                                     software is released.
            Mandatory; Priority A                    TopconImagenetAL08-15.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        471 of 1656
                                                               NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                        Not
                                                                                                                 Met        Partially   Met   If score other than 'met' what are
              Question:                           Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                             START            5.12
5.12.10       Alaris model 8000 infusion pumps;   Affected componets are:
              Alaris models 8100, 8110, 8120
              infusion modules; Alaris models     1. Gray Interface connectors (two per unit) on
              8210, 8220 SpO2 modules. These      the 8000, 8100, 8110, 8120
              devices
                                                  and 8220 manufactured before March 16, 2004.
              are manufactured by Cardinal
              Health. (AL08-16)                   2. U9 socketed Integrated Circuit (IC) on the
                                                  8110 and 8120 display

                                                    boards manufactured before October 25, 2005.
              The components on the devices can
              fail resulting in a channel           3. U19 socketed IC on the 8100 module logic
                                                    boards manufactured before
              error that will shut down infusion or
              monitoring and activate audio and     September 8, 2005.

              visual alarms.

                                                  Note: Alaris will provide replacements free of
                                                  charge. They will also replace the components
                                                  on any units they receive for the ongoing
                                                  Occluder Spring Recall.




                                                  Actions:




                                                  1. By close of business June 27, 2008
                                                  determine if affected items are in the
              Mandatory; Priority A               AlarisComponentsAL08-16.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        472 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                          Not
                                                                                                                   Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                 START
5.12.10     (continued)... Alaris model 8000        ...(continued) for clinical use.
(continued) infusion pumps; Alaris models 8100,
            8110, 8120 infusion modules; Alaris     a. Connectors – acquire and replace all affected
            models 8210, 8220 SpO2 modules.         connectors.
            These devices
                                                    b. U9 and U19 ICs – acquire and replace all
            are manufactured by Cardinal            affected circuit boards.
            Health. (AL08-16)



            The components on the devices can
            fail resulting in a channel

            error that will shut down infusion or
            monitoring and activate audio and

            visual alarms.


            Mandatory; Priority A                   AlarisComponentsAL08-16.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        473 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                            Not
                                                                                                                     Met        Partially   Met   If score other than 'met' what are
              Question:                            Rationale/Assessment Methods:                                     (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                 START            5.12
5.12.11       Voicemail greetings for mental       Because it is possible to bypass facility
              health staff’s desk and/or VA issued switchboard greetings by
              cell phones. (AD08-03)
                                                   entering extensions or dialing direct to staff,
                                                   veterans may directly

              A VHA VISN reports that veterans       reach phones for mental health staff that are not
              left messages on phones assigned       manned 24 hours a

              to mental health staff only to         day/7days a week. If those phones are not
              attempt/complete suicide prior to      answered, it is imperative
              mental
                                                     that the veteran hear instructions for making
              health staff’s ability to return the   emergency contact with
              calls.
                                                     either 911 or the Suicide Prevention Hot Line.




                                                     Recommendations:




                                                     1. VA issued cell phones (including Blackberry)
                                                     and desk phones

                                                     assigned to mental health staff should include
                                                     standard elements

                                                     for their activated voice mail message as
                                                     illustrated by this example
              Recommended; Priority A                VoiceMailAdvisoryAD08-03.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        474 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                   (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                  START
5.12.11     (continued)... Voicemail greetings      ...(continued) leave a brief message and I will
(continued) for mental health staff’s desk and/or   return your call when I am able during normal
            VA issued cell phones. (AD08-03)        business hours”



             A VHA VISN reports that veterans       2. Personal cell phone numbers should not be
             left messages on phones assigned       given to patients. If

             to mental health staff only to         they have been given out, the standard
             attempt/complete suicide prior to      voicemail greeting should
             mental
                                                    be applied until all patients who received the
             health staff’s ability to return the   number have been given
             calls.
                                                    more appropriate contact phone numbers
             Recommended; Priority A                VoiceMailAdvisoryAD08-03.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                  Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        475 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
              Question:                            Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                     START            5.12
5.12.12       Monitor ceiling suspensions with     There were no injuries and cables prevented it
              motorized height movement used       from falling to the floor. While Philips believes it
              with X-ray systems manufactured by   is highly unlikely this will occur again, they will
              Philips Medical Systems. (AL08-17)   be sending service personnel to sites to
                                                   eliminate this risk starting this month. Philips
                                                   has identified 32 VA facilities affected by this
                                                   issue; the full notice is attached to this Alert.
              Philips reports that a ceiling
              mounted monitor used with an x-ray
              system fell from the ceiling
              suspension system.                   Actions:




                                                   Until Philips implements the Field Change Order
                                                   (FCO),




                                                   1. By close of business July 18, 2008 review the
                                                   attached list of sites/units

                                                   to determine if you are affected. If affected,
                                                   inform all users about the

                                                   following recommendations.

                                                   a. Do not place the monitor over the patient

                                                   b. Avoid unnecessary carriage movement

                                                   c. Do not stand under or near the carriage.
              Mandatory; Priority A                PhilipsMonitorCeilingSuspensionAL08-17.pdf                                                                                              END




          Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        476 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                   Not
                                                                                                                            Met        Partially   Met   If score other than 'met' what are
              Question:                              Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                        START            5.12
5.12.13       Power supply on Lionville Systems      Although the incident rate is low, Lionville
              mobile computing products, iPoint      recommends that facilities with units
              and iMed, manufactured before          manufactured before May 2007 contact them for
              May, 2007. (AL08-18)                   a free upgrade to the Lionville Power Solution
                                                     (LPS). This upgrade adds a thermal cutoff
                                                     switch to the power inverter to prevent the
                                                     possibility of overheating.
              A VA facility reports overheating of
              the medication cart with smoke

              emitted from the unit.                 Action:




                                                     1. If your facility is on the list of sites with units
                                                     manufactured before

                                                     May 2007 (See Alert Attachment 1), contact
                                                     Lionville Technical Services by

                                                     close of business August 15, 2008.




                                                     2. Schedule an upgrade of the LPS for each unit
                                                     with the Lionville

                                                     Technical Services Manager, Dave Moyer at 1-
                                                     800-523-7114,

                                                     Extension 253.
              Mandatory; Priority A                  LionvilleCartPowerSupplyAL08-18.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        477 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
              Question:                              Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                     START            5.12
5.12.14       Peripheral Blood Pressure and          This was the subject of Patient Safety Advisory
              Blood Glucose Measurement              AD08-02, released June
              Devices connected to Health Hero,
              Viterion, VitelNet and American        5, 2008 (Alert attachment). Because the
              Telecare Inc.                          permanent solution referenced in the Advisory
                                                     has not yet materialized, this item has now been
              (ATI) Home Telehealth Appliances       raised to the
              (AL08-19)
                                                     level of a Patient Safety Alert with required
                                                     actions.

              Several VA sites report incorrect
              date/time stamping from peripherally
              connected blood pressure               If the correct date/time is not manually entered
              measurement devices and blood          into the peripheral measurement device when
              glucose measurement devices that       the battery is depleted or changed, the device
              is automatically uploaded into the     will default to an incorrect date/time that is then
              Home                                   uploaded by the Home Telehealth appliance
                                                     and transmitted to the care coordinator. There is
              Telehealth appliance.                  currently no consistent automatic way to set
                                                     accurate date/time in the peripheral
                                                     measurement devices.




                                                     There is no problem currently identified with
                                                     data entered directly by

                                                     patients via manual entry into the Home
                                                     Telehealth Appliances.


              Mandatory; Priority A                  CCHTPeripheralDevicesAL08-19.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        478 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                              Not
                                                                                                                       Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                     START
5.12.14     (continued)... Peripheral Blood        ...(continued) ensure data
(continued) Pressure and Blood Glucose
            Measurement Devices connected to       displayed on vendor websites is verified for
            Health Hero, Viterion, VitelNet and    accuracy prior to clinical
            American Telecare Inc.
                                                   decision-making and placement in the CPRS
            (ATI) Home Telehealth Appliances       medical record.
            (AL08-19)


                                                   2. If the evaluation by the VISN CCHT Program
            Several VA sites report incorrect      Manager does not
            date/time stamping from peripherally
            connected blood pressure               result in assurance that appropriate practices
            measurement devices and blood          are in place to ensure
            glucose measurement devices that
            is automatically uploaded into the     measurements are always verified prior to
            Home                                   clinical decision-making and

            Telehealth appliance.                  placement in CPRS, they will suspend use of
                                                   automated data collection

                                                   from peripheral devices connected to home
                                                   telehealth devices. These

                                                   VISN CCHT programs will revert to manual data
                                                   entry by patients

                                                   instead. Manual data entry will ensure correct
                                                   time and date stamping of

                                                   measurements.
            Mandatory; Priority A                  CCHTPeripheralDevicesAL08-19.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        479 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                           Not
                                                                                                                    Met        Partially   Met   If score other than 'met' what are
              Question:                                Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                START            5.12
5.12.15       Same syringe used for IV                 CDC guidelines and general infection control
              (intravenous) line heparin flushes for   precautions require that any syringe or needle
              multiple patients (AL08-20)              used on one patient be considered
                                                       contaminated and cannot be used on any other
                                                       patient or be reintroduced into a multiuse vial.

              As routine practice in a VA medical      The concern about reuse of syringes applies to
              center, the same syringe was used        cardiac catheterization labs, emergency rooms,
              to administer heparin flushes to         endoscopy suites, operating rooms, patient
              patients via their IV lines during       treatment areas, radiology, and all other areas
              procedures in the cardiac cath lab.      using injectable medications.
              A multi-dose vial of heparin was
              used to fill a 10 ml syringe at the
              beginning of the day’s procedures,
              and the same syringe was used for        Actions:
              subsequent patients throughout the
              day.

                                                       By Close of Business, Friday, August, 15, 2008,
                                                       the facility director, using

                                                       available staff and resources will ensure that
                                                       notification is provided to all staff who perform
                                                       medication injections of the following information:




                                                       a). Do not use the same syringe to administer
                                                       medications to multiple

                                                       patients even if the needle is changed for each
                                                       patient. This applies
              Mandatory; Priority A                    SameSyringeAL08-20.pdf                                                                                                         END




          Recalls Alerts Advis - 5                                                 Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        480 of 1656
                                                                NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                       Not
                                                                                                                Met        Partially   Met   If score other than 'met' what are
            Question:                              Rationale/Assessment Methods:                                (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                              START
5.12.15     (continued)... Same syringe used       ...(continued) their first use, the needle and
(continued) for IV (intravenous) line heparin      syringe are considered contaminated. A syringe
            flushes for multiple patients (AL08-   can only be used multiple times if it is being
            20)                                    used on the same patient to dispense
                                                   medication using aseptic technique to protect
                                                   the needle or needleless device between uses.
                                                   The appropriate expiration time or safe-use time
             As routine practice in a VA medical   of the medication in the syringe must be
             center, the same syringe was used     considered.
             to administer heparin flushes to
             patients via their IV lines during
             procedures in the cardiac cath lab.
             A multi-dose vial of heparin was      c). Use fluid infusion and administration sets
             used to fill a 10 ml syringe at the   (i.e., intravenous bags,
             beginning of the day’s procedures,
             and the same syringe was used for     tubing and connectors) on one patient only and
             subsequent patients throughout the    dispose appropriately after
             day.
                                                   their use. Consider a syringe or needle /
                                                   cannula contaminated once it has

                                                   been used to enter or connect to a patient’s
                                                   intravenous infusion bag or

                                                   administration set.




                                                   d). When using multidose vials – both the
                                                   needle and syringe used to

                                                   access a multidose vial must be sterile.
             Mandatory; Priority A                 SameSyringeAL08-20.pdf                                                                                                         END




         Recalls Alerts Advis - 5                                              Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        481 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                     Not
                                                                                                                              Met        Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                                           (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                          START            5.12
5.12.16       Inpatient Medication Orders for         The IMO software functionality enables an
              Outpatients (IMO): Inability to enter   Outpatient location (i.e. Clinic)
              Unit Dose orders beyond midnight
              for patients checked in before          to use the Inpatient Meds (Unit Dose) ordering
              midnight. (AD08-04)                     program to enter

                                                      medication orders that are to be administered in
                                                      the clinic setting.
              When using IMO for a patient who
              was checked into an IMO clinic          Potential issues related to this
              before                                  appointment/encounter problem are:

              midnight and who remains in the         • When this problem occurs, a clinician will be
              outpatient location after midnight,     unable to access the
              their
                                                      CPRS Unit Dose medication ordering screens.
              current encounter no longer             CPRS will only
              functions for ordering Meds,
              Inpatient in                            permit entry of outpatient prescriptions in this
                                                      situation. If
              CPRS. This is especially
              problematic in a 24 hour Emergency Outpatient orders are entered and the patient
                                                   has an active
              Department setting as patients’
              appointments will often start on one Outpatient prescription for the same dispensed
              day                                  drug, the active

              and end on the next. Site reports       order is discontinued. Providers may forget to
              indicate this causes a number of        reorder the standing

              potential patient safety issues      Outpatient medication with the appropriate
              relating to medications (see General number of refills. This
              Recommended; Priority A                 InpatientMedicationOrdersAD08-04.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                           Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        482 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                   Not
                                                                                                                            Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                           (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                          START
5.12.16     (continued)... Inpatient Medication     ...(continued) receive
(continued) Orders for Outpatients (IMO):
            Inability to enter Unit Dose orders     their intended medications when needed. Sites
            beyond midnight for patients            report delays in
            checked in before midnight. (AD08-
            04)                                     medication administration for as long as 10
                                                    hours.

                                                    • If a second unscheduled appointment is
            When using IMO for a patient who        created after midnight in
            was checked into an IMO clinic
            before                                  order to be able to enter Unit Dose medications,
                                                    then notes and
            midnight and who remains in the
            outpatient location after midnight,     encounter information may subsequently be
            their                                   attached to this

            current encounter no longer             encounter instead of the original appointment.
            functions for ordering Meds,            All the encounter
            Inpatient in
                                               data in the unscheduled encounter is deleted if
            CPRS. This is especially           this unscheduled
            problematic in a 24 hour Emergency
                                                    encounter is deleted. The deleted encounter
            Department setting as patients’         data may include
            appointments will often start on one
            day                                     Diagnosis Codes, Immunizations, Education,
                                                    and Health Factors
            and end on the next. Site reports
            indicate this causes a number of        which may be used to trigger Clinical Reminders.

            potential patient safety issues
            relating to medications
            Recommended; Priority A  (see General   InpatientMedicationOrdersAD08-04.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                           Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        483 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
              Question:                              Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                      START            5.12
5.12.17       J & J Ethicon ENDOPATH ETS             Ethicon has started supplying these linear
              Endoscopic Linear Cutters (AD-         cutters (which do not have pre-loaded
              0805)                                  cartridges) with a red protective cover added to
                                                     the endeffector (cartridge jaw) which must be
                                                     removed prior to loading the instrument. This will
                                                     serve as a cognitive aid to staff to load the
              On September 22, 2008 Ethicon          instrument before use. Ethicon will exchange
              Endo-Surgery, LLC issued an            affected devices for MOD Code 02 replacement
                                                     products with the red protection covering.
              Important Customer Reminder to
              users stating that the ENDOPATH
              ETS Endoscopic Linear Cutter is not
              preloaded with staples. A small      Recommendation:
              number of incidences have been
              reported                             SPD or other personnel that supply the affected
                                                   devices to the
              related to the linear cutters being
              used without a cartridge causing the operating or procedure rooms where these
              instrument to cut tissue without     devices are used should label the packaging of
              applying a staple, preventing proper the linear cutters to remind clinicians to load the
              closure of the incision.             cutters with an appropriately sized cartridge
                                                   before use until replacement products are
                                                   obtained.

              The following Product codes and
              MOD Code 00 are affected:

              • ETS45 (ENDOPATH ETS45
              Endoscopic Linear Cutter)

              • ATS45 (ENDOPATH ETS-Flex45
              Articulating Linear Cutter)
              Recommended; Priority A               EndoscopicLinearCuttersAD08-05.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        484 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                       START            5.12
5.12.18       Shower curtains used in locked          Many locked mental health units have shower
              mental health units (AL09-01)           curtains for patient privacy and for patient safety
                                                      (e.g., to prevent water from pooling outside the
                                                      shower, reducing the potential for a slip and fall
                                                      hazard). While the shower curtain involved in
              A VAMC reported that a patient in a     this event was a vinyl/plastic combination, totally
              locked mental health unit used the      plastic or totally vinyl shower curtains also
              clear plastic, light-weight, bottom     present a suffocation hazard.
              portion of a shower curtain (see
              Alert Figure 1) to attempt suicide by
              suffocation. The patient ripped off
              the clear plastic portion from the      Actions:
              heavier vinyl portion and wrapped
              the material around their head.

                                                      1. By close of business (COB) October 17,
                                                      2008, identify all shower curtains in locked
                                                      mental health units that are plastic or vinyl in
                                                      any part of their composition and/or could be
                                                      used for suffocation.

                                                      NOTE: Removing the plastic and/or vinyl shower
                                                      curtains without addressing the following is not
                                                      recommended.

                                                      1) Addressing the slipping hazard posed by a
                                                      wet floor outside of the shower stall.

                                                      2) Considering the preservation of patient
                                                      dignity and privacy.


              Mandatory; Priority A                   Shower Curtains in Locked MH UnitsAL09-01.pdf                                                                                          END




          Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        485 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                        START
5.12.18     (continued)... Shower curtains used      ...(continued) suffocation. Acceptable
(continued) in locked mental health units (AL09-     alternatives are products that mitigate or reduce
            01)                                      the risk of suffocation and are unlikely to pose
                                                     any other hazards to patient or staff in locked
                                                     units. Examples include, but are not limited to,
                                                     the following:
             A VAMC reported that a patient in a
             locked mental health unit used the      a. Cloth shower curtains - provided that they 1)
             clear plastic, light-weight, bottom     have a suicide prevention track (i.e., a track that
             portion of a shower curtain (see        can’t be used as an anchor), 2) are breakaway,
             Alert Figure 1) to attempt suicide by   attached with Velcro, 3) have Velcro tabs
             suffocation. The patient ripped off     spaced at a minimum of approximately 12
             the clear plastic portion from the      inches apart (e.g., use only 3 Velcro tabs to
             heavier vinyl portion and wrapped       attach a 24” wide shower curtain), and 4) have
             the material around their head.         no more than 2 square inches of each Velcro
                                                     tab in contact with the curtain. Note that meeting
                                                     these requirements may require retrofitting
                                                     commercial cloth shower curtains. Note also that
                                                     the small number and placement of the Velcro
                                                     tabs will cause the shower curtain to look saggy,
                                                     but prevents the curtain from supporting a
                                                     patient’s weight. Additionally, since mold can
                                                     grow on cloth easily, be sure to launder and/or
                                                     replace the shower curtain as necessary.

                                                     b. The Soft Suicide Prevention Door (SSPD)
                                                     patented by Sheridan VAMC (see Alert Figure 2
                                                     and www.suicideproofing.com). This is a fire
                                                     resistant, foam core, Velcro-hinged door that
                                                     has been designed to pull easily from the door
                                                     jam when weight is applied. The vinyl covering
                                                     the foam is securely attached. This door is
             Mandatory; Priority A                   Shower Curtains in Locked MH UnitsAL09-01.pdf                                                                                          END




         Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        486 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                       START            5.12
5.12.19       Bleeding episodes during dialysis        VA dialysis centers performed more than 2.5
              (AD09-02)                               million chronic and acute dialysis treatments
                                                      during the period of time reviewed. In addition to
                                                      the review of RCA and Safety reports, the nurse-
                                                      managers of 65 VA dialysis centers were
              VA dialysis centers performed more      interviewed by telephone as were some Patient
              than 2.5 million chronic and acute      Safety Managers.
              dialysis treatments during the period
              of time reviewed. In addition to the
              review of RCA and Safety reports,
              the nurse-managers of 65 VA             All of the significant bleeding events involved
              dialysis centers were interviewed by    dislodgement of the venous needle or
              telephone as were some Patient          disconnection of the venous blood line at the
              Safety Managers.                        dialysis catheter connection. In the majority of
                                                      these cases, the venous pressure alarm on the
                                                      dialysis machine failed to detect the event until
                                                      significant blood loss had occurred. There
                                                      appeared to be no statistical difference in the
                                                      reported adverse bleeding events between the
                                                      four brands and multiple

                                                      models of dialysis machines involved, although
                                                      the number of incidents with each machine may
                                                      have been too small to draw any firm
                                                      conclusions.




                                                      Two major risk factors for bleeding during
                                                      dialysis were found: 1) 75% of the most severe
                                                      bleeds occurred in patients (continued)...
              Recommended; Priority A                 BleedingEpisodesDuringDialysisAD09-02.pdf                                                                                              END




          Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        487 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                       START
5.12.19     (continued)... Bleeding episodes        ...(continued) who were restless, confused,
(continued) during dialysis (AD09-02)               agitated, or uncooperative, and 12.5% in
                                                    patients who were asleep; 2) approximately 50%
                                                    of the severe bleeds occurred outside of the
                                                    chronic dialysis unit (in the ICU or in isolation
            VA dialysis centers performed more      rooms).
            than 2.5 million chronic and acute
            dialysis treatments during the period
            of time reviewed. In addition to the
            review of RCA and Safety reports,       In 50% of the severe bleeds, the access site
            the nurse-managers of 65 VA             was not visible at the time of the event, and in
            dialysis centers were interviewed by    the remaining 50%, the visibility of the access
            telephone as were some Patient          site was not documented in the RCA.
            Safety Managers.


                                                    Taping of the access site and restraint policies
                                                    and procedures varied across the 65 VA dialysis
                                                    centers. Many dialysis machines also lacked an
                                                    internal memory for alarms and shutdowns.




                                                    In addition to these findings, usability testing of
                                                    the Redsense portable alarm—an FDA-
                                                    approved device specifically designed to detect
                                                    venous needle dislodgement during
                                                    dialysis—was performed. Problems were found
                                                    with the clip and the sensor connection. The
                                                    manufacturer is currently redesigning the clip
                                                    and problems with the sensor connection
                                                    appear to have been solved.
            Recommended; Priority A                 BleedingEpisodesDuringDialysisAD09-02.pdf                                                                                              END




        Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        488 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                   Not
                                                                                                                            Met        Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                                         (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                        START            5.12
5.12.20       Methicillin-resistant Staphylococcus    Recommendations:
              aureus (MRSA) contamination in an
              orthopedic clinic room (AD09-03)

                                                      1) For joint/bursa injections that involve the
                                                      injection of more than one medication from one
              Several patients who received           syringe, it is strongly recommended to use
              joint/bursa injections in one           single dose vials of each medication since the
              orthopedic surgery clinic exam          use of multidose vials increases the risk for
              room, during a four-day period,         cross contamination among patients. (Note:
              developed infections. For those         opened single dose vials must be discarded
              patients who had cultures grown,        immediately after use on a patient). If use of
              MRSA was identified as the              single dose vial is not feasible, use the lowest
              causative agent. Infections may         volume multidose vial available.
              have been caused by improper
              preparation of injections, cross
              contamination between multidose
              vials and/or breach of appropriate      2) Appropriate aseptic technique needs to be
              practices following the collection of   maintained when
              a specimen for microbiological
              culture from a patient who was          preparing medications for injection and for skin
              infected with MRSA. During the          preparation before the injection. When preparing
              investigation issues related to         or drawing medications from single dose or
              documentation were also identified.     multidose vials, always follow safe injection and
                                                      administration practices.




                                                      3) If locked carts are used to store medications
                                                      and supplies in rooms used for orthopedic clinic,
                                                      they should not be used for any other purposes
                                                      (e.g. as a place to set specimens collected for
              Recommended; Priority A                 Methicillin-resistant Staphylococcus aureus (MRSA) AD09-03.pdf                                                                          END




          Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        489 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                            (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                         START
5.12.20     (continued)... Methicillin-resistant  ...(continued) are to be kept in closed cabinets,
(continued) Staphylococcus aureus (MRSA)          drawers, or closed carts.
            contamination in an orthopedic clinic
            room (AD09-03)

                                                     5) Following any procedure done on an infected
                                                     site, such as:
             Several patients who received
             joint/bursa injections in one           aspiration of pus, open drainage, debridement
             orthopedic surgery clinic exam          or obtaining cultures performed in an orthopedic
             room, during a four-day period,         clinic room, the examination table and horizontal
             developed infections. For those         surfaces in the room should be wiped down with
             patients who had cultures grown,        an EPAregistered hospital disinfectant before
             MRSA was identified as the              the next patient is placed in the room. If there is
             causative agent. Infections may         visible soilage, an EPA-registered
             have been caused by improper
             preparation of injections, cross        disinfectant/detergent should be used for
             contamination between multidose         cleaning and disinfecting. In addition, all
             vials and/or breach of appropriate      furniture such as exam tables, chairs, tables,
             practices following the collection of   carts, horizontal surfaces in
             a specimen for microbiological          examination/procedure rooms, sinks, and floors
             culture from a patient who was          in the clinics should be cleaned and disinfected
             infected with MRSA. During the          on a daily basis using appropriate cleaning
             investigation issues related to         agents and an EPA-registered hospital
             documentation were also identified.     disinfectant or an appropriate EPA-registered
                                                     hospital disinfectant/detergent.




                                                     6) In accordance with VHA Handbook 1004.1
                                                     VHA Informed Consent for Clinical Treatments
                                                     and Procedures (link in “Additional
             Recommended; Priority A                 Methicillin-resistant Staphylococcus aureus (MRSA) AD09-03.pdf                                                                          END




         Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        490 of 1656
                                                                           NCPS Patient Safety Assessment Tool

                                                                                                Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                          Not
                                                                                                                                   Met        Partially   Met   If score other than 'met' what are
              Question:                                     Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                               START            5.12
5.12.22       Medtronic Neuromodulation                     The intrathecal catheters and intrathecal
              Sutureless Connector Catheters                catheter revision kits use a sutureless connector
              used with SynchroMed and IsoMed               for attachment of the catheter to the implanted
              implantable infusion pumps:                   Medtronic SyncroMed II, SynchroMed EL, and

                                                  IsoMed infusion pumps. The catheter is part of
              Intrathecal Catheters, Model 8709SC an infusion system that stores and delivers
                                                  parenteral drugs to the intrathecal space.

              8731SC                                        Medtronic’s investigation indicates that reported
                                                            events have been caused by misalignment or
                                                            incomplete connection of the sutureless pump
              Revision Kit, Model 8578                      connector to the catheter port. Proper alignment
                                                            and full engagement of the sutureless pump
                                                            connector to the catheter port during attachment
              Segment Revision Kit, Model                   is critical to ensure the catheter is properly and
              8596SC                                        completely connected to the pump.

              (AL09-02)

                                                            Actions:

              There is a potential for
              misconnections of the Medtronic
              sutureless connector catheters from           1. By close of business October 31, 2008,
              the catheter port on the pump.                physicians responsible for implanting and
              These misconnections have                     managing patients must do the following:
              resulted in a blockage (occlusion)
              between the sutureless pump                   a. Read Attachments 1, 2, and 3.
              connector and the catheter port on
              the pump and disconnections from              b. Begin to perform the following procedures
              the pump connector.                           during implantation. Detailed instructions are
              Mandatory; Priority A can result in lack of
              Misconnections                                Medtronic Intrathecal Catheter AL09-02.pdf                                                                                               END




          Recalls Alerts Advis - 5                                                                Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        491 of 1656
                                                                 NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
            Question:                             Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                       START
5.12.22     (continued)... Medtronic              ...(continued) cerebrospinal fluid (csf) backflow
(continued) Neuromodulation Sutureless            through the catheter
            Connector Catheters used with
            SynchroMed and IsoMed
            implantable infusion pumps:           to the pump


            Intrathecal Catheters, Model 8709SC


            8731SC                                c. Follow recommendations for managing
                                                  patients with implanted sutureless “SC”
                                                  catheters, as outlined in Attachment 1.
            Revision Kit, Model 8578


            Segment Revision Kit, Model           2. By close of business October 31, 2008,
            8596SC                                contact your patients who have these devices to
                                                  educate them about the signs and symptoms of
            (AL09-02)                             drug underdose and withdrawal.



            There is a potential for              3. Effective immediately, all patients that present
            misconnections of the Medtronic       with an intrathecal pump should be provided
            sutureless connector catheters from   with education about the signs and symptoms of
            the catheter port on the pump.        drug underdose and withdrawal.
            These misconnections have
            resulted in a blockage (occlusion)
            between the sutureless pump
            connector and the catheter port on
            the pump and disconnections from
            the pump connector.
            Mandatory; Priority A                 Medtronic Intrathecal Catheter AL09-02.pdf                                                                                               END




        Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        492 of 1656
                                                                       NCPS Patient Safety Assessment Tool

                                                                                           Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                     Not
                                                                                                                              Met        Partially   Met   If score other than 'met' what are
              Question:                          Rationale/Assessment Methods:                                                (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                          START            5.12
5.12.23       Baxter Single Strength Dosing Card Actions:
              for BREVIBLOC Premixed Injection
              (esmolol HCl) 2,500 mg/250 mL (10
              mg/mL) Ready-to-use-Bags, 250 mL
              bags (AL09-03)                     1. Chief Nursing Officer (or designee), Chief of
                                                 Staff (or designee) and Chief of Pharmacy (or
                                                 designee) will ensure that all nurses, physicians,

              There is an error in the 121 lb (55         and pharmacists, respectively, are informed of
              kg) patient weight setting on the           this Patient Safety Alert and that clinical
              Single Strength Dosing Card for             departments under their management control
              Baxter's BREVIBLOC Premixed                 locate the incorrect dosing cards. The incorrect
              Injection (esmolol HCl) 2,500               dosing cards can be identified by the product
              mg/250 mL (10 mg/mL) Ready-to-              number 748762 4/07 on the back of the card as
              use-Bags, 250 mL bags. The                  shown in the Attachment.
              Maintenance Infusion listed under
              100 mcg/kg/min for the mcg/min
              setting is listed as 55000 (see
              below); it should read 5500. Baxter         Note: Be sure to look in all areas where these
              reports that the other rates listed on      cards may be located in your facility. These
              the dosing card are correct. The            cards often find their way into pharmacists’,
              dosing cards                                physicians’ or nurses’ pockets and are often
                                                          posted on desks or walls in areas such as, but
              were distributed to clinicians by           not limited to, cath labs, critical care areas,
              Baxter pharmaceutical sales                 emergency departments, operating rooms,
              representatives.                            pharmacy, post-anesthesia care units, and
                                                          telemetry monitoring units.


              Using the incorrect maintenance
              infusion value (55000 mcg/min)              2. Under no circumstances may these dosing
              could cause a patient receiving the         cards be used in their current form. Nurses,
              Mandatory; Priority A an adverse clinical
              infusion to have                            Baxter BREVIBLOC Inaccurate Dosing Card AL09-03.pdf                                                                                   END




          Recalls Alerts Advis - 5                                                           Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        493 of 1656
                                                                       NCPS Patient Safety Assessment Tool

                                                                                           Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                     Not
                                                                                                                              Met        Partially   Met   If score other than 'met' what are
            Question:                         Rationale/Assessment Methods:                                                   (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                            START
5.12.23     (continued)... Baxter Single      ...(continued) either destroy or correct the
(continued) Strength Dosing Card for          incorrect dose cards.
            BREVIBLOC Premixed Injection
            (esmolol HCl) 2,500 mg/250 mL (10
            mg/mL) Ready-to-use-Bags, 250 mL
            bags (AL09-03)



            There is an error in the 121 lb (55
            kg) patient weight setting on the
            Single Strength Dosing Card for
            Baxter's BREVIBLOC Premixed
            Injection (esmolol HCl) 2,500
            mg/250 mL (10 mg/mL) Ready-to-
            use-Bags, 250 mL bags. The
            Maintenance Infusion listed under
            100 mcg/kg/min for the mcg/min
            setting is listed as 55000 (see
            below); it should read 5500. Baxter
            reports that the other rates listed on
            the dosing card are correct. The
            dosing cards

            were distributed to clinicians by
            Baxter pharmaceutical sales
            representatives.



            Using the incorrect maintenance
            infusion value (55000 mcg/min)
            Mandatory; Priority A patient receiving the
            could cause a                                 Baxter BREVIBLOC Inaccurate Dosing Card AL09-03.pdf                                                                                   END




        Recalls Alerts Advis - 5                                                             Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        494 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                    Not
                                                                                                                             Met        Partially   Met   If score other than 'met' what are
              Question:                               Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                         START            5.12
5.12.25       Incorrect Patient Information           Actions:
              Displayed in CPRS v27 (AL09-04)


                                                      1. Medical Center Directors are instructed to
              When switching from one patient’s       send a certification message that a notification
              record to a second patient’s record     process has been implemented whereby all
              in the same session of CPRS while       clinical staff and users of CPRS have read and
              using CPRS v27, the first patient’s     been made aware of this Patient Safety Alert.
              information may still be displayed in   The certification message is to be sent from the
              the second patient’s CPRS display,      VAMC Director to the VISN Network Director to
              impacting patient care decisions. It    the Office of the DUSHOM (10N). A VISN
              is not known at this time if data       certification message must be sent to Megan
              entered for the second patient will     Friel, Acting Chief Biomedical
              be placed in the incorrect record.
              This problem occurs intermittently      Engineer, at megan.friel@va.gov, no later than 2
              and has been reported when              pm (EST) on Friday, November 7, 2008, which
              viewing clinical data on the Orders     certifies that all VA medical centers in that VISN
              and Notes Tabs.                         have completed this notification process.




                                                      2. Until a permanent software fix is available
                                                      (see Additional Information below), all CPRS
                                                      users must be aware that if either:

                                                      a) the Windows Screen Saver appears or

                                                      b) an “Access Violation” message displays, it is
                                                      an indication that you have experienced the
                                                      problem. Anytime either of these indications is
                                                      provided, users must immediately log off of
              Mandatory; Priority A                   Incorrect Patient Information Displayed in CPRSv27 AL09-04.pdf                                                                           END




          Recalls Alerts Advis - 5                                                          Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        495 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
            Question:                               Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                         START
5.12.25     (continued)... Incorrect Patient        ...(continued) CPRS
(continued) Information Displayed in CPRS v27
            (AL09-04)                               and then log onto CPRS again to continue your
                                                    activities.


            When switching from one patient’s
            record to a second patient’s record     3. If users experience an “Access Violation”
            in the same session of CPRS while       message or incorrect patient information after
            using CPRS v27, the first patient’s     switching from one patient’s CPRS record to a
            information may still be displayed in   second patient’s CPRS record, immediately
            the second patient’s CPRS display,      report the experience to your facility’s Clinical
            impacting patient care decisions. It    Application Coordinator (CAC) or designee.
            is not known at this time if data       Clinical Application Coordinators are
            entered for the second patient will     responsible for reporting any occurrence to the
            be placed in the incorrect record.      VA Service
            This problem occurs intermittently
            and has been reported when              Desk (1-888-596-4357) or logging a national
            viewing clinical data on the Orders     Remedy ™ help ticket.
            and Notes Tabs.

            Mandatory; Priority A                   Incorrect Patient Information Displayed in CPRSv27 AL09-04.pdf                                                                           END




        Recalls Alerts Advis - 5                                                          Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        496 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                Not
                                                                                                                         Met        Partially   Met   If score other than 'met' what are
              Question:                           Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                     START            5.12
5.12.26       CPRS v27 - Discontinued orders are Actions:
              no longer listed in order of
              discontinuation date/time (AL09-05)

                                                      1. Medical Center Directors are instructed to
                                                      send a certification message that a notification
              CPRS v27 (current version installed process has been implemented whereby all
              at all VA Medical Facilities), displays clinical staff and users of CPRS have read and
              discontinued orders by original order been made aware of this Patient Safety Alert.
              date, instead of the date the order     The certification message is to be sent from the
              was discontinued when viewing           VAMC Director to the VISN Network Director to
              Active Orders or Recent Activity. In the Office of the DUSHOM (10N). A VISN
              addition, the prefix “Discontinue” no
              longer appears in the discontinued      certification message should be sent to Megan
              orders in this view. These changes      Friel, Acting Chief
              have resulted in reported delays for
              stopping continuous infusion orders Biomedical Engineer, at megan.friel@va.gov no
              (e.g., stopping IV heparin drips).      later than 2 PM (EST) on Friday, November 7,
                                                      2008, which certifies that all VA medical centers
                                                      in that VISN have completed this notification
                                                      process.




                                                     2. Effective immediately, at the beginning of
                                                     each shift and every four (4) hours thereafter,
                                                     nursing staff shall review the BCMA Cover
                                                     Sheet to identify any IV’s or PCA’s that may
                                                     have been discontinued and are still infusing
                                                     (see Attachment 1).
              Mandatory; Priority A                  CPRSv27 Discontinued Orders AL09-05.pdf                                                                                               END




          Recalls Alerts Advis - 5                                                      Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        497 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
              Question:                             Rationale/Assessment Methods:                                          (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                       START            5.12
5.12.27       Maxi Move patient lifts with lock and Actions:
              load system (Combi Hanger):
              Manufactured by Arjo between
              November 2005 and April 2008.
              (AL09-06)                             1. By close of business December 2, 2008,
                                                    Biomedical Engineering will ensure that
                                                    replacement parts are ordered for affected Arjo
                                                    patient lift units (see Attachment 1).
              There is the potential for the “Lock
              and Load” hanger on the patient lift a. Units manufactured from November 2005,
              to unintentionally become dislocated through August 4, 2006, require replacement of
              when descending upon a rigid          the entire T-bar assembly.
              surface (e.g., a patient bed, the arm
              rest of a chair, the side rails of a  b. Units manufactured from August 6, 2006 to
              toilet commode chair). If the hanger April 7, 2008, require replacement of the T-bar
              is partially dislodged there is a     bushings.
              potential risk for complete
              detachment of the hanger while the
              patient is being moved. This could
              result in a patient fall. To date no  2. Until replacement components are installed,
              patient injuries have been reported. immediately inform users of the reported issue
              Arjo has identified 75 VA facilities  with this device and how to identify the issue
              affected by this issue.               (see Attachment 2).




                                                   Note: Only units with detachable hangers are
                                                   affected, permanently mounted/dedicated
                                                   hangers are not affected.
              Mandatory; Priority A                Maxi Move patient lifts with lock and load system Arjo AL09-06.pdf                                                                        END




          Recalls Alerts Advis - 5                                                        Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        498 of 1656
                                                                    NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                             Not
                                                                                                                      Met        Partially   Met   If score other than 'met' what are
              Question:                           Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                  START            5.12
5.12.28       Improper set-up and reprocessing of Actions:
              flexible endoscope tubing and
              accessories (AL09-07)

                                                        The Facility Director (or designee) will ensure
                                                        that all of the following three actions are carried
              Correct tubing modified with an           out by close of business January 7, 2009:
              incorrect connector was used to
              attach an Olympus flexible                1. All personnel who perform procedures with
              endoscope to its irrigation source        flexible endoscopes and/or reprocess
              (Olympus Flushing Pump and                endoscopes and their tubing and accessories
              accessories). This resulted in a          have read this Patient Safety Alert.
              backflow of body fluids into irrigation
              source tubing                             NOTE: Ensure you have identified all areas in
                                                        your facility
              (where backflow should not occur)
              during an endoscopic procedure.           where reprocessing of flexible endoscopes
                                                        occurs, which may

                                                        include, but are not limited to the following:
              Specifically, during some                 Ambulatory
              endoscopic procedures, the facility
              used an Olympus Auxiliary Water           Surgery, Endoscopy, GI, GU, OR, Respiratory,
              Tube (MAJ-855) that was modified          SPD, Urology,
              to have an Olympus Washing Tube
              (MH-974) connector attached               and Clinics to include CBOCs.
              instead of the connector intended to
              be used with the Olympus Auxiliary
              Water Tube (MAJ-855). The
              Auxiliary Water Tube (MAJ-855) is         2. For those facilities using the Olympus
              required to connect the Auxiliary         Flushing Pump and compatible endoscopes,
              Water Port on the endoscope to the        ensure that:
              Olympus Flushing Pump (OFP)
              Mandatory; Priority A                     OlympusScopeAL09-07.pdf                                                                                                         END




          Recalls Alerts Advis - 5                                                   Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        499 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                            Not
                                                                                                                     Met        Partially   Met   If score other than 'met' what are
            Question:                                 Rationale/Assessment Methods:                                  (1)         Met (2)    (3)   possible root causes
            2008 Alerts & Advisories                                                                                                                                                   START
5.12.28     (continued)... Improper set-up and        ...(continued) modify, create, or enhance
(continued) reprocessing of flexible endoscope        manufacturer
            tubing and accessories (AL09-07)
                                                      tubings and accessories.


            Correct tubing modified with an
            incorrect connector was used to           ii. the Olympus Auxiliary Water Tube (MAJ-855)
            attach an Olympus flexible                is supplied
            endoscope to its irrigation source
            (Olympus Flushing Pump and                non-sterile, and needs to be reprocessed before
            accessories). This resulted in a          initial
            backflow of body fluids into irrigation
            source tubing                             use and after each patient using steam
                                                      sterilization (refer
            (where backflow should not occur)
            during an endoscopic procedure.           to the instruction manual for your particular
                                                      endoscope).


            Specifically, during some
            endoscopic procedures, the facility       iii. the OFP Filter (7501355) and OFP Irrigation
            used an Olympus Auxiliary Water           Tube
            Tube (MAJ-855) that was modified
            to have an Olympus Washing Tube           (7501669) are supplied non-sterile, must be
            (MH-974) connector attached               sterilized
            instead of the connector intended to
            be used with the Olympus Auxiliary        prior to initial use, can be utilized all day, and
            Water Tube (MAJ-855). The                 must be discarded at the end of each day, as
            Auxiliary Water Tube (MAJ-855) is         per the manufacturer instructions.
            required to connect the Auxiliary
            Water Port on the endoscope to the
            Olympus Flushing Pump (OFP)
            Mandatory; Priority A                     OlympusScopeAL09-07.pdf                                                                                                          END




        Recalls Alerts Advis - 5                                                    Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        500 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
              Question:                              Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
              2008 Alerts & Advisories                                                                                                                                                      START            5.12
5.12.29       Suicide attempt in the Emergency       Recommendations:
              Room (ER) (AD09-05)


                                                     1. Staff in emergency rooms should be familiar
              Holiday seasons can present            with the Suicide Risk Assessment Pocket Card
              challenges to both patients and        (see the Attachment).
              staff. For example, holidays can
              trigger depression or suicidal
              ideation in patients, and staff may
              experience increased workload and      2. Patients appearing to ER staff to be at risk for
              stress and have added distractions.    self-harm should be kept in the line of sight, if
                                                     possible, while awaiting their evaluation.


              Patients attempt or complete suicide
              because they have both the will and    3. During the holidays (e.g., New Years, 4th of
              the opportunity to do so. Staff        July, Veteran’s Day, Thanksgiving, Winter
              vigilance in the ER setting is         Holidays, etc), ER staff should be aware of
              essential since it is the most         potential risks of holiday decorations (e.g.,
              common area where these patients       banners, strings of lights, garland) that are not
              first present.                         typically in the environment.
              Recommended; Priority A                Suicide Attempt In ER-AD09-05.pdf                                                                                                      END




          Recalls Alerts Advis - 5                                                       Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        501 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                  Not
                                                                                                                           Met        Partially   Met   If score other than 'met' what are
             Question:                                Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
             2009 Alerts & Advisories                                                                                                                                                        START            5.13
5.13.1       Product Recall: Duragesic® 50            Actions:
             mcg/h (Fentanyl Transdermal
             System) CII (patch) National Drug
             code (NDC) 50458-034-05, Lot #
             0817239 (AL 09-08)                       By close of business January 16, 2009,
                                                      Pharmacy Chiefs will:

                                                      1) Assure that all remaining products with the
                                                      affected lot number

             ALZA Corporation is recalling their      (#0817239) at the facility are returned to
             Duragesic® 50 mcg/h Fentanyl             McKesson, the pharmaceutical
             transdermal
                                                      prime vendor for VA. The product should NOT
             patches. A small number of these         be returned as instructed
             systems may have a cut along one
             side of the drug reservoir. The result   in the manufacturer/distributor’s product recall
             is the possibility of gel being          documents.
             released from the gel reservoir into
             the pouch in which the patch is
             packaged that will allow patients or
             caregivers to be directly exposed to     2) Determine whether the affected lot number
             Fentanyl gel. Exposure to Fentanyl       (refer to lot number provided
             gel may lead to serious adverse
             events, including respiratory            above) was dispensed to any patient(s). If so,
             depression and possible overdose,        identify the patient(s) and
             which may be fatal.
                                                      contact the patient(s) providing instructions on
                                                      how to obtain a new

                                                      supply of medication and return the medication
                                                      being recalled to the
             Mandatory; Priority A                    DuragesicFentanylPatchAL09.08.pdf                                                                                                      END




         Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        502 of 1656
                                                                  NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
            Question:                                Rationale/Assessment Methods:                                        (1)         Met (2)    (3)   possible root causes
            2009 Alerts & Advisories                                                                                                                                                        START
5.13.1      (continued)... Product Recall:           ...(continued) breathing need emergency help.
(continued) Duragesic® 50 mcg/h (Fentanyl            Family members or caretakers
            Transdermal System) CII (patch)
            National Drug code (NDC) 50458-          should call 911.”
            034-05, Lot # 0817239 (AL 09-08)


                                                     4) If patients cannot be reached by telephone,
                                                     follow-up with a letter. A

            ALZA Corporation is recalling their      sample letter can be found at:
            Duragesic® 50 mcg/h Fentanyl
            transdermal                              http://vaww.national.cmop.va.gov/PBM/Other%2
                                                     0Documents%20and%2
            patches. A small number of these
            systems may have a cut along one         0Resources/Recall%20Patient%20Letter%20Te
            side of the drug reservoir. The result   mplate.doc. This
            is the possibility of gel being
            released from the gel reservoir into     template can be altered according to site-
            the pouch in which the patch is          specific needs.
            packaged that will allow patients or
            caregivers to be directly exposed to
            Fentanyl gel. Exposure to Fentanyl
            gel may lead to serious adverse          5) Report any adverse reactions experienced
            events, including respiratory
            depression and possible overdose,
            which may be fatal.

            Mandatory; Priority A                    DuragesicFentanylPatchAL09.08.pdf                                                                                                      END




        Recalls Alerts Advis - 5                                                         Recalls Alerts Advis - 5 - Version: 01.30.2009                                                        503 of 1656
                                                                   NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS and ALERTS AND ADVISORIES - Element 5
                                                                                                                                                 Not
                                                                                                                          Met        Partially   Met   If score other than 'met' what are
             Question:                                Rationale/Assessment Methods:                                       (1)         Met (2)    (3)   possible root causes
             2009 Alerts & Advisories                                                                                                                                                       START            5.13
5.13.2       Digital Television’s (DTV) transition    Recommendations:
             and affect on wireless medical
             telemetry systems for physiologic
             patient monitoring (AD 09-06)
                                                      Managing a practical approach to assessing and
                                                      mitigating risk associated

             On February 17, 2009, all US             with these new DTV stations includes the
             television stations will stop            following important steps.
             broadcasting on

             analog airwaves and begin
             broadcasting only in digital. As a       1. Determine if the wireless medical telemetry
             result, some                             system in the medical

             of these new DTV station channels        center operates within the 608-614 MHz
             will now broadcast on Channels 36        (Channel 37) telemetry band.
             and

             38, which are adjacent to an
             authorized Wireless Medical              2. If the wireless medical telemetry system
             Telemetry                                operates withi