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Leadership Mistakes - Excel

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					 Patient Safety Assessment Tool
    Administration Elements
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

Element 8
    VISN Patient Safety Program
                                                     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
   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.
                                                     JCAHO_CAMH.pdf /A Page=295
              Mandatory;Priority A                   VHA PS Handbook.pdf /A Page=05
              Leadership/Support
   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.

                                                     JCAHO_CAMH.pdf /A Page=319
              Mandatory;Priority A                   VHA PS Handbook.pdf /A Page=7
              Leadership/Support
   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 matrix
              based upon the SAC score without       should be the authority for determining which
              approval from his/her supervisor or    cases become individual RCAs. Although top
              top management?                        management approval is ultimately needed to
                                                     begin an RCA, the PSM should be the primary
                                                     decision-maker.
              Recommended; Priority A                JCAHO_CAMH.pdf /A Page=319




Mgt Ldr - 1                                                                     Mgt Ldr - 1 - Version: 2007                                                         2 of 480
                                                      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
   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.

                                                      JCAHO_CAMH.pdf /A Page=319
              Mandatory;Priority A                    VHA PS Handbook.pdf /A Page=7
              Leadership/Support
   1.1.5      Are close call reports being            Review SPOT for potential SAC scores of 1and 2
              received?                               to determine if Safety Reports are being entered.
                                                      Have PSM show specific examples of close calls
                                                      including events that have become RCAs.

                                                      JCAHO_CAMH.pdf /A Page=320
              Mandatory;Priority A                    VHA PS Handbook.pdf /A Page=7
              Leadership/Support
   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.

                                                      JCAHO_CAMH.pdf /A Page=297
              Recommended; Priority C                 VHA PS Handbook.pdf /A Page=10
              Leadership/Support
   1.1.7      When criminal or intentionally unsafe   Verify via interviews with key personal (PSM,
              acts are identified during the RCA      Director, RCA team members). If systems issues
              process, is the RCA stopped, the        are identified a new RCA team may be chartered
              record sealed and top management        to complete the RCA following completion of the
              notified without revealing team         ABI.
              findings and conclusions?

              Mandatory;Priority A                    VHA PS Handbook.pdf /A Page=11




Mgt Ldr - 1                                                                      Mgt Ldr - 1 - Version: 2007                                                         3 of 480
                                                    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
   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 #0
                                                    Confidentiality 5705 Cognitive Aid.pdf /A Page=0
              Mandatory;Priority A                  JCAHO_CAMH.pdf /A Page=377
              Leadership/Support
   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 the
              NCPS?                                 reports received though the NCPS Facility
                                                    Report Process is another way to analyze
                                                    compliance to de-identification.
                                                    5705.pdf /A Page=0
                                                    Code of Federal Regulations_part 17.pdf /A Page=0
              Mandatory;Priority A                  JCAHO_CAMH.pdf /A Page=383
              Staffing
   1.2.1      Is there a full time Patient Safety   The Patient Safety program requirements should
              Manager?                              be met before other collateral duties are
                                                    assigned to the PSM.
                                                    Supporting the Patient Safety Program Memo.pdf /A Page=0
                                                    JCAHO_CAMH.pdf /A Page=320
              Mandatory;Priority A                  USH memo PSM Job Jar (2).pdf /A Page=0
              Staffing
   1.2.1.1    Is clerical support personnel       Depending on facility size, a rigorous work load
              provided if deemed necessary by the of RCA inputting, maintenance, and follow up
              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




Mgt Ldr - 1                                                                         Mgt Ldr - 1 - Version: 2007                                                         4 of 480
                                                        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
   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 /A Page=0
                                                        JCAHO_CAMH.pdf /A Page=373
              Mandatory; Priority A                     USH memo PSM Job Jar (2).pdf /A Page=0
              Resources
   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                   JCAHO_CAMH.pdf /A Page=373
              Resources
   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 guidance   December of 2001 that provided a list of PSM job
              distributed by the Assistant Deputy       responsibilities to assist in establishing the PSM
              Under Secretary for Health (in 12-        positions. The list captures the fundamental
              2001) to enhance qualifications?          activities that must be in place to 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/
                                                        JCAHO_CAMH.pdf /A Page=373
              Recommended; Priority A                   USH memo PSM Job Jar (2).pdf /A Page=0
              Resources
   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                   JCAHO_CAMH.pdf /A Page=320




Mgt Ldr - 1                                                                           Mgt Ldr - 1 - Version: 2007                                                         5 of 480
                                                   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
   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 #0




Mgt Ldr - 1                                                                       Mgt Ldr - 1 - Version: 2007                                                          6 of 480
                                                          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
  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                   VHA PS Handbook.pdf /A Page=12
                  Root Cause Analysis Activities
  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 PS Handbook.pdf /A Page=11
                  Root Cause Analysis Activities
  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 close      can included in an aggregated review (twice or
                  calls with a SAC potential score of 3   four times per FY depending on which event
                  addressed via the Aggregated            type) focusing on fixing related processes
                  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 start 07.pdf /A Page=0
                                                          Guidanceon New Standards for VHA Patient Safety Program.pdf /A Page=0
                  Mandatory; Priority A                   ISMP_Book.pdf /A Page=0
                  Root Cause Analysis Activities
  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                 JCAHO_CAMH.pdf /A Page=373




PS Prgm Mgt - 2                                                                      PS Prgm Mgt - 2 - Version: 2007                                                               7 of 480
                                                       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
  2.1.2.1         If individuals other than the PSMs   The appropriate training would be considered the
                  serve as advisors on RCA teams       three day Patient Safety Improvement Course
                  have they been appropriately         offered by NCPS, or the equivalent given by a
                  trained?                             trained PSO or PSM.
                  Recommended; Priority A
                  Root Cause Analysis Activities
  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 /A Page=0
                                                       RCATeamProcess.pdf /A Page=0
                  Recommended; Priority A              JCAHO_CAMH.pdf /A Page=373
                  Root Cause Analysis Activities
  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).
                                                       JCAHO_CAMH.pdf /A Page=320
                  Mandatory; Priority A                VHA PS Handbook.pdf /A Page=8
                  Root Cause Analysis Activities
  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 cause
                  outcomes?                            statements, actions that address the root
                                                       causes, and outcome measures that measure
                                                       the actions.
                  Mandatory; Priority A                JCAHO_CAMH.pdf /A Page=296
                  Root Cause Analysis Activities
  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 /A Page=0
                  Recommended; Priority B              USH memo PSM Job Jar (2).pdf /A Page=2




PS Prgm Mgt - 2                                                                     PS Prgm Mgt - 2 - Version: 2007                                                         8 of 480
                                                          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
  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. If
                  Measures being used within SPOT?        action and outcome tracking is reviewed at
                                                          committee meetings, the meeting minutes may
                                                          qualify as proof as well.
                                                          JCAHO_CAMH.pdf /A Page=296
                  Mandatory; Priority A                   VHA PS Handbook.pdf /A Page=14
                  Root Cause Analysis Activities
  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                 JCAHO_CAMH.pdf /A Page=294
                  Root Cause Analysis Activities
  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
                  Root Cause Analysis Activities
  2.1.7           Are Root Cause Contributing Factors Review 10 % of yearly (minimum of 4) RCA's for
                  in the RCA reports consistently     context.
                  written to meet the five rules of
                  causation?
                                                          CognitiveAids_TriageQuestions.pdf /A Page=12
                                                          JCAHO_CAMH.pdf /A Page=385
                  Recommended; Priority A                 VHA PS Handbook.pdf /A Page=9
                  Root Cause Analysis Activities
  2.1.8           Do the RCA reports identify pertinent Review a minimum of 4 RCA's for context.
                  Root Cause Contributing Factors?      RC/CFs should be appropriate for RCA event.
                                                        For instance, evaluate if the event descriptions
                                                        match the root cause statements developed
                                                        within the same RCA.
                  Recommended; Priority A                 JCAHO_CAMH.pdf /A Page=296




PS Prgm Mgt - 2                                                                      PS Prgm Mgt - 2 - Version: 2007                                                         9 of 480
                                                         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
  2.1.9           Do Actions in RCA reports target and   Review 10% of yearly (minimum of 4) RCA's.
                  address the Root Cause Contributing    Also review Actions and assess if they are
                  Factors?                               obtainable.
                  Recommended; Priority A                JCAHO_CAMH.pdf /A Page=296
                  Root Cause Analysis Activities
  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                JCAHO_CAMH.pdf /A Page=296
                  Root Cause Analysis Activities
  2.1.11          Are RCA reports completed within 45- Review 10% of yearly (minimum of 4) RCA's. If
                  days of the facility becoming aware reports are not competed, Actions cannot be
                  that an RCA is required?             implemented. Reminder: Coroner dates or peer
                                                       review dates are the 'date aware' on RCAs.

                  Mandatory; Priority A                  VHA PS Handbook.pdf /A Page=13
                  Root Cause Analysis Activities
  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.
                                                         Guidanceon New Standards for VHA Patient Safety Program.pdf /A
                  Mandatory; Priority A
                                                         Page=0




PS Prgm Mgt - 2                                                                     PS Prgm Mgt - 2 - Version: 2007                                                             10 of 480
                                                        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
  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 /A Page=0
                  General Programmatic Functions
  2.3.1           Does the PSM collaborate with other   Interview Engineering, Safety/IH, and/or Infection
                  entities, such as Biomedical          Control. Documentation should be shown such
                  Engineering staff, Occupational       as JCAHO projects, and participation of these
                  Safety Officer and/or Industrial      disciplines on RCA and HFMEA teams.
                  Hygienist, & Infection Control?
                  Recommended; Priority A               USH memo PSM Job Jar (2).pdf /A Page=0
                  General Programmatic Functions
  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.

                                                        JCAHO_CAMH.pdf /A Page=321
                  Mandatory; Priority A                 VHA PS Handbook.pdf /A Page=9
                  General Programmatic Functions
  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)
                                                        JCAHO_CAMH.pdf /A Page=319
                  Recommended; Priority A               VHA PS Handbook.pdf /A Page=10
                  General Programmatic Functions
  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




PS Prgm Mgt - 2                                                                  PS Prgm Mgt - 2 - Version: 2007                                                         11 of 480
                                                       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
  2.3.5           Is the topic of Patient Safety covered Verify NEO process and materials. Criteria that
                  in New Employee Orientation?           should be covered is: background information 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 #0
                                                        http://vaww.ncps.med.va.gov/education.html#neo http://vaww.ncps.med.va.gov/education.html#neo #0
                  Recommended; Priority A               JCAHO_CAMH.pdf /A Page=372
                  General Programmatic Functions
  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                 JCAHO_CAMH.pdf /A Page=372
                  General Programmatic Functions
  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 /A Page=0
                  General Programmatic Functions
  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 /A Page=0
                                                        NCPS HFMEA Critique Sheet.pdf /A Page=0
                  Mandatory; Priority A                 JCAHO_CAMH.pdf /A Page=297




PS Prgm Mgt - 2                                                                    PS Prgm Mgt - 2 - Version: 2007                                                                             12 of 480
                                                          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
  2.3.9           Does a system exist, and is it used,    Verify via feedback documentation and interview
                  to give feedback to staff that report   facility personnel. It is required to give feedback
                  adverse event and close call            to employees who report events which become
                  incidents that result in an RCA?        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 PS Handbook.pdf /A Page=12




PS Prgm Mgt - 2                                                                    PS Prgm Mgt - 2 - Version: 2007                                                         13 of 480
                                                   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
             Ethics, Rights and Responsibilities
   3.1.1     Patients and, when appropriate, their At a minimum, the patient and when appropriate,
             families are informed about the       his or her family, is informed about the following:
             outcomes of care, including
             unanticipated outcomes.               1) Outcomes of care, treatment, and services
                                                   that have been provided that the patient (or
                                                   family) must be knowledgeable about to
                                                   participate in current and future decisions
                                                   affecting the patient's care, treatment, and
                                                   service.

                                                    2) Unanticipated outcomes of care, treatment,
                                                    and services that relate to sentinel events
                                                    considered reviewable by the Joint Commission.

                                                    3) The responsible LIP or his or her designee
                                                    informs the patient (and when appropriate, his or
                                                    her family) about those unanticipated outcomes
                                                    of care, treatment, and services.


             RI.2.90                                JCAHO_CAMH.pdf /A Page=169




JC - 3                                                                           JC - 3 - Version: 2007                                                         14 of 480
                                                   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
             Ethics, Rights and Responsibilities
   3.1.2     The hospital respects the needs of  1) The hospital protects confidentiality of
             patients for confidentiality.       information about patients.

                                                    2) The hospital respects the privacy of patients.

                                                    3) Patients who desire private telephone
                                                    conversations have access to space and
                                                    telephones appropriate to their needs and the
                                                    care, treatment, and services provided.

                                                    4) The hospital provides for the safety and
                                                    security of patients and their property.

                                                    5) Not Applicable

                                                    6) Not Applicable

                                                    Additional Element of Performance for Hospital
                                                    Settings that Provide Longer Term Care( > 30
                                                    days):

                                                    7) The number of patients in a room is
                                                    appropriate to the hospital‘s goals and the
                                                    patients‘ ages, developmental levels, clinical
                                                    conditions, or diagnosis needs.
             RI.2.130                               JCAHO_CAMH.pdf /A Page=171
             Provision of Care, Treatment and Services
   3.2.1     Performance improvement               1) The hospital measures and assesses its
             processes seek to identify            restraint use to identify opportunities to introduce
             opportunities to reduce the risks     preventive strategies, alternatives to use, and
             associated with restraint use through process improvements that reduce the risks
             preventive strategies, innovative     associated with restraint use.
             alternatives, and process
             improvements.
             PC.11.20                               JCAHO_CAMH.pdf /A Page=209




JC - 3                                                                           JC - 3 - Version: 2007                                                         15 of 480
                                                    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
              Provision of Care, Treatment and Services
   3.2.2      Hospital policies and procedures  1) Policies and procedures include appropriate
              guide appropriate and safe use of details as to how the hospital does the following:
              restraint.                        Protects the patient and preserves his or her
                                                rights, dignity, and well-being during use; Bases
                                                use on the patient‘s assessed needs; Makes
                                                decisions about least-restrictive methods;
                                                Ensures safe application and removal by
                                                qualified staff; Monitors and reassesses the
                                                patient during use, using qualified staff; Meets
                                                patient needs during use; Addresses risk
                                                associated with vulnerable patient populations,
                                                such as emergency, pediatric, and cognitively or
                                                physically limited patients; Makes efforts to
                                                discuss the issue of restraint, when practical,
                                                with the patient and family around the time of its
                                                use; When orders are needed, limits individual
                                                orders to licensed independent practitioners;
                                                Requires renewal of orders in accordance with
                                                applicable law and regulation; Documents
                                                restraint episodes in the medical record (see
                                                standard PC.11.100)

                                                    2) The policies and procedures are developed by
                                                    (continued)...
              PC.11.30                              JCAHO_CAMH.pdf /A Page=208
               Provision of Care, Treatment and Services
   3.2.2       (continued)... Hospital policies and ...(continued) appropriate staff and approved by
   (continued) procedures guide appropriate and     the medical staff, nursing leadership, and, as
               safe use of restraint.               appropriate, others.
              PC.11.30                              JCAHO_CAMH.pdf /A Page=208




JC - 3                                                                           JC - 3 - Version: 2007                                                         16 of 480
                                                   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
             Provision of Care, Treatment and Services
   3.2.3     Patients in restraints are monitored. 1) Hospital policies and procedures, applicable
                                                   state law, protocols, individual orders, the
                                                   setting, and individual patient needs are used to
                                                   establish the frequency, nature, and extent of
                                                   monitoring of a patient in restraints.

                                                    2) A patient in restraints is monitored at least
                                                    every two hours or sooner according to patient
                                                    need and hospital policy.

                                                    3) Monitoring is accomplished by observation,
                                                    interaction with the patient, or related direct
                                                    examination of the patient by qualified staff.

             PC.11.70                               JCAHO_CAMH.pdf /A Page=211
             Provision of Care, Treatment and Services
   3.2.4     Staffing levels and assignments are The hospital bases its staffing levels and
             set to minimize circumstances that      assignments on a variety of factors, including the
             give rise to restraint or seclusion use following:
             and to maximize safety when
             restraint and seclusion are used.       1) Staff qualifications

                                                    2) The physical design of the environment

                                                    3) Diagnoses

                                                    4) Co-occurring conditions

                                                    5) Acuity levels

                                                    6) Age and developmental functioning of patients

             PC.12.20                               JCAHO_CAMH.pdf /A Page=214




JC - 3                                                                           JC - 3 - Version: 2007                                                         17 of 480
                                                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
             Provision of Care, Treatment and Services
   3.2.5     Staff is trained and competent to 1) The hospital educates staff about minimizing
             minimize the use of restraint and the use of restraint and seclusion and, before
             seclusion and, when use is        they participate in any use of restraint or
             indicated, to use restraint or    seclusion, assesses the competence of staff to
             seclusion safely.                 use them safely.

                                                 2) To minimize the use of restraint and seclusion,
                                                 all direct care staff and any other staff involved in
                                                 the use of restraint and seclusion receive
                                                 ongoing training in and demonstrate an
                                                 understanding of the following:The underlying
                                                 causes of threatening behaviors exhibited by the
                                                 patients; That sometimes a patient may exhibit
                                                 an aggressive behavior that is related to a
                                                 patient‘s medical condition and not related to his
                                                 or her emotional condition (for example,
                                                 threatening behavior that may result from
                                                 delirium in fevers or other medical conditions);
                                                 How staff behaviors can affect the behaviors of
                                                 the patients; De-escalation, mediation, self-
                                                 protection, and other techniques such as time-
                                                 out; How to recognize signs of physical distress
                                                 in patients who are being held, restrained, or
                                                 (continued)...
             PC.12.30                            JCAHO_CAMH.pdf /A Page=215




JC - 3                                                                        JC - 3 - Version: 2007                                                           18 of 480
                                                     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
               Provision of Care, Treatment and Services
   3.2.5       (continued)... Staff is trained and   ...(continued) secluded
   (continued) competent to minimize the use of
               restraint and seclusion and, when     3) Staff members who are authorized to apply
               use is indicated, to use restraint or restraint or seclusion receive the training and
               seclusion safely.                     demonstrate the competence cited in EP 2.

                                                     4) These direct care staff members also receive
                                                     ongoing training in and demonstrate competence
                                                     in the safe use of restraint, including physical
                                                     holding techniques, take-down procedures, and
                                                     the application and removal of mechanical
                                                     restraints.

                                                     5) Staff members who are authorized to perform
                                                     15-minute assessments of patients in restraint or
                                                     seclusion receive the training and demonstrate
                                                     the competence cited in EP 2.

                                                     6) These staff members authorized to perform 15-
                                                     minute assessments receive ongoing training
                                                     and demonstrate competence in the following:
                                                     Taking vital signs and interpreting their relevance
                                                     to the physical safety of the patient in restraint or
                                                     seclusion; Recognizing nutritional and hydration
                                                     needs; Checking circulation and range of motion
                                                     in the extremities; Addressing hygiene and
                                                     elimination; Addressing physical and
                                                     psychological status and comfort; Helping
                                                     patients meet behavior criteria for discontinuing
                                                     restraint or seclusion; Recognizing readiness for
                                                     discontinuing restraint or seclusion; Recognizing
                                                     signs of any incorrect application of restraints;
               PC.12.30                              JCAHO_CAMH.pdf /A Page=215




JC - 3                                                                            JC - 3 - Version: 2007                                                           19 of 480
                                                  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
             Provision of Care, Treatment and Services
   3.2.6     Restraint or seclusion is limited to  1) Restraint or seclusion is used only when
             emergencies in which there is an      nonphysical interventions are ineffective or not
             imminent risk of a patient physically viable and when there is an imminent risk of a
             harming himself or herself, staff, or patient physically harming himself or herself,
             others, and nonphysical               staff, or others.
             interventions would not be effective.
                                                   2) The type of physical intervention selected
                                                   considers information learned from the patient‘s
                                                   initial assessment.

                                                   3) The hospital does not permit restraint or
                                                   seclusion for any other purpose, such as
                                                   coercion, discipline, convenience, or retaliation
                                                   by staff.

                                                   4) The use of restraint or seclusion is not based
                                                   on a patient‘s restraint or seclusion history or
                                                   solely on a history of dangerous behavior.

             PC.12.60                              JCAHO_CAMH.pdf /A Page=216




JC - 3                                                                          JC - 3 - Version: 2007                                                         20 of 480
                                                  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
             Provision of Care, Treatment and Services
   3.2.7     Patients in restraint or seclusion are 1) A staff member who is trained and competent
             assessed and assisted.                 in accordance with standard PC.12.30 assesses
                                                    the patient at the initiation of restraint or
                                                    seclusion and every 15 minutes thereafter.

                                                  2) This assessment includes, as appropriate to
                                                  the type of restraint or seclusion, the following:
                                                  Signs of any injury associated with applying
                                                  restraint or seclusion; Nutrition and hydration;
                                                  Circulation and range of motion in the
                                                  extremities; Vital signs; Hygiene and elimination;
                                                  Physical and psychological status and comfort;
                                                  Readiness for discontinuation of restraint or
                                                  seclusion.

                                                  3) Staff helps patients meet behavior criteria for
                                                  discontinuing restraint or seclusion.

             PC.12.130                            JCAHO_CAMH.pdf /A Page=219
             Provision of Care, Treatment and Services
   3.2.8     Patients in restraint or seclusion are 1) Monitoring is done through continuous in-
             monitored.                             person observation by an assigned staff member
                                                    who is competent and trained in accordance with
                                                    standard PC.12.30.

                                                  2) After the first hour, a patient in seclusion
                                                  without restraints may be continuously monitored
                                                  using simultaneous video and audio equipment,
                                                  if consistent with the patient‘s condition or
                                                  wishes.

                                                  3) If the patient is in a physical hold, a second
                                                  staff person is assigned to observe the patient.

             PC.12.140                            JCAHO_CAMH.pdf /A Page=220




JC - 3                                                                         JC - 3 - Version: 2007                                                         21 of 480
                                                 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
             Provision of Care, Treatment and Services
   3.2.9     Patients are monitored during the  1) Appropriate methods are used to continuously
             procedure and/or administration of monitor oxygenation, ventilation, and circulation
             moderate or deep sedation or       during procedures that may affect the patient's
             anesthesia.                        physiological status.

                                                  2) The procedure and/or the administration of
                                                  moderate or deep sedation or anesthesia for
                                                  each patient are documented in the medical
                                                  record.
             PC.13.30                             JCAHO_CAMH.pdf /A Page=225
             Provision of Care, Treatment and Services
   3.2.10    Patients are monitored immediately 1) The patient's status is assessed on arrival in
             after the procedure and/or         the recovery area.
             administration of moderate or deep
             sedation or anesthesia.            2) Each patient's physiological status, mental
                                                status, and pain level are monitored.

                                                  3) Monitoring is at a level consistent with the
                                                  potential effect of the procedure and/or sedation
                                                  or anesthesia.

                                                  4) Patients are discharged from the recovery
                                                  area and the hospital by a qualified LIP
                                                  according to rigorously applied criteria approved
                                                  by the clinical leaders.

                                                  5) Patients who have received anesthesia in the
                                                  outpatient setting are discharged in the company
                                                  of a responsible, designated adult.
             PC.13.40                             JCAHO_CAMH.pdf /A Page=225




JC - 3                                                                         JC - 3 - Version: 2007                                                         22 of 480
                                                 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
             Provision of Care, Treatment and Services
   3.2.11    Electroconvulsive therapy is used 1) Written policies regulate electroconvulsive
             with adequate justification,      therapy.
             documentation, and regard for
             patient safety.                   2) Whenever electroconvulsive therapy is used,
                                               the procedure is adequately justified and
                                               documented in the patient‘s medical record.

                                                  3) Before initiating electroconvulsive therapy for
                                                  a child or youth, two qualified, experienced

                                                  child psychiatrists who are not directly involved
                                                  in treating the child or youth do

                                                  the following: Examine the child or youth;
                                                  Consult with the psychiatrist responsible for the
                                                  child or youth; Document their concurrence with
                                                  the treatment in the child‘s or youth‘s medical
                                                  record

                                                  4) Written consent for any electroconvulsive
                                                  therapy is obtained from the patient and
                                                  documented in the clinical/case record.
             PC.13.50                             JCAHO_CAMH.pdf /A Page=225
             Provision of Care, Treatment and Services
   3.2.12    When patients are transferred or    1) The hospital communicates appropriate
             discharged, appropriate information information to any organization or provider to
             related to the care, treatment, and which the patient is transferred or discharged.
             services provided is exchanged with
             other service providers.            2) The information shared includes the following,
                                                 as appropriate to the care, treatment, and
                                                 services provided: The reason for transfer or
                                                 discharge; The patient‘s physical and
                                                 psychosocial status; A summary of care,
                                                 treatment, and services provided and progress
                                                 toward goals; Community resources or referrals
                                                 provided to the patient
             PC.15.30                             JCAHO_CAMH.pdf /A Page=229




JC - 3                                                                         JC - 3 - Version: 2007                                                         23 of 480
                                                       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
             Medication Management
   3.3.1     Patient-specific information is readily   1) A written policy describes the minimum
             accessible to those involved in the       amount of information about the patient that is to
             medication management system.             be available to those involved in medication
                                                       management. Note: The hospital defines who
                                                       has this information; see standard IM.2.10.

                                                       2) At a minimum, the information includes the
                                                       following: - The patient's age; - The patient's sex;
                                                       - The patient's current medications; - The
                                                       patient's diagnoses, comorbidities, and
                                                       concurrently occurring conditions; - The patient's
                                                       relevant laboratory values; - The patient's
                                                       allergies and past sensitivities.

                                                       As appropriate to the patient, the hospital also
                                                       includes information regarding the following: -
                                                       Weight and height; - Pregnancy and lactation
                                                       status; - Any other information required by the
                                                       hospital for safe medication management.

                                                       3) The information is accessible when needed
                                                       (except in emergency situations when time does
                                                       not permit) to LIPs, appropriate health care
                                                       professionals, and staff.
             MM.1.10                                   JCAHO_CAMH.pdf /A Page=248




JC - 3                                                                              JC - 3 - Version: 2007                                                          24 of 480
                                                    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
             Medication Management
   3.3.2     Medications available for dispensing   1. Members of the medical staff, licensed
             or administration (including stock     independent practitioners, appropriate health
             medications) are selected, listed,     care professionals, and staff involved in ordering,
             and procured based on criteria.        dispensing, administering, and/or monitoring
                                                    effects of medications develop written criteria for
                                                    determining what medications are available for
                                                    dispensing or administration.
             Note: The formulary is synonymous
             with the list of medications available 2. At a minimum, the criteria include the
             for use.                               indication for use, effectiveness, risks (including
                                                    propensity for medication errors, abuse potential,
                                                    and sentinel events), and costs.

                                                    3. A list of medications for dispensing or
                                                    administration (including strength and dosage
                                                    form) is maintained and readily available.

                                                    Note: Sample medications are not required to be
                                                    on this list.

                                                    4. Processes and mechanisms are established
                                                    to monitor patient responses to a newly added
                                                    medication before the medication is made
                                                    available for dispensing or administration within
                                                    the hospital.

                                                    5. Medications designated as available for
                                                    dispensing or administration are reviewed at
                                                    least annually based on (continued)...


             MM.2.10                                JCAHO_CAMH.pdf /A Page=249




JC - 3                                                                           JC - 3 - Version: 2007                                                         25 of 480
                                                      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
               Medication Management
   3.3.2       (continued)... Medications available   ...(continued) emerging safety and efficacy
   (continued) for dispensing or administration       information.
               (including stock medications) are
               selected, listed, and procured based   6. The hospital has processes to approve and
               on criteria.                           procure medications that are not on the
                                                      hospital‘s medication list.

                                                     7. The hospital has processes to address
              Note: The formulary is synonymous medication shortages and outages, including the
              with the list of medications available following:
              for use.
                                                     ● Communicating with appropriate prescribers
                                                     and staff

                                                      ● Developing approved substitution protocols

                                                      ● Educating appropriate licensed independent
                                                      practitioners, appropriate health care
                                                      professionals, and staff about these protocols

                                                      ● Obtaining medications in the event of a
                                                      disaster
              MM.2.10                                 JCAHO_CAMH.pdf /A Page=249




JC - 3                                                                             JC - 3 - Version: 2007                                                         26 of 480
                                                   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
             Medication Management
   3.3.3     Medications are properly and safely   1. Only approved medications are routinely
             stored.                               stocked or stored.*

                                                   2. Medications are stored under conditions
                                                   suitable for product stability.
             Note: The following elements of
             performance also apply to             3. Unauthorized persons, in accordance with the
             emergency medications. Additional     hospital's policy and law or regulation, cannot
             requirements for emergency            obtain access to medications.
             medications are addressed at
             standard MM.2.30.                     4) Controlled substances are stored to prevent
                                                   diversion and according to state and federal laws
                                                   and regulations.

                                                   5) All expired, damaged, and/or contaminated
                                                   medications are segregated until they are
                                                   removed from the hospital.

                                                   6) Identify and, at a minimum, annually review a
                                                   list of look-alike/sound-alike drugs used in the
                                                   organization, and take action to prevent errors
                                                   involving the interchange of these drugs.

                                                   Note: The preceding requirement is not scored
                                                   here. It is scored at National Patient Safety Goal
                                                   3, Requirement 3C.

                                                   7) Medications and chemicals used to prepare
                                                   medications are accurately labeled with
                                                   contents, expiration dates, and appropriate
                                                   warnings.
             MM.2.20                               JCAHO_CAMH.pdf /A Page=248




JC - 3                                                                          JC - 3 - Version: 2007                                                         27 of 480
                                                  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
               Medication Management
   3.3.3       (continued)... Medications are     ...(continued) concentrations available in the
   (continued) properly and safely stored.        organization.

                                                  Note: The preceding requirement is not scored
                                                  here. It is scored at National Patient Safety
              Note: The following elements of     Goal 3, Reguirement 3B.
              performance also apply to
              emergency medications. Additional   9) Concentrated electrolytes are removed from
              requirements for emergency          care units or areas, (unless patient safety is at
              medications are addressed at        risk if the concentrated electrolyte is not
              standard MM.2.30.                   immediately available on a specific care unit or
                                                  area and specific precautions are taken to
                                                  prevent inadvertent administration.)

                                                  10) Medications in care areas are maintained in
                                                  the most ready-to-administer forms available
                                                  from the manufacturer or if feasible, in unit-doses
                                                  that have been repackaged by the pharmacy or
                                                  a licensed repackager.

                                                  11) Not Applicable.

                                                  12) Not Applicable.

                                                  13) All medication storage areas are periodically
                                                  inspected according to the hospital's policy to
                                                  make sure medications are stored properly.
              MM.2.20                             JCAHO_CAMH.pdf /A Page=248




JC - 3                                                                         JC - 3 - Version: 2007                                                         28 of 480
                                                    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
             Medication Management
   3.3.4     Emergency medications and/or           1) Not applicable.
             supplies, if any, are consistently
             available, controlled, and secure.     2) Hospital leadership, in conjunction with
                                                    members of the medical staff and LIPs, decides
                                                    which emergency medications and/or supplies
                                                    will be readily available in patient care areas.
             Note: The following requirements for
             emergency medications are in           3) Emergency medications are available in unit-
             addition to the requirements at        dose, age-specific, and ready-to-administer
             standard MM.2.2.0, which are also      forms, whenever possible.
             applicable to emergency
             medications.                           4) Not applicable.

                                                    5) Not applicable.

                                                    6) Emergency medications are stored in sealed
                                                    or in locked containers; in a locked room; or
                                                    under constant supervision in accordance with
                                                    law or regulation.

                                                    7) Emergency medications and supplies are
                                                    replaced as soon as possible after their use in
                                                    accordance with the hospital's policies and
                                                    procedures.
             MM.2.30                                JCAHO_CAMH.pdf /A Page=252




JC - 3                                                                           JC - 3 - Version: 2007                                                         29 of 480
                                                       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
             Medication Management
   3.3.5     A process is established to safely        The hospital addresses the use of medications
             manage medications brought into the       brought into the hospital by patients or their
             hospital by patients or their families.   families, including the following:

                                                       1) Defining when such medications can be used
                                                       or administered

                                                       2) Identifying the medication and visually
                                                       evaluating its integrity, when medications
                                                       brought in by the patient or family are allowed.

                                                       3) Informing the prescriber and patient if
                                                       medications brought into the hospital by patients
                                                       or their families are not permitted.

             MM.2.40                                   JCAHO_CAMH.pdf /A Page=252
             Medication Management
   3.3.6     Only medications needed to treat the 1. There is a documented diagnosis, condition,
             patient’s condition are ordered,     or indication-for-use for each medication
             provided, or administered.           ordered.
             MM.3.10                                   JCAHO_CAMH.pdf /A Page=253




JC - 3                                                                              JC - 3 - Version: 2007                                                         30 of 480
                                                   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
             Medication Management
   3.3.7     Medication orders are written clearly Written policy(ies) address the following:
             and transcribed accurately.
                                                   1) The required elements of a complete
                                                   medication order.

                                                   2) When generic or brand names are acceptable
                                                   or required as part of a medication order.

                                                   3) Whether or when indication for use is required
                                                   on a medication order.

                                                   4) Special precautions or procedures for ordering
                                                   drugs with look-alike or sound-alike names.

                                                   5) Actions to take when medication orders are
                                                   incomplete, illegible, or unclear.

                                                   6) The hospital specifies the required elements
                                                   of any of the following types of orders that it
                                                   deems acceptable for use:

                                                   -"As needed" (PRN) orders--orders acted upon
                                                   based on the occurrence of a specific indication
                                                   or symptom

                                                   -Standing orders--written instruciton to
                                                   administer a medication to a person in
                                                   circumstances specificed in instructions without
                                                   a prescription

                                                   -Hold orders--instruction to temporarily suspend
                                                   (place medication orders on hold) under
             MM.3.20                               JCAHO_CAMH.pdf /A Page=253




JC - 3                                                                          JC - 3 - Version: 2007                                                         31 of 480
                                                    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
               Medication Management
   3.3.7       (continued)... Medication orders are ...(continued) hold
   (continued) written clearly and transcribed
               accurately.                          -Automatic stop orders--a date or time to
                                                    discontinue a medication

                                                    -Resume orders*--restart an order which was
                                                    previously held (Note: See EP 10--A blanket
                                                    reinstatement of previous orders for medications
                                                    is not acceptable.)

                                                    -Titrating orders--orders in which the dose is
                                                    either progressively increased or decreased in
                                                    response to the patient's status

                                                    -Taper orders--orders in which the dose is
                                                    decreased by a particular amount with each
                                                    dosing interval

                                                    -Range orders--orders in which the dose or
                                                    dosing interval varies over a prescribed range,
                                                    depending on the situation or patient's status

                                                    -Orders for compounded drugs or drug mixtures
                                                    not commercially available

                                                    -Orders for medication-related devices (for
                                                    example, nebulizers and catheters)

                                                    -Orders for investigational medications

                                                    -Orders for herbal products
              MM.3.20                               JCAHO_CAMH.pdf /A Page=253




JC - 3                                                                           JC - 3 - Version: 2007                                                         32 of 480
                                                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
             Medication Management
   3.3.8     Medications are prepared safely.   1) When an on-site, licensed pharmacy is
                                                available, only the pharmacy compounds or
                                                admixes all sterile medications, intravenous
                                                admixtures, or other drugs except in
                                                emergencies or when not feasible (for example,
                                                when the product's stability is short).

                                                2) Wherever medications are prepared, staff
                                                uses safety materials and equipment while
                                                preparing hazardous medications.

                                                3) Wherever medications are prepared, staff
                                                uses techniques to assure accuracy in
                                                medication preparation.

                                                4) Wherever medications are prepared, staff
                                                uses appropriate techniques to avoid
                                                contamination during medication preparation,
                                                which include but are not limited to the following:

                                                - Using clean or sterile techniques

                                                - Maintaining clean, uncluttered, and functionally
                                                separate areas for product preparation to
                                                minimize the possibility of contamination

                                                - Using a laminar airflow hood or other class 100
                                                environment while preparing any intravenous (IV)
                                                admixture in the pharmacy, any sterile product
                                                made from (continued)...


             MM.4.20                            JCAHO_CAMH.pdf /A Page=257




JC - 3                                                                       JC - 3 - Version: 2007                                                         33 of 480
                                                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
               Medication Management
   3.3.8       (continued)... Medications are   ...(continued) non-sterile ingredients, or any
   (continued) prepared safely.                 sterile product that will not be used within 24
                                                hours

                                                - Visually inspecting the integrity of the
                                                medications
              MM.4.20                           JCAHO_CAMH.pdf /A Page=257




JC - 3                                                                       JC - 3 - Version: 2007                                                         34 of 480
                                             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
             Medication Management
   3.3.9     Medications are labeled.         1) Medications are labeled in a standardized
                                              manner according to law or regulation and
                                              standards of practice.

                                              2) Any time one or more medications are
                                              prepared but are not administered immediately,
                                              the medication container* must be labeled.

                                              (* A container can be any storage device such as
                                              a plastic bag, syringe, bottle, or box, medicine
                                              cup or basin.)

                                              3) At a minimum, all medications are labeled with
                                              the following:

                                              - Drug name, strength, amount (if not apparent
                                              from the container)

                                              - Expiration date* when not used within 24 hours

                                              (* Expiration date, also called the "beyond use
                                              date," refers to the last date this product should
                                              be used by the patient.)

                                              - Expiration time when expiration occurs in less
                                              than 24 hours

                                              - The date prepared and dilutent for all
                                              compounded IV admixtures and parenteral
                                              nutrition solutions.

                                              4) When preparing individulaized medications for
             MM.4.30                          JCAHO_CAMH.pdf /A Page=258




JC - 3                                                                     JC - 3 - Version: 2007                                                         35 of 480
                                                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
               Medication Management
   3.3.9       (continued)... Medications are   ...(continued) medication, the label also includes
   (continued) labeled.                         the following:

                                                - Patient name

                                                - Patient location

                                                - Directions for use and any applicable
                                                cautionary statements either on the label or
                                                attached as an accessory label (for example,
                                                "requires refrigeration," "for IM use only")
              MM.4.30                           JCAHO_CAMH.pdf /A Page=258




JC - 3                                                                       JC - 3 - Version: 2007                                                         36 of 480
                                                 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
             Medication Management
   3.3.10    Medications are dispensed safely.   1) Quantities of medications are dispensed
                                                 which minimize diversion and yet are still
                                                 consistent with the patient's needs.

                                                 2) Dispensing adheres to law, regulation,
                                                 licensure, and professional standards of practice,
                                                 including record keeping.

                                                 3) Medications are dispensed in a timely*
                                                 manner to meet patient needs.

                                                 (* TIMELY Defined by organization policy and
                                                 based on the intended use of the information)

                                                 4) Medications are dispensed in the most ready-
                                                 to-administer forms available from the
                                                 manufacturer or if feasible, in unit-doses that
                                                 have been repackaged by the pharmacy or
                                                 licensed repackager.

                                                 5) The hospital consistently uses the same dose
                                                 packaging system, or if a different system is
                                                 used, provides education about the use of the
                                                 dose packaging system to the patients impacted
                                                 by the change.
             MM.4.40                             JCAHO_CAMH.pdf /A Page=260




JC - 3                                                                        JC - 3 - Version: 2007                                                         37 of 480
                                                    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
             Medication Management
   3.3.11    The hospital has a system for safely   1) The hospital has a process for providing
             providing medications to meet          medications to meet patient needs when the
             patient needs when the pharmacy is     pharmacy is closed.
             closed.
                                                    2) When nonpharmacist health care
                                                    professionals are allowed by law and regulation
                                                    to obtain medications after the pharmacy is
                                                    closed, the following safeguards are applied:

                                                    - Access is limited to a set of medications that
                                                    has been approved by the hospital. These
                                                    medications can be stored in a night cabinet,
                                                    automated storage and distribution device, or a
                                                    limited section of the pharmacy.

                                                    - Only trained, designated prescribers and
                                                    nurses are permitted access to medications.

                                                    - Quality control procedures (such as an
                                                    independent second check by another individual
                                                    or a secondary verification built into the system,
                                                    such as bar coding) are in place to prevent
                                                    medication retrieval errors.

                                                    - The hospital arranges for a qualified pharmacist
                                                    to be available either on-call or at another
                                                    location (for example, at another organization
                                                    that has 24-hour pharmacy service) to answer
                                                    questions (continued)...
             MM.4.50                                JCAHO_CAMH.pdf /A Page=260




JC - 3                                                                           JC - 3 - Version: 2007                                                         38 of 480
                                                   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
               Medication Management
   3.3.11      (continued)... The hospital has a   ...(continued) or provide medications beyond
   (continued) system for safely providing         those accessible to non-pharmacy staff.
               medications to meet patient needs
               when the pharmacy is closed.        3) This process is evaluated on an on-going
                                                   basis to determine the medications accessed
                                                   routinely and the causes of accessing the
                                                   pharmacy after hours.

                                                   4) Changes are implemented as appropriate to
                                                   reduce the amount of times nonpharmacist
                                                   health care professionals are obtaining
                                                   medications after the pharmacy is closed.
              MM.4.50                              JCAHO_CAMH.pdf /A Page=260




JC - 3                                                                          JC - 3 - Version: 2007                                                         39 of 480
                                                    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
             Medication Management
   3.3.12    Medications dispensed by the           1) When the hospital has been informed of a
             hospital are retrieved when recalled   medication recall or discontinuation by the
             or discontinued by the manufacturer    manufacturer or the Food and Drug
             or the Food and Drug Administration    Administration (FDA) for safety reasons,
             for safety reasons.                    medications within the hospital are retrieved*
                                                    and handled per hospital policy and law and
                                                    regulation.

                                                    (* Although recalls are generally by lot number, a
                                                    hospital may retrieve all lots of a recalled
                                                    medication instead of recording and identifying
                                                    medications by their lot number.)

                                                    2) The hospital notifies all those ordering,
                                                    dispensing, and/or administering active*
                                                    medications of any manufacturer or FDA recall or
                                                    discontinuation.

                                                    (* Dispensed medications that have not passed
                                                    expiration date and perscriptions that can be
                                                    refilled without addtitional physician order.)

                                                    3) When the hospital has been informed of a
                                                    medication recall or discontinuation by the
                                                    manufacturer or the FDA for safety reasons,
                                                    patients who are actively receiving the
                                                    medication are identified and informed of the
                                                    recall or discontinuation.
             MM.4.70                                JCAHO_CAMH.pdf /A Page=260




JC - 3                                                                           JC - 3 - Version: 2007                                                         40 of 480
                                             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
             Medication Management
   3.3.13    Medications are safely and       1) Policies and procedures address health care
             accurately administered.         staff who are allowed to administer medications,
                                              with or without supervision, consistent with law
                                              or regulation and hospital policy.




                                              Before administering a medication, the licenced
                                              independent practitioner or qualified individual
                                              administering the medication does the following:

                                              2) Verifies that the medication selected for
                                              administration is the correct one based on the
                                              medication order and product label.

                                              3) Verifies that the medication is stable based on
                                              visual examination for particulates or
                                              discoloration and that the medication has not
                                              expired.

                                              4) Verifies that there is no contraindication for
                                              administering the medication.

                                              5) Verifies that the medication is being
                                              administered at the proper time, in the prescribed
                                              dose, and by the correct route.

                                              6) Advises the patient or, if appropriate, the
                                              patient‘s family, about any potential clinically
                                              significant adverse reaction or other concerns
                                              about administering a new medication*.
             MM.5.10                          JCAHO_CAMH.pdf /A Page=262




JC - 3                                                                     JC - 3 - Version: 2007                                                         41 of 480
                                                    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
               Medication Management
   3.3.13      (continued)... Medications are safely ...(continued) Please refer to PC.6.10, EP3 for
   (continued) and accurately administered.          additional information addressing the education
                                                     of patients regarding medication use.)

                                                    7) Discusses any unresolved, significant
                                                    concerns about the medication with the patient‘s
                                                    physician, prescriber (if different from the
                                                    physician), and/or relevant staff involved with the
                                                    patient‘s care, treatment, and service.

                                                    8) Policies and procedures address guidelines
                                                    for prescriber notification in the event of an
                                                    adverse drug reaction or medication error.

              MM.5.10                               JCAHO_CAMH.pdf /A Page=262




JC - 3                                                                           JC - 3 - Version: 2007                                                         42 of 480
                                                   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
             Medication Management
   3.3.14    Self-administered medications are     1) If self administration is allowed, procedures
             safely and accurately administered.   guide the safe and accurate self administration*
                                                   of medications or administration of medications
                                                   by a person who is not a staff member and
                                                   address training, supervision, and administration
                                                   documentation.

                                                   (* Self administration includes those instances
                                                   where a patient independently uses a
                                                   medication, including medications that may be
                                                   held by the hospital for the independent use by
                                                   the patient.)

                                                   2) Persons who administer medications but are
                                                   not staff members (for example, the patient if self-
                                                   administering) receive information about the
                                                   following:

                                                   - The nature of the medications to be
                                                   administered.

                                                   - How to administer medications, such as the
                                                   frequency, route of administration, and dose.

                                                   - The expected actions and side effects of the
                                                   medications to be administered.

                                                   - How to monitor the effects of the medications
                                                   on the patient.

                                                   3) Persons who administer medications but are
                                                   not staff members (including the patient if
                                                   JCAHO_CAMH.pdf /A Page=261
             MM.5.20                               The Joint Commission CAMH, MM.5.20 Pg. 263




JC - 3                                                                           JC - 3 - Version: 2007                                                         43 of 480
                                                  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
               Medication Management
   3.3.14      (continued)... Self-administered   ...(continued) self-administering and so forth) are
   (continued) medications are safely and         determined to be competent at medication
               accurately administered.           administration before being allowed to administer
                                                  medications.
                                                  JCAHO_CAMH.pdf /A Page=261
              MM.5.20                             The Joint Commission CAMH, MM.5.20 Pg. 263
               Medication Management
   3.3.15      The effects of medication(s) on    1) Each patient‘s response to his or her
               patients are monitored.            medication is monitored according to the clinical
                                                  needs of the patient and addresses the patient‘s
                                                  response to the prescribed medication and
                                                  actual or potential medication-related problems.

                                                  2) Monitoring a medication‘s effect on a patient
                                                  includes the following:

                                                  - Gathering the patient‘s own perceptions about
                                                  side effects, and when appropriate, perceived
                                                  efficacy

                                                  - Referring to information from the patient‘s
                                                  medical record, relevant laboratory results,
                                                  clinical response, and medication profile

                                                  3) The hospital has a process for monitoring the
                                                  patient‘s response to the first dose(s) of a
                                                  medication new to a patient when he or she is
                                                  under the direct care of the hospital.

              MM.6.10                             JCAHO_CAMH.pdf /A Page=263




JC - 3                                                                          JC - 3 - Version: 2007                                                         44 of 480
                                                  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
             Medication Management
   3.3.16    The hospital responds to actual or   1) The hospital has a process to respond to
             potential adverse drug events and    actual or potential adverse drug events and
             medication errors.                   medication errors.

                                                  2) Action is taken when an actual or potential
                                                  adverse drug event is identified (depending on
                                                  the hospital's services, this may be limited to
                                                  calling for outside assistance).

                                                  3) The hospital or responsible individual
                                                  complies with internal and external reporting
                                                  requirements for actual or potential adverse drug
                                                  events (for example, to the United States
                                                  Pharmacopoeia [USP], the FDA, and the Institute
                                                  for Safe Medication Practices [ISMP]).

             MM.6.20                              JCAHO_CAMH.pdf /A Page=264
             Medication Management
   3.3.17    The hospital develops processes for 1) The hospital identifies the high-risk or high-
             managing high-risk or high-alert    alert medications used within the hospital, if any.
             medications.
                                                 2) Based on the services provided, the hospital
                                                 develops processes for procuring, storing,
                                                 ordering, transcribing, preparing, dispensing,
                                                 administering, and/or monitoring high-risk or high-
                                                 alert medications.

                                                  3) The processes for managing high-risk or high-
                                                  alert medications are implemented.

             MM.7.10                              JCAHO_CAMH.pdf /A Page=266




JC - 3                                                                         JC - 3 - Version: 2007                                                         45 of 480
                                                   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
             Medication Management
   3.3.18    Investigational medications are       1) Procedures for the use of investigational
             safely controlled and administered.   medications specify a written process for
                                                   reviewing, approving, supervising, and
                                                   monitoring investigational medication use.

                                                   2) When the hospital operates a pharmacy,
                                                   procedures specify the pharmacy controls the
                                                   storage, dispensing, labeling, and distribution of
                                                   investigational medication.

                                                   3) Procedures specifiy that when a patient is
                                                   involved in an investigational protocol that is
                                                   independent of the hospital, the hospital will
                                                   review and accommodate the patient's continued
                                                   participation in the protocol (see standard
                                                   RI.2.180)

                                                   4) The procedures for the use of investigational
                                                   medications are implemented.
             MM.7.40                               JCAHO_CAMH.pdf /A Page=266




JC - 3                                                                          JC - 3 - Version: 2007                                                         46 of 480
                                                  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
             Surveillance, Prevention and Control of Infection
   3.4.1     The risk of development of a health 1. A hospitalwide IC program is implemented.
             care–associated infection is
             minimized through a hospitalwide    2. Individuals and/or positions with the authority
             infection control program.          to take steps to prevent or control the acquisition
                                                 and transmission of infectious agents are
                                                 identified.

                                                   3. All applicable organizational components and
                                                   functions are integrated into the IC program.

                                                   4. Systems are in place to communicate with
                                                   licensed independent practitioners, staff,
                                                   students/ trainees, volunteers, and as
                                                   appropriate, visitors, patients, and families about
                                                   infection prevention and control issues, including
                                                   their responsibilities in preventing the spread of
                                                   infection within the hospital.

                                                   5. The hospital has systems for reporting
                                                   infection surveillance, prevention, and control
                                                   information to the following:

                                                   ● The appropriate staff within the hospital

                                                   ● Federal, state, and local public health
                                                   authorities in accordance with law and regulation

                                                   ● Accrediting bodies (see Sentinel Event
                                                   Reporting, pages SE-8–SE-9, and National
                                                   Patient Safety Goals, pages APR-8–APR-10)

                                                   ● (continued)...
             IC.1.10                               JCAHO_CAMH.pdf /A Page=278




JC - 3                                                                          JC - 3 - Version: 2007                                                         47 of 480
                                                   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
               Surveillance, Prevention and Control of Infection
   3.4.1       (continued)... The risk of         ...(continued) The referring or receiving
   (continued) development of a health            organization when a patient was transferred or
               care–associated infection is       referred and the presence of an HAI was not
               minimized through a hospitalwide   known at the time of transfer or referral
               infection control program.
                                                  6. Systems for the investigation of outbreaks of
                                                  infectious diseases are in place.

                                                    7. Applicable policies and procedures are in
                                                    place throughout the hospital.

                                                    8. Not applicable

                                                    9. The hospital has a written IC plan* that
                                                    includes the following:

                                                    ● A description of prioritized risks

                                                    ● A statement of the goals of the IC program

                                                    ● A description of the hospital‘s strategies to
                                                    minimize, reduce, or eliminate the prioritized
                                                    risks

                                                    ● A description of how the strategies will be
                                                    evaluated

                                                    (* WRITTEN PLAN A succinct, useful document,
                                                    formulated beforehand, that identifies needs,
                                                    lists strategies to meet those needs, and sets
                                                    goals and objectives. The format of the "plan"
                                                    may include narratives, policies and procedures,
              IC.1.10                              JCAHO_CAMH.pdf /A Page=278




JC - 3                                                                          JC - 3 - Version: 2007                                                         48 of 480
                                                  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
             Surveillance, Prevention and Control of Infection
   3.4.2     Once the hospital has prioritized its 1) Interventions are designed to incorporate
             goals, strategies must be             relevant guidelines* for infection prevention and
             implemented to achieve those goals. control activities.

                                                   (* Examples of guidelines include those offered
                                                   by the CDC, Healthcare Infection Control
                                                   Practices Advisory Committee (HICPAC) and the
                                                   National Quality Forum (NQF).)




                                                   Interventions are implemented which include the
                                                   following (EPs 2 and 3):

                                                   2) A hospitalwide hand hygiene program that
                                                   complies with current Centers for Disease
                                                   Control and Prevention (CDC) hand hygiene
                                                   guidelines (National Patient Safety Goal 7,
                                                   requirement 7.a)

                                                   3) Methods to reduce the risks associated with
                                                   procedures, medical equipment,† and medical
                                                   devices, including the following:

                                                   ● Appropriate storage, cleaning, disinfection,
                                                   sterilization, and/or disposal of supplies and
                                                   equipment

                                                   ● Reuse of equipment designated by the
                                                   manufacturer as disposable in a manner that is
                                                   consistent with regulatory and professional
                                                   standards
             IC.4.10                               JCAHO_CAMH.pdf /A Page=280




JC - 3                                                                          JC - 3 - Version: 2007                                                         49 of 480
                                                    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
               Surveillance, Prevention and Control of Infection
   3.4.2       (continued)... Once the hospital has ...(continued) Fixed and portable equipment
   (continued) prioritized its goals, strategies must used for diagnosis, treatment, monitoring, and
               be implemented to achieve those        direct care of individuals.)
               goals.


                                                     4) Implementation of applicable precautions, as
                                                     appropriate, is based on the following:

                                                     ● The potential for transmission

                                                     ● The mechanism of transmission

                                                     ● The care, treatment, and service setting

                                                     ● The emergence and reemergence of
                                                     pathogens in the community that could affect the
                                                     hospital




                                                     Interventions are implemented which include the
                                                     following (EPs 5–7):

                                                     5) Screening for exposure and/or immunity to
                                                     infectious diseases that licensed independent
                                                     practitioners, staff, student/trainees, and
                                                     volunteers may come in contact with in their work
                                                     is available as warranted

                                                     6) Referral for assessment, potential testing,
                                                     immunization and/or prophylaxis/treatment, and
               IC.4.10                               JCAHO_CAMH.pdf /A Page=280




JC - 3                                                                            JC - 3 - Version: 2007                                                         50 of 480
                                                  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
             Surveillance, Prevention and Control of Infection
   3.4.3     The infection control program         1) The hospital formally evaluates and revises
             evaluates the effectiveness of the    the goals and program (or portions of the
             infection control interventions and,  program) at least annually and whenever risks
             as necessary, redesigns the infection significantly change.
             control interventions.
                                                   2) The evaluation addresses changes in the
                                                   scope of the IC program (for example, resulting
                                                   from the introduction of new services or new
                                                   sites of care).

                                                  3) The evaluation addresses changes in the
                                                  results of the IC program risk analysis.

                                                  4) The evaluation addresses emerging and
                                                  reemerging problems in the health care
                                                  community that potentially affect the hospital (for
                                                  example, highly infectious agents).

                                                  5) The evaluation addresses the assessment of
                                                  the success or failure of interventions for
                                                  preventing and controlling infection.

                                                  6) The evaluation addresses responses to
                                                  concerns raised by leadership and others within
                                                  the hospital.

                                                  7) The evaluation addresses the evolution of
                                                  relevant infection prevention and control
                                                  guidelines that are based on evidence or, in the
                                                  absence of evidence, expert consensus.
             IC.5.10                              JCAHO_CAMH.pdf /A Page=282




JC - 3                                                                         JC - 3 - Version: 2007                                                         51 of 480
                                                   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
             Surveillance, Prevention and Control of Infection
   3.4.4     As part of its emergency             1) The hospital determines its response to an
             management activities, the hospital influx of infectious patients.
             prepares to respond to an influx, or
             the risk of an influx, of infectious 2) The hospital has a plan for managing an
             patients.                            ongoing influx of potentially infectious patients
                                                  over an extended period.

                                                   3) The hospital does the following:

                                                   - Determines how it will keep abreast of current
                                                   information aobut the emergence of epidemics or
                                                   new infections which may result in the hospital
                                                   activating its response

                                                   - Determines how it will disseminate critical
                                                   information to staff and other key practitioners

                                                   - Identifies resources in the community (through
                                                   local, state and/or federal public health systems)
                                                   of obtaining additional information

             IC.6.10                               JCAHO_CAMH.pdf /A Page=283




JC - 3                                                                          JC - 3 - Version: 2007                                                         52 of 480
                                                 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
              Improving Organization Performance
   3.5.1      Processes for identifying and    Processes for identifying and managing sentinel
              managing sentinel events are     events include the following:
              defined and implemented.
                                               1) Defining ―sentinel event‖ and communicating
                                               this definition throughout the hospital. (At a
                                               minimum, the hospital‘s definition includes those
                                               events subject to review under the Joint
                                               Commission‘s Sentinel Event Policy as published
                                               in this manual and may include any process
                                               variation which does not affect the outcome or
                                               result in an adverse event, but for which a
                                               recurrence carries significant chance of a serious
                                               adverse outcome or result in an adverse event,
                                               often referred to as a ―near miss.‖)

                                                  2. Reporting sentinel events through established
                                                  channels in the hospital and, as appropriate, to
                                                  external agencies in accordance with law and
                                                  regulation

                                                  3. Conducting thorough and credible root cause
                                                  analyses that focus on process and system
                                                  factors

                                                  4. Creating, documenting, and implementing a
                                                  risk-reduction strategy and action plan that
                                                  includes measuring the effectiveness of process
                                                  and system improvements (continued)...


              PI.2.30                             JCAHO_CAMH.pdf /A Page=295
               Improving Organization Performance
   3.5.1       (continued)... Processes for        ...(continued) to reduce risk
   (continued) identifying and managing sentinel
               events are defined and implemented. 5. The processes are implemented.

              PI.2.30                             JCAHO_CAMH.pdf /A Page=295




JC - 3                                                                         JC - 3 - Version: 2007                                                         53 of 480
                                                 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
             Improving Organization Performance
   3.5.2     Information from data analysis is   1) The hospital uses the information from data
             used to make changes that improve analysis to identify and implement changes that
             performance and patient safety and will improve the quality of care, treatment, and
             reduce the risk of sentinel events. services.

                                                 2) The hospital identifies and implements
                                                 changes that will reduce the risk of sentinel
                                                 events.

                                                 3) The hospital uses the information from data
                                                 analysis to identify changes that will improve
                                                 patient safety.

                                                 4) Changes made to improve processes or
                                                 outcomes are evaluated to ensure that they
                                                 achieve the expected results.

                                                 5) Appropriate actions are undertaken when
                                                 planned improvements are not achieved or
                                                 sustained.
             PI.3.10                             JCAHO_CAMH.pdf /A Page=296




JC - 3                                                                        JC - 3 - Version: 2007                                                         54 of 480
                                                    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
             Improving Organization Performance
   3.5.3     An ongoing, proactive program for       The following proactive activities to reduce risks
             identifying and reducing                to patients are conducted:
             unanticipated adverse events and
             safety risks to patients is defined and 1) Selecting a high-risk* process to be analyzed
             implemented.                            (at least one high-risk process is chosen
                                                     annually--the choice should be based in part on
                                                     information published periodically by the Joint
                                                     Commission about the most frequent sentinel
                                                     events and risks).

                                                    (* HIGH RISK PROCESS A process that if not
                                                    planned and/or implemented correctly, has a
                                                    significant potential for impacting the safety of
                                                    the patient).

                                                    2) Describing the chosen process (for example,
                                                    through the use of a flowchart)

                                                    3) Identifying the ways in which the process
                                                    could break down* or fail to perform its desired
                                                    function.

                                                    (* The ways in which the processes could break
                                                    down or fail to perform its desired function are
                                                    many times refered to as "the failure modes.")

                                                    4) Identifying the possible effects that a
                                                    breakdown or failure of the process could have
                                                    on patients and the seriousness of the possible
                                                    effects.

                                                    5) Prioritizing the potential (continued)...
             PI.3.20                                JCAHO_CAMH.pdf /A Page=294




JC - 3                                                                           JC - 3 - Version: 2007                                                         55 of 480
                                                    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
               Improving Organization Performance
   3.5.3       (continued)... An ongoing, proactive ...(continued) process breakdowns or failures.
   (continued) program for identifying and reducing
               unanticipated adverse events and        6) Determining why the prioritized breakdowns or
               safety risks to patients is defined and failures could occur, which may include
               implemented.                            performing a hypothetical root cause analysis.

                                                     7) Redesigning the process and/or underlying
                                                     systems to minimize the risk of the effects on
                                                     patients.

                                                     8) Testing and implementing the redesigned
                                                     process.

                                                     9) Monitoring the effectiveness of the redesigned
                                                     process.
               PI.3.20                               JCAHO_CAMH.pdf /A Page=294




JC - 3                                                                            JC - 3 - Version: 2007                                                         56 of 480
                                                  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
             Leadership
   3.6.1     Services provided by consultation,   1) The leaders approve sources for the hospital‘s
             contractual arrangements, or other   services that are provided by consultation,
             agreements are provided safely and   contractual arrangements, or other agreements.
             effectively.
                                                  2) The medical staff advises the hospital‘s
                                                  leaders on the sources of clinical services to be
                                                  provided by consultation, contractual
                                                  arrangements, or other agreements.

                                                  3) Not applicable

                                                  4) The nature and scope of services provided by
                                                  consultation, contractual arrangements, or other
                                                  agreements are defined in writing.*

                                                  5) Services provided by consultation, contractual
                                                  arrangements, or other agreements meet
                                                  applicable Joint Commission standards.

                                                  6) The hospital evaluates the contracted care,
                                                  treatment, and services to determine whether
                                                  they are being provided according to the contract
                                                  and the level of safety and quality that the
                                                  hospital expects.

                                                  7) The hospital retains overall responsibility and
                                                  authority for services furnished under a contract.

                                                  8) All reference and contract laboratory
                                                  services† meet the applicable federal regulations
                                                  for (continued)...
             LD.3.50                              JCAHO_CAMH.pdf /A Page=311




JC - 3                                                                         JC - 3 - Version: 2007                                                         57 of 480
                                                      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
               Leadership
   3.6.1       (continued)... Services provided by    ...(continued) clinical laboratories and maintain
   (continued) consultation, contractual              evidence of the same.
               arrangements, or other agreements
               are provided safely and effectively.
               LD.3.50                                JCAHO_CAMH.pdf /A Page=311
               Leadership
   3.6.2       Communication is effective             1) The leaders ensure processes are in place for
               throughout the hospital.               communicating relevant information throughout
                                                      the hospital in a timely manner.

                                                      2) Effective communication occurs in the
                                                      hospital, among the hospital‘s programs, among
                                                      related hospitals, with outside organizations, and
                                                      with patients and families, as appropriate.

                                                      3) The leaders communicate the hospital‘s
                                                      mission and appropriate policies, plans, and
                                                      goals to all staff.

               LD.3.60                                JCAHO_CAMH.pdf /A Page=312




JC - 3                                                                             JC - 3 - Version: 2007                                                         58 of 480
                                                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
             Leadership
   3.6.3     The leaders define the required    A single set of criteria must be used to judge the
             qualifications and competence of   competency of all clinicians who provide care,
             those staff who provide care,      treatment, and services within the hospital,
             treatment, and services, and       regardless of whether they are an employee of
             recommend a sufficient number of   the hospital or a licensed practitioner.
             qualified and competent staff to
             provide care, treatment, and       Note: The qualification requirements pertaining
             services.                          to students and volunteers who work in the same
                                                capacity as staff when they provide care,
                                                treatment or services are addressed in Standard
                                                HR.1.20

                                                1) The leaders provide for the allocation of
                                                competent qualified staff.

                                                2) The leaders ensure that physician assistants
                                                and advanced practice registered nurses who
                                                practice within the hospital are credentialed and
                                                privileged and reprivileged through the medical
                                                staff process or an equivalent process that has
                                                been approved by the governing body. An
                                                equivalent process at a minimum does the
                                                following:

                                                ● Evaluates the applicant‘s credentials

                                                ● Evaluates the applicant‘s current competence

                                                ● Includes peer recommendations

                                                ● Involves communication with and input from
                                                (continued)...
             LD.3.70                            JCAHO_CAMH.pdf /A Page=312




JC - 3                                                                       JC - 3 - Version: 2007                                                         59 of 480
                                                       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
               Leadership
   3.6.3       (continued)... The leaders define the   ...(continued) individuals and committees,
   (continued) required qualifications and             including the Medical Staff Executive Committee,
               competence of those staff who           to make an informed decision regarding the
               provide care, treatment, and            applicant‘s request for privileges.
               services, and recommend a
               sufficient number of qualified and      3) Prior to the provision of care, treatment or
               competent staff to provide care,        services, the qualifications and competence of a
               treatment, and services.                non-employee individual, brought into the
                                                       hosptial by a licensed independent practitioner to
                                                       provide care, treatment or services within the
                                                       scope of the hospital's services are assessed by
                                                       the hospital and determined to be commensurate
                                                       with the qualifications and competence required
                                                       if the individual were to be employed by the
                                                       hospital to perform the same or similar service.

                                                       Note: When the service to be provided by the
                                                       individual is not currently performed by anyone
                                                       employed by the hospital, it is leadership's
                                                       responsibility to consult the appropriate
                                                       professional practice guidelines with respect to
                                                       expectations for credentials and competence.

                                                       4) The hospital reviews the qualifications,
                                                       performance, and competence of each non-
                                                       employee individual brought into the hospital by
                                                       a licensed independent practitioner to provide
                                                       care, treatment or services at the same
                                                       frequency as individuals employed by the
              LD.3.70                                  JCAHO_CAMH.pdf /A Page=312




JC - 3                                                                              JC - 3 - Version: 2007                                                         60 of 480
                                                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
             Leadership
   3.6.4     The leaders provide for adequate   1) The leaders provide for the arrangement and
             space, equipment, and other        allocation of space to facilitate efficient, effective
             resources.                         delivery of care, treatment, and services.

                                                2) The leaders provide for the appropriateness of
                                                interior and exterior space for the care,
                                                treatment, and services offered and for the ages
                                                and other characteristics of the patients.

                                                3) The leaders provide for the safe use,
                                                maintenance, accessibility, and supervision of
                                                grounds, equipment, and special activity areas.

                                                4) The leaders provide for adequate equipment
                                                and other resources.


             LD.3.80                            JCAHO_CAMH.pdf /A Page=315




JC - 3                                                                       JC - 3 - Version: 2007                                                            61 of 480
                                                 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
             Leadership
   3.6.5     The leaders ensure that an           The patient safety program includes the
             integrated patient safety program is following:
             implemented throughout the hospital.
                                                  1) One or more qualified individuals or an
                                                  interdisciplinary group assigned to manage the
                                                  organizationwide safety program.

                                                  2) Definition of the scope of the program's
                                                  oversight, typically ranging from no-harm,
                                                  frequently occurring "slips" to sentinel events
                                                  with serious adverse outcomes.

                                                  3) Integration into and participation of all
                                                  components of the hospital into the
                                                  organizationwide program.

                                                  4) Procedures for immediately responding to
                                                  system or process failures, including care,
                                                  treatment or services for the affected
                                                  individual(s), containing risk to others, and
                                                  preserving factual information for subsequent
                                                  analysis.

                                                  5) Clear systems for internal and external
                                                  reporting of information about system or process
                                                  failures.

                                                  6) Defined responses to various types of
                                                  unanticipated adverse events and processes for
                                                  conducting proactive risk assessment/risk
                                                  reduction activities.
             LD.4.40                              JCAHO_CAMH.pdf /A Page=320




JC - 3                                                                         JC - 3 - Version: 2007                                                         62 of 480
                                                   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
               Leadership
   3.6.5       (continued)... The leaders ensure   ...(continued) been involved in a sentinel event.
   (continued) that an integrated patient safety
               program is implemented throughout   (* Support systems provide individuals with the
               the hospital.                       additional help and support as well as additional
                                                   resources through the human resources function
                                                   or an employee assistance program. Support
                                                   systems recognize that conscientious health care
                                                   workers who are involved in sentinel events are
                                                   themselves victims of the event and require
                                                   support. Support systems also focus on the
                                                   process rather than on blaming the involved
                                                   individuals.)

                                                   8) Reports, at least annually, to the hospital's
                                                   governance or authority on system or process
                                                   failures and actions taken to improve safety, both
                                                   proactively and in response to actual
                                                   occurrences


              LD.4.40                              JCAHO_CAMH.pdf /A Page=320




JC - 3                                                                          JC - 3 - Version: 2007                                                         63 of 480
                                                   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
             Leadership
   3.6.6     The leaders allocate adequate         1) Sufficient staff is assigned to conduct activities
             resources for measuring, assessing,   for performance improvement and safety
             and improving the hospital's          improvement.
             performance and improving patient
             safety.                               2) Adequate time is provided for staff to
                                                   participate in activities for performance
                                                   improvement and safety improvement.

                                                   3) Adequate information systems are provided to
                                                   support activities for performance improvement
                                                   and safety improvement.

                                                   4) Staff is trained in performance improvement
                                                   and safety improvement approaches and
                                                   methods.
                                                   JCAHO_CAMH.pdf /A Page=321
             LD.4.60                               JCAHO_CAMH.pdf /A Page=321
             Leadership
   3.6.7     The leaders measure and assess the 1) Leaders continually monitor the effectiveness
             effectiveness of the performance   of the performance improvement and safety
             improvement and safety             improvement activities.
             improvement activities.
                                                2) The leaders develop and implement
                                                improvements for these activities.

                                                   3) The leaders assess the adequacy of the
                                                   human, information, physical, and financial
                                                   resources allocated to support performance
                                                   improvement and safety improvement activities.

             LD.4.70                               JCAHO_CAMH.pdf /A Page=321
             Management of Human Resources
   3.7.1     The hospital provides an adequate       1) The hospital has an adequate number and mix
             number and mix of staff that are        of staff to meet the care, treatment, and service
             consistent with the hospital’s staffing needs of the patients.
             plan.
             HR.1.10                               JCAHO_CAMH.pdf /A Page=365




JC - 3                                                                          JC - 3 - Version: 2007                                                           64 of 480
                                                    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
             Management of Human Resources
   3.7.2     The hospital has a process to ensure   1) The leaders define the required competence
             that a person’s qualifications are     and qualifications of staff in all program(s) or
             consistent with his or her job         service(s).
             responsibilities.
                                                    2) The leaders define the required competence
                                                    and qualifications of staff who make decisions
                                                    about and implement and monitor restraint or
                                                    seclusion use (see standard PC.12.30).

                                                    3) When the hospital requires current licensure,
                                                    certification, or registration, but the credentials
                                                    are not required by law or regulation, the hospital
                                                    verifies these credentials at the time of hire and
                                                    upon expiration of the credentials.

                                                    4) When current licensure, certification or
                                                    registration are required by law or regulation to
                                                    practice a profession,* the hosptial verifies these
                                                    credentials with the primary source at the time of
                                                    hire and upon expiration of the credentials.

                                                    (* PROFESSION is a specialized work function
                                                    within society, generally performed by a
                                                    professional. It often refers specifically to fields
                                                    that require extensive study and mastery of
                                                    specialized knowledge and skills. Examples
                                                    (continued)...


             HR.1.20                                JCAHO_CAMH.pdf /A Page=365




JC - 3                                                                           JC - 3 - Version: 2007                                                          65 of 480
                                                        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
               Management of Human Resources
   3.7.2       (continued)... The hospital has a        ...(continued) of a profession include but are not
   (continued) process to ensure that a person’s        limited to a nurse, pharmacist, medical
               qualifications are consistent with his   technologist, respiratory care practitioner,
               or her job responsibilities.             radiology technician and social worker.)

                                                        -- See Notes 1 - 3 --

                                                        The hospital also verifies the following (EPs 5-7):

                                                        5) Education, experience, and competence
                                                        appropriate for assigned responsibilities.

                                                        6) Information on criminal background if required
                                                        by law, regulation or policy.

                                                        7) Compliance with applicable health screening
                                                        requirements established by the hospital*.

                                                        (* The American's with Disabilities Act (ADA)
                                                        bars certain discrimination based on physical or
                                                        mental impairments. To prevent such
                                                        discrimination the act prohibits or mandates
                                                        various activities. Hospitals should examine their
                                                        hiring and evaluation procedures for activities
                                                        prohibited or mandated. For example, health
                                                        care organizations need to determine whether
                                                        the ADA applies to some or all applicants to their
                                                        organization. If applicable, the ADA would
                                                        prohibit an inquiry about the applicant's overall
                                                        health status. The inquiry must be limited to
                                                        dealing with the applicant's ability to perform
                                                        essential job functions, perhaps defined by the
               HR.1.20                                  JCAHO_CAMH.pdf /A Page=365




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                                               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
             Management of Human Resources
   3.7.3     Orientation provides initial job As appropriate, each staff member, student, and
             training and information.        volunteer is oriented to the following:

                                                1. The hospital's mission and goals.

                                                2. Hospitalwide policies and procedures
                                                (including safety and infection control) and
                                                relevant unit, setting, or program-specific policies
                                                and procedures.

                                                3. Specific job duties and responsibilities and
                                                unit, setting, or program-specific job duties and
                                                responsibilities related to safety and infection
                                                control.

                                                4. Not applicable.

                                                5. Cultural diversity and sensitivity.

                                                6. Staff, students, and volunteers are educated
                                                about the rights of patients and ethical aspects of
                                                care, treatment, and services and the process
                                                used to address ethical issues.

                                                7. Not applicable.

                                                8. Orientation and education for forensic staff
                                                include how to interact with patients; procedures
                                                for responding to unusual clinical events and
                                                incidents; the hospital's channels of clinical,
                                                security, and administrative communication; and
                                                distinctions between administrative and clinical
             HR.2.10                            JCAHO_CAMH.pdf /A Page=372




JC - 3                                                                       JC - 3 - Version: 2007                                                          67 of 480
                                                        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
             Management of Human Resources
   3.7.4     Staff members, licensed                    Staff members, licensed independent
             independent practitioners, students,       practitioners, students, and volunteers, as
             and volunteers, as appropriate, can        appropriate, can describe or demonstrate the
             describe or demonstrate their roles        following:
             and responsibilities, based on
             specific job duties or responsibilities,   1) Risks within the hospital‘s environment
             relative to safety.
                                                        2) Actions to eliminate, minimize, or report risks

                                                        3) Procedures to follow in the event of an
                                                        incident

                                                        4) Reporting processes for common problems,
                                                        failures, and user errors

             HR.2.20                                    JCAHO_CAMH.pdf /A Page=372




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                                                  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
             Management of Human Resources
   3.7.5     Ongoing education, including in-     The following occurs for staff, students, and
             services, training, and other        volunteers who work in the same capacity as
             activities, maintains and improves   staff providing care, treatment, and services:
             competence.
                                                  1) Training occurs when job responsibilities or
                                                  duties change

                                                  2) Participation in ongoing in-services, training,
                                                  or other activities occurs to increase staff,
                                                  student, or volunteer knowledge of work-related
                                                  issues

                                                  3) Ongoing in-services and other education and
                                                  training are appropriate to the needs of the
                                                  population(s) served and comply with law and
                                                  regulation

                                                  4) Ongoing in-services, training, or other
                                                  activities emphasize specific job-related aspects
                                                  of safety and infection prevention and control

                                                  5) Ongoing in-services, training, or other
                                                  education incorporate methods of team training,
                                                  when appropriate

                                                  6) Ongoing in-services, training, or other
                                                  education reinforce the need and ways to report
                                                  unanticipated adverse events

                                                  7) Ongoing in-services or other education are
                                                  offered in response to learning needs identified
                                                  through performance (continued)...
             HR.2.30                              JCAHO_CAMH.pdf /A Page=373




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                                                      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
               Management of Human Resources
   3.7.5       (continued)... Ongoing education,      ...(continued) improvement findings and other
   (continued) including in-services, training, and   data analysis (that is, data from staff surveys,
               other activities, maintains and        performance evaluations, or other needs
               improves competence.                   assessments)

                                                      8) Ongoing education is documented
              HR.2.30                                 JCAHO_CAMH.pdf /A Page=373




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                                               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
             Management of Information
   3.8.1     Information privacy and           1) The hospital has developed a written
             confidentiality are maintained.   policy(ies) for addressing the privacy* and
                                               confidentiality** of informtion that is based on
                                               and consistent with law or regulation.

                                               (* PRIVACY An individual's right to limit the
                                               disclosure of personal information.

                                               ** CONFIDENTIALITY The safekeeping of
                                               data/information so as to restrict access to
                                               individuals who have need, reason, and
                                               permission for such access.)

                                               2) The hospital‘s policy, including significant
                                               changes to the policy, has been communicated
                                               to staff.

                                               3) The hospital implements the policy.

                                               4) The hospital monitors compliance with its
                                               policy.

                                               5) The hospital improves privacy and
                                               confidentiality by monitoring information and
                                               developments in technology.

                                               6) Individuals for whom identifiable health data
                                               and information are maintained or collected are
                                               made aware of how the data will be used and
                                               whether it will be disclosed.

                                               7) Personal identifiers are removed to the extent
             IM.2.10                           JCAHO_CAMH.pdf /A Page=383




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                                                     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
               Management of Information
   3.8.1       (continued)... Information privacy    ...(continued) consistent with maintaining the
   (continued) and confidentiality are maintained.   usefulness of the information.

                                                     8) Protected health information* is used for the
                                                     purposes identified or as required by law and not
                                                     further disclosed without patient authorization.

                                                     (* PROTECTED HEALTH INFORMATION Health
                                                     information that contains information such that
                                                     an individual can be identified as the subject of
                                                     that information.)

                                                     9) The hospital preserves the confidentiality of
                                                     data and information identified as sensitive.

               IM.2.10                               JCAHO_CAMH.pdf /A Page=383




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                                             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
             Management of Information
   3.8.2     Continuity of information is     1) The hospital has a business
             maintained.                      continuity/disaster recovery plan for its
                                              information systems

                                              2) For electronic systems, the business
                                              continuity/disaster recovery plan includes the
                                              following:

                                              ● Plans for scheduled and unscheduled
                                              interruptions, which includes end-user training
                                              with the downtime procedures

                                              ● Contingency procedures for operations
                                              interruptions (hardware, software, or other
                                              systems failure)

                                              ● Plans for minimal interruptions as a result of
                                              scheduled downtime

                                              ● An emergency service plan

                                              ● A back-up system (electronic or manual)

                                              ● Data retrieval, including retrieval from storage
                                              and information presently in the system, retrieval
                                              of data in the event of system interruption, and
                                              back up of data

                                              3) The plan is tested periodically as defined by
                                              the hospital (or in accordance with law or
                                              regulation) to ensure that the business
                                              interruption back-up techniques are effective.
             IM.2.30                          JCAHO_CAMH.pdf /A Page=384




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                                                    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
             Management of Information
   3.8.3     The hospital has a complete and        1) Only authorized individuals make entries in
             accurate medical record for patients   the medical record.
             assessed, cared for, treated, or
             served.                                2) The hospital defines which entries made by
                                                    nonindependent practitioners require
                                                    countersigning consistent with law and
                                                    regulation.

                                                    3) Standardized formats are used for
                                                    documenting all care, treatment, and services
                                                    provided to patients.

                                                    4) Medical record entries* are dated, the author
                                                    identified and, when necessary according to law
                                                    or regulation or hospital policy, authenticated,
                                                    either by written signature, electronic signature,
                                                    or computer key or rubber stamp**.

                                                    (* For paper based records, countersignatures
                                                    entered for purposes of authentication after
                                                    transcription or for verbal orders are dated when
                                                    required by law or regulations or organizational
                                                    policy. For electronic records, electronic
                                                    signatures will be date-stamped.

                                                    ** Authentication is shown by written signature or
                                                    initials, rubber stamp signatures, or computer
                                                    key. Authorized users of signature stamps or
                                                    comptuer keys sign a statement assuring that
                                                    (continued)...
             IM.6.10                                JCAHO_CAMH.pdf /A Page=388




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                                                     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
               Management of Information
   3.8.3       (continued)... The hospital has a     ...(continued) they alone will use the stamp or
   (continued) complete and accurate medical         key.)
               record for patients assessed, cared
               for, treated, or served.              5) The author authenticates either by written
                                                     authentication, electronic signature, computer
                                                     key, or rubber stamp the following:

                                                     ● The history and physical examination

                                                     ● Operative reports

                                                     ● Consultations

                                                     ● Discharge summary

                                                     6) The medical record contains sufficient
                                                     information to identify the patient; support the
                                                     diagnosis/condition; justify the care, treatment,
                                                     and services; document the course and results
                                                     of care, treatment, and services; and promote
                                                     continuity of care among providers.

                                                     7) A concise discharge summary* providing
                                                     information to other caregivers and facilitating
                                                     continuity of care includes the following:

                                                     ● The reason for hospitalization

                                                     ● Significant findings

                                                     ● Procedures performed and care, treatment,
                                                     and services provided
              IM.6.10                                JCAHO_CAMH.pdf /A Page=388




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                                                   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
             Management of Information
   3.8.4     Records contain patient-specific      1) Medical records contain, as applicable, the
             information, as appropriate, to the   following clinical/case information:
             care, treatment, and services
             provided.                             ● Emergency care, treatment, and services
                                                   provided to the patient before his or her arrival, if
                                                   any

                                                   ● Documentation and findings of assessments*

                                                   (* See the "Provision of Care, Treatment and
                                                   Services" chapter in this manual)

                                                   ● Conclusions or impressions drawn from
                                                   medical history and physical examination

                                                   ● The diagnosis, diagnostic impression, or
                                                   conditions

                                                   ● The reason(s) for admission of care, treatment,
                                                   and services

                                                   ● Goals of the treatment and treatment plan

                                                   ● Diagnostic and therapeutic orders

                                                   ● Diagnostic and therapeutic procedures, tests,
                                                   and results

                                                   ● Progress notes made by authorized individuals

                                                   ● Reassessments and plan of care revisions
             IM.6.20                               JCAHO_CAMH.pdf /A Page=390




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                                                      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
               Management of Information
   3.8.4       (continued)... Records contain         ...(continued) rate of administration,
   (continued) patient-specific information, as       administration devices used, access site or
               appropriate, to the care, treatment,   route, known drug allergies, and adverse drug
               and services provided.                 reactions)

                                                      ● Medications dispensed or prescribed on
                                                      discharge

                                                      ● Relevant diagnoses/conditions established
                                                      during the course of care, treatment, and
                                                      services

                                                      2) Medical records contain, as applicable, the
                                                      following demographic information:

                                                      ● The patient‘s name, sex, address, date of birth,
                                                      and authorized representative

                                                      ● Legal status of patients receiving behavioral
                                                      health care services

                                                      ● The patient's language and communication
                                                      needs

                                                      3) Medical records contain, as applicable, the
                                                      following information:

                                                      ● Evidence of known advance directives

                                                      ● Evidence of informed consent when required
                                                      by hospital policy
               IM.6.20                                JCAHO_CAMH.pdf /A Page=390




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                                                 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
             Management of Information
   3.8.5     The medical record thoroughly       1) The licenced independent practitioner
             documents operative or other high   (responsible for the patient) records the
             risk procedures and the use of      provisional diagnosis before the operative or
             moderate or deep sedation or        other high-risk procedures.*
             anesthesia (see also standards
             PC.13.30 and PC.13.40)              (* OPERATIVE and OTHER HIGH RISK
                                                 PROCEDURES Procedures including operative,
                                                 other invasive, and non-invasive procedures that
                                                 place the patient at risk.)

                                                 2) Operative or other high risk procedure reports
                                                 dictated or written immediately* after an
                                                 operative or other high risk procedure record the
                                                 name of the individually licensed practitioner and
                                                 assistants; procedure(s) preformed and
                                                 discription of the procedure; findings; estimated
                                                 blood loss; specimines removed; and post-
                                                 operative diagnosis.

                                                 -- See Note 1 --

                                                 3) An operative or other high risk procedure
                                                 progress note is entered in the medical record
                                                 immediately after the procedure, if the full
                                                 operative or other high risk procedure report
                                                 cannot be entered into the medical record
                                                 immediately after the operation or procedure.

                                                 4) The completed operative or other high risk
                                                 (continued)...
             IM.6.30                             JCAHO_CAMH.pdf /A Page=391




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                                                     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
               Management of Information
   3.8.5       (continued)... The medical record     ...(continued) procedure report is authenticated
   (continued) thoroughly documents operative or     by the licensed independent practitioner and
               other high risk procedures and the    made available in the medical record as soon as
               use of moderate or deep sedation or   possible after the procedure.
               anesthesia (see also standards
               PC.13.30 and PC.13.40)                5) Postoperative documentation records the
                                                     patient‘s vital signs and level of consciousness;
                                                     medications (including intravenous fluids) and
                                                     blood and blood components administered;
                                                     unusual events or complications, including blood
                                                     transfusion reactions; and the management of
                                                     those events.

                                                     6) Postoperative documentation records the
                                                     patient‘s discharge from the postsedation or
                                                     postanesthesia care area by the responsible
                                                     licensed independent practitioner or according to
                                                     discharge criteria.

                                                     7) The use of approved discharge criteria to
                                                     determine the patient‘s readiness for discharge is
                                                     documented in the medical record.

                                                     8) Postoperative documentation records the
                                                     name of the licensed independent practitioner
                                                     responsible for discharge.

                                                     9) Not applicable

                                                     10) The history and physical examination and
                                                     the results of indicated diagnositic tests are
                                                     recorded before th operative or other high-risk
              IM.6.30                                JCAHO_CAMH.pdf /A Page=391




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                                                     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
             Management of Information
   3.8.6     For patients receiving continuing       1) The summary list(s) is initiated for each
             ambulatory care services, the           patient by the third visit and maintained
             medical record contains a summary       thereafter.
             list(s) of all significant diagnoses,
             procedures, drug allergies, and         2) The summary list(s) contains the following
             medications.                            information:

                                                     ● Known* significant medical diagnoses and
                                                     conditions

                                                     ● Known significant operative and invasive
                                                     procedures

                                                     ● Known adverse and allergic drug reactions

                                                     ● Known long-term medications, including
                                                     current prescriptions, over-the-counter drugs,
                                                     and herbal preparations

                                                     (* "Known" refers to information gathered during
                                                     ambulatory care assessment and treatment.)

                                                     3) The summary list(s) is quickly and easily
                                                     available for practitioners to access needed
                                                     information.
             IM.6.40                                 JCAHO_CAMH.pdf /A Page=392
             Management of Information
   3.8.7     The hospital provides access to all   1) There is a manual or automated mechanism
             relevant information from a patient’s to track the location of all components of the
             record as needed for use in patient medical record.
             care, treatment, and services.
                                                   2) The hospital uses a system to assemble
                                                   required information or make available a
                                                   summary of information relative for patient care,
                                                   treatment, and services when the patient is seen.

             IM.6.60                                 JCAHO_CAMH.pdf /A Page=393




JC - 3                                                                            JC - 3 - Version: 2007                                                         80 of 480
                                                  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
   3.9.1     #1a: Improve the accuracy of      Use at least two patient identifiers (neither to be
             patient identification.           the patient‘s room number) whenever:
                                               administering medications or blood products;
                                               taking blood samples, collecting laboratory
                                               samples and other specimens for clinical testing;
                                               or providing any other treatments or procedures.
                                               Use two identifiers to label sample collection
                                               containers in the presence of the patient.
                                               Processes are established to maintain samples‘
                                               identity throughout the pre-analytical, analytical
                                               and post-analytical processes.

             HOSP, LTC, BHC, HC, AMC & Lab         TIPS_JanFeb07.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.1.1   #1b: Improve the accuracy of patient (Expanded): Prior to the start of any invasive
             identification.                      procedure, conduct a final verification process to
                                                  confirm the correct patient, procedure, site and
                                                  availability of appropriate documents. This
                                                  verification process uses active — not passive —
                                                  communication techniques (see Universal
                                                  Protocol). The patient's identity is re-established
                                                  if the practitioner leaves the patient's location
                                                  prior to initiating the procedure. Marking the site
                                                  is required unless the practitioner is in
                                                  continuous attendance from the time of the
                                                  decision to do the procedure and patient
                                                  consent, to the initiation of the procedure (for
                                                  example: bone marrow collection, or fine needle
                                                  aspiration).
             LTC, HC & Lab                         TIPS_JanFeb07.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.2     #2a: Improve the effectiveness of For verbal or telephone orders or for telephonic
             communication among caregivers.   reporting of critical test results, verify the
                                               complete order or test result by having the
                                               person receiving the order or test result "read-
                                               back" the complete order or test result.

             HOSP, LTC, BHC, HC, AC & Lab          JCAHO 2007 Goals - TIPS Article.pdf /A Page=2




JC - 3                                                                             JC - 3 - Version: 2007                                                         81 of 480
                                                 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
   3.9.2.1   #2b: Improve the effectiveness of Standardize a list of abbreviations, acronyms
             communication among caregivers.   and symbols that are not to be used throughout
                                               the organization.
             HOSP, LTC, BHC, HC, AC & Lab         JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.2.2   #2c: Improve the effectiveness of Measure, assess and, if appropriate, take action
             communication among caregivers.   to improve the timeliness of reporting of critical
                                               test results and values.
             HOSP, BHC, HC, AC & Lab              JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.2.3   #2d: Improve the effectiveness of Values defined as critical by the lab are reported
             communication among caregivers.   directly to a responsible licensed caregiver.
                                               When the patient‘s responsible licensed
                                               caregiver is not available within the time frame,
                                               there is a mechanism to report the critical
                                               information to an alternative response caregiver.

             Lab only                             JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.2.4   #2e: Improve the effectiveness of (New): Implement a standardized approach to
             communication among caregivers.   "hand off" communications, including an
                                               opportunity to ask and respond to questions.
             HOSP, LTC, BHC, HC, AC & Lab         JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.3     #3a: RETIRED - Improve the safety a) Remove concentrated electrolytes (including,
             of using medications.             but not limited to, potassium chloride, potassium
                                               phosphate, sodium chloride >0.9%) from patient
                                               care units.
             RETIRED                              2006 NPSG TIPS_JanFeb06Poster.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.3.1   #3b: Improve the safety of using  Standardize and limit the number drug
             medications.                      concentrations available in the organization.
             HOSP, LTC, BHC, HC & AMC             JCAHO 2007 Goals - TIPS Article.pdf /A Page=2




JC - 3                                                                            JC - 3 - Version: 2007                                                         82 of 480
                                                  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
   3.9.3.2   #3c: Improve the safety of using  Identify and, at a minimum, annually review a list
             medications.                      of look-alike/sound-alike drugs used in the
                                               organization, and take action to prevent errors
                                               involving the interchange of these drugs.
             HOPS, LTC, BHC, HC & AMC             JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.3.3   #3d: Improve the safety of using  (New): Label all medications, medication
             medications.                      containers (e.g., syringes, medicine cups,
                                               basins) or other solutions

                                                  on and off the sterile field in perioperative and
                                                  other procedural settings.
             HOSP & AMC                           JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.4     #4: RETIRED - As of 2005 this goal a) Use a pre-op verification process, such as a
             is now surveyed under the Universal checklist, to confirm appropriate documents are
             Protocol: Eliminate wrong-site,     available.
             wrong-patient, wrong-procedure.
                                                 b) Implement a process to mark the surgical site
                                                 and involve the patient in the process.
             RETIRED (HOSP, LTC & AMC)            JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.5     #5: RETIRED - improve the safety of Ensure free-flow protection on all general-use
             using infusion pumps.               and PCA (patient controlled analgesia)
                                                 intravenous infusion pumps used in the
                                                 organization
             RETIRED ( HOSP, BHC, HC & AMC)       JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.6     #6: RETIRED - As of 2005 this goal a) Implement regular preventive maintenance
             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 (HOSP, LTC, BHC, HC & AMC)   JCAHO 2007 Goals - TIPS Article.pdf /A Page=2




JC - 3                                                                            JC - 3 - Version: 2007                                                         83 of 480
                                                  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
   3.9.7     #7a: Reduce the risk of health care- Comply with current Centers for Disease Control
             associated infections.               and Prevention (CDC) hand-hygiene guidelines.

                                                  CDC Hand Hygiene.pdf /A Page=0
             HOSP, LTC, BHC, HC, AMC & Lab        JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.7.1   #7b: Reduce the risk of health care- Manage as sentinel events all identified cases of
             associated infections.               unanticipated death or major permanent loss of
                                                  function associated with a health care-
                                                  associated infection.
             HOSP, LTC, BHC, HC, AC & Lab         JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.8     #8a: Accurately and completely    Implement a process for obtaining and
             reconcile medications across the  documenting a complete list of the patient‘s,
             continuum of care.                resident‘s or client ‘s current medications upon
                                               their admission to the organization, to include
                                               their involvement. This process includes a
                                               comparison of the medications the organization
                                               provides to those on the list.
             HOSP, LTC, BHC, HC & AMC             JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
             The Joint Commission Patient Safety Goals
   3.9.8.1   #8b: Accurately and completely    A complete list of the patient‘s medications is
             reconcile medications across the  communicated to the next provider of service
             continuum of care.                when it refers or transfers a patient to another
                                               setting, service, practitioner or level of care
                                               within or outside the organization.
             HOSP, LTC, BHC, HC & AMC             JCAHO 2007 Goals - TIPS Article.pdf /A Page=2




JC - 3                                                                             JC - 3 - Version: 2007                                                         84 of 480
                                                  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
   3.9.9      #9: Reduce the risk of patient harm 9b) Implement a fall reduction program, including
              resulting from falls.               a transfer protocol, and evaluate the
                                                  effectiveness of the program.




                                                   [9a was REPLACED WITH REQUIREMENT 9b:
                                                   Assess and periodically reassess each patient's
                                                   risk for falling, including the potential risk
                                                   associated with the patient's medication regimen,
                                                   and take action to address any identified risks.]

              HOSP, LTC & HC                       JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
              The Joint Commission Patient Safety Goals
   3.9.10     #10a: Reduce the risk of influenza Develop and implement a protocol for
              and pneunococcal disease in        administration and documentation of the flu
              institutionalized older adults.    vaccine.
              LTC                                  JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
              The Joint Commission Patient Safety Goals
   3.9.10.1   #10b: Reduce the risk of influenza Develop and implement a protocol for
              and pneunococcal disease in        administration and documentation of the
              institutionalized older adults.    pneumococcus vaccine.
              LTC                                  JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
              The Joint Commission Patient Safety Goals
   3.9.10.2   #10c: Reduce the risk of influenza Develop and implement a protocol to identify
              and pneunococcal disease in        new cases of influenza and to manage an
              institutionalized older adults.    outbreak.
              LTC                                  JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
              The Joint Commission Patient Safety Goals
   3.9.11     #11: Reduce the risk of surgical  Educate staff, including operating licensed
              fires.                            independent practitioners and anesthesia
                                                providers, on how to control heat sourses and
                                                manage fuels, with enough time for patient
                                                preparation; also, and establish guidelines to
                                                minimize oxygen concentration under drapes.
              AMC                                  JCAHO 2007 Goals - TIPS Article.pdf /A Page=2




JC - 3                                                                             JC - 3 - Version: 2007                                                         85 of 480
                                                    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
   3.9.12     #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.
                                                     JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
              NA                                     JCAHO_CAMH.pdf /A Page=392
              The Joint Commission Patient Safety Goals
   3.9.13     #13a (EXPANDED TO ALL                 Define and communicate the means for patients
              SETTINGS): Encourage the active       and their families to report concerns about
              involvement of patients and their     safety, and encourage them to do so.
              families in the patient’s own care as
              a patient safety

              strategy.
              HOSP, LTC, BHC, HC, AMC & Lab          JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
              The Joint Commission Patient Safety Goals
   3.9.14     #14a: Prevent healthcare-         Assess and periodically reassess each patient‘s
              associated pressure ulcers        risk for developing a pressure ulcer (decubitus
              (decubitus ulcers).               ulcer) and take

                                                     action to address any identified risks.
              LTC                                    JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
              The Joint Commission Patient Safety Goals
   3.9.15     #15a (NEW): The organization            The organization identifies patients at risk for
              identifies safety risks inherent in its suicide. Applicable to psychiatric hospitals and
              patient population, (suicide risk).     patients being treated for emotional or behavioral
                                                      disorders in general hospitals.
              HOSP, BHC                              JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
              The Joint Commission Patient Safety Goals
   3.9.15.1   #15b (NEW): The organization            The organization identifies risks associated with
              identifies safety risks inherent in its long-term oxygen therapy, such as home fires.
              patient population, (long-term
              oxygen therapy)
              HC                                     JCAHO 2007 Goals - TIPS Article.pdf /A Page=2




JC - 3                                                                               JC - 3 - Version: 2007                                                         86 of 480
                                                         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
   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 #0
                   Recommended; Priority B               JCAHO_CAMH.pdf /A Page=348
                   Procurement and Equipment
   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 #0
                   Recommended; Priority B               Copyrighted Refs.doc #0
                   Procurement and Equipment
   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.
                                                         JCAHO_CAMH.pdf /A Page=348
                   Recommended; Priority A               JCAHO_CAMH.pdf /A Page=359
                   Procurement and Equipment
   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               JCAHO_CAMH.pdf /A Page=348




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                                                           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
   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
                   Procurement and Equipment
   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
                   Procurement and Equipment
   4.1.5.1         Is the BPAs (Blanket Purchase           A standardization group has previously
                   Agreements) followed?                   evaluated equipment and has placed them on
                                                           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
                   Procurement and Equipment
   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 with
                   are appropriate actions taken?       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
                   Procurement and Equipment
   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.
                   Recommended; Priority A                 JCAHO_CAMH.pdf /A Page=348




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                                                          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
   5.1.1             Is a system in place to disseminate Facility should have a robust system to ensure
                     and track medical product, device,  communication to all personnel affected. An
                     food, biologics and pharmaceutical ideal system would be functional 24-7, and not
                     recalls, patient safety alerts and  dependant upon a single individual.
                     advisories?
                     Mandatory; Priority A                VHA Directive 2004-047.pdf /A Page=0
                     Recalls and VA Patient Safety Alerts & Advisories
   5.1.2             Are VA Patient Safety Alert and     Interview PSM on local process that tracks
                     Advisory recommendations and        completion of recommendations. Or, if
                     suggestions implemented and         applicable, check on the VA‘s Desert Pacific
                     tracked until completed?            Healthcare Network‘s Hazardous Recall/Alerts
                                                         Database.
                                                          http://vaww.nbc.med.va.gov/visn/recalls/
                     Recommended; Priority A              JCAHO_CAMH.pdf /A Page=348
                     1998 Alerts & Advisories
   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 /A Page=0




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

                     Mandatory; Priority A                    COBE.pdf /A Page=0




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                                                           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
   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 is than 7/31/98.
                     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 /A Page=0




Recalls Alerts Advis - 5                                                           Recalls Alerts Advis - 5 - Version: 2007                                                         91 of 480
                                                             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
   5.2.4             Boston Scientific/SCIMED NIR ON™        1. Facilities will immediately discontinue use of
                     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 manufacturer,
                     The balloon portion of the delivery     Boston Scientific/SCIMED (Maple Grove, MN)
                     catheter can develop pinhole leaks      who will replace them with the NIR ON™
                     and rupture at inflation pressures as   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 /A Page=0
                     1998 Alerts & Advisories
   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 /A Page=0




Recalls Alerts Advis - 5                                                               Recalls Alerts Advis - 5 - Version: 2007                                                         92 of 480
                                                            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
   5.2.6             Invivo Research Inc.'s Milennia 3500 1. Determine if facility contains any monitors
                     multiparameter patient monitor,      manufactured before December 1998.
                     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 software
                     The FDA has issued an advisory for upgrade to fix the problem that is now available.
                     this patient monitor. It has a
                     potential New Year’s Eve problem on 3. Contact Invivo Research Inc at 407-275-3220
                     every year including 1998-1999.      and ask for customer service.

                     Mandatory; Priority A                  PtMonitor.pdf /A Page=0
                     1998 Alerts & Advisories
   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 the record does not print the year, only the month,
                     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 /A Page=0




Recalls Alerts Advis - 5                                                              Recalls Alerts Advis - 5 - Version: 2007                                                         93 of 480
                                                          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
   5.3.1             GE/Marquette Clinical Information    1. Do not use the APEX pulse oximeter while it is
                     Center (V1.4 and all previous        connected to the APEX S telemetry transmitter.
                     software revisions), 4/99
                                                          2. The APEX pulse oximeter may continue to be
                                                          used as a standalone device. In this case, the
                                                          interface cables between the pulse oximeter and
                     Versions used with the APEX S        the telemetry transmitter (PN. 412926-001, -002, -
                     telemetry transmitter and APEX       003) should be removed from patient use.
                     pulse oximeter. 4/99
                                                          3. GE/Marquette will provide a software update
                                                          for your CIC upon completion of testing and
                                                          validation. A GE-Marquette service
                     The “ALL ALARMS OFF” visual          representative will then contact you to schedule
                     message on the CIC waveform          updates. Once your CIC software is updated,
                     window disappears and the alarms     you may again use your APEX Pulse Oximeter
                     remain off when the following        while it is connected to your APEX S
                     conditions are met: 1.The user turns transmitters.
                     off alarms on the CIC, THEN
                                                          4. If you have any questions concerning this
                     2. A. The APEX pulse oximeter is     safety alert, please contact Tom Lower,
                     turned on or turned off while        GE/Marquette's Telemetry Product Manager
                     connected to the APEX S telemetry (414) 362-2572.
                     transmitter OR B. The APEX pulse
                     oximeter is connected to or
                     disconnected from the APEX S
                     telemetry transmitter.
                     Mandatory; Priority A                Telemetry.pdf /A Page=0




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                                                                              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
   5.3.2             Boston Scientific/SCIMED; Discovery   1. VA medical facilities will immediately either
                     Catheters catalog numbers C3020       replace the Discovery catheter with the
                     and C3005 (All lots); 6/99            UltraCross intravascular ultrasound catheter or
                                                           discontinue use of the product.

                                                           2. Return all unused products to the
                     The distal segment of the sheath of   manufacturer, Boston Scientific/SCIMED (Maple
                     Discovery catheters may separate      Grove, MN) who will replace them with the
                     from the proximal segment. The        UltraCross intravascular ultrasound catheter at
                     separations have led to surgical      no cost or credit your account.
                     intervention in some cases where
                     the separation occurred in vivo.      3. For further information regarding the product
                                                           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 /A Page=0




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                                                             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
   5.3.3             Hoyer Power Lift Actuators              1. "Verify if you have any affected units in use. If
                     Manufactured by Sunrise Medical         so, there are two options to remedy the problem:
                     used on all serial numbers of:          Option 1: Order and install no-cost upgrade kits.
                     (Descriptions), 8/99                    Option 2: Send in affected actuators (NOT the
                                                             entire lift) for a no cost upgrade.

                                                             2. You can use the form enclosed in the attached
                     Retro-fit Power, Retro-fit Power        manufacturer's notice to report affected actuators
                     Conversion Kit 59105, Power             to Sunrise Medical. Contact Sunrise Medical at
                     Partner Lifter 53005, Power Partner     (800) 556-5438 to arrange for delivery of the kit
                     Stand-Assist Lifter 53006, Power        or upgrading the actuator.
                     Chrome Hoyer Lifter, Scanac
                     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 /A Page=0




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


                     Mandatory; Priority A                  UroView.pdf /A Page=0




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                                                                                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
   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"" displays
                     Models NPB-190 and NPB-195, all          both show ""0"" after a short audible tone.
                     units manufactured before October 9
                     1998. The manufacturer has               2. If the pulse oximeter performs as indicated
                     received reports of the affected pulse   above, no further action is required.
                     oximeters failing to alarm when the
                     sensor is disconnected from the          3. However, if the pulse oximeter displays
                     patient.                                 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 /A Page=0




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                                                                                                                                                  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
   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 a must attach a second device to the same outlet,
                     “Low Flow” alarm on a patient          as the ventilator, test the output of the branching
                     ventilator attached to the oxygen wall device with a flow analyzer to ensure sufficient
                     outlet via a “T” adapter on the supply flow to the ventilator.
                     side of the flowmeter.

                     Mandatory; Priority A                  Vent.pdf /A Page=0
                     2000 Alerts & Advisories
   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 one under the names: Cliniswab, Clinipad, Clinidine,
                     lot with Pseudomonas aeruginosa,         Cliniguard, EZ Prep, Cooper Instrument Corp.,
                     Stenotrophomonas maltophilia, and Moore Medical Corp., and Rauscher.
                     Coagulase Negative Staphylococcus
                     which was recalled in December
                     1999.

                     Mandatory; Priority A                  Clinipad.pdf /A Page=0




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                                                                                                                                  Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                         (1)   Met (2)     (3) possible root causes
                     2000 Alerts & Advisories
   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 /A Page=0
                     2001 Alerts & Advisories
   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 compatible
                     MRI bore, the iron-filled bag flew into   by testing it with the MRI magnet - this could
                     the magnet and pinned the patient’s       have catastropic consequences.
                     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 /A Page=0




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                                                                                                                                    Met   Partially   Met If score other than 'met' what are
                     Question:                                 Rationale/Assessment Methods:                                        (1)   Met (2)     (3) possible root causes
                     2001 Alerts & Advisories
   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 accident)       mattress and bedrail that are equal to or wider
                     was trapped while laying on his left      than 60mm used for high risk patients ( frail,
                     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 /A Page=0
                     Mandatory; Priority A                     VHA Patient Safety Alert on Bed Rail Entrapment 2001.doc Pg. 0




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                                                                                                                                                  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
   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 dimensions
                     wedged in the bed rail opening while 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 /A Page=0
                     Mandatory; Priority A                 VHA Patient Safety Alert on Bed Rail Entrapment 2001.doc Pg. 0
                     2001 Alerts & Advisories
   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 /A Page=0




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                                                                                                                            Met   Partially   Met If score other than 'met' what are
                     Question:                             Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                     2001 Alerts & Advisories
   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 /A Page=0




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                                                                                                                              Met   Partially   Met If score other than 'met' what are
                     Question:                             Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     2001 Alerts & Advisories
   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 /A Page=0
                     2001 Alerts & Advisories
   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 /A Page=0




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                                                                                                                            Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                     2001 Alerts & Advisories
   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 record   correct prompt if not visible when entering new
                     with patient identifier “NW” when      orders. Orders are entered at the "Action"
                     attempting to access the NW (new       prompt rather than the "Patient" prompt.
                     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 /A Page=0




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                                                                                                                             Met   Partially   Met If score other than 'met' what are
                     Question:                            Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     2001 Alerts & Advisories
   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 syringes in the box with an oral syringe.
                     we use in USA. Nurse almost
                     administered the wrong dosage.       4. Alert staff that passes medication that devices
                                                          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 /A Page=0




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                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                                Rationale/Assessment Methods:                                     (1)   Met (2)     (3) possible root causes
                     2001 Alerts & Advisories
   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 catheters     2. Prior to insertion/installation in patients:
                     may crack and/or form small blisters     Inspect each catheter for small blisters (blebs),
                     (blebs), if wrong disinfectants and/or   cracks and defects as you remove them from the
                     cleaning solutions are used.             sterile packaging. If any defect is found prior 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 /A Page=0




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


                     Mandatory; Priority A                   ZollDefib.pdf /A Page=0




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                                                                                                                           Met   Partially   Met If score other than 'met' what are
                     Question:                            Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                     2002 Alerts & Advisories
   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 in biopsy port housing upgrade when practical.
                     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 to VAMC Cincinnati.
                     the next patient exposed to the
                     scope.


                     Mandatory; Priority A                BronchOlympusMar02.pdf /A Page=0




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                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                                Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                     2002 Alerts & Advisories
   5.6.3             Baxter Colleague infusion pumps, all 1. If you have not arlready received and
                     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 the insulators for installation by Biomedical
                     pump body (usually during cleaning), Engineering.
                     there is a risk of a short circuit later
                     causing the pump to rapidly cycle on 2. If a pump us exposed to excessive fluids or
                     and off. This can happen without         starts cycling on and off, remove it and contact
                     any alarms; if this happens during       Biomedical Engineering to arrange for service.
                     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 /A Page=0




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                                                                                                                                 Met   Partially   Met If score other than 'met' what are
                     Question:                               Rationale/Assessment Methods:                                       (1)   Met (2)     (3) possible root causes
                     2002 Alerts & Advisories
   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 /A Page=0
                     Mandatory; Priority A                  PhilipsViridia.pdf /A Page=0




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                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                               Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     2002 Alerts & Advisories
   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 October
                     text after running Microsoft Word       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 /A Page=0
                     2002 Alerts & Advisories
   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 Pain",      Guideline for Management of Postoperative
                     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 /A Page=0




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                                                                                                                                                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
   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 /A Page=0




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                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     2002 Alerts & Advisories
   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 /A Page=0




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                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                                 Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                     2002 Alerts & Advisories
   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 cords          3. Determine the total number of power cords
                     used with GE Dinamap Vital Signs          affected by this notice, whether they show
                     Monitors. This compromises one of         broken ground pins or not. They can be
                     the safety features designed to limit     identified by their manufacture date code as
                     patients' risk of electrical shock,       follows. Two numbers are imprinted on the hot
                     should an electrical fault occur in the   and neutral blades; one is the week and the
                     equipment. Unless the pin has             other is the year of manufacture. Blades made
                     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 /A Page=0




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                                                                                                                                                      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
   5.6.10            Potential for incorrectly attaching       1. Use only standardized irrigation kits identified
                     Allegiance Irrigation Kit caps to Foley   by the Medical/Surgical Users Group; acquire
                     catheters, 2/02.                          from LSL Industries purchased under (BPA)
                                                               Blanket Purchase Agreement # VANAC90NP-00-
                                                               035 with Foley catheters.

                     The tubing cap (Catalog #3T4121) of       2. Check with Materials Management to
                     the Allegiance irrigation kit is small    determine if Allegiance Irrigation kits are present
                     enough to fit into a Foley catheter,      in your facility. If so, alert all clinical staff of this
                     resulting in an obstructed Foley          possible problem and the manufacturer‘s
                     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 /A Page=0




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                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                             Rationale/Assessment Methods:                                       (1)   Met (2)     (3) possible root causes
                     2002 Alerts & Advisories
   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 who 3. Consider removing air flowmeters when not in
                     inadvertently had their oxygen tubing use; this may require addressing informal norms
                     hooked up to air regulators with      through training, incentives.
                     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 /A Page=0




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                                                                                                                                                       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
   5.6.12            Addendum to Patient Safety                1. The National Center for Patient Safety and the
                     Advisory Issued on February 27,           VA Medical/Surgical Users‘ Group are working
                     2002 Concerning Allegiance                with the VA National Acquisition Center and
                     Irrigation Kits, 5/02                     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 /A Page=0




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                                                                                                                                            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
   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 medical 2. Refer to the revised page 3 of the operator
                     center used them for extended          and service manuals (attached), copy and insert
                     procedures, use of these pumps for the revised pages in all SSCOR 2314, 2314B
                     extended high vacuum/high              and 2315 operator and service manuals. If
                     occlusion can lead to overheating      manuals are not available they can be obtained
                     and premature pump failure, making from the manufacturer or from the Center for
                     the equipment unavailable for use      Engineering and Occupational Safety & Health
                     and limiting needed suction.           (CEOSH) at (314) 543-6700 or at
                                                            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 /A Page=0




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                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                                 Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                     2002 Alerts & Advisories
   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 in   ―TAPERING ORDER‖ or ―PART OF COMPLEX
                     a patient receiving multiple doses in     ORDER‖.
                     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 /A Page=0




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                                                                                                                            Met   Partially   Met If score other than 'met' what are
               Question:                                   Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
               2002 Alerts & Advisories
   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 in displayed within BCMA before administering a
                     a patient receiving multiple doses in medication.
                     one day, if the provider didn’t notice
                     the shift in start dates.

                     Recommended; Priority A               CPRScomplexorders.pdf /A Page=0




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                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     2002 Alerts & Advisories
   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 pneumococcal
                     The FDA has determined that, over vaccines [Pnu-ImuneR 23 and PneumovaxR]] for
                     the past 14 years, 52 cases of         adults with increased risk of invasive
                     meningitis have been reported          pneumococcal disease). Therefore, all veterans
                     worldwide, out of which 12 known       who are candidates for cochlear implant (s)
                     deaths have resulted from these        should be ascertained of their immunization
                     cases. It was identified that 24 cases status prior to surgery as well as all patients with
                     (of the 52 worldwide cases) were in existing implants received from VA and non-VA
                     North America.                         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 /A Page=0




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                                                                                                                                                   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
   5.6.15      (continued)... Cochlear Implant                ...(continued) adults related to cochlear implants,
   (continued) Recipients may be at increased risk            the use of Hib vaccine in this scenario would be
               for bacterial meningitis, 9/02                 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) were in      2. In some of the reported cases, patients may
                     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 /A Page=0




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                                                                                                                                              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
   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 (VDL), "now."
                     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 /A Page=0
                     2002 Alerts & Advisories
   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 to
                     corrected information, the printed    verify accuracy and manually linked if necessary.
                     copy does not. This may result in
                     incorrect information being relied
                     upon when making clinical decisions.


                     Recommended; Priority A               CPRSConsultantNoteAmendments.pdf /A Page=0




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                                                                                                                              Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                     (1)   Met (2)     (3) possible root causes
                     2003 Alerts & Advisories
   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 is
                     machine is turned off and in a pain-   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 /A Page=0




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                                                                                                                                                    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
   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 instructions
                     the unit’s internal ECG and Safety      with each affected defibrillator and train potential
                     Monitoring functions can lead to an users on the work around. Remember to
                     error condition. This error condition schedule training again after the software
                     will cause the defibrillator to issue a upgrade is installed.
                     "Shock Advised" message,
                     immediately followed by "No
                     Treatment Delivered" and "Change
                     Batteries" messages.

                     Mandatory; Priority A                   ZollDefibFeb2003.pdf /A Page=0
                     2003 Alerts & Advisories
   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 /A Page=0




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                                                                                                                                                  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
   5.7.4             ACCU-CHEK® Comfort Curve® and           1. For inpatient and clinic areas: Within the next
                     Advantage® test strips manufactured     72 hours, inspect the inventory and check the
                     by Roche Diagnostics Corp; 5/03         bottom of any unused or currently in-use vials 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,
                     The bottom of the vial may be           as a standard practice, inspect each vial for
                     cracked which may cause inaccurate cracks before each use. If you find cracked vials,
                     blood glucose results due to            do not use the strips and call 1-800-440-3638 to
                     changes in humidity. This product       arrange for a replacement product.
                     correction refers to all lots currently
                     available of the ACCU-CHEK®             2. Patients at home: The Pharmacy Benefits
                     Comfort Curve® test strips, part        Management (PBM) is notifying outpatients.
                     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 /A Page=0
                     2003 Alerts & Advisories
   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 pumps
                     A new manufacturer requirement for 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 ANNETM, line tests per manufacturer instructions for the
                     manufactured by Abbott Laboratories pumps listed.
                     Hospital Product Division.

                     Mandatory; Priority A                  AbbottPumpsAir_Line.pdf /A Page=0




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                                                                                                                                               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
   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 /A Page=0




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                                                                                                                                                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
   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 /A Page=0
                     2003 Alerts & Advisories
   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 affected
                     Power cord ground pins on some         by this notice. Affected cords are identified by
                     portable monitors broke off. This      their manufacture date with codes as follows: 09 -
                     fracture compromises one of the        01 through 16 - 02 (week - year) is imprinted on
                     safety features designed to limit      the hot and neutral cord blades. Immediately
                     patients' risk of electrical shock.    replace any cords with a broken ground pin with
                     Unless the pin has broken, patient     a spare and schedule replacement of other cords
                     safety is not compromised.             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 /A Page=0




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                                                                                                                                 Met   Partially   Met If score other than 'met' what are
                     Question:                               Rationale/Assessment Methods:                                       (1)   Met (2)     (3) possible root causes
                     2003 Alerts & Advisories
   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 the
                     cover Geo-Matt® seat cushions and       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 /A Page=0




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                                                                                                                          Met   Partially   Met If score other than 'met' what are
                     Question:                             Rationale/Assessment Methods:                                  (1)   Met (2)     (3) possible root causes
                     2003 Alerts & Advisories
   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 /A Page=0




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                                                                                                                                  Met   Partially   Met If score other than 'met' what are
                     Question:                                 Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     2003 Alerts & Advisories
   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 self     2. If the foil pouches appear to be compromised
                     test), Catalog # 1937642 (packaged        do not use the test strips and notify Roche
                     48 strips per box), Catalog #             Diagnostics Point of Care Technical Service at
                     1937634 (packaged 12 strips per           (800) 428-4674 within the U.S., or visit the
                     box), Lot #s 591, 619, 600 and 583.       CoaguChek Web site at http://www.coaguchek-
                     Extended to all lots with an expiration   usa.com. To receive replacement product, fax
                     date of on or before March 1, 2005.,      the replacement request form to Roche
                     A packaging defect involved the           Diagnostics at (800) 722-7222 within the U.S.
                     opening scoremark intruding into the
                     sealed pouch containing the product.      3. If the foil pouches appear to be intact run
                     This defect may allow air and             duplicate tests, is the test strip lot number is
                     moisture to enter the sealed pouch        lower that lot 670 . Duplicate test results should
                     causing erroneous readings when           be within +/-1.0 international normalized ratio
                     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 /A Page=0




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                                                                                                                                                  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
   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 /A Page=0




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                                                                                                                             Met   Partially   Met If score other than 'met' what are
                     Question:                         Rationale/Assessment Methods:                                         (1)   Met (2)     (3) possible root causes
                     2003 Alerts & Advisories
   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 at
                     unusable.                         paul.sherman@med.va.gov if you have the
                                                       affected plug and did not receive the letter from
                                                       Olympus.

                     Recommended; Priority A                OlympusCYF.pdf /A Page=0
                     2003 Alerts & Advisories
   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 /A Page=0




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                                                                                                                                                  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
   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 /A Page=0




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                                                                                                                                                  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
   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 procedures
                     Technologies, Inc.will no longer be      and FDA approved devices should be
                     sold. 6/03                               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 /A Page=0
                     2003 Alerts & Advisories
   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 same
                     renewed three times although the         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 /A Page=0




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                                                                                                                                                  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
   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 or manufacturer) tools and materials used for
                     “Y” connector designed to connect to reprocessing must also be covered during the in-
                     endoscopes incorporating dual ports service training.
                     was connected to endoscopes with
                     single ports. Under this condition an 2. Validate that appropriate reprocessing
                     indeterminate amount of sterilizing     connectors are being utilized with each model of
                     solution may have been directed to endoscope. Some manufacturers provide
                     the unconnected port, possibly          cognitive aids such as instruction placards and
                     leading to inadequate sterilization of these must be available and intact where
                     the endoscope.                          provided.

                                                             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 /A Page=0




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                                                                                                                                               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
   5.8.1       (continued)... Proper Connectors for       ...(continued) the in-service training requirement
   (continued) Sterlization of all Gastrointestinal       and report completion to the VISN Patient Safety
               Fiberoptic Endoscopes, 2/04                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 Management.
                     Using an incorrect connector to link
                     sterilizing solution to endoscopes      5. Scheduled procedures may continue while the
                     during reprocessing (cleaning and       above actions are undertaken.
                     sterilizing) procedures. A dual-port 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 /A Page=0




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                                                                                                                                                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
   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 /A Page=0




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                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                               Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     2004 Alerts & Advisories
   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 stations
                     reaching near or completely empty       are provided for all alarm conditions related to
                     and both sites did not meet the         the Oxygen Utility System. Test all alarm
                     NFPA-99 requirement for two,            conditions to ensure the alarm annunciation is
                     independent 24/7 supervised areas       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 /A Page=0




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                                                                                                                                                  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
   5.8.3       (continued)... Oxygen Utility System, ...(continued) so alarm conditions are not
   (continued) 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 /A Page=0




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                                                                                                                                                    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
   5.8.4             Implantable Cardioverter Defibrillator 1. Immediately check patient records in CPRS to
                     (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 Services,
                     GEM DR 7271; Medtronic, implanted         listed in the Contact section of this notification if
                     in 1997 and 1998, During a cardiac        you cannot reach the local representative) for
                     event requiring cardioversion or          assistance with determining whether the
                     defibrillation, internal capacitors may   identified implant requires follow-up action as
                     take longer to charge and can cause       identified by Medtronic.
                     a delay or non-delivery of
                     appropriate shock therapy.                3. If follow-up action is necessary, see the
                                                               attached letter from Medtronic describing
                                                               required actions.
                     Mandatory; Priority A                     MedtronicICDAlert042804.pdf /A Page=0
                     2004 Alerts & Advisories
   5.8.5             Class I recall of Medtronic MiniMed 1.If you still have any of the above mentioned
                     Paradigm® Quick-set® Plus Infusion product in inventory, immediately stop
                     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 /A Page=0




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                                                                                                                                                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
   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, 0100740, 3. For identified lamps with cracked pivot
                     0100580, 0102180 and 0102540,        supports- If possible, remove them from service.
                     Due to an inherent weakness in the a. Users: Inspect each light daily before use for
                     original composition of the pivot    normal movement and stability. If the light
                     support casting, the pivot joint can appears loose or unstable, contact Engineering
                     fail and the light may fall onto a   to have it checked. b. Engineering: Inspect
                     patient.                             identified lights every two weeks until new
                                                          components are installed.

                     Mandatory; Priority A                 BurtonLightsJune04.pdf /A Page=0




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                                                                                                                                                   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
   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 deleted          2. When records with missing or truncated text
                     or truncated automatically without         are identified:(a) Refer them to the author for
                     the author being made aware that           review of the note and to add an addendum if
                     this occurred when the document is         needed (b) If the author is no longer available or
                     signed. The Office of Information          is unable to remember what information is
                     (OI) has developed a patch that may        missing a disclaimer, similar to the following,
                     be used to identify potentially            should be added to the file ―DISCLAIMER: This
                     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 /A Page=0




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                                                                                                                                                   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
   5.8.7       (continued)... CPRS Text Integration ...(continued) allow the disclaimer to be added.
   (continued) 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 /A Page=0




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   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
   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 (those
                     with slight pressure on the flexible   with lot numbers higher than 1a-c) before you
                     suction liner precipitated the         ship the affected units back to DeRoyal for free
                     discharge.                             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 /A Page=0




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   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
   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 /A Page=0




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                                                                                                                                                    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
   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 /A Page=0
                     2004 Alerts & Advisories
   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) Taxus         2. By close of business July 30, 2004, ensure
                     Express 2 Over-the-wire (OTW)            you have on site replacements from FDA
                     Paclitaxel-Eluting 3) Express 2          approved stent suppliers, for existing, affected
                     Monorail (MR) bare-metal 4) Express      models (―recalled stents‖) of Boston Scientific
                     2 Over-the Wire (OTW) bare-metal.        stent systems. Do not sequester the ―recalled
                     The FDA and the manufacturer             stents‖ from use until you have replacements on
                     received reports 43 confirmed “no        hand.
                     deflation” (failure of the balloon to
                     deflate within one minute after          3. Contact your local Boston Scientific sales
                     deployment of the stent) complaints      representative to exchange the affected stents
                     related to the Taxus Express 2           one for one with their replacements.
                     device system.
                     Mandatory; Priority A                    BostonScientificStentRecallJuly04.pdf /A Page=0




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                                                                                                                                                 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
   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 /A Page=0
                     2004 Alerts & Advisories
   5.8.12            Automated External Defibrillators      1. Immediately check your inventory to determine
                     (AED) manufactured by Access           if you have any Access Cardiosystems AEDs
                     Cardiosystems, Inc., operation         and remove units from service affected by items
                     failure, 11/04                         1 and 2 above.

                                                            2. Other Access Cardiosystems units can remain
                                                            in service only as long as you have consumables
                     Units with serial numbers ranging      on hand to support them or until February 1,
                     from 075690 to 077140 may              2005, then they must be removed from service
                     experience a malfunction in the        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 /A Page=0




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                                                                                                                                                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
   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 reports install test patch PSJ*5*127.
                     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 /A Page=0
                     2004 Alerts & Advisories
   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 case
                     Facility drug files may contain entries by case basis, from view of the providers.
                     that are for pharmacy use only.          Restricting the products in CPRS file 101.43
                     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 only.                2. If a restricted product is needed for clinical
                                                              patient use, incorporate the item in a quick order
                                                              instead, thus removing the potential of mis-
                                                              prescribing.
                     Recommended; Priority A                CPRSDrugFile042804.pdf /A Page=0




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                                                                                                                                               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
   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 /A Page=0
                     2004 Alerts & Advisories
   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 medical
                     administration set and the exterior    devices before use. If the device is found to be in
                     door. If the door latch is broken it   need of repair, it should be removed from service
                     may not properly activate the free     and sent to biomedical engineering for service.
                     flow protection mechanism on the IV
                     set, and free flow of medication may 3. Assure that there are an adequate number of
                     occur if other methods of free flow  pumps available to adjust for peak utilizations
                     protection are not employed.         and/or maintenance cycles.

                     Recommended; Priority A                ALARISGeminiInfusionPumps.pdf /A Page=0




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                                                                                                                                               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
   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 recommendations
                     radios/walkie-talkies, 11/04        for areas where wireless communication devices
                                                         are restricted. For two-way radios, 20 feet from
                                                         medical equipment is a minimum recommended
                                                         distance (ECRI Health Devices 2003 Mar;
                     When operated in close proximity to 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 /A Page=0




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                                                                                                                                                  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
   5.8.18                                              During surgery at a VA medical facility the power
                     Power supplies for flat panel patient
                     monitor, Model 91415-A            supply for the flat panel patient monitor degraded
                                                       to the point where the audio circuit stopped
                     manufactured by Spacelabs Medical working, affecting the alarm function. This was
                     between January 2000 and          unknown to the operator and when the patient
                                                       experienced a cardiovascular event, the alarm
                     December 2001. 11/03.             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 /A Page=0




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                                                                                                                                          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
   5.8.18      (continued)... Power supplies for flat ...(continued) audio prior to each procedure or
   (continued) panel patient monitor, Model 91415- with
               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 /A Page=0




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                                                                                                                                                  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
   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 staff
                     to operate. This was an O-ring type understand and enforce the existing program to
                     fire sprinkler manufactured by            control smoking materials, especially when
                     Central Sprinkler Company (Model          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 to:
                     scheduled for replacement.                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 /A Page=0




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                                                                                                                                                      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
   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 cannot
                     oxygen completed the fire triangle          be met, consider installing sprinkler protection,
                     and resulted in the death of a              modifying the number (mix) of non-ambulatory to
                     patient, In the room of fire origin, the    ambulatory patients in the smoke zone, reducing
                     fire sprinkler closest to the fire failed   the size of the smoke zone(s) or a combination of
                     to operate. This was an O-ring type         these actions. 2) For fully sprinkler protected
                     fire sprinkler manufactured by              patient care buildings with overnight stay: One
                     Central Sprinkler Company (Model            responder for every four non-ambulatory
                     GB). These O-ring sprinklers, along         patients. If this response ratio cannot be met
                     with other models, were recalled by         conduct a risk assessment to determine if an
                     the manufacturer in 2001 and were           appropriate level of safety is being provided. For
                     scheduled for replacement.                  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 at:
                     Mandatory; Priority A                       FireResponseAlert.pdf /A Page=0




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                                                                                                                                                    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
   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 /A Page=0




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                                                                                                                                               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
   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 7274 2. Replace entire device in first priority group
                     Marquis DR, Model 7232 Maximo         patients (see item B of attached letter from VA
                     VR,Model 7278 Maximo DR, Model National ICD Surveillance Center).
                     7277 InSync Marquis, Model7289
                     InSync II Marquis, Model 7279         3. Follow one of three options for those patients
                     InSync III Marquis,Model 7285 In      who are not on the first–priority group. (see
                     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 /A Page=0




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   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
   5.9.4             Spacelabs Medical Monitor, model        1. Immediately identify and locate all monitors
                     90385 Universal Clinical Workstation affected by this notice.
                     (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 screw
                     purchased after, or serviced by         in the center (See photos in attached Spacelabs
                     Spacelabs Medical after March 18        Medical notice for more detail) If neither a nor b
                     1997 are not affected, The monitor      is present, the bases need upgrading.
                     base becomes fatigued and
                     separates from the monitor display. 3. If units have not been upgraded contact
                     In that case, gravity is all that keeps Spacelabs Medical Monitoring Technical Support
                     the monitor together and movement at (800) 522-7025 to arrange upgrades.
                     can cause the monitor to fall, risking
                     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 /A Page=0




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                                                                                                                                                  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
   5.9.5             Louvered heating, ventilating, and air   1. Survey all locked Behavioral Health Units to
                     conditioning (HVAC) grilles in locked    determine if louvered grilles are present that may
                     Behavioral Health Units, 2/05 (AL05-     be used as an anchor point.
                     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 for
                     anchor point for a noose made from       other purposes.
                     clothing or other flexible material.

                     Mandatory; Priority A                    LouveredHVACGrilleFeb28.pdf /A Page=0
                     2005 Alerts & Advisories
   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 the   3. If the settings have changed or do not match
                     setting selected by the customer.        those required for your protocol, correct them per
                     The setting may not be noticed until     the directions.
                     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 /A Page=0




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                                                                                                                                                   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
   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 /A Page=0




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                                                                                                                            Met   Partially   Met If score other than 'met' what are
                     Question:                            Rationale/Assessment Methods:                                     (1)   Met (2)     (3) possible root causes
                     2005 Alerts & Advisories
   5.9.8             Enclosed Bed systems                 1. VA facilities may continue to use Vail enclosed
                     manufactured by Vail Products Inc,   beds on a case by case basis only when there is
                     3/05 (AL05-09)                       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 care for certain
                     Models: 500, 1000, and 2000, FDA     types of patients and disease states. In certain
                     issued recommendations for users     instances, use of enclosed beds provides the
                     based on cited safety problems.      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 /A Page=0




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                                                                                                                                            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
   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 access
                     Models: 500, 1000, and 2000, FDA   to the patient. (Side rails should be up at all
                     issued recommendations for users   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)
                     Mandatory; Priority A              VailBedMarch2005.pdf /A Page=0




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                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     2005 Alerts & Advisories
   5.9.9             VistA Imaging v3.0 versions released   1. Advise clinicians who view EKGs to verify that
                     since 10/1/03 patch MAG*3.0*24,        the ―Show MUSE EKGs‖ option under Options >
                     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 /A Page=0
                     2005 Alerts & Advisories
   5.9.10            CM 100-Heartstart Adapter Cable        1. Immediately (within the next 24 hours) remove
                     man'f'd by Laerdal Medical Corp,       CM 100-Heartstart Adapter Cable from service
                     5/05, (AL05-10).                       and inventory.

                                                           2. Assure replacement cable from another
                                                           source is available for each defirillator where the
                     This product is designed for use with cable was removed.
                     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 /A Page=0




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                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                               Rationale/Assessment Methods:                                     (1)   Met (2)     (3) possible root causes
                     2005 Alerts & Advisories
   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-up
                     (mg/dL) and milli-mole per liter        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 /A Page=0




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                                                                                                                                               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
   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 delivering (https://icd.sanfrancisco.med.va.gov). This list,
                     high-voltage shock therapy when         provided by Guidant, consists of all the VA
                     ventricular tachycardia or fibrillation patients in the company‘s database that have an
                     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 /A Page=0




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   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
   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 delivery,
                     preventing the device from delivering and ICD replacement should be considered at
                     high-voltage shock therapy when         that time.
                     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 /A Page=0
                     2005 Alerts & Advisories
   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 Alert
                     6/05 (AL05-14)                        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 /A Page=0




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                                                                                                                                                  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
   5.9.14            Guidant Corporation recalls               1.Within two weeks, electrophysiology/cardiology
                     additional models (update to PS           staff or other appropriate caregivers must identify
                     Alert AL05-013 dated 6/8/05), 7/05        all affected patients by implementing each of the
                     (AL05-15)                                 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 found on one list and not on another.
                     Additional models of Implantable
                     Cardioverter-Defibrillators (ICD), and    a) Review the manufacturers letters (See Links
                     has added Cardiac                         below).
                     Resynchronization Therapy
                     Defibrillators (CRT-D) to the recall      b) Review the patient list posted on the VA
                     list. These devices can develop an        National ICD Surveillance Center intranet
                     internal short circuit without warning,   website (https://icd.sanfrancisco.med.va.gov).
                     resulting in failure to deliver a shock   This list, provided by Guidant, consists of all VA
                     when needed. In addition, Guidant         patients in the company‘s database that have an
                     sent letters to physicians notifying      implanted Guidant device affected by this recall.
                     them that identified models of Atrial     Double check by providing name of your facility
                     Therapy devices (AVT) and CRT-D           and implant physician‘s name. (See attachment
                     devices will require reprogramming.       2)

                     ICDs (FDA Class I Recall) Guidant         c) Review the VA National registry for ICDs and
                     Ventak Prizm 2 DR, Model 1861,            CRT-R implants, Washington VAMC, point of
                     Implantable Cardioverter-                 contact is Ronald.Jones1@va.gov.
                     Defibrillators (ICDs) manufactured
                     before April 16, 2002,CRT-Ds (FDA         d) Review your patient records for all patients
                     Class I Recall) Guidant Contak            with implanted Guidant devices affected by this
                     Renewal, Model H135, Cardiac              (continued)...
                     Resynchronization Therapy
                     Defibrillators (CRT-D) manufactured
                     on or before August 26,
                     2004,Guidant Contak Renewal 2,
                     Model H155, A
                     Mandatory; Priority Cardiac               GuidantICDsCRTsUpdateJuly05.pdf /A Page=0




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                                                                                                                                                  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
   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 therapy
                     Cardioverter-Defibrillators (ICD), and    delivery
                     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 delivery,
                     Model H155, A
                     Mandatory; Priority Cardiac               GuidantICDsCRTsUpdateJuly05.pdf /A Page=0




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                                                                                                                                             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
   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 /A Page=0




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                                                                                                                                                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
   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 /A Page=0




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                                                                                                                                                 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
   5.9.17            Olympus 180 series endoscopes and      Olympus model CFQ180AL scopes were being
                     Steris Quick Connects, 10/05, (AL06-   reprocessed in a Steris System 1 when it was
                     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 /A Page=0




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                                                                                                                                            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
   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 /A Page=0




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                                                                                                                                                 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
   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 /A Page=0




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                                                                                                                                                    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
   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 or
                     critical flags were not being set for     seek assistance by logging a Remedy ticket with
                     positive tests of hemocult. As a          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 /A Page=0




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                                                                                                                                                    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
   5.9.20      (continued)... LEDI III Lab Electronic ...(continued) omissions were identified and it
   (continued) Data Interchange, 8/05, (AL05-016). was determined that the provider was not
                                                      notified, report the situation to the provider
                                                      immediately. If the provider is no longer with the
                                                      facility, then notification should be given to the
               VistA Laboratory Package, patch        Chief of Service.
               LR*5.2*286


                                                               5. By COB Monday, September 12, 2005:
                     A VHA facility recently reported that     Identify and report, to the Patient Safety
                     critical flags were not being set for     Manager, the number of patients that were not
                     positive tests of hemocult. As a          notified of positive test results since
                     result, over 200 positive tests for       implementing the patch, along with the date all
                     hemocult did not trigger a flag to        patients will be notified. If your facility is not
                     alert providers. Although the site        impacted, submit a negative report. The Patient
                     has made the proper modifications         Safety Manager should report this information to
                     and taken necessary actions, this         the Network Patient Safety Officer who will report
                     Patient Safety Alert is issued to alert   this information to the National Center for Patient
                     other sites that may be affected.         Safety, attention Joe DeRosier/Lori King.


                     Mandatory; Priority A                     LEDI-IIIPatch Aug 26 05.pdf /A Page=0




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                                                                                                                                              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
   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 /A Page=0




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                                                                                                                                 Met   Partially   Met If score other than 'met' what are
                     Question:                                 Rationale/Assessment Methods:                                     (1)   Met (2)     (3) possible root causes
                     2005 Alerts & Advisories
   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 being     prior to changing a value, and use the
                     entered into this model of PCA pump       confirmation screen to assure that values that
                     that could result in an adverse           have been entered in fact have been accepted
                     medication event. To date, there          by the device.
                     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 rather, will
                     increase the original value by adding
                     Recommended; Priority A                   HospiraPCA3Advisory Nov 29 05.pdf /A Page=0




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                                                                                                                                                 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
   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 could
                     VistA package allergy file (120.8)     help clinical staff to remember this when entering
                     may have allergy entries that have     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. Information
                     A patient had a drug allergy entered 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 class be addressed to the OI National Help Desk, who
                     was assigned to that entry. Years       will set up a remedy ticket to assist you with any
                     later, a provider ordered cefazolin - a issue.
                     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 /A Page=0




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                                                                                                                                                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
   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-194/V- have a list of patients with you or your
                     232) and Atlas VR/DR (Models V-        colleagues as the follow-up physician.
                     199/V-240) units. St. Jude Medical
                     (SJM) reported 60 failures out of      A. Review the manufacturer's letter (See Links
                     36,000 devices (0.167%) with no        below).
                     serious patient injuries or death. The
                     cause of this failure mode has been B. Review the patient list posted on the VA ICD
                     identified as cosmic radiation         Surveillance Center intranet website
                     damage to a vendor-supplied static (https://ICD.sanfrancisco.med.va.gov). It
                     random access memory (SRAM)            consists of a list of VA patients provided by SJM.
                     chip in these ICDs.                    The SJM list is made up of all the VA 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 /A Page=0




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                                                                                                                                               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
   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 failures out of      3. Follow the actions contained in Attachment 1.
                     36,000 devices (0.167%) with no        This guidance was prepared by Dr. Edmund
                     serious patient injuries or death. The Keung, Director of the VA ICD Surveillance
                     cause of this failure mode has been Center, and details the best course of action for
                     identified as cosmic radiation         your patients.
                     damage to a vendor-supplied static
                     random access memory (SRAM)
                     chip in these ICDs.

                     Mandatory; Priority A                 SJM_ICDAlert Nov 15 05.pdf /A Page=0




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                                                                                                                                                  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
   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 more A. Review the manufactuer's letters (See Links
                     of the following malfunctions may    below).
                     occur:
                                                          B. Review the patient list posted on the VA
                      - Intermittent or permanent loss of Western Pacemaker Surveillance Center intranet
                     pacing output without warning;       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 /A Page=0




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                                                                                                                                             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
   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 more 2. For first Failure Mode only: By COB Friday,
                     of the following malfunctions may    November 25, 2005: interrogate all affected
                     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 a
                     appearance of a reset warning           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 1.
                     (0.073%). Seven (7) of these         This guidance was prepared by Dr. Edmund
                     devices were found to exhibit no
                     Mandatory; Priority A                GuidantInsigniaNexusPacemakers Oct 24 05.pdf /A Page=0




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                                                                                                                                                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
   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 entry are
                     Positive Hepatitis C (HCV) reports      EL Enter/verify data (Load list) [LRVRW2] or EM
                     did not generate a critical value alert Enter/verify/modify data (manual) [LRENTER].
                     to the provider (as normally
                     expected) when the test results were
                     entered using the Batch Data Entry
                     option [LRSTUF]. Test results           2. By COB Friday, October 28, 2005: Review
                     entered using the Enter/Verify/Modify the past 12 months of data to determine if any
                     Data (Manual) [LRENTER] option          tests capable of being batch-entered and
                     generated the appropriate critical      containing a delta check did not generate a
                     alerts.                                 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 /A Page=0




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                                                                                                                                              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
   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 /A Page=0
                     2006 Alerts & Advisories
   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 /A Page=0




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                                                                                                                                              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
   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 /A Page=0
                     2006 Alerts & Advisories
   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 /A Page=0




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                                                                                                                                                    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
   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 /A Page=0
                     2006 Alerts & Advisories
   5.10.6            Transrectal ultrasound transducer  During patient safety rounds in the Urology Clinic
                     assembly, manufactured by B-K      at the reporting facility, the lumen of a needle
                     Medical Systems, Inc., 4/06 (AL06- guide of a reprocessed (i.e., ready to be used for
                     011)                               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 clean the
                     Specific models are 8808 and 8551, 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 /A Page=0




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                                                                                                                                               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
   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 /A Page=0




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                                                                                                                                               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
   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 or   VHA believes the
                     exploded due to suspected improper
                     use of gaskets/washers. None of        fire risk of reusing them outweighs the additional
                     these reports involve VA facilities.   expense of using sealing washers.)
                     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 metal-    4. Always inspect the regulator and CGA 870
                     bound elastomeric sealing washer       seal before
                     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 metal
                     plastic crush gasket suitable for      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 /A Page=0




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                                                                                                                                            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
   5.10.9            Renewing medications using           Specific Incident: After installing OR*3*215
                     Computerized Records System          (CPRS GUIv26) a VA medical center reports that
                     (CPRS), version 26., 05/06, (AL06-   providers noticed renewed medications are not
                     13).                                 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 /A Page=0




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                                                                                                                                                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
   5.10.9      (continued)... Renewing medications         ...(continued) properly renewed.
   (continued) using Computerized Records
               System (CPRS), version 26., 05/06,          a. Providers must review the medications being
               (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 /A Page=0
                     2006 Alerts & Advisories
   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 (CRM)
                     includes INSIGNIA and NEXUS           Group, formerly Guidant's CRM business.
                     pacemakers 06/06                      Boston Scientific acquired Guidant on April 21,
                                                           2006.


                     Also includes CONTAK RENEWAL
                     TR/TR2 cardiac resynchronization      Boston Scientific/Guidant has recently confirmed
                     therapy (CRT) pacemakes, and          five (5) reports of device malfunction associated
                     VENTAK PRIZM 2 VITALITY and           with the failure of a low voltage capacitor. This
                     VITALITY 2 implantable cardioverter   may lead to a device malfunction, including
                     defibrillators (ICDs.)                intermittent or permanent loss of therapy, or
                                                           premature battery depletion.

                     Mandatory; Priority A                 BostonScientificImplantableAL06-14.pdf /A Page=0




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                                                                                                                                                 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
   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, among defibrillator until the battery cools.
                     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 /A Page=0




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                                                                                                                                                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
   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 /A Page=0




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                                                                                                                                                    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
   5.10.12           Shutdown of Donor Referral Services At this time it has been determined that tissue
                     (DRS) Tissue Harvesting Co by FDA from DRS was sold or distributed to:
                     (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)", due to           • Global Orthopedic, Ellisville, MS
                     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 /A Page=0




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                                                                                                                                                    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
   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 tissue-   for testing once it is determined that they have
                     based products (HCT/Ps)", due to           received the recalled material. Refer to VHA
                     violations of Good Manufacturing           Directive 2005-049 ―Disclosure of Adverse
                     Practices (GMP).                           Events to Patients.‖
                     Recommended; Priority A                    DRS tissue AD06-06.pdf /A Page=0




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                                                                                                                                                 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
   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 a
                     All models of Alaris® SE infusion     keyboard entry registers twice while pressing the
                     pumps - formerly the Signature        key once. For example, an infusion rate intended
                                                           to be 4.0 mL/hr where a key bounce occurs,
                     Edition® Infusion System. Alaris is a 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 /A Page=0




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                                                                                                                                               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
   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 /A Page=0




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                                                                                                                                            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
   5.10.14           BCMA v3.0 Patch PSB*3.0*13 (AL06- Four facilities report that BCMA scanners are
                     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 /A Page=0




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   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
   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 /A Page=0




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                                                                                                                                                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
   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 for
                     incomplete set of images (missing a    the creation of a scout (localizer) image using the
                     slice) for review. The missing slice   Referenced Image Sequence field (0008,1140)
                     almost resulted in a spinal tumor
                     being missed. The facility was using   2) The operator performing the imaging
                     VistA Imaging Patch MAG*3*18           procedure chooses to generate a referenced
                     (released on June 16, 2006) to read    image sequence (done at the MRI console).
                     the images.


                                                            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

                                                            MAG*3*18 after the completion of the patch and
                     Mandatory; Priority A                  VistA Rad Patch MAG 318 AL07-01.pdf /A Page=0




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                                                                                                                                                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
   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 using   begin to do so until this sequencing problem is
                     VistA Imaging Patch MAG*3*18           corrected.
                     (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 /A Page=0




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                                                                                                                                              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
   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 is an
                     3) a user attempts to process a          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 /A Page=0




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                                                                                                                                               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
   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 associated
                     when the following conditions are      with BCMA,
                     present:
                                                          disabling CCOW in BCMA will reduce the
                     1) CPRS v26 and BCMA (post install probability of sites
                     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 facility
                     Patient B) via the CPRS “File/Select BCMA Coordinator must advise BCMA users that
                     Patient” patient selection             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 a
                     the “Problem Changing Clinical
                     Mandatory; Priority A                 CPRS CCOW AL07-03.pdf /A Page=0




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                                                                                                                                                 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
   5.11.3            Gemini PC series infusion pumps        Recommendations:
                     manufactured by Alaris,
                                                            1. DO NOT use medication pumps, or other
                     formerly IMED, (AD07-01).              medical devices that

                                                            are in need of repair.

                     A VA medical facility reported a
                     Gemini PC series infusion pump
                                                            2. As standard practice, operators of medical
                     exhibiting free flow while connected   devices should inspect and conduct operational
                     to a patient. Upon                     checks consistent with manufacturer
                                                            recommendations on all medical devices before
                     examination it was discovered that     use. If the device is found to be in need of repair,
                     the free-flow protection latch         it should be labeled as defective, removed from
                                                            service, and sent to biomedical engineering for
                     was broken. Discussions with other     service.
                     VA medical facilities confirm

                     that the free-flow protection latch on
                     the Gemini PC series infusion          3. For sites using the Gemini PC series referred
                                                            to in this Advisory,
                     pump is prone to breaking and
                     therefore commonly inspected           include inspection of the free-flow protection
                                                            latch in maintenance
                     before each use.
                                                            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 /A Page=0




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                                                                                                                            Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                     2007 Alerts & Advisors
   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 /A Page=0




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                                                                                                                                              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
   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 /A Page=0




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                                                                                                                                              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
   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 /A Page=0




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                                                                                                                                    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
   5.11.5      (continued)... Reprocessing of   ...(continued) (sterilization)
   (continued) resectoscope system’s working
               elements (used in                equipment – to determine if a device can be
                                                reprocessed using their reprocessing equipment
                     urology) (AD 07-03)        – 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 /A Page=0




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                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     2007 Alerts & Advisors
   5.11.6            Privacy curtains and privacy curtain   Locked mental health unit sleeping rooms -
                     support structures (e.g., track        provided with privacy

                     and track supports) in locked mental curtains to meet patient privacy needs - conflict
                     health units. (AL07-04).             with the need to

                                                            keep patients safe from self harm. Patient
                                                            privacy is important;
                     A VAMC reported that a patient used
                     a privacy curtain (and its            however, patient safety must come first. Privacy
                                                           curtains and their
                     support) in a sleeping room located
                     in a locked mental health unit to     components are not appropriate in this protected
                     commit suicide by hanging. The        environment.
                     patient used the privacy curtain as a
                     noose - knotting it to make it more   A review of inpatient suicide and parasuicide
                     rope-like while it remained attached events in VHA over the past 5 years reveals that
                     to the curtain support structure. The approximately 54% of the reported
                     entire system supported the full
                     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 /A Page=0




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                                                                                                                                                  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
   5.11.6      (continued)... Privacy curtains and           ...(continued) business (COB) Friday, February
   (continued) privacy curtain support structures            23, 2007
               (e.g., track
                                                          identify every location accessible to patients in
                     and track supports) in locked mental your locked mental
                     health units. (AL07-04).
                                                          health units that have privacy curtains and/or
                                                          support systems for

                     A VAMC reported that a patient used the curtains and remove the curtains.
                     a privacy curtain (and its

                     support) in a sleeping room located
                     in a locked mental health unit to       2. By COB Friday, March 9, 2007 remove any
                     commit suicide by hanging. The          privacy curtain
                     patient used the privacy curtain as a
                     noose - knotting it to make it more     supportive structures (e.g. tracks and track
                     rope-like while it remained attached    supports) that could be used as an anchor for
                     to the curtain support structure. The   suicide by hanging.
                     entire system supported the full
                     weight of the patient.

                     Mandatory; Priority A                   Privacy Curtain AL07-04.pdf /A Page=0




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                                                                                                                                               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
   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 of
                     C50A2, C50A3                         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 /A Page=0




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                                                                                                                                           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
   5.11.7      (continued)... Medtronic Vitatron      ...(continued) Pacemaker Surveillance Center
   (continued) dual chamber cardiac pacemakers T-     intranet website
               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 /A Page=0




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                                                                                                                                              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
   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 /A Page=0




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                                                                                                                                                 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
   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 /A Page=0




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                                                                                                                                               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
   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 /A Page=0




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                                                                                                                                          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
   5.11.9      (continued)... Boston Scientific        ...(continued) a through c. It is important that ALL
   (continued) Corporation’s Cardiac Rhythm            INFORMATION sources be reviewed to insure
               Management Division (previously         that patients will not be missed, as they may be
               called Guidant) recall of Implantable   found on one list and not on another. a) Review
               Cardiac Defibrillators (ICDs) and       the manufacturers letters (see the links under
               Cardiac Resynchronization Therapy       Additional Information). b) Retrieve and review a
               Defibrillators (CRT-Ds), (AL07-07).     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 /A Page=0




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                                                                                                                                                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
   5.11.10           Shelhigh, Inc. implantable medical     FDA states that the company‘s deficiencies could
                     products, (AL07-08).                   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 neurosurgery),
                     On April 17, 2007, the FDA seized all annuloplasty rings to repair heart valves, and
                     implantable medical products from      arterial grafts.
                     Shelhigh, Inc. and on May 2, 2007,
                     the FDA issued a press release
                     disclosing a formal request to
                     Shelhigh, Inc., of Union, New Jersey These products have been issued under supplier
                     “to recall all of its medical products names of Shelhigh, Inc., Integra NeuroSciences,
                     remaining in the marketplace           and Integra LifeSciences Corp.
                     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 /A Page=0




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                                                                                 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
   5.11.10     (continued)... Shelhigh, Inc.                  ...(continued) that these physicians are aware of
   (continued) implantable medical products, (AL07-           this issue, especially if patients under their care
               08).                                           have already received one of the implants.



                     On April 17, 2007, the FDA seized all    a) Retrieve and review a list of your patients with
                     implantable medical products from        the affected
                     Shelhigh, Inc. and on May 2, 2007,
                     the FDA issued a press release           products, sent to your facility Patient Safety
                     disclosing a formal request to           Manager under
                     Shelhigh, Inc., of Union, New Jersey
                     “to recall all of its medical products   separate cover by secured FedEx. This list
                     remaining in the marketplace             includes all the
                     including hospital inventories,
                     because of sterility concerns.”          patients in the VHA Prosthetics database that
                     Shelhigh, Inc. does not agree with       have implanted
                     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 /A Page=0




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                                                                               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
   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 provider
                     variable dose medications in BCMA       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 /A Page=0




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                                                                               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
   5.11.11     (continued)... BCMA Double Scans              ...(continued) medication is automatically entered
   (continued) Alert (AL 07-09).                             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 /A Page=0




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                                                                                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
   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 is    subject. Aside from general cautions regarding
                     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 first   patient care other than minimal risk associated
                     Sunday of November beginning this         with time stamp issues.
                     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 /A Page=0




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                                                                                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
   5.11.12     (continued)... Daylight Saving Time             ...(continued) patches made available by medical
   (continued) (DST) changes, (AD07-04)                        equipment manufacturers to address DST.



                     With the passage of the Energy            Note: Software patches from sources other than
                     Policy Act of 2005 the start of DST is    the medical device manufacturer cannot be
                     changed from the first Sunday in          installed on medical devices without the explicit
                     April to the second Sunday in March       consent of the medical device manufacturer.
                     and the end of DST is changed from
                     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 /A Page=0




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                                                                             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
   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 section exterior connecting corridors between buildings
                     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 suspended
                     buildings collapsed and fell through ceiling, inspect the plaster lathe system at
                     an existing suspended ceiling,        approximately 8 foot intervals down the length of
                     injuring two patients. The exterior   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 plaster
                     recent rains was a factor; however, ceiling that is showing signs of deterioration
                     the wire lathe and fasteners securing and/or damage and prevent patients, staff or
                     the ceiling to the wood rafters and   visitors from using the exterior connecting
                     ties showed advanced deterioration. corridor between buildings until it is 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 before
                     Mandatory; Priority A                 NCPS Alert AL07-10.pdf /A Page=0




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                                                                              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
   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 project
               buildings. (AL07-10)                        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 the
                     An approximately twenty foot section VISN NRM 2008 operating plans. VISNs should
                     of a plaster ceiling over an          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 /A Page=0




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                                                                                Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                   Not
                                                                                                                                 Met   Partially   Met If score other than 'met' what are
                     Question:                               Rationale/Assessment Methods:                                       (1)   Met (2)     (3) possible root causes
                     Cognitive Aids
   6.1.1             Is the Anesthesia Cognitive Aid         Safety Staff to talk about implementation of the
                     provided on all anesthesia              aid and give feedback on how the aid was
                     machines?                               received by affected staff. Look for aid on
                                                             anesthesia machines when walking the OR.
                     Recommended; Priority C                 cognitive_aids_anesthesiology.pdf /A Page=0
                     Cognitive Aids
   6.1.2             Are the American Heart Association      Safety Staff to talk about implementation of the
                     Handbooks being used and well           aid and give feedback on how the aid was
                     received on all facility crash carts?   received by affected staff. This aid should be
                                                             attached to all code carts in the facility.

                     Communication of Patient Tests Results
   6.2.1             Does the facility have a written policy Policy should include: 1) Description of the
                     for communication of emergent or        process for communication of test results to the
                     abnormal diagnostic findings?           requesting providers (or surrogates) and how
                                                             and when the documentation of this
                                                             communication should occur.
                     Mandatory; Priority A                   VHA Directive 2003-043 Test Results.pdf /A Page=0
                     Communication of Patient Tests Results
   6.2.1.1           Is there a process to address the Often reports from these entities do not get
                     receipt of fee basis and outside  placed in the electronic record due to limited or
                     contract diagnostic practitioner  no access. However, the facility should
                     reports?                          recognize this vulnerability and ensure a process
                                                       exists to address situations so these results are
                                                       entered with the medical record.
                     Recommended; Priority B                 VHA Directive 2003-043 Test Results.pdf /A Page=0
                     Communication of Patient Tests Results
   6.2.2             Are all results (positive or negative) Documentation should include appropriate test
                     documented electronically by the       related patient history to assist radiologist,
                     diagnostic provider in the patients    laboratory, or nuclear medicine personnel in
                     medical record in a timely manner? making a judgment call on critical findings. A
                                                            standard process should be in place to handle
                                                            fee basis and outside contract reports which
                                                            often do not get scanned in the electronic chart.

                                                             IL 10-2002-017.pdf /A Page=0
                     Mandatory; Priority A                   VHA Directive 2003-043 Test Results.pdf /A Page=0




Policies, Tools Aids - 6                                                              Policies, Tools Aids - 6 - Version: 2007                                                        225 of 480
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                                                                                Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                  Not
                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                               Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     Communication of Patient Tests Results
   6.2.3             Are emergent and abnormal               Direct communication is defined as face-to-face
                     diagnostic test results communicated telephone conversation; or via a hand carried
                     directly from the diagnostic            report (electronic communication does not
                     practitioner to the ordering            suffice). This direct communication (from the
                     practitioner or ordering practitioner’s diagnostic practitioner to the ordering practitioner
                     appropriate surrogate?                  or his/her surrogate) and any subsequent
                                                             change in care plan must be documented in the
                                                             VistA computer system. The test results and
                                                             care plan changes must also be communicated
                                                             to the patient and/or family by the ordering
                                                             practitioner (or surrogate).

                     Mandatory; Priority A                   VHA Directive 2003-043 Test Results.pdf /A Page=0
                     Communication of Patient Tests Results
   6.2.4             Has the communication process for Has the communication process for contacting
                     contacting treating providers in the treating providers in the event of a diagnostic
                     event of a diagnostic abnormal or    abnormal or emergent test result been simplified
                     emergent test result been simplified in the facility?
                     in the facility?
                     Mandatory; Priority B
                     Patient Safety Performance Measures
   6.3.1             Has the timely verification of   "Measure 16: Radiology – Timeliness of
                     radiology reports been addressed Verifying Reports.
                     appropriately to meet the 2007   Indicator: Percent of imaging reports verified
                     Patient Safety Performance       within two days. Practices that aid in timely
                     Measures (Measure 16)?           follow up are: Use of PACS system; avoidance
                                                      of pre-registering patients; the use of voice
                                                      recognition transcribing; sending subspecialty
                                                      images to facilities with staff/capacity; using
                                                      electronic transmission for images acquired at
                                                      CBOCs rather than printed images that require
                                                      manual transport via van; Provide weekend and
                                                      off-tour coverage; and, implementing
                                                      teleradiology, including VISN-wide teleradiology."

                                                             07 Measure 16.doc #0
                     Mandatory; Priority A                   Improving Radiology Reporting.pdf /A Page=0




Policies, Tools Aids - 6                                                             Policies, Tools Aids - 6 - Version: 2007                                                        226 of 480
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                                                                            Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                               Not
                                                                                                                             Met   Partially   Met If score other than 'met' what are
                     Question:                          Rationale/Assessment Methods:                                        (1)   Met (2)     (3) possible root causes
                     Patient Safety Performance Measures
   6.3.2             Has the Surgical Care Improvement "Components measured and indicators are: 14a1
                     Project (SCIP) addressed           Prophylactic Antibiotics Began timely: Percent of
                     appropriately to meet the 2007     patients receiving prophylactic antibiotic within
                     Patient Safety Performance Measure one hour prior to surgical incision.14a2 Correct
                     (Measure 14)?                      Prophylactic Antibiotic Given: Percent of patients
                                                        receiving prophylactic antibiotics consistent with
                                                        current guidelines (specific to each type of
                                                        surgical procedure). 14a3 Prophylactic
                                                        Antibiotic Discontinued Timely: Percent of
                                                        patients with prophylactic antibiotic discontinued
                                                        within 24 hours after surgery end time (48 hours
                                                        for CABG and cardiac surgery).
                                                        14a4 Cardiac Surgery Patients with Controlled
                                                        Serum Glucose: Percent of cardiac surgery
                                                        patients with controlled 0600 post operative
                                                        serum glucose. 14a5 Normothermia and
                                                        Colorectal Surgery: Percent of colorectal surgery
                                                        patients with immediate normothermia within the
                                                        first 10 minutes of admission to PACU.14a6
                                                        Surgery Patients with Appropriate Hair Removal:
                                                        Percent of patients with appropriate surgical site
                                                        hair removal."
                                                          FY06 Tech Manual Revision 1-06.pdf /A Page=160
                     Mandatory; Priority A                07 Measure 14.doc #0




Policies, Tools Aids - 6                                                          Policies, Tools Aids - 6 - Version: 2007                                                        227 of 480
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                                                                                Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                  Not
                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                             Rationale/Assessment Methods:                                        (1)   Met (2)     (3) possible root causes
                     Patient Safety Environmental Concerns
   6.4.1             Is the Domestic hot water             "Facility should have a local policy that
                     temperature controlled via regulating addresses criteria listed in the related VA
                     hardware and preventative             Directive, such as the risk assessment process,
                     maintenance inspections/checks?       search procedures, and staff training plan.
                                                           Review documents to verify. Also if a patient is
                                                           determined missing, the local law enforcement
                                                           should be contacted and the patient put into the
                                                           National Crime Information Computer (NCIC)
                                                           system. These agencies must also be informed
                                                           in a timely manner to cancel this alert when a
                                                           missing patient is recovered. This policy should
                                                           not preclude those Police and Security Services
                                                           units from entering this data themselves
                                                           provided they have the capability to do so."

                                                             JCAHO_CAMH.pdf /A Page=349
                     Mandatory; Priority A                   VHA Directive 2002-073.pdf /A Page=0
                     Escape & Elopement Prevention
   6.5.1             Does the facility have a written plan   Facility should have a local policy that addresses
                     to help prevent wandering and           criteria listed in the related VA Directive, such as
                     missing patient events and a process    the risk assessment process, search procedures,
                     to manage the events that do occur?     and staff training plan. Review documents to
                                                             verify. Also if a patient is determined missing, the
                                                             local law enforcement should be contacted and
                                                             the patient put into the National Crime
                                                             Information Computer (NCIC) system. These
                                                             agencies must also be informed in a timely
                                                             manner to cancel this alert when a missing
                                                             patient is recovered. This policy should not
                                                             preclude those Police and Security Services
                                                             units from entering this data themselves
                                                             provided they have the capability to do so.

                     Mandatory; Priority A                   VHA Directive 2002-013.pdf /A Page=0




Policies, Tools Aids - 6                                                             Policies, Tools Aids - 6 - Version: 2007                                                        228 of 480
                                                             NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                    Not
                                                                                                                                  Met   Partially   Met If score other than 'met' what are
                     Question:                               Rationale/Assessment Methods:                                        (1)   Met (2)     (3) possible root causes
                     Escape & Elopement Prevention
   6.5.2             Are Missing Patient incidents both      Actual SAC score of 3 requires an individual
                     adverse events, and, close calls with   RCA to be done. All others should be an
                     a SAC potential score of 3,             aggregated review (twice per FY) focusing on
                     addressed via the Aggregate Review      fixing related processes.
                     Process?
                                                             VHA Directive 2002-013.pdf /A Page=0
                     Mandatory; Priority A                   VHA PS Handbook.pdf /A Page=0
                     Escape & Elopement Prevention
   6.5.2.1           Does the missing patient event log      The Missing Patient Aggregated Review Log
                     capture the information outlined in     should contain the following 17 elements for
                     SPOT for each case?                     each event and close call: Case number, Age,
                                                             Date, Time & Location reported missing; Length
                                                             of time missing; Level of privileges; Previous
                                                             episodes; if treatment plan reflects an order of
                                                             supervision; primary diagnosis; persons notified
                                                             (name, date and time); type of search conducted
                                                             (general or grid); date and location found;
                                                             condition (injuries); barriers to prevent escape or
                                                             elopement; and, activity at time of elopement or
                                                             escape.
                     Mandatory; Priority A                   Agg review criteria.pdf /A Page=0
                     Escape & Elopement Prevention
   6.5.2.2           Does the information captured in the    The purpose of capturing information in the log is
                     log used to drive the root causes,      for the aggregate team to analyze trends in the
                     actions and outcomes in the             data collected to help determine where there is a
                     aggregated reports?                     need to focus, such as a particular facility
                                                             location, time of day, patient population, etc.

                     Mandatory; Priority A                   Agg review criteria.pdf /A Page=0




Policies, Tools Aids - 6                                                               Policies, Tools Aids - 6 - Version: 2007                                                        229 of 480
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                                                                               Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                 Not
                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     Escape & Elopement Prevention
   6.5.3             Are drills conducted for the search of Missing Patient Drills that integrate findings from
                     missing patients?                      environmental rounds or other patient safety
                                                            processes (such as aggregated RCAs), must be
                                                            conducted that at each medical center or site of
                                                            jurisdiction, including CBOCs. Once staff have
                                                            received initial training, additional drills must be
                                                            conducted at least annually to effectively
                                                            evaluate known areas of vulnerability throughout
                                                            and surrounding the facility. Once staff are fully
                                                            trained, an actual search during which the
                                                            search plan is fully implemented and a critique is
                                                            completed may take the place of the drill for the
                                                            shift involved in the actual search. It is
                                                            recommended that the sites for missing patient
                                                            drills be prioritized based on known areas of
                                                            vulnerability and lessons learned from RCAs and
                                                            other risk management or performance
                                                            improvement processes.

                     Mandatory; Priority A                  VHA Directive 2002-013.pdf /A Page=0
                     Escape & Elopement Prevention
   6.5.4             Is there an existing patient escape    Show example of an assessment and tools. The
                     and elopement risk assessment          NCPS Cognitive Aid is one example of a tool that
                     conducted for all patients? If so      could be used.
                     what tools are used?
                                                            Escape Elopement Cognitive Aid.pdf /A Page=0
                     Mandatory; Priority A                  JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                     Escape & Elopement Prevention
   6.5.5             What additional policies or            Examples would be: Independent polices on
                     procedures does the facility have in   topics such as Patient Privileging, Supervision
                     place to prevent missing patients?     and/or Surveillance; monitoring/assessing
                                                            hazardous areas (such as
                                                            maintenance/construction areas), etc.
                     Mandatory; Priority A                  VHA Directive 2002-013.pdf /A Page=0




Policies, Tools Aids - 6                                                            Policies, Tools Aids - 6 - Version: 2007                                                        230 of 480
                                                           NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                  Not
                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                             Rationale/Assessment Methods:                                        (1)   Met (2)     (3) possible root causes
                     Escape & Elopement Prevention
   6.5.5.1           What measures are taken with          Examples would be: use of electronic devices
                     patients identified as high-risk?     (with comprehensive testing regimen - i.e. check
                                                           every 24 hours; regular preventive maintenance
                                                           checks, and annual performance testing); special
                                                           precautions for field trips and transporting; and
                                                           patient identification.
                     Mandatory; Priority A                 VHA Directive 2002-013.pdf /A Page=0
                     Fall Prevention
   6.6.1             Are Fall incidents both adverse       Actual SAC score of 3 requires an individual
                     events, and, close calls with a SAC   RCA to be done. All others should be an
                     potential score of 3, addressed via   aggregated review (once per FY quarter)
                     the Aggregate Review Process?         focusing on fixing related processes.

                                                           completefallstoolkit.pdf /A Page=0
                     Mandatory; Priority A                 VHA PS Handbook.pdf /A Page=0
                     Fall Prevention
   6.6.2             Does the patient falls event log      The Patient Falls Aggregated Review Log should
                     capture the information outlined in   contain the following 11 elements for each event
                     SPOT for each case?                   and close call: Case number; Age; Sex; Event
                                                           (day, date, time); Outpatient/Inpatient status;
                                                           functional and cognitive factors; assistive
                                                           devices in use or ordered; communication issues
                                                           (staff to staff, staff to patient, etc.); environmental
                                                           factors; what happened and treatment plan;
                                                           other comments.

                     Mandatory; Priority A                 Agg review criteria.pdf /A Page=0
                     Fall Prevention
   6.6.3             Have facility Physical Therapists     Show example via review of SPOT team
                     been involved as team members for     membership data for aggregate review RCAs.
                     RCA's or Aggregate Reviews            Also talk with Physical Therapy Service to
                     involving Falls?                      determine their involvement.
                     Mandatory; Priority A                 JCAHO 2007 Goals - TIPS Article.pdf /A Page=0




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                                                                               Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                  Not
                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                             Rationale/Assessment Methods:                                        (1)   Met (2)     (3) possible root causes
                     Fall Prevention
   6.6.4             Does a process exist to conduct an    Review assessment/reassessment process. The
                     initial assessment, and subsequent    assessment methods and/or tools used should
                     reassessments as appropriate on all   be consistent throughout the facility. The
                     patients for fall risk?               reassessment process is determined at the
                                                           facility level, can be based on an interval of time
                                                           or on patient status change (transfer, medication,
                                                           fall incident, etc.).
                     Mandatory; Priority A                 JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                     Fall Prevention
   6.6.4.1           NCPS Falls Toolkit and Fall           The Falls Toolkit provides a compendium of
                     Prevention and Management             practical suggestions to improve falls programs
                     cognitive aid been distributed and    and reduce falls and injuries from falls.
                     used?                                 Templates, successful practices, cognitive aids
                                                           and advice on measuring are all included in their
                                                           resources. The Fall Prevention an Management
                                                           is an older NCPS cognitive aid that can also
                                                           helpful to determine assessment and prevention
                                                           methods.
                     Recommended; Priority B               completefallstoolkit.pdf /A Page=0
                     Fall Prevention
   6.6.5             Does the facility have effective tools Review any and evaluate effectiveness (I.e. Hip
                     or specialized equipment used in the Pads, patient surveys, labeling high risk patients,
                     facilities fall prevention strategy?   use of non-skid socks, Morse Fall Risk
                                                            Assessment, floor mats, walkers, canes, etc.)

                     Recommended; Priority A
                     Fall Prevention
   6.6.5.1           Are these processes, tools or           It is important that the off shifts are given
                     equipment available to all staff on all concurrent tools and opportunities to improve the
                     shifts?                                 care of our patients.
                     Recommended; Priority A




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                                                                             Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                Not
                                                                                                                              Met   Partially   Met If score other than 'met' what are
                     Question:                           Rationale/Assessment Methods:                                        (1)   Met (2)     (3) possible root causes
                     Magnetic Resonance (MR) Imaging Safe Practices
   6.7.1             Does the facility have a written MR Review written plan. The program should
                     Safety Program?                     include: The appointment of an MRI Officer; how
                                                         to secure MRI areas; a current list of MRI
                                                         compatible equipment in the facility; and training
                                                         requirements. Written documents should be
                                                         reviewed/updated at least annually
                                                           ACR MR Safety Guidelines.pdf /A Page=1
                     Mandatory; Priority B                 MRIHazard Summary.pdf /A Page=0
                     Magnetic Resonance (MR) Imaging Safe Practices
   6.7.2             Is there an on going training and    Review training materials, plan and training
                     competency program for all effected records. Check to see if that not only necessary
                     staff that covers hazard recognition clinical personnel are trained, but that
                     and policies/procedure?              emergency, transport, maintenance,
                                                          housekeeping, security, and medical
                                                          residents/fellows are included as well. If clinical
                                                          or support are not trained they should not be
                                                          allowed to work in the direct vicinity of the MR
                                                          equipment.
                     Recommended; Priority B               MRIHazard Summary.pdf /A Page=0
                     Magnetic Resonance (MR) Imaging Safe Practices
   6.7.3             Are MR technicians                    Review training materials, training plan, and
                     trained/competent in the specifics of records. "Specifics of MRI Safety" include items
                     MR safety?                            such as positioning of conductive leads, cables,
                                                           sensors, and the patients' extremities; and
                                                           precautions required for unconscious patients.

                     Recommended; Priority B               MRIHazard Summary.pdf /A Page=0
                     Magnetic Resonance (MR) Imaging Safe Practices
   6.7.4             Has the MR noise level been         MR scans can be loud with noise levels
                     assessed and patients provided with exceeding 100 dBA depending upon the type of
                     hearing protection if needed?       magnet (open or closed), the design and the
                                                         manufacturer. Interview staff, check required
                                                         policy procedure, look for posted signs.

                     Recommended; Priority B




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                                                                               Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                 Not
                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                          Rationale/Assessment Methods:                                          (1)   Met (2)     (3) possible root causes
                     Magnetic Resonance (MR) Imaging Safe Practices
   6.7.5             Has the MR Hazard Supplement       The Hazard Summary published by NCPS in
                     developed by NCPS been shared      2001 can serve as a guideline and a reference
                     with all MR staff and discussed to for those working in an MR environment. This
                     determine what barriers are being  Hazard summary can be found on the NCPS
                     implemented locally to prevent     intranet and internet websites:
                     adverse events?                    vaww.ncps.med.va.gov or www.patientsafey.gov

                     Recommended; Priority B
                     Magnetic Resonance (MR) Imaging Safe Practices
   6.7.6             Has a plan been developed and       Regular code drills should be conducted in the
                     tested to address patients who need MR environment to help acclimate medical
                     emergency care (code) within the    responders to a consistent approach of removing
                     MR room?                            the patient from the magnet area.
                     Recommended; Priority B
                     Medication Use Process Safety Concerns
   6.8.1             Is VHA Quality Directive for Unit- Facility is required to have a written policy within
                     Dose Packaging and Barcode         each inpatient pharmacy; and, all Medication
                     Labeling being followed?           must have machine-readable bar-coded labels.

                                                           Quality unit-dose barcode.pdf /A Page=0
                     Mandatory; Priority A                 VHA PS Handbook.pdf /A Page=23
                     Medication Use Process Safety Concerns
   6.8.1.1           Are measurables of this directive BCMA coordinators are responsible for
                     being followed up on?             establishing baseline data and measuring the
                                                       process over time. Also direct observation must
                                                       be done to determine the scannability of different
                                                       medications for a total of twenty observations per
                                                       quarter. Assessor to review related
                                                       documentation to verify.
                     Mandatory; Priority A                 Quality unit-dose barcode.pdf /A Page=0
                     Medication Use Process Safety Concerns
   6.8.2             Are patients educated regarding their Review patient education policy related to
                     prescribed medication, as inpatients medication education. The facility should have a
                     and as part of the discharge          standard approach throughout the organization.
                     process?
                                                           ISMP_Book.pdf /A Page=0
                     Recommended; Priority A               JCAHO_CAMH.pdf /A Page=0




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                                                                               Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                 Not
                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                          Rationale/Assessment Methods:                                          (1)   Met (2)     (3) possible root causes
                     Medication Use Process Safety Concerns
   6.8.3             Does the facility have contingency Review plan, interview staff.
                     plans in place for the loss of the
                     CPRS, POE, BCMA, and VISTA
                     system?
                     Mandatory; Priority A
                     Medication Use Process Safety Concerns
   6.8.3.1           Have these information system        It is important to ensure your contingency plans
                     contingency plans been tested (via a are realistic and workable, it is not ideal to find
                     drill), which included a             faults in the plan at the time of an emergency.
                     debriefing/critique?                 After testing, if problems are found the plan
                                                          should be adjusted accordingly.
                     Recommended; Priority A
                     Misidentification Prevention
   6.9.1             Is there a SOP for ordering,           VHA Directive requires a written Standard
                     processing, transporting, and          Operating Procedure regarding verification of
                     transfusing blood or blood products    patients' identification. Assessor to review SOP.
                     according to VHA Directive 1200-
                     029, Transfusion verification and
                     identification requirements of all
                     Sites?
                     Mandatory; Priority A                  VHA Directive 2005-029.pdf /A Page=0




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                                                                              Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                 Not
                                                                                                                               Met   Partially   Met If score other than 'met' what are
                     Question:                           Rationale/Assessment Methods:                                         (1)   Met (2)     (3) possible root causes
                     Medical/Surgical Resident PS Involvement (ACGME)
   6.10.1            Have patient safety topics,         Incorporating patient safety at the prime level of
                     exercises, and educational          medical training can fulfill some requirements of
                     opportunities been incorporated in  the Accreditation Council on Graduate Medical
                     the resident training/curriculum at Education (ACGME). And thereby help your
                     your facility?                      university affiliate meet new and challenging
                                                         education requirements. Having residents on
                                                         RCA teams or teaching them patient safety is an
                                                         upstream method for engraining patient safety
                                                         practices into the medical field. Other benefits
                                                         are: the learning of basic tools for root cause
                                                         analysis and human factors system design to
                                                         help them problem solve when patient safety
                                                         events occur during their practices; increase
                                                         awareness of patient safety issues; increase
                                                         participation on RCA teams; and promote patient
                                                         safety event reporting. Finally, some state laws
                                                         require medical students and residents to learn
                                                         about and participate in patient safety (e.g.,
                                                         Florida).

                                                          http://www.acgme.org/outcome/comp/compFull.asp #0
                     Recommended; Priority B              http://www.patientsafety.gov/curriculum/index.html #0




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                                                                              Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                Not
                                                                                                                              Met   Partially   Met If score other than 'met' what are
                     Question:                            Rationale/Assessment Methods:                                       (1)   Met (2)     (3) possible root causes
                     Surgical and Invasive Procedures Safety
   6.11.1            Is a surgical policy been developed Policy should address: pre-closing wound
                     and implemented to meet the criteria exploration for every case; towels, sponges,
                     in the VHA Directive 2006-030        pads, etc. are not to be cut or used for dressings
                     Prevention of Retained Surgical      and must be detectable by radiograph; counting
                     Items?                               methods must comply with AORN standards;
                                                          sponges, towels, pads and sharps must be
                                                          counted in all applicable cases; if count is
                                                          incorrect staff must inform surgeon, conduct a
                                                          search, and radiography of the surgical field
                                                          must be done with a radiology interpretation with
                                                          in 30 minutes where applicable; requirement for
                                                          divergence from standard practice to be
                                                          documented. Policy should also include special
                                                          precautions for high risk surgeries, and indicate
                                                          the a process in place to locally review all
                                                          retained items close calls and adverse events
                                                          and require them to be reported appropriately to
                                                          NCPS.

                     Mandatory; Priority A                 VHA Directive 2006-30.pdf /A Page=0
                     Surgical and Invasive Procedures Safety
   6.11.2            Has the Ensuring Correct Surgery  To meet the Directive the following must be met:
                     Directive been fully implemented? (1) A local policy is in place that incorporates the
                                                       steps as described on the correct Site Surgery
                                                       poster. (2) The execution of these steps is
                                                       documented in the patient's record. (3) The
                                                       implementation of the steps and conformance to
                                                       the local policy are monitored for compliance.

                     Mandatory; Priority A                 VHA Directive 2004-028 (2002-070).pdf /A Page=0




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                                                                                  Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                     Not
                                                                                                                                   Met   Partially   Met If score other than 'met' what are
                     Question:                               Rationale/Assessment Methods:                                         (1)   Met (2)     (3) possible root causes
                     Surgical and Invasive Procedures Safety
   6.11.3            Is a written local policy in place that A local written policy can be incorporated into an
                     address moderate sedation done by overall facility sedation and anesthesia care
                     non-anesthesia providers?               policy. Moderate sedation section should
                                                             include: requirement for privileged staff to be
                                                             involved in the planning and providing for
                                                             moderate sedation; patient chart shall include
                                                             history and physical that is done less than 30
                                                             days prior to procedure; all assessments must
                                                             be signed by a licensed independent practitioner
                                                             prior to sedation; a re-evaluation should occur
                                                             immediately before procedure, with vital signs
                                                             documented; requirement that sufficient numbers
                                                             of qualified staff are present during sedation.
                                                             Also, the policy should address staff that
                                                             administer, monitor, and/or supervise moderate
                                                             sedation have had competency based education,
                                                             training and experience that follow criteria
                                                             required in the related VHA Directive.

                     Recommended; Priority A                VHA Directive 2006-023.pdf /A Page=0
                     Surgical and Invasive Procedures Safety
   6.11.4            Is there an effort being made to  "IHI has recognized four practices that may help
                     reduce surgical complications?    to reduce the occur ace of surgical
                                                       complications. 1. Surgical Site Infection
                                                       Prevention 2. Beta Blockers for Patients on Beta
                                                       Blockers Prior to Admission 3. Venous
                                                       Thromboembolism (TVE) Prophylaxis 4.
                                                       Ventilator-Associated Pneumonia Prevention
                                                       (For postoperative patients) Each of the
                                                       recommendations have a set of criteria. See the
                                                       IHI How to guides for more information."
                                                            IHI 5 Milion Lives Kit - Reduce Surgical Complications.doc #0
                     Recommended; Priority B                IHI 5 Million Lives Kit - Prevent Surgical Site Infections.doc #0
                     Violence Prevention
   6.14.1            Are there existing processes,          Review written policy.
                     policies, or protocols that address
                     the handling of violent patients?
                     Mandatory; Priority A                  JCAHO_CAMH.pdf /A Page=0




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                                                                                  Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                     Not
                                                                                                                                   Met   Partially   Met If score other than 'met' what are
                     Question:                                 Rationale/Assessment Methods:                                       (1)   Met (2)     (3) possible root causes
                     Violence Prevention
   6.14.2            Has the facility and/or VISN              It is VHA policy that all facilities must have
                     implemented the use of behavioral         installed the required patches and initiated
                     patient record flags (PRFs) into the      facility-wide use of Behavioral Patient Record
                     medical record (CPRS/VIST-A) to           Flags (PRFs). Ensure that Category I Behavioral
                     indicate a potentially violent patient?   PRFs are originated and accessible. Individual
                                                               Networks and facilities determine whether
                                                               optional Category II PRFs are to be used.
                                                               Category definitions are found in related VHA
                                                               Directive.
                     Mandatory; Priority A                     VHA Directive 2003-048.pdf /A Page=0
                     Hospital Acquired Infections Prevention
   6.15.1            Has the recommendations for the        Prevention recommendations are: early
                     prevention of Norovirus (Norwalk-like identification; implementation of contact
                     viruses) in VHA Information Letter IL- precautions of infected patients (48-hours post
                     10-2007-010 been applied?              symptoms); infected staff should remain off duty
                                                            (48-hours post symptoms); cleaners to wear
                                                            masks; patient and staff hand hygiene and
                                                            training; and, environment of care cleaning
                                                            regimen (outlined in Information Letter) if
                                                            contamination of an area has occurred.

                                                               noro-factsheet.pdf /A Page=0
                     Recommended; Priority B                   IL 10-2007-010 noro.pdf /A Page=0
                     Hospital Acquired Infections Prevention
   6.15.2            Have stringent institutional practices The following precautions are recommended in
                     that minimize the potential for spread the care of patients with C. Difficile: caregiver
                     and transmission of C. difficile been should use gloves when in contact with the
                     implemented?                           patient along with the use of antimicrobial soap
                                                            after care is given (alcohol based hand rubs may
                                                            not be sufficient); private patient rooms should
                                                            be provided and disposable rectal thermometers
                                                            should replace electronic devices for affected
                                                            patients."
                     Recommended; Priority B                   USH IL-10-2005-018.pdf /A Page=0




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                                                          NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                Not
                                                                                                                              Met   Partially   Met If score other than 'met' what are
                     Question:                          Rationale/Assessment Methods:                                         (1)   Met (2)     (3) possible root causes
                     Hospital Acquired Infections Prevention
   6.15.3            Has an influenza vaccination       It is VHA policy that a program be implemented
                     program been implemented?          at the recommendation of the CDC Advisory
                                                        Committee on Immunization Practices. The
                                                        program should include vaccinating target
                                                        groups; indications of who should not be
                                                        vaccinated; which vaccine of the two available in
                                                        the US should be given to which target groups;
                                                        the requirement of patient consent and education
                                                        about the vaccines given; required
                                                        documentation of related adverse events; and
                                                        the use of antiviral agents for Influenza. The VA
                                                        influenza Toolkit Manual for 2006-2007 offers
                                                        strategies for implementation.

                                                           VA_Flu_Manual_06-07.pdf /A Page=0
                     Mandatory; Priority A                 VHA Directive 2006-058 FLU.pdf /A Page=0
                     Hospital Acquired Infections Prevention
   6.15.4            Has the MRSA Initiative been       The Methicillin-Resistant Staphylococcus Aureus
                     implemented at the facility?       (MRSA) Initiative was set forth in the VHA
                                                        Directive 2007-002. It includes the
                                                        implementation of the following: Active
                                                        Surveillance/Screening on unit where the
                                                        initiative has been implemented; where patients
                                                        are found positive Contact Precautions are
                                                        required (defined by CDC) and the patient will
                                                        become "flagged" as being positive until testing
                                                        negative; the Hand Hygiene program plays an
                                                        important role with MRSA-positive patients and
                                                        should be in place. The Resources required to
                                                        fully implement this Directive are: adequate
                                                        staffing in the Laboratory to support the initiative;
                                                        and the appointment of an MRSA Initiative
                                                        Coordinator.

                                                           CDC Isolation2007.pdf /A Page=0
                     Mandatory; Priority A                 VHA Directive 2007-002.pdf /A Page=0




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                                                                              Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                Not
                                                                                                                              Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                     (1)   Met (2)     (3) possible root causes
                     Hospital Acquired Infections Prevention
   6.15.5            Are measures in place for preventing VHA prevention recommendations outlined in IL
                     myiasis and is there a process for     10-2007-007 are to: standardize wound care
                     intervention if myiasis is discovered? needs through an established policy/procedure,
                                                            protocol, and/or dedicated wound care team;
                                                            maintain wounds in accordance with Information
                                                            Letter criteria items 2.a.1 (b) through (g); ensure
                                                            staff patients and families are educated about
                                                            proper wound care; control the environment of
                                                            care by minimizing exposure to flies through
                                                            sanitation, waste removal, and physical
                                                            exclusions at window and door openings coupled
                                                            with positive air flow/air intake. If an infestation
                                                            occurs, the following is recommended: care for
                                                            the patient and mitigating the source of flies (use
                                                            of a standard procedure); appoint a single
                                                            person to lead mitigation efforts of pest control,
                                                            environment of care and public relations; and
                                                            identification of the genus and species. Myiasis
                                                            can be health care-associated or community
                                                            related and should be addressed with all patients
                                                            including, those who are homeless, have chronic
                                                            open skin (continued)...



                     Recommended; Priority B                USH IL-10-2007-009.pdf /A Page=0
               Hospital Acquired Infections Prevention
   6.15.5      (continued)... Are measures in place ...(continued) lesions, are comatose, or have
   (continued) for preventing myiasis and is there a other disabilities.
               process for intervention if myiasis is
               discovered?
                     Recommended; Priority B                USH IL-10-2007-009.pdf /A Page=0




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                                                          NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                     Not
                                                                                                                                   Met   Partially   Met If score other than 'met' what are
                     Question:                            Rationale/Assessment Methods:                                            (1)   Met (2)     (3) possible root causes
                     Hospital Acquired Infections Prevention
   6.15.6            Is there an effort being made to     Central venous catheters can disrupt the integrity
                     reduce the incidence of central line of the skin, making infection with bacteria and/or
                     infections?                          fungi possible. Infection may spread to the
                                                          bloodstream increasing the changes of sepsis
                                                          which can lead to death, and/or prolong
                                                          hospitalization. The Institute of Healthcare
                                                          Improvement's 100k Lives Campaign gives
                                                          detailed guidance on how to help reduce
                                                          incidence of occurrence by following the five
                                                          components of the "central line bundle." These
                                                          components are: 1) Hand hygiene; 2) Maximal
                                                          barrier precautions; 3) Chlorhexidine skin
                                                          antisepsis; 4) Optimal catheter site selection,
                                                          with subclavian vein as the preferred site for non-
                                                          tunneled catheters; 5) Daily review of line
                                                          necessity, with prompt removal of unnecessary
                                                          lines.
                     Recommended; Priority B               IHI 5 Million Lives Kit - Prevent Central Line Infections.doc #0
                     Hospital Acquired Infections Prevention
   6.15.7            Is there an effort being made to    VAP is the leading cause of death among
                     reduce the incidence of Ventilator- hospital-acquired infections. VAP can prolong
                     Associated Pneumonia (VAP)?         time spent on the ventilator, length of ICU stay,
                                                         and length of hospital stay after discharge from
                                                         the ICU. The Institute of Healthcare
                                                         Improvement's 100k Lives Campaign gives
                                                         detailed guidance on how to help reduce
                                                         incidence of occurrence by following the four
                                                         components of "the ventilator bundle." These
                                                         components are: 1. Elevation of the head of the
                                                         bed to between 30 and 45 degrees. 2. Daily
                                                         ―sedation vacation‖ and daily assessment of
                                                         readiness to extubate. 3. Peptic ulcer disease
                                                         (PUD) prophylaxis. 4. Deep venous thrombosis
                                                         (DVT) prophylaxis (unless contraindicated)
                                                           IHI 5 Million Lives Kit - Prevent Ventilator-Associated Pneumonia.doc
                     Recommended; Priority B
                                                           #0




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                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                   Not
                                                                                                                                 Met   Partially   Met If score other than 'met' what are
                     Question:                                Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     Fire Prevention for Patient Safety
   6.16.1            Has the facility abided by the           Actions for this Directive include: Implementation
                     directions set forth in VHA Directive-   of a local policy; and, Implementation of staffing
                     2004-037 Planning for Fire               levels for fire response based on assessed
                     Response?                                needs (for overnight patient care buildings not
                                                              fully sprinkler-protected the staff to patient ratio
                                                              is 1 responder to every 2 non-ambulatory
                                                              patients; or, overnight patient care buildings fully
                                                              sprinkler-protected the ratio is 1 responder to
                                                              every 4 non-ambulatory patients.)

                     Mandatory; Priority A                    VHA Directive 2005-037.pdf /A Page=0
                     Fire Prevention for Patient Safety
   6.16.2            Have the appropriate measures            A policy must be written and implemented that
                     been implemented to reduce the fire      addresses items below: Each facility must
                     hazard of smoking when oxygen            ensure that smoking is prohibited in patient
                     treatment is expected for inpatients     sleeping rooms; that oxygen cylinders/delivery
                     as required by VHA Directive 2006-       equipment are not permitted within smoking
                     021?                                     shelters; and patients who smoke are offered
                                                              nicotine replacement therapy. A fire-risk
                                                              assessment must be conducted for all new
                                                              oxygen therapy inpatients who smoke, with
                                                              reassessments as directed. Policy must also
                                                              stipulate that upon identification of high risk
                                                              inpatients the following actions are to be
                                                              implemented: A committee must review each
                                                              case to determine restrictions for environmental
                                                              or clinical requirements; and patient must be
                                                              assigned a to sleeping room that is either
                                                              protected by quick response sprinklers, or,
                                                              standard response sprinklers AND smoke
                                                              detection, or, located as close to the nursing
                                                              station as possible. Also, high-risk patients and
                                                              their family members/visitors must sign an
                                                              acknowledgment that smoking materials may not
                                                              be brought into the (continued)...
                     Mandatory; Priority A                    VHA Directive 2006-021.pdf /A Page=0




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                                                          NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                               Not
                                                                                                                             Met   Partially   Met If score other than 'met' what are
               Question:                                  Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
               Fire Prevention for Patient Safety
   6.16.2      (continued)... Have the appropriate        ...(continued) facility; and high-risk patients are
   (continued) measures been implemented to               be given fire-resistive sleep ware.
               reduce the fire hazard of smoking
               when oxygen treatment is expected
               for inpatients as required by VHA
               Directive 2006-021?
                     Mandatory; Priority A                VHA Directive 2006-021.pdf /A Page=0
                     Fire Prevention for Patient Safety
   6.16.2.1          Has appropriate action been taken    A policy must be written and implemented that
                     for home care patients who have      addresses items below: A fire risk assessment is
                     oxygen therapy prescribed as well?   conducted for all new oxygen therapy home care
                                                          patients with reassessments as directed;
                                                          contract serves must require education and/or
                                                          warning information for patients and
                                                          families/caregivers on the hazards of smoking
                                                          while oxygen is in use; vendor's checklist should
                                                          include inspection for warning signs, smoke
                                                          alarm and verification veteran has been
                                                          instructed to test alarms monthly, instructions for
                                                          oxygen use/shut off, and verification that
                                                          veteran/family/cohabitants are given fire/oxygen
                                                          hazard educational materials. Vendors are
                                                          required to notify clinical staff if smoke alarms
                                                          are not present or not functioning.


                     Mandatory; Priority A                VHA Directive 2006-021.pdf /A Page=0




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                                                            NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                   Not
                                                                                                                                 Met   Partially   Met If score other than 'met' what are
                     Question:                              Rationale/Assessment Methods:                                        (1)   Met (2)     (3) possible root causes
                     Other Patient Safety Initiatives
   6.17.1            Has a facility assessment of all       The 2001 VHA Patient Safety Alert on Bed
                     patient beds been completed in         Entrapment requires an assessment hospital
                     accordance with 2001 VHA Alert on      beds which address two entrapment zones.
                     Bed Rail Entrapment and 2005 FDA       Official FDA guidance was released in March
                     guidance to reduce entrapments with    2006 which addresses the assessment of 4
                     appropriate actions taken?             zones. Ensure the facility has initiated a hospital
                                                            wide assessment with marking of non-compliant
                                                            beds and a plan for replacement of these beds.

                                                            FDA Guidance to Reduce Entrapments 2006.pdf /A Page=0
                     Mandatory; Priority A                  BedEntrap.pdf /A Page=0
                     Other Patient Safety Initiatives
   6.17.2            Has the facility developed and         A policy must be written and implemented that
                     implemented a policy to address out-   addresses items below: Confirmation of
                     of-operating room airway               competence of staff who perform airway
                     management as accordance to VHA        management, and all trainees must be
                     Directive 2005-031?                    supervised by licensed independent practitioner
                                                            who is privileged for airway management or
                                                            equivalent; A requirement for use of devices to
                                                            confirm tube placement in concert with
                                                            auscultation, (i.e., portable capnography,
                                                            esophageal bulbs, syringes, or colorimeteric
                                                            devices) is required. Also, stipulation regarding
                                                            the use of esophageal detection devices (EDD)
                                                            and end-tidal carbon dioxide (ETCO2)
                                                            colorimeteric devices should be clarified via local
                                                            policy. This policy should only address out of the
                                                            operating room emergent/urgent situations, such
                                                            as a "code." Outpatient facilities are exempt
                                                            from having a local policy, if emergency airway
                                                            management is not performed in the facility.

                     Mandatory; Priority A                  VHA Directive 2005-031.pdf /A Page=0




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                                                        NCPS Patient Safety Assessment Tool

                                                                          Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                            Not
                                                                                                                          Met   Partially   Met If score other than 'met' what are
                     Question:                          Rationale/Assessment Methods:                                     (1)   Met (2)     (3) possible root causes
                     Other Patient Safety Initiatives
   6.17.3            Has the facility implemented       The recommendation are: Develop and
                     recommendations acordance USH IL   implement strategies to properly assess, treat,
                     10-2006-013 New JCAHO              and manage patients identified at risk for suicide;
                     Performace Requirement for         Document the relevant risk factors for suicide in
                     Mitgating the Risk of Suicide?     each patient's medical record; Document
                                                        treatment and the treatment setting in a manner
                                                        that addresses the presence of (or absence of)
                                                        relevant risk factors that increase risk for suicide;
                                                        Provide the appropriate telephone number(s) for
                                                        telephone calls during working hours and other
                                                        times, in writing, to at-risk patients;
                                                        Documentation of these instructions should be
                                                        recorded in the patient‘s medical record; Instruct
                                                        patients and their significant others to call the
                                                        facility's Emergency Department or Urgent Care
                                                        Center if they have a crisis situation; Ensure that
                                                        the local or regional mental health hotline knows
                                                        about VA as a resource in case a veteran should
                                                        contact them; and Ensure that the safety
                                                        concerns in the design of the inpatient mental
                                                        health unit (and its furnishings) are addressed.


                     Recommended; Priority B            USH IL-10-2006-13.pdf /A Page=0




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                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                   Not
                                                                                                                                 Met   Partially   Met If score other than 'met' what are
                     Question:                                Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                     Other Patient Safety Initiatives
   6.17.4            Has the facility developed and           This Directive stipulates implementing a policy
                     implemented a policy to address the      with the componets of this program, which are: A
                     sterility of non-biological implanable   description of the processes and procedures to
                     devices in accordance with VHA           be followed if the non-biological implantable
                     Directive 2007-001?                      device is not sterile upon receipt; Who in the
                                                              operating room is responsible for: (a) Checking
                                                              the integrity of the package appropriate color
                                                              change of the external chemical indicator tape,
                                                              expiration date, and (b) Documenting this check
                                                              prior to use; Who in the facility is responsible for
                                                              managing an inventory of all routinely-used non-
                                                              biological implants, such as screws or nails or
                                                              plates that are needed in sets of assorted sizes
                                                              and not on consignment. Relase of statements
                                                              that: non-biological implantable devices are not
                                                              to be sterilized by flash sterilization; all
                                                              sterilization loads containing these non-biological
                                                              implantable devices are monitored with the
                                                              appropriate biological monitor; and, after
                                                              sterilization, non-biological implantable devices
                                                              are quarantined in SPD and not released
                                                              (continued)...
                     Mandatory; Priority A                    VHA Directive 2007-001 Implantable Devices.pdf /A Page=0
               Other Patient Safety Initiatives
   6.17.4      (continued)... Has the facility     ...(continued) until the spore test is found to be
   (continued) developed and implemented a policy negative (48 hours).
               to address the sterility of non-
               biological implanable devices in
               accordance with VHA Directive 2007-
               001?
                     Mandatory; Priority A                    VHA Directive 2007-001 Implantable Devices.pdf /A Page=0




Policies, Tools Aids - 6                                                              Policies, Tools Aids - 6 - Version: 2007                                                        247 of 480
                                                          NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                  Not
                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                            Rationale/Assessment Methods:                                         (1)   Met (2)     (3) possible root causes
                     Other Patient Safety Initiatives
   6.17.5            Has the use of Rapid Response        Rapid Response Teams or Pre-code teams can
                     Teams been implemented?              be implemented to help prevent a patient from
                                                          reaching code status by systematically
                                                          employing a team of individuals as "go to" staff
                                                          for patients that show declining status or other
                                                          causes for concern. The Institute of Healthcare
                                                          Improvement's 100k Lives Campaign gives
                                                          detailed guidance on how to help institutions
                                                          implement teams by offering recommendations
                                                          about how to structure teams, use of SBAR
                                                          communication, criteria for calling a code, setting
                                                          response times and more.

                     Recommended; Priority B              IHI 5 Million Lives Kit - Rapid Response Teams.doc #0
                     Other Patient Safety Initiatives
   6.17.6            Is there an effort being made to     Studies have shown that patients with AMI
                     improve the treatment and outcomes   should receive specified components of care in
                     for patients with Acute Myocardial   order to reduce morbidity and mortality.
                     Infraction (AMI)?                    Specificities of individual treatment plans may
                                                          vary based on clinical condition and other co-
                                                          morbidities, however, there is strong evidence in
                                                          the literature to support that seven key care
                                                          components should be provided to all AMI
                                                          patients. The Institute of Healthcare
                                                          Improvement's 5 Million Lives Campaign is using
                                                          this clinical guidance to drive the AMI element.
                                                          The 7 components of care are: 1) Early
                                                          administration of aspirin; 2) Aspirin at discharge;
                                                          3) Early administration of beta-blocker; 4) Beta-
                                                          blocker at discharge; 5) ACE-inhibitor or
                                                          angiotensin receptor blockers (ARB) at
                                                          discharge for patients with systolic dysfunction;
                                                          6) Timely initiation of reperfusion (thrombolysis
                                                          or percutaneous intervention); 7) Smoking
                                                          cessation counseling.
                                                          IHI 5 Million Lives Kit - Improved Care for Acute Myocardial
                     Recommended; Priority B
                                                          Infarction.doc #0




Policies, Tools Aids - 6                                                             Policies, Tools Aids - 6 - Version: 2007                                                        248 of 480
                                                          NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                  Not
                                                                                                                                Met   Partially   Met If score other than 'met' what are
                     Question:                            Rationale/Assessment Methods:                                         (1)   Met (2)     (3) possible root causes
                     Other Patient Safety Initiatives
   6.17.7            Is there an effort being made to     Numerous studies have established a firm
                     improve the treatment and outcomes   evidence base indicating that specific
                     for patients with Congestive Heart   components of CHF care reduce morbidity and
                     Failure (CHF)?                       mortality. IHI has recommended the following
                                                          seven key care components be provided to all
                                                          CHF patients, in the absence of
                                                          contraindications or intolerance: 1. Left
                                                          ventricular systolic (LVS) function assessment.
                                                          2. ACE-inhibitor or angiotensin receptor blockers
                                                          (ARB) at discharge for CHF patients with systolic
                                                          dysfunction (Left Ventricular Ejection Fraction
                                                          (LVEF) <40%). 3. Anticoagulant at discharge for
                                                          CHF patients with chronic or recurrent atrial
                                                          fibrillation (AF). 4. Smoking cessation advice
                                                          and counseling. 5. Discharge instructions that
                                                          address all of the following: activity level, diet,
                                                          discharge medications, follow-up appointment,
                                                          weight monitoring, and what to do if symptoms
                                                          worsen. 6. Influenza immunization (seasonal). 7.
                                                          Pneumococcal immunization

                     Recommended; Priority B              IHI 5 Million Lives Kit - CHF.doc #0




Policies, Tools Aids - 6                                                             Policies, Tools Aids - 6 - Version: 2007                                                        249 of 480
                                                         NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                Not
                                                                                                                              Met   Partially   Met If score other than 'met' what are
                     Question:                           Rationale/Assessment Methods:                                        (1)   Met (2)     (3) possible root causes
                     Other Patient Safety Initiatives
   6.17.8            Have suggested strategies in         The Information letter recommends the
                     Information Letter IL 10-2006-013   following: Develop and implement strategies to
                     been implemented to address JC      properly assess, treat, and manage patients
                     National Patient Safety Goal 15,    identified at risk for suicide; document the
                     Mitigating the Risk of Suicide?     relevant risk factors for suicide in each patient's
                                                         medical record; document treatment and the
                                                         treatment setting in a manner that addresses the
                                                         presence of (or absence of) relevant risk factors
                                                         that increase risk for suicide and features that
                                                         may decrease risk for suicide; provide the
                                                         appropriate telephone number(s) for calls during
                                                         working hours and other times, in writing, to at-
                                                         risk patients and/or significant others (also
                                                         document this in the patient‘s medical record);
                                                         instruct patients and their significant others to
                                                         call the facility's Emergency Department or
                                                         Urgent Care Center if they have a crisis situation
                                                         (or local suicide prevention hotlines if after
                                                         hours); ensure that the safety concerns in the
                                                         design of the inpatient mental health unit (and its
                                                         furnishings) are addressed; and, establish and
                                                         (continued)...
                                                         TIPS_JanFeb07.pdf /A Page=2
                     Mandatory                           USH IL-10-2006-13 Pg. 0
               Other Patient Safety Initiatives
   6.17.8      (continued)... Have suggested             ...(continued) implement a policy stating who is
   (continued) strategies in Information Letter IL 10-   responsible for identifying and working with local
               2006-013 been implemented to              agencies so that VA patients receive emergency
               address JC National Patient Safety        support and referral to the VA as soon as
               Goal 15, Mitigating the Risk of           possible.
               Suicide?
                                                         TIPS_JanFeb07.pdf /A Page=2
                     Mandatory                           USH IL-10-2006-13 Pg. 0




Policies, Tools Aids - 6                                                           Policies, Tools Aids - 6 - Version: 2007                                                        250 of 480
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                    Not
                                                                                                                                  Met   Partially   Met If score other than 'met' what are
                     Question:                           Rationale/Assessment Methods:                                            (1)   Met (2)     (3) possible root causes
                     Tubing Management
   6.18.1            Does the organization have a tubing Ask if a tubing management policy is available
                     management policy?                  for review. I Check for inclusion of basic
                                                         elements listed herein such as who can
                                                         reconnect tubings, retracing of tubings as part of
                                                         standard practice, etc.
                                                              ISMP Safety Alert June 2004 - misconnections.pdf /A Page=0
                     Recommended                              JC SEA Issue 36.pdf /A Page=0
                     Tubing Management
   6.18.2            Does the organization have a policy      Interview staff regarding what tubings are
                     that identifies high risk tubings such   defined as high risk by the organization and what
                     as epidural or arterial lines and        labeling practice they have standardized across
                     which requires labeling of such high     the organization.
                     risk lines?
                                                              ISMP Safety Alert June 2004 - misconnections.pdf /A Page=0
                     Recommended                              JC SEA Issue 36.pdf /A Page=0
                     Tubing Management
   6.18.3            Does the organization have as a        Ask to review policy. Interview non-clinical staff
                     policy that non-clinical staff not be  about tubing connections/disconnections.
                     allowed to connect and disconnect      Provide simple scenario and elicit their response.
                     patient tubings but to obtain clinical
                     staff assistance for any perceived or
                     real need to connect or disconnect
                     tubing?
                                                              ISMP Safety Alert June 2004 - misconnections.pdf /A Page=0
                     Recommended                              JC SEA Issue 36.pdf /A Page=0
                     Tubing Management
   6.18.4            Does the organization have a policy Ask to review policy.
                     in place prohibiting purchase of non-
                     intravenous equipment (e.g., blood
                     pressure devices, oxygen tubing,
                     etc.) that can physically connect with
                     or without force with luer slip and
                     luer lock IV line connectors?

                                                              ISMP Safety Alert June 2004 - misconnections.pdf /A Page=0
                     Recommended                              JC SEA Issue 36.pdf /A Page=0




Policies, Tools Aids - 6                                                               Policies, Tools Aids - 6 - Version: 2007                                                        251 of 480
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
   POLICIES, TOOLS AND AIDS - Element 6
                                                                                                                                                    Not
                                                                                                                                  Met   Partially   Met If score other than 'met' what are
                     Question:                             Rationale/Assessment Methods:                                          (1)   Met (2)     (3) possible root causes
                     Tubing Management
   6.18.5            Do all staff, including housekeeping, Ask to see content used for orientation of new
                     ancillary staff, transport staff,     employees.
                     volunteers, and students have
                     content included in their orientation
                     and annual review about the risks
                     associated with tubing
                     misconnections?
                                                              ISMP Safety Alert June 2004 - misconnections.pdf /A Page=0
                     Recommended                              JC SEA Issue 36.pdf /A Page=0
                     Tubing Management
   6.18.6            Can the organization describe, as        Ask to see staffing measures improvement
                     part of its staffing measures and        documents and identify whether the organization
                     improvement activities, efforts it has   has included staff fatigue as a variable. This
                     taken to identify and manage risks       would be evidenced by things such as controls
                     associated with staff fatigue and        related to overtime, number of days worked in
                     mistakes such as misconnections?         sequence, shift work considerations, etc.

                                                              ISMP Safety Alert June 2004 - misconnections.pdf /A Page=0
                     Recommended                              JC SEA Issue 36.pdf /A Page=0
                     Tubing Management
   6.18.7            Can the organization provide at least Interview staff that are involved with new
                     one example of having conducted       equipment purchases.
                     performance, safety, and usability
                     testing prior to a new tubing and/or
                     catheter purchase to identify
                     potential misconnection risks?

                                                              ISMP Safety Alert June 2004 - misconnections.pdf /A Page=0
                     Mandatory                                JC SEA Issue 36.pdf /A Page=0




Policies, Tools Aids - 6                                                               Policies, Tools Aids - 6 - Version: 2007                                                        252 of 480
 Patient Safety Assessment Tool
   Implementation Element 7
Element 7.1
    Long Term Care
Element 7.2
    Behavioral Health Care Units (Locked)
Element 7.3
    Acute Care
Element 7.4
    Intensive Care
Element 7.5
    Operating Room Care
Element 7.6
    Radiology
Element 7.7
    Pharmacy
                                                            NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   LONG TERM CARE UNITS 7.1                             Facility unit/ward name:
                                                                                                                                               Not
                                                                                                                             Met   Partially   Met If score other than 'met' what are
                  Question:                                 Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                  Bed Safety
   7.1.1.1        If bed rails are installed/used are       Entrapment can result in suffocation. Follow July
                  they free of entrapment potential (for    2001 NCPS Patient Safety Alert Action items
                  patients identified as high risk for      including: assessing existing beds for horizontal
                  entrapment): 1) rail to mattress, 2)      gap between mattress and bed rail must be less
                  between split rails, 3) rail to board -   than 2 3/8 inches when the mattress is pushed to
                  either end, 4) board to mattress, or,     the opposite side; permanently mark all non-
                  5) within rail?                           complying bed assemblies; fill gaps created
                                                            between the mattress and bed rail that are equal
                                                            or wider than 2 3/8 inches for high risk patients;
                                                            reduce the rail to rail openings, and openings
                                                            with in rail gaps to less than 4 3/4 inches by
                                                            using rail netting, clear padding or retrofit kits;
                                                            ensure new beds purchased meet requirements.


                                                            FDA Hospital Bed Safety.pdf /A Page=0
                                                            BedEntrap.pdf /A Page=0
                  Mandatory                                 BedEntrapPoster.pdf /A Page=0
                  Bed Safety
   7.1.1.2        When beds and/or mattresses are re- New beds brought into the facility should meet
                  ordered for purchase or lease are   the entrapement criteria.
                  they reviewed for entrapment risk?

                  Recommended
                  Bed Safety
   7.1.1.3        Are non-compliant beds clearly            All new beds must meet requirement, & existing
                  marked as to indicate entrapment          non-compliant beds marked. Staff should be
                  risk?                                     knowledgeable about the markings and
                                                            requirements.
                  Mandatory                                 BedEntrap.pdf /A Page=0
                  Bed Safety
   7.1.1.4        Are beds designed to facilitate           Bed attributes would include: Stand assistive
                  patient transfer?                         devices to assist patients to stand, room for base
                                                            of lifting device to fit under the bed, clear area
                                                            around bed for staff and lifting equipment
                                                            access, variable position capabilities.

                  Recommended                               OSHA Guidelines Nursing Homes.pdf /A Page=0




Long Term Care - 7.1                                                                  Long Term Care - 7.1 - Version: 2007                                                        254 of 480
                                                          NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   LONG TERM CARE UNITS 7.1                              Facility unit/ward name:
                                                                                                                                            Not
                                                                                                                          Met   Partially   Met If score other than 'met' what are
                  Question:                                Rationale/Assessment Methods:                                  (1)   Met (2)     (3) possible root causes
                  Bed Safety
   7.1.1.5        Is the appropriate bed-type matched      An overall evaluation of beds in the facility is
                  to the level of care needed for each     recommended, and there should be a
                  patient?                                 determination if appropriate beds are placed in
                                                           the appropriate care environment. Issues to
                                                           consider are: LTC patients can acquire bed
                                                           sores; cardiac patients beds designed to
                                                           facilitate CPR, etc.
                  Recommended
                  Bed Safety
   7.1.1.7        Are measures in place to help            In addition to facility fire prevention practices,
                  prevent fires resulting from the use     extra steps should be taken for electrical beds:
                  of electric hospital beds?               Connect the bed's power cord directly to a wall-
                                                           mounted receptacle without the use of extension
                                                           cords or power strips; Do not cover any power
                                                           cord with a rug or carpet; conduct regular
                                                           inspections for dust build up (bed frame,
                                                           motor/hardware, mattress, etc.); regularly test
                                                           bed movement and hand/panel controls; inspect
                                                           the patient control panel (if cracked liquids can
                                                           get in); check that circuits are not overloaded
                                                           with other equipment; encourage reporting of
                                                           improper functioning; and assure that
                                                           manufacturers' recalls are followed.

                  Recommended                              FDA Bed Fires.pdf /A Page=0
                  Code Carts
   7.1.2.1        Are code carts locked when not in        Drugs have potential to be taken from unsecured
                  use, and is equipment in good            carts in common areas. Verify cart inspection
                  condition clean and covered?             records.
                  Mandatory                                JCAHO_CAMH.pdf /A Page=252
                  Code Carts
   7.1.2.3        Are equipment and drugs easily           Standardizing the location of supplies and
                  retrievable on/in code carts, and is     equipment will increase the code response
                  there standard organization in all       efficiency. An oversight committee should exist
                  carts throughout the hospital?           (i.e., Cardiac arrest committee) and the
                                                           committee should provide recommendation for
                                                           how carts are maintained.
                  Recommended




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 2007                                                        255 of 480
                                                          NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   LONG TERM CARE UNITS 7.1                             Facility unit/ward name:
                                                                                                                                          Not
                                                                                                                        Met   Partially   Met If score other than 'met' what are
                  Question:                               Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
                  Code Carts
   7.1.2.3.1      Are there post-code, other debriefing   Evaluation of codes in key for improving
                  forms that are filled out to offer      performance. Review any documentation that is
                  feedback on how codes are               available regarding code review if any.
                  preformed to allow feedback
                  regarding process improvements?
                  Recommended
                  Code Carts
   7.1.2.4        Is the VHA modified version of the      Inspect top of cart and review checklist of
                  ECC (Emergency Cardiac Care)            contents if provided.
                  AHA (American Heart Association)
                  Handbook of Cardiovascular Care
                  Cognitive Aid located on all carts?
                  Recommended
                  Code Carts
   7.1.2.5        Are CO2 detectors available on code Inspect carts. Adjunctive devices (i.e.
                  carts for confirming esophageal     colorimetric, syringe, or bulb devices) should be
                  intubations?                        adequately stocked and readily available for use
                                                      in all carts. Review cart checklist talk with cart
                                                      preparers in SPD (Supply Processing and
                                                      Distribution) Service.
                  Mandatory                               AirwayMgmt.pdf /A Page=0
                  Code Carts
   7.1.2.6        Is there a standardized system (e.g.    Cart should be locked with an integrity seal, look
                  checklist) or method used to verify     for a valid checklist or equivalent system on the
                  that code carts are fully stocked and   cart, dated with last check/update date. Items
                  properly equipped before they are       such as these should be on the checklist: O2
                  sent to the units and a daily           tank volume; tubing ; CO2 detectors; appropriate
                  inspection on each unit?                medications; AED (or other defibrillators) and
                                                          suction machine functionality; laryngoscope with
                                                          batteries; cardiac board, etc.

                  Recommended




Long Term Care - 7.1                                                             Long Term Care - 7.1 - Version: 2007                                                        256 of 480
                                                          NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   LONG TERM CARE UNITS 7.1                           Facility unit/ward name:
                                                                                                                                            Not
                                                                                                                          Met   Partially   Met If score other than 'met' what are
                  Question:                               Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                  Electrical Safety
   7.1.3.1        Are electrical receptacles in, or       All areas designated as wet locations, or areas
                  serving, wet areas or behavioral        used for behavioral health patients, require (wet)
                  health areas provided with Ground       or recommend (behavioral health) ground-fault
                  Fault Circuit Interruption (GFCI)       protection. These types of receptacles are
                  protection or an isolated power         designed to stop the flow of electrical current,
                  system?                                 preventing shock or electrocution. For
                                                          behavioral health areas, electrical receptacles
                                                          must be protected, covered, or completely
                                                          removed in patient rooms to protect patients who
                                                          my try to harm themselves.

                                                          http://vaww.ceosh.med.va.gov/ #0
                                                          NFPA 99 ch 4.pdf /A Page=03
                  Mandatory                               NFPA 99 ch 4.pdf /A Page=04
                  Electrical Safety
   7.1.3.2        Are electrical receptacles fitted with Observe conditions on unit.
                  covers, secured, and free of loose or
                  exposed wiring?
                                                          http://vaww.ceosh.med.va.gov/ #0
                  Mandatory                               NFPA 99 ch 4.pdf /A Page=08
                  Electrical Safety
   7.1.3.3        Are emergency power receptacles         Staff should be able to identify emergency
                  appropriately identified and only       receptacles. Assessor should inspect locations
                  used for equipment needing to be on     of these outlets that should be the color red or
                  emergency power circuits?               have a red sticker identifing them.
                                                          http://vaww.ceosh.med.va.gov/ #0
                  Mandatory                               NFPA 99 ch 4.pdf /A Page=21
                  Electrical Safety
   7.1.3.4        Are electrically powered medical        Cords are free of physical defects including
                  devices in good condition and in line   cracks, frayed ends, or missing prongs. The
                  with the facility Preventative          presence of a PM sticker to indicate devices are
                  Maintenance (PM) process?               up to date is also important.
                                                          http://vaww.ceosh.med.va.gov/ #0
                                                          NFPA 99 Ch 8.pdf /A Page=03
                  Mandatory                               VHA Directive 2002-030.pdf /A Page=0




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                                                                                                                                             Not
                                                                                                                           Met   Partially   Met If score other than 'met' what are
                  Question:                              Rationale/Assessment Methods:                                     (1)   Met (2)     (3) possible root causes
                  Electrical Safety
   7.1.3.5        Are there at least 4 receptacles (6 in Inspect patient rooms.
                  critical care) for each patient bed?

                                                           http://vaww.ceosh.med.va.gov/ #0
                  Mandatory                                NFPA 99 ch 4.pdf /A Page=03
                  Electrical Safety
   7.1.3.6        If used, are power cords and             Facilities should strive to eliminate the use of
                  electrical extension cords placed        extension cords for small working spaces such
                  where they are free from mechanical      as the operating room, patient rooms, or exam
                  damage, properly sized (gauge) to        rooms. A plan should be in place to install
                  prevent overheating, and arranged        permanently affixed receptacles supplied by the
                  so that they do not present a tripping   appropriate electrical circuit (emergency or
                  hazard?                                  critical branch) if cords are being used.

                                                           http://vaww.ceosh.med.va.gov/ #0
                                                           NFPA 99 Ch 10.pdf /A Page=02
                  Recommended                              NFPA 99 Ch 10.pdf /A Page=03
                  Environmental and Housekeeping Safety
   7.1.4.1        Are hot water temperatures taken    Temperature should be less than 120 F at the
                  manually using a thermometer        tap and 110F in baths.
                  before patient use or immersion
                  (including partial immersion) takes
                  place?
                  Mandatory                                VHA Directive 2002-073.pdf /A Page=0
                  Environmental and Housekeeping Safety
   7.1.4.2        Are supply and return air registers Observe conditions on the unit.
                  clean and free of lint and dust?
                  Mandatory                                JCAHO_CAMH.pdf /A Page=358
                  Environmental and Housekeeping Safety
   7.1.4.3        Does general housekeeping appear Cleanliness, sanitation, odor, etc.
                  to be a priority?
                  Mandatory                                JCAHO_CAMH.pdf /A Page=358




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                                                                                                                                          Not
                                                                                                                        Met   Partially   Met If score other than 'met' what are
                  Question:                            Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                  Environmental and Housekeeping Safety
   7.1.4.4        Are storage rooms neat, organized, Inspect storage areas. Organized, well light
                  well light and temperature           rooms will help prevent mistakes. Ensuring
                  controlled? Is all storage 18" below extreme temperatures do not occur will uphold
                  fire sprinklers and off the floor?   the integrity of the supplies. Keeping boxes off
                                                       of floor keeps supplies sanitary.
                                                        NFPA 13 ch 8.pdf /A Page=11
                  Mandatory                             JCAHO_CAMH.pdf /A Page=344
                  Environmental and Housekeeping Safety
   7.1.4.5        Are patient care area corridors and Observe conditions on the unit by checking for
                  stairways unobstructed and kept free blocked doors.
                  of storage?
                                                        http://vaww.ceosh.med.va.gov/ #0
                                                        NFPA 101 (LSC) Ch 7.pdf /A Page=05
                  Mandatory                             JCAHO_CAMH.pdf /A Page=344
                  Environmental and Housekeeping Safety
   7.1.4.6        Are patient areas free of unlabeled All cleaning products, medication, employee
                  or unattended containers, such as   food or drink, etc., should not be left in patient
                  cleaning products or medication?    care areas or patient rooms.
                  Mandatory                             JCAHO_CAMH.pdf /A Page=333
                  Environmental and Housekeeping Safety
   7.1.4.7        Are hazards clearly identified and Pre-construction meetings should proactively
                  properly controlled during         address all necessary interventions to remediate
                  construction and renovation?       such issues. However, patient /staff concerns
                                                     may flag potential problems. Examples of
                                                     hazards: walkways maintained; marked exit
                                                     paths; guarded floor openings and overhead
                                                     hazards; dust generation; and excessive noise.

                                                        29CRF 1926.20(b).pdf /A Page=1
                                                        JCAHO_CAMH.pdf /A Page=347
                  Mandatory                             VHA Directive 2004-012.pdf /A Page=0




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                                                                                                                                             Not
                                                                                                                           Met   Partially   Met If score other than 'met' what are
                  Question:                             Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                  Environmental and Housekeeping Safety
   7.1.4.8        Are high hazard areas such as:        High hazard areas must be locked to prevent
                  Roofs, service areas, medication      access to patients and have warning signs and
                  rooms, labs, radiation areas,         labels.
                  confined spaces, high voltage areas,
                  laser areas, low use areas (such as
                  sub-floors and interstitial spaces),
                  etc. labeled with appropriate signage
                  and locked to prevent unauthorized
                  entrance?
                  Mandatory                              VA Directive 7703c(4)(a)
                  Environmental and Housekeeping Safety
   7.1.4.10       Are steps taken to eliminate/control Infestations can occur, such as myiasis, without
                  "pests" in the hospital environment? preventative measures or monitors. Special
                                                       considerations should be made for sterile
                                                       environments.
                  Mandatory                              VHA Program Guide 1850.2 Pest Control.pdf /A Page=6
                  Equipment Safety
   7.1.5.1        Is medical equipment being        Check inspection tags, or other identifiers on the
                  inspected in accordance with the  equipment that indicates it has been inspected.
                  Preventative Maintenance Program? Interview staff to determine how to interpret
                                                    identifiers.
                                                         http://vaww.ceosh.med.va.gov/ #0
                                                         NFPA 99 CH 8.pdf /A Page=0
                  Mandatory                              JCAHO goals.pdf /A Page=0
                  Equipment Safety
   7.1.5.2        Is back up patient care/monitoring     Uninterruptible monitoring and support should be
                  equipment readily available in the     planned for.
                  event of failure and or emergency?
                  Recommended                            JCAHO_CAMH.pdf /A Page=348




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                                                                                                                                             Not
                                                                                                                           Met   Partially   Met If score other than 'met' what are
                  Question:                                  Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
                  Equipment Safety
   7.1.5.3        Is the equipment used on each              Multiple reports have been received of patients
                  patient positioned in a way that it is     being inadvertently shocked while on external
                  evident the equipment is in use for        pacer/defibrillators. (The patient is connected to
                  that patient?                              the pacer/defibrillator and the curtain around the
                                                             bed is pulled closed with the equipment on one
                                                             side and the patient on the other, shift change
                                                             occurs and the defibrillator is tested while it is
                                                             still pacing the patient).
                  Recommended
                  Equipment Safety
   7.1.5.4        Are alarms audible by care staff,          The unit layout/configuration (e.g., walls, doors,
                  unique in tone and pitch to prevent        size) and ambient noise levels impact whether
                  masking*, and are limits                   staff will hear the alarms. Nuisance alarms are
                  appropriately set to reduce unwanted       caused when limits are not appropriately set, this
                  or false alarms?                           can create staff complacency, annoyance to
                                                             patients, and results in a delayed staff response
                                                             (cry wolf syndrome).

                  *Masking occurs when the frequency
                  and intensity of two independent
                  separate alarms blend together. "  Observe conditions in the unit and interview staff
                                                     as to what is done during breaks to cover patient
                                                     monitoring. Clinical alarms, bathroom alarms,
                                                     and nurse calls are included here.

                  Mandatory                                  JCAHO goals.pdf /A Page=0
                  Equipment Safety
   7.1.5.5        Are work arounds avoided in the use Due to factors listed above, devices can be
                  of medical devices with alarms?     disabled, turned off, turned down, etc. Signs of
                                                      workarounds include: post it notes suck to
                                                      equipment, worn silencer buttons, and taped
                                                      down or temporally disabled buttons.
                  Recommended                                JCAHO goals.pdf /A Page=0




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                                                                                                                                             Not
                                                                                                                           Met   Partially   Met If score other than 'met' what are
                  Question:                                Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                  Equipment Safety
   7.1.5.6        Is the equipment designed such that      Should not see post-it notes or permanently
                  its operation is intuitive to the user   posted signs indicating warnings about
                  and does not require use of adjunct      seemingly logical machine operation (i.e. a sign
                  devices to complete the required         reading such messages as: "Don't press
                  tasks?                                   'ENTER' key to enter data.") Interview staff and
                                                           inspect equipment in area.
                  Recommended
                  Equipment Safety
   7.1.5.7        Is patient care and monitoring           All screens/interfaces are readable and at or
                  equipment positioned so that             near eye level; key pads within reach; equipment
                  caregivers can easily reach and/or       is not blocking each other; adequate space to
                  read displays and controls?              move around, including head clearance on
                                                           mounted devices.
                  Recommended
                  Equipment Safety
   7.1.5.8        Are liquids kept away from medical       To prevent spillage which can result in
                  equipment?                               malfunctioning.
                                                           http://vaww.ceosh.med.va.gov/ #0
                                                           NFPA 70 110.11.pdf /A Page=0
                  Recommended                              VA Circular 10-90-035.pdf /A Page=0
                  Equipment Safety
   7.1.5.9        Are disposable medical                   Inspect storage rooms and other stock areas in
                  devices/supplies stored in a way that    the area/unit (e.g. folding supplies like hoses and
                  the integrity of the devices is kept     tubing causes kinking that has prevented them
                  intact (i.e. not bent or folded)?        from functioning properly).
                  Recommended
                  Equipment Safety
   7.1.5.11       Are locations of AEDs and                Placing this equipment in the same location of
                  defibrillators standardized              each care unit will assist staff who work on or
                  throughout the patient care areas of     between several care units locate the equipment
                  the facility?                            during emergent situations.
                  Recommended




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                                                                                                                                             Not
                                                                                                                           Met   Partially   Met If score other than 'met' what are
                  Question:                                Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                  Equipment Safety
   7.1.5.13       Has the facility eliminated sterile      Having sterile water for injection available in
                  water (in forms easily confused with     ward stock, either in multi-dose vials or bags,
                  medications) from ward stock?            creates the potential for confusion with
                                                           intravenous medication/fluids. Warnings have
                                                           been published (ISMP) regarding water being
                                                           confused with other medications resulting in fatal
                                                           hemolysis. If soft bags are unavoidable, due to
                                                           equipment, 2 liter bags are preferred, however
                                                           they still carry a potential vulnerability since they
                                                           can be attached to intravenous lines.
                                                           Engineering their use out is best when new
                                                           equipment is purchased. If sterile water is in
                                                           ward stock for irrigation purposes, plastic bottles
                                                           that require tubing that cannot be connected to
                                                           intravenous lines are preferred.
                                                           FDA PS News_ Show #22 12-03.pdf /A Page=0
                                                           ISMP 9-03 - Preventing Medication Errors.pdf /A Page=0
                  Recommended                              NCPS Alert 4-6-06.pdf /A Page=0
                  Equipment Safety
   7.1.5.14       Is the use of cell phones or other       Look for signage, and ask staff about protocols.
                  devices that can affect monitoring
                  and other medical equipment
                  controlled in applicable areas?
                  Recommended
                  Escape and Elopement Prevention
   7.1.6.1        Is a system in place to clearly Look for screening processes, such as colored
                  identify high risk escape or    gowns, photos, designated identifiers for these
                  elopement patients to staff?    patients, etc.
                                                           Escape Elopement Cognitive Aid.pdf /A Page=0
                  Recommended                              JCAHO_CAMH.pdf /A Page=188
                  Escape and Elopement Prevention
   7.1.6.2        If electronic systems such as wander Test wander guard system to ensure accuracy.
                  guards are used, are methods in
                  place to ensure they function
                  correctly?
                  Recommended                              JCAHO 2007 Goals - TIPS Article.pdf /A Page=2




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   LONG TERM CARE UNITS 7.1                            Facility unit/ward name:
                                                                                                                                           Not
                                                                                                                         Met   Partially   Met If score other than 'met' what are
                  Question:                              Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                  Escape and Elopement Prevention
   7.1.6.3        If wander guard systems are in         Observe if in use, interview appropriate staff to
                  place, are they included in the        determine if properly maintained - ward staff
                  preventative maintenance inspection    should be able to speak to reliability of system.
                  program?
                  Recommended                            JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
                  Escape and Elopement Prevention
   7.1.6.4        Are annual drills of the full missing Review records of drills or critiques of missing
                  patient process (grid search)         patient searches.
                  conducted at least annually if the
                  plan wasn't exercised during a real
                  event?
                  Mandatory                              VHA Directive 2002-013.pdf /A Page=0
                  Escape and Elopement Prevention
   7.1.6.5        Is a risk assessment for elopement     Awareness of the potential for
                  completed at the time of admission     elopement/wandering behavior is the first step in
                  or transfer and regularly during the   prevention. Review documentation or interview
                  patients stay?                         staff to verify that the assessment is being
                                                         completed. Consider using electronic flags in
                                                         CPRS to inform clinicians if the patient is a high
                                                         risk. A change in the patients care (i.e., to a
                                                         new bed/unit, or new/change in medication) is a
                                                         key time for reassessment.

                  Mandatory                              VHA Directive 2002-013.pdf /A Page=0
                  Escape and Elopement Prevention
   7.1.6.5.1      Are staff familiar with the faciliities Ask staff working in the area to describe the
                  elopement risk assessment               process.
                  process?
                  Mandatory                              VHA Directive 2002-013.pdf /A Page=0




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   LONG TERM CARE UNITS 7.1                                 Facility unit/ward name:
                                                                                                                                                      Not
                                                                                                                                    Met   Partially   Met If score other than 'met' what are
                  Question:                                   Rationale/Assessment Methods:                                         (1)   Met (2)     (3) possible root causes
                  Escape and Elopement Prevention
   7.1.6.6        Is a processes in place and used to         If patient privileges are not clear this often can
                  keep track of high risk patients when       lead to lack of communication on patient status
                  they are off of the unit?                   and location. A tracking or documentation
                                                              system can be used to help staff know patient
                                                              habits, and is a method to communicate this
                                                              information at the shift change. Also transport of
                                                              patients off the unit should be planned and
                                                              scheduled with competent escorts who
                                                              understand the potential for a high risk patient to
                                                              elope.
                  Recommended                                 JCAHO_CAMH.pdf /A Page=333
                  Escape and Elopement Prevention
   7.1.6.7        Is a system in place to clearly Look for screening processes, such as colored
                  identify high risk escape or    gowns, photos, designated identifiers for these
                  elopement patients to staff?    patients, etc.
                  Recommended
                  Fall Prevention
   7.1.7.1        Are all patient or procedure rooms          Observe conditions on the unit. Patient sleeping
                  and common areas provided with              rooms and private bathrooms should be provided
                  adequate lighting so that the patients      with nightlights. Assess for shadows or glare that
                  ability to ambulate safely is not           may adversly impact ambulation.
                  impeded?
                  Mandatory                                   JCAHO_CAMH.pdf /A Page=333
                  Fall Prevention
   7.1.7.2        Are mechanical assist devices used          Have staff show example, and conduct
                  to lift or transfer patients accessible     interviews to determine facility consistency.
                  and used by staff when needed?

                  Recommended
                  Fall Prevention
   7.1.7.2.1      Are preventative measures                   Staff training, proper number of staff present, no
                  implemented to prevent falls from           obstructions in lift area.
                  manual lifting and/or handling
                  patients?
                                                              http://vaww.ncps.med.va.gov/Tools/CognitiveAids/FallPrev/index.html
                                                              #0
                  Recommended                                 SPHMAlgorithms.pdf /A Page=0




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   LONG TERM CARE UNITS 7.1                              Facility unit/ward name:
                                                                                                                                              Not
                                                                                                                            Met   Partially   Met If score other than 'met' what are
                  Question:                                Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                  Fall Prevention
   7.1.7.3        Are all patient care or procedure        Floors should be free of liquids, electrical cords,
                  room the floors free of environmental    wires, tubes, or other connectors which can
                  slipping and tripping hazards?           create fall hazards. Patient rooms should be free
                                                           of lfloor clutter or other low hanging objects that
                                                           could be a tripping hazard.
                  Mandatory                                JCAHO_CAMH.pdf /A Page=333
                  Fall Prevention
   7.1.7.4        Are shower/bathroom areas provided       Inspect areas. Bathrooms should be provided
                  with adequate lighting, proper           with night lights. Assess bathroom flooring
                  drainage, non-slip floor surfaces, and   conditions for excessive moisture and water
                  installed handrails?                     build up. Also assess for use of non skid floor
                                                           surfaces to prevent falls. If raised seats are
                                                           used on toilets they should be a contrasting color
                                                           that is visible to the patient.
                  Mandatory                                JCAHO_CAMH.pdf /A Page=333
                  Fall Prevention
   7.1.7.5        Are call buttons within reach of the     Inspect all areas.
                  patient?
                                                           Sentinel Event Alert #14.doc #0
                  Recommended                              JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                  Fall Prevention
   7.1.7.6        Are bed and chair alarms used and        Show examples. False or unwanted alarms sets
                  audible, and, are they configured to     up the care givers for complacency.
                  reduce the number of
                  false/unwanted alarms?
                                                           Sentinel Event Alert #14.pdf /A Page=0
                  Mandatory                                JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                  Fall Prevention
   7.1.7.7        Does the facility have a Fall            Interview staff - protocol should evaluate: 1) A
                  Prevention & Management Protocol         risk screen; 2) Protective device matched to risk
                  or equivalent?                           level; 3) First responder assessment to identify
                                                           patients for immediate physician evaluation and
                                                           4) Treatment plan for follow up, post fall.

                  Mandatory                                JCAHO 2007 Goals - TIPS Article.pdf /A Page=0




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   LONG TERM CARE UNITS 7.1                                 Facility unit/ward name:
                                                                                                                                                 Not
                                                                                                                               Met   Partially   Met If score other than 'met' what are
                  Question:                                   Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                  Fall Prevention
   7.1.7.8        Is a uniform tool used to assess            Identifying high risk patients will help care team
                  which patients are at high risk for         to put proactive and preventative measures in
                  falls, and is there criteria to             place. Assessor should look for identifiers and
                  determine: 1) When they are                 interview staff.
                  assessed, and 2) What triggers a
                  reassessment?
                                                              JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                  Mandatory                                   JCAHO_CAMH.pdf /A Page=192
                  Fall Prevention
   7.1.7.9        Is there at least one patient lift, OR      Review equipment, interview staff. Patients
                  table, radiololgy table, etc. available     weighing in excess of 400 pounds are not
                  that has sufficient lifting/holding         uncommon. If equipment cannot support the
                  capacity to meet the needs of               weight of the patient contingency plans should
                  bariatric patients?                         be developed to provide care.
                  Recommended                                 Copyrighted Refs.doc #0
                  Fall Prevention
   7.1.7.9.1      Is the load carrying capacity of the        Labels and warnings are minimal actions and
                  equipment obvious to care                   humans often disregard them but they are one
                  providers?                                  barrier that should be in place. Talk with the
                                                              care providers in the area to determine if they
                                                              know what the load capacities are. Other
                                                              cognitive aids may be necessary depending
                                                              upon the knowledge level.
                   Recommended                                Copyrighted Refs.doc #0
                  Fire Safety
   7.1.8.1        Are staff members familiar with fire        Interview staff to determine familiarity.
                  emergency procedures, and the fire
                  prevention plan for their service
                  area?
                                                              NFPA 101 (LSC) Ch 7.pdf /A Page=0
                                                              NFPA 101 (LSC) Ch 7.pdf /A Page=05
                  Mandatory                                   NFPA 2006 101.7.2.3.pdf /A Page=08




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   LONG TERM CARE UNITS 7.1                              Facility unit/ward name:
                                                                                                                                              Not
                                                                                                                            Met   Partially   Met If score other than 'met' what are
                  Question:                             Rationale/Assessment Methods:                                       (1)   Met (2)     (3) possible root causes
                  Fire Safety
   7.1.8.2        Can clinical staff identify smoke and Interview staff to determine familiarity. Staff
                  fire walls in their immediate area?   must be knowledgeable regarding where to
                                                        move patients in the event of a fire.
                                                           NFPA 101 (LSC) Ch 7.pdf /A Page=0
                                                           NFPA 101 (LSC) Ch 7.pdf /A Page=05
                  Mandatory                                JCAHO_CAMH.pdf /A Page=344
                  Fire Safety
   7.1.8.3        Is the fire alarm signal easily          Interview staff to determine familiarity, if alarm is
                  distinguishable from other alarms        not witnessed.
                  (e.g., equipment, nurse call, etc.)?
                                                           http://vaww.ceosh.med.va.gov/ #0
                  Mandatory                                NFPA 72.4.4.3.6.1.pdf /A Page=08
                  Fire Safety
   7.1.8.4        Can staff describe the process on       Look for signs placed by pull stations, and
                  how they are notified when the fire     interview to determine if announcements are
                  alarm system is out of service in their made on PA system, etc
                  area or being tested?
                                                           http://vaww.ceosh.med.va.gov/ #0
                  Mandatory                                NFPA 101.19.7.1.2.pdf /A Page=08
                  Fire Safety
   7.1.8.5        Are flame retardant pajamas or           Smoking risk patients are patients who are
                  aprons provided for patients who         known to routinely violate the "no smoking" rules
                  smoke and are identified as a            established by the facility. They smoke in non
                  "smoking risk"?                          designated areas when unsupervised and may
                                                           have a physical or mental condition that could
                                                           lead them to drop a cigarette, ashes, or match
                                                           causing clothing or hair to ignite. Flame
                                                           retardant pajamas or aprons can be a preventive
                                                           measure for these patients.

                                                           VA Circular 10-90-035.pdf /A Page=0
                  Mandatory                                VA MP-3 Part III 32.36(b) & (d).pdf /A Page=21




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   LONG TERM CARE UNITS 7.1                                Facility unit/ward name:
                                                                                                                                                Not
                                                                                                                              Met   Partially   Met If score other than 'met' what are
                  Question:                                  Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                  Fire Safety
   7.1.8.5.1      If flame retardant pajamas or linens       Interview staff, determine if practices are
                  are used, is a process in place to         consistent with policy. If the material has a fire
                  ensure integrity of the flame              retardant applied it will wash out over a period of
                  retardant agent is maintained on           time.
                  these articles after repeated
                  laundering?
                  Recommended                                VA MP-3 Part III 32.36(c) & (d).pdf /A Page=21
                  Infection Control
   7.1.9.1        Are all linen carts (clean and soiled)     Observe conditions on the unit.
                  kept covered and the bottom of the
                  cart is a solid surface (without
                  openings)?
                  Mandatory                                  JCAHO_CAMH.pdf /A Page=280
                  Infection Control
   7.1.9.2        Are sharps containers accessible           Observe conditions in unit/area. Patients and
                  and not over filled?                       employees are often stuck by sharps not
                                                             properly disposed of due to overfilling of these
                                                             containers.
                  Mandatory                                  JCAHO_CAMH.pdf /A Page=238
                  Infection Control
   7.1.9.3        Is the facilities latex free policy being Show example if available. Consider inspecting
                  followed including providing latex        supply and code carts. Look for latex-free
                  free supplies and devices?                identification on glove boxes, supply packages,
                                                            etc. Determine if the other devices are available
                                                            as latex-free such as tourniquets and medical
                                                            tubing. In pharmacy, check for a latex protocol
                                                            in IV room.
                  Mandatory                                  IL 16-97-001.pdf /A Page=0




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                                                                            Part II Implementation
   LONG TERM CARE UNITS 7.1                               Facility unit/ward name:
                                                                                                                                               Not
                                                                                                                             Met   Partially   Met If score other than 'met' what are
                  Question:                                 Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                  Infection Control
   7.1.9.4        Are the VA recommended hand               Alcohol-based hand rub (ABHR) disinfectants
                  hygiene guidelines followed?              should be located to promote their use (including
                                                            in patient rooms, on carts). Clinicians should
                                                            also be offered the small (2-4 oz.) personal
                                                            containers of hand gel. In addition to the ABHR
                                                            gel/foam a lotion (to prevent skin dryness)
                                                            should also be available.




                                                            Staff who come in contact with patients or
                                                            prepare sterile products (such as IV drugs)
                                                            should not have artificial fingernails.

                                                            CDC Hand Hygiene.pdf /A Page=0
                                                            Sentinel Event Alert #28.pdf /A Page=0
                  Mandatory                                 JCAHO_CAMH.pdf /A Page=279
                  Infection Control
   7.1.9.5        Is the integrity of negative/positive     Door remains closed if in use, Personal
                  pressure isolation rooms tested and       Protective Equipment used. Signage outside to
                  maintained (once per day for              identify hazard exists.
                  occupied, monthly for non-
                  occupied)?

                                                            Staff should understand what actions to take if
                                                            the room pressures are out of range when they
                                                            are checked.
                                                            CDC Environment IC Healthcare.pdf /A Page=0
                  Mandatory                                 29CFR 1910.145.pdf /A Page=0
                  Infection Control
   7.1.9.5.1      Is there a process in place to            Establishing these temporary rooms should be
                  establilsh temporary                      part of the facilities Emergency Prepardness
                  negative/positive pressure rooms if       Plan.
                  they are needed?
                  Recommended




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                                                                                                                                              Not
                                                                                                                            Met   Partially   Met If score other than 'met' what are
                  Question:                                Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                  Medical Gas Safety
   7.1.10.1       Are piped in oxygen and                  The use of color coding should be eliminated.
                  compressed air identified by a           Using color adapters can cause confusion during
                  prominent label and not merely by        use, mixing up the gases being administered.
                  color adapters?                          Fixes include: replacing tubing with a type that
                                                           does not use adaptors or using only clear
                                                           adaptors.
                  Recommended                              Air_O2WallInlet.pdf /A Page=0
                  Medical Gas Safety
   7.1.10.2       Are air flow meters removed when         Flow meters are only used for specific
                  not in use (for nebulized medication     treatments, are not required during emergencies
                  treatments)?                             and should not be left attached to be confused
                                                           with O2 flow meter.
                  Recommended                              Air_O2WallInlet.pdf /A Page=0
                  Medical Gas Safety
   7.1.10.3       Do staff know where the emergency Staff to demonstrate competency. Also verify
                  oxygen shut-off is, and when and  that labels, warnings or other signage posted at
                  how to use it?                    the shut off point in accurate and up to date.

                                                           http://vaww.ceosh.med.va.gov/ #0
                                                           NFPA 99 Ch 5.pdf /A Page=17
                  Mandatory                                JCAHO_CAMH.pdf /A Page=356
                  Medical Gas Safety
   7.1.10.4       Does the storage and use of portable     If color identifies type, must be the same hue &
                  medical gas containers appear to be      intensity; flammables separated from oxidizers;
                  in compliance with CGA                   secured at all times (full or empty); container in
                  (Compressed Gas Association)             good condition; only a limited quantity permitted
                  Standards?                               in use area (less than 12 E-cylinders, or 1 H-
                                                           cylinder per area).
                                                           Copyrighted Refs.doc #0
                  Mandatory                                O2CylHazardSumm.pdf /A Page=0




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                                                                                                                                            Not
                                                                                                                          Met   Partially   Met If score other than 'met' what are
                  Question:                          Rationale/Assessment Methods:                                        (1)   Met (2)     (3) possible root causes
                  Medical Gas Safety
   7.1.10.4.1     Do area/unit personnel know how to Cylinders should not be left standing unsecured,
                  correctly handle oxygen cylinders? they should not be lifted using the flow meter
                                                     assembly.




                                                           They should understand the purpose of both the
                                                           main cylinder valve and the flow meter valve.
                                                           Cylinders not in use must be turned off using the
                                                           main cylinder valve.




                                                           Cylinders should be opened slowly.




                                                           Organic ointments or oils should not be used in
                                                           or around oxygen.
                  Mandatory                                O2CylHazardSumm.pdf /A Page=0
                  Medical Gas Safety
   7.1.10.5       Are pins on medical gas regulators       Pins should be in place and found undamaged.
                  intact, and is damaged equipment
                  immediately removed from service?
                                                           O2CylHazardSumm.pdf /A Page=0
                  Mandatory                                NFPA 99 ch 9 gas equip.pdf /A Page=2
                  Medical Gas Safety
   7.1.10.6       Are oxygen cylinders with ball-type      When placed in the horizontal position, the ball
                  regulators used with the cylinder in     valve mechanism will not function, and an
                  the vertical position?                   inaccurate reading will show on the gauge.
                  Mandatory                                O2CylHazardSumm.pdf /A Page=0




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                                                                                                                                           Not
                                                                                                                         Met   Partially   Met If score other than 'met' what are
                  Question:                              Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                  Medication Safety
   7.1.11.1       Are all medication refrigerators       Check floor refrigerators, ensure correct labeling
                  maintained appropriately?              and appropriate separations from employee
                                                         food/drink.




                                                         Review temperature log (or electronic
                                                         temperature monitoring device/log) and verify
                                                         that the thermometer is working.




                                                         Staff should know what actions to take if the
                                                         temperatures in the refrigerators are out of
                                                         range.
                                                         ISMP_Book.pdf /A Page=30
                                                         JCAHO_CAMH.pdf /A Page=249
                  Mandatory                              capsLink2003-08-01 fridge.pdf /A Page=0
                  Medication Safety
   7.1.11.2       Do medication carts remained locked Randomly survey carts in the area.
                  and inaccessible to patients when
                  not in use?
                  Mandatory                              JCAHO_CAMH.pdf /A Page=249
                  Medication Safety
   7.1.11.3       Are the tops of medication carts,      Randomly survey carts in the area. Clean carts
                  clean, free of stray drugs, sharps     will help prevent medication error by eliminating
                  and food?                              opportunities for mix-ups . It will also avoid drug
                                                         being taken by mental health patients or those
                                                         with cognitive impairment.
                                                         ISMP_Book.pdf /A Page=13
                  Mandatory                              JCAHO_CAMH.pdf /A Page=249
                  Medication Safety
   7.1.11.4       Are receptacles for medication         Door locking mechanism cannot be defeated for
                  storage locked and are controlled      any reason. Door should not be held open.
                  substances double locked?
                                                         ISMP_Book.pdf /A Page=24
                  Mandatory                              JCAHO_CAMH.pdf /A Page=249




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                                                                                                                                              Not
                                                                                                                            Met   Partially   Met If score other than 'met' what are
                  Question:                              Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                  Medication Safety
   7.1.11.6       Is area stock limited to emergency     Review approved floor stock and IV solution list
                  medication and IV solutions which      (e.g. 3% NaCl should not generally be available).
                  are appropriate to patient care in the
                  unit?
                                                           ISMP_Book.pdf /A Page=25
                  Recommended                              JCAHO_CAMH.pdf /A Page=253
                  Medication Safety
   7.1.11.7       Are bags containing sterile water for Controlling the acquisition of sterile water may
                  injection prohibited from being       help to prevent it from being inadvertently given
                  ordered or stocked on patient care    intravenously.
                  areas without special permission and
                  precaution?
                                                           FDA PS News_ Show #22 12-03.pdf /A Page=0
                  Recommended                              ISMP 9-03 - Preventing Medication Errors.pdf /A Page=0
                  Medication Safety
   7.1.11.8       Have concentrated electrolyte       Such as: potassium chloride and potassium
                  solutions been removed from patient phosphate
                  floors/care areas?
                                                           Sentinel Event Alert #1.pdf /A Page=0
                                                           Sentinel Event Alert #11.pdf /A Page=0
                  Mandatory                                JCAHO_CAMH.pdf /A Page=249
                  Medication Safety
   7.1.11.9.1     Are only standard concentrations of      Floor stock of high-alert drugs should be limited
                  high alert medications kept in the       to critically needed medications, with minimal
                  area/unit to minimize the potential of   number of doses, and be pre-made solutions (if
                  calculation and compounding errors?      available).

                                                           ISMP_Book.pdf /A Page=23
                                                           Sentinel Event Alert #11.pdf /A Page=0
                  Mandatory                                JCAHO_CAMH.pdf /A Page=249
                  Medication Safety
   7.1.11.10      Is a unit dose medication system         Look in patient bins for products that are in the
                  used including liquids?                  final pagkage of use. Bulk containers should not
                                                           be used.
                                                           ISMP_Book.pdf /A Page=22
                                                           Sentinel Event Alert #11.pdf /A Page=0
                  Recommended                              JCAHO_CAMH.pdf /A Page=249




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                                                                                                                                             Not
                                                                                                                           Met   Partially   Met If score other than 'met' what are
                  Question:                             Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
                  Medication Safety
   7.1.11.13      Is drug preparation done primarily in Interview floor staff. It is safest for mixtures to be
                  the pharmacy and not on care units? completed in pharmacy areas.

                                                          Sentinel Event Alert #11.pdf /A Page=0
                  Mandatory                               JCAHO_CAMH.pdf /A Page=257
               Medication Safety
   7.1.11.13.1 Is medication mixing (admixtures) on Interview floor staff. If admixtures are done on
               inpatient care units a discouraged   units, the area should be a designated area that
               practice?                            is clean and secure. It is safest for mixtures to
                                                    be completed in pharmacy areas only.

                  Recommended
                  Medication Safety
   7.1.11.14      Are procedures in place to prevent      Infection control literature documents nosocomial
                  sterile product use from patient to     infections occur irrespective of changing needles
                  patient (including medications)?        or IV tubing's.
                                                          ASA December 2000 Newsletter.pdf /A Page=0
                  Recommended                             ISMP Safety Alert June 2000.doc #0
                  Medication Safety
   7.1.11.15      Are IV over-wrap bags utilized and      The protective over-wrap for some solutions
                  properly labeled with manufacturers     serves to control the amount of water vapor that
                  instructions?                           escapes from an IV solution. Once unwrapped it
                                                          is best to use the solution right way.

                                                          FDA PS News_ Show #22 12-03.pdf /A Page=0
                  Recommended                             ISMP Safety Alert June 2000.doc #0
                  Medication Safety
   7.1.11.16      Are IV bags free of markings, such      The volatile chemical from the ink may leach into
                  as expiration dates, applied by staff IV solutions.
                  with ink pens or felt markers (prior to
                  use)?
                  Recommended                             FDA PS News_ Show #22 12-03.pdf /A Page=0
                  Medication Safety
   7.1.11.17      Is an independent double check          The double check should Include patient
                  completed for all infusion pump         monitoring and verifying the number of types of
                  settings for high alert medications     pumps.
                  and look alike/sound alike drugs?
                  Recommended                             Sentinel Event Alert #11.pdf /A Page=0




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                                                                      Part II Implementation
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                                                                                                                                        Not
                                                                                                                      Met   Partially   Met If score other than 'met' what are
                  Question:                             Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
                  Medication Safety
   7.1.11.19      Are appropriate reversal agents       In the event of an unusual reaction or overdose
                  (flumazenil, naloxone, protamine,     the agents need to be available. Look on the
                  etc.) available based on the drug     code cart drug list.
                  being administered and clinical
                  setting?
                                                        ISMP_Book.pdf /A Page=24
                  Mandatory                             JCAHO_CAMH.pdf /A Page=252
               Medication Safety
   7.1.11.19.1 Does the facility track use of reversal Such as reviewing automated dispensing
               agents?                                 machine records, which can be used as a tracer
                                                       order for adverse drug events. (e.g., reversal
                                                       agent s used in Endosocpy, Radiology, Acute
                                                       Care, etc., may be a signal to misadministration
                                                       or unsafe practices occurring. Tracking may also
                                                       alert to anesthesia adverse events occurring.
                                                       Other citeria to consider is increased surgical
                                                       times, durg interactions, and allergies.

                  Recommended
                  Medication Safety
   7.1.11.21      Is there a process for monitoring     Review monitoring records. To trial BCMA, test
                  BCMA?                                 5 bar codes scans to ensure process is working,
                                                        coding should match the electronic medical
                                                        record to the patient, allowing the information on
                                                        the patients armband to be matched with the
                                                        electronic information.
                  Recommended                           ISMP_Book.pdf /A Page=13
               Medication Safety
   7.1.11.21.1 Is BCMA used to administer               Observe staff. An oversight committee (i.e.,
               medication without using work            BCMA committee) should be monitoring for work
               arounds?                                 arounds.
                  Recommended




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                                                                      Part II Implementation
   LONG TERM CARE UNITS 7.1                           Facility unit/ward name:
                                                                                                                                        Not
                                                                                                                      Met   Partially   Met If score other than 'met' what are
               Question:                                Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
               Medication Safety
   7.1.11.21.2 What is the protocol for handling        One of the driving forces to increase medication
               medication preparations that are         safety within the VA as been to ensure staff are
               incorrectly bar coded or labeled, or     compliant and are able to scan medications into
               have labels that do not scan?            BCMA. Pharmacy and or adhoc groups such as
                                                        BCMA committee should have a (QA) monitor for
                                                        ensuring medications dispensed from pharmacy
                                                        are able to be scanned, and secondly QA
                                                        monitor for medication scanning on the unit
                                                        Lastly there is a greater likelihood for a
                                                        medication error to occur when staff are able to
                                                        administer medications that have an
                                                        incorrect/improper barcode.

                  Recommended                           JCAHO_CAMH.pdf /A Page=253
               Medication Safety
   7.1.11.21.3 Is there a helpdesk for BCMA             Test hotline number available on all shifts;
               available during all shifts?             interview off-shift staff if available.
                  Recommended
                  Medication Safety
   7.1.11.22.1 Do the VISTA modules effectively        Show example, if available. Test the software to
                  alert to potential food/drug/herbal  ensure there is not an option for turning off the
                  interactions and duplicate drug      alerts.
                  therapies? Are users prohibited from
                  turning them off (the alerts)?
                  Recommended
                  Medication Safety
   7.1.11.25      Is current drug reference information Interview area/unit staff, show where information
                  made readily accessible to            is kept and how it is retrieved. One or two
                  caregivers, if so how?                reference sources should be available as well as
                                                        access to pharmacist.
                                                        ISMP_Book.pdf /A Page=15
                  Recommended                           JCAHO_CAMH.pdf /A Page=385




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                                                                                                                                               Not
                                                                                                                             Met   Partially   Met If score other than 'met' what are
                  Question:                                 Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                  Medication Safety
   7.1.11.26      Are up-to-date facility specific          Interview unit staff, show where information is
                  protocols, guidelines, dosing scales,     kept and how it is retrieved. (e.g. use of
                  and/or checklists readily available for   electrolyte replacement, aminoglycoside, and
                  staff?                                    anti-coagulant guidelines).
                                                            ISMP_Book.pdf /A Page=15
                  Mandatory                                 JCAHO_CAMH.pdf /A Page=385
                  Medication Safety
   7.1.11.27      Are specific precautions followed         Discuss protocols with staff (such as insulin and
                  when handling look/sound alike            heparin vials; and hydromorphone and
                  drugs?                                    morphine). In pharmacy, discuss what is being
                                                            done with the look alike medication project.

                                                            Sentinel Event Alert #19.pdf /A Page=0
                  Recommended                               JCAHO_CAMH.pdf /A Page=249
                  Medication Safety
   7.1.11.28      Do prohibited abbreviations conform For example "u" in unit may be mistaken for "0"
                  to minimum TJC Patient Safety Goal resulting in ten fold over dosage.
                  requirements?
                                                            ISMP_Book.pdf /A Page=19
                                                            Sentinel Event Alert #11.pdf /A Page=0
                  Mandatory                                 Sentinel Event Alert #23.pdf /A Page=0
                  Medication Safety
   7.1.11.29      If Automated Dispensing Machines          Written documents should include which drugs
                  (ADMs) are used, is staff aware of a      are available - including strengths and doses,
                  written policy, and can they explain      how often drugs are inspected for expiration
                  how the machine works?                    dates, drugs not used but removed, and content
                                                            review.
                   Recommended                              JCAHO_CAMH.pdf /A Page=260
                  Medication Safety
   7.1.11.32      If ADMs are used, are there               Show example reports, where filed on units;
                  capabilities to run override reports      interview Nurse Manger. Have staff reveal how
                  that track discrepancy and utilization    reports are used and acted upon, and if there is
                  at least monthly?                         a process to deal with variances.
                  Recommended                               ISMP_Book.pdf /A Page=16




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                                                                                                                                              Not
                                                                                                                            Met   Partially   Met If score other than 'met' what are
                  Question:                             Rationale/Assessment Methods:                                       (1)   Met (2)     (3) possible root causes
                  Medication Safety
   7.1.11.34      Are patients educated regarding their Show example.
                  prescribed medication, as inpatients
                  and as part of the discharge
                  process?
                  Mandatory                                 JCAHO_CAMH.pdf /A Page=201
                  Medication Safety
   7.1.11.35      Does the care provided by           Interview clinicians to determine if Pharmacists
                  Pharmacists meet the clinical needs are available for consult, and if they participate in
                  of the patients in scope and        rounds or access patient medication history.
                  frequency?
                                                            ISMP_Book.pdf /A Page=16
                  Mandatory                                 JCAHO_CAMH.pdf /A Page=254
                  Medication Safety
   7.1.11.42      Is a process in place to reconcile     Observe a patient discharge is possible, or
                  patient medications upon admission, interview staff that are responsible for the patient
                  transfer or discharge and is a current discharge process.
                  list of medications given to the
                  patient when discharge from a
                  VAMC, and if medications are
                  changed exiting a clinic?
                  Mandatory                                 JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                  General Patient Safety Concerns
   7.1.12.1       Is read-back used for all verbal order Observe verbal ordering if possible, and
                  and critical value reports?            interview staff. Verify that telephone voice mail
                                                         orders are not accepted.
                                                            ISMP_Book.pdf /A Page=20
                                                            JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                  Mandatory                                 Read Back verbal_orders_advisory.pdf /A Page=0
                  General Patient Safety Concerns
   7.1.12.2       Are NCPS or locally developed             Randomly interview nursing staff on the floor.
                  cognitive aids available on the floor     Look for aids at nurses stations.
                  for staff to reference (Escape and
                  Elopement; Fall Prevention, etc.)?
                  Recommended




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                                                                          Part II Implementation
   LONG TERM CARE UNITS 7.1                             Facility unit/ward name:
                                                                                                                                             Not
                                                                                                                           Met   Partially   Met If score other than 'met' what are
                  Question:                              Rationale/Assessment Methods:                                     (1)   Met (2)     (3) possible root causes
                  General Patient Safety Concerns
   7.1.12.3       Are patient records kept confidential, Ensure records or computer screens are not left
                  including computer information?        unattended and openly visible.

                  Mandatory                               JCAHO_CAMH.pdf /A Page=383
                  General Patient Safety Concerns
   7.1.12.4       Are staff wearing identification        Monitor patient care areas. Interview staff about
                  badges and are unauthorized             policies such as the handling of drug
                  persons kept out of patient care        manufacturer representatives that visit
                  areas?                                  unexpectedly. Patient charts should not be left in
                                                          patient rooms where patients are waiting.
                  Mandatory                               JCAHO_CAMH.pdf /A Page=189
                  General Patient Safety Concerns
   7.1.12.5       Are restraints used in accordance       Look for restraint devices or alternative devices
                  with local policy and are restraint     in the area that may be in use. Document any
                  alternative devices available and       questionable use. Review patient record where
                  used when appropriate?                  restraints were used to determine if appropriate.

                                                          Sentinel Event Alert #8.pdf /A Page=0
                  Mandatory                               JCAHO_CAMH.pdf /A Page=208




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   LONG TERM CARE UNITS 7.1                            Facility unit/ward name:
                                                                                                                                           Not
                                                                                                                         Met   Partially   Met If score other than 'met' what are
                  Question:                              Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                  General Patient Safety Concerns
   7.1.12.6       Are there practices in place to        Requires using two patient identifiers for any
                  decrease the likelihood of patient     administrations, draws or procedures/images,
                  misidentification?                     and at outpatient pharmacy. Other suggestion
                                                         include the use of record and room flags for
                                                         same/similar/common names; four or less beds
                                                         in patient rooms; special procedure for the
                                                         transporting of patients at high risk for
                                                         misidentification.




                                                         VHA Directive 2005-029 dictates mandatory
                                                         patient identification requirements for
                                                         transfusions and the handling of blood and blood
                                                         products, including "active" identification (patient
                                                         be asked to state he/her name and Social
                                                         Security Number) and crossmatch with patient
                                                         arm band and consent form. Also the verifying
                                                         staff member must remain with the patient until
                                                         administration or collection begins.

                                                         JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                  Mandatory                              VHA Directive 2005-029.pdf /A Page=0
                  General Patient Safety Concerns
   7.1.12.6.1     Upon collection of blood or blood      It is a requirement of the reference Directive that
                  products is a informed consent         prior to ordering the blood products for
                  obtained?                              transfusion, an informed consent is documented
                                                         in the patient's record, ensuring that the patient
                                                         is aware of the transfusion to take place.

                  Mandatory                              VHA Directive 2005-029.pdf /A Page=0




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                                                                         Part II Implementation
   LONG TERM CARE UNITS 7.1                             Facility unit/ward name:
                                                                                                                                            Not
                                                                                                                          Met   Partially   Met If score other than 'met' what are
                  Question:                               Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                  General Patient Safety Concerns
   7.1.12.6.2     Is the labeling of blood samples or     When blood collection is completed at the
                  specimens done at the bedside,          bedside or in the clinic the blood container must
                  rather than in bulk (at the nurses      be immediately labeled before leaving the patient
                  station) to prevent mislabeling?        at minimum with the following: patient's full
                                                          name, Social Security Number, collector's
                                                          identification, and date of collection.

                  Mandatory                               VHA Directive 2005-029.pdf /A Page=0
                  General Patient Safety Concerns
   7.1.12.6.3     Is there an existing protocol for       When a patient can't communicate verbally or
                  patient identification with non-        otherwise the requirements for blood transfusion
                  communicative patients?                 are covered under VHA Directive 2005-029
                                                          which includes: a person with knowledge of the
                                                          patient (i.e., family) should be asked to state full
                                                          Social Security Number of patient. Another
                                                          recommendation is that a special protocol should
                                                          be followed to ensure correct identification, such
                                                          as, a photo ID or a color coded armband to flag a
                                                          common name or a name that is similar to
                                                          another admitted patient.

                  Mandatory                               VHA Directive 2005-029.pdf /A Page=0
                  General Patient Safety Concerns
   7.1.12.7       Are there monitoring processes in    Look for a preventative maintenance log that
                  place for portable food and beverage periodically checks the temperature of the
                  warming or heating devices?          warming device to help prevent scalding by
                                                       liquids or burns from food tray items. First and
                                                       second degree scalding can occur to patients
                                                       with cognitive or motor difficulties while being fed
                                                       in bed as well.
                  Recommended




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                                                                         Part II Implementation
   LONG TERM CARE UNITS 7.1                           Facility unit/ward name:
                                                                                                                                             Not
                                                                                                                           Met   Partially   Met If score other than 'met' what are
                  Question:                               Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                  General Patient Safety Concerns
   7.1.12.8       Are handoffs between shifts or          A consistent process should exist to update on-
                  transfer of care between units          coming staff or new unit staff of patient status.
                  standardized?                           Interview staff and compare answers between
                                                          units. Look for use of SBAR or other
                                                          communication tool.
                                                          Copyrighted Refs.doc #0
                  Mandatory                               JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                  General Patient Safety Concerns
   7.1.12.9       Is the transfer of care between         A consistent process should occur during
                  disciplines for off-unit appointments   appointments and when patients are sent back
                  standardized, including the             and forth from units, including patient
                  continuation of monitoring patient      identification means, patient record transfer, and
                  status and patient medical devices      the monitoring of the patient's condition and
                  such as IV pumps and oxygen level       needed medical devices. Stopping and
                  while the patient is visiting, being    resumption of IV medications should be planned
                  treated/tested, and during transport?   and documented. Interview staff in all areas
                                                          compare answers to determine standardization.

                  Recommended                             USP CAPSLink July 2004.pdf /A Page=0
                  General Patient Safety Concerns
   7.1.12.10      Are patients searched for contraband To ensure the safety of the patients and staff
                  upon admission to each applicable    members it is essential to have a rigorous search
                  area/unit?                           process of each individual patient. Observe an
                                                       admission, or interview staff to evaluate
                                                       consistency throughout the facility.
                  Recommended
                  General Patient Safety Concerns
   7.1.12.11      Does the facility have an emergency A local protocol should include a mechanism for
                  response protocol for dealing with  staff to communicate the emergency (via a
                  disruptive patients?                special extension or a separate alarm system)
                                                      and a security response when a patient, staff or
                                                      visitor becomes threatening or out of control.
                                                      Staff should be familiar with the protocol and
                                                      have confidence in how to respond.

                  Recommended




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                                                      NCPS Patient Safety Assessment Tool

                                                                      Part II Implementation
   LONG TERM CARE UNITS 7.1                          Facility unit/ward name:
                                                                                                                                         Not
                                                                                                                       Met   Partially   Met If score other than 'met' what are
                  Question:                            Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                  General Patient Safety Concerns
   7.1.12.12      When performing procedures           The facility's Conscious Sedation protocol should
                  outside of the operating room are    be followed in all areas.
                  appropriate sedation protocols and
                  privileges followed when applicable?

                                                       JCAHO_CAMH.pdf /A Page=224
                  Mandatory                            VHA Directive 2006-023.pdf /A Page=0




Long Term Care - 7.1                                                            Long Term Care - 7.1 - Version: 2007                                                        284 of 480
                                                         NCPS Patient Safety Assessment Tool

                                                                        Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                          Facility unit/ward name:
                                                                                                                                         Not
                                                                                                                       Met   Partially   Met If score other than 'met' what are
                   Question:                             Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
                   Code Carts
   7.2.2.1.1       Are code carts secured and            If carts are missing items then they could be
                   inaccessible to patients to prevent   ineffective in when needed in an emergency.
                   tampering where appropriate (i.e.,    Check that carts are put away in affected areas.
                   Behavioral Health areas)?
                   Recommended
                   Code Carts
   7.2.2.4         Is the VHA modified version of the    Inspect top of cart and review checklist of
                   ECC (Emergency Cardiac Care)          contents if provided.
                   AHA (American Heart Association)
                   Handbook of Cardiovascular Care
                   Cognitive Aid located on all carts?
                   Recommended
                   Code Carts
   7.2.2.5         Are CO2 detectors available on code Inspect carts. Adjunctive devices (i.e.
                   carts for confirming esophageal     colorimetric, syringe, or bulb devices) should be
                   intubations?                        adequately stocked and readily available for use
                                                       in all carts. Review cart checklist talk with cart
                                                       preparers in SPD (Supply Processing and
                                                       Distribution) Service.
                   Mandatory                             AirwayMgmt.pdf /A Page=0
                   Environmental and Housekeeping Safety
   7.2.4.1         Are hot water temperatures taken    Temperature should be less than 120 F at the
                   manually using a thermometer        tap and 110F in baths.
                   before patient use or immersion
                   (including partial immersion) takes
                   place?
                   Mandatory                             VHA Directive 2002-073.pdf /A Page=0
                   Environmental and Housekeeping Safety
   7.2.4.2         Are supply and return air registers Observe conditions on the unit.
                   clean and free of lint and dust?
                   Mandatory                             JCAHO_CAMH.pdf /A Page=358
                   Environmental and Housekeeping Safety
   7.2.4.3         Does general housekeeping appear Cleanliness, sanitation, odor, etc.
                   to be a priority?
                   Mandatory                             JCAHO_CAMH.pdf /A Page=358




Psych Care - 7.2                                                                    Psych Care - 7.2 - Version: 2007                                                        285 of 480
                                                        NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                          Facility unit/ward name:
                                                                                                                                         Not
                                                                                                                       Met   Partially   Met If score other than 'met' what are
                   Question:                            Rationale/Assessment Methods:                                  (1)   Met (2)     (3) possible root causes
                   Environmental and Housekeeping Safety
   7.2.4.4         Are storage rooms neat, organized, Inspect storage areas. Organized, well light
                   well light and temperature           rooms will help prevent mistakes. Ensuring
                   controlled? Is all storage 18" below extreme temperatures do not occur will uphold
                   fire sprinklers and off the floor?   the integrity of the supplies. Keeping boxes off
                                                        of floor keeps supplies sanitary.
                                                         NFPA 13 ch 8.pdf /A Page=11
                   Mandatory                             JCAHO_CAMH.pdf /A Page=344
                   Environmental and Housekeeping Safety
   7.2.4.5         Are patient care area corridors and Observe conditions on the unit by checking for
                   stairways unobstructed and kept free blocked doors.
                   of storage?
                                                         http://vaww.ceosh.med.va.gov/ #0
                                                         NFPA 101 (LSC) Ch 7.pdf /A Page=05
                   Mandatory                             JCAHO_CAMH.pdf /A Page=344
                   Environmental and Housekeeping Safety
   7.2.4.7         Are hazards clearly identified and Pre-construction meetings should proactively
                   properly controlled during         address all necessary interventions to remediate
                   construction and renovation?       such issues. However, patient /staff concerns
                                                      may flag potential problems. Examples of
                                                      hazards: walkways maintained; marked exit
                                                      paths; guarded floor openings and overhead
                                                      hazards; dust generation; and excessive noise.

                                                         29CRF 1926.20(b).pdf /A Page=1
                                                         JCAHO_CAMH.pdf /A Page=347
                   Mandatory                             VHA Directive 2004-012.pdf /A Page=0
                   Environmental and Housekeeping Safety
   7.2.4.10        Are steps taken to eliminate/control Infestations can occur, such as myiasis, without
                   "pests" in the hospital environment? preventative measures or monitors. Special
                                                        considerations should be made for sterile
                                                        environments.
                   Mandatory                             VHA Program Guide 1850.2 Pest Control.pdf /A Page=6




Psych Care - 7.2                                                                    Psych Care - 7.2 - Version: 2007                                                        286 of 480
                                                          NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                           Facility unit/ward name:
                                                                                                                                           Not
                                                                                                                         Met   Partially   Met If score other than 'met' what are
                   Question:                              Rationale/Assessment Methods:                                  (1)   Met (2)     (3) possible root causes
                   Equipment Safety
   7.2.5.1         Is medical equipment being             Check inspection tags, or other identifiers on the
                   inspected in accordance with the       equipment that indicates it has been inspected.
                   Preventative Maintenance Program?      Interview staff to determine how to interpret
                                                          identifiers.
                                                          http://vaww.ceosh.med.va.gov/ #0
                                                          NFPA 99 CH 8.pdf /A Page=0
                   Mandatory                              JCAHO goals.pdf /A Page=0
                   Equipment Safety
   7.2.5.4         Are alarms audible by care staff,      The unit layout/configuration (e.g., walls, doors,
                   unique in tone and pitch to prevent    size) and ambient noise levels impact whether
                   masking*, and are limits               staff will hear the alarms. Nuisance alarms are
                   appropriately set to reduce unwanted   caused when limits are not appropriately set, this
                   or false alarms?                       can create staff complacency, annoyance to
                                                          patients, and results in a delayed staff response
                                                          (cry wolf syndrome).

                   *Masking occurs when the frequency
                   and intensity of two independent
                   separate alarms blend together. "  Observe conditions in the unit and interview staff
                                                      as to what is done during breaks to cover patient
                                                      monitoring. Clinical alarms, bathroom alarms,
                                                      and nurse calls are included here.

                   Mandatory                              JCAHO goals.pdf /A Page=0
                   Equipment Safety
   7.2.5.8         Are liquids kept away from medical     To prevent spillage which can result in
                   equipment?                             malfunctioning.
                                                          http://vaww.ceosh.med.va.gov/ #0
                                                          NFPA 70 110.11.pdf /A Page=0
                   Recommended                            VA Circular 10-90-035.pdf /A Page=0
                   Equipment Safety
   7.2.5.11        Are locations of AEDs and              Placing this equipment in the same location of
                   defibrillators standardized            each care unit will assist staff who work on or
                   throughout the patient care areas of   between several care units locate the equipment
                   the facility?                          during emergent situations.
                   Recommended




Psych Care - 7.2                                                                      Psych Care - 7.2 - Version: 2007                                                        287 of 480
                                                          NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                           Facility unit/ward name:
                                                                                                                                          Not
                                                                                                                        Met   Partially   Met If score other than 'met' what are
                   Question:                              Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
                   Escape and Elopement Prevention
   7.2.6.1         Is a system in place to clearly        Look for screening processes, such as colored
                   identify high risk escape or           gowns, photos, designated identifiers for these
                   elopement patients to staff?           patients, etc.
                                                          Escape Elopement Cognitive Aid.pdf /A Page=0
                   Recommended                            JCAHO_CAMH.pdf /A Page=188
                   Escape and Elopement Prevention
   7.2.6.2         If electronic systems such as wander Test wander guard system to ensure accuracy.
                   guards are used, are methods in
                   place to ensure they function
                   correctly?
                   Recommended                            JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
                   Escape and Elopement Prevention
   7.2.6.3         If wander guard systems are in      Observe if in use, interview appropriate staff to
                   place, are they included in the     determine if properly maintained - ward staff
                   preventative maintenance inspection should be able to speak to reliability of system.
                   program?
                   Recommended                            JCAHO 2007 Goals - TIPS Article.pdf /A Page=2
                   Escape and Elopement Prevention
   7.2.6.4         Are annual drills of the full missing Review records of drills or critiques of missing
                   patient process (grid search)         patient searches.
                   conducted at least annually if the
                   plan wasn't exercised during a real
                   event?
                   Mandatory                              VHA Directive 2002-013.pdf /A Page=0
                   Escape and Elopement Prevention
   7.2.6.5         Is a risk assessment for elopement     Awareness of the potential for
                   completed at the time of admission     elopement/wandering behavior is the first step in
                   or transfer and regularly during the   prevention. Review documentation or interview
                   patients stay?                         staff to verify that the assessment is being
                                                          completed. Consider using electronic flags in
                                                          CPRS to inform clinicians if the patient is a high
                                                          risk. A change in the patients care (i.e., to a
                                                          new bed/unit, or new/change in medication) is a
                                                          key time for reassessment.

                   Mandatory                              VHA Directive 2002-013.pdf /A Page=0




Psych Care - 7.2                                                                     Psych Care - 7.2 - Version: 2007                                                        288 of 480
                                                            NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                             Facility unit/ward name:
                                                                                                                                            Not
                                                                                                                          Met   Partially   Met If score other than 'met' what are
                   Question:                               Rationale/Assessment Methods:                                  (1)   Met (2)     (3) possible root causes
                   Escape and Elopement Prevention
   7.2.6.5.1       Are staff familiar with the faciliities Ask staff working in the area to describe the
                   elopement risk assessment               process.
                   process?
                   Mandatory                                VHA Directive 2002-013.pdf /A Page=0
                   Escape and Elopement Prevention
   7.2.6.6         Is a processes in place and used to If patient privileges are not clear this often can
                   keep track of high risk patients when lead to lack of communication on patient status
                   they are off of the unit?             and location. A tracking or documentation
                                                         system can be used to help staff know patient
                                                         habits, and is a method to communicate this
                                                         information at the shift change. Also transport of
                                                         patients off the unit should be planned and
                                                         scheduled with competent escorts who
                                                         understand the potential for a high risk patient to
                                                         elope.
                   Recommended                              JCAHO_CAMH.pdf /A Page=333
                   Escape and Elopement Prevention
   7.2.6.7         Is a system in place to clearly Look for screening processes, such as colored
                   identify high risk escape or    gowns, photos, designated identifiers for these
                   elopement patients to staff?    patients, etc.
                   Recommended
                   Fall Prevention
   7.2.7.1         Are all patient or procedure rooms       Observe conditions on the unit. Patient sleeping
                   and common areas provided with           rooms and private bathrooms should be provided
                   adequate lighting so that the patients   with nightlights. Assess for shadows or glare that
                   ability to ambulate safely is not        may adversly impact ambulation.
                   impeded?
                   Mandatory                                JCAHO_CAMH.pdf /A Page=333
                   Fall Prevention
   7.2.7.3         Are all patient care or procedure     Floors should be free of liquids, electrical cords,
                   room the floors free of environmental wires, tubes, or other connectors which can
                   slipping and tripping hazards?        create fall hazards. Patient rooms should be free
                                                         of lfloor clutter or other low hanging objects that
                                                         could be a tripping hazard.
                   Mandatory                                JCAHO_CAMH.pdf /A Page=333




Psych Care - 7.2                                                                       Psych Care - 7.2 - Version: 2007                                                        289 of 480
                                                          NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                           Facility unit/ward name:
                                                                                                                                          Not
                                                                                                                        Met   Partially   Met If score other than 'met' what are
                   Question:                              Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
                   Fire Safety
   7.2.8.1         Are staff members familiar with fire   Interview staff to determine familiarity.
                   emergency procedures, and the fire
                   prevention plan for their service
                   area?
                                                          NFPA 101 (LSC) Ch 7.pdf /A Page=0
                                                          NFPA 101 (LSC) Ch 7.pdf /A Page=05
                   Mandatory                              NFPA 2006 101.7.2.3.pdf /A Page=08
                   Fire Safety
   7.2.8.2         Can clinical staff identify smoke and Interview staff to determine familiarity. Staff
                   fire walls in their immediate area?   must be knowledgeable regarding where to
                                                         move patients in the event of a fire.
                                                          NFPA 101 (LSC) Ch 7.pdf /A Page=0
                                                          NFPA 101 (LSC) Ch 7.pdf /A Page=05
                   Mandatory                              JCAHO_CAMH.pdf /A Page=344
                   Fire Safety
   7.2.8.3         Is the fire alarm signal easily        Interview staff to determine familiarity, if alarm is
                   distinguishable from other alarms      not witnessed.
                   (e.g., equipment, nurse call, etc.)?
                                                          http://vaww.ceosh.med.va.gov/ #0
                   Mandatory                              NFPA 72.4.4.3.6.1.pdf /A Page=08
                   Fire Safety
   7.2.8.4         Can staff describe the process on       Look for signs placed by pull stations, and
                   how they are notified when the fire     interview to determine if announcements are
                   alarm system is out of service in their made on PA system, etc
                   area or being tested?
                                                          http://vaww.ceosh.med.va.gov/ #0
                   Mandatory                              NFPA 101.19.7.1.2.pdf /A Page=08




Psych Care - 7.2                                                                     Psych Care - 7.2 - Version: 2007                                                        290 of 480
                                                            NCPS Patient Safety Assessment Tool

                                                                            Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                              Facility unit/ward name:
                                                                                                                                                Not
                                                                                                                              Met   Partially   Met If score other than 'met' what are
                   Question:                                Rationale/Assessment Methods:                                     (1)   Met (2)     (3) possible root causes
                   Fire Safety
   7.2.8.5         Are flame retardant pajamas or           Smoking risk patients are patients who are
                   aprons provided for patients who         known to routinely violate the "no smoking" rules
                   smoke and are identified as a            established by the facility. They smoke in non
                   "smoking risk"?                          designated areas when unsupervised and may
                                                            have a physical or mental condition that could
                                                            lead them to drop a cigarette, ashes, or match
                                                            causing clothing or hair to ignite. Flame
                                                            retardant pajamas or aprons can be a preventive
                                                            measure for these patients.

                                                            VA Circular 10-90-035.pdf /A Page=0
                   Mandatory                                VA MP-3 Part III 32.36(b) & (d).pdf /A Page=21
                   Fire Safety
   7.2.8.5.1       If flame retardant pajamas or linens     Interview staff, determine if practices are
                   are used, is a process in place to       consistent with policy. If the material has a fire
                   ensure integrity of the flame            retardant applied it will wash out over a period of
                   retardant agent is maintained on         time.
                   these articles after repeated
                   laundering?
                   Recommended                              VA MP-3 Part III 32.36(c) & (d).pdf /A Page=21
                   Fire Safety
   7.2.8.6         Are fire equipment cabinets and fire     These should be locked to prevent tampering,
                   alarm pull stations locked?              however ALL staff should carry key on their
                                                            person at all times for unlocking in an
                                                            emergency.
                   Recommended                              fire prot design man.doc #25
                   Infection Control
   7.2.9.1         Are all linen carts (clean and soiled)   Observe conditions on the unit.
                   kept covered and the bottom of the
                   cart is a solid surface (without
                   openings)?
                   Mandatory                                JCAHO_CAMH.pdf /A Page=280




Psych Care - 7.2                                                                           Psych Care - 7.2 - Version: 2007                                                        291 of 480
                                                               NCPS Patient Safety Assessment Tool

                                                                               Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                                Facility unit/ward name:
                                                                                                                                                 Not
                                                                                                                               Met   Partially   Met If score other than 'met' what are
                   Question:                                   Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                   Infection Control
   7.2.9.3         Is the facilities latex free policy being   Show example if available. Consider inspecting
                   followed including providing latex          supply and code carts. Look for latex-free
                   free supplies and devices?                  identification on glove boxes, supply packages,
                                                               etc. Determine if the other devices are available
                                                               as latex-free such as tourniquets and medical
                                                               tubing. In pharmacy, check for a latex protocol
                                                               in IV room.
                   Mandatory                                   IL 16-97-001.pdf /A Page=0
                   Infection Control
   7.2.9.4.1       Is alcohol hand gel stored so that is Patients that may have substance abuse
                   available for staff to access, but kept problems could attempt to drink the hand gel due
                   away and secured from patients that to most containing 60% or more alcohol.
                   may ingest it in areas such as
                   Behavioral Health, Detoxification
                   Units, or Urgent Care?

                   Recommended
                   Medication Safety
   7.2.11.1        Are all medication refrigerators            Check floor refrigerators, ensure correct labeling
                   maintained appropriately?                   and appropriate separations from employee
                                                               food/drink.




                                                               Review temperature log (or electronic
                                                               temperature monitoring device/log) and verify
                                                               that the thermometer is working.




                                                               Staff should know what actions to take if the
                                                               temperatures in the refrigerators are out of
                                                               range.
                                                               ISMP_Book.pdf /A Page=30
                                                               JCAHO_CAMH.pdf /A Page=249
                   Mandatory                                   capsLink2003-08-01 fridge.pdf /A Page=0




Psych Care - 7.2                                                                            Psych Care - 7.2 - Version: 2007                                                        292 of 480
                                                        NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                          Facility unit/ward name:
                                                                                                                                          Not
                                                                                                                        Met   Partially   Met If score other than 'met' what are
                   Question:                           Rationale/Assessment Methods:                                    (1)   Met (2)     (3) possible root causes
                   Medication Safety
   7.2.11.2        Do medication carts remained locked Randomly survey carts in the area.
                   and inaccessible to patients when
                   not in use?
                   Mandatory                             JCAHO_CAMH.pdf /A Page=249
                   Medication Safety
   7.2.11.3        Are the tops of medication carts,     Randomly survey carts in the area. Clean carts
                   clean, free of stray drugs, sharps    will help prevent medication error by eliminating
                   and food?                             opportunities for mix-ups . It will also avoid drug
                                                         being taken by mental health patients or those
                                                         with cognitive impairment.
                                                         ISMP_Book.pdf /A Page=13
                   Mandatory                             JCAHO_CAMH.pdf /A Page=249
                   Medication Safety
   7.2.11.4        Are receptacles for medication        Door locking mechanism cannot be defeated for
                   storage locked and are controlled     any reason. Door should not be held open.
                   substances double locked?
                                                         ISMP_Book.pdf /A Page=24
                   Mandatory                             JCAHO_CAMH.pdf /A Page=249
                   Medication Safety
   7.2.11.6        Is area stock limited to emergency     Review approved floor stock and IV solution list
                   medication and IV solutions which      (e.g. 3% NaCl should not generally be available).
                   are appropriate to patient care in the
                   unit?
                                                         ISMP_Book.pdf /A Page=25
                   Recommended                           JCAHO_CAMH.pdf /A Page=253
                   Medication Safety
   7.2.11.10       Is a unit dose medication system      Look in patient bins for products that are in the
                   used including liquids?               final pagkage of use. Bulk containers should not
                                                         be used.
                                                         ISMP_Book.pdf /A Page=22
                                                         Sentinel Event Alert #11.pdf /A Page=0
                   Recommended                           JCAHO_CAMH.pdf /A Page=249




Psych Care - 7.2                                                                     Psych Care - 7.2 - Version: 2007                                                        293 of 480
                                                          NCPS Patient Safety Assessment Tool

                                                                        Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                          Facility unit/ward name:
                                                                                                                                          Not
                                                                                                                        Met   Partially   Met If score other than 'met' what are
                   Question:                              Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
                   Medication Safety
   7.2.11.21       Is there a process for monitoring      Review monitoring records. To trial BCMA, test
                   BCMA?                                  5 bar codes scans to ensure process is working,
                                                          coding should match the electronic medical
                                                          record to the patient, allowing the information on
                                                          the patients armband to be matched with the
                                                          electronic information.
                   Recommended                            ISMP_Book.pdf /A Page=13
               Medication Safety
   7.2.11.21.1 Is BCMA used to administer                 Observe staff. An oversight committee (i.e.,
               medication without using work              BCMA committee) should be monitoring for work
               arounds?                                   arounds.
                   Recommended
                   Medication Safety
   7.2.11.21.2 What is the protocol for handling          One of the driving forces to increase medication
                   medication preparations that are       safety within the VA as been to ensure staff are
                   incorrectly bar coded or labeled, or   compliant and are able to scan medications into
                   have labels that do not scan?          BCMA. Pharmacy and or adhoc groups such as
                                                          BCMA committee should have a (QA) monitor for
                                                          ensuring medications dispensed from pharmacy
                                                          are able to be scanned, and secondly QA
                                                          monitor for medication scanning on the unit
                                                          Lastly there is a greater likelihood for a
                                                          medication error to occur when staff are able to
                                                          administer medications that have an
                                                          incorrect/improper barcode.

                   Recommended                            JCAHO_CAMH.pdf /A Page=253
               Medication Safety
   7.2.11.21.3 Is there a helpdesk for BCMA               Test hotline number available on all shifts;
               available during all shifts?               interview off-shift staff if available.
                   Recommended
                   Medication Safety
   7.2.11.25       Is current drug reference information Interview area/unit staff, show where information
                   made readily accessible to            is kept and how it is retrieved. One or two
                   caregivers, if so how?                reference sources should be available as well as
                                                         access to pharmacist.
                                                          ISMP_Book.pdf /A Page=15
                   Recommended                            JCAHO_CAMH.pdf /A Page=385




Psych Care - 7.2                                                                     Psych Care - 7.2 - Version: 2007                                                        294 of 480
                                                             NCPS Patient Safety Assessment Tool

                                                                             Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                              Facility unit/ward name:
                                                                                                                                              Not
                                                                                                                            Met   Partially   Met If score other than 'met' what are
                   Question:                                 Rationale/Assessment Methods:                                  (1)   Met (2)     (3) possible root causes
                   Medication Safety
   7.2.11.26       Are up-to-date facility specific          Interview unit staff, show where information is
                   protocols, guidelines, dosing scales,     kept and how it is retrieved. (e.g. use of
                   and/or checklists readily available for   electrolyte replacement, aminoglycoside, and
                   staff?                                    anti-coagulant guidelines).
                                                             ISMP_Book.pdf /A Page=15
                   Mandatory                                 JCAHO_CAMH.pdf /A Page=385
                   Medication Safety
   7.2.11.27       Are specific precautions followed         Discuss protocols with staff (such as insulin and
                   when handling look/sound alike            heparin vials; and hydromorphone and
                   drugs?                                    morphine). In pharmacy, discuss what is being
                                                             done with the look alike medication project.

                                                             Sentinel Event Alert #19.pdf /A Page=0
                   Recommended                               JCAHO_CAMH.pdf /A Page=249
                   Medication Safety
   7.2.11.28       Do prohibited abbreviations conform For example "u" in unit may be mistaken for "0"
                   to minimum TJC Patient Safety Goal resulting in ten fold over dosage.
                   requirements?
                                                             ISMP_Book.pdf /A Page=19
                                                             Sentinel Event Alert #11.pdf /A Page=0
                   Mandatory                                 Sentinel Event Alert #23.pdf /A Page=0
                   Medication Safety
   7.2.11.29       If Automated Dispensing Machines          Written documents should include which drugs
                   (ADMs) are used, is staff aware of a      are available - including strengths and doses,
                   written policy, and can they explain      how often drugs are inspected for expiration
                   how the machine works?                    dates, drugs not used but removed, and content
                                                             review.
                   Recommended                               JCAHO_CAMH.pdf /A Page=260
                   Medication Safety
   7.2.11.32       If ADMs are used, are there               Show example reports, where filed on units;
                   capabilities to run override reports      interview Nurse Manger. Have staff reveal how
                   that track discrepancy and utilization    reports are used and acted upon, and if there is
                   at least monthly?                         a process to deal with variances.
                   Recommended                               ISMP_Book.pdf /A Page=16




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                                                           NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                            Facility unit/ward name:
                                                                                                                                           Not
                                                                                                                         Met   Partially   Met If score other than 'met' what are
                   Question:                             Rationale/Assessment Methods:                                   (1)   Met (2)     (3) possible root causes
                   Medication Safety
   7.2.11.34       Are patients educated regarding their Show example.
                   prescribed medication, as inpatients
                   and as part of the discharge
                   process?
                   Mandatory                               JCAHO_CAMH.pdf /A Page=201
                   Medication Safety
   7.2.11.35       Does the care provided by           Interview clinicians to determine if Pharmacists
                   Pharmacists meet the clinical needs are available for consult, and if they participate in
                   of the patients in scope and        rounds or access patient medication history.
                   frequency?
                                                           ISMP_Book.pdf /A Page=16
                   Mandatory                               JCAHO_CAMH.pdf /A Page=254
                   Medication Safety
   7.2.11.42       Is a process in place to reconcile     Observe a patient discharge is possible, or
                   patient medications upon admission, interview staff that are responsible for the patient
                   transfer or discharge and is a current discharge process.
                   list of medications given to the
                   patient when discharge from a
                   VAMC, and if medications are
                   changed exiting a clinic?
                   Mandatory                               JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                   General Patient Safety Concerns
   7.2.12.1        Is read-back used for all verbal order Observe verbal ordering if possible, and
                   and critical value reports?            interview staff. Verify that telephone voice mail
                                                          orders are not accepted.
                                                           ISMP_Book.pdf /A Page=20
                                                           JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                   Mandatory                               Read Back verbal_orders_advisory.pdf /A Page=0
                   General Patient Safety Concerns
   7.2.12.2        Are NCPS or locally developed           Randomly interview nursing staff on the floor.
                   cognitive aids available on the floor   Look for aids at nurses stations.
                   for staff to reference (Escape and
                   Elopement; Fall Prevention, etc.)?
                   Recommended




Psych Care - 7.2                                                                      Psych Care - 7.2 - Version: 2007                                                        296 of 480
                                                         NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                           Facility unit/ward name:
                                                                                                                                           Not
                                                                                                                         Met   Partially   Met If score other than 'met' what are
                   Question:                              Rationale/Assessment Methods:                                  (1)   Met (2)     (3) possible root causes
                   General Patient Safety Concerns
   7.2.12.3        Are patient records kept confidential, Ensure records or computer screens are not left
                   including computer information?        unattended and openly visible.

                   Mandatory                             JCAHO_CAMH.pdf /A Page=383
                   General Patient Safety Concerns
   7.2.12.4        Are staff wearing identification      Monitor patient care areas. Interview staff about
                   badges and are unauthorized           policies such as the handling of drug
                   persons kept out of patient care      manufacturer representatives that visit
                   areas?                                unexpectedly. Patient charts should not be left in
                                                         patient rooms where patients are waiting.
                   Mandatory                             JCAHO_CAMH.pdf /A Page=189
                   General Patient Safety Concerns
   7.2.12.5        Are restraints used in accordance     Look for restraint devices or alternative devices
                   with local policy and are restraint   in the area that may be in use. Document any
                   alternative devices available and     questionable use. Review patient record where
                   used when appropriate?                restraints were used to determine if appropriate.

                                                         Sentinel Event Alert #8.pdf /A Page=0
                   Mandatory                             JCAHO_CAMH.pdf /A Page=208




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                                                                       Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                         Facility unit/ward name:
                                                                                                                                        Not
                                                                                                                      Met   Partially   Met If score other than 'met' what are
                   Question:                            Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
                   General Patient Safety Concerns
   7.2.12.6        Are there practices in place to      Requires using two patient identifiers for any
                   decrease the likelihood of patient   administrations, draws or procedures/images,
                   misidentification?                   and at outpatient pharmacy. Other suggestion
                                                        include the use of record and room flags for
                                                        same/similar/common names; four or less beds
                                                        in patient rooms; special procedure for the
                                                        transporting of patients at high risk for
                                                        misidentification.




                                                        VHA Directive 2005-029 dictates mandatory
                                                        patient identification requirements for
                                                        transfusions and the handling of blood and blood
                                                        products, including "active" identification (patient
                                                        be asked to state he/her name and Social
                                                        Security Number) and crossmatch with patient
                                                        arm band and consent form. Also the verifying
                                                        staff member must remain with the patient until
                                                        administration or collection begins.

                                                        JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                   Mandatory                            VHA Directive 2005-029.pdf /A Page=0
                   General Patient Safety Concerns
   7.2.12.6.1      Upon collection of blood or blood    It is a requirement of the reference Directive that
                   products is a informed consent       prior to ordering the blood products for
                   obtained?                            transfusion, an informed consent is documented
                                                        in the patient's record, ensuring that the patient
                                                        is aware of the transfusion to take place.

                   Mandatory                            VHA Directive 2005-029.pdf /A Page=0




Psych Care - 7.2                                                                   Psych Care - 7.2 - Version: 2007                                                        298 of 480
                                                         NCPS Patient Safety Assessment Tool

                                                                        Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                          Facility unit/ward name:
                                                                                                                                         Not
                                                                                                                       Met   Partially   Met If score other than 'met' what are
                   Question:                             Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
                   General Patient Safety Concerns
   7.2.12.6.2      Is the labeling of blood samples or   When blood collection is completed at the
                   specimens done at the bedside,        bedside or in the clinic the blood container must
                   rather than in bulk (at the nurses    be immediately labeled before leaving the patient
                   station) to prevent mislabeling?      at minimum with the following: patient's full
                                                         name, Social Security Number, collector's
                                                         identification, and date of collection.

                   Mandatory                             VHA Directive 2005-029.pdf /A Page=0
                   General Patient Safety Concerns
   7.2.12.6.3      Is there an existing protocol for     When a patient can't communicate verbally or
                   patient identification with non-      otherwise the requirements for blood transfusion
                   communicative patients?               are covered under VHA Directive 2005-029
                                                         which includes: a person with knowledge of the
                                                         patient (i.e., family) should be asked to state full
                                                         Social Security Number of patient. Another
                                                         recommendation is that a special protocol should
                                                         be followed to ensure correct identification, such
                                                         as, a photo ID or a color coded armband to flag a
                                                         common name or a name that is similar to
                                                         another admitted patient.

                   Mandatory                             VHA Directive 2005-029.pdf /A Page=0
                   General Patient Safety Concerns
   7.2.12.7        Are there monitoring processes in    Look for a preventative maintenance log that
                   place for portable food and beverage periodically checks the temperature of the
                   warming or heating devices?          warming device to help prevent scalding by
                                                        liquids or burns from food tray items. First and
                                                        second degree scalding can occur to patients
                                                        with cognitive or motor difficulties while being fed
                                                        in bed as well.
                   Recommended




Psych Care - 7.2                                                                    Psych Care - 7.2 - Version: 2007                                                        299 of 480
                                                           NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                            Facility unit/ward name:
                                                                                                                                           Not
                                                                                                                         Met   Partially   Met If score other than 'met' what are
                   Question:                               Rationale/Assessment Methods:                                 (1)   Met (2)     (3) possible root causes
                   General Patient Safety Concerns
   7.2.12.8        Are handoffs between shifts or          A consistent process should exist to update on-
                   transfer of care between units          coming staff or new unit staff of patient status.
                   standardized?                           Interview staff and compare answers between
                                                           units. Look for use of SBAR or other
                                                           communication tool.
                                                           Copyrighted Refs.doc #0
                   Mandatory                               JCAHO 2007 Goals - TIPS Article.pdf /A Page=0
                   General Patient Safety Concerns
   7.2.12.9        Is the transfer of care between         A consistent process should occur during
                   disciplines for off-unit appointments   appointments and when patients are sent back
                   standardized, including the             and forth from units, including patient
                   continuation of monitoring patient      identification means, patient record transfer, and
                   status and patient medical devices      the monitoring of the patient's condition and
                   such as IV pumps and oxygen level       needed medical devices. Stopping and
                   while the patient is visiting, being    resumption of IV medications should be planned
                   treated/tested, and during transport?   and documented. Interview staff in all areas
                                                           compare answers to determine standardization.

                   Recommended                             USP CAPSLink July 2004.pdf /A Page=0
                   General Patient Safety Concerns
   7.2.12.10       Are patients searched for contraband To ensure the safety of the patients and staff
                   upon admission to each applicable    members it is essential to have a rigorous search
                   area/unit?                           process of each individual patient. Observe an
                                                        admission, or interview staff to evaluate
                                                        consistency throughout the facility.
                   Recommended
                   General Patient Safety Concerns
   7.2.12.11       Does the facility have an emergency A local protocol should include a mechanism for
                   response protocol for dealing with  staff to communicate the emergency (via a
                   disruptive patients?                special extension or a separate alarm system)
                                                       and a security response when a patient, staff or
                                                       visitor becomes threatening or out of control.
                                                       Staff should be familiar with the protocol and
                                                       have confidence in how to respond.

                   Recommended




Psych Care - 7.2                                                                      Psych Care - 7.2 - Version: 2007                                                        300 of 480
                                                        NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                          Facility unit/ward name:
                                                                                                                                          Not
                                                                                                                        Met   Partially   Met If score other than 'met' what are
               Question:                                 Rationale/Assessment Methods:                                  (1)   Met (2)     (3) possible root causes
               General Patient Safety Concerns
   7.2.12.11.1 Is there an assessment used to            Review assessment process/documents.
               determine if a patient is potentially
               violent?
                   Mandatory; Priority A                 VA IL-10-97-006 Violent Behavior.pdf /A Page=0
                   Mental Health Locked Unit Checklist
   7.2.13.1        General Criteria
                   Mental Health Locked Unit Checklist
   7.2.13.1.1      Are floor coverings free of tripping Floor coverings should be secured to the floor, in
                   hazards?                             good repair without tripping hazards, and not
                                                        easily torn or dislodged.


                   Are floor coverings secured to the
                   floor?
                   Recommended
                   Mental Health Locked Unit Checklist
   7.2.13.1.2      Are floor-mounted HVAC vents      Floor-mounted HVAC vents should not be used.
                   removed?                          There should be no exposed and accessible
                                                     HVAC equipment such as floor mounted fan coil
                                                     units, radiators, convectors, or finned tube
                                                     radiation.
                   Recommended
                   Mental Health Locked Unit Checklist
   7.2.13.1.3      Are door thresholds secured to the  Avoid thresholds where possible. Look for other
                   floor and no higher than 3/4 inches projections on the floor that could be tripping
                   above the floor?                    hazards or could be removed easily to be used
                                                       for self-harm or as a weapon.


                   Are door thresholds secured using
                   tamper resistant anchors or
                   fasteners?
                   Recommended




Psych Care - 7.2                                                                     Psych Care - 7.2 - Version: 2007                                                        301 of 480
                                                         NCPS Patient Safety Assessment Tool

                                                                   Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                     Facility unit/ward name:
                                                                                                                                Not
                                                                                                              Met   Partially   Met If score other than 'met' what are
                   Question:                         Rationale/Assessment Methods:                            (1)   Met (2)     (3) possible root causes
                   Mental Health Locked Unit Checklist
   7.2.13.1.4      Are wall coverings and paint non- Non-toxic wall paper, glue, and paint should be
                   toxic?                            used. Paint and wall paper should not be
                                                     peeling.


                   Are wall coverings secured to the
                   wall and not peeling?
                   Recommended
                   Mental Health Locked Unit Checklist
   7.2.13.1.5      Are picture frames and coverings  No glass coverings; no sharp edges; wood
                   made of non-breakable material?   frames only, no metal frames; secured to the
                                                     wall; may also be frameless; smaller is better;
                                                     safe pictures are encouraged for milieu.

                   Are picture frames secured to the
                   walls using tamper resistant screws
                   or anchors?
                   Recommended




Psych Care - 7.2                                                           Psych Care - 7.2 - Version: 2007                                                        302 of 480
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                                                                    Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                      Facility unit/ward name:
                                                                                                                                  Not
                                                                                                                Met   Partially   Met If score other than 'met' what are
                   Question:                           Rationale/Assessment Methods:                            (1)   Met (2)     (3) possible root causes
                   Mental Health Locked Unit Checklist
   7.2.13.1.6      Are the number and locations of     GFCI-protected outlets, adequate number of
                   electrical receptacles in the room  outlets, short electrical cords. Equipment with
                   adequate?                           cords should be located close to the wall outlet;
                                                       cords should be too short to loop around the
                                                       neck and secure to an anchor point for hanging.
                                                       Flush mounted switches reduce the risk of using
                   Are receptacles and switches        a projecting switch to propel self or other person
                   covered by metal plates that are    into the projection.
                   secured by tamper resistant screws?



                   Are the electrical boxes flush
                   mounted?



                   Are all receptacles provided with
                   GFCI protection?

                   Recommended
                   Mental Health Locked Unit Checklist
   7.2.13.1.7      Are HVAC vents flush with the wall? Vents should be flush with the wall and secured
                                                       with tamperproof anchors; grates or mesh
                                                       covering is preferred or a louvered vent should
                                                       not support weight (over 15 pounds). Vents
                   Are HVAC vents secured with         should not be able to be removed and used as a
                   tamper resistant screws?            weapon or for self-harm. See:
                                                       http://www.anemostat.com/a-
                                                       catalog/sec_index_fs.htm

                   Are louvers designed so that they
                   cannot be used to secure any item
                   that might be used to attempt suicide
                   by hanging?

                   Recommended




Psych Care - 7.2                                                             Psych Care - 7.2 - Version: 2007                                                        303 of 480
                                                        NCPS Patient Safety Assessment Tool

                                                                     Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                       Facility unit/ward name:
                                                                                                                                   Not
                                                                                                                 Met   Partially   Met If score other than 'met' what are
                   Question:                             Rationale/Assessment Methods:                           (1)   Met (2)     (3) possible root causes
                   Mental Health Locked Unit Checklist
   7.2.13.1.8      Are corner guards present on all wall Wall edges and corners should be protected by
                   edges?                                corner guards.
                   Recommended
                   Mental Health Locked Unit Checklist
   7.2.13.1.9      If used, is vinyl baseboard secured Vinyl baseboard is used in many buildings. It
                   to the wall so that it cannot be easily should be secured to the wall. Look for sections
                   removed and used as a weapon?           that may be loose or have gaps making it easy to
                                                           remove. If removed it could be used as a
                                                           weapon.
                   Recommended
                   Mental Health Locked Unit Checklist
   7.2.13.1.10 Has all surface-mounted wire          In older buildings, it is not unusual for wiring to
                   molding been removed?             newer receptacles to be run in surface-mounted
                                                     wire molding. Ideally, wire should be run inside
                                                     of the wall and out of sight. Surface-mounted
                                                     molding could potentially be used as an anchor
                                                     point and should be replaced with flush wall-
                                                     mounted receptacles. Prior to being replaced,
                                                     any surface-mounted wire molding must be
                                                     secured tight to the wall with no gaps and
                                                     secured with tamper resistant screws.
                   Recommended
                   Mental Health Locked Unit Checklist
   7.2.13.1.11 Corner mirrors are secured with         Corner mirrors may be necessary for safety, but
                   tamper resistant screws and are     must not provide an anchor for hanging and must
                   flush mounted so that they will not be made of non-glass material.
                   support a rope or material for
                   hanging.
                   Recommended




Psych Care - 7.2                                                              Psych Care - 7.2 - Version: 2007                                                        304 of 480
                                                       NCPS Patient Safety Assessment Tool

                                                                    Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                      Facility unit/ward name:
                                                                                                                                  Not
                                                                                                                Met   Partially   Met If score other than 'met' what are
               Question:                             Rationale/Assessment Methods:                              (1)   Met (2)     (3) possible root causes
               Mental Health Locked Unit Checklist
   7.2.13.1.12 Are bulletin boards, message          Look at each item. All items must be secured to
               boards, posters, telephones, door     the wall in a manner that prevents removal or
               stops, exit signs, and lights secured use as a weapon or for self-harm. It must be
               using tamper resistant screws?        flush with the wall or beveled in a manner so that
                                                     it cannot be used as an anchor for hanging. If
                                                     lights are on the wall, the glass bulbs should not
                                                     be easily accessed. See:
               Are dispensers for alcohol based      http://www.elights.com/vanwalceilfi.html
               hand cleaners not accessible to
               patients?

                                                        Alcohol based gels and foams may be consumed
                                                        by patients and therefore should not be
                                                        accessible to them.

                   Recommended
                   Mental Health Locked Unit Checklist
   7.2.13.1.13 Are items projecting from the wall,       Cords should be too short to use to wrap around
                   even if otherwise considered a safety a neck and hang from any securing point
                   item, designed so they cannot be      (maximum of 12 inches). Wall telephones
                   used for harm of self or to harm      should only be in locations that can be
                   others? For wall-mounted sprinklers, continuously observed by staff and the cord
                   see sprinkler criteria under Ceilings between the telephone base and the hand set
                   section.                              should be as short as practically possible.
                                                         Hooks and hangers, even if structured with
                                                         safety features, should be evaluated for risk to
                                                         others. Drinking fountains should be secured to
                                                         the wall and visible to staff - see
                                                         http://www.plandstainless.co.uk/products/product
                                                         .php?product_code=HAWSHWBFA8.VRC

                   Recommended




Psych Care - 7.2                                                             Psych Care - 7.2 - Version: 2007                                                        305 of 480
                                                          NCPS Patient Safety Assessment Tool

                                                                       Part II Implementation
   BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2                         Facility unit/ward name:
                                                                                                                                      Not
                                                                                                                    Met   Partially   Met If score other than 'met' what are
               Question:                         Rationale/Assessment Methods:                                      (1)   Met (2)     (3) possible root causes
               Mental Health Locked Unit Checklist
   7.2.13.1.14