Stock Resume Examples

Document Sample
Stock Resume Examples Powered By Docstoc
					Patient Safety Assessment Tool
        Version 7-2006
Patient Safety Assessment Tool
    Administration Elements
Element 1
    Management and Leadership

Element 2
    Patient Safety Program Management

Element 3
    JCAHO (Comprehensive Accreditation Manual for Hospitals)

Element 4
    Procurement and Equipment Management

Element 5
    Recalls and VHA Alerts & Advisories

Element 6
    Patient Safety Policies, Tools & Aids
                                                     NCPS Patient Safety Assessment Tool

                                                                      Part I Administrative
   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 CAM-H, LD.4.40 Pg. 290
                                                     JCAHO CAM-H, PI.2.30 Pg. 265
              Mandatory;Priority A                   VHA PS Handbook 4.e.1.b & 5.b Pg. 08
              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 CAM-H, LD.4.10 & LD.4.60 Pg. 289
              Mandatory;Priority A                   VHA PS Handbook 4.e.4.a Pg. 07
              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 CAM-H, LD.4.40 & LD.4.60 Pg. 290




Mgt Ldr - 1                                                                    Mgt Ldr - 1 - Version: 08.01.2006                                                         3 of 351
                                                      NCPS Patient Safety Assessment Tool

                                                                         Part I Administrative
   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 CAM-H, LD.4.10 & LD.4.40 Pg. 289
              Mandatory;Priority A                    VHA PS Handbook 4.e.4.d Pg. 09
              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 CAM-H, LD.4.40 Pg. 290
              Mandatory;Priority A                    VHA PS Handbook 4.c - 4.c.2, 6.a.3, & 6.i Pg. 07
              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.

              Recommended; Priority C                 VHA PS Handbook 5.c Pg. 09
              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 6.d-h Pg. 10




Mgt Ldr - 1                                                                       Mgt Ldr - 1 - Version: 08.01.2006                                                         4 of 351
                                                     NCPS Patient Safety Assessment Tool

                                                                         Part I Administrative
   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.

                                                      NCPS Confidentiality 5705 Cognitive Aid
                                                      JCAHO CAM-H, IM 2.10 Pg. 347
              Mandatory;Priority A                    VHA PS Handbook Pg. 07
              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.
              NCPS?
                                                      JCAHO CAM-H, IM 2.10 Pg. 332
                                                      38 USC 5705
              Mandatory;Priority A                    Code of Federal Regulations Part 17
              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.
                                                      JCAHO CAM-H LD.4.40 & LD.4.60 Pg. 290
              Mandatory;Priority A                    USH memo PSO & PSM Job Responsibilities
              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
              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 CAM-H, HR.2.30 Pg. 320




Mgt Ldr - 1                                                                       Mgt Ldr - 1 - Version: 08.01.2006                                                         5 of 351
                                                        NCPS Patient Safety Assessment Tool

                                                                         Part I Administrative
   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
   1.3.1.1    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/
                                                        USH memo PSO & PSM Job Responsibilities
              Recommended; Priority A                   JCAHO CAM-H, HR.2.30 Pg. 338
              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 CAM-H, LD.4.60 Pg. 291
              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




Mgt Ldr - 1                                                                      Mgt Ldr - 1 - Version: 08.01.2006                                                         6 of 351
                                                          NCPS Patient Safety Assessment Tool

                                                                            Part I Administrative
  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). Review
                  reported patient safety events,         if SAC scores reasonably reflect severity and
                  including close calls?                  frequency of events occurring.
                                                          JCAHO CAM-H, PI.2.20, PI.2.30 & IM.4.10 Pg. 266
                  Mandatory; Priority A                   VHA PS Handbook, 6.k & 7.a.7 Pg. 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, 7.a.1-4b Pg. 12
                  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.

                                                          VHA PS Handbook, 7.a.4 & Appendix C Pg. 12
                                                          Aggregate Review Schedule Cognitive Aid
                                                          JCAHO CAM-H, PI.2.10, PI.2.20 & MM.8.10 Pg. 264
                  Mandatory; Priority A                   ISMP Self Assessement 173




PS Prgm Mgt - 2                                                                   PS Prgm Mgt - 2 - Version: 08.01.2006                                                         7 of 351
                                                       NCPS Patient Safety Assessment Tool

                                                                          Part I Administrative
  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           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 CAM-H, HR.2.30 Pg. 336
                  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.

                                                       RCA Team Process
                                                       JCAHO CAM-H, HR.2.30 Pg. 338
                  Recommended; Priority A              Charter Memo
                  Root Cause Analysis Activities
  2.1.4           Is RCA team membership               Review 10% of yearly (minimum of 4) RCA's to
                  appropriate for the adverse event    determine if appropriate personal participate
                  being evaluated?                     based on relevance to RCA content. Team
                                                       members' titles/qualifications should be
                                                       documented in the RCA (SPOT database).
                                                       JCAHO CAM-H, LD.4.60 Pg. 291
                  Mandatory; Priority A                VHA PS Handbook, 4.e.1.a Pg. 07
                  Root Cause Analysis Activities
  2.1.4.1         Does the PSM direct and advise the   Review 10 % of yearly (minimum of 4) RCA's
                  RCA/Aggregate Review teams as        and interview selective team members and the
                  necessary to produce the desired     PSM. RCA documentation should include
                  outcomes?                            defined root cause statements, actions that
                                                       address the root causes, and outcome measures
                                                       that measure the actions.
                                                       JCAHO CAM-H, PI.3.10 Pg. 265
                  Mandatory; Priority A                VHA PS Handbook, Appendix C Pg. 23




PS Prgm Mgt - 2                                                               PS Prgm Mgt - 2 - Version: 08.01.2006                                                         8 of 351
                                                       NCPS Patient Safety Assessment Tool

                                                                         Part I Administrative
  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
  2.1.4.2         Does the PSM serve as an advisor     Review 10 % of yearly (minimum of 4) RCA's
                  and not as the leader, recorder or   and interview team members and the PSM.
                  team member on RCAs?                 Review RCA charter memos to determine PSM
                                                       role in each RCA reviewed.
                                                       USH memo PSO & PSM Job Responsibilities Pg. 2
                  Recommended; Priority B              Charter Memo Form
                  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 CAM-H, PI.3.10 Pg. 265
                  Mandatory; Priority A                VHA PS Handbook, 7.b Pg. 14
                  Root Cause Analysis Activities
  2.1.6           Are the RCA Actions completed with Review 10 % of yearly (minimum of 4) RCA's to
                  the specified time frame?          evaluate time 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 CAM-H, PI.1.10 Pg. 251
                  Root Cause Analysis Activities
  2.1.6.1         Are Action completion and follow up Review 10 % of yearly (minimum of 4) RCA's
                  dates reasonable?                   looking for time 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?
                                                       JCAHO CAM-H, IM.3.10 Pg. 349
                                                       5 Rules of Causation NPCS Cognitive Aid Pg. 12
                  Recommended; Priority A              VHA PS Handbook, 4.e.2.a-e Pg. 07




PS Prgm Mgt - 2                                                                PS Prgm Mgt - 2 - Version: 08.01.2006                                                         9 of 351
                                                      NCPS Patient Safety Assessment Tool

                                                                        Part I Administrative
  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
  2.1.8           Do the RCA reports identify pertinent Review 10 % of yearly (minimum of 4) RCA's for
                  Root Cause Contributing Factors?      context. 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 CAM-H, PI3.10 Pg. 265
                  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 CAM-H, PI.3.10 Pg. 265
                  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 CAM-H, PI.3.10 Pg. 265
                  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, Figure 1 Pg. 13
                  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 inter-agency agreement




PS Prgm Mgt - 2                                                               PS Prgm Mgt - 2 - Version: 08.01.2006                                                         10 of 351
                                                        NCPS Patient Safety Assessment Tool

                                                                         Part I Administrative
  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
  2.3.1           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 PSO & PSM Job Responsibilities
                  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.

                                                        VHA PS Handbook, 2.a-b
                  Mandatory; Priority A                 JCAHO CAM-H, LD.4.70 Pg. 291
                  General Programmatic Functions
  2.3.3           Is the PSM involved in the Patient    Show examples of Alerts/Advisories from facility,
                  Safety Alerts/Advisories/Recall       and documentation from tracking. Interview
                  process, including tracking issues to PSM.
                  resolution?
                                                        JCAHO CAM-H, LD.4.40, LD4.50, & LD.4.60 Pg. 272
                  Recommended; Priority A               VHA PS Handbook, 5.c Pg. 09
                  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: 08.01.2006                                                         11 of 351
                                                       NCPS Patient Safety Assessment Tool

                                                                          Part I Administrative
  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.

                                                        NCPS PS 101 Training "Why Bother" Power Point
                  Recommended; Priority A               JCAHO CAM-H, HR.2.10 Pg. 336
                  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 CAM-H, HR.2.30 Pg. 338
                  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 PSO & PSM Job Responsibilities
                  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?

                                                        NCPS HFMEA Analysis Process Flipbook
                                                        NCPS HFMEA Critique Sheet
                                                        JCAHO CAM-H, PI.3.20 Pg. 365
                  Mandatory; Priority A                 VHA PS Handbook, 5.d Pg. 09




PS Prgm Mgt - 2                                                                 PS Prgm Mgt - 2 - Version: 08.01.2006                                                         12 of 351
                                                          NCPS Patient Safety Assessment Tool

                                                                           Part I Administrative
  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, 6.h Pg. 11




PS Prgm Mgt - 2                                                                 PS Prgm Mgt - 2 - Version: 08.01.2006                                                         13 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                   If score other than
                                                                                                                                         Met   Partially   Not Met '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, his or her family, is informed
           families are informed about the       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.

           Previously: 3.1.13                     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
           Ethics, Rights and Responsibilities
3.1.2      The hospital respects the needs of     1) The hospital protects confidentiality of information about patients.
           patients for confidentiality, privacy,
           and security.                          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
           Previously: 3.1.17                     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 - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                        14 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                    If score other than
                                                                                                                                          Met   Partially   Not Met 'met' what are
              Question:                             Rationale/Assessment Methods:                                                         (1)   Met (2)       (3)   possible root causes
              Provision of Care, Treatment and Services
3.2.1         Performance improvement               1) The hospital measures and assesses its restraint use to identify opportunities
              processes seek to identify            to introduce preventive strategies, alternatives to use, and process improvements
              opportunities to reduce the risks     that reduce the risks associated with restraint use.
              associated with restraint use through
              preventive strategies, innovative
              alternatives, and process
              improvements.
              PC.11.20
              Provision of Care, Treatment and Services
3.2.2         Hospital policies and procedures  1) Policies and procedures include appropriate details as to how the hospital does
              guide appropriate and safe use of the following: Protects the patient and preserves his or her rights, dignity, and well-
              restraint.                        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
              Previously: 3.2.4.15              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)
                                                (continued)...
              PC.11.30
              Provision of Care, Treatment and Services
3.2.2                                           ...(continued) 2) The policies and procedures are developed by appropriate staff
(continued)                                     and approved by the medical staff, nursing leadership, and, as appropriate,
              PC.11.30                          others.




         JCAHO - 3                                                                 JCAHO - 3 - Version: 08.01.2006                                                         15 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                  If score other than
                                                                                                                                        Met   Partially   Not Met '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 restraint 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.

           Previously: 3.2.4.19                  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
           Provision of Care, Treatment and Services
3.2.4      Staffing levels and assignments are The hospital bases its staffing levels and assignments on a variety of factors,
           set to minimize circumstances that      including the following:
           give rise to restraint or seclusion use
           and to maximize safety when             1) Staff qualifications
           restraint and seclusion are used.
                                                   2) The physical design of the environment

                                                 3) Diagnoses
           Previously: 3.2.4.24
                                                 4) Co-occurring conditions

                                                 5) Acuity levels

                                                 6) Age and developmental functioning of patients
           PC.12.20




        JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                         16 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                If score other than
                                                                                                                                      Met   Partially   Not Met '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 the use of restraint and seclusion
              minimize the use of restraint and and, before they participate in any use of restraint or seclusion, assesses the
              seclusion and, when use is        competence of staff to use them safely.
              indicated, to use restraint or
              seclusion 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
              Previously: 3.2.4.25              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 (continued)...
              PC.12.30
              Provision of Care, Treatment and Services
3.2.5                                           ...(continued) in patients who are being held, restrained, or secluded
(continued)
                                                   3) Staff members who are authorized to apply restraint or seclusion receive the
                                                   training and 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.
              PC.12.30




         JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                      17 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                  If score other than
                                                                                                                                        Met   Partially   Not Met 'met' what are
            Question:                         Rationale/Assessment Methods:                                                             (1)   Met (2)       (3)   possible root causes
            Provision of Care, Treatment and Services
3.2.5                                         ...(continued)
(continued)                                   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; Recognizing when to contact a medically trained licensed
                                              independent practitioner or emergency medical services to evaluate and/or treat
            PC.12.30                          the patient‘s physical status
              Provision of Care, Treatment and Services
3.2.5                                           ...(continued)
(continued)                                     7) Staff members who, in the absence of a licensed independent practitioner, are
                                                authorized to initiate restraint or seclusion, and/or perform
                                                evaluations/reevaluations of patients in restraint or seclusion to assess their
                                                readiness for discontinuation or establish the need to secure a new order, receive
                                                the training and demonstrate the competence cited above.

                                                  8) These staff members are also educated and demonstrate competence in the
                                                  following: Recognizing how age, developmental considerations, gender issues,
                                                  ethnicity, and history of sexual or physical abuse may affect the way in which a
                                                  patient reacts to physical contact; Using behavior criteria for discontinuing
                                                  restraint or seclusion and how to help patients in meeting these criteria

                                                  9) A sufficient number of staff with direct care responsibility receives additional
                                                  training to ensure that an appropriate number of staff members are available at all
                                                  times who are competent to initiate first aid and cardiopulmonary resuscitation.
              PC.12.30




         JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                        18 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                  If score other than
                                                                                                                                        Met   Partially   Not Met 'met' what are
            Question:                         Rationale/Assessment Methods:                                                             (1)   Met (2)       (3)   possible root causes
            Provision of Care, Treatment and Services
3.2.5                                         ...(continued)
(continued)                                   10) The hospital has a plan for providing emergency medical services.

                                                  11) The viewpoints of patients who have experienced restraint or seclusion are
                                                  incorporated into staff training and education to help staff better understand all
                                                  aspects of restraint and seclusion.

                                                  12) Whenever possible, such patients contribute to the training and education
           PC.12.30                               curricula and/or participate in staff training and education.
           Provision of Care, Treatment and Services
3.2.6      Restraint or seclusion is limited to  1) Restraint or seclusion is used only when nonphysical interventions are
           emergencies in which there is an      ineffective or not viable and when there is an imminent risk of a patient physically
           imminent risk of a patient physically harming himself or herself, staff, or others.
           harming himself or herself, staff, or
           others, and nonphysical               2) The type of physical intervention selected considers information learned from
           interventions would not be effective. 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.
           Previously: 3.2.4.28
                                                  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
           Provision of Care, Treatment and Services
3.2.7      Patients in restraint or seclusion are 1) A staff member who is trained and competent in accordance with standard
           assessed and assisted.                 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,
           Previously: 3.2.4.35                   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 - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                       19 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                    If score other than
                                                                                                                                          Met   Partially   Not Met 'met' what are
            Question:                              Rationale/Assessment Methods:                                                          (1)   Met (2)       (3)   possible root causes
            Provision of Care, Treatment and Services
3.2.8       Patients in restraint or seclusion are 1) Monitoring is done through continuous in-person observation by an assigned
            monitored.                             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
            Previously: 3.2.4.36                 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
            Provision of Care, Treatment and Services
3.2.9       Patients are monitored during the  1) Appropriate methods are used to continuously monitor oxygenation, ventilation,
            procedure and/or administration of and circulation during procedures that may affect the patient's physiological
            moderate or deep sedation or       status.
            anesthesia.
                                               2) The procedure and/or the administration of moderate or deep sedation or
                                               anesthesia for each patient are documented in the medical record.

            Previously: 3.2.5.3
            PC.13.30
            Provision of Care, Treatment and Services
3.2.10      Patients are monitored immediately 1) The patient's status is assessed on arrival in the recovery area.
            after the procedure and/or
            administration of moderate or deep 2) Each patient's physiological status, mental status, and pain level are
            sedation or anesthesia.            monitored.

                                                 3) Monitoring is at a level consistent with the potential effect of the procedure
                                                 and/or sedation or anesthesia.
            Previously: 3.2.5.4
                                                 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 - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                          20 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                 If score other than
                                                                                                                                       Met   Partially   Not Met '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 therapy.
            with adequate justification,
            documentation, and regard for     2) Whenever electroconvulsive therapy is used, the procedure is adequately
            patient safety.                   justified and documented in the patient‘s medical record.

                                                3) Before initiating electroconvulsive therapy for a child or youth, two qualified,
                                                experienced
            Previously: 3.2.5.5
                                                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
            Provision of Care, Treatment and Services
3.2.12      When patients are transferred or    1) The hospital communicates appropriate information to any organization or
            discharged, appropriate information provider to which the patient is transferred or discharged.
            related to the care, treatment, and
            services provided is exchanged with 2) The information shared includes the following, as appropriate to the care,
            other service providers.            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
            Previously: 3.2.5.13
            PC.15.30




         JCAHO - 3                                                               JCAHO - 3 - Version: 08.01.2006                                                        21 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                     If score other than
                                                                                                                                           Met   Partially   Not Met '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 amount of information about the patient
           accessible to those involved in the       that is to be available to those involved in medication management. Note: The
           medication management system.             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 CAM-H, MM.1.10 Pg. 230




        JCAHO - 3                                                                      JCAHO - 3 - Version: 08.01.2006                                                      22 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                   If score other than
                                                                                                                                         Met   Partially   Not Met '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 independent practitioners, appropriate
           or administration (including stock     health care professionals, and staff involved in ordering, dispensing,
           medications) are selected, listed,     administering, and/or monitoring effects of medications develop written criteria for
           and procured based on criteria.        determining what medications are available for dispensing or administration.

                                                  2. At a minimum, the criteria include the indication for use, effectiveness, risks
                                                  (including propensity for medication errors, abuse potential, and sentinel events),
           Note: The formulary is synonymous and costs.
           with the list of medications available
           for use.                               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 (continued)...
           MM.2.10                                JCAHO CAM-H, MM.2.10 Pg. 230




        JCAHO - 3                                                                   JCAHO - 3 - Version: 08.01.2006                                                       23 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                If score other than
                                                                                                                                      Met   Partially   Not Met 'met' what are
            Question:                              Rationale/Assessment Methods:                                                      (1)   Met (2)       (3)   possible root causes
            Medication Management
3.3.2       (continued)... Medications available   ...(continued) administration are reviewed at least annually based on emerging
(continued) for dispensing or administration       safety and efficacy information.
            (including stock medications) are
            selected, listed, and procured based   6. The hospital has processes to approve and procure medications that are not on
            on criteria.                           the hospital‘s medication list.

                                                   7. The hospital has processes to address medication shortages and outages,
                                                   including the following:
           Note: The formulary is synonymous
           with the list of medications available ● Communicating with appropriate prescribers and staff
           for use.
                                                  ● 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 CAM-H, MM.2.10 Pg. 230




        JCAHO - 3                                                                    JCAHO - 3 - Version: 08.01.2006                                                   24 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                             If score other than
                                                                                                                                   Met   Partially   Not Met '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 stocked or stored.*
           stored.
                                                 2. Medications are stored under conditions suitable for product stability.

                                                 3. Unauthorized persons, in accordance with the hospital's policy and law or
           Note: The following elements of       regulation, cannot obtain access to medications.
           performance also apply to
           emergency medications. Additional     4) Controlled substances are stored to prevent diversion and according to state
           requirements for emergency            and federal laws and regulations.
           medications are addressed at
           standard MM.2.30.                     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. (continued)...
           MM.2.20                               JCAHO CAM-H, MM.2.10 Pg. 231




        JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                  25 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                  If score other than
                                                                                                                                        Met   Partially   Not Met 'met' what are
            Question:                          Rationale/Assessment Methods:                                                            (1)   Met (2)       (3)   possible root causes
            Medication Management
3.3.3       (continued)... Medications are     ...(continued)
(continued) properly and safely stored.
                                               8) Standarize and limit the number of drug concentrations available in the
                                               organization.

           Note: The following elements of     Note: The preceding requirement is not scored here. It is scored at National
           performance also apply to           Patient Safety Goal 3, Reguirement 3B.
           emergency medications. Additional
           requirements for emergency          9) Concentrated electrolytes are removed from care units or areas, (unless
           medications are addressed at        patient safety is at risk if the concentrated electrolyte is not immediately available
           standard MM.2.30.                   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 CAM-H, MM.2.10 Pg. 231




        JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                         26 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                  If score other than
                                                                                                                                        Met   Partially   Not Met '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   3) Emergency medications are available in unit-dose, age-specific, and ready-to-
           emergency medications are in           administer forms, whenever possible.
           addition to the requirements at
           standard MM.2.2.0, which are also      4) Not applicable.
           applicable to emergency
           medications.                           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 CAM-H, MM.2.30 Pg. 232
           Medication Management
3.3.5      A process is established to safely      The hospital addresses the use of medications brought into the hospital by
           manage medications brought into the patients or their families, including the following:
           hospital by patients or their families.
                                                   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 CAM-H, MM.2.40 Pg. 233
           Medication Management
3.3.6      Only medications needed to treat the 1. There is a documented diagnosis, condition, or indication-for-use for each
           patient’s condition are ordered,     medication ordered.
           provided, or administered.
           MM.3.10                                JCAHO CAM-H, MM.3.10 Pg. 233




        JCAHO - 3                                                                   JCAHO - 3 - Version: 08.01.2006                                                      27 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                               If score other than
                                                                                                                                     Met   Partially   Not Met '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 specified conditions and to alert (continued)...
           MM.3.20                              JCAHO CAM-H, MM.3.20 Pg. 233




        JCAHO - 3                                                                 JCAHO - 3 - Version: 08.01.2006                                                     28 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                               If score other than
                                                                                                                                     Met   Partially   Not Met 'met' what are
            Question:                            Rationale/Assessment Methods:                                                       (1)   Met (2)       (3)   possible root causes
            Medication Management
3.3.7       (continued)... Medication orders are ...(continued) users at specified times while a medication is on 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

                                                  -Orders for medications at discharge.
            MM.3.20                               JCAHO CAM-H, MM.3.20 Pg. 233




        JCAHO - 3                                                                   JCAHO - 3 - Version: 08.01.2006                                                   29 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                    If score other than
                                                                                                                                          Met   Partially   Not Met 'met' what are
           Question:                             Rationale/Assessment Methods:                                                            (1)   Met (2)       (3)   possible root causes
3.3.7       (continued)... Medication orders are ...(continued)
(continued) written clearly and transcribed      7) In addition, the hospital minimizes the use of verbal and telephone medication
           accurately.                           orders.

                                                 8) In addition, the hospital reviews and updates preprinted order sheets as
                                                 needed to support clarity, accuracy, and safety.

                                                 9) In addition, the hospital specifies that blanket reinstatement of previous orders--
                                                 a summary order to resume all previous orders--for medications are not
                                                 acceptable.

                                                 10) In addition, the hospital defines in writing when weight-based dosing for
                                                 pediatric populations is required.

                                                 11) Not applicable

                                                 12) Not applicable

                                                 13) Policies and procedures regarding medicaiton orders are implemented.
           MM.3.20                               JCAHO CAM-H, MM.3.20 Pg. 233




        JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                         30 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                               If score other than
                                                                                                                                     Met   Partially   Not Met '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).
              Previously: 3.3.9
                                                 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 (continued)...
              MM.4.20
              Medication Management
3.3.8                                            ...(continued) the pharmacy, any sterile product made from non-sterile
(continued)                                      ingredients, or any sterile product that will not be used within 24 hours

              MM.4.20                            - Visually inspecting the integrity of the medications




         JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                     31 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                             If score other than
                                                                                                                                   Met   Partially   Not Met '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
           Previously: 3.3.10                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 multiple patients, or when the
                                             person preparing the (continued)...
           MM.4.30                           JCAHO CAM-H, MM.4.20 Pg. 235
            Medication Management
3.3.9       (continued)... Medications are   ...(continued) individualized medications is not the person administering the
(continued) labeled.                         medication, the label also includes the following:

                                             - Patient name

           Previously: 3.3.10                - 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 CAM-H, MM.4.20 Pg. 235




        JCAHO - 3                                                              JCAHO - 3 - Version: 08.01.2006                                                      32 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                               If score other than
                                                                                                                                     Met   Partially   Not Met '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
            Previously: 3.3.11                  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 CAM-H, MM.4.30 Pg. 235




         JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                     33 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                    If score other than
                                                                                                                                          Met   Partially   Not Met '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 medications to meet patient needs
            providing medications to meet          when the pharmacy is closed.
            patient needs when the pharmacy is
            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:

            Previously 3.3.12                      - 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 (continued)...
            MM.4.50                                JCAHO CAM-H, MM.4.40 Pg. 236
            Medication Management
3.3.11      (continued)... The hospital has a      ...(continued) has 24-hour pharmacy service) to answer questions or provide
(continued) system for safely providing            medications beyond 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
            Previously 3.3.12                      nonpharmacist health care professionals are obtaining medications after the
                                                   pharmacy is closed.
            MM.4.50                                JCAHO CAM-H, MM.4.40 Pg. 236




         JCAHO - 3                                                                   JCAHO - 3 - Version: 08.01.2006                                                       34 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                      If score other than
                                                                                                                                            Met   Partially   Not Met '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 medication recall or discontinuation
            hospital are retrieved when recalled   by the manufacturer or the Food and Drug Administration (FDA) for safety
            or discontinued by the manufacturer    reasons, medications within the hospital are retrieved* and handled per hospital
            or the Food and Drug Administration    policy and law and regulation.
            for safety reasons.
                                                   (* 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.)
            Previously: 3.3.13
                                                   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 CAM-H, MM.4.50 Pg. 236




         JCAHO - 3                                                                   JCAHO - 3 - Version: 08.01.2006                                                         35 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                   If score other than
                                                                                                                                         Met   Partially   Not Met '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 staff who are allowed to
            accurately administered.              administer medications, with or without supervision, consistent with law or
                                                  regulation and hospital policy.

                                                  Before administering a medication, the licenced independent practitioner or
            Previously: 3.3.16                    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 (continued)...
            MM.5.10                               JCAHO CAM-H, MM.4.70 Pg. 237
            Medication Management
3.3.13      (continued)... Medications are safely ...(continued) concerns about administering a new medication*.
(continued) and accurately administered.
                                                  (* Please refer to PC.6.10, EP3 for additional information addressing the
                                                  education of patients regarding medication use.)

            Previously: 3.3.16                    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 CAM-H, MM.4.70 Pg. 237




         JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                       36 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                If score other than
                                                                                                                                      Met   Partially   Not Met '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 guide the safe and accurate self
            safely and accurately administered.   administration* of medications or administration of medications by a person who
                                                  is not a staff member and address training, supervision, and administration
                                                  documentation.

            Previously: 3.3.17                    (* 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 (continued)...
            MM.5.20                               JCAHO CAM-H, MM.4.80 Pg. 237
            Medication Management
3.3.14      (continued)... Self-administered      ...(continued) staff members (including the patient if self-administering and so
(continued) medications are safely and            forth) are determined to be competent at medication administration before being
            accurately administered.              allowed to administer medications.



            Previously: 3.3.17
            MM.5.20                               JCAHO CAM-H, MM.4.80 Pg. 237




         JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                    37 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                 If score other than
                                                                                                                                       Met   Partially   Not Met 'met' what are
            Question:                            Rationale/Assessment Methods:                                                         (1)   Met (2)       (3)   possible root causes
            Medication Management
3.3.15      The effects of medication(s) on      1) Each patient‘s response to his or her medication is monitored according to the
            patients are monitored.              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:
            Previously: 3.3.18
                                                 - 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
            Medication Management
3.3.16      The hospital responds to actual or   1) The hospital has a process to respond to actual or potential adverse drug
            potential adverse drug events and    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).
            Previously: 3.3.19
                                                 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 CAM-H, MM.5.10 Pg. 238




         JCAHO - 3                                                                 JCAHO - 3 - Version: 08.01.2006                                                      38 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                 If score other than
                                                                                                                                       Met   Partially   Not Met 'met' what are
            Question:                           Rationale/Assessment Methods:                                                          (1)   Met (2)       (3)   possible root causes
            Medication Management
3.3.17      The hospital develops processes for 1) The hospital identifies the high-risk or high-alert medications used within the
            managing high-risk or high-alert    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.
            Previously: 3.3.20
                                                3) The processes for managing high-risk or high-alert medications are
                                                implemented.
            MM.7.10                               JCAHO CAM-H, MM.5.20 Pg. 239
            Medication Management
3.3.18      Investigational medications are       1) Procedures for the use of investigational medications specify a written process
            safely controlled and administered.   for reviewing, approving, supervising, and monitoring investigational medication
                                                  use.

                                                  2) When the hospital operates a pharmacy, procedures specify the pharmacy
            Previously: 3.3.23                    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 CAM-H, MM.6.10 Pg. 239




         JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                     39 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                  If score other than
                                                                                                                                        Met   Partially   Not Met '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 to take steps to prevent or control
           infection control program.          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
                                                 (continued)...
           IC.1.10                               JCAHO CAM-H, IC.1.10 Pg. 250




        JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                       40 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                               If score other than
                                                                                                                                     Met   Partially   Not Met '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) National Patient Safety Goals, pages APR-8–APR-10)
(continued) development of a health
            care–associated infection is       ● The referring or receiving organization when a patient was transferred or
            minimized through a hospitalwide   referred and the presence of an HAI was not known at the time of transfer or
            infection control program.         referral

                                                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, protocols, practice guidelines, clinical paths, care maps, or a
                                                combination of these.)

           IC.1.10                              JCAHO CAM-H, IC.1.10 Pg. 250




        JCAHO - 3                                                                 JCAHO - 3 - Version: 08.01.2006                                                     41 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                              If score other than
                                                                                                                                    Met   Partially   Not Met '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 relevant guidelines* for infection
           goals, strategies must be             prevention and control activities.
           implemented to achieve those goals.
                                                 (* Examples of guidelines include those offered by the CDC, Healthcare Infection
                                                 Control Practices Advisory Committee (HICPAC) and the National Quality Forum
                                                 (NQF).)
           Previously: 3.4.5
                                                 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

                                                ● The appropriate use of (continued)...
           IC.4.10




        JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                     42 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                 If score other than
                                                                                                                                       Met   Partially   Not Met 'met' what are
              Question:                          Rationale/Assessment Methods:                                                         (1)   Met (2)       (3)   possible root causes
              Surveillance, Prevention and Control of Infection
3.4.2                                            ...(continued) personal protective equipment
(continued)
                                                  († MEDICAL EQUIPMENT Fixed and portable equipment used for diagnosis,
                                                  treatment, monitoring, and direct care of individuals.)

                                                  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
            IC.4.10                            contact with in their work is available as warranted
            Surveillance, Prevention and Control of Infection
3.4.2                                          ...(continued)
(continued)                                    6) Referral for assessment, potential testing, immunization and/or
                                               prophylaxis/treatment, and counseling as appropriate of licensed independent
                                               practitioners, staff, students/trainees, and volunteers who are identified as
                                               potentially having an infectious disease or risk of infectious disease that may put
                                               the population they serve at risk

                                                  7) Referral for assessment, potential testing, immunization and/or
                                                  prophylaxis/treatment, and counseling as appropriate of patients,
                                                  students/trainees, and volunteers who have been exposed to infectious
                                                  disease(s) at the hospital and licensed independent practitioners or staff who are
                                                  occupationally exposed

                                                  8) Reduction of risks associated with animals brought into the hospital (such as
              IC.4.10                             management of animal waste).




         JCAHO - 3                                                                   JCAHO - 3 - Version: 08.01.2006                                                    43 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                          Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                If score other than
                                                                                                                                      Met   Partially   Not Met '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 the goals and program (or portions
           evaluates the effectiveness of the    of the program) at least annually and whenever risks significantly change.
           infection control interventions and,
           as necessary, redesigns the infection 2) The evaluation addresses changes in the scope of the IC program (for
           control interventions.                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.
           Previously: 3.4.6
                                                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 - 3                                                               JCAHO - 3 - Version: 08.01.2006                                                        44 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                 If score other than
                                                                                                                                       Met   Partially   Not Met '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 influx of infectious patients.
           management activities, the hospital
           prepares to respond to an influx, or 2) The hospital has a plan for managing an ongoing influx of potentially infectious
           the risk of an influx, of infectious patients over an extended period.
           patients.
                                                3) The hospital does the following:

                                                 - Determines how it will keep abreast of current information aobut the emergence
           Previously: 3.4.9                     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
           Improving Organization Performance
3.5.1      Processes for identifying and    Processes for identifying and managing sentinel events include the following:
           managing sentinel events are
           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
           Previously: 3.5.4                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 (continued)...
           PI.2.30




        JCAHO - 3                                                                 JCAHO - 3 - Version: 08.01.2006                                                       45 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                If score other than
                                                                                                                                      Met   Partially   Not Met 'met' what are
              Question:                        Rationale/Assessment Methods:                                                          (1)   Met (2)       (3)   possible root causes
              Improving Organization Performance
3.5.1                                          ...(continued) effectiveness of process and system improvements to reduce risk
(continued)
              PI.2.30                             5. The processes are implemented.
              Improving Organization Performance
3.5.2         Information from data analysis is   1) The hospital uses the information from data analysis to identify and implement
              used to make changes that improve changes that will improve the quality of care, treatment, and services.
              performance and patient safety and
              reduce the risk of sentinel events. 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
              Previously: 3.5.5                    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 - 3                                                                 JCAHO - 3 - Version: 08.01.2006                                                     46 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                    If score other than
                                                                                                                                          Met   Partially   Not Met '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 to patients are conducted:
            identifying and reducing
            unanticipated adverse events and        1) Selecting a high-risk* process to be analyzed (at least one high-risk process is
            safety risks to patients is defined and chosen annually--the choice should be based in part on information published
            implemented.                            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
            Previously: 3.5.6                      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 (continued)...
            PI.3.20                                JCAHO CAM-H, PI.2.20 Pg. 264
            Improving Organization Performance
3.5.3       (continued)... An ongoing, proactive ...(continued) possible effects.
(continued) program for identifying and reducing
            unanticipated adverse events and        5) Prioritizing the potential process breakdowns or failures.
            safety risks to patients is defined and
            implemented.                            6) Determining why the prioritized breakdowns or failures could occur, which may
                                                    include performing a hypothetical root cause analysis.

                                                   7) Redesigning the process and/or underlying systems to minimize the risk of the
            Previously: 3.5.6                      effects on patients.

                                                   8) Testing and implementing the redesigned process.

                                                   9) Monitoring the effectiveness of the redesigned process.
            PI.3.20                                JCAHO CAM-H, PI.2.20 Pg. 264




        JCAHO - 3                                                                    JCAHO - 3 - Version: 08.01.2006                                                       47 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                             Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                   If score other than
                                                                                                                                         Met   Partially   Not Met '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 services that are provided by
              contractual arrangements, or other   consultation, contractual arrangements, or other agreements.
              agreements are provided safely and
              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.

              Previously: 3.6.13                   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 (continued)...
              LD.3.50
              Leadership
3.6.1                                              ...(continued) services† meet the applicable federal regulations for clinical
(continued)   LD.3.50                              laboratories and maintain evidence of the same.




         JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                       48 of 351
                                                        NCPS Patient Safety Assessment Tool

                                                                        Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                              If score other than
                                                                                                                                    Met   Partially   Not Met 'met' what are
           Question:                          Rationale/Assessment Methods:                                                         (1)   Met (2)       (3)   possible root causes
           Leadership
3.6.2      Communication is effective         1) The leaders ensure processes are in place for communicating relevant
           throughout the hospital.           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
           Previously: 3.6.14                 families, as appropriate.

                                              3) The leaders communicate the hospital‘s mission and appropriate policies,
                                              plans, and goals to all staff.
           LD.3.60
           Leadership
3.6.3      The leaders define the required    A single set of criteria must be used to judge the competency of all clinicians who
           qualifications and competence of   provide care, treatment, and services within the hospital, regardless of whether
           those staff who provide care,      they are an employee of the hospital or a licensed practitioner.
           treatment, and services, and
           recommend a sufficient number of   Note: The qualification requirements pertaining to students and volunteers who
           qualified and competent staff to   work in the same capacity as staff when they provide care, treatment or services
           provide care, treatment, and       are addressed in Standard HR.1.20
           services.
                                              1) The leaders provide for the allocation of competent qualified staff.

                                              2) The leaders ensure that physician assistants and advanced practice registered
           Previously: 3.6.15                 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 (continued)...
           LD.3.70




        JCAHO - 3                                                              JCAHO - 3 - Version: 08.01.2006                                                       49 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                  If score other than
                                                                                                                                        Met   Partially   Not Met 'met' what are
              Question:                          Rationale/Assessment Methods:                                                          (1)   Met (2)       (3)   possible root causes
              Leadership
3.6.3                                            ...(continued) recommendations
(continued)
                                                 ● Involves communication with and input from individuals and committees,
                                                 including the Medical Staff Executive Committee, to make an informed decision
                                                 regarding the applicant‘s request for privileges.

                                                 3) Prior to the provision of care, treatment or services, the qualifications and
                                                 competence of a 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.
              LD.3.70
              Leadership
3.6.3                                            ...(continued)
(continued)                                      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
              LD.3.70                            individuals employed by the hospital.
              Leadership
3.6.4         The leaders provide for adequate   1) The leaders provide for the arrangement and allocation of space to facilitate
              space, equipment, and other        efficient, effective delivery of care, treatment, and services.
              resources.
                                                 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.
              Previously: 3.6.16
                                                 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 - 3                                                               JCAHO - 3 - Version: 08.01.2006                                                         50 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                               Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                       If score other than
                                                                                                                                             Met   Partially   Not Met '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 following:
              integrated patient safety program is
              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-
              Previously: 3.6.27                    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.

                                                    7) (continued)...
              LD.4.40
              Leadership
3.6.5                                               ...(continued) Defined support systems* for staff members who have been
(continued)                                         involved in a sentinel event.

                                                    (* Support systems provide individuals with the 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
              LD.4.40                               response to actual occurrences




         JCAHO - 3                                                                   JCAHO - 3 - Version: 08.01.2006                                                          51 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                 If score other than
                                                                                                                                       Met   Partially   Not Met '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 for performance improvement
           resources for measuring, assessing,   and safety improvement.
           and improving the hospital's
           performance and improving patient     2) Adequate time is provided for staff to participate in activities for performance
           safety.                               improvement and safety improvement.

                                                 3) Adequate information systems are provided to support activities for
                                                 performance improvement and safety improvement.
           Previously: 3.6.29
                                                 4) Staff is trained in performance improvement and safety improvement
                                                 approaches and methods.
           LD.4.60
           Leadership
3.6.7      The leaders measure and assess the 1) Leaders continually monitor the effectiveness of the performance improvement
           effectiveness of the performance   and safety improvement activities.
           improvement and safety
           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
           Previously: 3.6.30                    improvement activities.
           LD.4.70
           Management of Human Resources
3.7.1      The hospital provides an adequate       1) The hospital has an adequate number and mix of staff to meet the care,
           number and mix of staff that are        treatment, and service needs of the patients.
           consistent with the hospital’s staffing
           plan.

           Previously: 3.8.1
           HR.1.10




        JCAHO - 3                                                                 JCAHO - 3 - Version: 08.01.2006                                                       52 of 351
                                                                NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                        If score other than
                                                                                                                                              Met   Partially   Not Met '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 and qualifications of staff in all
              that a person’s qualifications are     program(s) or service(s).
              consistent with his or her job
              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).

              Previously: 3.8.2                      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 (continued)...

              HR.1.20
              Management of Human Resources
3.7.2                                                ...(continued) mastery of specialized knowledge and skills. Examples of a
(continued)                                          profession include but are not limited to a nurse, pharmacist, medical
                                                     technologist, respiratory care practitioner, 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*.
              HR.1.20




         JCAHO - 3                                                                    JCAHO - 3 - Version: 08.01.2006                                                          53 of 351
                                                          NCPS Patient Safety Assessment Tool

                                                                          Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                          If score other than
                                                                                                                                Met   Partially   Not Met 'met' what are
            Question:                     Rationale/Assessment Methods:                                                         (1)   Met (2)       (3)   possible root causes
            Management of Human Resources
3.7.2                                     ...(continued)
(continued)                               (* 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 privledges or position requirements sought. The Joint Commission has and
                                          will absolutely construe these standards to be consistent with hosptial's effort to
                                          meet ADA compliance efforts.)

                                               8) through 17) Not Applicable
                                               18) All staff that provide patient care possess a license, certification, or
                                               registration as required by law and regulation.

                                               -- See Notes 4 and 5 --

                                               19) through 45) Not applicable
                                               46) Staff supervises students when they provide patient care, treatment,
           HR.1.20                             and services as part of their training.




        JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                 54 of 351
                                                          NCPS Patient Safety Assessment Tool

                                                                           Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                  If score other than
                                                                                                                                        Met   Partially   Not Met '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 volunteer is oriented to the
           training and information.        following:

                                               1. The hospital's mission and goals.

           Previously: 3.8.4                   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 seclusion and restraint.
           HR.2.10




        JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                         55 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                       If score other than
                                                                                                                                             Met   Partially   Not Met '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 practitioners, students, and volunteers, as
           independent practitioners, students,       appropriate, can describe or demonstrate the following:
           and volunteers, as appropriate, can
           describe or demonstrate their roles        1) Risks within the hospital‘s environment
           and responsibilities, based on
           specific job duties or responsibilities,   2) Actions to eliminate, minimize, or report risks
           relative to safety.
                                                      3) Procedures to follow in the event of an incident

                                                      4) Reporting processes for common problems, failures, and user errors
           Previously: 3.8.5
           HR.2.20
           Management of Human Resources
3.7.5      Ongoing education, including in-   The following occurs for staff, students, and volunteers who work in the same
           services, training, and other      capacity as staff providing care, treatment, and services:
           activities, maintains and improves
           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
           Previously: 3.8.6
                                                      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
                                                      (continued)...
           HR.2.30




        JCAHO - 3                                                                       JCAHO - 3 - Version: 08.01.2006                                                       56 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                              If score other than
                                                                                                                                    Met   Partially   Not Met 'met' what are
            Question:                     Rationale/Assessment Methods:                                                             (1)   Met (2)       (3)   possible root causes
            Management of Human Resources
3.7.5                                     ...(continued) learning needs identified through performance improvement
(continued)                               findings and other data analysis (that is, data from staff surveys, performance
                                          evaluations, or other needs assessments)

           HR.2.30                             8) Ongoing education is documented
           Management of Information
3.8.1      Information privacy and             1) The hospital has developed a written policy(ies) for addressing the privacy*
           confidentiality are maintained.     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.
           Previously: 3.9.2
                                               ** 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 possible (continued)...
           IM.2.10                             JCAHO CAM-H, HR.1.10 Pg. 331




        JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                     57 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                  If score other than
                                                                                                                                        Met   Partially   Not Met 'met' what are
            Question:                             Rationale/Assessment Methods:                                                         (1)   Met (2)       (3)   possible root causes
            Management of Information
3.8.1       (continued)... Information privacy    ...(continued) for uses and disclosures of health information, consistent with
(continued) and confidentiality are maintained.   maintaining the 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.
            Previously: 3.9.2
                                                  (* 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 CAM-H, HR.1.10 Pg. 331




        JCAHO - 3                                                                   JCAHO - 3 - Version: 08.01.2006                                                      58 of 351
                                                      NCPS Patient Safety Assessment Tool

                                                                         Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                           If score other than
                                                                                                                                 Met   Partially   Not Met '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 continuity/disaster recovery plan for its information
           maintained.                    systems

                                          2) For electronic systems, the business continuity/disaster recovery plan includes
                                          the following:
           Previously: 3.9.4
                                          ● 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.

                                          4) The business continuity/disaster recovery plan is implemented when
                                          information systems are interrupted.

           IM.2.30                        JCAHO CAM-H, HR.1.20 Pg. 331




        JCAHO - 3                                                           JCAHO - 3 - Version: 08.01.2006                                                       59 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                            Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                  If score other than
                                                                                                                                        Met   Partially   Not Met '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 the medical record.
           accurate medical record for patients
           assessed, cared for, treated, or       2) The hospital defines which entries made by nonindependent practitioners
           served.                                require countersigning consistent with law and regulation.

                                                  3) Standardized formats are used for documenting all care, treatment, and
                                                  services provided to patients.
           Previously: 3.9.8
                                                  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 (continued)...
           IM.6.10




        JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                       60 of 351
                                                     NCPS Patient Safety Assessment Tool

                                                                    Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                          If score other than
                                                                                                                                Met   Partially   Not Met 'met' what are
              Question:                   Rationale/Assessment Methods:                                                         (1)   Met (2)       (3)   possible root causes
              Management of Information
3.8.3                                     ...(continued) stamps or comptuer keys sign a statement assuring that they alone
(continued)                               will use the stamp or key.)

                                          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;
              IM.6.10                     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

                                          ● The patient‘s condition at discharge

                                          ● Information to the patient and family, as appropriate




         JCAHO - 3                                                           JCAHO - 3 - Version: 08.01.2006                                                     61 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                                Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                 If score other than
                                                                                                                                       Met   Partially   Not Met '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 following clinical/case information:
           information, as appropriate, to the
           care, treatment, and services         ● Emergency care, treatment, and services provided to the patient before his or
           provided.                             her arrival, if any

                                                 ● Documentation and findings of assessments*

           Previously: 3.9.9                     (* 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

                                                 ● Relevant observations

                                                 ● Response to care, treatment, and services provided

                                                 ● Consultation reports
           IM.6.20                               JCAHO CAM-H, HR.2.10 Pg. 336




        JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                      62 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                     If score other than
                                                                                                                                           Met   Partially   Not Met 'met' what are
            Question:                              Rationale/Assessment Methods:                                                           (1)   Met (2)       (3)   possible root causes
            Management of Information
3.8.4       (continued)... Records contain         ...(continued) administered (including the strength, dose, or rate of administration,
(continued) patient-specific information, as       administration devices used, access site or route, known drug allergies, and
            appropriate, to the care, treatment,   adverse drug reactions)
            and services provided.
                                                   ● Medications dispensed or prescribed on discharge

                                                   ● Relevant diagnoses/conditions established during the course of care, treatment,
            Previously: 3.9.9                      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

                                                   ● Records of communication with the patient regarding care, treatment, and
                                                   services, for example, telephone calls or e-mail

                                                   ● Patient-generated information (for example, information entered into the record
                                                   over the Web or in previsit computer systems)

            IM.6.20                                JCAHO CAM-H, HR.2.10 Pg. 336




         JCAHO - 3                                                                   JCAHO - 3 - Version: 08.01.2006                                                        63 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                              Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                               If score other than
                                                                                                                                     Met   Partially   Not Met '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 (responsible for the patient) records the
           documents operative or other high   provisional diagnosis before the operative or other high-risk procedures.*
           risk procedures and the use of
           moderate or deep sedation or        (* OPERATIVE and OTHER HIGH RISK PROCEDURES Procedures including
           anesthesia (see also standards      operative, other invasive, and non-invasive procedures that place the patient at
           PC.13.30 and PC.13.40)              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
           Previously: 3.9.10                  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 (continued)...
           IM.6.30                             JCAHO CAM-H, HR.2.10 Pg. 338




        JCAHO - 3                                                                JCAHO - 3 - Version: 08.01.2006                                                      64 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                 If score other than
                                                                                                                                       Met   Partially   Not Met '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.
(continued) thoroughly documents operative or
            other high risk procedures and the    4) The completed operative or other high risk procedure report is authenticated by
            use of moderate or deep sedation or   the licensed independent practitioner and made available in the medical record as
            anesthesia (see also standards        soon as possible after the procedure.
            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
           Previously: 3.9.10                     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 procedures.
           IM.6.30                                JCAHO CAM-H, HR.2.10 Pg. 338




        JCAHO - 3                                                                   JCAHO - 3 - Version: 08.01.2006                                                     65 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                      If score other than
                                                                                                                                            Met   Partially   Not Met '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 patient by the third visit and maintained
           ambulatory care services, the           thereafter.
           medical record contains a summary
           list(s) of all significant diagnoses,   2) The summary list(s) contains the following information:
           procedures, drug allergies, and
           medications.                            ● Known* significant medical diagnoses and conditions

                                                   ● Known significant operative and invasive procedures

           Previously: 3.9.11                      ● 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 CAM-H, HR.2.30 Pg. 338
           Management of Information
3.8.7      The hospital provides access to all   1) There is a manual or automated mechanism to track the location of all
           relevant information from a patient’s components of the medical record.
           record as needed for use in patient
           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
           Previously: 3.9.13                    the patient is seen.
           IM.6.60
           JCAHO Goals
3.9.1      #1a: Improve the accuracy of            Use at least two patient identifiers (neither to be the patient‘s room number)
           patient identification.                 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
           Previously: 3.12.1                      samples‘ identity throughout the pre-analytical, analytical and post-analytical
                                                   processes.
            HOSP, LTC, BHC, HC, AMC & Lab




        JCAHO - 3                                                                    JCAHO - 3 - Version: 08.01.2006                                                         66 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                  Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                     If score other than
                                                                                                                                           Met   Partially   Not Met 'met' what are
             Question:                            Rationale/Assessment Methods:                                                            (1)   Met (2)       (3)   possible root causes
             JCAHO Goals
3.9.1.1      #1b: Improve the accuracy of patient (Expanded): Prior to the start of any invasive procedure, conduct a final
             identification.                      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
             Previously: 3.12.1.1                 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
             JCAHO Goals
3.9.2        #2a: Improve the effectiveness of     For verbal or telephone orders or for telephonic reporting of critical test results,
             communication among caregivers.       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.
             Previously: 3.12.2
              HOSP, LTC, BHC, HC, AC & Lab         JCAHO CAM-H, IM.2.10 Pg. 347
             JCAHO Goals
3.9.2.1      #2b: Improve the effectiveness of     Standardize a list of abbreviations, acronyms and symbols that are not to be used
             communication among caregivers.       throughout the organization.

             Previously: 3.12.2.1
             HOSP, LTC, BHC, HC, AC & Lab
             JCAHO Goals
3.9.2.2      #2c: Improve the effectiveness of     Measure, assess and, if appropriate, take action to improve the timeliness of
             communication among caregivers.       reporting of critical test results and values.

             Previously: 3.12.2.2
             HOSP, BHC, HC, AC & Lab
             JCAHO Goals
3.9.2.3      #2d: Improve the effectiveness of     Values defined as critical by the lab are reported directly to a responsible licensed
             communication among caregivers.       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
             Previously: 3.12.2.3                  alternative response caregiver.
             Lab only




          JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                        67 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                 If score other than
                                                                                                                                       Met   Partially   Not Met 'met' what are
             Question:                            Rationale/Assessment Methods:                                                        (1)   Met (2)       (3)   possible root causes
             JCAHO Goals
3.9.2.4      #2e: Improve the effectiveness of    (New): Implement a standardized approach to "hand off" communications,
             communication among caregivers.      including an opportunity to ask and respond to questions.

             Previously: 3.12.2.4
              HOSP, LTC, BHC, HC, AC & Lab
             JCAHO Goals
3.9.3        #3a: RETIRED - Improve the safety a) Remove concentrated electrolytes (including, but not limited to, potassium
             of using medications.             chloride, potassium phosphate, sodium chloride >0.9%) from patient care units.

             Previously: 3.12.3
             RETIRED
             JCAHO Goals
3.9.3.1      #3b: Improve the safety of using     Standardize and limit the number drug concentrations available in the
             medications.                         organization.

             Previously: 3.12.3.1
              HOSP, LTC, BHC, HC & AMC
             JCAHO Goals
3.9.3.2      #3c: Improve the safety of using     Identify and, at a minimum, annually review a list of look-alike/sound-alike drugs
             medications.                         used in the organization, and take action to prevent errors involving the
                                                  interchange of these drugs.
             Previously: 3.12.3.2
              HOPS, LTC, BHC, HC & AMC
             JCAHO Goals
3.9.3.3      #3d: Improve the safety of using     (New): Label all medications, medication containers (e.g., syringes, medicine
             medications.                         cups, basins) or other solutions

             Previously: 3.12.3.3                 on and off the sterile field in perioperative and other procedural settings.
             HOSP & AMC
             JCAHO Goals
3.9.4        #4: RETIRED - As of 2005 this goal a) Use a pre-op verification process, such as a checklist, to confirm appropriate
             is now surveyed under the Universal documents are available.
             Protocol: Eliminate wrong-site,
             wrong-patient, wrong-procedure.     b) Implement a process to mark the surgical site and involve the patient in the
                                                 process.
             Previously: 3.12.4
             RETIRED (HOSP, LTC & AMC)            JCAHO CAM-H, IM.2.30 Pg. 348




          JCAHO - 3                                                                 JCAHO - 3 - Version: 08.01.2006                                                     68 of 351
                                                              NCPS Patient Safety Assessment Tool

                                                                                 Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                 If score other than
                                                                                                                                       Met   Partially   Not Met 'met' what are
             Question:                           Rationale/Assessment Methods:                                                         (1)   Met (2)       (3)   possible root causes
             JCAHO Goals
3.9.5        #5: RETIRED - improve the safety of Ensure free-flow protection on all general-use and PCA (patient controlled
             using infusion pumps.               analgesia) intravenous infusion pumps used in the organization

             Previously: 3.12.5
             RETIRED ( HOSP, BHC, HC & AMC)
             JCAHO Goals
3.9.6        #6: RETIRED - As of 2005 this goal   a) Implement regular preventive maintenance and testing of alarm systems.
             is now surveyed under EC
             standards: Improve the               b) Assure that alarms are activated with appropriate settings and are sufficiently
             effectiveness of clinical alarm      audible with respect to distances and competing noise within the unit.
             systems.

             Previously: 3.12.6
             RETIRED (HOSP, LTC, BHC, HC & AMC)
             JCAHO Goals
3.9.7        #7a: Reduce the risk of health care- Comply with current Centers for Disease Control and Prevention (CDC) hand-
             associated infections.               hygiene guidelines.



             Previously: 3.12.7
             HOSP, LTC, BHC, HC, AMC & Lab
             JCAHO Goals
3.9.7.1      #7b: Reduce the risk of health care- Manage as sentinel events all identified cases of unanticipated death or major
             associated infections.               permanent loss of function associated with a health care-associated infection.

             Previously: 3.12.7.1
             HOSP, LTC, BHC, HC, AC & Lab
             JCAHO Goals
3.9.8        #8a: Accurately and completely       Implement a process for obtaining and documenting a complete list of the
             reconcile medications across the     patient‘s, resident‘s or client ‘s current medications upon their admission to the
             continuum of care.                   organization, to include their involvement. This process includes a comparison of
                                                  the medications the organization provides to those on the list.
             Previously: 3.12.8
             HOSP, LTC, BHC, HC & AMC             JCAHO CAM-H, IM.6.10 Pg. 352




          JCAHO - 3                                                                 JCAHO - 3 - Version: 08.01.2006                                                     69 of 351
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                       If score other than
                                                                                                                                             Met   Partially   Not Met 'met' what are
              Question:                             Rationale/Assessment Methods:                                                            (1)   Met (2)       (3)   possible root causes
              JCAHO Goals
3.9.8.1       #8b: Accurately and completely        A complete list of the patient‘s medications is communicated to the next provider
              reconcile medications across the      of service when it refers or transfers a patient to another setting, service,
              continuum of care.                    practitioner or level of care within or outside the organization.

              Previously: 3.12.8.1
              HOSP, LTC, BHC, HC & AMC
              JCAHO Goals
3.9.9         #9: Reduce the risk of patient harm   9b) Implement a fall reduction program, including a transfer protocol, and
              resulting from falls.                 evaluate the effectiveness of the program.

              Previously: 3.12.9

                                                    [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 CAM-H, IM.6.20 Pg. 354
              JCAHO Goals
3.9.10        #10a: Reduce the risk of influenza    Develop and implement a protocol for administration and documentation of the flu
              and pneunococcal disease in           vaccine.
              institutionalized older adults.

              Previously: 3.12.10
               LTC                                  JCAHO CAM-H, IM.6.30 Pg. 355
              JCAHO Goals
3.9.10.1      #10b: Reduce the risk of influenza    Develop and implement a protocol for administration and documentation of the
              and pneunococcal disease in           pneumococcus vaccine.
              institutionalized older adults.

              Previously: 3.12.10.1
              LTC
              JCAHO Goals
3.9.10.2      #10c: Reduce the risk of influenza    Develop and implement a protocol to identify new cases of influenza and to
              and pneunococcal disease in           manage an outbreak.
              institutionalized older adults.

              Previously: 3.12.10.2
              LTC




           JCAHO - 3                                                                  JCAHO - 3 - Version: 08.01.2006                                                         70 of 351
                                                                NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
JOINT COMMISSION on ACCREDITATION of HEALTHCARE ORGANIZATIONS (Comprehensive Accreditation Manual for Hospitals) - Element 3

                                                                                                                                                                If score other than
                                                                                                                                      Met   Partially   Not Met 'met' what are
            Question:                               Rationale/Assessment Methods:                                                     (1)   Met (2)       (3)   possible root causes
            JCAHO Goals
3.9.11      #11: Reduce the risk of surgical        Educate staff, including operating licensed independent practitioners and
            fires.                                  anesthesia providers, on how to control heat sourses and manage fuels, with
                                                    enough time for patient preparation; also, and establish guidelines to minimize
            Previously: 3.12.11                     oxygen concentration under drapes.
             AMC                                    JCAHO CAM-H, IM.6.40 Pg. 356
            JCAHO Goals
3.9.12      #12: NOT APPLICIABLE -                  Inform and encourage components and practitioner sites to implement the
            Implementation of applicable            applicable National Patient Safety Goals and associated requirements.
            National Patient Safety Goals and
            associated requirements by
            components and practitioner sites.

            Previously: 3.12.12
            NA                                      JCAHO CAM-H, IM.6.50 Pg. 356
            JCAHO Goals
3.9.13      #13 (New): Encourage the active         Define and communicate the means for patients and their families to report
            involvement of patients and their       concerns about safety, and encourage them to do so.
            families in the patient’s own care as
            a patient safety strategy.

            Previously: 3.12.13
            HC & Lab                                JCAHO CAM-H, IM.6.60 Pg. 357
            JCAHO Goals
3.9.14      #14: (New): Prevent healthcare-         Assess and periodically reassess each patient‘s risk for developing a pressure
            associated pressure ulcers              ulcer (decubitus ulcer) and take
            (decubitus ulcers).
                                                    action to address any identified risks.
            Previously: 3.12.14
            LTC




         JCAHO - 3                                                                    JCAHO - 3 - Version: 08.01.2006                                                  71 of 351
                                                         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.
                                                         Ginsburg G. Human Factors Engineering: a tool for medical device
                                                         evaluation in hospital procurement decision-making. J. Biomed Inform.
                                                         2005;38:213-219
                   Recommended; Priority B               JCAHO CAM-H, EC.6.10 Pg. 314
                   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?)
                                                         Kaye R, Crowley J. Medical device use-safety. Rockville, MD; U.S.
                                                         FDA ; 2000. No. 1497
                   Recommended; Priority B               Human Factors Design Process for Medical Devices. Arlington, VA; AAMI; 2001. ANSI/AAMI
                   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 CAM-H, EC.9.10 Pg. 321
                   Recommended; Priority A               JCAHO CAM-H, EC.6.10 Pg. 314
                   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 CAM-H, EC.6.10 Pg. 314




Procure Equip mgt - 4                                                           Procure Equip mgt - 4 - Version: 08.01.2006                                                             72 of 351
                                                           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 BPA (Blanket Purchase            A standardization group has previously
                   Agreement) 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 CAM-H, EC.6.10 Pg. 314




Procure Equip mgt - 4                                                         Procure Equip mgt - 4 - Version: 08.01.2006                                                         73 of 351
                                                                NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                             Not If score other than
                                                                                                                                           Met   Partially   Met 'met' what are
               Question:                           Alert/Advisory Actions                                                                  (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 communication to all personnel
               and track medical product, device,  affected. An ideal system would be functional 24-7, and not dependant upon a
               food, biologics and pharmaceutical single individual.
               recalls, patient safety alerts and
               advisories?
               Mandatory; Priority A                VHA Directive 2004-047
               Recalls and VA Patient Safety Alerts & Advisories
5.1.2          Are VA Patient Safety Alert and     Interview PSM on local process that tracks completion of recommendations. Or, if
               Advisory recommendations and        applicable, check on the VA‘s Desert Pacific Healthcare Network‘s Hazardous
               suggestions implemented and         Recall/Alerts Database.
               tracked until completed?
                                                    JCAHO CAM-H, EC.6.10 Pg. 314
               Recommended; Priority A              http://vaww.nbc.med.va.gov/visn/recalls/
               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                VHA Alert, Patient Burns from Hot Water, 6/1998




        Recalls, Alerts Advis - 5                                                       Recalls, Alerts Advis - 5 - Version: 08.01.2006                                   74 of 351
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                               Not If score other than
                                                                                                                                             Met   Partially   Met 'met' what are
               Question:                                Alert/Advisory Actions                                                               (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
               with incidents of hemolysis. A total     3. Special instructions are available for clinics, which must provide treatment
               of four patient deaths have been         before replacements arrive and for which the only blood tubing sets available are
               reported following dialysis treatment,   those subject to the recall. Call GAMBRO Healthcare (800) 456-7339 (24 HOUR)
               none in VA. All lot numbers of           for these instructions.
               catalog numbers: 003109-400,
               003109-410, 003110-500, 003111-          4. Contact GAMBRO Healthcare for further questions, Tim Schoenberg at (800)
               500, 003112-500, 003113-500,             525-2623 x4010.
               003114-500, 003210-500, 003212-
               500 003101-000, 003212-515.

               Mandatory; Priority A                    VHA Alert COBE® CENTURYSYSTEM® 3 Blood Tubing Sets, 6/1998
               1998 Alerts & Advisories
5.2.3          Truncation of Viral Loads in Network 1. IRM sections should fix data fields in NHE to allow the full (which may include
               Health Exchange, 7/98                   ―< or >‖ characters) value to be entered. Two VISNs have collaborated and
                                                       developed a routine that has been shared with their counterparts in other VISN
                                                       facilities. This is an interim measure. A national patch should be made available
                                                       no later than 7/31/98.
               The NHE viral load value field only
               allowed for a 4 digit value to be       2. A National Online Information Sharing (NOIS) (CIN-0698-41578) has been
               transmitted, when in fact, the value is submitted to the national developers of the NHE alerting them to this matter.
               often 6 digits long.
                                                       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                    VHA Alert, Truncation of Viral Loads in Network Health Exchange, 7/1998




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                  75 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                            Not If score other than
                                                                                                                                                                          Met   Partially   Met 'met' what are
               Question:                             Alert/Advisory Actions                                                                                               (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 the product. These device failures
               RANGER™ With SOX™                     may result in emergency interventions, including coronary bypass surgery.
               Premounted Stent, 10/98
                                                     2. Return all unused product to the manufacturer, Boston Scientific/SCIMED
                                                     (Maple Grove, MN) who will replace them with the NIR ON™ RANGER™ Without
                                                     SOX™ at no cost.
               The balloon portion of the delivery
               catheter can develop pinhole leaks 3. For further information regarding the product recall and exchange program, call
               and rupture at inflation pressures as the SCIMED customer service line at 1-888-724-6334.
               low as 3 ATM. This problem
               manifests during the stent
               deployment procedure.
               Mandatory; Priority A                   VHA Alert, Boston Scientific/SCIMED: NIR ON™ RANGER™ WITH SOX™ premounted stent, 10/1998
               1998 Alerts & Advisories
5.2.5          Blakemore tube 3-lumen, X-ray           1. VHA Medical Facilities that have received these catalog numbers of catheters
               opaque, 2 balloon catheter, 21          are to immediately cease using them.
               French, 36" long, by Rusch Int'nat'l,
               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, Derek Monjure (800) 553-5214.
               Batch Number – E343601, Sterilized
               by EtO – 01/95, Use By” – 01/2000,
               In pre-use testing, they discovered
               the balloons were deteriorated
               beyond use.
               Mandatory; Priority A                   VHA Alert, Blakemore tube 3-lumen, X-ray opaque, 2 balloon catheter, 12 French, 36", by Rusch Int'nat'l, 10/1998
               1998 Alerts & Advisories
5.2.6          Invivo Research Inc.'s Milennia 3500 1. Determine if facility contains any monitors manufactured before December
               multiparameter patient monitor,      1998.
               12/98
                                                    2. The manufacturer advises the problem will not occur if the clock is neither
               The FDA has issued an advisory for tested nor reset on December 31 - January 1. Invivo has a software upgrade to
               this patient monitor. It has a       fix the problem that is now available.
               potential New Year’s Eve problem on
               every year including 1998-1999.      3. Contact Invivo Research Inc at 407-275-3220 and ask for customer service.

               Mandatory; Priority A                   VHA Alert, Invivo Research Inc.'s Millennia 3500 multiparameter patient monitor, 12/1998




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                               76 of 351
                                                                  NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                    Not If score other than
                                                                                                                                                                  Met   Partially   Met 'met' what are
               Question:                            Alert/Advisory Actions                                                                                        (1)   Met (2)     (3) possible root causes
               1998 Alerts & Advisories
5.2.7          Hewlett-Packard Defibrillator, model 1. Device will defibrillate properly but will not print out the month, day, hour, and
               43100a/43200a, 12/98                 minute.

               They will experience a minor date      2. The manufacturer advises it should be reset to 1998 (not 1999) after which the
               change problem upon the start of the   unit will work properly for the year 1999 (because the event record does not print
               New Year, January 1, 1999. The         the year, only the month, 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                  VHA Alert, Hewlett-Packard Defibrillator, FDA advisory, 12/1998
               1999 Alerts & Advisories
5.3.1          GE/Marquette Clinical Information      1. Do not use the APEX pulse oximeter while it is connected to the APEX S
               Center (V1.4 and all previous          telemetry transmitter.
               software revisions), 4/99
                                                      2. The APEX pulse oximeter may continue to be used as a standalone device. In
               Versions used with the APEX S          this case, the interface cables between the pulse oximeter and the telemetry
               telemetry transmitter and APEX         transmitter (PN. 412926-001, -002, -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
               The “ALL ALARMS OFF” visual            testing and validation. A GE-Marquette service representative will then contact
               message on the CIC waveform            you to schedule updates. Once your CIC software is updated, you may again use
               window disappears and the alarms       your APEX Pulse Oximeter while it is connected to your APEX S transmitters.
               remain off when the following
               conditions are met: 1.The user turns   4. If you have any questions concerning this safety alert, please contact Tom
               off alarms on the CIC, THEN            Lower, GE/Marquette's Telemetry Product Manager (414) 362-2572.

               2. A. The APEX pulse oximeter is
               turned on or turned off while
               connected to the APEX S telemetry
               transmitter OR B. The APEX pulse
               oximeter is connected to or
               disconnected from the APEX S
               telemetry transmitter.
               Mandatory; Priority A                  VHA Alert, GE/Marquette Clinical Info Ctr w/the APEX S telemetry transmitter & APEX pulse oximeter 4/1999




        Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                         77 of 351
                                                                NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                 Not If score other than
                                                                                                                                               Met   Partially   Met 'met' what are
               Question:                           Alert/Advisory Actions                                                                      (1)   Met (2)     (3) possible root causes
               1999 Alerts & Advisories
5.3.2          Boston Scientific/SCIMED; Discovery 1. VA medical facilities will immediately either replace the Discovery catheter with
               Catheters catalog numbers C3020     the UltraCross intravascular ultrasound catheter or discontinue use of the product.
               and C3005 (All lots); 6/99
                                                   2. Return all unused products to the manufacturer, Boston Scientific/SCIMED
               The distal segment of the sheath of (Maple Grove, MN) who will replace them with the UltraCross intravascular
               Discovery catheters may separate    ultrasound catheter at no cost or credit your account.
               from the proximal segment. The
               separations have led to surgical    3. For further information regarding the product recall and exchange program, call
               intervention in some cases where    SCIMED at 1-800-862-1284 from 8:30 a.m. to 5 p.m. (EDT).
               the separation occurred in vivo.

               Mandatory; Priority A                 VHA Alert, Boston Scientific/SCIMED: Discovery Catheters catalog #C3020 & C3005, 6/1999




        Recalls, Alerts Advis - 5                                                     Recalls, Alerts Advis - 5 - Version: 08.01.2006                                         78 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                       Not If score other than
                                                                                                                                                                     Met   Partially   Met 'met' what are
               Question:                               Alert/Advisory Actions                                                                                        (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 so, there are two options to
               Manufactured by Sunrise Medical         remedy the problem: Option 1: Order and install no-cost upgrade kits. Option 2:
               used on all serial numbers of:          Send in affected actuators (NOT the entire lift) for a no cost upgrade.
               (Descriptions), 8/99
                                                   2. You can use the form enclosed in the attached manufacturer's notice to report
               Retro-fit Power, Retro-fit Power    affected actuators to Sunrise Medical. Contact Sunrise Medical at (800) 556-5438
               Conversion Kit 59105, Power         to arrange for delivery of the kit or upgrading the actuator.
               Partner Lifter 53005, Power Partner
               Stand-Assist Lifter 53006, Power
               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                   VHA Alert, Hoyer Power Lift Actuators Manufactured by Sunrise Medical...serial numbers, description, 8/1999




        Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                           79 of 351
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                             Not If score other than
                                                                                                                                                           Met   Partially   Met 'met' what are
               Question:                                Alert/Advisory Actions                                                                             (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 regional service manager
               8/99                                     (information attached) for your area to schedule the no-cost upgrade.

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

               Mandatory; Priority A                    VHA Alert, OEC Medical Systems' UroView Models 2600, 2500 & 2000, 8/1999
               1999 Alerts & Advisories
5.3.5          Nellcor Puritan Bennett Pulse            1. To verify proper operation of the affected units, perform the following test: 1.
               Oximeters manufactured by                With the pulse oximeter ""OFF"", connect an approved Nellcor sensor to the NPB
               Mallinckrodt Medical, 9/99               190 or NPB 195 pulse oximeter. 2. Turn the pulse oximeter ""ON"" 3. Verify that
                                                        the ""%Sp02"" and ""BPM"" displays both show ""0"" after a short audible tone.
               Models NPB-190 and NPB-195, all
               units manufactured before October 9      2. If the pulse oximeter performs as indicated above, no further action is required.
               1998. The manufacturer has
               received reports of the affected pulse   3. However, if the pulse oximeter displays alternating ""--"" and ""00"" (dashes
               oximeters failing to alarm when the      and zeroes), it may be susceptible to the aforementioned problem. If your pulse
               sensor is disconnected from the          oximeter is affected: 1. Remove it from clinical service immediately. 2. Contact
               patient.                                 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                    VHA Alert, Nellcor Puritan Bennett Pulse Oximeters manf by Mallinckrodt Medical; models...9/1999




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                80 of 351
                                                                  NCPS Patient Safety Assessment Tool

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

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

               Mandatory; Priority A                  VHA Alert, The Clinipad Corporation is recalling Sterile & Nonsterile products..., 12/2000
               2000 Alerts & Advisories
5.4.3          Medtronic Dual Chamber Temporary 1. Immediately affix a warning label to these pacemakers that show steps to clear
               Pacemaker Model 5388, 8/00             0004 error. Label: WARNING: If error code 0004 appears immediately release
                                                      battery door. REMOVE battery until error message clears. REINSTALL battery.
               Model may become inactive if a
               button is touched while it is in "self 2. Verify and document that all staff who utilize or come in contact have been
               test" mode.                            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                VHA Alert, Medtonic Dual Chamber Temporary Pacemaker model 5388, 8/2000




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                        81 of 351
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                   Not If score other than
                                                                                                                                                 Met   Partially   Met 'met' what are
               Question:                        Alert/Advisory Actions                                                                           (1)   Met (2)     (3) possible root causes
               2001 Alerts & Advisories
5.5.1          Magnetic Resonance Imaging (MRI) 1. Purchase "sand bags" for patient care that do not contain iron and properly
               Systems, all, 2/01.              label the bags.

               A “sand bag” attached to a patient’s      2. If facility uses bags that contain iron, these bags should be labeled "Contains
               arm undergoing an MRI exam                Iron: DO NOT expose to MRI."
               contained iron pellets (unknown to
               staff) encased in heavy vinyl; brand      3. Patients should disrobe and wear clothing 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 by testing it with the MRI magnet
               MRI bore, the iron-filled bag flew into   - this could have catastropic consequences.
               the magnet and pinned the patient’s
               forearm to the side of the magnet.        5. Staff should consider all items to be unsafe for the MRI environment until
                                                         proven otherwise.
               Mandatory; Priority A                     VHA Alert, Magnetic Resonance Imaging (MRI) systems, all., 2/2001
               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
               A patient experienced a close call        gaps, 120mm for bed rail openings).
               event when his head became
               wedged in the bed rail opening while      2. Within 120 days of alert, permanently mark all non-complying bed assemblies
               having a coughing episode. The            using a method that clearly communicates the bed entrapment risk to staff.
               patient was found by the nursing
               staff with a partially obstructed         3. Immediately fill gaps created between the mattress and bedrail that are equal to
               airway and was released without           or wider than 60mm used for high risk patients ( frail, elderly, confused, physically
               injury. This alert patient with a right   impaired) with suitable materials (e.g. high density fire retardant foam wedges) to
               side CVA (cerebrovascular accident)       reduce risk of entrapment.
               was trapped while laying on his left
               side.                                     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 (continued)...


               Mandatory; Priority A                     VHA Alert, Bed Rail Entrapment, 7/2001




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                      82 of 351
                                                                     NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                 Not If score other than
                                                                                                                                               Met   Partially   Met 'met' what are
               Question:                           Alert/Advisory Actions                                                                      (1)   Met (2)     (3) possible root causes
               2001 Alerts & Advisories
5.5.2          (continued)... Bed Rail Entrapment, ...(continued) perpendicular to the mattress). Materials include bed rail netting or
(continued)    7/01.                               clear padding or bed rail retrofit kits.

                                                         5. When new bed assemblies or replacement mattresses are purchased openings
                                                         within the bed side rails and gaps between the mattress and the side rail shall not
               A patient experienced a close call        exceed the dimensions specified in this Alert.
               event when his head became
               wedged in the bed rail opening while
               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.

               Mandatory; Priority A                     VHA Alert, Bed Rail Entrapment, 7/2001
               2001 Alerts & Advisories
5.5.3          General Electric Advantage                1. Identify the affected workstations; affected models contain all iteration of
               Windows workstation, models               software version AW4.0_02. Other software versions are not affected.
               2273156-2 and 2273220-2, 7/01
                                                   2. If affected, contact your local GE field engineer, schedule the upgrade to
               The ROI (Region Of Interest)        version AW4.0_03 and ask if you are on the effectivity list. If so, you should
               function on the workstation can     receive the software at no cost.
               change value, depending upon the
               display mode selected (i.e.; moving
               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                     VHA Alert, General Electric Advantage Windows workstation...7/01




        Recalls, Alerts Advis - 5                                                           Recalls, Alerts Advis - 5 - Version: 08.01.2006                                   83 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                              Not If score other than
                                                                                                                                            Met   Partially   Met 'met' what are
               Question:                             Alert/Advisory Actions                                                                 (1)   Met (2)     (3) possible root causes
               2001 Alerts & Advisories
5.5.4          Corruption of VistA Imaging           1. Facility directors must immediately consult with the Chief of IRM to determine if
               files,8/01                            part of the routine system management includes moving globals. While moving
                                                     data from one volume to another if your facility is using DICOM image gateway or
               Patient images and audio fax files    MUMPS AudioFax system or any other satellite system that uses DDP to access
               may become miss-associated when data you are at risk and must implement the guidance contained in Office of
               the repacking utility is run and all  Information alert #AXP 123. This OI Alert may be found at
               “globals” are not properly shutdown. http://vaww.va.gov/custsvc/cssupp/axp/axp123.htm
               This means that clinical information
               could appear in a patients record     2. Also do not move data from one volume to another without coordinating the
               which is incorrect and the care giver move with the other satellite that uses DDP to access VistA data. In any case all
               would have no way of knowing that facility directors must respond to oialert@med.va.gov with copies to
               the information is invalid.           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                 VHA Alert, Corruption of VistA Imaging files, 8/2001
               2001 Alerts & Advisories
5.5.5          Clinician Awareness of Corruption of 1. Facility Directors must ensure that: All clinicians are sensitive to and aware of
               VistA Imaging files, 8/01             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                 VHA Alert, Clinician Awareness of Corruption of VistA Imaging files, 8/2001




        Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                   84 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                 Not If score other than
                                                                                                                                               Met   Partially   Met 'met' what are
               Question:                              Alert/Advisory Actions                                                                   (1)   Met (2)     (3) possible root causes
               2001 Alerts & Advisories
5.5.6          Pharmacy Package - Synonym             Interim 1. Review all drug entries in the Pharmacy Package drug and synonym
               Lookup Resulted in Wrong               files to ensure that there is consistent use of upper and lower case letters.
               Medication Being Displayed or
               Selected, 1/01                         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                VHA Alert, Pharmacy Package - Synonym Lookup Resulted in Wrong Medication...1/2001
               2001 Alerts & Advisories
5.5.7          Computerized Medical Record 'List      1. Review the records of patents with identifier NW to determine if orders have
               Manager Version', 7/01                 been erroneously entered and take appropriate action.

               Inadvertent access to medical record   2. Notify staff of the potential for error if the correct prompt if not visible when
               with patient identifier “NW” when      entering new orders. Orders are entered at the "Action" prompt rather than the
               attempting to access the NW (new       "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                VHA Advisory, Computerized Medical Record 'List Manager Version,' 7/2001




        Recalls, Alerts Advis - 5                                                       Recalls, Alerts Advis - 5 - Version: 08.01.2006                                       85 of 351
                                                                  NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                 Not If score other than
                                                                                                                                               Met   Partially   Met 'met' what are
               Question:                            Alert/Advisory Actions                                                                     (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
               Graduated markings on the            unit dose liquid.
               risperidone syringe (pipette) that
               comes in the medication box are      3. Advise the caregiver to use USA standard, oral syringe by replacing the pipette
               opposite of the markings on syringes that comes 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                VHA Advisory, Risperidone oral medication syringe (pipette). 8/2001
               2001 Alerts & Advisories
5.5.9          Hemodialysis Catheters: Ash Split      1. Do not use Alcohol, Acetone, Hydrogen Peroxide, and other ointments on these
               and Vaxcel, 8/01                       catheters. If these agents are not necessary in the unit, remove them from the
                                                      premises.
               These long-term indwelling catheters
               may crack and/or form small blisters 2. Prior to insertion/installation in patients: Inspect each catheter for small blisters
               (blebs), if wrong disinfectants and/or (blebs), cracks and defects as you remove them from the sterile packaging. If any
               cleaning solutions are used.           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                VHA Advisory, Hemodialysis Catheters: Ash Split and Vaxcel, 8/2001




        Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                     86 of 351
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                          Not If score other than
                                                                                                                                                                        Met   Partially   Met 'met' what are
               Question:                                Alert/Advisory Actions                                                                                          (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 this alert, arrange for Biomedical
               Series AEDs with software versions       Engineering to confirm whether or not your units are affected via the serial number
               below 30.00, 1/02                        and software version.

               Specific defibrillators: T98F00046 to    2. If affected:a) M Series Advisory defibrillators and AEDs with manual operation
               T01K27762, AEDs: T98F00092 to            option - Disable the auto charge configuarion and contact your local Zoll
               T01J27533, In the auto-charge            representative to obtain the corrective software. You can continue to use the
               mode, the charging circuit may           defibrillatr in the manual configuration. b) Fully Automatic AEDs - Remove the
               generate an artifact on the              affected units from service and contact your local Zoll representative for the
               electrocardiograph (ECG) signal that     corrective software. Do Not use the units until the software has been upgraded.
               can lead the units to display "No        Assure that you identify a loaner unit to provide coverage for the removed unit.
               Shock Advised" even during
               shockable ventricular fibrillation.
               Mandatory; Priority A                    VHA Alert, Zoll M Series Advisory defibrillators and M Series AEDs with software versions below 30.00, 1/2002
               2002 Alerts & Advisories
5.6.2          Bronchoscopes manufactured by            1. Immediately identify all units affected. Remove them from service and test
               Olympus America, Inc., per               them for a loose portal following Olympus procedure.
               manufacturer's letter, 3/02
                                                        2. If you detect any looseness in the biopsy channel port, discontinue using the
               Affected models: BF-40, BF-40, BF -      affected bronchoscope, notify Olympus via fax and return it to Olympus per their
               P40, BF-1T40, BF-3C40, BF -XP40,         directions for immediate upgrade.
               BF -XT40, BF –240, BF -P240, BF-
               1T240, BF-6C240, BF-160, BF-             3. If the unit is not affected, it can be used. However, Olympus requests it be
               P160, BF-1T160, BF-3C160, BF -           returned for a biopsy port housing upgrade when practical.
               XT160, per manufacturer’s letter, A
               loose biopsy port can trap bacteria in   4. Finally, if you have affected units, review relevant patient records to determine
               a spot that the usual disinfecting       if there is a pattern of increased pseudomonas infections associated with the use
               process may not reach.                   of these bronchoscopes and report positive findings to Dr. Gary Roselle, VAMC
               Epidemiologists traced the problem       Cincinnati.
               to the Olympus bronchoscopes,
               which were picking up bacteria from
               one patient, shielding them from the
               disinfectants and transferring them to
               the next patient exposed to the
               scope.
               Mandatory; Priority A                    VHA Alert, Bronchoscopes manufactured by Olympus America, Inc. per manufacturer's letter, 3/2002




        Recalls, Alerts Advis - 5                                                           Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                            87 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                     Not If score other than
                                                                                                                                                   Met   Partially   Met 'met' what are
               Question:                                Alert/Advisory Actions                                                                     (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 responded to this notice, immediately
               units may be affected, 5/02              (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 either
               Product codes 2M8151, 2M8151R, arrange modification or obtain the insulators for installation by Biomedical
               2M8153, 2M8153R, If fluid enters the Engineering.
               pump body (usually during cleaning),
               there is a risk of a short circuit later 2. If a pump us exposed to excessive fluids or starts cycling on and off, remove it
               causing the pump to rapidly cycle on and contact Biomedical Engineering to arrange for service.
               and off. This can happen without
               any alarms; if this happens during       3. Copy, post, and follow Baxter‘s recommended cleaning procedures.
               use, therapy delivery may be
               interrupted.                             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                   VHA Alert, Baxter Colleague infusion pumps, 5/02
               2002 Alerts & Advisories
5.6.4          Phillips/Agilent/Hewlett Packard        1. If you have the affected units and did not already receive and respond to
               Viridia information centers; 5/02.      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) 548-8833 to arrange replacement of
               personal computer. This PC is used the hard drives.
               in models M3150A, M3151A,
               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.
                                                       VHA Alert, Phillips/Agilent/Hewlett Packard Viridia information centers, 5/02
               Mandatory; Priority A                   VHA Alert, Philips/Agilent/Hewlett Packard Viridia Info centers; 5/2002




        Recalls, Alerts Advis - 5                                                           Recalls, Alerts Advis - 5 - Version: 08.01.2006                                       88 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                  Not If score other than
                                                                                                                                                                Met   Partially   Met 'met' what are
               Question:                               Alert/Advisory Actions                                                                                   (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 OR*3*155 was released; nearly all
               CPRS progress notes, 8/02.              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 checking
               Four VA medical facilities report       option on CPRS only. A permanent fix is scheduled to be released first week of
               random deletion of progress note        October 2002.)
               text after running Microsoft Word
               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                   VHA Alert, Inadvertent deletion of text from CPRS Progress Notes, 8/2002
               2002 Alerts & Advisories
5.6.6          Recall of the Pocket Guide "VA/DoD 1. Retrieve and destroy all existing Pocket Guides for the ―VA/DoD Clinical
               Clinical Practice Guideline for    Practice Guideline for Management of Postoperative Pain.‖ The guide is white,
               Management of Postoperative Pain", quad-folded, laminated and contains the Equianalgesic Table.
               9/02.

               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                   VHA Alert, Recall of "VA/DoD Clinical Practice Guideline for Management of Postoperative Pain," 9/2002




        Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                      89 of 351
                                                                  NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                           Not If score other than
                                                                                                                                                                         Met   Partially   Met 'met' what are
               Question:                            Alert/Advisory Actions                                                                                               (1)   Met (2)     (3) possible root causes
               2002 Alerts & Advisories
5.6.7          MEDISYSTEMS Corp., blood tubing 1. Check your inventory for the affected products, Medisystems Product code D3-
               for dialysis, 9/02                   9694/9793 or K3-9694/9793, Baxter Product code 5M9694. Contact the
                                                    manufacturer for alternative blood tubing products so that you will not compromise
               Product Code D3-9694/9793 or         needed dialysis treatments. Immediately (within 24 hours) remove affected tubing
               K39694/9793, Baxter Code 5M9694, from service in a manner that does not compromise the provision of necessary
               There are reports outside the VA     dialysis treatment.
               healthcare system that this blood
               tubing may be linked to deaths and
               injuries when used with the Meridian
               model of dialysis machines
               manufactured by Baxter Healthcare
               Corporation.
               Mandatory; Priority A                  MEDISYSTEMS Corp., blood tubing for dialysis, 9/2002
               2002 Alerts & Advisories
5.6.8          4341B Thoracentesis Catheters in       1. Remove all stock with the identified lot numbers from the inventory.
               Thoracentesis Trays distributed by
               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.


                                                      VHA Alert, 4341B Thoracentesis Catheters in Thoracentesis Trays distributed by Allegiance Heathcare Corporation,
               Mandatory; Priority A
                                                      11/2002




        Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                                90 of 351
                                                                       NCPS Patient Safety Assessment Tool

                                                                                             Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                         Not If score other than
                                                                                                                                                                       Met   Partially   Met 'met' what are
                Question:                                 Alert/Advisory Actions                                                                                       (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 determine if the specified monitors
                Vital Signs Monitors, all models          are in use at the facility.
                distributed btwn June 2001 & Oct
                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 affected by this notice, whether they
                used with GE Dinamap Vital Signs          show broken ground pins or not. They can be identified by their manufacture date
                Monitors. This compromises one of         code as follows. Two numbers are imprinted on the hot and neutral blades; one is
                the safety features designed to limit     the week and the other is the year of manufacture. Blades made between (week -
                patients' risk of electrical shock,       year) 09 - 01 and 16 - 02 are affected.
                should an electrical fault occur in the
                equipment. Unless the pin has             4. Contact General Electric to replace all the power cords affected by this notice.
                broken, patient safety is not             The contact at GE is Erik Granby; he can be contacted at (813) 887-2545 or via e-
                compromised.                              mail at erik.granby@med.ge.com.

                                                          5. When new cords are installed, return the affected cords to GE for disposal.
                                                          VHA Alert, Power cords used with GE Dinamap Vital Signs Monitors, all models between June 2001 & Oct 2002,
                Mandatory; Priority A
                                                          11/2002
                2002 Alerts & Advisories
5.6.10          Potential for incorrectly attaching     1. Use only standardized irrigation kits identified by the Medical/Surgical Users
                Allegiance Irrigation Kit caps to Foley Group; acquire from LSL Industries purchased under (BPA) Blanket Purchase
                catheters, 2/02.                        Agreement # VANAC90NP-00-035 with Foley catheters.

                The tubing cap (Catalog #3T4121) of       2. Check with Materials Management to determine if Allegiance Irrigation kits are
                the Allegiance irrigation kit is small    present in your facility. If so, alert all clinical staff of this possible problem and the
                enough to fit into a Foley catheter,      manufacturer‘s intended use and design of the cap. Make copies of the attached
                resulting in an obstructed Foley          WARNING sheet and distribute with Allegiance irrigation kits. Place signs in areas
                catheter.                                 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                   VHA Advisory, Potential for incorrectly attaching Allegiance Irrigation Kit, 2/2002




         Recalls, Alerts Advis - 5                                                              Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                       91 of 351
                                                                      NCPS Patient Safety Assessment Tool

                                                                                           Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                                   Not If score other than
                                                                                                                                                                                 Met   Partially   Met 'met' what are
                Question:                                 Alert/Advisory Actions                                                                                                 (1)   Met (2)     (3) possible root causes
                2002 Alerts & Advisories
5.6.11          Confusion between Oxygen &                1. Purchase clear adaptors and avoid green-yellow confusion.
                Compressed Air Wall Outlet, 3/02
                                                          2. When appropriate, purchase compressed air tubing that does not require
                Close calls have occurred when low        "Christmas Tree" 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 use; this may require addressing
                inadvertently had their oxygen tubing     informal norms through training, incentives.
                hooked up to air regulators with
                green adapters instead of oxygen.         4. More prominently label air and oxygen outlets.

                                                          5. Respiratory Therapy, Nursing, and Pharmacy must work together for the
                                                          smoothest implementation of any redesign or training.
                Recommended; Priority A                   VHA Advisory, Confusion between Oxygen & Compressed Air Wall Outlet, 3/2002
                2002 Alerts & Advisories
5.6.12          Addendum to Patient Safety                1. The National Center for Patient Safety and the VA Medical/Surgical Users‘
                Advisory Issued on February 27,           Group are working with the VA National Acquisition Center and vendors to modify
                2002 Concerning Allegiance                the configuration of the caps so that inadvertent insertion is effectively precluded.
                Irrigation Kits, 5/02                     Until we can find a vendor who is willing to modify the configuration, continue to
                                                          remind caregivers that blockage/obstruction could occur. Use the attached
                It has come to our attention that         WARNING sheet to distribute with the products.
                even the larger size caps of the
                standardized product we suggested
                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.
                                                          VHA Advisory, Addendum to Patient Safety Advisory issued on February 27, 2002 concerning Allegiance Irrigation Kits,
                Recommended; Priority A
                                                          5/2002




         Recalls, Alerts Advis - 5                                                           Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                                    92 of 351
                                                                 NCPS Patient Safety Assessment Tool

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




         Recalls, Alerts Advis - 5                                                      Recalls, Alerts Advis - 5 - Version: 08.01.2006                                              93 of 351
                                                                     NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                  Not If score other than
                                                                                                                                                Met   Partially   Met 'met' what are
                Question:                                 Alert/Advisory Actions                                                                (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
                When renewing an automatically            complex orders and at renewal time, reference the list and enter complex orders
                stopped medication order of a             first.
                tapering dose, or editing an existing
                order of a single dose the start/stop     2. Notify pharmacy of all your complex orders when you initiate them by including
                dates will be changed and overlap         a statement in the Provider Comments on CPRS such as ―TAPERING ORDER‖ or
                the current order. This could result in   ―PART OF COMPLEX ORDER‖.
                a patient receiving multiple doses in
                one day, if the provider didn’t notice    3. When editing or renewing orders, review the displayed start/stop dates in CPRS
                the shift in start dates.                 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 (continued)...
                Recommended; Priority A                   VHA Advisory, CPRS & Inpatient Complex Medication Orders, 8/2002
                2002 Alerts & Advisories
5.6.14          (continued)... CPRS & Inpatient           ...(continued) order when verifying within inpatient meds.
(continued)     Complex Medication Orders, 8/02
                                                          For Providers authorized to administer medication:
                When renewing an automatically
                stopped medication order of a             1. Before administering medications double check against the electronic MAR to
                tapering dose, or editing an existing     make sure that this is part of a complex order and proper start date and time. Be
                order of a single dose the start/stop     aware of cases where multiple doses are due on the same date.
                dates will be changed and overlap
                the current order. This could result in   2. Review the last action for that medication displayed within BCMA before
                a patient receiving multiple doses in     administering a medication.
                one day, if the provider didn’t notice
                the shift in start dates.

                Recommended; Priority A                   VHA Advisory, CPRS & Inpatient Complex Medication Orders, 8/2002




         Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                     94 of 351
                                                                   NCPS Patient Safety Assessment Tool

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

                Recommended; Priority A                VHA Advisory, Cochlear Implant Recipients may be at Increased Risk for Bacterial Meningitis, 9/2002
                2002 Alerts & Advisories
5.6.15          (continued)... Cochlear Implant        ...(continued) CDC specifically notes the use of Hib vaccine in adults related to
(continued)     Recipients may be at increased risk    cochlear implants, the use of Hib vaccine in this scenario would be based on
                for bacterial meningitis, 9/02         theoretical risk.
                                                       For additional info on immunizations refer to the following websites.
                The FDA has determined that, over      http://www.cdc.gov/nip/publications/pink/
                the past 14 years, 52 cases of          http://www.cdc.gov/mmwr/preview/mmwrrhtml/00025228
                meningitis have been reported          http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf
                worldwide, out of which 12 known       "
                deaths have resulted from these
                cases. It was identified that 24 cases 2. In some of the reported cases, patients may have had overt or sub-clinical otitis
                (of the 52 worldwide cases) were in media prior to surgery or before meningitis developed. Physicians are encouraged
                North America.                         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                VHA Advisory, Cochlear Implant Recipients may be at Increased Risk for Bacterial Meningitis, 9/2002




         Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                   95 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                        Not If score other than
                                                                                                                                                                      Met   Partially   Met 'met' what are
                Question:                            Alert/Advisory Actions                                                                                           (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 when they are released. These
                and BCMA Version 2 (PSJ*5*94 and     patches are currently undergoing testing and are scheduled for release by
                PSB*2*13), 11/02                     November 30, 2002.

                Original IV continuous orders do not 2. In the interim when pharmacists renew IV continuous orders, indicate the start
                appear on the Virtual Due List (VDL), date as "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              VHA Advisory, Inpatient Medications Version 5.0 and BCMA Version 2, 11/2002
                2002 Alerts & Advisories
5.6.17          CPRS consultant note amendments 1. Patient Safety Managers should check with the Chief MIS and others who are
                are not printing and displaying after authorized to amend consultant notes, to ensure that all documents are manually
                changes are entered 12/02             LINK under ‗Consults hierarchy‘ when documents are amended. Authorized
                                                      amenders should also verify that the amended document is listed under the
                Specifics are: TIU version 1.0,       related document hierarchy. There should be two documents, the amended
                Consults version 3.0, A VA Medical document and the retracted document.
                Center reported that amended
                consult notes did not print with      2. Notes that have been previously amended should be reviewed against the
                updated information after authorized electronic data to verify accuracy and manually linked if necessary.
                personnel entered them. While the
                electronic record displays the
                corrected information, the printed
                copy does not. This may result in
                incorrect information being relied
                upon when making clinical decisions.


                Recommended; Priority A              VHA Advisory, CPRS consultant note amendments are not printing & displaying after changes are entered, 12/2002




         Recalls, Alerts Advis - 5                                                     Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                               96 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                               Not If score other than
                                                                                                                                                             Met   Partially   Met 'met' what are
               Question:                               Alert/Advisory Actions                                                                                (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 the SCD sleeves when first
               Sequential Compression Device           applied to a patient. In particular, activate the cooling button for 30 seconds to
               (SCD) 1/03                              ensure that no observable over-inflation occurs.

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

               Mandatory; Priority A                   VHA Alert, Connection tubing set used with SCD and manufactured by Kendall (Tyco Healthcare) 1/2003
               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,
               Serial numbers X02K000812 to            turn the AED off for 10 seconds, then restart; or b) Attach the pads to the patient
               X02K0077486. While handling             prior to turning the AED on.
               electrodes prior to attaching them to
               a patient, communication between        3. Place the appropriate work around instructions with each affected defibrillator
               the unit’s internal ECG and Safety      and train potential users on the work around. Remember to schedule training
               Monitoring functions can lead to an again after the software upgrade is installed.
               error condition. This error condition
               will cause the defibrillator to issue a
               "Shock Advised" message,
               immediately followed by "No
               Treatment Delivered" and "Change
               Batteries" messages.

               Mandatory; Priority A                   VHA Alert, Zoll AED Plus, Public Access Defibrillator, 2/2003




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                  97 of 351
                                                                  NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                  Not If score other than
                                                                                                                                                Met   Partially   Met 'met' what are
               Question:                              Alert/Advisory Actions                                                                    (1)   Met (2)     (3) possible root causes
               2003 Alerts & Advisories
5.7.3          Counterfeit drugs labeled as           1. Follow this link for details on identifying the counterfeit products and directions:
               PROCRIT® (Epoetin alfa) 40,000         http://www.procrit.com/counterfeit/letter.html
               units/mL; 3/03
                                                    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 patient(s) is indicated.
               02/2004; and P004839, expiration
               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                  VHA Alert, Counterfeit drugs labeled as PROCRIT® (Epoetin alfa), 3/2003
               2003 Alerts & Advisories
5.7.4          ACCU-CHEK® Comfort Curve® and 1. For inpatient and clinic areas: Within the next 72 hours, inspect the inventory
               Advantage® test strips manufactured and check the bottom of any unused or currently in-use vials for cracks. Make
               by Roche Diagnostics Corp; 5/03         sure that the lot specific code key inside each strip box is kept associated with the
                                                       correct vial as you conduct this inspection. Also, as a standard practice, inspect
               The bottom of the vial may be           each vial for cracks before each use. If you find cracked vials, do not use the
               cracked which may cause inaccurate strips and call 1-800-440-3638 to arrange for a replacement product.
               blood glucose results due to
               changes in humidity. This product       2. Patients at home: The Pharmacy Benefits Management (PBM) is notifying
               correction refers to all lots currently outpatients.
               available of the ACCU-CHEK®
               Comfort Curve® test strips, part
               numbers 2030420, 2030365,
               2030373, 2030381, 3000133,
               3000141 and the ACCU-CHEK®
               Advantage® test strips, part
               numbers 336, 553, 787, and 966.


               Mandatory; Priority A                  VHA Alert, ACCU-CHEK® Comfort Curve® and ACCU-CHEK® Advantage® test strips, 5/2003




        Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                       98 of 351
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                               Not If score other than
                                                                                                                                             Met   Partially   Met 'met' what are
               Question:                              Alert/Advisory Actions                                                                 (1)   Met (2)     (3) possible root causes
               2003 Alerts & Advisories
5.7.5          In-line air filter requirement for      1. If you use these pumps immediately acquire IV administration sets from the
               Abbott Pumps, 6/03                      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-line tests per manufacturer instructions for the pumps listed.
               Plus, APMTM, APMII, and ANNETM,
               manufactured by Abbott Laboratories
               Hospital Product Division.

               Mandatory; Priority A                  VHA Alert, In-line filter requirement for Abbott Pumps, 6/2003
               2003 Alerts & Advisories
5.7.6          Decimal point display issue with       1. Check to see if you have these pumps at you facility. If these pumps are not
               Abbott APM II pump, 6/03               used, then no further action is required.

               The APM II Pump will not display a     2. If you have these pumps review the analgesic formulary to determine if your
               decimal point on the screen when       facility uses Fentanyl or other analgesics that are administered via a PCA pump in
               entering values in the tenths of       the microgram per milliliter concentration range. If these medications are not used
               micrograms per milliliter (mcg/mL).    no further action is required.
               However, the decimal point is
               displayed when the value entered is    3. If the pumps are present and used to administer Fentanyl or other analgesics
               in the milligrams/milliliter (mg/mL)   ensure that there is a facility guideline for use of these drugs with PCA pumps. a.
               range.                                 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 (continued)...
               Mandatory; Priority A                  VHA Alert, Decimal point display issue with Abbott APM II pump, 6/2003




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                  99 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                              Not If score other than
                                                                                                                                            Met   Partially   Met 'met' what are
               Question:                            Alert/Advisory Actions                                                                  (1)   Met (2)     (3) possible root causes
               2003 Alerts & Advisories
5.7.6          (continued)... Decimal point display ...(continued) review all PCA medication orders for accuracy, to make sure
(continued)    issue with Abbott APM II pump, 6/03 medication orders and 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                 VHA Alert, Decimal point display issue with Abbott APM II pump, 6/2003
               2003 Alerts & Advisories
5.7.7          Power cords for Hill-Rom Century+     1. Check the medical equipment inventory to determine if you have Hill-Rom,
               electric beds, distributed between    Century + electric beds and inspect the power cords for beds that fall within the
               Jan 1 1999 and July 1 2002; 7/03      affected range.

               Power cord ground pins on some        2. Determine the number of power cords affected by this notice. Affected cords
               portable monitors broke off. This     are identified by their manufacture date with codes as follows: 09 - 01 through 16 -
               fracture compromises one of the       02 (week - year) is imprinted on the hot and neutral cord blades. Immediately
               safety features designed to limit     replace any cords with a broken ground pin with a spare and schedule
               patients' risk of electrical shock.   replacement of other cords with an imprinted date that falls within the affected
               Unless the pin has broken, patient    range.
               safety is not compromised.
                                                     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                 VHA Alert, Power cords for Hill-Rom Century+ electric beds, 7/2003




        Recalls, Alerts Advis - 5                                                       Recalls, Alerts Advis - 5 - Version: 08.01.2006                                   100 of 351
                                                                  NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                  Not If score other than
                                                                                                                                                Met   Partially   Met 'met' what are
               Question:                               Alert/Advisory Actions                                                                   (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 consider to be high risk for self-harm,
               manufactured by Span America to         remove the plastic cover.
               cover Geo-Matt® seat cushions and
               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 harm.
               A patient in locked psychiatric ward
               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                   VHA Alert, Soft Skin™ protective sleeve manf by Span America, 7/2003
               2003 Alerts & Advisories
5.7.9          J&J/Cordis Cypher™ Sirolimus-           1. Interventional Cardiologist: In addition to following the manufacturer‘s
               Eluting Coronary Stent, 11/03           recommendation (see attached letter from Cordis dated July 7, 2003), coordinate
                                                       with the post-stent care physicians to ensure that the required antiplatelet therapy
               Informing Physicians of sub-acute       regimen is continued post-stenting.
               thromboses (SAT) and
               hypersensitivity reactions with the     2. Post-stent care Physicians: As recommended by Cordis
               use of the Cordis CypherTM drug         http://www.fda.gov/bbs/topics/news/cordis_ltr.pdf and referred to by the FDA
               eluting Coronary Stent.                 ―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                   VHA Alert, J&J/Cordis Cypher™ Sirolimus-Eluting Coronary Stent, 11/2003




        Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                      101 of 351
                                                                     NCPS Patient Safety Assessment Tool

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

                Mandatory; Priority A                     VHA Alert, Roche Diagnostics Corp. CoaguChek PT Test Strips, 11/2003
                2003 Alerts & Advisories
5.7.11          Counterfeit PROLENE                       1. Physicians, nurses, and all other healthcare professionals must carefully
                Polypropylene Mesh, 11/03                 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 the distributor
                Product code PMII bearing lot             to discuss refund/replacement of the product(s). Refer to the attached
                numbers RBE609 (expiration date           photographs for information on how to identify counterfeit PROLENE mesh.
                1/07) and RJJ130 (expiration date
                7/07). Prolene flat mesh 3" x 6",         2. Review surgical records for patients to determine if they are recipients of the
                Physicians, nurses and all other          counterfeit mesh. Involve your regional counsel when communicating with
                healthcare professionals should           affected patients. We are waiting for the FDA to issue additional information
                carefully examine all PROLENE flat        regarding the mechanical properties, biocompatibility or sterility of the material.
                mesh product before using it to           This additional information may be used as needed when communicating with
                determine if it is counterfeit based      patients who have received this mesh.
                upon photographs provided by
                Ethicon.
                Mandatory; Priority A                     VHA Alert, Counterfeit PROLENE Polypropylene Mesh, 11/2003




         Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                      102 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                         Not If score other than
                                                                                                                                       Met   Partially   Met 'met' what are
                Question:                         Alert/Advisory Actions                                                               (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
                Earlier production MAJ-891 plugs  production, replacement plugs have a gray rubber locking ring.
                can bind when connected to the
                aforementioned cystoscopes. This 3. Contact Olympus immediately if you have the affected plug. Refer to
                binding can lead the operator to  attachment for more information.
                apply excessive force when
                removing the plug, thus damaging  4. Contact Paul Sherman at CEOSH via e-mail at paul.sherman@med.va.gov if
                the cystoscope and rendering it   you have the affected plug and did not receive the letter from Olympus.
                unusable.

                Recommended; Priority A             VHA Advisory, Olympus Cystoscopes w/MAJ 891 Forceps/Irrigation Plug, 2/2003
                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
                Models: CF-Q160L, CF-Q160I, CF- cycle even if the channels were not utilized during the preceding patient
                160S, CF-Q160AL, CF-Q160AI and procedure.
                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             VHA Advisory, Olympus EXERA Gastrointestinal Endoscopes, 3/2003




         Recalls, Alerts Advis - 5                                                   Recalls, Alerts Advis - 5 - Version: 08.01.2006                                 103 of 351
                                                                     NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                    Not If score other than
                                                                                                                                                                  Met   Partially   Met 'met' what are
                Question:                                Alert/Advisory Actions                                                                                   (1)   Met (2)     (3) possible root causes
                2003 Alerts & Advisories
5.7.14          Adverse Reaction/Allergy database        1. Information Resource Management (IRM) at VAMCs should monitor the VistA M
                of CPRS GUI v20 Allergy Reaction         error trap, at least on a daily basis (until a patch is released) to determine if the
                Tracking v4.0; 4/03                      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-entered.
                Allergy information does not get
                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                  VHA Advisory, Adverse Reaction/Allergy database of CPRS GUI v20 Allergy Reaction Tracking v4.0, 4/2003
                2003 Alerts & Advisories
5.7.15          The Ancure ® Endograft System            1. Because the Ancure ® device will no longer be supported in the near future
                made by EndoVascular                     other procedures and FDA approved devices should be considered for cases
                Technologies, Inc.will no longer be      requiring endovascular repair.
                sold. 6/03

                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                  VHA Advisory, Ancure ® Endograft System will no longer be sold, 6/2003




         Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                     104 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                Not If score other than
                                                                                                                                                              Met   Partially   Met 'met' what are
                Question:                     Alert/Advisory Actions                                                                                          (1)   Met (2)     (3) possible root causes
                2003 Alerts & Advisories
5.7.16          METFORMIN Orders on CPRS V3.0 1. Mark metformin in the facility drug file as ―Not Renewable‖ until the order check
                GUI v22; 9/03                 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 order, use the COPY feature.
                renewed three times although the
                serum creatinine values before         3. Review patients that are currently receiving metformin with serum creatinine
                renewal were above 1.5mg/dL.           values higher than normal and take appropriate interventions.


                Recommended; Priority A                VHA Advisory, METFORMIN Orders on CPRS V3.0 GUI v22, 9/2003
                2004 Alerts & Advisories
5.8.1           Proper Connectors for Sterlization of 1. By March 5, 2004 conduct in-service training at all sites including VA medical
                all Gastrointestinal Fiberoptic         centers and CBOCs for personnel tasked with reprocessing gastrointestinal
                Endoscopes, 2/04                        fiberoptic endoscopes. The in-service training must address manufacturer
                                                        instructions for proper reprocessing of specific models of gastrointestinal fiberoptic
                Using an incorrect connector to link endoscopes for consistency with local work procedures. All third party (other than
                sterilizing solution to endoscopes      the endoscope manufacturer) tools and materials used for reprocessing must also
                during reprocessing (cleaning and       be covered during the in-service training.
                sterilizing) procedures. A dual-port or
                “Y” connector designed to connect to 2. Validate that appropriate reprocessing connectors are being utilized with each
                endoscopes incorporating dual ports model of endoscope. Some manufacturers provide cognitive aids such as
                was connected to endoscopes with instruction placards and these must be available and intact where provided.
                single ports. Under this condition an
                indeterminate amount of sterilizing     3. Incorporate knowledge of proper handling and reprocessing of gastrointestinal
                solution may have been directed to fiberoptic endoscopes into JCAHO competency assessment requirements for
                the unconnected port, possibly          individuals tasked with this (continued)...
                leading to inadequate sterilization of
                the endoscope.


                Mandatory; Priority A                  VHA Alert, Proper Connectors for Sterilization of all Gastrointestinal Fiberoptic Endoscopes, 2/2004




         Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                  105 of 351
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                               Not If score other than
                                                                                                                                                             Met   Partially   Met 'met' what are
               Question:                               Alert/Advisory Actions                                                                                (1)   Met (2)     (3) possible root causes
               2004 Alerts & Advisories
5.8.1          (continued)... Proper Connectors for ...(continued) assignment.
(continued)    Sterlization of all Gastrointestinal
               Fiberoptic Endoscopes, 2/04             4. Facility Patient Safety Managers will monitor the in-service training requirement
                                                       and report completion to the VISN Patient Safety Officer. Reporting instructions
               Using an incorrect connector to link for the VISN PSO will be provided in a separate communication from the office of
               sterilizing solution to endoscopes      the Deputy Under Secretary for Health for Operations and Management.
               during reprocessing (cleaning and
               sterilizing) procedures. A dual-port or 5. Scheduled procedures may continue while the above actions are undertaken.
               “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                  VHA Alert, Proper Connectors for Sterilization of all Gastrointestinal Fiberoptic Endoscopes, 2/2004
               2004 Alerts & Advisories
5.8.2          Potential bacterial contamination of   1. Immediately remove and quarantine the affected nasal spray bottles from
               Twice-A-Day Nasal Spray                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                  VHA Alert, Twice-A-Day Nasal Spray manufactured by Propharma Inc., 3/2004




        Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                  106 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                              Not If score other than
                                                                                                                                            Met   Partially   Met 'met' what are
               Question:                               Alert/Advisory Actions                                                               (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
               Two VA Medical Centers reported a       NFPA-99 5.1.3.4.11.6, 2002 Edition)
               loss of service in the Oxygen Utility
               System. In both incidents the alarm     2. Ensure that a minimum of two, independent 24/7 and constantly attended
               on the main tank did not sound until    monitoring stations are provided for all alarm conditions related to the Oxygen
               reaching near or completely empty       Utility System. Test all alarm conditions to ensure the alarm annunciation is
               and both sites did not meet the         working.
               NFPA-99 requirement for two,
               independent 24/7 supervised areas       3. If either of the conditions in 1. or 2. above cannot be met, the Medical Center
               where mandatory alarm conditions        must publish, over the Director‘s signature, a comprehensive Interim Life Safety
               for the Oxygen Utility System are       Measure that fully addresses and compensates for the non-compliant condition.
               annunciated                             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
                                                       (continued)...
               Mandatory; Priority A                   VHA Alert, Oxygen Utility System, 4/2004
               2004 Alerts & Advisories
5.8.3          (continued)... Oxygen Utility System, ...(continued) current demands to ensure an adequate supply of Oxygen so alarm
(continued)    4/04                                  conditions are not triggered between refills.

               Two VA Medical Centers reported a       5. Ensure qualified and trained technical staff such as a Biomedical Engineering
               loss of service in the Oxygen Utility   Technician, SPD Technician or Pipe Fitter monitors tank refilling procedures.
               System. In both incidents the alarm
               on the main tank did not sound until    6. Ensure an adequate supply of portable oxygen with an appropriate mixture of
               reaching near or completely empty       tanks is available for deployment at point of health care delivery in the event of
               and both sites did not meet the         total Oxygen Utility System failure. All tanks must be properly stored.
               NFPA-99 requirement for two,
               independent 24/7 supervised areas       7. Set, maintain, and document appropriate Oxygen Utility System preventive
               where mandatory alarm conditions        maintenance and testing protocols.
               for the Oxygen Utility System are
               annunciated                             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                   VHA Alert, Oxygen Utility System, 4/2004




        Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                 107 of 351
                                                                     NCPS Patient Safety Assessment Tool

                                                                                           Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                            Not If score other than
                                                                                                                                                          Met   Partially   Met 'met' what are
               Question:                              Alert/Advisory Actions                                                                              (1)   Met (2)     (3) possible root causes
               2004 Alerts & Advisories
5.8.4          Implantable Cardioverter Defibrillator 1. Immediately check patient records in CPRS to identify patients with the ICD
               (ICD), 4/04                            implants described in this notification.

               Models Micro-Jewell II 7223Cx and         2. Contact your local Medtronic sales representative (or Medtronic Technical
               GEM DR 7271; Medtronic, implanted         Services, listed in the Contact section of this notification if you cannot reach the
               in 1997 and 1998, During a cardiac        local representative) for assistance with determining whether the identified implant
               event requiring cardioversion or          requires follow-up action as identified by Medtronic.
               defibrillation, internal capacitors may
               take longer to charge and can cause       3. If follow-up action is necessary, see the attached letter from Medtronic
               a delay or non-delivery of                describing required actions.
               appropriate shock therapy.

               Mandatory; Priority A                     VHA Alert, Implantable Cardioverter Defibrillator (ICD), 4/2004
               2004 Alerts & Advisories
5.8.5          Class I recall of Medtronic MiniMed 1.If you still have any of the above mentioned product in inventory, immediately
               Paradigm® Quick-set® Plus Infusion stop distributing them to your patients.
               Sets, 5/04
                                                   2. Please complete the enclosed Distributor Response Form indicating how you
               Model MMT-359S6, MMT-359S9,         will proceed with this mandatory notification and return it by fax as soon as
               MMT-359L6 and MMT-359L9,            possible to the manufacturer.
               Problems with the infusion sets can
               interrupt insulin flow resulting in 3. Please also complete the enclosed Exchange Request Form so that
               serious injury.                     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                     VHA Alert, Class 1 Recall of Medtronic MiniMed Paradigm® Quick-set® Plus Infusion Sets, 5/2004




        Recalls, Alerts Advis - 5                                                             Recalls, Alerts Advis - 5 - Version: 08.01.2006                                           108 of 351
                                                                      NCPS Patient Safety Assessment Tool

                                                                                           Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                    Not If score other than
                                                                                                                                                  Met   Partially   Met 'met' what are
               Question:                                  Alert/Advisory Actions                                                                  (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 available on-line at
               CoolSpot™ and Outpatient®                  http://www.burtonmedical.com/safetyNote.htm).
               Fleximount™, 6/04
                                                          2. Identify and inspect all units affected by this alert for cracked pivot supports,
               Single Ceiling and Track Mount with        and complete Burton Medical's form to obtain new pivot supports and arms.
               Single Trolley manufactured by
               Burton Medical before August 2000.         3. For identified lamps with cracked pivot supports- If possible, remove them from
               Model numbers: 0100540, 0100740,           service. a. Users: Inspect each light daily before use for normal movement and
               0100580, 0102180 and 0102540,              stability. If the light appears loose or unstable, contact Engineering to have it
               Due to an inherent weakness in the         checked. b. Engineering: Inspect identified lights every two weeks until new
               original composition of the pivot          components are installed.
               support casting, the pivot joint can
               fail and the light may fall onto a
               patient.
               Mandatory; Priority A                      VHA Alert, Minor Surgery/Exam lights: CoolSpot™ and Outpatient® Flexmount™, 6/2004
               2004 Alerts & Advisories
5.8.7          CPRS Text Integration Utility (TIU)        1. Run patch TIU*1*174 for all patient records created after January 1, 2004 and
               v1.0 documents, 6/04                       at least daily thereafter until permanent solutions are implemented. Review all
                                                          records identified by this patch to determine if text has been deleted or truncated.
               Reported and confirmed that text
               stored in Text Integration Utility (TIU)   2. When records with missing or truncated text are identified:(a) Refer them to the
               document file 8925 may be deleted          author for review of the note and to add an addendum if needed (b) If the author is
               or truncated automatically without         no longer available or is unable to remember what information is missing a
               the author being made aware that           disclaimer, similar to the following, should be added to the file ―DISCLAIMER: This
               this occurred when the document is         completed document may have text that was electronically deleted in error. (c) If
               signed. The Office of Information          the note is of significant concern, and the author is no longer available, the record
               (OI) has developed a patch that may        should be referred to the site medical record committee or other functional group
               be used to identify potentially            that processes records that are suspected as being incomplete. The committee
               affected patient records.                  may decide to forward the note to the service (continued)...


               Mandatory; Priority A                      VHA Alert, CPRS Text Integration Utility (TIU) v1.0 documents, 6/2004




        Recalls, Alerts Advis - 5                                                            Recalls, Alerts Advis - 5 - Version: 08.01.2006                                    109 of 351
                                                                      NCPS Patient Safety Assessment Tool

                                                                                           Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                  Not If score other than
                                                                                                                                                Met   Partially   Met 'met' what are
               Question:                            Alert/Advisory Actions                                                                      (1)   Met (2)     (3) possible root causes
               2004 Alerts & Advisories
5.8.7          (continued)... CPRS Text Integration ...(continued) chief or equivalent to either complete the note or allow the
(continued)    Utility (TIU) v1.0 documents, 6/04   disclaimer to be added.

               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                      VHA Alert, CPRS Text Integration Utility (TIU) v1.0 documents, 6/2004
               2004 Alerts & Advisories
5.8.8          DeRoyal ReliaFlex™ Suction                 1. Review the attached letter from DeRoyal and sequester all affected models and
               Canisters with Liners, 6/04                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) 71-9301, canister
               DeRoyal suction canisters that are         liner, 3200cc, Lot numbers lower than 6096
               used with the ReliaFlexTM suction
               liner system have violently                2. With the help of your Logistics office or your material management service,
               discharged blood and body fluids           contact your local DeRoyal sales representative or distributor to make sure that
               when the full liners were removed by       you have an adequate supply of the redesigned ReliaFlexTM suction liners (those
               clinical staff from the hard outer         with lot numbers higher than 1a-c) before you ship the affected units back to
               shell. Unsecured caps on the               DeRoyal for free replacement. DeRoyal has agreed to accept returns on partial
               tandem port and pour spouts along          cases.
               with slight pressure on the flexible
               suction liner precipitated the             3. In lieu of continuing to use the ReliaFlexTM suction liner system, you may elect
               discharge.                                 to use the DeRoyal CrystalineTM Disposable Canister System.
               Mandatory; Priority A                      VHA Employee Safety Alert, DeRoyal ReliaFlex™ Suction Canisters with Liners, 6/2004




        Recalls, Alerts Advis - 5                                                            Recalls, Alerts Advis - 5 - Version: 08.01.2006                                  110 of 351
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                 Not If score other than
                                                                                                                                               Met   Partially   Met 'met' what are
               Question:                                Alert/Advisory Actions                                                                 (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 paging technology and confirm
               using paging technology to notify        that alarm protocols classify the paging component as a secondary (or back-up)
               clinical staff, 7/04                     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 manage physiologic monitoring
               technology to notify clinical staff of systems and other clinically significant primary alarms when patients are being
               alarms or other critical clinical      monitored.
               information.
                                                      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) (continued)...


               Mandatory; Priority A                    VHA Alert, Failure of medical alarm systems using paging technology, 7/2004
               2004 Alerts & Advisories
5.8.9          (continued)... Failure of medical        ...(continued) there must be positive feedback to the initiator of the page that the
(continued)    alarm systems using paging               message was received and responded to in a timely manner. This allows
               technology to notify clinical staff,     appropriate action to be taken to deliver clinical care if the page was not
               7/04                                     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                    VHA Alert, Failure of medical alarm systems using paging technology, 7/2004




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                   111 of 351
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                Not If score other than
                                                                                                                                              Met   Partially   Met 'met' what are
                Question:                               Alert/Advisory Actions                                                                (1)   Met (2)     (3) possible root causes
                2004 Alerts & Advisories
5.8.10          Boston Scientific Stent System          1. Confirm that your facility received the manufacturer‘s recall letter dated
                Recall, 7/04                            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 you have on site replacements from
                Express 2 Over-the-wire (OTW)           FDA approved stent suppliers, for existing, affected models (―recalled stents‖) of
                Paclitaxel-Eluting 3) Express 2         Boston Scientific stent systems. Do not sequester the ―recalled stents‖ from use
                Monorail (MR) bare-metal 4) Express     until you have replacements on hand.
                2 Over-the Wire (OTW) bare-metal.
                The FDA and the manufacturer            3. Contact your local Boston Scientific sales representative to exchange the
                received reports 43 confirmed “no       affected stents one for one with their replacements.
                deflation” (failure of the balloon to
                deflate within one minute after
                deployment of the stent) complaints
                related to the Taxus Express 2
                device system.
                Mandatory; Priority A                   VHA Alert, Boston Scientific Stent System Recall, 7/2004
                2004 Alerts & Advisories
5.8.11          Shiley Tracheosoft XLT Extended         1. Patients with the affected models (see below) should be contacted and
                Length Tracheostomy Tube and            arrangements made to exchange the equipment.
                Cannula FDA Class I Recall, 8/04
                                                        2. If you have the affected devices in stock work with your materials management
                The outer cannula may separate          (AMMS) to make sure that a recall package has been received. Follow the
                from the hub and neck flange            instructions in the package to receive credit for the recalled products.
                allowing the outer cannula to travel
                farther into the patient’s airway       3. If you have these devices in stock and did not receive a recall package from the
                leading to obstruction of the airway    company, contact Nellcor/Tyco Technical Services Department at 1-800-635-
                and significantly interfering with      5267.
                breathing and ventilation.
                Mandatory; Priority A                   VHA Alert, Shiley Tracheosoft XLT recall, 8/2004




         Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                  112 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                              Not If score other than
                                                                                                                                            Met   Partially   Met 'met' what are
                Question:                              Alert/Advisory Actions                                                               (1)   Met (2)     (3) possible root causes
                2004 Alerts & Advisories
5.8.12          Automated External Defibrillators      1. Immediately check your inventory to determine if you have any Access
                (AED) manufactured by Access           Cardiosystems AEDs and remove units from service affected by items 1 and 2
                Cardiosystems, Inc., operation         above.
                failure, 11/04
                                                       2. Other Access Cardiosystems units can remain in service only as long as you
                Units with serial numbers ranging      have consumables on hand to support them or until February 1, 2005, then they
                from 075690 to 077140 may              must be removed from service and replaced with AEDs from other manufacturers.
                experience a malfunction in the
                shock delivery circuit and fail to     3. If you are affected, plan for emergency replacement of any Access
                deliver therapeutic shocks.            Cardiosystems defibrillators in stock.

                Mandatory; Priority A                  VHA Alert, Access Cardiosystems, Inc. AED operation failure, 11/2004
                2004 Alerts & Advisories
5.8.13          Renewal prompts for "one-time only" 1. Check the attachment to determine if you are one of the sites that has already
                medication orders, 12/04            installed CPRS test patch PSJ*5*127.

                After installation of CPRS patch         2. If your site is NOT listed on the attachment and you have installed patch
                PSJ*5*110, several close call reports PSJ*5*110, then 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                  VHA Alert, Renewal promts for "one time only" medication orders, 12/2004




         Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                 113 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                       Not If score other than
                                                                                                                                                     Met   Partially   Met 'met' what are
                Question:                               Alert/Advisory Actions                                                                       (1)   Met (2)     (3) possible root causes
                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
                Facility drug files may contain entries RESTRICT these products on a case by case basis, from view of the providers.
                that are for pharmacy use only.          Restricting the products in CPRS file 101.43 prevents providers from seeing them
                Some of these entries may be             but will permit pharmacy staff access to them through the back door CHUI
                inappropriate or harmful for patient     interface.
                administration. In addition, some
                items are in the drug file for inventory 2. If a restricted product is needed for clinical patient use, incorporate the item in a
                management purposes only.                quick order instead, thus removing the potential of mis-prescribing.

                Recommended; Priority A                 VHA Advisory, Drug File view from CPRS, 4/2004
                2004 Alerts & Advisories
5.8.15          Tubing separation of Edwards            1. Caregivers should always inspect disposable products for obvious defects
                Lifesciences VAMP Plus®                 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
                may result in blood leaks and           3. Be vigilant of any blood leaks or dampened blood pressure waveforms when
                potential for exsanguinations. The      using this transducer.
                complaint rate is presently about 1%
                and disconnects have not been           4. Contact your local representatives to exchange, free of charge, all defective,
                specific to one lot.                    Edwards Lifesciences transducer devices.
                Recommended; Priority A                 VHA Advisory, Tubing separation of Edwards Lifesciences VAMP Plus® monitoring kits, 7/2004
                2004 Alerts & Advisories
5.8.16          ALARIS (IMED) Gemini Infusion           1. DO NOT use medication pumps, or other medical devices that are in need of
                Pumps, 10/04                            repair.

                Pump provides automatic free flow       2. As a standard practice, operators of medical devices should inspect and
                protection via the medication           conduct operational checks, as specified in the manufacturers operations manual,
                administration set and the exterior     on all equipment and medical 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 and sent to biomedical
                may not properly activate the free      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 pumps available to adjust for
                occur if other methods of free flow     peak utilizations and/or maintenance cycles.
                protection are not employed.
                Recommended; Priority A                 VHA Advisory, ALARIS (IMED) Gemini Infusion Pumps, 10/2004




         Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                          114 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                    Not If score other than
                                                                                                                                                  Met   Partially   Met 'met' what are
                Question:                               Alert/Advisory Actions                                                                    (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 addressing EMI risks including
                from the use of two-way hand held       recommendations for areas where wireless communication devices are restricted.
                radios/walkie-talkies, 11/04            For two-way radios, 20 feet from medical equipment is a minimum recommended
                                                        distance (ECRI Health Devices 2003 Mar; 32(3):118-21).
                When operated in close proximity to
                medical devices. Oxygen             2. Refer to your EMI policy and modify to improve if necessary.
                concentrators in the nursing home
                unit alarmed and sometimes shut     3. Train radio users (generally Engineering, Safety and Police personnel) to
                down, requiring a reset when two-   maintain appropriate distances from medical equipment when using radios.
                way radios were keyed to transmit
                from approximately 10 feet away.
                Distance and transmitter
                management are the most
                controllable and effective.

                Recommended; Priority A                 VHA Advisory, EMI from use of two-way hand held radios, 11/2004
                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
                A fire in a VA hospital caused by the facility and complete replacement by March 15, 2005. If this cannot be
                improper use of smoking materials, accomplished the facility director must contact Mr. Ken Faulstich, Chief, Fire
                combined with the presence of             Protection Engineering (10NB) (202) 273-5869 to arrive at an acceptable solution.
                oxygen completed the fire triangle
                and resulted in the death of a            2. Clinical management staff will ensure that staff understand and enforce the
                patient, In the room of fire origin, the existing program to control smoking materials, especially when 100% oxygen is in
                fire sprinkler closest to the fire failed use.
                to operate. This was an O-ring type
                fire sprinkler manufactured by            3. Occupational Safety and Health or VA Fire Department personnel will review
                Central Sprinkler Company (Model          the fire plan to: A) There will be an adequate number of staff, including clinical
                GB). These O-ring sprinklers, along staff, immediately responding to the fire area regardless of the day of the week or
                with other models, were recalled by time of day, to assist in patient relocation to the next smoke zone should it
                the manufacturer in 2001 and were become necessary. The number of responders needed is (continued)...
                scheduled for replacement.

                Mandatory; Priority A                   VHA Alert, Fire Response and Planning, 1/2005




         Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                       115 of 351
                                                                      NCPS Patient Safety Assessment Tool

                                                                                           Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                      Not If score other than
                                                                                                                                                    Met   Partially   Met 'met' what are
               Question:                                   Alert/Advisory Actions                                                                   (1)   Met (2)     (3) possible root causes
               2005 Alerts & Advisories
5.9.1          (continued)... Fire Response and            ...(continued) dependent upon the number of patients in the impacted smoke zone
(continued)    Planning, 1/05                              and the acuity level of the patients. Based upon past fire events, the minimum
                                                           recommended staff response (not counting Fire Department Personnel) is: 1) For
               A fire in a VA hospital caused by the       patient care buildings with overnight stay that are not fully sprinkler protected: One
               improper use of smoking materials,          responder for every two non-ambulatory patients. If this response ratio cannot be
               combined with the presence of               met, consider installing sprinkler protection, modifying the number (mix) of non-
               oxygen completed the fire triangle          ambulatory to ambulatory patients in the smoke zone, reducing the size of the
               and resulted in the death of a              smoke zone(s) or a combination of these actions. 2) For fully sprinkler protected
               patient, In the room of fire origin, the    patient care buildings with overnight stay: One responder for every four non-
               fire sprinkler closest to the fire failed   ambulatory patients. If this response ratio cannot be met conduct a risk
               to operate. This was an O-ring type         assessment to determine if an appropriate level of safety is being provided. For
               fire sprinkler manufactured by              the purposes of this Alert non-ambulatory patients shall include individuals with
               Central Sprinkler Company (Model            cognitive or behavioral impairments that need assistance when relocating to an
               GB). These O-ring sprinklers, along         adjacent smoke zone. B) The fire plan clearly identifies the individual in the
               with other models, were recalled by         unit/area responsible for turning off the room or zone oxygen shut off control valve
               the manufacturer in 2001 and were           should it be necessary. This is especially important in surgery and ICU areas.
               scheduled for replacement.                  (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
               Mandatory; Priority A                       VHA Alert, Fire Response and Planning, 1/2005
               2005 Alerts & Advisories
5.9.1          (continued)...                              ...(continued)
(continued)                                                4. Occupational Safety and Health or Facilities Management/Engineering
                                                           personnel shall verify that personnel and equipment are available to limit damage
                                                           to the building immediately after fire department personnel declare the fire is
                                                           extinguished. This may be accomplished by evacuating smoke, shutting off
                                                           sprinkler control valves and containment of sprinkler and fire hose discharge
                                                           water. Water damage may be limited through the use of plugs specifically
                                                           designed to seal open fire sprinklers and absorbent ―pigs‖ to dike water on the
                                                           floor to keep it from spreading. Smoke spread may be limited by opening
                                                           windows, stopping the HVAC environmental air re-circulation and by using
                                                           dedicated portable exhaust fans.
               Mandatory; Priority A                       VHA Alert, Fire Response and Planning, 1/2005




        Recalls, Alerts Advis - 5                                                            Recalls, Alerts Advis - 5 - Version: 08.01.2006                                      116 of 351
                                                                     NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                  Not If score other than
                                                                                                                                                Met   Partially   Met 'met' what are
               Question:                                 Alert/Advisory Actions                                                                 (1)   Met (2)     (3) possible root causes
               2005 Alerts & Advisories
5.9.1          (continued)...                            ...(continued)
(continued)
                                                         5. Occupational Safety and Health or Police and Security Service personnel shall
                                                         develop a policy or SOP that addresses when the fire scene is to be secured after
                                                         the event and before clean up, to permit an investigation to be conducted by
                                                         qualified individuals. The purpose of this investigation is to determine fire cause
                                                         and assess the effectiveness of both active (e.g. suppression and detection) and
                                                         passive (e.g. smoke and fire barriers) fire protection systems.

                                                         6. Occupational Safety and Health or VA Fire Department personnel shall report
                                                         all fires in accordance with VHA Directive 2003-051, Fire Incident Reporting,
                                                         dated 09-16-03, using the on-line fire incident form. This form may be found at:
                                                         http://vaww.ceosh.med.va.gov/Forms/FireProtection/FireIncident.htm

               Mandatory; Priority A                     VHA Alert, Fire Response and Planning, 1/2005
               2005 Alerts & Advisories
5.9.2          Nellcor pulse oximeters,                  1. Immediately (within the next 48 hours) determine and identify all affected units.
               manufacturered after November 8,          Only units manufactured after November 8, 2001 (after S/N G01844386) are
               2001, 1/05                                affected.

               Model 595 and limited quantities of       2. Until the speaker assemblies are replaced, users should routinely test speaker
               models 395, 295, and 290. Affected        functions by: a. Listening for the tone emitted during the Power On Test. b.
               units were manufactured after             Activating audio pulse tones while monitoring patients to hear patient‘s pulse to
               November 8 2001. Nellcor notified         provide positive confirmation of speaker function; volume can be set low to
               known affected customers by letter        minimize disturbing patients.
               dates October 18 2004, Alarm
               speakers and other audio                  3. Ensure user and Biomedical Engineering inspections include alarm testing
               notifications are reported to fail at a   according to manufacturer recommendations.
               higher rate than expected which
               could result in serious patient injury.   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                     VHA Alert, Nellcor pulse oximeters manufactured after November 8, 2001, 1/2005




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                    117 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                              Not If score other than
                                                                                                                                            Met   Partially   Met 'met' what are
               Question:                             Alert/Advisory Actions                                                                 (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 by using all steps a - e: a) The
               manufactured between 4/01 and         manufacturer‘s letter available from the local Medtronic representative b) List
               12/03, see list., 2/05.               obtained from Medtronic available from Dr. Ed Keung, Director of VA National ICD
                                                     Surveillance Center (see attached letter from VA National ICD Surveillance
               Medtronic Implantable Cardioverter- Center) c) VA National ICD Surveillance Center Registry at
               Defibrillator (ICD) and Cardiac       https://icd.sanfrancisco.med.va.gov d) VA National registry for ICD implants
               Resynchronization Therapy             Washington VAMC e) Your patient records.
               Defibrillator (CRT-D), Models and
               batteries manufactured between        2. Replace entire device in first priority group patients (see item B of attached
               April 2001 and December 2003,         letter from VA National ICD Surveillance Center).
               Model 7230 Marquis VR, Model 7274
               Marquis DR, Model 7232 Maximo         3. Follow one of three options for those patients who are not on the first–priority
               VR,Model 7278 Maximo DR, Model group. (see attached letter from VA National ICD Surveillance Center).
               7277 InSync Marquis, Model7289
               InSync II Marquis, Model 7279
               InSync III Marquis,Model 7285 In
               Sync III Protect (not implanted in
               US), a potential battery shorting
               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                 VHA Alert, Medtronic Cardiac Defibrillators, 2/2005




        Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                  118 of 351
                                                                  NCPS Patient Safety Assessment Tool

                                                                                       Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                Not If score other than
                                                                                                                                              Met   Partially   Met 'met' what are
               Question:                               Alert/Advisory Actions                                                                 (1)   Met (2)     (3) possible root causes
               2005 Alerts & Advisories
5.9.4          Spacelabs Medical Monitor, model        1. Immediately identify and locate all monitors affected by this notice.
               90385 Universal Clinical Workstation
               (UCW), 2/05                             2. Inspect the monitors to see if they have been upgraded by: a. Looking for a
                                                       label on the bottom of the monitor that reads either ―Part No. 010-0681-00 Rev. N‖
               Affected units were manufactured        or ―FEB 0509‖ or b. Inspecting the bottom of the pedestal for a screw in the center
               between 1994 and 1997, units            (See photos in attached Spacelabs Medical notice for more detail) If neither a nor
               purchased after, or serviced by         b is present, the bases need upgrading.
               Spacelabs Medical after March 18
               1997 are not affected, The monitor      3. If units have not been upgraded contact Spacelabs Medical Monitoring
               base becomes fatigued and               Technical Support at (800) 522-7025 to arrange upgrades.
               separates from the monitor display.
               In that case, gravity is all that keeps 4. Until the bases are upgraded, notify users of affected monitors of this issue and
               the monitor together and movement the risks. Users should examine units for noticeable wear or cracked bases, and
               can cause the monitor to fall, risking if present, contact Biomedical Engineering. Biomedical Engineering can determine
               patient or caregiver injury.            whether the unit is safe for continued use.

               Mandatory; Priority A                  VHA Alert, Spacelabs Medical Monitor, 2/2005
               2005 Alerts & Advisories
5.9.5          Louvered heating, ventilating, and air 1. Survey all locked Behavioral Health Units to determine if louvered grilles are
               conditioning (HVAC) grilles in locked present that may be used as an anchor point.
               Behavioral Health Units, 2/05
                                                      2. If louvered grilles are present in these Behavioral Health Units upgrade them by
               Louvered grilles covering HVAC         installing a woven wire cloth grille or replace them with a suitable grille that
               openings located in locked mental cannot be used as an anchor point. Breakaway grilles should not be used as the
               health units may be used as an         broken parts may be used for other purposes.
               anchor point for a noose made from
               clothing or other flexible material.
               Mandatory; Priority A                  VHA Alert, Louvered HVAC grilles in locked Behavioral Health Units, 2/2005




        Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                    119 of 351
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                      Not If score other than
                                                                                                                                                    Met   Partially   Met 'met' what are
               Question:                                Alert/Advisory Actions                                                                      (1)   Met (2)     (3) possible root causes
               2005 Alerts & Advisories
5.9.6          LIFEPAK 12 Defibrillator/Monitors        1. Within 48 hours, identify all LIFEPAK 12 biphasic defibrillators deployed at your
               with Adaptive Biphasic technology,       facility.
               all units, man'f'd by Medtronic, 3/05
                                                        2. Check user settings to verify they are configured for what your facility protocol
               Units that have undergone a              requires: Step–by–step directions, Basic directions are included in the enclosed
               software upgrade or reinstallation       notice from Medtronic, Detailed directions are included 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 those required for your protocol,
               setting selected by the customer.        correct them per the directions.
               The setting may not be noticed until
               use, resulting in inappropriate energy   4. Record all defibrillator serial numbers and settings that have changed, plus
               delivery.                                your contact information and call Medtronic Technical Support at (877) 873-7630
                                                        to provide this information.

               Mandatory; Priority A                    VHA Alert, LIFEPAK 12 defibrillator/monitors w/adaptive biphasic technology, 3/2005
               2005 Alerts & Advisories
5.9.7          CPRS National Drug File V 4.0            1. Check with your IT/computer service (IRM) to determine if your facility is
               Adverse Reaction Tracking, 3/05          affected -- Data Updates PSN*4*95 and PSN*4*97 installed.

               Clinicians at facilities that recently   2. If your facility is affected, notify all clinical users (e.g. clinicians, pharmacists)
               installed National Drug File (NDF)       that the allergy tracking software is not functional and requires providers to assure
               Data Updates PSN*4*95 and                that new orders entered for patients are checked manually against the current
               PSN*4*97 may not be notified of          allergy history until this is resolved.
               drug allergies and will be unaware
               that the allergy check was not           3. Do not uninstall these Data Updates or it may adversely affect other programs
               completed.                               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                    VHA Alert, CPRS National Drug File V 4.0 Adverse Reaction Tracking, 3/2005




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                        120 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                 Not If score other than
                                                                                                                                               Met   Partially   Met 'met' what are
               Question:                            Alert/Advisory Actions                                                                     (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 beds on a case by case basis
               manufactured by Vail Products Inc,   only when there is a clinical determination that this is in the best interest of patient
               3/05                                 care. Vail enclosed beds, similar to all enclosed bed systems, may be considered
                                                    in the continuum of care for certain types of patients and disease states. In
               Models: 500, 1000, and 2000, FDA     certain instances, use of enclosed beds provides the most humane and least
               issued recommendations for users     restrictive care modality.
               based on cited safety problems.
                                                    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.doc 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. (continued)...

               Mandatory; Priority A                VHA Alert, Enclosed Bed systems manufactured by Vail Products Inc., 3/2005
               2005 Alerts & Advisories
5.9.8          (continued)... Enclosed Bed          ...(continued) The gaps must be less than 2 and 3/8 inch (60 mm) horizontal
(continued)    systems manufactured by Vail         distance at the widest spot. b) If using a Vail enclosed bed with side rails visually
               Products Inc, 3/05                   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
               Models: 500, 1000, and 2000, FDA     caregiver needs access to the patient. (Side rails should be up at all other times
               issued recommendations for users     as a patient can get their head between the mattress and the bottom vinyl cover
               based on cited safety problems.      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.

               Mandatory; Priority A                VHA Alert, Enclosed Bed systems manufactured by Vail Products Inc., 3/2005




        Recalls, Alerts Advis - 5                                                     Recalls, Alerts Advis - 5 - Version: 08.01.2006                                        121 of 351
                                                     NCPS Patient Safety Assessment Tool

                                                                          Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                    Not If score other than
                                                                                                                                  Met   Partially   Met 'met' what are
               Question:                  Alert/Advisory Actions                                                                  (1)   Met (2)     (3) possible root causes
               2005 Alerts & Advisories
5.9.8          (continued)...             ...(continued)
(continued)                               3. By close of business (COB) April 29 2005: "Ensure that your local written
                                          protocol or policy on enclosed beds incorporates: inspecting mattress gaps at
                                          regular and appropriate intervals (e.g., new patients, new mattresses, once a
                                          month), keeping the side rails and end bolsters of enclosed beds (such as Vail) in
                                          up position, regularly visually inspecting any enclosed bed systems for any
                                          degradation of materials, parts, or mechanisms and addressing as needed (e.g.,
                                          new patients, once a month), ensuring that beds will not be left in up position
                                          when patient is unattended, inspecting enclosed beds for any mechanical or
                                          material defects before accepting for purchase or lease, and ensuring that the
                                          appropriate mattress accompanies the bed before put in service.
               Mandatory; Priority A      VHA Alert, Enclosed Bed systems manufactured by Vail Products Inc., 3/2005
               2005 Alerts & Advisories
5.9.8          (continued)...             ...(continued) d) Ensure that Vail enclosed beds with a high-low adjustable
(continued)                               mechanism such as the Vail 1000 are not left in the up position when the patient is
                                          unattended. Additional hazards are created by the bed left in this position.e)
                                          Ensure that you are using only the mattress recommended by Vail and the gap
                                          complies with the criteria from action (a) above. f) If using other enclosed beds,
                                          follow actions a) through e) as applicable.
                                          3. By close of business (COB) April 29 2005: "Ensure that your local written
                                          protocol or policy on enclosed beds incorporates: inspecting mattress gaps at
                                          regular and appropriate intervals (e.g., new patients, new mattresses, once a
                                          month), keeping the side rails and end bolsters of enclosed beds (such as Vail) in
                                          up position, regularly visually inspecting any enclosed bed systems for any
                                          degradation of materials, parts, or mechanisms and addressing as needed (e.g.,
                                          new patients, once a month), ensuring that beds will not be left in up position
                                          when patient is unattended, inspecting enclosed beds for any mechanical or
               Mandatory; Priority A      material defects before manufactured by Vail Products Inc., lease,
                                          VHA Alert, Enclosed Bed systemsaccepting for purchase or 3/2005 and ensuring that the




        Recalls, Alerts Advis - 5                                           Recalls, Alerts Advis - 5 - Version: 08.01.2006                                     122 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                   Not If score other than
                                                                                                                                                 Met   Partially   Met 'met' what are
                Question:                              Alert/Advisory Actions                                                                    (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 the ―Show MUSE EKGs‖ option
                since 10/1/03 patch MAG*3.0*24,        under Options > View Preferences is enabled (the box is checked), and that they
                4/05                                   should not disable it.

                In certain situations, the VistA     2. Advice clinicians to check the patient‘s name on an EKG viewed via the VistA
                Imaging Display EKG viewer window Imaging Display application to be sure that the name and EKG correspond to the
                will not update properly when a      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                  VHA Alert, VistA Imaging v3.0, versions released since 10/1/03 patch MAG*3.0*24, 4/2005
                2005 Alerts & Advisories
5.9.10          CM 100-Heartstart Adapter Cable        1. Immediately (within the next 24 hours) remove CM 100-Heartstart Adapter
                man'f'd by Laerdal Medical Corp,       Cable from service and inventory.
                5/05
                                                      2. Assure replacement cable from another source is available for each defirillator
                This product is designed for use with where the 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                  VHA Alert, CM 100-heartstart adaptor cable by Laerdal Medical Corp, 5/2005




         Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                      123 of 351
                                                                     NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                              Not If score other than
                                                                                                                                                                            Met   Partially   Met 'met' what are
                Question:                                 Alert/Advisory Actions                                                                                            (1)   Met (2)     (3) possible root causes
                2005 Alerts & Advisories
5.9.11          Blood glucose meters, models              1. Diabetes educators, outpatient pharmacists, and other cliniciansinvolved in
                OneTouch, Ultra, InDuo, and               diabetes management must be notified about the design vulnerabilities of
                OneTouch FastTake man'f'd by              LifeScan devices.
                LifeScan, Inc., 5/05
                                                          2. Clinicians with diabetes patients using LifeScan must: a) No later than the next
                LifeScan has received reports of          visit, confirm with all diabetes patients that their glucose meter is properly set up
                adverse events related to the device      with mg/dL, NOT mmol/L. b) Understand the importance of training the patient on
                inadvertently set to the incorrect unit   the complex device set-up and calibration.
                of measure: milligram per deciliter
                (mg/dL) and milli-mole per liter          3. Acceptable alternative blood glucose meters are available that do not exhibit
                (mmol/L). In the United States, it is     this vulnerability and facilities should consider providing those devices instead.
                mg/dL. However the units of
                measure can be unintentionally
                changed during the task of setting
                the date and time.
                Mandatory; Priority A                     VHA Alert, Blood glucose meters, models OneTouch, Ultra, InDuo, and OneTouch FastTake by LifeScan, Inc., 5/2005

                2005 Alerts & Advisories
5.9.12          Guidant Model 1861 Ventak Prizm 2 1. Within two weeks, electrophysiology/cardiology staff or other appropriate
                DR, ICDs manufactured before            parties must identify all affected patients by implementing each of the following
                November 2002, 6/05                     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
                An unpredictable breach of an           on another. a) Review the manufacturer's letter. b) Review the patient list posted
                insulator in the device. This insulator on the VA National ICD Surveillance Center intranet website
                defect could result in at least partial (https://icd.sanfrancisco.med.va.gov). This list, provided by Guidant, consists of all
                diversion of current in the high-       the VA patients in the company‘s database that have an implanted model 1861
                voltage output circuitry, thereby       ICD which had been manufactured prior to November 13, 2002 and VA patients
                preventing the device from delivering having this implant that are being followed at a VA facility. c) Review the VA
                high-voltage shock therapy when         National registry for ICD implants Washington VAMC, point of contact is
                ventricular tachycardia or fibrillation Ronald.Jones1@va.gov. d) Review your patient records for all patients with
                is detected.                            implanted Guidant (continued)...

                Mandatory; Priority A                     VHA Alert, Guidant Corp. Model 1861 Ventak Prizm 2 DR, ICDs, 6/2005




         Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                               124 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                Not If score other than
                                                                                                                                              Met   Partially   Met 'met' what are
                Question:                               Alert/Advisory Actions                                                                (1)   Met (2)     (3) possible root causes
                2005 Alerts & Advisories
5.9.12          (continued)... Guidant Model 1861       ...(continued) model 1861Ventak Prizm 2 DR, ICD devices.
(continued)     Ventak Prizm 2 DR, ICDs
                manufactured before November            2. Within the next 45 calendar days, interrogate all Guidant Model 1861 ICDs for
                2002, 6/05                              ―no telemetry‖ or ―warning screen‖ conditions. These conditions indicate that the
                                                        ICD may be inoperative. If one of these conditions is present, replace with a
                An unpredictable breach of an           suitable new device. a) If the interrogation of the Guidant model 1861 ICD does
                insulator in the device. This insulator not reveal a problem, the patient should be followed at the manufacturer‘s
                defect could result in at least partial recommended intervals of every 3 months. However patients should be instructed
                diversion of current in the high-       to return immediately for device interrogation following any shock delivery, and
                voltage output circuitry, thereby       ICD replacement should be considered at that time.
                preventing the device from delivering
                high-voltage shock therapy when         3. Follow the actions contained in Attachment 2. This guidance was prepared by
                ventricular tachycardia or fibrillation Dr. Edmund Keung of the VA National ICD Surveillance Center as the best course
                is detected.                            of action for your patients.

                Mandatory; Priority A                   VHA Alert, Guidant Corp. Model 1861 Ventak Prizm 2 DR, ICDs, 6/2005
                2005 Alerts & Advisories
5.9.13          Smiths Medical, Fast Flow Fluid  1. Promptly (within one week) check local inventory to identify all units affected by
                Warmer Models 250, 500 and 1000, this Alert and institute recommended practices to minimize risk (attached) for all
                6/05                             users of Smiths Medical Fast Flow Fluid Warmers, models 250, 500 and 1000.

                Hospitals in Australia report serious   2. Procure and install the Smiths Medical accessory Air Detector/Clamp, model H-
                patient injury from intravascular air   31 that is designed to reduce the risk of air embolism introduction while using the
                embolisms introduced while using        Smiths Medical Fast Flow Fluid Warmers, models 250, 500 and 1000.
                the Smiths Medical fluid warmers
                identified in this Alert.

                Mandatory; Priority A                   VHA Alert, Smiths Medical, Fast Flow Fluid Warmer Models 250, 500 and 1000, 6/2005




         Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                   125 of 351
                                                                      NCPS Patient Safety Assessment Tool

                                                                                           Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                           Not If score other than
                                                                                                                                                         Met   Partially   Met 'met' what are
                Question:                                 Alert/Advisory Actions                                                                         (1)   Met (2)     (3) possible root causes
                2005 Alerts & Advisories
5.9.14          Guidant Corporation recalls               1.Within two weeks, electrophysiology/cardiology staff or other appropriate
                additional models (update to PS           caregivers must identify all affected patients by implementing each of the following
                Alert AL05-013 dated 6/8/05), 7/05        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
                Additional models of Implantable          on another.
                Cardioverter-Defibrillators (ICD), and
                has added Cardiac                         a) Review the manufacturers letters (See Links below).
                Resynchronization Therapy
                Defibrillators (CRT-D) to the recall      b) Review the patient list posted on the VA National ICD Surveillance Center
                list. These devices can develop an        intranet website (https://icd.sanfrancisco.med.va.gov). This list, provided by
                internal short circuit without warning,   Guidant, consists of all VA patients in the company‘s database that have an
                resulting in failure to deliver a shock   implanted Guidant device affected by this recall. Double check by providing name
                when needed. In addition, Guidant         of your facility and implant physician‘s name. (See attachment 2)
                sent letters to physicians notifying
                them that identified models of Atrial     c) Review the VA National registry for ICDs and CRT-R implants, Washington
                Therapy devices (AVT) and CRT-D           VAMC, point of contact is Ronald.Jones1@va.gov.
                devices will require reprogramming.
                                                          d) Review your patient records for all patients with (continued)...
                ICDs (FDA Class I Recall) Guidant
                Ventak Prizm 2 DR, Model 1861,
                Implantable Cardioverter-
                Defibrillators (ICDs) manufactured
                before April 16, 2002,CRT-Ds (FDA
                Class I Recall) Guidant Contak
                Renewal, Model H135, Cardiac
                Resynchronization Therapy
                Defibrillators (CRT-D) manufactured
                on or before August 26,
                2004,Guidant Contak Renewal 2,
                Model H155, Cardiac
                Resynchronization Therapy
                Defibrillators (CRT-D) manufactured
                on or before A
                Mandatory; PriorityAugust 26, 2004,AVTs   VHA Alert, Guidant Corporation recalls additional models (update to PS Alert AL05-13) 7/2005




         Recalls, Alerts Advis - 5                                                           Recalls, Alerts Advis - 5 - Version: 08.01.2006                                           126 of 351
                                                                     NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                          Not If score other than
                                                                                                                                                        Met   Partially   Met 'met' what are
               Question:                                 Alert/Advisory Actions                                                                         (1)   Met (2)     (3) possible root causes
               2005 Alerts & Advisories
5.9.14         (continued)... Guidant Corporation        ...(continued) implanted Guidant devices affected by this recall.
(continued)    recalls additional models (update to
               PS Alert AL05-013 dated 6/8/05),          2.Within the next 45 calendar days, interrogate all affected ICDs and CRT-Ds
               7/05                                      devices for:

               Additional models of Implantable          a) Loss of telemetry/programming/interrogation.
               Cardioverter-Defibrillators (ICD), and
               has added Cardiac                         b) Loss of tachyarrhythmia detection and therapy delivery
               Resynchronization Therapy
               Defibrillators (CRT-D) to the recall      c) Loss of pacing therapy.
               list. These devices can develop an
               internal short circuit without warning,   d) Programmer display of a red warning screen upon attempted device
               resulting in failure to deliver a shock   interrogation.
               when needed. In addition, Guidant
               sent letters to physicians notifying      e) Programmer display of yellow warning screen indicating out of range shocking
               them that identified models of Atrial     impedance.
               Therapy devices (AVT) and CRT-D
               devices will require reprogramming.       f) Corrective reprogramming in the appropriate models.

                                                         Conditions a) to e) indicate that the affected device may be inoperative. If one or
                                                         more of these conditions is present, replace with a suitable new device.

                                                         3. If If the interrogation of the affected device does not reveal a problem, the
                                                         patient should be followed at the manufacturer‘s recommended intervals of every
                                                         3 months. However, patients should be instructed to return immediately for device
                                                         interrogation following any shock delivery, and affected device replacement
                                                         should be considered at that time.
               Mandatory; Priority A                     VHA Alert, Guidant Corporation recalls additional models (update to PS Alert AL05-13) 7/2005




        Recalls, Alerts Advis - 5                                                           Recalls, Alerts Advis - 5 - Version: 08.01.2006                                           127 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                        Not If score other than
                                                                                                                                                      Met   Partially   Met 'met' what are
               Question:                               Alert/Advisory Actions                                                                         (1)   Met (2)     (3) possible root causes
               2005 Alerts & Advisories
5.9.14         (continued)...                          ...(continued) implanted Guidant devices affected by this recall.
(continued)    ICDs (FDA Class I Recall) Guidant
               Ventak Prizm 2 DR, Model 1861,          2.Within the next 45 calendar days, interrogate all affected ICDs and CRT-Ds
               Implantable Cardioverter-               devices for:
               Defibrillators (ICDs) manufactured
               before April 16, 2002,CRT-Ds (FDA       a) Loss of telemetry/programming/interrogation.
               Class I Recall) Guidant Contak
               Renewal, Model H135, Cardiac            b) Loss of tachyarrhythmia detection and therapy delivery
               Resynchronization Therapy
               Defibrillators (CRT-D) manufactured     c) Loss of pacing therapy.
               on or before August 26,
               2004,Guidant Contak Renewal 2,          d) Programmer display of a red warning screen upon attempted device
               Model H155, Cardiac                     interrogation.
               Resynchronization Therapy
               Defibrillators (CRT-D) manufactured     e) Programmer display of yellow warning screen indicating out of range shocking
               on or before August 26, 2004,AVTs       impedance.
               (FDA Class II Recall) Guidant
               Ventak Prizm, Model 1900, Atrial
               Therapy device (AVT) all serial
               numbers,Guidant Vitality Model
               A135, Atrial Therapy device (AVT) all
               serial numbers,Guidant Vitality
               Model A155...
               Mandatory; Priority A                   VHA Alert, Guidant Corporation recalls additional models (update to PS Alert AL05-13) 7/2005




        Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                           128 of 351
                                                                    NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                         Not If score other than
                                                                                                                                                       Met   Partially   Met 'met' what are
               Question:                                Alert/Advisory Actions                                                                         (1)   Met (2)     (3) possible root causes
               2005 Alerts & Advisories
5.9.14         (continued)...                           ...(continued)
(continued)    Guidant Contak Renewal 3, Model          f) Corrective reprogramming in the appropriate models.
               M155, Atrial Therapy device (AVT)
               all serial numbers,Guidant Contak        Conditions a) to e) indicate that the affected device may be inoperative. If one or
               Renewal 3, HE, Model M157, Atrial        more of these conditions is present, replace with a suitable new device.
               Therapy device (AVT) all serial
               numbers,Guidant Contak Renewal 3,        3. If If the interrogation of the affected device does not reveal a problem, the
               HE, Model M159, Atrial Therapy           patient should be followed at the manufacturer‘s recommended intervals of every
               device (AVT) all serial                  3 months. However, patients should be instructed to return immediately for device
               numbers,Guidant Contak Renewal 4,        interrogation following any shock delivery, and affected device replacement
               Model M170, Atrial Therapy device        should be considered at that time.
               (AVT) all serial numbers,Guidant
               Contak Renewal 4, Model M175,            4. Follow the actions contained in Attachment 1. This guidance was prepared by
               Atrial Therapy device (AVT) all serial   Dr. Edmund Keung Director of the VA National ICD Surveillance Center as the
               numbers,Guidant Contak Renewal 4,        best course of action for your patients.
               HE, Model M177, Atrial Therapy
               device (AVT) all serial
               numbers,Guidant Contak Renewal 4,
               HE, Model M179, Atrial Therapy
               device (AVT) all serial numbers.

               Mandatory; Priority A                    VHA Alert, Guidant Corporation recalls additional models (update to PS Alert AL05-13) 7/2005




        Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                           129 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                                        Not If score other than
                                                                                                                                                                      Met   Partially   Met 'met' what are
                Question:                              Alert/Advisory Actions                                                                                         (1)   Met (2)     (3) possible root causes
                2005 Alerts & Advisories
5.9.15          Depression Screening for Veteran       1. All clinical and administrative services that may be involved with treating
                Patients Recently Separated from       recently separated veterans should review the current policy, or standard
                Active Military Duty, 1/05             operating procedure (SOP) addressing depression or suicide prevention
                                                       screening for Veterans recently separated from active military duty. (If this policy
                Depression screening for recently      or SOP does not exist it should be developed.)
                separated Veterans may increase
                early identification of possible       2. Refer to the websites, information letter and video identified in this advisory,
                psychiatric problems and/or            then provide pertinent information to any and all interested inpatient and
                suicidality.                           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                VHA Advisory, Depression screening for veteran patients recently separated from active military duty, 1/2005
                2005 Alerts & Advisories
5.9.16          CPRS - Transferring Outpatient         Notify all users, when transferring medications from Outpatient to Inpatient, using
                Medication Orders to Inpatient         the Medication Screen in CPRS; they need to scroll down, whenever text appears
                Medication Orders, 6/05                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                VHA Advisory, CPRS - Transferring outpatient medication orders to inpatient medication orders, 6/2005




         Recalls, Alerts Advis - 5                                                         Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                          130 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                   Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                          Not If score other than
                                                                                                                                        Met   Partially   Met 'met' what are
                Question:                         Alert/Advisory Actions                                                                (1)   Met (2)     (3) possible root causes
                2005 Alerts & Advisories
5.9.17          Olympus 180 series endoscopes and Olympus model CFQ180AL scopes were being reprocessed in a Steris System 1
                Steris Quick Connects, 10/05.     when it was 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               VHA Alert, Olympus 180 series endoscopes & Steris Quick Connects, 10/2005
                2005 Alerts & Advisories
5.9.18          MEDRAD Stellant CT Injector         Heat maintainers for Stellant CT Injector Systems, manufactured by MEDRAD,
                Systems, 11/05.                     Inc. Part numbers for the heat maintainers are 3007871, 3007872, 3009707 and
                                                    3009708. (Note: Part numbers for the Stellant injector systems are 3007301,
                The manufacturer reports the heat   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               VHA Alert, MEDRAD Stellant CT Injector Systems, 11/2005




         Recalls, Alerts Advis - 5                                                    Recalls, Alerts Advis - 5 - Version: 08.01.2006                                 131 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                Not If score other than
                                                                                                                                              Met   Partially   Met 'met' what are
                Question:                              Alert/Advisory Actions                                                                 (1)   Met (2)     (3) possible root causes
                2005 Alerts & Advisories
5.9.19          Injector connector relays on patient    The manufacturer reports failures of Injector connector relays for the table models
                tables, 12/05                           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 and
                Tables manufactured by Philips          employees at risk. Philips will be upgrading affected systemsas parts are
                Medical, table models AD5 and AD6 available, to be completed by mid-2006. Philips Medical hasidentified 42 VA
                used with the Integris, Integris Allura medical facilities affected by this Alert.
                and Allura

                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                  VHA Alert, Injector Conntor Relays on Patient Tables, 12/2005




         Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                   132 of 351
                                                                      NCPS Patient Safety Assessment Tool

                                                                                            Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                     Not If score other than
                                                                                                                                                   Met   Partially   Met 'met' what are
                Question:                                 Alert/Advisory Actions                                                                   (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 individuals must review the
                Interchange, 8/05                         laboratory test setups to identify those tests using "set of codes."



                VistA Laboratory Package, patch           2. By close of business (COB) Tuesday, August 30, 2005: If any lab test used
                LR*5.2*286                                "set of codes" and the site recognizes that they now need to modify the set up,
                                                          they should make the modifications or seek assistance by logging a Remedy
                                                          ticket with National Help Desk.

                A VHA facility recently reported that
                critical flags were not being set for
                positive tests of hemocult. As a          3. By COB Friday, September 9, 2005: Once modifications/corrections have been
                result, over 200 positive tests for       made, the site needs to review the historical data from the time the patch was
                hemocult did not trigger a flag to        installed (January 2005, or eariler if you were a test site) to present date to
                alert providers. Although the site        determine potential critical flag omissions. If there were critical flag omissions in
                has made the proper modifications         the historical data, the site needs to review the comment field to see if the critical
                and taken necessary actions, this         value was recognized and called to the attention of the provider as required by the
                Patient Safety Alert is issued to alert   College of American Pathologists and VHA (continued)...
                other sites that may be affected.

                Mandatory; Priority A                     VHA Patient Safety Alert, LEDI III Lab Electronic Data Interchange, 8/2005




         Recalls, Alerts Advis - 5                                                            Recalls, Alerts Advis - 5 - Version: 08.01.2006                                    133 of 351
                                                                      NCPS Patient Safety Assessment Tool

                                                                                            Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                   Not If score other than
                                                                                                                                                 Met   Partially   Met 'met' what are
                Question:                              Alert/Advisory Actions                                                                    (1)   Met (2)     (3) possible root causes
                2005 Alerts & Advisories
5.9.20          (continued)... LEDI III Lab Electronic ...(continued) Directive 2003-043.
(continued)     Data Interchange, 8/05
                                                       4. If critical flag omissions were identified and it was determined that the provider
                VistA Laboratory Package, patch        was not notified, report the situation to the provider immediately. If the provider is
                LR*5.2*286                             no longer with the facility, then notification should be given to the Chief of Service.

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

                Mandatory; Priority A                     VHA Patient Safety Alert, LEDI III Lab Electronic Data Interchange, 8/2005
                2005 Alerts & Advisories
5.9.21          Sulfa Allergy Order Checks, 12/05         By close of business (COB) 12/28/05, the Pharmacy ADPAC (or designee) must
                                                          edit the Message filed in the Drug file (50) to display the following message for
                VistA allergy file (120.8) - Certain      each of the drugs shown in Attachment #1:
                drug classes are not currently
                generating order checks for patients MESSAGE: "SULFA cross drug classes may NOT trigger an ORDER CHECK"
                with a documented allergy.           (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                     VHA Alert, Sulfa Allergy Order Checks, 12/2005




         Recalls, Alerts Advis - 5                                                            Recalls, Alerts Advis - 5 - Version: 08.01.2006                                  134 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                              Not If score other than
                                                                                                                                            Met   Partially   Met 'met' what are
                Question:                             Alert/Advisory Actions                                                                (1)   Met (2)     (3) possible root causes
                2005 Alerts & Advisories
5.9.22          Hospira LifeCare PCA3 Infustion       1. Notify clinicians of this programming vulnerability and include this information
                Pumps List No: 12384-04, 11/05        in all training sessions (e.g., in-service, orientation) conducted on this PCA
                                                      infusion pump.
                Hospira Inc. has identified two
                potential scenarios that may lead to
                incorrect medication flow rates being
                entered into this model of PCA pump 2. Also, clinicians must use the clear key "CLR" prior to changing a value, and
                that could result in an adverse       use the confirmation screen to assure that values that have been entered in fact
                medication event. To date, there      have been accepted 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. ...

                Recommended; Priority A               VHA Advisory, Hospira LifeCare PCA3 Infustion Pumps List No: 12384-04, 11/2005




         Recalls, Alerts Advis - 5                                                      Recalls, Alerts Advis - 5 - Version: 08.01.2006                                   135 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                            Not If score other than
                                                                                                                                          Met   Partially   Met 'met' what are
            Question:                               Alert/Advisory Actions                                                                (1)   Met (2)     (3) possible root causes
            2005 Alerts & Advisories
5.9.22      (Continued...) NOTE: Taking these       1. Notify clinicians of this programming vulnerability and include this information
(Continued) steps will not overwrite the original   in all training sessions (e.g., in-service, orientation) conducted on this PCA
            value of dose, dose limit, rate or      infusion pump.
            concentration, but rather, will
            increase the original value by adding
            additional digits. For example, if a
            "1" was originally entered and then a   2. Also, clinicians must use the clear key "CLR" prior to changing a value, and
            "5" was entered after reentering the    use the confirmation screen to assure that values that have been entered in fact
            programming screen, the value           have been accepted by the device.
            displayed could be "15" instead of
            "5".
            Scenario 2: While in "Service"
            mode, an inccorect dose or rate
            value may appear on the display
            when creating a stored protocol.
            This error may affect the first
            protocol created, but will not affect
            subsequent protocols.
              Recommended; Priority A               VHA Advisory, Hospira LifeCare PCA3 Infustion Pumps List No: 12384-04, 11/2005




       Recalls, Alerts Advis - 5                                                      Recalls, Alerts Advis - 5 - Version: 08.01.2006                                   136 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                              Not If score other than
                                                                                                                                            Met   Partially   Met 'met' what are
                Question:                             Alert/Advisory Actions                                                                (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 select the ingredient file from CPRS
                                                      GUI allergy entry process or directly through VistA CHUI interface, unless there is
                VistA package allergy file (120.8)    a specific reason to use an ingredient level entry. A cognitive aid could help
                may have allergy entries that have    clinical staff to remember this when entering allergens.
                been accidentally entered without a
                VA drug class - when a drug class
                entry was appropriate.
                                                        2. Medication administration records and patient charts can be used to review
                A patient had a drug allergy entered allergy information until this issue is resolved (see Addl. Information below).
                into VistA in 1997 prior to
                implementing CPRS. The allergen
                cephradine was selected as being an
                ingredient of a product, versus a       3. In the interim, any specific concerns should be addressed to the OI National
                drug, and therefore no VA drug class Help Desk, who will set up a remedy ticket to assist you with any issue.
                was assigned to that entry. Years
                later, a provider ordered cefazolin - a
                drug in the same drug class as
                cephradine, but not the exact
                ingredient as cephradine. No allergy
                warning occurred because ingredient
                level warnings only occur if there is
                an exact item match. The patient
                received the cefazolin.


                Recommended; Priority A               VHA Advisory,VA Drug Class Allergy Entry, 11/2005




         Recalls, Alerts Advis - 5                                                      Recalls, Alerts Advis - 5 - Version: 08.01.2006                                   137 of 351
                                                                  NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                               Not If score other than
                                                                                                                                             Met   Partially   Met 'met' what are
                Question:                             Alert/Advisory Actions                                                                 (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, November 28, 2005:
                Cardioverter Defibrillators, 11/05     electrophysiology/cardiology staff or other appropriate parties must identify all
                                                       affected patients by implementing each of the following steps a through c. It is
                Temporary loss of pacing function      important that ALL INFORMATION sources be reviewed to insure that patients will
                and permanent loss of tachycardia      not be overlooked, as affected patients may be found on one list and not on
                detection may occur in selected        another. Your local SJM representative may have a list of patients with you or
                Photon DR (Model V-230HV) and all your colleagues as the follow-up physician.
                Photon Micro VR/DR (Model V-194/V-
                232) and Atlas VR/DR (Models V-        A. Review the manufacturer's letter (See Links below).
                199/V-240) units. St. Jude Medical
                (SJM) reported 60 failures out of      B. Review the patient list posted on the VA ICD Surveillance Center intranet
                36,000 devices (0.167%) with no        website (https://ICD.sanfrancisco.med.va.gov). It consists of a list of VA patients
                serious patient injuries or death. The provided by SJM. The SJM list is made up of all the VA patients in the company's
                cause of this failure mode has been databse that have an SJM device implanted at a VA facility and are affected by
                identified as cosmic radiation         this recall. (See Attachment 2)
                damage to a vendor-supplied static
                random access memory (SRAM)            C. Review your patient (continued)...
                chip in these ICDs.

                Mandatory; Priority A                 VHA Alert, St. Jude Medical Implantable Cardioverter Defibrillators, 11/2005




         Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                  138 of 351
                                                                NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                            Not If score other than
                                                                                                                                          Met   Partially   Met 'met' what are
               Question:                            Alert/Advisory Actions                                                                (1)   Met (2)     (3) possible root causes
               2005 Alerts & Advisories
5.9.24         (continued)... St. Jude Medical      ...(continued) records for all patients with implanted SJM devices affected by this
(continued)    Implantable Cardioverter             recall.
               Defibrillators, 11/05

               Temporary loss of pacing function
               and permanent loss of tachycardia      2. By COB Wednesday, December 15, 2005: interrogate all affected devices for:
               detection may occur in selected        Hardware Reset Mode. If the device is in the Hardware Reset Mode, acing at VVI
               Photon DR (Model V-230HV) and all at 60 ppm and no tachycardia detection and theraphy, replace the device with a
               Photon Micro VR/DR (Model V-194/V- suitable new device immediately.
               232) and Atlas VR/DR (Models V-
               199/V-240) units. St. Jude Medical
               (SJM) reported 60 failures out of
               36,000 devices (0.167%) with no        3. Follow the actions contained in Attachment 1. This guidance was prepared by
               serious patient injuries or death. The Dr. Edmund Keung, Director of the VA ICD Surveillance Center, and details the
               cause of this failure mode has been best course of action for your patients.
               identified as cosmic radiation
               damage to a vendor-supplied static
               random access memory (SRAM)
               chip in these ICDs.

               Mandatory; Priority A                VHA Alert, St. Jude Medical Implantable Cardioverter Defibrillators, 11/2005




        Recalls, Alerts Advis - 5                                                       Recalls, Alerts Advis - 5 - Version: 08.01.2006                                 139 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                             Not If score other than
                                                                                                                                                           Met   Partially   Met 'met' what are
                Question:                             Alert/Advisory Actions                                                                               (1)   Met (2)     (3) possible root causes
                2005 Alerts & Advisories
5.9.25          Insignia and Nexus Implantable        1. By close of business (COB) Monday, November 7, 2005:
                Cardiac Pacemakers manufactured       electrophysiology/cardiology staff or other appropriate parties must identify all
                by Guidant Corp, 10/05                affected patients by implementing each of the following steps a through d. It is
                                                      important that ALL INFORMATION sources be reviewed to insure that patients will
                Guidant Corporation is voluntarily    not be overlooked, as affected patients may be found on one list and not on
                advising physicians, by letter about  another.
                two separate failure modes within
                the INSIGNIA and NEXUS families of A. Review the manufactuer's letters (See Links below).
                cardiac pacemakers. One or more
                of the following malfunctions may    B. Review the patient list posted on the VA Western Pacemaker Surveillance
                occur:                               Center intranet website (https://pacemaker.sanfrancisco.med.va.gov). This list
                                                     combines the patients with the affected devices that are already being followed
                 - Intermittent or permanent loss of via TTM by the VA Western Pacemaker Surveillance Center with a list of VA
                pacing output without warning;       patients provided by Guidant. The Guidant list consists of all the VA patients in
                                                     the company's database that have a Guidant device implanted at the VA facility
                 - Intermittent or permanent loss of and is affected by this recall. (continued)...
                telemetry;

                - Reversion of VVI mode or
                appearance of a reset warning
                message upon interrogation

                Mandatory; Priority A                 VHA Alert, Insignia and Nexus Implantable Cardiac Pacemakers manufactured by Guidant Corp, 10/2005




         Recalls, Alerts Advis - 5                                                      Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                  140 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                             Not If score other than
                                                                                                                                                           Met   Partially   Met 'met' what are
            Question:                                 Alert/Advisory Actions                                                                               (1)   Met (2)     (3) possible root causes
            2005 Alerts & Advisories
5.9.25      (continued)...                            1. By close of business (COB) Monday, November 7, 2005:
(Continued) First Failure Mode: May occur in          electrophysiology/cardiology staff or other appropriate parties must identify all
            selected Insignia and Nexus               affected patients by implementing each of the following steps a through d. It is
            implanted units. Guidant reported 36      important that ALL INFORMATION sources be reviewed to insure that patients will
            failures out of 49,500 devices            not be overlooked, as affected patients may be found on one list and not on
            (0.073%). Seven (7) of these              another.
            devices were found to exhibit no
            output during the implant                 A. Review the manufactuer's letters (See Links below).
            procedures. For the remaining 29,
            the majority of failures occurred early   B. Review the patient list posted on the VA Western Pacemaker Surveillance
            in life (mean implant time of 7           Center intranet website (https://pacemaker.sanfrancisco.med.va.gov). This list
            months). This failure mode exhibits       combines the patients with the affected devices that are already being followed
            a decreasing rate with implant time,      via TTM by the VA Western Pacemaker Surveillance Center with a list of VA
            with no failures reported beyond 22       patients provided by Guidant. The Guidant list consists of all the VA patients in
            months of implantation. Guidant           the company's database that have a Guidant device implanted at the VA facility
            predicts the failure rate to be           and is affected by this recall. (continued)...
            between 0.017% to 0.037% over the
            remaining device lifetime among the
            lifetime among the active device
            population of 41,000 (24,000 in the
            US). Three (3) instances of syncope
            and six (6) instances of bradycardia
            or heart block - with no death
            associated - have been reported.
            The cause of this failure mode has
            been identified as foreign material
            within a crystal timing component.

              Mandatory; Priority A                   VHA Alert, Insignia and Nexus Implantable Cardiac Pacemakers manufactured by Guidant Corp, 10/2005




       Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                  141 of 351
                                                                 NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                             Not If score other than
                                                                                                                                                           Met   Partially   Met 'met' what are
               Question:                              Alert/Advisory Actions                                                                               (1)   Met (2)     (3) possible root causes
               2005 Alerts & Advisories
5.9.25         (continued)...                         ...(continued) (See Attachment 2)
(continued)    Second Failure Mode: May occur in
               all Insignia and Nexus units.          C. Review the VA National registry for pacemaker implants and the VA Eastern
               Guidant reported 16 failures out of    Pacemaker Surveillance Center, Washington DC VAMC, point of contact is
               341,000 devices (0.0047%). A no        Ronald.Jones1@va.gov.
               output condition was discovered at
               the implant procedure or pre-implant   D. Review your patient records for all patients with implanted Guidant devices
               testing. Guidant reported 1            affected by this recall.
               occurrence of syncope and
               resuscitated cardiac arrest as a       2. For first Failure Mode only: By COB Friday, November 25, 2005: interrogate all
               result of no pacing output from the    affected devices for:
               replacement pacemaker during an
               elective puluse generator              A. Intermittent or permanent loss of pacing output without warning;
               replacement procedure. The cause
               of the second failure mode has not     B. Intermittent or permanent loss of telemetry;
               yet been established. There are
               approximately 145,000 active           C. Reversion to VVI mode or appearance of a reset warning message upon
               devices in the U.S.                    interrogation with a programmer.

                                                      If one or more of these conditions are present, replace the device with a suitable
                                                      new device immediately.

                                                      3. Follow the actinos contained in Attachment 1. 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                  VHA Alert, Insignia and Nexus Implantable Cardiac Pacemakers manufactured by Guidant Corp, 10/2005




        Recalls, Alerts Advis - 5                                                       Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                  142 of 351
                                                                      NCPS Patient Safety Assessment Tool

                                                                                           Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                              Not If score other than
                                                                                                                                                            Met   Partially   Met 'met' what are
                Question:                                 Alert/Advisory Actions                                                                            (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 14, 2005, the Laboratory ADPAC
                Does Not Execute Delta Checks,            or other qualified individual must place the Batch Data Entry [LRSTUF] option
                10/05                                     OUT OF ORDER until VistA patch LR*5.2*347 is released and installed.
                                                          Acceptable alternate methods for data entry are EL Enter/verify data (Load list)
                Positive Hepatitis C (HCV) reports        [LRVRW2] or EM Enter/verify/modify data (manual) [LRENTER].
                did not generate a critical value alert
                to the provider (as normally              2. By COB Friday, October 28, 2005: Review the past 12 months of data to
                expected) when the test results were      determine if any tests capable of being batch-entered and containing a delta
                entered using the Batch Data Entry        check did not generate a critical value flag.
                option [LRSTUF]. Test results
                entered using the Enter/Verify/Modify     3. By COB Friday, November 4, 2005: Notify providers of any critical flag
                Data (Manual) [LRENTER] option            omissions that were identified, provided the patient has not already had
                generated the appropriate critical        subsequent follo up. If the provider is no longer with the facility, then notification
                alerts.                                   should be given to the Chief of Service. Affected patients should be notified of
                                                          positive test results as soon as possible.

                Mandatory; Priority A                     VHA Patient Safety Alert, Use of Batch Data Entry Option Does Not Execute Delta Checks, 10/2005
                2006 Alerts & Advisories
5.10.1          Physician Advisory issued by              Medtronic is reporting 19 failures out of 38000 devices (0.05%) due to: loss of
                Medtronic Inc. on the Sigma Series        rate response; premature battery depletion; intermittent or total loss of telemetry;
                single and dual chamber                   or loss of pacing output in the identified Sigma pacemaker units. The cause of the
                pacemakers, 1/06                          failure has been identified as separation of (i.e. loss of contact) redundant
                                                          interconnection wires from the hybrid block in the pacemaker circuit.
                The Sigma Series single and dual
                chamber pacemakers include:
                SD203, SD303, SDR203, SDR303,
                SDR306, SVDD303, SS103, SS106,
                SS203, SS303, SSR203, SSR303,
                SSR306, SVVI103.
                Recommended; Priority A                   VHA Patient Safety Alert, Medtronic Inc. on the Sigma pacemakers, 1/06




         Recalls, Alerts Advis - 5                                                           Recalls, Alerts Advis - 5 - Version: 08.01.2006                                              143 of 351
                                                               NCPS Patient Safety Assessment Tool

                                                                                    Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                            Not If score other than
                                                                                                                                                          Met   Partially   Met 'met' what are
                Question:                          Alert/Advisory Actions                                                                                 (1)   Met (2)     (3) possible root causes
                2006 Alerts & Advisories
5.10.2          Patient Pump Pain Management       Baxter reports incidents of unrequested patient doses delivered due to the
                Systems manufactured by Baxter     following:
                Healthcare Corp, 01/06.
                                                   Damaged PCA patient cord/button;
                Products include Ipump Pain Mgmt
                System, APII Infusion Pump and     Partial button sticking; and
                PCA II Infusion Pump.
                                                   Fluid in the pump or PCA button.

                                                   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            VHA Patient Safety Advisory, Ipump Pain Management System mfd by Baxter Healthcare Corporation, 1/06
                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              Hurricaine®Spray (benzocaine 20%)

                Specific use of Topical Spray      Cetacaine®Spray (benzocaine 14% butyl aminobenzoate 2% and tetracaine 2%)
                Benzocaine to Anesthetize the
                Surfaces of the Nasopharynx,       Topex® Spray (benzocaine 20%)
                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              VHA Patient Safety Alert, Cessation of Topical Benzocaine Usage 2/06




         Recalls, Alerts Advis - 5                                                    Recalls, Alerts Advis - 5 - Version: 08.01.2006                                                   144 of 351
                                                                    NCPS Patient Safety Assessment Tool

                                                                                          Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                              Not If score other than
                                                                                                                                                            Met   Partially   Met 'met' what are
                Question:                               Alert/Advisory Actions                                                                              (1)   Met (2)     (3) possible root causes
                2006 Alerts & Advisories
5.10.4          Alaris IV Tubing sets, mfd by           Several VA facilities report failures when loading administration sets in Alaris
                Cardinal Health, Alaris Products,       Signature series infusion pumps. The sets are difficult to load, and, when they do
                3/06                                    load, may malfunction or become occluded.

                This includes commonly used             Production runs from the latter part of the calendar year 2005 into January 2006 of
                72023E and 72033E sets.                 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                   VHA Patient Safety Alert, Cardinal Alaris IV Tubing Sets, 03/06
                2006 Alerts & Advisories
5.10.5          Mix-up (wrong route of                  Since 2001, VA facilities have reported five cases of accidental infusion into an IV
                administration) of bladder irrigation   line or PICC line. Amphotericin B (See Attachment #1, Patient Safety Alert AL06-
                with intravenous (IV) infusions, 4/06   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                   VHA Patient Safety Alert, Ampho Bladder Irrigation Alert, 04/06
                2006 Alerts & Advisories
5.10.6          Transrectal ultrasound transducer  During patient safety rounds in the Urology Clinic at the reporting facility, the
                assembly, manufactured by B-K      lumen of a needle guide of a reprocessed (i.e., ready to be used for a procedure)
                Medical Systems, Inc., 4/06        reusable B-K Medical transrectal ultrasound transducer assembly was found to be
                                                   soiled. Upon investigation, it was discovered that brushes were not being used to
                Specific models are 8808 and 8551, clean the lumen of the needle guide.
                and are manufactured by B-K
                Medical Systems, Inc., Wilmington,
                MA.
                Mandatory; Priority A                   VHA Patient Safety Alert, Transrectal ultrasound transducer mfd by B-K Medical Systems, Inc. 4/06




         Recalls, Alerts Advis - 5                                                          Recalls, Alerts Advis - 5 - Version: 08.01.2006                                               145 of 351
                                                                NCPS Patient Safety Assessment Tool

                                                                                      Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                  Not If score other than
                                                                                                                                                Met   Partially   Met 'met' what are
                Question:                           Alert/Advisory Actions                                                                      (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 erupted during the transfilling of liquid
                liquid oxygen Dewar to a portable   oxygen from a Dewar to a portable container resulting in property damage and the
                oxygen container., 03/06            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             VHA Patient Safety Advisory, Transfilling liquid O2 to portable O2 Container, 03/06




         Recalls, Alerts Advis - 5                                                      Recalls, Alerts Advis - 5 - Version: 08.01.2006                                       146 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                        Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                 Not If score other than
                                                                                                                                               Met   Partially   Met 'met' what are
                Question:                              Alert/Advisory Actions                                                                  (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                          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, VHA believes the
                with oxygen cylinders have burned or   fire risk of reusing them outweighs the additional expense of using sealing
                exploded due to suspected improper     washers.)
                use of gaskets/washers. None of
                these reports involve VA facilities.   3. Always ―crack‖ cylinder valves (open the valve just enough to
                The incidents are related to the       allow gas to escape for a very short time) before attaching regulators in order to
                reuse of single-use gaskets.           expel foreign matter from the outlet port of
                                                       the valve.
                General Information: Two types of
                washers, or CGA 870 seals, are         4. Always inspect the regulator and CGA 870 seal before
                commonly used to create the seal at    attaching it to the valve to insure that the regulator and seal are in good condition
                the cylinder valve / regulator         and the regulator is equipped with only one integral metal and rubber seal that is
                interface. The type required by many   in good condition.
                regulator manufacturers is a metal-
                bound elastomeric sealing washer       5. Tighten the T-handle firmly by hand, but do not use wrenches
                that is designed for multiple use      or other hand tools that may over-torque the handle.
                applications. The other common
                type, often supplied free-of-charge    6. Open the post valve slowly, while maintaining a grip on the
                with refilled oxygen cylinders, is a   valve wrench so that it can be closed quickly if gas escapes at the juncture of the
                plastic crush gasket suitable for      regulator and valve.
                single use applications.

                Recommended; Priority A                VHA Patient Safety Advisory, O2 Regulator Fires, 05/06




         Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                    147 of 351
                                                                NCPS Patient Safety Assessment Tool

                                                                                     Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                              Not If score other than
                                                                                                                                            Met   Partially   Met 'met' what are
                Question:                            Alert/Advisory Actions                                                                 (1)   Met (2)     (3) possible root causes
                2006 Alerts & Advisories
5.10.9          Renewing medications using           Specific Incident: After installing OR*3*215 (CPRS GUIv26) a VA medical center
                Computerized Records System          reports that providers noticed renewed medications are not showing up on their
                (CPRS), version 26., 05/06           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 (continued)...

                                                     VHA Patient Safety Alert, Renewing Medications using CPRS v26, 05/06
                2006 Alerts & Advisories
5.10.9          (continued)... Renewing medications ...(continued) following immediately to assure medications are properly renewed.
(continued)     using Computerized Records
                System (CPRS), version 26., 05/06 a. Providers must review the medications being 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.
                                                     VHA Patient Safety Alert, Renewing Medications using CPRS v26, 05/06




         Recalls, Alerts Advis - 5                                                     Recalls, Alerts Advis - 5 - Version: 08.01.2006                                    148 of 351
                                                                   NCPS Patient Safety Assessment Tool

                                                                                         Part I Adminstrative
RECALLS, ALERTS AND ADVISORIES - Element 5
                                                                                                                                                                           Not If score other than
                                                                                                                                                         Met   Partially   Met 'met' what are
                 Question:                             Alert/Advisory Actions                                                                            (1)   Met (2)     (3) possible root causes
                 2006 Alerts & Advisories
5.10.10          Boston Scientific Corp. recalling a   These products are manufactured by the Company's Cardiac Rhythm
                 subset of devices that includes       Management (CRM) Group, formerly Guidant's CRM business. Boston Scientific
                 INSIGNIA and NEXUS pacemakers         acquired Guidant on April 21, 2006.
                 06/06

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

                 Mandatory; Priority A                 Boston Scientific Corp. recall subset of devices including Insignia and Nexus pacemakers, 06/06




          Recalls, Alerts Advis - 5                                                        Recalls, Alerts Advis - 5 - Version: 08.01.2006                                             149 of 351
                                                            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
                     Cognitive Aids
   6.1.1 - 6.1.2           RESERVED
                     Prevention of Hospital Acquired Infections
   6.2.1             Does the facility have a policy to The policy must include provisions for routine
                     address and define hand hygiene    use of alcohol based hand rub or antimicrobial
                     practices according VHA Directive  soap after direct patient contact, as well as
                     2005-002?                          guidelines for use before specific hands on
                                                        clinical tasks. Also the policy should denote the
                                                        placement of hand rubs at or near the entrance
                                                        to each patient room, but not to be located over
                                                        or adjacent to ignition sources (must be at least
                                                        6" away from electrical receptacles and
                                                        switches).
                     Mandatory; Priority A                  VHA Directive 2005-002
                     Prevention of Hospital Acquired Infections
   6.2.2             Are measures in place for preventing VHA prevention recommendations outlined in IL
                     myiasis and is there a process for     10-2002-017 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 (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 mitigate 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
                                                            identify the genus and species. Myiasis can be
                                                            health care-associated or community related and
                                                            should be addressed with all patients including,
                                                            those who are (continued)...


                     Recommended; Priority A                USH IL 10-2002-017




Policies, Tools Aids - 6                                                          Policies, Tools Aids - 6 - Version: 08.01.2006                                                        150 of 351
                                                          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
               Prevention of Hospital Acquired Infections
   6.2.2       (continued)... Are measures in place ...(continued) homeless, have chronic open skin
   (continued) for preventing myiasis and is there a lesions, are comatose, or have other disabilities.
               process for intervention if myiasis is
               discovered?
                     Recommended; Priority A               USH IL 10-2002-017
                     Prevention of Hospital Acquired Infections
   6.2.3             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 recital thermometers
                                                            should replace electronic devices for affected
                                                            patients.
                     Recommended; Priority A               USH IL-10-2005-018
                     Prevention of Hospital Acquired Infections
   6.2.4             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 2005-2006 offers
                                                        strategies for implementation.

                                                           VHA Influenza Toolkit Manual for 2005-2006
                     Mandatory; Priority A                 VHA Directive 2005-047




Policies, Tools Aids - 6                                                         Policies, Tools Aids - 6 - Version: 08.01.2006                                                        151 of 351
                                                          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
                     Prevention of Hospital Acquired Infections
   6.2.5             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 100K Lives Kit: Prevent Ventilator- Associated Pneumonia, How to
                     Recommended; Priority B
                                                          Guide




Policies, Tools Aids - 6                                                        Policies, Tools Aids - 6 - Version: 08.01.2006                                                        152 of 351
                                                           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
                     Prevention of Hospital Acquired Infections
   6.2.6             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.

                                                           IHI 100K Lives Kit: Prevent Central Line Infections, How to Guide
                     Patient Safety Performance Measures
   6.3.1             Has the timely reporting of radiology 2006: 90% of reports read in 48 hours (2 days).
                     reports been addressed                Practices that aid in timely follow up are: Use of
                     appropriately to meet the 2006        PACS system; avoidance of pre-registering
                     Patient Safety Performance            patients; the use of voice recognition
                     Measures (Measure 19)?                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.

                                                           FY06 VA Patient Safety Performance Measure Pg. 154
                     Mandatory; Priority A                 Improving Radiology Reporting




Policies, Tools Aids - 6                                                          Policies, Tools Aids - 6 - Version: 08.01.2006                                                        153 of 351
                                                             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
                     Patient Safety Performance Measures
   6.3.2             Has the prevention of surgical site Two components are measured: a) The percent
                     infection been addressed            of patients receiving prophylactic antibiotic timely
                     appropriately to meet (or plan to   prior; and, b) Percent of patients with
                     meet) the 2006 Patient Safety       prophylactic antibiotic discontinued in a timely
                     Performance Measure (Measure        manner.
                     20)?
                     Mandatory; Priority A                   FY06 VA Patient Safety Performance Measure Pg. 160
                     Patient Safety Environmental Concerns
   6.4.1             Is there a written program to help    Verify written program and confirm with plant
                     prevent scalding of patients by       engineering personnel. PM to include: Mixing
                     following the VHA Directive 2002-     valve inspection and outlet temperature taken
                     073 on Domestic Hot Water             with calibrated thermometer. Frequency of
                     Temperature Limits by having a        inspections are determined at local level.
                     process in place to ensure regulating
                     hardware controls temperature and
                     that preventative maintenance
                     inspections/checks are up to date?

                                                             JCAHO CAM-H, EC.1.20 Pg. 303
                     Mandatory; Priority A                   VHA Directive 2002-073
                     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.
                     Mandatory; Priority A                   VHA Directive 2002-013




Policies, Tools Aids - 6                                                          Policies, Tools Aids - 6 - Version: 08.01.2006                                                        154 of 351
                                                          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
   6.5.1.1           Are Missing Patient "mock" drills    Missing Patient Drills that integrate findings from
                     periodically conducted?              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
                     Escape & Elopement Prevention
   6.5.2             What measures does the facility      Examples would include: Polices on topics such
                     have in place to prevent missing     as Patient Privileging, Supervision and/or
                     patients?                            Surveillance; Conducting Drills;
                                                          Monitoring/Assessing hazardous areas (such as
                                                          maintenance/construction areas).
                     Mandatory; Priority A                VHA Directive 2002-013
                     Escape & Elopement Prevention
   6.5.2.1           What measures are taken with high- Use of electronic devices (with comprehensive
                     risk patients?                     testing regimen - i.e. check every 24 hours;
                                                        regular PM checks, and annual performance
                                                        testing); Special precautions for field trips and
                                                        transporting; and patient identification.
                     Recommended; Priority A




Policies, Tools Aids - 6                                                       Policies, Tools Aids - 6 - Version: 08.01.2006                                                        155 of 351
                                                            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
                     Fall Prevention
   6.6.1             Has the 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                NCPS Falls Toolkit
                     Fall Prevention
   6.6.2             Are there any unique processes,        Review any and evaluate effectiveness (I.e. Hip
                     tools, or specialized equipment used   Pads, patient surveys, labeling high risk, non-
                     in the facilities fall prevention      skid socks, or Morse Fall Risk Assessment, floor
                     strategy?                              mats, walkers, canes.)
                     Recommended; Priority A
                     Fall Prevention
   6.6.2.1           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
                     Magnetic Resonance 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.
                                                            NCPS MRI Hazard Summary
                     Recommended; Priority A                American College of Radiology White Paper on MR Safety Pg. 1




Policies, Tools Aids - 6                                                          Policies, Tools Aids - 6 - Version: 08.01.2006                                                        156 of 351
                                                           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
                     Magnetic Resonance Imaging Safe Practices
   6.7.2             Are MR technicians                    Review training materials, training plan, and
                     trained/competent in the specifics of records. "Specifics of MRI Safety" includes (but
                     MR safety?                            not limited to) items such as positioning of
                                                           conductive leads, cables, sensors, and the
                                                           patients' extremities; and precautions required
                                                           for unconscious patients.
                                                           NCPS MRI Hazard Summary
                     Recommended; Priority A               American College of Radiology White Paper on MR Safety (AJR:178, June 2002)
                     Magnetic Resonance Imaging Safe Practices
   6.7.3             Is there an on going training and    Review training materials, training plan and
                     competency program for all effected training records. Check to see if that not only
                     staff that covers hazard recognition necessary 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. The training can utilize information
                                                          published in the 2001 NCPS MRI Hazard
                                                          Summary. Experts in the MR Safety field and
                                                          MR suppliers often have MR Safety training
                                                          videos available as well.
                     Recommended; Priority B               NCPS MRI Hazard Summary
                     Magnetic Resonance Imaging Safe Practices
   6.7.4             Has a plan been developed and       Drills should be conducted in the MR
                     tested to address patients who need 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. At least one
                                                         drill per year is recommended if an actual code
                                                         was not called since the last drill.

                     Recommended; Priority B




Policies, Tools Aids - 6                                                        Policies, Tools Aids - 6 - Version: 08.01.2006                                                          157 of 351
                                                            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
                     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.

                                                            VHA Directive 2006-008
                     Mandatory; Priority A                  VHA PS Handbook Pg. 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                  VHA Directive 2006-08
                     Medication Use Process Safety Concerns
   6.8.2             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                  VHA Handbook 1907.1 Pg. 27
                     Medication Use Process Safety Concerns
   6.8.2.1           Have these information system        It is important to ensure contingency plans are
                     contingency plans been tested (via a realistic and workable, it is not ideal to find faults
                     drill), which included a             in the plan at the time of an emergency. After
                     debriefing/critique?                 testing, if problems are found the plan should be
                                                          adjusted accordingly.
                     Recommended; Priority A                VHA Handbook 1907.1 Pg. 27
                     Medication Use Process Safety Concerns
   6.8.3             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 process standard approach throughout the organization.

                     Mandatory; Priority A                  ISMP Self Assessment questions 145-153, and N29a-b Pg. 34




Policies, Tools Aids - 6                                                            Policies, Tools Aids - 6 - Version: 08.01.2006                                                        158 of 351
                                                           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
                     Medication Use Process Safety Concerns
   6.8.4             Has the facility implemented or       The ISMP Self Assessment is strongly
                     participated in the Institute of Safe recommended as a comprehensive guideline to
                     Medication Practices Self             follow for medication safe practices.
                     Assessment?
                     Recommended; Priority B                ISMP Self Assessemnt
                     Patient Safety Realted Directives & Best Practices
   6.9.1             Is there a SOP for ordering,        VHA Directive requires a written Standard
                     processing, transporting, and       Operating Procedure (SOP) regarding
                     transfusing blood or blood products verification of patients' identification. Assessor
                     according to VHA Directive 1200-    to review SOP.
                     029, Transfusion verification and
                     identification requirements of all
                     sites?
                     Mandatory; Priority A                  VHA Directive 2005-029
                     Patient Safety Realted Directives & Best Practices
   6.9.2             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.
                                                            VHA Directive 2003-043 Ordering and Reporting Patient Test Results




Policies, Tools Aids - 6                                                           Policies, Tools Aids - 6 - Version: 08.01.2006                                                        159 of 351
                                                           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
                     Patient Safety Realted Directives & Best Practices
   6.9.3             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 the Education (ACGME). And thereby help the
                     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).

                                                            ACGME Requirements
                     Recommended; Priority A                NCPS Curriculum Workshop Brochure
                     Patient Safety Realted Directives & Best Practices
   6.9.4             Has the facility developed and      1.Confirm approved local policy and process for
                     implemented a program and policy to emergency out of-OR airway management. This
                     address out-of-operating room       must include: use of devices to confirm tube
                     airway management in accordance placement, demonstrated subject matter
                     with VHA Directive 2005-031?        expertise, along with confirming technical and
                                                         procedural skills. These should be explicit with
                                                         an objective assessment instrument.

                                                            2.Review list of those that have confirmed
                                                            competencies from this process and check dates
                                                            for annual reassessment.
                     Mandatory; Priority A                  VHA Directive 2005-031




Policies, Tools Aids - 6                                                         Policies, Tools Aids - 6 - Version: 08.01.2006                                                        160 of 351
                                                           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
                     Patient Safety Realted Directives & Best Practices
   6.9.5             Has a Medical Team Training (MTT) Medical Team Training principles of
                     project been implemented in any of communication adopted from aviation-based
                     the facilities' critical care areas such Crew Resource Management have face validity
                     as the operating room, ambulatory        for improving the effectiveness of communication
                     clinic or ICU?                           between multiple disciplines of staff working
                                                              together in clinical units like the OR, ICU, and
                                                              ambulatory clinics. There are narrative and
                                                              questionnaire data that demonstrate
                                                              improvements in communication and job
                                                              satisfaction, and gains in performance measures
                                                              in VA facilities that have participated in the VA
                                                              Medical Team Training program. Breakdowns in
                                                              communication have been found to be
                                                              fundamental in surgical procedures associated
                                                              with retained foreign bodies. Discuss the MTT
                                                              program with the PSM and review results of
                                                              program implementation in relevant VA Medical
                                                              Centers.
                                                            Awad S, et al. Bridging the communication gap. Am J Surg. 190 (2005)
                                                            770–774
                                                            TIPS Volume 6, Issue 2 March/April 2006
                     Patient Safety Realted Directives & Best Practices
   6.9.6             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 100k Lives Kit: Rapid Response Teams, How to Guide




Policies, Tools Aids - 6                                                          Policies, Tools Aids - 6 - Version: 08.01.2006                                                        161 of 351
                                                           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
                     Patient Safety Realted Directives & Best Practices
   6.9.7             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 100k 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 100k Lives Kit: Improved Care for Acute Myocardial Infraction, How
                     Recommended; Priority B
                                                           to Guide
                     Violence Prevention for Patients
   6.10.1            Are there existing processes,         Review written policy.
                     policies, or protocols that address
                     the handling of violent patients?
                     Recommended; Priority A               VA IL-10-97-006 Violent Behavior
                     Violence Prevention for Patients
   6.10.2            Does the facility have a policy         Look for policy statement documentation.
                     statement to address the use of flags
                     in the medical record (VISTA) to
                     indicate a potentially violent patient?

                                                           VHA Directive 2003-048




Policies, Tools Aids - 6                                                          Policies, Tools Aids - 6 - Version: 08.01.2006                                                         162 of 351
                                                          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
                     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.

                                                           Prevention of Retained Foreign Bodies After Surgery
                     Mandatory; Priority A                 VHA Directive 2006-030
                     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.

                                                           VHA Directive 2004-28 (2002-070)
                                                           NCPS TIPS, Vol. 4, Issue 4 Sept/Oct 2004
                                                           Prevention of Retained Foreign Bodies After Surgery




Policies, Tools Aids - 6                                                         Policies, Tools Aids - 6 - Version: 08.01.2006                                                        163 of 351
                                                           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
                     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
                     addresses moderate sedation done overall facility sedation and anesthesia care
                     by 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.

                                                            VHA Directive 2006-023
                     Mandatory; Priority A                  Prevention of Retained Foreign Bodies After Surgery




Policies, Tools Aids - 6                                                          Policies, Tools Aids - 6 - Version: 08.01.2006                                                        164 of 351
                                                            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 with Oxygen Use
   6.12.1            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 (continued)...
                     Mandatory; Priority A                  VHA Directive 2006-021
               Fire Prevention with Oxygen Use
   6.12.1      (continued)... Have the appropriate          ...(continued) that smoking materials may not be
   (continued) measures been implemented to                 brought into the facility; and high-risk patients
               reduce the fire hazard of smoking            are be given fire-resistive sleep ware.
               when oxygen treatment is expected
               for inpatients as required by VHA
               Directive 2006-021?
                     Mandatory; Priority A                  VHA Directive 2006-021




Policies, Tools Aids - 6                                                         Policies, Tools Aids - 6 - Version: 08.01.2006                                                        165 of 351
                                                          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 with Oxygen Use
   6.12.2            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




Policies, Tools Aids - 6                                                       Policies, Tools Aids - 6 - Version: 08.01.2006                                                        166 of 351
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
                       Patient Safety Assessment Tool
                       Part II Implementation
                       Element: Long Term Care - 7.1
                           Categories:
                           Bed Safety                              1-2
                           Code Carts                              2-3
                           Electrical Safety                       4-5
                           Environmental and Housekeeping Safety   5-7
                           Equipment Safety                        7 - 10
                           Escape and Elopement Prevention         10 - 12
                           Fall Prevention                         12 - 14
                           Fire Safety                             14 - 16
                           Infection Control                       16 - 17
                           Medical Gas Safety                      17 - 18
                           Medication Safety                       18 - 25
                           General Patient Safety Concerns         25 - 29



Tuesday, August 01, 2006                                                     168 of 351
                                                            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
                                                            JCAHO Sentinel Event Alert #27
                                                            Preventing Bed Entrapment Poster
                  Mandatory                                 Patient Safety Alert 7-13-01, Bed Rail Entrapment
                  Bed Safety
   7.1.1.2        Are bed rails easy to use, and have       Manipulate bed rails if available and interview
                  staff been trained on the usage?          staff.

                  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.
                  risk?
                  Mandatory                                 Patient Safety Alert 7-13-01, Bed Rail Entrapment
                  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 for Nursing Homes




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                        169 of 351
                                                          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 LTC patients can acquire bed sores; cardiac
                  to the level of care needed for each patients beds designed to facilitate CPR, etc.
                  patient?
                  Recommended
                  Bed Safety
   7.1.1.6             RESERVED
                  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.
                                                           FDA Public Health Notification: Safety Tips for Preventing Hospital Bed
                  Recommended
                                                           Fires
                  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?                               records.
                  Mandatory                                JCAHO CAM-H: MM.2.30 Pg. 232
                  Code Carts
   7.1.2.1.1 - 7.1.2.2     RESERVED
                  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.
                  carts throughout the hospital?
                  Recommended




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                             170 of 351
                                                          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
   7.1.2.4        Is the VHA modified version of the      Inspect top of cart and review checklist of
                  AHA Handbook of Cardiovascular          contents if provided.
                  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.
                  Recommended                             VHA Airway Directive
                  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?                      tank volume; tubing ; CO2 detectors; appropriate
                                                          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: 08.01.2006                                                        171 of 351
                                                       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
                                                        can be completely removed or covered in patient
                                                        rooms to protect patients who my try to harm
                                                        themselves.

                                                        National Fire Protection Guidebooks (NFPA)
                                                        NFPA 99-4.3.2.2.8.1 Pg. 04
                  Mandatory                             NFPA 99-4.3.2.2.6.2(D) Pg. 03
                  Electrical Safety
   7.1.3.2        Are electrical receptacles fitted with Observe conditions on unit.
                  covers, secured, and free of loose or
                  exposed wiring?
                                                        NFPA 99-4.3.3.2.1. Pg. 08
                  Mandatory                             National Fire Protection Association
                  Electrical Safety
   7.1.3.2.1           RESERVED
                  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.
                  emergency power circuits?
                                                        NFPA 99 4.4.2.2.4.2(B). Pg. 21
                  Mandatory                             National Fire Protection Association
                  Electrical Safety
   7.1.3.4        Are electrically powered medical      Cords are free of physical defects including
                  devices in good condition?            cracks, frayed ends, or missing prongs.
                                                        NFPA 99-8.4.1.3.1 Pg. 03
                                                        National Fire Protection Association
                  Mandatory                             VHA Directive 2002-030, Electrical Safety Policy for Patient Care Equipment




Long Term Care - 7.1                                                            Long Term Care - 7.1 - Version: 08.01.2006                                                            172 of 351
                                                           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
   7.1.3.5        Are there at least 4 receptacles (6 in Inspect patient rooms.
                  critical care) for each patient bed?

                                                           National Fire Protection Association
                  Mandatory                                NFPA 99 4.3.2.2.6.2 (A) Pg. 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.

                                                           NFPA 99 10.2.2.2.7.1 Pg. 03
                                                           National Fire Protection Association Online Guidelines
                                                           NFPA 99 10.2.2.2.1.1. Pg. 02
                  Recommended                              JCAHO CAM-H EC.1.10 Pg. 303
                  Electrical Safety
   7.1.3.7             RESERVED
                  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, Domestic Hot Water Temperature Limits
                  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?
                  Recommended                              JCAHO CAM-H, EC 8.10 Pg. 320
                  Environmental and Housekeeping Safety
   7.1.4.3        Does general housekeeping appear Cleanliness, sanitation, odor, etc.
                  to be a priority?
                  Recommended                              JCAHO CAM-H, EC 8.10 Pg. 320




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                        173 of 351
                                                        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
                  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.
                  Recommended                           JCAHO CAM-H, EC 5.20 Pg. 310
                  Environmental and Housekeeping Safety
   7.1.4.5        Are patient care area hallways and   Observe conditions on the unit.
                  stairways unobstructed and kept free
                  of storage?
                                                        National Fire Protection Association
                                                        JCAHO CAM-H, ED 5.20 Pg. 310
                  Mandatory                             NFPA 101 (LSC) 7.1.10. Pg. 05
                  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 CAM-H, EC 1.10 Pg. 303
                  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.

                                                        JCAHO CAM-H, EC 5.50 Pg. 313
                                                        VHA Directive 2004-012
                  Mandatory                             29CFR 1926.20(b) Pg. 1




Long Term Care - 7.1                                                            Long Term Care - 7.1 - Version: 08.01.2006                                                        174 of 351
                                                        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
                  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 caution
                  signage and locked to prevent
                  unauthorized entrance?

                  Mandatory                              VA Directive 7703c(4)(a)
                  Environmental and Housekeeping Safety
   7.1.4.9             RESERVED
                  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.
                  Recommended
                  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.
                                                         JCAHO Patient Safety Goals #6a
                                                         National Fire Protection Association Guidelines 99.8.2.2.2
                                                         National Fire Protection Association Codes Online
                  Mandatory                              JCAHO CAM-H, EC 6.20 Pg. 315
                  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 CAM-H, EC 6.10 Pg. 314




Long Term Care - 7.1                                                             Long Term Care - 7.1 - Version: 08.01.2006                                                        175 of 351
                                                            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
                  Equipment Safety
   7.1.5.3        Is the equipment used on each              There is no chance equipment would be
                  patient positioned in a way that it is     inadvertently shut off because it is not in sight of
                  evident the equipment is in use for        the patient.
                  that patient?
                  Recommended
                  Equipment Safety
   7.1.5.4        Are alarms audible and easily              Alarms may be broadcast to an outside room or
                  distinguished above ambient                another area such as a central nursing station.
                  background noise level?                    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 Patient Safety Goals, Goal #6b
                  Equipment Safety
   7.1.5.4.1           RESERVED
                  Equipment Safety
   7.1.5.5        Are all devices that alarm specifically    Masking is when the frequency and intensity of
                  set up for each patient to reduce          two separate alarms blend together causing
                  issues such as, "masking", nuisance,       heightened confusion; nuisance alarms are
                  or altered priority due to unwanted        caused when limits are not appropriately set, this
                  false or alarms?                           can create staff complacency, annoyance to
                                                             patients, and results in a delayed staff response
                                                             (cry wolf syndrome).
                  Recommended                                JCAHO Patient Safety Goals, Goal #6b
                  Equipment Safety
   7.1.5.5.1      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




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                        176 of 351
                                                           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
                  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 well organized in each         near eye level; key pads within reach; equipment
                  patient/procedure room to avoid          is not blocking each other; adequate space to
                  clutter and permit the caregivers to     move around, including head clearance on
                  be able to reach and read all            mounted devices.
                  equipment?
                  Recommended
                  Equipment Safety
   7.1.5.8        Are liquids kept away from medical       To prevent spillage which can result in
                  equipment?                               malfunctioning.
                                                           NFPA 70 110.11 Pg. 2
                                                           National Fire Protection Association
                  Recommended                              VA Circular 10-90-035
                  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
   7.1.5.10 - 7.1.5.10.1   RESERVED
                  Equipment Safety
   7.1.5.11       Are the location and model of AEDs The location on the code cart or within unit
                  standardized throughout the facility? should be the same from area to area. Compare
                                                        models in unit, and from unit to unit.
                  Recommended
                  Equipment Safety
   7.1.5.12            RESERVED




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                        177 of 351
                                                           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
                  Equipment Safety
   7.1.5.13       Does the hospital purchase                Having sterile water for injection in units on the
                  humidification devices that do not        floor creates the potential for misuse. Warnings
                  require the use of sterile water?         have been published (ISMP) regarding water
                                                            being confused with other medications resulting
                                                            in it being give intravenously resulting in fatal
                                                            hemolysis.
                                                            FDA Patient Safety News, #22, 12-03, Store IV Bags in Their
                                                            Overwraps
                  Recommended                               ISMP 9/18/2003, How sterile water bags show up on nursing units
                  Equipment Safety
   7.1.5.13.1     If humidification devices use sterile     If sterile water must be used it is recommend that
                  water is it provided in 2 Liter bags      it be used in 2 Liter bags. The 2 Liter bags will
                  and labeled "Sterile Water"?              help distinguish the sterile water from the 1 Liter
                                                            bags of IV solutions, also pour bottles could be
                                                            considered.
                                                            ISMP 9/18/2003, How sterile water bags show up on nursing units
                  Recommended                               FDA Patient Safety News, Show #22, 12-03, Store IV Bags in Their Overwraps
                  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 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?
                                                            JCAHO CAM-H, PC.1.1 Pg. 183
                  Recommended                               Cognitive Aids - Escape Elopement
                  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




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                           178 of 351
                                                         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
                  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 Patient Safety Goals, Goal #6a
                  Escape and Elopement Prevention
   7.1.6.4        Have staff been involved in an  Interview staff.
                  elopement drill (grid search)?
                  Recommended
                  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.

                                                         VHA Directive 2002-013, Management of Wandering & Missing Patient
                  Mandatory
                                                         Events
                  Escape and Elopement Prevention
   7.1.6.5.1      If an elopement risk assessment is Discuss with ward staff the wander and
                  to be completed for patients, are  elopement policies.
                  staff familiar with the
                  wandering/elopement prevention
                  protocol or SOP?
                                                         VHA Directive 2002-013, Management of Wandering & Missing Patient
                  Mandatory
                                                         Events




Long Term Care - 7.1                                                           Long Term Care - 7.1 - Version: 08.01.2006                                                         179 of 351
                                                             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
                  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
                  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?                          with nightlights.
                  Recommended                                 JCAHO CAM-H, EC.1.10 Pg. 303
                  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?
                  Recommended




Long Term Care - 7.1                                                             Long Term Care - 7.1 - Version: 08.01.2006                                                        180 of 351
                                                           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
                  Fall Prevention
   7.1.7.3        Are the floors clean and free of         Floors should be free of liquids, electrical cords,
                  slipping and tripping hazards?           wires, tubes, or other connectors which can
                                                           create fall hazards. Patient rooms should be free
                                                           of low-lying objects that could be tripped over
                                                           causing falls.
                  Recommended                              JCAHO CAM-H, EC.1.10 Pg. 303
                  Fall Prevention
   7.1.7.4        Do shower/bathroom areas have            Inspect areas specified. Bathrooms should be
                  adequate lighting, proper drainage,      provided with night lights. If a raised seats are
                  non-slip floor surfaces, and handrails   used on toilets are they is the color of it
                  installed?                               contracting to toilet to help patients see it clearly.

                  Recommended                              JCAHO CAM-H, EC.1.10 Pg. 303
                  Fall Prevention
   7.1.7.5        Are call buttons within reach of the     Inspect all areas.
                  patient?
                  Recommended
                  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, Fatal Falls: Lessons for the Future
                  Recommended                              JCAHO Patient Safety Goals, Goal #6b
                  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.

                  Recommended




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                        181 of 351
                                                          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
                  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?
                  Recommended                              JCAHO CAM-H, PC.2.120 and PC.2.150 Pg. 186
                  Fall Prevention
   7.1.7.9        Does equipment (lifting equipment,       Review equipment, interview staff. Patients
                  OR tables, etc.) have sufficient         weighing in excess of 400 pounds are not
                  capacity to meet the needs of            uncommon. If equipment cannot support the
                  bariatric patients?                      weight of the patient contingency plans should
                                                           be developed to provide care.
                  Recommended
                  Fall Prevention
   7.1.7.10            RESERVED
                  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?
                                                           JCAHO CAM-H, HR.2.20 Pg. 338
                                                           JCAHO CAM-H, EC.5.20 Pg. 310
                                                           NFPA 101.7.2.3 Pg. 08
                                                           NFPA 101.7.2.1 Pg. 05
                  Mandatory                                NFPA 101.7.1.1.
                  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.
                                                           JCAHO CAM-H, EC.5.20 Pg. 310
                                                           JCAHO CAM-H, HR.2.20 Pg. 338
                                                           NFPA 101.7.2.1 Pg. 05
                  Mandatory                                NFPA 101.7.1.1




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                        182 of 351
                                                          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
                  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.)?
                                                           National Fire Protection Association
                  Mandatory                                NFPA 72.4.4.3.6.1 Pg. 08
                  Fire Safety
   7.1.8.4        Is the area staff notified when the fire Interview staff.
                  alarm system is out of service or
                  being tested?
                                                           NFPA 101.19.7.1.2 Pg. 08
                  Mandatory                                National Fire Protection Association
                  Fire Safety
   7.1.8.4.1      Are cognitive aids used to remind        Look for signs placed by pull stations, and
                  staff when the fire alarm system is      interview to determine if announcements are
                  not functioning?                         made on PA system, etc.
                  Recommended
                  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
                  Recommended                              VA MP-3, Part III, 32.36(b) & (d) Pg. 21
                  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.
                  ensure integrity of the flame
                  retardant agent is maintained on
                  these articles after repeated
                  laundering?
                  Recommended                              VA MP-3, Part III, 32.36(c) & (d) Pg. 21




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                        183 of 351
                                                            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
                  Fire Safety
   7.1.8.6             RESERVED
                  Infection Control
   7.1.9.1        Are all linen carts (clean and soiled)     Observe conditions on the unit.
                  kept covered?
                  Mandatory                                  JCAHO CAM-H, IC.4.10 Pg. 252
                  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 CAM-H, EC.4.10 Pg. 252
                  Infection Control
   7.1.9.3        Is the latex allergy policy followed       Show example if available. Consider inspecting
                  and are latex free supplies and            supply and code carts. Look for latex-free
                  equipment available?                       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 Latex Information
                  Infection Control
   7.1.9.4        Are the VA recommended hand                The individual products should be an alcohol rub
                  hygiene guidelines followed, such as       (for disinfecting) and a hospital approved lotion
                  having alcohol-based gel                   (to prevent skin dryness). Also, staff who come
                  disinfectants located to promote use       in contact with patients or prepare sterile
                  (including inpatient rooms), and           products (such as IV drugs) should not have
                  providing individual products to all       artificial fingernails. Clinicians should also be
                  necessary staff?                           offered the small (2-4 oz.) personal containers of
                                                             hand gel. Gel should be in convenient locations
                                                             including all carts (mobile care, medication carts,
                                                             code, respiratory).

                                                             VHA Hand Hygiene Directive, 2005-002 July 2005
                                                             JCAHO CAM-H, IC.4.10 Pg. 252
                                                             JCAHO Patient Safety Goals, Goal #7a
                                                             CDC Guidelines for Hand Hygiene in Health-care Settings
                  Mandatory                                  Sentinel Event Alert 1-22-2003, Infection related sentinel events




Long Term Care - 7.1                                                                 Long Term Care - 7.1 - Version: 08.01.2006                                                        184 of 351
                                                           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
                  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)?
                                                            OSHA, 29 CFR 1910.145
                  Mandatory                                 CDC Guidelines for Environmental Infection Control in Health-Care Facilities
                  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.
                                                            Patient Safety Advisory 3-5-2002, Confusion Between Oxygen &
                  Recommended
                                                            Compressed Air Wall Outlet
                  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.
                                                            Patient Safety Advisory 3-5-2002, Confusion Between Oxygen &
                  Recommended
                                                            Compressed Air Wall Outlet
                  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.

                                                            National Fire Protection Association
                                                            NFPA 5.1.4.2.1. Pg. 17
                  Mandatory                                 JCAHO CAM-H, EC.7.50 Pg. 319
                  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).
                                                            NCPS O2 Hazard Summary
                  Mandatory                                 NCGA (Compressed Gas Association) C-9, 3.7 & 4.6




Long Term Care - 7.1                                                                 Long Term Care - 7.1 - Version: 08.01.2006                                                            185 of 351
                                                           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
                  Medical Gas Safety
   7.1.10.4.1     Are all area/unit personnel             Staff to demonstrate competency.
                  competent in understanding the
                  handling procedures of oxygen
                  cylinders, including how to obtain full
                  cylinders? If so, is current practices
                  in line with the facility's written
                  procedure?
                  Mandatory                                 NCPS O2 Hazard Summary
                  Medical Gas Safety
   7.1.10.5       Are pins on medical gas regulators        Pins should be in place and found undamaged.
                  and cylinders in good repair and is
                  damaged equipment immediately
                  removed from service?
                  Recommended                               NCPS O2 Hazard Summary
                  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.
                  Recommended                               NCPS O2 Hazard Summary
                  Medical Gas Safety
   7.1.10.7       Is the facility medical gas policy or     Review the policy if available. Questions
                  procedure followed when medical           technicians to determine if policy is known and
                  gases are used in clinics and exam        followed.
                  rooms?
                  Recommended
                  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.

                                                            ISMP Medication Safety Self Assessment #117 Pg. 30
                                                            JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                  Mandatory                                 US Pharmacopeia Caps Link, August 2003




Long Term Care - 7.1                                                              Long Term Care - 7.1 - Version: 08.01.2006                                                        186 of 351
                                                       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
                  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 CAM-H, MM.2.20, EP-3 & EP-4 Pg. 231
                  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 and        will help prevent medication error by eliminating
                  syringes?                             opportunities for mix-ups . It will also avoid drug
                                                        being taken by mental health patients or those
                                                        with cognitive impairment.
                                                        JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                  Mandatory                             ISMP Self Assessment 14 Pg. 13
                  Medication Safety
   7.1.11.3.1     Is medication logically organized and Clearly marked labels and nametags.
                  identified by patient?
                  Recommended                           JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                  Medication Safety
   7.1.11.4       Are medication storage rooms          Door locking mechanism cannot be defeated for
                  secured at all times?                 any reason. Door should not be held open.
                                                        ISMP Self Assessment 75 Pg. 24
                  Mandatory                             JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                  Medication Safety
   7.1.11.5            RESERVED
                  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?
                                                        JCAHO CAM-H, MM.3.20 Pg. 233
                  Recommended                           ISMP Self Assessment 82 Pg. 25
                  Medication Safety
   7.1.11.6.1 - 7.1.11.6.2      RESERVED




Long Term Care - 7.1                                                         Long Term Care - 7.1 - Version: 08.01.2006                                                        187 of 351
                                                           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
                  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 Patient Safety News, Show #22, 12-03, Store IV Bags in Their
                                                           Overwraps
                  Recommended                              ISMP Medication Safety Alert, 9-03, How sterile waterbags show up on nursing units.
                  Medication Safety
   7.1.11.8       Have concentrated electrolyte       Such as: potassium chloride and potassium
                  solutions been removed from patient phosphate
                  floors/care areas?
                                                           JCAHO Patient Safety Goals, Goal #3a
                                                           Sentinel Event Alert #1, Medication error prevention
                                                           Sentinel Event Alert #11, High-Alert Medications and Patient Safety
                  Mandatory                                JCAHO CAM-H, MM.2.20, EP-9 Pg. 231
                  Medication Safety
   7.1.11.8.1     Is access limited to electrolyte    Review local policies, and interview pharmacy
                  replacement solutions (above or     staff. Show example.
                  below 0.9% sodium chloride) outside
                  the pharmacy?
                  Recommended                              ISMP Self Assessment 92 Pg. 26
                  Medication Safety
   7.1.11.9            RESERVED
                  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).

                                                           JCAHO Patient Safety Goals, Goal #3b
                                                           Sentinel Event Alert #11, 11-19-99, High-Alert Medications and Patient Safety
                                                           ISMP Self Assessment 67.1 & 20 Pg. 23
                                                           JCAHO CAM-H, MM 2.20, EP-8 Pg. 231
                  Mandatory                                JCAHO CAM-H, MM 7.10 Pg. 240




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                                   188 of 351
                                                         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
                  Medication Safety
   7.1.11.10      Is a unit dose medication system        Look in patient bins for bulk containers.
                  used including half tablets and
                  liquids?
                                                          Sentinel Event Alert #11, 1-19-99, High-Alert Medications and Patient
                                                          Safety
                                                          JCAHO CAM-H, MM.2.20 Pg. 231
                  Recommended                             ISMP Self Assessment 64 Pg. 22
                  Medication Safety
   7.1.11.10.1 - 7.1.11.12      RESERVED
                  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, 11-19-99, High Alert Medications & Patient
                                                          Safety
                  Recommended                             JCAHO CAM-H, MM.4.20 Pg. 235
                  Medication Safety
   7.1.11.13.1 If admixtures are done in inpatient      Interview floor staff. If admixtures are done on
                  care areas, is an independent double- units, the area should be a designated area that
                  check system utilized?                is clean and secure. It is safest for mixtures to
                                                        be completed in pharmacy areas.
                  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.
                                                          American Soc of Anesthesiology Newsletter Dec 2000
                  Recommended                             ISMP Medication Safety Alert June 2000
                  Medication Safety
   7.1.11.15      Are premixed IV solutions kept in       The protective over-wrap for some solutions
                  over-wrap bags until they are ready     serves to control the amount of water vapor that
                  to be used (if applicable)?             escapes from an IV solution. Once unwrapped it
                                                          is best to use the solution right way.

                                                          FDA Patient Safety News, #22, 12-03, Store IV Bags in Their
                  Recommended
                                                          Overwraps




Long Term Care - 7.1                                                              Long Term Care - 7.1 - Version: 08.01.2006                                                           189 of 351
                                                        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
                  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)?
                                                        FDA Patient Safety News, #22, 12-03, Store IV Bags in Their
                  Recommended
                                                        Overwraps
                  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?                              pumps.
                                                        Sentinel Event Alert #11, 11-19-99, High-Alert Medications & Patient
                  Recommended
                                                        Safety
                  Medication Safety
   7.1.11.18           RESERVED
                  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.
                  etc.) available based on the drug
                  being administered?
                  Recommended                           ISMP Self Assessment 79 Pg. 24
               Medication Safety
   7.1.11.19.1 Is there a process to monitor the         Such as reviewing automated dispensing
               reversal agent use?                       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.

                  Recommended
                  Medication Safety
   7.1.11.20           RESERVED
                  Medication Safety
   7.1.11.21      Is there machine readable coding    Show mechanism (i.e. BCMA) in use. Machine
                  throughout the medication           readable coding should match the electronic
                  administration process (e.g. BCMA)? medical record to the patient, allowing the
                                                      information on the patients armband to be
                                                      matched with the electronic information.

                  Recommended                           ISMP Medication Safety Self Assessment, #11 Pg. 13




Long Term Care - 7.1                                                            Long Term Care - 7.1 - Version: 08.01.2006                                                          190 of 351
                                                            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
               Medication Safety
   7.1.11.21.1 Is BCMA used to administer                   Observe staff.
               medication without using work
               arounds?
                  Recommended
                  Medication Safety
   7.1.11.21.2 What is the protocol for handling            Interview staff and compare practices to policy of
                  incorrect bar coded or labeled            facility/Pharmacy.
                  medications?
                  Recommended                               JCAHO CAM-H, MM.3.20, EP-5 Pg. 233
               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           RESERVED
               Medication Safety
   7.1.11.22.1 Do the VISTA modules effectively             Show example, if available.
               alert to potential food/drug/herbal
               interactions and duplicate drug
               therapies?
                  Recommended
                  Medication Safety
   7.1.11.23 - 7.1.11.24    RESERVED
                  Medication Safety
   7.1.11.25      Is drug reference information made Interview area/unit staff, show where information
                  readily accessible to caregivers, if so is kept and how it is retrieved. One or two
                  how?                                    reference sources should be available as well as
                                                          access to pharmacist.
                                                            ISMP Self Assessment 18.2 Pg. 15
                  Recommended                               JCAHO-CAMH. IM.3.10 Pg. 349
                  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).
                                                            JCAHO CAM-H, IM.3.10 Pg. 349
                  Recommended                               ISMP Medication Safety Self Assessment, #19 Pg. 15




Long Term Care - 7.1                                                              Long Term Care - 7.1 - Version: 08.01.2006                                                        191 of 351
                                                           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
                  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.

                                                           JCAHO CAM-H, MM.2.20, EP-6 Pg. 231
                  Recommended                              Sentinel Event Alert #19, May 2001, Look-alike, sound-alike drug names
                  Medication Safety
   7.1.11.27.1          RESERVED
                  Medication Safety
   7.1.11.28      Do prohibited abbreviations conform For example "u" in unit may be mistaken for "0"
                  to minimum JCHAO Patient Safety     resulting in ten fold over dosage.
                  Goal requirements?
                                                           ISMP Medication Safety Self Assessment #40 Pg. 19
                                                           JCAHO Patient Safety Goals, Goal #2b
                                                           JCAHO CAM-H, MM.3.20 Pg. 233
                                                           Sentinel Event Alert #11, 11-19-99, High-Alert Medications & Patient Safety
                                                           Sentinel Event Alert #23, 9-2001, Medication errors related to ....abbreviations
                  Mandatory                                JCAHO CAM-H, IM.3.10 Pg. 349
                  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 CAM-H, MM.4.50 Pg. 236
                  Medication Safety
   7.1.11.30 - 7.1.11.31.1       RESERVED
                  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 Medication Safety Self Assessment #26 Pg. 16
                  Medication Safety
   7.1.11.33           RESERVED




Long Term Care - 7.1                                                               Long Term Care - 7.1 - Version: 08.01.2006                                                                192 of 351
                                                           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
                  Medication Safety
   7.1.11.34      Are patients educated regarding their Show example.
                  prescribed medication, as inpatients
                  and as part of the discharge
                  process?
                  Recommended                               JCAHO CAM-H, PC.6.10 Pg. 193
                  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 Medication Safety Self Assessment #23 Pg. 16
                  Recommended                               JCAHO CAM-H, MM.4.10 Pg. 234
                  Medication Safety
   7.1.11.36 - 7.1.11.41.1      RESERVED
                  Medication Safety
   7.1.11.42      Has a effective process begun to          JCAHO is requiring all facilites have a plan in
                  reconcile patient medications upon        place by January 2006.
                  admission, transfer or discharge?
                  Recommended
                  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.
                                                            JCAHO CAM-H, MM.3.20, EP-7 Pg. 233
                                                            JCAHO Patient Safety Goals, Goal #2a
                  Mandatory                                 ISMP Medication Safety Self Assessment #45 Pg. 20
                  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
                  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.

                  Recommended                               JCAHO CAM-H, IM.2.10 Pg. 347




Long Term Care - 7.1                                                              Long Term Care - 7.1 - Version: 08.01.2006                                                        193 of 351
                                                         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
   7.1.12.4       Are staff required to wear              Monitor patient care areas. Interview staff about
                  identification badges, and are          policies such as the handling of drug
                  unauthorized persons kept out of        manufacturer representatives that visit
                  patient care areas?                     unexpectedly.
                  Recommended                             JCAHO CAM-H, PC.1.2 & PC 2.2 Pg. 182
                  General Patient Safety Concerns
   7.1.12.5       Are restraints used in accordance       Randomly interview staff. Look for restraint
                  with local policy and are restraint     devices or alterative devices in the area.
                  alternative devices available and
                  used when appropriate?
                                                          Sentinel Event Alert #8, 11-98, Preventing Restraint Deaths
                  Recommended                             JCAHO CAM-H, PC.11.10 & PC.12.10 Pg. 199
                  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 identifcation requriements 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
                                                          adminstration or collection begins.

                  Mandatory; Priority A                   JCAHO Patient Safety Goals, Goal #1a




Long Term Care - 7.1                                                              Long Term Care - 7.1 - Version: 08.01.2006                                                        194 of 351
                                                         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
   7.1.12.6.1     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; Priority A
                  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; Priority A
                  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; Priority A




Long Term Care - 7.1                                                       Long Term Care - 7.1 - Version: 08.01.2006                                                        195 of 351
                                                          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
   7.1.12.7       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
                  General Patient Safety Concerns
   7.1.12.8       Is transfer of care between shifts      A consistent process should exist to update on-
                  standardized?                           coming staff of patient statues. Interview staff
                                                          and compare answers between units.
                  Recommended
                  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
                  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




Long Term Care - 7.1                                                          Long Term Care - 7.1 - Version: 08.01.2006                                                        196 of 351
                                                        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
   7.1.12.11      Does the facility have an emergency   The protocol should be made up of a mechanism
                  response protocol for dealing with    for 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
                  General Patient Safety Concerns
   7.1.12.11.1          RESERVED
                  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?

                  Mandatory                             JCAHO CAM-H, PC.13.20 Pg. 214
                  Psychiatric Precautions
   7.1.13.1 - 7.1.13.18       RESERVED
                  Surgical or Invasive Procedure Precautions
   7.1.14.1 - 7.1.14.19       RESERVED
                  Imaging and X-rays Precautions
   7.1.15.1 - 7.1.15.12       RESERVED




Long Term Care - 7.1                                                       Long Term Care - 7.1 - Version: 08.01.2006                                                        197 of 351
                       Patient Safety Assessment Tool
                       Part II Implementation
                       Element: Psych Care - 7.2
                           Categories:
                           Bed Safety                              1
                           Code Carts                              1
                           Electrical Safety                       2-3
                           Environmental and Housekeeping Safety   3-4
                           Equipment Safety                        5
                           Escape and Elopement Prevention         6-7
                           Fall Prevention                         7-8
                           Fire Safety                             8-9
                           Infection Control                       9 - 10
                           Medication Safety                       10 - 15
                           General Patient Safety Concerns         15 - 19
                           Psychiatric Precautions                 19 - 22



Tuesday, August 01, 2006                                                     198 of 351
                                                         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
                   Bed Safety
   7.2.1.1 - 7.2.1.7     RESERVED
                   Code Carts
   7.2.2.1         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?                            records.
                   Mandatory                             JCAHO CAM-H: MM.2.30 Pg. 232
                   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
   7.2.2.2 - 7.2.2.3     RESERVED
                   Code Carts
   7.2.2.4         Is the VHA modified version of the    Inspect top of cart and review checklist of
                   AHA Handbook of Cardiovascular        contents if provided.
                   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.
                   Recommended                           VHA Airway Directive
                   Code Carts
   7.2.2.6          RESERVED




Psych Care - 7.2                                                                Psych Care - 7.2 - Version: 08.01.2006                                                        199 of 351
                                                         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
                   Electrical Safety
   7.2.3.1         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
                                                         can be completely removed or covered in patient
                                                         rooms to protect patients who my try to harm
                                                         themselves.

                                                         National Fire Protection Guidebooks (NFPA)
                                                         NFPA 99-4.3.2.2.8.1 Pg. 04
                   Mandatory                             NFPA 99-4.3.2.2.6.2(D) Pg. 03
                   Electrical Safety
   7.2.3.2         Are electrical receptacles fitted with Observe conditions on unit.
                   covers, secured, and free of loose or
                   exposed wiring?
                                                         NFPA 99-4.3.3.2.1. Pg. 08
                   Mandatory                             National Fire Protection Association
                   Electrical Safety
   7.2.3.2.1       In applicable patient care areas is   Electrical lines should not be run on the outside
                   wire molding (or other exposed        of walls and/or ceilings in areas where
                   conduit) not allowed for running      psychiatric patients can reside as inpatients, be
                   electrical lines?                     seen as outpatients or be triaged. Wire moldings
                                                         or conduit could be tampered with, resulting in
                                                         an exposed live electrical line.
                                                         National Fire Protection Association
                   Recommended                           NFPA 99 4.3.2.2.6.2 (D) Pg. 03
                   Electrical Safety
   7.2.3.3          RESERVED
                   Electrical Safety
   7.2.3.4         Are electrically powered medical      Cords are free of physical defects including
                   devices in good condition?            cracks, frayed ends, or missing prongs.
                                                         NFPA 99-8.4.1.3.1 Pg. 03
                                                         National Fire Protection Association
                   Mandatory                             VHA Directive 2002-030, Electrical Safety Policy for Patient Care Equipment




Psych Care - 7.2                                                                    Psych Care - 7.2 - Version: 08.01.2006                                                             200 of 351
                                                         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
                   Electrical Safety
   7.2.3.5 - 7.2.3.7     RESERVED
                   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, Domestic Hot Water Temperature Limits
                   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?
                   Recommended                           JCAHO CAM-H, EC 8.10 Pg. 320
                   Environmental and Housekeeping Safety
   7.2.4.3         Does general housekeeping appear Cleanliness, sanitation, odor, etc.
                   to be a priority?
                   Recommended                           JCAHO CAM-H, EC 8.10 Pg. 320
                   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.
                   Recommended                           JCAHO CAM-H, EC 5.20 Pg. 310
                   Environmental and Housekeeping Safety
   7.2.4.5         Are patient care area hallways and   Observe conditions on the unit.
                   stairways unobstructed and kept free
                   of storage?
                                                         National Fire Protection Association
                                                         JCAHO CAM-H, ED 5.20 Pg. 310
                   Mandatory                             NFPA 101 (LSC) 7.1.10. Pg. 05
                   Environmental and Housekeeping Safety
   7.2.4.6         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 CAM-H, EC 1.10 Pg. 303




Psych Care - 7.2                                                                   Psych Care - 7.2 - Version: 08.01.2006                                                        201 of 351
                                                        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
   7.2.4.7         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.

                                                        JCAHO CAM-H, EC 5.50 Pg. 313
                                                        VA Directive 7703c(4)(a)
                   Mandatory                            29CFR 1926.20(b)
                   Environmental and Housekeeping Safety
   7.2.4.8         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 caution
                   signage and locked to prevent
                   unauthorized entrance?

                   Mandatory                            VA Directive 7703c(4)(a)
                   Environmental and Housekeeping Safety
   7.2.4.9          RESERVED
                   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.
                   Recommended




Psych Care - 7.2                                                                   Psych Care - 7.2 - Version: 08.01.2006                                                        202 of 351
                                                        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.
                                                        JCAHO Patient Safety Goals #6a
                                                        National Fire Protection Association Guidelines 99.8.2.2.2
                                                        National Fire Protection Association Codes Online
                   Mandatory                            JCAHO CAM-H, EC 6.20 Pg. 315
                   Equipment Safety
   7.2.5.2 - 7.2.5.3     RESERVED
                   Equipment Safety
   7.2.5.4         Are alarms audible and easily        Alarms may be broadcast to an outside room or
                   distinguished above ambient          another area such as a central nursing station.
                   background noise level?              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 Patient Safety Goals, Goal #6b
                   Equipment Safety
   7.2.5.4.1 - 7.2.5.7     RESERVED
                   Equipment Safety
   7.2.5.8         Are liquids kept away from medical   To prevent spillage which can result in
                   equipment?                           malfunctioning.
                                                        NFPA 70 110.11.
                   Recommended                          National Fire Protection Association
                   Equipment Safety
   7.2.5.9 - 7.2.5.10.1        RESERVED
                   Equipment Safety
   7.2.5.11        Are the location and model of AEDs The location on the code cart or within unit
                   standardized throughout the facility? should be the same from area to area. Compare
                                                         models in unit, and from unit to unit.
                   Recommended
                   Equipment Safety
   7.2.5.12 - 7.2.5.14         RESERVED




Psych Care - 7.2                                                                  Psych Care - 7.2 - Version: 08.01.2006                                                        203 of 351
                                                          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 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?
                                                          JCAHO CAM-H, PC.1.1 Pg. 183
                   Recommended                            Cognitive Aids - Escape Elopement
                   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
                   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 Patient Safety Goals, Goal #6a
                   Escape and Elopement Prevention
   7.2.6.4         Have staff been involved in an  Interview staff.
                   elopement drill (grid search)?
                   Recommended
                   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.

                                                          VHA Directive 2002-013, Management of Wandering & Missing Patient
                   Mandatory
                                                          Events




Psych Care - 7.2                                                                  Psych Care - 7.2 - Version: 08.01.2006                                                           204 of 351
                                                         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       If an elopement risk assessment is Discuss with ward staff the wander and
                   to be completed for patients, are  elopement policies.
                   staff familiar with the
                   wandering/elopement prevention
                   protocol or SOP?
                                                          VHA Directive 2002-013, Management of Wandering & Missing Patient
                   Mandatory
                                                          Events
                   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
                   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?                     with nightlights.
                   Recommended                            JCAHO CAM-H, EC.1.10 Pg. 303
                   Fall Prevention
   7.2.7.2 - 7.2.7.2.1     RESERVED
                   Fall Prevention
   7.2.7.3         Are the floors clean and free of       Floors should be free of liquids, electrical cords,
                   slipping and tripping hazards?         wires, tubes, or other connectors which can
                                                          create fall hazards. Patient rooms should be free
                                                          of low-lying objects that could be tripped over
                                                          causing falls.
                   Recommended                            JCAHO CAM-H, EC.1.10 Pg. 303




Psych Care - 7.2                                                                  Psych Care - 7.2 - Version: 08.01.2006                                                           205 of 351
                                                            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
                   Fall Prevention
   7.2.7.4         Do shower/bathroom areas have            Inspect areas specified. Bathrooms should be
                   adequate lighting, proper drainage,      provided with night lights. If a raised seats are
                   non-slip floor surfaces, and handrails   used on toilets are they is the color of it
                   installed?                               contracting to toilet to help patients see it clearly.

                   Recommended                              JCAHO CAM-H, EC.1.10 Pg. 303
                   Fall Prevention
   7.2.7.5 - 7.2.7.10     RESERVED
                   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?
                                                            JCAHO CAM-H, HR.2.20 Pg. 338
                                                            JCAHO CAM-H, EC.5.20 Pg. 310
                                                            NFPA 101.7.2.3 Pg. 08
                                                            NFPA 101.7.2.1 Pg. 05
                   Mandatory                                NFPA 101.7.1.1.
                   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.
                                                            JCAHO CAM-H, EC.5.20 Pg. 310
                                                            JCAHO CAM-H, HR.2.20 Pg. 338
                                                            NFPA 101.7.2.1 Pg. 05
                   Mandatory                                NFPA 101.7.1.1
                   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.)?
                                                            National Fire Protection Association
                   Mandatory                                NFPA 72.1.5.4.4. Pg. 08
                   Fire Safety
   7.2.8.4         Is the area staff notified when the fire Interview staff.
                   alarm system is out of service or
                   being tested?
                                                            NFPA 101.19.7.1.2 Pg. 08
                   Mandatory                                National Fire Protection Association




Psych Care - 7.2                                                                      Psych Care - 7.2 - Version: 08.01.2006                                                        206 of 351
                                                            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
   7.2.8.4.1       Are cognitive aids used to remind        Look for signs placed by pull stations, and
                   staff when the fire alarm system is      interview to determine if announcements are
                   not functioning?                         made on PA system, etc.
                   Recommended
                   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 Circ. 10-90
                   Recommended                              VA MP-3, Part III, 32.36(b) & (d)
                   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.
                   ensure integrity of the flame
                   retardant agent is maintained on
                   these articles after repeated
                   laundering?
                   Recommended                              VA MP-3, Part III, 32.36(c) & (d)
                   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
                   Infection Control
   7.2.9.1         Are all linen carts (clean and soiled)   Observe conditions on the unit.
                   kept covered?
                   Mandatory                                JCAHO CAM-H, IC.4.10 Pg. 252
                   Infection Control
   7.2.9.2          RESERVED




Psych Care - 7.2                                                                       Psych Care - 7.2 - Version: 08.01.2006                                                        207 of 351
                                                          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 latex allergy policy followed   Show example if available. Consider inspecting
                   and are latex free supplies and        supply and code carts. Look for latex-free
                   equipment available?                   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 Latex Information
                   Infection Control
   7.2.9.4 - 7.2.9.5     RESERVED
                   Medical Gas Safety
   7.2.10.1 - 7.2.10.7         RESERVED
                   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.

                                                          ISMP Medication Safety Self Assessment #117 Pg. 30
                   Mandatory                              JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                   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 CAM-H, MM.2.20, EP-3 & EP-4 Pg. 231
                   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 and         will help prevent medication error by eliminating
                   syringes?                              opportunities for mix-ups . It will also avoid drug
                                                          being taken by mental health patients or those
                                                          with cognitive impairment.
                                                          JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                   Mandatory                              ISMP Self Assessment 14 Pg. 13
                   Medication Safety
   7.2.11.3.1      Is medication logically organized and Clearly marked labels and nametags.
                   identified by patient?
                   Recommended                            JCAHO CAM-H, MM.2.20, EP-13 Pg. 231




Psych Care - 7.2                                                                   Psych Care - 7.2 - Version: 08.01.2006                                                        208 of 351
                                                         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
   7.2.11.4        Are medication storage rooms          Door locking mechanism cannot be defeated for
                   secured at all times?                 any reason. Door should not be held open.
                                                         ISMP Self Assessment 75 Pg. 24
                   Mandatory                             JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                   Medication Safety
   7.2.11.5          RESERVED
                   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?
                                                         JCAHO CAM-H, MM.3.20 Pg. 233
                   Recommended                           ISMP Self Assessment 82 Pg. 25
                   Medication Safety
   7.2.11.6.1 - 7.2.11.6.2       RESERVED
                   Medication Safety
   7.2.11.7        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 Patient Safety News, Show #22, 12-03, Store IV Bags in Their
                                                         Overwraps
                   Recommended                           ISMP Medication Safety Alert, 9-03, How sterile waterbags show up on nursing units.
                   Medication Safety
   7.2.11.8 - 7.2.11.9.1       RESERVED
                   Medication Safety
   7.2.11.10       Is a unit dose medication system      Look in patient bins for bulk containers.
                   used including half tablets and
                   liquids?
                                                         Sentinel Event Alert #11, 1-19-99, High-Alert Medications and Patient
                                                         Safety
                                                         JCAHO CAM-H, MM.2.20 Pg. 231
                   Recommended                           ISMP Self Assessment 64 Pg. 22
                   Medication Safety
   7.2.11.10.1 - 7.2.11.12       RESERVED




Psych Care - 7.2                                                                   Psych Care - 7.2 - Version: 08.01.2006                                                                     209 of 351
                                                          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
   7.2.11.13       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, 11-19-99, High Alert Medications & Patient
                                                           Safety
                   Recommended                             JCAHO CAM-H, MM.4.20 Pg. 235
                   Medication Safety
   7.2.11.13.1 If admixtures are done in inpatient       Interview floor staff. If admixtures are done on
                   care areas, is an independent double- units, the area should be a designated area that
                   check system utilized?                is clean and secure. It is safest for mixtures to
                                                         be completed in pharmacy areas.
                   Recommended
                   Medication Safety
   7.2.11.14 - 7.2.11.18     RESERVED
                   Medication Safety
   7.2.11.19       Are appropriate reversal agents         In the event of an unusual reaction or overdose
                   (flumazenil, naloxone, protamine,       the agents need to be available.
                   etc.) available based on the drug
                   being administered?
                   Recommended                             ISMP Self Assessment 79 Pg. 24
               Medication Safety
   7.2.11.19.1 Is there a process to monitor the           Such as reviewing automated dispensing
               reversal agent use?                         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.

                   Recommended
                   Medication Safety
   7.2.11.20          RESERVED
                   Medication Safety
   7.2.11.21       Is there machine readable coding    Show mechanism (i.e. BCMA) in use. Machine
                   throughout the medication           readable coding should match the electronic
                   administration process (e.g. BCMA)? medical record to the patient, allowing the
                                                       information on the patients armband to be
                                                       matched with the electronic information.

                   Recommended                             ISMP Medication Safety Self Assessment, #11 Pg. 13




Psych Care - 7.2                                                                     Psych Care - 7.2 - Version: 08.01.2006                                                            210 of 351
                                                             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
   7.2.11.21.1 Is BCMA used to administer                    Observe staff.
               medication without using work
               arounds?
                   Recommended
                   Medication Safety
   7.2.11.21.2 What is the protocol for handling             Interview staff and compare practices to policy of
                   incorrect bar coded or labeled            facility/Pharmacy.
                   medications?
                   Recommended                               JCAHO CAM-H, MM.3.20, EP-5 Pg. 233
               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
   7.2.11.22 - 7.2.11.24     RESERVED
                   Medication Safety
   7.2.11.25       Is drug reference information made Interview area/unit staff, show where information
                   readily accessible to caregivers, if so is kept and how it is retrieved. One or two
                   how?                                    reference sources should be available as well as
                                                           access to pharmacist.
                                                             ISMP Self Assessment 18.2 Pg. 15
                   Recommended                               JCAHO-CAMH. IM.3.10 Pg. 349
                   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).
                                                             JCAHO CAM-H, IM.3.10 Pg. 349
                   Recommended                               ISMP Medication Safety Self Assessment, #19 Pg. 15
                   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.

                                                             JCAHO CAM-H, MM.2.20, EP-6 Pg. 231
                   Recommended                               Sentinel Event Alert #19, May 2001, Look-alike, sound-alike drug names




Psych Care - 7.2                                                                      Psych Care - 7.2 - Version: 08.01.2006                                                               211 of 351
                                                            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
   7.2.11.27.1           RESERVED
                   Medication Safety
   7.2.11.28       Do prohibited abbreviations conform For example "u" in unit may be mistaken for "0"
                   to minimum JCHAO Patient Safety     resulting in ten fold over dosage.
                   Goal requirements?
                                                            ISMP Medication Safety Self Assessment #40 Pg. 19
                                                            JCAHO Patient Safety Goals, Goal #2b
                                                            JCAHO CAM-H, MM.3.20 Pg. 233
                                                            Sentinel Event Alert #11, 11-19-99, High-Alert Medications & Patient Safety
                                                            Sentinel Event Alert #23, 9-2001, Medication errors related to ....abbreviations
                   Mandatory                                JCAHO CAM-H, IM.3.10 Pg. 349
                   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 CAM-H, MM.4.50 Pg. 236
                   Medication Safety
   7.2.11.30 - 7.2.11.31.1       RESERVED
                   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 Medication Safety Self Assessment #26 Pg. 16
                   Medication Safety
   7.2.11.33           RESERVED
                   Medication Safety
   7.2.11.34       Are patients educated regarding their Show example.
                   prescribed medication, as inpatients
                   and as part of the discharge
                   process?
                   Recommended                              JCAHO CAM-H, PC.6.10 Pg. 193




Psych Care - 7.2                                                                       Psych Care - 7.2 - Version: 08.01.2006                                                                 212 of 351
                                                           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
   7.2.11.35       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 Medication Safety Self Assessment #23 Pg. 16
                   Recommended                             JCAHO CAM-H, MM.4.10 Pg. 234
                   Medication Safety
   7.2.11.36 - 7.2.11.41.1       RESERVED
                   Medication Safety
   7.2.11.42       Has a effective process begun to        JCAHO is requiring all facilites have a plan in
                   reconcile patient medications upon      place by January 2006.
                   admission, transfer or discharge?
                   Recommended
                   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.
                                                           JCAHO CAM-H, MM.3.20, EP-7 Pg. 233
                                                           JCAHO Patient Safety Goals, Goal #2a
                   Mandatory                               ISMP Medication Safety Self Assessment #45 Pg. 20
                   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
                   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.

                   Recommended                             JCAHO CAM-H, IM.2.10 Pg. 347
                   General Patient Safety Concerns
   7.2.12.4        Are staff required to wear              Monitor patient care areas. Interview staff about
                   identification badges, and are          policies such as the handling of drug
                   unauthorized persons kept out of        manufacturer representatives that visit
                   patient care areas?                     unexpectedly.
                   Recommended                             JCAHO CAM-H, PC.1.2 & PC 2.2 Pg. 182




Psych Care - 7.2                                                                   Psych Care - 7.2 - Version: 08.01.2006                                                        213 of 351
                                                         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
   7.2.12.5        Are restraints used in accordance     Randomly interview staff. Look for restraint
                   with local policy and are restraint   devices or alterative devices in the area.
                   alternative devices available and
                   used when appropriate?
                                                         Sentinel Event Alert #8, 11-98, Preventing Restraint Deaths
                   Recommended                           JCAHO CAM-H, PC.11.10 & PC.12.10 Pg. 199
                   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 identifcation requriements 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
                                                         adminstration or collection begins.

                   Mandatory; Priority A                 JCAHO Patient Safety Goals, Goal #1a
                   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; Priority A




Psych Care - 7.2                                                                   Psych Care - 7.2 - Version: 08.01.2006                                                        214 of 351
                                                         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; Priority A
                   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; Priority A
                   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
                   General Patient Safety Concerns
   7.2.12.8        Is transfer of care between shifts    A consistent process should exist to update on-
                   standardized?                         coming staff of patient statues. Interview staff
                                                         and compare answers between units.
                   Recommended




Psych Care - 7.2                                                            Psych Care - 7.2 - Version: 08.01.2006                                                        215 of 351
                                                           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
   7.2.12.9        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
                   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 The protocol should be made up of a mechanism
                   response protocol for dealing with  for 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
                   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




Psych Care - 7.2                                                                    Psych Care - 7.2 - Version: 08.01.2006                                                        216 of 351
                                                          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
   7.2.12.12       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?

                   Mandatory                              JCAHO CAM-H, PC.13.20 Pg. 214
                   Psychiatric Precautions
   7.2.13.1        Are all mounted fixtures designed to Breakaway rods and sprinkler heads; flush
                   prevent attachment of devices that   mounted vent covers free of louvers; no
                   could be used to inflict self-harm?  attachment points on furniture parts or doors
                                                        (i.e., hooks) or any thing fixed to the walls or
                                                        ceilings. Tamper resistant screws should be
                                                        used on all devices the patient has access to.
                   Recommended
                   Psychiatric Precautions
   7.2.13.2        Are light fixtures flush-mounting type, Inspect ward and patient rooms. Tamper
                   and indicated for use in psychiatric    resistant screws/attachment devices should be
                   areas used?                             used.
                   Recommended
                   Psychiatric Precautions
   7.2.13.3        Are observation, restroom, and         Mirrors should be stainless steel, not glass.
                   patient room mirrors shatter-
                   resistive?
                   Recommended
                   Psychiatric Precautions
   7.2.13.4        Is the psychiatric ward and patient    If cords are present, should be shortened to 4
                   rooms free of cords?                   inches or less. Any length of cord is not
                                                          recommended for seclusion rooms.
                   Recommended
                   Psychiatric Precautions
   7.2.13.5        Is the psychiatric ward and patient    Inspect ward and patient rooms.
                   rooms free of coat hangers, lamps,
                   steel trash cans or other items that
                   could be used as weapons?
                   Recommended




Psych Care - 7.2                                                               Psych Care - 7.2 - Version: 08.01.2006                                                        217 of 351
                                                            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
                   Psychiatric Precautions
   7.2.13.6        Is furniture that could be tipped over   Inspect ward and patient rooms. Often even
                   secured to the walls or floor and free   small furniture parts can be disassembled and
                   of removable parts/drawers?              misused by patties, such as chair leg pads (fixed
                                                            with nails) and springs used to keep things open
                                                            or closed.
                   Recommended
                   Psychiatric Precautions
   7.2.13.7        Are ceilings in bathrooms, sleeping      Ceilings and walls should be constructed of dry-
                   rooms and other spaces not in direct     wall board, plaster/lath or metal panel.
                   line of sight of the nursing station     Fasteners (such as screws and brackets) should
                   constructed of permanent fixed           be tamper-resistant, meaning they cannot be
                   material with no exposed piping and      removed without use of a special tool.
                   are fixtures or access panels
                   attached with tamper-resistant
                   fasteners?
                   Recommended
                   Psychiatric Precautions
   7.2.13.8        Are trash receptacles free of plastic    Inspect ward and patient rooms.
                   trash bags in patient rooms and
                   other areas not in sight of the
                   nursing station?
                   Recommended
                   Psychiatric Precautions
   7.2.13.9        Are sharps containers tamper proof Inspect ward and patient rooms.
                   and installed for specifications within
                   psychiatric wards?
                   Recommended
                   Psychiatric Precautions
   7.2.13.10       Are rooms free of combustibles?          Excluding items such as beds, linens, furniture.
                                                            Mattresses should be fire-resistive, however.

                   Recommended




Psych Care - 7.2                                                              Psych Care - 7.2 - Version: 08.01.2006                                                        218 of 351
                                                          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
                   Psychiatric Precautions
   7.2.13.11       Are electric and manually adjustable   Platform beds are the safest for an acute
                   beds been eliminated unless clinical   psychiatric environment. If electrical beds are
                   need indicates?                        necessary, power cords should be shortened
                                                          and securely fastened. When possible beds
                                                          should be secured to the walls or the floor.
                   Recommended
                   Psychiatric Precautions
   7.2.13.12       Have necessary precautions been        Breakaway or flush mount fixtures; no exposed
                   taken in the design of bath/shower     piping; flush electrical fixtures; shatter proof
                   areas, including toilets?              mirrors; electrical fixture covers; institutional
                                                          toilet and fixtures; doors cannot lock. Shelves
                                                          used as an alternative to assist bars.

                   Recommended
                   Psychiatric Precautions
   7.2.13.13       Are all doors constructed and          Doors open outward; no hold open devices
                   installed for psychiatric areas?       attached; handle type openers (no knobs). Door
                                                          windows are made of wired, laminated or plexi-
                                                          glass. Hinge guards applied.
                   Recommended
                   Psychiatric Precautions
   7.2.13.14       Are windows constructed and            Windows should be fixed, remain locked or have
                   installed for psychiatric areas?       maximum opening of 6"; have no or minimal
                                                          window treatments, with cords shortened if any;
                                                          breakaway rods; glass should be wired,
                                                          laminated or plexi-glass; and weather stripping, if
                                                          provided, shall be permanently affixed or shall
                                                          not be capable of being removed with the use of
                                                          a special tool.
                   Recommended
                   Psychiatric Precautions
   7.2.13.15       Is alcohol-based sanitation gel kept   Inspect ward and patient rooms. Interview staff
                   in areas not accessible to patients?   to determine if vulnerability has been identified.

                   Recommended
                   Psychiatric Precautions
   7.2.13.16          RESERVED




Psych Care - 7.2                                                             Psych Care - 7.2 - Version: 08.01.2006                                                        219 of 351
                                                          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
                   Psychiatric Precautions
   7.2.13.17       Are special precautions in place for   All fixtures (covers/vents/windows) secured with
                   seclusion rooms?                       tamper-proof screws; all furniture is free of
                                                          separate pieces/parts, and secured; room free of
                                                          decorations; solid ceilings and walls; institutional
                                                          sprinklers; laminated glazing or wired glass in
                                                          windows; mirrors that are non-breakable yet
                                                          provide a true image (not distorted).

                   Recommended
                   Psychiatric Precautions
   7.2.13.18       Are seclusion room beds free of        No protrusions, posts, or sharp edges/corners;
                   potential hazards to patients?         head/foot boards removed or secured; bed
                                                          secured to the floor.
                   Recommended
                   Surgical or Invasive Procedure Precautions
   7.2.14.1 - 7.2.14.19    RESERVED
                   Imaging and X-rays Precautions
   7.2.15.1 - 7.2.15.12    RESERVED




Psych Care - 7.2                                                             Psych Care - 7.2 - Version: 08.01.2006                                                        220 of 351
                       Patient Safety Assessment Tool
                       Part II Implementation
                       Element: Acute Care - 7.3
                           Categories:
                           Bed Safety                              1-2
                           Code Carts                              2-3
                           Electrical Safety                       4-5
                           Environmental and Housekeeping Safety   5-7
                           Equipment Safety                        7 - 10
                           Escape and Elopement Prevention         10 - 12
                           Fall Prevention                         12 - 14
                           Fire Safety                             14 - 16
                           Infection Control                       16 - 17
                           Medical Gas Safety                      17 - 18
                           Medication Safety                       18 - 25
                           General Patient Safety Concerns         25 - 29



Tuesday, August 01, 2006                                                     221 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                             Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                          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
   7.3.1.1         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
                                                             JCAHO Sentinel Event Alert #27
                                                             Preventing Bed Entrapment Poster
                   Mandatory                                 Patient Safety Alert 7-13-01, Bed Rail Entrapment
                   Bed Safety
   7.3.1.2         Are bed rails easy to use, and have       Manipulate bed rails if available and interview
                   staff been trained on the usage?          staff.

                   Recommended
                   Bed Safety
   7.3.1.3         Are non-compliant beds clearly            All new beds must meet requirement, & existing
                   marked as to indicate entrapment          non-compliant beds marked.
                   risk?
                   Mandatory                                 Patient Safety Alert 7-13-01, Bed Rail Entrapment
                   Bed Safety
   7.3.1.4         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 for Nursing Homes




Acute Care - 7.3                                                                       Acute Care - 7.3 - Version: 08.01.2006                                                        222 of 351
                                                          NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                       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
   7.3.1.5         Is the appropriate bed-type matched LTC patients can acquire bed sores; cardiac
                   to the level of care needed for each patients beds designed to facilitate CPR, etc.
                   patient?
                   Recommended
                   Bed Safety
   7.3.1.6         Are beds with built-in weight scales   Preventative maintenance tags should be up to
                   accurate and functioning correctly?    date. Interview nurses if any double checks are
                                                          in place for weight of patients.
                   Recommended
                   Bed Safety
   7.3.1.7         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.
                                                          FDA Public Health Notification: Safety Tips for Preventing Hospital Bed
                   Recommended
                                                          Fires
                   Code Carts
   7.3.2.1         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?                             records.
                   Mandatory                              JCAHO CAM-H: MM.2.30 Pg. 232
                   Code Carts
   7.3.2.1.1 - 7.3.2.2     RESERVED




Acute Care - 7.3                                                                    Acute Care - 7.3 - Version: 08.01.2006                                                               223 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                       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
   7.3.2.3         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.
                   carts throughout the hospital?
                   Recommended
                   Code Carts
   7.3.2.4         Is the VHA modified version of the      Inspect top of cart and review checklist of
                   AHA Handbook of Cardiovascular          contents if provided.
                   Care Cognitive Aid located on all
                   carts?
                   Recommended
                   Code Carts
   7.3.2.5         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.
                   Recommended                             VHA Airway Directive
                   Code Carts
   7.3.2.6         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?                      tank volume; tubing ; CO2 detectors; appropriate
                                                           medications; AED (or other defibrillators) and
                                                           suction machine functionality; laryngoscope with
                                                           batteries; cardiac board, etc.

                   Recommended




Acute Care - 7.3                                                                  Acute Care - 7.3 - Version: 08.01.2006                                                        224 of 351
                                                        NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                       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
   7.3.3.1         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
                                                         can be completely removed or covered in patient
                                                         rooms to protect patients who my try to harm
                                                         themselves.

                                                         National Fire Protection Guidebooks (NFPA)
                                                         NFPA 99-4.3.2.2.8.1 Pg. 04
                   Mandatory                             NFPA 99-4.3.2.2.6.2(D) Pg. 03
                   Electrical Safety
   7.3.3.2         Are electrical receptacles fitted with Observe conditions on unit.
                   covers, secured, and free of loose or
                   exposed wiring?
                                                         NFPA 99-4.3.3.2.1. Pg. 08
                   Mandatory                             National Fire Protection Association
                   Electrical Safety
   7.3.3.2.1          RESERVED
                   Electrical Safety
   7.3.3.3         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.
                   emergency power circuits?
                                                         NFPA 99 4.4.2.2.4.2(B). Pg. 21
                   Mandatory                             National Fire Protection Association
                   Electrical Safety
   7.3.3.4         Are electrically powered medical      Cords are free of physical defects including
                   devices in good condition?            cracks, frayed ends, or missing prongs.
                                                         NFPA 99-8.4.1.3.1 Pg. 03
                                                         National Fire Protection Association
                   Mandatory                             VHA Directive 2002-030, Electrical Safety Policy for Patient Care Equipment




Acute Care - 7.3                                                                    Acute Care - 7.3 - Version: 08.01.2006                                                             225 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                             Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                          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
   7.3.3.5         Are there at least 4 receptacles (6 in Inspect patient rooms.
                   critical care) for each patient bed?

                                                            National Fire Protection Association
                   Mandatory                                NFPA 99 4.3.2.2.6.2 (A) Pg. 03
                   Electrical Safety
   7.3.3.6         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.

                                                            NFPA 99 10.2.2.2.7.7 Pg. 03
                                                            National Fire Protection Association Online Guidelines
                                                            NFPA 99 10.2.2.2.1.1. Pg. 02
                   Recommended                              JCAHO CAM-H ec.1.10 Pg. 303
                   Electrical Safety
   7.3.3.7          RESERVED
                   Environmental and Housekeeping Safety
   7.3.4.1         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, Domestic Hot Water Temperature Limits
                   Environmental and Housekeeping Safety
   7.3.4.2         Are supply and return air registers Observe conditions on the unit.
                   clean and free of lint and dust?
                   Recommended                              JCAHO CAM-H, EC 8.10 Pg. 320
                   Environmental and Housekeeping Safety
   7.3.4.3         Does general housekeeping appear Cleanliness, sanitation, odor, etc.
                   to be a priority?
                   Recommended                              JCAHO CAM-H, EC 8.10 Pg. 320




Acute Care - 7.3                                                                       Acute Care - 7.3 - Version: 08.01.2006                                                        226 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                       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
   7.3.4.4         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.
                   Recommended                           JCAHO CAM-H, EC 5.20 Pg. 310
                   Environmental and Housekeeping Safety
   7.3.4.5         Are patient care area hallways and   Observe conditions on the unit.
                   stairways unobstructed and kept free
                   of storage?
                                                         National Fire Protection Association
                                                         JCAHO CAM-H, ED 5.20 Pg. 310
                   Mandatory                             NFPA 101 (LSC) 7.1.10. Pg. 05
                   Environmental and Housekeeping Safety
   7.3.4.6         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 CAM-H, EC 1.10 Pg. 303
                   Environmental and Housekeeping Safety
   7.3.4.7         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.

                                                         JCAHO CAM-H, EC 5.50 Pg. 313
                                                         VA Directive 7703c(4)(a)
                   Mandatory                             29CFR 1926.20(b)




Acute Care - 7.3                                                                    Acute Care - 7.3 - Version: 08.01.2006                                                        227 of 351
                                                        NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                      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
   7.3.4.8         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 caution
                   signage and locked to prevent
                   unauthorized entrance?

                   Mandatory                            VA Directive 7703c(4)(a)
                   Environmental and Housekeeping Safety
   7.3.4.9          RESERVED
                   Environmental and Housekeeping Safety
   7.3.4.10        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.
                   Recommended
                   Equipment Safety
   7.3.5.1         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.
                                                        JCAHO Patient Safety Goals #6a
                                                        National Fire Protection Association Guidelines 99.8.2.2.2
                                                        National Fire Protection Association Codes Online
                   Mandatory                            JCAHO CAM-H, EC 6.20 Pg. 315
                   Equipment Safety
   7.3.5.2         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 CAM-H, EC 6.10 Pg. 314




Acute Care - 7.3                                                                   Acute Care - 7.3 - Version: 08.01.2006                                                        228 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                            Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                         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
   7.3.5.3         Is the equipment used on each             There is no chance equipment would be
                   patient positioned in a way that it is    inadvertently shut off because it is not in sight of
                   evident the equipment is in use for       the patient.
                   that patient?
                   Recommended
                   Equipment Safety
   7.3.5.4         Are alarms audible and easily             Alarms may be broadcast to an outside room or
                   distinguished above ambient               another area such as a central nursing station.
                   background noise level?                   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 Patient Safety Goals, Goal #6b
                   Equipment Safety
   7.3.5.4.1       Is the unit layout/configuration          Observe conditions and interview staff.
                   conducive to hearing all alarms,
                   especially for isolation rooms?
                   Recommended
                   Equipment Safety
   7.3.5.5         Are all devices that alarm specifically   Masking is when the frequency and intensity of
                   set up for each patient to reduce         two separate alarms blend together causing
                   issues such as, "masking", nuisance,      heightened confusion; nuisance alarms are
                   or altered priority due to unwanted       caused when limits are not appropriately set, this
                   false or alarms?                          can create staff complacency, annoyance to
                                                             patients, and results in a delayed staff response
                                                             (cry wolf syndrome).
                   Recommended                               JCAHO Patient Safety Goals, Goal #6b
                   Equipment Safety
   7.3.5.5.1       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




Acute Care - 7.3                                                                     Acute Care - 7.3 - Version: 08.01.2006                                                        229 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                             Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                          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
   7.3.5.6         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
   7.3.5.7         Is patient care and monitoring           All screens/interfaces are readable and at or
                   equipment well organized in each         near eye level; key pads within reach; equipment
                   patient/procedure room to avoid          is not blocking each other; adequate space to
                   clutter and permit the caregivers to     move around, including head clearance on
                   be able to reach and read all            mounted devices.
                   equipment?
                   Recommended
                   Equipment Safety
   7.3.5.8         Are liquids kept away from medical       To prevent spillage which can result in
                   equipment?                               malfunctioning.
                                                            NFPA 70 110.11.
                   Recommended                              National Fire Protection Association
                   Equipment Safety
   7.3.5.9         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
   7.3.5.10        Is a reliable system used to identify    Examples: Color coding or directional arrows for
                   which tubes and connectors go to         input jacks. If color labeling is used it must be
                   which devices?                           consistent throughout the unit.
                   Recommended
                   Equipment Safety
   7.3.5.10.1      Are the tubes/connectors kept out of Taped down, or use of a hanger or device can
                   the way to avoid them from being     help to lead them away from the patient.
                   inadvertently unplugged?
                   Recommended




Acute Care - 7.3                                                                       Acute Care - 7.3 - Version: 08.01.2006                                                        230 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                        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
   7.3.5.11        Are the location and model of AEDs The location on the code cart or within unit
                   standardized throughout the facility? should be the same from area to area. Compare
                                                         models in unit, and from unit to unit.
                   Recommended
                   Equipment Safety
   7.3.5.12          RESERVED
                   Equipment Safety
   7.3.5.13        Does the hospital purchase              Having sterile water for injection in units on the
                   humidification devices that do not      floor creates the potential for misuse. Warnings
                   require the use of sterile water?       have been published (ISMP) regarding water
                                                           being confused with other medications resulting
                                                           in it being give intravenously resulting in fatal
                                                           hemolysis.
                                                           FDA Patient Safety News, #22, 12-03, Store IV Bags in Their
                                                           Overwraps
                   Recommended                             ISMP 9/18/2003, How sterile water bags show up on nursing units
                   Equipment Safety
   7.3.5.13.1      If humidification devices use sterile   If sterile water must be used it is recommend that
                   water is it provided in 2 Liter bags    it be used in 2 Liter bags. The 2 Liter bags will
                   and labeled "Sterile Water"?            help distinguish the sterile water from the 1 Liter
                                                           bags of IV solutions, also pour bottles could be
                                                           considered.
                                                           ISMP 9/18/2003, How sterile water bags show up on nursing units
                   Recommended                             FDA Patient Safety News, Show #22, 12-03, Store IV Bags in Their Overwraps
                   Equipment Safety
   7.3.5.14        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
   7.3.6.1         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?
                                                           JCAHO CAM-H, PC.1.1 Pg. 183
                   Recommended                             Cognitive Aids - Escape Elopement




Acute Care - 7.3                                                                    Acute Care - 7.3 - Version: 08.01.2006                                                             231 of 351
                                                          NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                      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
   7.3.6.2         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
                   Escape and Elopement Prevention
   7.3.6.3         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 Patient Safety Goals, Goal #6a
                   Escape and Elopement Prevention
   7.3.6.4         Have staff been involved in an  Interview staff.
                   elopement drill (grid search)?
                   Recommended
                   Escape and Elopement Prevention
   7.3.6.5         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.

                                                          VHA Directive 2002-013, Management of Wandering & Missing Patient
                   Mandatory
                                                          Events
                   Escape and Elopement Prevention
   7.3.6.5.1       If an elopement risk assessment is Discuss with ward staff the wander and
                   to be completed for patients, are  elopement policies.
                   staff familiar with the
                   wandering/elopement prevention
                   protocol or SOP?
                                                          VHA Directive 2002-013, Management of Wandering & Missing Patient
                   Mandatory
                                                          Events




Acute Care - 7.3                                                                  Acute Care - 7.3 - Version: 08.01.2006                                                           232 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                       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
   7.3.6.6         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
                   Escape and Elopement Prevention
   7.3.6.7         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
   7.3.7.1         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?                        with nightlights.
                   Recommended                               JCAHO CAM-H, EC.1.10 Pg. 303
                   Fall Prevention
   7.3.7.2         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
   7.3.7.2.1       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?
                   Recommended




Acute Care - 7.3                                                                  Acute Care - 7.3 - Version: 08.01.2006                                                        233 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                             Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                          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
   7.3.7.3         Are the floors clean and free of         Floors should be free of liquids, electrical cords,
                   slipping and tripping hazards?           wires, tubes, or other connectors which can
                                                            create fall hazards. Patient rooms should be free
                                                            of low-lying objects that could be tripped over
                                                            causing falls.
                   Recommended                              JCAHO CAM-H, EC.1.10 Pg. 303
                   Fall Prevention
   7.3.7.4         Do shower/bathroom areas have            Inspect areas specified. Bathrooms should be
                   adequate lighting, proper drainage,      provided with night lights. If a raised seats are
                   non-slip floor surfaces, and handrails   used on toilets are they is the color of it
                   installed?                               contracting to toilet to help patients see it clearly.

                   Recommended                              JCAHO CAM-H, EC.1.10 Pg. 303
                   Fall Prevention
   7.3.7.5         Are call buttons within reach of the     Inspect all areas.
                   patient?
                   Recommended
                   Fall Prevention
   7.3.7.6         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, Fatal Falls: Lessons for the Future
                   Recommended                              JCAHO Patient Safety Goals, Goal #6b
                   Fall Prevention
   7.3.7.7         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.

                   Recommended




Acute Care - 7.3                                                                       Acute Care - 7.3 - Version: 08.01.2006                                                        234 of 351
                                                          NCPS Patient Safety Assessment Tool

                                                                            Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                        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
   7.3.7.8         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?
                   Recommended                            JCAHO CAM-H, PC.2.120 and PC.2.150 Pg. 186
                   Fall Prevention
   7.3.7.9         Does equipment (lifting equipment,     Review equipment, interview staff. Patients
                   OR tables, etc.) have sufficient       weighing in excess of 400 pounds are not
                   capacity to meet the needs of          uncommon. If equipment cannot support the
                   bariatric patients?                    weight of the patient contingency plans should
                                                          be developed to provide care.
                   Recommended
                   Fall Prevention
   7.3.7.10          RESERVED
                   Fire Safety
   7.3.8.1         Are staff members familiar with fire   Interview staff to determine familiarity.
                   emergency procedures, and the fire
                   prevention plan for their service
                   area?
                                                          JCAHO CAM-H, HR.2.20 Pg. 338
                                                          JCAHO CAM-H, EC.5.20 Pg. 310
                                                          NFPA 101.7.2.3 Pg. 08
                                                          NFPA 101.7.2.1 Pg. 05
                   Mandatory                              NFPA 101.7.1.1.
                   Fire Safety
   7.3.8.2         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.
                                                          JCAHO CAM-H, EC.5.20 Pg. 310
                                                          JCAHO CAM-H, HR.2.20 Pg. 338
                                                          NFPA 101.7.2.1 Pg. 05
                   Mandatory                              NFPA 101.7.1.1




Acute Care - 7.3                                                                  Acute Care - 7.3 - Version: 08.01.2006                                                        235 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                             Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                          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
   7.3.8.3         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.)?
                                                            National Fire Protection Association
                   Mandatory                                NFPA 72.1.5.4.4. Pg. 08
                   Fire Safety
   7.3.8.4         Is the area staff notified when the fire Interview staff.
                   alarm system is out of service or
                   being tested?
                                                            NFPA 101.19.7.1.2 Pg. 08
                   Mandatory                                National Fire Protection Association
                   Fire Safety
   7.3.8.4.1       Are cognitive aids used to remind        Look for signs placed by pull stations, and
                   staff when the fire alarm system is      interview to determine if announcements are
                   not functioning?                         made on PA system, etc.
                   Recommended
                   Fire Safety
   7.3.8.5         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 Circ. 10-90
                   Recommended                              VA MP-3, Part III, 32.36(b) & (d)
                   Fire Safety
   7.3.8.5.1       If flame retardant pajamas or linens     Interview staff, determine if practices are
                   are used, is a process in place to       consistent with policy.
                   ensure integrity of the flame
                   retardant agent is maintained on
                   these articles after repeated
                   laundering?
                   Recommended                              VA MP-3, Part III, 32.36(c) & (d)




Acute Care - 7.3                                                                       Acute Care - 7.3 - Version: 08.01.2006                                                        236 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                             Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                          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
   7.3.8.6          RESERVED
                   Infection Control
   7.3.9.1         Are all linen carts (clean and soiled)   Observe conditions on the unit.
                   kept covered?
                   Mandatory                                JCAHO CAM-H, IC.4.10 Pg. 252
                   Infection Control
   7.3.9.2         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 CAM-H, EC.4.10 Pg. 252
                   Infection Control
   7.3.9.3         Is the latex allergy policy followed     Show example if available. Consider inspecting
                   and are latex free supplies and          supply and code carts. Look for latex-free
                   equipment available?                     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 Latex Information
                   Infection Control
   7.3.9.4         Are the VA recommended hand              The individual products should be an alcohol rub
                   hygiene guidelines followed, such as     (for disinfecting) and a hospital approved lotion
                   having alcohol-based gel                 (to prevent skin dryness). Also, staff who come
                   disinfectants located to promote use     in contact with patients or prepare sterile
                   (including inpatient rooms), and         products (such as IV drugs) should not have
                   providing individual products to all     artificial fingernails. Clinicians should also be
                   necessary staff?                         offered the small (2-4 oz.) personal containers of
                                                            hand gel. Gel should be in convenient locations
                                                            including all carts (mobile care, medication carts,
                                                            code, respiratory).

                                                            VHA Hand Hygiene Directive, 2005-002 July 2005
                                                            JCAHO CAM-H, IC.4.10 Pg. 252
                                                            JCAHO Patient Safety Goals, Goal #7a
                                                            CDC Guidelines for Hand Hygiene in Health-care Settings
                   Mandatory                                Sentinel Event Alert 1-22-2003, Infection related sentinel events




Acute Care - 7.3                                                                       Acute Care - 7.3 - Version: 08.01.2006                                                        237 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                            Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                         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
   7.3.9.5         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)?
                                                           OSHA, 29 CFR 1910.145
                   Mandatory                               CDC Guidelines for Environmental Infection Control in Health-Care Facilities
                   Medical Gas Safety
   7.3.10.1        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.
                                                           Patient Safety Advisory 3-5-2002, Confusion Between Oxygen &
                   Recommended
                                                           Compressed Air Wall Outlet
                   Medical Gas Safety
   7.3.10.2        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.
                                                           Patient Safety Advisory 3-5-2002, Confusion Between Oxygen &
                   Recommended
                                                           Compressed Air Wall Outlet
                   Medical Gas Safety
   7.3.10.3        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.

                                                           National Fire Protection Association
                                                           NFPA 5.1.4.2.1. Pg. 17
                   Mandatory                               JCAHO CAM-H, EC.7.50 Pg. 319
                   Medical Gas Safety
   7.3.10.4        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).
                                                           NCPS O2 Hazard Summary
                   Mandatory                               NCGA (Compressed Gas Association) C-9, 3.7 & 4.6




Acute Care - 7.3                                                                      Acute Care - 7.3 - Version: 08.01.2006                                                              238 of 351
                                                          NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                      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
                   Medical Gas Safety
   7.3.10.4.1      Are all area/unit personnel             Staff to demonstrate competency.
                   competent in understanding the
                   handling procedures of oxygen
                   cylinders, including how to obtain full
                   cylinders? If so, is current practices
                   in line with the facility's written
                   procedure?
                   Mandatory                              NCPS O2 Hazard Summary
                   Medical Gas Safety
   7.3.10.5        Are pins on medical gas regulators     Pins should be in place and found undamaged.
                   and cylinders in good repair and is
                   damaged equipment immediately
                   removed from service?
                   Recommended                            NCPS O2 Hazard Summary
                   Medical Gas Safety
   7.3.10.6        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.
                   Recommended                            NCPS O2 Hazard Summary
                   Medical Gas Safety
   7.3.10.7          RESERVED
                   Medication Safety
   7.3.11.1        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.

                                                          ISMP Medication Safety Self Assessment #117 Pg. 30
                   Mandatory                              JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                   Medication Safety
   7.3.11.2        Do medication carts remained locked Randomly survey carts in the area.
                   and inaccessible to patients when
                   not in use?
                   Mandatory                              JCAHO CAM-H, MM.2.20, EP-3 & EP-4 Pg. 231




Acute Care - 7.3                                                                  Acute Care - 7.3 - Version: 08.01.2006                                                        239 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                      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
   7.3.11.3        Are the tops of medication carts,     Randomly survey carts in the area. Clean carts
                   clean, free of stray drugs and        will help prevent medication error by eliminating
                   syringes?                             opportunities for mix-ups . It will also avoid drug
                                                         being taken by mental health patients or those
                                                         with cognitive impairment.
                                                         JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                   Mandatory                             ISMP Self Assessment 14 Pg. 13
                   Medication Safety
   7.3.11.3.1      Is medication logically organized and Clearly marked labels and nametags.
                   identified by patient?
                   Recommended                           JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                   Medication Safety
   7.3.11.4        Are medication storage rooms          Door locking mechanism cannot be defeated for
                   secured at all times?                 any reason. Door should not be held open.
                                                         ISMP Self Assessment 75 Pg. 24
                   Mandatory                             JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                   Medication Safety
   7.3.11.5          RESERVED
                   Medication Safety
   7.3.11.6        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?
                                                         JCAHO CAM-H, MM.3.20 Pg. 233
                   Recommended                           ISMP Self Assessment 82 Pg. 25
                   Medication Safety
   7.3.11.6.1 - 7.3.11.6.2       RESERVED
                   Medication Safety
   7.3.11.7        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 Patient Safety News, Show #22, 12-03, Store IV Bags in Their
                                                         Overwraps
                   Recommended                           ISMP Medication Safety Alert, 9-03, How sterile waterbags show up on nursing units.
                   Medication Safety
   7.3.11.8          RESERVED




Acute Care - 7.3                                                                   Acute Care - 7.3 - Version: 08.01.2006                                                                     240 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                             Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                         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
   7.3.11.8.1      Is access limited to electrolyte    Review local policies, and interview pharmacy
                   replacement solutions (above or     staff. Show example.
                   below 0.9% sodium chloride) outside
                   the pharmacy?
                   Recommended                              ISMP Self Assessment 92 Pg. 26
                   Medication Safety
   7.3.11.9          RESERVED
                   Medication Safety
   7.3.11.9.1      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).

                                                            JCAHO Patient Safety Goals, Goal #3b
                                                            Sentinel Event Alert #11, 11-19-99, High-Alert Medications and Patient Safety
                                                            ISMP Self Assessment 67.1 & 20 Pg. 23
                                                            JCAHO CAM-H, MM 2.20, EP-8 Pg. 231
                   Mandatory                                JCAHO CAM-H, MM 7.10 Pg. 240
                   Medication Safety
   7.3.11.10       Is a unit dose medication system         Look in patient bins for bulk containers.
                   used including half tablets and
                   liquids?
                                                            Sentinel Event Alert #11, 1-19-99, High-Alert Medications and Patient
                                                            Safety
                                                            JCAHO CAM-H, MM.2.20 Pg. 231
                   Recommended                              ISMP Self Assessment 64 Pg. 22
                   Medication Safety
   7.3.11.10.1 - 7.3.11.12       RESERVED
                   Medication Safety
   7.3.11.13       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, 11-19-99, High Alert Medications & Patient
                                                            Safety
                   Recommended                              JCAHO CAM-H, MM.4.20 Pg. 235




Acute Care - 7.3                                                                      Acute Care - 7.3 - Version: 08.01.2006                                                               241 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                      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
   7.3.11.13.1 If admixtures are done in inpatient   Interview floor staff. If admixtures are done on
               care areas, is an independent double- units, the area should be a designated area that
               check system utilized?                is clean and secure. It is safest for mixtures to
                                                     be completed in pharmacy areas.
                   Recommended
                   Medication Safety
   7.3.11.14       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.
                                                         American Soc of Anesthesiology Newsletter Dec 2000
                   Recommended                           ISMP Medication Safety Alert June 2000
                   Medication Safety
   7.3.11.15       Are premixed IV solutions kept in      The protective over-wrap for some solutions
                   over-wrap bags until they are ready    serves to control the amount of water vapor that
                   to be used (if applicable)?            escapes from an IV solution. Once unwrapped it
                                                          is best to use the solution right way.

                                                         FDA Patient Safety News, #22, 12-03, Store IV Bags in Their
                   Recommended
                                                         Overwraps
                   Medication Safety
   7.3.11.16       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)?
                                                         FDA Patient Safety News, #22, 12-03, Store IV Bags in Their
                   Recommended
                                                         Overwraps
                   Medication Safety
   7.3.11.17       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?                              pumps.
                                                         Sentinel Event Alert #11, 11-19-99, High-Alert Medications & Patient
                   Recommended
                                                         Safety
                   Medication Safety
   7.3.11.18          RESERVED
                   Medication Safety
   7.3.11.19       Are appropriate reversal agents        In the event of an unusual reaction or overdose
                   (flumazenil, naloxone, protamine,      the agents need to be available.
                   etc.) available based on the drug
                   being administered?
                   Recommended                           ISMP Self Assessment 79 Pg. 24




Acute Care - 7.3                                                                   Acute Care - 7.3 - Version: 08.01.2006                                                            242 of 351
                                                     NCPS Patient Safety Assessment Tool

                                                                     Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                  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
   7.3.11.19.1 Is there a process to monitor the      Such as reviewing automated dispensing
               reversal agent use?                    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.

                   Recommended
                   Medication Safety
   7.3.11.20          RESERVED
                   Medication Safety
   7.3.11.21       Is there machine readable coding    Show mechanism (i.e. BCMA) in use. Machine
                   throughout the medication           readable coding should match the electronic
                   administration process (e.g. BCMA)? medical record to the patient, allowing the
                                                       information on the patients armband to be
                                                       matched with the electronic information.

                   Recommended                        ISMP Medication Safety Self Assessment, #11 Pg. 13
               Medication Safety
   7.3.11.21.1 Is BCMA used to administer             Observe staff.
               medication without using work
               arounds?
                   Recommended
                   Medication Safety
   7.3.11.21.2 What is the protocol for handling      Interview staff and compare practices to policy of
                   incorrect bar coded or labeled     facility/Pharmacy.
                   medications?
                   Recommended                        JCAHO CAM-H, MM.3.20, EP-5 Pg. 233
               Medication Safety
   7.3.11.21.3 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
   7.3.11.22          RESERVED




Acute Care - 7.3                                                              Acute Care - 7.3 - Version: 08.01.2006                                                        243 of 351
                                                             NCPS Patient Safety Assessment Tool

                                                                             Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                          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
   7.3.11.22.1 Do the VISTA modules effectively              Show example, if available.
               alert to potential food/drug/herbal
               interactions and duplicate drug
               therapies?
                   Recommended
                   Medication Safety
   7.3.11.23 - 7.3.11.24     RESERVED
                   Medication Safety
   7.3.11.25       Is drug reference information made Interview area/unit staff, show where information
                   readily accessible to caregivers, if so is kept and how it is retrieved. One or two
                   how?                                    reference sources should be available as well as
                                                           access to pharmacist.
                                                             ISMP Self Assessment 18.2 Pg. 15
                   Recommended                               JCAHO-CAMH. IM.3.10 Pg. 349
                   Medication Safety
   7.3.11.26       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).
                                                             JCAHO CAM-H, IM.3.10 Pg. 349
                   Recommended                               ISMP Medication Safety Self Assessment, #19 Pg. 15
                   Medication Safety
   7.3.11.27       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.

                                                             JCAHO CAM-H, MM.2.20, EP-6 Pg. 231
                   Recommended                               Sentinel Event Alert #19, May 2001, Look-alike, sound-alike drug names
                   Medication Safety
   7.3.11.27.1          RESERVED




Acute Care - 7.3                                                                       Acute Care - 7.3 - Version: 08.01.2006                                                              244 of 351
                                                            NCPS Patient Safety Assessment Tool

                                                                             Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                          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
   7.3.11.28       Do prohibited abbreviations conform For example "u" in unit may be mistaken for "0"
                   to minimum JCHAO Patient Safety     resulting in ten fold over dosage.
                   Goal requirements?
                                                            ISMP Medication Safety Self Assessment #40 Pg. 19
                                                            JCAHO Patient Safety Goals, Goal #2b
                                                            JCAHO CAM-H, MM.3.20 Pg. 233
                                                            Sentinel Event Alert #11, 11-19-99, High-Alert Medications & Patient Safety
                                                            Sentinel Event Alert #23, 9-2001, Medication errors related to ....abbreviations
                   Mandatory                                JCAHO CAM-H, IM.3.10 Pg. 349
                   Medication Safety
   7.3.11.29       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 CAM-H, MM.4.50 Pg. 236
                   Medication Safety
   7.3.11.30 - 7.3.11.31.1       RESERVED
                   Medication Safety
   7.3.11.32       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 Medication Safety Self Assessment #26 Pg. 16
                   Medication Safety
   7.3.11.33           RESERVED
                   Medication Safety
   7.3.11.34       Are patients educated regarding their Show example.
                   prescribed medication, as inpatients
                   and as part of the discharge
                   process?
                   Recommended                              JCAHO CAM-H, PC.6.10 Pg. 193




Acute Care - 7.3                                                                       Acute Care - 7.3 - Version: 08.01.2006                                                                 245 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                       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
   7.3.11.35       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 Medication Safety Self Assessment #23 Pg. 16
                   Recommended                             JCAHO CAM-H, MM.4.10 Pg. 234
                   Medication Safety
   7.3.11.36 - 7.3.11.41.1       RESERVED
                   Medication Safety
   7.3.11.42       Has a effective process begun to        JCAHO is requiring all facilites have a plan in
                   reconcile patient medications upon      place by January 2006.
                   admission, transfer or discharge?
                   Recommended
                   General Patient Safety Concerns
   7.3.12.1        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.
                                                           JCAHO CAM-H, MM.3.20, EP-7 Pg. 233
                                                           JCAHO Patient Safety Goals, Goal #2a
                   Mandatory                               ISMP Medication Safety Self Assessment #45 Pg. 20
                   General Patient Safety Concerns
   7.3.12.2        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
                   General Patient Safety Concerns
   7.3.12.3        Are patient records kept confidential, Ensure records or computer screens are not left
                   including computer information?        unattended and openly visible.

                   Recommended                             JCAHO CAM-H, IM.2.10 Pg. 347
                   General Patient Safety Concerns
   7.3.12.4        Are staff required to wear              Monitor patient care areas. Interview staff about
                   identification badges, and are          policies such as the handling of drug
                   unauthorized persons kept out of        manufacturer representatives that visit
                   patient care areas?                     unexpectedly.
                   Recommended                             JCAHO CAM-H, PC.1.2 & PC 2.2 Pg. 182




Acute Care - 7.3                                                                   Acute Care - 7.3 - Version: 08.01.2006                                                        246 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                      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
   7.3.12.5        Are restraints used in accordance     Randomly interview staff. Look for restraint
                   with local policy and are restraint   devices or alterative devices in the area.
                   alternative devices available and
                   used when appropriate?
                                                         Sentinel Event Alert #8, 11-98, Preventing Restraint Deaths
                   Recommended                           JCAHO CAM-H, PC.11.10 & PC.12.10 Pg. 199
                   General Patient Safety Concerns
   7.3.12.6        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 identifcation requriements 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
                                                         adminstration or collection begins.

                   Mandatory; Priority A                 JCAHO Patient Safety Goals, Goal #1a
                   General Patient Safety Concerns
   7.3.12.6.1      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; Priority A




Acute Care - 7.3                                                                   Acute Care - 7.3 - Version: 08.01.2006                                                        247 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                      Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                  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
   7.3.12.6.2      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; Priority A
                   General Patient Safety Concerns
   7.3.12.6.3      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; Priority A
                   General Patient Safety Concerns
   7.3.12.7        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
                   General Patient Safety Concerns
   7.3.12.8        Is transfer of care between shifts    A consistent process should exist to update on-
                   standardized?                         coming staff of patient statues. Interview staff
                                                         and compare answers between units.
                   Recommended




Acute Care - 7.3                                                             Acute Care - 7.3 - Version: 08.01.2006                                                        248 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                        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
   7.3.12.9        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
                   General Patient Safety Concerns
   7.3.12.10       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
   7.3.12.11       Does the facility have an emergency The protocol should be made up of a mechanism
                   response protocol for dealing with  for 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
                   General Patient Safety Concerns
   7.3.12.11.1 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




Acute Care - 7.3                                                                    Acute Care - 7.3 - Version: 08.01.2006                                                        249 of 351
                                                       NCPS Patient Safety Assessment Tool

                                                                      Part II Implementation
   ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3                  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
   7.3.12.12       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?

                   Mandatory                            JCAHO CAM-H, PC.13.20 Pg. 214
                   Psychiatric Precautions
   7.3.13.1 - 7.3.13.18        RESERVED
                   Surgical or Invasive Procedure Precautions
   7.3.14.1 - 7.3.14.19        RESERVED
                   Imaging and X-rays Precautions
   7.3.15.1 - 7.3.15.12        RESERVED




Acute Care - 7.3                                                             Acute Care - 7.3 - Version: 08.01.2006                                                        250 of 351
                       Patient Safety Assessment Tool
                       Part II Implementation
                       Element: ICU - 7.4
                           Categories:
                           Bed Safety                              1-2
                           Code Carts                              2-3
                           Electrical Safety                       4-5
                           Environmental and Housekeeping Safety   5-6
                           Equipment Safety                        7 - 10
                           Escape and Elopement Prevention         10
                           Fall Prevention                         11 - 12
                           Fire Safety                             13
                           Infection Control                       14 - 15
                           Medical Gas Safety                      15 - 16
                           Medication Safety                       16 - 24
                           General Patient Safety Concerns         24 - 29



Tuesday, August 01, 2006                                                     251 of 351
                                                       NCPS Patient Safety Assessment Tool

                                                                       Part II Implementation
   INTENSIVE CARE UNITS 7.4                        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
   7.4.1.1   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
                                                       JCAHO Sentinel Event Alert #27
                                                       Preventing Bed Entrapment Poster
             Mandatory                                 Patient Safety Alert 7-13-01, Bed Rail Entrapment
             Bed Safety
   7.4.1.2   Are bed rails easy to use, and have       Manipulate bed rails if available and interview
             staff been trained on the usage?          staff.

             Recommended
             Bed Safety
   7.4.1.3   Are non-compliant beds clearly            All new beds must meet requirement, & existing
             marked as to indicate entrapment          non-compliant beds marked.
             risk?
             Mandatory                                 Patient Safety Alert 7-13-01, Bed Rail Entrapment
             Bed Safety
   7.4.1.4   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 for Nursing Homes




ICU - 7.4                                                                            ICU - 7.4 - Version: 08.01.2006                                                        252 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   INTENSIVE CARE UNITS 7.4                             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
   7.4.1.5       Is the appropriate bed-type matched LTC patients can acquire bed sores; cardiac
                 to the level of care needed for each patients beds designed to facilitate CPR, etc.
                 patient?
                 Recommended
                 Bed Safety
   7.4.1.6       Are beds with built-in weight scales     Preventative maintenance tags should be up to
                 accurate and functioning correctly?      date. Interview nurses if any double checks are
                                                          in place for weight of patients.
                 Recommended
                 Bed Safety
   7.4.1.7       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.
                                                          FDA Public Health Notification: Safety Tips for Preventing Hospital Bed
                 Recommended
                                                          Fires
                 Code Carts
   7.4.2.1       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?                               records.
                 Mandatory                                JCAHO CAM-H: MM.2.30 Pg. 232
                 Code Carts
   7.4.2.1.1 - 7.4.2.2   RESERVED




ICU - 7.4                                                                               ICU - 7.4 - Version: 08.01.2006                                                                  253 of 351
                                                     NCPS Patient Safety Assessment Tool

                                                                      Part II Implementation
   INTENSIVE CARE UNITS 7.4                         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
   7.4.2.3   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.
             carts throughout the hospital?
             Recommended
             Code Carts
   7.4.2.4   Is the VHA modified version of the       Inspect top of cart and review checklist of
             AHA Handbook of Cardiovascular           contents if provided.
             Care Cognitive Aid located on all
             carts?
             Recommended
             Code Carts
   7.4.2.5   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.
             Recommended                              VHA Airway Directive
             Code Carts
   7.4.2.6   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?                       tank volume; tubing ; CO2 detectors; appropriate
                                                      medications; AED (or other defibrillators) and
                                                      suction machine functionality; laryngoscope with
                                                      batteries; cardiac board, etc.

             Recommended




ICU - 7.4                                                                    ICU - 7.4 - Version: 08.01.2006                                                        254 of 351
                                                    NCPS Patient Safety Assessment Tool

                                                                      Part II Implementation
   INTENSIVE CARE UNITS 7.4                        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
   7.4.3.1     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
                                                     can be completely removed or covered in patient
                                                     rooms to protect patients who my try to harm
                                                     themselves.

                                                     National Fire Protection Guidebooks (NFPA)
                                                     NFPA 99-4.3.2.2.8.1 Pg. 04
               Mandatory                             NFPA 99-4.3.2.2.6.2(D) Pg. 03
               Electrical Safety
   7.4.3.2     Are electrical receptacles fitted with Observe conditions on unit.
               covers, secured, and free of loose or
               exposed wiring?
                                                     NFPA 99-4.3.3.2.1. Pg. 08
               Mandatory                             National Fire Protection Association
               Electrical Safety
   7.4.3.2.1      RESERVED
               Electrical Safety
   7.4.3.3     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.
               emergency power circuits?
                                                     NFPA 99 4.4.2.2.4.2(B). Pg. 21
               Mandatory                             National Fire Protection Association
               Electrical Safety
   7.4.3.4     Are electrically powered medical      Cords are free of physical defects including
               devices in good condition?            cracks, frayed ends, or missing prongs.
                                                     NFPA 99-8.4.1.3.1 Pg. 03
                                                     National Fire Protection Association
               Mandatory                             VHA Directive 2002-030, Electrical Safety Policy for Patient Care Equipment




ICU - 7.4                                                                          ICU - 7.4 - Version: 08.01.2006                                                                 255 of 351
                                                      NCPS Patient Safety Assessment Tool

                                                                       Part II Implementation
   INTENSIVE CARE UNITS 7.4                      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
   7.4.3.5   Are there at least 4 receptacles (6 in Inspect patient rooms.
             critical care) for each patient bed?

                                                      National Fire Protection Association
             Mandatory                                NFPA 99 4.3.2.2.6.2 (A) Pg. 03
             Electrical Safety
   7.4.3.6   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.

                                                      NFPA 99 10.2.2.2.7.7 Pg. 03
                                                      National Fire Protection Association Online Guidelines
                                                      NFPA 99 10.2.2.2.1.1. Pg. 02
             Recommended                              JCAHO CAM-H ec.1.10 Pg. 303
             Electrical Safety
   7.4.3.7    RESERVED
             Environmental and Housekeeping Safety
   7.4.4.1   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, Domestic Hot Water Temperature Limits
             Environmental and Housekeeping Safety
   7.4.4.2   Are supply and return air registers Observe conditions on the unit.
             clean and free of lint and dust?
             Recommended                              JCAHO CAM-H, EC 8.10 Pg. 320
             Environmental and Housekeeping Safety
   7.4.4.3   Does general housekeeping appear Cleanliness, sanitation, odor, etc.
             to be a priority?
             Recommended                              JCAHO CAM-H, EC 8.10 Pg. 320




ICU - 7.4                                                                            ICU - 7.4 - Version: 08.01.2006                                                        256 of 351
                                                       NCPS Patient Safety Assessment Tool

                                                                        Part II Implementation
   INTENSIVE CARE UNITS 7.4                          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
   7.4.4.4       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.
                 Recommended                           JCAHO CAM-H, EC 5.20 Pg. 310
                 Environmental and Housekeeping Safety
   7.4.4.5       Are patient care area hallways and   Observe conditions on the unit.
                 stairways unobstructed and kept free
                 of storage?
                                                       National Fire Protection Association
                                                       JCAHO CAM-H, ED 5.20 Pg. 310
                 Mandatory                             NFPA 101 (LSC) 7.1.10. Pg. 05
                 Environmental and Housekeeping Safety
   7.4.4.6       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 CAM-H, EC 1.10 Pg. 303
                 Environmental and Housekeeping Safety
   7.4.4.7       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.

                                                       JCAHO CAM-H, EC 5.50 Pg. 313
                                                       VA Directive 7703c(4)(a)
                 Mandatory                             29CFR 1926.20(b)
                 Environmental and Housekeeping Safety
   7.4.4.8 - 7.4.4.9   RESERVED
                 Environmental and Housekeeping Safety
   7.4.4.10      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.
                 Recommended




ICU - 7.4                                                                            ICU - 7.4 - Version: 08.01.2006                                                        257 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   INTENSIVE CARE UNITS 7.4                             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
   7.4.5.1     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.
                                                          JCAHO Patient Safety Goals #6a
                                                          National Fire Protection Association Guidelines 99.8.2.2.2
                                                          National Fire Protection Association Codes Online
               Mandatory                                  JCAHO CAM-H, EC 6.20 Pg. 315
               Equipment Safety
   7.4.5.2     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 CAM-H, EC 6.10 Pg. 314
               Equipment Safety
   7.4.5.3     Is the equipment used on each              There is no chance equipment would be
               patient positioned in a way that it is     inadvertently shut off because it is not in sight of
               evident the equipment is in use for        the patient.
               that patient?
               Recommended
               Equipment Safety
   7.4.5.4     Are alarms audible and easily              Alarms may be broadcast to an outside room or
               distinguished above ambient                another area such as a central nursing station.
               background noise level?                    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 Patient Safety Goals, Goal #6b
               Equipment Safety
   7.4.5.4.1   Is the unit layout/configuration           Observe conditions and interview staff.
               conducive to hearing all alarms,
               especially for isolation rooms?
               Recommended




ICU - 7.4                                                                               ICU - 7.4 - Version: 08.01.2006                                                        258 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   INTENSIVE CARE UNITS 7.4                           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
   7.4.5.5     Are all devices that alarm specifically   Masking is when the frequency and intensity of
               set up for each patient to reduce         two separate alarms blend together causing
               issues such as, "masking", nuisance,      heightened confusion; nuisance alarms are
               or altered priority due to unwanted       caused when limits are not appropriately set, this
               false or alarms?                          can create staff complacency, annoyance to
                                                         patients, and results in a delayed staff response
                                                         (cry wolf syndrome).
               Recommended                               JCAHO Patient Safety Goals, Goal #6b
               Equipment Safety
   7.4.5.5.1   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
               Equipment Safety
   7.4.5.6     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
   7.4.5.7     Is patient care and monitoring            All screens/interfaces are readable and at or
               equipment well organized in each          near eye level; key pads within reach; equipment
               patient/procedure room to avoid           is not blocking each other; adequate space to
               clutter and permit the caregivers to      move around, including head clearance on
               be able to reach and read all             mounted devices.
               equipment?
               Recommended
               Equipment Safety
   7.4.5.8     Are liquids kept away from medical        To prevent spillage which can result in
               equipment?                                malfunctioning.
                                                         NFPA 70 110.11.
               Recommended                               National Fire Protection Association




ICU - 7.4                                                                              ICU - 7.4 - Version: 08.01.2006                                                        259 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   INTENSIVE CARE UNITS 7.4                             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
   7.4.5.9      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
   7.4.5.10     Is a reliable system used to identify     Examples: Color coding or directional arrows for
                which tubes and connectors go to          input jacks. If color labeling is used it must be
                which devices?                            consistent throughout the unit.
                Recommended
                Equipment Safety
   7.4.5.10.1   Are the tubes/connectors kept out of Taped down, or use of a hanger or device can
                the way to avoid them from being     help to lead them away from the patient.
                inadvertently unplugged?
                Recommended
                Equipment Safety
   7.4.5.11     Are the location and model of AEDs The location on the code cart or within unit
                standardized throughout the facility? should be the same from area to area. Compare
                                                      models in unit, and from unit to unit.
                Recommended
                Equipment Safety
   7.4.5.12     Are clocks synchronized and               During codes the monitoring equipment has a
                accurate?                                 clock and the room or unit has a clock and the
                                                          times on all clocks should be the same.
                Recommended
                Equipment Safety
   7.4.5.13     Does the hospital purchase                Having sterile water for injection in units on the
                humidification devices that do not        floor creates the potential for misuse. Warnings
                require the use of sterile water?         have been published (ISMP) regarding water
                                                          being confused with other medications resulting
                                                          in it being give intravenously resulting in fatal
                                                          hemolysis.
                                                          FDA Patient Safety News, #22, 12-03, Store IV Bags in Their
                                                          Overwraps
                Recommended                               ISMP 9/18/2003, How sterile water bags show up on nursing units




ICU - 7.4                                                                              ICU - 7.4 - Version: 08.01.2006                                                           260 of 351
                                                          NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   INTENSIVE CARE UNITS 7.4                              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
   7.4.5.13.1    If humidification devices use sterile     If sterile water must be used it is recommend that
                 water is it provided in 2 Liter bags      it be used in 2 Liter bags. The 2 Liter bags will
                 and labeled "Sterile Water"?              help distinguish the sterile water from the 1 Liter
                                                           bags of IV solutions, also pour bottles could be
                                                           considered.
                                                           ISMP 9/18/2003, How sterile water bags show up on nursing units
                 Recommended                               FDA Patient Safety News, Show #22, 12-03, Store IV Bags in Their Overwraps
                 Equipment Safety
   7.4.5.14      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
   7.4.6.1 - 7.4.6.4     RESERVED
                 Escape and Elopement Prevention
   7.4.6.5       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.

                                                           VHA Directive 2002-013, Management of Wandering & Missing Patient
                 Mandatory
                                                           Events
                 Escape and Elopement Prevention
   7.4.6.5.1 - 7.4.6.6    RESERVED
                 Escape and Elopement Prevention
   7.4.6.7       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




ICU - 7.4                                                                               ICU - 7.4 - Version: 08.01.2006                                                                261 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                       Part II Implementation
   INTENSIVE CARE UNITS 7.4                           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
   7.4.7.1     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?                        with nightlights.
               Recommended                               JCAHO CAM-H, EC.1.10 Pg. 303
               Fall Prevention
   7.4.7.2     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
   7.4.7.2.1   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?
               Recommended
               Fall Prevention
   7.4.7.3     Are the floors clean and free of          Floors should be free of liquids, electrical cords,
               slipping and tripping hazards?            wires, tubes, or other connectors which can
                                                         create fall hazards. Patient rooms should be free
                                                         of low-lying objects that could be tripped over
                                                         causing falls.
               Recommended                               JCAHO CAM-H, EC.1.10 Pg. 303
               Fall Prevention
   7.4.7.4     Do shower/bathroom areas have             Inspect areas specified. Bathrooms should be
               adequate lighting, proper drainage,       provided with night lights. If a raised seats are
               non-slip floor surfaces, and handrails    used on toilets are they is the color of it
               installed?                                contracting to toilet to help patients see it clearly.

               Recommended                               JCAHO CAM-H, EC.1.10 Pg. 303
               Fall Prevention
   7.4.7.5     Are call buttons within reach of the      Inspect all areas.
               patient?
               Recommended




ICU - 7.4                                                                        ICU - 7.4 - Version: 08.01.2006                                                        262 of 351
                                                      NCPS Patient Safety Assessment Tool

                                                                        Part II Implementation
   INTENSIVE CARE UNITS 7.4                          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
   7.4.7.6    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, Fatal Falls: Lessons for the Future
              Recommended                              JCAHO Patient Safety Goals, Goal #6b
              Fall Prevention
   7.4.7.7    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.

              Recommended
              Fall Prevention
   7.4.7.8    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?
              Recommended                              JCAHO CAM-H, PC.2.120 and PC.2.150 Pg. 186
              Fall Prevention
   7.4.7.9    Does equipment (lifting equipment,       Review equipment, interview staff. Patients
              OR tables, etc.) have sufficient         weighing in excess of 400 pounds are not
              capacity to meet the needs of            uncommon. If equipment cannot support the
              bariatric patients?                      weight of the patient contingency plans should
                                                       be developed to provide care.
              Recommended
              Fall Prevention
   7.4.7.10     RESERVED




ICU - 7.4                                                                            ICU - 7.4 - Version: 08.01.2006                                                        263 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                            Part II Implementation
   INTENSIVE CARE UNITS 7.4                            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
   7.4.8.1       Are staff members familiar with fire     Interview staff to determine familiarity.
                 emergency procedures, and the fire
                 prevention plan for their service
                 area?
                                                          JCAHO CAM-H, HR.2.20 Pg. 338
                                                          JCAHO CAM-H, EC.5.20 Pg. 310
                                                          NFPA 101.7.2.3 Pg. 08
                                                          NFPA 101.7.2.1 Pg. 05
                 Mandatory                                NFPA 101.7.1.1.
                 Fire Safety
   7.4.8.2       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.
                                                          JCAHO CAM-H, EC.5.20 Pg. 310
                                                          JCAHO CAM-H, HR.2.20 Pg. 338
                                                          NFPA 101.7.2.1 Pg. 05
                 Mandatory                                NFPA 101.7.1.1
                 Fire Safety
   7.4.8.3       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.)?
                                                          National Fire Protection Association
                 Mandatory                                NFPA 72.1.5.4.4. Pg. 08
                 Fire Safety
   7.4.8.4       Is the area staff notified when the fire Interview staff.
                 alarm system is out of service or
                 being tested?
                                                          NFPA 101.19.7.1.2 Pg. 08
                 Mandatory                                National Fire Protection Association
                 Fire Safety
   7.4.8.4.1     Are cognitive aids used to remind        Look for signs placed by pull stations, and
                 staff when the fire alarm system is      interview to determine if announcements are
                 not functioning?                         made on PA system, etc.
                 Recommended
                 Fire Safety
   7.4.8.5 - 7.4.8.6   RESERVED




ICU - 7.4                                                                               ICU - 7.4 - Version: 08.01.2006                                                        264 of 351
                                                      NCPS Patient Safety Assessment Tool

                                                                       Part II Implementation
   INTENSIVE CARE UNITS 7.4                         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
   7.4.9.1   Are all linen carts (clean and soiled)   Observe conditions on the unit.
             kept covered?
             Mandatory                                JCAHO CAM-H, IC.4.10 Pg. 252
             Infection Control
   7.4.9.2   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 CAM-H, EC.4.10 Pg. 252
             Infection Control
   7.4.9.3   Is the latex allergy policy followed     Show example if available. Consider inspecting
             and are latex free supplies and          supply and code carts. Look for latex-free
             equipment available?                     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 Latex Information
             Infection Control
   7.4.9.4   Are the VA recommended hand              The individual products should be an alcohol rub
             hygiene guidelines followed, such as     (for disinfecting) and a hospital approved lotion
             having alcohol-based gel                 (to prevent skin dryness). Also, staff who come
             disinfectants located to promote use     in contact with patients or prepare sterile
             (including inpatient rooms), and         products (such as IV drugs) should not have
             providing individual products to all     artificial fingernails. Clinicians should also be
             necessary staff?                         offered the small (2-4 oz.) personal containers of
                                                      hand gel. Gel should be in convenient locations
                                                      including all carts (mobile care, medication carts,
                                                      code, respiratory).

                                                      VHA Hand Hygiene Directive, 2005-002 July 2005
                                                      JCAHO CAM-H, IC.4.10 Pg. 252
                                                      JCAHO Patient Safety Goals, Goal #7a
                                                      CDC Guidelines for Hand Hygiene in Health-care Settings
             Mandatory                                Sentinel Event Alert 1-22-2003, Infection related sentinel events




ICU - 7.4                                                                            ICU - 7.4 - Version: 08.01.2006                                                           265 of 351
                                                      NCPS Patient Safety Assessment Tool

                                                                       Part II Implementation
   INTENSIVE CARE UNITS 7.4                       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
   7.4.9.5    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)?
                                                      OSHA, 29 CFR 1910.145
              Mandatory                               CDC Guidelines for Environmental Infection Control in Health-Care Facilities
              Medical Gas Safety
   7.4.10.1   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.
                                                      Patient Safety Advisory 3-5-2002, Confusion Between Oxygen &
              Recommended
                                                      Compressed Air Wall Outlet
              Medical Gas Safety
   7.4.10.2   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.
                                                      Patient Safety Advisory 3-5-2002, Confusion Between Oxygen &
              Recommended
                                                      Compressed Air Wall Outlet
              Medical Gas Safety
   7.4.10.3   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.

                                                      National Fire Protection Association
                                                      NFPA 5.1.4.2.1. Pg. 17
              Mandatory                               JCAHO CAM-H, EC.7.50 Pg. 319
              Medical Gas Safety
   7.4.10.4   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).
                                                      NCPS O2 Hazard Summary
              Mandatory                               NCGA (Compressed Gas Association) C-9, 3.7 & 4.6




ICU - 7.4                                                                           ICU - 7.4 - Version: 08.01.2006                                                                  266 of 351
                                                        NCPS Patient Safety Assessment Tool

                                                                        Part II Implementation
   INTENSIVE CARE UNITS 7.4                            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
                Medical Gas Safety
   7.4.10.4.1   Are all area/unit personnel             Staff to demonstrate competency.
                competent in understanding the
                handling procedures of oxygen
                cylinders, including how to obtain full
                cylinders? If so, is current practices
                in line with the facility's written
                procedure?
                Mandatory                                NCPS O2 Hazard Summary
                Medical Gas Safety
   7.4.10.5     Are pins on medical gas regulators       Pins should be in place and found undamaged.
                and cylinders in good repair and is
                damaged equipment immediately
                removed from service?
                Recommended                              NCPS O2 Hazard Summary
                Medical Gas Safety
   7.4.10.6     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.
                Recommended                              NCPS O2 Hazard Summary
                Medical Gas Safety
   7.4.10.7       RESERVED
                Medication Safety
   7.4.11.1     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.

                                                         ISMP Medication Safety Self Assessment #117 Pg. 30
                Mandatory                                JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                Medication Safety
   7.4.11.2     Do medication carts remained locked Randomly survey carts in the area.
                and inaccessible to patients when
                not in use?
                Mandatory                                JCAHO CAM-H, MM.2.20, EP-3 & EP-4 Pg. 231




ICU - 7.4                                                                           ICU - 7.4 - Version: 08.01.2006                                                        267 of 351
                                                     NCPS Patient Safety Assessment Tool

                                                                     Part II Implementation
   INTENSIVE CARE UNITS 7.4                         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
   7.4.11.3     Are the tops of medication carts,     Randomly survey carts in the area. Clean carts
                clean, free of stray drugs and        will help prevent medication error by eliminating
                syringes?                             opportunities for mix-ups . It will also avoid drug
                                                      being taken by mental health patients or those
                                                      with cognitive impairment.
                                                      JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                Mandatory                             ISMP Self Assessment 14 Pg. 13
                Medication Safety
   7.4.11.3.1   Is medication logically organized and Clearly marked labels and nametags.
                identified by patient?
                Recommended                           JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                Medication Safety
   7.4.11.4     Are medication storage rooms          Door locking mechanism cannot be defeated for
                secured at all times?                 any reason. Door should not be held open.
                                                      ISMP Self Assessment 75 Pg. 24
                Mandatory                             JCAHO CAM-H, MM.2.20, EP-13 Pg. 231
                Medication Safety
   7.4.11.5       RESERVED
                Medication Safety
   7.4.11.6     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?
                                                      JCAHO CAM-H, MM.3.20 Pg. 233
                Recommended                           ISMP Self Assessment 82 Pg. 25
                Medication Safety
   7.4.11.6.1   Do emergency medications provided Example of needle-less systems: blunt tip, pre-
                in code carts and/or emergency drug dawn syringes, etc.
                boxes "fit" with needle-less systems
                used in the area such that
                treatments can be safely and
                promptly initiated?
                Recommended




ICU - 7.4                                                                       ICU - 7.4 - Version: 08.01.2006                                                        268 of 351
                                                       NCPS Patient Safety Assessment Tool

                                                                        Part II Implementation
   INTENSIVE CARE UNITS 7.4                          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
   7.4.11.6.2   Do staff periodically practice with the Conducting mock drills will facilitate use during
                emergency equipment and supplies emergencies when seconds count.
                or participate in mock codes to
                increase familiarity with these
                devices?
                Recommended
                Medication Safety
   7.4.11.7     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 Patient Safety News, Show #22, 12-03, Store IV Bags in Their
                                                       Overwraps
                Recommended                            ISMP Medication Safety Alert, 9-03, How sterile waterbags show up on nursing units.
                Medication Safety
   7.4.11.8     Have concentrated electrolyte       Such as: potassium chloride and potassium
                solutions been removed from patient phosphate
                floors/care areas?
                                                       JCAHO Patient Safety Goals, Goal #3a
                                                       Sentinel Event Alert #1, Medication error prevention
                                                       Sentinel Event Alert #11, High-Alert Medications and Patient Safety
                Mandatory                              JCAHO CAM-H, MM.2.20, EP-9 Pg. 231
                Medication Safety
   7.4.11.8.1   Is access limited to electrolyte    Review local policies, and interview pharmacy
                replacement solutions (above or     staff. Show example.
                below 0.9% sodium chloride) outside
                the pharmacy?
                Recommended                            ISMP Self Assessment 92 Pg. 26
                Medication Safety
   7.4.11.9       RESERVED




ICU - 7.4                                                                            ICU - 7.4 - Version: 08.01.2006                                                                        269 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   INTENSIVE CARE UNITS 7.4                          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
   7.4.11.9.1   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).

                                                         JCAHO Patient Safety Goals, Goal #3b
                                                         Sentinel Event Alert #11, 11-19-99, High-Alert Medications and Patient Safety
                                                         ISMP Self Assessment 67.1 & 20 Pg. 23
                                                         JCAHO CAM-H, MM 2.20, EP-8 Pg. 231
                Mandatory                                JCAHO CAM-H, MM 7.10 Pg. 240
                Medication Safety
   7.4.11.10    Is a unit dose medication system         Look in patient bins for bulk containers.
                used including half tablets and
                liquids?
                                                         Sentinel Event Alert #11, 1-19-99, High-Alert Medications and Patient
                                                         Safety
                                                         JCAHO CAM-H, MM.2.20 Pg. 231
                Recommended                              ISMP Self Assessment 64 Pg. 22
               Medication Safety
   7.4.11.10.1 Are single-dose containers (with          For infection control and medication safety
               preference to pre-filed syringes)         purposes. This may be a future JCAHO PS
               exclusively used?                         Goal.
                Recommended
                Medication Safety
   7.4.11.11 - 7.4.11.12    RESERVED
                Medication Safety
   7.4.11.13    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, 11-19-99, High Alert Medications & Patient
                                                         Safety
                Recommended                              JCAHO CAM-H, MM.4.20 Pg. 235
                Medication Safety
   7.4.11.13.1 If admixtures are done in inpatient    Interview floor staff. If admixtures are done on
                care areas, is an independent double- units, the area should be a designated area that
                check system utilized?                is clean and secure. It is safest for mixtures to
                                                      be completed in pharmacy areas.
                Recommended




ICU - 7.4                                                                              ICU - 7.4 - Version: 08.01.2006                                                                  270 of 351
                                                      NCPS Patient Safety Assessment Tool

                                                                        Part II Implementation
   INTENSIVE CARE UNITS 7.4                          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
   7.4.11.14   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.
                                                       American Soc of Anesthesiology Newsletter Dec 2000
               Recommended                             ISMP Medication Safety Alert June 2000
               Medication Safety
   7.4.11.15   Are premixed IV solutions kept in       The protective over-wrap for some solutions
               over-wrap bags until they are ready     serves to control the amount of water vapor that
               to be used (if applicable)?             escapes from an IV solution. Once unwrapped it
                                                       is best to use the solution right way.

                                                       FDA Patient Safety News, #22, 12-03, Store IV Bags in Their
               Recommended
                                                       Overwraps
               Medication Safety
   7.4.11.16   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)?
                                                       FDA Patient Safety News, #22, 12-03, Store IV Bags in Their
               Recommended
                                                       Overwraps
               Medication Safety
   7.4.11.17   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?                               pumps.
                                                       Sentinel Event Alert #11, 11-19-99, High-Alert Medications & Patient
               Recommended
                                                       Safety
               Medication Safety
   7.4.11.18      RESERVED
               Medication Safety
   7.4.11.19   Are appropriate reversal agents         In the event of an unusual reaction or overdose
               (flumazenil, naloxone, protamine,       the agents need to be available.
               etc.) available based on the drug
               being administered?
               Recommended                             ISMP Self Assessment 79 Pg. 24




ICU - 7.4                                                                            ICU - 7.4 - Version: 08.01.2006                                                               271 of 351
                                                    NCPS Patient Safety Assessment Tool

                                                                    Part II Implementation
   INTENSIVE CARE UNITS 7.4                        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
   7.4.11.19.1 Is there a process to monitor the     Such as reviewing automated dispensing
               reversal agent use?                   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.

               Recommended
               Medication Safety
   7.4.11.20      RESERVED
               Medication Safety
   7.4.11.21   Is there machine readable coding    Show mechanism (i.e. BCMA) in use. Machine
               throughout the medication           readable coding should match the electronic
               administration process (e.g. BCMA)? medical record to the patient, allowing the
                                                   information on the patients armband to be
                                                   matched with the electronic information.

               Recommended                           ISMP Medication Safety Self Assessment, #11 Pg. 13
               Medication Safety
   7.4.11.21.1 Is BCMA used to administer            Observe staff.
               medication without using work
               arounds?
               Recommended
               Medication Safety
   7.4.11.21.2 What is the protocol for handling     Interview staff and compare practices to policy of
               incorrect bar coded or labeled        facility/Pharmacy.
               medications?
               Recommended                           JCAHO CAM-H, MM.3.20, EP-5 Pg. 233
               Medication Safety
   7.4.11.21.3 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
   7.4.11.22      RESERVED




ICU - 7.4                                                                        ICU - 7.4 - Version: 08.01.2006                                                        272 of 351
                                                           NCPS Patient Safety Assessment Tool

                                                                           Part II Implementation
   INTENSIVE CARE UNITS 7.4                           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
   7.4.11.22.1 Do the VISTA modules effectively            Show example, if available.
               alert to potential food/drug/herbal
               interactions and duplicate drug
               therapies?
                 Recommended
                 Medication Safety
   7.4.11.23 - 7.4.11.24   RESERVED
                 Medication Safety
   7.4.11.25     Is drug reference information made Interview area/unit staff, show where information
                 readily accessible to caregivers, if so is kept and how it is retrieved. One or two
                 how?                                    reference sources should be available as well as
                                                         access to pharmacist.
                                                           ISMP Self Assessment 18.2 Pg. 15
                 Recommended                               JCAHO-CAMH. IM.3.10 Pg. 349
                 Medication Safety
   7.4.11.26     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).
                                                           JCAHO CAM-H, IM.3.10 Pg. 349
                 Recommended                               ISMP Medication Safety Self Assessment, #19 Pg. 15
                 Medication Safety
   7.4.11.27     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.

                                                           JCAHO CAM-H, MM.2.20, EP-6 Pg. 231
                 Recommended                               Sentinel Event Alert #19, May 2001, Look-alike, sound-alike drug names
                 Medication Safety
   7.4.11.27.1        RESERVED




ICU - 7.4                                                                               ICU - 7.4 - Version: 08.01.2006                                                                  273 of 351
                                                         NCPS Patient Safety Assessment Tool

                                                                          Part II Implementation
   INTENSIVE CARE UNITS 7.4                          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
   7.4.11.28    Do prohibited abbreviations conform For example "u" in unit may be mistaken for "0"
                to minimum JCHAO Patient Safety     resulting in ten fold over dosage.
                Goal requirements?
                                                         ISMP Medication Safety Self Assessment #40 Pg. 19
                                                         JCAHO Patient Safety Goals, Goal #2b
                                                         JCAHO CAM-H, MM.3.20 Pg. 233
                                                         Sentinel Event Alert #11, 11-19-99, High-Alert Medications & Patient Safety
                                                         Sentinel Event Alert #23, 9-2001, Medication errors related to ....abbreviations
                Mandatory                                JCAHO CAM-H, IM.3.10 Pg. 349
                Medication Safety
   7.4.11.29    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 CAM-H, MM.4.50 Pg. 236
                Medication Safety
   7.4.11.30 - 7.4.11.31.1    RESERVED
                Medication Safety
   7.4.11.32    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 Medication Safety Self Assessment #26 Pg. 16
                Medication Safety
   7.4.11.33        RESERVED
                Medication Safety
   7.4.11.34    Are patients educated regarding their Show example.
                prescribed medication, as inpatients
                and as part of the discharge
                process?
                Recommended                              JCAHO CAM-H, PC.6.10 Pg. 193




ICU - 7.4                                                                               ICU - 7.4 - Version: 08.01.2006                                                                    274 of 351
                                                       NCPS Patient Safety Assessment Tool

                                                                      Part II Implementation
   INTENSIVE CARE UNITS 7.4                          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
   7.4.11.35    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 Medication Safety Self Assessment #23 Pg. 16
                Recommended                            JCAHO CAM-H, MM.4.10 Pg. 234
                Medication Safety
   7.4.11.36 - 7.4.11.39     RESERVED
               Medication Safety
   7.4.11.39.1 Is there a mechanism to verify          Safe labeling of medications and solutions
               contents of a syringe or container      (including contrast media) in perioperative
               before drug administration to patient   settings, operating rooms, ambulatory surgery,
               during a procedure or code?             clinics, cardiac catheterization area, endoscopy,
                                                       radiology, dental, or other areas where operative
                                                       and invasive procedures may be performed an
                                                       independent double check should be confirmed
                                                       by the person who administers the agent.

                Recommended
                Medication Safety
   7.4.11.40 - 7.4.11.41.1    RESERVED
                Medication Safety
   7.4.11.42    Has a effective process begun to       JCAHO is requiring all facilites have a plan in
                reconcile patient medications upon     place by January 2006.
                admission, transfer or discharge?
                Recommended
                General Patient Safety Concerns
   7.4.12.1     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.
                                                       JCAHO CAM-H, MM.3.20, EP-7 Pg. 233
                                                       JCAHO Patient Safety Goals, Goal #2a
                Mandatory                              ISMP Medication Safety Self Assessment #45 Pg. 20




ICU - 7.4                                                                          ICU - 7.4 - Version: 08.01.2006                                                        275 of 351
                                                       NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   INTENSIVE CARE UNITS 7.4                           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
   7.4.12.2   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
              General Patient Safety Concerns
   7.4.12.3   Are patient records kept confidential, Ensure records or computer screens are not left
              including computer information?        unattended and openly visible.

              Recommended                               JCAHO CAM-H, IM.2.10 Pg. 347
              General Patient Safety Concerns
   7.4.12.4   Are staff required to wear                Monitor patient care areas. Interview staff about
              identification badges, and are            policies such as the handling of drug
              unauthorized persons kept out of          manufacturer representatives that visit
              patient care areas?                       unexpectedly.
              Recommended                               JCAHO CAM-H, PC.1.2 & PC 2.2 Pg. 182
              General Patient Safety Concerns
   7.4.12.5   Are restraints used in accordance         Randomly interview staff. Look for restraint
              with local policy and are restraint       devices or alterative devices in the area.
              alternative devices available and
              used when appropriate?
                                                        Sentinel Event Alert #8, 11-98, Preventing Restraint Deaths
              Recommended                               JCAHO CAM-H, PC.11.10 & PC.12.10 Pg. 199




ICU - 7.4                                                                             ICU - 7.4 - Version: 08.01.2006                                                        276 of 351
                                                      NCPS Patient Safety Assessment Tool

                                                                      Part II Implementation
   INTENSIVE CARE UNITS 7.4                          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
   7.4.12.6     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 identifcation requriements 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
                                                       adminstration or collection begins.

                Mandatory; Priority A                  JCAHO Patient Safety Goals, Goal #1a
                General Patient Safety Concerns
   7.4.12.6.1   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; Priority A




ICU - 7.4                                                                          ICU - 7.4 - Version: 08.01.2006                                                        277 of 351
                                                       NCPS Patient Safety Assessment Tool

                                                                    Part II Implementation
   INTENSIVE CARE UNITS 7.4                           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
   7.4.12.6.2   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; Priority A
                General Patient Safety Concerns
   7.4.12.6.3   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; Priority A
                General Patient Safety Concerns
   7.4.12.7     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
                General Patient Safety Concerns
   7.4.12.8     Is transfer of care between shifts      A consistent process should exist to update on-
                standardized?                           coming staff of patient statues. Interview staff
                                                        and compare answers between units.
                Recommended




ICU - 7.4                                                                     ICU - 7.4 - Version: 08.01.2006                                                        278 of 351
                                                        NCPS Patient Safety Assessment Tool

                                                                         Part II Implementation
   INTENSIVE CARE UNITS 7.4                            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
   7.4.12.9    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
               General Patient Safety Concerns
   7.4.12.10   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
   7.4.12.11   Does the facility have an emergency The protocol should be made up of a mechanism
               response protocol for dealing with  for 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
               General Patient Safety Concerns
   7.4.12.11.1 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




ICU - 7.4                                                                             ICU - 7.4 - Version: 08.01.2006                                                        279 of 351
                                                    NCPS Patient Safety Assessment Tool

                                                                   Part II Implementation
   INTENSIVE CARE UNITS 7.4                       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
   7.4.12.12    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?

                Mandatory                            JCAHO CAM-H, PC.13.20 Pg. 214
                Psychiatric Precautions
   7.4.13.1 - 7.4.13.18     RESERVED
                Surgical or Invasive Procedure Precautions
   7.4.14.1 - 7.4.14.19     RESERVED
                Imaging and X-rays Precautions
   7.4.15.1 - 7.4.15.12     RESERVED




ICU - 7.4                                                                    ICU - 7.4 - Version: 08.01.2006                                                        280 of 351
                       Patient Safety Assessment Tool
                       Part II Implementation
                       Element: OR - 7.5
                           Categories:
                           Bed Safety                                   1
                           Code Carts                                   1
                           Electrical Safety                            2-3
                           Environmental and Housekeeping Safety        3-4
                           Equipment Safety                             5-7
                           Escape and Elopement Prevention              8
                           Fall Prevention                              8-9
                           Fire Safety                                  10
                           Infection Control                            11
                           Medical Gas Safety                           12 - 13
                           Medication Safety                            13 - 20
                           General Patient Safety Concerns              20 - 23
                           Surgical or Invasive Procedure Precautions   23 - 27



Tuesday, August 01, 2006                                                          281 of 351
                                                        NCPS Patient Safety Assessment Tool

                                                                       Part II Implementation
   PRE-OP HOLDING OPERATING ROOM & POST ANESTHESIA UNIT                                     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
   7.5.1.1 - 7.5.1.3   RESERVED
                 Bed Safety
   7.5.1.4       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 for Nursing Homes
                 Bed Safety
   7.5.1.5 - 7.5.1.7   RESERVED
                 Code Carts
   7.5.2.1 - 7.5.2.2   RESERVED
                 Code Carts
   7.5.2.3       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.
                 carts throughout the hospital?
                 Recommended
                 Code Carts
   7.5.2.4       Is the VHA modified version of the     Inspect top of cart and review checklist of
                 AHA Handbook of Cardiovascular         contents if provided.
                 Care Cognitive Aid located on all
                 carts?
                 Recommended
                 Code Carts
   7.5.2.5 - 7.5.2.6   RESERVED




OR - 7.5                                                                           OR - 7.5 - Version: 08.01.2006                                                        282 of 351
                                                    NCPS Patient Safety Assessment Tool

                                                                      Part II Implementation
   PRE-OP HOLDING OPERATING ROOM & POST ANESTHESIA UNIT                                     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
   7.5.3.1     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
                                                     can be completely removed or covered in patient
                                                     rooms to protect patients who my try to harm
                                                     themselves.

                                                     National Fire Protection Guidebooks (NFPA)
                                                     NFPA 99-4.3.2.2.8.1 Pg. 04
               Mandatory                             NFPA 99-4.3.2.2.6.2(D) Pg. 03
               Electrical Safety
   7.5.3.2     Are electrical receptacles fitted with Observe conditions on unit.
               covers, secured, and free of loose or
               exposed wiring?
                                                     NFPA 99-4.3.3.2.1. Pg. 08
               Mandatory                             National Fire Protection Association
               Electrical Safety
   7.5.3.2.1      RESERVED
               Electrical Safety
   7.5.3.3     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.
               emergency power circuits?
                                                     NFPA 99 4.4.2.2.4.2(B). Pg. 21
               Mandatory                             National Fire Protection Association
               Electrical Safety
   7.5.3.4     Are electrically powered medical      Cords are free of physical defects including
               devices in good condition?            cracks, frayed ends, or missing prongs.
                                                     NFPA 99-8.4.1.3.1 Pg. 03
                                                     National Fire Protection Association
               Mandatory                             VHA Directive 2002-030, Electrical Safety Policy for Patient Care Equipment
               Electrical Safety
   7.5.3.5      RESERVED




OR - 7.5                                                                            OR - 7.5 - Version: 08.01.2006                                                                 283 of 351
                                                      NCPS Patient Safety Assessment Tool

                                                                       Part II Implementation
   PRE-OP HOLDING OPERATING ROOM & POST ANESTHESIA UNIT                                      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
   7.5.3.6   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.

                                                      NFPA 99 10.2.2.2.7.7 Pg. 03
                                                      National Fire Protection Association Online Guidelines
                                                      NFPA 99 10.2.2.2.1.1. Pg. 02
             Recommended                              JCAHO CAM-H ec.1.10 Pg. 303
             Electrical Safety
   7.5.3.7   If provided are electrical isolation     NCPS has observed increasing number of
             transformers and switchgear serving      electrical blackouts and brownouts in operating
             the operating rooms properly sized       suites due to the increased power demand of
             to carry the maximum expected            new equipment being used in the OR's.
             electrical load?                         Facilities Engineering should conduct an
                                                      analysis to verify the adequacy of these
                                                      devices/equipment.
             Recommended
             Environmental and Housekeeping Safety
   7.5.4.1    RESERVED
             Environmental and Housekeeping Safety
   7.5.4.2   Are supply and return air registers Observe conditions on the unit.
             clean and free of lint and dust?
             Recommended                              JCAHO CAM-H, EC 8.10 Pg. 320
             Environmental and Housekeeping Safety
   7.5.4.3   Does general housekeeping appear Cleanliness, sanitation, odor, etc.
             to be a priority?
             Recommended                              JCAHO CAM-H, EC 8.10 Pg. 320
             Environ