PSAT

Patient Safety Assessment Too
Version 2009
sment Tool (PSAT)

009
Patient Safety Assessmen

Administration Elemen
Element 1
Management and Leadership
Element 2
Patient Safety Program Management
Element 3
JCAHO (CAM-H)
Element 4
Procurement and Equipment Management
Element 5
Recalls and VA Alerts & Advisories
Element 6
Patient Safety Policies, Tools & Aids
essment Tool
Elements
ent
gement
NCPS Patient Safety Assessment Tool

Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1
1.1.1
Question:
Leadership/Support
Rationale/Assessment Methods:
Does a non-punitive environment

exist that promotes reporting of
errors and mistakes?
Interview leadership and staff. Review of SPOT

data to evaluate if a systems approach is
consistently used. Ask leaders or PSM about
Patient Safety Culture Survey Results and related
action plan for dimensions that showed nonfavorable results.
Met
(1)
Partially
Met (2)
Not
Met If score other than 'met' what are
(3) possible root causes
JC- CAMH LD-03-01-01.pdf

Mandatory;Priority A
VHA Handbook 1050 01 PSI.pdf /A Page=3
Leadership/Support
1.1.2
Are staff made available to serve on

RCA teams including physicians,
pharmacists and employees on offtours when needed?
Review RCA's looking for a mix of staff

participation and interview Patient Safety
Managers and upper management. Employees
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.

Leadership/Support
1.1.3
Mgt Ldr - 1
Is the Patient Safety Manager

permitted to charter RCA teams
based upon the SAC score without
approval from his/her supervisor or
top management?
Interview PSM and management. The PSM or

other individuals trained on using the SAC matrix
should be the authority for determining which
cases become individual RCAs. Although top
management approval is ultimately needed to
begin an RCA, the PSM should be the primary
decision-maker.
Recommended; Priority A
Mgt Ldr - 1 - Version: 01.30.2009
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Question:
Leadership/Support
1.1.4
Met
(1)
Partially
Met (2)
Not
Do RCA teams meet with top

Interview PSM and management. Evidence
management to discuss their findings should show management interaction with the
and recommendations?
teams, including suggestions/recommendations
made. Reports should not be without justification
for actions not approved.
Leadership/Support
1.1.5
Are close call reports being

received?
Review SPOT for potential SAC scores of 1and 2

to determine if Safety Reports are being entered.
Have PSM show specific examples of close calls
including events that have become RCAs.
VHA Handbook 1050 01 PSI.pdf
Leadership/Support
1.1.6
Are lessons learned from RCAs and

best practices shared with the
Network?
Show reports made to VISN, or others that have

been shared. Methods for sharing information
could include: meetings, conference calls, e-mail
correspondence, summaries done by PSO, etc.
Recommended; Priority C
Leadership/Support
1.1.7
Mgt Ldr - 1
When criminal or intentionally unsafe

acts are identified during the RCA
process, is the RCA stopped, the
record sealed and top management
notified without revealing team
findings and conclusions?
Verify via interviews with key personal (PSM,

Director, RCA team members). If systems issues
are identified a new RCA team may be chartered
to complete the RCA following completion of the
ABI.
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1.1.8
Question:
Leadership/Support
Are confidentiality rules complied

with in the Patient Safety RCA
Process?
Conduct interviews, review how records are

managed (e.g., locked office, record access,
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.
Met
(1)
Partially
Met (2)
Not
202 Briefing.ppt
Confidentiality 5705 Cognitive Aid.pdf
JC- CAMH IM-02-01-03.pdf
Leadership/Support
1.1.9
Are RCA reports de-identified

thoroughly prior to submission to
NCPS?
Review a random sample of submitted RCAs in

the SPOT database for identifiers. Reviewing the
reports received though the NCPS Facility Report
Process is another way to analyze compliance to
de-identification.
5705.pdf
Code of Federal Regulations_part 17.pdf
Staffing
1.2.1
Is there a full time Patient Safety

Manager?
The Patient Safety program requirements should

be met before other collateral duties are assigned
to the PSM.
Supporting the Patient Safety Program Memo.pdf
USH memo PSM Job Jar (2).pdf
Staffing
1.2.1.1
Is clerical support personnel provided Depending on facility size, a rigorous work load of
if deemed necessary by the PSM or RCA inputting, maintenance, and follow up can
PSO?
keep the PSM from being able to perform other
duties, therefore clerical support, if justified,
should be provided.
Recommended; Priority B
Mgt Ldr - 1
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1.2.2
Question:
Staffing
Does the Patient Safety Manager

report directly to the Medical Center
Director or Chief of Staff?
VA Memorandum to Network Directors specifies

that "facility Patient Safety Managers be
organizationally aligned to report directly to top
management (i.e., Director or COS)."
Met
(1)
Partially
Met (2)
Not
Supporting the Patient Safety Program Memo.pdf

Mandatory; Priority A
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?
Resources
1.3.1.1
If needed, is specific training being

provided for the PSM to meet job
responsibilities listed in the guidance
distributed by the Assistant Deputy
Under Secretary for Health (in 122001) to enhance qualifications?
A memorandum was sent out by the Assistant

Deputy Under Secretary for Health (10N) in
December of 2001 that provided a list of PSM job
responsibilities to assist in establishing the PSM
positions. The list captures the fundamental
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/

Resources
1.3.2
Mgt Ldr - 1
Is there dedicated space and

equipment for the Patient Safety
Program including an appropriate
meeting space, a portable notebook
computer, and an LCD projector?
Private work space should be provided to the

PSM when needed to help to comply with
confidentiality guidelines of 5705. A dedicated
work space or room for RCA teams should also
be provided for team meetings. LCD projector
and notebook should be made available to teams
upon request.
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1.3.3
Mgt Ldr - 1
Question:
Resources
Is Information Technology support

personnel provided to assist the
patient safety program to complete
related tasks?
IT staff is often needed for SPOT help or for

patient safety related upgrades to software such
as CPRS.
http://vaww.ncps.med.va.gov/Tools/SPOT/installation.html
Mgt Ldr - 1 - Version: 01.30.2009
Met
(1)
Partially
Met (2)
Not
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PATIENT SAFETY PROGRAM MANAGEMENT - Element 2
2.1.1
Question:
Root Cause Analysis Activities
Are questions 1-7 consistently

completed in SPOT to assess all
reported patient safety events,
including close calls?
The SPOT database should be used to enter

Safety Reports (i.e., items 1-7 in SPOT).
Met
(1)
Partially
Met (2)
Not
JCAHO_CAMH.pdf /A Page=294
JC- CAMH PI-01-01-01.pdf

2.1.1.1
Are RCAs completed as dictated by

SAC scoring?
Incidents where the Safety Report indicates an

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.

2.1.1.2
Are Medication, Para-Suicide/OutPatient Suicides, Falls and

Elopement adverse events and close
calls with a SAC potential score of 3
addressed via the Aggregated
Review Process?
Actual SAC score of 3 requires an individual

RCA to be done. All others of these event types
can included in an aggregated review (twice or
four times per FY depending on which event type)
focusing on fixing related processes (NOTE: Any
event can receive an individual RCA, even if it
meets the criteria for an inclusion in an aggregate
report). Facility-wide logs should be kept in the
facility SPOT database or other database. The
incident data captured should follow guidelines in
Appendix C of the NCPS Handbook (each event
type has unique criteria). Assessor should review
logs and aggregate reports to verify process is
being followed.
AggReviewSchedule 09 & 10 11x17.pdf

Guidanceon New Standards for VHA Patient Safety Program.pdf
ISMP_Book.pdf

2.1.2
Has the Patient Safety Manager

Show certificate(s) of completion from attendees.
attended the NCPS three day Patient
Safety Improvement training?
PS Prgm Mgt - 2
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2.1.2.1
Question:
If individuals other than the PSMs

serve as advisors on RCA teams
have they been appropriately
trained?
The appropriate training would be considered the

three day Patient Safety Improvement Course
offered by NCPS, or the equivalent given by a
trained PSO or PSM.
Met
(1)
Partially
Met (2)
Not

2.1.3
Are RCA teams orientated to the

Patient Safety Process prior to
participating on a RCA team?
PSM to show presentation materials of what is

reviewed with all new team members. Interview
team members, and/or review training records.
Charter Memo.pdf
RCATeamProcess.pdf

2.1.4
Is RCA team membership

appropriate for the adverse event
being evaluated?
Review a minimum of 4 RCA's to determine if

appropriate personal participate based on
relevance to RCA content. Team members'
titles/qualifications should be documented in the
RCA (SPOT database).

2.1.4.1
Does the PSM direct and advise the

RCA/Aggregate Review teams as
necessary to produce the desired
outcomes?
Review a minimum of 4 RCA's and interview

selective team members and the PSM. RCA
documentation should include defined root cause
statements, actions that address the root causes,
and outcome measures that measure the actions.

2.1.4.2
Does the PSM serve as an advisor

and not as the leader, recorder or
team member on RCAs?
Review a minimum of 4 RCA's and interview team

members and the PSM. Review RCA charter
memos to determine PSM role in each RCA
reviewed.
Charter Memo.pdf
PS Prgm Mgt - 2
USH memo PSM Job Jar (2).pdf /A Page=2
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Question:
2.1.5
Met
(1)
Partially
Met (2)
Not
Is a follow-up and review process for Show RCA updates, SPOT follow up table, SPOT
RCA Actions and Outcome Measures action dates, or other tracking methods. If action
being used within SPOT?
and outcome tracking is reviewed at committee
meetings, the meeting minutes may qualify as
proof as well.

2.1.6
Are the RCA Actions completed with

the specified time frame?
Review a minimum of 4 RCA's to 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.

2.1.6.1
Are Action completion and follow up

dates reasonable?
Review a minimum of 4 RCA's looking for time

frames and action completion rates. In some
cases it is necessary to implement actions
immediately to prevent another occurrence.

2.1.7
Are Root Cause Contributing Factors Review 10 % of yearly (minimum of 4) RCA's for
in the RCA reports consistently
context.
written to meet the five rules of
causation?
CognitiveAids_TriageQuestions.pdf /A Page=12

2.1.8
Do the RCA reports identify pertinent Review a minimum of 4 RCA's for context.
Root Cause Contributing Factors?
RC/CFs should be appropriate for RCA event.
For instance, evaluate if the event descriptions
match the root cause statements developed
within the same RCA.
PS Prgm Mgt - 2
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Question:
2.1.9
Met
(1)
Partially
Met (2)
Not
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?
appropriate (e.g., if the root cause is about
training then the action(s) should be about
training as well to address the root cause).

2.1.10
Do the Outcome Measures in the

RCA reports effectively measure the
Actions?
Review 10% of yearly (minimum of 4) RCA's.

Look for relation to Action and for numerators,
denominators, and thresholds. The NCPS Facility
Reports provided as feedback to each station
often address outcome measures and show
relevant examples and rewrites.

2.1.11
Are RCA reports completed within

45-days of the facility becoming
aware that an RCA is required?
Review 10% of yearly (minimum of 4) RCA's. If

reports are not competed, Actions cannot be
implemented. Reminder: Coroner dates or peer
review dates are the 'date aware' on RCAs.

2.1.12
PS Prgm Mgt - 2
Are at least 4 individual RCAs being

completed each fiscal year in
addition to the required 4 Aggregated
Reviews? Note: Zero event
Aggregated Reviews do not count
towards the minimum number of
reviews. Additional individual RCAs
or Wild Card Aggregated Reviews
must be completed to reach the
required level of 8 reviews per year.
The minimum requirement guidance was set forth

in December 2006 by NCPS that each facility will
complete a minimum of 4 individual RCAs per
year (exception: 1/1/07 - 9/30/07 only 3 are due.)
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2.2.1
Question:
Patient Safety Reporting System
Has the Patient Safety Reporting

System (PSRS) program been
instituted at the facility?
Confirm that the PSRS program been

communicated adequately, such as with all new
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.
NASA_VA_agree.pdf
Met
(1)
Partially
Met (2)
Not
General Programmatic Functions

2.3.1
Does the PSM collaborate with other

entities, such as Biomedical
Engineering staff, Occupational
Safety Officer and/or Industrial
Hygienist, & Infection Control?
Interview Engineering, Safety/IH, and/or Infection

Control. Documentation should be shown such as
JCAHO projects, and participation of these
disciplines on RCA and HFMEA teams.

2.3.2
Does the patient safety information

discussed in committee meetings
reach top management for their
consideration and action?
Review committee structure to determine if

adequate information is flowing up through the
organization (such committees as EOC, QI, PS,
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.

2.3.3
Is the PSM involved in the Patient

Safety Alerts/Advisories process,
including tracking issues to
resolution?
Show examples of Alerts/Advisories from facility,

and documentation from tracking. Interview PSM.
(Note: PSMs should not be involved in the Recall
process)

2.3.4
Are Patient Safety Program

successes publicized within the
facility?
Check documentation from town meeting

agenda/minutes, postings, newsletters, e-mails,
or other.
PS Prgm Mgt - 2
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Question:
2.3.5
Met
(1)
Partially
Met (2)
Not
Is the topic of Patient Safety covered Verify NEO process and materials. Criteria that
in New Employee Orientation?
should be covered is: background information on
patient safety (presentations such as 'Why
Bother?' and 'Beyond Blame'), existence of
NCPS, employee's responsibilities for patient
safety (such as reporting and training), overview
of RCA process, PSRS, etc.
WhyBother.ppt
http://vaww.ncps.med.va.gov/education.html#neo
http://vaww.ncps.med.va.gov/education.html#neo
JC- CAMH HR-01-04-01.pdf

2.3.6
Is continuing education being

provided for employees on Patient
Safety topics?
Review training methods used. Not all

employees will require the same level of
continuing education on Patient Safety. Review
examples from the past 12 months and determine
if training was proved based on the assessed
needs.

2.3.7
Does the PSM consult with experts

within or outside the VA when
needed?
Intervention with, NCPS, JCAHO, ASRAM,

ASHE, ISMP, ECRI, IHI, etc. The referencing of
written resources as well as telephone contact is
appropriate.

2.3.8
Is at least one HFMEA (or proactive PSM should initiate evaluations and/or advise
risk analysis) been completed for
personnel involved with the evaluations.
each JCAHO accredited program or Assessor should review completed reports.
has a single analysis been done that
covers all programs?
HFMEA.pdf
NCPS HFMEA Critique Sheet.pdf
PS Prgm Mgt - 2
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2.3.9
Question:
Does a system exist, and is it used,

to give feedback to staff that report
adverse event and close call
incidents that result in an RCA?
Prompt feedback to those reporting adverse

events has been credited in other reporting
systems with being one of the cornerstones that
establishes trust in the system. It demonstrates
the seriousness and
Met
(1)
Partially
Met (2)
Not
commitment on the part of the organization to the

importance of the reporting effort. Reporters are
to be made acutely aware that their effort of
reporting was not just a paperwork drill.
Verify via feedback documentation and interview

facility personnel. It is required to give feedback
to employees who report events which become
RCAs (of the actions and outcome measures).
However, other feedback of all events reported
(safety reports and aggregate log entries) are
helpful as well when communicated in facility
publications (i.e., web or newsletters) or when
given in a report to each Service Location as an
overall analysis.
PS Prgm Mgt - 2
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JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3
Question:
The Joint Commission Patient Safety Goals
3.9.1
Met
(1)
Partially
Met (2)
Not
Goal 1: Improve the Accuracy of

Patient Identification
HOSP, LTC, BHC, HC, AMC & Lab
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Question:
3.9.1.1
NPSG.01.01.01
Use at least two patient identifiers

when providing care, treatment, and
services.
Met
(1)
Partially
Met (2)
Not
Elements of Performance as doucumented for the

Hospital Progam
1) Prior to any specimen collection, medication

administration, transfusion, or treatment, the
hospital actively involves the patient and, as
needed, the family in the identification and
matching process. When active patient
involvement is not possible or the patients
reliability is in question, the hospital will designate
the caregiver responsible for identity verification.
Wrong-patient errors occur in

virtually all stages of diagnosis and
treatment. The intent for this goal is
two-fold: first, to reliably identify the
individual as the person for whom the Note: The involvement of a single caregiver is
service or treatment is intended;
acceptable as long as the other components of
second, to match the service or
patient identification are satisfied.
treatment to that individual.
2) Two patient identifiers are used when
administering medications, blood, or blood
components.
3) Two patient identifiers are used when

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

other treatments or procedures.
2009 NPSGs Chart TIPS (2).pdf

The Joint Commission NPSG.01.01.01
JC - 3
TIPS Jan Feb 09
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Question:
3.9.1.1
(continued)... NPSG.01.01.01
(continued)
Met
(1)
Partially
Met (2)
Not
...(continued) other specimens are labeled in the

presence of the patient.
Use at least two patient identifiers

when providing care, treatment, and
services.
Wrong-patient errors occur in

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

TIPS Jan Feb 09

3.9.1.2
NPSG.01.02.01
This standard comes under the Universal

Protocal for Hospitals and Ambulatory Care
Accrediation Programs.
Conduct a verification process before

starting invasive/surgical procedures.
Elements of Performace for other Accredication
Programs unavailable in PSAT.
HOSP & AMC
JC - 3
TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
JC - 3 - Version: 01.30.2009
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Question:
3.9.1.3
NPSG.01.03.01
Eliminate transfusion errors related

to patient misidentification.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1) Before initiating a blood or blood component

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

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

verification process, the second individual
conducting the identification verification must be
qualified to participate in the process.

JC- NPSG-01-03-01.pdf
HOSP & AMC
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Question:
3.9.2
Met
(1)
Partially
Met (2)
Not
Goal 2: Improve the Effectiveness of

Communication Among Caregivers
HOSP, LTC, BHC, HC, AMC & LAB
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Question:
3.9.2.1
NPSG.02.01.01
For verbal or telephone orders or for

telephone reporting of critical test
results, the individual giving the order
or test result verifies the complete
order or test result by having the
person receiving the information
record and "read back" the complete
order or test result.
Ineffective communication is the

most frequently cited root cause for
sentinel events. Effective
communication that is timely,
accurate, complete, unambiguous,
and understood by the recipient
reduces error and results in improved
patient safety.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 The individual receiving the information writes

down the complete order or test result or enters it
into a computer.
2 The individual receiving the information reads

back the complete order or test result.
3 The hospital defines the acceptable length of

time for reporting the results of routine tests with
critical abnormal values or findings.

time between the availability of critical tests and
critical results and values and receipt by the
responsible licensed caregiver.
3 The individual who gave the order or test result

confirms the information that was read back.

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Question:
3.9.2.2
NPSG.02.02.01
Met
(1)
Partially
Met (2)
Not

Hospital Progam
There is a standardized list of

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

symbols, and dose designations not to be used
includes the following:
- U,u
- IU
- Q.D., QD, q.d., qd
- Q.O.D., QOD, q.o.d, qod
- Trailing zero (X.0 mg)
- Lack of leading zero (.X mg)
- MS
- MSO4
- MgSO4
Note: A trailing zero may be used only when
required to demonstrate the level of precision of
the value
2009
NPSGs Chart
being
TIPS
reported,
(2).pdf
such as for laboratory
JC - 3
TIPS Jan Feb 09
JC - 3 - Version: 01.30.2009
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Question:
3.9.2.2
(continued)
Met
(1)
Partially
Met (2)
Not
...(continued) entered as free text into a

computer.
There is a standardized list of

abbreviations, acronyms, symbols,
4 The hospital does not include any
and dose designations that are not to abbreviations, acronyms, symbols, and dose
be used throughout the hospital.
designations identified as not to be used on
preprinted forms.
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TIPS Jan Feb 09
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Question:
3.9.2.3
NPSG.02.03.01
The hospital measures, assesses,

and, if needed, takes action to
improve the timeliness of reporting
and the timeliness of receipt of
critical tests and critical results and
values by the responsible licensed
caregiver.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 The hospital defines critical tests and critical

results and values.

time between the ordering of critical tests and
reporting the results of these tests, whether
normal or abnormal.

time for reporting the results of routine tests with
critical abnormal values or findings.

time between the availability of critical tests and
critical results and values and receipt by the
responsible licensed caregiver.
5 The hospital collects data on the timeliness of

reporting critical test results and critical results
and values from routine tests.
2009
6
The
NPSGs
hospital
Chart TIPS
assesses
(2).pdf
the data on the
JC - 3
TIPS Jan Feb 09
JC - 3 - Version: 01.30.2009
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Question:
3.9.2.3
(continued)
Met
(1)
Partially
Met (2)
Not
...(continued) action to improve the timeliness of

reporting critical test results and critical results
and values from routine tests and measures the
effectiveness of those actions.
The hospital measures, assesses,

and, if needed, takes action to
improve the timeliness of reporting
and the timeliness of receipt of
critical tests and critical results and
values by the responsible licensed
caregiver.
JC - 3
TIPS Jan Feb 09
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Question:
3.9.2.4
NPSG.02.05.01
The hospital implements a

standardized approach to hand-off
communications, including an
opportunity to ask and respond to
questions.
Health care has numerous types of

patient hand-offs, including, but not
limited to, nursing shift changes;
physician transfer of complete
responsibility for a patient; physician
transfer of on-call responsibility;
acceptance of temporary
responsibility for staff leaving the unit
for a short time; anesthesiologist
report to post-anesthesia recovery
room nurse; nursing and physician
hand-off from the emergency
department to inpatient units,
different hospitals, nursing homes,
and home health care; and critical
laboratory and radiology results sent
to physician offices. The primary
objective of a hand-off is to provide
accurate information about a
patient's care, treatment, and
services; current condition; and any
recent or anticipated changes. The
information communicated during a
hand-off must be accurate in order to
meet patient safety goals.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 The hospitals process for effective hand-off

communication includes the following: Interactive
communication that allows for the opportunity for
questioning between the giver and receiver of
patient information.
2 The hospital's process for effective hand-off

communication includes the following: Up-to-date
information regarding the patients condition,
care, treatment, medications, services, and any
recent or anticipated changes. (See also
NPSG.08.01.01, EP 4)

communication includes the following: A method
to verify the received information, including
repeat-back or read-back techniques.

communication includes the following: An
opportunity for the receiver of the hand-off
information to review relevant patient historical
data, which may include previous care, treatment,
and services.
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Question:
3.9.2.4
(continued)
Met
(1)
Partially
Met (2)
Not
...(continued) during hand-offs are limited to

minimize the possibility that information fails to be
conveyed or is forgotten.
The hospital implements a

standardized approach to hand-off
communications, including an
opportunity to ask and respond to
questions.
Health care has numerous types of

patient hand-offs, including, but not
limited to, nursing shift changes;
physician transfer of complete
responsibility for a patient; physician
transfer of on-call responsibility;
acceptance of temporary
responsibility for staff leaving the unit
for a short time; anesthesiologist
report to post-anesthesia recovery
room nurse; nursing and physician
hand-off from the emergency
department to inpatient units,
different hospitals, nursing homes,
and home health care; and critical
laboratory and radiology results sent
to physician offices. The primary
objective of a hand-off is to provide
accurate information about a
patient's care, treatment, and
services; current condition; and any
recent or anticipated changes. The
information communicated during a
hand-off must be accurate in order to
meet patient safety goals.

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Question:
3.9.3
Met
(1)
Partially
Met (2)
Not
Goal 3: Improve the Safety of Using

Medication
HOSP, LTC, BHC, HC & AMC

3.9.3.1
NPSG.03.03.01
The hospital identifies and, at a

minimum, annually reviews a list of
look-alike/sound-alike medications
used by the hospital and takes action
to prevent errors involving the
interchange of these medications.

Hospital Progam
1 The hospital identifies a list of look-alike/soundalike medications used by the hospital. The list
includes a minimum of 10 look-alike/sound-alike
medication combinations selected from the tables
of look-alike/sound-alike medications posted on
The Joint Commission Web site at
http://www.jointcommission.org.
2 The hospital reviews the list of lookalike/sound-alike medications at least annually.
3 The hospital takes action to prevent errors

involving the interchange of the medications on
the list of look-alike/sound-alike medications.

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Question:
3.9.3.2
NPSG.03.04.01
Label all medications, medication

containers (for example, syringes,
medicine cups, basins), or other
solutions on and off the sterile field.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 Medications and solutions both on and off the

sterile field are labeled even if there is only one
medication being used.
Medications or other solutions in

unlabeled containers are
unidentifiable. Errors, sometimes
tragic, have resulted from
medications and other solutions
removed from their original
containers and placed into unlabeled
containers. This unsafe practice
neglects basic principles of
medication management safety yet
has been routine in many
organizations.
2 Labeling occurs when any medication or

solution is transferred from the original packaging
to another container.
The labeling of all medications,

medication containers, and solutions
is a risk reduction activity consistent
with safe medication practices. This
practice addresses a recognized risk
point in the safe administration of
medications in perioperative and
other procedural settings.
4 All medication or solution labels are verified

both verbally and visually by two qualified
individuals whenever the person preparing the
medication or solution is not the person who will
be administering it.
3 Medication or solution labels include the

medication name, strength, amount (if not
apparent from the container), expiration date
when not used within 24 hours, and expiration
time when expiration occurs in less than 24
hours.
5 No more than one medication or solution is

labeled at one time.
HOSP & AMC
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Question:
3.9.3.2
(continued)
Label all medications, medication

containers (for example, syringes,
medicine cups, basins), or other
solutions on and off the sterile field.
Met
(1)
Partially
Met (2)
Not
...(continued) reference in the perioperative or

procedural area until the conclusion of the
procedure.
8 All labeled containers on the sterile field are

discarded at the conclusion of the procedure.
Medications or other solutions in

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

medication containers, and solutions
is a risk reduction activity consistent
with safe medication practices. This
practice addresses a recognized risk
point in the safe administration of
medications in perioperative and
other procedural settings.

HOSP & AMC
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Question:
3.9.3.3
NPSG.03.05.01
Met
(1)
Partially
Met (2)
Not

Hospital Progam
Reduce the likelihood of patient harm

associated with the use of
1 The hospital implements a defined
anticoagulant therapy.
anticoagulation management program to
individualize the care provided to each patient
receiving anticoagulant therapy.
Note: This requirement applies only
to hospitals that provide
anticoagulant therapy and/or longterm anticoagulation prophylaxis (for
example, atrial fibrillation) where the
clinical expectation is that the
patients laboratory values for
coagulation will remain outside
normal values. This requirement
does not apply to routine situations in
which short-term prophylactic
anticoagulation is used for venous
thrombo-embolism prevention (for
example, related to procedures or
hospitalization) and the clinical
expectation is that the patients
laboratory values for coagulation will
remain within, or close to, normal
values.
2 To reduce compounding and labeling errors,

the hospital uses only oral unit dose products,
pre-filled syringes, or pre-mixed infusion bags
when these types of products are available. Note:
For pediatric patients, pre-loaded syringe
products should only be used if specifically
designed for children.
3 The hospital uses approved protocols for the

initiation and maintenance of anticoagulant
therapy appropriate to the medication used, to the
condition being treated, and to the potential for
medication interactions.
4 For patients starting on warfarin, a baseline

International Normalized Ratio (INR) is available,
Anticoagulation therapy poses risks and for all patients receiving warfarin therapy, a
to patients and often leads to
current INR is available and is used to monitor
adverse drug events due to complex and adjust this therapy.
dosing, requisite follow-up
monitoring, and inconsistent patient 2009 NPSGs Chart TIPS (2).pdf
HOSP, LTC, HC & AMC
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Question:
3.9.3.3
(continued)
Met
(1)
Partially
Met (2)
Not
...(continued) services are provided by the

hospital, the service is notified of all patients
receiving warfarin and responds according to its
established food/medication interaction program.
Reduce the likelihood of patient harm

associated with the use of
anticoagulant therapy.
Note: This requirement applies only

to hospitals that provide
anticoagulant therapy and/or longterm anticoagulation prophylaxis (for
example, atrial fibrillation) where the
clinical expectation is that the
patients laboratory values for
coagulation will remain outside
normal values. This requirement
does not apply to routine situations in
which short-term prophylactic
anticoagulation is used for venous
thrombo-embolism prevention (for
example, related to procedures or
hospitalization) and the clinical
expectation is that the patients
laboratory values for coagulation will
remain within, or close to, normal
values.
6 When heparin is administered intravenously

and continuously, the hospital uses
programmable infusion pumps in order to provide
consistent and accurate dosing.
7 The hospital has a written policy that

addresses baseline and ongoing laboratory tests
that are required for heparin and low molecular
weight heparin therapies.
8 The hospital provides education regarding

anticoagulant therapy to prescribers, staff,
patients, and families. Note: Patient/family
education includes the importance of follow-up
monitoring, compliance issues, dietary
restrictions, and potential for adverse drug
reactions and interactions.
9 The hospital evaluates its anticoagulation

Anticoagulation therapy poses risks safety practices, takes appropriate action to
to patients and often leads to
improve its practices, and measures the
adverse drug events due to complex effectiveness of those actions on a regular basis.
dosing, requisite follow-up
monitoring, and inconsistent patient 2009 NPSGs Chart TIPS (2).pdf
HOSP, LTC, HC & AMC
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Question:
3.9.4
Met
(1)
Partially
Met (2)
Not
Goal 4: RETIRED - As of 2005 this

a) Use a pre-op verification process, such as a
goal is now surveyed under the
checklist, to confirm appropriate documents are
Universal Protocol: Eliminate wrong- available.
site, wrong-patient, wrong-procedure.
b) Implement a process to mark the surgical site
and involve the patient in the process.
RETIRED

3.9.5
Goal 5: RETIRED - improve the

safety of using infusion pumps.
Ensure free-flow protection on all general-use

and PCA (patient controlled analgesia)
intravenous infusion pumps used in the
organization
RETIRED

3.9.6
Goal 6: RETIRED - As of 2005 this

goal is now surveyed under EC
standards: Improve the
effectiveness of clinical alarm
systems.
a) Implement regular preventive maintenance and

testing of alarm systems.
b) Assure that alarms are activated with
appropriate settings and are sufficiently audible
with respect to distances and competing noise
within the unit.
RETIRED

3.9.7
Goal 7: Reduce the Risk of Health

Care-Associated Infections
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Question:
3.9.7.1
NPSG.07.01.01
Comply with current World Health

Organization (WHO) hand hygiene
guidelines or Centers for Disease
Control and Prevention (CDC) hand
hygiene guidelines.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 The hospital complies with current World

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

hand hygiene guidelines will reduce
the transmission by staff to patients
of infectious agents, thereby
decreasing the incidence of health
careassociated infections.
CDC Hand Hygiene.pdf

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Question:
3.9.7.2
NPSG.07.02.01
Manage as sentinel events all

identified cases of unanticipated
death or major permanent loss of
function related to a health care
associated infection.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 The hospital manages all identified cases of

unanticipated death or major permanent loss of
function associated with a health careassociated
infection as sentinel events (that is, the hospital
conducts a root cause analysis).
A significant percentage of patients

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

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Question:
3.9.7.3
NPSG.07.03.01
Met
(1)
Partially
Met (2)
Not

Hospital Progam
Implement evidence-based practices

to prevent health careassociated
1 As of April 1, 2009, the hospitals leadership
infections due to multidrug-resistant has assigned responsibility for oversight and
organisms in acute care hospitals.
coordination of the development, testing, and
implementation of NPSG.07.03.01.
Note 1: This requirement applies to,
but is not limited to, epidemiologically
important organisms such as
methicillin-resistant Staphylococcus
aureus (MRSA), Clostridium difficile
(CDI), vancomycin-resistant
Enterococci (VRE), and multiple
drug-resistant gram negative
bacteria.
2 As of July 1, 2009, an implementation work

plan is in place that identifies adequate
resources, assigned accountabilities, and a time
line for full implementation of NPSG.07.03.01 by
January 1, 2010.
3 As of October 1, 2009, pilot testing in at least

one clinical unit is under way, for the
requirements in NPSG.07.03.01.
Note 2: This requirement has a oneyear phase-in period that includes
defined expectations for planning,
development, and testing
4 As of January 1, 2010, the elements of
(milestones) at three, six, and nine
performance in NPSG.07.03.01 are fully
months in 2009, with the expectation implemented across the hospital.
of full implementation by January 1,
2010.
patients continue to acquire health

careassociated infections at an
alarming rate. Risks and patient
5 As of January 1, 2010, conduct periodic risk

assessments for multidrug-resistant organism
acquisition and transmission. (See also
IC.01.03.01, EPs 1-5)
The Joint Commission NPSG 07.03.01
HOSP
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Question:
Met
(1)
Partially
Met (2)
Not
3.9.7.3
(continued)
...(continued) health careassociated infections,

multidrug-resistant organisms, and prevention
strategies at hire and annually thereafter. Note:
The education provided recognizes the diverse
Implement evidence-based practices roles of staff and licensed independent
to prevent health careassociated
practitioners and is consistent with their roles
infections due to multidrug-resistant within the hospital. (See also HR.01.05.03, EP 4)
organisms in acute care hospitals.
Note 1: This requirement applies to,

but is not limited to, epidemiologically
important organisms such as
methicillin-resistant Staphylococcus
aureus (MRSA), Clostridium difficile
(CDI), vancomycin-resistant
Enterococci (VRE), and multiple
drug-resistant gram negative
bacteria.

months in 2009, with the expectation
2010.
7 As of January 1, 2010, the hospital educates

patients, and their families as needed, who are
infected or colonized with a multidrug-resistant
organism about health careassociated infection
strategies.
8 As of January 1, 2010, the hospital implements

a surveillance program for multidrug-resistant
organisms based on the risk assessment.
9 As of January 1, 2010, the hospital measures

and monitors multidrug-resistant organism
prevention processes and outcomes including the
following:
- Multidrug-resistant organism infection rates
using evidence-based metrics
- Compliance with evidence-based guidelines or
best practices
patients continue to acquire health

careassociated infections at an
alarming rate. Risks and patient
- Evaluation of the education program provided to

staffNPSGs
2009
and licensed
Chart TIPS (2).pdf
independent practitioners
The Joint Commission NPSG 07.03.01
HOSP
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Question:
3.9.7.4
NPSG.07.04.01
Met
(1)
Partially
Met (2)
Not

Hospital Progam
Implement best practices or

evidence-based guidelines to prevent 1 As of April 1, 2009, the hospitals leadership
central lineassociated bloodstream has assigned responsibility for oversight and
infections.
Note 1: This requirement covers
short- and long-term central venous
catheters and peripherally inserted
central catheter (PICC) lines.

January 1, 2010.

one clinical unit is under way for the requirements
(milestones) at three, six, and nine in NPSG.07.04.01.
2010.
implemented across the hospital.

health care workers who are involved in these
procedures about health careassociated
infections, central lineassociated bloodstream
infections,
2009
NPSGs Chart
andTIPS
the(2).pdf
importance of prevention.
HOSP, LTC, HC & AMC
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Question:
3.9.7.4
(continued)
Met
(1)
Partially
Met (2)
Not
...(continued) procedures is added to an

individuals job responsibilities.
Implement best practices or

evidence-based guidelines to prevent 6 As of January 1, 2010, prior to insertion of a
central lineassociated bloodstream central venous catheter, the hospital educates
infections.
patients and, as needed, their families about
central lineassociated bloodstream infection
prevention.
Note 1: This requirement covers
short- and long-term central venous
catheters and peripherally inserted
central catheter (PICC) lines.

policies and practices aimed at reducing the risk
of central lineassociated bloodstream infections
that meet regulatory requirements and are
aligned with evidence-based standards (for
Note 2: This requirement has a one- example, the Centers for Disease Control and
year phase-in period that includes
Prevention (CDC) and/or professional
organization guidelines)
of full implementation by January 1, 8 As of January 1, 2010, the hospital conducts
2010.
periodic risk assessments for surgical site
infections, measures central lineassociated
bloodstream infection rates, monitors compliance
with best practices or evidence-based guidelines,
and evaluates the effectiveness of prevention
efforts.
9 As of January 1, 2010, the hospital provides

central lineassociated bloodstream infections
rate NPSGs
2009
data and
Chart TIPS
prevention
(2).pdf
outcome measures to
HOSP, LTC, HC & AMC
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Question:
3.9.7.5
NPSG.07.05.01
Implement best practices for

preventing surgical site infections.
Note: This requirement has a oneyear phase-in period that includes

2010.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 As of April 1, 2009, the hospitals leadership

has assigned responsibility for oversight and

January 1, 2010.

one clinical unit is under way, for the
requirements in NPSG.07.05.01.

implemented across the hospital.

health care workers involved in surgical
procedures about health care associated
infections, surgical site infections, and the
importance
2009
NPSGs Chart
of TIPS
prevention.
(2).pdf
Education occurs upon
HOSP & AMC
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Question:
3.9.7.5
(continued)
Implement best practices for

preventing surgical site infections.
Note: This requirement has a oneyear phase-in period that includes

2010.
Met
(1)
Partially
Met (2)
Not
...(continued) an individuals job responsibilities.
6 As of January 1, 2010, prior to all surgical

procedures, the hospital educates patients, and
their families as needed, who are undergoing a
surgical procedure about surgical site infection
prevention.

policies and practices aimed at reducing the risk
of surgical site infections that meet regulatory
requirements and are aligned with evidencebased standards (for example, the Centers for
Disease Control and Prevention (CDC) and/or
professional organization guidelines). (See also
UP.01.03.01, EP 5)
8 As of January 1, 2010, the hospital conducts

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

follow evidence-based guidelines, and surgical
site infection rates are measured for the first 30
daysNPSGs
2009
following
Chart TIPS
procedures
(2).pdf
that do not involve
HOSP & AMC
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Question:
3.9.8
Met
(1)
Partially
Met (2)
Not
Goal 8: Accurately and Completely

Reconcile Medication Across the
Continuum of Care
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Question:
3.9.8.1
NPSG.08.01.01
A process exists for comparing the

patients current medications with
those ordered for the patient while
under the care of the hospital.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 At the time the patient enters the hospital or is

admitted, a complete list of the medications the
patient is taking at home (including dose, route,
and frequency) is created and documented. The
patient and, as needed, the family are involved in
creating this list.
2 The medications ordered for the patient while

under the care of the hospital are compared to
those on the list created at the time of entry to the
hospital or admission.
3 Any discrepancies (that is, omissions,

duplications, adjustments, deletions, additions)
are reconciled and documented while the patient
is under the care of the hospital.
4 When the patients care is transferred within

the hospital (for example, from the ICU to a floor),
the current provider(s) informs the receiving
provider(s) about the up-to-date reconciled
medication list and documents the
communication. (See also NPSG.02.05.01, EP 2).
Note: Updating the status of a (continued)...
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Question:
3.9.8.1
(continued)
Met
(1)
Partially
Met (2)
Not
...(continued) patients medications is also an

important component of all patient care hand-offs.
A process exists for comparing the

patients current medications with
those ordered for the patient while
under the care of the hospital.
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Question:
3.9.8.2
NPSG.08.02.01
When a patient is referred to or

transferred from one hospital to
another, the complete and reconciled
list of medications is communicated
to the next provider of service, and
the communication is documented.
Alternatively, when a patient leaves
the hospitals care to go directly to
his or her home, the complete and
reconciled list of medications is
provided to the patients known
primary care provider, the original
referring provider, or a known next
provider of service.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 The patients most current reconciled

medication list is communicated to the next
provider of service, either within or outside the
hospital. The communication between providers
is documented.
2 At the time of transfer, the transferring hospital

informs the next provider of service how to obtain
clarification on the list of reconciled medications.
Note: When the next provider of

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

patients reconciled medication list to
the next provider of service reduces
the risk of transition-related adverse
drug events. The communication
enables the next provider of service

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Question:
3.9.8.3
NPSG.08.03.01
When a patient leaves the hospitals

care, a complete and reconciled list
of the patients medications is
provided directly to the patient and,
as needed, the family, and the list is
explained to the patient and/or family.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 When the patient leaves the hospitals care,

the current list of reconciled medications is
provided and explained to the patient and, as
needed, the family. This interaction is
documented. Note: Patients and families are
reminded to discard old lists and to update any
records with all medication providers or retail
pharmacies.
The accurate communication of the

patients medication list to the patient
and, as needed, the family, reduces
the risk of transition-related adverse
drug events. A thorough knowledge
of the patients medications is
essential for the patients primary
care provider or next provider of
service to manage the subsequent
stages of care for the patient.

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Question:
3.9.8.4
NPSG.08.04.01
In settings where medications are

used minimally, or prescribed for a
short duration, modified medication
reconciliation processes are
performed.
Note: This requirement does not

apply to hospitals that do not
administer medications. It may be
important for health care
organizations to know which types of
medications their patients are taking
because these medications could
affect the care, treatment, and
services provided.
Met
(1)
Partially
Met (2)
Not

Hospital Progam
1 The hospital obtains and documents an

accurate list of the patients current medications
and known allergies in order to safely prescribe
any setting-specific medications (for example,
intravenous contrast media, local anesthesia,
antibiotics) and to assess for potential allergic or
adverse drug reactions.
2 When only short-term medications (for

example, a preprocedure medication or a shortterm course of an antibiotic) will be prescribed
and no changes are made to the patient's current
medication list, the patient and, as needed, the
family are provided with a list containing the short
term medication additions that the patient will
continue after leaving the hospital. Note: This list
of new short term medications is not considered
to be part of the original, known, and current
medication list. When patients leave these
settings, a list of the original, known, and current
medications does not need to be (continued)...

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Question:
3.9.8.4
(continued)
In settings where medications are

used minimally, or prescribed for a
short duration, modified medication
reconciliation processes are
performed.
Note: This requirement does not

apply to hospitals that do not
administer medications. It may be
important for health care
organizations to know which types of
medications their patients are taking
because these medications could
affect the care, treatment, and
services provided.
Met
(1)
Partially
Met (2)
Not
...(continued) provided, unless the patient is

assessed to be confused or unable to
comprehend adequately. In this case, the
patients family is provided both medication lists
and the circumstances are documented.
3 In these settings, a complete, documented

medication reconciliation process is used when:
Any new long-term (chronic) medications are
prescribed.

There is a prescription change for any of the
patients current, known long-term medications.

The patient is required to be subsequently
admitted to an organization from these settings
for ongoing care.
6 When a complete, documented, medication

reconciliation is required in any of these settings,
the complete list of reconciled medications is
provided to the patient, and their family as
needed, and to the patients known primary care
provider or original referring provider or a known
nextNPSGs
2009
provider
Chart of
TIPS
service.
(2).pdf
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Question:
3.9.9
Met
(1)
Partially
Met (2)
Not
Goal 9: Reduce the Risk of Patient

Harm Resulting for Falls
HOSP, LTC & HC
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Question:
3.9.9.1
NPSG.09.02.01
Met
(1)
Partially
Met (2)
Not

Hospital Progam
The hospital implements a fall

reduction program that includes an
1 The hospital establishes a fall reduction
evaluation of the effectiveness of the program.
program.
2 The fall reduction program includes an
evaluation appropriate to the patient population,
settings, and services provided.
3 The fall reduction program includes

interventions to reduce the patients fall risk
factors.
4 Staff receive education and training for the fall

reduction program.
5 The hospital educates the patient and, as

needed, the family on the fall reduction program
and any individualized fall reduction strategies.
6 The hospital evaluates the fall reduction

program to determine the effectiveness of the
program. Note: Outcome indicators such as
decreased
2009
NPSGs Chart
number
TIPS (2).pdf
of falls and decreased number
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Question:
3.9.10
Met
(1)
Partially
Met (2)
Not
Goal 10: Reduce the Risk of

Influenza and Pneumococcal
Disease in Institutionalized Older
Adults
LTC

3.9.10.1
NPSG.10.01.01
Elements of Performance listed in JC resource

"Meeting the 2009 NPSGs"
Develop and implement a protocol

for administration and documentation 1 Appropriate protocols are developed to
of the flu vaccine.
determine whether to administer the flu vaccine to
a patient.
2 There is evidence that protocols were

implement for residents identified as high risk.
JC Reference for this Goal is unavailable in PSAT

LTC
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Question:
3.9.10.2
NPSG.10.02.01
Met
(1)
Partially
Met (2)
Not

Develop and implement a protocol

for administration and documentation 1 Appropriate protocols are developed to
of the pneumococcus vaccine.
determine whether to administer the
pneunnococcus vaccine to a patient.
2 There is evidence that protocols were

implemented to for patients identified as high risk.

LTC
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Question:
3.9.10.3
NPSG.10.03.01
Met
(1)
Partially
Met (2)
Not

Develop and implement a protocol to

identify new cases of influenza and 1 Protocols are developed to identify cases of
to manage an outbreak.
influenza and to manage an outbreak.
2 There is evidence that the protocols are

followed for patients displaying signs and
symptoms of influenza.

LTC

3.9.11
Goal 11: Reduce the Risk of

Surgical Fires
AMC
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Question:
3.9.11.1
NPSG.11.01.01
Met
(1)
Partially
Met (2)
Not

Educate staff, including operating

licensed independent practitioners
1 Organizations asses the risk for surgical fires
and anesthesia providers, on how to based on equipment and procedures used.
control heat sources and manage
fuels, and establish guidelines to
minimize oxygen concentration under
drapes.
2 The organization establishes guidelines to
minimize oxygen concentration under drapes.
3 Organizations that identify themselves as at risk

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

provide staff training on methods to avoid the use
of flammable solutions and materials.

AMC

3.9.12
Goal 12: NOT APPLICIABLE Implementation of applicable

National Patient Safety Goals and
associated requirements by
components and practitioner sites.
Inform and encourage components and

practitioner sites to implement the applicable
National Patient Safety Goals and associated
requirements.
NA
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Question:
3.9.13
Met
(1)
Partially
Met (2)
Not
Goal 13: Encourage the Active

Involvement of Patients and Their
Families in the Patients Own Care
as a Patient Safety Strategy
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Question:
3.9.13.1
NPSG.13.01.01
Met
(1)
Partially
Met (2)
Not

Hospital Progam
Identify the ways in which the patient

and his or her family can report
1 The patient and family are educated on
concerns about safety and
available reporting methods for concerns related
encourage them to do so.
to care, treatment, and services and patient
safety issues.
Communication with the patient and
family about all aspects of care,
treatment, and services is an
important characteristic of a culture
of safety. When the patient knows
what to expect, he or she is more
aware of possible errors and choices.
The patient can also be an important
source of information about potential
adverse events and hazardous
conditions.
2 The hospital provides the patient with

information regarding infection control measures
for hand hygiene practices, respiratory hygiene
practices, and contact precautions according to
the patients condition. The information is
discussed with the patient and his or her family
members on the day the patient enters the
hospital or as soon as possible (for example,
within 2448 hours). The patients understanding
of this information is evaluated and documented.
(See also PC.02.03.01, EP 25)
Note: The information provided to the patient may
be in any form of media.
3 For surgical patients, the hospital describes the

measures that will be taken to prevent adverse
events in surgery. Examples include, but are not
limited to, patient identification practices,
(continued)...

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Question:
Met
(1)
Partially
Met (2)
Not
3.9.13.1
(continued)
...(continued) prevention of surgical infections,

and marking of the procedure sites. The patients
understanding is evaluated and documented.
(See also PC.02.03.01, EP 25). Note: The
Identify the ways in which the patient information provided to the patient may be in any
and his or her family can report
form of media.
concerns about safety and
encourage them to do so.
4 The hospital encourages patients and their
families to report concerns about safety.
Communication with the patient and
family about all aspects of care,
treatment, and services is an
important characteristic of a culture
of safety. When the patient knows
what to expect, he or she is more
aware of possible errors and choices.
The patient can also be an important
source of information about potential
adverse events and hazardous
conditions.

TIPS Jan Feb 09

3.9.14
Goal 14: Prevent Health CareAssociated Pressure Ulcers

(Decubitus Ulcers)
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Question:
3.9.14.1
NPSG.14.01.01
Assess and periodically reassess

each patient's risk for developing a
pressure ulcer and take action to
address any identified risks.
Met
(1)
Partially
Met (2)
Not

1 There is a plan for the prediction, prevention,

and early treatment of pressure ulcers, which
addresses the following:
-Identifying individuals at risk and the specific
factors that place them at risk.
-Maintaining and improving tissue tolerance to
pressure in order to prevent injury.
-Protecting against the adverse effects of external
mechanical forces.
-Reducing the incidence of pressure ulcers
through staff educational programs.
2 Initial assessments are performed at admission.
3 A systematic resk assessment is conducted

using a vaildated risk assesment tool such as the
Braden Scale or Norton Scale.
4 Pressure ulcer risk is reassessed at periodic

intervals.
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Question:
3.9.15
Met
(1)
Partially
Met (2)
Not
Goal 15: The Organization Identifies

Safety Risks Inherent In Its Patient
Population
HOSP, BHC & HC

3.9.15.1
NPSG.15.01.01

Hospital Progam
The hospital identifies patients at risk

for suicide.
1 The risk assessment includes identification of
specific patient factors and environmental
features that may increase or decrease the risk
for suicide.
Note: This requirement only applies
to psychiatric hospitals and patients
being treated for emotional or
behavioral disorders in general
2 The hospital addresses the patients immediate
hospitals.
safety needs and most appropriate setting for
treatment.
Suicide of a care recipient while in a
staffed, round-the-clock care setting
is a frequently reported type of
sentinel event. Identification of
individuals at risk for suicide while
under the care of or following
discharge from a health care
organization is an important step in
protecting these at-risk individuals.
3 The hospital provides information such as a

crisis hotline to individuals at risk for suicide and
their family members

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Question:
3.9.15.2
NPSG.15.02.01
The organization identifies risks

associated with long-term oxygen
therapy, such as home fires.
Met
(1)
Partially
Met (2)
Not

1 The home safety risk assessment includes

presence or absence and working order of smoke
detectors, fire extinguishers, and fire safety plans
and review of all medical equipment.
2 The organization provides education to the

patient and family regarding the findings of the
home safety risk assessment, possible
interventions, causes of fire and fire prevention
activities.

HC

3.9.16
Goal 16: Improve Recognition and

Response to Changes in a Patient's
Condition
HOSP
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Question:
3.9.16.1
NPSG.16.01.01
Met
(1)
Partially
Met (2)
Not

Hospital Progam
The hospital selects a suitable

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

and practices is conducted with the staff and
licensed independent practitioners who may
request assistance and those who may respond
to those requests.
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Question:
Met
(1)
Partially
Met (2)
Not
...(continued) intervention program and any

underlying organizational system issues, takes
appropriate action to improve its intervention
system, and measures the effectiveness of those
The hospital selects a suitable
actions on a regular basis. Note: Hospitals are
method that enables health care staff not required to create rapid response teams or
medical emergency teams in order to meet this
members to directly request
additional assistance from a specially goal. The existence of these types of teams does
trained individual(s) when the
not mean that all of the elements of performance
are automatically achieved.
patients condition appears to be
worsening.
3.9.16.1
(continued)
significant number of critical

cardiopulmonary arrests and patient
mortality.
A significant number of critical


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3.10.1
Question:
Universal Protocol
UP.01.01.01: Conduct a
preprocedure verification process.

Hospital Progam
The preprocedure verification is an

ongoing process of information
gathering and verification, beginning
with the decision to perform a
procedure, continuing through all
settings and interventions involved in
the preprocedure preparation of the
patient, up to and including the timeout just before the start of the
procedure.
1 Verification of the correct person, correct site,

and correct procedure occurs at the following
times:
Met
(1)
Partially
Met (2)
Not
- At the time the procedure is scheduled

- At the time of preadmission testing and
assessment
- At the time of admission or entry into the facility
for a procedure, whether elective or emergent
- Before the patient leaves the preprocedure area

The purpose of the preprocedure
or enters the procedure room
verification process is to make sure
that all relevant documents and
- Anytime the responsibility for care of the patient
related information or equipment are: is transferred to another member of the
procedural care team, (including the anesthesia
- Available prior to the start of the
providers) at the time of, and during, the
procedure.
procedure
- Correctly identified, labeled, and
matched to the patients identifiers.
- With the patient involved, awake and aware, if

possible
- Reviewed and are consistent with

the patients expectations and with
the teams understanding of the
2 When the patient is in the preprocedure area,
intended patient, procedure, and site. immediately prior to moving the patient to the
procedure room, a checklist (for example, paper,
electronic, or other medium such as a wallmounted whiteboard) is used to review and verify
Missing information or discrepancies 2009
that NPSGs
the following
Chart TIPS items
(2).pdf are available and
The Joint Commission UP.01.01.01
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Question:
Universal Protocol
Met
(1)
Partially
Met (2)
Not
3.10.1
(continued)... UP.01.01.01: Conduct ...(continued) matched to the patient:
(continued) a preprocedure verification process.
- Relevant documentation (for example, history

and physical, nursing assessment, and preanesthesia assessment)
The preprocedure verification is an
ongoing process of information
gathering and verification, beginning
with the decision to perform a
procedure, continuing through all
settings and interventions involved in
the preprocedure preparation of the
patient, up to and including the timeout just before the start of the
procedure.
- Accurately completed, and signed, procedure

consent form
- Correct diagnostic and radiology test results (for
example, radiology images and scans, or
pathology and biopsy reports) that are properly
labeled
- Any required blood products, implants, devices,
and/or special equipment for the procedure
The purpose of the preprocedure

verification process is to make sure
that all relevant documents and
related information or equipment are:
- Available prior to the start of the
procedure.
- Correctly identified, labeled, and
matched to the patients identifiers.
- Reviewed and are consistent with
the patients expectations and with
the teams understanding of the
intended patient, procedure, and site.
Missing information or discrepancies

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3.10.2
Question:
Universal Protocol
UP.01.02.01: Mark the procedure

site.

Hospital Progam
Met
(1)
Partially
Met (2)
Not
Marking the procedure site allows

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

patient is moved to the location where the
procedure will be performed and takes place with
the patient involved, awake and aware, if
possible.
3 The procedure site is marked by a licensed

independent practitioner or other provider who is
privileged or permitted by the hospital to perform
the intended surgical or nonsurgical invasive
procedure. This individual will be involved directly
in the procedure and will be (continued)...

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Question:
Universal Protocol
Met
(1)
Partially
Met (2)
Not
3.10.2
(continued)... UP.01.02.01: Mark the ...(continued) present at the time the procedure is
(continued) procedure site.
performed. Note: Final confirmation and
verification of the site mark takes place during the

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

characteristics:
- It is made at or near the procedure site or the
incision site. Other nonprocedure site(s) are not
marked unless necessary for some other aspect
of care.
- It includes, preferably, the surgeons or
proceduralists initials, with or without a line
representing the proposed incision.
- It is made using a marker that is sufficiently
permanent to remain visible after completion of
the skin prep and sterile draping. Adhesive site
markers are not to be used as the sole means of
marking the site.
- It is positioned to be visible after the patient has
his or her skin prepped, is in his or her final
position, and sterile draping is completed.

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Question:
Universal Protocol
3.10.3
Met
(1)
Partially
Met (2)
Not
UP.01.03.01: A time-out is performed Elements of Performance as doucumented for the

immediately prior to starting
Hospital Progam
procedures.
The purpose of the time-out

immediately before starting the
procedure is to conduct a final
assessment that the correct patient,
site, positioning, and procedure are
identified and that, as applicable, all
relevant documents, related
information, and necessary
equipment are available.
1 The time-out is conducted prior to starting the

procedure and, ideally, prior to the introduction of
the anesthesia process (including
general/regional anesthesia, local anesthesia,
and spinal anesthesia), unless contraindicated.
2 The time-out has the following characteristics:

- It is standardized (as defined by the hospital).
The time-out is consistently initiated

by a designated member of the team
and includes active communication
among all relevant members of the
procedure team. It is conducted in a
standardized fail-safe mode (that is,
the procedure is not started until all
questions or concerns are resolved).
- It is initiated by a designated member of the

team.
- It involves the immediate members of the
procedure team including the proceduralist(s), the
anesthesia providers, the circulating nurse, the
operating room technician, and other active
participants as appropriate for the procedure, who
will be participating in the procedure at its
inception.
- It involves interactive verbal communication
between all team members, and any team
member is able to express concerns about the
procedure verification.
- It includes a defined process for reconciling
differences in responses.
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Question:
Universal Protocol
Met
(1)
Partially
Met (2)
Not
3.10.3
(continued)... UP.01.03.01: A time...(continued) During the time-out, other activities
(continued) out is performed immediately prior to are suspended, to the extent possible without
starting procedures.
The purpose of the time-out

immediately before starting the
procedure is to conduct a final
assessment that the correct patient,
site, positioning, and procedure are
identified and that, as applicable, all
relevant documents, related
information, and necessary
equipment are available.
compromising patient safety, so that all relevant

members of the team are focused on the active
confirmation of the correct patient, procedure,
site, and other critical elements.
4 When two or more procedures are being

performed on the same patient, a time-out is
performed to confirm each subsequent procedure
before it is initiated.
5 The time-out addresses the following:

The time-out is consistently initiated
by a designated member of the team
and includes active communication
among all relevant members of the
procedure team. It is conducted in a
standardized fail-safe mode (that is,
the procedure is not started until all
questions or concerns are resolved).
- Correct patient identity

- Confirmation that the correct side and site are
marked
- An accurate procedure consent form
- Agreement on the procedure to be done
- Correct patient position
- Relevant images and results are properly
labeled and appropriately displayed
- The need to administer antibiotics or fluids for
irrigation purposes (See also NPSG.07.05.01, EP
7)
-2009
Safety
NPSGs
precautions
Chart TIPS (2).pdf
based on patient history or
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PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
4.1.1
Question:
Procurement and Equipment
Are Human Factors Engineering

principals considered when
purchasing medical devices?
The medical devices are evaluated for ease of

use; feedback to the user (verbal and visual);
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.
Met
(1)
Partially
Met (2)
Not
Copyrighted Refs.doc
JC- CAMH EC-02-04-01.pdf

4.1.2
Is equipment assessed for usability

and maintainability prior to
procurement?
Internal and external failure rates or other past

history reports should be considered when
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?)

4.1.3
Is equipment inspection scope and

frequency modified based on
inspection results or user input?
Show evidence of the PM inspection

modifications. Interview Biomedical Service
personnel have them show evidence of tracking
and modification if applicable.

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?
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PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4
4.1.4.1
Question:
Is the effectiveness of this training

assessed?
Not only should training occur, but the

competency testing or other measures of
effectiveness should be applied.
Met
(1)
Partially
Met (2)
Not

4.1.5
When feasible, is equipment

standardized by manufacturer and
model?
Limiting the number of systems/equipment

clinicians and maintenance staff are required to
operate/maintain will reduce latent errors in the
system. Interview personnel, review examples.

4.1.5.1
Are you in compliance with VISN or

National BPAs (Blanket Purchase
Agreements)?
A standardization group has previously 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.

4.1.6
When errors are identified that are

Review documentation or log of these inspections
unable to be duplicated or repeated, or evaluations. While proficiency with the
are appropriate actions taken?
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.

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.
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RECALLS and ALERTS AND ADVISORIES - Element 5
Question:
Recalls and VA Patient Safety Alerts & Advisories
5.1.1
Met
(1)
Partially
Met (2)
Not
Has the Facility implemented a

At minimum the program must cover:
product recall program in accordance
with the requirements of VHA
Directive 2008-080, Recall of
Defective Medical Devices and
(1) Ensuring recalled medical devices or medical
Medical Products, including Food
products are not used at any facility.
and Food Products?
(2) Designating a FRC and back-up FRC(s).
(3) Ensuring all recalls are completed by the due

date specified on the VHA Alert and Recall
Management System Web site.
(4) Designating FDASs, and alternates, for all

categories identified in Attachment B of the Alert.
(5) Ensuring that action status or

recommendations of Recalls, VHA Patient Safety
Alerts, and Patient Safety Advisories are
implemented and documented on the VHA Alert
and Recall Management System Web site.
Recalls Alerts Advis - 5
(6) Reporting internally-identified equipment

design or product failure experiences that may
cause serious adverse health consequences or
death, or temporary or medically reversible
adverse
VHA
Directive
health
2008-080
consequences,
recalls.pdf
to the Product
Recalls Alerts Advis - 5 - Version: 01.30.2009
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Question:
5.1.1
(continued)... Has the Facility
(continued) implemented a product recall
Met
(1)
Partially
Met (2)
Not
...(continued) implanted in VA patients at non-VA

facilities, including affiliates or private institutions.
program in accordance with the

requirements of VHA Directive 2008080, Recall of Defective Medical
Devices and Medical Products,
(8) Ensuring that facility-initiated contracts require
including Food and Food Products? vendors to notify the Facility Contracting Officer
of any recalls or important product safety issues
as described in subparagraph 4j(2).
VHA Directive 2008-080 recalls.pdf
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Question:
5.1.1.1
At minimum do the responsibilities of

the Facility Recall Coordinator (FRC)
include items 1-7 as stated in the
rationale?
Met
(1)
Partially
Met (2)
Not
(1) Coordinating and disseminating logisticsrelated recall information to the Facility

Designated Area Specialists (FDASs), and
verifying and reporting that recall actions are
completed within the facility by the due date.
(2) Working with the facility Contracting Officer to

obtain recalls or important product safety issues
received from facility-initiated contracts, including
information described in subparagraph 4d(4).
(3) Maintaining an up-to-date list of the FDASs

including name, email address, and phone
numbers and providing this list to the Network
Recall Coordinator.
(4) Verifying that the appropriate action has been

taken, e.g., identifying numbers and locations of
medical devices and products; removing,
sequestering, and returning the products for
credit; and providing suitable alternate products
so that essential activities are not adversely
impacted.
(5) Documenting action status on the VHA Alert

and Recall Management System Web site.
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Question:
Met
(1)
Partially
Met (2)
Not
5.1.1.1
(continued)... At minimum do the
(continued) responsibilities of the Facility Recall
...(continued) for maintaining records that details

the steps taken to resolve recalls, such as:
Coordinator (FRC) include items 1-7 distribution lists, response times, number of items
as stated in the rationale?
identified, final disposition of affected items, and
date resolved.
(7) Contacting the PRO (10X) and the NRC with

any recalls or important product safety issues
received from facility-initiated contracts or locallyidentified product or device issues potentially
impacting product or patient safety (e.g., recall
letter sent from supplier to OR or Chief of Supply,
Processing and Distribution (SPD)), including
information described in subparagraph 4d(4).
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Question:
5.1.1.2
Met
(1)
Partially
Met (2)
Not
At minimum do the responsibilities of (1) Providing technical expertise on completing

the Facility Designated Area
recalls in coordination with the FRC.
Specialists include items 1-4 as
stated in the rationale?
(2) Serving as the subject matter expert and
investigator on internally-identified hazards within
their area of expertise or specialty.
(3) Communicating recall information to their

respective Designated Service Area Specialists in
VACO, when national notification may be
appropriate, including the described in
subparagraph 4d(4).
(4) Implementing actions specified by the FRC by

the due date, and reporting back to the FRC
when those actions have been completed.

5.1.2
Are VA Patient Safety Alert and

Advisory actions and
recommendations implemented and
tracked until completed?
Check the VHA Alert and Recall Management

System at
http://vaww.nbc.med.va.gov/visn/recalls/ to see if
Alerts and Advisories are being addressed
appropriately.
Interview PSM to review local process that tracks

completion of recommendations.
http://vaww.nbc.med.va.gov/visn/recalls/
76 of 578

5.2.1
Question:
1998 Alerts & Advisories
Patient Burns from Hot Water, 6/98
1. Carefully review VHA Directive 97-027 to

ensure your policies and procedures are
compliant.
Met
(1)
Partially
Met (2)
Not
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.
ScaldAlert.pdf

5.2.2
COBE CENTURYSYSTEM 3
Blood Tubing Sets, 6/98
1. Identify blood tubing sets and cease their use.

2. Quarantine any inventory and arrange return to
GAMBRO Healthcare.
Blood tubing sets may be associated

with incidents of hemolysis. A total of
four patient deaths have been
reported following dialysis treatment,
none in VA. All lot numbers of
catalog numbers: 003109-400,
003109-410, 003110-500, 003111500, 003112-500, 003113-500,
003114-500, 003210-500, 003212500 003101-000, 003212-515.
3. Special instructions are available for clinics,

which must provide treatment before
replacements arrive and for which the only blood
tubing sets available are those subject to the
recall. Call GAMBRO Healthcare (800) 456-7339
(24 HOUR) for these instructions.
COBE.pdf
4. Contact GAMBRO Healthcare for further

questions, Tim Schoenberg at (800) 525-2623
x4010.
77 of 578

Question:
5.2.3
Met
(1)
Partially
Met (2)
Not
Truncation of Viral Loads in Network 1. IRM sections should fix data fields in NHE to
Health Exchange, 7/98
allow the full (which may include < or >
characters) value to be entered. Two VISNs have
collaborated and developed a routine that has
been shared with their counterparts in other VISN
The NHE viral load value field only
facilities. This is an interim measure. A national
allowed for a 4 digit value to be
patch should be made available no later than
transmitted, when in fact, the value is 7/31/98.
often 6 digits long.
2. A National Online Information Sharing (NOIS)
(CIN-0698-41578) has been submitted to the
national developers of the NHE alerting them to
this matter.
3. Facilities should undertake a review of whether
clinicians have looked up viral load results using
NHE. And whether clinical judgements were
based on these values rather than looking up the
results in VistA directly. If this has happened then
it must be determined whether patients treatment
protocol is accurate and that the laboratory
values were not truncated which may have
resulted in inappropriate treatment. Corrective
actions should be taken immediately.
Trunc.pdf
78 of 578

Question:
5.2.4
Met
(1)
Partially
Met (2)
Not
Boston Scientific/SCIMED NIR ON 1. Facilities will immediately discontinue use of

RANGER With SOX
the product. These device failures may result in
Premounted Stent, 10/98
emergency interventions, including coronary
bypass surgery.
The balloon portion of the delivery
catheter can develop pinhole leaks
and rupture at inflation pressures as
low as 3 ATM. This problem
manifests during the stent
deployment procedure.
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.
3. For further information regarding the product
recall and exchange program, call the SCIMED
customer service line at 1-888-724-6334.
Ranger.pdf

5.2.5
Blakemore tube 3-lumen, X-ray

opaque, 2 balloon catheter, 21
French, 36" long, by Rusch Int'nat'l,
10/98
1. VHA Medical Facilities that have received

these catalog numbers of catheters are to
immediately cease using them.
2. Quarantine any inventory and arrange their
return to Rusch International for a no cost
exchange.
Blakemore tube 21 Fr, 36 inches

long, Model Number 2300-21,
3. Contact Rusch International for exchange,
Batch Number E343601, Sterilized Derek Monjure (800) 553-5214.
by EtO 01/95, Use By 01/2000,
In pre-use testing, they discovered
the balloons were deteriorated
beyond use.
BlakeTube.pdf
79 of 578

Question:
5.2.6
Met
(1)
Partially
Met (2)
Not
Invivo Research Inc.'s Milennia 3500 1. Determine if facility contains any monitors
multiparameter patient monitor,
manufactured before December 1998.
12/98
2. The manufacturer advises the problem will not
occur if the clock is neither tested nor reset on
December 31 - January 1. Invivo has a software
The FDA has issued an advisory for upgrade to fix the problem that is now available.
this patient monitor. It has a
potential New Years Eve problem on 3. Contact Invivo Research Inc at 407-275-3220
every year including 1998-1999.
and ask for customer service.
PtMonitor.pdf

5.2.7
Hewlett-Packard Defibrillator, model

43100a/43200a, 12/98
1. Device will defibrillate properly but will not print

out the month, day, hour, and minute.
2. The manufacturer advises it should be reset to

1998 (not 1999) after which the unit will work
They will experience a minor date
properly for the year 1999 (because the event
change problem upon the start of the record does not print the year, only the month,
New Year, January 1, 1999. The
day, etc.).
Hewlett-Packard 43100a/43200a will
defibrillate properly.
3. "At the end of 1999 it will need to be reset
again, from 1998 to year 2000, after which it
should work properly. Thirty-nine thousand of
these defibrillators were sold worldwide between
1985 and 1992. Hewlett-Packards website is:
www.hp.com
"
Defib.pdf
80 of 578

5.3.1
Question:
GE/Marquette Clinical Information

Center (V1.4 and all previous
software revisions), 4/99
1. Do not use the APEX pulse oximeter while it is

connected to the APEX S telemetry transmitter.
Versions used with the APEX S

telemetry transmitter and APEX
pulse oximeter. 4/99
Met
(1)
Partially
Met (2)
Not
2. The APEX pulse oximeter may continue to be

used as a standalone device. In this case, the
interface cables between the pulse oximeter and
the telemetry transmitter (PN. 412926-001, -002,
-003) should be removed from patient use.
3. GE/Marquette will provide a software update
for your CIC upon completion of testing and
validation. A GE-Marquette service representative
will then contact you to schedule updates. Once
your CIC software is updated, you may again use
your APEX Pulse Oximeter while it is connected
to your APEX S transmitters.
The ALL ALARMS OFF visual

message on the CIC waveform
window disappears and the alarms
remain off when the following
conditions are met: 1.The user turns
off alarms on the CIC, THEN
4. If you have any questions concerning this
safety alert, please contact Tom Lower,
2. A. The APEX pulse oximeter is
GE/Marquette's Telemetry Product Manager (414)
turned on or turned off while
362-2572.
connected to the APEX S telemetry
transmitter OR B. The APEX pulse
oximeter is connected to or
disconnected from the APEX S
telemetry transmitter.
Telemetry.pdf
81 of 578

Question:
5.3.2
Met
(1)
Partially
Met (2)
Not
Boston Scientific/SCIMED; Discovery 1. VA medical facilities will immediately either

Catheters catalog numbers C3020
replace the Discovery catheter with the
and C3005 (All lots); 6/99
UltraCross intravascular ultrasound catheter or
discontinue use of the product.
The distal segment of the sheath of
Discovery catheters may separate
from the proximal segment. The
separations have led to surgical
intervention in some cases where the
separation occurred in vivo.
2. Return all unused products to the

manufacturer, Boston Scientific/SCIMED (Maple
Grove, MN) who will replace them with the
UltraCross intravascular ultrasound catheter at no
cost or credit your account.
3. For further information regarding the product
recall and exchange program, call SCIMED at 1800-862-1284 from 8:30 a.m. to 5 p.m. (EDT).
Catheter.pdf
82 of 578

5.3.3
Question:
Hoyer Power Lift Actuators

Manufactured by Sunrise Medical
used on all serial numbers of:
(Descriptions), 8/99
1. "Verify if you have any affected units in use. If

so, there are two options to remedy the problem:
Option 1: Order and install no-cost upgrade kits.
Option 2: Send in affected actuators (NOT the
entire lift) for a no cost upgrade.
Retro-fit Power, Retro-fit Power

Conversion Kit 59105, Power
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.
Met
(1)
Partially
Met (2)
Not
2. You can use the form enclosed in the attached

manufacturer's notice to report affected actuators
to Sunrise Medical. Contact Sunrise Medical at
(800) 556-5438 to arrange for delivery of the kit or
upgrading the actuator.
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.
Hoyer.pdf
83 of 578

5.3.4
Question:
OEC Medical Systems' UroView,

8/99
1. If you have an affected system, contact the

regional service manager (information attached)
for your area to schedule the no-cost upgrade.
Model 2600, Model 2500, and Model

2000 urologic Xray systems, with 30"
and 36" Leg Extensions, all serial
numbers. 8/99. The 30 and 36 Leg
Extension accessory utilized in
conjunction with the UroView X-ray
imaging system may not properly
engage and lock in place and can
potentially disengage when the
UroView is tilted beyond 70 degrees
reverse Trendelenberg, potentially
resulting in patient injury or
equipment damage.
Met
(1)
Partially
Met (2)
Not
2. "Until the modification is complete you can

safely use the 30 or 36 Leg Extension if you
take the following precautions:
1. When the Leg Extension is installed, the
operator should confirm that the locks positively
engage and snap back to the lock position.
2. From the foot end of the Leg Extension, lift the
platform up from side to side to ensure that the
accessory is firmly secured.
"
3. If the locks do not snap back or if the table
accessory rails or Leg Extension side rails are
loose, call your local OEC Field Service office for
service support.
UroView.pdf
84 of 578

5.3.5
Question:
Nellcor Puritan Bennett Pulse

Oximeters manufactured by
Mallinckrodt Medical, 9/99
1. To verify proper operation of the affected units,

perform the following test: 1. With the pulse
oximeter ""OFF"", connect an approved Nellcor
sensor to the NPB 190 or NPB 195 pulse
oximeter. 2. Turn the pulse oximeter ""ON"" 3.
Verify that the ""%Sp02"" and ""BPM"" displays
both show ""0"" after a short audible tone.
Models NPB-190 and NPB-195, all

units manufactured before October 9
1998. The manufacturer has
received reports of the affected pulse
oximeters failing to alarm when the
sensor is disconnected from the
patient.
Met
(1)
Partially
Met (2)
Not
2. If the pulse oximeter performs as indicated

above, no further action is required.
3. However, if the pulse oximeter displays
alternating ""--"" and ""00"" (dashes and zeroes),
it may be susceptible to the aforementioned
problem. If your pulse oximeter is affected: 1.
Remove it from clinical service immediately. 2.
Contact Mallinckrodt Technical Service at 1-800635-5267, 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.
PulseOx.pdf
85 of 578

Question:
5.4.1
Met
(1)
Partially
Met (2)
Not
Patient Ventilators (all

makes/models) used with flow
meters, 1/00
1. Unless recommended by the equipment

manufacturer, attach the ventilator directly to the
supply outlet on the patient panel. In most cases,
there are two outlets available. If the patient
requires more than two supplies, branch off the
outlet NOT used by the ventilator. If you must
A VA Medical recently experienced a attach a second device to the same outlet, as the
Low Flow alarm on a patient
ventilator, test the output of the branching device
ventilator attached to the oxygen wall with a flow analyzer to ensure sufficient flow to
outlet via a T adapter on the supply the ventilator.
side of the flowmeter.
Vent.pdf

5.4.2
The Clinipad Corporation is recalling 1. Recall of sterile and non-sterile products

Sterile and Non-sterile products,
including: Sterile Povidone Iodine, Tincture of
12/00
Iodine, Benzoin Tincture, Acetone Alcohol, and
Alcohol Antiseptic Products, Sterile Cliniguard
Protective Dressing, and Specified Lots of
Nonsterile Products. The products (swabsticks,
The company has confirmed
prep pads, towelettes, ointments and pouches, as
microbial contamination in some lots well as protective dressings) are distributed under
of its sterile products, including one the names: Cliniswab, Clinipad, Clinidine,
lot with Pseudomonas aeruginosa,
Cliniguard, EZ Prep, Cooper Instrument Corp.,
Stenotrophomonas maltophilia, and Moore Medical Corp., and Rauscher.
Coagulase Negative Staphylococcus
which was recalled in December
1999.
Clinipad.pdf
86 of 578

Question:
5.4.3
Met
(1)
Partially
Met (2)
Not
Medtronic Dual Chamber Temporary 1. Immediately affix a warning label to these

Pacemaker Model 5388, 8/00
pacemakers that show steps to clear 0004 error.
Label: WARNING: If error code 0004 appears
immediately release battery door. REMOVE
battery until error message clears. REINSTALL
Model may become inactive if a
battery.
button is touched while it is in "self
test" mode.
2. Verify and document that all staff who utilize or
come in contact have been trained on how to
clear the 0004 error code.
3. Report identical or similar design related
events to the FDA and through appropriate
channels within the VA.
Pacemaker.pdf

5.5.1
Magnetic Resonance Imaging (MRI)

Systems, all, 2/01.
A sand bag attached to a patients

arm undergoing an MRI exam
contained iron pellets (unknown to
staff) encased in heavy vinyl; brand
name North West. When the
patient was being moved into the
MRI bore, the iron-filled bag flew into
the magnet and pinned the patients
forearm to the side of the magnet.
1. Purchase "sand bags" for patient care that do

not contain iron and properly label the bags.
2. If facility uses bags that contain iron, these
bags should be labeled "Contains Iron: DO NOT
expose to MRI."
3. Patients should disrobe and wear clothing
tested for your MRI environment.
4. DO NOT verify that a "sand bag" is compatible
by testing it with the MRI magnet - this could have
catastropic consequences.
5. Staff should consider all items to be unsafe for
the MRI environment until proven otherwise.
MRIgenalert.pdf
87 of 578

5.5.2
Question:
Bed Rail Entrapment, 7/01.
1. Within 120 days of alert, complete inventory of

all existing beds and identify those that do not
meet the dimensions specified in this Alert
(60mm for bed gaps, 120mm for bed rail
openings).
A patient experienced a close call

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.
Met
(1)
Partially
Met (2)
Not
2. Within 120 days of alert, permanently mark all

non-complying bed assemblies using a method
that clearly communicates the bed entrapment
risk to staff.
3. Immediately fill gaps created between the
mattress and bedrail that are equal to or wider
than 60mm used for high risk patients ( frail,
elderly, confused, physically impaired) with
suitable materials (e.g. high density fire retardant
foam wedges) to reduce risk of entrapment.
4. Immediately reduce the openings within the
bed rails to less than 120mm in size for beds
used for high risk patients (frail, elderly, confused,
physically impaired). Depending upon the bed
side rail type this opening may exist between
horizontal bars (bars parallel to mattress) or
vertical bars (bars perpendicular to the mattress).
Materials include bed rail (continued)...
BedEntrap.pdf
VHA Patient Safety Alert on Bed Rail Entrapment 2001.doc
88 of 578

Question:
5.5.2
(continued)... Bed Rail Entrapment,
(continued) 7/01.
Met
(1)
Partially
Met (2)
Not
...(continued) netting or clear padding or bed rail

retrofit kits.
5. When new bed assemblies or replacement

mattresses are purchased openings within the
A patient experienced a close call
bed side rails and gaps between the mattress and
event when his head became
the side rail shall not exceed the dimensions
wedged in the bed rail opening while specified in this Alert.
having a coughing episode. The
patient was found by the nursing staff
with a partially obstructed airway and
was released without injury. This
alert patient with a right side CVA
(cerebrovascular accident) was
trapped while laying on his left side.
BedEntrap.pdf
VHA Patient Safety Alert on Bed Rail Entrapment 2001.doc

5.5.3
General Electric Advantage Windows 1. Identify the affected workstations; affected

workstation, models 2273156-2 and models contain all iteration of software version
2273220-2, 7/01
AW4.0_02. Other software versions are not
affected.
2. If affected, contact your local GE field engineer,
The ROI (Region Of Interest)
schedule the upgrade to version AW4.0_03 and
function on the workstation can
ask if you are on the effectivity list. If so, you
change value, depending upon the
should receive the software at no cost.
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.
GEWorksta.pdf
89 of 578

Question:
5.5.4
Met
(1)
Partially
Met (2)
Not
Corruption of VistA Imaging files,8/01 1. Facility directors must immediately consult with
the Chief of IRM to determine if part of the routine
system management includes moving globals.
While moving data from one volume to another if
Patient images and audio fax files
your facility is using DICOM image gateway or
may become miss-associated when MUMPS AudioFax system or any other satellite
the repacking utility is run and all
system that uses DDP to access data you are at
globals are not properly shutdown. risk and must implement the guidance contained
This means that clinical information in Office of Information alert #AXP 123. This OI
could appear in a patients record
Alert may be found at
which is incorrect and the care giver http://vaww.va.gov/custsvc/cssupp/axp/axp123.ht
would have no way of knowing that
m
the information is invalid.
2. Also do not move data from one volume to
another without coordinating the move with the
other satellite that uses DDP to access VistA
data. In any case all facility directors must
respond to oialert@med.va.gov with copies to
Gerry.Barry@med.va.gov and
Debbie.Channell@med.va.gov (to ensure receipt
of this message) by close of business August 21,
2001 and report whether this alert applies to their
operation and if applicable that the appropriate
procedures are being executed. Negative replies
are required.
PACS1.pdf
90 of 578

Question:
5.5.5
Met
(1)
Partially
Met (2)
Not
Clinician Awareness of Corruption of 1. Facility Directors must ensure that: All

VistA Imaging files, 8/01
clinicians are sensitive to and aware of this
potenital problem. Any clinical concerns related
to images should be immediately pursued in
consultation with the Chief IRM.
Patient images and audio fax files
may become miss-associated when
the repacking utility is run and all
globals are not properly shutdown.
This means that clinical information
could appear in a patients record
which is incorrect and the care giver
would have no way of knowing that
the information is invalid.
PACS2.pdf

5.5.6
Pharmacy Package - Synonym

Lookup Resulted in Wrong
Medication Being Displayed or
Selected, 1/01
Interim 1. Review all drug entries in the Pharmacy

Package drug and synonym files to ensure that
there is consistent use of upper and lower case
letters.
Interim 2. Notify all pharmacy personnel that the
Pharmacy Package drug lookup feature is case
sensitive. Post reminders in Pharmacy and all
satellite Pharmacy's.
Solution: Pharmacy service in conjunction with
the Offuce of Information Management will
update the Pharmacy Package lookup feature to
eliminate case sensitivity. If a single match is
found, users will be prompted to verify the match
is correct. These updates will be provided by
Inpatient Medications patch PSJ*5*55 and
Outpatient Pharmacy patch PSO*7*54.
DrugSyn.pdf
91 of 578

5.5.7
Question:
Computerized Medical Record 'List

Manager Version', 7/01
1. Review the records of patents with identifier

NW to determine if orders have been erroneously
entered and take appropriate action.
Inadvertent access to medical record

with patient identifier NW when
attempting to access the NW (new
order) prompt resulting in wrong
orders for patient NW
Met
(1)
Partially
Met (2)
Not
2. Notify staff of the potential for error if the

correct prompt if not visible when entering new
orders. Orders are entered at the "Action" prompt
rather than the "Patient" prompt.
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.
CPRSManager.pdf
92 of 578

5.5.8
Question:
Risperidone oral medication syringe

(pipette), 8/01
1. Consider using oral tablets.
Met
(1)
Partially
Met (2)
Not
2. For those inpatients that cannot tolerate

tablets, have pharmacy prepackage unit dose
liquid.
Graduated markings on the
risperidone syringe (pipette) that
comes in the medication box are
opposite of the markings on syringes
we use in USA. Nurse almost
administered the wrong dosage.
3. Advise the caregiver to use USA standard, oral

syringe by replacing the pipette that comes in the
box with an oral syringe.
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.
Pipette.pdf
93 of 578

5.5.9
Question:
Hemodialysis Catheters: Ash Split

and Vaxcel, 8/01
1. Do not use Alcohol, Acetone, Hydrogen

Peroxide, and other ointments on these
catheters. If these agents are not necessary in
the unit, remove them from the premises.
These long-term indwelling catheters

may crack and/or form small blisters
(blebs), if wrong disinfectants and/or
cleaning solutions are used.
2. Prior to insertion/installation in patients: Inspect

each catheter for small blisters (blebs), cracks
and defects as you remove them from the sterile
packaging. If any defect is found prior to
installation, stop and sequester the catheter and
its packaging and call your risk manager and/or
patient safety officer.
Met
(1)
Partially
Met (2)
Not
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.
HemodiCatheterAdv.pdf
94 of 578

5.6.1
Question:
Zoll M Series defibrillators and M

Series AEDs with software versions
below 30.00, 1/02
1. Immediately (within 24 hours) upon receiving

this alert, arrange for Biomedical Engineering to
confirm whether or not your units are affected via
the serial number and software version.
Specific defibrillators: T98F00046 to

T01K27762, AEDs: T98F00092 to
T01J27533, In the auto-charge
mode, the charging circuit may
generate an artifact on the
electrocardiograph (ECG) signal that
can lead the units to display "No
Shock Advised" even during
shockable ventricular fibrillation.
Met
(1)
Partially
Met (2)
Not
2. If affected:a) M Series Advisory defibrillators

and AEDs with manual operation option - Disable
the auto charge configuarion and contact your
local Zoll representative to obtain the corrective
software. You can continue to use the defibrillatr
in the manual configuration. b) Fully Automatic
AEDs - Remove the affected units from service
and contact your local Zoll representative for the
corrective software. Do Not use the units until the
software has been upgraded. Assure that you
identify a loaner unit to provide coverage for the
removed unit.
ZollDefib.pdf
95 of 578

5.6.2
Question:
Bronchoscopes manufactured by
Olympus America, Inc., per
manufacturer's letter, 3/02
1. Immediately identify all units affected. Remove

them from service and test them for a loose portal
following Olympus procedure.
Met
(1)
Partially
Met (2)
Not
2. If you detect any looseness in the biopsy

channel port, discontinue using the affected
Affected models: BF-40, BF-40, BF bronchoscope, notify Olympus via fax and return
-P40, BF-1T40, BF-3C40, BF -XP40, it to Olympus per their directions for immediate
BF -XT40, BF 240, BF -P240, BF- upgrade.
1T240, BF-6C240, BF-160, BF-P160,
BF-1T160, BF-3C160, BF -XT160,
3. If the unit is not affected, it can be used.
per manufacturers letter, A loose
However, Olympus requests it be returned for a
biopsy port can trap bacteria in a
biopsy port housing upgrade when practical.
spot that the usual disinfecting
process may not reach.
4. Finally, if you have affected units, review
Epidemiologists traced the problem relevant patient records to determine if there is a
to the Olympus bronchoscopes,
pattern of increased pseudomonas infections
which were picking up bacteria from associated with the use of these bronchoscopes
one patient, shielding them from the and report positive findings to Dr. Gary Roselle,
disinfectants and transferring them to VAMC Cincinnati.
the next patient exposed to the
scope.
BronchOlympusMar02.pdf
96 of 578

Question:
5.6.3
Met
(1)
Partially
Met (2)
Not
Baxter Colleague infusion pumps, all 1. If you have not arlready received and
units may be affected, 5/02
responded to this notice, immediately (within 24
hours) identify all units affected by this alert and
contact Baxter at 1-800-843-7867, select 2 (for
Technical Assistance) then 1 (for Colleague) to
Product codes 2M8151, 2M8151R,
either arrange modification or obtain the
2M8153, 2M8153R, If fluid enters the insulators for installation by Biomedical
pump body (usually during cleaning), Engineering.
there is a risk of a short circuit later
causing the pump to rapidly cycle on 2. If a pump us exposed to excessive fluids or
and off. This can happen without
starts cycling on and off, remove it and contact
any alarms; if this happens during
Biomedical Engineering to arrange for service.
use, therapy delivery may be
interrupted.
3. Copy, post, and follow Baxters recommended
cleaning procedures.
4. As recommended by the manufacturers 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.
BaxterColleagueMay02.pdf
97 of 578

5.6.4
Question:
Phillips/Agilent/Hewlett Packard
Viridia information centers; 5/02.
1. If you have the affected units and did not

already receive and respond to Phillips Medical
Systems letter, immediately check your central
station monitoring serial numbers against the list
in the attached letter from Phillips Medical.
Met
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Partially
Met (2)
Not
Central station monitors using the

Hewlett Packard Vectra VL400
2. If affected, contact Phillips Medical at (800)
personal computer. This PC is used 548-8833 to arrange replacement of the hard
in models M3150A, M3151A,
drives.
M3153A and M3150AU#A01 central
station monitors. All units shipped
between Feb 1, 2001 and Feb 21,
2000 are affected. Bedside monitors
are NOT affected., The hard disk
drive installed in the units may fail,
causing loss of central station
monitoring and alarming. Bedside
monitoring and alarms are not
affected.
PhilipsViridia1.pdf
PhilipsViridia.pdf
98 of 578

Question:
5.6.5
Met
(1)
Partially
Met (2)
Not
Inadvertent deletion of text from

CPRS progress notes, 8/02.
1. On August 20, 2002, the emergency patch

OR*3*155 was released; nearly all stations have
already installed this patch. Within 24 hours of
this alert, ensure that your facility has installed
the patch. (This patch removes the spell checking
Four VA medical facilities report
option on CPRS only. A permanent fix is
random deletion of progress note text scheduled to be released first week of October
after running Microsoft Word spell
2002.)
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.
SpellCheckThin.pdf

5.6.6
Recall of the Pocket Guide "VA/DoD

Clinical Practice Guideline for
Management of Postoperative Pain",
9/02.
1. Retrieve and destroy all existing Pocket Guides

for the VA/DoD Clinical Practice Guideline for
Management of Postoperative Pain. The guide is
white, quad-folded, laminated and contains the
Equianalgesic Table.
These printed version units were

distributed mid-July 2002. There is a
typographical error in some of the
pocket guides. The column Dosage
forms available may be printed
incorrectly in the Equianalgesic Table
for Fentanyl (IV). The table should
read Injection: 50 g/ml
(micrograms/ml) not Injection: 50
mg/ml (milligrams/ml).
PocketGuideRecall.pdf
99 of 578

Question:
5.6.7
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Met (2)
Not
MEDISYSTEMS Corp., blood tubing

for dialysis, 9/02
1. Check your inventory for the affected products,

Medisystems Product code D3-9694/9793 or K39694/9793, 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
K39694/9793, Baxter Code 5M9694, 24 hours) remove affected tubing from service in
There are reports outside the VA
a manner that does not compromise the provision
healthcare system that this blood
of necessary dialysis treatment.
tubing may be linked to deaths and
injuries when used with the Meridian
model of dialysis machines
manufactured by Baxter Healthcare
Corporation.
BaxterTubingSept02[1].pdf
100 of 578

5.6.8
Question:
4341B Thoracentesis Catheters in

Thoracentesis Trays distributed by
Allegiance Healthcare Corp., 11/02
1. Remove all stock with the identified lot

numbers from the inventory.
Met
(1)
Partially
Met (2)
Not
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.
AllegianceThoraCatheter.pdf
101 of 578

Question:
5.6.9
Met
(1)
Partially
Met (2)
Not
Power cords used with GE Dinamap 1. Check the medical equipment inventory to
Vital Signs Monitors, all models
determine if the specified monitors are in use at
distributed btwn June 2001 & Oct
the facility.
2002, 11/02
2. Immediately replace any cords with a broken
ground pin with another spare power cord that is
not affected by this notice.
A VA medical center reported ground
pins breaking on the power cords
3. Determine the total number of power cords
used with GE Dinamap Vital Signs
affected by this notice, whether they show broken
Monitors. This compromises one of ground pins or not. They can be identified by
the safety features designed to limit their manufacture date code as follows. Two
patients' risk of electrical shock,
numbers are imprinted on the hot and neutral
should an electrical fault occur in the blades; one is the week and the other is the year
equipment. Unless the pin has
of manufacture. Blades made between (week broken, patient safety is not
year) 09 - 01 and 16 - 02 are affected.
compromised.
4. Contact General Electric to replace all the
power cords affected by this notice. The contact
at GE is Erik Granby; he can be contacted at
(813) 887-2545 or via e-mail at
erik.granby@med.ge.com.
5. When new cords are installed, return the
affected cords to GE for disposal.
GEDinamapCord.pdf
102 of 578

Question:
5.6.10
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Potential for incorrectly attaching

1. Use only standardized irrigation kits identified
Allegiance Irrigation Kit caps to Foley by the Medical/Surgical Users Group; acquire
catheters, 2/02.
from LSL Industries purchased under (BPA)
Blanket Purchase Agreement # VANAC90NP-00035 with Foley catheters.
The tubing cap (Catalog #3T4121) of
the Allegiance irrigation kit is small
enough to fit into a Foley catheter,
resulting in an obstructed Foley
catheter.
2. Check with Materials Management to

determine if Allegiance Irrigation kits are present
in your facility. If so, alert all clinical staff of this
possible problem and the manufacturers
intended use and design of the cap. Make copies
of the attached WARNING sheet and distribute
with Allegiance irrigation kits. Place signs in areas
where this product is used to remind staff to
remove cap from urinary bag tubing (if it is their
practice to cap the bag tubing), prior to reinsertion
to Foley catheter.
Foleycath.pdf
103 of 578

5.6.11
Question:
Confusion between Oxygen &

Compressed Air Wall Outlet, 3/02
1. Purchase clear adaptors and avoid greenyellow confusion.
Met
(1)
Partially
Met (2)
Not
2. When appropriate, purchase compressed air

tubing that does not require "Christmas Tree"
adapters, so adapters are not needed for air.
Close calls have occurred when low

oxygen saturation on pulse oximeters
revealed that patients who
3. Consider removing air flowmeters when not in
inadvertently had their oxygen tubing use; this may require addressing informal norms
hooked up to air regulators with
through training, incentives.
green adapters instead of oxygen.
4. More prominently label air and oxygen outlets.
5. Respiratory Therapy, Nursing, and Pharmacy
must work together for the smoothest
implementation of any redesign or training.
Air_O2WallInlet.pdf
104 of 578

Question:
5.6.12
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(1)
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Met (2)
Not
Addendum to Patient Safety Advisory

Issued on February 27, 2002
Concerning Allegiance Irrigation Kits,
5/02
1. The National Center for Patient Safety and the

VA Medical/Surgical Users Group are working
with the VA National Acquisition Center and
vendors to modify the configuration of the caps so
that inadvertent insertion is effectively precluded.
Until we can find a vendor who is willing to modify
the configuration, continue to remind caregivers
It has come to our attention that even that blockage/obstruction could occur. Use the
the larger size caps of the
attached WARNING sheet to distribute with the
standardized product we suggested products.
in the previous advisory have been
incorrectly inserted into the drainage
port of larger Foley catheters. The
tubing cap of the standardized LSL
urinary drainage bag was
inadvertently left on and inserted into
the drainage port of a Foley catheter.
This obstructed the flow of urine from
a patient.
AllegIrrig.pdf
105 of 578

Question:
5.6.13
Met
(1)
Partially
Met (2)
Not
SSCOR Inc, Suction Pumps, Models 1. Check the medical equipment inventory to
2314, 2314B, and 2315, all units,
determine if you have the specified pumps.
7/02
Model numbers for the SSCOR suction units can
be found on a silver label on the back of the units.
Ensure any units on hand are being used as
intended, and not placed in areas where they can
These pumps are designed for short- be used for long term or continuous suction.
term suction, primarily during
resuscitation efforts, yet one medical 2. Refer to the revised page 3 of the operator and
center used them for extended
service manuals (attached), copy and insert the
procedures, use of these pumps for revised pages in all SSCOR 2314, 2314B and
extended high vacuum/high
2315 operator and service manuals. If manuals
occlusion can lead to overheating
are not available they can be obtained from the
and premature pump failure, making manufacturer or from the Center for Engineering
the equipment unavailable for use
and Occupational Safety & Health (CEOSH) at
and limiting needed suction.
(314) 543-6700 or at
http://vaww.ceosh.med.va.gov.
3. Label pumps to reflect intended use:
CAUTION: Not for continuous suction; for short
term use only.
4. Train users on the intended use of these
pumps and the possible risk associated with use
beyond the equipments design. If necessary,
purchase appropriate suction systems for wound
or procedural drainage.
SSCOR7_02.pdf
106 of 578

5.6.14
Question:
CPRS & Inpatient Complex

Medication Orders, 8/02
For Providers authorized to enter orders:
When renewing an automatically

stopped medication order of a
tapering dose, or editing an existing
order of a single dose the start/stop
dates will be changed and overlap
the current order. This could result in
a patient receiving multiple doses in
one day, if the provider didnt notice
the shift in start dates.
Met
(1)
Partially
Met (2)
Not
1. When entering a complex medication orders,

keep a written list of all your complex orders and
at renewal time, reference the list and enter
complex orders first.
2. Notify pharmacy of all your complex orders
when you initiate them by including a statement in
the Provider Comments on CPRS such as
TAPERING ORDER or PART OF COMPLEX
ORDER.
3. When editing or renewing orders, review the
displayed start/stop dates in CPRS and be aware
that a new order might be inadvertently created
and that new orders start/stop dates will be
changed and overlap the current order.
For Pharmacy staff:
1. Pay particular attention to tapering orders.
Devise a method or process to alert others in the
pharmacy as tapering orders are received. For
Example: Include a statement in the Special
Instructions such as TAPERING ORDER or
PART OF COMPLEX ORDER.
2. Review the BCMA last action displayed on
renewed order when verifying within inpatient
meds.
For (continued)...
CPRScomplexorders.pdf
107 of 578

Question:
5.6.14
(continued)... CPRS & Inpatient
(continued) Complex Medication Orders, 8/02
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(1)
Partially
Met (2)
Not
...(continued) Providers authorized to administer

medication:
1. Before administering medications double check
against the electronic MAR to make sure that this
is part of a complex order and proper start date
and time. Be aware of cases where multiple
doses are due on the same date.
When renewing an automatically

stopped medication order of a
tapering dose, or editing an existing
order of a single dose the start/stop
dates will be changed and overlap
2. Review the last action for that medication
the current order. This could result in displayed within BCMA before administering a
a patient receiving multiple doses in medication.
one day, if the provider didnt notice
the shift in start dates.
CPRScomplexorders.pdf
108 of 578

Question:
5.6.15
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Met (2)
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Cochlear Implant Recipients may be 1. "The FDA advised that cochlear implant
at increased risk for bacterial
candidates, as well as those already implanted,
meningitis, 9/02
may benefit from vaccinations against organisms
commonly associated with bacterial meningitis,
particularly S. pneumoniae and H. influenzae
(ACIP recommends 23valent pneumococcal
The FDA has determined that, over vaccines [Pnu-ImuneR 23 and PneumovaxR]] for
the past 14 years, 52 cases of
adults with increased risk of invasive
meningitis have been reported
pneumococcal disease). Therefore, all veterans
worldwide, out of which 12 known
who are candidates for cochlear implant (s)
deaths have resulted from these
should be ascertained of their immunization
cases. It was identified that 24 cases status prior to surgery as well as all patients with
(of the 52 worldwide cases) were in existing implants received from VA and non-VA
North America.
facilities. Previously unvaccinated adults with a
high-risk condition (functional or anatomic
aspleina, immunodeficiency, [particularly, persons
with IgG2 subclass deficiency],
immunosuppression from cancer chemotherapy,
and infection with human immunodeficiency virus)
should be given at least one dose of any licensed
Hib conjugate vaccine. As neither FDA nor CDC
specifically notes the use of Hib vaccine in
(continued)...
CochlearImplantAdvisory.pdf
109 of 578

Question:
5.6.15
(continued)... Cochlear Implant
(continued) Recipients may be at increased risk
for bacterial meningitis, 9/02
The FDA has determined that, over

the past 14 years, 52 cases of
meningitis have been reported
worldwide, out of which 12 known
deaths have resulted from these
cases. It was identified that 24 cases
(of the 52 worldwide cases) were in
North America.
Met
(1)
Partially
Met (2)
Not
...(continued) adults related to cochlear implants,

the use of Hib vaccine in this scenario would be
based on theoretical risk.
For additional info on immunizations refer to the
following websites.
http://www.cdc.gov/nip/publications/pink/
http://www.cdc.gov/mmwr/preview/mmwrrhtml/00
025228
http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf
"
2. In some of the reported cases, patients may
have had overt or sub-clinical otitis media prior to
surgery or before meningitis developed.
Physicians are encouraged to consider
appropriate prophylactic perioperative antibiotic
treatment, and to diagnose and treat otitis media
promptly in patients with cochlear implants.
3. Patient Safety Managers, please make sure
that Primary Care Physicians, EENT specialists
(on Surgery service) and Audiologists are aware
of this. Follow FDA MedWatch reporting
instructions to report cases of meningitis in
cochlear implant recipients.
CochlearImplantAdvisory.pdf
110 of 578

Question:
5.6.16
Met
(1)
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Met (2)
Not
Inpatient Medications Version 5.0

1. Install CPRS/BCMA PSJ*5*94 and PSB*2*13
and BCMA Version 2 (PSJ*5*94 and when they are released. These patches are
PSB*2*13), 11/02
currently undergoing testing and are scheduled
for release by November 30, 2002.
2. In the interim when pharmacists renew IV
Original IV continuous orders do not continuous orders, indicate the start date as
appear on the Virtual Due List (VDL), "now."
if a renewal order is entered with a
future date/time. The original order
and the renewed order will not
display on the VDL until the start
date/time of the renewed order is
reached. This could lead to a missed
IV administration.
BCMA_VDL_Advisory.pdf

5.6.17
CPRS consultant note amendments

are not printing and displaying after
changes are entered 12/02
1. Patient Safety Managers should check with the

Chief MIS and others who are authorized to
amend consultant notes, to ensure that all
documents are manually LINK under Consults
hierarchy when documents are amended.
Authorized amenders should also verify that the
amended document is listed under the related
document hierarchy. There should be two
documents, the amended document and the
retracted document.
Specifics are: TIU version 1.0,

Consults version 3.0, A VA Medical
Center reported that amended
consult notes did not print with
updated information after authorized
personnel entered them. While the
2. Notes that have been previously amended
electronic record displays the
should be reviewed against the electronic data to
corrected information, the printed
verify accuracy and manually linked if necessary.
copy does not. This may result in
incorrect information being relied
upon when making clinical decisions.
CPRSConsultantNoteAmendments.pdf
111 of 578

5.7.1
Question:
Connection tubing set used with

Sequential Compression Device
(SCD) 1/03
1. Notify staff to observe for normal inflation on

the SCD sleeves when first applied to a patient.
In particular, activate the cooling button for 30
seconds to ensure that no observable overinflation occurs.
Models 6235, 7325, 5320 and 5325

manufactured by Kendall (Tyco
Healthcare). The recalled tubing
sets have a reversed connector and
pose a serious hazard. Underr this
condition the SCD becomes a
tourniquet applying up to 200 mmHg
pressure around the extremity. This
condition can persist even after the
machine is turned off and in a paincontrolled patient, could go unnoticed
for several hours, leading to
permanent tissue damage.
2. Inspect all Kendall SCD tubing sets to confirm

that none of the recalled sets remain on site
(identification instructions are attached). Either
positively identify blank (no lot number label)
tubing sets for proper connectors or treat them as
suspect.
KendallConnectTubing.pdf
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Met (2)
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3. Contact Kendall to obtain replacement

connection tubing sets. The contact at Kendall is
Karen Tabaczynski; she can be contacted at
(508) 261-8037.
112 of 578

5.7.2
Question:
Zoll AED Plus, Public Access

Defibrillator (PAD) distributed before
Dec 8 2002, 2/03
1. Immediately identify all affected units.
Serial numbers X02K000812 to

X02K0077486. While handling
electrodes prior to attaching them to
a patient, communication between
the units internal ECG and Safety
Monitoring functions can lead to an
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.
Met
(1)
Partially
Met (2)
Not
2. For AEDs awaiting updating, determine which

of the following work around procedures is best
suited for your application: a) If the error condition
is activated, turn the AED off for 10 seconds, then
restart; or b) Attach the pads to the patient prior to
turning the AED on.
3. Place the appropriate work around instructions
with each affected defibrillator and train potential
users on the work around. Remember to
schedule training again after the software
upgrade is installed.
ZollDefibFeb2003.pdf

5.7.3
Counterfeit drugs labeled as

PROCRIT (Epoetin alfa) 40,000
units/mL; 3/03
1. Follow this link for details on identifying the

counterfeit products and directions:
http://www.procrit.com/counterfeit/letter.html
2. Inspect your stock and immediately remove all
affected product.
Lot numbers: P007645, expiration

10/2004; P004677, expiration
3. Notify the physician in charge if follow-up of
02/2004; and P004839, expiration
patient(s) is indicated.
02/2004. FDA testing of the
counterfeit products indicates they
are contaminated with bacteria and
some counterfeit products contain no
active ingredient.
Procritcounterfeit.pdf
113 of 578

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

5.7.5
In-line air filter requirement for Abbott 1. If you use these pumps immediately acquire IV
Pumps, 6/03
administration sets from the manufacturer that are
configured with the required air elimination filters
or IV extension sets configured with the required
air elimination filters for the pumps listed.
A new manufacturer requirement for
air elimination filters and air-in-line
2. Immediately review and revise operating and
detection tests for Intravenous
maintenance procedures to incorporate air-in-line
Infusion Pumps, models AIM, AIM tests per manufacturer instructions for the pumps
Plus, APMTM, APMII, and ANNETM, listed.
manufactured by Abbott Laboratories
Hospital Product Division.
AbbottPumpsAir_Line.pdf
114 of 578

5.7.6
Question:
Decimal point display issue with

Abbott APM II pump, 6/03
1. Check to see if you have these pumps at you

facility. If these pumps are not used, then no
further action is required.
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.
Met
(1)
Partially
Met (2)
Not
2. If you have these pumps review the analgesic

formulary to determine if your facility uses
Fentanyl or other analgesics that are
administered via a PCA pump in the microgram
per milliliter concentration range. If these
medications are not used no further action is
required.
3. If the pumps are present and used to
administer Fentanyl or other analgesics ensure
that there is a facility guideline for use of these
drugs with PCA pumps. a. Guidelines must cover
all aspects of medication ordering, dispensing,
administration and monitoring. b. Make sure that
a standard dose in whole numbers is ordered.
Use only whole numbers without a decimal. c.
Make sure that a standard solution is dispensed
to the patient at a concentration that is compatible
with PCA pumps. Only use whole numbers
without decimals. d. Have Pharmacy review all
PCA medication orders for accuracy, to
(continued)...
AbbottPumpsDecimalReadout.pdf
115 of 578

Question:
5.7.6
(continued)... Decimal point display
(continued) issue with Abbott APM II pump, 6/03
Met
(1)
Partially
Met (2)
Not
...(continued) make sure medication orders and

dispensing meets your facilitys 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.
AbbottPumpsDecimalReadout.pdf

5.7.7
Power cords for Hill-Rom Century+

electric beds, distributed between
Jan 1 1999 and July 1 2002; 7/03
Power cord ground pins on some

portable monitors broke off. This
fracture compromises one of the
safety features designed to limit
patients' risk of electrical shock.
Unless the pin has broken, patient
safety is not compromised.
1. Check the medical equipment inventory to

determine if you have Hill-Rom, Century + electric
beds and inspect the power cords for beds that
fall within the affected range.
2. Determine the number of power cords affected
by this notice. Affected cords are identified by
their manufacture date with codes as follows: 09 01 through 16 - 02 (week - year) is imprinted on
the hot and neutral cord blades. Immediately
replace any cords with a broken ground pin with a
spare and schedule replacement of other cords
with an imprinted date that falls within the
affected range.
3. Contact Hill-Rom technical support at 800-4453720 for replacement power cords. We also
suggest you provide them with updated contact
information for future notices.
HillRomPower.pdf
116 of 578

5.7.8
Question:
Soft Skin protective sleeve

manufactured by Span America to
cover Geo-Matt seat cushions and
mattresses, 7/03
1. If this product is present in any areas you

consider to be high risk for self-harm, remove the
plastic cover.
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.
Met
(1)
Partially
Met (2)
Not
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.
SoftskinAlert.pdf
117 of 578

5.7.9
Question:
J&J/Cordis Cypher SirolimusEluting Coronary Stent, 11/03
1. Interventional Cardiologist: In addition to

following the manufacturers recommendation
(see attached letter from Cordis dated July 7,
2003), coordinate with the post-stent care
physicians to ensure that the required antiplatelet
therapy regimen is continued post-stenting.
Informing Physicians of sub-acute

thromboses (SAT) and
hypersensitivity reactions with the
use of the Cordis CypherTM drug
eluting Coronary Stent.
Met
(1)
Partially
Met (2)
Not
2. Post-stent care Physicians: As recommended

by Cordis
http://www.fda.gov/bbs/topics/news/cordis_ltr.pdf
and referred to by the FDA Administration of
continued antiplatelet therapy for three (3)
months post-stenting is considered critical.
3. Report all adverse events to Cordis at 1 800
327 7714 and FDA via MedWatch.
CYPHER_DES.pdf
118 of 578

5.7.10
Question:
Roche Diagnostics Corp.

CoaguCheck PT Test Strips, 11/03
1. Inspect all CoaguChek PT test-strip foil

pouches before use to verify pouch integrity,
regardless of the lot number. Refer to the
attached photographs to help identify defective
packages.
Catalog # 3116247 (professional

use), Catalog # 3116239 (patient self
test), Catalog # 1937642 (packaged
48 strips per box), Catalog #
1937634 (packaged 12 strips per
box), Lot #s 591, 619, 600 and 583.
Extended to all lots with an expiration
date of on or before March 1, 2005.,
A packaging defect involved the
opening scoremark intruding into the
sealed pouch containing the product.
This defect may allow air and
moisture to enter the sealed pouch
causing erroneous readings when
the strips are used.
Met
(1)
Partially
Met (2)
Not
2. If the foil pouches appear to be compromised

do not use the test strips and notify Roche
Diagnostics Point of Care Technical Service at
(800) 428-4674 within the U.S., or visit the
CoaguChek Web site at http://www.coaguchekusa.com. To receive replacement product, fax the
replacement request form to Roche Diagnostics
at (800) 722-7222 within the U.S.
3. If the foil pouches appear to be intact run
duplicate tests, is the test strip lot number is lower
that lot 670 . Duplicate test results should be
within +/-1.0 international normalized ratio (INR)
of each other for values less than 4.5 INR. If
values are greater than +/-1.0 INR or greater than
4.5 INR, consult with the physician or pathologist
at your facility.
CoaguChekClassIrecall.pdf
119 of 578

Question:
5.7.11
Met
(1)
Partially
Met (2)
Not
Counterfeit PROLENE Polypropylene 1. Physicians, nurses, and all other healthcare

Mesh, 11/03
professionals must carefully examine all
PROLENE flat mesh (3x6) before use. Do not
use any product that is suspected to be
counterfeit. If counterfeit mesh is found contact
Product code PMII bearing lot
the distributor to discuss refund/replacement of
numbers RBE609 (expiration date
the product(s). Refer to the attached photographs
1/07) and RJJ130 (expiration date
for information on how to identify counterfeit
7/07). Prolene flat mesh 3" x 6",
PROLENE mesh.
Physicians, nurses and all other
healthcare professionals should
2. Review surgical records for patients to
carefully examine all PROLENE flat determine if they are recipients of the counterfeit
mesh product before using it to
mesh. Involve your regional counsel when
determine if it is counterfeit based
communicating with affected patients. We are
upon photographs provided by
waiting for the FDA to issue additional information
Ethicon.
regarding the mechanical properties,
biocompatibility or sterility of the material. This
additional information may be used as needed
when communicating with patients who have
received this mesh.
CounterfeitProlene.pdf
120 of 578

Question:
5.7.12
Met
(1)
Partially
Met (2)
Not
Olympus Cystoscopes, models CYF- 1. Check inventory for affected cystoscopes.

4/4A and CYF-240/240A with MAJ891 Forceps/Irrigation Plug, 2/03
2. Inspect the MAJ-891 plug (refer to the photo in
the attached Olympus notice). Earlier production,
affected plugs have a black rubber locking ring;
later production, replacement plugs have a gray
Earlier production MAJ-891 plugs
rubber locking ring.
can bind when connected to the
aforementioned cystoscopes. This
3. Contact Olympus immediately if you have the
binding can lead the operator to
affected plug. Refer to attachment for more
apply excessive force when removing information.
the plug, thus damaging the
cystoscope and rendering it
4. Contact Paul Sherman at CEOSH via e-mail at
unusable.
paul.sherman@med.va.gov if you have the
affected plug and did not receive the letter from
Olympus.
OlympusCYF.pdf

5.7.13
Olympus EXERA Gastrointestinal

Endoscopes, 3/03
Models: CF-Q160L, CF-Q160I, CF160S, CF-Q160AL, CF-Q160AI and

GIF-2T160, The manufacturer issued
a safety notice to remind users that
the auxiliary water channel must be
reprocessed each time the
endoscope is used.
1. Follow manufacturer instructions.

2. All channels of all endoscopes must be
reprocessed during each reprocessing cycle even
if the channels were not utilized during the
preceding patient procedure.
OlympusEXERA.pdf
121 of 578

5.7.14
Question:
Adverse Reaction/Allergy database

of CPRS GUI v20 Allergy Reaction
Tracking v4.0; 4/03
1. Information Resource Management (IRM) at

VAMCs should monitor the VistA M error trap, at
least on a daily basis (until a patch is released) to
determine if the data has been recorded properly
in file 120.8. If the data is not recorded on file
120.8, then the data will need to be re-entered.
Met
(1)
Partially
Met (2)
Not
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.
CPRSAllergy.pdf
122 of 578

5.7.15
Question:
The Ancure Endograft System

made by EndoVascular
Technologies, Inc.will no longer be
sold. 6/03
1. Because the Ancure device will no longer be

supported in the near future other procedures and
FDA approved devices should be considered for
cases requiring endovascular repair.
Met
(1)
Partially
Met (2)
Not
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.
Ancure.pdf

5.7.16
METFORMIN Orders on CPRS V3.0 1. Mark metformin in the facility drug file as Not
GUI v22; 9/03
Renewable until the order check function in
CPRS is upgraded with patch OR*3*190 currently
being developed.
A patients order for metformin was
renewed three times although the
serum creatinine values before
renewal were above 1.5mg/dL.
2. In the interim, if you wish to continue the same

order, use the COPY feature.
Metformin9_03.pdf
3. Review patients that are currently receiving

metformin with serum creatinine values higher
than normal and take appropriate interventions.
123 of 578

Question:
5.8.1
Met
(1)
Partially
Met (2)
Not
Proper Connectors for Sterlization of 1. By March 5, 2004 conduct in-service training at

all Gastrointestinal Fiberoptic
all sites including VA medical centers and CBOCs
Endoscopes, 2/04
for personnel tasked with reprocessing
gastrointestinal fiberoptic endoscopes. The inservice training must address manufacturer
instructions for proper reprocessing of specific
Using an incorrect connector to link models of gastrointestinal fiberoptic endoscopes
sterilizing solution to endoscopes
for consistency with local work procedures. All
during reprocessing (cleaning and
third party (other than the endoscope
sterilizing) procedures. A dual-port or manufacturer) tools and materials used for
Y connector designed to connect to reprocessing must also be covered during the inendoscopes incorporating dual ports service training.
was connected to endoscopes with
single ports. Under this condition an 2. Validate that appropriate reprocessing
indeterminate amount of sterilizing
connectors are being utilized with each model of
solution may have been directed to endoscope. Some manufacturers provide
the unconnected port, possibly
cognitive aids such as instruction placards and
leading to inadequate sterilization of these must be available and intact where
the endoscope.
provided.
3. Incorporate knowledge of proper handling and
reprocessing of gastrointestinal fiberoptic
endoscopes into JCAHO competency
assessment requirements for individuals tasked
with this assignment.
4. Facility Patient Safety Managers will monitor
(continued)...
EndoscopeCleaning_all.pdf
124 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.8.1
(continued)... Proper Connectors for ...(continued) the in-service training requirement
(continued) Sterlization of all Gastrointestinal
and report completion to the VISN Patient Safety
Fiberoptic Endoscopes, 2/04
Officer. Reporting instructions for the VISN PSO

will be provided in a separate communication
from the office of the Deputy Under Secretary for
Health for Operations and Management.
Using an incorrect connector to link

sterilizing solution to endoscopes
5. Scheduled procedures may continue while the
during reprocessing (cleaning and
above actions are undertaken.
sterilizing) procedures. A dual-port or
Y connector designed to connect to
endoscopes incorporating dual ports
was connected to endoscopes with
single ports. Under this condition an
indeterminate amount of sterilizing
solution may have been directed to
the unconnected port, possibly
leading to inadequate sterilization of
the endoscope.
EndoscopeCleaning_all.pdf
125 of 578

5.8.2
Question:
Potential bacterial contamination of

Twice-A-Day Nasal Spray
manufactured by Propharma Inc.,
3/04
1. Immediately remove and quarantine the

affected nasal spray bottles from inventory.
Met
(1)
Partially
Met (2)
Not
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.
PropharmaNasalSpray.pdf
126 of 578

5.8.3
Question:
Oxygen Utility System, 4/04
1. Conduct alarm-set point verification through

the use of a qualified third party expert. The set
points must be code compliant and this action
documented. (see NFPA-99 5.1.3.4.11.6, 2002
Edition)
Two VA Medical Centers reported a

loss of service in the Oxygen Utility
System. In both incidents the alarm
on the main tank did not sound until
reaching near or completely empty
and both sites did not meet the
NFPA-99 requirement for two,
independent 24/7 supervised areas
where mandatory alarm conditions
for the Oxygen Utility System are
annunciated
Met
(1)
Partially
Met (2)
Not
2. Ensure that a minimum of two, independent

24/7 and constantly attended monitoring stations
are provided for all alarm conditions related to the
Oxygen Utility System. Test all alarm conditions to
ensure the alarm annunciation is working.
3. If either of the conditions in 1. or 2. above
cannot be met, the Medical Center must publish,
over the Directors signature, a comprehensive
Interim Life Safety Measure that fully addresses
and compensates for the non-compliant
condition. The ILSM must remain in effect until
the code requirements are met. In addition
appropriate staff must be trained on the ILSM
requirements, and this training needs to be
documented.
4. Review the oxygen delivery contract and verify
the delivery schedule meets current demands to
ensure an adequate supply of Oxygen
(continued)...
OxygenUtilitySystemAlert040504.pdf
127 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.8.3
(continued)... Oxygen Utility System, ...(continued) so alarm conditions are not
(continued) 4/04
triggered between refills.
Two VA Medical Centers reported a

loss of service in the Oxygen Utility
System. In both incidents the alarm
on the main tank did not sound until
reaching near or completely empty
and both sites did not meet the
NFPA-99 requirement for two,
independent 24/7 supervised areas
where mandatory alarm conditions
for the Oxygen Utility System are
annunciated
5. Ensure qualified and trained technical staff

such as a Biomedical Engineering Technician,
SPD Technician or Pipe Fitter monitors tank
refilling procedures.
6. Ensure an adequate supply of portable oxygen
with an appropriate mixture of tanks is available
for deployment at point of health care delivery in
the event of total Oxygen Utility System failure. All
tanks must be properly stored.
7. Set, maintain, and document appropriate
Oxygen Utility System preventive maintenance
and testing protocols.
8. Review Medical Center Utility Shutdown Policy,
as required by JCAHO to assure appropriate
safeguards are in place in the event of unplanned
utility shutdowns.
OxygenUtilitySystemAlert040504.pdf
128 of 578

Question:
5.8.4
Met
(1)
Partially
Met (2)
Not
Implantable Cardioverter Defibrillator 1. Immediately check patient records in CPRS to

(ICD), 4/04
identify patients with the ICD implants described
in this notification.
Models Micro-Jewell II 7223Cx and
GEM DR 7271; Medtronic, implanted
in 1997 and 1998, During a cardiac
event requiring cardioversion or
defibrillation, internal capacitors may
take longer to charge and can cause
a delay or non-delivery of appropriate
shock therapy.
2. Contact your local Medtronic sales

representative (or Medtronic Technical Services,
listed in the Contact section of this notification if
you cannot reach the local representative) for
assistance with determining whether the identified
implant requires follow-up action as identified by
Medtronic.
3. If follow-up action is necessary, see the
attached letter from Medtronic describing required
actions.
MedtronicICDAlert042804.pdf

5.8.5
Class I recall of Medtronic MiniMed 1.If you still have any of the above mentioned
Paradigm Quick-set Plus Infusion product in inventory, immediately stop distributing
Sets, 5/04
them to your patients.
Model MMT-359S6, MMT-359S9,

MMT-359L6 and MMT-359L9,
Problems with the infusion sets can
interrupt insulin flow resulting in
serious injury.
2. Please complete the enclosed Distributor

Response Form indicating how you will proceed
with this mandatory notification and return it by
fax as soon as possible to the manufacturer.
3. Please also complete the enclosed Exchange
Request Form so that arrangements can be made
to return all affected product to the manufacturer
for disposal and send you the replacement
products of your choice.
MedtronicMiniMedInsulinSetAlert051904.pdf
129 of 578

5.8.6
Question:
Minor Surgery/Exam lights:

CoolSpot and Outpatient
Fleximount, 6/04
1. Review Burton Medicals notice (attached and

available on-line at
http://www.burtonmedical.com/safetyNote.htm).
Single Ceiling and Track Mount with

Single Trolley manufactured by
Burton Medical before August 2000.
Model numbers: 0100540, 0100740,
0100580, 0102180 and 0102540,
Due to an inherent weakness in the
original composition of the pivot
support casting, the pivot joint can
fail and the light may fall onto a
patient.
Met
(1)
Partially
Met (2)
Not
2. Identify and inspect all units affected by this

alert for cracked pivot supports, and complete
Burton Medical's form to obtain new pivot
supports and arms.
3. For identified lamps with cracked pivot
supports- If possible, remove them from service.
a. Users: Inspect each light daily before use for
normal movement and stability. If the light
appears loose or unstable, contact Engineering to
have it checked. b. Engineering: Inspect
identified lights every two weeks until new
components are installed.
BurtonLightsJune04.pdf
130 of 578

5.8.7
Question:
CPRS Text Integration Utility (TIU)

v1.0 documents, 6/04
1. Run patch TIU*1*174 for all patient records

created after January 1, 2004 and at least daily
thereafter until permanent solutions are
implemented. Review all records identified by
this patch to determine if text has been deleted or
truncated.
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.
Met
(1)
Partially
Met (2)
Not
2. When records with missing or truncated text

are identified:(a) Refer them to the author for
review of the note and to add an addendum if
needed (b) If the author is no longer available or
is unable to remember what information is
missing a disclaimer, similar to the following,
should be added to the file DISCLAIMER: This
completed document may have text that was
electronically deleted in error. (c) If the note is of
significant concern, and the author is no longer
available, the record should be referred to the site
medical record committee or other functional
group that processes records that are suspected
as being incomplete. The committee may decide
to forward the note to the service chief or
equivalent to either complete the note or
(continued)...
CPRS_TIUJune04.pdf
131 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.8.7
(continued)... CPRS Text Integration ...(continued) allow the disclaimer to be added.
(continued) Utility (TIU) v1.0 documents, 6/04
Reported and confirmed that text

stored in Text Integration Utility (TIU)
document file 8925 may be deleted
or truncated automatically without the
author being made aware that this
occurred when the document is
signed. The Office of Information
(OI) has developed a patch that may
be used to identify potentially
affected patient records.
CPRS_TIUJune04.pdf
132 of 578

5.8.8
Question:
DeRoyal ReliaFlex Suction

Canisters with Liners, 6/04
1. Review the attached letter from DeRoyal and

sequester all affected models and lot numbers. a)
71-9101, canister liner, 1300cc, Lot numbers
lower than 5951 b) 71-9201, canister liner,
1800cc, Lot numbers lower than 5949 c) 71-9301,
canister liner, 3200cc, Lot numbers lower than
6096
DeRoyal suction canisters that are

used with the ReliaFlexTM suction
liner system have violently
discharged blood and body fluids
when the full liners were removed by
clinical staff from the hard outer shell.
Unsecured caps on the tandem port
and pour spouts along with slight
pressure on the flexible suction liner
precipitated the discharge.
Met
(1)
Partially
Met (2)
Not
2. With the help of your Logistics office or your

material management service, contact your local
DeRoyal sales representative or distributor to
make sure that you have an adequate supply of
the redesigned ReliaFlexTM suction liners (those
with lot numbers higher than 1a-c) before you
ship the affected units back to DeRoyal for free
replacement. DeRoyal has agreed to accept
returns on partial cases.
3. In lieu of continuing to use the ReliaFlexTM
suction liner system, you may elect to use the
DeRoyal CrystalineTM Disposable Canister
System.
DeRoyalSuctionCanister.pdf
133 of 578

5.8.9
Question:
Failure of medical alarm systems

using paging technology to notify
clinical staff, 7/04
1. Determine if your facility uses a medical alarm

paging technology and confirm that alarm
protocols classify the paging component as a
secondary (or back-up) notificaiton method and
that it is not used as the primary alarm or
communication method.
Reports documenting the failure of

medical alarm systems using paging
technology to notify clinical staff of
alarms or other critical clinical
information.
Met
(1)
Partially
Met (2)
Not
2. Verify that staff is assigned to monitor and

manage physiologic monitoring systems and
other clinically significant primary alarms when
patients are being monitored.
3. Evaluate the physical layout of your patient
care areas to determine where monitoring staff
(monitor watcher) is needed. Perform this
assessment as though you did not have an alarm
paging system. Note: If you use a medical alarm
system using paging technology to comply with
JCAHO Patient Safety Goal No. 6b compliance
must be reassessed without the use of the paging
system.
4. If a medical system using paging technology is
used as a component of the clinical staff
notification process (i.e., secondary or back-up)
there must be positive feedback to the initiator of
(continued)...
AlarmPagingJuly04.pdf
134 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.8.9
(continued)... Failure of medical
(continued) alarm systems using paging
...(continued) the page that the message was

received and responded to in a timely manner.
technology to notify clinical staff, 7/04 This allows appropriate action to be taken to
deliver clinical care if the page was not
acknowledged.
Reports documenting the failure of
medical alarm systems using paging
technology to notify clinical staff of
alarms or other critical clinical
information.
AlarmPagingJuly04.pdf

5.8.10
Boston Scientific Stent System

Recall, 7/04
Models: 1) Taxus Express 2 Monorail

(MR) Paclitaxel-Eluting 2) Taxus
Express 2 Over-the-wire (OTW)
Paclitaxel-Eluting 3) Express 2
Monorail (MR) bare-metal 4) Express
2 Over-the Wire (OTW) bare-metal.
The FDA and the manufacturer
received reports 43 confirmed no
deflation (failure of the balloon to
deflate within one minute after
deployment of the stent) complaints
related to the Taxus Express 2 device
system.
1. Confirm that your facility received the

manufacturers recall letter dated 7/21/2004.
(Letters were sent to Director of Cardiac
Catheterization Labs and Risk Manager). If not
contact Boston Scientific at (800) 832-7822.
2. By close of business July 30, 2004, ensure you
have on site replacements from FDA approved
stent suppliers, for existing, affected models
(recalled stents) of Boston Scientific stent
systems. Do not sequester the recalled stents
from use until you have replacements on hand.
3. Contact your local Boston Scientific sales
representative to exchange the affected stents
one for one with their replacements.
BostonScientificStentRecallJuly04.pdf
135 of 578

5.8.11
Question:
Shiley Tracheosoft XLT Extended

Length Tracheostomy Tube and
Cannula FDA Class I Recall, 8/04
1. Patients with the affected models (see below)

should be contacted and arrangements made to
exchange the equipment.
The outer cannula may separate

from the hub and neck flange
allowing the outer cannula to travel
farther into the patients airway
leading to obstruction of the airway
and significantly interfering with
breathing and ventilation.
Met
(1)
Partially
Met (2)
Not
2. If you have the affected devices in stock work

with your materials management (AMMS) to
make sure that a recall package has been
received. Follow the instructions in the package
to receive credit for the recalled products.
3. If you have these devices in stock and did not
receive a recall package from the company,
contact Nellcor/Tyco Technical Services
Department at 1-800-635-5267.
ShileyTracheosoftAug04.pdf

5.8.12
Automated External Defibrillators

(AED) manufactured by Access
Cardiosystems, Inc., operation
failure, 11/04
Units with serial numbers ranging

from 075690 to 077140 may
experience a malfunction in the
shock delivery circuit and fail to
deliver therapeutic shocks.
1. Immediately check your inventory to determine

if you have any Access Cardiosystems AEDs and
remove units from service affected by items 1 and
2 above.
2. Other Access Cardiosystems units can remain
in service only as long as you have consumables
on hand to support them or until February 1,
2005, then they must be removed from service
and replaced with AEDs from other
manufacturers.
3. If you are affected, plan for emergency
replacement of any Access Cardiosystems
defibrillators in stock.
AccessAEDsNov04.pdf
136 of 578

Question:
5.8.13
Met
(1)
Partially
Met (2)
Not
Renewal prompts for "one-time only" 1. Check the attachment to determine if you are
medication orders, 12/04
one of the sites that has already installed CPRS
test patch PSJ*5*127.
2. If your site is NOT listed on the attachment and
After installation of CPRS patch
you have installed patch PSJ*5*110, then install
PSJ*5*110, several close call reports 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.
RenewalofOnetimeOrders.pdf

5.8.14
Drug File view from CPRS, 4/04
1. Facility pharmacy staff should review the

CPRS drug file listings to identify products that
are inappropriate for clinical use, and then work
with IRM to RESTRICT these products on a case
Facility drug files may contain entries by case basis, from view of the providers.
that are for pharmacy use only.
Restricting the products in CPRS file 101.43
Some of these entries may be
prevents providers from seeing them but will
inappropriate or harmful for patient
permit pharmacy staff access to them through the
administration. In addition, some
back door CHUI interface.
items are in the drug file for inventory
management purposes only.
2. If a restricted product is needed for clinical
patient use, incorporate the item in a quick order
instead, thus removing the potential of misprescribing.
CPRSDrugFile042804.pdf
137 of 578

5.8.15
Question:
Tubing separation of Edwards

Lifesciences VAMP Plus
Disposable Pressure Transducers
Monitoring Kits, 7/04
1. Caregivers should always inspect disposable

products for obvious defects before use.
Relative to tubing disconnects that

may result in blood leaks and
potential for exsanguinations. The
complaint rate is presently about 1%
and disconnects have not been
specific to one lot.
3. Be vigilant of any blood leaks or dampened

blood pressure waveforms when using this
transducer.
EdwardsVAMPXducerJul04.pdf
Met
(1)
Partially
Met (2)
Not
2. Follow directions for use and, ensure all

connections are secure and finger tight during
set-up of pressure monitoring systems.
4. Contact your local representatives to

exchange, free of charge, all defective, Edwards
Lifesciences transducer devices.

5.8.16
ALARIS (IMED) Gemini Infusion

Pumps, 10/04
1. DO NOT use medication pumps, or other

medical devices that are in need of repair.
2. As a standard practice, operators of medical
devices should inspect and conduct operational
checks, as specified in the manufacturers
operations manual, on all equipment and medical
devices before use. If the device is found to be in
need of repair, it should be removed from service
and sent to biomedical engineering for service.
Pump provides automatic free flow

protection via the medication
administration set and the exterior
door. If the door latch is broken it
may not properly activate the free
flow protection mechanism on the IV
set, and free flow of medication may 3. Assure that there are an adequate number of
occur if other methods of free flow
pumps available to adjust for peak utilizations
protection are not employed.
and/or maintenance cycles.
ALARISGeminiInfusionPumps.pdf
138 of 578

5.8.17
Question:
Electro-magnetic Interference (EMI)

from the use of two-way hand held
radios/walkie-talkies, 11/04
1. Check to see if you have current policy

addressing EMI risks including recommendations
for areas where wireless communication devices
are restricted. For two-way radios, 20 feet from
medical equipment is a minimum recommended
distance (ECRI Health Devices 2003 Mar;
32(3):118-21).
When operated in close proximity to

medical devices. Oxygen
concentrators in the nursing home
unit alarmed and sometimes shut
down, requiring a reset when twoway radios were keyed to transmit
from approximately 10 feet away.
Distance and transmitter
management are the most
controllable and effective.
Met
(1)
Partially
Met (2)
Not
2. Refer to your EMI policy and modify to improve

if necessary.
3. Train radio users (generally Engineering,
Safety and Police personnel) to maintain
appropriate distances from medical equipment
when using radios.
EMIAdvisoryNov04.pdf
139 of 578

Question:
5.8.18
Met
(1)
Partially
Met (2)
Not
Power supplies for flat panel patient

monitor, Model 91415-A
During surgery at a VA medical facility the power

supply for the flat panel patient monitor degraded
to the point where the audio circuit stopped
manufactured by Spacelabs Medical working, affecting the alarm function. This was
between January 2000 and
unknown to the operator and when the patient
experienced a cardiovascular event, the alarm
December 2001. 11/03.
was not heard resulting in a patient incident.
Action:
1. Immediately (within 24 hours) identify all units

affected according to the instructions in the
attached Recall from Spacelabs Medical.
Note: these power supplies are only used with flat

panel patient monitors; CRT patient monitors are
not affected.
2. Request replacement supplies as per the

attached Recall from
Spacelabs Medical.
3. Until the affected power supplies are replaced:
a.) Where feasible, use the patient monitoring

system'sDisplay
Spacelabs
audio
Nov 2003.pdf
140 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.8.18
(continued)... Power supplies for flat ...(continued) audio prior to each procedure or
(continued) panel patient monitor, Model 91415- with
A
each shift change, whichever is most frequent. If
manufactured by Spacelabs Medical the audio test
between January 2000 and
fails, immediately switch to another system or
December 2001. 11/03.
enable the patient
monitoring systems audio and notify Biomedical
Engineering.
c.) Place a warning label on the flat panel patient
monitor
informing the user about required testing prior to
each procedure
or with each shift change, whichever is more
frequent.
Spacelabs Display Nov 2003.pdf
141 of 578

Question:
5.9.1
Met
(1)
Partially
Met (2)
Not
Fire Response and Planning, 1/05
1. Facilities Management or Engineering Service

personnel will initiate immediate replacement of
the recalled Central O-ring sprinklers if any are
still present in the facility and complete
A fire in a VA hospital caused by the replacement by March 15, 2005. If this cannot be
improper use of smoking materials, accomplished the facility director must contact Mr.
combined with the presence of
Ken Faulstich, Chief, Fire Protection Engineering
oxygen completed the fire triangle
(10NB) (202) 273-5869 to arrive at an acceptable
and resulted in the death of a patient, solution.
In the room of fire origin, the fire
sprinkler closest to the fire failed to
2. Clinical management staff will ensure that staff
operate. This was an O-ring type fire understand and enforce the existing program to
sprinkler manufactured by Central
control smoking materials, especially when 100%
Sprinkler Company (Model GB).
oxygen is in use.
These O-ring sprinklers, along with
other models, were recalled by the
3. Occupational Safety and Health or VA Fire
manufacturer in 2001 and were
Department personnel will review the fire plan to:
scheduled for replacement.
A) There will be an adequate number of staff,
including clinical staff, immediately responding to
the fire area regardless of the day of the week or
time of day, to assist in patient relocation to the
next smoke zone should it become necessary.
The number of responders needed is dependent
upon the number of patients in the (continued)...
FireResponseAlert.pdf
142 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.9.1
(continued)... Fire Response and
(continued) Planning, 1/05
...(continued) impacted smoke zone 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 patient care buildings with
A fire in a VA hospital caused by the overnight stay that are not fully sprinkler
improper use of smoking materials, protected: One responder for every two noncombined with the presence of
ambulatory patients. If this response ratio cannot
oxygen completed the fire triangle
be met, consider installing sprinkler protection,
and resulted in the death of a patient, modifying the number (mix) of non-ambulatory to
In the room of fire origin, the fire
ambulatory patients in the smoke zone, reducing
sprinkler closest to the fire failed to
the size of the smoke zone(s) or a combination of
operate. This was an O-ring type fire these actions. 2) For fully sprinkler protected
sprinkler manufactured by Central
patient care buildings with overnight stay: One
Sprinkler Company (Model GB).
responder for every four non-ambulatory patients.
These O-ring sprinklers, along with
If this response ratio cannot be met conduct a
other models, were recalled by the
risk assessment to determine if an appropriate
manufacturer in 2001 and were
level of safety is being provided. For the purposes
scheduled for replacement.
of this Alert non-ambulatory patients shall include
individuals with cognitive or behavioral
impairments that need assistance when
relocating to an adjacent smoke zone. B) The fire
plan clearly identifies the individual in the
unit/area responsible for turning off the room or
zone oxygen shut off control valve should it be
necessary. This is especially important in surgery
and ICU areas. (Note: Preventing fires in surgical
areas is a JCAHO 2005 Patient Safety goal for
AHC. See Goal #11; Reduce the risk of surgical
fires. Additional information on this goal may be
found at:
http://www.jcaho.org/accredited+organizations/pat
ient+safety/05+npsg/05_npsg_amb.htm C) A
requirement to telephone the fire department is
part of the written fire plan as newly required in
NFPA 101, 19.7.2.2. D) Qualified staff are
identified who are provided with special keys
FireResponseAlert.pdf
143 of 578

5.9.2
Question:
Nellcor pulse oximeters,

manufacturered after November 8,
2001, 1/05
1. Immediately (within the next 48 hours)

determine and identify all affected units. Only
units manufactured after November 8, 2001 (after
S/N G01844386) are affected.
Model 595 and limited quantities of

models 395, 295, and 290. Affected
units were manufactured after
November 8 2001. Nellcor notified
known affected customers by letter
dates October 18 2004, Alarm
speakers and other audio
notifications are reported to fail at a
higher rate than expected which
could result in serious patient injury.
Met
(1)
Partially
Met (2)
Not
2. Until the speaker assemblies are replaced,

users should routinely test speaker functions by:
a. Listening for the tone emitted during the Power
On Test. b. Activating audio pulse tones while
monitoring patients to hear patients pulse to
provide positive confirmation of speaker function;
volume can be set low to minimize disturbing
patients.
3. Ensure user and Biomedical Engineering
inspections include alarm testing according to
manufacturer recommendations.
4. If the speaker fails, immediately remove the
unit from service and replace with another unit,
making sure the speaker is functioning on the
replacement unit. Contact Nellcor at the phone
numbers listed below and see the attached for
replacement speakers and/or service.
Nellcor595Jan05.pdf
144 of 578

Question:
5.9.3
Met
(1)
Partially
Met (2)
Not
Medtronic (ICD) and (CRT-D)

manufactured between 4/01 and
12/03, see list., 2/05.
1. Within two weeks, identify all affected patients

by using all steps a - e: a) The manufacturers
letter available from the local Medtronic
representative b) List obtained from Medtronic
available from Dr. Ed Keung, Director of VA
National ICD Surveillance Center (see attached
Medtronic Implantable Cardioverter- letter from VA National ICD Surveillance Center)
Defibrillator (ICD) and Cardiac
c) VA National ICD Surveillance Center Registry
Resynchronization Therapy
at https://icd.sanfrancisco.med.va.gov d) VA
Defibrillator (CRT-D), Models and
National registry for ICD implants Washington
batteries manufactured between April VAMC e) Your patient records.
2001 and December 2003, Model
7230 Marquis VR, Model 7274
2. Replace entire device in first priority group
Marquis DR, Model 7232 Maximo
patients (see item B of attached letter from VA
VR,Model 7278 Maximo DR, Model National ICD Surveillance Center).
7277 InSync Marquis, Model7289
InSync II Marquis, Model 7279
3. Follow one of three options for those patients
InSync III Marquis,Model 7285 In
who are not on the firstpriority group. (see
Sync III Protect (not implanted in
attached letter from VA National ICD Surveillance
US), a potential battery shorting
Center).
mechanism (embedded in the
device) that may occur in a subset of
ICDs and CRT-Ds. If shorting occurs,
battery depletion can occur within a
few hours to a few days, after which
there is loss of device function.
MedtronicICDsCRT-DsFeb05.pdf
145 of 578

Question:
5.9.4
Met
(1)
Partially
Met (2)
Not
Spacelabs Medical Monitor, model

1. Immediately identify and locate all monitors
90385 Universal Clinical Workstation affected by this notice.
(UCW), 2/05, (
2. Inspect the monitors to see if they have been
upgraded by: a. Looking for a label on the bottom
of the monitor that reads either Part No. 010Affected units were manufactured
0681-00 Rev. N or FEB 0509 or b. Inspecting
between 1994 and 1997, units
the bottom of the pedestal for a screw in the
purchased after, or serviced by
center (See photos in attached Spacelabs
Spacelabs Medical after March 18
Medical notice for more detail) If neither a nor b is
1997 are not affected, The monitor
present, the bases need upgrading.
base becomes fatigued and
separates from the monitor display. 3. If units have not been upgraded contact
In that case, gravity is all that keeps Spacelabs Medical Monitoring Technical Support
the monitor together and movement at (800) 522-7025 to arrange upgrades.
can cause the monitor to fall, risking
patient or caregiver injury.
4. Until the bases are upgraded, notify users of
affected monitors of this issue and the risks.
Users should examine units for noticeable wear
or cracked bases, and if present, contact
Biomedical Engineering. Biomedical Engineering
can determine whether the unit is safe for
continued use.
SpacelabsUCWAlertFeb05.pdf
146 of 578

Question:
5.9.5
Met
(1)
Partially
Met (2)
Not
Louvered heating, ventilating, and air 1. Survey all locked Behavioral Health Units to
conditioning (HVAC) grilles in locked determine if louvered grilles are present that may
Behavioral Health Units, 2/05 (AL05- be used as an anchor point.
06)
2. If louvered grilles are present in these
Behavioral Health Units upgrade them by
installing a woven wire cloth grille or replace
Louvered grilles covering HVAC
them with a suitable grille that cannot be used as
openings located in locked mental
an anchor point. Breakaway grilles should not be
health units may be used as an
used as the broken parts may be used for other
anchor point for a noose made from purposes.
clothing or other flexible material.
LouveredHVACGrilleFeb28.pdf

5.9.6
LIFEPAK 12 Defibrillator/Monitors
1. Within 48 hours, identify all LIFEPAK 12
with Adaptive Biphasic technology, all biphasic defibrillators deployed at your facility.
units, man'f'd by Medtronic, 3/05
(AL05-07)
2. Check user settings to verify they are
configured for what your facility protocol requires:
Stepbystep directions, Basic directions are
included in the enclosed notice from Medtronic,
Units that have undergone a
Detailed directions are included in the users
software upgrade or reinstallation
manual.
may revert to a default energy setting
of 125 Joules, rather than the setting 3. If the settings have changed or do not match
selected by the customer. The
those required for your protocol, correct them per
setting may not be noticed until use, the directions.
resulting in inappropriate energy
delivery.
4. Record all defibrillator serial numbers and
settings that have changed, plus your contact
information and call Medtronic Technical Support
at (877) 873-7630 to provide this information.
LP12BiphasicAlertMarch05.pdf
147 of 578

5.9.7
Question:
CPRS National Drug File V 4.0

Adverse Reaction Tracking, 3/05
(AL05-08)
1. Check with your IT/computer service (IRM) to

determine if your facility is affected -- Data
Updates PSN*4*95 and PSN*4*97 installed.
Clinicians at facilities that recently

installed National Drug File (NDF)
Data Updates PSN*4*95 and
PSN*4*97 may not be notified of
drug allergies and will be unaware
that the allergy check was not
completed.
Met
(1)
Partially
Met (2)
Not
2. If your facility is affected, notify all clinical users

(e.g. clinicians, pharmacists) that the allergy
tracking software is not functional and requires
providers to assure that new orders entered for
patients are checked manually against the current
allergy history until this is resolved.
3. Do not uninstall these Data Updates or it may
adversely affect other programs in the system.
4. If your facility has not installed Patches
PSN*4*95 and PSN*4*97 do not install until
further guidance is issued from the Office of
Information.
NationalDrugFile031105.pdf
148 of 578

Question:
5.9.8
Met
(1)
Partially
Met (2)
Not
Enclosed Bed systems manufactured 1. VA facilities may continue to use Vail enclosed
by Vail Products Inc, 3/05 (AL05-09) beds on a case by case basis only when there is
a clinical determination that this is in the best
interest of patient care. Vail enclosed beds,
similar to all enclosed bed systems, may be
Models: 500, 1000, and 2000, FDA considered in the continuum of care for certain
issued recommendations for users
types of patients and disease states. In certain
based on cited safety problems.
instances, use of enclosed beds provides the
most humane and least restrictive care modality.
2. By close of business (COB) March 31 2005: a)
Visually ensure that Vail enclosed beds meet the
requirement for mattress gaps as spelled out in
the VHA Patient Safety Alert on bed entrapment
risk from 2001:
http://vaww.ncps.med.va.gov/alerts/BedEntrap.do
c Accomplish this by pushing the mattress to one
side with the side rails in the up and latched
position. Also, measure the gaps at the foot and
head of the bed with the mattress pushed to one
end and the head and foot rails in the up and
latched position. The gaps must be less than 2
and 3/8 inch (60 mm) (continued)...
VailBedMarch2005.pdf
149 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.9.8
(continued)... Enclosed Bed systems ...(continued) horizontal distance at the widest
(continued) manufactured by Vail Products Inc,
spot. b) If using a Vail enclosed bed with side rails
3/05 (AL05-09)
Models: 500, 1000, and 2000, FDA

issued recommendations for users
based on cited safety problems.
visually confirm that the side rails and the bolsters

at the head and foot are up and properly latched,
except when patient is entering or exiting the bed,
or if the caregiver needs access to the patient.
(Side rails should be up at all other times as a
patient can get their head between the mattress
and the bottom vinyl cover presenting a
suffocation hazard.) c) Visually inspect Vail
enclosed beds for any defects and repair or
replace as soon as is practical with patient safety
as the deciding factor. Inspect for broken welds
at the joint on the frames and visually inspect the
sleeping surface and components such as, but
not limited to, zippers, netting, and Velcro
connection points for proper attachment and
function. d) Ensure that Vail enclosed beds with a
high-low adjustable mechanism such as the Vail
1000 are not left in the up position when the
patient is unattended. Additional hazards are
created by the bed left in this position.e) Ensure
that you are using only the mattress
recommended by Vail and the gap complies with
the criteria from action (a) above. f) If using other
enclosed beds, follow actions a) through e) as
applicable.
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,
VailBedMarch2005.pdf
150 of 578

Question:
5.9.9
Met
(1)
Partially
Met (2)
Not
VistA Imaging v3.0 versions released 1. Advise clinicians who view EKGs to verify that
since 10/1/03 patch MAG*3.0*24,
the Show MUSE EKGs option under Options >
4/05 (AL05-10)
View Preferences is enabled (the box is
checked), and that they should not disable it.
2. Advice clinicians to check the patients name
In certain situations, the VistA
on an EKG viewed via the VistA Imaging Display
Imaging Display EKG viewer window application to be sure that the name and EKG
will not update properly when a
correspond to the current patient in CPRS.
clinician views an EKG. Rather than
showing the current patient, the EKG
viewer window will continue to show
the previous patient, it is possible
that the clinician will miss this
information and proceed to reading
and acting on the EKG for the wrong
patient.
VistAImagingDisplayEKGApril05.pdf

5.9.10
CM 100-Heartstart Adapter Cable

man'f'd by Laerdal Medical Corp,
5/05, (AL05-10).
1. Immediately (within the next 24 hours) remove

CM 100-Heartstart Adapter Cable from service
and inventory.
2. Assure replacement cable from another source

is available for each defirillator where the cable
This product is designed for use with 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.
LaerdalAdapterCables.pdf
151 of 578

5.9.11
Question:
Blood glucose meters, models

OneTouch, Ultra, InDuo, and
OneTouch FastTake man'f'd by
LifeScan, Inc., 5/05 (AL05-11).
1. Diabetes educators, outpatient pharmacists,

and other cliniciansinvolved in diabetes
management must be notified about the design
vulnerabilities of LifeScan devices.
Met
(1)
Partially
Met (2)
Not
2. Clinicians with diabetes patients using

LifeScan must: a) No later than the next visit,
LifeScan has received reports of
confirm with all diabetes patients that their
adverse events related to the device glucose meter is properly set up with mg/dL, NOT
inadvertently set to the incorrect unit mmol/L. b) Understand the importance of training
of measure: milligram per deciliter
the patient on the complex device set-up and
(mg/dL) and milli-mole per liter
calibration.
(mmol/L). In the United States, it is
mg/dL. However the units of
3. Acceptable alternative blood glucose meters
measure can be unintentionally
are available that do not exhibit this vulnerability
changed during the task of setting
and facilities should consider providing those
the date and time.
devices instead.
LifeScanOneTouchAlertMay2005.pdf
152 of 578

Question:
5.9.12
Met
(1)
Partially
Met (2)
Not
Guidant Model 1861 Ventak Prizm 2 1. Within two weeks, electrophysiology/cardiology

DR, ICDs manufactured before
staff or other appropriate parties must identify all
November 2002, 6/05, (AL05-013)
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 not be missed, as they
An unpredictable breach of an
may be found on one list and not on another. a)
insulator in the device. This insulator Review the manufacturer's letter. b) Review the
defect could result in at least partial patient list posted on the VA National ICD
diversion of current in the highSurveillance Center intranet website
voltage output circuitry, thereby
(https://icd.sanfrancisco.med.va.gov). This list,
preventing the device from delivering provided by Guidant, consists of all the VA
high-voltage shock therapy when
patients in the companys database that have an
ventricular tachycardia or fibrillation implanted model 1861 ICD which had been
is detected.
manufactured prior to November 13, 2002 and VA
patients having this implant that are being
followed at a VA facility. c) Review the VA
National registry for ICD implants Washington
VAMC, point of contact is
Ronald.Jones1@va.gov. d) Review your patient
records for all patients with implanted Guidant
model 1861Ventak Prizm 2 DR, ICD devices.
2. (continued)...
GuidantICDAlertJune2005.pdf
153 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.9.12
(continued)... Guidant Model 1861
(continued) Ventak Prizm 2 DR, ICDs
...(continued) Within the next 45 calendar days,

interrogate all Guidant Model 1861 ICDs for no
manufactured before November
telemetry or warning screen conditions. These
2002, 6/05, (AL05-013)
conditions indicate that the ICD may be
inoperative. If one of these conditions is present,
replace with a suitable new device. a) If the
interrogation of the Guidant model 1861 ICD does
An unpredictable breach of an
not reveal a problem, the patient should be
insulator in the device. This insulator followed at the manufacturers recommended
defect could result in at least partial intervals of every 3 months. However patients
diversion of current in the highshould be instructed to return immediately for
voltage output circuitry, thereby
device interrogation following any shock delivery,
preventing the device from delivering and ICD replacement should be considered at
high-voltage shock therapy when
that time.
ventricular tachycardia or fibrillation
is detected.
3. Follow the actions contained in Attachment 2.
This guidance was prepared by Dr. Edmund
Keung of the VA National ICD Surveillance
Center as the best course of action for your
patients.
GuidantICDAlertJune2005.pdf

5.9.13
Smiths Medical, Fast Flow Fluid

Warmer Models 250, 500 and 1000,
6/05 (AL05-14)
Hospitals in Australia report serious

patient injury from intravascular air
embolisms introduced while using
the Smiths Medical fluid warmers
identified in this Alert.
1. Promptly (within one week) check local

inventory to identify all units affected by this Alert
and institute recommended practices to minimize
risk (attached) for all users of Smiths Medical
Fast Flow Fluid Warmers, models 250, 500 and
1000.
2. Procure and install the Smiths Medical
accessory Air Detector/Clamp, model H-31 that is
designed to reduce the risk of air embolism
introduction while using the Smiths Medical Fast
Flow Fluid Warmers, models 250, 500 and 1000.
SmithsMedicalFluidWarmerJune2005.pdf
154 of 578

5.9.14
Question:
Guidant Corporation recalls

additional models (update to PS Alert
AL05-013 dated 6/8/05), 7/05 (AL0515)
1.Within two weeks, electrophysiology/cardiology

staff or other appropriate caregivers must identify
all affected patients by implementing each of the
insure that patients will not be missed, as they
may be found on one list and not on another.
Additional models of Implantable

Cardioverter-Defibrillators (ICD), and
has added Cardiac
Defibrillators (CRT-D) to the recall
list. These devices can develop an
internal short circuit without warning,
resulting in failure to deliver a shock
when needed. In addition, Guidant
sent letters to physicians notifying
them that identified models of Atrial
Therapy devices (AVT) and CRT-D
devices will require reprogramming.
ICDs (FDA Class I Recall) Guidant
Ventak Prizm 2 DR, Model 1861,
Implantable CardioverterDefibrillators (ICDs) manufactured
before April 16, 2002,CRT-Ds (FDA
Class I Recall) Guidant Contak
Renewal, Model H135, Cardiac
Defibrillators (CRT-D) manufactured
on or before August 26,
2004,Guidant Contak Renewal 2,
Model H155, Cardiac
on or before August 26, 2004,AVTs
(FDA Class
Mandatory;
Priority
II ARecall) Guidant Ventak
Met
(1)
Partially
Met (2)
Not
a) Review the manufacturers letters (See Links

below).
b) Review the patient list posted on the VA
National ICD Surveillance Center intranet website
(https://icd.sanfrancisco.med.va.gov). This list,
provided by Guidant, consists of all VA patients in
the companys database that have an implanted
Guidant device affected by this recall. Double
check by providing name of your facility and
implant physicians name. (See attachment 2)
c) Review the VA National registry for ICDs and
CRT-R implants, Washington VAMC, point of
contact is Ronald.Jones1@va.gov.
d) Review your patient records for all patients
with implanted Guidant devices affected by this
(continued)...
GuidantICDsCRTsUpdateJuly05.pdf
155 of 578

Question:
5.9.14
(continued)... Guidant Corporation
(continued) recalls additional models (update to
PS Alert AL05-013 dated 6/8/05),

7/05 (AL05-15)
Met
(1)
Partially
Met (2)
Not
...(continued) recall.
2.Within the next 45 calendar days, interrogate all
affected ICDs and CRT-Ds devices for:
a) Loss of telemetry/programming/interrogation.
Additional models of Implantable

Cardioverter-Defibrillators (ICD), and
has added Cardiac
Defibrillators (CRT-D) to the recall
list. These devices can develop an
internal short circuit without warning,
resulting in failure to deliver a shock
when needed. In addition, Guidant
sent letters to physicians notifying
them that identified models of Atrial
Therapy devices (AVT) and CRT-D
devices will require reprogramming.
b) Loss of tachyarrhythmia detection and therapy

delivery
ICDs (FDA Class I Recall) Guidant

Ventak Prizm 2 DR, Model 1861,
Implantable CardioverterDefibrillators (ICDs) manufactured
before April 16, 2002,CRT-Ds (FDA
Class I Recall) Guidant Contak
Renewal, Model H135, Cardiac
on or before August 26,
2004,Guidant Contak Renewal 2,
Model H155, Cardiac
on or before August 26, 2004,AVTs
(FDA Class
Mandatory;
Priority
II ARecall) Guidant Ventak
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.
c) Loss of pacing therapy.

d) Programmer display of a red warning screen
upon attempted device interrogation.
e) Programmer display of yellow warning screen
indicating out of range shocking impedance.
f) Corrective reprogramming in the appropriate
models.
3. If If the interrogation of the affected device

does not reveal a problem, the patient should be
followed at the manufacturers 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.
GuidantICDsCRTsUpdateJuly05.pdf
156 of 578

5.9.15
Question:
Depression Screening for Veteran

Patients Recently Separated from
Active Military Duty, 1/05
1. All clinical and administrative services that may

be involved with treating recently separated
veterans should review the current policy, or
standard operating procedure (SOP) addressing
depression or suicide prevention screening for
Veterans recently separated from active military
duty. (If this policy or SOP does not exist it should
be developed.)
Depression screening for recently

separated Veterans may increase
early identification of possible
psychiatric problems and/or
suicidality.
Met
(1)
Partially
Met (2)
Not
2. Refer to the websites, information letter and

video identified in this advisory, then provide
pertinent information to any and all interested
inpatient and outpatient clinical and administrative
services.
3. Ensure that discharge planning for patients
treated for depression and/or suicidality includes
information - - or direct referral, as needed - - to
mental health services available in or near their
home community (e.g., address, phone number,
point of contact, fee arrangements, etc.).
DepressionScreeningAdvisoryJan05.pdf
157 of 578

5.9.16
Question:
CPRS - Transferring Outpatient

Medication Orders to Inpatient
Medication Orders, 6/05 (AD05-14)
Notify all users, when transferring medications

from Outpatient to Inpatient, using the Medication
Screen in CPRS; they need to scroll down,
whenever text appears in the first line of the
information box, until the patch is installed.
Met
(1)
Partially
Met (2)
Not
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.
CPRSAdvisoryOutpatientMedstoInpatientMeds.pdf
158 of 578

Question:
5.9.17
Met
(1)
Partially
Met (2)
Not
Olympus 180 series endoscopes and Olympus model CFQ180AL scopes were being
Steris Quick Connects, 10/05, (AL06- reprocessed in a Steris System 1 when it was
01).
discovered the attached Quick Connect cognitive
aid (placard) did not list it for use with the CF!
180AL. The Steris Quick Connect QLC 1676,
which is compatible with the Olympus CFQ160AL
colonoscope, is not intended to be used with the
Olympus CFQ180AL colonoscope.
1) Effective immediately do not use the Steris

System 1 to reprocess Olympus 180 series
endoscopes.
2) Immediately begin to follow manufacturers
(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.
SterisQuickConnectOlympusAlert Oct 10 05.pdf
159 of 578

5.9.18
Question:
MEDRAD Stellant CT Injector

Systems, 11/05, (AL06-04).
Heat maintainers for Stellant CT Injector

Systems, manufactured by MEDRAD, Inc. Part
numbers for the heat maintainers are 3007871,
3007872, 3009707 and 3009708. (Note: Part
numbers for the Stellant injector systems are
3007301, 3010432, 3007300 and 3010091.)
The manufacturer reports the heat

maintainers used on the Stellant
injector systems may malfunction
and overheat the syringe and
contrast media.
Met
(1)
Partially
Met (2)
Not
Action: Respond to MEDRAD's letter dated

10/12/05 to determine if you have the affected
heat maintainer.
MEDRADStellantCT Nov 01 05.pdf
160 of 578

Question:
5.9.19
Met
(1)
Partially
Met (2)
Not
Injector connector relays on patient

tables, 12/05, (AL06-06)
The manufacturer reports failures of Injector

connector relays for the table models listed,
although none are reported in VA. If a relay fails,
high voltage can be present on a pin of the
exposed injector connectors, placing patients and
Tables manufactured by Philips
employees at risk. Philips will be upgrading
Medical, table models AD5 and AD6 affected systemsas parts are available, to be
used with the Integris, Integris Allura completed by mid-2006. Philips Medical
and Allura
hasidentified 42 VA medical facilities affected by
this Alert.
Xper x-ray systems.
If affected and you have not already done so:
1. Within one week, identify affected tables, and
until the tables are
upgraded,
2. Cover the connectors (diagrams in attached
Philips notification) with
nonconductive material, and
3. Inform users to exercise caution when
connecting/disconnecting the
injector connector from the table and when
cleaning near the connector.
PhilipsTableAL06-06 Dec 21 05.pdf
161 of 578

5.9.20
Question:
LEDI III Lab Electronic Data

Interchange, 8/05, (AL05-016).
1. The Laboratory ADPAC or other qualified

individuals must review the laboratory test setups
to identify those tests using "set of codes."
VistA Laboratory Package, patch

LR*5.2*286
A VHA facility recently reported that

critical flags were not being set for
positive tests of hemocult. As a
result, over 200 positive tests for
hemocult did not trigger a flag to alert
providers. Although the site has
made the proper modifications and
taken necessary actions, this Patient
Safety Alert is issued to alert other
sites that may be affected.
Met
(1)
Partially
Met (2)
Not
2. By close of business (COB) Tuesday, August

30, 2005: If any lab test used "set of codes" and
the site recognizes that they now need to modify
the set up, they should make the modifications or
seek assistance by logging a Remedy ticket with
National Help Desk.
3. By COB Friday, September 9, 2005: Once

modifications/corrections have been made, the
site needs to review the historical data from the
time the patch was installed (January 2005, or
eariler if you were a test site) to present date to
determine potential critical flag omissions. If
there were critical flag omissions in the historical
data, the site needs to review the comment field
to see if the critical value was recognized and
called to the attention of the provider as required
by the College of American Pathologists and VHA
Directive 2003-043.
4. If critical flag (continued)...
LEDI-IIIPatch Aug 26 05.pdf
162 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.9.20
(continued)... LEDI III Lab Electronic ...(continued) omissions were identified and it was
(continued) Data Interchange, 8/05, (AL05-016). determined that the provider was not notified,
VistA Laboratory Package, patch

LR*5.2*286
report the situation to the provider immediately. If

the provider is no longer with the facility, then
notification should be given to the Chief of
Service.
A VHA facility recently reported that

critical flags were not being set for
positive tests of hemocult. As a
result, over 200 positive tests for
hemocult did not trigger a flag to alert
providers. Although the site has
made the proper modifications and
taken necessary actions, this Patient
Safety Alert is issued to alert other
sites that may be affected.
5. By COB Monday, September 12, 2005:

Identify and report, to the Patient Safety Manager,
the number of patients that were not notified of
positive test results since implementing the patch,
along with the date all patients will be notified. If
your facility is not impacted, submit a negative
report. The Patient Safety Manager should report
this information to the Network Patient Safety
Officer who will report this information to the
National Center for Patient Safety, attention Joe
DeRosier/Lori King.
LEDI-IIIPatch Aug 26 05.pdf
163 of 578

5.9.21
Question:
Sulfa Allergy Order Checks, 12/05,

(AL06-07)
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 each of the drugs shown in
Attachment #1:
VistA allergy file (120.8) - Certain

drug classes are not currently
generating order checks for patients
with a documented allergy.
Met
(1)
Partially
Met (2)
Not
MESSAGE: "SULFA cross drug classes may NOT

trigger an ORDER CHECK" (refer to screen shot
below).
This message is intended to alert clinicians that a

drug-allergy order check for "SULFAS" may not
trigger appropriately, and that they must manually
check for allergies for these products. Other
appropriate messages may be added to address
other identified products (e.g., iodine, aspirin,
erythromycin, food); however, because of their
prevalence, "sulfa" must be addressed.
SulfaOrderChecks Dec 23 05.pdf
164 of 578

5.9.22
Question:
Hospira LifeCare PCA3 Infustion

Pumps List No: 12384-04, 11/05,
(AD06-02).
1. Notify clinicians of this programming

vulnerability and include this information 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
that could result in an adverse
medication event. To date, there
have been no reported adverse
events associated with either
scenario.
Scenario 1: Enter a number for

dose, dose limit, rate or
concentration, without pressing
"ENTER" to accept the value; Press
either the "History" key or
"Silence/Volume" key, scroll through
history or silence/volume and reenter
the programming screen; Press a
number key to change the value
previously entered for dose, dose
limit, rate or concentration. NOTE:
Taking these steps will not overwrite
the original value of dose, dose limit,
rate or concentration, but rather, will
increase the original value by adding
additional digits. For example, if a
"1" was originally entered and then a
"5" was entered after reentering the
programming
Recommended;
Priority
screen,
A
the value
Met
(1)
Partially
Met (2)
Not
2. Also, clinicians must use the clear key "CLR"

prior to changing a value, and use the
confirmation screen to assure that values that
have been entered in fact have been accepted by
the device.
HospiraPCA3Advisory Nov 29 05.pdf
165 of 578

5.9.23
Question:
VA Drug Class Allergy Entry, 11/05,

(AD06-01).
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 a specific reason to use
an ingredient level entry. A cognitive aid could
help clinical staff to remember this when entering
allergens.
VistA package allergy file (120.8)

may have allergy entries that have
been accidentally entered without a
VA drug class - when a drug class
entry was appropriate.
A patient had a drug allergy entered

into VistA in 1997 prior to
implementing CPRS. The allergen
cephradine was selected as being an
ingredient of a product, versus a
drug, and therefore no VA drug class
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.
Met
(1)
Partially
Met (2)
Not
2. Medication administration records and patient

charts can be used to review allergy information
until this issue is resolved (see Addl. Information
below).
3. In the interim, any specific concerns should be

addressed to the OI National Help Desk, who will
set up a remedy ticket to assist you with any
issue.
DrugClassIngredientAllergies Nov 17 05.pdf
166 of 578

Question:
5.9.24
Met
(1)
Partially
Met (2)
Not
St. Jude Medical Implantable

Cardioverter Defibrillators, 11/05,
(AL06-05)
1. By the close of business (COB) Monday,

November 28, 2005: electrophysiology/cardiology
following steps a through c. It is important that
Temporary loss of pacing function
insure that patients will not be overlooked, as
and permanent loss of tachycardia
affected patients may be found on one list and
detection may occur in selected
not on another. Your local SJM representative
Photon DR (Model V-230HV) and all may have a list of patients with you or your
Photon Micro VR/DR (Model Vcolleagues as the follow-up physician.
194/V-232) and Atlas VR/DR (Models
V-199/V-240) units. St. Jude Medical A. Review the manufacturer's letter (See Links
(SJM) reported 60 failures out of
below).
36,000 devices (0.167%) with no
serious patient injuries or death. The B. Review the patient list posted on the VA ICD
cause of this failure mode has been Surveillance Center intranet website
identified as cosmic radiation
(https://ICD.sanfrancisco.med.va.gov). It consists
damage to a vendor-supplied static of a list of VA patients provided by SJM. The
random access memory (SRAM)
SJM list is made up of all the VA patients in the
chip in these ICDs.
company's databse that have an SJM device
implanted at a VA facility and are affected by this
recall. (See Attachment 2)
C. Review your patient records for all patients
with implanted SJM devices (continued)...
SJM_ICDAlert Nov 15 05.pdf
167 of 578

Question:
5.9.24
(continued)... St. Jude Medical
(continued) Implantable Cardioverter
Met
(1)
Partially
Met (2)
Not
...(continued) affected by this recall.
Defibrillators, 11/05, (AL06-05)

2. By COB Wednesday, December 15, 2005:
interrogate all affected devices for: Hardware
Temporary loss of pacing function
Reset Mode. If the device is in the Hardware
and permanent loss of tachycardia
Reset Mode, acing at VVI at 60 ppm and no
detection may occur in selected
tachycardia detection and theraphy, replace the
Photon DR (Model V-230HV) and all device with a suitable new device immediately.
Photon Micro VR/DR (Model V194/V-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
serious patient injuries or death. The Keung, Director of the VA ICD Surveillance
cause of this failure mode has been Center, and details the best course of action for
identified as cosmic radiation
your patients.
damage to a vendor-supplied static
random access memory (SRAM)
chip in these ICDs.
SJM_ICDAlert Nov 15 05.pdf
168 of 578

Question:
5.9.25
Met
(1)
Partially
Met (2)
Not
1. By close of business (COB) Monday,

November 7, 2005: electrophysiology/cardiology
insure that patients will not be overlooked, as
Guidant Corporation is voluntarily
advising physicians, by letter about
affected patients may be found on one list and
two separate failure modes within the not on another.
INSIGNIA and NEXUS families of
cardiac pacemakers. One or more of A. Review the manufactuer's letters (See Links
below).
the following malfunctions may
occur:
B. Review the patient list posted on the VA
Western Pacemaker Surveillance Center intranet
- Intermittent or permanent loss of
website
pacing output without warning;
(https://pacemaker.sanfrancisco.med.va.gov).
This list combines the patients with the affected
telemetry;
devices that are already being followed via TTM
by the VA Western Pacemaker Surveillance
Center with a list of VA patients provided by
- Reversion of VVI mode or
Guidant. The Guidant list consists of all the VA
appearance of a reset warning
message upon interrogation
patients in the company's database that have a
Guidant device implanted at the VA facility and is
affected by this recall. (See Attachment 2)
Insignia and Nexus Implantable
Cardiac Pacemakers manufactured
by Guidant Corp, 10/05, (AL06-03)
First Failure Mode: May occur in

C. Review the VA National (continued)...
selected Insignia and Nexus
implanted units. Guidant reported 36
failures out of 49,500 devices
(0.073%). Seven (7) of these
devices were found to exhibit no
output during the implant procedures.
For the remaining 29, the majority of
failures occurred early in life (mean
implant time of 7 months). This
failure mode
Mandatory;
Priorityexhibits
A
a decreasing
GuidantInsigniaNexusPacemakers Oct 24 05.pdf
169 of 578

Question:
5.9.25
(continued)... Insignia and Nexus
(continued) Implantable Cardiac Pacemakers
manufactured by Guidant Corp,

10/05, (AL06-03)
Met
(1)
Partially
Met (2)
Not
...(continued) registry for pacemaker implants and

the VA Eastern Pacemaker Surveillance Center,
Washington DC VAMC, point of contact is
Ronald.Jones1@va.gov.
D. Review your patient records for all patients
with implanted Guidant devices affected by this
recall.
Guidant Corporation is voluntarily

advising physicians, by letter about
two separate failure modes within the
INSIGNIA and NEXUS families of
cardiac pacemakers. One or more of 2. For first Failure Mode only: By COB Friday,
the following malfunctions may
November 25, 2005: interrogate all affected
occur:
devices for:
pacing output without warning;
A. Intermittent or permanent loss of pacing

output without warning;

telemetry;
B. Intermittent or permanent loss of telemetry;
- Reversion of VVI mode or

appearance of a reset warning
message upon interrogation
C. Reversion to VVI mode or appearance of a

reset warning message upon interrogation with a
programmer.
If one or more of these conditions are present,
replace the device with a suitable new device
immediately.
First Failure Mode: May occur in

selected Insignia and Nexus
implanted units. Guidant reported 36
failures out of 49,500 devices
(0.073%). Seven (7) of these
devices were found to exhibit no
output during the implant procedures.
For the remaining 29, the majority of
failures occurred early in life (mean
implant time
Mandatory;
Priorityof
A 7 months). This
3. Follow the actinos contained in Attachment 1.

Keung, Director of the VA Western Pacemaker
Surveillance Center, and details the best course
of action for your patients.
GuidantInsigniaNexusPacemakers Oct 24 05.pdf
170 of 578

Question:
5.9.26
Met
(1)
Partially
Met (2)
Not
Use of Batch Data Entry Option Does 1. By close of business (COB) Friday, October
Not Execute Delta Checks, 10/05,
14, 2005, the Laboratory ADPAC or other
(AL06-02)
qualified individual must place the Batch Data
Entry [LRSTUF] option OUT OF ORDER until
VistA patch LR*5.2*347 is released and installed.
Acceptable alternate methods for data entry are
Positive Hepatitis C (HCV) reports
EL Enter/verify data (Load list) [LRVRW2] or EM
did not generate a critical value alert Enter/verify/modify data (manual) [LRENTER].
to the provider (as normally
expected) when the test results were
entered using the Batch Data Entry
option [LRSTUF]. Test results
2. By COB Friday, October 28, 2005: Review the
entered using the Enter/Verify/Modify past 12 months of data to determine if any tests
Data (Manual) [LRENTER] option
capable of being batch-entered and containing a
generated the appropriate critical
delta check did not generate a critical value flag.
alerts.
3. By COB Friday, November 4, 2005: Notify
providers of any critical flag omissions that were
identified, provided the patient has not already
had subsequent follo up. If the provider is no
longer with the facility, then notification should be
given to the Chief of Service. Affected patients
should be notified of positive test results as soon
as possible.
VistABatchDataEntryDeltaChecks Oct 11 05.pdf
171 of 578

5.10.1
Question:
Physician Advisory issued by

Medtronic Inc. on the Sigma Series
single and dual chamber
pacemakers, 1/06. (AL06-08).
Medtronic is reporting 19 failures out of 38000

devices (0.05%) due to: loss of rate response;
premature battery depletion; intermittent or total
loss of telemetry; or loss of pacing output in the
identified Sigma pacemaker units. The cause of
the failure has been identified as separation of
(i.e. loss of contact) redundant interconnection
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.
Met
(1)
Partially
Met (2)
Not
MedtronicSigmaAL Jan 09 06.pdf

5.10.2
Patient Pump Pain Management

Systems manufactured by Baxter
Healthcare Corp, 01/06, (AD06-03).
Baxter reports incidents of unrequested patient

doses delivered due to the following:
Damaged PCA patient cord/button;
Partial button sticking; and
Products include Ipump Pain Mgmt

System, APII Infusion Pump 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.
BaxterPCAAD06-03 Jan 10 06.pdf
172 of 578

5.10.3
Question:
Cessation of Topical Spray

Benzocaine Usage in topical
anesthetization, 2/06, (AL06-09).
Affected products include, but are not limited to:
Met
(1)
Partially
Met (2)
Not
HurricaineSpray (benzocaine 20%)

CetacaineSpray (benzocaine 14% butyl
aminobenzoate 2% and tetracaine 2%)
Specific use of Topical Spray

Benzocaine to Anesthetize the
Topex Spray (benzocaine 20%)
Surfaces of the Nasopharynx,
Oropharynx, Laryngotracheal Region
and Airway.
Several cases have been reported where
benzocaine used as a topical anesthetic on the
surfaces of the nasopharynx, oropharynx,
laryngotracheal region, and airway has resulted in
severe, and in some cases fatal,
methemoglobinemia (MHb).
Benzocaine-WWW Feb 08 06.pdf

5.10.4
Alaris IV Tubing sets, mfd by

Cardinal Health, Alaris Products,
3/06. (AL06-10).
Several VA facilities report failures when loading

administration sets in Alaris Signature series
infusion pumps. The sets are difficult to load,
and, when they do load, may malfunction or
become occluded.
This includes commonly used

72023E and 72033E sets.
Production runs from the latter part of the
calendar year 2005 into January 2006 of all Alaris
tubing sets, including 72023E and 72033E
(commonly used in VA), for Alaris Signature
infusion pumps, may be affected by this problem.
CardinalAlarisIVTubingSets Mar 06 06.pdf
173 of 578

5.10.5
Question:
Mix-up (wrong route of

administration) of bladder irrigation
with intravenous (IV) infusions, 4/06,
(AL06-012).
Since 2001, VA facilities have reported five cases

of accidental infusion into an IV line or PICC line.
Amphotericin B (See Attachment #1, Patient
Safety Alert AL06-012) was given intravenously
when it was intended for irrigation of the bladder
via a catheter. The same adverse event could
occurr with Glycine. Amphotericin B and Glycine
are both contraindicated in patients with kidney or
liver disease and when Amphotericin B is infused
via IV line, it can induce serious complications
(e.g., kidney failure.)
AmphoBladderIrrigationAlert Apr 06 06.pdf
Met
(1)
Partially
Met (2)
Not

5.10.6
Transrectal ultrasound transducer

assembly, manufactured by B-K
Medical Systems, Inc., 4/06 (AL06011)
Specific models are 8808 and 8551,

and are manufactured by B-K
Medical Systems, Inc., Wilmington,
MA.
During patient safety rounds in the Urology Clinic

at the reporting facility, the lumen of a needle
guide of a reprocessed (i.e., ready to be used for
a procedure) reusable B-K Medical transrectal
ultrasound transducer assembly was found to be
soiled. Upon investigation, it was discovered that
brushes were not being used to clean the lumen
of the needle guide.
B-KMedicalTransducerAlert06-011 Apr 03 06.pdf
174 of 578

5.10.7
Question:
Transfilling liquid oxygen from a

liquid oxygen Dewar to a portable
oxygen container., 03/06 (AD06-04)
Specific Incident: A VA facility reports a fire

erupted during the transfilling of liquid oxygen
from a Dewar to a portable container resulting in
property damage and the unscheduled relocation
of several patients; there were no injuries.
Met
(1)
Partially
Met (2)
Not
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.
O2TransfillingAD06-04.pdf
175 of 578

5.10.8
Question:
Oxygen Regulator Fires Resulting

from Incorrect Use of CGA 870
Seals., 05/06, (AD06-05)
1. Never use plastic crush gaskets.
Met
(1)
Partially
Met (2)
Not
2. Instead always use the sealing washer

specified by the
regulator manufacturer.
Specific Incident: FDA has received

12 reports in which regulators used
with oxygen cylinders have burned or
exploded due to suspected improper
use of gaskets/washers. None of
these reports involve VA facilities.
The incidents are related to the
reuse of single-use gaskets.
General Information: Two types of

washers, or CGA 870 seals, are
commonly used to create the seal at
the cylinder valve / regulator
interface. The type required by many
regulator manufacturers is a metalbound elastomeric sealing washer
that is designed for multiple use
applications. The other common
type, often supplied free-of-charge
with refilled oxygen cylinders, is a
plastic crush gasket suitable for
single use applications.
(Note: While FDA accepts using crush gaskets,

VHA believes the
fire risk of reusing them outweighs the additional
expense of using sealing washers.)
3. Always crack cylinder valves (open the valve
just enough to
allow gas to escape for a very short time) before
attaching regulators in order to expel foreign
matter from the outlet port of
the valve.
4. Always inspect the regulator and CGA 870 seal
before
attaching it to the valve to insure that the
regulator and seal are in good condition and the
regulator is equipped with only one integral metal
and rubber seal that is in good condition.
5. Tighten the T-handle firmly by hand, but do not
use wrenches
or other hand tools that may over-torque the
handle.
O2SealsAD06-05.pdf
6.
Open the post valve slowly, while maintaining a
176 of 578

5.10.9
Question:
Renewing medications using

Computerized Records System
(CPRS), version 26., 05/06, (AL0613).
Specific Incident: After installing OR*3*215

(CPRS GUIv26) a VA medical center reports that
providers noticed renewed medications are not
showing up on their signature list. Its 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
Met
(1)
Partially
Met (2)
Not
v26, CANCEL is the default choice. Pressing the

Enter or "Space keys activates the default
choice. Providers, who are accustomed to
pressing the Enter key to close the dialog, may
not notice that the renewal medication order is
canceled rather than being renewed. Providers
need to click the OK button to accept the
renewal, or press tab or an arrow key to cause
the OK button to respond to an Enter key
press.
Actions: 1. Do not install CPRS version 26

(OR*3*215) until this issue is corrected.
2. If patch OR*3*215 is already installed,
implement the following immediately to assure
medications are (continued)...
CPRSv26MedrenewAL06-13.pdf
177 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.10.9
(continued)... Renewing medications ...(continued) properly renewed.
(continued) using Computerized Records System
(CPRS), version 26., 05/06, (AL0613).
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.
CPRSv26MedrenewAL06-13.pdf

5.10.10
Boston Scientific Corp (AL06-14),

recalling a subset of devices that
includes INSIGNIA and NEXUS
pacemakers 06/06
Also includes CONTAK RENEWAL

TR/TR2 cardiac resynchronization
therapy (CRT) pacemakes, and
VENTAK PRIZM 2 VITALITY and
VITALITY 2 implantable cardioverter
defibrillators (ICDs.)
These products are manufactured by the

Company's Cardiac Rhythm Management (CRM)
Group, formerly Guidant's CRM business.
Boston Scientific acquired Guidant on April 21,
2006.
Boston Scientific/Guidant has recently confirmed

five (5) reports of device malfunction associated
with the failure of a low voltage capacitor. This
may lead to a device malfunction, including
intermittent or permanent loss of therapy, or
premature battery depletion.
BostonScientificImplantableAL06-14.pdf
178 of 578

5.10.11
Question:
Sealed Lead-Acid Batteries for

External Defibrillators (AL06-15)
A VA medical center reports multiple external

defibrillators not functioning properly on battery
mode after a limited number of discharges
although the internal batteries were fully charged.
Upon further investigation it was discovered that
the second source batteries contain internal
thermal breakers and heat generated by the
battery
Met
(1)
Partially
Met (2)
Not
Sealed, lead-acid batteries for

external defibrillators supplied by
non-OEM (Original Equipment
Manufacturer) or second source
suppliers. Second source suppliers after a limited number of discharges can trip the
include Alpha Source, Anybattery,
thermal breaker, temporarily disabling the
R&D Batteries and Unipower, among defibrillator until the battery cools.
others.
Actions:
1. By close of business July 25, 2006 identify

external defibrillators in your facility powered by
second source batteries and contact the battery
supplier to determine if internal thermal breakers
are incorporated into the battery.
2. If the defibrillator battery incorporates an

internal thermal breaker, replace it with a battery
acquired directly from the defibrillator
manufacturer (OEM), or if a second source
battery is to be used, ensure that no thermal
breaker is employed.
Defibrillator Batteries AL06-15.pdf
179 of 578

Question:
5.10.11
(continued)... Sealed Lead-Acid
(continued) Batteries for External Defibrillators
Met
(1)
Partially
Met (2)
Not
...(continued) a replacement battery is not

available:
(AL06-15)
(a) Instruct users and code response teams to
plug in the defibrillator during a code if the
defibrillator appears to fail to charge and
discharge normally (temporary signage can
assist).
Sealed, lead-acid batteries for

external defibrillators supplied by
non-OEM (Original Equipment
Manufacturer) or second source
(b) Assure code team defibrillators are equipped
suppliers. Second source suppliers with a fully charged spare battery.
include Alpha Source, Anybattery,
R&D Batteries and Unipower, among
others.
Defibrillator Batteries AL06-15.pdf
180 of 578

Question:
5.10.12
Met
(1)
Partially
Met (2)
Not
Shutdown of Donor Referral Services At this time it has been determined that tissue
(DRS) Tissue Harvesting Co by FDA from DRS was sold or distributed to:
(AD06-06)
Alamo Tissue Services of San Antonio, Texas
FDA issued an order to Donor
Referral Services (DRS) of Raleigh,
North Carolina, to cease
manufacturing and to retain human
cells, tissues, and cellular and tissuebased products (HCT/Ps)", due to
violations of Good Manufacturing
Practices (GMP).
Bonebank Allographs, San Antonio, TX

DCI, Nashville, TN
Global Orthopedic, Ellisville, MS
Lost Mountain Bank of Kennesaw, Georgia
Neuro Tec, Marietta, GA
US Tissue (AlloSource) of Cincinnati, Ohio and
Salt Lake City, Utah
Tissue Management Solutions, Scottsdale, AZ
Tissue Net of Orlando, Florida (may have
received from US Tissue (AlloSource) of
Cincinnati)
West Coast Medical, Seattle, WA
Recommendations:
a) Verify if your facility has purchased the human

cells, tissue, and cellular and tissue-based
products
DRS
tissue AD06-06.pdf
from DRS or any of their direct or
181 of 578

Question:
5.10.12
(continued)... Shutdown of Donor
(continued) Referral Services (DRS) Tissue
Met
(1)
Partially
Met (2)
Not
...(continued) sources to replace the affected

products.
Harvesting Co by FDA (AD06-06)
FDA issued an order to Donor

Referral Services (DRS) of Raleigh,
North Carolina, to cease
manufacturing and to retain human
cells, tissues, and cellular and tissuebased products (HCT/Ps)", due to
violations of Good Manufacturing
Practices (GMP).
d) If alternative sources are not immediately

available, the physicians should assess the
impact of denying use of this product against the
patients medical outcome.
e) Individuals who have received this material will
likely need notification and patient call back for
testing once it is determined that they have
received the recalled material. Refer to VHA
Directive 2005-049 Disclosure of Adverse Events
to Patients.
DRS tissue AD06-06.pdf
182 of 578

Question:
5.10.13
Met
(1)
Partially
Met (2)
Not
Alaris SE infusion pumps (AL0616)
On August 15, 2006 Cardinal Health initiated a

voluntary field corrective action to address
concerns about the sensitivity of the keypad that
can lead to key bounce, with a potential to result
in over infusion. Key bounce occurs when a
All models of Alaris SE infusion
keyboard entry registers twice while pressing the
pumps - formerly the Signature
key once. For example, an infusion rate intended
to be 4.0 mL/hr where a key bounce occurs,
Edition Infusion System. Alaris is a results in an entry of 44.0 mL/hr.
subsidiary of Cardinal Health, Inc.
Subsequently, on August 28, 2006 Cardinal
Health suspended
manufacturing and distribution of the Alaris SE
infusion pumps
resultant from FDA actions.
Actions: If your facility has an affected pump

please assure the following:
1. Your facility has received the letters and

warning labels sent by
Cardinal Health for the Alaris SE infusion
pumps, and that the warning labels have been
appropriately affixed.
2. If your Alaris infusion pumps have the

Guardrails software, enforce the appropriate
use of
Alaris
SE the
Keyboard
software
AL06-16.pdf
by always selecting New
183 of 578

Question:
5.10.13
(continued)... Alaris SE infusion
(continued) pumps (AL06-16)
All models of Alaris SE infusion

pumps - formerly the Signature
Met
(1)
Partially
Met (2)
Not
...(continued) your Alaris infusion pumps do not

have the Guardrails
software, consider acquiring the software and
implementing in locations where high risk
medications are used.
4. Assure that clinical staffs who program these

Edition Infusion System. Alaris is a pumps or any
subsidiary of Cardinal Health, Inc.
programmable medical device visually verify the
intended device setting before beginning
treatment and leaving the area.
Alaris SE Keyboard AL06-16.pdf
184 of 578

Question:
5.10.14
Met
(1)
Partially
Met (2)
Not
BCMA v3.0 Patch PSB*3.0*13

(AL06-17)
Four facilities report that BCMA scanners are

producing an audible sound when nurses scan
certain medications, as expected, but the status
of the medication doesnt update to G (given) on
the BCMA screen. No adverse events occurred
BCMA scanners are producing an
since nurses noticed the Virtual Due List (VDL)
audible sound when nurses scan
did not update and took corrective action;
certain medications, as expected, but however, had they not taken corrective action,
the status of the
another caregiver could believe the medication
wasnt provided and
medication doesnt update to G
(given) on the BCMA screen.
administer it again.
General Information: As identified by the Office of

Information Patient Safety Office this problem is
linked to the installation of BCMA v3.0 Patch
PSB*3.0*13. When using the patch, BCMA will
not update the medication status in the VDL to
G (given) following administration of a
medication that (1) has been renewed
and (2) has had special instructions (inserted by
the provider) removed prior to the order being
accepted by Pharmacy. When the status of the
medication is not updated to G in the VDL, the
medication will show up (continued)...
BCMA patch PSB-30-13 AL06-17.pdf
185 of 578

Question:
5.10.14
(continued)... BCMA v3.0 Patch
(continued) PSB*3.0*13 (AL06-17)
Met
(1)
Partially
Met (2)
Not
...(continued) on the missed medication report.

Hence, the possibility exists that another
caregiver could administer the medication again
and overdose the patient.
BCMA scanners are producing an

audible sound when nurses scan
certain medications, as expected, but Action: By COB September 14, 2006:
the status of the
medication doesnt update to G
(given) on the BCMA screen.
1. For sites that have not installed BCMA v3.0

Patch PSB*3.0*13 (i.e., those sites who do not
appear on the list shown in Attachment A), the
IRM (or designee) must IMMEDIATELY take steps
to ensure that the patch is NOT installed. Once
completed, there are no further actions for these
sites and sites will be notified when it is okay to
administer the patch.
2. For sites that have already installed BCMA
v3.0 Patch PSB*3.0*13 (i.e., those sites who
appear on Attachment A), DO NOT uninstall the
patch.
Instead, the following actions are to be taken to

minimize the risk to patients while a permanent
solution is developed.
a. Pharmacy must complete the following twostep process when they delete special
instructions from a pending renewal order, in
orderpatch
BCMA
to prevent
PSB-30-13the
AL06-17.pdf
null special instructions field
186 of 578

Question:
2007 Alerts & Advisors
5.11.1
Met
(1)
Partially
Met (2)
Not
VistA Imaging Patch MAG*3*18 This Patient Safety Alert only affects those
VistARad Enhancements (AL07-01). facilities that read MRI images using MAG*3*18.
This problem occurs if these conditions are
present:
A Radiologist reviewing a series of
images from a MRI study discovered
the software presented an
incomplete set of images (missing a
slice) for review. The missing slice
almost resulted in a spinal tumor
being missed. The facility was using
VistA Imaging Patch MAG*3*18
(released on June 16, 2006) to read
the images.
1) The Site is using an MRI device that allows for

the creation of a scout (localizer) image using the
Referenced Image Sequence field (0008,1140)
2) The operator performing the imaging
procedure chooses to generate a referenced
image sequence (done at the MRI console).
If these conditions are present when the exam is

opened using VistARad Patch MAG*3*18, the
image that serves as the scout (localizer) in the
referenced image series is moved out of its
original series in the Viewer window and placed
into the VistARad Scout Image window. The
radiologist needs to recognize that the image is
missing and then go to the Scout Image window
to view the image that was removed from the
original series.
This removal of scout images became a known
problem with Patch
MAG*3*18 after the completion of the patch and
prior to its release to the (continued)...
VistA Rad Patch MAG 318 AL07-01.pdf
187 of 578

Question:
5.11.1
(continued)... VistA Imaging Patch
(continued) MAG*3*18 - VistARad
Enhancements (AL07-01).
A Radiologist reviewing a series of

images from a MRI study discovered
the software presented an
incomplete set of images (missing a
slice) for review. The missing slice
almost resulted in a spinal tumor
being missed. The facility was using
VistA Imaging Patch MAG*3*18
(released on June 16, 2006) to read
the images.
Met
(1)
Partially
Met (2)
Not
...(continued) field. Therefore the problem was

included in the ReadMe.txt file as PROBLEM 7:
Scout Image problem on MRI exams.
Action:
1. If you are NOT currently using VistA Imaging

Patch MAG*3*18 to view MRI images do not
begin to do so until this sequencing problem is
corrected.
2. If VistA Imaging Patch MAG*3*18 is being used
to read MR images complete the following:
a. By close of business (COB) 10/6/2006, make
sure that all radiologists who review MRI studies
read and understand ReadMe.txt file Problem 7
that is included with the Patch.
b. By COB 10/20/2006 assess whether any MRI
studies read using Patch 18 need further
analysis. Clinical judgment must be used in
prioritizing and scheduling studies that need to be
re-read.
VistA Rad Patch MAG 318 AL07-01.pdf
188 of 578

Question:
5.11.2
Met
(1)
Partially
Met (2)
Not
Incorrect electronic chart associated This problem is not specific to CPRS v26 and
with patient name in CPRS (AL07BCMA; it was
03).
introduced with CPRS v22.16 (released
December of 2003) and
Clinical orders (e.g. medications,
progress notes) and other clinical
data may be inadvertently entered
into VistA for the incorrect patient
when the following conditions are
present:
continued with later versions (current version is

26.68), and any
patient context CCOW-enabled application. The
BCMA CCOWenabled version (PSB*3*13
released August 2006) increased the probability
of this occurring in CPRS.
1) CPRS v26 and BCMA (post install

PSB*3*13) are both open and
Action: By close of business (COB) on Monday,
November 27, 2006:
displaying information for the same
patient (e.g., Patient A), and
1. The facility IT support must edit the BCMA
desktop shortcut
2) an action is pending in BCMA
(e.g., critical unviewed information on parameters on all applicable workstations to
the IVP/IVPB tab) for Patient A,, and include /noccow (without quotes) which will
disable CCOW, and then notify the facility BCMA
3) a user attempts to process a
Coordinator of this action. (The following is an
notification for another patient (e.g.
example of the BCMA desktop shortcut
Patient B) via the CPRS File/Select parameter setting with CCOW disabled
Patient patient selection
C:\Program Files\vista\BCMA\BCMA.exe"
/noccow) AL07-03 November 21, 2006
screen pathway, and
4) the user selects Break Link from
the Problem Changing Clinical Data Note 1: This action will result in loss of patient
pop-up window prompt, instead of
synchronization
Cancel (see Figure 1).
between BCMA and CPRS or any other CCOW
enabled clinical
CPRS CCOW AL07-03.pdf
189 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.2
(continued)... Incorrect electronic
...(continued) installation of Patch
(continued) chart associated with patient name in
CPRS (AL07-03).
PSB*3*13. All non-CCOW related changes

included in PSB*3*13
will remain active.
Clinical orders (e.g. medications,

progress notes) and other clinical
data may be inadvertently entered
into VistA for the incorrect patient
when the following conditions are
present:
Note 2: While this CCOW issue is not associated

with BCMA,
disabling CCOW in BCMA will reduce the

1) CPRS v26 and BCMA (post install probability of sites
PSB*3*13) are both open and
encountering this problem in CPRS and have
displaying information for the same minimal impact to
patient (e.g., Patient A), and
patient synchronization across all other CCOW
2) an action is pending in BCMA
enabled
(e.g., critical unviewed information on
the IVP/IVPB tab) for Patient A,, and applications
3) a user attempts to process a
notification for another patient (e.g.
Patient B) via the CPRS File/Select
Patient patient selection
2. Once Action 1 has been completed, the facility

BCMA Coordinator must advise BCMA users that
CCOW is disabled.
screen pathway, and

4) the user selects Break Link from
the Problem Changing Clinical Data
pop-up window prompt, instead of
Cancel (see Figure 1).
3. Clinical Application Coordinators (CACs) or

designee must inform clinical users to select
Cancel instead of Break Link, if prompted by a
Problem Changing Clinical Data pop-up window
(see Figure 1). If Break Link is chosen instead of
Cancel, users must immediately close CPRS
and open a new session.
CPRS CCOW AL07-03.pdf
190 of 578

5.11.3
Question:
Gemini PC series infusion pumps

manufactured by Alaris, formerly
IMED, (AD07-01).
Recommendations:
Met
(1)
Partially
Met (2)
Not
1. DO NOT use medication pumps, or other

medical devices that
are in need of repair.
A VA medical facility reported a

Gemini PC series infusion pump
exhibiting free flow while connected
to a patient. Upon
examination it was discovered that
the free-flow protection latch
was broken. Discussions with other
VA medical facilities confirm
2. As standard practice, operators of medical

devices should inspect and conduct operational
checks consistent with manufacturer
recommendations on all medical devices before
use. If the device is found to be in need of repair,
it should be labeled as defective, removed from
service, and sent to biomedical engineering for
service.
that the free-flow protection latch on

the Gemini PC series infusion
pump is prone to breaking and
therefore commonly inspected
before each use.
3. For sites using the Gemini PC series referred

to in this Advisory,
include inspection of the free-flow protection latch
in maintenance
and operational checks. A sample inspection
protocol developed by a VA medical facility is
attached to this Advisory as Attachment 1.
4. Assure that there are an adequate number of

pumps available to adjust for peak utilizations
and/or maintenance cycles.
Alaris Gemini PC Latch AD07-01.pdf
191 of 578

5.11.4
Question:
VistA Pharmacy Package: use of

alpha characters in Infusion Rate
field, (AD 07-02).
VA facilities have the flexibility for entering

information into the VistA field titled Infusion
Rate that can lead to misunderstanding of the
infusion rate information. The capability to add
this nomenclature (text followed by @0) has been
available in the VistA system since 1994.
Met
(1)
Partially
Met (2)
Not
A VA facility pharmacist entered T@0

in the Infusion Rate field to
instruct the pharmacy printer not to
print labels for an IV morphine
infusion. Caregivers believed that
this abbreviation, which displays on
the BCMA screen, meant that the
medication could be titrated. This
misinterpretation resulted in a
medication misadministration and
inaccurate documentation.
Recommendations: Implementation of all the

following is recommended:
1. Avoid the use of non-standardized

abbreviations or nomenclature (e.g. T@0) prior
to the @ symbol.
2. In the situation where there is a desire to

prevent labels from being printed, use full text
(e.g. No labels@0, check with caregivers or
providers to ensure that the full text is not prone
to misinterpretation) so that communication
between pharmacy and other caregivers or
providers is complete, clear, accurate and
consistent.
3. If the medication order specifies an infusion

rate, include that
information in the infusion rate field even if no

labels are required. (e.g. 2ml/hr@0 instead of
VistaCPRSBCMATOAD07-02.pdf
T@0).
192 of 578

Question:
5.11.4
(continued)... VistA Pharmacy
(continued) Package: use of alpha characters in
Infusion Rate field, (AD 07-02).
Met
(1)
Partially
Met (2)
Not
...(continued) administration of a medication order

is based on a titration, FULL instructions (e.g.
Titrate@0) AND parameters for titration (e.g.
Infuse at 1ml/hr. May titrate as per protocol to
2ml/hr.) should be included in the Other print:
information field (see Attachment A).
A VA facility pharmacist entered T@0

in the Infusion Rate field to
instruct the pharmacy printer not to
print labels for an IV morphine
infusion. Caregivers believed that
this abbreviation, which displays on
the BCMA screen, meant that the
medication could be titrated. This
misinterpretation resulted in a
medication misadministration and
inaccurate documentation.
VistaCPRSBCMATOAD07-02.pdf
193 of 578

5.11.5
Question:
Reprocessing of resectoscope
systems working elements (used in
urology) (AD 07-03)
During their SPD Healthcare Failure Mode and

Effects Analysis
Met
(1)
Partially
Met (2)
Not
(HFMEA) on rigid cystoscopes, a VA Medical

Center identified they were improperly
reprocessing Karl Storz model 27050E
resectoscope working elements. The device
manufacturers instructions indicate the working
element cannot be sterilized in a STERRAD
sterilization system, which was currently being
used for sterilization.
A contributing factor to the improper sterilization

of the resectoscope systems working element is
the manufacturers reprocessing instructions that
may be open to misinterpretation. The
manufacturers instructions indicate sterilization
using a STERRAD sterilization system can be
used for sterilization of Karl Storzs resectoscope
working elements; however, an asterisk (*)
which could be easily overlooked indicates that
STERRAD sterilization system cannot be used
for the 27050 series of Karl Storz resectoscope
working elements.
Reliance on instructions provided with

reprocessors (continued)...
Resectoscope Working Element Reprocessing.pdf
194 of 578

Question:
5.11.5
(continued)... Reprocessing of
(continued) resectoscope systems working
elements (used in urology) (AD 0703)
Met
(1)
Partially
Met (2)
Not
...(continued) (sterilization)
equipment to determine if a device can be
reprocessed using their reprocessing equipment
could also contribute to improper reprocessing.
For example, the resectoscope working element
discussed in this Patient Safety Advisory has
multiple lumens and holes having different inside
diameters that are constructed from different
materials (e.g., stainless steel, Teflon). Without a
thorough knowledge of all of the lumens and
holes that
exist (some of which are not obvious and easily
overlooked see
Attachment 2), a facility could easily come to the
incorrect conclusion (based on reprocessing
information from STERRAD) that sterilization
using a STERRAD sterilization system would be
acceptable for the Karl Storz resectoscope
working element 27050E.
Resectoscope working elements are part of

resectoscope systems and are used in Urology in
the transurethral resection of tissue; including the
ablation or cutting of prostate tissue (as in
transurethral resection of the prostate [TURP])
and superficial bladder tumors, and to cauterize
minor bleeding in the prostate and bladder. An
example of a resectoscope systems working
element is shown in Attachment 1.
Resectoscope Working Element Reprocessing.pdf
195 of 578

5.11.6
Question:
Privacy curtains and privacy curtain

support structures (e.g., track and
track supports) in locked mental
health units. (AL07-04).
Locked mental health unit sleeping rooms provided with privacy
Met
(1)
Partially
Met (2)
Not
curtains to meet patient privacy needs - conflict

with the need to
keep patients safe from self harm. Patient privacy

A VAMC reported that a patient used is important;
a privacy curtain (and its
however, patient safety must come first. Privacy
support) in a sleeping room located curtains and their
in a locked mental health unit to
commit suicide by hanging. The
components are not appropriate in this protected
patient used the privacy curtain as a environment.
noose - knotting it to make it more
rope-like while it remained attached A review of inpatient suicide and parasuicide
to the curtain support structure. The events in VHA over the past 5 years reveals that
entire system supported the full
approximately 54% of the reported
weight of the patient.
suicide/parasuicide events have occurred in
locked inpatient
psychiatric and detox units. 70% of the reported
events involved
hanging, drug overdose, or cutting with a sharp
object. The majority of items used for nooses for
suicides include bedding or clothing (including
belts and shoelaces). Various items have been
used for anchors in the suicide and parasuicides
including, but not limited to, doors, wardrobe
cabinets, bed rails, shower fixtures, bathroom
stalls, handrails, and window latches.
Privacy Curtain AL07-04.pdf

Actions:
196 of 578

Question:
5.11.6
(continued)... Privacy curtains and
(continued) privacy curtain support structures
...(continued) business (COB) Friday, February

23, 2007
(e.g., track and track supports) in

locked mental health units. (AL0704).
identify every location accessible to patients in

your locked mental
Met
(1)
Partially
Met (2)
Not
health units that have privacy curtains and/or

support systems for
A VAMC reported that a patient used
a privacy curtain (and its
the curtains and remove the curtains.
support) in a sleeping room located
in a locked mental health unit to
commit suicide by hanging. The
patient used the privacy curtain as a
noose - knotting it to make it more
rope-like while it remained attached
to the curtain support structure. The
entire system supported the full
weight of the patient.
2. By COB Friday, March 9, 2007 remove any

privacy curtain
supportive structures (e.g. tracks and track
supports) that could be used as an anchor for
suicide by hanging.
Privacy Curtain AL07-04.pdf
197 of 578

Question:
5.11.7
Met
(1)
Partially
Met (2)
Not
Medtronic Vitatron dual chamber

Medtronic Corporation is voluntarily advising
cardiac pacemakers T-series and C- physicians, by letter, about problems that might
series, (AL07-05).
occur, under certain conditions, within the Vitatron
dual chamber cardiac pacemakers T-series and
C-series.
Device Name
Numbers
Model
C50 D
C50A2, C50A3
C50A1,
C60 DR
C60A2, C60A3
C60A1,
C70 DR
C70A3
T60 DR
T60A1
T70 DR
T70A1
Specific Incident: A software anomaly can cause

the pacemakers to present clinically as a reset of
the pacemaker or inhibition of pacing, if these
devices are programmed to specific parameters
and if the patients intrinsic heart rate falls below
the programmed lower heart rate.
Actions:
1. By close of business (COB) Monday March 12,

2007, electrophysiology/cardiology staff or other
appropriate parties must identify all affected
patients by implementing each of the following
steps a through c. It is important that ALL
INFORMATION sources be reviewed to insure
that patients will not be overlooked, as affected
patients may be found on one list and not on
another.
a) Review the manufacturers letter (See
Attachment 1).
Western (continued)...
Medtronic Vitatron AL07-05.pdf
198 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.7
(continued)... Medtronic Vitatron
...(continued) Pacemaker Surveillance Center
(continued) dual chamber cardiac pacemakers T- intranet website
series and C-series, (AL07-05).
Device Name
Numbers
Model
C50 D
C50A2, C50A3
C50A1,
C60 DR
C60A2, C60A3
C60A1,
C70 DR
C70A3
T60 DR
T60A1
T70 DR
T70A1
(https://pacemaker.sanfrancisco.med.va.gov).
(See Attachment
2.) This list combines the patients with the
affected devices that are already being followed
via Trans Telephonic Monitoring (TTM) by the VA
Eastern and Western Pacemaker Surveillance
Centers with a list of VA patients provided by
Medtronic. The Medtronic list consists of all the
VA patients in the companys databases that have
had a Medtronic device implanted at a VA facility
and are affected by this.
c) Review your patient records for all patients with
implanted Medtronic devices affected by this
notification.
2. By close of business (COB) March 23, 2007,

follow the recommendations contained in
Attachment 2. This guidance was prepared by Dr.
Edmund Keung, Director of the VA Western
Pacemaker Surveillance Center, and details the
best course of action for your patients.
Medtronic Vitatron AL07-05.pdf
199 of 578

5.11.8
Question:
Tonometer Tips, (AL07-06)
The 120 day extension, previously issued by The

Acting Principal Deputy Under Secretary for
Health, for the Tonometer Tips Reprocessing
Patient Safety Alert (AL07-02) required that
Action #2 be completed by March 7, 2007. The
extension was granted to provide sufficient time
to determine a reprocessing procedure for U.S.
customers to use for Haag-Streit reusable
tonometer tips.
http://vaww.ncps.med.va.gov/Dialogue/pslog/view
.asp?eid=94
Reprocessing instructions for HaagStreit reusable tips (prisms) used to

measure intraocular pressure.
Met
(1)
Partially
Met (2)
Not
Proposed reprocessing instructions were sent to

all VHA facilities at the end of January, 2007, for
review and comment. This Alert provides the final
instructions to be used for reprocessing HaagStreit reusable tonometer tips in the U.S. These
instructions have been provided to VA by the
manufacturer; the need to follow reprocessing
instructions as provided by the manufacturer
complies with VA Handbook 7176, Part 6, 610.
Action:
By close of business Friday, March 30, 2007, use

the instructions
detailed in Attachment 1 to reprocess Haag-Streit
(continued)...
Tonometer Tips AL07-06.pdf
200 of 578

Question:
5.11.8
(continued)... Tonometer Tips,
(continued) (AL07-06)
Met
(1)
Partially
Met (2)
Not
...(continued) reusable tonometer tips in the U.S.
Reprocessing instructions for HaagStreit reusable tips (prisms) used to

measure intraocular pressure.
Tonometer Tips AL07-06.pdf
201 of 578

5.11.9
Question:
Boston Scientific Corporations

Cardiac Rhythm Management
Division (previously called Guidant)
recall of Implantable Cardiac
Defibrillators (ICDs) and Cardiac
Defibrillators (CRT-Ds), (AL07-07).
The following Guidant ICD and CRT-D device

models have low-voltage capacitors that may be
subject to degradation and may cause
accelerated battery depletion.
Device Name
Vitality DS DR/VR
T125/T135
Vitality EL DR
T127
Not
A155
Vitality 2 DR/VR
T165/T175
Vitality 2 EL DR/VR
Partially
Met (2)
Model Numbers
Vitality AVT
Met
(1)
T167/T177
Vitality DR HE
T180
Contak Renewal 3
H170/H175
Contak Renewal 3
HE H177/H179
Contak Renewal 4
H190/H195
Contak Renewal 4
HE H197/H199
Contak Renewal 3
RF H210/H215
Contak Renewal 3
RF HE H217/H219
Contak Renewal 4
RF H230/H235
Contak Renewal 4
RF HE H239
Guidant BSCI-ICDs CRTs AlertAL07-07 -VAWW.pdf
202 of 578

Question:
5.11.9
(continued)... Boston Scientific
(continued) Corporations Cardiac Rhythm
Management Division (previously

called Guidant) recall of Implantable
Cardiac Defibrillators (ICDs) and
Cardiac Resynchronization Therapy
Defibrillators (CRT-Ds), (AL07-07).
Met
(1)
Partially
Met (2)
Not
...(continued) a through c. It is important that ALL

that patients will not be missed, as they may be
found on one list and not on another. a) Review
the manufacturers letters (see the links under
Additional Information). b) Retrieve and review a
list of your patients with the affected devices
(ICDs and CRT-Ds) on the VA National ICD
Surveillance Center intranet website
(https://icd.sanfrancisco.med.va.gov, see
Attachment 2 for instructions). This list consists of
all the patients in Guidants database that have
implanted devices affected by this and previous
recalls (some devices are affected by more than
one recall). c) Review your patient records for all
patients with implanted Guidant devices affected
by this recall.
2. Within the next 30 calendar days, follow the

actions contained in Attachment 1. This guidance
was prepared by Dr. Edmund Keung, Director of
the VA National ICD Surveillance Center, as the
best course of action for your patients.
Guidant BSCI-ICDs CRTs AlertAL07-07 -VAWW.pdf
203 of 578

Question:
5.11.10
Met
(1)
Partially
Met (2)
Not
Shelhigh, Inc. implantable medical

products, (AL07-08).
FDA states that the companys deficiencies could

compromise the safety and effectiveness of the
products. The affected products include heart
valves, conduits, surgical patches, dural patches
(to aid in tissue recovery after neurosurgery),
On April 17, 2007, the FDA seized all annuloplasty rings to repair heart valves, and
implantable medical products from
arterial grafts.
Shelhigh, Inc. and on May 2, 2007,
the FDA issued a press release
disclosing a formal request to
Shelhigh, Inc., of Union, New Jersey These products have been issued under supplier
to recall all of its medical products
names of Shelhigh, Inc., Integra NeuroSciences,
remaining in the marketplace
and Integra LifeSciences Corp.
including hospital inventories,
because of sterility concerns.
Shelhigh, Inc. does not agree with
the FDA
Actions:
position and consequently is not
implementing the requested recall.
1. By COB May 21, 2007 determine if you have

any of the affected medical products listed in
Attachment A, remove them from inventory and
sequester.
2. Immediate action should be taken to purchase

alternative medical products from other suppliers
to replace the affected items.
3. By close of business (COB) May 25, 2007,

notify all primary care physicians of the potential
for contamination of the specified Shelhigh, Inc.,
Integra NeuroSciences, and Integra LifeSciences
Corp products listed in Attachment A. Notification
is to beImplantables
Shelhigh
providedAL07-08.pdf
so (continued)...
204 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.10
(continued)... Shelhigh, Inc.
...(continued) that these physicians are aware of
(continued) implantable medical products, (AL07- this issue, especially if patients under their care
08).
have already received one of the implants.
On April 17, 2007, the FDA seized all

implantable medical products from
Shelhigh, Inc. and on May 2, 2007,
the FDA issued a press release
disclosing a formal request to
Shelhigh, Inc., of Union, New Jersey
to recall all of its medical products
remaining in the marketplace
including hospital inventories,
because of sterility concerns.
Shelhigh, Inc. does not agree with
the FDA
a) Retrieve and review a list of your patients with

the affected
position and consequently is not

implementing the requested recall.
products, sent to your facility Patient Safety

Manager under
separate cover by secured FedEx. This list
includes all the
patients in the VHA Prosthetics database that
have implanted
products that are the subject of this notification.
As this list may
not be complete also complete action 3.b) below.
b) Review your patient records for all patients

with implanted
Shelhigh, Inc., Integra NeuroSciences, and
Integra LifeSciences
Corp products to identify those implanted with
affected products.
Shelhigh
4.
OnlyImplantables
in emergency
AL07-08.pdf
cases should any of the
205 of 578

5.11.11
Question:
BCMA Double Scans Alert (AL 0709).
A VAMC discovered an inappropriate 4 digit

number as the unit of
Met
(1)
Partially
Met (2)
Not
administration in the medication administration

log for a patient
Incorrect units of administration can
be documented when scanning
variable dose medications in BCMA
receiving Morphine. At another facility, a provider

reported viewing 743 as the unit of
administration for a regular Insulin order. These
inappropriate entries become part of the patients
medical record, can be misinterpreted as the
dose the patient received, and may consequently
be used by physicians to plan future treatments.
General Information: After scanning a medication

in BCMA, there are instances where the user is
presented with a pop-up dialog box for free-text
entry; BCMA is expecting the user to enter the
units of administration of the scanned medication
into the pop-up box. If the user doesnt notice the
pop-up box and doesnt enter the expected text
into it either because the user inadvertently
double scanned the same medication or
proceeded to scan another medication - the
internal entry number (IEN) or synonym of the
scanned (continued)...
BCMA Double Scans Alert 07-09.pdf
206 of 578

Question:
5.11.11
(continued)... BCMA Double Scans
(continued) Alert (AL 07-09).
Met
(1)
Partially
Met (2)
Not
...(continued) medication is automatically entered

into the free-text pop-up box. This number is
stored in the Medication History Report as the
units of administration for the first scanned
medication.
Incorrect units of administration can

be documented when scanning
variable dose medications in BCMA
Examples: if a variable dose medication
(Medication 1) is
inadvertently scanned twice, the IEN of
Medication 1 would appear
as the units of administration for Medication 1 in
the Medication
History Report. Similarly, if Medication 2 was
scanned (and no text
was entered into the pop-up box that appeared)
and then Medication 3 was subsequently
scanned, the IEN for Medication 3 would be
entered as the units of administration for
Medication 2 in the Medication History Report.
Actions:
1. By close of business (COB) Friday, June 22,

2007, BCMA
Coordinators (or designee) must inform BCMA

usersDouble
BCMA
that Scans Alert 07-09.pdf
207 of 578

5.11.12
Question:
Daylight Saving Time (DST)

changes, (AD07-04)
In general, this change does not affect basic

medical device operation, but could lead to
discrepancies for some record keeping activity.
Manufacturers are expected to provide formal
communications to customers shortly and the
FDA is likewise preparing information on this
subject. Aside from general cautions regarding
devices that communicate with each other, where
each device includes a separate clock, there are
no indications for direct impact on patient care
other than minimal risk associated with time
stamp issues.
With the passage of the Energy

Policy Act of 2005 the start of DST is
changed from the first Sunday in
April to the second Sunday in March
and the end of DST is changed from
the last Sunday in October to the first
Sunday of November beginning this
year, 2007.
Met
(1)
Partially
Met (2)
Not
Recommendation: Managing a practical approach

to addressing DST changes includes the
following important steps:
1. Awareness describe and communicate the
scope of the DST change to facility staff using
newsletters, daily bulletins and other normal
communication mechanisms.
2. Assessment using available technical

documentation, identify the inventory of devices
with internal clocks that track date and time.
Assessment also includes identifying software

(continued)...
DST_AD07-04.pdf
208 of 578

Question:
5.11.12
(continued)... Daylight Saving Time
(continued) (DST) changes, (AD07-04)
With the passage of the Energy

Policy Act of 2005 the start of DST is
changed from the first Sunday in
April to the second Sunday in March
and the end of DST is changed from
the last Sunday in October to the first
Sunday of November beginning this
year, 2007.
Met
(1)
Partially
Met (2)
Not
...(continued) patches made available by medical

equipment manufacturers to address DST.
Note: Software patches from sources other than

the medical device manufacturer cannot be
installed on medical devices without the explicit
consent of the medical device manufacturer.
3. Prioritize assign priority to devices requiring

action and address the following at minimum:
- life support, examples include defibrillators,
ventilators
- critical patient monitoring, examples include
ICU, vital signs monitors
- synchronization between devices/systems using
real-time clocks such
as BCMA laptops communicating with VistA
- diagnostic devices such as imaging, ECG, and
laboratory analyzers
- other devices such as sterilizers/reprocessing
equipment
- pumps such as infusion pumps and PCA pumps
may be candidates to
remain on Standard Time since they are stand

alone devices with clocks
DST_AD07-04.pdf
209 of 578

5.11.13
Question:
Ceiling collapse in exterior

connecting corridor between
buildings. (AL07-10)
By close of business (COB) on Friday, August 31,

2007:
Met
(1)
Partially
Met (2)
Not
1. Survey all plaster lathe ceiling systems in

An approximately twenty foot section exterior connecting corridors between buildings
of a plaster ceiling over an
for bulging or cracking that may indicate the
ceiling system is unsound. If the plaster lathe
exterior connecting corridor between ceiling system is obscured by a lower suspended
buildings collapsed and fell through ceiling, inspect the plaster lathe system at
an existing suspended ceiling,
approximately 8 foot intervals down the length of
injuring two patients. The exterior
the exterior connecting corridor.
connecting corridor roof system was
approximately 57 years old and did
not have ridge or soffit vents. There
was no evidence that moisture from 2. Take immediate action to shore up any plaster
recent rains was a factor; however,
ceiling that is showing signs of deterioration
the wire lathe and fasteners securing and/or damage and prevent patients, staff or
the ceiling to the wood rafters and
visitors from using the exterior connecting corridor
ties showed advanced deterioration. between buildings until it is safe to do so. Initiate
a project to permanently shore up the ceiling
system or remove the plaster lathe assembly.
NOTE: Plaster lathe ceilings may be an integral

component of the
connecting corridors fire rated assembly. Consult
with your Network Safety Manager before
proceeding to remove the ceiling.
3. If the plaster lathe ceiling (continued)...

NCPS Alert AL07-10.pdf
210 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.13
(continued)... Ceiling collapse in
...(continued) system in place is not properly
(continued) exterior connecting corridor between vented and is to remain in place, initiate a project
buildings. (AL07-10)
to install vents in the exterior connecting corridors

between buildings. Facilities must develop station
level or NRM project plans. NRM projects plans
should be incorporated into the VISN NRM 2008
An approximately twenty foot section operating plans. VISNs should target correcting
of a plaster ceiling over an
these deficiencies by September 30, 2008.
exterior connecting corridor between
buildings collapsed and fell through
an existing suspended ceiling,
injuring two patients. The exterior
connecting corridor roof system was
approximately 57 years old and did
not have ridge or soffit vents. There
was no evidence that moisture from
recent rains was a factor; however,
the wire lathe and fasteners securing
the ceiling to the wood rafters and
ties showed advanced deterioration.
NCPS Alert AL07-10.pdf
211 of 578

5.11.14
Question:
VistAWeb may display a different

patients data than other open
desktop applications when using
TeleReader (AL07-11).
This problem is specific to the use of TeleReader

along with the VistAWeb application. TeleReader
is primarily used in VHA for telereading of retinal
images, but is also used at some sites for
teledermatology and teledentistry.
A VA Medical Center reported that

VistA Imaging patient data (retinal
images) from one patient were
displayed with a different patients
VistAWeb electronic chart when the
following conditions were met: 1.
CCOW-enabled applications of
TeleReader, VistAWeb, CPRS GUI,
and VistA Imaging were all open on
the same workstation and displaying
information for the same patient,
AND THEN 2. A patient selection
change was initiated from within
TeleReader. While the newly
selected patients image was
displayed in Vista Imaging, VistAWeb
was unable to change to the newly
selected patients data. Therefore,
providers did not have access to the
correct historical data (VistAWeb
electronic chart data) when viewing
patient data (e.g., progress notes, lab
results, images) in other applications.
This can lead to a delay in follow-up
care and subsequent disease
progression.
Met
(1)
Partially
Met (2)
Not
Action:
By close of business (COB) on Thursday,
September 13, 2007, inform optometrists,
dentists, dermatologists, and other clinicians
using TeleReader of this problem and instruct
them to immediately discontinue use of VistAWeb
if it is being used on the same workstation as
TeleReader (until the national patch is available to
fix this problem). Users will need to set CPRS to
use Remote Data Views (RDV) as the default
viewer for remote patient data. See Figure 1 (on
the following page) for instructions for selecting
RDV to view remote data in CPRS. If you have
any issues selecting RDV to view remote data,
contact your Clinical Application Coordinator
(CAC) for help.
NOTE: We discourage readers who have the
option of using a second workstation to set up
(continued)...
TelereaderAL07-11.pdf
212 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.14
(continued)... VistAWeb may display ...(continued) VistAWeb (without TeleReader) on
(continued) a different patients data than other
the second workstation. This puts the onus on the
open desktop applications when

using TeleReader (AL07-11).
user to switch to a new patient on the second

workstation each time a patient change is made
in TeleReader (on the first workstation) and
presents the same potential error that exists with
the current use of VistAWeb with TeleReader.
A VA Medical Center reported that

VistA Imaging patient data (retinal
images) from one patient were
displayed with a different patients
VistAWeb electronic chart when the
following conditions were met: 1.
CCOW-enabled applications of
TeleReader, VistAWeb, CPRS GUI,
and VistA Imaging were all open on
the same workstation and displaying
information for the same patient,
AND THEN 2. A patient selection
change was initiated from within
TeleReader. While the newly
selected patients image was
displayed in Vista Imaging, VistAWeb
was unable to change to the newly
selected patients data. Therefore,
providers did not have access to the
correct historical data (VistAWeb
electronic chart data) when viewing
patient data (e.g., progress notes, lab
results, images) in other applications.
This can lead to a delay in follow-up
care and subsequent disease
progression.
TelereaderAL07-11.pdf
213 of 578

Question:
5.11.15
Met
(1)
Partially
Met (2)
Not
Medtronic SynchroMed EL
As of June 15, 2007, Medtronic received 354
implantable infusion pump (AL08-01) inquiries/complaints from health care
professionals worldwide, regarding gear shaft
wear on the SynchroMed EL implantable drug
infusion pumps. Medtronic estimates that
Models: 8626-10, 8626L-10, 8626approximately 52,000 of these pumps, that may
18, 8626L-18, 8627-10, 8627L-10,
experience gear shaft wear, are still implanted in
8627-18, 8627L-18
patients worldwide. If a pump motor stall occurs,
drug delivery will stop abruptly without warning
and result in loss of therapy. Drug withdrawal
from Intrathecal Baclofen (ITB) therapy can be
Medtronic issued an Urgent Medical fatal if not treated properly and effectively.
Device Correction SynchroMed EL
Pump Motor Stall Due to gear Shaft
Wear in August 2007.
Actions:
1. If you have these devices in stock do not use
them.
2. By close of business (COB) Friday, October 26,
2007 identify all affected
steps a through c.
It is important that ALL INFORMATION sources
be reviewed to insure that
patients will not be overlooked, as affected
patients may be found on one list and not on
another.
a) Review the manufacturers letters (Attachment
1 and 2).
MedtronicSynchroMedAL08-01.pdf
b)
(continued)...
214 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.15
(continued)... Medtronic
...(continued) Review the VA physician/caregiver
(continued) SynchroMed EL implantable infusion list and their associated patients with an affected
pump (AL08-01)
device available from your Network (VISN)

Patient Safety Officer (PSO) and contact the
physician/caregiver to implement action 3 below.
Models: 8626-10, 8626L-10, 862618, 8626L-18, 8627-10, 8627L-10,

8627-18, 8627L-18
c) Review patient records for all other patients

with implanted Medtronic
SynchroMed EL devices affected by this recall
that might have been
Medtronic issued an Urgent Medical

Device Correction SynchroMed EL
Pump Motor Stall Due to gear Shaft
Wear in August 2007.
implanted at a non-VA facility and have their VA

physician/caregiver
implement action 3 below.
3. By close of business (COB) Friday, November
30, 2007 physicians/caregivers must follow
Patient Management Recommendations #1
through #4 contained in the manufacturers letters
(Alert Attachments 1 and 2) and reproduced
below:
Patient Management Recommendation #1

If a patient presents symptoms of underinfusion
or withdrawal, a clinician can confirm a pump
motor stall through a drug refill volume
discrepancy and x-ray pump roller study. If a
pump motor stall is confirmed, immediate
replacement of this pump is necessary for
continued intrathecal therapy.
MedtronicSynchroMedAL08-01.pdf
215 of 578

Question:
5.11.16
Met
(1)
Partially
Met (2)
Not
Sprint Fidelis Defibrillation Leads,

manufactured by Medtronic (AL0802)
The Sprint Fidelis leads are used to deliver

therapy in defibrillators, including Implantable
Cardioverter Defibrillators (ICD) and Cardiac
Resynchronization Therapy - Defibrillators (CRTD). More than 268,000 of the leads have been
implanted worldwide, and Medtronic and the FDA
Medtronic issued a recall of its Sprint estimate that fractures have occurred in less than
Fidelis leads, models 6930, 6931, 1 percent of the leads. Medtronic reports that lead
6948, and 6949 due to a potential for fractures may have contributed to five deaths.
fracture.
Actions:
1. By close of business (COB) Friday, October 26,
2007, materials management or cardiology staff
must remove affected leads from stock; these
leads should not be used.
2. By COB Friday, November 9, 2007,

electrophysiology/cardiology staff or other
appropriate parties must identify all affected
steps a through c and then implement action 3
below. It is important that ALL INFORMATION
sources be reviewed to insure that patients will
not be overlooked, as affected patients may be
found on one list and (continued)...
MedtronicSprintFidelisAL08-02.pdf
216 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.16
(continued)... Sprint Fidelis
...(continued) not on another.
(continued) Defibrillation Leads, manufactured by
Medtronic (AL08-02)
Medtronic issued a recall of its Sprint

Fidelis leads, models 6930, 6931,
6948, and 6949 due to a potential for
fracture.
a) Review the manufacturers letter (See Alert

Attachment 1).
National ICD Surveillance Center intranet website
(https://ICDPM.sanfrancisco.med.va.gov). (See
Alert Attachment 2.) This list combines patients
with affected leads who are already in the
Centers database with a list of VA patients
provided by Medtronic.
c) Review your patient records for all patients with
implanted Medtronic leads affected by this
notification that might have been implanted at a
non-VA facility.
3. By COB Friday, December 28, 2007, follow the

recommendations contained in Alert Attachment
2. This guidance was prepared by Dr. Edmund
Keung, Director of the VA National Surveillance
Center, and details the best course of action for
your patients.
MedtronicSprintFidelisAL08-02.pdf
217 of 578

5.11.17
Question:
Updated Haag-Streit reusable

tonometer tip (prism) reprocessing
instructions for U.S. customers (AL
08-03) ADDENDUM TO PATIENT
SAFETY ALERTS AL07-06 and
AL07-02
Haag-Streit has revised their reprocessing

instructions for their reusable tonometer tips to
also permit disinfection with a 10% aqueous
solution of sodium hypochlorite (household
bleach). The new instructions may be found in
Attachment 1 and at
http://www.newsmaker.ch/upload/customers/haag
streit/Disinfect_in_the_USA.pdf.
AL07-06 (ISSUED ON MARCH 7,

2007)
Haag-Streit has also revised the rinsing step in

their new instructions. Supplemental VHA
reprocessing instructions are also provided in
Alert Attachment 2.
AL07-08 (ISSUED OCTOBER 26,

2006)
Met
(1)
Partially
Met (2)
Not
CONCERNING REPROCESSING
OF REUSABLE TONOMETER TIPS
(PRISMS) USED TO MEASURE
INTRAOCULAR PRESSURE
TonometerTipsReprocessingAL08-03.pdf
218 of 578

Question:
5.11.18
Met
(1)
Partially
Met (2)
Not
Model 8100 infusion pump modules

shipped before September 27, 2007;
a component of the Alaris Medley
infusion pump system, distributed by
Cardinal Health (AL08-04)
The springs can be missing, bent or broken,

risking medication over-infusion. Cardinal Health
identified 5,560 units of the model 8100 module
at 30 VA Medical Centers and sent notices to
Biomedical Engineering, Materials Management,
Nursing and Risk Management via certified letter.
Cardinal Health is establishing teams to visit each
hospital and arrange for definitive testing of all
Cardinal Health reports that some of modules that is expected to be completed over
the 8100 pump modules may have
the next several months. The only definitive test
misassembled occluder springs.
is an x-ray of each module to examine the
occluder springs.
Actions:
1. By close of business (COB) on Friday,

December 7, 2007:
a. If you have Alaris Medley pumps and have not
received notification from
Cardinal Health, check Attachment 1 to see if
your facility is affected.
b. If your facility is affected and did not receive
Cardinal Healths customer
letter (Attachment 2), contact Cardinal Health at
(800) 625-6627 and the VA Center for
Engineering and Occupational Safety & Health
(CEOSH).
Alaris8100AL08-04.pdf
219 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.18
(continued)... Model 8100 infusion
(continued) pump modules shipped before
...(continued) possible, arrange to send modules

not currently in use to Cardinal Health for x-ray
September 27, 2007; a component of testing. Cardinal Health will bear the cost of
the Alaris Medley infusion pump
shipping and testing. Ensure you have enough
system, distributed by Cardinal
infusion pumps and modules on hand for use
Health (AL08-04)
before sending modules to Cardinal Health for xray.
Cardinal Health reports that some of
the 8100 pump modules may have
3. Monitor the modules impacted by this
misassembled occluder springs.
notification for potential inaccurate
flow. If you suspect inaccurate flow with a
particular device, remove the
device from service and contact Cardinal Health
at (800) 854-7128 (select
option 3) to arrange for a device failure
investigation.
Alaris8100AL08-04.pdf
220 of 578

5.11.19
Question:
Positive displacement, needle-free

intravascular connector valves (AD08-01)
Recent published literature suggests the

possibility of increased BSI
Met
(1)
Partially
Met (2)
Not
rates associated with some positive

displacement, needle-free
A VAMC reports their blood stream
infection (BSI) rates increased in
intravascular connector valves. (See Addl.

Information below.)
2005 and 2006 when compared to

their BSI rates before 2005. The
Suggestions:
increase coincides with use of lueractivated mechanical valves and
positive displacement, needle-free
intravascular connector valves.
1) If you are considering a switch to positive

displacement, needlefree
intravascular connector valves for central venous
catheters or
PICC (Peripherally Inserted Central Catheter)
lines, please consider
the published literature cited below in the Addl.
Information section
before making a decision.
2) If you have already begun to use positive
displacement, needlefree
intravascular connector valves for central venous
catheters or
PICC lines, please review your BSI rates before
and after the change.
NeedlelessValvesAD08-01.pdf
NOTE:
If you have experienced a change in the
221 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.19
(continued)... Positive displacement, ...(continued) (734) 930-5890 or via email at
(continued) needle-free intravascular connector
valves (AD-08-01)
Judith.Anderson4@va.gov.
3) Always follow manufacturers latest instructions
on the safe use of
A VAMC reports their blood stream

infection (BSI) rates increased in
2005 and 2006 when compared to
their BSI rates before 2005. The
their devices; ensure that training has occurred,

and there is
demonstrated competency.
increase coincides with use of lueractivated mechanical valves and

positive displacement, needle-free
intravascular connector valves.
NeedlelessValvesAD08-01.pdf
222 of 578

Question:
5.11.20
Met
(1)
Partially
Met (2)
Not
Potential for medication errors due to Both problems can occur when a pharmacist is
VistA Patch PSJ*5.0*175
processing orders for a
patient currently receiving multiple medications
within the same drug class.
Two patient safety vulnerabilities
were identified following the
installation of
The processing pharmacist will receive a

Duplicate drug class order
VistA Pharmacy patch PSJ*5.0*175 check message. The pharmacist is prompted to

released on October 25, 2007. These discontinue one or more
vulnerabilities can occur when a
Pharmacist is processing a
medication
order.
of the possible duplicate medications (see Alert

Attachment A). If the
pharmacist enters YES to the prompt, instead of
accepting the defaulted
1. Two VA Medical centers report that NO value, then for the first problem above, the
a Unit Dose dispensed drug did not medication dispensed may not be the same as
the medication prescribed.
match the Unit Dose ordered drug.
This problem is not easily detected.
It can result in drug B being
dispensed when drug A was
ordered, if
the patient has both drug A and
drug B as current orders and both
drugs are in the same therapeutic
category.
2. Two VA Medical Centers report
deletion of past IV order data in the
Actions:
1. Immediately notify pharmacists of this Patient
Safety Alert and advise
them to reply NO to the prompt Do you wish to
DISCONTINUE any of
the listed orders?, if they are processing an order
via [PSJ OE] Inpatient
Order Entry or [PSJI ORDER] Order Entry (IV).
(See Alert Attachment A)
VistAPatchPSJAL08-05.pdf
223 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.20
...(continued) Immediately notify Information
(continued)... Potential for
(continued) medication errors due to VistA Patch Technology (IT) service to:
PSJ*5.0*175
a. Do NOT back out VistA patch PSJ*5.0*175.
Emergency patch
Two patient safety vulnerabilities
were identified following the
installation of
PSJ*5.0*201 is planned for release the week of

December 10,
2007, to restore pre-PSJ*5.0*175 state. This

VistA Pharmacy patch PSJ*5.0*175 emergency patch
released on October 25, 2007. These
must be installed immediately upon release.
vulnerabilities can occur when a
b. Identify the source of your facilitys Bar Code
Pharmacist is processing a
Medication
medication
order.
Administration (BCMA) backup contingency

software. If the
1. Two VA Medical centers report that

a Unit Dose dispensed drug did not software is NOT the nationally released
BarCodeBackUp
match the Unit Dose ordered drug.
This problem is not easily detected. (BCBU), notify BCMA users that the Medication
Administration
It can result in drug B being
dispensed when drug A was
Record (MAR) and/or Medication Administration
ordered, if
History (MAH)
the patient has both drug A and
drug B as current orders and both
may not be complete.
drugs are in the same therapeutic

category.
2. Two VA Medical Centers report
deletion Priority
Mandatory;
of past
A IV order data in the
VistAPatchPSJAL08-05.pdf
224 of 578

5.11.21
Question:
FDA CLASS II recall of Boston

Scientific Corporations Cardiac
Rhythm Management Division
(previously called Guidant)
Implantable Cardiac Defibrillators
(ICDs) and Cardiac
Defibrillators (CRT-Ds). (AL08-06)
Actions:
NOTE: Some models addressed in

this Alert also appear in Patient
Safety Alert AL07-07 issued on April
18, 2007. This Alert provides new
information addressing a new battery
problem.
Met
(1)
Partially
Met (2)
Not
1.Within 14 calendar days of the issuance of this

Alert, electrophysiology/cardiology staff or other
appropriate caregivers must identify all affected
patients by implementing both of the following
steps a and b. It is important that ALL
found on one list and not on another.
a) Retrieve and review a list of your patients with

the affected devices (ICDs and CRT-Ds) on the
VA National ICD Surveillance Center intranet
website (https://icdpm.sanfrancisco.med.va.gov,
see Attachment 3 for instructions). This list
consists of all the patients in Guidants database
that have implanted devices affected by this and
A subset of the following Guidant ICD previous recalls (some devices are affected by
more than one recall).
and CRT-D device models have a
buildup of internal battery impedance
that may lengthen ICD and CRT-D
charge times and display the Elective with implanted Guidant devices affected by this
Replacement Indicator (ERI) or End recall.
of Life Indicator (EOL) even though
battery voltage and capacity remain
available. This issue can result in
2. Within the next 90 calendar days of the
delayed delivery of shock therapy.
issuance of this Alert, follow the actions contained
in (continued)...
Device Model Name
Numbers
Model
GuidantBSCI-ICDsCRTsAlert-AL08-06-VAWW.pdf
225 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.11.21
(continued)... FDA CLASS II recall of ...(continued) Attachment 2. This guidance was
(continued) Boston Scientific Corporations
prepared by Dr. Edmund Keung, Director of the

Division (previously called Guidant)
Implantable Cardiac Defibrillators
(ICDs) and Cardiac
Defibrillators (CRT-Ds). (AL08-06)
NOTE: Some models addressed in

this Alert also appear in Patient
Safety Alert AL07-07 issued on April
18, 2007. This Alert provides new
information addressing a new battery
problem.
VA National ICD Surveillance Center, as the best

course of action for your patients.
NOTE: Because the incidence rate is very low

and prolongation of charge time and ERI/EOL
can be identified by close monitoring (see
information contained within the Attachments
below), prophylactic replacement of the devices is
not recommended.
A subset of the following Guidant ICD

and CRT-D device models have a
buildup of internal battery impedance
that may lengthen ICD and CRT-D
charge times and display the Elective
Replacement Indicator (ERI) or End
of Life Indicator (EOL) even though
battery voltage and capacity remain
available. This issue can result in
delayed delivery of shock therapy.
Device Model Name

Numbers
Model
GuidantBSCI-ICDsCRTsAlert-AL08-06-VAWW.pdf
226 of 578

5.12.1
Question:
Implant orientation of Implantable

Cardioverter Defibrillators (ICDs) and
Cardiac Resynchronization Therapy
Devices (CRT-Ds) manufactured by
Boston Scientific Corporations
Division, previously under the name
Guidant (AL08-08)
Actions:
Met
(1)
Partially
Met (2)
Not
1. By Close of Business (COB) April 30, 2008,

electrophysiology and/or
cardiology staff or other appropriate caregivers
must identify all affected
patients by implementing steps a, b, c and step d

A subset of the following Guidant
if indicated. It is important that ALL
ICDs and CRT-Ds models implanted INFORMATION sources be reviewed to insure
in a
found on one list and not on another.
specific location and in an
uncommon orientation - beneath the a) Retrieve and review a list of your patients with
pectoral muscle with the serial
the affected devices
number facing the ribs - may be
subject to component damage and
(ICDs) on the VA National ICD Surveillance
device malfunction. This can impact Center intranet website
the devices ability to deliver
appropriate shock therapy.
(https://icdpm.sanfrancisco.med.va.gov, see
Attachment 3 for instructions.
May 12, 2006 Poplation
This list includes all the patients in Guidants
Device Model Name
database that have implanted
Model Numbers
devices affected by this and previous recalls
Contak Renewal 3 & 3 HE
(some devices are affected by
H170/H173/H175/H177/H179
more than one recall).
Contak Renewal 3 AVT & 3 AVT HE
M150/M155/M157/M159
with implanted Guidant
H190/H195/H197/H199
Mandatory;
Priority A
devices affected by this recall.
GuidantBSCIICDsCRTsAlertAL08-07.pdf
227 of 578

Question:
5.12.1
(continued)... Implant orientation of
(continued) Implantable Cardioverter
Defibrillators (ICDs) and Cardiac

Resynchronization Therapy Devices
(CRT-Ds) manufactured by Boston
Scientific Corporations Cardiac
Rhythm Management Division,
previously under the name Guidant
(AL08-08)
Met
(1)
Partially
Met (2)
Not
...(continued) identified in steps a and b above, to

determine if devices location and orientation are
verifiable. If device
location or orientation is not verifiable or a postimplant CXR is not
available then proceed to step d. If device
orientation is verified as beneath the pectoral
muscle with the serial number facing the ribs then
proceed to Action 2 below.
A subset of the following Guidant

d) Contact the patients identified at step c above
ICDs and CRT-Ds models implanted (those with device
in a
orientation or location not verifiable) to have an
Anterior/Posterior (AP)
specific location and in an
uncommon orientation - beneath the
pectoral muscle with the serial
Chest x-ray to determine/verify specific device
orientation or to have a
number facing the ribs - may be
subject to component damage and
device malfunction. This can impact physical examination of the implant area to best
the devices ability to deliver
determine the location of
appropriate shock therapy.
the device.
May 12, 2006 Poplation
Device Model Name
Model Numbers
H170/H173/H175/H177/H179
2. Review and plan appropriate action as

discussed in Attachment 2 prepared by Dr.
Edmund Keung, Director of the VA National ICD
Surveillance Center.
Contak Renewal 3 AVT & 3 AVT HE

M150/M155/M157/M159
Mandatory;Renewal
Contak
Priority A
4 & 4 HE
GuidantBSCIICDsCRTsAlertAL08-07.pdf
228 of 578

5.12.2
Question:
VistA Anesthesia and Nurse

Interoperative Report patch
TIU*1.0*215, released June 28,
2007. (AL08-08)
VistA patch TIU*1*236 was subsequently

released on November
Met
(1)
Partially
Met (2)
Not
15, 2007 to restore the VistA Surgical Notes and

addendum
function to the pre-TIU*1*215 state. As of

A VHA VISN reports that VistA patch November 20, 2007, all
TIU*1.0*215 has not been
VA Medical Facilities have installed TIU*1*236.
creating addendums when either the
Anesthesia or Nurse
Intraoperative Report is edited via
Surgery case editors [e.g. OSS
Operation (Short Screen)]. If
changes were made by Surgery
personnel to surgical data via the
Surgery case editor, such as
Actions:
1. By Close of Business (COB) February 15,

2008 review
Attachment 1, the list of facilities that installed
VistA patch
ESU Coagulation Range or

coagulation therapy changes,
TIU*1*215.
addended data is not available for

viewing via the Surgery tab in
a. If your facility/healthcare system is listed in

Attachment 1,
CPRS, resulting in inaccurate

surgery information.
execute Actions 2, 3 and 4.

b. If your facility/healthcare system is not on the
list, execute
Action 2 only.
VistAPatchTIU1215AL08-08.pdf
229 of 578

Question:
5.12.2
(continued)... VistA Anesthesia and
(continued) Nurse Interoperative Report patch
TIU*1.0*215, released June 28,

2007. (AL08-08)
Met
(1)
Partially
Met (2)
Not
...(continued) (or their designees) in a formal

letter (see
sample letter in Alert Attachment 2).
A VHA VISN reports that VistA patch 4. By COB April 30, 2008, the Chief of Anesthesia
TIU*1.0*215 has not been
(or their
creating addendums when either the designee) and the Operating Room Supervisor
Anesthesia or Nurse
(or their designee)
Intraoperative Report is edited via
Surgery case editors [e.g. OSS
must compare Anesthesia notes and Nurse

Intraoperative Reports
Operation (Short Screen)]. If

changes were made by Surgery
respectively, with CPRS Surgical Note(s). VistA

patch TIU*1*231
personnel to surgical data via the

Surgery case editor, such as
provides software tools to assist with the process.

If the
ESU Coagulation Range or

coagulation therapy changes,
discrepancy contains significant clinical data,

facilities must
addended data is not available for

viewing via the Surgery tab in
reconcile the information and follow

documentation provided within
CPRS, resulting in inaccurate

surgery information.
the TIU*1*231 patch description to correct the

missing addendums.
If the discrepancy was caused by VistA patch
TIU*1.0*215,
information in the surgical case editors is
probably the most recent
VistAPatchTIU1215AL08-08.pdf
230 of 578

Question:
5.12.3
Met
(1)
Partially
Met (2)
Not
Baxter - Allergic Reactions to Heparin A possible link to severe allergic reactions has
Sodium (AL08-09)
been associated with the use of Baxter multiple
dose heparin vials and single dose vials. 40% of
the cases are estimated as serious, based on
preliminary and ongoing review. The number of
The Food and Drug Administration
reports seen in the past two months is a marked
(FDA) announced on February 11,
increase from the number of reports associated
2008, that since December 2007,
with heparin use normally received. Since the
Baxter and FDA have received 350
January 17, 2008, recall, Baxter has also
reports of adverse reactions to
received similar reports of adverse patient
heparin dispensed from Baxter multi reactions occurring in other lots of 1,000 units/ml,
dose vials. On January 17, 2008,
10 ml and 30 ml multi-dose vials, 5,000 units/ml
Baxter issued a recall of 9 specific
and 10,000 units/ml multi-dose vials and 5,000
heparin lots (see affected lots listed units/ml single-dose vials when single doses were
under Action 1 below). The increase combined to create a larger bolus dose. The
in adverse events was reported in
increase in reported adverse reactions has
patients receiving high bolus doses primarily occurred when used in the following
of heparin. Adverse events reported clinical settings:
include: allergic or hypersensitivitytype reactions, with symptoms of oral Hemodialysis
swelling, nausea, vomiting, sweating,
shortness of breath, and cases of
Invasive cardiovascular procedures (cardiac
severe hypotension requiring
valvular surgery,
treatment. Most events develop
within minutes of heparin initiation,
coronary artery bypass graft (CABG) surgery,
although the possibility of a delayed carotid
response has not been excluded.
endarterectomy and cardiac catheterization);
(continued)...
HeparinAlert08-09.pdf
231 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.12.3
(continued)... Baxter - Allergic
...(continued) Apheresis procedures (photo and
(continued) Reactions to Heparin Sodium (AL08- plasma)
09)
The Food and Drug Administration

(FDA) announced on February 11,
2008, that since December 2007,
Baxter and FDA have received 350
reports of adverse reactions to
heparin dispensed from Baxter multi
dose vials. On January 17, 2008,
Baxter issued a recall of 9 specific
heparin lots (see affected lots listed
under Action 1 below). The increase
in adverse events was reported in
patients receiving high bolus doses
of heparin. Adverse events reported
include: allergic or hypersensitivitytype reactions, with symptoms of oral
swelling, nausea, vomiting, sweating,
shortness of breath, and cases of
severe hypotension requiring
treatment. Most events develop
within minutes of heparin initiation,
although the possibility of a delayed
response has not been excluded.
There have been isolated reports of reactions

with other forms of heparin including premixed
bags.
Actions:
1. By close of business (COB) February 20, 2008,
Pharmacy Chiefs will assure that the following 9
lots of Baxter multi-dose heparin vials are
removed from inventory, segregated and
returned. Use the following link for information on
returning affected product.
Recall Update - Baxter HealthCare - Heparin

Inj.doc
See Attached Alert for affected vials and lot

numbers.
2. Baxter has stopped manufacturing multi-dose

heparin vials; therefore, use alternative
manufacturers of multi-dose heparin when
available until further notice.
HeparinAlert08-09.pdf
232 of 578

5.12.4
Question:
Expanded Recall of Baxter Heparin

Products, AL08-10
This Patient Safety Alert supplements Patient

Safety Alert AL08-09 (PSAT question 5.12.3). Any
future updates relating to the original or expanded
Baxter heparin recalls will be communicated
through the National Center for Patient Safetys
Patient Safety Log.
Baxter initially recalled nine lots of

multi-dose heparin sodium injection
products (e.g., vials, syringes) on
January 17, 2008. This recall has
now been expanded to include the
following products:
all remaining lots of Baxter multidose heparin sodium injection
products,
all lots of Baxter single-dose
heparin sodium injection products,
and
Partially
Met (2)
Not
Actions:
By close of business Saturday March 1, 2008:

1. Implement the Actions in Patient Safety Alert
AL08-09, if not already completed.
all lots of Baxter heparin flush

products.
2. Pharmacy Chiefs (or designee) must assure

that the following products are removed from
inventory, segregated and returned to the
supplier:
NOTE: This recall does not involve

Baxter's heparin pre-mix IV solutions
in bags (heparin sodium in 5%
dextrose injection and heparin
sodium in 0.9% sodium chloride
injection).
a) all remaining lots of Baxter multi-dose heparin

sodium injection
ExpandedBaxterHeparinAL08-10.pdf
Met
(1)
products
b) all lots of Baxter single-dose heparin sodium
233 of 578

5.12.5
Question:
STERIS C1160 Universal Flexible

Processing Trays used with the
STERIS System 1 Sterile Processing
Systems (AL08-11)
STERIS identified this issue internally during

quality control procedures; STERIS indicated
there have been no adverse incidents reported
from facilities regarding this issue. It is possible,
however, that devices (e.g., endoscopes,
esophageal dilators) sterilized in the STERIS
System 1 with C1160 trays may not have been
adequately sterilized. Additional diagnostic cycles
recommended by STERIS will ensure the
processor is operating within acceptable limits.
Met
(1)
Partially
Met (2)
Not
STERIS Corporation issued an

Urgent Recall Notice about the
design/operation of the C1160
universal flexible processing tray that
may compromise the ability of the
STERIS System 1 Sterile Processor
to provide an effective sterilization
Prior to STERIS Urgent Recall Notice, STERIS
cycle when the C1160 tray is used.
operating instructions indicated that a diagnostic
cycle is only required to be run once every 24
hours. Since the discovery that the C1160 tray
may compromise the ability of the STERIS
NOTE: This Patient Safety Alert
System 1 to provide an effective sterilization cycle
applies to all STERIS System 1
when the C1160 tray is used, STERIS is now
models and
indicating that, in addition, diagnostic cycles be
run after each C1160 tray is processed in the
all serial numbers of C1160 trays.
STERIS System 1.
This Patient Safety Alert does not
apply
to C1200, C1220, or C1140 trays.
Actions:
Chief of SPD (or designee) will ensure the
following actions are carried out (continued)...
SterisSystemIAlertAL08-11.pdf
234 of 578

Question:
5.12.5
(continued)... STERIS C1160
(continued) Universal Flexible Processing Trays
Met
(1)
Partially
Met (2)
Not
...(continued) by close of business Friday, March

14, 2008:
used with the STERIS System 1

Sterile Processing Systems (AL0811)
1. Reprocessing personnel who utilize the
STERIS System 1 must read this
STERIS Corporation issued an
Urgent Recall Notice about the
design/operation of the C1160
universal flexible processing tray that
may compromise the ability of the
STERIS System 1 Sterile Processor
to provide an effective sterilization
cycle when the C1160 tray is used.
Patient Safety Alert and the attachments.

NOTE: Be sure to identify all areas in your facility
that have STERIS
System 1 Processing Systems that may include,
but are not limited
to the following: Ambulatory Surgery, Endoscopy,
GI, GU, OR,
NOTE: This Patient Safety Alert

applies to all STERIS System 1
models and
Respiratory, SPD, and Urology.
all serial numbers of C1160 trays.

This Patient Safety Alert does not
apply
2. If possible, discontinue the use of STERIS

C1160 trays with the STERIS
to C1200, C1220, or C1140 trays.
System 1 until STERIS is able to correct the

problem at your facility. (STERIS began field
correction on March 7, 2008.) Use alternative
trays in the meantime to sterilize your devices.
NOTE: The alternative trays must be suitable for
use with the
particular device(s) to be reprocessed and with
the STERIS System 1
SterisSystemIAlertAL08-11.pdf
235 of 578

Question:
5.12.6
Met
(1)
Partially
Met (2)
Not
Free-text patient allergy entries in the Earlier versions (prior to December 2003) of the
Computerized Patient Record
VistA Adverse Reaction
System (CPRS) (AL08-12)
Tracking (ART) and CPRS software allowed
users to enter free-text patient
Free-text allergy entries in CPRS do
not generate automatic drug-allergy
allergies. Since 2003, ART and CPRS no longer

permit entry of free-text
order checks necessary for effective

medication management. Patients
with
allergies. In June 2007, a software utility

(GMRA*4*29) was provided to
automate mapping of existing free-text patient

a known allergy may be administered allergy entries to standard
a medication or served a food
product for which they could have a entries. Remaining free text allergy entries were
severe reaction.
either too ambiguous to be reliably mapped, or
may contain multiple reactants.
Actions:
1. By close of business (COB), March 26, 2008,
pharmacy ADPACs (or
designees) must:
a) run the VistA option Allergy clean up utility
within the VistA
Adverse Reaction Tracking Managers menu to
obtain a list of
free-text allergy entries (see Step 1 of Attachment
2 for
FreeTextAllergiesAlertAL08-12.pdf
236 of 578

Question:
5.12.6
(continued)... Free-text patient
(continued) allergy entries in the Computerized
Patient Record System (CPRS)

(AL08-12)
Free-text allergy entries in CPRS do

not generate automatic drug-allergy
order checks necessary for effective
medication management. Patients
with
Met
(1)
Partially
Met (2)
Not
...(continued) facilities must submit an initial

report - even those
with negative reports (i.e., those facilities with
zero free-text
allergy entries). If your facilitys report is negative,
no further
action is required after submitting your negative
report. If your
facilitys report is positive (i.e., contains free-text
allergy
a known allergy may be administered

a medication or served a food
entries), then proceed to actions 2 and 3 after
product for which they could have a submitting your
severe reaction.
positive report.
2. By COB, June 20, 2008, Pharmacy ADPACs

(or designees) must ensure
all remaining free text allergy entries are resolved.
See Attachment 2 for
detailed instructions for resolving free-text allergy
entries. ADPACS (if
they are not Pharmacists) will need to work with
Pharmacists and use
clinical judgment to resolve free-text allergy
entries by either:
FreeTextAllergiesAlertAL08-12.pdf
237 of 578

5.12.7
Question:
Improper reprocessing of flexible

endoscope biopsy valves (AL08-13)
The caps of the semi-disposable biopsy valves

were not opened up (see the figures in Alert
Attachment 1), and hence were not cleaned,
brushed, and disinfected or sterilized according to
the manufacturers instructions. This resulted in
the presence of bioburden on the semidisposable
Met
(1)
Partially
Met (2)
Not
A VA medical center noted that their

semi-disposable (i.e., reusable to an
extent; limited use) biopsy valves
biopsy valves. The facility has since switched to
(Olympus part number MB-358) for use of disposable biopsy
their colonoscopes (Olympus Model
CF-180AL) and esophago-gastrovalves for their flexible endoscopes.
duodeno (EGD) scopes (Olympus
Model GIF-H180) were not being
reprocessed properly.
NOTE: While the Specific Incident section
references a specific
manufacturers flexible endoscopes and biopsy
valves, THIS PATIENT
SAFETY ALERT APPLIES TO ALL
COLONOSCOPES, EGD, AND
ULTRASOUND SCOPES THAT HAVE BIOPSY
VALVES,
REGARDLESS OF MANUFACTURER OR
MODEL.
Biopsy valves cover the biopsy port of flexible

endoscopes used for various
endoscopic procedures. While disposable biopsy

valves are most often used for bronchoscopes,
other flexible endoscopes (e.g., colonoscopes,
FlexibleEndoscopeBiopsyValvesAL08-13.pdf
238 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.12.7
(continued)... Improper reprocessing ...(continued) biopsy valves. The reusable biopsy
(continued) of flexible endoscope biopsy valves valves must be opened up for cleaning and
(AL08-13)
A VA medical center noted that their

semi-disposable (i.e., reusable to an
extent; limited use) biopsy valves
(Olympus part number MB-358) for
their colonoscopes (Olympus Model
CF-180AL) and esophago-gastroduodeno (EGD) scopes (Olympus
Model GIF-H180) were not being
reprocessed properly.
reprocessed according to the flexible endoscope

manufacturers instructions.
Actions:
Chief of SPD (or designee) must ensure the
following actions are carried out by close of
business Tuesday, April 8, 2008:
1. All personnel who reprocess flexible

endoscopes have read this Patient
Safety Alert and the attachment.
NOTE: Ensure you have identified all areas in
your facility that
reprocess flexible endoscopes, which may
include, but are not
limited to the following: Ambulatory Surgery,
Endoscopy, GI,
GU, OR, Respiratory, SPD, Urology, and Clinics
to include
CBOCs.
FlexibleEndoscopeBiopsyValvesAL08-13.pdf
2.
As requested by VA Central Office, in an email
239 of 578

5.12.8
Question:
Collimator screws on x-ray systems

manufactured by Philips Medical,
collimator models 9896 010 00612,
9896 010 00614, and 9896 010
00615 used on the Bucky Diagnot,
Digital Diagnost, Easy Diagnost, and
Thorovision x-ray systems. (AL08-14)
The manufacturer issued an Urgent Device

Correction
Met
(1)
Partially
Met (2)
Not
(Alert Attachment 1) about collimator screws

securing the collimator to
the stand in the models listed above where they
may become
loose and fall out. If the screws fall out, there is a
small chance
the collimator could fall from the x-ray stand,
placing patients and
employees at risk, although no incidents of this
type have been
reported.
Philips Medical is upgrading affected systems as

quickly as
possible, to be completed by October 2008.
Actions:
If your facility is affected and you have not

already done so:
PhilipsCollimatorScrewsAL08-14.pdf
240 of 578

Question:
5.12.9
Met
(1)
Partially
Met (2)
Not
Topcon IMAGEnet DICOM Interface This can happen when the local Topcon hard
2 Retinal Image Acquisition Systems drive is filled to capacity
distributed by Topcon Medical
Systems. (AL08-15)
with imaging studies, and the operator uses
Microsoft Windows Explorer instead of the
IMAGEnet copy/delete window to manage
images. Deleting images with Windows Explorer,
VA sites report patient identification rather than using the Topcon IMAGEnet
errors during image transmission
copy/delete, can result in incorrect association
from
between patient retinal images and patient
demographics. Incorrect information will be
Topcon IMAGEnet DICOM interface displayed in CPRS/VistA Imaging viewers.
2 Retinal Imaging Workstations to
VistA
Imaging.
Actions:
All Topcon operators will immediately employ the

following standard operating procedures:
1. Topcon IMAGEnet tools will be used at all
times to manage images on Topcon systems;
Windows Explorer may not be used.
2. All images will be deleted from local Topcon

hard drives once verification of successful DICOM
transmission to VistA Imaging occurs.
a) Operators must view the imaging study in VistA
Imaging and verify
that it belongs to the patient being imaged in that

session.
TopconImagenetAL08-15.pdf
241 of 578

Question:
5.12.9
(continued)... Topcon IMAGEnet
(continued) DICOM Interface 2 Retinal Image
Met
(1)
Partially
Met (2)
Not
...(continued) failure that prevents transmission
Acquisition Systems distributed by

of images from the local Topcon IMAGEnet
Topcon Medical Systems. (AL08-15) Workstation to the VistA
Imaging gateway, images may reside on the local
Topcon workstation
VA sites report patient identification
errors during image transmission
from
Topcon IMAGEnet DICOM interface
2 Retinal Imaging Workstations to
VistA
Imaging.
temporarily. Once transmission ability is restored,

images must be
transmitted and deleted. Under no circumstance
should images greater
than seven days old remain on the Topcon
Workstation.
3. All Topcon IMAGEnet devices must be

upgraded to version 2.11 as soon as the software
is released.
TopconImagenetAL08-15.pdf
242 of 578

5.12.10
Question:
Alaris model 8000 infusion pumps;

Alaris models 8100, 8110, 8120
infusion modules; Alaris models
8210, 8220 SpO2 modules. These
devices
Affected componets are:
Met
(1)
Partially
Met (2)
Not
1. Gray Interface connectors (two per unit) on the

8000, 8100, 8110, 8120
and 8220 manufactured before March 16, 2004.
are manufactured by Cardinal

Health. (AL08-16)
2. U9 socketed Integrated Circuit (IC) on the 8110

and 8120 display
boards manufactured before October 25, 2005.

The components on the devices can
fail resulting in a channel
3. U19 socketed IC on the 8100 module logic
boards manufactured before
error that will shut down infusion or
monitoring and activate audio and
September 8, 2005.
visual alarms.
Note: Alaris will provide replacements free of
charge. They will also replace the components on
any units they receive for the ongoing Occluder
Spring Recall.
Actions:
1. By close of business June 27, 2008 determine

if affected items are in the
facility inventory. If yes, notify caregivers and
continue using the devices
AlarisComponentsAL08-16.pdf
as
necessary but ensure that an appropriate
243 of 578

Question:
5.12.10
(continued)... Alaris model 8000
(continued) infusion pumps; Alaris models 8100,
8110, 8120 infusion modules; Alaris

models 8210, 8220 SpO2 modules.
These devices
are manufactured by Cardinal
Health. (AL08-16)
Met
(1)
Partially
Met (2)
Not
...(continued) for clinical use.

a. Connectors acquire and replace all affected
connectors.
b. U9 and U19 ICs acquire and replace all
affected circuit boards.
The components on the devices can

fail resulting in a channel
error that will shut down infusion or
monitoring and activate audio and
visual alarms.
AlarisComponentsAL08-16.pdf
244 of 578

Question:
5.12.11
Met
(1)
Partially
Met (2)
Not
Voicemail greetings for mental health Because it is possible to bypass facility

staffs desk and/or VA issued cell
switchboard greetings by
phones. (AD08-03)
entering extensions or dialing direct to staff,
veterans may directly
A VHA VISN reports that veterans left reach phones for mental health staff that are not
messages on phones assigned
manned 24 hours a
to mental health staff only to
attempt/complete suicide prior to
mental
health staffs ability to return the
calls.
day/7days a week. If those phones are not

answered, it is imperative
that the veteran hear instructions for making
emergency contact with
either 911 or the Suicide Prevention Hot Line.
Recommendations:
1. VA issued cell phones (including Blackberry)

and desk phones
assigned to mental health staff should include
standard elements
for their activated voice mail message as
illustrated by this example
voicemail greeting:
You have reached the phone of [insert name,
title]. If this is a
VoiceMailAdvisoryAD08-03.pdf
245 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.12.11
(continued)... Voicemail greetings for ...(continued) leave a brief message and I will
(continued) mental health staffs desk and/or VA return your call when I am able during normal
issued cell phones. (AD08-03)
business hours
A VHA VISN reports that veterans left 2. Personal cell phone numbers should not be
messages on phones assigned
given to patients. If
to mental health staff only to
attempt/complete suicide prior to
mental
health staffs ability to return the
calls.
they have been given out, the standard voicemail

greeting should
be applied until all patients who received the
number have been given
more appropriate contact phone numbers
VoiceMailAdvisoryAD08-03.pdf
246 of 578

5.12.12
Question:
Monitor ceiling suspensions with

motorized height movement used
with X-ray systems manufactured by
Philips Medical Systems. (AL08-17)
There were no injuries and cables prevented it

from falling to the floor. While Philips believes it is
highly unlikely this will occur again, they will be
sending service personnel to sites to eliminate
this risk starting this month. Philips has identified
32 VA facilities affected by this issue; the full
notice is attached to this Alert.
Met
(1)
Partially
Met (2)
Not
Philips reports that a ceiling mounted

monitor used with an x-ray system
fell from the ceiling suspension
system.
Actions:
Until Philips implements the Field Change Order

(FCO),
1. By close of business July 18, 2008 review the

attached list of sites/units
to determine if you are affected. If affected, inform
all users about the
following recommendations.
a. Do not place the monitor over the patient
b. Avoid unnecessary carriage movement
c. Do not stand under or near the carriage.
2. If, during use of the carriage, users find

abnormal carriage behavior
PhilipsMonitorCeilingSuspensionAL08-17.pdf
247 of 578

5.12.13
Question:
Power supply on Lionville Systems

mobile computing products, iPoint
and iMed, manufactured before May,
2007. (AL08-18)
Although the incident rate is low, Lionville

recommends that facilities with units
manufactured before May 2007 contact them for
a free upgrade to the Lionville Power Solution
(LPS). This upgrade adds a thermal cutoff switch
to the power inverter to prevent the possibility of
overheating.
Met
(1)
Partially
Met (2)
Not
A VA facility reports overheating of

the medication cart with smoke
emitted from the unit.
Action:
1. If your facility is on the list of sites with units

manufactured before
May 2007 (See Alert Attachment 1), contact
Lionville Technical Services by
close of business August 15, 2008.
2. Schedule an upgrade of the LPS for each unit

with the Lionville
Technical Services Manager, Dave Moyer at 1800-523-7114,
Extension 253.
LionvilleCartPowerSupplyAL08-18.pdf
248 of 578

Question:
5.12.14
Met
(1)
Partially
Met (2)
Not
Peripheral Blood Pressure and Blood This was the subject of Patient Safety Advisory
Glucose Measurement Devices
AD08-02, released June
connected to Health Hero, Viterion,
VitelNet and American Telecare Inc. 5, 2008 (Alert attachment). Because the
permanent solution referenced in the Advisory
(ATI) Home Telehealth Appliances
has not yet materialized, this item has now been
(AL08-19)
raised to the
level of a Patient Safety Alert with required
actions.
Several VA sites report incorrect
date/time stamping from peripherally
connected blood pressure
measurement devices and blood
glucose measurement devices that is
automatically uploaded into the
Home
Telehealth appliance.
If the correct date/time is not manually entered

into the peripheral measurement device when the
battery is depleted or changed, the device will
default to an incorrect date/time that is then
uploaded by the Home Telehealth appliance and
transmitted to the care coordinator. There is
currently no consistent automatic way to set
accurate date/time in the peripheral measurement
devices.
There is no problem currently identified with data

entered directly by
patients via manual entry into the Home
Telehealth Appliances.
Action:
CCHTPeripheralDevicesAL08-19.pdf
249 of 578

Question:
5.12.14
(continued)... Peripheral Blood
(continued) Pressure and Blood Glucose
Measurement Devices connected to

Health Hero, Viterion, VitelNet and
American Telecare Inc.
(ATI) Home Telehealth Appliances
(AL08-19)
Several VA sites report incorrect

date/time stamping from peripherally
connected blood pressure
measurement devices and blood
glucose measurement devices that is
automatically uploaded into the
Home
Telehealth appliance.
Met
(1)
Partially
Met (2)
Not
...(continued) ensure data

displayed on vendor websites is verified for
accuracy prior to clinical
decision-making and placement in the CPRS
medical record.
2. If the evaluation by the VISN CCHT Program

Manager does not
result in assurance that appropriate practices are
in place to ensure
measurements are always verified prior to clinical
decision-making and
placement in CPRS, they will suspend use of
automated data collection
from peripheral devices connected to home
telehealth devices. These
VISN CCHT programs will revert to manual data
entry by patients
instead. Manual data entry will ensure correct
time and date stamping of
measurements.
CCHTPeripheralDevicesAL08-19.pdf
250 of 578

Question:
5.12.15
Met
(1)
Partially
Met (2)
Not
Same syringe used for IV

CDC guidelines and general infection control
(intravenous) line heparin flushes for precautions require that any syringe or needle
multiple patients (AL08-20)
used on one patient be considered contaminated
and cannot be used on any other patient or be
reintroduced into a multiuse vial.
As routine practice in a VA medical
center, the same syringe was used to
administer heparin flushes to
patients via their IV lines during
procedures in the cardiac cath lab. A
multi-dose vial of heparin was used
to fill a 10 ml syringe at the beginning
of the days procedures, and the
same syringe was used for
subsequent patients throughout the
day.
The concern about reuse of syringes applies to

cardiac catheterization labs, emergency rooms,
endoscopy suites, operating rooms, patient
treatment areas, radiology, and all other areas
using injectable medications.
Actions:
By Close of Business, Friday, August, 15, 2008,

the facility director, using
available staff and resources will ensure that
notification is provided to all staff who perform
medication injections of the following information:
a). Do not use the same syringe to administer

medications to multiple
patients even if the needle is changed for each
patient. This applies
regardless of the location of the injection port.

Use of IV ports that are distal from the patient is
still a risk and must not to be utilized in this
SameSyringeAL08-20.pdf
manner.
251 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.12.15
(continued)... Same syringe used for ...(continued) their first use, the needle and
(continued) IV (intravenous) line heparin flushes syringe are considered contaminated. A syringe
for multiple patients (AL08-20)
can only be used multiple times if it is being used

on the same patient to dispense medication using
aseptic technique to protect the needle or
needleless device between uses. The appropriate
As routine practice in a VA medical
expiration time or safe-use time of the medication
center, the same syringe was used to in the syringe must be considered.
administer heparin flushes to
patients via their IV lines during
procedures in the cardiac cath lab. A
multi-dose vial of heparin was used c). Use fluid infusion and administration sets (i.e.,
to fill a 10 ml syringe at the beginning intravenous bags,
of the days procedures, and the
same syringe was used for
tubing and connectors) on one patient only and
subsequent patients throughout the dispose appropriately after
day.
their use. Consider a syringe or needle / cannula
contaminated once it has
been used to enter or connect to a patients
intravenous infusion bag or
administration set.
d). When using multidose vials both the needle

and syringe used to
access a multidose vial must be sterile.
Furthermore, a needle or syringe that has been
used to administer medication to a patient shall
never be used again to access a multidose vial.
SameSyringeAL08-20.pdf
252 of 578

5.12.16
Question:
Inpatient Medication Orders for

Outpatients (IMO): Inability to enter
Unit Dose orders beyond midnight for
patients checked in before midnight.
(AD08-04)
The IMO software functionality enables an

Outpatient location (i.e. Clinic)
Met
(1)
Partially
Met (2)
Not
to use the Inpatient Meds (Unit Dose) ordering

program to enter
medication orders that are to be administered in
the clinic setting.
When using IMO for a patient who

was checked into an IMO clinic
before
midnight and who remains in the
outpatient location after midnight,
their
Potential issues related to this

appointment/encounter problem are:
When this problem occurs, a clinician will be
unable to access the
CPRS Unit Dose medication ordering screens.

current encounter no longer functions CPRS will only
for ordering Meds, Inpatient in
permit entry of outpatient prescriptions in this
CPRS. This is especially problematic situation. If
in a 24 hour Emergency
Outpatient orders are entered and the patient has
Department setting as patients
an active
appointments will often start on one
day
Outpatient prescription for the same dispensed
drug, the active
and end on the next. Site reports
indicate this causes a number of
order is discontinued. Providers may forget to
reorder the standing
potential patient safety issues
relating to medications (see General Outpatient medication with the appropriate
number of refills. This
Information below).
may also lead subsequent staff to misinterpret the
medication
InpatientMedicationOrdersAD08-04.pdf
profile
and assume that the therapy has been
253 of 578

Question:
5.12.16
(continued)... Inpatient Medication
(continued) Orders for Outpatients (IMO):
Met
(1)
Partially
Met (2)
Not
...(continued) receive
Inability to enter Unit Dose orders

their intended medications when needed. Sites
beyond midnight for patients checked report delays in
in before midnight. (AD08-04)
medication administration for as long as 10 hours.
When using IMO for a patient who
was checked into an IMO clinic
before
midnight and who remains in the
outpatient location after midnight,
their
If a second unscheduled appointment is created

after midnight in
order to be able to enter Unit Dose medications,
then notes and
encounter information may subsequently be
attached to this
current encounter no longer functions encounter instead of the original appointment. All
for ordering Meds, Inpatient in
the encounter
CPRS. This is especially problematic data in the unscheduled encounter is deleted if
in a 24 hour Emergency
this unscheduled
Department setting as patients
appointments will often start on one
day
and end on the next. Site reports
indicate this causes a number of
encounter is deleted. The deleted encounter data

may include
Diagnosis Codes, Immunizations, Education, and
Health Factors
which may be used to trigger Clinical Reminders.
potential patient safety issues

relating to medications (see General
Information below).
IMO is a medication ordering process for

Outpatient Clinics. Its use
enables medication orders to go through order
checks and pharmacist
InpatientMedicationOrdersAD08-04.pdf
254 of 578

5.12.17
Question:
J & J Ethicon ENDOPATH ETS

Endoscopic Linear Cutters (AD0805)
Ethicon has started supplying these linear cutters

(which do not have pre-loaded cartridges) with a
red protective cover added to the endeffector
(cartridge jaw) which must be removed prior to
loading the instrument. This will serve as a
cognitive aid to staff to load the instrument before
use. Ethicon will exchange affected devices for
MOD Code 02 replacement products with the red
protection covering.
On September 22, 2008 Ethicon

Endo-Surgery, LLC issued an
Met
(1)
Partially
Met (2)
Not
Important Customer Reminder to

users stating that the ENDOPATH
ETS Endoscopic Linear Cutter is not
preloaded with staples. A small
Recommendation:
number of incidences have been
SPD or other personnel that supply the affected
reported
devices to the
related to the linear cutters being
used without a cartridge causing the operating or procedure rooms where these
instrument to cut tissue without
devices are used should label the packaging of
applying a staple, preventing proper the linear cutters to remind clinicians to load the
cutters with an appropriately sized cartridge
closure of the incision.
before use until replacement products are
obtained.
The following Product codes and
MOD Code 00 are affected:
ETS45 (ENDOPATH ETS45
Endoscopic Linear Cutter)
ATS45 (ENDOPATH ETS-Flex45
Articulating Linear Cutter)
CTS45 (ETS Compact-Flex 45
Articulating Endoscopic Linear
Cutter)
EndoscopicLinearCuttersAD08-05.pdf
255 of 578

5.12.18
Question:
Shower curtains used in locked

mental health units (AL09-01)
Many locked mental health units have shower

curtains for patient privacy and for patient safety
(e.g., to prevent water from pooling outside the
shower, reducing the potential for a slip and fall
hazard). While the shower curtain involved in this
event was a vinyl/plastic combination, totally
plastic or totally vinyl shower curtains also
present a suffocation hazard.
Met
(1)
Partially
Met (2)
Not
A VAMC reported that a patient in a

locked mental health unit used the
clear plastic, light-weight, bottom
portion of a shower curtain (see Alert
Figure 1) to attempt suicide by
suffocation. The patient ripped off the
clear plastic portion from the heavier Actions:
vinyl portion and wrapped the
material around their head.
1. By close of business (COB) October 17, 2008,

identify all shower curtains in locked mental
health units that are plastic or vinyl in any part of
their composition and/or could be used for
suffocation.
NOTE: Removing the plastic and/or vinyl shower
curtains without addressing the following is not
recommended.
1) Addressing the slipping hazard posed by a wet
floor outside of the shower stall.
2) Considering the preservation of patient dignity
and privacy.
2. By COB October 31, 2008, identify safer

alternatives to plastic or vinyl shower curtains that
could be used to reduce the potential for
Shower Curtains in Locked MH UnitsAL09-01.pdf
(continued)...
256 of 578

Question:
5.12.18
(continued)... Shower curtains used
(continued) in locked mental health units (AL09-
01)
A VAMC reported that a patient in a

locked mental health unit used the
clear plastic, light-weight, bottom
portion of a shower curtain (see Alert
Figure 1) to attempt suicide by
suffocation. The patient ripped off the
clear plastic portion from the heavier
vinyl portion and wrapped the
material around their head.
Met
(1)
Partially
Met (2)
Not
...(continued) suffocation. Acceptable alternatives

are products that mitigate or reduce the risk of
suffocation and are unlikely to pose any other
hazards to patient or staff in locked units.
Examples include, but are not limited to, the
following:
a. Cloth shower curtains - provided that they 1)
have a suicide prevention track (i.e., a track that
cant be used as an anchor), 2) are breakaway,
attached with Velcro, 3) have Velcro tabs spaced
at a minimum of approximately 12 inches apart
(e.g., use only 3 Velcro tabs to attach a 24 wide
shower curtain), and 4) have no more than 2
square inches of each Velcro tab in contact with
the curtain. Note that meeting these requirements
may require retrofitting commercial cloth shower
curtains. Note also that the small number and
placement of the Velcro tabs will cause the
shower curtain to look saggy, but prevents the
curtain from supporting a patients weight.
Additionally, since mold can grow on cloth easily,
be sure to launder and/or replace the shower
curtain as necessary.
b. The Soft Suicide Prevention Door (SSPD)
patented by Sheridan VAMC (see Alert Figure 2
and www.suicideproofing.com). This is a fire
resistant, foam core, Velcro-hinged door that has
been designed to pull easily from the door jam
when weight is applied. The vinyl covering the
foam is securely attached. This door is available
from Kennon Products, Inc. (800-356-0809 or
sales@suicideproofing.com).
c. On new construction, when feasible, shower

areas Curtains
Shower
shouldin be
Locked
configured
MH UnitsAL09-01.pdf
to provide privacy by
257 of 578

5.12.19
Question:
Bleeding episodes during dialysis

(AD09-02)
VA dialysis centers performed more than 2.5

million chronic and acute dialysis treatments
during the period of time reviewed. In addition to
the review of RCA and Safety reports, the nursemanagers of 65 VA dialysis centers were
interviewed by telephone as were some Patient
Safety Managers.
VA dialysis centers performed more

than 2.5 million chronic and acute
dialysis treatments during the period
of time reviewed. In addition to the
review of RCA and Safety reports,
the nurse-managers of 65 VA dialysis
centers were interviewed by
telephone as were some Patient
Safety Managers.
Met
(1)
Partially
Met (2)
Not
All of the significant bleeding events involved

dislodgement of the venous needle or
disconnection of the venous blood line at the
dialysis catheter connection. In the majority of
these cases, the venous pressure alarm on the
dialysis machine failed to detect the event until
significant blood loss had occurred. There
appeared to be no statistical difference in the
reported adverse bleeding events between the
four brands and multiple
models of dialysis machines involved, although
the number of incidents with each machine may
have been too small to draw any firm conclusions.
Two major risk factors for bleeding during dialysis

were found: 1) 75% of the most severe bleeds
occurred in patients (continued)...
BleedingEpisodesDuringDialysisAD09-02.pdf
258 of 578

Question:
5.12.19
(continued)... Bleeding episodes
(continued) during dialysis (AD09-02)
VA dialysis centers performed more

than 2.5 million chronic and acute
dialysis treatments during the period
of time reviewed. In addition to the
review of RCA and Safety reports,
the nurse-managers of 65 VA dialysis
centers were interviewed by
telephone as were some Patient
Safety Managers.
Met
(1)
Partially
Met (2)
Not
...(continued) who were restless, confused,

agitated, or uncooperative, and 12.5% in patients
who were asleep; 2) approximately 50% of the
severe bleeds occurred outside of the chronic
dialysis unit (in the ICU or in isolation rooms).
In 50% of the severe bleeds, the access site was

not visible at the time of the event, and in the
remaining 50%, the visibility of the access site
was not documented in the RCA.
Taping of the access site and restraint policies

and procedures varied across the 65 VA dialysis
centers. Many dialysis machines also lacked an
internal memory for alarms and shutdowns.
In addition to these findings, usability testing of

the Redsense portable alarman FDA-approved
device specifically designed to detect venous
needle dislodgement during dialysiswas
performed. Problems were found with the clip and
the sensor connection. The manufacturer is
currently redesigning the clip and problems with
the sensor connection appear to have been
solved.
Recommendations:
BleedingEpisodesDuringDialysisAD09-02.pdf
259 of 578

5.12.20
Question:
Methicillin-resistant Staphylococcus
aureus (MRSA) contamination in an
orthopedic clinic room (AD09-03)
Recommendations:
Met
(1)
Partially
Met (2)
Not
1) For joint/bursa injections that involve the

injection of more than one medication from one
Several patients who received
syringe, it is strongly recommended to use single
joint/bursa injections in one
dose vials of each medication since the use of
orthopedic surgery clinic exam room, multidose vials increases the risk for cross
during a four-day period, developed contamination among patients. (Note: opened
infections. For those patients who
single dose vials must be discarded immediately
had cultures grown, MRSA was
after use on a patient). If use of single dose vial is
identified as the causative agent.
not feasible, use the lowest volume multidose vial
Infections may have been caused by available.
improper preparation of injections,
cross contamination between
multidose vials and/or breach of
appropriate practices following the
2) Appropriate aseptic technique needs to be
collection of a specimen for
maintained when
microbiological culture from a patient
who was infected with MRSA. During preparing medications for injection and for skin
the investigation issues related to
preparation before the injection. When preparing
documentation were also identified. or drawing medications from single dose or
multidose vials, always follow safe injection and
administration practices.
3) If locked carts are used to store medications

and supplies in rooms used for orthopedic clinic,
they should not be used for any other purposes
(e.g. as a place to set specimens collected for
culture).
Methicillin-resistant
4)
All sterile supplies
Staphylococcus
in clinic
aureus
rooms
(MRSA) AD09-03.pdf
(continued)...
260 of 578

Question:
5.12.20
(continued)... Methicillin-resistant
(continued) Staphylococcus aureus (MRSA)
Met
(1)
Partially
Met (2)
Not
...(continued) are to be kept in closed cabinets,

drawers, or closed carts.
contamination in an orthopedic clinic

room (AD09-03)
5) Following any procedure done on an infected
site, such as:
Several patients who received
joint/bursa injections in one
orthopedic surgery clinic exam room,
during a four-day period, developed
infections. For those patients who
had cultures grown, MRSA was
identified as the causative agent.
Infections may have been caused by
improper preparation of injections,
cross contamination between
multidose vials and/or breach of
appropriate practices following the
collection of a specimen for
microbiological culture from a patient
who was infected with MRSA. During
the investigation issues related to
documentation were also identified.
aspiration of pus, open drainage, debridement or

obtaining cultures performed in an orthopedic
clinic room, the examination table and horizontal
surfaces in the room should be wiped down with
an EPAregistered hospital disinfectant before the
next patient is placed in the room. If there is
visible soilage, an EPA-registered
disinfectant/detergent should be used for cleaning
and disinfecting. In addition, all furniture such as
exam tables, chairs, tables, carts, horizontal
surfaces in examination/procedure rooms, sinks,
and floors in the clinics should be cleaned and
disinfected on a daily basis using appropriate
cleaning agents and an EPA-registered hospital
disinfectant or an appropriate EPA-registered
hospital disinfectant/detergent.
6) In accordance with VHA Handbook 1004.1

VHA Informed Consent for Clinical Treatments
and Procedures (link in Additional
Information section below), the patients informed

signature consent should be obtained for
treatments and procedures that require injections
of any substance into a joint space or body cavity,
including any non-vascular
Methicillin-resistant
Staphylococcus aureus
space.
(MRSA)
iMed
AD09-03.pdf
261 of 578

5.12.22
Question:
Medtronic Neuromodulation
Sutureless Connector Catheters
used with SynchroMed and IsoMed
implantable infusion pumps:
The intrathecal catheters and intrathecal catheter

revision kits use a sutureless connector for
attachment of the catheter to the implanted
Medtronic SyncroMed II, SynchroMed EL, and
Met
(1)
Partially
Met (2)
Not
IsoMed infusion pumps. The catheter is part of an

INDURA One-Piece (1P)
Intrathecal Catheters, Model 8709SC infusion system that stores and delivers
parenteral drugs to the intrathecal space.
Intrathecal Catheters, Model
Medtronics investigation indicates that reported
8731SC
events have been caused by misalignment or
incomplete connection of the sutureless pump
Sutureless Pump Connector
Revision Kit, Model 8578
connector to the catheter port. Proper alignment
and full engagement of the sutureless pump
connector to the catheter port during attachment
Intrathecal Catheter Pump
is critical to ensure the catheter is properly and
Segment Revision Kit, Model
completely connected to the pump.
8596SC
(AL09-02)
Actions:
There is a potential for
misconnections of the Medtronic
sutureless connector catheters from
the catheter port on the pump. These
misconnections have resulted in a
blockage (occlusion) between the
sutureless pump connector and the
catheter port on the pump and
disconnections from the pump
connector. Misconnections can result
in lack of therapeutic effect, clinically
significant or fatal drug underdose, or
return of underlying symptoms and/or
withdrawal symptoms. Drug
withdrawal
Mandatory;
Priority
from
A Intrathecal Baclofen
1. By close of business October 31, 2008,

physicians responsible for implanting and
managing patients must do the following:
a. Read Attachments 1, 2, and 3.
b. Begin to perform the following procedures
during implantation. Detailed instructions are
provided in Attachments 2 and 3.
verify (continued)...
Medtronic Intrathecal Catheter AL09-02.pdf
262 of 578

Question:
5.12.22
(continued)... Medtronic
(continued) Neuromodulation Sutureless
Met
(1)
Partially
Met (2)
Not
...(continued) cerebrospinal fluid (csf) backflow

through the catheter
Connector Catheters used with

SynchroMed and IsoMed implantable ensure alignment of the sutureless connector
infusion pumps:
to the pump
snap the sutureless connector into place
INDURA One-Piece (1P)
Intrathecal Catheters, Model 8709SC
tug and rotate to test the connection
Intrathecal Catheters, Model
c. Follow recommendations for managing patients
8731SC
with implanted sutureless SC catheters, as
Sutureless Pump Connector
outlined in Attachment 1.
Revision Kit, Model 8578
Intrathecal Catheter Pump
Segment Revision Kit, Model
8596SC
(AL09-02)
There is a potential for

misconnections of the Medtronic
sutureless connector catheters from
the catheter port on the pump. These
misconnections have resulted in a
blockage (occlusion) between the
sutureless pump connector and the
catheter port on the pump and
disconnections from the pump
connector. Misconnections can result
in lack of therapeutic effect, clinically
significant or fatal drug underdose, or
return of underlying symptoms and/or
withdrawal
Mandatory;
Priority
symptoms.
A
Drug
2. By close of business October 31, 2008, contact

your patients who have these devices to educate
them about the signs and symptoms of drug
underdose and withdrawal.
3. Effective immediately, all patients that present

with an intrathecal pump should be provided with
education about the signs and symptoms of drug
underdose and withdrawal.
Medtronic Intrathecal Catheter AL09-02.pdf
263 of 578

Question:
5.12.23
Met
(1)
Partially
Met (2)
Not
Baxter Single Strength Dosing Card Actions:

for BREVIBLOC Premixed Injection
(esmolol HCl) 2,500 mg/250 mL (10
mg/mL) Ready-to-use-Bags, 250 mL
bags (AL09-03)
1. Chief Nursing Officer (or designee), Chief of
Staff (or designee) and Chief of Pharmacy (or
designee) will ensure that all nurses, physicians,
There is an error in the 121 lb (55 kg)
patient weight setting on the Single
Strength Dosing Card for Baxter's
BREVIBLOC Premixed Injection
bags. The Maintenance Infusion
listed under 100 mcg/kg/min for the
mcg/min setting is listed as 55000
(see below); it should read 5500.
Baxter reports that the other rates
listed on the dosing card are correct.
The dosing cards
were distributed to clinicians by
Baxter pharmaceutical sales
representatives.
Using the incorrect maintenance

infusion value (55000 mcg/min) could
cause a patient receiving the infusion
to have an adverse clinical outcome.
Baxter sent an Important Correction
of Drug Information letter to Directors
of Nursing and Directors of
Pharmacy on August 27, 2008, to
inform them
Mandatory;
Priorityof
A error within
and pharmacists, respectively, are informed of

this Patient Safety Alert and that clinical
departments under their management control
locate the incorrect dosing cards. The incorrect
dosing cards can be identified by the product
number 748762 4/07 on the back of the card as
shown in the Attachment.
Note: Be sure to look in all areas where these

cards may be located in your facility. These cards
often find their way into pharmacists, physicians
or nurses pockets and are often posted on desks
or walls in areas such as, but not limited to, cath
labs, critical care areas, emergency departments,
operating rooms, pharmacy, post-anesthesia care
units, and telemetry monitoring units.
2. Under no circumstances may these dosing

cards be used in their current form. Nurses,
physicians, pharmacists and department
managers must (continued)...
Baxter BREVIBLOC Inaccurate Dosing Card AL09-03.pdf
264 of 578

Question:
Met
(1)
Partially
Met (2)
Not
5.12.23
(continued)... Baxter Single Strength ...(continued) either destroy or correct the
(continued) Dosing Card for BREVIBLOC
incorrect dose cards.
Premixed Injection (esmolol HCl)

2,500 mg/250 mL (10 mg/mL)
Ready-to-use-Bags, 250 mL bags
(AL09-03)
There is an error in the 121 lb (55 kg)

patient weight setting on the Single
Strength Dosing Card for Baxter's
BREVIBLOC Premixed Injection
bags. The Maintenance Infusion
listed under 100 mcg/kg/min for the
mcg/min setting is listed as 55000
(see below); it should read 5500.
Baxter reports that the other rates
listed on the dosing card are correct.
The dosing cards
were distributed to clinicians by
Baxter pharmaceutical sales
representatives.
Using the incorrect maintenance

infusion value (55000 mcg/min) could
cause a patient receiving the infusion
to have an adverse clinical outcome.
Baxter sent an Important Correction
of Drug Information letter to Directors
of Nursing and Directors of
Pharmacy
Mandatory;
Priority
on AAugust 27, 2008, to
Baxter BREVIBLOC Inaccurate Dosing Card AL09-03.pdf
265 of 578

5.12.25
Question:
Incorrect Patient Information

Displayed in CPRS v27 (AL09-04)
Actions:
When switching from one patients

record to a second patients record in
the same session of CPRS while
using CPRS v27, the first patients
information may still be displayed in
the second patients CPRS display,
impacting patient care decisions. It is
not known at this time if data entered
for the second patient will be placed
in the incorrect record. This problem
occurs intermittently and has been
reported when viewing clinical data
on the Orders and Notes Tabs.
Met
(1)
Partially
Met (2)
Not
1. Medical Center Directors are instructed to send

a certification message that a notification process
has been implemented whereby all clinical staff
and users of CPRS have read and been made
aware of this Patient Safety Alert. The certification
message is to be sent from the VAMC Director to
the VISN Network Director to the Office of the
DUSHOM (10N). A VISN certification message
must be sent to Megan Friel, Acting Chief
Biomedical
Engineer, at megan.friel@va.gov, no later than 2
pm (EST) on Friday, November 7, 2008, which
certifies that all VA medical centers in that VISN
have completed this notification process.
2. Until a permanent software fix is available (see

Additional Information below), all CPRS users
must be aware that if either:
a) the Windows Screen Saver appears or
b) an Access Violation message displays, it is
an indication that you have experienced the
problem. Anytime either of these indications is
provided, users must immediately log off of
(continued)...
Incorrect Patient Information Displayed in CPRSv27 AL09-04.pdf
266 of 578

Question:
5.12.25
(continued)... Incorrect Patient
(continued) Information Displayed in CPRS v27
(AL09-04)
When switching from one patients

record to a second patients record in
the same session of CPRS while
using CPRS v27, the first patients
information may still be displayed in
the second patients CPRS display,
impacting patient care decisions. It is
not known at this time if data entered
for the second patient will be placed
in the incorrect record. This problem
occurs intermittently and has been
reported when viewing clinical data
on the Orders and Notes Tabs.
Met
(1)
Partially
Met (2)
Not
...(continued) CPRS
and then log onto CPRS again to continue your
activities.
3. If users experience an Access Violation

message or incorrect patient information after
switching from one patients CPRS record to a
second patients CPRS record, immediately report
the experience to your facilitys Clinical
Application Coordinator (CAC) or designee.
Clinical Application Coordinators are responsible
for reporting any occurrence to the VA Service
Desk (1-888-596-4357) or logging a national
Remedy help ticket.
Incorrect Patient Information Displayed in CPRSv27 AL09-04.pdf
267 of 578

Question:
5.12.26
Met
(1)
Partially
Met (2)
Not
CPRS v27 - Discontinued orders are Actions:

no longer listed in order of
discontinuation date/time (AL09-05)
1. Medical Center Directors are instructed to send
a certification message that a notification process
CPRS v27 (current version installed has been implemented whereby all clinical staff
at all VA Medical Facilities), displays and users of CPRS have read and been made
discontinued orders by original order aware of this Patient Safety Alert. The certification
date, instead of the date the order
message is to be sent from the VAMC Director to
was discontinued when viewing
the VISN Network Director to the Office of the
Active Orders or Recent Activity. In
DUSHOM (10N). A VISN
addition, the prefix Discontinue no
longer appears in the discontinued
certification message should be sent to Megan
orders in this view. These changes
Friel, Acting Chief
have resulted in reported delays for
stopping continuous infusion orders Biomedical Engineer, at megan.friel@va.gov no
(e.g., stopping IV heparin drips).
later than 2 PM (EST) on Friday, November 7,
2008, which certifies that all VA medical centers
in that VISN have completed this notification
process.
2. Effective immediately, at the beginning of each

shift and every four (4) hours thereafter, nursing
staff shall review the BCMA Cover Sheet to
identify any IVs or PCAs that may have been
discontinued and are still infusing (see
Attachment 1).
CPRSv27 Discontinued Orders AL09-05.pdf
268 of 578

5.12.27
Question:
Maxi Move patient lifts with lock and

load system (Combi Hanger):
Manufactured by Arjo between
November 2005 and April 2008.
(AL09-06)
Actions:
There is the potential for the Lock

and Load hanger on the patient lift
to unintentionally become dislocated
when descending upon a rigid
surface (e.g., a patient bed, the arm
rest of a chair, the side rails of a toilet
commode chair). If the hanger is
partially dislodged there is a potential
risk for complete detachment of the
hanger while the patient is being
moved. This could result in a patient
fall. To date no patient injuries have
been reported. Arjo has identified 75
VA facilities affected by this issue.
Met
(1)
Partially
Met (2)
Not
1. By close of business December 2, 2008,

Biomedical Engineering will ensure that
replacement parts are ordered for affected Arjo
patient lift units (see Attachment 1).
a. Units manufactured from November 2005,
through August 4, 2006, require replacement of
the entire T-bar assembly.
b. Units manufactured from August 6, 2006 to
April 7, 2008, require replacement of the T-bar
bushings.
2. Until replacement components are installed,

immediately inform users of the reported issue
with this device and how to identify the issue (see
Attachment 2).
Note: Only units with detachable hangers are

affected, permanently mounted/dedicated
hangers are not affected.
Maxi Move patient lifts with lock and load system Arjo AL09-06.pdf
269 of 578

Question:
5.12.28
Met
(1)
Partially
Met (2)
Not
Improper set-up and reprocessing of Actions:

flexible endoscope tubing and
accessories (AL09-07)
Correct tubing modified with an

incorrect connector was used to
attach an Olympus flexible
endoscope to its irrigation source
(Olympus Flushing Pump and
accessories). This resulted in a
backflow of body fluids into irrigation
source tubing
(where backflow should not occur)
during an endoscopic procedure.
Specifically, during some endoscopic

procedures, the facility used an
Olympus Auxiliary Water Tube (MAJ855) that was modified to have an
Olympus Washing Tube (MH-974)
connector attached instead of the
connector intended to be used with
the Olympus Auxiliary Water Tube
(MAJ-855). The Auxiliary Water
Tube (MAJ-855) is required to
connect the Auxiliary Water Port on
the endoscope to the Olympus
Flushing Pump (OFP) Filter
(7501335), which is connected to the
OFP Irrigation Tube (7501669). (See
the photograph in Attachment 1,
which depicts
Mandatory;
Priority Aproper set-up of the
The Facility Director (or designee) will ensure that

all of the following three actions are carried out by
close of business January 7, 2009:
1. All personnel who perform procedures with
flexible endoscopes and/or reprocess
endoscopes and their tubing and accessories
have read this Patient Safety Alert.
NOTE: Ensure you have identified all areas in
your facility
where reprocessing of flexible endoscopes
occurs, which may
include, but are not limited to the following:
Ambulatory
Surgery, Endoscopy, GI, GU, OR, Respiratory,
SPD, Urology,
and Clinics to include CBOCs.
2. For those facilities using the Olympus Flushing

Pump and compatible endoscopes, ensure that:
a. the set-up shown in Attachment 1 is being

consistently utilized.
OlympusScopeAL09-07.pdf
270 of 578

Question:
5.12.28
(continued)... Improper set-up and
(continued) reprocessing of flexible endoscope
Met
(1)
Partially
Met (2)
Not
...(continued) modify, create, or enhance

manufacturer
tubing and accessories (AL09-07)

tubings and accessories.
Correct tubing modified with an
incorrect connector was used to
attach an Olympus flexible
endoscope to its irrigation source
(Olympus Flushing Pump and
accessories). This resulted in a
backflow of body fluids into irrigation
source tubing
(where backflow should not occur)
during an endoscopic procedure.
Specifically, during some endoscopic

procedures, the facility used an
Olympus Auxiliary Water Tube (MAJ855) that was modified to have an
Olympus Washing Tube (MH-974)
connector attached instead of the
connector intended to be used with
the Olympus Auxiliary Water Tube
(MAJ-855). The Auxiliary Water
Tube (MAJ-855) is required to
connect the Auxiliary Water Port on
the endoscope to the Olympus
Flushing Pump (OFP) Filter
(7501335), which is connected to the
OFP Irrigation Tube (7501669). (See
the photograph in Attachment 1,
which depicts
Mandatory;
Priority Aproper set-up of the
ii. the Olympus Auxiliary Water Tube (MAJ-855) is

supplied
non-sterile, and needs to be reprocessed before
initial
use and after each patient using steam
sterilization (refer
to the instruction manual for your particular
endoscope).
iii. the OFP Filter (7501355) and OFP Irrigation

Tube
(7501669) are supplied non-sterile, must be
sterilized
prior to initial use, can be utilized all day, and
must be discarded at the end of each day, as per
the manufacturer instructions.
iv. the OFP Fluid Container (7501352) is supplied

nonsterile,
OlympusScopeAL09-07.pdf
must
be sterilized prior to initial use, can be
271 of 578

5.12.29
Question:
Suicide attempt in the Emergency

Room (ER) (AD09-05)
Recommendations:
Holiday seasons can present

challenges to both patients and staff.
For example, holidays can trigger
depression or suicidal ideation in
patients, and staff may experience
increased workload and stress and
have added distractions.
Partially
Met (2)
Not
1. Staff in emergency rooms should be familiar

with the Suicide Risk Assessment Pocket Card
(see the Attachment).
2. Patients appearing to ER staff to be at risk for

self-harm should be kept in the line of sight, if
possible, while awaiting their evaluation.
Patients attempt or complete suicide

because they have both the will and
the opportunity to do so. Staff
vigilance in the ER setting is
essential since it is the most common
area where these patients first
present.
3. During the holidays (e.g., New Years, 4th of

July, Veterans Day, Thanksgiving, Winter
Holidays, etc), ER staff should be aware of
potential risks of holiday decorations (e.g.,
banners, strings of lights, garland) that are not
typically in the environment.
Suicide Attempt In ER-AD09-05.pdf
Met
(1)
272 of 578

5.13.1
Question:
Product Recall: Duragesic 50

mcg/h (Fentanyl Transdermal
System) CII (patch) National Drug
code (NDC) 50458-034-05, Lot #
0817239 (AL 09-08)
Actions:
Met
(1)
Partially
Met (2)
Not
By close of business January 16, 2009,

Pharmacy Chiefs will:
1) Assure that all remaining products with the
affected lot number
ALZA Corporation is recalling their

Duragesic 50 mcg/h Fentanyl
transdermal
patches. A small number of these
systems may have a cut along one
side of the drug reservoir. The result
is the possibility of gel being released
from the gel reservoir into the pouch
in which the patch is packaged that
will allow patients or caregivers to be
directly exposed to Fentanyl gel.
Exposure to Fentanyl gel may lead to
serious adverse events, including
respiratory depression and possible
overdose, which may be fatal.
(#0817239) at the facility are returned to

McKesson, the pharmaceutical
prime vendor for VA. The product should NOT be
returned as instructed
in the manufacturer/distributors product recall
documents.
2) Determine whether the affected lot number

(refer to lot number provided
above) was dispensed to any patient(s). If so,
identify the patient(s) and
contact the patient(s) providing instructions on
how to obtain a new
supply of medication and return the medication
being recalled to the
pharmacy so that your facility can double check
them.
DuragesicFentanylPatchAL09.08.pdf
273 of 578

Question:
5.13.1
(continued)... Product Recall:
(continued) Duragesic 50 mcg/h (Fentanyl
Transdermal System) CII (patch)

National Drug code (NDC) 50458034-05, Lot # 0817239 (AL 09-08)
Met
(1)
Partially
Met (2)
Not
...(continued) breathing need emergency help.

Family members or caretakers
should call 911.
4) If patients cannot be reached by telephone,

follow-up with a letter. A
ALZA Corporation is recalling their
Duragesic 50 mcg/h Fentanyl
transdermal
patches. A small number of these
systems may have a cut along one
side of the drug reservoir. The result
is the possibility of gel being released
from the gel reservoir into the pouch
in which the patch is packaged that
will allow patients or caregivers to be
directly exposed to Fentanyl gel.
Exposure to Fentanyl gel may lead to
serious adverse events, including
respiratory depression and possible
overdose, which may be fatal.
sample letter can be found at:

http://vaww.national.cmop.va.gov/PBM/Other
%20Documents%20and%2
0Resources/Recall%20Patient%20Letter
%20Template.doc. This
template can be altered according to site-specific
needs.
5) Report any adverse reactions experienced
DuragesicFentanylPatchAL09.08.pdf
274 of 578

5.13.2
Question:
Digital Televisions (DTV) transition

and affect on wireless medical
telemetry systems for physiologic
patient monitoring (AD 09-06)
Recommendations:
Met
(1)
Partially
Met (2)
Not
Managing a practical approach to assessing and

mitigating risk associated
On February 17, 2009, all US
television stations will stop
broadcasting on
analog airwaves and begin
broadcasting only in digital. As a
result, some
of these new DTV station channels
will now broadcast on Channels 36
and
38, which are adjacent to an
authorized Wireless Medical
Telemetry
with these new DTV stations includes the

following important steps.
1. Determine if the wireless medical telemetry

system in the medical
center operates within the 608-614 MHz (Channel
37) telemetry band.
2. If the wireless medical telemetry system

operates within the frequency
Service (WMTS) band (TV Channel

37), increasing the risk for
interference
band utilized by Channel 37, then:
and the possibility for disruption of

patient monitoring.
a. Check to determine whether a new station will

be broadcasting
on Channel 36 or 38 and the proximity of the
transmitter to the
Many VHA medical centers operate

their wireless medical telemetry
systems within the Channel 37
WMTS band.
Recommended;
Priority
Television
A
stations
medical center. This information can be found at

http://www.fcc.gov/dtv/markets/.
DTVTransitionsAffectonMedicalTelemetryAD09-06.pdf
275 of 578

Question:
5.13.2
(continued)... Digital Televisions
(continued) (DTV) transition and affect on
wireless medical telemetry systems

for physiologic patient monitoring
(AD 09-06)
Met
(1)
Partially
Met (2)
Not
...(continued) potential risk

and to possibly retune affected transmitters.
On February 17, 2009, all US

television stations will stop
broadcasting on
analog airwaves and begin
broadcasting only in digital. As a
result, some
of these new DTV station channels
will now broadcast on Channels 36
and
38, which are adjacent to an
authorized Wireless Medical
Telemetry
Service (WMTS) band (TV Channel
37), increasing the risk for
interference
and the possibility for disruption of
patient monitoring.
Many VHA medical centers operate

their wireless medical telemetry
Recommended;
systems
within
Priority
the
A Channel 37
DTVTransitionsAffectonMedicalTelemetryAD09-06.pdf
276 of 578

POLICIES, TOOLS AND AIDS - Element 6
6.1.1
Question:
Cognitive Aids
Is the Anesthesia Cognitive Aid

provided on all anesthesia
machines?
Safety Staff to talk about implementation of the

aid and give feedback on how the aid was
received by affected staff. Look for aid on
anesthesia machines when walking the OR.
cognitive_aids_anesthesiology.pdf
Met
(1)
Partially
Met (2)
Not
Cognitive Aids
6.1.2
Are the American Heart Association

Handbooks being used and well
received on all facility crash carts?
Safety Staff to talk about implementation of the

aid and give feedback on how the aid was
received by affected staff. This aid should be
attached to all code carts in the facility.
Communication of Patient Tests Results

6.2.1
Does the facility have a written policy Policy should include: 1) Description of the
for communication of emergent or
process for communication of test results to the
abnormal diagnostic findings?
requesting providers (or surrogates) and how and
when the documentation of this communication
should occur.
VHA Directive 2003-043 Test Results.pdf

6.2.1.1
Is there a process to address the

receipt of fee basis and outside
contract diagnostic practitioner
reports?
Often reports from these entities do not get

placed in the electronic record due to limited or
no access. However, the facility should recognize
this vulnerability and ensure a process exists to
address situations so these results are entered
with the medical record.

6.2.2
Are all results (positive or negative)

documented electronically by the
diagnostic provider in the patients
medical record in a timely manner?
Documentation should include appropriate test

related patient history to assist radiologist,
laboratory, or nuclear medicine personnel in
making a judgment call on critical findings. A
standard process should be in place to handle fee
basis and outside contract reports which often do
not get scanned in the electronic chart.
IL 10-2002-017.pdf
Policies, Tools Aids - 6
Policies, Tools Aids - 6 - Version: 01.30.2009
277 of 578

Question:
6.2.3
Are emergent and abnormal

diagnostic test results communicated
directly from the diagnostic
practitioner to the ordering
practitioner or ordering practitioners
appropriate surrogate?
Direct communication is defined as face-to-face

telephone conversation; or via a hand carried
report (electronic communication does not
suffice). This direct communication (from the
diagnostic practitioner to the ordering practitioner
or his/her surrogate) and any subsequent change
in care plan must be documented in the VistA
computer system. The test results and care plan
changes must also be communicated to the
patient and/or family by the ordering practitioner
(or surrogate).
Met
(1)
Partially
Met (2)
Not
Patient Safety Mental Health Concerns

6.3.1
Have suggested strategies in

Information Letter IL 10-2006-013
been implemented to address JC
National Patient Safety Goal 15,
Mitigating the Risk of Suicide?
The Information letter recommends the following:

Develop and implement strategies to properly
assess, treat, and manage patients identified at
risk for suicide; document the relevant risk factors
for suicide in each patient's medical record;
document treatment and the treatment setting in
a manner that addresses the presence of (or
absence of) relevant risk factors that increase risk
for suicide and features that may decrease risk
for suicide; provide the appropriate telephone
number(s) for calls during working hours and
other times, in writing, to at-risk patients and/or
significant others (also document this in the
patients medical record); instruct patients and
their significant others to call the facility's
Emergency Department or Urgent Care Center if
they have a crisis situation (or local suicide
prevention hotlines if after hours); ensure that the
safety concerns in the design of the inpatient
mental health unit (and its furnishings) are
addressed; and, establish and implement
(continued)...
USH IL-10-2006-13.pdf
278 of 578

Question:
Met
(1)
Partially
Met (2)
Not
6.3.1
(continued)... Have suggested
...(continued) a policy stating who is responsible
(continued) strategies in Information Letter IL 10- for identifying and working with local agencies so
2006-013 been implemented to

address JC National Patient Safety
Goal 15, Mitigating the Risk of
Suicide?
that VA patients receive emergency support and

referral to the VA as soon as possible.
USH IL-10-2006-13.pdf

6.3.2
Has the facility implemented the

required actions of VHA Directive
2008-036 Use of Patient Record
Flags to Identify Patient at High Risk
for Suicide?
The primary purpose of the High Risk for Suicide

PRF is to communicate to VA staff that a veteran
is at high risk for suicide and the presence of a
flag should be considered when making treatment
decisions.
Facility Actions: (Director) 1. Ensure the Category

II High Risk for suicide are originated and
accesible through CPRS; 2. Establishing a
process for requesting, assigning, reviewing, and
evaluating these PRFs, and coordinating this with
existing processes for managing the PRF
Program; 3. Ensuring training, by the SPC, of
appropriate staff about entire PRF process; 4.
Evaluating the facility process to ensure that
Category II High Risk for Suicide PRFs are
assigned appropriately; 5. Ensuring that each
indicated PRF in a patients record is
accompanied by a TIU Progress Note written at
the time the Suicide PRF is established; 6.
Ensuring a Category II PRF is used as a local
alert for patients at high risk for suicidal behavior;
and,
7. Ensuring when a High Risk for Suicide PRF
(continued)...
VHA Directive 2008-036 record flags.pdf
279 of 578

Question:
6.3.2
(continued)... Has the facility
(continued) implemented the required actions of
VHA Directive 2008-036 Use of

Patient Record Flags to Identify
Patient at High Risk for Suicide?
Met
(1)
Partially
Met (2)
Not
...(continued) is placed on a patients chart, it is

re-evaluated at least every 90 days to ensure that
the PRF is promptly removed when the high risk
status is resolved. (Chief of Staff) 1. Instituting
procedures to ensure that the utilization of a
Category II PRF for High Risk for Suicide and the
associated processes for recommending such a
PRF are ethical, clinically appropriate, supported
by adequate resources, and used in accordance
with this Directive; and 2. (2) Providing for a
response to patient requests for deactivation of
their Category II PRF for suicide risk. For Suicide
Prevention Coordinator responsible actions see
Directive.
VHA Directive 2008-036 record flags.pdf
Patient Safety Environmental Concerns

6.4.1
Is the Domestic hot water

temperature controlled via regulating
hardware and preventative
maintenance inspections/checks?
"Facility should have a local policy that addresses

criteria listed in the related VA Directive, such as
the risk assessment process, search procedures,
and staff training plan. Review documents to
verify. Also if a patient is determined missing, the
local law enforcement should be contacted and
the patient put into the National Crime Information
Computer (NCIC) system. These agencies must
also be informed in a timely manner to cancel this
alert when a missing patient is recovered. This
policy should not preclude those Police and
Security Services units from entering this data
themselves provided they have the capability to
do so."
VHA Directive 2002-073.pdf
280 of 578

Question:
Patient Safety Environmental Concerns
6.4.2
Has the facility reviewed the

information in IL 10-2008-011 Under
Secretary for Helath's Information
Letter on Bed Bugs, and taken the
detection, intervention, patient care
and prevention strategies into
consideration?
This Information Letter addresses bed bug

issues, and is provided to assist staff at Veterans
Health Administration (VHA) facilities in
diagnosing patients presenting with bed bug
bites, recognizing bed bugs, and preventing and
mitigating bed bug infestations at VHA facilities.
NOTE: Information for use in educating patients
on bed bug infestations in community-based
residences is provided in Att. A of the Directive.
IL 10-2008-011 bed bugs.pdf
Met
(1)
Partially
Met (2)
Not
Escape & Elopement Prevention

6.5.1
Does the facility have a written plan

to help prevent wandering and
missing patient events and a process
to manage the events that do occur?
The facility should have a local policy that

addresses criteria listed in the related VA
Directive, such as the risk assessment process including documentation, early intervention
strategies, search procedures, and staff training
plan. Responsibilities should be delineated for
security needs, clinical assessments, Search
Coordinators/Command responsibilities for all
shifts, a person to communicate with family, and
specific staff assigned to specific areas for
searching. Also time frames for associated
processes must be defined (when to search,
when to contact family, etc.). Review documents
to verify.
VHA Directive 2008-057 missing pt.pdf
281 of 578

6.5.2
Question:
Are Missing Patient incidents both

adverse events, and, close calls with
a SAC potential score of 3,
addressed via the Aggregate Review
Process?

RCA to be done. All others should be an
aggregated review (twice per FY) focusing on
fixing related processes.
Met
(1)
Partially
Met (2)
Not
Directive 2008-057 states: [It is required to]

ensure that the comprehensive review and
assessment of the facility's process and any
aggregated data on actual missing patient events
or close calls are incorporated into the
appropriate committee activity at the facility to
continuously and systemically enhance
environmental safety.

6.5.2.1
Does the missing patient event log

capture the information outlined in
SPOT for each case?
The Missing Patient Aggregated Review Log

should contain the following 17 elements for each
event and close call: Case number, Age, Date,
Time & Location reported missing; Length of time
missing; Level of privileges; Previous episodes; if
treatment plan reflects an order of supervision;
primary diagnosis; persons notified (name, date
and time); type of search conducted (general or
grid); date and location found; condition (injuries);
barriers to prevent escape or elopement; and,
activity at time of elopement or escape.
Agg review criteria.pdf
282 of 578

6.5.2.2
Question:
Does the information captured in the

log used to drive the root causes,
actions and outcomes in the
aggregated reports?
The purpose of capturing information in the log is

for the aggregate team to analyze trends in the
data collected to help determine where there is a
need to focus, such as a particular facility
location, time of day, patient population, etc.
Met
(1)
Partially
Met (2)
Not

6.5.3
Are drills conducted for the search of Missing Patient Drills that integrate findings from
missing patients?
environmental rounds or other patient safety
processes (such as aggregated RCAs), must be
conducted that at each medical center or site of
jurisdiction, including CBOCs. Once staff have
received initial training, additional drills must be
conducted at least annually to effectively evaluate
known areas of vulnerability throughout and
surrounding the facility. Once staff are fully
trained, an actual search during which the search
plan is fully implemented and a critique is
completed may take the place of the drill for the
shift involved in the actual search. It is
recommended that the sites for missing patient
drills be prioritized based on known areas of
vulnerability and lessons learned from RCAs and
other risk management or performance
improvement processes.
283 of 578

6.5.4
Question:
Is the prevention and effective

management of wandering and
missing patient being addressed?
VHA Directive 2008-057 addresses two areas for

prevention:
Met
(1)
Partially
Met (2)
Not
Assessment of cognitive impairment: which

includes documentation of assessments when
admission status changes, during outpatient
evaluations, after a reported change in mental
status or if a patient has a history of wandering.
Secondly, Minimizing Risks: which includes
policies on patient privileging, integrating lessons
learned from actual events and close calls into
staff training, orientation of all new staff, missing
patient drills, and, monitoring and assessment of
hazardous areas (i.e., construction sites) and
ensuring the location of incapacitated patients.
284 of 578

Question:
6.5.5
Met
(1)
Partially
Met (2)
Not
Are additional strategies being

VHA Directive 2008-057 states these
utilized at the facility to enhance and enhancements:
prevent missing patients events for
incapacitated patients?
Use of Electronic technology, such as a wander
alert system (this is an optional tool).
Careful review and assessment of locations for

activities away from the facility, especially for
patients known to be incapacitated. During such
activities, patients should be under constant
supervision with review of findings.
Identification of incapacitated patients in the

event they become missing, which includes
pictures and physical descriptions. This is a
strategy to enhance the search procedures.
Once a patient is identified as both incapacitated
and missing the facility is to issue a local intranet
announcement to all employees.
Transport precautions must be taken if a patient is

known to be incapacitated.

6.5.5.1
Is a single individual, defined in local See 2008-059 Directive Attachment A: PATIENT

policy, as responsible for gathering
SEARCHES USING GRID SECTORS
all pertinent infromation concerning
the grid search?
285 of 578

6.6.1
Question:
Fall Prevention
Are Fall incidents both adverse

events, and, close calls with a SAC
potential score of 3, addressed via
the Aggregate Review Process?

RCA to be done. All others should be an
aggregated review (once per FY quarter) focusing
on fixing related processes.
Met
(1)
Partially
Met (2)
Not
completefallstoolkit.pdf
VHA PS Handbook.pdf
Fall Prevention
6.6.2
Does the patient falls event log

capture the information outlined in
SPOT for each case?
The Patient Falls Aggregated Review Log should

contain the following 11 elements for each event
and close call: Case number; Age; Sex; Event
(day, date, time); Outpatient/Inpatient status;
functional and cognitive factors; assistive devices
in use or ordered; communication issues (staff to
staff, staff to patient, etc.); environmental factors;
what happened and treatment plan; other
comments.
Fall Prevention
6.6.3
Have facility Physical Therapists

been involved as team members for
RCA's or Aggregate Reviews
involving Falls?
Show example via review of SPOT team

membership data for aggregate review RCAs.
Also talk with Physical Therapy Service to
determine their involvement.
JCAHO 2007 Goals - TIPS Article.pdf
Fall Prevention
6.6.4
Does a process exist to conduct an

initial assessment, and subsequent
reassessments as appropriate on all
patients for fall risk?
Review assessment/reassessment process. The

assessment methods and/or tools used should be
consistent throughout the facility. The
reassessment process is determined at the facility
level, can be based on an interval of time or on
patient status change (transfer, medication, fall
incident, etc.).
JCAHO 2007 Goals - TIPS Article.pdf
286 of 578

6.6.4.1
Question:
Fall Prevention
NCPS Falls Toolkit and Fall

Prevention and Management
cognitive aid been distributed and
used?
The Falls Toolkit provides a compendium of

practical suggestions to improve falls programs
and reduce falls and injuries from falls.
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.
completefallstoolkit.pdf
Met
(1)
Partially
Met (2)
Not
Fall Prevention
6.6.5
Does the facility have effective tools Review any and evaluate effectiveness (I.e. Hip
or specialized equipment used in the Pads, patient surveys, labeling high risk patients,
facilities fall prevention strategy?
use of non-skid socks, Morse Fall Risk
Assessment, floor mats, walkers, canes, etc.)
Fall Prevention
6.6.5.1
Are these processes, tools or

It is important that the off shifts are given
equipment available to all staff on all concurrent tools and opportunities to improve the
shifts?
care of our patients.
Magnetic Resonance (MR) Imaging Safe Practices

6.7.1
Does the facility have a written MR

Safety Program?
Review written plan. The program should

include: The appointment of an MRI Officer; how
to secure MRI areas; a current list of MRI
compatible equipment in the facility; reporting of
MR incidents to NCPS and FDA; and training
requirements for all associated staff. Written
documents should be reviewed/updated at least
annually.
ACR Guide for Safety MR 2007.pdf
Mandatory; Priority B
MRI Hazard Summary 2008.pdf
287 of 578

Question:
6.7.2
Is there an on going training and

competency program for all effected
staff that covers hazard recognition
and policies/procedure?
Met
(1)
Partially
Met (2)
Not
Review training materials, plan and training

records. Check to see if that not only necessary
clinical personnel are trained, but that 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.
SEA 38 MRI.pdf

6.7.3
Are MR technicians trained and

competent in the specifics of MR
safety?
Review training materials, training plan, and

records. "Specifics of MRI Safety" include items
such as positioning of conductive leads, cables,
sensors, and the patients' extremities;
precautions required for unconscious patients;
MR Technicians having control of the
environment including entrance of all persons in
and out of the MR room.
SEA 38 MRI.pdf

6.7.4
Has the MR noise level been

MR scans can be loud with noise levels
assessed and patients provided with exceeding 100 dBA depending upon the type of
hearing protection if needed?
magnet (open or closed), the design and the
manufacturer. Interview staff, check required
policy procedure, look for posted signs.
SEA 38 MRI.pdf
288 of 578

Question:
6.7.5
Has the MR Hazard Supplement

developed by NCPS been shared
with all MR staff and discussed to
determine what barriers are being
implemented locally to prevent
adverse events?
The Hazard Summary published by NCPS in

2001 and updated in 2008 can serve as a
guideline and a reference for those working in an
MR environment. This Hazard summary can be
found on the NCPS intranet and internet
websites: vaww.ncps.med.va.gov or
www.patientsafey.gov
Met
(1)
Partially
Met (2)
Not

6.7.6
Has a plan been developed and

tested to address patients who need
emergency care (code) within the MR
room?
Regular code drills should be conducted in the

MR environment to help acclimate medical
responders to a consistent approach of removing
the patient from the magnet area. Codes or drills
should not be conducted in the magnet room.
SEA 38 MRI.pdf

6.7.7
Has the ventilation system for the

cryogenic gas been inspected by a
qualified individual to ensure it is
capable of functioning and not
obstructed?
Cryogen vent systems should be adequately

designed, as minimum design requirements have
been revised by some MR system suppliers, and
the system are to be inspected by qualified
individuals at least annually.
Medication Use Process Safety Concerns

6.8.1
Is VHA Quality Directive for UnitDose Packaging and Barcode

Labeling being followed?
Facility is required to have a written policy within

each inpatient pharmacy; and, all Medication
must have machine-readable bar-coded labels.
Quality unit-dose barcode.pdf
289 of 578

Question:
6.8.1.1
Are measurables of this directive

(VHA 2006-008) being followed up
on?
BCMA coordinators are responsible for

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.
Quality unit-dose barcode.pdf
Met
(1)
Partially
Met (2)
Not

6.8.2
Is communication with the patient

about medications part of the
adverse-drug event prevention
strategy?
These strategies should include medication

reconciliation and patient education regarding
prescribed medication.
Review patient education policy related to

medication education and IHI 5 Million Lives Tool
Kit: Prevent Adverse Drug Events. The facility
should have a standard approach throughout the
organization.
IHI 5 Million lives Kit - Med Rec.doc
ISMP_Book.pdf
JC- CAMH MM-06-01-03.pdf

6.8.3
Does the facility have contingency

plans in place for the loss of the
CPRS, POE, BCMA, and VISTA
system?
Review plan, interview staff.

6.8.3.1
Have these information system

contingency plans been tested (via a
drill), which included a
debriefing/critique?
It is important to ensure your contingency plans

are realistic and workable, it is not ideal to find
faults in the plan at the time of an emergency.
After testing, if problems are found the plan
should be adjusted accordingly.
290 of 578

Question:
6.8.4
Does the hospital show efforts to

manage High-alert medications
appropriately?
Met
(1)
Partially
Met (2)
Not
The facility Director is responsible for:

(1) Ensuring Potassium Chloride for Injection
Concentrate USP is only utilized as part of a
pharmacy-managed IV admixture program;
therefore, storage of the medication must be in
the pharmacy and is the responsibility of the
Pharmacy Service.
(2) Ensuring all Potassium Chloride for Injection

Concentrate USP is removed from all wards,
intensive care units, operating suites, and clinics.
NOTE: It is not to be considered as ward stock.
(3) Ensuring written medication use policies are

established that include guidance regarding safe
handling of Potassium Chloride for Injection
Concentrate USP, which must specifically state
that:
(a) It is VA policy not to have Potassium Chloride
for Injection Concentrate USP and other
hypertonic injectable solutions on the wards and
similar sites,
(b) Normal or routine VA practice is for IV
solutions to be mixed centrally,
(c) Cardioplegic solutions are prepared by, or
supplied by, Pharmacy Service (continued)...
IHI 5 Million Lives Kit - Prevent Harm from High-Alert Medications.doc

The Joint Commission MM.01.01.03
VHA Directive 2008-027 The Availablity of Potassuim Chloride for Injection Concentrate USP
291 of 578

Question:
6.8.4
(continued)... Does the hospital
(continued) show efforts to manage High-alert
medications appropriately?
Met
(1)
Partially
Met (2)
Not
...(continued) only,
(d) Unit dose drug distribution is required for
inpatient areas.
The Chief, Pharmacy Service, or designee, at VA

medical facilities that perform heart transplant and
open heart surgery, is responsible for ensuring:
(1) Cardioplegic solutions are only prepared by, or

supplied by, the Pharmacy Service.
(2) Those solutions are hand-delivered to the

operating room (OR) by Pharmacy Service.
(3) Those solutions are clearly labeled For

Cardioplegia Only, and contain the patients
name.
(4) Those solutions are secured in one location

in, or adjacent to, the cardiac surgery suite, i.e.,
the OR automatic medication dispensing machine
or the locked perfusionists cabinet.
(5)
is Kit
limited
toHarm
the from
cardiac
surgeon,
IHI 5Access
Million Lives
- Prevent
High-Alert
Medications.doc
The Joint Commission MM.01.01.03
VHA Directive 2008-027 The Availablity of Potassuim Chloride for Injection Concentrate USP
292 of 578

Question:
6.8.5
As VA Directive 2008-028 stipulates,

If requested by a VA prescriber, does
the VA medical center pharmacy staff
make urgently needed outpatient
prescription medication available to
patients within 24 hours of
notification, using the most
appropriate means available,
including CBOCs?
Met
(1)
Partially
Met (2)
Not
The facility Director, or designee, is responsible

for ensuring written policies are established to
address the timely delivery of urgently needed
outpatient prescription medications.
The VA prescriber must notify the pharmacy when

a new prescription or refill is urgently needed due
to a change in the patients clinical condition.
NOTE: If the prescriber determines that
medication is needed sooner than 24 hours, the
prescriber needs to make arrangements for the
patient to receive urgent medical care or instruct
the patient to contact the local emergency
medical care system.
The Chief of Pharmacy must contact the patient

or the patients
representative to determine the most appropriate
means to make the prescription available and
must take all necessary steps to make the
prescription available. This may include:
(1) Making the prescription available at a VA
pharmacy for pick up.
(2) Providing the prescription through a non-VA
pharmacy under contract to VA.
(3) Mailing or (continued)...
VHA Directive 2008-028 urgent outpt meds.pdf
293 of 578

Question:
6.8.5
(continued)... As VA Directive 2008(continued) 028 stipulates, If requested by a VA
Met
(1)
Partially
Met (2)
Not
...(continued) shipping the medication overnight

via commercial or government carrier.
prescriber, does the VA medical

center pharmacy staff make urgently
needed outpatient prescription
medication available to patients
within 24 hours of notification, using
the most appropriate means
available, including CBOCs?
VHA Directive 2008-028 urgent outpt meds.pdf

6.8.6
Has a anticoagulation therapy

management program been
implemented?
See Attachment A of the Draft VHA Directive on

Anticoagulation Therapy Management.
VHA DRAFT Dir Anticoag.DOC
Misidentification Prevention
6.9.1
Is there a SOP for ordering,

processing, transporting, and
transfusing blood or blood products
according to VHA Directive 1200029, Transfusion verification and
identification requirements of all
Sites?
VHA Directive requires a written Standard

Operating Procedure regarding verification of
patients' identification. Assessor to review SOP.
294 of 578

Question:
Medical/Surgical Resident PS Involvement (ACGME)
6.10.1
Have patient safety topics, exercises,

and educational opportunities been
incorporated in the resident
training/curriculum at your facility?
Met
(1)
Partially
Met (2)
Not
Incorporating patient safety at the prime level of

medical training can fulfill some requirements of
the Accreditation Council on Graduate Medical
Education (ACGME). And thereby help your
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 Comp.pdf
http://www.patientsafety.gov/curriculum/index.html
295 of 578

Question:
Surgical and Invasive Procedures Safety
6.11.1
Is a surgical policy been developed

and implemented to meet the criteria
in the VHA Directive 2006-030
Prevention of Retained Surgical
Items?
Policy should address: pre-closing wound

exploration for every case; towels, sponges,
pads, etc. are not to be cut or used for dressings
and must be detectable by radiograph; counting
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.
Met
(1)
Partially
Met (2)
Not

6.11.2
Has the Ensuring Correct Surgery

Directive been fully implemented?
To meet the Directive the following must be met:

(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 2004-028 (2002-070).pdf
296 of 578

Question:
6.11.3
Is a written local policy in place that

address moderate sedation done by
non-anesthesia providers?
A local written policy can be incorporated into an

overall facility sedation and anesthesia care
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 reevaluation 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.
Met
(1)
Partially
Met (2)
Not

6.11.4
Is there an effort being made to

reduce surgical complications?
IHI has recognized four practices that may help to

reduce the occur ace of surgical complications. 1.
Surgical Site Infection Prevention 2. Beta
Blockers for Patients on Beta Blockers Prior to
Admission 3. Venous Thromboembolism (TVE)
Prophylaxis 4. Ventilator-Associated Pneumonia
Prevention (For postoperative patients) Each of
the recommendations have a set of criteria. See
the IHI How-to-Guides for more information.
IHI 5 Milion Lives Kit - Reduce Surgical Complications.doc

IHI 5 Million Lives Kit - Prevent Surgical Site Infections.doc
297 of 578

6.12.1
Question:
Pressure Ulcer Management
Are pressure ulcers effectively

addressed through an assessment,
management and prevention
program that includes delineated
responsibilities outlined in VHA
Handbook 1180.2?
The responsibilities of the medical Center Director

are: a) at risk patients receive appropriate
assessment and care; b) a patient with pressure
ulcers is treated to heal, prevent infection and
prevent new sores; c) a system is in place to be
sure assessments are timely and appropriate;
Interventions are implemented, monitored and
revised as needed; changes in condition are
recognized, evaluated, reported to the
practitioner, and addressed; the interdisciplinary
team is educated in all aspects of this program.
Met
(1)
Partially
Met (2)
Not
Responsibility of the interdisciplinary clinical

team: implementing education to staff, patient &
family; b) Assessing the patient; c) performing a
skin risk assessment on all patients at the time of
admission, upon transfer or discharge utilizing the
Braden Scale. Outpatients are referred to team
for assessment; d) documenting the results of
assessments and entry into CPRS; e)
Formulating a plan of care based on assessment
that includes: acute care high risk patients
assessed (continued)...
IHI 5 Million Lives Kit - Pressure Ulcers.doc

VHA Handbook 1180.2 Assessment and Prevention of Pressure Ulcers
298 of 578

Question:
Met
(1)
Partially
Met (2)
Not
6.12.1
(continued)... Are pressure ulcers
(continued) effectively addressed through an
...(continued) at least every 48 hours. Long term

care patients weekly for 4 weeks, then monthly;
assessment, management and
nutritional status assessment; friction injuries are
prevention program that includes
prevented/reduced; wound care staff consultation
delineated responsibilities outlined in is obtained for patients with ulcers.
VHA Handbook 1180.2?
See referenced VHA Handbook for thorough
guidance.
IHI 5 Million Lives Kit - Pressure Ulcers.doc

VHA Handbook 1180.2 Assessment and Prevention of Pressure Ulcers
299 of 578

6.12.2
Question:
Is a pressure ulcer risk assessments

conducted at the time of admission
and are subsequent re-assessments
appropriate and timely in accordance
with VA Handbook 1180.2?
Risk Factors:
Met
(1)
Partially
Met (2)
Not
a. Evidence suggests that risk factors include

immobility and the associated friction and
shearing, incontinence, cognitive impairment, and
poor nutritional status.
b. An admission evaluation distinguishes the
patient at risk of developing a pressure ulcer, and
identifies the patient with existing pressure
ulcer(s) or areas of skin that are at risk for
breakdown. NOTE: Because a patient at risk can
develop a pressure ulcer within 2 to 6 hours of
the onset of pressure, the at-risk patient needs to
be identified and have interventions
implemented promptly in an attempt to prevent
pressure ulcers.
c. The admission evaluation helps define those
initial care approaches, and may identify
preexisting signs (such as a purple or very dark
area that is surrounded by profound redness,
edema, or induration) suggesting that deep tissue
damage has already occurred and additional
deep tissue loss may occur.
Risk Assessment: Pressure ulcers most
commonly occur on the lower body, (continued)...
VHA Handbook 1180.2 Pres Ulc.pdf /A Page=9
300 of 578

Question:
Met
(1)
Partially
Met (2)
Not
6.12.2
(continued)... Is a pressure ulcer risk ...(continued) primarily the sacral region and
(continued) assessments conducted at the time heels. Pressure ulcer risk assessment is an
of admission and are subsequent reassessments appropriate and timely

in accordance with VA Handbook
1180.2?
integral part of preventing pressure ulcers.

Factors that have been determined to place
patients at an increased risk of pressure ulcers
are sometimes
a. Intrinsic factors may include: advanced age,
immobility, impaired cognition, loss of sensation
(e.g. diabetes or spinal cord injury), poor
nutritional status and incontinence.
b. Extrinsic factors include: pressure, friction,
adaptive equipment (e.g., casts, splints,
wheelchair), and shear forces.
c. For patients with an activity or mobility deficit,
pressure ulcer assessment and prevention begin
upon admission (see App. B).
(1) Initial assessment of the patient includes a
review of any records available, interdisciplinary
history and physical evaluations, and information
from the patient and family
members.
(2) Initially, the Wound Care Specialist, or other
member of the Interdisciplinary team, needs to
determine the location, stage, and size of any
known or newly identified pressure ulcer.
d. Risk assessment is repeated on a regularly
scheduled basis or when there is a significant
change in the individuals condition
301 of 578

6.12.2.1
Question:
Is the pressure ulcer assessment

comprehensive and include the use
of the Braden Scale?
COMPREHENSIVE ASSESSMENT
Met
(1)
Partially
Met (2)
Not
A complete assessment is essential to an

effective pressure ulcer prevention and treatment
program. A comprehensive individual evaluation
helps the facility to identify the patient at risk
of developing pressure ulcers, the level and
nature of risk(s); and identify the presence of
pressure ulcers. The comprehensive assessment,
evaluates the patients intrinsic risks, the
patients skin condition, other factors (including
causal factors) which place the patient at risk for
developing pressure ulcers and/or experiencing
delayed healing, and identifies the nature of the
pressure to which the patient may be subjected.
a. The assessment needs to identify which risk
factors can be removed or modified. This
comprehensive assessment should also address
those factors that have been identified as having
an impact on the development, treatment and/or
healing of pressure ulcers, including, at a
minimum: risk factors, pressure points, nutrition
and hydration deficits, (continued)...
302 of 578

Question:
6.12.2.1
(continued)... Is the pressure ulcer
(continued) assessment comprehensive and
Met
(1)
Partially
Met (2)
Not
...(continued) exposure to moisture
include the use of the Braden Scale? and the impact of moisture on skin.
b. Pressure ulcers are to be assessed in the
context of the patients overall physical and
psychological health. Pressure ulcers must be
assessed and documented routinely, but
deterioration either in the patient's overall
condition or in the pressure ulcer itself mandates
more immediate reassessment as well as a
reevaluation of the treatment plan.
BRADEN SCALE
The Braden Scale is a clinically reliable and valid
instrument utilized by healthcare personnel to
score or predict an individuals level of risk for
developing pressure ulcers. The Braden Scale
assesses six domains: activity, dietary intake,
friction, mobility, sensory perception, and skin
moisture (see App. A of Handbook).
303 of 578

6.12.2.2
Question:
Are required pressure ulcer

assessments appropriately
documented?
Doumentation
Met
(1)
Partially
Met (2)
Not
a. pressure ulcer risk assessment using the

Braden Scale must be documented on acute care
and long term care inpatients at the time of
admission, upon inter or intra facility transfer,
discharge, and at other times as appropriate.
Outpatients who present with pressure ulcers, a
history of pressure ulcers, or who are identified as
potentially high-risk for pressure ulcers need to
be referred to the Interdisciplinary Team for
comprehensive assessment.
b. Acute care inpatients identified as being at risk
on the Braden Scale (score less than 18) must be
reassessed every 48 hours, and more frequently
if the risk potential is increased. All
long-term care patients must be reassessed
weekly for 4 weeks, and then at least monthly,
regardless of Braden score.
c. A risk assessment must be documented in a
narrative note, including describing any related
preventive and/or management measures taken
by the appropriate Interdisciplinary Team
members. When possible, use the (continued)...
304 of 578

Question:
6.12.2.2
(continued)... Are required pressure
(continued) ulcer assessments appropriately
documented?
Met
(1)
Partially
Met (2)
Not
...(continued) electronic medical record CPRSVeterans Health Information Systems and

Technology Architecture (VistA) imaging package
(or other electronic means of storage), to store
electronic wound photographs.
d. The documentation must:
(1) Be clear; (2) Be concise; (3) Be regular, i.e.,
weekly; (4) Be expressed in consistent language;
and (5) Indicate improvement or deterioration of
pressure ulcer and treatment.
NOTE: see Appendix F for further information.
e. If a pressure ulcer is identified upon
examination, a Wound Care Specialist and/or
other member of the Interdisciplinary Team, as
defined, must be consulted to validate the
etiology,
location, stage, and size of the pressure ulcer and
must initiate the following documentation:
(1) Location, (2) Stage, (3) Size (cm), (4)
Undermining, (5) Tunnel, (6) Sinus Tract, (7)
Necrotic Tissue, (8) Drainage, (9) Granulation,
(10) Epithelialization, (11) Pain (per 5th vital sign
criteria), (12) Odor, (13) Surrounding Skin, (14)
Erythema, (15) Other discoloration, (16)
Induration (hardness), and (17) Maceration.
f. Pressure ulcer and/or wound care orders must
be signed by a Primary Provider (Physician,
Physician Assistant, Advanced Practice Nurse) as
appropriate. Only trained Wound Care
305 of 578

6.12.3
Question:
Is the prevention of pressure ulcers

managed by the appropriate
caregivers (interdiciplinary team);
and is care planning a part of the
team's responsiblities including
patient/family edcuation?
PREVENTION
Met
(1)
Partially
Met (2)
Not
a. The first step in prevention is the identification

of the patient at risk of developing pressure ulcers
using the Braden Scale risk level (see App. C of
Handbook). This is followed by implementation of
appropriate individualized interventions and
monitoring for the effectiveness of the
interventions. Intensification of these
interventions is often required with any change in
level of risk as determined on the standardized
assessment. Prevention of pressure ulcers is an
interdisciplinary team responsibility. Effective
interdisciplinary teams provide systematic risk
assessment, implementation of preventive and
therapeutic measures, education of patient and/or
caregiver and/or significant other, documentation
of clinical status, and monitoring of incidence and
outcomes.
b. Interdisciplinary team will be comprised at least
the following: Nursing (RN, LPNu, and NA),
Primary Provider (Physician, PA, Advanced
Practice Nurses), Dietitian, Clinical Pharmacist
Specialist, (continued)...
306 of 578

Question:
6.12.3
(continued)... Is the prevention of
(continued) pressure ulcers managed by the
appropriate caregivers
(interdiciplinary team); and is care
planning a part of the team's
responsiblities including
patient/family edcuation?
Met
(1)
Partially
Met (2)
Not
...(continued) Rehabilitation Staff (e.g.,

Occupational Therapist, Physical Therapist), and
a Wound Care Specialist.
(1) The Primary Provider needs to be familiar with
team function and organization with established
protocols. Knowledge of these areas facilitates
their role as a team participant, as more effective
communicators, and as leaders in therapeutic
interventions.
(2) Nursing staff play a major role in coordinating
systematic preventive interventions.
(3) Dietitians are valuable resources for nutritional
assessments and recommendations for
supplements and methods for providing nutrition.
(4) Clinical Pharmacy Specialists can assist with
recommendations for ulcer management, product
availability, and parenteral nutrition formulation.
(5) Physical and Occupational therapists, as well
as, other rehabilitative staff are resources for
improving mobility, and devising or recommending
protective and pressure-relieving
devices.
CARE PLANNING
a. In addition to the patients total risk score, the
interdisciplinary team is responsible for the
patients care and will review each risk factor and
potential cause(s) individually to:
VHA Identify
(1)
Handbook 1180.2
thosePres
factors
Ulc.pdfthat
/A Page=11
increase the
307 of 578

6.12.4
Question:
Does the facility have the required

local procedures in place to assess
and treat patients and residents for
sink breakdown; and is the process
documented in accordance with VHA
Directive 2006-066 Reporting and
Tracking of Pressure Ulcers?
It is VHA policy that all acute care inpatients,

nursing home residents, home care and high risk
outpatients must be screened for risk of skin
breakdown, and must receive appropriate
interdisciplinary management with appropriate
documentation to support the review of these
processes.
VHA Directive 2006-066 Track Pres Ulc.pdf
Met
(1)
Partially
Met (2)
Not

6.12.4.1
Are organization processes in place

to meet the intent of the System-wide
Ongoing Assesssment and Review
Strategy (SOARS) assessment guide
for pressure ulcers and the MDS
Pressure Ulcer Quality Indicators for
Nursing Home Residents?
The SOARS assessment guide can be found at:

http://soars.vssc.med.va.gov/Assessment
%20Tools/default.aspx
The MDS Pressure Ulcer Quality Indicators for

Nursing Home Resident can be found at:
http:/www.cms.hhs.gov/NursingHomeQualityInits/
10_NHQIQualityMeasures.asp#TopOfPage
Pressure Ulcers_SOARS.doc
VHA Directive 2006-066 Track Pres Ulc.pdf /A Page=2
Violence Prevention
6.14.1
Are there existing processes,

Review written policy.
policies, or protocols that address the
handling of violent patients?
JCAHO_CAMH.pdf
308 of 578

6.14.2
Question:
Violence Prevention
Has the facility and/or VISN

implemented the use of behavioral
patient record flags (PRFs) into the
medical record (CPRS/VIST-A) to
indicate a potentially violent patient?
It is VHA policy that all facilities must have

installed the required patches and initiated
facility-wide use of Behavioral Patient Record
Flags (PRFs). Ensure that Category I Behavioral
PRFs are originated and accessible. Individual
Networks and facilities determine whether
optional Category II PRFs are to be used.
Category definitions are found in related VHA
Directive.
Met
(1)
Partially
Met (2)
Not
Hospital Acquired Infections Prevention

6.15.1
Has the recommendations for the

prevention of Norovirus (Norwalk-like
viruses) in VHA Information Letter IL10-2007-010 been applied?
Prevention recommendations are: early

identification; implementation of contact
precautions of infected patients (48-hours post
symptoms); infected staff should remain off duty
(48-hours post symptoms); cleaners to wear
masks; patient and staff hand hygiene and
training; and, environment of care cleaning
regimen (outlined in Information Letter) if
contamination of an area has occurred.
noro-factsheet.pdf
IL 10-2007-010 noro.pdf

6.15.2
Have stringent institutional practices

that minimize the potential for spread
and transmission of C. difficile been
implemented?
The following precautions are recommended in

the care of patients with C. Difficile: caregiver
should use gloves when in contact with the
patient along with the use of antimicrobial soap
after care is given (alcohol based hand rubs may
not be sufficient); private patient rooms should be
provided and disposable rectal thermometers
should replace electronic devices for affected
patients."
USH IL-10-2005-018.pdf
309 of 578

Question:
6.15.3
Has an influenza vaccination

program been implemented?
Met
(1)
Partially
Met (2)
Not
It is VHA policy that a program be implemented at

the recommendation of the CDC Advisory
Committee on Immunization Practices. The
program should include vaccinating target
groups; indications of who should not be
vaccinated; which vaccine of the two available in
the US should be given to which target groups;
the requirement of patient consent and education
about the vaccines given; required documentation
of related adverse events; and the use of antiviral
agents for Influenza. The VA influenza Toolkit
Manual for 2006-2007 offers strategies for
implementation.
VAInfluenzaManual0809.pdf
VHA Directive 2008-057 Flu 08-09.pdf

6.15.4
Has the MRSA Initiative been

implemented at the facility?
The Methicillin-Resistant Staphylococcus Aureus

(MRSA) Initiative was set forth in the VHA
Directive 2007-002. It includes the
implementation of the following: Active
Surveillance/Screening on unit where the initiative
has been implemented; where patients are found
positive Contact Precautions are required
(defined by CDC) and the patient will become
"flagged" as being positive until testing negative;
the Hand Hygiene program plays an important
role with MRSA-positive patients and should be in
place. The Resources required to fully implement
this Directive are: adequate staffing in the
Laboratory to support the initiative; and the
appointment of an MRSA Initiative Coordinator.
CDC Isolation2007.pdf
IHI 5 Million Lives Kit - MRSA.doc
310 of 578

Question:
6.15.5
Met
(1)
Partially
Met (2)
Not
Are measures in place for preventing VHA prevention recommendations outlined in IL

myiasis and is there a process for
10-2007-007 are to: standardize wound care
intervention if myiasis is discovered? needs through an established policy/procedure,
protocol, and/or dedicated wound care team;
maintain wounds in accordance with Information
Letter criteria items 2.a.1 (b) through (g); ensure
staff patients and families are educated about
proper wound care; control the environment of
care by minimizing exposure to flies through
sanitation, waste removal, and physical
exclusions at window and door openings coupled
with positive air flow/air intake. If an infestation
occurs, the following is recommended: care for
the patient and mitigating the source of flies (use
of a standard procedure); appoint a single person
to lead mitigation efforts of pest control,
environment of care and public relations; and
identification of the genus and species. Myiasis
can be health care-associated or community
related and should be addressed with all patients
including, those who are homeless, have chronic
open skin (continued)...
USH IL-10-2007-009.pdf

6.15.5
(continued)... Are measures in place ...(continued) lesions, are comatose, or have
(continued) for preventing myiasis and is there a other disabilities.
process for intervention if myiasis is

discovered?
USH IL-10-2007-009.pdf
311 of 578

Question:
6.15.6

reduce the incidence of central line
infections?
Central venous catheters can disrupt the integrity

of the skin, making infection with bacteria and/or
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 nontunneled catheters; 5) Daily review of line
necessity, with prompt removal of unnecessary
lines.
IHI 5 Million Lives Kit - Prevent Central Line Infections.doc
Met
(1)
Partially
Met (2)
Not

6.15.7

reduce the incidence of VentilatorAssociated Pneumonia (VAP)?
VAP is the leading cause of death among

hospital-acquired infections. VAP can prolong
time spent on the ventilator, length of ICU stay,
and length of hospital stay after discharge from
the ICU. The Institute of Healthcare
detailed guidance on how to help reduce
incidence of occurrence by following the four
components of "the ventilator bundle." These
components are: 1. Elevation of the head of the
bed to between 30 and 45 degrees. 2. Daily
sedation vacation and daily assessment of
readiness to extubate. 3. Peptic ulcer disease
(PUD) prophylaxis. 4. Deep venous thrombosis
(DVT) prophylaxis (unless contraindicated)
IHI 5 Million Lives Kit - Prevent Ventilator-Associated Pneumonia.doc
312 of 578

Question:
6.15.8
Are patients that are high-risk for,

exposed to, diagnosed with, or being
treated for HIV being managed
appropriately through the
implementation of VHA Directive
2008-082 National HIV Program and
USH IL-10-2005-17?
Met
(1)
Partially
Met (2)
Not
Directive 2008-082 stipulates (Exerpts from the

Directive):
Now that HIV can be seen as a treatable chronic

disease, priorities for VHA include: the need for
earlier diagnosis of HIV infection, improved
access to care for HIV-infected veterans; the
integration of HIV and primary care, providing
ongoing prevention services to veterans living
with HIV, and a focus on high-quality care as the
HIV-positive veteran population ages. The first
priority is particularly important, given that the
CDC has recommended making HIV testing part
of routine medical care (see subpar 5a), and that
there may be a high prevalence of undiagnosed
HIV infection among veterans seen at some VHA
facilities (see subpar 5c).
Facility Director. The facility Director is

responsible for:
(1) Identifying an HIV Lead Clinician to be the
principal point of contact for communications and
reporting from, and to, on HIV-related issues. The
HIV Lead Clinician must be a provider committed
to excellence in the (continued)...
IL-10-2005-17 HIV testing.pdf

VHA Directive 2008-082 National HIV Program
313 of 578

Question:
6.15.8
(continued)... Are patients that are
(continued) high-risk for, exposed to, diagnosed
with, or being treated for HIV being

managed appropriately through the
implementation of VHA Directive
2008-082 National HIV Program and
USH IL-10-2005-17?
Met
(1)
Partially
Met (2)
Not
...(continued) diagnosis and care of HIV-infected

veterans.
(2) Reviewing, on an annual basis, the contact
information for the facilitys HIV Lead Clinician.
Any changes in staffing or the contact information
need to be faxed by January 15 of each year to
the CPHP at 202-273-6243, or sent by email to
publichealth@va.gov (include the name, address,
phone, fax, e-mail address, and other locator
information for the HIV Lead Clinician).
c. Facility HIV Lead Clinician. The HIV Lead
Clinician is responsible for:
(1) Serving as an advocate for excellence in
patient-centered diagnosis and care of HIVinfected veterans.
(2) Serving as a point of contact for
communications to and from the CPHP office
regarding the VHA HIV Program.
(3) Working with the local HIV CCR Coordinator
to optimize the use of local population
management tools and for reporting to Chief of
Staff and Facility Director. NOTE: Responsibilities
of the CCR Coordinator can be found at:
http://vaww1.va.gov/vhapublications/ViewPublicat
ion.asp?pub_ID=1383
Recommendation from IL-10-2005-17:

Given the great opportunity to prevent morbidity
and mortality,
IL-10-2005-17
HIV testing.pdf
to benefit the health of veterans
VHA Directive 2008-082 National HIV Program
314 of 578

6.16.1
Question:
Fire Prevention for Patient Safety
Has the facility abided by the

directions set forth in VHA Directive2004-037 Planning for Fire
Response?
Actions for this Directive include: Implementation

of a local policy; and, Implementation of staffing
levels for fire response based on assessed needs
(for overnight patient care buildings not fully
sprinkler-protected the staff to patient ratio is 1
responder to every 2 non-ambulatory patients; or,
overnight patient care buildings fully sprinklerprotected the ratio is 1 responder to every 4 nonambulatory patients.)
Met
(1)
Partially
Met (2)
Not

6.16.2
Have the appropriate measures been

implemented to reduce the fire
hazard of smoking when oxygen
treatment is expected for inpatients
as required by VHA Directive 2006021?
A policy must be written and implemented that

addresses items below: Each facility must ensure
that smoking is prohibited in patient sleeping
rooms; that oxygen cylinders/delivery equipment
are not permitted within smoking shelters; and
patients who smoke are offered nicotine
replacement therapy. A fire-risk assessment must
be conducted for all new oxygen therapy
inpatients who smoke, with reassessments as
directed. Policy must also stipulate that upon
identification of high risk inpatients the following
actions are to be implemented: A committee must
review each case to determine restrictions for
environmental or clinical requirements; and
patient must be assigned a to sleeping room that
is either protected by quick response sprinklers,
or, standard response sprinklers AND smoke
detection, or, located as close to the nursing
station as possible. Also, high-risk patients and
their family members/visitors must sign an
acknowledgment that smoking materials may not
be brought into the (continued)...
315 of 578

Question:
6.16.2
(continued)... Have the appropriate
(continued) measures been implemented to
Met
(1)
Partially
Met (2)
Not
...(continued) facility; and high-risk patients are be

given fire-resistive sleep ware.
reduce the fire hazard of smoking

when oxygen treatment is expected
for inpatients as required by VHA
Directive 2006-021?

6.16.2.1
Has appropriate action been taken

for home care patients who have
oxygen therapy prescribed as well?

addresses items below: A fire risk assessment is
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.
316 of 578

6.17.1
Question:
Other Patient Safety Initiatives
Has a facility assessment of all

patient beds been completed in
accordance with 2001 VHA Alert on
Bed Rail Entrapment and 2005 FDA
guidance to reduce entrapments with
appropriate actions taken?
The 2001 VHA Patient Safety Alert on Bed

Entrapment requires an assessment hospital
beds which address two entrapment zones.
Official FDA guidance was released in March
2006 which addresses the assessment of 4
zones. Ensure the facility has initiated a hospital
wide assessment with marking of non-compliant
beds and a plan for replacement of these beds.
Met
(1)
Partially
Met (2)
Not
FDA Guidance to Reduce Entrapments 2006.pdf

BedEntrap.pdf

6.17.2
Has the facility developed and

implemented a policy to address outof-operating room airway
management as accordance to VHA
Directive 2005-031?

addresses items below: Confirmation of
competence of staff who perform airway
management, and all trainees must be supervised
by licensed independent practitioner who is
privileged for airway management or equivalent;
A requirement for use of devices to confirm tube
placement in concert with auscultation, (i.e.,
portable capnography, esophageal bulbs,
syringes, or colorimeteric devices) is required.
Also, stipulation regarding the use of esophageal
detection devices (EDD) and end-tidal carbon
dioxide (ETCO2) colorimeteric devices should be
clarified via local policy. This policy should only
address out of the operating room
emergent/urgent situations, such as a "code."
Outpatient facilities are exempt from having a
local policy, if emergency airway management is
not performed in the facility.
317 of 578

6.17.4
Question:
Has the facility developed and

implemented a policy to address the
sterility of non-biological implanable
devices in accordance with VHA
Directive 2007-001?
This Directive stipulates implementing a policy

with the componets of this program, which are: A
description of the processes and procedures to
be followed if the non-biological implantable
device is not sterile upon receipt; Who in the
operating room is responsible for: (a) Checking
the integrity of the package appropriate color
change of the external chemical indicator tape,
expiration date, and (b) Documenting this check
prior to use; Who in the facility is responsible for
managing an inventory of all routinely-used nonbiological implants, such as screws or nails or
plates that are needed in sets of assorted sizes
and not on consignment. Relase of statements
that: non-biological implantable devices are not
to be sterilized by flash sterilization; all
sterilization loads containing these non-biological
implantable devices are monitored with the
appropriate biological monitor; and, after
sterilization, non-biological implantable devices
are quarantined in SPD and not released
(continued)...
VHA Directive 2007-001 Implantable Devices.pdf
Met
(1)
Partially
Met (2)
Not

6.17.4
(continued)... Has the facility
...(continued) until the spore test is found to be
(continued) developed and implemented a policy negative (48 hours).
to address the sterility of nonbiological implanable devices in

accordance with VHA Directive 2007001?
VHA Directive 2007-001 Implantable Devices.pdf
318 of 578

6.17.5
Question:
Has the use of Rapid Response

Teams been implemented?
Rapid Response Teams or Pre-code teams can

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
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.
IHI 5 Million Lives Kit - Rapid Response Teams.doc
Met
(1)
Partially
Met (2)
Not

6.17.6

improve the treatment and outcomes
for patients with Acute Myocardial
Infraction (AMI)?
Studies have shown that patients with AMI should

receive specified components of care in order to
reduce morbidity and mortality. Specificities of
individual treatment plans may vary based on
clinical condition and other co-morbidities,
however, there is strong evidence in the literature
to support that seven key care components
should be provided to all AMI patients. The
Institute of Healthcare Improvement's 5 Million
Lives Campaign is using this clinical guidance to
drive the AMI element. The 7 components of care
are: 1) Early administration of aspirin; 2) Aspirin at
discharge; 3) Early administration of beta-blocker;
4) Beta-blocker at discharge; 5) ACE-inhibitor or
angiotensin receptor blockers (ARB) at discharge
for patients with systolic dysfunction; 6) Timely
initiation of reperfusion (thrombolysis or
percutaneous intervention); 7) Smoking cessation
counseling.
IHI 5 Million Lives Kit - Improved Care for Acute Myocardial

Infarction.doc
319 of 578

6.17.7
Question:

improve the treatment and outcomes
for patients with Congestive Heart
Failure (CHF)?
Numerous studies have established a firm

evidence base indicating that specific
components of CHF care reduce morbidity and
mortality. IHI has recommended the following
seven key care components be provided to all
CHF patients, in the absence of contraindications
or intolerance: 1. Left ventricular systolic (LVS)
function assessment. 2. ACE-inhibitor or
angiotensin receptor blockers (ARB) at discharge
for CHF patients with systolic dysfunction (Left
Ventricular Ejection Fraction (LVEF) <40%). 3.
Anticoagulant at discharge for CHF patients with
chronic or recurrent atrial fibrillation (AF). 4.
Smoking cessation advice and counseling. 5.
Discharge instructions that address all of the
following: activity level, diet, discharge
medications, follow-up appointment, weight
monitoring, and what to do if symptoms worsen.
6. Influenza immunization (seasonal). 7.
Pneumococcal immunization
IHI 5 Million Lives Kit - CHF.doc
Met
(1)
Partially
Met (2)
Not

6.17.8
Have the recommendations in the

information letter IL 10-2007-018 for
Intermittent Catheterization and the
use of sterile catheters been
implemented in that catheters are not
reused?
VA clinicians should follow the manufacturers

instructions for catheter use. Catheters identified
as single-use devices should not be re-used in
any setting. Patients should be provided with an
adequate number of catheters to use a sterile
catheter each catheterization. Patients, family
members, and attendants need to be informed
that catheters are identified for single-use only.
IL 10-2007-018 inter cath.pdf
320 of 578

Question:
Tubing Management
6.18.1
Met
(1)
Partially
Met (2)
Not
Does the organization have a tubing Ask if a tubing management policy is available for
management policy?
review. I Check for inclusion of basic elements
listed herein such as who can reconnect tubings,
retracing of tubings as part of standard practice,
etc.
ISMP Safety Alert June 2004 - misconnections.pdf
Recommended
JC SEA Issue 36.pdf
Tubing Management
6.18.2
Does the organization have a policy

that identifies high risk tubings such
as epidural or arterial lines and which
requires labeling of such high risk
lines?
Interview staff regarding what tubings are defined

as high risk by the organization and what labeling
practice they have standardized across the
organization.
Recommended
JC SEA Issue 36.pdf
Tubing Management
6.18.3
Does the organization have as a

Ask to review policy. Interview non-clinical staff
policy that non-clinical staff not be
about tubing connections/disconnections. Provide
allowed to connect and disconnect
simple scenario and elicit their response.
patient tubings but to obtain clinical
staff assistance for any perceived or
real need to connect or disconnect
tubing?
Recommended
JC SEA Issue 36.pdf
Tubing Management
6.18.4
Does the organization have a policy Ask to review policy.

in place prohibiting purchase of nonintravenous equipment (e.g., blood
pressure devices, oxygen tubing,
etc.) that can physically connect with
or without force with luer slip and luer
lock IV line connectors?
Recommended
JC SEA Issue 36.pdf
321 of 578

Question:
Tubing Management
6.18.5
Met
(1)
Partially
Met (2)
Not
Do all staff, including housekeeping, Ask to see content used for orientation of new
ancillary staff, transport staff,
employees.
volunteers, and students have
content included in their orientation
and annual review about the risks
associated with tubing
misconnections?
Recommended
JC SEA Issue 36.pdf
Tubing Management
6.18.6
Can the organization describe, as

part of its staffing measures and
improvement activities, efforts it has
taken to identify and manage risks
associated with staff fatigue and
mistakes such as misconnections?
Ask to see staffing measures improvement

documents and identify whether the organization
has included staff fatigue as a variable. This
would be evidenced by things such as controls
related to overtime, number of days worked in
sequence, shift work considerations, etc.
Recommended
JC SEA Issue 36.pdf
Tubing Management
6.18.7
Can the organization provide at least Interview staff that are involved with new
one example of having conducted
equipment purchases.
performance, safety, and usability
testing prior to a new tubing and/or
catheter purchase to identify
potential misconnection risks?
Mandatory
JC SEA Issue 36.pdf
322 of 578
Patient Safety Assessmen

Implementation Elemen
Element 7.1
Long Term Care
Element 7.2
Behavioral Health Care Units (Locked)
Element 7.3
Acute Care
Element 7.4
Intensive Care
Element 7.5
Operating Room Care
Element 7.6
Radiology
Element 7.7
Pharmacy
Element 7.8
Outpatient Areas
Element 7.9
Domicilary
essment Tool
n Element 7
ked)

Part II Implementation
LONG TERM CARE UNITS 7.1
7.1.1.1
Facility unit/ward name:
Question:
Bed Safety
If bed rails are installed/used are

they free of entrapment potential (for
patients identified as high risk for
entrapment): 1) rail to mattress, 2)
between split rails, 3) rail to board
-either end, 4) board to mattress, or,
5) within rail?
Entrapment can result in suffocation. Follow July

2001 NCPS Patient Safety Alert Action items
including: assessing existing beds for horizontal
gap between mattress and bed rail must be less
than 2 3/8 inches when the mattress is pushed to
the opposite side; permanently mark all noncomplying 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.
Met
(1)
Partially
Met (2)
Not
FDA Hospital Bed Safety.pdf

BedEntrap.pdf
Mandatory
BedEntrapPoster.pdf
Bed Safety
7.1.1.2
When beds and/or mattresses are

New beds brought into the facility should meet
re-ordered for purchase or lease are the entrapement criteria.
they reviewed for entrapment risk?
Recommended
Bed Safety
7.1.1.3
Are non-compliant beds clearly

marked as to indicate entrapment
risk?
All new beds must meet requirement, & existing

non-compliant beds marked. Staff should be
knowledgeable about the markings and
requirements.
Mandatory
BedEntrap.pdf
Bed Safety
7.1.1.4
Long Term Care - 7.1
Are beds designed to facilitate

patient transfer?
Bed attributes would include: Stand assistive

devices to assist patients to stand, room for base
of lifting device to fit under the bed, clear area
around bed for staff and lifting equipment access,
variable position capabilities.
Recommended
OSHA Guidelines Nursing Homes.pdf
Long Term Care - 7.1 - Version: 01.30.2009
325 of 578

Question:
Bed Safety
7.1.1.5
Met
(1)
Partially
Met (2)
Not
Is the appropriate bed-type matched An overall evaluation of beds in the facility is

to the level of care needed for each recommended, and there should be a
patient?
determination if appropriate beds are placed in
the appropriate care environment. Issues to
consider are: LTC patients can acquire bed sores;
cardiac patients beds designed to facilitate CPR,
etc.
Recommended
Bed Safety
7.1.1.7
Are measures in place to help

In addition to facility fire prevention practices,
prevent fires resulting from the use of extra steps should be taken for electrical beds:
electric hospital beds?
Connect the bed's power cord directly to a wallmounted receptacle without the use of extension
cords or power strips; Do not cover any power
cord with a rug or carpet; conduct regular
inspections for dust build up (bed frame,
motor/hardware, mattress, etc.); regularly test bed
movement and hand/panel controls; inspect the
patient control panel (if cracked liquids can get
in); check that circuits are not overloaded with
other equipment; encourage reporting of improper
functioning; and assure that manufacturers'
recalls are followed.
Recommended
FDA Bed Fires.pdf
Code Carts
7.1.2.1
Are code carts locked when not in

use, and is equipment in good
condition clean and covered?
Drugs have potential to be taken from unsecured

carts in common areas. Verify cart inspection
records.
Mandatory
Code Carts
7.1.2.3
Are equipment and drugs easily

retrievable on/in code carts, and is
there standard organization in all
carts throughout the hospital?
Standardizing the location of supplies and

equipment will increase the code response
efficiency. An oversight committee should exist
(i.e., Cardiac arrest committee) and the
committee should provide recommendation for
how carts are maintained.
Recommended
326 of 578

Question:
Code Carts
7.1.2.3.1
Met
(1)
Partially
Met (2)
Not
Are there post-code, other debriefing Evaluation of codes in key for improving
forms that are filled out to offer
performance. Review any documentation that is
feedback on how codes are
available regarding code review if any.
preformed to allow feedback
regarding process improvements?
Recommended
Code Carts
7.1.2.4
Is the VHA modified version of the

Inspect top of cart and review checklist of
ECC (Emergency Cardiac Care) AHA contents if provided.
(American Heart Association)
Handbook of Cardiovascular Care
Cognitive Aid located on all carts?
Recommended
Code Carts
7.1.2.5
Are CO2 detectors available on code Inspect carts. Adjunctive devices (i.e. colorimetric,
carts for confirming esophageal
syringe, or bulb devices) should be adequately
intubations?
stocked and readily available for use in all carts.
Review cart checklist talk with cart preparers in
SPD (Supply Processing and Distribution)
Service.
Mandatory
Code Carts
7.1.2.6
Is there a standardized system (e.g.

checklist) or method used to verify
that code carts are fully stocked and
properly equipped before they are
sent to the units and a daily
inspection on each unit?
Cart should be locked with an integrity seal, look

for a valid checklist or equivalent system on the
cart, dated with last check/update date. Items
such as these should be on the checklist: O2
tank volume; tubing ; CO2 detectors; appropriate
medications; AED (or other defibrillators) and
suction machine functionality; laryngoscope with
batteries; cardiac board, etc.
Recommended
327 of 578

7.1.3.1
Question:
Electrical Safety
Are electrical receptacles in, or

serving, wet areas or behavioral
health areas provided with Ground
Fault Circuit Interruption (GFCI)
protection or an isolated power
system?
All areas designated as wet locations, or areas

used for behavioral health patients, require (wet)
or recommend (behavioral health) ground-fault
protection. These types of receptacles are
designed to stop the flow of electrical current,
preventing shock or electrocution. For behavioral
health areas, electrical receptacles must be
protected, covered, or completely removed in
patient rooms to protect patients who my try to
harm themselves.
Met
(1)
Partially
Met (2)
Not
http://vaww.ceosh.med.va.gov/
NFPA 99 ch 4.pdf /A Page=03
Mandatory
Electrical Safety
7.1.3.2
Are electrical receptacles fitted with Observe conditions on unit.

covers, secured, and free of loose or
exposed wiring?
Mandatory
Electrical Safety
7.1.3.3
Are emergency power receptacles

appropriately identified and only used
for equipment needing to be on
emergency power circuits?
Staff should be able to identify emergency

receptacles. Assessor should inspect locations of
these outlets that should be the color red or have
a red sticker identifing them.
Mandatory
Electrical Safety
7.1.3.4
Are electrically powered medical

devices in good condition and in line
with the facility Preventative
Maintenance (PM) process?
Cords are free of physical defects including

cracks, frayed ends, or missing prongs. The
presence of a PM sticker to indicate devices are
up to date is also important.
NFPA 99 Ch 8.pdf /A Page=03
Mandatory
VHA Directive 2008-011 Elect Safety Equip.pdf
328 of 578

Question:
Electrical Safety
7.1.3.5
Met
(1)
Partially
Met (2)
Not
Are there at least 4 receptacles (6 in Inspect patient rooms.

critical care) for each patient bed?
Mandatory
Electrical Safety
7.1.3.6
If used, are power cords and

electrical extension cords placed
where they are free from mechanical
damage, properly sized (gauge) to
prevent overheating, and arranged
so that they do not present a tripping
hazard?
Facilities should strive to eliminate the use of

extension cords for small working spaces such as
the operating room, patient rooms, or exam
rooms. A plan should be in place to install
permanently affixed receptacles supplied by the
appropriate electrical circuit (emergency or critical
branch) if cords are being used.
Recommended
Environmental and Housekeeping Safety

7.1.4.1
Are hot water temperatures taken

Temperature should be less than 120 F at the tap
manually using a thermometer before and 110F in baths.
patient use or immersion (including
partial immersion) takes place?
Mandatory

7.1.4.2
Are supply and return air registers

clean and free of lint and dust?
Observe conditions on the unit.
Mandatory

7.1.4.3
Does general housekeeping appear

to be a priority?
Cleanliness, sanitation, odor, etc.
Mandatory
329 of 578

Question:
7.1.4.4
Are storage rooms neat, organized,

well light and temperature
controlled? Is all storage 18" below
fire sprinklers and off the floor?
Met
(1)
Partially
Met (2)
Not
Inspect storage areas. Organized, well light

rooms will help prevent mistakes. Ensuring
extreme temperatures do not occur will uphold
the integrity of the supplies. Keeping boxes off of
floor keeps supplies sanitary.
Mandatory
JC- CAMH LS-02-01-35.pdf

7.1.4.5
Are egress corridors and stairways

unobstructed and kept free of
storage?
Observe conditions on the unit by checking for

blocked doors.
NFPA 101 ch 7 - 2009.pdf
Mandatory

7.1.4.6
Are patient or resident areas free of

unlabeled or unattended containers,
such as cleaning products or
medication?
All cleaning products, medication, employee food

or drink, etc., should not be left in patient care
areas or patient rooms.
Mandatory

7.1.4.7
Are hazards clearly identified and

properly controlled during
construction and renovation?
Pre-construction meetings should proactively

address all necessary interventions to remediate
such issues. However, patient/resident or staff
concerns may flag potential problems. Examples
of hazards: walkways maintained; marked exit
paths; guarded floor openings and overhead
hazards; dust generation; and excessive noise.
29CRF 1926.20(b).pdf /A Page=1
Mandatory
330 of 578

Question:
7.1.4.8
Met
(1)
Partially
Met (2)
Not
Are high hazard areas such as:

High hazard areas must be locked to prevent
Roofs, service areas, medication
access to patients/residents and have warning
rooms, labs, radiation areas,
signs and labels.
confined spaces, high voltage areas,
laser areas, low use areas (such as
sub-floors and interstitial spaces),
etc. labeled with appropriate signage
and locked to prevent unauthorized
entrance?
Mandatory
VA Directive 7703c(4)(a)

7.1.4.10
Are steps taken to eliminate/control

"pests" in the hospital environment?
Infestations can occur, such as myiasis, without

preventative measures or monitors. Special
considerations should be made for sterile
environments.
Mandatory
VHA Program Guide 1850.2 Pest Control.pdf /A Page=6
Equipment Safety
7.1.5.1
Is medical equipment being

Check inspection tags, or other identifiers on the
inspected in accordance with the
equipment that indicates it has been inspected.
Preventative Maintenance Program? Interview staff to determine how to interpret
identifiers.
NFPA 99 CH 8.pdf
Mandatory
Equipment Safety
7.1.5.2
Is back up patient care/monitoring

equipment readily available in the
event of failure and or emergency?
Uninterruptible monitoring and support should be

planned for.
Recommended
331 of 578

7.1.5.3
Question:
Equipment Safety
Is the equipment used on each

patient positioned in a way that it is
evident the equipment is in use for
that patient?
Multiple reports have been received of patients

being inadvertently shocked while on external
pacer/defibrillators. (The patient is connected to
the pacer/defibrillator and the curtain around the
bed is pulled closed with the equipment on one
side and the patient on the other, shift change
occurs and the defibrillator is tested while it is still
pacing the patient).
Met
(1)
Partially
Met (2)
Not
Recommended
Equipment Safety
7.1.5.4
Are alarms audible by care staff,

unique in tone and pitch to prevent
masking*, and are limits
appropriately set to reduce unwanted
or false alarms?
The unit layout/configuration (e.g., walls, doors,

size) and ambient noise levels impact whether
staff will hear the alarms. Nuisance alarms are
caused when limits are not appropriately set, this
can create staff complacency, annoyance to
patients, and results in a delayed staff response
(cry wolf syndrome).
*Masking occurs when the frequency

and intensity of two independent
separate alarms blend together. "
Observe conditions in the unit and interview staff
as to what is done during breaks to cover patient
monitoring. Clinical alarms, bathroom alarms, and
nurse calls are included here.
Mandatory
Equipment Safety
7.1.5.5
Are work arounds avoided in the use Due to factors listed above, devices can be
of medical devices with alarms?
disabled, turned off, turned down, etc. Signs of
workarounds include: post it notes suck to
equipment, worn silencer buttons, and taped
down or temporally disabled buttons.
Recommended
332 of 578

7.1.5.6
Question:
Equipment Safety
Is the equipment designed such that

its operation is intuitive to the user
and does not require use of adjunct
devices to complete the required
tasks?
Should not see post-it notes or permanently

posted signs indicating warnings about seemingly
logical machine operation (i.e. a sign reading
such messages as: "Don't press 'ENTER' key to
enter data.") Interview staff and inspect
equipment in area.
Met
(1)
Partially
Met (2)
Not
Recommended
Equipment Safety
7.1.5.7
Is patient care and monitoring

equipment positioned so that
caregivers can easily reach and/or
read displays and controls?
All screens/interfaces are readable and at or near

eye level; key pads within reach; equipment is not
blocking each other; adequate space to move
around, including head clearance on mounted
devices.
Recommended
Equipment Safety
7.1.5.8
Are liquids kept away from medical

equipment?
To prevent spillage which can result in

malfunctioning.
NFPA 70 Article 110-2008.pdf
Recommended
VA Circular 10-90-035.pdf
Equipment Safety
7.1.5.9
Are disposable medical

devices/supplies stored in a way that
the integrity of the devices is kept
intact (i.e. not bent or folded)?
Inspect storage rooms and other stock areas in

the area/unit (e.g. folding supplies like hoses and
tubing causes kinking that has prevented them
from functioning properly).
Recommended
Equipment Safety
7.1.5.11
Are locations of AEDs and

Placing this equipment in the same location of
defibrillators standardized throughout each care unit will assist staff who work on or
the patient care areas of the facility? between several care units locate the equipment
during emergent situations.
Recommended
333 of 578

7.1.5.13
Question:
Equipment Safety
Has the facility eliminated sterile

water (in forms easily confused with
medications) from ward stock?
Having sterile water for injection available in ward

stock, either in multi-dose vials or bags, creates
the potential for confusion with intravenous
medication/fluids. Warnings have been published
(ISMP) regarding water being confused with other
medications resulting in fatal hemolysis. If soft
bags are unavoidable, due to equipment, 2 liter
bags are preferred, however they still carry a
potential vulnerability since they can be attached
to intravenous lines. Engineering their use out is
best when new equipment is purchased. If sterile
water is in ward stock for irrigation purposes,
plastic bottles that require tubing that cannot be
connected to intravenous lines are preferred.
Met
(1)
Partially
Met (2)
Not
FDA PS News_ Show #22 12-03.pdf

ISMP 9-03 - Preventing Medication Errors.pdf
Recommended
NCPS Alert 4-6-06.pdf
Equipment Safety
7.1.5.14
Is the use of cell phones or other

devices that can affect monitoring
and other medical equipment
controlled in applicable areas as
specified in local policy?
Look for signage, and ask staff about

policy/protocols.
Recommended
Escape and Elopement Prevention

7.1.6.1
Is a system in place to clearly identify Look for screening processes, such as colored
high risk escape or elopement
gowns, photos, designated identifiers for these
patients to staff?
patients, etc.
Recommended
Escape Elopement Cognitive Aid.pdf

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
334 of 578

Question:
7.1.6.3
Met
(1)
Partially
Met (2)
Not
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

7.1.6.4
Are annual drills of the full missing

patient process (grid search)
conducted at least annually if the
plan wasn't exercised during a real
event?
Review records of drills or critiques of missing

patient searches.
Mandatory

7.1.6.5
Is a risk assessment for elopement

completed at the time of admission
or transfer and regularly during the
patients stay?
Awareness of the potential for

elopement/wandering behavior is the first step in
prevention. Review documentation or interview
staff to verify that the assessment is being
completed. Consider using electronic flags in
CPRS to inform clinicians if the patient is a high
risk. A change in the patients care (i.e., to a new
bed/unit, or new/change in medication) is a key
time for reassessment.
Mandatory

7.1.6.5.1
Are staff familiar with the faciliities

Ask staff working in the area to describe the
elopement risk assessment process? process.
Mandatory
335 of 578

Question:
7.1.6.6
Met
(1)
Partially
Met (2)
Not
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.
Mandatory

7.1.6.7
patients to staff?
patients, etc.
Recommended
Fall Prevention
7.1.7.1
Are all patient/resident rooms,

procedure rooms and common areas
provided with adequate lighting so
that the patients ability to ambulate
safely is not impeded?
Observe conditions on the unit. Patient sleeping

rooms and private bathrooms should be provided
with nightlights. Assess for shadows or glare that
may adversly impact ambulation.
Mandatory
Fall Prevention
7.1.7.2
Are mechanical assist devices used

to lift or transfer patients accessible
and used by staff when needed?
Have staff show example, and conduct interviews

to determine facility consistency.
Recommended
Fall Prevention
7.1.7.2.1
Are preventative measures

implemented to prevent falls from
manual lifting and/or handling
patients?
Staff training, proper number of staff present, no

obstructions in lift area.
http://vaww.ncps.med.va.gov/Tools/CognitiveAids/FallPrev/index.html
Recommended
SPHMAlgorithms.pdf
336 of 578

7.1.7.3
Question:
Fall Prevention
Are all floors in patient/resident

rooms or procedure rooms free of
environmental slipping and tripping
hazards?
Floors should be free of liquids, electrical cords,

wires, tubes, or other connectors which can
create fall hazards. Patient/resident/procedure
rooms should be free of floor clutter or other low
hanging objects that could be a tripping hazard.
Mandatory
Met
(1)
Partially
Met (2)
Not
Fall Prevention
7.1.7.4
Are shower/bathroom areas provided

with adequate lighting, proper
drainage, non-slip floor surfaces, and
installed handrails?
Inspect areas. Bathrooms should be provided

with night lights. Assess bathroom flooring
conditions for excessive moisture and water build
up. Also assess for use of non skid floor surfaces
to prevent falls. If raised seats are used on toilets
they should be a contrasting color that is visible to
the patient.
Mandatory
Fall Prevention
7.1.7.5
Are call buttons within reach of the

patient?
Inspect all areas.
Recommended
Sentinel Event Alert #14.pdf
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?
Mandatory
Fall Prevention
7.1.7.7
Does the facility have a Fall

Prevention & Management Protocol
or equivalent?
Interview staff - protocol should evaluate: 1) A risk

screen; 2) Protective device matched to risk level;
3) First responder assessment to identify patients
for immediate physician evaluation and 4)
Treatment plan for follow up, post fall.
Mandatory
337 of 578

7.1.7.8
Question:
Fall Prevention
Is a uniform tool used to assess

which patients are at high risk for
falls, and is there criteria to
determine: 1) When they are
assessed, and 2) What triggers a
reassessment, including applicable
timeframes?
Identifying high risk patients will help care team to

put proactive and preventative measures in place.
Assessor should look for identifiers and interview
staff.
Met
(1)
Partially
Met (2)
Not
JC- CAMH PC-01-02-01.pdf

Mandatory
Fall Prevention
7.1.7.9
Is there at least one patient lift, OR

table, radiololgy table, etc. available
that has sufficient lifting/holding
capacity to meet the needs of
bariatric patients?
Review equipment, interview staff. Patients

weighing in excess of 400 pounds are not
uncommon. If equipment cannot support the
weight of the patient contingency plans should be
developed to provide care.
Recommended
Fall Prevention
7.1.7.9.1
Is the load carrying capacity of the

equipment obvious to care
providers?
Labels and warnings are minimal actions and

humans often disregard them but they are one
barrier that should be in place. Talk with the care
providers in the area to determine if they know
what the load capacities are. Other cognitive aids
may be necessary depending upon the
knowledge level.
Recommended
Fire Safety
7.1.8.1
Are staff members familiar with fire

emergency procedures, and the fire
prevention plan for their service
area?
Interview staff to determine familiarity.

JC- CAMH EC-02-03-01-pdf.pdf
Mandatory
338 of 578

7.1.8.2
Question:
Fire Safety
Can clinical staff identify smoke and

fire walls in their immediate area?
Interview staff to determine familiarity. Staff must

be knowledgeable regarding where to move
patients in the event of a fire.
Met
(1)
Partially
Met (2)
Not

Mandatory
Fire Safety
7.1.8.3
Is the fire alarm signal easily

distinguishable from other alarms
(e.g., equipment, nurse call, etc.)?
Interview staff to determine familiarity, if alarm is

not witnessed.
Mandatory
NFPA 72 Chapter 4 -2007.pdf
Fire Safety
7.1.8.4
Can staff describe the process on

Look for signs placed by pull stations, and
how they are notified when the fire
interview to determine if announcements are
alarm system is out of service in their made on PA system, etc
area or being tested?
NFPA 101 Ch 19.pdf
Mandatory
Fire Safety
7.1.8.5
Are flame retardant pajamas or

aprons provided for patients who
smoke and are identified as a
"smoking risk"?
Smoking risk patients are patients who are known

to routinely violate the "no smoking" rules
established by the facility. They smoke in non
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.
Mandatory
VA MP-3 Part III 32.36(b) & (d).pdf /A Page=21
339 of 578

7.1.8.5.1
Question:
Fire Safety
If flame retardant pajamas or linens

are used, is a process in place to
ensure integrity of the flame
retardant agent is maintained on
these articles after repeated
laundering?
Interview staff, determine if practices are

consistent with policy. If the material has a fire
retardant applied it will wash out over a period of
time.
Recommended
VA MP-3 Part III 32.36(c) & (d).pdf /A Page=21
Met
(1)
Partially
Met (2)
Not
Infection Control
7.1.9.1
Are all linen carts (clean and soiled)

kept covered and the bottom of the
cart is a solid surface (without
openings)?
Mandatory
JC- CAMH IC-02-02-01.pdf
Infection Control
7.1.9.2
Are sharps containers accessible

and not over filled?
Observe conditions in unit/area. Patients and

employees are often stuck by sharps not properly
disposed of due to overfilling of these containers.
Mandatory
Infection Control
7.1.9.3
Is the facilities latex free policy being Show example if available. Consider inspecting
followed including providing latex
supply and code carts. Look for latex-free
free supplies and devices?
identification on glove boxes, supply packages,
etc. Determine if the other devices are available
as latex-free such as tourniquets and medical
tubing. In pharmacy, check for a latex protocol in
IV room.
Mandatory
IL 16-97-001.pdf
340 of 578

7.1.9.4
Question:
Infection Control
Are the VA recommended hand

hygiene guidelines followed?
Alcohol-based hand rub (ABHR) disinfectants

should be located to promote their use (including
in patient rooms, on carts). Clinicians should also
be offered the small (2-4 oz.) personal containers
of hand gel. In addition to the ABHR gel/foam a
lotion (to prevent skin dryness) should also be
available.
Met
(1)
Partially
Met (2)
Not
Staff who come in contact with patients or

prepare sterile products (such as IV drugs)
should not have artificial fingernails.

Mandatory
Infection Control
7.1.9.5
Is the integrity of negative/positive

pressure isolation rooms tested and
maintained (once per day for
occupied, monthly for nonoccupied)?
Door remains closed if in use, Personal Protective

Equipment used. Signage outside to identify
hazard exists.
Staff should understand what actions to take if

the room pressures are out of range when they
are checked.
CDC Environment IC Healthcare.pdf
Mandatory
29CFR 1910.145.pdf
Infection Control
7.1.9.5.1
Is there a process in place to

establilsh temporary
negative/positive pressure rooms if
they are needed?
Establishing these temporary rooms should be

part of the facilities Emergency Prepardness
Plan.
Recommended
341 of 578

Question:
Medical Gas Safety
7.1.10.1
Met
(1)
Partially
Met (2)
Not
Are piped in oxygen and compressed The use of color coding should be eliminated.
air identified by a prominent label
Using color adapters can cause confusion during
and not merely by color adapters?
use, mixing up the gases being administered.
Fixes include: replacing tubing with a type that
does not use adaptors or using only clear
adaptors.
Recommended
Air_O2WallInlet.pdf
Medical Gas Safety

7.1.10.2
Are air flow meters removed when

not in use (for nebulized medication
treatments)?
Flow meters are only used for specific treatments,

are not required during emergencies and should
not be left attached to be confused with O2 flow
meter.
Recommended
Air_O2WallInlet.pdf
Medical Gas Safety

7.1.10.3
Do staff know where the emergency

oxygen shut-off is, and when and
how to use it?
Staff to demonstrate competency. Also verify that

labels, warnings or other signage posted at the
shut off point in accurate and up to date.
Mandatory
Medical Gas Safety

7.1.10.4
Does the storage and use of portable

medical gas containers appear to be
in compliance with CGA
(Compressed Gas Association)
Standards?
If color identifies type, must be the same hue &

intensity; flammables separated from oxidizers;
secured at all times (full or empty); container in
good condition; only a limited quantity permitted
in use area (less than 12 E-cylinders, or 1 Hcylinder per area).
Mandatory
O2CylHazardSumm.pdf
342 of 578

7.1.10.4.1
Question:
Medical Gas Safety
Do area/unit personnel know how to

correctly handle oxygen cylinders?
Cylinders should not be left standing unsecured,

they should not be lifted using the flow meter
assembly.
Met
(1)
Partially
Met (2)
Not
They should understand the purpose of both the

main cylinder valve and the flow meter valve.
Cylinders not in use must be turned off using the
main cylinder valve.
Cylinders should be opened slowly.
Organic ointments or oils should not be used in or

around oxygen.
Mandatory
O2CylHazardSumm.pdf
Medical Gas Safety

7.1.10.5
Are pins on medical gas regulators

intact, and is damaged equipment
immediately removed from service?
Pins should be in place and found undamaged.
O2CylHazardSumm.pdf
Mandatory
NFPA 99 ch 9 gas equip.pdf /A Page=2
Medical Gas Safety

7.1.10.6
Are oxygen cylinders with ball-type

regulators used with the cylinder in
the vertical position?
When placed in the horizontal position, the ball

valve mechanism will not function, and an
inaccurate reading will show on the gauge.
Mandatory
O2CylHazardSumm.pdf
343 of 578

7.1.11.1
Question:
Medication Safety
Are all medication refrigerators

maintained appropriately?
Check floor refrigerators, ensure correct labeling

and appropriate separations from employee
food/drink.
Met
(1)
Partially
Met (2)
Not
Review temperature log (or electronic

temperature monitoring device/log) and verify that
the thermometer is working.
Staff should know what actions to take if the

temperatures in the refrigerators are out of range.
ISMP_Book.pdf /A Page=30
Mandatory
capsLink2003-08-01 fridge.pdf
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
Medication Safety
7.1.11.3
Are the tops of medication carts,

Randomly survey carts in the area. Clean carts
clean, free of stray drugs, sharps and will help prevent medication error by eliminating
food?
opportunities for mix-ups . It will also avoid drug
being taken by mental health patients or those
with cognitive impairment.
Mandatory
Medication Safety
7.1.11.4
Are receptacles for medication

storage locked and are controlled
substances double locked?
Door locking mechanism cannot be defeated for

any reason. Door should not be held open.
Mandatory
344 of 578

Question:
Medication Safety
7.1.11.6
Met
(1)
Partially
Met (2)
Not
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?
Recommended
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?
Recommended
Medication Safety
7.1.11.8
Have concentrated electrolyte

Such as: potassium chloride and potassium
solutions been removed from patient phosphate
floors/care areas?
Mandatory
Medication Safety
7.1.11.9.1
Are only standard concentrations of

high alert medications kept in the
area/unit to minimize the potential of
calculation and compounding errors?
Floor stock of high-alert drugs should be limited to

critically needed medications, with minimal
number of doses, and be pre-made solutions (if
available).
Mandatory
Medication Safety
7.1.11.10
Is a unit dose medication system

used including liquids?
Look in patient bins for products that are in the

final pagkage of use. Bulk containers should not
be used.
Recommended
345 of 578

Question:
Medication Safety
7.1.11.13
Met
(1)
Partially
Met (2)
Not
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.
Mandatory
Medication Safety
7.1.11.13.1
Is medication mixing (admixtures) on Interview floor staff. If admixtures are done on

inpatient care units a discouraged
units, the area should be a designated area that
practice?
is clean and secure. It is safest for mixtures to be
completed in pharmacy areas only.
Recommended
Medication Safety
7.1.11.14
Are procedures in place to prevent

sterile product use from patient to
patient (including medications)?
Infection control literature documents nosocomial

infections occur irrespective of changing needles
or IV tubing's.
ASA December 2000 Newsletter.pdf
Recommended
ISMP June 2000 Alert.pdf
Medication Safety
7.1.11.15
Are IV over-wrap bags utilized and

properly labeled with manufacturers
instructions?
The protective over-wrap for some solutions

serves to control the amount of water vapor that
escapes from an IV solution. Once unwrapped it
is best to use the solution right way.
Recommended
Medication Safety
7.1.11.16
Are IV bags free of markings, such

The volatile chemical from the ink may leach into
as expiration dates, applied by staff IV solutions.
with ink pens or felt markers (prior to
use)?
Recommended
Medication Safety
7.1.11.17
Is an independent double check

completed for all infusion pump
settings for high alert medications
and look alike/sound alike drugs?
The double check should Include patient

monitoring and verifying the number of types of
pumps.
Recommended
346 of 578

7.1.11.19
Question:
Medication Safety
Are appropriate reversal agents

(flumazenil, naloxone, protamine,
etc.) available based on the drug
being administered and clinical
setting?
In the event of an unusual reaction or overdose

the agents need to be available. Look on the
code cart drug list.
Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.1.11.19.1
Does the facility track use of reversal Such as reviewing automated dispensing
agents?
machine records, which can be used as a tracer
order for adverse drug events. (e.g., reversal
agent s used in Endosocpy, Radiology, Acute
Care, etc., may be a signal to misadministration
or unsafe practices occurring. Tracking may also
alert to anesthesia adverse events occurring.
Other citeria to consider is increased surgical
times, durg interactions, and allergies.
Recommended
Medication Safety
7.1.11.21
Is there a process for monitoring

BCMA?
Review monitoring records. To trial BCMA, test 5

bar codes scans to ensure process is working,
coding should match the electronic medical
record to the patient, allowing the information on
the patients armband to be matched with the
electronic information.
Recommended
Medication Safety
7.1.11.21.1
Is BCMA used to administer

medication without using work
arounds?
Observe staff. An oversight committee (i.e.,

BCMA committee) should be monitoring for work
arounds.
Recommended
347 of 578

7.1.11.21.2
Question:
Medication Safety
What is the protocol for handling

medication preparations that are
incorrectly bar coded or labeled, or
have labels that do not scan?
One of the driving forces to increase medication

safety within the VA as been to ensure staff are
compliant and are able to scan medications into
BCMA. Pharmacy and or adhoc groups such as
BCMA committee should have a (QA) monitor for
ensuring medications dispensed from pharmacy
are able to be scanned, and secondly QA monitor
for medication scanning on the unit Lastly there
is a greater likelihood for a medication error to
occur when staff are able to administer
medications that have an incorrect/improper
barcode.
Recommended
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.1.11.21.3
Is there a helpdesk for BCMA

available during all shifts?
Test hotline number available on all shifts;

interview off-shift staff if available.
Recommended
Medication Safety
7.1.11.22.1
Do the VISTA modules effectively

Show example, if available. Test the software to
alert to potential food/drug/herbal
ensure there is not an option for turning off the
interactions and duplicate drug
alerts.
therapies? Are users prohibited from
turning them off (the alerts)?
Recommended
Medication Safety
7.1.11.25
Is current drug reference information Interview area/unit staff, show where information
made readily accessible to
is kept and how it is retrieved. One or two
caregivers, if so how?
reference sources should be available as well as
access to pharmacist.
Recommended
348 of 578

7.1.11.26
Question:
Medication Safety
Are up-to-date facility specific

protocols, guidelines, dosing scales,
and/or checklists readily available for
staff?
Interview unit staff, show where information is

kept and how it is retrieved. (e.g. use of
electrolyte replacement, aminoglycoside, and
anti-coagulant guidelines).
Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.1.11.27
Are specific precautions followed

when handling look/sound alike
drugs?
Discuss protocols with staff (such as insulin and

heparin vials; and hydromorphone and morphine).
In pharmacy, discuss what is being done with the
look alike medication project.
Recommended
Medication Safety
7.1.11.28
Is a prohibited abbreviations in
effect?
For example "u" in unit may be mistaken for "0"

resulting in ten fold over dosage.
Mandatory
Medication Safety
7.1.11.29
If Automated Dispensing Machines

(ADMs) are used, is staff aware of a
written policy, and can they explain
how the machine works?
Written documents should include which drugs

are available - including strengths and doses,
how often drugs are inspected for expiration
dates, drugs not used but removed, and content
review.
Recommended
Medication Safety
7.1.11.32
If ADMs are used, are there

capabilities to run override reports
that track discrepancy and utilization
at least monthly?
Show example reports, where filed on units;

interview Nurse Manger. Have staff reveal how
reports are used and acted upon, and if there is a
process to deal with variances.
Recommended
349 of 578

Question:
Medication Safety
7.1.11.34
Met
(1)
Partially
Met (2)
Not
Are patients educated regarding their Show example.

prescribed medication, as inpatients
and as part of the discharge
process?
Mandatory
Medication Safety
7.1.11.35
Does the care provided by

Pharmacists meet the clinical needs
of the patients in scope and
frequency?
Interview clinicians to determine if Pharmacists

are available for consult, and if they participate in
rounds or access patient medication history.
Mandatory
Medication Safety
7.1.11.42
Is a process in place to reconcile

Observe a patient discharge is possible, or
patient medications upon admission, interview staff that are responsible for the patient
transfer or discharge and is a current discharge process.
list of medications given to the
patient when discharge from a
VAMC, and if medications are
changed exiting a clinic?
Mandatory
General Patient Safety Concerns

7.1.12.1
Is read-back used for all verbal order Observe verbal ordering if possible, and interview
and critical value reports?
staff. Verify that telephone voice mail orders are
not accepted.
Mandatory
Read Back verbal_orders_advisory.pdf

7.1.12.2
Are NCPS or locally developed

cognitive aids available on the floor
for staff to reference (Escape and
Elopement; Fall Prevention, etc.)?
Randomly interview nursing staff on the floor.

Look for aids at nurses stations.
Recommended
350 of 578

7.1.12.3
Question:
Are patient/resident records kept

confidential, including computer
information?
Ensure records or computer screens are not left

unattended and openly visible.
Mandatory
Met
(1)
Partially
Met (2)
Not

7.1.12.4
Are staff wearing identification

badges and are unauthorized
persons kept out of patient care
areas?
Monitor patient care areas. Interview staff about

policies such as the handling of drug
manufacturer representatives that visit
unexpectedly. Patient charts should not be left in
patient rooms where patients are waiting.
Mandatory

7.1.12.5
Are restraints used in accordance

with local policy and are restraint
alternative devices available and
used when appropriate?
Look for restraint devices or alternative devices in

the area that may be in use. Document any
questionable use. Review patient record where
restraints were used to determine if appropriate.
Mandatory
351 of 578

7.1.12.6
Question:
Are there practices in place to

decrease the likelihood of patient
misidentification?
Requires using two patient identifiers for any

administrations, draws or procedures/images, 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.
Met
(1)
Partially
Met (2)
Not
VHA Directive 2005-029 dictates mandatory

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

7.1.12.6.1
Upon collection of blood or blood

products is a informed consent
obtained?
It is a requirement of the reference Directive that

prior to ordering the blood products for
transfusion, an informed consent is documented
in the patient's record, ensuring that the patient is
aware of the transfusion to take place.
Mandatory
352 of 578

7.1.12.6.2
Question:
Is the labeling of blood samples or

specimens done at the bedside,
rather than in bulk (at the nurses
station) to prevent mislabeling?
When blood collection is completed at the

bedside or in the clinic the blood container must
be immediately labeled before leaving the patient
at minimum with the following: patient's full
name, Social Security Number, collector's
identification, and date of collection.
Mandatory
Met
(1)
Partially
Met (2)
Not

7.1.12.6.3
Is there an existing protocol for

patient identification with noncommunicative patients?
When a patient can't communicate verbally or

otherwise the requirements for blood transfusion
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

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
353 of 578

7.1.12.8
Question:
Are handoffs between shifts or

transfer of care between units
standardized?
A consistent process should exist to update oncoming staff or new unit staff of patient status.
Interview staff and compare answers between
units. Look for use of SBAR or other
communication tool.
Met
(1)
Partially
Met (2)
Not
Mandatory

7.1.12.9
Is the transfer of care between

disciplines for off-unit appointments
standardized, including the
continuation of monitoring patient
status and patient medical devices
such as IV pumps and oxygen level
while the patient is visiting, being
treated/tested, and during transport?
A consistent process should occur during

appointments and when patients are sent back
and forth from units, including patient
identification means, patient record transfer, and
the monitoring of the patient's condition and
needed medical devices. Stopping and
resumption of IV medications should be planned
and documented. Interview staff in all areas
compare answers to determine standardization.
Recommended
USP CAPSLink July 2004.pdf

7.1.12.10
Are patients searched and residents

questioned for contraband upon
admission to each applicable
area/unit?
To ensure the safety of the patients/residents and

staff members it is essential to have a rigorous
search process of each individual patient.
Observe an admission, or interview staff to
evaluate consistency throughout the facility.
Recommended

7.1.12.11
Does the facility have an emergency A local protocol should include a mechanism for
response protocol for dealing with
staff to communicate the emergency (via a
disruptive patients?
special extension or a separate alarm system)
and a security response when a patient, staff or
visitor becomes threatening or out of control.
Staff should be familiar with the protocol and
have confidence in how to respond.
Recommended
354 of 578

Question:
7.1.12.12
Met
(1)
Partially
Met (2)
Not
When performing procedures outside The facility's Conscious Sedation protocol should
of the operating room are
be followed in all areas.
appropriate sedation protocols and
privileges followed when applicable?
Mandatory
Imaging and X-rays Precautions

7.1.15.3.2
Does a cognitive aid or other

Patients should be positioned to avoid crossing
guidance exist for MR Technicians on leads and creating loops (i.e., as if when a hand a
patient positioning?
touches leg); sensors should be placed away
from the RF coils; and periodic checks of the
senor sites should be made on unconscious
patients. Also, sandbags suitable for the MR
environment used for patient positioning should
be MR safe and labeled as such.
Recommended
SEA 38 MRI.pdf

7.1.15.3.3
Are manufacturer approved fiber

optic, carbon fiber or graphic leads
and low impedance ECG electrodes
used on equipment that is brought
into the MR scan room?
Use manufacturer-approved fiber optic, carbon

fiber or graphite leads instead of conductive leads
on medical devices. Also, use manufacturerapproved large surface area, low impedance
ECG electrodes
Recommended
355 of 578

Question:
Domiciliary Patient Safety Concerns
7.1.16.1
Is a face to face assessment with a

standardized assessment tool
conducted and documented on each
potential resident before
acceptance/admission into the
Domiciliary (or Hoptel) evaluating for
falls and suicidal/homicidal risk?
Met
(1)
Partially
Met (2)
Not
Some residents that enter into the

Domiciliary/Hoptel program are those that have or
have had Mental Health issues or factors that
make them at higher risk for falls, therefore a
specific standardize mechanism needs to be in
place to assure that residents who are at risk for
receive appropriate care.
Review admission documentation and mental
health assessment program.
Mandatory
VHA Handbook PRRTP.pdf /A Page=11

7.1.16.1.1
If a veteran is accecpted/admited is
there a specific frequency for
periodic re-evaluations throughout
the stay for falls and mental health?
It is important to reassess patients on a

systematic schedule, to ensure the patient
remains in a safe environment. Each assessment
should be documented. Review assessment
frequencies in resident records or in care plans.
Mandatory
VHA Handbook PRRTP.pdf

7.1.16.1.2
Are appropriate Domiciliary staff

thoroughly trained on the Falls and
Mental Health assessment program,
including all staff working on offshifts?
All staff should receive specific training regarding

assessment programs with emphasis on suicidal
and homicidal behaviors (i.e., despondent,
depressed, agitated, potentially violent.
Recommended

7.1.16.2
Has a standard assessment tool

been developed and used to assess
the competency of the veterans
working at the open domiciliary
entrances that monitor access?
These veterans need training to handle difficult

situations such as when another veteran, who
may be a friend, wants to enter the building with
contraband. They also need to know what action
to take if they believe another veteran is acting
intoxicated or may be harmful to others or
themselves.
Recommended
356 of 578

Question:
7.1.16.3
Is amount of time residents have with

planned activities monitored with the
goal of increasing the contact hours
with each resident?
Current VHA policy requires a minimum of 4

hours per day, 7 days per week of therapeutic
activities. If residents are only occupied for 1 to 2
hours per day, 5 days per week with no activities
on weekends or holidays the activities should be
increased.
Mandatory
Met
(1)
Partially
Met (2)
Not

7.1.16.4
Are break room and kitchen

refrigerators monitored periodically to
assure appropriate temperatures are
maintained?
The FDA Food code requires all food to

consistanly remain below 41 degrees Farinheight.
Therefore it is recommended in gerenal industry
that refridgerators are maintained between 35 38 degrees F. Any refridgerator should be part of
a preventive maintence schedule to check for
proper functioning.
http://www.cfsan.fda.gov/~dms/fc05-toc.html
Recommended
FDA Food Code 2005, Chap. 3 Food.pdf

7.1.16.5
Is staffing in the Domiciliary on all

shifts, holidays and weekends
assessed and modified as needed?
Per VA policy, see minimum Domiciliary staffing

levels. Review staffing versus resident
population to verify if appropriate.
Mandatory

7.1.16.6
Has the Mental Health Residential

Program Annual Safety and Security
Assessment being completed on the
directed schedule?
The Deputy Under Secretary for Health for

Oepration and Management put forth a
Memorandum for residental programs to
complete the attached assessment annually and
report key findings. Check for documentation that
this assessment has be completed and items
followed up on.
Mandatory
MH Annual Assess memo & attach.pdf
357 of 578

BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2
7.2.2.1.1
Question:
Code Carts
Are code carts secured and

inaccessible to patients to prevent
tampering where appropriate (i.e.,
Behavioral Health areas)?
If carts are missing items then they could be

ineffective in when needed in an emergency.
Check that carts are put away in affected areas.
Met
(1)
Partially
Met (2)
Not
Recommended
Code Carts
7.2.2.4

Recommended
Code Carts
7.2.2.5
intubations?
Service.
Mandatory

7.2.4.1

Mandatory

7.2.4.2

Mandatory

7.2.4.3
Psych Care - 7.2

to be a priority?
Mandatory
Psych Care - 7.2 - Version: 01.30.2009
358 of 578

Question:
7.2.4.4

Met
(1)
Partially
Met (2)
Not

Mandatory

7.2.4.5

storage?

blocked doors.
NFPA 101 ch 7 - 2009.pdf
Mandatory

7.2.4.7


Mandatory

7.2.4.10


environments.
Mandatory
Psych Care - 7.2
359 of 578

Question:
Equipment Safety
7.2.5.1
Met
(1)
Partially
Met (2)
Not

identifiers.
NFPA 99 CH 8.pdf
Mandatory
Equipment Safety
7.2.5.4

or false alarms?


Mandatory
Equipment Safety
7.2.5.8

equipment?

malfunctioning.
Recommended
Equipment Safety
7.2.5.11

Recommended
Psych Care - 7.2
360 of 578

Question:
7.2.6.1
Met
(1)
Partially
Met (2)
Not
patients to staff?
patients, etc.
Recommended

7.2.6.2
correctly?
Recommended

7.2.6.3

program?
Recommended

7.2.6.4

event?

patient searches.
Mandatory

7.2.6.5
Psych Care - 7.2

patients stay?

Mandatory
361 of 578

Question:
7.2.6.5.1
Met
(1)
Partially
Met (2)
Not

Mandatory

7.2.6.6
Mandatory

7.2.6.7
patients to staff?
patients, etc.
Recommended
Fall Prevention
7.2.7.1


Mandatory
Fall Prevention
7.2.7.3
Psych Care - 7.2

hazards?

Mandatory
362 of 578

7.2.8.1
Question:
Fire Safety

area?
Met
(1)
Partially
Met (2)
Not

Mandatory
Fire Safety
7.2.8.2


Mandatory
Fire Safety
7.2.8.3


not witnessed.
Mandatory
Fire Safety
7.2.8.4

NFPA 101 Ch 19.pdf
Mandatory
Psych Care - 7.2
363 of 578

7.2.8.5
Question:
Fire Safety

"smoking risk"?

for these patients.
Met
(1)
Partially
Met (2)
Not
Mandatory
Fire Safety
7.2.8.5.1

laundering?

time.
Recommended
Fire Safety
7.2.8.6
Are fire equipment cabinets and fire

alarm pull stations locked?
These should be locked to prevent tampering,

however ALL staff should carry key on their
person at all times for unlocking in an emergency.
Recommended
fire prot design man.doc #25
Infection Control
7.2.9.1
Psych Care - 7.2

openings)?
Mandatory
364 of 578

Question:
Infection Control
7.2.9.3
Met
(1)
Partially
Met (2)
Not
IV room.
Mandatory
IL 16-97-001.pdf
Infection Control
7.2.9.4.1
Is alcohol hand gel stored so that is Patients that may have substance abuse
available for staff to access, but kept problems could attempt to drink the hand gel due
away and secured from patients that to most containing 60% or more alcohol.
may ingest it in areas such as
Behavioral Health, Detoxification
Units, or Urgent Care?
Recommended
Medication Safety
7.2.11.1


food/drink.


Mandatory
Psych Care - 7.2
365 of 578

Question:
Medication Safety
7.2.11.2
Met
(1)
Partially
Met (2)
Not

not in use?
Mandatory
Medication Safety
7.2.11.3

food?
Mandatory
Medication Safety
7.2.11.4


Mandatory
Medication Safety
7.2.11.6

unit?
Recommended
Medication Safety
7.2.11.10


be used.
Recommended
Psych Care - 7.2
366 of 578

7.2.11.21
Question:
Medication Safety

BCMA?

Recommended
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.2.11.21.1

arounds?

arounds.
Recommended
Medication Safety
7.2.11.21.2


barcode.
Recommended
Medication Safety
7.2.11.21.3


Recommended
Medication Safety
7.2.11.25
Recommended
Psych Care - 7.2
367 of 578

7.2.11.26
Question:
Medication Safety

staff?

Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.2.11.27

drugs?

Recommended
Medication Safety
7.2.11.28
effect?

Mandatory
Medication Safety
7.2.11.29


review.
Recommended
Medication Safety
7.2.11.32
Psych Care - 7.2

at least monthly?

Recommended
368 of 578

Question:
Medication Safety
7.2.11.34
Met
(1)
Partially
Met (2)
Not

process?
Mandatory
Medication Safety
7.2.11.35

frequency?

Mandatory
Medication Safety
7.2.11.42

Mandatory

7.2.12.1
not accepted.
Mandatory

7.2.12.2


Recommended
Psych Care - 7.2
369 of 578

7.2.12.3
Question:

information?

Mandatory
Met
(1)
Partially
Met (2)
Not

7.2.12.4

areas?

Mandatory

7.2.12.5


Mandatory
Psych Care - 7.2
370 of 578

7.2.12.6
Question:

misidentification?

misidentification.
Met
(1)
Partially
Met (2)
Not

Mandatory

7.2.12.6.1
Psych Care - 7.2

obtained?

Mandatory
371 of 578

7.2.12.6.2
Question:


Mandatory
Met
(1)
Partially
Met (2)
Not

7.2.12.6.3


Mandatory

7.2.12.7

in bed as well.
Recommended
Psych Care - 7.2
372 of 578

7.2.12.8
Question:

standardized?
communication tool.
Met
(1)
Partially
Met (2)
Not
Mandatory

7.2.12.9


Recommended

7.2.12.10

area/unit?

Recommended

7.2.12.11
Recommended
Psych Care - 7.2
373 of 578

7.2.12.11.1
Question:
Is there an assessment used to

determine if a patient is potentially
violent?
Review assessment process/documents.
Met
(1)
Partially
Met (2)
Not

VA IL-10-97-006 Violent Behavior.pdf
Mental Health Locked Unit Checklist

7.2.13.1
General Criteria
7.2.13.1.1
Are floor coverings free of tripping

hazards?
Floor coverings should be secured to the floor, in

good repair without tripping hazards, and not
easily torn or dislodged.
Are floor coverings secured to the

floor?
Recommended

7.2.13.1.2
Are floor-mounted HVAC vents

removed?
Floor-mounted HVAC vents should not be used.

There should be no exposed and accessible
HVAC equipment such as floor mounted fan coil
units, radiators, convectors, or finned tube
radiation.
Recommended

7.2.13.1.3
Are door thresholds secured to the

floor and no higher than 3/4 inches
above the floor?
Avoid thresholds where possible. Look for other

projections on the floor that could be tripping
hazards or could be removed easily to be used
for self-harm or as a weapon.
Are door thresholds secured using

tamper resistant anchors or
fasteners?
Recommended
Psych Care - 7.2
374 of 578

Question:
7.2.13.1.4
Are wall coverings and paint nontoxic?
Met
(1)
Partially
Met (2)
Not
Non-toxic wall paper, glue, and paint should be

used. Paint and wall paper should not be peeling.
Are wall coverings secured to the

wall and not peeling?
Recommended

7.2.13.1.5
Are picture frames and coverings

made of non-breakable material?
No glass coverings; no sharp edges; wood

frames only, no metal frames; secured to the wall;
may also be frameless; smaller is better; safe
pictures are encouraged for milieu.
Are picture frames secured to the

walls using tamper resistant screws
or anchors?
Recommended
Psych Care - 7.2
375 of 578

Question:
7.2.13.1.6
Met
(1)
Partially
Met (2)
Not
Are the number and locations of

electrical receptacles in the room
adequate?
GFCI-protected outlets, adequate number of

outlets, short electrical cords. Equipment with
cords should be located close to the wall outlet;
cords should be too short to loop around the neck
and secure to an anchor point for hanging. Flush
mounted switches reduce the risk of using a
Are receptacles and switches
projecting switch to propel self or other person
covered by metal plates that are
into the projection. If the outlet will be used for
secured by tamper resistant screws? medical equipment it should be tamper resistant
but not GFCI as GFCI outlet may trip and shut off
the equipment (added August 2008).
Are the electrical boxes flush
mounted?
Are all receptacles provided with

GFCI protection?
Recommended

7.2.13.1.7
Are HVAC vents flush with the wall?
Vents should be flush with the wall and secured

with tamperproof anchors; grates or mesh
covering is preferred or a louvered vent should
not support weight (over 15 pounds). Vents
Are HVAC vents secured with tamper should not be able to be removed and used as a
resistant screws?
weapon or for self-harm. See:
http://www.anemostat.com/acatalog/sec_index_fs.htm
Are louvers designed so that they
cannot be used to secure any item
that might be used to attempt suicide
by hanging?
Recommended
Psych Care - 7.2
376 of 578

Question:
7.2.13.1.8
Met
(1)
Partially
Met (2)
Not
Are corner guards present on all wall Wall edges and corners should be protected by
edges?
corner guards.
Recommended

7.2.13.1.9
If used, is vinyl baseboard secured to Vinyl baseboard is used in many buildings. It

the wall so that it cannot be easily
should be secured to the wall. Look for sections
removed and used as a weapon?
that may be loose or have gaps making it easy to
remove. If removed it could be used as a
weapon.
Recommended

7.2.13.1.10 Has all surface-mounted wire
molding been removed?
In older buildings, it is not unusual for wiring to

newer receptacles to be run in surface-mounted
wire molding. Ideally, wire should be run inside of
the wall and out of sight. Surface-mounted
molding could potentially be used as an anchor
point and should be replaced with flush wallmounted receptacles. Prior to being replaced,
any surface-mounted wire molding must be
secured tight to the wall with no gaps and
secured with tamper resistant screws.
Recommended

7.2.13.1.11
Corner mirrors are secured with

tamper resistant screws and are
flush mounted so that they will not
support a rope or material for
hanging.
Corner mirrors may be necessary for safety, but

must not provide an anchor for hanging and must
be made of non-glass material.
Recommended
Psych Care - 7.2
377 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.1.12 Are bulletin boards, message boards, Look at each item. All items must be secured to
posters, telephones, door stops, exit the wall in a manner that prevents removal or use
signs, and lights secured using
as a weapon or for self-harm. It must be flush
tamper resistant screws?
with the wall or beveled in a manner so that it
cannot be used as an anchor for hanging. If
lights are on the wall, the glass bulbs should not
be easily accessed. See:
Are dispensers for alcohol based
http://www.elights.com/vanwalceilfi.html
hand cleaners not accessible to
patients?
Alcohol based gels and foams may be consumed
by patients and therefore should not be
accessible to them.
Recommended

7.2.13.1.13 Are items projecting from the wall,
even if otherwise considered a safety

item, designed so they cannot be
used for harm of self or to harm
others? For wall-mounted sprinklers,
see sprinkler criteria under Ceilings
section.
Cords should be too short to use to wrap around

a neck and hang from any securing point
(maximum of 12 inches). Wall telephones should
only be in locations that can be continuously
observed by staff and the cord between the
telephone base and the hand set should be as
short as practically possible. Hooks and hangers,
even if structured with safety features, should be
evaluated for risk to others. Drinking fountains
should be secured to the wall and visible to staff see
http://www.plandstainless.co.uk/products/product.
php?product_code=HAWSHWBFA8.VRC
Recommended
Psych Care - 7.2
378 of 578

Question:
7.2.13.1.14 Are wall mounted exposed room
thermostats removed from patient

areas?
Met
(1)
Partially
Met (2)
Not
No wall mounted exposed room thermostat in

patient areas. Use duct mounted temperature
sensor programmable from a remote control
panel or (if necessary) recessed wall mounted
aspirating type room thermostat with a tamper
resistant perforated cover.
Recommended

7.2.13.1.15 Are ceilings that are in areas not in
the direct line of sight of the nursing

station constructed of solid materials
such as plaster/lath, gypsum board,
or a metal pan system the requires
the use special tools for removal?
Are ceilings free of hanging objects

such as plant hangers and wind
chimes?
In areas accessible to patients and not

continuously observable by staff (e.g., patient bed
rooms, day rooms), ceilings should be solid or of
a rigid, locking tile. The space above a lay-in
suspended ceiling will almost always contain
pipes, conduits, ductwork, and other building
features that could be used as an anchor for
hanging. Look for hiding places above lay-in
ceilings, look for material that would be harmful if
ingested. There should not be items hanging from
the ceiling.
Recommended

7.2.13.1.16 Are access doors in solid ceilings
locked using a key or special tool to

prevent unauthorized access and
secured to the ceiling using tamper
resistant fasteners?
Access doors are needed to access electrical and

mechanical equipment above the ceiling.
Patients having access to this space may harm
themselves or others or use the space for storing
contraband items.
Recommended

7.2.13.1.17 Are light fixtures flush mounted in the Light fixture coverings should be secure and of
ceiling, tamper resistant, and

provided with break-resistant panels
or covers and designed so they
cannot serve as an anchor point for
hanging?
break-resistant material so that bulbs cannot be

accessed. Tamper resistant screws/attachment
devices should be used.
Recommended
Psych Care - 7.2
379 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.1.18 Are vents in the ceiling flush with the If the ceiling is not solid, ceiling vents will not be
ceiling surface and secured with

tamper resistant fasteners?
tamper-proof. Large box-like projections with

HVAC equipment/vents should be evaluated for
level of safety. Louvers can be used as an
anchor point; mesh or grates are preferable or the
louver should not support weight.
Are vents in the ceiling designed so

they cannot serve as an anchor point
for hanging?
Recommended

7.2.13.1.19 Are fire sprinklers the institutional
type that cannot be used as an

anchor point for hanging?
Institutional sprinklers should be used for

sprinklers installed on the walls as well as the
ceiling. An institutional sprinkler is designed to
resist tampering and to not provide an anchor for
hanging; the fusible element is designed to
breakaway rather than support the weight of a
person.
See
http://www.reliablesprinkler.com/sprinklers_produ
cts.php?cid=28
Recommended
Psych Care - 7.2
380 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.1.20 Does the glazing material in windows See below for glazing requirements from VA
comply with VA specifications

(nominal 7/16 inches thick and
laminated)?
Are windows restricted so that the
maximum opening is 6 inches or
locked to prevent them from being
opened by a patient? Do staff know
the location of the key need to unlock
the window and is it accessible to
them if it is needed?
Master Specification Section 08810, Glass and

Glazing. If the unit was designed as a mental
health unit it is likely that the glazing meets the
requirements. If the unit was converted from a
different use, the glazing may not meet the
requirements for mental health units. Consult with
facility Engineering staff regarding use of Section
08810.
"Excerpted from VA Master Specification Section

08810:
1. Mental health and behavioral science service

for psychiatric, alcohol, and drug dependency
treatment areas require ""Security Glazing""
assemblies, resistant to breakage and use as
weapons.
2. Security (seclusion) rooms, including room

doors, use 11 mm (7/16 inch) laminated clear
glass, clear heat strengthened glass clad
polycarbonate, or clear tempered glass clad
polycarbonate.
3. For patient ward glazing use laminated

assemblies of tinted, heat strengthened, clear,
clear tempered, or clear heat strengthened glass.
Recommended

7.2.13.1.20
(continued)
Psych Care - 7.2
Recommended
...(continued) optional glazing of clear heat

strengthened glass clad polycarbonate, or clear
tempered glass clad polycarbonate for 11 mm
inch (7/16) thick laminated glass."
381 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.1.21 Are window frames designed to
The frame should be simple and made of a

prevent them from being broken by a material in a manner that would make it difficult to
patient?
break off a piece of the frame. High floor
windows must be secured to prevent jumping, but
provisions must be made to ensure that a locked
window can be unlocked by staff in an
Are the windows free of projections emergency.
that could serve as an anchor point
for hanging?
Recommended

7.2.13.1.22 Are window covering designed so
they cannot be used for hanging?
Shades, or blinds inside of window panes are

safest choices. There should be no cords or
ropes attached and curtains should not be used.
Hardware should be flush with the wall so that it
cant be used to secure a noose. It should also
be tamper proof to prevent it being removed and
used as a weapon or for self harm.
Is the hardware supporting the

window covering designed and
installed such that it cannot serve as
an anchor point for hanging and
secured with tamper resistant
fasteners?
See
http://www.pella.com/maint/blinds/casement.asp?
path=/maint/blinds/casement/operating
And http://www.variolightsonnenschutz.de/eng/produkte.html
Recommended
Psych Care - 7.2
382 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.1.23 Do corridor doors to patient-occupied Normal operation could be door swing into the
rooms have the ability to swing out

into the corridor? (Only New Units)
room, but if necessary (e.g., patient barricaded

inside the room), staff could release the door stop
so that the door could swing into the corridor.
Refer to the Life Safety Code (NFPA 101) for the
complete set of door requirements.
Are corridor doors arranged to limit

the transfer of smoke?
Corridor doors must limit the transfer of smoke
between the corridor and the room. If the gap
Are doors that are within rooms and between the door and the frame is excessive (it is
that open to other in-room areas
preferred that the gap not exceed 1/8-inch), a
such as bath/shower/toilet areas (i.e., gasket or sweep can be installed around the edge
not corridor doors) designed to
of the door to limit the transfer of smoke. If a
eliminate anchor points?
gasket or sweep is used, it should be cut into
sections that are short enough (e.g., 12 inches or
less) so that if the gasket or sweep is removed it
cannot be used for self harm.
Are doors on closets or wardrobe
cabinets removed or designed to
eliminate anchor points?
For doors NOT opening to the corridor, the
preferred door design is an angled top (hinge side
higher) with an approximately 6-inch gap between
the top of the door and the door frame. Doors
that do not open to the corridor are not required
(continued)...
Recommended
Psych Care - 7.2
383 of 578

Question:
Met
(1)
Partially
Met (2)
Not
...(continued) to limit the transfer of smoke, so the

dimension of the gap between the door and the
frame is not specified. Doors to wardrobe
cabinets or closets should be removed and
shelves should replace rods and hangers.
7.2.13.1.23
(continued)
Recommended
For more information please see the MHEOC

Checklist General Criteria.
7.2.13.1.24 Are doors, including the glazing
See question 19 above regarding glazing.
material, made of a substantial

material to prevent them from being
broken or damaged by a patient?
Recommended

7.2.13.1.25 Are swinging doors provided with
The dual-swing doors discussed in item 23 above

are supported by a post at the top and bottom of
the door and do not have hinges. Such hardware
is acceptable as long as the gap at the top of the
door is sufficiently small to reduce the risk that the
post could be used as an anchor point. If piano
hinges are used, it is recommended to use pianotype hinges that are flush-mounted to the door
Are three point hinges designed and frame.
installed so they do not protrude
providing an anchor point for
hanging?
See http://www.rockler.com/CategoryView.cfm?
Cat_ID=51
Spring loaded hinges are acceptable if the door is
Are doors free of hold-open devices required to be self closing by a code or
and self-closers that could be used
regulation.
as an anchor point for hanging?
piano hinges or other hardware that
reduces the risk of the hardware
being used as an anchor? (Only New
Units)
Recommended
Psych Care - 7.2
384 of 578


Met
(1)
Question:
7.2.13.1.26 Is the door latching hardware
designed and installed to prevent it

from being used as an anchor point
for hanging?
Partially
Met (2)
Not
Hardware should be designed with a taper or a

lever so a noose would slip off with the weight of
a person Use round edges type.
See http://www.oddballindustries.com/
link for "Door Lock"
Click the
Recommended

7.2.13.1.27 Are closets free of clothes rods that
Spring-loaded hooks designed for mental health

could be used as an anchor point for areas should be used in lieu of closet rods and
hanging?
hangers.
Are closets free of clothes hangers

(plastic, wood, and metal)?
Recommended
Psych Care - 7.2
385 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.1.28 Are shelves in closets secured with
If there is a television or other electrical or heavy

tamper resistant fasteners and
item on the shelf, it should be secured so that it
designed so they cannot be used as cannot be pulled off onto someone, and the
an anchor for hanging?
electrical cord must be short and plugged directly
into the electrical receptacle. Sets of shelves
should be short or low in height (low profile) to
prevent the patient from reaching the ceiling.
Are heavy items on shelves placed
low to the floor and secured in place
to prevent them from being
removed?
Is each shelf layer secured and not

removable so that it cannot be pulled
apart to be used as a weapon?
Recommended

7.2.13.1.29 Are racks secured to the wall with
tamper resistant fasteners?
Any racks must be flush with the wall and

secured with tamper-proof screws.
Are racks designed so they cannot

be used as an anchor point for
hanging?
Are racks free of parts or pieces that

can be removed and used as a
weapon?
Recommended
Psych Care - 7.2
386 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.1.30 Is furniture secured or heavy enough Furniture should be heavy and difficult to pick up
to prevent it from being picked up

and thrown or moved to block a
door?
and move; it should be made of wood or study

plastic; knobs and pulls should be designed to not
support weight. Furniture should be low profile
type so that it cannot be used by the patient to
reach the ceiling.
Is furniture designed to prevent it

from being pulled apart or splintered
to be used as a weapon for self-harm Information on specialized furniture can be found
or harm to others? Examples of
at: www.norix.com and: http://www.maxpotential hazards are pieces of metal secure.com/
such as drawer roller assembly, or a
part of a bed or chair that could be
removed and used as a weapon.
Recommended

7.2.13.1.31 Are sinks secured to the wall or floor There should be no exposed piping or conduit in
so that they cannot be easily moved? patient areas. The sink faucet should be a single
unit with a round handle that is designed with a
taper or a round lever so a noose would slip off
with the weight of a person. A sensor type faucet
Is the plumbing enclosed in a
is preferable since this has no lever. Hot water
tamper-resistant enclosure to prevent should be regulated so that it is 105 - 110
access by patients?
degrees F at the tap (see VHA Directive 2002073, Domestic Hot Water Temperature Limits).
Is under-sink storage secured?
Is the temperature of the hot water

tested to ensure it will not cause a
burn?
Recommended
Psych Care - 7.2
387 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.1.32 Is the unit designed to eliminate blind Some older buildings have configurations that
spots? Note: In existing buildings

alternate and equivalent methods
must be in place (e.g., non breakable
mirrors) to increase visibility.
result in hallways that are not visible from the

nurses station; these areas should have cameras
or staff assignment that allows for ease of
visibility (staff assignment as an approach to this
may not be successful due to fluctuations).
Rooms that house patients on special watches
should not have any areas that are not visible.
Blind corners or hallway intersections should
have a corner mirror (non-glass material) installed
at the ceiling as discussed above.
Recommended

7.2.13.1.33 Are chemicals, including those in
housekeeping carts, secured when

not in use?
All chemicals, housekeeping supplies and

equipment, and maintenance carts and
equipment must be secured or have someone in
attendance.
Recommended

7.2.13.1.34 Are devices such as blood pressure
cuffs and other medical equipment

kept inaccessible to patients?
Blood pressure cuffs can be placed around the

neck and inflated, or the cords and hoses can be
used for self harm or to harm others. Other
medical equipment may present dangers also.
These items should be kept in locked rooms or
where a staff member is in attendance.
Recommended

7.2.13.1.35 Are trash cans in areas accessible to The trash cans should be lined with paper liners.
the patients free of plastic bags that

can present a suffocation hazard?
Recommended
Psych Care - 7.2
388 of 578

Question:
7.2.13.1.36 Is the area free of unnecessary
cords?
Met
(1)
Partially
Met (2)
Not
If cords are present, they should be 12 inches or

less. Cords of any length are not recommended
for seclusion rooms.
Recommended

7.2.13.1.37 Is the area free of lamps, steel trash
Inspect ward and patient rooms.
cans, and other items that could be

used as weapons?
Recommended

7.2.13.1.38 Are sharps containers tamper-
Inspect ward and patient rooms.
resistant and installed only in

locations where the containers can
be continuously monitored by staff?
Recommended

7.2.13.1.39 Are combustible materials in the
rooms kept to a minimum?
Excluding items such as beds, linens, furniture.

Mattresses should be fire-resistant, however.
Recommended

7.2.13.2
Psych Care - 7.2
Sleeping Rooms
389 of 578

Question:
7.2.13.2.1
Are all mounted fixtures designed to

prevent attachment of devices that
could be used to inflict self-harm?
Met
(1)
Partially
Met (2)
Not
"Breakaway rods and sprinkler heads; flush

mounted vent covers free of louvers; no
attachment points on furniture parts or doors (i.e.,
no hooks) or anything fixed to the walls or
ceilings. Tamper-resistant screws should be used
on all devices.
http://www.oddballindustries.com/ (Shower head,
closet bar, clothes/towel hook)
http://www.tamperproof.com/ (Tamper-resistant
screws)
http://www.generalcubicle.com/carriers3.php
(Pop-out hooks for curtain tracks)"
Recommended

7.2.13.2.2
Are patient room mirrors shatterresistant?
Mirrors should be stainless steel, not glass.
Recommended

7.2.13.2.3
Have electric and manually

adjustable beds been eliminated
unless indicated by clinical need?
Platform beds are the safest for an acute

psychiatric environment. If electric beds are
necessary, power cords should be shortened and
securely fastened.
Recommended

7.2.13.2.4
Are emergency call cords, if used,

shortened and/or permanently
attached to beds?
Inspect ward and patient rooms. Cords should be

made out of plastic bead type materials or
breakaway type (15 lbs. max weight). Cords
must be segmented in such a way as to break
into segments that are no longer than 12 inches.
Recommended
Psych Care - 7.2
390 of 578

Question:
7.2.13.2.5
Met
(1)
Partially
Met (2)
Not
Have all privacy curtains and tracks Privacy Curtains have been used to commit
for hanging the privacy curtains been suicide by hanging. See patient safety alert on
removed?
privacy curtains:
http://vaww.ncps.med.va.gov/Guidelines/alerts/Do
cs/PrivacyCurtainAL07-04.pdf
Recommended

7.2.13.3
Bathrooms
7.2.13.3.1
Are light fixtures securely mounted to

the ceiling by inaccessible fasteners
or tamper resistant fasteners (or
equivalent) with non breakable
lenses?
Flush mounted fixtures are recommended,

however surface mounted lights are acceptable
provided they do not provide an anchor point for
hanging. All energized parts must be secured
with tamper resistant fasteners. Surface mounted
lights should be avoided. It is required by NFPA
70 to have GFCI circuits in all wet locations.
Recommended

7.2.13.3.2
Are walls solid (gypsum, plaster/lath, Ceramic tile may be broken and the shards used
concrete block, etc.) and free of
for self injury or as a weapon. If gypsum board
glazing materials?
walls are provided in rooms serving patients in
seclusion rooms additional protection is needed.
These walls should be provided with a backing
material such as fire treated plywood, or
Note: Only new units need to be free equivalent, to provide additional structural
of ceramic tile.
integrity.
Recommended
Psych Care - 7.2
391 of 578

Question:
7.2.13.3.3
Are grab rails installed around the

toilet and shower areas the closed
type that prevent materials from
being wrapped around them?
Are all grab rails eliminated where

they are not needed?
Met
(1)
Partially
Met (2)
Not
The grab rail should be of a design that permits

them to be easily grasped while preventing
materials from being threaded through that meet
UFAS standards. For example rails with
continuous filer that extends down from the
bottom of the rail before going to the wall (in
showers drill very small holes for drainage) or
slanted design with two anchoring points for top
and bottom only (The bottom connection should
not exceed more than 12 inches above the floor
surface) - that still meet UFAS standards.
http://www.oddballindustries.com/
Recommended

7.2.13.3.4
Are toilet paper holders recessed in

the wall and designed to hold the
paper without providing materials
that could be used as a weapon?
Toilet paper holders may have metal spring clips

used to hold the paper roll in place. These clips
may be used as weapons. Toilet paper holders
should be a soft plastic rod so that it can not
support weight of a person.
Recommended

7.2.13.3.5
Have towel bars been removed and

replaced with flip-down type hooks
designed to support the weight of a
bath towel and nothing heavier?
Recommended

7.2.13.3.6
Are mirrors shatter proof or other non Polished stainless steel mirrors are preferred.
breakable material and affixed to the
wall using tamper resistant
fasteners?
Recommended
Psych Care - 7.2
392 of 578

Question:
7.2.13.3.7
If electrical receptacles have not

been removed and covered by a
plate fastened using a tamper
resistant fastener, is a Ground Fault
Circuit Interrupter (GFCI) receptacle
or GFCI circuit breaker provided?
Met
(1)
Partially
Met (2)
Not
Removal of the receptacle is preferred [MET]. If a

receptacle must be used, GFCI protection is
required to reduce the risk of shocks and
electrocutions, and the receptacle cover must be
fastened with tamper resistant screws
[PARTIALLY MET]. An electrical receptacle
requires that an electrical cord be plugged into it
to be used. Electrical cords may be used as a
lanyard (noose) and must be strictly controlled.
Ideally electrical receptacles and the need for
cords should be eliminated altogether.
Recommended

7.2.13.3.8
If provided, are Emergency Call

buttons mounted using tamper
resistant fasteners and located
approximately 1 foot above the floor
level and 38 to 44 above the floor.
Pull cords should be of plastic
breakaway beads in lieu of cords.
Joint Commission requires the call buttons (when

provided) to be accessible to someone who has
fallen on the floor. If plastic break-away beads
are used the unit should develop a protocol for
quickly and easily replacing the beads as they are
removed or pulled off by patients.
Recommended
Psych Care - 7.2
393 of 578

Question:
7.2.13.3.9
For new units, are toilets floor

mounted with no exposed piping that
could serve as an anchor point for
hanging and free of removable seat
covers? (Only New Units)
Met
(1)
Partially
Met (2)
Not
Plumbing fixtures should be enclosed to minimize

risks. See Yeager et al. Measured response to
identified suicide risk and violence: What you
need to know about psychiatric patient safety.
Brief Treatment and Crisis Intervention.
2005:5:121-141.
For existing units, are all pipes and

plumbing that could be used as an
anchor point enclosed?
Do toilet partitions have no cross

connections that could be used for
hanging?
Recommended

7.2.13.3.10 In areas accessible to patients in
seclusion, are toilets shatter proof

(e.g. metal)?
Porcelain toilets can be broken and the pieces

used as a weapon or self harm. See these webpages for toilets:
http://www.acorneng.com/acorn_catalog/PDF/cat
alogpdf/p/1440.pdf
And
http://www.eljer.com/
Recommended
Psych Care - 7.2
394 of 578

Question:
7.2.13.3.11
Are privacy dividers angled down at

least 30 degrees toward the floor to
prevent hanging?
Met
(1)
Partially
Met (2)
Not
Use electronic sensor for flushing.
Recommended

7.2.13.3.12 Are sinks securely mounted to the
Sink piping can be used as a weapon and an

wall and all supply and waste
anchor point.
plumbing concealed and inaccessible
(with tamper resistant fasteners)?
Recommended

7.2.13.3.13 Are faucets and spouts in sinks and
showers institutional type? There

should be no handheld shower
devices and no temperature
adjusting devices with in the showers
(unless recessed). Shower heads
should be institutional type. Soap
Holders should be recessed. Floor
drain plates should have tamperresistant screws.
Institutional faucets will not provide an anchor

point for hanging. Consider using automatic
on/off faucets to eliminate the faucet handles.
Push button controls for the shower are also an
acceptable alternative. Break away fixtures are
also permitted but only if they can be tested
without damaging the fixture.
Recommended

7.2.13.3.14 Is the water temperature limited to a
maximum of 110 degrees F?
Check the water by running the faucet in the sink

or shower or install temperature control guard for
all faucet and set temperature to 105-110
degrees F.
Recommended
Psych Care - 7.2
395 of 578

Question:
7.2.13.3.15 Are shower curtains hung from
ceiling mounted tracks with curtains

designed to tear away when a static
load of 15 pounds or more is
applied? Tracks in bathrooms should
be the flush type and not surface
mounted.
Met
(1)
Partially
Met (2)
Not
Shower Curtains are important for privacy and to

keep water from flooding the floor - causing fall
hazards. It is vital to check that the mounted
tracks cannot be used as an anchor point for
hanging. Break away curtain rods may be used
as a weapon and are not recommended. Note:
On new construction showers can be built to
provide privacy by walking around a corner so
that doors or curtains are not needed.
Recommended

7.2.13.3.16 Are doors arranged to swing out of
the bathroom and not provided with

locks? (Only New Units)
There is no Life Safety Code requirement for the

construction of doors to toilets and shower rooms
(as long as the rooms are not used for storage).
Doors to these rooms may be removed and
breakaway curtains used to ensure patient
privacy. However, if corridor doors are used and
are designed to swing into the corridor, the Life
Safety Code requirements must be met regarding
door swing into the corridor and corridor
obstruction by the fully-open door. See the
discussion under General Criteria regarding use
of dual swing doors or the use of alcoves for
outward swinging doors.

7.2.13.3.17 Is flush mounted door hardware
installed or hardware that will not

provide an anchor point for hanging?
Recommended

7.2.13.4
Psych Care - 7.2
Selclusion Rooms
396 of 578

Question:
7.2.13.4.1
Met
(1)
Partially
Met (2)
Not
Is the floor resistant to damage and Flooring in seclusion rooms should be seamless
of a material that provides cushioning or have heat welded seams to prevent tampering
in the event of a fall?
and damage. Flooring material should have
some cushioning to decrease the risk of injury in
a fall.
Recommended

7.2.13.4.2
Is the wall material impact-resistant? VA specifies that walls should be constructed of

double layer gypsum wall board or concrete
masonry unit construction. Walls should be bare
with no projections. Thermostats, outlets and
Are the walls smooth with no objects switches should be outside the room in the
that could pose a risk of self-harm or vestibule.
used for hanging?
Recommended

7.2.13.4.3
Is the ceiling solid surface?
Ceiling must be solid surface with no projections.

No access above ceiling and access to light
fixtures must be fully recessed, tamperproof and
break-resistant.
Recommended

7.2.13.4.4
Are light switches outside the room

and are they on a dimmer switch?
Light switch should be outside of the room and

able to be controlled by staff. There should be
the ability to dim the light rather than turning on a
full overhead light in the room to observe patient.
Recommended

7.2.13.4.5
Do doors open out from room?
Doors to seclusion rooms must swing out from

the room. See the discussion under General
Criteria regarding use of dual swing doors or the
use of alcoves for outward swinging doors.
Recommended
Psych Care - 7.2
397 of 578

Question:
7.2.13.4.6
Met
(1)
Partially
Met (2)
Not
Is door made of steel or is a wood

Doors should be made of a material that cannot
door coated with hard epoxy to
be easily damaged by pulling off pieces of wood
prevent chipping off pieces of wood? that could be used for harmful purposes.
Recommended

7.2.13.4.7
Is all glass impact-resistant and is

glass kept to a minimum ideally
seclusion rooms should not have
windows other than the observation
window in the door. There should be
no curtains or external window
coverings.
Consideration should be given to eliminating

exterior windows in seclusion rooms. If present,
they should be small, locked, and of a material
that meets VA requirements for glazing (see
discussion under General Criteria). The
observation window in the door should be only
large enough to see into the room adequately.
No window covering or hardware should be
accessible to the patient.
Recommended

7.2.13.4.8
Is the ceiling 9 ft minimum height?

(Only New Units)
The room should be of a size and configuration to

ensure that the patient has adequate room and
that he/she may be visualized in any location in
the room by staff from outside the room. Joint
Commission standards require 1:1 observation at
window for the first hour of seclusion; after that,
the patient may be observed via camera from the
nurses station. Cameras must be flush to the
ceiling in a corner away from the bed so the
patient cannot reach the camera by standing on
the bed.
Recommended

7.2.13.4.9
Is the room at least 7 feet wide and

no greater than 11 feet long? (Only
New Units)
Hallway cameras should visualize the seclusion

room door.
Recommended

7.2.13.4.10 Are blind spots eliminated?
Recommended
Psych Care - 7.2
398 of 578

Question:
7.2.13.4.11
Met
(1)
Partially
Met (2)
Not
If there are blind spots are there

cameras in the room for patient
visualization?
Recommended

7.2.13.4.12 Are the cameras flush mounted and
away from the location of the bed?

Recommended

7.2.13.4.13 Is there a camera located outside of
the room in a hallway?

Recommended

7.2.13.4.14 Is the seclusion room located near
the nursing station? (Only New

Units)
Ideally the seclusion room should be close to the

nurses station and should be separated from
other patients by a vestibule or area that will allow
separation of these patients from other patient
activities. In addition there should be access,
outside of the seclusion room, to a toilet for these
patients only. The room should have ready staff
access. There should be no toilet or access to a
bathroom inside the seclusion room, but these
patients should have easy access to a toilet that
is close to the seclusion room but separated from
other patients. A vestibule or anteroom can
provide separation, safe access, and increase
patient privacy.
Recommended

7.2.13.4.15 Is the only furniture in the room a
psych style box bed, bolted to the

floor?
There should be no furniture other than a bed that

is bolted to the floor or a mattress.
Recommended
Psych Care - 7.2
399 of 578

Question:
7.2.13.4.16 Are seclusion room beds free of
potential hazards to patients?
Met
(1)
Partially
Met (2)
Not
No protrusions, posts, or sharp edges/corners;

head/foot boards removed or secured; bed
secured to the floor.
Recommended

7.2.13.4.17 Are special precautions in place for
seclusion rooms?
All fixtures (covers/vents/windows) secured with

tamper-resistant 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.
Recommended

7.2.13.5
Entrance to Unit
Recommended

7.2.13.5.1
Is a Sally Port provided at the

entrance into the unit used by staff,
visitors and patients?
The Sally Port is the space between two locked

doors that must be traversed to enter the unit.
When entering the unit the first door is unlocked
to enter the Sally Port and the second door
remains closed and locked. ONLY when the first
door is closed and locked the second door
opening to the unit is opened. This arrangement
prevents patients from bolting out of the unit
when the door closest to the unit is opened; it
also eliminates tailgating. Sally Port door should
be wide enough for a code cart, bed, or laundry
cart to move through.
Recommended

7.2.13.5.2
Is there a "panic button" in the Sally

Port that rings into the nurses
station?
It is important for staff to be able to communicate

emergency situations.
Recommended
Psych Care - 7.2
400 of 578

Question:
7.2.13.5.3
Is there a window into the Sally Port

from outside?
Met
(1)
Partially
Met (2)
Not
It is important to be able to see inside the Sally

Port from outside for staff safety.
Recommended

7.2.13.5.4
Are entrances and exits to the unit in Staff need to be able to see who is standing
line of sight of the nursing station?
around the exit doors.
(Only New Units)
Recommended

7.2.13.5.5
Are the entrance doors, if

electronically controlled, capable of
being operated from the nursing
station?
Having the option of controlling the door from the

nursing station will save staff time and offers less
distractions. However, this should not be
provided if staff cannot see who is at the door.
See this web-site for information on electronic
locks:
http://www.sdcsecurity.com/category.aspx?id=6
Recommended

7.2.13.5.6
Is camera surveillance of the Sally

Port entrance provided and
monitored at the nursing station?
Camera surveillance will assist staff in

determining who is trying to enter the unit without
needed to walk to the entrance door.
Recommended

7.2.13.6
Dinning Rooms
Recommended

7.2.13.6.1
Are the tables in very high security or

forensic unit Dining Rooms fixed to
the floor or secured so they cannot
be moved or overturned?
The intent is to provide a secure environment that

will prevent tables from being moved or
overturned. This may be accomplished in several
ways. They can be physically secured or too
heavy to move.
Recommended
Psych Care - 7.2
401 of 578

Question:
7.2.13.6.2
Are dining room furnishings (e.g.

chairs) physically heavy or secured
to the floor or table?
Met
(1)
Partially
Met (2)
Not
The intent is to prevent furniture from being

thrown.
Recommended

7.2.13.6.3
Is the temperature of food and liquids

being served in the dining room
monitored to ensure that
temperatures do not exceed 130
degrees F?
This is important to prevent patients and staff

from receiving 3rd degree burns (can occur in 10
seconds at 130 degrees F temperature) from
spilled or thrown food/liquids.
Recommended

7.2.13.6.4
If steel knives are used, are they

Rigid plastic utensils (knives, spoons, forks)
without an efficient cutting edge (e.g. should not be used as they can easily be broken
butter knives)?
and used as a weapon or cutting implement. If
disposable medium-weight bendable plastic
cutlery is used, it should also be counted and
tracked so that patients cannot take it and use to
Is the silverware counted before and harm themselves or others.
after meals to ensure it is not taken
and used for self-harm?
Do especially high-risk patients use a

spoon only or use disposable
medium-weight bendable plastic
cutlery? (Food should be cut for
them)
Recommended

7.2.13.7
Psych Care - 7.2
Nursing Station
402 of 578

Question:
7.2.13.7.1
Are nursing stations secured from

unauthorized entry?
Met
(1)
Partially
Met (2)
Not
Walls around nursing stations should be

substantial (i.e. not modular office furniture) and
fixed in place. Doors should be capable of being
locked. As younger, more agile patients are
admitted the likelihood of a patient climbing over
a counter increases. Counters should be tall and
wide, if open above, to prevent this from
occurring.
Recommended

7.2.13.7.2
Are objects in the nursing station

kept out of reach of the patients?
This is particularly important around pass through

openings or near counters.
Recommended

7.2.13.7.3
Are panic alarms provided for staff

use in nursing stations?
Panic alarms monitored by the VA Police are

needed to provide immediate support to staff in
the event of a disruptive patient event. Testing of
alarm should be done on a periodic basis at a
frequency determined by staff. Alarm testing
should be documented in a log.
Recommended

7.2.13.8
Psych Care - 7.2
Utility Rooms
403 of 578

Question:
7.2.13.8.1
Are all chemicals stored in a locked

utility room?
Does the utility room have a selflocking door?
Met
(1)
Partially
Met (2)
Not
It is critical that patients on locked mental health

units do not have access to cleaning supplies at
any time. A patient can drink a fatal dose of
cleaning chemicals within seconds.
Environmental staff may not continually observe
chemicals (due to a variety of reasons) or to think
of the chemicals as lethal. In addition, brooms
and other cleaning instruments can be used as
weapons and must also be either locked or under
constant supervision. Consider alarming the utility
room door to sound when the door is open. The
utility room should also meet all other fire and
environmental codes.
Recommended

7.2.13.8.2
Does the utility cart fit into the utility

room such that the door can be
locked behind it?
It is critical that patients on locked mental health

units do not have access to cleaning supplies at
any time. A patient can drink a fatal dose of
cleaning chemicals within seconds.
Environmental staff may not continually observe
chemicals (due to a variety of reasons) or to think
of the chemicals as lethal. In addition, brooms
and other cleaning instruments can be used as
weapons and must also be either locked or under
constant supervision. Consider alarming the utility
room door to sound when the door is open. The
utility room should also meet all other fire and
environmental codes.
Recommended
Psych Care - 7.2
404 of 578

Question:
7.2.13.8.3
Are cleaning chemicals locked or

under direct staff observation at all
times?
Met
(1)
Partially
Met (2)
Not
Consider the use of signs in the utility room and

on the utility cart reminding staff of the need for
constant vigilance with chemicals and other
cleaning instruments such as brooms and other
tools. Consider the use of locking utility carts.
Recommended

7.2.13.9
Staff Offices
7.2.13.9.1
Do doors to staff offices have the

ability to swing outward from the
room? (Only New Units)
This helps prevent staff from being locked in with

patient. Important Note: The door swing must
meet the requirements of NFPA 101 Life Safety
Code. Installing doors that normally swing into the
corridor could create corridor obstructions that are
not in compliance with the Life Safety Code. One
option for solving this problem is to build an
alcove for each door so that when the door is in
the full open position it does not extend more
than 7 inches into the corridor (see NFPA 101,
2006 edition, section 7.2.1.4.4). Another option is
to consider dual-swinging doors. See the
discussion under General Criteria.
Recommended

7.2.13.9.2
Are the doors to staff offices locked This is a staff safety issue. Other staff members
when unoccupied or when staff are in should be able to unlock the office door in case of
the office alone?
an emergency. Consider use of Dutch doors for
staff offices in low-security areas. A Dutch door
that is open at the top and closed at the bottom
can offer an open appearance while restricting
easy access into the room.
Recommended
Psych Care - 7.2
405 of 578

Question:
7.2.13.9.3
When a patient is in the office is the

door unlocked or left open?
Met
(1)
Partially
Met (2)
Not
Consider the use of interview rooms rather than

personal offices to interview patients. Interview
rooms should be equipped with panic buttons.
Recommended

7.2.13.9.4
Are computers secured to the desk,

and is the desk free of objects that
could be grabbed by a patient and
used to harm themselves or others?
Remove all unnecessary paperwork and objects

from desktop during patient treatment or
interview. Unsecured items in the office can be
used as a projectile.
Recommended

7.2.13.9.5
Is the furniture arranged so that staff The office furniture should be arranged so that
can have access to the exit if
the patient is not in a position to block access to
needed?
the exit.
Recommended

7.2.13.9.6
Are panic alarms installed in staff

offices as needed? Are the panic
alarms periodically tested to ensure
that they are functioning correctly?
Alarms should sound at the nurse station and

police. Testing of panic alarms should be done
on a periodic schedule with a frequency as
determined by staff. Alarm testing should be
recorded in a log.
Recommended

7.2.13.9.7
Windows - See General Criteria

Recommended

7.2.13.9.8
Are receptacles that are not in use

secured with a cover and are power
strips (if used) hidden under the desk
and secured on the floor or wall?
Reduce the risk of patients inserting objects in the

outlets. Consider using outlet covers that allow
appliances to be plugged in then locked down.
Use of power strips is not encouraged. If
additional electric outlets are needed, flush wallmounted outlets should be installed.
Recommended

7.2.13.10
Psych Care - 7.2
Outdoor Areas
406 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.10.1 Are fences designed to be not easily A fence must be a minimum of 10 feet high and
climbable (e.g., chain-link fences can with strong structural support to withstand force.
be easily climbed and should not be
used)?
Is the fence anchored to handle body

force?
Recommended

7.2.13.10.2 If there is a gate:
If present, a gate must be secured to the fence

with enough strength to withstand force. Each
staff member must carry a key at all times for
unlocking the gate.
Does the gate swing outward?
Is the hinge installed on the outside?
Is the gate wired with an alarm

system?
Do staff members have keys to

unlock the gate?
Recommended
Psych Care - 7.2
407 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.10.3 Can trees or branches be used to go Keep trees low and within the confine space of
over the fence (due to height or

proximity to the fence)?
the fence area, keep bushes and flower beds

small so they cannot hide patients. Allow no dirt
or rocks on grounds. Groundskeepers should
maintain a daily/weekly schedule to upkeep
grounds.
Can the tree branches be used as

weapons?
Are the bushes large enough to hide

patients?
Are there rocks or dirt that can be

used to throw at others?
Are there any toxic plants?
Recommended
Psych Care - 7.2
408 of 578

Question:
7.2.13.10.4 Are light fixtures out of the reach of
patients?
Met
(1)
Partially
Met (2)
Not
Switch for outdoor light must be located inside the

building. Tamper-resistant enclosures and lamp
covers will hamper attempts to get inside the
lighting fixtures.
Are surface-mounted outdoor lights

equipped with tamper-resistant
enclosures?
Are pole-mounted lights equipped

with tamper-resistant enclosures and
access holes equipped with tamperresistant screws?
Are the light fixtures and poles

designed to be not easily climbed?
Is there sufficient light for the entire

outdoor area?
Recommended
Psych Care - 7.2
409 of 578

Question:
7.2.13.10.5 Ideally, outdoor areas should be
monitored by cameras. If cameras

are used:
Met
(1)
Partially
Met (2)
Not
Staff must be train to monitor camera when

patients are outdoors. A procedure must be in
place for response to alarm. A periodic check of
security system and alarm must be done to
prevent system malfunction, and recorded in a
log.
Are the cameras located high

enough to have a 180 degree view of
the outdoor area?
Are the cameras secured with

tamper-resistant covers?
Is there always a specific staff

member(s) assigned to monitor the
cameras and activate the alarm if
there is any problem?
How quickly can police respond to

calls?
Recommended

7.2.13.10.6 Is furniture secured to the ground or
too heavy to be easily moved?
Is furniture located at a sufficient

distance away from the fence to
prevent it being using to get over the
fence?
Outdoor furniture must be anchor to concrete pad

and away from trees, fences or doors to prevent
patients from escaping the outdoor area. Staff
must check the condition of the furniture on a
regular basis to ensure it is not broken or
unsecured.
Recommended
Psych Care - 7.2
410 of 578

Question:
Met
(1)
Partially
Met (2)
Not
7.2.13.10.7 If the courtyard is elevated, are there Some courtyards are on upper floors. These
are no skylights that could be broken must be checked for potential jumping sites.
through or unprotected ledges or
walkways?
Recommended

7.2.13.11
Kitchen, Laundry, and OT Rooms

7.2.13.11.1
Are kitchens secured with a selfclosing self-locking door, or is there a

control switch at the nurses station
that activates the power to the
appliances (this control switch can be
on a timer)?

access to patients and have warning signs and
labels. Generally, only patients assessed at low
risk for suicide should be allowed in the kitchen
even under supervision. If there are appliances
such as refrigerators they should be secured to
the wall and glass bulbs should not be
accessible.
Is a protocol in place for observing all

patients using the kitchen?
If the kitchen area has a sink, is the

sink securely mounted to the wall
and all supply and waste plumbing
concealed and inaccessible with
tamper resistant screws?
Recommended

7.2.13.11.2
If there is a stove top, does it have a Self explanatory.

key switch to active the heat?
Recommended
Psych Care - 7.2
411 of 578

Question:
7.2.13.11.3
Are laundry rooms secured with a

self-closing self-locking door?
Met
(1)
Partially
Met (2)
Not

risk for suicide should be allowed in the Laundry
Room even under supervision.
Is a protocol in place for observing

patients using the laundry room?
Recommended

7.2.13.11.4
Are laundry chemicals kept locked

and away from the patients when
they are not being supervised?
Self explanatory.
Recommended

7.2.13.11.5
Are OT rooms secured and not

available to patients when they are
not supervised?

risk for suicide should be allowed in the OT room
even under supervision.
Recommended
Psych Care - 7.2
412 of 578

ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3
7.3.1.1
Question:
Bed Safety

5) within rail?

Met
(1)
Partially
Met (2)
Not

BedEntrap.pdf
Mandatory
BedEntrapPoster.pdf
Bed Safety
7.3.1.2

Recommended
Bed Safety
7.3.1.3
Acute Care - 7.3

risk?

requirements.
Mandatory
BedEntrap.pdf
Acute Care - 7.3 - Version: 01.30.2009
413 of 578

Question:
Bed Safety
7.3.1.5
Met
(1)
Partially
Met (2)
Not

patient?
etc.
Recommended
Bed Safety
7.3.1.6
Are beds with built-in weight scales

accurate and functioning correctly?
Preventative maintenance tags should be up to

date. Scale calibration should be considered and
manufacturer and/or facility policy
recommendations followed.
Recommended
Bed Safety
7.3.1.7

Recommended
FDA Bed Fires.pdf
Code Carts
7.3.2.1


records.
Mandatory
Acute Care - 7.3
414 of 578

7.3.2.3
Question:
Code Carts


Met
(1)
Partially
Met (2)
Not
Recommended
Code Carts
7.3.2.3.1
Recommended
Code Carts
7.3.2.4

Recommended
Code Carts
7.3.2.5
intubations?
Service.
Mandatory
Acute Care - 7.3
415 of 578

7.3.2.6
Question:
Code Carts


Met
(1)
Partially
Met (2)
Not
Recommended
Electrical Safety
7.3.3.1

system?

harm themselves.
Mandatory
Electrical Safety
7.3.3.2

exposed wiring?
Mandatory
Electrical Safety
7.3.3.3


Mandatory
Acute Care - 7.3
416 of 578

7.3.3.4
Question:
Electrical Safety


Met
(1)
Partially
Met (2)
Not
Mandatory
Electrical Safety
7.3.3.5

Mandatory
Electrical Safety
7.3.3.6

hazard?

Recommended

7.3.4.1

Mandatory

7.3.4.2
Acute Care - 7.3

Mandatory
417 of 578

Question:
7.3.4.3

to be a priority?
Mandatory
Met
(1)
Partially
Met (2)
Not

7.3.4.4


Mandatory

7.3.4.5

storage?

blocked doors.
NFPA 101 ch 7 - 2009.pdf
Mandatory

7.3.4.6

medication?

Mandatory

7.3.4.7


Mandatory
Acute Care - 7.3
418 of 578

Question:
7.3.4.8
Met
(1)
Partially
Met (2)
Not

signs and labels.
entrance?
Mandatory

7.3.4.10


environments.
Mandatory
Equipment Safety
7.3.5.1

identifiers.
NFPA 99 CH 8.pdf
Mandatory
Equipment Safety
7.3.5.2
Acute Care - 7.3


planned for.
Recommended
419 of 578

7.3.5.3
Question:
Equipment Safety

that patient?

Met
(1)
Partially
Met (2)
Not
Recommended
Equipment Safety
7.3.5.4

or false alarms?


Mandatory
Equipment Safety
7.3.5.5
Recommended
Acute Care - 7.3
420 of 578

7.3.5.6
Question:
Equipment Safety

tasks?

equipment in area.
Met
(1)
Partially
Met (2)
Not
Recommended
Equipment Safety
7.3.5.7


devices.
Recommended
Equipment Safety
7.3.5.8

equipment?

malfunctioning.
Recommended
Equipment Safety
7.3.5.9


Recommended
Acute Care - 7.3
421 of 578

7.3.5.10
Question:
Equipment Safety
Is a reliable system used to identify

which tubes and connectors go to
which devices?
Examples are color coding or directional arrows

for input jacks. Color coding should be used with
caution and given consideration for colorblindness, staff training, and consistency which
are all issues related to using a color code
system. Labeling of all tubing may not always be
practical however, certain high risk catherters
(epidural, intrathecal arterial) should be required.
The use of universal connectors should be strictly
avoided and not made available for staff use.
Met
(1)
Partially
Met (2)
Not

Recommended
JC SEA Issue 36.pdf
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
JC SEA Issue 36.pdf
422 of 578

Question:
Equipment Safety
7.3.5.10.2
Met
(1)
Partially
Met (2)
Not
Are staff observed to trace tubes and The following circumstances would benefit from
lines back to points of origin in
tracing tubes and lines back to their sources:
appropriate circumstances?
A disconnection of any tube (IV, blood pressure
cuff, urinary catheter, etc.) with the need to
reconnnect correctly;
-A tubing sporadically connected (left
disconnected inbetween) which when connected
has to be verified as to its accurate connecting
point (Note--blood pressure cuff would fall into
this category since they are often removed from
the patient inbetween taking of vital signs. Also,
quite often, cuffs are left on patients, but the
tubing is disconnected. There has been the
problem of a noninvasive BP tube connected to a
luer connector or to a urinary catheter)
-Additional tubes coming onto the scene of care
which prior to connection would require retracing
of tubings and potentially labeling for tubes added
which would be considered high risk;
-Change of location (packing the patient up and
moving the patient, enroute, and then arrival);
-Change of shift (change of (continued)...

Recommended
Acute Care - 7.3
The Joint Commission SEA Issue 36
423 of 578

Question:
Equipment Safety
7.3.5.10.2
(continued)... Are staff observed to
(continued) trace tubes and lines back to points
of origin in appropriate
circumstances?
Met
(1)
Partially
Met (2)
Not
...(continued) caregivers). Which also might

include new significant others/visitors coming
onto the scene.
Recommended
Equipment Safety
7.3.5.10.4
Can staff describe how they include

tubing considerations for individual
patients when they assess for fall
risk?
Interview and ask to see example of contents

from the plan of care that address tubing
management as a fall risk for patients with
multiple tubings.
Recommended
JC SEA Issue 36.pdf
Equipment Safety
7.3.5.10.5
As part of the orientation, are the

patient and family instructed to get
help from clinical staff if there is a
real or perceived need to connect or
disconnect any devices or tubings?
Ask to review anything that represents the

content used for orientation of patients and
families. Ask staff what they tell patients relative
to tubing connections and disconnections and
how they reinforce this each shift.
Mandatory
JC SEA Issue 36.pdf
Equipment Safety
7.3.5.11

Recommended
Acute Care - 7.3
424 of 578

7.3.5.13
Question:
Equipment Safety


Met
(1)
Partially
Met (2)
Not

Recommended
Equipment Safety
7.3.5.14


policy/protocols.
Recommended

7.3.6.1
patients to staff?
patients, etc.
Recommended

7.3.6.2
correctly?
Recommended
Acute Care - 7.3
425 of 578

Question:
7.3.6.3
Met
(1)
Partially
Met (2)
Not

program?
Recommended

7.3.6.4

event?

patient searches.
Mandatory

7.3.6.5

patients stay?

Mandatory

7.3.6.5.1

Mandatory
Acute Care - 7.3
426 of 578

Question:
7.3.6.6
Met
(1)
Partially
Met (2)
Not
Mandatory

7.3.6.7
patients to staff?
patients, etc.
Recommended
Fall Prevention
7.3.7.1


Mandatory
Fall Prevention
7.3.7.2


Recommended
Fall Prevention
7.3.7.2.1

patients?

Recommended
Acute Care - 7.3
SPHMAlgorithms.pdf
427 of 578

7.3.7.3
Question:
Fall Prevention

hazards?

Mandatory
Met
(1)
Partially
Met (2)
Not
Fall Prevention
7.3.7.4


the patient.
Mandatory
Fall Prevention
7.3.7.5

patient?
Inspect all areas.
Recommended
Fall Prevention
7.3.7.6
alarms?
Mandatory
Fall Prevention
7.3.7.7

or equivalent?

Mandatory
Acute Care - 7.3
428 of 578

7.3.7.8
Question:
Fall Prevention

timeframes?

staff.
Met
(1)
Partially
Met (2)
Not

Mandatory
Fall Prevention
7.3.7.9

bariatric patients?

Recommended
Fall Prevention
7.3.7.9.1

providers?

knowledge level.
Recommended
Fire Safety
7.3.8.1

area?

Mandatory
Acute Care - 7.3
429 of 578

7.3.8.2
Question:
Fire Safety


Met
(1)
Partially
Met (2)
Not

Mandatory
Fire Safety
7.3.8.3


not witnessed.
Mandatory
Fire Safety
7.3.8.4

NFPA 101 Ch 19.pdf
Mandatory
Fire Safety
7.3.8.5

"smoking risk"?

for these patients.
Mandatory
Acute Care - 7.3
430 of 578

7.3.8.5.1
Question:
Fire Safety

laundering?

time.
Recommended
Met
(1)
Partially
Met (2)
Not
Infection Control
7.3.9.1

openings)?
Mandatory
Infection Control
7.3.9.2


Mandatory
Infection Control
7.3.9.3
IV room.
Mandatory
Acute Care - 7.3
IL 16-97-001.pdf
431 of 578

7.3.9.4
Question:
Infection Control


available.
Met
(1)
Partially
Met (2)
Not


Mandatory
Infection Control
7.3.9.5


hazard exists.

are checked.
Mandatory
29CFR 1910.145.pdf
Infection Control
7.3.9.5.1

they are needed?

Plan.
Recommended
Acute Care - 7.3
432 of 578

Question:
Medical Gas Safety
7.3.10.1
Met
(1)
Partially
Met (2)
Not
adaptors.
Recommended
Air_O2WallInlet.pdf
Medical Gas Safety

7.3.10.2

treatments)?

meter.
Recommended
Air_O2WallInlet.pdf
Medical Gas Safety

7.3.10.3

how to use it?

Mandatory
Medical Gas Safety

7.3.10.4

Standards?

Mandatory
Acute Care - 7.3
O2CylHazardSumm.pdf
433 of 578

7.3.10.4.1
Question:
Medical Gas Safety


assembly.
Met
(1)
Partially
Met (2)
Not


around oxygen.
Mandatory
O2CylHazardSumm.pdf
Medical Gas Safety

7.3.10.5

O2CylHazardSumm.pdf
Mandatory
Medical Gas Safety

7.3.10.6
Acute Care - 7.3


Mandatory
O2CylHazardSumm.pdf
434 of 578

7.3.11.1
Question:
Medication Safety


food/drink.
Met
(1)
Partially
Met (2)
Not


Mandatory
Medication Safety
7.3.11.2

not in use?
Mandatory
Medication Safety
7.3.11.3

food?
Mandatory
Medication Safety
7.3.11.4


Mandatory
Acute Care - 7.3
435 of 578

Question:
Medication Safety
7.3.11.6
Met
(1)
Partially
Met (2)
Not

unit?
Recommended
Medication Safety
7.3.11.7
intravenously.
precaution?
Recommended
Medication Safety
7.3.11.9.1


available).
Mandatory
Medication Safety
7.3.11.10


be used.
Recommended
Medication Safety
7.3.11.13
Mandatory
Acute Care - 7.3
436 of 578

Question:
Medication Safety
7.3.11.13.1
Met
(1)
Partially
Met (2)
Not

practice?
Recommended
Medication Safety
7.3.11.14


or IV tubing's.
Recommended
Medication Safety
7.3.11.15

instructions?

Recommended
Medication Safety
7.3.11.16

use)?
Recommended
Medication Safety
7.3.11.17
Acute Care - 7.3


pumps.
Recommended
437 of 578

7.3.11.19
Question:
Medication Safety

setting?

Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.3.11.19.1
agents?
Recommended
Medication Safety
7.3.11.21

BCMA?

Recommended
Medication Safety
7.3.11.21.1

arounds?

arounds.
Recommended
Acute Care - 7.3
438 of 578

7.3.11.21.2
Question:
Medication Safety


barcode.
Recommended
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.3.11.21.3


Recommended
Medication Safety
7.3.11.22.1

alerts.
Recommended
Medication Safety
7.3.11.25
Recommended
Acute Care - 7.3
439 of 578

7.3.11.26
Question:
Medication Safety

staff?

Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.3.11.27

drugs?

Recommended
Medication Safety
7.3.11.28
effect?

Mandatory
Medication Safety
7.3.11.29


review.
Recommended
Medication Safety
7.3.11.32
Acute Care - 7.3

at least monthly?

Recommended
440 of 578

Question:
Medication Safety
7.3.11.34
Met
(1)
Partially
Met (2)
Not

process?
Mandatory
Medication Safety
7.3.11.35

frequency?

Mandatory
Medication Safety
7.3.11.42

Mandatory

7.3.12.1
not accepted.
Mandatory

7.3.12.2


Recommended
Acute Care - 7.3
441 of 578

7.3.12.3
Question:

information?

Mandatory
Met
(1)
Partially
Met (2)
Not

7.3.12.4

areas?

Mandatory

7.3.12.5


Mandatory
Acute Care - 7.3
442 of 578

7.3.12.6
Question:

misidentification?

misidentification.
Met
(1)
Partially
Met (2)
Not

Mandatory

7.3.12.6.1
Acute Care - 7.3

obtained?

Mandatory
443 of 578

7.3.12.6.2
Question:


Mandatory
Met
(1)
Partially
Met (2)
Not

7.3.12.6.3


Mandatory

7.3.12.7

in bed as well.
Recommended
Acute Care - 7.3
444 of 578

7.3.12.8
Question:

standardized?
communication tool.
Met
(1)
Partially
Met (2)
Not
Mandatory

7.3.12.9


Recommended

7.3.12.10

area/unit?

Recommended

7.3.12.11
Recommended
Acute Care - 7.3
445 of 578

7.3.12.11.1
Question:
Is there an assessment used to

determine if a patient is potentially
violent?
Review assessment process/documents.
Met
(1)
Partially
Met (2)
Not

VA IL-10-97-006 Violent Behavior.pdf

7.3.12.12
Mandatory
Acute Care - 7.3
446 of 578

INTENSIVE CARE UNITS 7.4
7.4.1.1
Question:
Bed Safety

5) within rail?

Met
(1)
Partially
Met (2)
Not

BedEntrap.pdf
Mandatory
BedEntrapPoster.pdf
Bed Safety
7.4.1.2

Recommended
Bed Safety
7.4.1.3
ICU - 7.4

risk?

requirements.
Mandatory
BedEntrap.pdf
ICU - 7.4 - Version: 01.30.2009
447 of 578

Question:
Bed Safety
7.4.1.5
Met
(1)
Partially
Met (2)
Not

patient?
etc.
Recommended
Bed Safety
7.4.1.6
Are beds with built-in weight scales

accurate and functioning correctly?
Preventative maintenance tags should be up to

date. Scale calibration should be considered and
manufacturer and/or facility policy
recommendations followed.
Recommended
Bed Safety
7.4.1.7

Recommended
FDA Bed Fires.pdf
Code Carts
7.4.2.1


records.
Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
448 of 578

7.4.2.3
Question:
Code Carts


Met
(1)
Partially
Met (2)
Not
Recommended
Code Carts
7.4.2.3.1
Recommended
Code Carts
7.4.2.4

Recommended
Code Carts
7.4.2.5
intubations?
Service.
Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
449 of 578

7.4.2.6
Question:
Code Carts


Met
(1)
Partially
Met (2)
Not
Recommended
Electrical Safety
7.4.3.1

system?

harm themselves.
Mandatory
Electrical Safety
7.4.3.2

exposed wiring?
Mandatory
Electrical Safety
7.4.3.3


Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
450 of 578

7.4.3.4
Question:
Electrical Safety


Met
(1)
Partially
Met (2)
Not
Mandatory
Electrical Safety
7.4.3.5

Mandatory
Electrical Safety
7.4.3.6

hazard?

Recommended

7.4.4.1

Mandatory

7.4.4.2
ICU - 7.4

Mandatory
ICU - 7.4 - Version: 01.30.2009
451 of 578

Question:
7.4.4.3

to be a priority?
Mandatory
Met
(1)
Partially
Met (2)
Not

7.4.4.4


Mandatory

7.4.4.5

storage?

blocked doors.
NFPA 101 ch 7 - 2009.pdf
Mandatory

7.4.4.6

medication?

Mandatory

7.4.4.7


Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
452 of 578

Question:
7.4.4.10

Met
(1)
Partially
Met (2)
Not

environments.
Mandatory
Equipment Safety
7.4.5.1

identifiers.
NFPA 99 CH 8.pdf
Mandatory
Equipment Safety
7.4.5.2


planned for.
Recommended
Equipment Safety
7.4.5.3

that patient?

Recommended
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
453 of 578

7.4.5.4
Question:
Equipment Safety

or false alarms?

Met
(1)
Partially
Met (2)
Not

Mandatory
Equipment Safety
7.4.5.5
Recommended
Equipment Safety
7.4.5.6

tasks?

equipment in area.
Recommended
Equipment Safety
7.4.5.7


devices.
Recommended
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
454 of 578

7.4.5.8
Question:
Equipment Safety

equipment?

malfunctioning.
Met
(1)
Partially
Met (2)
Not
Recommended
Equipment Safety
7.4.5.9


Recommended
Equipment Safety
7.4.5.10

which devices?


Recommended
JC SEA Issue 36.pdf
Equipment Safety
7.4.5.10.1
Recommended
ICU - 7.4
JC SEA Issue 36.pdf
ICU - 7.4 - Version: 01.30.2009
455 of 578

Question:
Equipment Safety
7.4.5.10.2
Met
(1)
Partially
Met (2)
Not

Recommended
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
456 of 578

Question:
Equipment Safety
7.4.5.10.2
circumstances?
Met
(1)
Partially
Met (2)
Not

onto the scene.
Recommended
Equipment Safety
7.4.5.10.4

risk?

multiple tubings.
Recommended
JC SEA Issue 36.pdf
Equipment Safety
7.4.5.10.5


Mandatory
JC SEA Issue 36.pdf
Equipment Safety
7.4.5.11

Recommended
Equipment Safety
7.4.5.12
Are clocks synchronized and

accurate?
During codes the monitoring equipment has a

clock and the room or unit has a clock and the
times on all clocks should be the same.
Recommended
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
457 of 578

7.4.5.13
Question:
Equipment Safety


Met
(1)
Partially
Met (2)
Not

Recommended
Equipment Safety
7.4.5.14


policy/protocols.
Recommended

7.4.6.5
ICU - 7.4

patients stay?

Mandatory
ICU - 7.4 - Version: 01.30.2009
458 of 578

Question:
7.4.6.7
Met
(1)
Partially
Met (2)
Not
patients to staff?
patients, etc.
Recommended
Fall Prevention
7.4.7.1


Mandatory
Fall Prevention
7.4.7.2


Recommended
Fall Prevention
7.4.7.2.1

patients?

Recommended
SPHMAlgorithms.pdf
Fall Prevention
7.4.7.3
ICU - 7.4

hazards?

Mandatory
ICU - 7.4 - Version: 01.30.2009
459 of 578

7.4.7.4
Question:
Fall Prevention


the patient.
Mandatory
Met
(1)
Partially
Met (2)
Not
Fall Prevention
7.4.7.5

patient?
Inspect all areas.
Recommended
Fall Prevention
7.4.7.6
alarms?
Mandatory
Fall Prevention
7.4.7.7

or equivalent?

Mandatory
Fall Prevention
7.4.7.8

timeframes?

staff.

Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
460 of 578

7.4.7.9
Question:
Fall Prevention

bariatric patients?

Recommended
Met
(1)
Partially
Met (2)
Not
Fall Prevention
7.4.7.9.1

providers?

knowledge level.
Recommended
Fire Safety
7.4.8.1

area?

Mandatory
Fire Safety
7.4.8.2


Mandatory
Fire Safety
7.4.8.3


not witnessed.
Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
461 of 578

Question:
Fire Safety
7.4.8.4
Met
(1)
Partially
Met (2)
Not

NFPA 101 Ch 19.pdf
Mandatory
Infection Control
7.4.9.1

openings)?
Mandatory
Infection Control
7.4.9.2


Mandatory
Infection Control
7.4.9.3
IV room.
Mandatory
ICU - 7.4
IL 16-97-001.pdf
ICU - 7.4 - Version: 01.30.2009
462 of 578

7.4.9.4
Question:
Infection Control


available.
Met
(1)
Partially
Met (2)
Not


Mandatory
Infection Control
7.4.9.5


hazard exists.

are checked.
Mandatory
29CFR 1910.145.pdf
Infection Control
7.4.9.5.1

they are needed?

Plan.
Recommended
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
463 of 578

Question:
Medical Gas Safety
7.4.10.1
Met
(1)
Partially
Met (2)
Not
adaptors.
Recommended
Air_O2WallInlet.pdf
Medical Gas Safety

7.4.10.2

treatments)?

meter.
Recommended
Air_O2WallInlet.pdf
Medical Gas Safety

7.4.10.3

how to use it?

Mandatory
Medical Gas Safety

7.4.10.4

Standards?

Mandatory
ICU - 7.4
O2CylHazardSumm.pdf
ICU - 7.4 - Version: 01.30.2009
464 of 578

7.4.10.4.1
Question:
Medical Gas Safety


assembly.
Met
(1)
Partially
Met (2)
Not


around oxygen.
Mandatory
O2CylHazardSumm.pdf
Medical Gas Safety

7.4.10.5

O2CylHazardSumm.pdf
Mandatory
Medical Gas Safety

7.4.10.6
ICU - 7.4


Mandatory
O2CylHazardSumm.pdf
ICU - 7.4 - Version: 01.30.2009
465 of 578

7.4.11.1
Question:
Medication Safety


food/drink.
Met
(1)
Partially
Met (2)
Not


Mandatory
Medication Safety
7.4.11.2

not in use?
Mandatory
Medication Safety
7.4.11.3

food?
Mandatory
Medication Safety
7.4.11.4


Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
466 of 578

Question:
Medication Safety
7.4.11.6
Met
(1)
Partially
Met (2)
Not

unit?
Recommended
Medication Safety
7.4.11.6.1
If needle-less sytems are used are

Example of needle-less systems: blunt tip, preemergency medication delivery
dawn syringes, etc.
systems for drugs in code carts and
emergency drug boxes compatible
are adaptors provided and available?
Recommended
Medication Safety
7.4.11.6.2
If codes are not called within a

Conducting mock drills will facilitate use during
specified duration, does the
emergencies when seconds count.
organization use an alternate method
(e.g. mock codes) to maintain staff
competency with emergency
medication?
Recommended
Medication Safety
7.4.11.7
intravenously.
precaution?
Recommended
Medication Safety
7.4.11.8

floors/care areas?
Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
467 of 578

7.4.11.9.1
Question:
Medication Safety


available).
Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.4.11.10


be used.
Recommended
Medication Safety
7.4.11.10.1
Are single-dose perenteral

containers (with preference to prefiled syringes) used when possible?
For infection control and medication safety

purposes.
Mandatory
Medication Safety
7.4.11.13
Mandatory
Medication Safety
7.4.11.13.1

practice?
Recommended
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
468 of 578

7.4.11.14
Question:
Medication Safety


or IV tubing's.
Met
(1)
Partially
Met (2)
Not

Recommended
Medication Safety
7.4.11.15

instructions?

Recommended
Medication Safety
7.4.11.16

use)?
Recommended
Medication Safety
7.4.11.17


pumps.
Recommended
Medication Safety
7.4.11.19

setting?

Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
469 of 578

Question:
Medication Safety
7.4.11.19.1
Met
(1)
Partially
Met (2)
Not
agents?
Recommended
Medication Safety
7.4.11.21

BCMA?

Recommended
Medication Safety
7.4.11.21.1

arounds?

arounds.
Recommended
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
470 of 578

7.4.11.21.2
Question:
Medication Safety


barcode.
Recommended
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.4.11.21.3


Recommended
Medication Safety
7.4.11.22.1

alerts.
Recommended
Medication Safety
7.4.11.25
Recommended
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
471 of 578

7.4.11.26
Question:
Medication Safety

staff?

Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.4.11.27

drugs?

Recommended
Medication Safety
7.4.11.28
effect?

Mandatory
Medication Safety
7.4.11.29


review.
Recommended
Medication Safety
7.4.11.32
ICU - 7.4

at least monthly?

Recommended
ICU - 7.4 - Version: 01.30.2009
472 of 578

Question:
Medication Safety
7.4.11.34
Met
(1)
Partially
Met (2)
Not

process?
Mandatory
Medication Safety
7.4.11.35

frequency?

Mandatory
Medication Safety
7.4.11.39.1
Is there a process to verify contents

of a syringe or container before drug
administration to patient during a
procedure or code?
Safe labeling of medications and solutions

(including contrast media) in perioperative
settings, operating rooms, ambulatory surgery,
clinics, cardiac catheterization area, endoscopy,
radiology, dental, or other areas where operative
and invasive procedures may be performed an
independent double check of should be confirmed
by the person who administers the agent. The
medication should be labeled before contents are
transferred and the medication should not be left
unattended for any reason.
Recommended
Medication Safety
7.4.11.42

Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
473 of 578

Question:
7.4.12.1
Met
(1)
Partially
Met (2)
Not
not accepted.
Mandatory

7.4.12.2


Recommended

7.4.12.3

information?

Mandatory

7.4.12.4

areas?

Mandatory

7.4.12.5


Mandatory
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
474 of 578

7.4.12.6
Question:

misidentification?

misidentification.
Met
(1)
Partially
Met (2)
Not

Mandatory

7.4.12.6.1
ICU - 7.4

obtained?

Mandatory
ICU - 7.4 - Version: 01.30.2009
475 of 578

7.4.12.6.2
Question:


Mandatory
Met
(1)
Partially
Met (2)
Not

7.4.12.6.3


Mandatory

7.4.12.7

in bed as well.
Recommended
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
476 of 578

7.4.12.8
Question:

standardized?
communication tool.
Met
(1)
Partially
Met (2)
Not
Mandatory

7.4.12.9


Recommended

7.4.12.10

area/unit?

Recommended

7.4.12.11
Recommended
ICU - 7.4
ICU - 7.4 - Version: 01.30.2009
477 of 578

Question:
7.4.12.12
Met
(1)
Partially
Met (2)
Not
Mandatory
Surgical or Invasive Procedure Precautions

7.4.14.2
ICU - 7.4
Has the VHA OR Self Assessment

#1: Self-Assessment Tool for
Observing Steps Required by VHA
Directives 2004-028 (Ensuring
Correct Surgery and Invasive
Procedures) and 2006-030
(Prevention of Retained Surgical
Items, being used?
This self assessment tool provides a relatively

quick way to assess local policy compliance with
requirements of related VHA Directives.
Mandatory
ORSAT 1 In-OR for VAMC Policies 2004-028 & 2006-030_51107.doc
ICU - 7.4 - Version: 01.30.2009
478 of 578

PRE-OP HOLDING OPERATING ROOM & POST ANESTHESIA UNIT
Question:
Code Carts
7.5.2.4
Met
(1)
Partially
Met (2)
Not

Recommended
Electrical Safety
7.5.3.1

system?

harm themselves.
Mandatory
Electrical Safety
7.5.3.2

exposed wiring?
Mandatory
Electrical Safety
7.5.3.3


Mandatory
OR - 7.5
OR - 7.5 - Version: 01.30.2009
479 of 578

7.5.3.4
Question:
Electrical Safety


Met
(1)
Partially
Met (2)
Not
Mandatory
Electrical Safety
7.5.3.6

hazard?

Recommended
Electrical Safety
7.5.3.7
If provided are electrical isolation

transformers and switchgear serving
the operating rooms properly sized to
carry the maximum expected
electrical load; and is there an
assessment done when new
equipment is added to the system?
NCPS has observed increasing number of

electrical blackouts and brownouts in operating
suites due to the increased power demand of new
equipment being used in the OR's. Facilities
Engineering should conduct an analysis to verify
the adequacy of these devices/equipment.
Recommended

7.5.4.2

Mandatory

7.5.4.3
OR - 7.5

to be a priority?
Mandatory
OR - 7.5 - Version: 01.30.2009
480 of 578

Question:
7.5.4.4

Met
(1)
Partially
Met (2)
Not

Mandatory

7.5.4.5

storage?

blocked doors.
NFPA 101 ch 7 - 2009.pdf
Mandatory

7.5.4.6

medication?

Mandatory

7.5.4.7


Mandatory

7.5.4.9
OR - 7.5
Are battery operated lights provided

in Operating Rooms and any other
Anesthetizing Location?
Due to lag time between the loss of power and

activation of the emergency generator battery
operated lights shall be provided.
Mandatory
OR - 7.5 - Version: 01.30.2009
481 of 578

Question:
7.5.4.10

Met
(1)
Partially
Met (2)
Not

environments.
Mandatory
Equipment Safety
7.5.5.1

identifiers.
NFPA 99 CH 8.pdf
Mandatory
Equipment Safety
7.5.5.2


planned for.
Recommended
Equipment Safety
7.5.5.3

that patient?

Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
482 of 578

7.5.5.4
Question:
Equipment Safety

or false alarms?

Met
(1)
Partially
Met (2)
Not

Mandatory
Equipment Safety
7.5.5.5
Recommended
Equipment Safety
7.5.5.6

tasks?

equipment in area.
Recommended
Equipment Safety
7.5.5.7


devices.
Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
483 of 578

7.5.5.8
Question:
Equipment Safety

equipment?

malfunctioning.
Met
(1)
Partially
Met (2)
Not
Recommended
Equipment Safety
7.5.5.9


Recommended
Equipment Safety
7.5.5.10

which devices?


Recommended
JC SEA Issue 36.pdf
Equipment Safety
7.5.5.10.1
Recommended
OR - 7.5
JC SEA Issue 36.pdf
OR - 7.5 - Version: 01.30.2009
484 of 578

Question:
Equipment Safety
7.5.5.10.2
Met
(1)
Partially
Met (2)
Not

Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
485 of 578

Question:
Equipment Safety
7.5.5.10.2
circumstances?
Met
(1)
Partially
Met (2)
Not

onto the scene.
Recommended
Equipment Safety
7.5.5.10.4

risk?

multiple tubings.
Recommended
JC SEA Issue 36.pdf
Equipment Safety
7.5.5.10.5


Mandatory
JC SEA Issue 36.pdf
Equipment Safety
7.5.5.11

Recommended
Equipment Safety
7.5.5.12
Are clocks synchronized and

accurate?
During codes the monitoring equipment has a

clock and the room or unit has a clock and the
times on all clocks should be the same.
Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
486 of 578

7.5.5.13
Question:
Equipment Safety


Met
(1)
Partially
Met (2)
Not

Recommended
Equipment Safety
7.5.5.14


policy/protocols.
Recommended

7.5.6.5
OR - 7.5

patients stay?

Mandatory
OR - 7.5 - Version: 01.30.2009
487 of 578

Question:
7.5.6.6
Met
(1)
Partially
Met (2)
Not
Mandatory

7.5.6.7
patients to staff?
patients, etc.
Recommended
Fall Prevention
7.5.7.2


Recommended
Fall Prevention
7.5.7.2.1

patients?

Recommended
SPHMAlgorithms.pdf
Fall Prevention
7.5.7.3
OR - 7.5

hazards?

Mandatory
OR - 7.5 - Version: 01.30.2009
488 of 578

7.5.7.9
Question:
Fall Prevention

bariatric patients?

Recommended
Met
(1)
Partially
Met (2)
Not
Fall Prevention
7.5.7.9.1

providers?

knowledge level.
Recommended
Fire Safety
7.5.8.1

area?

Mandatory
Fire Safety
7.5.8.2


Mandatory
Fire Safety
7.5.8.3


not witnessed.
Mandatory
OR - 7.5
OR - 7.5 - Version: 01.30.2009
489 of 578

Question:
Fire Safety
7.5.8.4
Met
(1)
Partially
Met (2)
Not

NFPA 101 Ch 19.pdf
Mandatory
Infection Control
7.5.9.1

openings)?
Mandatory
Infection Control
7.5.9.2


Mandatory
Infection Control
7.5.9.3
IV room.
Mandatory
OR - 7.5
IL 16-97-001.pdf
OR - 7.5 - Version: 01.30.2009
490 of 578

7.5.9.4
Question:
Infection Control


available.
Met
(1)
Partially
Met (2)
Not


Mandatory
Medical Gas Safety

7.5.10.1
adaptors.
Recommended
Air_O2WallInlet.pdf
Medical Gas Safety

7.5.10.3

how to use it?

Mandatory
OR - 7.5
OR - 7.5 - Version: 01.30.2009
491 of 578

7.5.10.4
Question:
Medical Gas Safety

Standards?

Met
(1)
Partially
Met (2)
Not
Mandatory
O2CylHazardSumm.pdf
Medical Gas Safety

7.5.10.4.1


assembly.


around oxygen.
Mandatory
O2CylHazardSumm.pdf
Medical Gas Safety

7.5.10.5

O2CylHazardSumm.pdf
Mandatory
OR - 7.5
OR - 7.5 - Version: 01.30.2009
492 of 578

7.5.10.6
Question:
Medical Gas Safety


Mandatory
O2CylHazardSumm.pdf
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.5.11.1


food/drink.


Mandatory
Medication Safety
7.5.11.2

not in use?
Mandatory
Medication Safety
7.5.11.4


Mandatory
OR - 7.5
OR - 7.5 - Version: 01.30.2009
493 of 578

Question:
Medication Safety
7.5.11.6
Met
(1)
Partially
Met (2)
Not

unit?
Recommended
Medication Safety
7.5.11.6.1

dawn syringes, etc.
Recommended
Medication Safety
7.5.11.6.2
If codes are not called within a

Conducting mock drills will facilitate use during
specified duration, does the
emergencies when seconds count.
organization use an alternate method
(e.g. mock codes) to maintain staff
competency with emergency
medication?
Recommended
Medication Safety
7.5.11.7
intravenously.
precaution?
Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
494 of 578

7.5.11.9.1
Question:
Medication Safety


available).
Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.5.11.10.1


purposes.
Mandatory
Medication Safety
7.5.11.11
Are the sizes of injectable drugs in

vials or ampoules matched to the
clinical situation?
Helps to prevent overdose and reduces the

hazard associated with multi-dose vials. This
may be a future JCAHO PS Goal.
Recommended
Medication Safety
7.5.11.14


or IV tubing's.
Recommended
Medication Safety
7.5.11.15

instructions?

Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
495 of 578

Question:
Medication Safety
7.5.11.16
Met
(1)
Partially
Met (2)
Not

use)?
Recommended
Medication Safety
7.5.11.17


pumps.
Recommended
Medication Safety
7.5.11.19

setting?

Mandatory
Medication Safety
7.5.11.19.1
agents?
Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
496 of 578

7.5.11.19.2
Question:
Medication Safety
If naloxone has been used to reverse

the effects of morphine or
meperidine, is the patient observed
for a minimum of two hours to ensure
that re-narcotization has not taken
place?
There have been cases where the anesthesia

reversal agent wears off and the anesthesia
begins to take effect again after patients have
been discharged.
Met
(1)
Partially
Met (2)
Not
Recommended
Medication Safety
7.5.11.25
Recommended
Medication Safety
7.5.11.26

staff?

Mandatory
Medication Safety
7.5.11.27

drugs?

Recommended
Medication Safety
7.5.11.28
effect?

Mandatory
OR - 7.5
OR - 7.5 - Version: 01.30.2009
497 of 578

7.5.11.29
Question:
Medication Safety


review.
Met
(1)
Partially
Met (2)
Not

Recommended
Medication Safety
7.5.11.34

process?
Mandatory
Medication Safety
7.5.11.36
Are medications used in surgical

cases organized and standardized
per case type to minimize interprovider variation?
Standardization is an important patient safety

principle.
Recommended
Medication Safety
7.5.11.37
OR - 7.5
Are chemical products and

medications (including contract
media) used in the operative suite,
treatment areas, pharmacy or clinics
purchased in sizes appropriate for
their clinical situation (single dose,
single patient, individually labeled)
and kept in a labeled state to the
point of administration?
If appropriate sizes are acquired for each clinical

situation it eliminates the transfer of containers,
omitting the vulnerability of mislabeling or misadministration. Labels are required on all
medications, solutions, etc. on and off the sterile
field, even if only one medication/solution is
given. If pre-made single dose containers are not
available for sterile procedures, sterile markers
with blank labels and/or pre-printed labels should
be made available to include in pre-made sterile
packs.
Mandatory
JC- CAMH MM.05.01.09.pdf
OR - 7.5 - Version: 01.30.2009
498 of 578

7.5.11.39
Question:
Medication Safety
Are medications drawn up for use in

the sterile field accurately and
consistently labeled?
Eliminate the use of unlabeled sterile basins.

Encourage the use of sterile-packed unit dose
medications.
Met
(1)
Partially
Met (2)
Not

Mandatory
Medication Safety
7.5.11.39.1

procedure or code?

Recommended
Medication Safety
7.5.11.40
Do respiratory care professionals

administer respiratory treatments?
Having these individuals give the medication is a

barrier against improper administration.
Registered nurses that perform respiratory tasks
should have documented competency.
Recommended
Medication Safety
7.5.11.41
Are emergency medications to treat

malignant hyperthermia readily
available?
These cases are rare, however, the medication to

treat it can expire before it is needed. There
should be mechanism to check the expiration
date and availability on a periodic basis.
MH Medical Professionals FAQs.pdf
Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
499 of 578

Question:
Medication Safety
7.5.11.41.1
Met
(1)
Partially
Met (2)
Not
If sterile water is used to dilute IV

1 L bags of water can be confused for IV bags
dantrolene in emergency boxes in
and inadvertently infused.
treating of malignant hyperthermia is
it provided in 50 mL vials vs. 1 L
bags?
Recommended
Medication Safety
7.5.11.42

Mandatory

7.5.12.1
not accepted.
Mandatory

7.5.12.3

information?

Mandatory

7.5.12.4
OR - 7.5

areas?

Mandatory
OR - 7.5 - Version: 01.30.2009
500 of 578

7.5.12.6
Question:

misidentification?

misidentification.
Met
(1)
Partially
Met (2)
Not

Mandatory

7.5.12.6.1
OR - 7.5

obtained?

Mandatory
OR - 7.5 - Version: 01.30.2009
501 of 578

7.5.12.6.2
Question:


Mandatory
Met
(1)
Partially
Met (2)
Not

7.5.12.6.3


Mandatory

7.5.12.11
Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
502 of 578

Question:
7.5.14.1
Is there physical evidence that the

VHA Ensuring Correct Surgery
Directive is being followed inside OR
for surgeries and outside the OR for
other invasive procedures?
Met
(1)
Partially
Met (2)
Not
Observe a pre-op team "time out"; or interview

clinicians who participate on surgical teams.
Look for posters, use of a white board, review
documentation if available. View surgical
package software to see if steps are documented.
OR SAT 2 for VAMC Policies 2004-028.doc
Mandatory
VHA Directive 2004-028 (2002-070).pdf

7.5.14.2
Has the VHA OR Self Assessment

#1: Self-Assessment Tool for
Observing Steps Required by VHA
Directives 2004-028 (Ensuring
Correct Surgery and Invasive
Procedures) and 2006-030
(Prevention of Retained Surgical
Items, being used?
This self assessment tool provides a relatively

quick way to assess local policy compliance with
requirements of related VHA Directives.
Mandatory
ORSAT 1 In-OR for VAMC Policies 2004-028 & 2006-030_51107.doc

7.5.14.3
Are the required actions stipulated in Interview staff involved with surgeries ensure that
the Prevention of Retained Surgical the following takes place: methodical wound
Items Directive being followed?
exploration; items placed in the surgical field must
not be cut or used for dressing; items must be
counted (using AORN guidelines); if a
discrepancy is discovered measures are taken to
resolve (i.e. radiography is done). Note: surgical
counts and other requirements may be omitted in
some emergency situations.
ORSAT 3 for VAMC Policies 2006-030.doc

Mandatory

7.5.14.3.1
OR - 7.5
If an item is missing and radiological

interpretation is needed are
guidelines of referenced Directive
followed?
Radiographs must be interpreted during normal

working hours in real time (i.e., within 30
minutes). Teleradioloy can and should be used if
available on off-shifts, if available.
Mandatory
OR - 7.5 - Version: 01.30.2009
503 of 578

Question:
7.5.14.4
Does each surgical team conduct a

post-operative debriefing to discuss
recently completed surgical cases?
Talk with staff to determine if successes are

acknowledged, if miscommunications occurred, or
improvements are discussed.
Recommended
MTTBD_Sep06.pdf
Met
(1)
Partially
Met (2)
Not

7.5.14.5
If the staff that makes up the surgical Reducing staff change over helps to eliminate
team does not remain consistent
errors. Show written protocol, and interview
during a procedure is there a
clinicians who participate on surgical teams.
protocol to brief on coming staff
regarding current surgical procedure
status?
Recommended

7.5.14.6
Are all members of the surgical team Interview staff to determine if professional or
encouraged to, and feel comfortable, organizational barriers exist between team
speaking up if they recognize a
members which can impede patient care.
potential problem?
MTT BG No Qs July 6 07 (2).doc
Recommended
RulesOfConduct.pdf

7.5.14.7
If ESU's (Electro-surgical units) are

used, is there a standardized
protocol of where the unit is placed
during a surgical procedure to
prevent inadvertent fire or burns
when not in active use?
Ask staff of protocol; look for use of an insolated

holster or device.
Recommended
OR - 7.5
NFPA 99.8.5.2.3.1.pdf /A Page=03
OR - 7.5 - Version: 01.30.2009
504 of 578

Question:
7.5.14.8
If ESU, lasers, or other heat

producing equipment is used during
surgical procedures in the lungs,
throat, or near the nose or mouth is
compressed oxygen turned off and
oxygen given time to dissipate prior
to activating the equipment?
An oxygen enriched atmosphere greatly

increases the risk of fire and therefore must be
controlled before the heat source is introduced.
Oxygen can be trapped in body hair and
dressings and time is needed for it to dissipate.
Recommended
Met
(1)
Partially
Met (2)
Not

7.5.14.9
Do guidelines exist for using flash

sterilizers?
Flash sterilizers are only to be used in an

emergency, when no other method of sterilization
is available. VA SPD Handbook 7176 describes
requirements when using this equipment, such as
utilization of a log to document what items that
are flashed (including, at minimum, patient
identification, operator identification, sterilizer
identification, date and time of cycle, load
contents, and time and temperature of the
exposure) to potentially help to identify any
infections that may have occurred because of
flash sterilization.
Mandatory
VHA Handbook 7176 SPD.pdf

7.5.14.10
Are blood and blood products that

are earmarked and prepared for a
specific patient verified (via protocol
for double checks) for type and
cross-match before the surgical
procedure begins?
Interview staff.
Recommended

7.5.14.11
Is the temporary storage and/or

An 'OR central storage' should be avoided;
labeling of blood and blood products rather, the use of separate bins, or local storage
in the surgical suite set up to avoid
in each operating room is optimal. Blood bank
potential mix-ups?
oversight of storage is expected.
Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
505 of 578

Question:
7.5.14.12
Met
(1)
Partially
Met (2)
Not
Are procedures in place to help

A patient pre-op evaluation should be done and
prevent intra-operative myocardial
preventive medication regimen given or other
ischemia in high risk patients such as intervention for high risk patients.
a beta-blocker protocol?
Recommended

7.5.14.13
Is a pre-operative evaluation
completed for each patient to
determine the risk of acquiring a
Surgical Site Infection (SSI)?
If patients are determined to be at significant risk,

it may be necessary to give peri-operative
antibiotics. Postpone elective procedures,
remove hair for surgical site by clipping (not
shaving), etc.
Recommended

7.5.14.14
Has a protocol been defined for the

use of pneumatic tourniquets?
Ensure proper fit; keep inflation time and

pressure to minimum; require continuous
monitoring of the time and pressure display;
ensure manufactures recommendations are
followed for use and maintenance; and require
staff training on device.
Recommended

7.5.14.15
Is there a system in place to verify

that prosthetic devices are available
in the correct size and properly
sterilized prior to surgery?
Vulnerabilities can exist in the acquiring and

placement of these devices. Double checks and
labeling are inefficient and often ineffective
methods of verification. Bar coding systems and
repackaging are more reliable methods to ensure
proper sterilization and size.
Tamuz_Dbl checks and high reliability_2006.pdf
Mandatory
VHA Handbook 7176 SPD.pdf

7.5.14.16
Is there a system in place to ensure NCPS is aware of battery operated saws that
that battery operated surgical
have stopped working during surgery and manual
equipment is fully charged and has a hand saws were not available.
manual back up if needed?
Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
506 of 578

Question:
7.5.14.17
Are environmental distractions

minimized during surgical
procedures?
Met
(1)
Partially
Met (2)
Not
Radio volume, checking pagers, answering cell

phones, talking, etc.
Recommended

7.5.14.18
Is the VA Anesthesia Cognitive Aid

Inspect machines.
attached to all anesthesia machines?
Recommended
cognitive_aids_anesthesiology.pdf

7.5.14.19
Does the OR service specific fire

plan address the use of heat
producing equipment in and around
oxygen enriched atmospheres and/or
flammable preparations?
Lasers are an ignition source and can cause fire,

explosion and consequently serious burns to
patients or staff in an oxygen enriched
environment.
NFPA 99 ch 13.pdf
Recommended
OR - 7.5
OR - 7.5 - Version: 01.30.2009
507 of 578

RADIOLOGY AREA
7.6.2.1
Question:
Code Carts


records.
Met
(1)
Partially
Met (2)
Not
Mandatory
Code Carts
7.6.2.3


Recommended
Code Carts
7.6.2.3.1
Recommended
Code Carts
7.6.2.4

Recommended
Code Carts
7.6.2.5
intubations?
Service.
Mandatory
Radiology - 7.6
Radiology - 7.6 - Version: 01.30.2009
508 of 578

RADIOLOGY AREA
7.6.3.1
Question:
Electrical Safety

system?

harm themselves.
Met
(1)
Partially
Met (2)
Not
Mandatory
Electrical Safety
7.6.3.2

exposed wiring?
Mandatory
Electrical Safety
7.6.3.3


Mandatory
Electrical Safety
7.6.3.4


Mandatory
Radiology - 7.6
509 of 578

RADIOLOGY AREA
7.6.3.6
Question:
Electrical Safety

hazard?

Met
(1)
Partially
Met (2)
Not
Recommended

7.6.4.2

Mandatory

7.6.4.3

to be a priority?
Mandatory

7.6.4.4


Mandatory

7.6.4.5

storage?

blocked doors.
NFPA 101 ch 7 - 2009.pdf
Mandatory
Radiology - 7.6
510 of 578

RADIOLOGY AREA
Question:
7.6.4.6

medication?
Met
(1)
Partially
Met (2)
Not

Mandatory

7.6.4.7


Mandatory

7.6.4.8

signs and labels.
entrance?
Mandatory

7.6.4.10


environments.
Mandatory
Radiology - 7.6
511 of 578

RADIOLOGY AREA
Question:
Equipment Safety
7.6.5.1
Met
(1)
Partially
Met (2)
Not

identifiers.
NFPA 99 CH 8.pdf
Mandatory
Equipment Safety
7.6.5.6

tasks?

equipment in area.
Recommended
Equipment Safety
7.6.5.7


devices.
Recommended
Equipment Safety
7.6.5.8

equipment?

malfunctioning.
Recommended
Equipment Safety
7.6.5.9


Recommended
Radiology - 7.6
512 of 578

RADIOLOGY AREA
7.6.5.10.4
Question:
Equipment Safety

risk?

multiple tubings.
Met
(1)
Partially
Met (2)
Not

Recommended
JC SEA Issue 36.pdf
Equipment Safety
7.6.5.10.5


Mandatory
JC SEA Issue 36.pdf
Equipment Safety
7.6.5.11

Recommended
Equipment Safety
7.6.5.14


policy/protocols.
Recommended
Radiology - 7.6
513 of 578

RADIOLOGY AREA
Question:
7.6.6.6
Met
(1)
Partially
Met (2)
Not
Mandatory

7.6.6.7
patients to staff?
patients, etc.
Recommended
Fall Prevention
7.6.7.1


Mandatory
Fall Prevention
7.6.7.2


Recommended
Fall Prevention
7.6.7.2.1

patients?

Recommended
Radiology - 7.6
SPHMAlgorithms.pdf
514 of 578

RADIOLOGY AREA
7.6.7.3
Question:
Fall Prevention

hazards?

Mandatory
Met
(1)
Partially
Met (2)
Not
Fall Prevention
7.6.7.4


the patient.
Mandatory
Fall Prevention
7.6.7.9

bariatric patients?

Recommended
Fall Prevention
7.6.7.9.1
Radiology - 7.6

providers?

knowledge level.
Recommended
515 of 578

RADIOLOGY AREA
7.6.8.1
Question:
Fire Safety

area?
Met
(1)
Partially
Met (2)
Not

Mandatory
Fire Safety
7.6.8.2


Mandatory
Fire Safety
7.6.8.3


not witnessed.
Mandatory
Fire Safety
7.6.8.4

NFPA 101 Ch 19.pdf
Mandatory
Infection Control
7.6.9.1
Radiology - 7.6

openings)?
Mandatory
516 of 578

RADIOLOGY AREA
7.6.9.2
Question:
Infection Control


Mandatory
Met
(1)
Partially
Met (2)
Not
Infection Control
7.6.9.3
IV room.
Mandatory
IL 16-97-001.pdf
Infection Control
7.6.9.4


available.


Mandatory
Radiology - 7.6
517 of 578

RADIOLOGY AREA
Question:
Medical Gas Safety
7.6.10.1
Met
(1)
Partially
Met (2)
Not
adaptors.
Recommended
Air_O2WallInlet.pdf
Medical Gas Safety

7.6.10.2

treatments)?

meter.
Recommended
Air_O2WallInlet.pdf
Medical Gas Safety

7.6.10.3

how to use it?

Mandatory
Medical Gas Safety

7.6.10.5

O2CylHazardSumm.pdf
Mandatory
Medical Gas Safety

7.6.10.6


Mandatory
O2CylHazardSumm.pdf
Medication Safety
7.6.11.4


Mandatory
Radiology - 7.6
518 of 578

RADIOLOGY AREA
Question:
Medication Safety
7.6.11.8
Met
(1)
Partially
Met (2)
Not

floors/care areas?
Mandatory
Medication Safety
7.6.11.9.1


available).
Mandatory
Medication Safety
7.6.11.10.1


purposes.
Mandatory
Medication Safety
7.6.11.15

instructions?

Recommended
Medication Safety
7.6.11.16

use)?
Recommended
Radiology - 7.6
519 of 578

RADIOLOGY AREA
7.6.11.17
Question:
Medication Safety


pumps.
Recommended
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.6.11.19

setting?

Mandatory
Medication Safety
7.6.11.19.1
agents?
Recommended
Medication Safety
7.6.11.22.1

alerts.
Recommended
Radiology - 7.6
520 of 578

RADIOLOGY AREA
Question:
Medication Safety
7.6.11.25
Met
(1)
Partially
Met (2)
Not
Recommended
Medication Safety
7.6.11.26

staff?

Mandatory
Medication Safety
7.6.11.27

drugs?

Recommended
Medication Safety
7.6.11.28
effect?

Mandatory
Medication Safety
7.6.11.32
Radiology - 7.6

at least monthly?

Recommended
521 of 578

RADIOLOGY AREA
Question:
Medication Safety
7.6.11.34
Met
(1)
Partially
Met (2)
Not

process?
Mandatory
Medication Safety
7.6.11.39
Are medications drawn up for use in

the sterile field accurately and
consistently labeled?
Eliminate the use of unlabeled sterile basins.

Encourage the use of sterile-packed unit dose
medications.
Mandatory
Medication Safety
7.6.11.39.1

procedure or code?

Recommended
Medication Safety
7.6.11.42

Mandatory
Radiology - 7.6
522 of 578

RADIOLOGY AREA
Question:
7.6.12.1
Met
(1)
Partially
Met (2)
Not
not accepted.
Mandatory

7.6.12.3

information?

Mandatory

7.6.12.4

areas?

Mandatory

7.6.12.5


Mandatory
Radiology - 7.6
523 of 578

RADIOLOGY AREA
7.6.12.6
Question:

misidentification?

misidentification.
Met
(1)
Partially
Met (2)
Not

Mandatory

7.6.12.6.1
Radiology - 7.6

obtained?

Mandatory
524 of 578

RADIOLOGY AREA
7.6.12.6.2
Question:


Mandatory
Met
(1)
Partially
Met (2)
Not

7.6.12.6.3


Mandatory

7.6.12.9
Radiology - 7.6


Recommended
525 of 578

RADIOLOGY AREA
Question:
7.6.12.11
Met
(1)
Partially
Met (2)
Not
Recommended

7.6.12.12
Mandatory

7.6.15.1
In Magnetic Resonance (MR) areas,

do physical barriers separate the
magnet area from waiting rooms,
changing rooms, reception areas,
etc. and does adequate signage exist
to warn of associated hazards?
Any objects which contain ferromagnetic

materials (from watches to floor buffers) have the
potential of being drawn into/towards the MR
equipment due to the powerful magnets used.
MR machines are always "on", creating a
continuous hazard. The suites/areas which
house this equipment should be configured to
keep the procedure area separate from other
associated areas (changing, waiting, etc.). Also,
signage should be placed in all areas, on doors
and other thresholds to warn of present hazards.
The 5 Gauss line should fall within the magnet
room, but if it does not there should be posted
signage to identify it. Providing technicians with
cognitive aids and/or posters can also help create
reminders.
Mandatory
Radiology - 7.6
SEA 38 MRI.pdf
526 of 578

RADIOLOGY AREA
7.6.15.2
Question:
In MR areas, are staff able to explain

the patient assessment process to
the patient or patient's family before
or at the time of scheduling the
exam?
Before the MR procedure, each patient should be

assessed twice (two separate instances) for all
associated risk factors, including an evaluation of
medical history. There may be different
assessments during the course of scheduling and
conducting the tests. Some risk factors include:
implants (such as a pacemakers/defibrillators),
insulin medication pumps, neurostimulators,
intracranial aneurysm clips,
prosthetics/orthopedic repairs, ocular
metal/fragments; stents less than 6 weeks old;
electrodes and wires including PA lines;
transdermal medication patches; pregnancy; the
need for having an oxygen tank, IV, or other
device during the procedure; history of shrapnel
injuries or piercings. Also, having claustrophobia
or tattoos is good to check for, it may not affect
the ability to have a MRI scan, but the staff can
then be aware the condition exists. A
standardized checklist of all possible risk factors
should be available for review.
Met
(1)
Partially
Met (2)
Not

Mandatory
Radiology - 7.6
SEA 38 MRI.pdf
527 of 578

RADIOLOGY AREA
7.6.15.2.1
Question:
In MR areas, are patients briefed

before the procedure regarding the
hazards/risk factors, provided with a
patient alarm, and offered hearing
protection?
Before the procedure, the patient should be

educated about the MR scan, again asked about
implants, and instructed to change clothes into a
hospital provided gown. The patient should be
instructed to remove all metal from his/her person
(jewelry, hairpins/barrettes, wire bras, zippers,
etc.) and be provided a locker for storage. A
personal alarm should be provided for the patient
to keep with him/her which will allow staff to be
alerted if experiencing discomfort. Hearing
protection should be offered to each patient which
can reduce anxiety and provide extra comfort if
the machine is loud (often over 80 Decibels at
machine - consult Industrial Hygienist).
Met
(1)
Partially
Met (2)
Not
ACR white paper on MR Safety.pdf /A Page=12

Recommended
Radiology - 7.6
SEA 38 MRI.pdf
528 of 578

RADIOLOGY AREA
7.6.15.3
Question:
Are all devices, equipment, and

products assumed to be unsafe for
the MR environment unless proven
otherwise?
Each MR machine has a magnet strength rating

in Tesla (T), and all equipment/devices should be
tested and found safe for use in your MR
environment (e.g., for a 1.5 T magnet) by the
medical equipment manufacturer. Equipment
includes but is not limited to: sandbags, gurneys,
stretchers, wheelchairs, oxygen and fire
extinguishing cylinders, floor buffers, office chairs,
IV pumps, monitoring devices, AEDs and other
emergency equipment. A MR safe or MR
conditional label affixed by the manufacturer will
meet this requirement. A database should be
maintained of all MR safe or conditional devices,
and if a new MR machine is purchased or existing
system upgraded, a re-evaluation should be
conducted.
Met
(1)
Partially
Met (2)
Not

Mandatory
Radiology - 7.6
SEA 38 MRI.pdf
529 of 578

RADIOLOGY AREA
7.6.15.3.1
Question:
Are materials and equipment that are

brought into the MR scan room
tested with a hand held magnet or
verified in writing by the
manufacturer to be safe for your MR
environment?
A hand-held magnet cam be used to screen

objects on or accompanying patients and other
items that need to be brought into the MR
environment. Note that this has limited
effectiveness; for example, ferromagnetic springs
within a pillow have gone undetected with a
hand-held magnet.
Met
(1)
Partially
Met (2)
Not
Do not make assumptions about implants,

devices, or equipment (e.g., sand bags that
actually contain iron). Err on the side of caution,
assuming materials are not suitable for the MR
environment unless they are proven to be so. If
you do not know if your implants, devices or
equipment are MR Conditional, MR Safe, or MR
Unsafe, you can
take three steps:
a. Read the technical information about the
device or implant
b. Call the manufacturer of the device or implant
and obtain information regarding the suitability of
the device in the MR environment in writing
c. Call the manufacturer of the MR system

Recommended
Radiology - 7.6
SEA 38 MRI.pdf
530 of 578

RADIOLOGY AREA
Question:
7.6.15.3.2
Met
(1)
Partially
Met (2)
Not
Does a cognitive aid or other

Patients should be positioned to avoid crossing
guidance exist for MR Technicians on leads and creating loops (i.e., as if when a hand a
patient positioning?
touches leg); sensors should be placed away
from the RF coils; and periodic checks of the
senor sites should be made on unconscious
patients. Also, sandbags suitable for the MR
environment used for patient positioning should
be MR safe and labeled as such.
Recommended
SEA 38 MRI.pdf

7.6.15.3.3
Are manufacturer approved fiber

optic, carbon fiber or graphic leads
and low impedance ECG electrodes
used on equipment that is brought
into the MR scan room?
Use manufacturer-approved fiber optic, carbon

fiber or graphite leads instead of conductive leads
on medical devices. Also, use manufacturerapproved large surface area, low impedance
ECG electrodes
Recommended

7.6.15.4
In MR areas, does the clinical and

technical staff demonstrate
competency in the facility's policy
requirements (such as: MR
equipment compatibility, identification
of the MR Safety Officer, associated
MR hazards, and emergency
procedures) and are they able to
name the MR Safety Officer
assigned for the facility?
Interview staff. Look for use of cognitive aids

(equipment lists, patient checklists, procedure
checklist, etc.). Compare current practices with
written policy. Inquire if emergency drills are
conducted for fire, medical, and civil disturbances.

Recommended
Radiology - 7.6
SEA 38 MRI.pdf
531 of 578

RADIOLOGY AREA
7.6.15.5
Question:
Can staff describe contraindications

to using contrast media, and how to
manage adverse reactions?
The clinical status, medication history and lab

results of the patient should be known before the
administration of any contrast media. Staff
should readily be able to recognize the signs of a
reaction and be familiar with how to manage an
adverse reaction. Appropriate emergency drugs
should be readily available in an emergency drug
box or code cart.
Met
(1)
Partially
Met (2)
Not
Recommended

7.6.15.6
Are policies, guidelines, charts or

other cognitive aids available to
inform staff about the proper use,
indication, and routes of each type of
contrast agent in use or any other
drugs administered in radiology
which require monitoring (e.g., pain
medicine, sedation, anti-coagulants)?
For example neurotoxic or ionic contrast agents

should not be administered intrathecally (may
cause death). All contrast media administrations
should require a redundant check. High alert
medication administered upon transfer into
radiology require the same standard of care
regarding monitoring.
Recommended

7.6.15.7
Are different types of contrast media

agents stored separately (ionic and
non-ionic) from one another in the
departments and/or in the pharmacy,
and are they labeled with applicable
warnings?
All contrast agents should secured and stored

separately based on its use and provided with
warning labels such as "not for intrathecal use,"
or kits should be packaged by pharmacy for
specific procedures such as myelography.
Beware of look-alikes as well with contrast agents
(for example, ionic Hypaque and non-ionic
Omipaque 300 are in similar looking vials from
same manufacturer).
Recommended
capsLink2004-07-01 rad.pdf

7.6.15.8
Are physician orders for contrast

All "drugs" require a physician order, even if they
media or nuclear medicines formally are not distributed by pharmacy, and access to
documented in the patients record? this information is required by others (e.g., to
evaluate renal failure, rash, anaphylaxis, etc.).
Recommended
Radiology - 7.6
532 of 578

RADIOLOGY AREA
7.6.15.9
Question:
If the facility uses teleradiology via

PACS (Picture Archiving and
Communications System) are ACR
(American College of Radiology)
recommendations being followed?
ACR has criteria recommendations including the

following: display monitors, identification (patient
id, date, facility, body part/side, data compression,
patient history), transmission, data archive and
retrieval, data security, system reliability and
redundancy, and licensing. If equipment does not
meet the standards diagnosis's could be affected.
Met
(1)
Partially
Met (2)
Not
ACR TS for Dig Im Data Mgt.pdf

Recommended
ACR TS for telerad.pdf

7.6.15.10
Are all results (positive or negative)

documented electronically by the
diagnostic provider in the patients
medical record in a timely manner?
Documentation should include appropriate test

related patient history to assist radiologist,
laboratory, or nuclear medicine personnel in
making a judgment call on critical findings. A
standard process should be in place to handle fee
basis and outside contract reports which often do
not get scanned in the electronic chart.

7.6.15.11
Are abnormal radiology, laboratory

and pathology findings requiring
urgent attention communicated
directly?
Direct communication is defined as face-to-face

or telephone conversation; or written as
customary protocol.

7.6.15.12
Radiology - 7.6
Has the communication process for

contacting treating providers in the
event of an abnormal report been
simplified in the facility?
The issuance of pagers; maintenance of VISTA

contacts; the viewing of alerts in CPRS; and /or
establishment of a system of surrogates for taking
responsibility for abnormal results.
533 of 578

PHARMACY AREA
7.7.2.2
Question:
Code Carts
Is there a standard method for

rotating stock in code carts before it
has expired, or replacing stock after
it has expired?
Expired medications and equipment could cause

delays in code responses.
Recommended
Met
(1)
Partially
Met (2)
Not
Code Carts
7.7.2.3


Recommended
Code Carts
7.7.2.3.1
Recommended
Code Carts
7.7.2.6


Recommended

7.7.4.3
Pharmacy - 7.7

to be a priority?
Mandatory
Pharmacy - 7.7 - Version: 01.30.2009
534 of 578

PHARMACY AREA
Question:
7.7.4.4

Met
(1)
Partially
Met (2)
Not

Mandatory
Equipment Safety
7.7.5.9


Recommended
Equipment Safety
7.7.5.10.4

risk?

multiple tubings.
Recommended
JC SEA Issue 36.pdf
Equipment Safety
7.7.5.10.5


Mandatory
JC SEA Issue 36.pdf
Infection Control
7.7.9.2
Pharmacy - 7.7


Mandatory
535 of 578

PHARMACY AREA
Question:
Infection Control
7.7.9.3
Met
(1)
Partially
Met (2)
Not
IV room.
Mandatory
IL 16-97-001.pdf
Infection Control
7.7.9.4


available.


Mandatory
Pharmacy - 7.7
536 of 578

PHARMACY AREA
7.7.11.1
Question:
Medication Safety


food/drink.
Met
(1)
Partially
Met (2)
Not


Mandatory
Medication Safety
7.7.11.2

not in use?
Mandatory
Medication Safety
7.7.11.4


Mandatory
Medication Safety
7.7.11.5
Does the organization (attention to

Sufficient space, lighting, etc.
look-alike, sound-alike) of
medications, including high risk
medications, facilitate the prevention
of errors?
Recommended
Pharmacy - 7.7
537 of 578

PHARMACY AREA
Question:
Medication Safety
7.7.11.6
Met
(1)
Partially
Met (2)
Not

unit?
Recommended
Medication Safety
7.7.11.6.1

dawn syringes, etc.
Recommended
Medication Safety
7.7.11.7
intravenously.
precaution?
Recommended
Medication Safety
7.7.11.8

floors/care areas?
Mandatory
Pharmacy - 7.7
538 of 578

PHARMACY AREA
7.7.11.9
Question:
Medication Safety
Are high alert drug IV

solutions/concentrations
standardized?
Facility should have local established standards

for IV admixtures and administration of high alert
medications (look for standardized
concentrations, drip charts or cognitive aids for
titratable or frequently changing drugs, and premade solutions when commercially
available);staff should be able to articulate the
precautions to be taken with these medications.
Mandatory
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.7.11.10


be used.
Recommended
Medication Safety
7.7.11.10.1


purposes.
Mandatory
Medication Safety
7.7.11.11
Are the sizes of injectable drugs in

vials or ampoules matched to the
clinical situation?
Helps to prevent overdose and reduces the

hazard associated with multi-dose vials. This
may be a future JCAHO PS Goal.
Recommended
Medication Safety
7.7.11.12
Has the facility prospectively

analyzed which medications can
have smaller total dose bag sizes?
To reduce the danger of accidental free flow, it is

safer to prepare smaller bags.
Recommended
Pharmacy - 7.7
539 of 578

PHARMACY AREA
Question:
Medication Safety
7.7.11.13
Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.7.11.13.1

practice?
Recommended
Medication Safety
7.7.11.14


or IV tubing's.
Recommended
Medication Safety
7.7.11.15

instructions?

Recommended
Medication Safety
7.7.11.16

use)?
Recommended
Pharmacy - 7.7
540 of 578

PHARMACY AREA
7.7.11.19
Question:
Medication Safety

setting?

Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.7.11.19.1
agents?
Recommended
Medication Safety
7.7.11.20
Are adverse drug reactions entered Review ten entries of admitted patients, it should
(in VISTA) and tracked and reviewed be shown that 100% have a valid entry in the
for each patient?
adverse drug reaction package. Also review
actions taken by Medication Aggregrate Review
Teams or P & T Committee reivews.
Recommended
Medication Safety
7.7.11.21
Pharmacy - 7.7

BCMA?

Recommended
541 of 578

PHARMACY AREA
7.7.11.21.1
Question:
Medication Safety

arounds?

arounds.
Met
(1)
Partially
Met (2)
Not
Recommended
Medication Safety
7.7.11.21.2


barcode.
Recommended
Medication Safety
7.7.11.21.3


Recommended
Medication Safety
7.7.11.22
Does the medication ordering system Requires allergy info first; safety alerts cannot be
have added safe guards as a forcing bypassed; previous orders discontinued before
function?
new added; RPh varies all orders before
processing; and the class of drug is including in
the ordering information.
Recommended
Medication Safety
7.7.11.22.1

alerts.
Recommended
Pharmacy - 7.7
542 of 578

PHARMACY AREA
7.7.11.23
Question:
Medication Safety
Does the facility have a contingency

plan for the loss of the BCMA
system? Is staff aware and
competent in this process?
Review plan, interview staff. Ensure it is common

knowledge what to do in case of a breakdown.
Also review records of last test.
Recommended
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.7.11.24
Does the Information Management

Review written documents. Interview pharmacy
Service have a mirror test account to and engineering staff familiar with procedure.
test patch installations in VISTA?
Recommended
Medication Safety
7.7.11.25
Recommended
Medication Safety
7.7.11.26

staff?

Mandatory
Medication Safety
7.7.11.27

drugs?

Recommended
Pharmacy - 7.7
543 of 578

PHARMACY AREA
7.7.11.27.1
Question:
Medication Safety
Is the purpose (indication) of the

medication order/prescription
communicated to the pharmacy?
If the pharmacy staff is told the indication of the

medication it can serve as another method to
minimize confusion between look/sound alike
drugs.
Recommended
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.7.11.28
effect?

Mandatory
Medication Safety
7.7.11.29


review.
Recommended
Medication Safety
7.7.11.30
If ADMs are used, is there a staff

education and competency review
program?
Interview staff.
Recommended
Medication Safety
7.7.11.31
If ADMs are used, do Pharmacists

check drugs before restocking, is a
bar coding system used?
Review policy and interview staff.
Recommended
Medication Safety
7.7.11.31.1
If ADMs are used, does the system

have pharmacy profile interface?
Review policy and interview staff.
Recommended
Pharmacy - 7.7
544 of 578

PHARMACY AREA
7.7.11.32
Question:
Medication Safety

at least monthly?

Recommended
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.7.11.33
Do prescription labels include both

the generic and brand names?
This helps with non-VA medications to alert

patients and providers of duplicate therapy. Most
VA facilities dispense only generic medications,
but having the brand names listed can serve this
purpose.
Recommended
Medication Safety
7.7.11.34

process?
Mandatory
Medication Safety
7.7.11.35

frequency?

Mandatory
Pharmacy - 7.7
545 of 578

PHARMACY AREA
7.7.11.37
Question:
Medication Safety
Are chemical products and

medications (including contract
media) used in the operative suite,
treatment areas, pharmacy or clinics
purchased in sizes appropriate for
their clinical situation (single dose,
single patient, individually labeled)
and kept in a labeled state to the
point of administration?
If appropriate sizes are acquired for each clinical

situation it eliminates the transfer of containers,
omitting the vulnerability of mislabeling or misadministration. Labels are required on all
medications, solutions, etc. on and off the sterile
field, even if only one medication/solution is
given. If pre-made single dose containers are not
available for sterile procedures, sterile markers
with blank labels and/or pre-printed labels should
be made available to include in pre-made sterile
packs.
Mandatory
Met
(1)
Partially
Met (2)
Not
Medication Safety
7.7.11.38
Does the pharmacy use laminair flow Inspect pharmacy area for hood.
hoods in the production of parenteral
IV solutions?
Recommended
Medication Safety
7.7.11.39.1

procedure or code?

Recommended
Pharmacy - 7.7
546 of 578

PHARMACY AREA
7.7.11.41
Question:
Medication Safety
Are emergency medications to treat

malignant hyperthermia readily
available?
These cases are rare, however, the medication to

treat it can expire before it is needed. There
should be mechanism to check the expiration
date and availability on a periodic basis.
Met
(1)
Partially
Met (2)
Not
MH Medical Professionals FAQs.pdf

Recommended
Medication Safety
7.7.11.41.1
If sterile water is used to dilute IV

1 L bags of water can be confused for IV bags
dantrolene in emergency boxes in
and inadvertently infused.
treating of malignant hyperthermia is
it provided in 50 mL vials vs. 1 L
bags?
Recommended
Medication Safety
7.7.11.42

Mandatory

7.7.12.1
not accepted.
Mandatory

7.7.12.3
Pharmacy - 7.7

information?

Mandatory
547 of 578

PHARMACY AREA
7.7.12.4
Question:

areas?

Mandatory
Met
(1)
Partially
Met (2)
Not

7.7.12.6

misidentification?

misidentification.

Mandatory
Pharmacy - 7.7
548 of 578

PHARMACY AREA
7.7.12.6.1
Question:

obtained?

Mandatory
Met
(1)
Partially
Met (2)
Not

7.7.12.6.2


Mandatory

7.7.12.6.3
Pharmacy - 7.7


Mandatory
549 of 578

PHARMACY AREA
7.7.15.7
Pharmacy - 7.7
Question:
Are different types of contrast media

agents stored separately (ionic and
non-ionic) from one another in the
departments and/or in the pharmacy,
and are they labeled with applicable
warnings?
All contrast agents should secured and stored

separately based on its use and provided with
warning labels such as "not for intrathecal use,"
or kits should be packaged by pharmacy for
specific procedures such as myelography.
Beware of look-alikes as well with contrast agents
(for example, ionic Hypaque and non-ionic
Omipaque 300 are in similar looking vials from
same manufacturer).
Recommended
capsLink2004-07-01 rad.pdf
Met
(1)
Partially
Met (2)
Not
550 of 578

Outpatient Areas
7.8.2.1
Question:
Code Carts


records.
Met
(1)
Partially
Met (2)
Not
Mandatory
Code Carts
7.8.2.3


Recommended
Code Carts
7.8.2.3.1
Recommended
Code Carts
7.8.2.4

Recommended
Code Carts
7.8.2.5
intubations?
Service.
Mandatory
Outpatient Areas- 7.8
Outpatient Areas- 7.8 - Version: 01.30.2009
551 of 578

Outpatient Areas
7.8.2.6
Question:
Code Carts


Met
(1)
Partially
Met (2)
Not
Recommended
Electrical Safety
7.8.3.1

system?

harm themselves.
Mandatory
Electrical Safety
7.8.3.2

exposed wiring?
Mandatory
Electrical Safety
7.8.3.3


Mandatory
552 of 578

Outpatient Areas
7.8.3.4
Question:
Electrical Safety


Met
(1)
Partially
Met (2)
Not
Mandatory
Electrical Safety
7.8.3.6

hazard?

Recommended

7.8.4.1

Mandatory

7.8.4.2

Mandatory

7.8.4.3

to be a priority?
Mandatory
553 of 578

Outpatient Areas
Question:
7.8.4.4

Met
(1)
Partially
Met (2)
Not

Mandatory

7.8.4.5

storage?

blocked doors.
NFPA 101 ch 7 - 2009.pdf
Mandatory

7.8.4.6

medication?

Mandatory

7.8.4.7


Mandatory
554 of 578

Outpatient Areas
Question:
7.8.4.8
Met
(1)
Partially
Met (2)
Not

signs and labels.
entrance?
Mandatory

7.8.4.10


environments.
Mandatory
Equipment Safety
7.8.5.1

identifiers.
NFPA 99 CH 8.pdf
Mandatory
Equipment Safety
7.8.5.2


planned for.
Recommended
555 of 578

Outpatient Areas
7.8.5.3
Question:
Equipment Safety

that patient?

Met
(1)
Partially
Met (2)
Not
Recommended
Equipment Safety
7.8.5.6

tasks?

equipment in area.
Recommended
Equipment Safety
7.8.5.9


Recommended
Equipment Safety
7.8.5.11

Recommended
Fall Prevention
7.8.7.1


Mandatory
556 of 578

Outpatient Areas
7.8.7.3
Question:
Fall Prevention

hazards?

Mandatory
Met
(1)
Partially
Met (2)
Not
Fire Safety
7.8.8.2


Mandatory
Fire Safety
7.8.8.4

NFPA 101 Ch 19.pdf
Mandatory
Infection Control
7.8.9.2


Mandatory
Infection Control
7.8.9.3
IV room.
Mandatory
IL 16-97-001.pdf
557 of 578

Outpatient Areas
7.8.9.4
Question:
Infection Control


available.
Met
(1)
Partially
Met (2)
Not


Mandatory
Medication Safety
7.8.11.4


Mandatory
Medication Safety
7.8.11.19

setting?

Mandatory
558 of 578

Outpatient Areas
Question:
Medication Safety
7.8.11.19.1
Met
(1)
Partially
Met (2)
Not
agents?
Recommended
Medication Safety
7.8.11.20
Are adverse drug reactions entered Review ten entries of admitted patients, it should
(in VISTA) and tracked and reviewed be shown that 100% have a valid entry in the
for each patient?
adverse drug reaction package. Also review
actions taken by Medication Aggregrate Review
Teams or P & T Committee reivews.
Recommended
Medication Safety
7.8.11.22
Does the medication ordering system Requires allergy info first; safety alerts cannot be
have added safe guards as a forcing bypassed; previous orders discontinued before
function?
new added; RPh varies all orders before
processing; and the class of drug is including in
the ordering information.
Recommended
Medication Safety
7.8.11.22.1

alerts.
Recommended
559 of 578

Outpatient Areas
Question:
Medication Safety
7.8.11.25
Met
(1)
Partially
Met (2)
Not
Recommended
Medication Safety
7.8.11.26

staff?

Mandatory
Medication Safety
7.8.11.27

drugs?

Recommended
Medication Safety
7.8.11.28
effect?

Mandatory
Medication Safety
7.8.11.33
Do prescription labels include both

the generic and brand names?
This helps with non-VA medications to alert

patients and providers of duplicate therapy. Most
VA facilities dispense only generic medications,
but having the brand names listed can serve this
purpose.
Recommended
560 of 578

Outpatient Areas
Question:
Medication Safety
7.8.11.34
Met
(1)
Partially
Met (2)
Not

process?
Mandatory
Medication Safety
7.8.11.39.1

procedure or code?

Recommended
Medication Safety
7.8.11.42

Mandatory

7.8.12.1
not accepted.
Mandatory
561 of 578

Outpatient Areas
7.8.12.3
Question:

information?

Mandatory
Met
(1)
Partially
Met (2)
Not

7.8.12.4

areas?

Mandatory

7.8.12.6

misidentification?

misidentification.

Mandatory
562 of 578

Outpatient Areas
7.8.12.6.1
Question:

obtained?

Mandatory
Met
(1)
Partially
Met (2)
Not

7.8.12.6.3


Mandatory

7.8.12.11
Recommended
563 of 578

Outpatient Areas
Question:
7.8.12.12
Met
(1)
Partially
Met (2)
Not
Mandatory
564 of 578

Domiciliary
Question:
Electrical Safety
7.9.3.2
Met
(1)
Partially
Met (2)
Not

exposed wiring?
Mandatory
Electrical Safety
7.9.3.4


Mandatory
Electrical Safety
7.9.3.6

hazard?

Recommended

7.9.4.2

Mandatory

7.9.4.3
Domiciliary - 7.9

to be a priority?
Mandatory
Domiciliary - 7.9 - Version: 01.30.2009
565 of 578

Domiciliary
Question:
7.9.4.4

Met
(1)
Partially
Met (2)
Not

Mandatory

7.9.4.5

storage?

blocked doors.
NFPA 101 ch 7 - 2009.pdf
Mandatory

7.9.4.6

medication?

Mandatory

7.9.4.7


Mandatory
Domiciliary - 7.9
566 of 578

Domiciliary
Question:
7.9.4.8
Met
(1)
Partially
Met (2)
Not

signs and labels.
entrance?
Mandatory

7.9.4.10


environments.
Mandatory
Equipment Safety
7.9.5.1

identifiers.
NFPA 99 CH 8.pdf
Mandatory
Fall Prevention
7.9.7.1
Domiciliary - 7.9


Mandatory
567 of 578

Domiciliary
7.9.7.3
Question:
Fall Prevention

hazards?

Mandatory
Met
(1)
Partially
Met (2)
Not
Fire Safety
7.9.8.4

NFPA 101 Ch 19.pdf
Mandatory
Infection Control
7.9.9.3
IV room.
Mandatory
IL 16-97-001.pdf
Infection Control
7.9.9.4.1
Is alcohol hand gel stored so that is Patients that may have substance abuse
available for staff to access, but kept problems could attempt to drink the hand gel due
away and secured from patients that to most containing 60% or more alcohol.
may ingest it in areas such as
Behavioral Health, Detoxification
Units, or Urgent Care?
Recommended
Domiciliary - 7.9
568 of 578

Domiciliary
7.9.11.4
Question:
Medication Safety


Met
(1)
Partially
Met (2)
Not
Mandatory
Medication Safety
7.9.11.25
Recommended
Medication Safety
7.9.11.27

drugs?

Recommended

7.9.12.3

information?

Mandatory

7.9.12.4
Domiciliary - 7.9

areas?

Mandatory
569 of 578

Domiciliary
7.9.12.6
Question:

misidentification?

misidentification.
Met
(1)
Partially
Met (2)
Not

Mandatory

7.9.16.1
Is a face to face assessment with a

standardized assessment tool
conducted and documented on each
potential resident before
acceptance/admission into the
Domiciliary (or Hoptel) evaluating for
falls and suicidal/homicidal risk?
Some residents that enter into the

Domiciliary/Hoptel program are those that have or
have had Mental Health issues or factors that
make them at higher risk for falls, therefore a
specific standardize mechanism needs to be in
place to assure that residents who are at risk for
receive appropriate care.
Review admission documentation and mental
health assessment program.
Mandatory
Domiciliary - 7.9
570 of 578

Domiciliary
Question:
7.9.16.1.1
If a veteran is accecpted/admited is
there a specific frequency for
periodic re-evaluations throughout
the stay for falls and mental health?
It is important to reassess patients on a

systematic schedule, to ensure the patient
remains in a safe environment. Each assessment
should be documented. Review assessment
frequencies in resident records or in care plans.
Mandatory
VHA Handbook PRRTP.pdf
Met
(1)
Partially
Met (2)
Not

7.9.16.1.2
Are appropriate Domiciliary staff

thoroughly trained on the Falls and
Mental Health assessment program,
including all staff working on offshifts?
All staff should receive specific training regarding

assessment programs with emphasis on suicidal
and homicidal behaviors (i.e., despondent,
depressed, agitated, potentially violent.
Recommended

7.9.16.2
Has a standard assessment tool

been developed and used to assess
the competency of the veterans
working at the open domiciliary
entrances that monitor access?
These veterans need training to handle difficult

situations such as when another veteran, who
may be a friend, wants to enter the building with
contraband. They also need to know what action
to take if they believe another veteran is acting
intoxicated or may be harmful to others or
themselves.
Recommended

7.9.16.3
Domiciliary - 7.9
Is amount of time residents have with

planned activities monitored with the
goal of increasing the contact hours
with each resident?
Current VHA policy requires a minimum of 4

hours per day, 7 days per week of therapeutic
activities. If residents are only occupied for 1 to 2
hours per day, 5 days per week with no activities
on weekends or holidays the activities should be
increased.
Mandatory
571 of 578

Domiciliary
Question:
7.9.16.4
Are break room and kitchen

refrigerators monitored periodically to
assure appropriate temperatures are
maintained?
The FDA Food code requires all food to

consistanly remain below 41 degrees Farinheight.
Therefore it is recommended in gerenal industry
that refridgerators are maintained between 35 38 degrees F. Any refridgerator should be part of
a preventive maintence schedule to check for
proper functioning.
http://www.cfsan.fda.gov/~dms/fc05-toc.html
Recommended
FDA Food Code 2005, Chap. 3 Food.pdf
Met
(1)
Partially
Met (2)
Not

7.9.16.5
Is staffing in the Domiciliary on all

shifts, holidays and weekends
assessed and modified as needed?
Per VA policy, see minimum Domiciliary staffing

levels. Review staffing versus resident
population to verify if appropriate.
Mandatory

7.9.16.6
Domiciliary - 7.9
Has the Mental Health Residential

Program Annual Safety and Security
Assessment being completed on the
directed schedule?
The Deputy Under Secretary for Health for

Oepration and Management put forth a
Memorandum for residental programs to
complete the attached assessment annually and
report key findings. Check for documentation that
this assessment has be completed and items
followed up on.
Mandatory
MH Annual Assess memo & attach.pdf
572 of 578
VISN Patient Safety Program
8.1.1
Question:
Leadership/Support
Does the PSO report directly to the

Network Director?
It is important that the Patient Safety Program

have direct access to top management. No
waivers have been approved by the DUSHOM
permitting alternate reporting arrangements.
Mandatory
Supporting PS Prog Memo 6-07.pdf
Met
(1)
Partially
Met (2)
Not
Leadership/Support
8.1.2
Does the PSO routinely brief the

Top management must be aware of the status of
Executive Leadership Committee (or the Patient Safety Program in the VISN.
equivalent) on patient safety issues? Periodically briefing the ELC is an effective way
of ensuring this communication is occurring.
Recommended
IHI 5 Million Lives Kit - Boards on Board.doc
Leadership/Support
8.1.3
Has the PSO provided training to

leaders in the VISN on patient
safety?
VISN leaders (i.e., Network Director, Chief

Medical Officer, Deputy Network Director, and
Service Line Managers) need to have a basic
understanding of the Patient Safety Handbook,
RCA process, HFMEAs, Patient Safety
Alerts/Advisories, and the program statistics
provided on the NCPS intranet site.
Documentation that leaders have attended either
a VHA national training program or training
provided by the PSO should be available.
Mandatory
Staffing
8.2.1
Is there a full time PSO in the VISN? A full time PSO position is required in the Network
office. If a PSO job becomes available the VISN
should staff the position in a timely manner (e.g.,
6 months).
Mandatory
CNO memo PSP.pdf
Staffing
8.2.1.1
VISN PS Program
Does each facility in the VISN have

a full time PSM?
The PSO should track and report vacant PSM

positions to the Network Director. Vacant
positons should be filled in a timely manner (e.g.
6 months).
Mandatory
VISN PS Program - Version: 01.30.2009
573 of 578
8.2.2
Question:
Staffing
Are PSO collateral duties kept to a

minimum?
Collateral duties assigned should fit under the

patient safety umbrella. Too many collateral
duties will shift attention away from core patient
safety program responsibilities.
Mandatory
Supporting PS Prog Memo 6-07.pdf
Met
(1)
Partially
Met (2)
Not
Staffing
8.2.3
Does the PSO work to ensure human The PSO should assess staffing of the patient
resources (e.g., clerical support) are safety program during annual site visits.
provided to assist PSMs meet
minimum Patient Safety Program
requirements?
Recommended
Resources
8.3.1
Does the PSO have adequate

Equipment may include laptop or tablet
equipment (e.g., computers, camera) computers, references, camera, software, work
to complete assigned work?
space, and meeting space.
Recommended
Resources
8.3.2
Has the PSO attended the NCPS

HFMEA training course?
The PSO serves as a coach and first line

resource for VISN facilities when questions arise
on completing proactive risk
Mandatory
Resources
8.3.3
Has the PSO attended the NCPS

101 RCA training course?
The PSO serves as a coach and advisor to PSMs

on RCA issues. 101 covers the fundamentals of
the VA patient safety program.
Mandatory
Resources
8.3.4
Is the PSO funded to attend

continuing education patient safety
training conferences?
As the VISN patient safety expert it is imporant

for the PSO to be up to date on developments in
the patient safety field.
Recommended
VISN PS Program
574 of 578
Question:
RCA Activities
8.4.1
Met
(1)
Partially
Met (2)
Not
Does the PSO verify that facilities are PSMs should be periodically evaluated to ensure
applying the Safety Assessment
that they are using Safety Assessment Code
Code to events to meet the intent of correctly.
the Patient Safety Handbook?
Mandatory
VHA PS Handbook.pdf
RCA Activities
8.4.2
Are RCA, Aggregated Review and

HFMEA reports completed by the
facilities reviewed and critiqued with
comments being provided to the
PSM?
Annually, at least 50% of the minimum required

individual RCAs/Aggregated Reviews and at least
one HFMEAs for each facility should be reviewed
with comments provided to the PSM. The intent is
to help the facility improve the end product. The
optimal timeframe to complete and return the
reviews is within 30 days of submission.
Mandatory
RCA Activities
8.4.3
Does the PSO work with the facilities

to improve the quality of RCAs (e.g.
root causes, actions, and outcome
measures) and Aggregated Review
when needed?
Assistance can be provided in many ways

including written comments, teleconferences, and
formalized training. Documentation that these
activities have taken place should be available.
Mandatory
RCA Activities
8.4.4
Is guidance and assistance being

provided for facilities that routinely
have RCAs and Aggregated Reviews
that exceed 45 days with evidence
that compliance is improving?
SPOT data should be continuously reviewed and

PSOs should have in depth knowledge of what
work is being done and how timely it is being
completed regarding patient safety at each of
their facilities. Performance data is available on
the NCPS VA web site.
Mandatory
VISN PS Program
VHA PS Handbook.pdf
575 of 578
Question:
RCA Activities
8.4.5
Met
(1)
Partially
Met (2)
Not
Is there evidence that the PSO uses The most current version of VISN SPOT should
VISN SPOT?
be available and any request for a report from
VISN SPOT should be able to be created. (Some
examples would be reviewing action strength,
looking at Triage question data, evaluation of
team membership, etc.)
Mandatory

8.5.1
Were site visits conducted by the

PSO during the past 12 months at
every VISN medical center or
hospital using questions from the
ePSAT with a written report being
provided?
Annual visits to VISN facilities should be

conducted with a a written report (that can be
followed up) submitted.
Recommended

8.5.2
When requested by leadership,

PSM, etc. does the PSO provide
patient safety training within the
Network?
The PSO is the first line consultant on all patient

safety issues and conducting training on the
patient safety program is an appropriate way to
continue to provide support.
Mandatory

8.5.3
Are regularly scheduled (e.g.,

monthly) teleconference calls or
other means of communication
maintained with the PSMs?
Each PSO should keep in regular contact with the

PSMs and ideas should be shared across the
VISN. The recommended way to do this is to
hold regular calls.
Mandatory

8.5.4
Does the PSO participate in the

monthly national PSO
teleconferences and the national
PSM teleconferences?
Staying current on national patient safety

program issues is vital to the PSO role and
necessary to perform the job effecively.
Recommended
VISN PS Program
576 of 578
Question:
8.5.5
Met
(1)
Partially
Met (2)
Not
Is an Annual Patient Safety Program The annual report should cover metrics (RCA,
Report prepared covering patient
Aggregated Reviews, HFMEAs completion and
safety accomplishments in the VISN? timeliness, action implementation), status of
program objectives, and list new objectives and
strategies for improving the network patient safety
program during the next fiscal year.
Recommended

8.5.5.1
Does the VISN require Annual

Annual Reports are used to to document what
Patient Safety Program Reports from has been done and to share successes within the
each facility and is a summary of all VISN and out.
reports developed and presented to
VISN leadership?
Recommended

8.5.6
Is an orientation program in place

and are visits made by the PSO to
provide assistance and training to
new PSMs in the VISN?
At minimum the orientation program should cover

SACing events, RCA training, a schedule of
pertinent conference calls and introduction to
other PSMs in the VISN. Mentoring is
recommend between senior PSMs and new hire
PSMs.
Mandatory

8.5.7

that actions specified in Patient
Safety Alerts are completed and
sustained?
Use of the VISN 22 web site meets this

requirement.
Mandatory

8.5.8
VISN PS Program

that recommendations contained in
Patient Safety Advisories are
completed or alternate equivalent
measures are implemented?
Use of the VISN 22 web site meets this

requirement.
Mandatory
577 of 578
8.5.9
Question:
Are lessons learned and best

practices disseminated and shared
across the VISN and with NCPS?
If outstanding programs or actions have been

implemented it is important to share with others
so that, if applicable and feasible, others can
benefit from success of across the VA. Some
examples are newsletters, conference calls,
formal comments, etc.
Mandatory
Met
(1)
Partially
Met (2)
Not

8.5.10
Is the PSO familiar with FDA medical It is important to understand the reporting
device reporting requirements?
requirements to be able to assist the facilities in
following the guidance.
Mandatory
VISN PS Program
578 of 578

PSAT

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Patient Safety Assessment Too

sment Tool (PSAT)

Patient Safety Assessmen

NCPS Patient Safety Assessment Tool

Does a non-punitive environment

Interview leadership and staff. Review of SPOT

JC- CAMH LD-03-01-01.pdf

VHA Handbook 1050 01 PSI.pdf /A Page=3

Are staff made available to serve on

Review RCA's looking for a mix of staff

JC- CAMH LD-03-05-01.pdf

VHA Handbook 1050 01 PSI.pdf /A Page=6

Is the Patient Safety Manager

Interview PSM and management. The PSM or

JC- CAMH LD-03-01-01.pdf

Mgt Ldr - 1 - Version: 01.30.2009

NCPS Patient Safety Assessment Tool

Do RCA teams meet with top

VHA Handbook 1050 01 PSI.pdf /A Page=6

Are close call reports being

Review SPOT for potential SAC scores of 1and 2

VHA Handbook 1050 01 PSI.pdf

Are lessons learned from RCAs and

Show reports made to VISN, or others that have

VHA Handbook 1050 01 PSI.pdf

When criminal or intentionally unsafe

Verify via interviews with key personal (PSM,

VHA Handbook 1050 01 PSI.pdf /A Page=9

Mgt Ldr - 1 - Version: 01.30.2009

NCPS Patient Safety Assessment Tool

Are confidentiality rules complied

Conduct interviews, review how records are

JC- CAMH IM-02-01-03.pdf

Are RCA reports de-identified

Review a random sample of submitted RCAs in

JC- CAMH IM-02-01-03.pdf

Is there a full time Patient Safety

The Patient Safety program requirements should

USH memo PSM Job Jar (2).pdf

Mgt Ldr - 1 - Version: 01.30.2009

NCPS Patient Safety Assessment Tool

Does the Patient Safety Manager

VA Memorandum to Network Directors specifies

Supporting the Patient Safety Program Memo.pdf

USH memo PSM Job Jar (2).pdf

Does management support patient

JC- CAMH LD-03-05-01.pdf

If needed, is specific training being

A memorandum was sent out by the Assistant

JC- CAMH LD-03-06-01.pdf

USH memo PSM Job Jar (2).pdf

Is there dedicated space and

Private work space should be provided to the

JC- CAMH LD-03-02-01.pdf

Mgt Ldr - 1 - Version: 01.30.2009

NCPS Patient Safety Assessment Tool

Is Information Technology support

IT staff is often needed for SPOT help or for

Mgt Ldr - 1 - Version: 01.30.2009

NCPS Patient Safety Assessment Tool

Are questions 1-7 consistently

The SPOT database should be used to enter

JC- CAMH PI-01-01-01.pdf