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
ds
NCPS Patient Safety Assessment Tool
Part I Adminstrative
MANAGEMENT AND LEADERSHIP - Element 1

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

Leadership/Support
1.1.3 Is the Patient Safety Manager Interview PSM and management. The PSM or
permitted to charter RCA teams other individuals trained on using the SAC matrix
based upon the SAC score without should be the authority for determining which
approval from his/her supervisor or cases become individual RCAs. Although top
top management? management approval is ultimately needed to
begin an RCA, the PSM should be the primary
decision-maker.
Recommended; Priority A JC- CAMH LD-03-01-01.pdf
Mgt Ldr - 1 Mgt Ldr - 1 - Version: 01.30.2009 5 of 578


Not
Leadership/Support
1.1.4 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 Review SPOT for potential SAC scores of 1and 2
received? to determine if Safety Reports are being entered.
Have PSM show specific examples of close calls
including events that have become RCAs.

Mandatory;Priority A VHA Handbook 1050 01 PSI.pdf
Leadership/Support
1.1.6 Are lessons learned from RCAs and Show reports made to VISN, or others that have
best practices shared with the been shared. Methods for sharing information
Network? could include: meetings, conference calls, e-mail
correspondence, summaries done by PSO, etc.

Recommended; Priority C VHA Handbook 1050 01 PSI.pdf
Leadership/Support
1.1.7 When criminal or intentionally unsafe Verify via interviews with key personal (PSM,
acts are identified during the RCA Director, RCA team members). If systems issues
process, is the RCA stopped, the are identified a new RCA team may be chartered
record sealed and top management to complete the RCA following completion of the
notified without revealing team ABI.
findings and conclusions?


Not
Leadership/Support
1.1.8 Are confidentiality rules complied Conduct interviews, review how records are
with in the Patient Safety RCA managed (e.g., locked office, record access,
Process? etc.). Leadership should possess general
knowledge of 5705 protection for patient safety
data and PSMs should have in-depth knowledge
of all 5705 confidentiality rules related to sharing
data collected. If de-identified, tables 18 and 19
of the RCA are appropriate for sharing.
202 Briefing.ppt
Confidentiality 5705 Cognitive Aid.pdf
Mandatory;Priority A JC- CAMH IM-02-01-03.pdf
Leadership/Support
1.1.9 Are RCA reports de-identified Review a random sample of submitted RCAs in
thoroughly prior to submission to the SPOT database for identifiers. Reviewing the
NCPS? reports received though the NCPS Facility Report
Process is another way to analyze compliance to
de-identification.
5705.pdf
Code of Federal Regulations_part 17.pdf
Mandatory;Priority A JC- CAMH IM-02-01-03.pdf
Staffing
1.2.1 Is there a full time Patient Safety The Patient Safety program requirements should
Manager? be met before other collateral duties are assigned
to the PSM.
Supporting the Patient Safety Program Memo.pdf
Mandatory;Priority A 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


Not
Staffing
1.2.2 Does the Patient Safety Manager VA Memorandum to Network Directors specifies
report directly to the Medical Center that "facility Patient Safety Managers be
Director or Chief of Staff? organizationally aligned to report directly to top
management (i.e., Director or COS)."
Supporting the Patient Safety Program Memo.pdf

Mandatory; Priority A USH memo PSM Job Jar (2).pdf
Resources
1.3.1 Does management support patient Verify via training certificates, training records,
safety staff by funding attendance at etc.
patient safety training/conferences?
Recommended; Priority C JC- CAMH LD-03-05-01.pdf

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

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


Not
Resources
1.3.3 Is Information Technology support IT staff is often needed for SPOT help or for
personnel provided to assist the patient safety related upgrades to software such
patient safety program to complete as CPRS.
related tasks?
Recommended; Priority B http://vaww.ncps.med.va.gov/Tools/SPOT/installation.html

PATIENT SAFETY PROGRAM MANAGEMENT - Element 2

Not
Root Cause Analysis Activities
2.1.1 Are questions 1-7 consistently The SPOT database should be used to enter
completed in SPOT to assess all Safety Reports (i.e., items 1-7 in SPOT).
reported patient safety events,
including close calls?
JCAHO_CAMH.pdf /A Page=294
Mandatory; Priority A JC- CAMH PI-01-01-01.pdf
2.1.1.1 Are RCAs completed as dictated by Incidents where the Safety Report indicates an
SAC scoring? actual or potential SAC score of 3 should have a
RCA team chartered. Other incidents that score
lower than 3 can receive an RCA based on a
local/network decision.
Mandatory; Priority A VHA Handbook 1050 01 PSI.pdf /A Page=16
2.1.1.2 Are Medication, Para-Suicide/Out- Actual SAC score of 3 requires an individual
Patient Suicides, Falls and RCA to be done. All others of these event types
Elopement adverse events and close can included in an aggregated review (twice or
calls with a SAC potential score of 3 four times per FY depending on which event type)
addressed via the Aggregated focusing on fixing related processes (NOTE: Any
Review Process? event can receive an individual RCA, even if it
meets the criteria for an inclusion in an aggregate
report). Facility-wide logs should be kept in the
facility SPOT database or other database. The
incident data captured should follow guidelines in
Appendix C of the NCPS Handbook (each event
type has unique criteria). Assessor should review
logs and aggregate reports to verify process is
being followed.
AggReviewSchedule 09 & 10 11x17.pdf

Guidanceon New Standards for VHA Patient Safety Program.pdf
Mandatory; Priority A ISMP_Book.pdf
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 PS Prgm Mgt - 2 - Version: 01.30.2009 10 of 578


Not
2.1.2.1 If individuals other than the PSMs The appropriate training would be considered the
serve as advisors on RCA teams three day Patient Safety Improvement Course
have they been appropriately offered by NCPS, or the equivalent given by a
trained? trained PSO or PSM.
Recommended; Priority A
2.1.3 Are RCA teams orientated to the PSM to show presentation materials of what is
Patient Safety Process prior to reviewed with all new team members. Interview
participating on a RCA team? team members, and/or review training records.
Charter Memo.pdf
RCATeamProcess.pdf
2.1.4 Is RCA team membership Review a minimum of 4 RCA's to determine if
appropriate for the adverse event appropriate personal participate based on
being evaluated? relevance to RCA content. Team members'
titles/qualifications should be documented in the
RCA (SPOT database).
2.1.4.1 Does the PSM direct and advise the Review a minimum of 4 RCA's and interview
RCA/Aggregate Review teams as selective team members and the PSM. RCA
necessary to produce the desired documentation should include defined root cause
outcomes? statements, actions that address the root causes,
and outcome measures that measure the actions.
Mandatory; Priority A
2.1.4.2 Does the PSM serve as an advisor Review a minimum of 4 RCA's and interview
and not as the leader, recorder or team members and the PSM. Review RCA
team member on RCAs? charter memos to determine PSM role in each
RCA reviewed.
Charter Memo.pdf
Recommended; Priority B USH memo PSM Job Jar (2).pdf /A Page=2


Not
2.1.5 Is a follow-up and review process for Show RCA updates, SPOT follow up table, SPOT
RCA Actions and Outcome action dates, or other tracking methods. If action
Measures being used within SPOT? and outcome tracking is reviewed at committee
meetings, the meeting minutes may qualify as
proof as well.
JC- CAMH PI-02-01-01.pdf
2.1.6 Are the RCA Actions completed with Review a minimum of 4 RCA's to evaluate time
the specified time frame? frames, have PSM show results and show
tracking items to completion with dates. Changes
may also be observed on the units in lieu of
reviewing documentation.
Recommended; Priority B JC- CAMH PI-03-01-01.pdf
2.1.6.1 Are Action completion and follow up Review a minimum of 4 RCA's looking for time
dates reasonable? frames and action completion rates. In some
cases it is necessary to implement actions
immediately to prevent another occurrence.
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
Recommended; Priority A VHA Handbook 1050 01 PSI.pdf
2.1.8 Do the RCA reports identify pertinent Review a minimum of 4 RCA's for context.
Root Cause Contributing Factors? RC/CFs should be appropriate for RCA event.
For instance, evaluate if the event descriptions
match the root cause statements developed
within the same RCA.
Recommended; Priority A JC- CAMH PI-02-01-01.pdf


Not
2.1.9 Do Actions in RCA reports target and Review 10% of yearly (minimum of 4) RCA's.
address the Root Cause Contributing Also review Actions and assess if they are
Factors? 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 Review 10% of yearly (minimum of 4) RCA's.
RCA reports effectively measure the Look for relation to Action and for numerators,
Actions? denominators, and thresholds. The NCPS Facility
Reports provided as feedback to each station
often address outcome measures and show
relevant examples and rewrites.
2.1.11 Are RCA reports completed within Review 10% of yearly (minimum of 4) RCA's. If
45-days of the facility becoming reports are not competed, Actions cannot be
aware that an RCA is required? implemented. Reminder: Coroner dates or peer
review dates are the 'date aware' on RCAs.

2.1.12 Are at least 4 individual RCAs being The minimum requirement guidance was set forth
completed each fiscal year in in December 2006 by NCPS that each facility will
addition to the required 4 Aggregated complete a minimum of 4 individual RCAs per
Reviews? Note: Zero event year (exception: 1/1/07 - 9/30/07 only 3 are due.)
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.


Not
Patient Safety Reporting System
2.2.1 Has the Patient Safety Reporting Confirm that the PSRS program been
System (PSRS) program been communicated adequately, such as with all new
instituted at the facility? employees, and regularly there after. Inquire if
forms are provided in the facility where clinicians
will use and see them such as lounges and office
areas.
Recommended; Priority B NASA_VA_agree.pdf
General Programmatic Functions
2.3.1 Does the PSM collaborate with other Interview Engineering, Safety/IH, and/or Infection
entities, such as Biomedical Control. Documentation should be shown such as
Engineering staff, Occupational JCAHO projects, and participation of these
Safety Officer and/or Industrial disciplines on RCA and HFMEA teams.
Hygienist, & Infection Control?
Recommended; Priority A USH memo PSM Job Jar (2).pdf
2.3.2 Does the patient safety information Review committee structure to determine if
discussed in committee meetings adequate information is flowing up through the
reach top management for their organization (such committees as EOC, QI, PS,
consideration and action? etc.). Have PSM show how action and outcome
measure tracking is presented at committees. A
general idea of how patient safety issues are
channeled should be evident.
JC- CAMH PI-03-01-01.pdf

2.3.3 Is the PSM involved in the Patient Show examples of Alerts/Advisories from facility,
Safety Alerts/Advisories process, and documentation from tracking. Interview
including tracking issues to PSM. (Note: PSMs should not be involved in the
resolution? Recall process)
2.3.4 Are Patient Safety Program Check documentation from town meeting
successes publicized within the agenda/minutes, postings, newsletters, e-mails,
facility? or other.


Not
2.3.5 Is the topic of Patient Safety covered Verify NEO process and materials. Criteria that
in New Employee Orientation? should be covered is: background information on
patient safety (presentations such as 'Why
Bother?' and 'Beyond Blame'), existence of
NCPS, employee's responsibilities for patient
safety (such as reporting and training), overview
of RCA process, PSRS, etc.
WhyBother.ppt
http://vaww.ncps.med.va.gov/education.html#neo
http://vaww.ncps.med.va.gov/education.html#neo
Recommended; Priority A JC- CAMH HR-01-04-01.pdf
2.3.6 Is continuing education being Review training methods used. Not all
provided for employees on Patient employees will require the same level of
Safety topics? continuing education on Patient Safety. Review
examples from the past 12 months and determine
if training was proved based on the assessed
needs.
Mandatory; Priority A JC- CAMH HR-01-05-03.pdf
2.3.7 Does the PSM consult with experts Intervention with, NCPS, JCAHO, ASRAM,
within or outside the VA when ASHE, ISMP, ECRI, IHI, etc. The referencing of
needed? written resources as well as telephone contact is
appropriate.
Recommended; Priority C USH memo PSM Job Jar (2).pdf
2.3.8 Is at least one HFMEA (or proactive PSM should initiate evaluations and/or advise
risk analysis) been completed for personnel involved with the evaluations.
each JCAHO accredited program or Assessor should review completed reports.
has a single analysis been done that
covers all programs?
HFMEA.pdf
NCPS HFMEA Critique Sheet.pdf
Mandatory; Priority A JC- CAMH LD-04-04-05.pdf


Not
2.3.9 Does a system exist, and is it used, Prompt feedback to those reporting adverse
to give feedback to staff that report events has been credited in other reporting
adverse event and close call systems with being one of the cornerstones that
incidents that result in an RCA? establishes trust in the system. It demonstrates
the seriousness and
commitment on the part of the organization to the

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

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

JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3

Not
The Joint Commission Patient Safety Goals
3.9.1 Goal 1: Improve the Accuracy of
Patient Identification
HOSP, LTC, BHC, HC, AMC & Lab
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Not
3.9.1.1 NPSG.01.01.01 Elements of Performance as doucumented for the
Hospital Progam
Use at least two patient identifiers

when providing care, treatment, and 1) Prior to any specimen collection, medication
services. administration, transfusion, or treatment, the
hospital actively involves the patient and, as
needed, the family in the identification and
matching process. When active patient
Wrong-patient errors occur in involvement is not possible or the patient’s
virtually all stages of diagnosis and reliability is in question, the hospital will designate
treatment. The intent for this goal is the caregiver responsible for identity verification.
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
HOSP, LTC, BHC, HC, AMC & Lab TIPS Jan Feb 09
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Not
3.9.1.1 (continued)... NPSG.01.01.01 ...(continued) other specimens are labeled in the
(continued) presence of the patient.
Use at least two patient identifiers

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

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

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 TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
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Not
Hospital Progam
Eliminate transfusion errors related

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

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

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

JC- NPSG-01-03-01.pdf
HOSP & AMC TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
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Not
3.9.2 Goal 2: Improve the Effectiveness of
Communication Among Caregivers
HOSP, LTC, BHC, HC, AMC & LAB
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Not
Hospital Progam
For verbal or telephone orders or for

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

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

confirms the information that was read back.

HOSP, LTC, BHC, HC, AMC & LAB TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
JC - 3 JC - 3 - Version: 01.30.2009 22 of 578


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 being reported, such as for laboratory
HOSP, LTC, BHC, HC, AMC & LAB TIPS Jan Feb 09
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Not
3.9.2.2 (continued)... NPSG.02.02.01 ...(continued) entered as free text into a
(continued) computer.
There is a standardized list of

abbreviations, acronyms, symbols, 4 The hospital does not include any
and dose designations that are not 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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Not
Hospital Progam
The hospital measures, assesses,

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

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

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

reporting critical test results and critical results
and values from routine tests.
6 The hospital assesses the data on the

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Not
3.9.2.3 (continued)... NPSG.02.03.01 ...(continued) action to improve the timeliness of
(continued) reporting critical test results and critical results
and values from routine tests and measures the
effectiveness of those actions.
The hospital measures, assesses,
and, if needed, takes action to
improve the timeliness of reporting
and the timeliness of receipt of
critical tests and critical results and
values by the responsible licensed
caregiver.

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Not
Hospital Progam
The hospital implements a

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

patient hand-offs, including, but not 2 The hospital's process for effective hand-off
limited to, nursing shift changes; communication includes the following: Up-to-date
physician transfer of complete information regarding the patient’s condition,
responsibility for a patient; physician care, treatment, medications, services, and any
transfer of on-call responsibility; recent or anticipated changes. (See also
acceptance of temporary NPSG.08.01.01, EP 4)
responsibility for staff leaving the unit
for a short time; anesthesiologist
report to post-anesthesia recovery
room nurse; nursing and physician 3 The hospital’s process for effective hand-off
hand-off from the emergency communication includes the following: A method
department to inpatient units, to verify the received information, including
different hospitals, nursing homes, repeat-back or read-back techniques.
and home health care; and critical
laboratory and radiology results sent
to physician offices. The primary
objective of a hand-off is to provide 4 The hospital’s process for effective hand-off
accurate information about a communication includes the following: An
patient's care, treatment, and opportunity for the receiver of the hand-off
services; current condition; and any information to review relevant patient historical
recent or anticipated changes. The data, which may include previous care, treatment,
information communicated during a and services.
hand-off must be accurate in order to
meet patient safety goals. 2009 NPSGs Chart TIPS (2).pdf
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Not
3.9.2.4 (continued)... NPSG.02.05.01 ...(continued) during hand-offs are limited to
(continued) minimize the possibility that information fails to be
conveyed or is forgotten.
The hospital implements a

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

patient hand-offs, including, but not
limited to, nursing shift changes;
physician transfer of complete
responsibility for a patient; physician
transfer of on-call responsibility;
acceptance of temporary
responsibility for staff leaving the unit
for a short time; anesthesiologist
report to post-anesthesia recovery
room nurse; nursing and physician
hand-off from the emergency
department to inpatient units,
different hospitals, nursing homes,
and home health care; and critical
laboratory and radiology results sent
to physician offices. The primary
objective of a hand-off is to provide
accurate information about a
patient's care, treatment, and
services; current condition; and any
recent or anticipated changes. The
information communicated during a
hand-off must be accurate in order to
meet patient safety goals. 2009 NPSGs Chart TIPS (2).pdf
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Not
3.9.3 Goal 3: Improve the Safety of Using
Medication
HOSP, LTC, BHC, HC & AMC
Hospital Progam
The hospital identifies and, at a

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

look-alike/sound-alike medications at least
annually.
3 The hospital takes action to prevent errors

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

HOSP, LTC, BHC, HC & AMC TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
JC - 3 JC - 3 - Version: 01.30.2009 29 of 578


Not
Hospital Progam
Label all medications, medication

containers (for example, syringes, 1 Medications and solutions both on and off the
medicine cups, basins), or other sterile field are labeled even if there is only one
solutions on and off the sterile field. medication being used.
Medications or other solutions in 2 Labeling occurs when any medication or

unlabeled containers are solution is transferred from the original packaging
unidentifiable. Errors, sometimes to another container.
tragic, have resulted from
medications and other solutions
removed from their original
containers and placed into unlabeled 3 Medication or solution labels include the
containers. This unsafe practice medication name, strength, amount (if not
neglects basic principles of apparent from the container), expiration date
medication management safety yet when not used within 24 hours, and expiration
has been routine in many time when expiration occurs in less than 24
organizations. hours.
The labeling of all medications, 4 All medication or solution labels are verified
medication containers, and solutions both verbally and visually by two qualified
is a risk reduction activity consistent individuals whenever the person preparing the
with safe medication practices. This medication or solution is not the person who will
practice addresses a recognized risk be administering it.
point in the safe administration of
medications in perioperative and
other procedural settings.
5 No more than one medication or solution is
labeled at one time.
HOSP & AMC TIPS Jan Feb 09
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Not
3.9.3.2 (continued)... NPSG.03.04.01 ...(continued) reference in the perioperative or
(continued) procedural area until the conclusion of the
procedure.
Label all medications, medication

containers (for example, syringes,
medicine cups, basins), or other 8 All labeled containers on the sterile field are
solutions on and off the sterile field. discarded at the conclusion of the procedure.
Medications or other solutions in 9 At shift change or break relief, all 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.

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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 long- 2 To reduce compounding and labeling errors,
term anticoagulation prophylaxis (for the hospital uses only oral unit dose products,
example, atrial fibrillation) where the pre-filled syringes, or pre-mixed infusion bags
clinical expectation is that the when these types of products are available. Note:
patient’s laboratory values for For pediatric patients, pre-loaded syringe
coagulation will remain outside products should only be used if specifically
normal values. This requirement designed for children.
does not apply to routine situations in
which short-term prophylactic
anticoagulation is used for venous
thrombo-embolism prevention (for 3 The hospital uses approved protocols for the
example, related to procedures or initiation and maintenance of anticoagulant
hospitalization) and the clinical therapy appropriate to the medication used, to the
expectation is that the patient’s condition being treated, and to the potential for
laboratory values for coagulation will medication interactions.
remain within, or close to, normal
values.
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 TIPS Jan Feb 09
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Not
3.9.3.3 (continued)... NPSG.03.05.01 ...(continued) services are provided by the
(continued) hospital, the service is notified of all patients
receiving warfarin and responds according to its
established food/medication interaction program.
Reduce the likelihood of patient harm
associated with the use of
anticoagulant therapy.
6 When heparin is administered intravenously
and continuously, the hospital uses
programmable infusion pumps in order to provide
Note: This requirement applies only consistent and accurate dosing.
to hospitals that provide
anticoagulant therapy and/or long-
term anticoagulation prophylaxis (for
example, atrial fibrillation) where the 7 The hospital has a written policy that
clinical expectation is that the addresses baseline and ongoing laboratory tests
patient’s laboratory values for that are required for heparin and low molecular
coagulation will remain outside weight heparin therapies.
normal values. This requirement
does not apply to routine situations in
which short-term prophylactic
anticoagulation is used for venous 8 The hospital provides education regarding
thrombo-embolism prevention (for anticoagulant therapy to prescribers, staff,
example, related to procedures or patients, and families. Note: Patient/family
hospitalization) and the clinical education includes the importance of follow-up
expectation is that the patient’s monitoring, compliance issues, dietary
laboratory values for coagulation will restrictions, and potential for adverse drug
remain within, or close to, normal reactions and interactions.
values.
9 The hospital evaluates its anticoagulation

Anticoagulation therapy poses risks 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
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Not
3.9.4 Goal 4: RETIRED - As of 2005 this a) Use a pre-op verification process, such as a
goal is now surveyed under the checklist, to confirm appropriate documents are
Universal Protocol: Eliminate wrong- available.
site, wrong-patient, wrong-procedure.
b) Implement a process to mark the surgical site
and involve the patient in the process.
RETIRED
3.9.5 Goal 5: RETIRED - improve the Ensure free-flow protection on all general-use
safety of using infusion pumps. and PCA (patient controlled analgesia)
intravenous infusion pumps used in the
organization
RETIRED
3.9.6 Goal 6: RETIRED - As of 2005 this a) Implement regular preventive maintenance and
goal is now surveyed under EC testing of alarm systems.
standards: Improve the
effectiveness of clinical alarm b) Assure that alarms are activated with
systems. appropriate settings and are sufficiently audible
with respect to distances and competing noise
within the unit.
RETIRED
3.9.7 Goal 7: Reduce the Risk of Health
Care-Associated Infections
HOSP, LTC, BHC, HC, AMC & LAB
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Not
Hospital Progam
Comply with current World Health

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

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

HOSP, LTC, BHC, HC, AMC & LAB JC- NPSG-07-01-01.pdf
JC - 3 JC - 3 - Version: 01.30.2009 35 of 578


Not
Hospital Progam
Manage as sentinel events all

identified cases of unanticipated 1 The hospital manages all identified cases of
death or major permanent loss of unanticipated death or major permanent loss of
function related to a health care– function associated with a health care–associated
associated infection. 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 care–associated 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?

HOSP, LTC, BHC, HC, AMC & LAB TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
JC - 3 JC - 3 - Version: 01.30.2009 36 of 578


Not
Hospital Progam
Implement evidence-based practices

to prevent health care–associated 1 As of April 1, 2009, the hospital’s 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 2 As of July 1, 2009, an implementation work
important organisms such as plan is in place that identifies adequate
methicillin-resistant Staphylococcus resources, assigned accountabilities, and a time
aureus (MRSA), Clostridium difficile line for full implementation of NPSG.07.03.01 by
(CDI), vancomycin-resistant January 1, 2010.
Enterococci (VRE), and multiple
drug-resistant gram negative
bacteria.
3 As of October 1, 2009, pilot testing in at least
one clinical unit is under way, for the
requirements in NPSG.07.03.01.
Note 2: This requirement has a one-
year phase-in period that includes
defined expectations for planning,
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.
5 As of January 1, 2010, conduct periodic risk

assessments for multidrug-resistant organism
patients continue to acquire health acquisition and transmission. (See also
care–associated infections at an IC.01.03.01, EPs 1-5)
alarming rate. Risks and patient 2009 NPSGs Chart TIPS (2).pdf
The Joint Commission NPSG 07.03.01
HOSP TIPS Jan Feb 09
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Not
3.9.7.3 (continued)... NPSG.07.03.01 ...(continued) health care–associated infections,
(continued) multidrug-resistant organisms, and prevention
strategies at hire and annually thereafter. Note:
The education provided recognizes the diverse
Implement evidence-based practices roles of staff and licensed independent
to prevent health care–associated 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.
7 As of January 1, 2010, the hospital educates

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

year phase-in period that includes 9 As of January 1, 2010, the hospital measures
defined expectations for planning, and monitors multidrug-resistant organism
development, and testing prevention processes and outcomes including the
(milestones) at three, six, and nine following:
months in 2009, with the expectation
of full implementation by January 1, - Multidrug-resistant organism infection rates
2010. using evidence-based metrics
- Compliance with evidence-based guidelines or

best practices
patients continue to acquire health
care–associated infections at an - Evaluation of the education program provided to
alarming rate. Risks and patient staff and licensed independent practitioners
The Joint Commission NPSG 07.03.01
JC - 3 JC - 3 - Version: 01.30.2009 38 of 578


Not
Hospital Progam
Implement best practices or

evidence-based guidelines to 1 As of April 1, 2009, the hospital’s leadership
prevent central line–associated has assigned responsibility for oversight and
bloodstream infections. coordination of the development, testing, and
Note 1: This requirement covers

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

defined expectations for planning, 3 As of October 1, 2009, pilot testing in at least
development, and testing one clinical unit is under way for the requirements
(“milestones”) at three, six, and nine in NPSG.07.04.01.
of full implementation by January 1,
2010.
4 As of January 1, 2010, the elements of
performance in NPSG.07.04.01 are fully
implemented across the hospital.

health care workers who are involved in these
procedures about health care–associated
infections, central line–associated bloodstream
infections, and the importance of prevention.
JC - 3 JC - 3 - Version: 01.30.2009 39 of 578


Not
3.9.7.4 (continued)... NPSG.07.04.01 ...(continued) procedures is added to an
(continued) individual’s job responsibilities.
Implement best practices or

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

short- and long-term central venous
catheters and peripherally inserted 7 As of January 1, 2010, the hospital implements
central catheter (PICC) lines. policies and practices aimed at reducing the risk
of central line–associated 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
defined expectations for planning, organization guidelines)
development, and testing
(“milestones”) at three, six, and nine
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 line–associated
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 line–associated bloodstream infections
rate data and prevention outcome measures to
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Not
Hospital Progam
Implement best practices for

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

one clinical unit is under way, for the
requirements in NPSG.07.05.01.
4 As of January 1, 2010, the elements of

performance in NPSG.07.05.01 are fully
implemented across the hospital.

health care workers involved in surgical
procedures about health care associated
infections, surgical site infections, and the
importance of prevention. Education occurs upon
JC - 3 JC - 3 - Version: 01.30.2009 41 of 578


Not
3.9.7.5 (continued)... NPSG.07.05.01 ...(continued) an individual’s job responsibilities.
(continued)
Implement best practices for 6 As of January 1, 2010, prior to all surgical

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

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

strategies follow evidence-based guidelines, and
surgical site infection rates are measured for the
first 30 days following procedures that do not
JC - 3 JC - 3 - Version: 01.30.2009 42 of 578


Not
3.9.8 Goal 8: Accurately and Completely
Reconcile Medication Across the
Continuum of Care
TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
JC - 3 JC - 3 - Version: 01.30.2009 43 of 578


Not
Hospital Progam
A process exists for comparing the

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

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

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

the hospital (for example, from the ICU to a floor),
the current provider(s) informs the receiving
provider(s) about the up-to-date reconciled
medication list and documents the
communication. (See also NPSG.02.05.01, EP
2). Note: Updating the status of a (continued)...

HOSP, LTC, BHC, HC & AMC TIPS Jan Feb 09
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Not
3.9.8.1 (continued)... NPSG.08.01.01 ...(continued) patient’s medications is also an
(continued) important component of all patient care hand-offs.
A process exists for comparing the

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

HOSP, LTC, BHC, HC & AMC TIPS Jan Feb 09
JC - 3 JC - 3 - Version: 01.30.2009 45 of 578


Not
Hospital Progam
When a patient is referred to or

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

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

patient’s 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 2009 NPSGs Chart TIPS (2).pdf
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Not
Hospital Progam
When a patient leaves the hospital’s

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

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

JC - 3 JC - 3 - Version: 01.30.2009 47 of 578


Not
Hospital Progam
In settings where medications are

used minimally, or prescribed for a 1 The hospital obtains and documents an
short duration, modified medication accurate list of the patient’s current medications
reconciliation processes are and known allergies in order to safely prescribe
performed. any setting-specific medications (for example,
intravenous contrast media, local anesthesia,
antibiotics) and to assess for potential allergic or
adverse drug reactions.
Note: This requirement does not
apply to hospitals that do not
administer medications. It may be
important for health care 2 When only short-term medications (for
organizations to know which types of example, a preprocedure medication or a short-
medications their patients are taking term course of an antibiotic) will be prescribed
because these medications could and no changes are made to the patient's current
affect the care, treatment, and medication list, the patient and, as needed, the
services provided. 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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Not
3.9.8.4 (continued)... NPSG.08.04.01 ...(continued) provided, unless the patient is
(continued) assessed to be confused or unable to
comprehend adequately. In this case, the
patient’s family is provided both medication lists
In settings where medications are and the circumstances are documented.
used minimally, or prescribed for a
short duration, modified medication
reconciliation processes are
performed. 3 In these settings, a complete, documented
medication reconciliation process is used when:
Any new long-term (chronic) medications are
prescribed.
Note: This requirement does not
apply to hospitals that do not
administer medications. It may be
important for health care 4 In these settings, a complete, documented
organizations to know which types of medication reconciliation process is used when:
medications their patients are taking There is a prescription change for any of the
because these medications could patient’s current, known long-term medications.
affect the care, treatment, and
services provided.
5 In these settings, a complete, documented

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

reconciliation is required in any of these settings,
the complete list of reconciled medications is
provided to the patient, and their family as
needed, and to the patient’s known primary care
provider or original referring provider or a known
next provider of service.
JC - 3 JC - 3 - Version: 01.30.2009 49 of 578


Not
3.9.9 Goal 9: Reduce the Risk of Patient
Harm Resulting for Falls
HOSP, LTC & HC TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
JC - 3 JC - 3 - Version: 01.30.2009 50 of 578


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 patient’s fall risk
factors.
4 Staff receive education and training for the fall

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

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

program to determine the effectiveness of the
program. Note: Outcome indicators such as
decreased number of falls and decreased number
HOSP, LTC & HC TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
JC - 3 JC - 3 - Version: 01.30.2009 51 of 578


Not
3.9.10 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 TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
JC - 3 JC - 3 - Version: 01.30.2009 52 of 578


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.

JC - 3 JC - 3 - Version: 01.30.2009 53 of 578


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.

3.9.11 Goal 11: Reduce the Risk of
Surgical Fires
AMC
JC - 3 JC - 3 - Version: 01.30.2009 54 of 578


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 TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
3.9.12 Goal 12: NOT APPLICIABLE - Inform and encourage components and
Implementation of applicable practitioner sites to implement the applicable
National Patient Safety Goals and National Patient Safety Goals and associated
associated requirements by requirements.
components and practitioner sites.
NA
JC - 3 JC - 3 - Version: 01.30.2009 55 of 578


Not
3.9.13 Goal 13: Encourage the Active
Involvement of Patients and Their
Families in the Patient’s Own Care
as a Patient Safety Strategy
HOSP, LTC, BHC, HC, AMC & Lab
JC - 3 JC - 3 - Version: 01.30.2009 56 of 578


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, 2 The hospital provides the patient with
treatment, and services is an information regarding infection control measures
important characteristic of a culture for hand hygiene practices, respiratory hygiene
of safety. When the patient knows practices, and contact precautions according to
what to expect, he or she is more the patient’s condition. The information is
aware of possible errors and choices. discussed with the patient and his or her family
The patient can also be an important members on the day the patient enters the
source of information about potential hospital or as soon as possible (for example,
adverse events and hazardous within 24–48 hours). The patient’s understanding
conditions. 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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Not
3.9.13.1 (continued)... NPSG.13.01.01 ...(continued) prevention of surgical infections,
(continued) and marking of the procedure sites. The patient’s
understanding is evaluated and documented.
(See also PC.02.03.01, EP 25). 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.

3.9.14 Goal 14: Prevent Health Care-
Associated Pressure Ulcers
(Decubitus Ulcers)
LTC
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Not
Assess and periodically reassess

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

factors that place them at risk.
-Maintaining and improving tissue tolerance to

pressure in order to prevent injury.
-Protecting against the adverse effects of external

mechanical forces.
-Reducing the incidence of pressure ulcers

through staff educational programs.
2 Initial assessments are performed at admission.
3 A systematic resk assessment is conducted

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

intervals.

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Not
3.9.15 Goal 15: The Organization Identifies
Safety Risks Inherent In Its Patient
Population
HOSP, BHC & HC
Hospital Progam
The hospital identifies patients at risk

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

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

HOSP & BHC TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
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Not
The organization identifies risks

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

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

HC TIPS Jan Feb 09 Pgs 1 & 2 FIN 12 3 08.pdf
3.9.16 Goal 16: Improve Recognition and
Response to Changes in a Patient's
Condition
HOSP
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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
patient’s condition appears to be
worsening.
2 The hospital develops criteria for calling
additional assistance to respond to a change in
the patient’s condition or a perception of change
significant number of critical by the staff, the patient, and/or family.
inpatient events are preceded by
warning signs prior to the event. A
majority of patients who have
cardiopulmonary or respiratory arrest 3 Based on the hospital’s criteria, staff seek
demonstrate clinical deterioration in additional assistance when they have concerns
advance. Early response to changes about a patient’s condition.
in a patient’s 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 patient’s condition
worsens.
A significant number of critical

warning signs prior to the event. A 5 Formal education for urgent response policies
majority of patients who have and practices is conducted with the staff and
cardiopulmonary or respiratory arrest licensed independent practitioners who may
demonstrate clinical deterioration in request assistance and those who may respond
advance. Early response to changes to those requests.
trained individual(s) may reduce 2009 NPSGs Chart TIPS (2).pdf
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Not
3.9.16.1 (continued)... NPSG.16.01.01 ...(continued) intervention program and any
(continued) underlying organizational system issues, takes
appropriate action to improve its intervention
system, and measures the effectiveness of 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
members to directly request “medical emergency teams” in order to meet this
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
patient’s condition appears to be are automatically achieved.
worsening.
significant number of critical

cardiopulmonary or respiratory arrest
demonstrate clinical deterioration in
advance. Early response to changes
trained individual(s) may reduce
cardiopulmonary arrests and patient
mortality.
A significant number of critical

cardiopulmonary or respiratory arrest
demonstrate clinical deterioration in
advance. Early response to changes
trained individual(s) may reduce 2009 NPSGs Chart TIPS (2).pdf
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Not
Universal Protocol
3.10.1 UP.01.01.01: Conduct a Elements of Performance as doucumented for the
preprocedure verification process. Hospital Progam
The preprocedure verification is an 1 Verification of the correct person, correct site,

ongoing process of information and correct procedure occurs at the following
gathering and verification, beginning times:
with the decision to perform a
procedure, continuing through all - At the time the procedure is scheduled
settings and interventions involved in
the preprocedure preparation of the - At the time of preadmission testing and
patient, up to and including the time- assessment
out just before the start of the
procedure. - At the time of admission or entry into the facility
for a procedure, whether elective or emergent
- 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 - With the patient involved, awake and aware, if
matched to the patient’s identifiers. possible
- Reviewed and are consistent with

the patient’s expectations and with
the team’s 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 wall-
mounted whiteboard) is used to review and verify
Missing information or discrepancies that the following items are available and
The Joint Commission UP.01.01.01
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Not
Universal Protocol
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 pre-
anesthesia assessment)
The preprocedure verification is an
ongoing process of information - Accurately completed, and signed, procedure
gathering and verification, beginning consent form
with the decision to perform a
procedure, continuing through all - Correct diagnostic and radiology test results (for
settings and interventions involved in example, radiology images and scans, or
the preprocedure preparation of the pathology and biopsy reports) that are properly
patient, up to and including the time- labeled
out just before the start of the
procedure. - 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 patient’s identifiers.
- Reviewed and are consistent with

the patient’s expectations and with
the team’s understanding of the
intended patient, procedure, and site.
Missing information or discrepancies 2009 NPSGs Chart TIPS (2).pdf

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Not
Universal Protocol
3.10.2 UP.01.02.01: Mark the procedure Elements of Performance as doucumented for the
site. Hospital Progam
Marking the procedure site allows 1 For all procedures involving incision or
staff to identify without ambiguity the percutaneous puncture or insertion, the intended
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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Not
Universal Protocol
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 surgeon’s or

proceduralist’s initials, with or without a line
representing the proposed incision.
- It is made using a marker that is sufficiently

permanent to remain visible after completion of
the skin prep and sterile draping. Adhesive site
markers are not to be used as the sole means of
marking the site.
- It is positioned to be visible after the patient has

his or her skin prepped, is in his or her final
position, and sterile draping is completed.

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Not
Universal Protocol
3.10.3 UP.01.03.01: A time-out is performed Elements of Performance as doucumented for the
immediately prior to starting Hospital Progam
procedures.
1 The time-out is conducted prior to starting the

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

The time-out is consistently initiated team.
by a designated member of the team
and includes active communication - It involves the immediate members of the
among all relevant members of the procedure team including the proceduralist(s), the
procedure team. It is conducted in a anesthesia providers, the circulating nurse, the
standardized fail-safe mode (that is, operating room technician, and other active
the procedure is not started until all participants as appropriate for the procedure, who
questions or concerns are resolved). 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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Not
Universal Protocol
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. compromising patient safety, so that all relevant
members of the team are focused on the active
confirmation of the correct patient, procedure,
site, and other critical elements.
The purpose of the time-out
immediately before starting the
procedure is to conduct a final
assessment that the correct patient, 4 When two or more procedures are being
site, positioning, and procedure are performed on the same patient, a time-out is
identified and that, as applicable, all performed to confirm each subsequent procedure
relevant documents, related before it is initiated.
information, and necessary
equipment are available.
5 The time-out addresses the following:
The time-out is consistently initiated - Correct patient identity

by a designated member of the team
and includes active communication - Confirmation that the correct side and site are
among all relevant members of the marked
procedure team. It is conducted in a
standardized fail-safe mode (that is, - An accurate procedure consent form
the procedure is not started until all
questions or concerns are resolved). - 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 precautions based on patient history or
NPSGs Chart TIPS (2).pdf
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PROCUREMENT AND EQUIPMENT MANAGEMENT - Element 4

Not
Procurement and Equipment
4.1.1 Are Human Factors Engineering The medical devices are evaluated for ease of
principals considered when use; feedback to the user (verbal and visual);
purchasing medical devices? level of knowledge transfer from existing
equipment; and the impact of slips or mistakes on
providing patient care. The use of informal
usability groups to test the devices is
recommended.
Copyrighted Refs.doc
Mandatory; Priority A JC- CAMH EC-02-04-01.pdf
4.1.2 Is equipment assessed for usability Internal and external failure rates or other past
and maintainability prior to history reports should be considered when
procurement? purchasing or replacing new equipment. Look for
evidence of a usability testing process (via an
evaluation addressing such things as: Does the
equipment prominently display the mode to the
user?; Are buttons spaced far enough apart to
prevent inadvertent activation?; Is the readout
clear and unambiguous?; Will parallax be an
issue?)
4.1.3 Is equipment inspection scope and Show evidence of the PM inspection
frequency modified based on modifications. Interview Biomedical Service
inspection results or user input? personnel have them show evidence of tracking
and modification if applicable.
Recommended; Priority A JC- CAMH EC-02-04-01.pdf
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

Not
4.1.4.1 Is the effectiveness of this training Not only should training occur, but the
assessed? competency testing or other measures of
effectiveness should be applied.
4.1.5 When feasible, is equipment Limiting the number of systems/equipment
standardized by manufacturer and clinicians and maintenance staff are required to
model? operate/maintain will reduce latent errors in the
system. Interview personnel, review examples.
4.1.5.1 Are you in compliance with VISN or A standardization group has previously evaluated
National BPAs (Blanket Purchase equipment and has placed them on the BPA list.
Agreements)? 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

Not
Recalls and VA Patient Safety Alerts & Advisories
5.1.1 Has the Facility implemented a At minimum the program must cover:
product recall program in accordance
with the requirements of VHA
Directive 2008-080, “Recall of
Defective Medical Devices and (1) Ensuring recalled medical devices or medical
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.
(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 health consequences, to the Product
VHA Directive 2008-080 recalls.pdf
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Not
5.1.1 (continued)... Has the Facility ...(continued) implanted in VA patients at non-VA
(continued) implemented a product recall facilities, including affiliates or private institutions.
program in accordance with the
requirements of VHA Directive 2008-
080, “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).
Mandatory; Priority A VHA Directive 2008-080 recalls.pdf


Not
5.1.1.1 At minimum do the responsibilities of (1) Coordinating and disseminating logistics-
the Facility Recall Coordinator (FRC) related recall information to the Facility
include items 1-7 as stated in the Designated Area Specialists (FDASs), and
rationale? verifying and reporting that recall actions are
completed within the facility by the due date.
(2) Working with the facility Contracting Officer to

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

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

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

and Recall Management System Web site.


Not
5.1.1.1 (continued)... At minimum do the ...(continued) for maintaining records that details
(continued) responsibilities of the Facility Recall the steps taken to resolve recalls, such as:
Coordinator (FRC) include items 1-7 distribution lists, response times, number of 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 locally-
identified product or device issues potentially
impacting product or patient safety (e.g., recall
letter sent from supplier to OR or Chief of Supply,
Processing and Distribution (SPD)), including
information described in subparagraph 4d(4).


Not
5.1.1.2 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 Check the VHA Alert and Recall Management
Advisory actions and System at
recommendations implemented and http://vaww.nbc.med.va.gov/visn/recalls/ to see if
tracked until completed? 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/


Not
1998 Alerts & Advisories
5.2.1 Patient Burns from Hot Water, 6/98 1. Carefully review VHA Directive 97-027 to
ensure your policies and procedures are
compliant.
2. Your local policies and procedures must also

emphasize situations where partial immersion
takes place away from fixed tubs.
3. At 120 F, which is the exit temperature at the

faucet, serious burns can occur in seconds. It is
essential to measure water temperature with a
thermometer.
4. Make sure clinical staff is trained and aware

that temperature must be measured before any
immersion and the only acceptable method of
taking temperature is with an accurate
instrument.
Mandatory; Priority A ScaldAlert.pdf

5.2.2 COBE® CENTURYSYSTEM® 3 1. Identify blood tubing sets and cease their use.
Blood Tubing Sets, 6/98
2. Quarantine any inventory and arrange return to
GAMBRO Healthcare.
Blood tubing sets may be associated 3. Special instructions are available for clinics,
with incidents of hemolysis. A total which must provide treatment before
of four patient deaths have been replacements arrive and for which the only blood
reported following dialysis treatment, tubing sets available are those subject to the
none in VA. All lot numbers of recall. Call GAMBRO Healthcare (800) 456-7339
catalog numbers: 003109-400, (24 HOUR) for these instructions.
003109-410, 003110-500, 003111-
500, 003112-500, 003113-500, 4. Contact GAMBRO Healthcare for further
003114-500, 003210-500, 003212- questions, Tim Schoenberg at (800) 525-2623
500 003101-000, 003212-515. x4010.
Mandatory; Priority A COBE.pdf


Not
5.2.3 Truncation of Viral Loads in Network 1. IRM sections should fix data fields in NHE to
Health Exchange, 7/98 allow the full (which may include “< or >”
characters) value to be entered. Two VISNs
have collaborated and developed a routine that
has been shared with their counterparts in other
The NHE viral load value field only VISN facilities. This is an interim measure. A
allowed for a 4 digit value to be national patch should be made available no later
transmitted, when in fact, the value is than 7/31/98.
often 6 digits long.
2. A National Online Information Sharing (NOIS)
(CIN-0698-41578) has been submitted to the
national developers of the NHE alerting them to
this matter.
3. Facilities should undertake a review of whether

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


Not
5.2.4 Boston Scientific/SCIMED NIR ON™ 1. Facilities will immediately discontinue use of
RANGER™ With SOX™ the product. These device failures may result in
Premounted Stent, 10/98 emergency interventions, including coronary
bypass surgery.
2. Return all unused product to the manufacturer,

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

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


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

5.2.7 Hewlett-Packard Defibrillator, model 1. Device will defibrillate properly but will not print
43100a/43200a, 12/98 out the month, day, hour, and minute.
2. The manufacturer advises it should be reset to

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


Not
5.3.1 GE/Marquette Clinical Information 1. Do not use the APEX pulse oximeter while it is
Center (V1.4 and all previous connected to the APEX S telemetry transmitter.
software revisions), 4/99
2. The APEX pulse oximeter may continue to be
used as a standalone device. In this case, the
interface cables between the pulse oximeter and
Versions used with the APEX S the telemetry transmitter (PN. 412926-001, -002,
telemetry transmitter and APEX -003) should be removed from patient use.
pulse oximeter. 4/99
3. GE/Marquette will provide a software update
for your CIC upon completion of testing and
validation. A GE-Marquette service representative
The “ALL ALARMS OFF” visual will then contact you to schedule updates. Once
message on the CIC waveform your CIC software is updated, you may again use
window disappears and the alarms your APEX Pulse Oximeter while it is connected
remain off when the following to your APEX S transmitters.
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
turned on or turned off while (414) 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.
Mandatory; Priority A Telemetry.pdf


Not
5.3.2 Boston Scientific/SCIMED; Discovery 1. VA medical facilities will immediately either
Catheters catalog numbers C3020 replace the Discovery catheter with the
and C3005 (All lots); 6/99 UltraCross intravascular ultrasound catheter or
discontinue use of the product.
2. Return all unused products to the

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


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

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

electronic short can occur inside the
battery and motor housing. This
short can damage the batteries, drive
motor and housing resulting in loss of
power and lift functions. Additionally,
the short can cause smoke and
fumes.
Mandatory; Priority A Hoyer.pdf


Not
5.3.4 OEC Medical Systems' UroView, 1. If you have an affected system, contact the
8/99 regional service manager (information attached)
for your area to schedule the no-cost upgrade.
2. "Until the modification is complete you can

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


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


Not
5.4.1 Patient Ventilators (all 1. Unless recommended by the equipment
makes/models) used with flow manufacturer, attach the ventilator directly to the
meters, 1/00 supply outlet on the patient panel. In most cases,
there are two outlets available. If the patient
requires more than two supplies, branch off the
outlet NOT used by the ventilator. If you 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.
Mandatory; Priority A 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.
Mandatory; Priority A Clinipad.pdf


Not
5.4.3 Medtronic Dual Chamber Temporary 1. Immediately affix a warning label to these
Pacemaker Model 5388, 8/00 pacemakers that show steps to clear 0004 error.
Label: WARNING: If error code 0004 appears
immediately release battery door. REMOVE
battery until error message clears. REINSTALL
Model may become inactive if a battery.
button is touched while it is in "self
test" mode. 2. Verify and document that all staff who utilize or
come in contact have been trained on how to
clear the 0004 error code.
3. Report identical or similar design related

events to the FDA and through appropriate
channels within the VA.
Recommended; Priority A Pacemaker.pdf

5.5.1 Magnetic Resonance Imaging (MRI) 1. Purchase "sand bags" for patient care that do
Systems, all, 2/01. not contain iron and properly label the bags.
2. If facility uses bags that contain iron, these

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


Not
5.5.2 Bed Rail Entrapment, 7/01. 1. Within 120 days of alert, complete inventory of
all existing beds and identify those that do not
meet the dimensions specified in this Alert
(≥60mm for bed gaps, ≥120mm for bed rail
A patient experienced a close call openings).
event when his head became
wedged in the bed rail opening while 2. Within 120 days of alert, permanently mark all
having a coughing episode. The non-complying bed assemblies using a method
patient was found by the nursing that clearly communicates the bed entrapment
staff with a partially obstructed risk to staff.
airway and was released without
injury. This alert patient with a right 3. Immediately fill gaps created between the
side CVA (cerebrovascular accident) mattress and bedrail that are equal to or wider
was trapped while laying on his left than 60mm used for high risk patients ( frail,
side. elderly, confused, physically impaired) with
suitable materials (e.g. high density fire retardant
foam wedges) to reduce risk of entrapment.
4. Immediately reduce the openings within the

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


Not
5.5.2 (continued)... Bed Rail Entrapment, ...(continued) netting or clear padding or bed rail
(continued) 7/01. retrofit kits.
5. When new bed assemblies or replacement

mattresses are purchased openings within the
A patient experienced a close call bed side rails and gaps between the mattress 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
Mandatory; Priority A 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

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


Not
5.5.4 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.
Mandatory; Priority A PACS1.pdf


Not
5.5.5 Clinician Awareness of Corruption of 1. Facility Directors must ensure that: All
VistA Imaging files, 8/01 clinicians are sensitive to and aware of this
potenital problem. Any clinical concerns related
to images should be immediately pursued in
consultation with the Chief IRM.
Patient images and audio fax files
may become miss-associated when
the repacking utility is run and all
“globals” are not properly shutdown.
This means that clinical information
could appear in a patients record
which is incorrect and the care giver
would have no way of knowing that
the information is invalid.
Mandatory; Priority A PACS2.pdf

5.5.6 Pharmacy Package - Synonym Interim 1. Review all drug entries in the Pharmacy
Lookup Resulted in Wrong Package drug and synonym files to ensure that
Medication Being Displayed or there is consistent use of upper and lower case
Selected, 1/01 letters.
Interim 2. Notify all pharmacy personnel that the

Pharmacy Package drug lookup feature is case
sensitive. Post reminders in Pharmacy and all
satellite Pharmacy's.
Solution: Pharmacy service in conjunction with

the Offuce of Information Management will
update the Pharmacy Package lookup feature to
eliminate case sensitivity. If a single match is
found, users will be prompted to verify the match
is correct. These updates will be provided by
Inpatient Medications patch PSJ*5*55 and
Outpatient Pharmacy patch PSO*7*54.
Recommended; Priority A DrugSyn.pdf


Not
5.5.7 Computerized Medical Record 'List 1. Review the records of patents with identifier
Manager Version', 7/01 NW to determine if orders have been erroneously
entered and take appropriate action.
2. Notify staff of the potential for error if the

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


Not
5.5.8 Risperidone oral medication syringe 1. Consider using oral tablets.
(pipette), 8/01
2. For those inpatients that cannot tolerate
tablets, have pharmacy prepackage unit dose
liquid.
Graduated markings on the
risperidone syringe (pipette) that 3. Advise the caregiver to use USA standard, oral
comes in the medication box are syringe by replacing the pipette that comes in the
opposite of the markings on syringes box with an oral syringe.
we use in USA. Nurse almost
administered the wrong dosage. 4. Alert staff that passes medication that devices
that come in the box for liquid risperidone are
considered pipettes by the company, although
would normally be thought of as syringes by our
frontline users. The markings are opposite of the
syringes we are used to, and the are on the
plunger of the pipettes. If possible, DO NOT USE
THEM.
5. We are working to encourage the company to

provide a new pipette that meets USA standards.
Replace your liquid risperidone stock when the
new pipettes come out.
Recommended; Priority A Pipette.pdf


Not
5.5.9 Hemodialysis Catheters: Ash Split 1. Do not use Alcohol, Acetone, Hydrogen
and Vaxcel, 8/01 Peroxide, and other ointments on these
catheters. If these agents are not necessary in
the unit, remove them from the premises.
These long-term indwelling catheters 2. Prior to insertion/installation in patients: Inspect

may crack and/or form small blisters each catheter for small blisters (blebs), cracks
(blebs), if wrong disinfectants and/or and defects as you remove them from the sterile
cleaning solutions are used. packaging. If any defect is found prior to
installation, stop and sequester the catheter and
its packaging and call your risk manager and/or
patient safety officer.
3. During use site care: a) Inspect the catheter at

each patient's visit and b) Use only
manufacturer's recommended Iodine based
antiseptic soltions.
4. During use monitor patient's symptoms:

Inspect catheters for cracks and blisters of
patients who present with complaints of nausea,
vomiting, and shortness of breath.
Recommended; Priority A HemodiCatheterAdv.pdf


Not
5.6.1 Zoll M Series defibrillators and M 1. Immediately (within 24 hours) upon receiving
Series AEDs with software versions this alert, arrange for Biomedical Engineering to
below 30.00, 1/02 confirm whether or not your units are affected via
the serial number and software version.
2. If affected:a) M Series Advisory defibrillators

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


Not
5.6.2 Bronchoscopes manufactured by 1. Immediately identify all units affected. Remove
Olympus America, Inc., per them from service and test them for a loose portal
manufacturer's letter, 3/02 following Olympus procedure.
2. If you detect any looseness in the biopsy

channel port, discontinue using the affected
Affected models: BF-40, BF-40, BF - bronchoscope, notify Olympus via fax and return
P40, BF-1T40, BF-3C40, BF -XP40, it to Olympus per their directions for immediate
BF -XT40, BF –240, BF -P240, BF- upgrade.
1T240, BF-6C240, BF-160, BF-P160,
BF-1T160, BF-3C160, BF -XT160, 3. If the unit is not affected, it can be used.
per manufacturer’s 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.
Mandatory; Priority A BronchOlympusMar02.pdf


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

use the panel lockout feature during infusions as
standard procedure. This disables the on-off
switch, preventing the potential on-off cycling and
allows uninterrupted therapy. Panel lockout is
engaged and disengaged by pressing the black
lockout button on the back of the pump.
Remember to disengage panel lockout to change
pump settings.
Mandatory; Priority A BaxterColleagueMay02.pdf


Not
5.6.4 Phillips/Agilent/Hewlett Packard 1. If you have the affected units and did not
Viridia information centers; 5/02. already receive and respond to Phillips Medical
Systems letter, immediately check your central
station monitoring serial numbers against the list
in the attached letter from Phillips Medical.
Central station monitors using the
Hewlett Packard Vectra VL400 2. If affected, contact Phillips Medical at (800)
personal computer. This PC is used 548-8833 to arrange replacement of the hard
in models M3150A, M3151A, drives.
M3153A and M3150AU#A01 central
station monitors. All units shipped
between Feb 1, 2001 and Feb 21,
2000 are affected. Bedside monitors
are NOT affected., The hard disk
drive installed in the units may fail,
causing loss of central station
monitoring and alarming. Bedside
monitoring and alarms are not
affected.
PhilipsViridia1.pdf
Mandatory; Priority A PhilipsViridia.pdf


Not
5.6.5 Inadvertent deletion of text from 1. On August 20, 2002, the emergency patch
CPRS progress notes, 8/02. OR*3*155 was released; nearly all stations have
already installed this patch. Within 24 hours of
this alert, ensure that your facility has installed
the patch. (This patch removes the spell checking
Four VA medical facilities report option on CPRS only. A permanent fix is
random deletion of progress note scheduled to be released first week of October
text after running Microsoft Word 2002.)
spell checker while using CPRS GUI.
2. Patient Safety Managers need to verify that
clinicians are aware of this issue. In addition,
clinicians should report any unusual incidents
they notice relating to the functionality of progress
notes and associated tools to the Office of
Information Help Desk at 1-888-596-4357 and
others per medical center local policy.
Mandatory; Priority A SpellCheckThin.pdf

5.6.6 Recall of the Pocket Guide "VA/DoD 1. Retrieve and destroy all existing Pocket Guides
Clinical Practice Guideline for for the “VA/DoD Clinical Practice Guideline for
Management of Postoperative Pain", Management of Postoperative Pain.” The guide is
9/02. 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).”
Mandatory; Priority A PocketGuideRecall.pdf


Not
5.6.7 MEDISYSTEMS Corp., blood tubing 1. Check your inventory for the affected products,
for dialysis, 9/02 Medisystems Product code D3-9694/9793 or K3-
9694/9793, Baxter Product code 5M9694.
Contact the manufacturer for alternative blood
tubing products so that you will 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.
Mandatory; Priority A BaxterTubingSept02[1].pdf

Not
5.6.8 4341B Thoracentesis Catheters in 1. Remove all stock with the identified lot
Thoracentesis Trays distributed by numbers from the inventory.
Allegiance Healthcare Corp., 11/02
2. Follow product return instructions.
Lot Numbers: L1J035X, L1J088,

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

Not
5.6.9 Power cords used with GE Dinamap 1. Check the medical equipment inventory to
Vital Signs Monitors, all models determine if the specified monitors are in use at
distributed btwn June 2001 & Oct the facility.
2002, 11/02
2. Immediately replace any cords with a broken
ground pin with another spare power cord that is
not affected by this notice.
A VA medical center reported ground
pins breaking on the power cords 3. Determine the total number of power cords
used with GE Dinamap Vital Signs affected by this notice, whether they show 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.
Mandatory; Priority A GEDinamapCord.pdf

Not
5.6.10 Potential for incorrectly attaching 1. Use only standardized irrigation kits identified
Allegiance Irrigation Kit caps to Foley by the Medical/Surgical Users Group; acquire
catheters, 2/02. from LSL Industries purchased under (BPA)
Blanket Purchase Agreement # VANAC90NP-00-
035 with Foley catheters.
The tubing cap (Catalog #3T4121) of 2. Check with Materials Management to

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

Not
5.6.11 Confusion between Oxygen & 1. Purchase clear adaptors and avoid green-
Compressed Air Wall Outlet, 3/02 yellow confusion.
2. When appropriate, purchase compressed air

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

must work together for the smoothest
implementation of any redesign or training.
Recommended; Priority A Air_O2WallInlet.pdf

Not
5.6.12 Addendum to Patient Safety 1. The National Center for Patient Safety and the
Advisory Issued on February 27, VA Medical/Surgical Users’ Group are working
2002 Concerning Allegiance with the VA National Acquisition Center and
Irrigation Kits, 5/02 vendors to modify the configuration of the caps so
that inadvertent insertion is effectively precluded.
Until we can find a vendor who is willing to modify
the configuration, continue to 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.
Recommended; Priority A AllegIrrig.pdf

Not
5.6.13 SSCOR Inc, Suction Pumps, Models 1. Check the medical equipment inventory to
2314, 2314B, and 2315, all units, determine if you have the specified pumps.
7/02 Model numbers for the SSCOR suction units can
be found on a silver label on the back of the units.
Ensure any units on hand are being used as
intended, and not placed in areas where they 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 equipment’s design. If necessary,
purchase appropriate suction systems for wound
or procedural drainage.
Recommended; Priority A SSCOR7_02.pdf

Not
5.6.14 CPRS & Inpatient Complex For Providers authorized to enter orders:
Medication Orders, 8/02
1. When entering a complex medication orders,
keep a written list of all your complex orders and
at renewal time, reference the list and enter
When renewing an automatically complex orders first.
stopped medication order of a
tapering dose, or editing an existing 2. Notify pharmacy of all your complex orders
order of a single dose the start/stop when you initiate them by including a statement in
dates will be changed and overlap the Provider Comments on CPRS such as
the current order. This could result in “TAPERING ORDER” or “PART OF COMPLEX
a patient receiving multiple doses in ORDER”.
one day, if the provider didn’t notice
the shift in start dates. 3. When editing or renewing orders, review the
displayed start/stop dates in CPRS and be aware
that a new order might be inadvertently created
and that new order’s start/stop dates will be
changed and overlap the current order.
For Pharmacy staff:
1. Pay particular attention to tapering orders.

Devise a method or process to alert others in the
pharmacy as tapering orders are received. For
Example: Include a statement in the Special
Instructions such as “TAPERING ORDER” or
“PART OF COMPLEX ORDER”.
2. Review the BCMA last action displayed on

renewed order when verifying within inpatient
meds.
For (continued)...
Recommended; Priority A CPRScomplexorders.pdf

Not
5.6.14 (continued)... CPRS & Inpatient ...(continued) Providers authorized to administer
(continued) Complex Medication Orders, 8/02 medication:
1. Before administering medications double check

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

Not
5.6.15 Cochlear Implant Recipients may be 1. "The FDA advised that cochlear implant
at increased risk for bacterial candidates, as well as those already implanted,
meningitis, 9/02 may benefit from vaccinations against organisms
commonly associated with bacterial meningitis,
particularly S. pneumoniae and H. influenzae
(ACIP recommends 23valent pneumococcal
The FDA has determined that, over vaccines [Pnu-ImuneR 23 and PneumovaxR]] for
the past 14 years, 52 cases of adults with increased risk of invasive
meningitis have been reported pneumococcal disease). Therefore, all veterans
worldwide, out of which 12 known who are candidates for cochlear implant (s)
deaths have resulted from these should be ascertained of their immunization
cases. It was identified that 24 cases status prior to surgery as well as all patients with
(of the 52 worldwide cases) were in existing implants received from VA and non-VA
North America. facilities. Previously unvaccinated adults with a
high-risk condition (functional or anatomic
aspleina, immunodeficiency, [particularly, persons
with IgG2 subclass deficiency],
immunosuppression from cancer chemotherapy,
and infection with human immunodeficiency virus)
should be given at least one dose of any licensed
Hib conjugate vaccine. As neither FDA nor CDC
specifically notes the use of Hib vaccine in
(continued)...
Recommended; Priority A CochlearImplantAdvisory.pdf

Not
5.6.15 (continued)... Cochlear Implant ...(continued) adults related to cochlear implants,
(continued) Recipients may be at increased risk the use of Hib vaccine in this scenario would be
for bacterial meningitis, 9/02 based on theoretical risk.
For additional info on immunizations refer to the
following websites.
http://www.cdc.gov/nip/publications/pink/
The FDA has determined that, over
the past 14 years, 52 cases of http://www.cdc.gov/mmwr/preview/mmwrrhtml/00
meningitis have been reported 025228
worldwide, out of which 12 known http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf
deaths have resulted from these "
cases. It was identified that 24 cases
(of the 52 worldwide cases) were in 2. In some of the reported cases, patients may
North America. have had overt or sub-clinical otitis media prior to
surgery or before meningitis developed.
Physicians are encouraged to consider
appropriate prophylactic perioperative antibiotic
treatment, and to diagnose and treat otitis media
promptly in patients with cochlear implants.
3. Patient Safety Managers, please make sure

that Primary Care Physicians, EENT specialists
(on Surgery service) and Audiologists are aware
of this. Follow FDA MedWatch reporting
instructions to report cases of meningitis in
cochlear implant recipients.
Recommended; Priority A CochlearImplantAdvisory.pdf

Not
5.6.16 Inpatient Medications Version 5.0 1. Install CPRS/BCMA PSJ*5*94 and PSB*2*13
and BCMA Version 2 (PSJ*5*94 and when they are released. These patches are
PSB*2*13), 11/02 currently undergoing testing and are scheduled
for release by November 30, 2002.
2. In the interim when pharmacists renew IV

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

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

Not
5.7.1 Connection tubing set used with 1. Notify staff to observe for normal inflation on
Sequential Compression Device the SCD sleeves when first applied to a patient.
(SCD) 1/03 In particular, activate the cooling button for 30
seconds to ensure that no observable over-
inflation occurs.
Models 6235, 7325, 5320 and 5325 2. Inspect all Kendall SCD tubing sets to confirm
manufactured by Kendall (Tyco that none of the recalled sets remain on site
Healthcare). The recalled tubing (identification instructions are attached). Either
sets have a reversed connector and positively identify “blank” (no lot number label)
pose a serious hazard. Underr this tubing sets for proper connectors or treat them as
condition the SCD becomes a suspect.
tourniquet applying up to 200 mmHg
pressure around the extremity. This 3. Contact Kendall to obtain replacement
condition can persist even after the connection tubing sets. The contact at Kendall is
machine is turned off and in a pain- Karen Tabaczynski; she can be contacted at
controlled patient, could go (508) 261-8037.
unnoticed for several hours, leading
to permanent tissue damage.
Mandatory; Priority A KendallConnectTubing.pdf

Not
5.7.2 Zoll AED Plus, Public Access 1. Immediately identify all affected units.
Defibrillator (PAD) distributed before
Dec 8 2002, 2/03 2. For AEDs awaiting updating, determine which
of the following work around procedures is best
suited for your application: a) If the error condition
is activated, turn the AED off for 10 seconds, then
Serial numbers X02K000812 to restart; or b) Attach the pads to the patient prior
X02K0077486. While handling to turning the AED on.
electrodes prior to attaching them to
a patient, communication between 3. Place the appropriate work around instructions
the unit’s internal ECG and Safety with each affected defibrillator and train potential
Monitoring functions can lead to an users on the work around. Remember to
error condition. This error condition schedule training again after the software
will cause the defibrillator to issue a upgrade is installed.
"Shock Advised" message,
immediately followed by "No
Treatment Delivered" and "Change
Batteries" messages.
Mandatory; Priority A ZollDefibFeb2003.pdf

5.7.3 Counterfeit drugs labeled as 1. Follow this link for details on identifying the
PROCRIT® (Epoetin alfa) 40,000 counterfeit products and directions:
units/mL; 3/03 http://www.procrit.com/counterfeit/letter.html
2. Inspect your stock and immediately remove all

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

Not
5.7.4 ACCU-CHEK® Comfort Curve® and 1. For inpatient and clinic areas: Within the next
Advantage® test strips manufactured 72 hours, inspect the inventory and check the
by Roche Diagnostics Corp; 5/03 bottom of any unused or currently in-use vials for
cracks. Make sure that the lot specific code key
inside each strip box is kept associated with the
correct vial as you conduct this inspection. Also,
The bottom of the vial may be as a standard practice, inspect each vial for
cracked which may cause inaccurate cracks before each use. If you find cracked vials,
blood glucose results due to 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 ACCU-
CHEK® Advantage® test strips, part
numbers 336, 553, 787, and 966.
Mandatory; Priority A 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.
Mandatory; Priority A AbbottPumpsAir_Line.pdf

Not
5.7.6 Decimal point display issue with 1. Check to see if you have these pumps at you
Abbott APM II pump, 6/03 facility. If these pumps are not used, then no
further action is required.
2. If you have these pumps review the analgesic

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

Not
5.7.6 (continued)... Decimal point display ...(continued) make sure medication orders and
(continued) issue with Abbott APM II pump, 6/03 dispensing meets your facility’s guidelines and
are in whole number before sending to the patient
care unit for administration.
The APM II Pump will not display a

decimal point on the screen when
entering values in the tenths of
micrograms per milliliter (mcg/mL).
However, the decimal point is
displayed when the value entered is
in the milligrams/milliliter (mg/mL)
range.
Mandatory; Priority A AbbottPumpsDecimalReadout.pdf

5.7.7 Power cords for Hill-Rom Century+ 1. Check the medical equipment inventory to
electric beds, distributed between determine if you have Hill-Rom, Century + electric
Jan 1 1999 and July 1 2002; 7/03 beds and inspect the power cords for beds that
fall within the affected range.
2. Determine the number of power cords affected

Power cord ground pins on some by this notice. Affected cords are identified by
portable monitors broke off. This their manufacture date with codes as follows: 09 -
fracture compromises one of the 01 through 16 - 02 (week - year) is imprinted on
safety features designed to limit the hot and neutral cord blades. Immediately
patients' risk of electrical shock. replace any cords with a broken ground pin with a
Unless the pin has broken, patient spare and schedule replacement of other cords
safety is not compromised. with an imprinted date that falls within the
affected range.
3. Contact Hill-Rom technical support at 800-445-

3720 for replacement power cords. We also
suggest you provide them with updated contact
information for future notices.
Mandatory; Priority A HillRomPower.pdf

Not
5.7.8 Soft Skin™ protective sleeve 1. If this product is present in any areas you
manufactured by Span America to consider to be high risk for self-harm, remove the
cover Geo-Matt® seat cushions and plastic cover.
mattresses, 7/03
2. Remove any other plastic covers, sleeves,
wraps, liners, or bags that are accessible to the
patient from areas classified as high risk for self
A patient in locked psychiatric ward harm.
used a plastic cover on a Geo-Matt®
wheelchair cushion to commit
suicide. The patient removed the
protective sleeve/covering on the
cushion and placed it over their
head/face resulting in suffocation.
The wheelchair seat cushion was
purchased with the plastic cover in
place for incontinence protection. It is
worth restating that plastic trashcan
liners, sleeves, wraps, dry cleaning
bags, etc., present similar suffocation
hazards.
Mandatory; Priority A SoftskinAlert.pdf

Not
5.7.9 J&J/Cordis Cypher™ Sirolimus- 1. Interventional Cardiologist: In addition to
Eluting Coronary Stent, 11/03 following the manufacturer’s recommendation
(see attached letter from Cordis dated July 7,
2003), coordinate with the post-stent care
physicians to ensure that the required antiplatelet
Informing Physicians of sub-acute therapy regimen is continued post-stenting.
thromboses (SAT) and
hypersensitivity reactions with the 2. Post-stent care Physicians: As recommended
use of the Cordis CypherTM drug by Cordis
eluting Coronary Stent. http://www.fda.gov/bbs/topics/news/cordis_ltr.pdf
and referred to by the FDA “Administration of
continued antiplatelet therapy for three (3)
months post-stenting is considered critical.”
3. Report all adverse events to Cordis at 1 800

327 7714 and FDA via MedWatch.
Mandatory; Priority A CYPHER_DES.pdf

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

Not
5.7.11 Counterfeit PROLENE Polypropylene 1. Physicians, nurses, and all other healthcare
Mesh, 11/03 professionals must carefully examine all
PROLENE flat mesh (3”x6”) before use. Do not
use any product that is suspected to be
counterfeit. If counterfeit mesh is found contact
Product code PMII bearing lot the distributor to discuss refund/replacement of
numbers RBE609 (expiration date the product(s). Refer to the attached 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.
Mandatory; Priority A CounterfeitProlene.pdf

Not
5.7.12 Olympus Cystoscopes, models CYF- 1. Check inventory for affected cystoscopes.
4/4A and CYF-240/240A with MAJ-
891 Forceps/Irrigation Plug, 2/03 2. Inspect the MAJ-891 plug (refer to the photo in
the attached Olympus notice). Earlier production,
affected plugs have a black rubber locking ring;
later production, replacement plugs 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 information.
removing the plug, thus damaging
the cystoscope and rendering it 4. Contact Paul Sherman at CEOSH via e-mail at
unusable. paul.sherman@med.va.gov if you have the
affected plug and did not receive the letter from
Olympus.
Recommended; Priority A OlympusCYF.pdf

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

Not
5.7.14 Adverse Reaction/Allergy database 1. Information Resource Management (IRM) at
of CPRS GUI v20 Allergy Reaction VAMCs should monitor the VistA M error trap, at
Tracking v4.0; 4/03 least on a daily basis (until a patch is released) to
determine if the data has been recorded properly
in file 120.8. If the data is not recorded on file
120.8, then the data will need to be re-entered.
Allergy information does not get
recorded in the database if the
correct letter is not entered in the
“Enter Allergy Information” dialog
box, the allergy entry will appear on
the Orders Tab as an unreleased
order and the data is not sent to the
Allergy/Adverse Reaction Tracking
application. Therefore, the
information is not posted and will not
trigger allergy alerts.
Recommended; Priority A CPRSAllergy.pdf

Not
5.7.15 The Ancure ® Endograft System 1. Because the Ancure ® device will no longer be
made by EndoVascular supported in the near future other procedures and
Technologies, Inc.will no longer be FDA approved devices should be considered for
sold. 6/03 cases requiring endovascular repair.
Endo Vascular Technologies, Inc. of

Menlo Park, CA, is a subsidiary of
Indianapolis-based Guidant
Corporation. Ancure ® is the
registered name for a device used to
treat abdominal aortic aneurysm
without tradional surgical techniques.
This device will no longer be
supported in the near future. Other
procedures and FDA approved
devices should be considered for
cases requiring endovascular repair.
Recommended; Priority A Ancure.pdf

5.7.16 METFORMIN Orders on CPRS V3.0 1. Mark metformin in the facility drug file as “Not
GUI v22; 9/03 Renewable” until the order check function in
CPRS is upgraded with patch OR*3*190 currently
being developed.
A patient’s order for metformin was 2. In the interim, if you wish to continue the same
renewed three times although the order, use the COPY feature.
serum creatinine values before
renewal were above 1.5mg/dL. 3. Review patients that are currently receiving
metformin with serum creatinine values higher
than normal and take appropriate interventions.
Recommended; Priority A Metformin9_03.pdf

Not
5.8.1 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 in-
service training must address manufacturer
instructions for proper reprocessing of specific
Using an incorrect connector to link models of gastrointestinal fiberoptic endoscopes
sterilizing solution to endoscopes for consistency with local work procedures. All
during reprocessing (cleaning and third party (other than the endoscope
sterilizing) procedures. A dual-port or manufacturer) tools and materials used for
“Y” connector designed to connect to reprocessing must also be covered during the in-
endoscopes incorporating dual ports service training.
was connected to endoscopes with
single ports. Under this condition an 2. Validate that appropriate reprocessing
indeterminate amount of sterilizing connectors are being utilized with each model of
solution may have been directed to endoscope. Some manufacturers provide
the unconnected port, possibly cognitive aids such as instruction placards and
leading to inadequate sterilization of these must be available and intact where
the endoscope. provided.
3. Incorporate knowledge of proper handling and

reprocessing of gastrointestinal fiberoptic
endoscopes into JCAHO competency
assessment requirements for individuals tasked
with this assignment.
4. Facility Patient Safety Managers will monitor

(continued)...
Mandatory; Priority A EndoscopeCleaning_all.pdf

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.
Mandatory; Priority A EndoscopeCleaning_all.pdf

Not
5.8.2 Potential bacterial contamination of 1. Immediately remove and quarantine the
Twice-A-Day Nasal Spray affected nasal spray bottles from inventory.
manufactured by Propharma Inc.,
3/04
Product with Lot Number K4496,

generic name is Oxymetazoline HCl
0.05% with the following additional
identifiers: NDC# 0904-5217-35 and
0904-5217-30, Lot number K4496,
expiration date 10/06.
Mandatory; Priority A PropharmaNasalSpray.pdf

Not
5.8.3 Oxygen Utility System, 4/04 1. Conduct alarm-set point verification through
the use of a qualified third party expert. The set
points must be code compliant and this action
documented. (see NFPA-99 5.1.3.4.11.6, 2002
Two VA Medical Centers reported a Edition)
loss of service in the Oxygen Utility
System. In both incidents the alarm 2. Ensure that a minimum of two, independent
on the main tank did not sound until 24/7 and constantly attended monitoring stations
reaching near or completely empty are provided for all alarm conditions related to the
and both sites did not meet the Oxygen Utility System. Test all alarm conditions
NFPA-99 requirement for two, to ensure the alarm annunciation is working.
independent 24/7 supervised areas
where mandatory alarm conditions 3. If either of the conditions in 1. or 2. above
for the Oxygen Utility System are cannot be met, the Medical Center must publish,
annunciated over the Director’s signature, a comprehensive
Interim Life Safety Measure that fully addresses
and compensates for the non-compliant
condition. The ILSM must remain in effect until
the code requirements are met. In addition
appropriate staff must be trained on the ILSM
requirements, and this training needs to be
documented.
4. Review the oxygen delivery contract and verify

the delivery schedule meets current demands to
ensure an adequate supply of Oxygen
(continued)...
Mandatory; Priority A OxygenUtilitySystemAlert040504.pdf

Not
5.8.3 (continued)... Oxygen Utility System, ...(continued) so alarm conditions are not
(continued) 4/04 triggered between refills.
5. Ensure qualified and trained technical staff

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

as required by JCAHO to assure appropriate
safeguards are in place in the event of unplanned
utility shutdowns.
Mandatory; Priority A OxygenUtilitySystemAlert040504.pdf

Not
5.8.4 Implantable Cardioverter Defibrillator 1. Immediately check patient records in CPRS to
(ICD), 4/04 identify patients with the ICD implants described
in this notification.
2. Contact your local Medtronic sales

Models Micro-Jewell II 7223Cx and representative (or Medtronic Technical Services,
GEM DR 7271; Medtronic, implanted listed in the Contact section of this notification if
in 1997 and 1998, During a cardiac you cannot reach the local representative) for
event requiring cardioversion or assistance with determining whether the identified
defibrillation, internal capacitors may implant requires follow-up action as identified by
take longer to charge and can cause Medtronic.
a delay or non-delivery of appropriate
shock therapy. 3. If follow-up action is necessary, see the
attached letter from Medtronic describing required
actions.
Mandatory; Priority A MedtronicICDAlert042804.pdf

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.
2. Please complete the enclosed Distributor

Response Form indicating how you will proceed
Model MMT-359S6, MMT-359S9, with this mandatory notification and return it by
MMT-359L6 and MMT-359L9, fax as soon as possible to the manufacturer.
Problems with the infusion sets can
interrupt insulin flow resulting in 3. Please also complete the enclosed Exchange
serious injury. Request Form so that arrangements can be
made to return all affected product to the
manufacturer for disposal and send you the
replacement products of your choice.
Mandatory; Priority A MedtronicMiniMedInsulinSetAlert051904.pdf

Not
5.8.6 Minor Surgery/Exam lights: 1. Review Burton Medical’s notice (attached and
CoolSpot™ and Outpatient® available on-line at
Fleximount™, 6/04 http://www.burtonmedical.com/safetyNote.htm).
2. Identify and inspect all units affected by this

alert for cracked pivot supports, and complete
Single Ceiling and Track Mount with Burton Medical's form to obtain new pivot
Single Trolley manufactured by supports and arms.
Burton Medical before August 2000.
Model numbers: 0100540, 0100740, 3. For identified lamps with cracked pivot
0100580, 0102180 and 0102540, supports- If possible, remove them from service.
Due to an inherent weakness in the a. Users: Inspect each light daily before use for
original composition of the pivot normal movement and stability. If the light
support casting, the pivot joint can appears loose or unstable, contact Engineering to
fail and the light may fall onto a have it checked. b. Engineering: Inspect
patient. identified lights every two weeks until new
components are installed.
Mandatory; Priority A BurtonLightsJune04.pdf

Not
5.8.7 CPRS Text Integration Utility (TIU) 1. Run patch TIU*1*174 for all patient records
v1.0 documents, 6/04 created after January 1, 2004 and at least daily
thereafter until permanent solutions are
implemented. Review all records identified by
this patch to determine if text has been deleted or
Reported and confirmed that text truncated.
stored in Text Integration Utility (TIU)
document file 8925 may be deleted 2. When records with missing or truncated text
or truncated automatically without the are identified:(a) Refer them to the author for
author being made aware that this review of the note and to add an addendum if
occurred when the document is needed (b) If the author is no longer available or
signed. The Office of Information is unable to remember what information is
(OI) has developed a patch that may missing a disclaimer, similar to the following,
be used to identify potentially should be added to the file “DISCLAIMER: This
affected patient records. completed document may have text that was
electronically deleted in error. (c) If the note is of
significant concern, and the author is no longer
available, the record should be referred to the site
medical record committee or other functional
group that processes records that are suspected
as being incomplete. The committee may decide
to forward the note to the service chief or
equivalent to either complete the note or
(continued)...
Mandatory; Priority A CPRS_TIUJune04.pdf

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.
Mandatory; Priority A CPRS_TIUJune04.pdf

Not
5.8.8 DeRoyal ReliaFlex™ Suction 1. Review the attached letter from DeRoyal and
Canisters with Liners, 6/04 sequester all affected models and lot numbers. a)
71-9101, canister liner, 1300cc, Lot numbers
lower than 5951 b) 71-9201, canister liner,
1800cc, Lot numbers lower than 5949 c) 71-9301,
DeRoyal suction canisters that are canister liner, 3200cc, Lot numbers lower than
used with the ReliaFlexTM suction 6096
liner system have violently
discharged blood and body fluids 2. With the help of your Logistics office or your
when the full liners were removed by material management service, contact your local
clinical staff from the hard outer shell. DeRoyal sales representative or distributor to
Unsecured caps on the tandem port make sure that you have an adequate supply of
and pour spouts along with slight the redesigned ReliaFlexTM suction liners (those
pressure on the flexible suction liner with lot numbers higher than 1a-c) before you
precipitated the discharge. 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.
Mandatory; Priority A DeRoyalSuctionCanister.pdf

Not
5.8.9 Failure of medical alarm systems 1. Determine if your facility uses a medical alarm
using paging technology to notify paging technology and confirm that alarm
clinical staff, 7/04 protocols classify the paging component as a
secondary (or back-up) notificaiton method and
that it is not used as the primary alarm or
communication method.
Reports documenting the failure of
medical alarm systems using paging 2. Verify that staff is assigned to monitor and
technology to notify clinical staff of manage physiologic monitoring systems and
alarms or other critical clinical other clinically significant primary alarms when
information. patients are being monitored.
3. Evaluate the physical layout of your patient

care areas to determine where monitoring staff
(monitor watcher) is needed. Perform this
assessment as though you did not have an alarm
paging system. Note: If you use a medical alarm
system using paging technology to comply with
JCAHO Patient Safety Goal No. 6b compliance
must be reassessed without the use of the paging
system.
4. If a medical system using paging technology is

used as a component of the clinical staff
notification process (i.e., secondary or back-up)
there must be positive feedback to the initiator of
(continued)...
Mandatory; Priority A AlarmPagingJuly04.pdf

Not
5.8.9 (continued)... Failure of medical ...(continued) the page that the message was
(continued) alarm systems using paging received and responded to in a timely manner.
technology to notify clinical staff, This allows appropriate action to be taken to
7/04 deliver clinical care if the page was not
acknowledged.
Reports documenting the failure of

medical alarm systems using paging
technology to notify clinical staff of
alarms or other critical clinical
information.
Mandatory; Priority A AlarmPagingJuly04.pdf

5.8.10 Boston Scientific Stent System 1. Confirm that your facility received the
Recall, 7/04 manufacturer’s recall letter dated 7/21/2004.
(Letters were sent to Director of Cardiac
Catheterization Labs and Risk Manager). If not
contact Boston Scientific at (800) 832-7822.
Models: 1) Taxus Express 2 Monorail
(MR) Paclitaxel-Eluting 2) Taxus 2. By close of business July 30, 2004, ensure you
Express 2 Over-the-wire (OTW) have on site replacements from FDA approved
Paclitaxel-Eluting 3) Express 2 stent suppliers, for existing, affected models
Monorail (MR) bare-metal 4) Express (“recalled stents”) of Boston Scientific stent
2 Over-the Wire (OTW) bare-metal. systems. Do not sequester the “recalled stents”
The FDA and the manufacturer from use until you have replacements on hand.
received reports 43 confirmed “no
deflation” (failure of the balloon to 3. Contact your local Boston Scientific sales
deflate within one minute after representative to exchange the affected stents
deployment of the stent) complaints one for one with their replacements.
related to the Taxus Express 2
device system.
Mandatory; Priority A BostonScientificStentRecallJuly04.pdf

Not
5.8.11 Shiley Tracheosoft XLT Extended 1. Patients with the affected models (see below)
Length Tracheostomy Tube and should be contacted and arrangements made to
Cannula FDA Class I Recall, 8/04 exchange the equipment.
2. If you have the affected devices in stock work

with your materials management (AMMS) to
The outer cannula may separate make sure that a recall package has been
from the hub and neck flange received. Follow the instructions in the package
allowing the outer cannula to travel to receive credit for the recalled products.
farther into the patient’s airway
leading to obstruction of the airway 3. If you have these devices in stock and did not
and significantly interfering with receive a recall package from the company,
breathing and ventilation. contact Nellcor/Tyco Technical Services
Department at 1-800-635-5267.
Mandatory; Priority A ShileyTracheosoftAug04.pdf

5.8.12 Automated External Defibrillators 1. Immediately check your inventory to determine
(AED) manufactured by Access if you have any Access Cardiosystems AEDs and
Cardiosystems, Inc., operation remove units from service affected by items 1 and
failure, 11/04 2 above.
2. Other Access Cardiosystems units can remain

in service only as long as you have consumables
Units with serial numbers ranging on hand to support them or until February 1,
from 075690 to 077140 may 2005, then they must be removed from service
experience a malfunction in the and replaced with AEDs from other
shock delivery circuit and fail to manufacturers.
deliver therapeutic shocks.
3. If you are affected, plan for emergency
replacement of any Access Cardiosystems
defibrillators in stock.
Mandatory; Priority A AccessAEDsNov04.pdf

Not
5.8.13 Renewal prompts for "one-time only" 1. Check the attachment to determine if you are
medication orders, 12/04 one of the sites that has already installed CPRS
test patch PSJ*5*127.
2. If your site is NOT listed on the attachment 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.
Mandatory; Priority A 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 mis-
prescribing.
Recommended; Priority A CPRSDrugFile042804.pdf

Not
5.8.15 Tubing separation of Edwards 1. Caregivers should always inspect disposable
Lifesciences VAMP Plus® products for obvious defects before use.
Disposable Pressure Transducers
Monitoring Kits, 7/04 2. Follow directions for use and, ensure all
connections are secure and finger tight during
set-up of pressure monitoring systems.
Relative to tubing disconnects that 3. Be vigilant of any blood leaks or dampened

may result in blood leaks and blood pressure waveforms when using this
potential for exsanguinations. The transducer.
complaint rate is presently about 1%
and disconnects have not been 4. Contact your local representatives to
specific to one lot. exchange, free of charge, all defective, Edwards
Lifesciences transducer devices.
Recommended; Priority A EdwardsVAMPXducerJul04.pdf

5.8.16 ALARIS (IMED) Gemini Infusion 1. DO NOT use medication pumps, or other
Pumps, 10/04 medical devices that are in need of repair.
2. As a standard practice, operators of medical

devices should inspect and conduct operational
Pump provides automatic free flow checks, as specified in the manufacturers
protection via the medication operations manual, on all equipment and medical
administration set and the exterior devices before use. If the device is found to be in
door. If the door latch is broken it need of repair, it should be removed from service
may not properly activate the free and sent to biomedical engineering for service.
flow protection mechanism on the IV
set, and free flow of medication may 3. Assure that there are an adequate number of
occur if other methods of free flow pumps available to adjust for peak utilizations
protection are not employed. and/or maintenance cycles.
Recommended; Priority A ALARISGeminiInfusionPumps.pdf

Not
5.8.17 Electro-magnetic Interference (EMI) 1. Check to see if you have current policy
from the use of two-way hand held addressing EMI risks including recommendations
radios/walkie-talkies, 11/04 for areas where wireless communication devices
are restricted. For two-way radios, 20 feet from
medical equipment is a minimum recommended
distance (ECRI Health Devices 2003 Mar;
When operated in close proximity to 32(3):118-21).
medical devices. Oxygen
concentrators in the nursing home 2. Refer to your EMI policy and modify to improve
unit alarmed and sometimes shut if necessary.
down, requiring a reset when two-
way radios were keyed to transmit 3. Train radio users (generally Engineering,
from approximately 10 feet away. Safety and Police personnel) to maintain
Distance and transmitter appropriate distances from medical equipment
management are the most when using radios.
controllable and effective.
Recommended; Priority A EMIAdvisoryNov04.pdf

Not
5.8.18 Power supplies for flat panel patient
During surgery at a VA medical facility the power
monitor, Model 91415-A supply for the flat panel patient monitor degraded
to the point where the audio circuit stopped
manufactured by Spacelabs Medical working, affecting the alarm function. This was
between January 2000 and unknown to the operator and when the patient
experienced a cardiovascular event, the alarm
December 2001. 11/03. was not heard resulting in a patient incident.
Action:
1. Immediately (within 24 hours) identify all units

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

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

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

system's audio
Spacelabs Display Nov 2003.pdf

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 system’s audio and notify Biomedical

Engineering.
c.) Place a warning label on the flat panel patient

monitor
informing the user about required testing prior to

each procedure
or with each shift change, whichever is more

frequent.
Mandatory; Priority A Spacelabs Display Nov 2003.pdf

Not
5.9.1 Fire Response and Planning, 1/05 1. Facilities Management or Engineering Service
personnel will initiate immediate replacement of
the recalled Central O-ring sprinklers if any are
still present in the facility and complete
A fire in a VA hospital caused by the replacement by March 15, 2005. If this cannot 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)...
Mandatory; Priority A FireResponseAlert.pdf

Not
5.9.1 (continued)... Fire Response and ...(continued) impacted smoke zone and the
(continued) Planning, 1/05 acuity level of the patients. Based upon past fire
events, the minimum recommended staff
response (not counting Fire Department
Personnel) is: 1) For patient care buildings with
A fire in a VA hospital caused by the overnight stay that are not fully sprinkler
improper use of smoking materials, protected: One responder for every two non-
combined with the presence of ambulatory patients. If this response ratio cannot
oxygen completed the fire triangle be met, consider installing sprinkler protection,
and resulted in the death of a 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
Mandatory; Priority A FireResponseAlert.pdf

Not
5.9.2 Nellcor pulse oximeters, 1. Immediately (within the next 48 hours)
manufacturered after November 8, determine and identify all affected units. Only
2001, 1/05 units manufactured after November 8, 2001 (after
S/N G01844386) are affected.
2. Until the speaker assemblies are replaced,

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

unit from service and replace with another unit,
making sure the speaker is functioning on the
replacement unit. Contact Nellcor at the phone
numbers listed below and see the attached for
replacement speakers and/or service.
Mandatory; Priority A Nellcor595Jan05.pdf

Not
5.9.3 Medtronic (ICD) and (CRT-D) 1. Within two weeks, identify all affected patients
manufactured between 4/01 and by using all steps a - e: a) The manufacturer’s
12/03, see list., 2/05. letter available from the local Medtronic
representative b) List obtained from Medtronic
available from Dr. Ed Keung, Director of VA
National ICD Surveillance Center (see attached
Medtronic Implantable Cardioverter- letter from VA National ICD Surveillance Center)
Defibrillator (ICD) and Cardiac c) VA National ICD Surveillance Center Registry
Resynchronization Therapy at https://icd.sanfrancisco.med.va.gov d) VA
Defibrillator (CRT-D), Models and National registry for ICD implants Washington
batteries manufactured between 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 first–priority 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.
Mandatory; Priority A MedtronicICDsCRT-DsFeb05.pdf

Not
5.9.4 Spacelabs Medical Monitor, model 1. Immediately identify and locate all monitors
90385 Universal Clinical Workstation affected by this notice.
(UCW), 2/05, (
2. Inspect the monitors to see if they have been
upgraded by: a. Looking for a label on the bottom
of the monitor that reads either “Part No. 010-
Affected 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.
Mandatory; Priority A SpacelabsUCWAlertFeb05.pdf

Not
5.9.5 Louvered heating, ventilating, and air 1. Survey all locked Behavioral Health Units to
conditioning (HVAC) grilles in locked determine if louvered grilles are present that may
Behavioral Health Units, 2/05 (AL05- be used as an anchor point.
06)
2. If louvered grilles are present in these
Behavioral Health Units upgrade them by
installing a woven wire cloth grille or replace
Louvered grilles covering HVAC them with a suitable grille that cannot be used 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.
Mandatory; Priority A LouveredHVACGrilleFeb28.pdf

5.9.6 LIFEPAK 12 Defibrillator/Monitors 1. Within 48 hours, identify all LIFEPAK 12
with Adaptive Biphasic technology, biphasic defibrillators deployed at your facility.
all units, man'f'd by Medtronic, 3/05
(AL05-07) 2. Check user settings to verify they are
configured for what your facility protocol requires:
Step–by–step directions, Basic directions are
included in the enclosed notice from Medtronic,
Units that have undergone a Detailed directions are included in the user’s
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.
Mandatory; Priority A LP12BiphasicAlertMarch05.pdf

Not
5.9.7 CPRS National Drug File V 4.0 1. Check with your IT/computer service (IRM) to
Adverse Reaction Tracking, 3/05 determine if your facility is affected -- Data
(AL05-08) Updates PSN*4*95 and PSN*4*97 installed.
2. If your facility is affected, notify all clinical users

(e.g. clinicians, pharmacists) that the allergy
Clinicians at facilities that recently tracking software is not functional and requires
installed National Drug File (NDF) providers to assure that new orders entered for
Data Updates PSN*4*95 and patients are checked manually against the current
PSN*4*97 may not be notified of allergy history until this is resolved.
drug allergies and will be unaware
that the allergy check was not 3. Do not uninstall these Data Updates or it may
completed. adversely affect other programs in the system.
4. If your facility has not installed Patches

PSN*4*95 and PSN*4*97 do not install until
further guidance is issued from the Office of
Information.
Mandatory; Priority A NationalDrugFile031105.pdf

Not
5.9.8 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)...
Mandatory; Priority A VailBedMarch2005.pdf

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
3/05 (AL05-09) rails visually confirm that the side rails and the
bolsters at the head and foot are up and properly
latched, except when patient is entering or exiting
the bed, or if the caregiver needs access to the
Models: 500, 1000, and 2000, FDA patient. (Side rails should be up at all other times
issued recommendations for users as a patient can get their head between the
based on cited safety problems. 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
Mandatory; Priority A VailBedMarch2005.pdf

Not
5.9.9 VistA Imaging v3.0 versions released 1. Advise clinicians who view EKGs to verify that
since 10/1/03 patch MAG*3.0*24, the “Show MUSE EKGs” option under Options >
4/05 (AL05-10) View Preferences is enabled (the box is
checked), and that they should not disable it.
2. Advice clinicians to check the patient’s name

In certain situations, the VistA on an EKG viewed via the VistA Imaging Display
Imaging Display EKG viewer window application to be sure that the name and EKG
will not update properly when a correspond to the current patient in CPRS.
clinician views an EKG. Rather than
showing the current patient, the EKG
viewer window will continue to show
the previous patient, it is possible
that the clinician will miss this
information and proceed to reading
and acting on the EKG for the wrong
patient.
Mandatory; Priority A VistAImagingDisplayEKGApril05.pdf

5.9.10 CM 100-Heartstart Adapter Cable 1. Immediately (within the next 24 hours) remove
man'f'd by Laerdal Medical Corp, CM 100-Heartstart Adapter Cable from service
5/05, (AL05-10). and inventory.
2. Assure replacement cable from another source

is available for each defirillator where the 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.
Mandatory; Priority A LaerdalAdapterCables.pdf

Not
5.9.11 Blood glucose meters, models 1. Diabetes educators, outpatient pharmacists,
OneTouch, Ultra, InDuo, and and other cliniciansinvolved in diabetes
OneTouch FastTake man'f'd by management must be notified about the design
LifeScan, Inc., 5/05 (AL05-11). vulnerabilities of LifeScan devices.
2. Clinicians with diabetes patients using

LifeScan must: a) No later than the next visit,
LifeScan has received reports of confirm with all diabetes patients that their
adverse events related to the device glucose meter is properly set up with mg/dL, 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.
Mandatory; Priority A LifeScanOneTouchAlertMay2005.pdf

Not
5.9.12 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 high- Surveillance 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 company’s 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)...
Mandatory; Priority A GuidantICDAlertJune2005.pdf

Not
5.9.12 (continued)... Guidant Model 1861 ...(continued) Within the next 45 calendar days,
(continued) Ventak Prizm 2 DR, ICDs interrogate all Guidant Model 1861 ICDs for “no
manufactured before November telemetry” or “warning screen” conditions. These
2002, 6/05, (AL05-013) conditions indicate that the ICD may be
inoperative. If one of these conditions is present,
replace with a suitable new device. a) If the
interrogation of the Guidant model 1861 ICD does
An unpredictable breach of an not reveal a problem, the patient should be
insulator in the device. This insulator followed at the manufacturer’s recommended
defect could result in at least partial intervals of every 3 months. However patients
diversion of current in the high- should be instructed to return immediately for
voltage output circuitry, thereby device interrogation following any shock delivery,
preventing the device from delivering and ICD replacement should be considered at
high-voltage shock therapy when that time.
ventricular tachycardia or fibrillation
is detected. 3. Follow the actions contained in Attachment 2.
This guidance was prepared by Dr. Edmund
Keung of the VA National ICD Surveillance
Center as the best course of action for your
patients.
Mandatory; Priority A GuidantICDAlertJune2005.pdf

5.9.13 Smiths Medical, Fast Flow Fluid 1. Promptly (within one week) check local
Warmer Models 250, 500 and 1000, inventory to identify all units affected by this Alert
6/05 (AL05-14) and institute recommended practices to minimize
risk (attached) for all users of Smiths Medical
Fast Flow Fluid Warmers, models 250, 500 and
1000.
Hospitals in Australia report serious
patient injury from intravascular air 2. Procure and install the Smiths Medical
embolisms introduced while using accessory Air Detector/Clamp, model H-31 that is
the Smiths Medical fluid warmers designed to reduce the risk of air embolism
identified in this Alert. introduction while using the Smiths Medical Fast
Flow Fluid Warmers, models 250, 500 and 1000.
Mandatory; Priority A SmithsMedicalFluidWarmerJune2005.pdf

Not
5.9.14 Guidant Corporation recalls 1.Within two weeks, electrophysiology/cardiology
additional models (update to PS Alert staff or other appropriate caregivers must identify
AL05-013 dated 6/8/05), 7/05 (AL05- all affected patients by implementing each of the
15) following steps a through d. It is important that
insure that patients will not be missed, as they
may be found on one list and not on another.
Additional models of Implantable
Cardioverter-Defibrillators (ICD), and a) Review the manufacturers letters (See Links
has added Cardiac below).
Resynchronization Therapy
Defibrillators (CRT-D) to the recall b) Review the patient list posted on the VA
list. These devices can develop an National ICD Surveillance Center intranet website
internal short circuit without warning, (https://icd.sanfrancisco.med.va.gov). This list,
resulting in failure to deliver a shock provided by Guidant, consists of all VA patients in
when needed. In addition, Guidant the company’s database that have an implanted
sent letters to physicians notifying Guidant device affected by this recall. Double
them that identified models of Atrial check by providing name of your facility and
Therapy devices (AVT) and CRT-D implant physician’s name. (See attachment 2)
devices will require reprogramming.
c) Review the VA National registry for ICDs and
ICDs (FDA Class I Recall) Guidant CRT-R implants, Washington VAMC, point of
Ventak Prizm 2 DR, Model 1861, contact is Ronald.Jones1@va.gov.
Implantable Cardioverter-
Defibrillators (ICDs) manufactured d) Review your patient records for all patients
before April 16, 2002,CRT-Ds (FDA with implanted Guidant devices affected by this
Class I Recall) Guidant Contak (continued)...
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 II Recall) Guidant Ventak
Mandatory; Priority A GuidantICDsCRTsUpdateJuly05.pdf

Not
5.9.14 (continued)... Guidant Corporation ...(continued) recall.
(continued) recalls additional models (update to
PS Alert AL05-013 dated 6/8/05), 2.Within the next 45 calendar days, interrogate all
7/05 (AL05-15) affected ICDs and CRT-Ds devices for:
a) Loss of telemetry/programming/interrogation.
Additional models of Implantable b) Loss of tachyarrhythmia detection and therapy

Cardioverter-Defibrillators (ICD), and delivery
has added Cardiac
Resynchronization Therapy c) Loss of pacing therapy.
Defibrillators (CRT-D) to the recall
list. These devices can develop an d) Programmer display of a red warning screen
internal short circuit without warning, upon attempted device interrogation.
resulting in failure to deliver a shock
when needed. In addition, Guidant e) Programmer display of yellow warning screen
sent letters to physicians notifying indicating out of range shocking impedance.
them that identified models of Atrial
Therapy devices (AVT) and CRT-D f) Corrective reprogramming in the appropriate
devices will require reprogramming. models.
ICDs (FDA Class I Recall) Guidant Conditions a) to e) indicate that the affected
Ventak Prizm 2 DR, Model 1861, device may be inoperative. If one or more of
Implantable Cardioverter- these conditions is present, replace with a
Defibrillators (ICDs) manufactured suitable new device.
before April 16, 2002,CRT-Ds (FDA
Class I Recall) Guidant Contak 3. If If the interrogation of the affected device
Renewal, Model H135, Cardiac does not reveal a problem, the patient should be
Resynchronization Therapy followed at the manufacturer’s recommended
Defibrillators (CRT-D) manufactured intervals of every 3 months. However, patients
on or before August 26, should be instructed to return immediately for
2004,Guidant Contak Renewal 2, device interrogation following any shock delivery,
Model H155, Cardiac and affected device replacement should be
Resynchronization Therapy considered at that time.
on or before August 26, 2004,AVTs 4. Follow the actions contained in Attachment 1.
(FDA Class II Recall) Guidant Ventak
This guidance was prepared by Dr. Edmund
GuidantICDsCRTsUpdateJuly05.pdf

Not
5.9.15 Depression Screening for Veteran 1. All clinical and administrative services that may
Patients Recently Separated from be involved with treating recently separated
Active Military Duty, 1/05 veterans should review the current policy, or
standard operating procedure (SOP) addressing
depression or suicide prevention screening for
Veterans recently separated from active military
Depression screening for recently duty. (If this policy or SOP does not exist it should
separated Veterans may increase be developed.)
early identification of possible
psychiatric problems and/or 2. Refer to the websites, information letter and
suicidality. video identified in this advisory, then provide
pertinent information to any and all interested
inpatient and outpatient clinical and administrative
services.
3. Ensure that discharge planning for patients

treated for depression and/or suicidality includes
information - - or direct referral, as needed - - to
mental health services available in or near their
home community (e.g., address, phone number,
point of contact, fee arrangements, etc.).
Recommended; Priority A DepressionScreeningAdvisoryJan05.pdf

Not
5.9.16 CPRS - Transferring Outpatient Notify all users, when transferring medications
Medication Orders to Inpatient from Outpatient to Inpatient, using the Medication
Medication Orders, 6/05 (AD05-14) Screen in CPRS; they need to scroll down,
whenever text appears in the first line of the
information box, until the patch is installed.
When the “Transfer to” function,

located in the Medications Tab in
CPRS, is used to transfer existing
outpatient mediation orders to
inpatient orders, it can present
clinicians with an order dialog that
does not display dosing information.
There are limited visual clues to
direct the user to the fact that
additional critical information is
available.
Recommended; Priority A CPRSAdvisoryOutpatientMedstoInpatientMeds.pdf

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

System 1 to reprocess Olympus 180 series
endoscopes.
2) Immediately begin to follow manufacturer’s

(Olympus) recommended instructions to manually
clean and sterilize the 180 series scopes. Refer
to Olympus Reprocessing Manual, Instructions
for Evis Exera II Gastrointestinal Videoscope and
Colonovideoscope Type 180 series.
3) By close of business October 14, 2005, tag or

label Olympus 180 series endoscopes to remind
staff not to use the Steris System 1 for
reprocessing this model until a quick connect
harness for this scope is available.
Mandatory; Priority A SterisQuickConnectOlympusAlert Oct 10 05.pdf

Not
5.9.18 MEDRAD Stellant CT Injector Heat maintainers for Stellant CT Injector
Systems, 11/05, (AL06-04). Systems, manufactured by MEDRAD, Inc. Part
numbers for the heat maintainers are 3007871,
3007872, 3009707 and 3009708. (Note: Part
numbers for the Stellant injector systems are
The manufacturer reports the heat 3007301, 3010432, 3007300 and 3010091.)
maintainers used on the Stellant
injector systems may malfunction
and overheat the syringe and
contrast media. Action: Respond to MEDRAD's letter dated
10/12/05 to determine if you have the affected
heat maintainer.
Mandatory; Priority A MEDRADStellantCT Nov 01 05.pdf

Not
5.9.19 Injector connector relays on patient The manufacturer reports failures of Injector
tables, 12/05, (AL06-06) connector relays for the table models listed,
although none are reported in VA. If a relay fails,
high voltage can be present on a pin of the
exposed injector connectors, placing patients 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.
Mandatory; Priority A PhilipsTableAL06-06 Dec 21 05.pdf

Not
5.9.20 LEDI III Lab Electronic Data 1. The Laboratory ADPAC or other qualified
Interchange, 8/05, (AL05-016). individuals must review the laboratory test setups
to identify those tests using "set of codes."
VistA Laboratory Package, patch

LR*5.2*286 2. By close of business (COB) Tuesday, August
30, 2005: If any lab test used "set of codes" and
the site recognizes that they now need to modify
the set up, they should make the modifications or
A VHA facility recently reported that seek assistance by logging a Remedy ticket with
critical flags were not being set for National Help Desk.
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 3. By COB Friday, September 9, 2005: Once
made the proper modifications and modifications/corrections have been made, the
taken necessary actions, this Patient site needs to review the historical data from the
Safety Alert is issued to alert other time the patch was installed (January 2005, or
sites that may be affected. eariler if you were a test site) to present date to
determine potential critical flag omissions. If
there were critical flag omissions in the historical
data, the site needs to review the comment field
to see if the critical value was recognized and
called to the attention of the provider as required
by the College of American Pathologists and VHA
Directive 2003-043.
4. If critical flag (continued)...
Mandatory; Priority A LEDI-IIIPatch Aug 26 05.pdf

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,
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
VistA Laboratory Package, patch Service.
LR*5.2*286
5. By COB Monday, September 12, 2005:

A VHA facility recently reported that Identify and report, to the Patient Safety
critical flags were not being set for Manager, the number of patients that were not
positive tests of hemocult. As a notified of positive test results since implementing
result, over 200 positive tests for the patch, along with the date all patients will be
hemocult did not trigger a flag to alert notified. If your facility is not impacted, submit a
providers. Although the site has negative report. The Patient Safety Manager
made the proper modifications and should report this information to the Network
taken necessary actions, this Patient Patient Safety Officer who will report this
Safety Alert is issued to alert other information to the National Center for Patient
sites that may be affected. Safety, attention Joe DeRosier/Lori King.
Mandatory; Priority A LEDI-IIIPatch Aug 26 05.pdf

Not
5.9.21 Sulfa Allergy Order Checks, 12/05, By close of business (COB) 12/28/05, the
(AL06-07) Pharmacy ADPAC (or designee) must edit the
Message filed in the Drug file (50) to display the
following message for each of the drugs shown in
Attachment #1:
VistA allergy file (120.8) - Certain
drug classes are not currently
generating order checks for patients
with a documented allergy. MESSAGE: "SULFA cross drug classes may
NOT trigger an ORDER CHECK" (refer to screen
shot below).
This message is intended to alert clinicians that a

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

Not
5.9.22 Hospira LifeCare PCA3 Infustion 1. Notify clinicians of this programming
Pumps List No: 12384-04, 11/05, vulnerability and include this information in all
(AD06-02). training sessions (e.g., in-service, orientation)
conducted on this PCA infusion pump.
Hospira Inc. has identified two

potential scenarios that may lead to 2. Also, clinicians must use the clear key "CLR"
incorrect medication flow rates being prior to changing a value, and use the
entered into this model of PCA pump confirmation screen to assure that values that
that could result in an adverse have been entered in fact have been accepted by
medication event. To date, there the device.
have been no reported adverse
events associated with either
scenario.
Scenario 1: Enter a number for

dose, dose limit, rate or
concentration, without pressing
"ENTER" to accept the value; Press
either the "History" key or
"Silence/Volume" key, scroll through
history or silence/volume and reenter
the programming screen; Press a
number key to change the value
previously entered for dose, dose
limit, rate or concentration. NOTE:
Taking these steps will not overwrite
the original value of dose, dose limit,
rate or concentration, but rather, will
increase the original value by adding
additional digits. For example, if a
"1" was originally entered and then a
"5" was entered after reentering the
programming screen, the value
Recommended; Priority A HospiraPCA3Advisory Nov 29 05.pdf

Not
5.9.23 VA Drug Class Allergy Entry, 11/05, 1. Clinical staff should be reminded NOT to
(AD06-01). select the ingredient file from CPRS GUI allergy
entry process or directly through VistA CHUI
interface, unless there is a specific reason to use
an ingredient level entry. A cognitive aid could
VistA package allergy file (120.8) help clinical staff to remember this when entering
may have allergy entries that have allergens.
been accidentally entered without a
VA drug class - when a drug class
entry was appropriate.
2. Medication administration records and patient
charts can be used to review allergy information
until this issue is resolved (see Addl. Information
A patient had a drug allergy entered below).
into VistA in 1997 prior to
implementing CPRS. The allergen
cephradine was selected as being an
ingredient of a product, versus a 3. In the interim, any specific concerns should be
drug, and therefore no VA drug class addressed to the OI National Help Desk, who will
was assigned to that entry. Years set up a remedy ticket to assist you with any
later, a provider ordered cefazolin - a issue.
drug in the same drug class as
cephradine, but not the exact
ingredient as cephradine. No allergy
warning occurred because ingredient
level warnings only occur if there is
an exact item match. The patient
received the cefazolin.
Recommended; Priority A DrugClassIngredientAllergies Nov 17 05.pdf

Not
5.9.24 St. Jude Medical Implantable 1. By the close of business (COB) Monday,
Cardioverter Defibrillators, 11/05, November 28, 2005: electrophysiology/cardiology
(AL06-05) staff or other appropriate parties must identify all
affected patients by implementing each of the
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 colleagues as the follow-up physician.
V-194/V-232) and Atlas VR/DR
(Models V-199/V-240) units. St. A. Review the manufacturer's letter (See Links
Jude Medical (SJM) reported 60 below).
failures out of 36,000 devices
(0.167%) with no serious patient B. Review the patient list posted on the VA ICD
injuries or death. The cause of this Surveillance Center intranet website
failure mode has been identified as (https://ICD.sanfrancisco.med.va.gov). It consists
cosmic radiation damage to a of a list of VA patients provided by SJM. The
vendor-supplied static random SJM list is made up of all the VA patients in the
access memory (SRAM) chip in company's databse that have an SJM device
these ICDs. implanted at a VA facility and are affected by this
recall. (See Attachment 2)
C. Review your patient records for all patients

with implanted SJM devices (continued)...
Mandatory; Priority A SJM_ICDAlert Nov 15 05.pdf

Not
5.9.24 (continued)... St. Jude Medical ...(continued) affected by this recall.
(continued) Implantable Cardioverter
Defibrillators, 11/05, (AL06-05)
2. By COB Wednesday, December 15, 2005:

interrogate all affected devices for: Hardware
Temporary loss of pacing function Reset Mode. If the device is in the Hardware
and permanent loss of tachycardia Reset Mode, acing at VVI at 60 ppm and no
detection may occur in selected tachycardia detection and theraphy, replace the
Photon DR (Model V-230HV) and all device with a suitable new device immediately.
Photon Micro VR/DR (Model
V-194/V-232) and Atlas VR/DR
(Models V-199/V-240) units. St.
Jude Medical (SJM) reported 60 3. Follow the actions contained in Attachment 1.
failures out of 36,000 devices This guidance was prepared by Dr. Edmund
(0.167%) with no serious patient Keung, Director of the VA ICD Surveillance
injuries or death. The cause of this Center, and details the best course of action for
failure mode has been identified as your patients.
cosmic radiation damage to a
vendor-supplied static random
access memory (SRAM) chip in
these ICDs.
Mandatory; Priority A SJM_ICDAlert Nov 15 05.pdf

Not
5.9.25 Insignia and Nexus Implantable 1. By close of business (COB) Monday,
Cardiac Pacemakers manufactured November 7, 2005: electrophysiology/cardiology
by Guidant Corp, 10/05, (AL06-03) staff or other appropriate parties must identify all
affected patients by implementing each of the
following steps a through d. It is important that
Guidant Corporation is voluntarily insure that patients will not be overlooked, as
advising physicians, by letter about affected patients may be found on one list and
two separate failure modes within the not on another.
INSIGNIA and NEXUS families of
cardiac pacemakers. One or more of A. Review the manufactuer's letters (See Links
the following malfunctions may below).
occur:
B. Review the patient list posted on the VA
- Intermittent or permanent loss of Western Pacemaker Surveillance Center intranet
pacing output without warning; website
(https://pacemaker.sanfrancisco.med.va.gov).
- Intermittent or permanent loss of This list combines the patients with the affected
telemetry; devices that are already being followed via TTM
by the VA Western Pacemaker Surveillance
- Reversion of VVI mode or Center with a list of VA patients provided by
appearance of a reset warning Guidant. The Guidant list consists of all the VA
message upon interrogation patients in the company's database that have a
Guidant device implanted at the VA facility and is
affected by this recall. (See Attachment 2)
First Failure Mode: May occur in C. Review the VA National (continued)...

selected Insignia and Nexus
implanted units. Guidant reported 36
failures out of 49,500 devices
(0.073%). Seven (7) of these
devices were found to exhibit no
output during the implant
procedures. For the remaining 29,
the majority of failures occurred early
in life (mean implant time of 7
months). This failure mode exhibits GuidantInsigniaNexusPacemakers Oct 24 05.pdf

Not
5.9.25 (continued)... Insignia and Nexus ...(continued) registry for pacemaker implants and
(continued) Implantable Cardiac Pacemakers the VA Eastern Pacemaker Surveillance Center,
manufactured by Guidant Corp, Washington DC VAMC, point of contact is
10/05, (AL06-03) Ronald.Jones1@va.gov.
D. Review your patient records for all patients

with implanted Guidant devices affected by this
Guidant Corporation is voluntarily recall.
advising physicians, by letter about
two separate failure modes within the
INSIGNIA and NEXUS families of
cardiac pacemakers. One or more of 2. For first Failure Mode only: By COB Friday,
the following malfunctions may November 25, 2005: interrogate all affected
occur: devices for:
- Intermittent or permanent loss of A. Intermittent or permanent loss of pacing

pacing output without warning; output without warning;
- Intermittent or permanent loss of B. Intermittent or permanent loss of telemetry;

telemetry;
C. Reversion to VVI mode or appearance of a
- Reversion of VVI mode or reset warning message upon interrogation with a
appearance of a reset warning programmer.
message upon interrogation
If one or more of these conditions are present,
replace the device with a suitable new device
immediately.
First Failure Mode: May occur in
selected Insignia and Nexus
implanted units. Guidant reported 36
failures out of 49,500 devices 3. Follow the actinos contained in Attachment 1.
(0.073%). Seven (7) of these This guidance was prepared by Dr. Edmund
devices were found to exhibit no Keung, Director of the VA Western Pacemaker
output during the implant Surveillance Center, and details the best course
procedures. For the remaining 29, of action for your patients.
the majority of failures occurred early
in life (mean implant time of 7
Mandatory; Priority A GuidantInsigniaNexusPacemakers Oct 24 05.pdf

Not
5.9.26 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.
Mandatory; Priority A VistABatchDataEntryDeltaChecks Oct 11 05.pdf

Not
5.10.1 Physician Advisory issued by Medtronic is reporting 19 failures out of 38000
Medtronic Inc. on the Sigma Series devices (0.05%) due to: loss of rate response;
single and dual chamber premature battery depletion; intermittent or total
pacemakers, 1/06. (AL06-08). loss of telemetry; or loss of pacing output in the
identified Sigma pacemaker units. The cause of
the failure has been identified as separation of
(i.e. loss of contact) redundant interconnection
The Sigma Series single and dual wires from the hybrid block in the pacemaker
chamber pacemakers include: circuit.
SD203, SD303, SDR203, SDR303,
SDR306, SVDD303, SS103, SS106,
SS203, SS303, SSR203, SSR303,
SSR306, SVVI103.
Recommended; Priority A MedtronicSigmaAL Jan 09 06.pdf

5.10.2 Patient Pump Pain Management Baxter reports incidents of unrequested patient
Systems manufactured by Baxter doses delivered due to the following:
Healthcare Corp, 01/06, (AD06-03).
Damaged PCA patient cord/button;
Partial button sticking; and

Products include Ipump Pain Mgmt
System, APII Infusion Pump and Fluid in the pump or PCA button.
PCA II Infusion Pump.
The unrequested bolus doses do not exceed the
programmed total prescription limits.
Although Baxter has identified approximately 50

VAMCs affected by this notice, none of the
reported incidents are in VHA.
Recommended; Priority A BaxterPCAAD06-03 Jan 10 06.pdf

Not
5.10.3 Cessation of Topical Spray Affected products include, but are not limited to:
Benzocaine Usage in topical
anesthetization, 2/06, (AL06-09). Hurricaine®Spray (benzocaine 20%)
Cetacaine®Spray (benzocaine 14% butyl

aminobenzoate 2% and tetracaine 2%)
Specific use of Topical Spray
Benzocaine to Anesthetize the Topex® Spray (benzocaine 20%)
Surfaces of the Nasopharynx,
Oropharynx, Laryngotracheal Region
and Airway.
Several cases have been reported where
benzocaine used as a topical anesthetic on the
surfaces of the nasopharynx, oropharynx,
laryngotracheal region, and airway has resulted in
severe, and in some cases fatal,
methemoglobinemia (MHb).
Mandatory; Priority A Benzocaine-WWW Feb 08 06.pdf

5.10.4 Alaris IV Tubing sets, mfd by Several VA facilities report failures when loading
Cardinal Health, Alaris Products, administration sets in Alaris Signature series
3/06. (AL06-10). infusion pumps. The sets are difficult to load,
and, when they do load, may malfunction or
become occluded.
This includes commonly used

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

Not
5.10.5 Mix-up (wrong route of Since 2001, VA facilities have reported five cases
administration) of bladder irrigation of accidental infusion into an IV line or PICC line.
with intravenous (IV) infusions, 4/06, Amphotericin B (See Attachment #1, Patient
(AL06-012). Safety Alert AL06-012) was given intravenously
when it was intended for irrigation of the bladder
via a catheter. The same adverse event could
occurr with Glycine. Amphotericin B and Glycine
are both contraindicated in patients with kidney or
liver disease and when Amphotericin B is infused
via IV line, it can induce serious complications
(e.g., kidney failure.)
Mandatory; Priority A AmphoBladderIrrigationAlert Apr 06 06.pdf

5.10.6 Transrectal ultrasound transducer During patient safety rounds in the Urology Clinic
assembly, manufactured by B-K at the reporting facility, the lumen of a needle
Medical Systems, Inc., 4/06 (AL06- guide of a reprocessed (i.e., ready to be used for
011) a procedure) reusable B-K Medical transrectal
ultrasound transducer assembly was found to be
soiled. Upon investigation, it was discovered that
brushes were not being used to clean the lumen
Specific models are 8808 and 8551, of the needle guide.
and are manufactured by B-K
Medical Systems, Inc., Wilmington,
MA.
Mandatory; Priority A B-KMedicalTransducerAlert06-011 Apr 03 06.pdf

Not
5.10.7 Transfilling liquid oxygen from a Specific Incident: A VA facility reports a fire
liquid oxygen Dewar to a portable erupted during the transfilling of liquid oxygen
oxygen container., 03/06 (AD06-04) from a Dewar to a portable container resulting in
property damage and the unscheduled relocation
of several patients; there were no injuries.
General Information: Liquid oxygen stored in

Dewars can be transferred to smaller portable
containers for use by patients as a matter of
convenience. Patients can have smaller portable
oxygen containers filled at the healthcare facility
enabling them carry up to an eight-hour supply of
oxygen. The process of transferring the liquid
oxygen from the Dewar to fill the portable oxygen
container is commonly referred to as transfilling.
The
transfilling of liquid oxygen from one container to

another presents a potential hazard due to the
oxygen enriched atmosphere in the vicinity that
makes it easier for flammable material to ignite
and burn more vigorously. Materials not normally
considered combustible might burn in an oxygen
enriched atmosphere.
Recommended; Priority A O2TransfillingAD06-04.pdf

Not
5.10.8 Oxygen Regulator Fires Resulting 1. Never use plastic crush gaskets.
from Incorrect Use of CGA 870
Seals., 05/06, (AD06-05) 2. Instead always use the sealing washer
specified by the
regulator manufacturer.
Specific Incident: FDA has received
12 reports in which regulators used (Note: While FDA accepts using crush gaskets,
with oxygen cylinders have burned or VHA believes the
exploded due to suspected improper
use of gaskets/washers. None of fire risk of reusing them outweighs the additional
these reports involve VA facilities. expense of using sealing washers.)
The incidents are related to the
reuse of single-use gaskets. 3. Always “crack” cylinder valves (open the valve
just enough to
allow gas to escape for a very short time) before

General Information: Two types of attaching regulators in order to expel foreign
washers, or CGA 870 seals, are matter from the outlet port of
commonly used to create the seal at
the cylinder valve / regulator the valve.
interface. The type required by many
regulator manufacturers is a metal- 4. Always inspect the regulator and CGA 870 seal
bound elastomeric sealing washer before
that is designed for multiple use
applications. The other common attaching it to the valve to insure that the
type, often supplied free-of-charge regulator and seal are in good condition and the
with refilled oxygen cylinders, is a regulator is equipped with only one integral metal
plastic crush gasket suitable for and rubber seal that is in good condition.
single use applications.
5. Tighten the T-handle firmly by hand, but do not
use wrenches
or other hand tools that may over-torque the

handle.
6. Open the post valve slowly, while maintaining a
O2SealsAD06-05.pdf

Not
5.10.9 Renewing medications using Specific Incident: After installing OR*3*215
Computerized Records System (CPRS GUIv26) a VA medical center reports that
(CPRS), version 26., 05/06, (AL06- providers noticed renewed medications are not
13). showing up on their signature list. It’s been
discovered CPRS v26 contains a change to the
default action for completing the Outpatient
Medication and Inpatient Medication ordering
dialogs. In v25, the “OK” button is the default
choice. In
v26, “CANCEL” is the default choice. Pressing

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

(OR*3*215) until this issue is corrected.
2. If patch OR*3*215 is already installed,

implement the following immediately to assure
medications are (continued)...
CPRSv26MedrenewAL06-13.pdf

Not
5.10.9 (continued)... Renewing medications ...(continued) properly renewed.
(continued) using Computerized Records System
(CPRS), version 26., 05/06, (AL06- a. Providers must review the medications being
13). renewed and validate they are displayed upon
electronic signature.
b. For Inpatient medication orders, run the

‘Inpatient Stop Order
Notices’ [PSJ EXP] that provides information of

expired medication orders and/or medication
orders nearing expiration. This VistA option is
available within the Unit Dose Medications menu.
c. Do not uninstall patch OR*3*215 (CPRS

GUIv26), if your facility has already installed.
CPRSv26MedrenewAL06-13.pdf
5.10.10 Boston Scientific Corp (AL06-14), These products are manufactured by the
recalling a subset of devices that Company's Cardiac Rhythm Management (CRM)
includes INSIGNIA and NEXUS Group, formerly Guidant's CRM business.
pacemakers 06/06 Boston Scientific acquired Guidant on April 21,
2006.
Also includes CONTAK RENEWAL

TR/TR2 cardiac resynchronization Boston Scientific/Guidant has recently confirmed
therapy (CRT) pacemakes, and five (5) reports of device malfunction associated
VENTAK PRIZM 2 VITALITY and with the failure of a low voltage capacitor. This
VITALITY 2 implantable cardioverter may lead to a device malfunction, including
defibrillators (ICDs.) intermittent or permanent loss of therapy, or
premature battery depletion.
Mandatory; Priority A BostonScientificImplantableAL06-14.pdf

Not
5.10.11 Sealed Lead-Acid Batteries for A VA medical center reports multiple external
External Defibrillators (AL06-15) defibrillators not functioning properly on battery
mode after a limited number of discharges
although the internal batteries were fully charged.
Upon further investigation it was discovered that
Sealed, lead-acid batteries for the second source batteries contain internal
external defibrillators supplied by thermal breakers and heat generated by the
non-OEM (Original Equipment battery
Manufacturer) or second source
suppliers. Second source suppliers after a limited number of discharges can trip the
include Alpha Source, Anybattery, thermal breaker, temporarily disabling the
R&D Batteries and Unipower, among defibrillator until the battery cools.
others.
Actions:
1. By close of business July 25, 2006 identify

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

internal thermal breaker, replace it with a battery
acquired directly from the defibrillator
manufacturer (OEM), or if a second source

battery is to be used, ensure that no thermal
breaker is employed.
Mandatory; Priority A Defibrillator Batteries AL06-15.pdf

Not
5.10.11 (continued)... Sealed Lead-Acid ...(continued) a replacement battery is not
(continued) Batteries for External Defibrillators available:
(AL06-15)
(a) Instruct users and code response teams to
plug in the defibrillator during a code if the
defibrillator appears to fail to charge and
Sealed, lead-acid batteries for discharge normally (temporary signage can
external defibrillators supplied by assist).
non-OEM (Original Equipment
Manufacturer) or second source (b) Assure code team defibrillators are equipped
suppliers. Second source suppliers with a fully charged spare battery.
include Alpha Source, Anybattery,
R&D Batteries and Unipower, among
others.
Mandatory; Priority A Defibrillator Batteries AL06-15.pdf

Not
5.10.12 Shutdown of Donor Referral Services At this time it has been determined that tissue
(DRS) Tissue Harvesting Co by FDA from DRS was sold or distributed to:
(AD06-06)
• Alamo Tissue Services of San Antonio, Texas

FDA issued an order to Donor
Referral Services (DRS) of Raleigh, • Bonebank Allographs, San Antonio, TX
North Carolina, to “cease
manufacturing and to retain human • DCI, Nashville, TN
cells, tissues, and cellular and tissue-
based products (HCT/Ps)", due to • Global Orthopedic, Ellisville, MS
violations of Good Manufacturing
Practices (GMP). • Lost Mountain Bank of Kennesaw, Georgia
• Neuro Tec, Marietta, GA
• US Tissue (AlloSource) of Cincinnati, Ohio and

Salt Lake City, Utah
• Tissue Management Solutions, Scottsdale, AZ
• Tissue Net of Orlando, Florida (may have

received from US Tissue (AlloSource) of
Cincinnati)
• West Coast Medical, Seattle, WA
Recommendations:
a) Verify if your facility has purchased the human

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

Not
5.10.12 (continued)... Shutdown of Donor ...(continued) sources to replace the affected
(continued) Referral Services (DRS) Tissue products.
Harvesting Co by FDA (AD06-06)
d) If alternative sources are not immediately
available, the physicians should assess the
impact of denying use of this product against the
FDA issued an order to Donor patient’s medical outcome.
Referral Services (DRS) of Raleigh,
North Carolina, to “cease e) Individuals who have received this material will
manufacturing and to retain human likely need notification and patient call back for
cells, tissues, and cellular and tissue- testing once it is determined that they have
based products (HCT/Ps)", due to received the recalled material. Refer to VHA
violations of Good Manufacturing Directive 2005-049 “Disclosure of Adverse Events
Practices (GMP). to Patients.”
Recommended; Priority A DRS tissue AD06-06.pdf

Not
5.10.13 Alaris® SE infusion pumps (AL06-16) 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
All models of Alaris® SE infusion in over infusion. Key bounce occurs when a
pumps - formerly the Signature keyboard entry registers twice while pressing the
key once. For example, an infusion rate intended
Edition® Infusion System. Alaris is a to be 4.0 mL/hr where a key bounce occurs,
subsidiary of Cardinal Health, Inc. results in an entry of 44.0 mL/hr.
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 the software by always selecting “New
Alaris SE Keyboard AL06-16.pdf

Not
5.10.13 (continued)... Alaris® SE infusion ...(continued) your Alaris infusion pumps do not
(continued) pumps (AL06-16) have the Guardrails®
software, consider acquiring the software and

implementing in locations where high risk
All models of Alaris® SE infusion medications are used.
pumps - formerly the Signature
4. Assure that clinical staffs who program these
Edition® Infusion System. Alaris is a pumps or any
subsidiary of Cardinal Health, Inc.
programmable medical device visually verify the
intended device setting before beginning
treatment and leaving the area.
Mandatory; Priority A Alaris SE Keyboard AL06-16.pdf

Not
5.10.14 BCMA v3.0 Patch PSB*3.0*13 Four facilities report that BCMA scanners are
(AL06-17) producing an audible sound when nurses scan
certain medications, as expected, but the status
of the medication doesn’t update to “G” (given) on
the BCMA screen. No adverse events 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
wasn’t provided and
medication doesn’t update to “G”
(given) on the BCMA screen. administer it again.
General Information: As identified by the Office of

Information Patient Safety Office this problem is
linked to the installation of BCMA v3.0 Patch
PSB*3.0*13. When using the patch, BCMA will
not update the medication status in the VDL to
“G” (given) following administration of a
medication that (1) has been renewed
and (2) has had special instructions (inserted by

the provider) removed prior to the order being
accepted by Pharmacy. When the status of the
medication is not updated to “G” in the VDL, the
medication will show up (continued)...
Mandatory; Priority A BCMA patch PSB-30-13 AL06-17.pdf

Not
5.10.14 (continued)... BCMA v3.0 Patch ...(continued) on the missed medication report.
(continued) PSB*3.0*13 (AL06-17) Hence, the possibility exists that another
caregiver could administer the medication again
and overdose the patient.
BCMA scanners are producing an

audible sound when nurses scan
certain medications, as expected, but Action: By COB September 14, 2006:
the status of the
medication doesn’t update to “G”

(given) on the BCMA screen. 1. For sites that have not installed BCMA v3.0
Patch PSB*3.0*13 (i.e., those sites who do not
appear on the list shown in Attachment A), the
IRM (or designee) must IMMEDIATELY take
steps to ensure that the patch is NOT installed.
Once completed, there are no further actions for
these sites and sites will be notified when it is
okay to administer the patch.
2. For sites that have already installed BCMA

v3.0 Patch PSB*3.0*13 (i.e., those sites who
appear on Attachment A), DO NOT uninstall the
patch.
Instead, the following actions are to be taken to

minimize the risk to patients while a permanent
solution is developed.
a. Pharmacy must complete the following two-

step process when they delete special
instructions from a pending renewal order, in
order to prevent the null special instructions field
BCMA patch PSB-30-13 AL06-17.pdf

Not
2007 Alerts & Advisors
5.11.1 VistA Imaging Patch MAG*3*18 - This Patient Safety Alert only affects those
VistARad Enhancements (AL07-01). facilities that read MRI images using MAG*3*18.
This problem occurs if these conditions are
present:
A Radiologist reviewing a series of

images from a MRI study discovered
the software presented an 1) The Site is using an MRI device that allows for
incomplete set of images (missing a the creation of a scout (localizer) image using the
slice) for review. The missing slice Referenced Image Sequence field (0008,1140)
almost resulted in a spinal tumor
being missed. The facility was using 2) The operator performing the imaging
VistA Imaging Patch MAG*3*18 procedure chooses to generate a referenced
(released on June 16, 2006) to read image sequence (done at the MRI console).
the images.
If these conditions are present when the exam is

opened using VistARad Patch MAG*3*18, the
image that serves as the scout (localizer) in the
referenced image series is moved out of its
original series in the Viewer window and placed
into the VistARad “Scout Image” window. The
radiologist needs to recognize that the image is
missing and then go to the Scout Image window
to view the image that was removed from the
original series.
This removal of scout images became a known

problem with Patch
MAG*3*18 after the completion of the patch and

prior to its release to the (continued)...
Mandatory; Priority A VistA Rad Patch MAG 318 AL07-01.pdf

Not
5.11.1 (continued)... VistA Imaging Patch ...(continued) field. Therefore the problem was
(continued) MAG*3*18 - VistARad included in the ReadMe.txt file as PROBLEM 7:
Enhancements (AL07-01). “Scout Image problem on MRI exams.”
A Radiologist reviewing a series of Action:

images from a MRI study discovered
the software presented an
incomplete set of images (missing a
slice) for review. The missing slice 1. If you are NOT currently using VistA Imaging
almost resulted in a spinal tumor Patch MAG*3*18 to view MRI images do not
being missed. The facility was using begin to do so until this sequencing problem is
VistA Imaging Patch MAG*3*18 corrected.
(released on June 16, 2006) to read
the images. 2. If VistA Imaging Patch MAG*3*18 is being
used to read MR images complete the following:
a. By close of business (COB) 10/6/2006, make

sure that all radiologists who review MRI studies
read and understand ReadMe.txt file Problem 7
that is included with the Patch.
b. By COB 10/20/2006 assess whether any MRI

studies read using Patch 18 need further
analysis. Clinical judgment must be used in
prioritizing and scheduling studies that need to be
re-read.
Mandatory; Priority A VistA Rad Patch MAG 318 AL07-01.pdf

Not
5.11.2 Incorrect electronic chart associated This problem is not specific to CPRS v26 and
with patient name in CPRS (AL07- BCMA; it was
03).
introduced with CPRS v22.16 (released
December of 2003) and
Clinical orders (e.g. medications, continued with later versions (current version is
progress notes) and other clinical 26.68), and any
data may be inadvertently entered
into VistA for the incorrect patient patient context CCOW-enabled application. The
when the following conditions are BCMA CCOWenabled version (PSB*3*13
present: released August 2006) increased the probability
of this occurring in CPRS.
1) CPRS v26 and BCMA (post install
PSB*3*13) are both open and Action: By close of business (COB) on Monday,
November 27, 2006:
displaying information for the same
patient (e.g., Patient A), and 1. The facility IT support must edit the BCMA
desktop shortcut
2) an action is pending in BCMA
(e.g., critical unviewed information 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 “C:\
Patient” patient selection 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
Mandatory; Priority A CPRS CCOW AL07-03.pdf

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 Note 2: While this CCOW issue is not associated
when the following conditions are with BCMA,
present:
disabling CCOW in BCMA will reduce the
1) CPRS v26 and BCMA (post install probability of sites
PSB*3*13) are both open and
encountering this problem in CPRS and have
displaying information for the same minimal impact to
patient (e.g., Patient A), and
patient synchronization across all other CCOW
2) an action is pending in BCMA enabled
(e.g., critical unviewed information on
the IVP/IVPB tab) for Patient A,, and applications
3) a user attempts to process a

notification for another patient (e.g.
Patient B) via the CPRS “File/Select 2. Once Action 1 has been completed, the facility
Patient” patient selection BCMA Coordinator must advise BCMA users that
CCOW is disabled.
screen pathway, and
3. Clinical Application Coordinators (CACs) or
4) the user selects “Break Link” from designee must inform clinical users to select
the “Problem Changing Clinical Data” “Cancel” instead of “Break Link,” if prompted by a
pop-up window prompt, instead of “Problem Changing Clinical Data” pop-up window
“Cancel” (see Figure 1). (see Figure 1). If ‘Break Link’ is chosen instead of
‘Cancel’, users must immediately close CPRS
and open a new session.
Mandatory; Priority A CPRS CCOW AL07-03.pdf

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

A VA medical facility reported a
Gemini PC series infusion pump
exhibiting free flow while connected 2. As standard practice, operators of medical

to a patient. Upon devices should inspect and conduct operational
checks consistent with manufacturer
examination it was discovered that recommendations on all medical devices before
the free-flow protection latch use. If the device is found to be in need of repair,
it should be labeled as defective, removed from
was broken. Discussions with other service, and sent to biomedical engineering for
VA medical facilities confirm service.
that the free-flow protection latch on

the Gemini PC series infusion
3. For sites using the Gemini PC series referred
pump is prone to breaking and to in this Advisory,
therefore commonly inspected
include inspection of the free-flow protection latch
before each use. 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.
Recommended; Priority A Alaris Gemini PC Latch AD07-01.pdf

Not
5.11.4 VistA Pharmacy Package: use of VA facilities have the flexibility for entering
alpha characters in “Infusion Rate” information into the VistA field titled “Infusion
field, (AD 07-02). Rate” that can lead to misunderstanding of the
infusion rate information. The capability to add
this nomenclature (text followed by @0) has been
available in the VistA system since 1994.
A VA facility pharmacist entered
T@0 in the “Infusion Rate” field to
instruct the pharmacy printer not to Recommendations: Implementation of all the

print labels for an IV morphine following is recommended:
infusion. Caregivers believed that
this abbreviation, which displays on
the BCMA screen, meant that the
medication could be titrated. This 1. Avoid the use of non-standardized
misinterpretation resulted in a abbreviations or nomenclature (e.g. “T”@0) prior
medication misadministration and to the @ symbol.
inaccurate documentation.
2. In the situation where there is a desire to

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

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

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

Not
5.11.4 (continued)... VistA Pharmacy ...(continued) administration of a medication order
(continued) Package: use of alpha characters in is based on a titration, FULL instructions (e.g.
“Infusion Rate” field, (AD 07-02). Titrate@0) AND parameters for titration (e.g.
Infuse at 1ml/hr. May titrate as per protocol to
2ml/hr.) should be included in the “Other print:”
information field (see Attachment A).
A VA facility pharmacist entered
T@0 in the “Infusion Rate” field to
instruct the pharmacy printer not to

print labels for an IV morphine
infusion. Caregivers believed that
this abbreviation, which displays on
the BCMA screen, meant that the
medication could be titrated. This
misinterpretation resulted in a
medication misadministration and
inaccurate documentation.
Recommended; Priority A VistaCPRSBCMATOAD07-02.pdf

Not
5.11.5 Reprocessing of resectoscope During their SPD Healthcare Failure Mode and
system’s working elements (used in Effects Analysis
urology) (AD 07-03)
(HFMEA™) on rigid cystoscopes, a VA Medical
Center identified they were improperly
reprocessing Karl Storz model 27050E
resectoscope working elements. The device
manufacturer’s instructions indicate the working
element cannot be sterilized in a STERRAD®
sterilization system, which was currently being
used for sterilization.
A contributing factor to the improper sterilization

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

reprocessor’s (continued)...
Recommended; Priority A Resectoscope Working Element Reprocessing.pdf

Not
5.11.5 (continued)... Reprocessing of ...(continued) (sterilization)
(continued) resectoscope system’s working
elements (used in urology) (AD 07- equipment – to determine if a device can be
03) reprocessed using their reprocessing equipment
– could also contribute to improper reprocessing.
For example, the resectoscope working element
discussed in this Patient Safety Advisory has
multiple lumens and holes having different inside
diameters that are constructed from different
materials (e.g., stainless steel, Teflon). Without a
thorough knowledge of all of the lumens and
holes that
exist (some of which are not obvious and easily

overlooked – see
Attachment 2), a facility could easily come to the

incorrect conclusion (based on reprocessing
information from STERRAD®) that sterilization
using a STERRAD® sterilization system would be
acceptable for the Karl Storz resectoscope
working element 27050E.
Resectoscope working elements are part of

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

Not
5.11.6 Privacy curtains and privacy curtain Locked mental health unit sleeping rooms -
support structures (e.g., track and provided with privacy
track supports) in locked mental
health units. (AL07-04). curtains to meet patient privacy needs - conflict
with the need to
keep patients safe from self harm. Patient 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.
Actions:
Privacy Curtain AL07-04.pdf

Not
5.11.6 (continued)... Privacy curtains and ...(continued) business (COB) Friday, February
(continued) privacy curtain support structures 23, 2007
(e.g., track and track supports) in
locked mental health units. (AL07- identify every location accessible to patients in
04). your locked mental
health units that have privacy curtains and/or

support systems for
A VAMC reported that a patient used
a privacy curtain (and its the curtains and remove the curtains.
support) in a sleeping room located

in a locked mental health unit to
commit suicide by hanging. The 2. By COB Friday, March 9, 2007 remove any
patient used the privacy curtain as a privacy curtain
noose - knotting it to make it more
rope-like while it remained attached supportive structures (e.g. tracks and track
to the curtain support structure. The supports) that could be used as an anchor for
entire system supported the full suicide by hanging.
weight of the patient.
Mandatory; Priority A Privacy Curtain AL07-04.pdf

Not
5.11.7 Medtronic Vitatron dual chamber Medtronic Corporation is voluntarily advising
cardiac pacemakers T-series and C- physicians, by letter, about problems that might
series, (AL07-05). occur, under certain conditions, within the
Vitatron dual chamber cardiac pacemakers T-
series and C-series.
Device Name Model

Numbers
Specific Incident: A software anomaly can cause
C50 D C50A1, the pacemakers to present clinically as a reset of
C50A2, C50A3 the pacemaker or inhibition of pacing, if these
devices are programmed to specific parameters
C60 DR C60A1, and if the patient’s intrinsic heart rate falls below
C60A2, C60A3 the programmed lower heart rate.
C70 DR C70A3
T60 DR T60A1 Actions:
T70 DR T70A1
1. By close of business (COB) Monday March 12,

2007, electrophysiology/cardiology staff or other
appropriate parties must identify all affected
patients by implementing each of the following
steps a through c. It is important that ALL
INFORMATION sources be reviewed to insure
that patients will not be overlooked, as affected
patients may be found on one list and not on
another.
a) Review the manufacturer’s letter (See

Attachment 1).
b) Review the patient list posted on the VA

Western (continued)...
Mandatory; Priority A Medtronic Vitatron AL07-05.pdf

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). (https://pacemaker.sanfrancisco.med.va.gov).
(See Attachment
2.) This list combines the patients with the

Device Name Model affected devices that are already being followed
Numbers via Trans Telephonic Monitoring (TTM) by the VA
Eastern and Western Pacemaker Surveillance
C50 D C50A1, Centers with a list of VA patients provided by
C50A2, C50A3 Medtronic. The Medtronic list consists of all the
VA patients in the company’s databases that
C60 DR C60A1, have had a Medtronic device implanted at a VA
C60A2, C60A3 facility and are affected by this.
C70 DR C70A3 c) Review your patient records for all patients with
implanted Medtronic devices affected by this
T60 DR T60A1 notification.
T70 DR T70A1
2. By close of business (COB) March 23, 2007,

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

Not
5.11.8 Tonometer Tips, (AL07-06) The 120 day extension, previously issued by The
Acting Principal Deputy Under Secretary for
Health, for the Tonometer Tips Reprocessing
Patient Safety Alert (AL07-02) required that
Reprocessing instructions for Haag- Action #2 be completed by March 7, 2007. The
Streit reusable tips (prisms) used to extension was granted to provide sufficient time
measure intraocular pressure. to determine a reprocessing procedure for U.S.
customers to use for Haag-Streit reusable
tonometer tips.
http://vaww.ncps.med.va.gov/Dialogue/pslog/view
.asp?eid=94
Proposed reprocessing instructions were sent to

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

the instructions
detailed in Attachment 1 to reprocess Haag-Streit

(continued)...
Mandatory; Priority A Tonometer Tips AL07-06.pdf

Not
5.11.8 (continued)... Tonometer Tips, ...(continued) reusable tonometer tips in the U.S.
(continued) (AL07-06)
Reprocessing instructions for Haag-

Streit reusable tips (prisms) used to
measure intraocular pressure.
Mandatory; Priority A Tonometer Tips AL07-06.pdf

Not
5.11.9 Boston Scientific Corporation’s The following Guidant ICD and CRT-D device
Cardiac Rhythm Management models have low-voltage capacitors that may be
Division (previously called Guidant) subject to degradation and may cause
recall of Implantable Cardiac accelerated battery depletion.
Defibrillators (ICDs) and Cardiac
Defibrillators (CRT-Ds), (AL07-07).
Device Name Model Numbers
Vitality DS DR/VR T125/T135
Vitality EL DR T127
Vitality AVT A155
Vitality 2 DR/VR T165/T175
Vitality 2 EL DR/VR T167/T177
Vitality DR HE T180
Contak Renewal 3 H170/H175
Contak Renewal 3 HE H177/H179
Contak Renewal 4 H190/H195
Contak Renewal 4 HE H197/H199
Contak Renewal 3 RF H210/H215
Contak Renewal 3 RF HE H217/H219
Contak Renewal 4 RF H230/H235
Contak Renewal 4 RF HE H239

Mandatory; Priority A Guidant BSCI-ICDs CRTs AlertAL07-07 -VAWW.pdf

Not
5.11.9 (continued)... Boston Scientific ...(continued) a through c. It is important that ALL
(continued) Corporation’s Cardiac Rhythm INFORMATION sources be reviewed to insure
Management Division (previously that patients will not be missed, as they may be
called Guidant) recall of Implantable found on one list and not on another. a) Review
Cardiac Defibrillators (ICDs) and the manufacturers letters (see the links under
Cardiac Resynchronization Therapy Additional Information). b) Retrieve and review a
Defibrillators (CRT-Ds), (AL07-07). list of your patients with the affected devices
(ICDs and CRT-Ds) on the VA National ICD
Surveillance Center intranet website
(https://icd.sanfrancisco.med.va.gov, see
Attachment 2 for instructions). This list consists of
all the patients in Guidant’s database that have
implanted devices affected by this and previous
recalls (some devices are affected by more than
one recall). c) Review your patient records for all
patients with implanted Guidant devices affected
by this recall.
2. Within the next 30 calendar days, follow the

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

Not
5.11.10 Shelhigh, Inc. implantable medical FDA states that the company’s deficiencies could
products, (AL07-08). compromise the safety and effectiveness of the
products. The affected products include heart
valves, conduits, surgical patches, dural patches
(to aid in tissue recovery after neurosurgery),
On April 17, 2007, the FDA seized all annuloplasty rings to repair heart valves, and
implantable medical products from arterial grafts.
Shelhigh, Inc. and on May 2, 2007,
the FDA issued a press release
disclosing a formal request to
Shelhigh, Inc., of Union, New Jersey These products have been issued under supplier
“to recall all of its medical products names of Shelhigh, Inc., Integra NeuroSciences,
remaining in the marketplace and Integra LifeSciences Corp.
including hospital inventories,
because of sterility concerns.”
Shelhigh, Inc. does not agree with
the FDA Actions:
position and consequently is not 1. By COB May 21, 2007 determine if you have
implementing the requested recall. any of the affected medical products listed in
Attachment A, remove them from inventory and
sequester.
2. Immediate action should be taken to purchase

alternative medical products from other suppliers
to replace the affected items.
3. By close of business (COB) May 25, 2007,

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 be provided so (continued)...
Shelhigh Implantables AL07-08.pdf

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 a) Retrieve and review a list of your patients with
implantable medical products from the affected
Shelhigh, Inc. and on May 2, 2007,
the FDA issued a press release products, sent to your facility Patient Safety
disclosing a formal request to Manager under
Shelhigh, Inc., of Union, New Jersey
“to recall all of its medical products separate cover by secured FedEx. This list
remaining in the marketplace includes all the
including hospital inventories,
because of sterility concerns.” patients in the VHA Prosthetics database that
Shelhigh, Inc. does not agree with have implanted
the FDA
products that are the subject of this notification.
position and consequently is not As this list may
implementing the requested recall.
not be complete also complete action 3.b) below.
b) Review your patient records for all patients

with implanted
Shelhigh, Inc., Integra NeuroSciences, and

Integra LifeSciences
Corp products to identify those implanted with

affected products.
4. Only in emergency cases should any of the
Shelhigh Implantables AL07-08.pdf

Not
5.11.11 BCMA Double Scans Alert (AL 07- A VAMC discovered an inappropriate 4 digit
09). number as the unit of
administration in the medication administration

log for a patient
Incorrect units of administration can
be documented when scanning receiving Morphine. At another facility, a provider
variable dose medications in BCMA reported viewing “743” as the unit of
administration for a regular Insulin order. These
inappropriate entries become part of the patient’s
medical record, can be misinterpreted as the
dose the patient received, and may consequently
be used by physicians to plan future treatments.
General Information: After scanning a medication

in BCMA, there are instances where the user is
presented with a pop-up dialog box for free-text
entry; BCMA is expecting the user to enter the
units of administration of the scanned medication
into the pop-up box. If the user doesn’t notice the
pop-up box and doesn’t enter the expected text
into it – either because the user inadvertently
double scanned the same medication or
proceeded to scan another medication - the
internal entry number (IEN) or synonym of the
scanned (continued)...
Mandatory; Priority A BCMA Double Scans Alert 07-09.pdf

Not
5.11.11 (continued)... BCMA Double Scans ...(continued) medication is automatically entered
(continued) Alert (AL 07-09). into the free-text pop-up box. This number is
stored in the Medication History Report as the
units of administration for the first scanned
medication.
Incorrect units of administration can
be documented when scanning
variable dose medications in BCMA
Examples: if a variable dose medication
(Medication 1) is
inadvertently scanned twice, the IEN of

Medication 1 would appear
as the units of administration for Medication 1 in

the Medication
History Report. Similarly, if Medication 2 was

scanned (and no text
was entered into the pop-up box that appeared)

and then Medication 3 was subsequently
scanned, the IEN for Medication 3 would be
entered as the units of administration for
Medication 2 in the Medication History Report.
Actions:
1. By close of business (COB) Friday, June 22,

2007, BCMA
Coordinators (or designee) must inform BCMA

users that
BCMA Double Scans Alert 07-09.pdf

Not
5.11.12 Daylight Saving Time (DST) In general, this change does not affect basic
changes, (AD07-04) medical device operation, but could lead to
discrepancies for some record keeping activity.
Manufacturers are expected to provide formal
communications to customers shortly and the
With the passage of the Energy FDA is likewise preparing information on this
Policy Act of 2005 the start of DST is subject. Aside from general cautions regarding
changed from the first Sunday in devices that communicate with each other, where
April to the second Sunday in March each device includes a separate clock, there are
and the end of DST is changed from no indications for direct impact on patient care
the last Sunday in October to the first other than minimal risk associated with time
Sunday of November beginning this stamp issues.
year, 2007.
Recommendation: Managing a practical approach

to addressing DST changes includes the
following important steps:
1. Awareness – describe and communicate the

scope of the DST change to facility staff using
newsletters, daily bulletins and other normal
communication mechanisms.
2. Assessment – using available technical

documentation, identify the inventory of devices
with internal clocks that track date and time.
Assessment also includes identifying software

(continued)...
Recommended; Priority A DST_AD07-04.pdf

Not
5.11.12 (continued)... Daylight Saving Time ...(continued) patches made available by medical
(continued) (DST) changes, (AD07-04) equipment manufacturers to address DST.
With the passage of the Energy Note: Software patches from sources other than
Policy Act of 2005 the start of DST is the medical device manufacturer cannot be
changed from the first Sunday in installed on medical devices without the explicit
April to the second Sunday in March consent of the medical device manufacturer.
and the end of DST is changed from
the last Sunday in October to the first
Sunday of November beginning this
year, 2007. 3. Prioritize – assign priority to devices requiring
action and address the following at minimum:
- life support, examples include defibrillators,

ventilators
- critical patient monitoring, examples include

ICU, vital signs monitors
- synchronization between devices/systems using

real-time clocks such
as BCMA laptops communicating with VistA
- diagnostic devices such as imaging, ECG, and

laboratory analyzers
- other devices such as sterilizers/reprocessing

equipment
- 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

Not
5.11.13 Ceiling collapse in exterior By close of business (COB) on Friday, August 31,
connecting corridor between 2007:
buildings. (AL07-10)
1. Survey all plaster lathe ceiling systems in

An approximately twenty foot section exterior connecting corridors between buildings
of a plaster ceiling over an for bulging or cracking that may indicate the
ceiling system is unsound. If the plaster lathe
exterior connecting corridor between ceiling system is obscured by a lower suspended
buildings collapsed and fell through ceiling, inspect the plaster lathe system at
an existing suspended ceiling, approximately 8 foot intervals down the length of
injuring two patients. The exterior the exterior connecting corridor.
connecting corridor roof system was
approximately 57 years old and did
not have ridge or soffit vents. There
was no evidence that moisture from 2. Take immediate action to shore up any plaster
recent rains was a factor; however, ceiling that is showing signs of deterioration
the wire lathe and fasteners securing and/or damage and prevent patients, staff or
the ceiling to the wood rafters and visitors from using the exterior connecting 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)...

Mandatory; Priority A NCPS Alert AL07-10.pdf

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.
Mandatory; Priority A NCPS Alert AL07-10.pdf

Not
5.11.14 VistAWeb may display a different This problem is specific to the use of TeleReader
patient’s data than other open along with the VistAWeb application. TeleReader
desktop applications when using is primarily used in VHA for telereading of retinal
TeleReader (AL07-11). images, but is also used at some sites for
teledermatology and teledentistry.
A VA Medical Center reported that

VistA Imaging patient data (retinal Action:
images) from one patient were
displayed with a different patient’s By close of business (COB) on Thursday,
VistAWeb electronic chart when the September 13, 2007, inform optometrists,
following conditions were met: 1. dentists, dermatologists, and other clinicians
CCOW-enabled applications of using TeleReader of this problem and instruct
TeleReader, VistAWeb, CPRS GUI, them to immediately discontinue use of VistAWeb
and VistA Imaging were all open on if it is being used on the same workstation as
the same workstation and displaying TeleReader (until the national patch is available
information for the same patient, to fix this problem). Users will need to set CPRS
AND THEN 2. A patient selection to use Remote Data Views (RDV) as the default
change was initiated from within viewer for remote patient data. See Figure 1 (on
TeleReader. While the newly the following page) for instructions for selecting
selected patient’s image was RDV to view remote data in CPRS. If you have
displayed in Vista Imaging, VistAWeb any issues selecting RDV to view remote data,
was unable to change to the newly contact your Clinical Application Coordinator
selected patient’s data. Therefore, (CAC) for help.
providers did not have access to the
correct historical data (VistAWeb NOTE: We discourage readers who have the
electronic chart data) when viewing option of using a second workstation to set up
patient data (e.g., progress notes, (continued)...
lab results, images) in other
applications. This can lead to a delay
in follow-up care and subsequent
disease progression.
Mandatory; Priority A TelereaderAL07-11.pdf

Not
5.11.14 (continued)... VistAWeb may display ...(continued) VistAWeb (without TeleReader) on
(continued) a different patient’s data than other the second workstation. This puts the onus on the
open desktop applications when user to switch to a new patient on the second
using TeleReader (AL07-11). 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 patient’s
VistAWeb electronic chart when the
following conditions were met: 1.
CCOW-enabled applications of
TeleReader, VistAWeb, CPRS GUI,
and VistA Imaging were all open on
the same workstation and displaying
information for the same patient,
AND THEN 2. A patient selection
change was initiated from within
TeleReader. While the newly
selected patient’s image was
displayed in Vista Imaging, VistAWeb
was unable to change to the newly
selected patient’s data. Therefore,
providers did not have access to the
correct historical data (VistAWeb
electronic chart data) when viewing
patient data (e.g., progress notes,
lab results, images) in other
applications. This can lead to a delay
in follow-up care and subsequent
disease progression.
Mandatory; Priority A TelereaderAL07-11.pdf

Not
5.11.15 Medtronic SynchroMed EL As of June 15, 2007, Medtronic received 354
implantable infusion pump (AL08-01) inquiries/complaints from health care
professionals worldwide, regarding gear shaft
wear on the SynchroMed EL implantable drug
infusion pumps. Medtronic estimates that
Models: 8626-10, 8626L-10, 8626- approximately 52,000 of these pumps, that may
18, 8626L-18, 8627-10, 8627L-10, experience gear shaft wear, are still implanted in
8627-18, 8627L-18 patients worldwide. If a pump motor stall occurs,
drug delivery will stop abruptly without warning
and result in loss of therapy. Drug withdrawal
from Intrathecal Baclofen (ITB) therapy can be
Medtronic issued an Urgent Medical fatal if not treated properly and effectively.
Device Correction “SynchroMed EL
Pump Motor Stall Due to gear Shaft
Wear” in August 2007.
Actions:
1. If you have these devices in stock do not use

them.
2. By close of business (COB) Friday, October

26, 2007 identify all affected

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).
b) (continued)...
MedtronicSynchroMedAL08-01.pdf

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, 8626- c) Review patient records for all other patients
18, 8626L-18, 8627-10, 8627L-10, with implanted Medtronic
8627-18, 8627L-18
SynchroMed EL devices affected by this recall
that might have been
Medtronic issued an Urgent Medical implanted at a non-VA facility and have their VA
Device Correction “SynchroMed EL physician/caregiver
Pump Motor Stall Due to gear Shaft
Wear” in August 2007. implement action 3 below.
3. By close of business (COB) Friday, November

30, 2007 physicians/caregivers must follow
Patient Management Recommendations #1
through #4 contained in the manufacturer’s letters
(Alert Attachments 1 and 2) and reproduced
below:
Patient Management Recommendation #1
If a patient presents symptoms of underinfusion

or withdrawal, a clinician can confirm a pump
motor stall through a drug refill volume
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.
Mandatory; Priority A MedtronicSynchroMedAL08-01.pdf

Not
5.11.16 Sprint Fidelis® Defibrillation Leads, The Sprint Fidelis® leads are used to deliver
manufactured by Medtronic (AL08- therapy in defibrillators, including Implantable
02) Cardioverter Defibrillators (ICD) and Cardiac
Resynchronization Therapy - Defibrillators (CRT-
D). More than 268,000 of the leads have been
implanted worldwide, and Medtronic and the 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)...
Mandatory; Priority A MedtronicSprintFidelisAL08-02.pdf

Not
5.11.16 (continued)... Sprint Fidelis® ...(continued) not on another.
(continued) Defibrillation Leads, manufactured by
Medtronic (AL08-02) a) Review the manufacturer’s letter (See Alert
Attachment 1).
b) Review the patient list posted on the VA

Medtronic issued a recall of its Sprint National ICD Surveillance Center intranet website
Fidelis® leads, models 6930, 6931, (https://ICDPM.sanfrancisco.med.va.gov). (See
6948, and 6949 due to a potential for Alert Attachment 2.) This list combines patients
fracture. with affected leads who are already in the
Center’s database with a list of VA patients
provided by Medtronic.
c) Review your patient records for all patients with

implanted Medtronic leads affected by this
notification that might have been implanted at a
non-VA facility.
3. By COB Friday, December 28, 2007, follow the

recommendations contained in Alert Attachment
2. This guidance was prepared by Dr. Edmund
Keung, Director of the VA National Surveillance
Center, and details the best course of action for
your patients.
Mandatory; Priority A MedtronicSprintFidelisAL08-02.pdf

Not
5.11.17 Updated Haag-Streit reusable Haag-Streit has revised their reprocessing
tonometer tip (prism) reprocessing instructions for their reusable tonometer tips to
instructions for U.S. customers (AL also permit disinfection with a 10% aqueous
08-03) ADDENDUM TO PATIENT solution of sodium hypochlorite (household
SAFETY ALERTS AL07-06 and bleach). The new instructions may be found in
AL07-02 Attachment 1 and at
http://www.newsmaker.ch/upload/customers/haag
streit/Disinfect_in_the_USA.pdf.
AL07-06 (ISSUED ON MARCH 7, Haag-Streit has also revised the rinsing step in
2007) their new instructions. Supplemental VHA
reprocessing instructions are also provided in
AL07-08 (ISSUED OCTOBER 26, Alert Attachment 2.
2006)
CONCERNING REPROCESSING
OF REUSABLE TONOMETER TIPS
(PRISMS) USED TO MEASURE
INTRAOCULAR PRESSURE
Mandatory; Priority A TonometerTipsReprocessingAL08-03.pdf

Not
5.11.18 Model 8100 infusion pump modules The springs can be missing, bent or broken,
shipped before September 27, 2007; risking medication over-infusion. Cardinal Health
a component of the Alaris Medley identified 5,560 units of the model 8100 module
infusion pump system, distributed by at 30 VA Medical Centers and sent notices to
Cardinal Health (AL08-04) 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 Health’s customer
letter (Attachment 2), contact Cardinal Health at

(800) 625-6627 and the VA Center for
Engineering and Occupational Safety & Health
(CEOSH).
Mandatory; Priority A Alaris8100AL08-04.pdf

Not
5.11.18 (continued)... Model 8100 infusion ...(continued) possible, arrange to send modules
(continued) pump modules shipped before not currently in use to Cardinal Health for x-ray
September 27, 2007; a component 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 x-
ray.
Cardinal Health reports that some of

the 8100 pump modules may have 3. Monitor the modules impacted by this
misassembled occluder springs. notification for potential inaccurate
flow. If you suspect inaccurate flow with a

particular device, remove the
device from service and contact Cardinal Health

at (800) 854-7128 (select
option 3) to arrange for a device failure

investigation.
Mandatory; Priority A Alaris8100AL08-04.pdf

Not
5.11.19 Positive displacement, needle-free Recent published literature suggests the
intravascular connector valves (AD- possibility of increased BSI
08-01)
rates associated with some positive
displacement, needle-free
A VAMC reports their blood stream intravascular connector valves. (See Addl.
infection (BSI) rates increased in Information below.)
2005 and 2006 when compared to

their BSI rates before 2005. The
Suggestions:
increase coincides with use of luer-
activated mechanical valves and 1) If you are considering a switch to positive
displacement, needlefree
positive displacement, needle-free
intravascular connector valves. intravascular connector valves for central venous
catheters or
PICC (Peripherally Inserted Central Catheter)

lines, please consider
the published literature cited below in the Addl.

Information section
before making a decision.
2) If you have already begun to use positive

displacement, needlefree
intravascular connector valves for central venous

catheters or
PICC lines, please review your BSI rates before

and after the change.
NOTE: If you have experienced a change in the
NeedlelessValvesAD08-01.pdf

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 manufacturer’s latest instructions

on the safe use of
A VAMC reports their blood stream
infection (BSI) rates increased in their devices; ensure that training has occurred,
and there is
2005 and 2006 when compared to
their BSI rates before 2005. The demonstrated competency.
increase coincides with use of luer-

activated mechanical valves and
positive displacement, needle-free

intravascular connector valves.
Recommended; Priority A NeedlelessValvesAD08-01.pdf

Not
5.11.20 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 The processing pharmacist will receive a
installation of “Duplicate drug class” order
VistA Pharmacy patch PSJ*5.0*175 check message. The pharmacist is prompted to

released on October 25, 2007. discontinue one or more
These
of the possible duplicate medications (see Alert
vulnerabilities can occur when a Attachment A). If the
Pharmacist is processing a
medication pharmacist enters “YES” to the prompt, instead of
accepting the defaulted
order.
“NO” value, then for the first problem above, the
1. Two VA Medical centers report medication dispensed may not be the same as
that a Unit Dose dispensed drug did the medication prescribed.
not
match the Unit Dose ordered drug.

This problem is not easily detected. Actions:
It can result in drug “B” being 1. Immediately notify pharmacists of this Patient
dispensed when drug “A” was Safety Alert and advise
ordered, if
them to reply “NO” to the prompt “Do you wish to
the patient has both drug “A” and DISCONTINUE any of
drug “B” as current orders and both
the listed orders?”, if they are processing an order
drugs are in the same therapeutic via [PSJ OE] Inpatient
category.
Order Entry or [PSJI ORDER] Order Entry (IV).
2. Two VA Medical Centers report
(See Alert Attachment A)
VistAPatchPSJAL08-05.pdf

Not
5.11.20 (continued)... Potential for ...(continued) Immediately notify Information
(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 PSJ*5.0*201 is planned for release the week of
were identified following the December 10,
installation of
2007, to restore pre-PSJ*5.0*175 state. This
VistA Pharmacy patch PSJ*5.0*175 emergency patch
released on October 25, 2007.
These must be installed immediately upon release.
vulnerabilities can occur when a b. Identify the source of your facility’s Bar Code
Pharmacist is processing a Medication
medication
Administration (BCMA) backup contingency
order. software. If the
1. Two VA Medical centers report software is NOT the nationally released

that a Unit Dose dispensed drug did BarCodeBackUp
not
(BCBU), notify BCMA users that the Medication
match the Unit Dose ordered drug. Administration
This problem is not easily detected.
Record (MAR) and/or Medication Administration
It can result in drug “B” being History (MAH)
dispensed when drug “A” was
ordered, if may not be complete.
the patient has both drug “A” and

drug “B” as current orders and both
drugs are in the same therapeutic

category.
Mandatory; Priority A VistAPatchPSJAL08-05.pdf

Not
5.11.21 FDA CLASS II recall of Boston Actions:
Scientific Corporation’s Cardiac
Rhythm Management Division
(previously called Guidant)
Implantable Cardiac Defibrillators 1.Within 14 calendar days of the issuance of this
(ICDs) and Cardiac Alert, electrophysiology/cardiology staff or other
Resynchronization Therapy appropriate caregivers must identify all affected
Defibrillators (CRT-Ds). (AL08-06) patients by implementing both of the following
steps a and b. It is important that ALL
INFORMATION sources be reviewed to insure
that patients will not be missed, as they may be
NOTE: Some models addressed in found on one list and not on another.
this Alert also appear in Patient
Safety Alert AL07-07 issued on April a) Retrieve and review a list of your patients with
18, 2007. This Alert provides new the affected devices (ICDs and CRT-Ds) on the
information addressing a new battery VA National ICD Surveillance Center intranet
problem. website (https://icdpm.sanfrancisco.med.va.gov,
see Attachment 3 for instructions). This list
consists of all the patients in Guidant’s database
that have implanted devices affected by this and
A subset of the following Guidant previous recalls (some devices are affected by
ICD and CRT-D device models have more than one recall).
a buildup of internal battery
impedance that may lengthen ICD b) Review your patient records for all patients
and CRT-D charge times and display with implanted Guidant devices affected by this
the Elective Replacement Indicator recall.
(ERI) or End of Life Indicator (EOL)
even though battery voltage and
capacity remain available. This issue
can result in delayed delivery of 2. Within the next 90 calendar days of the
shock therapy. issuance of this Alert, follow the actions contained
in (continued)...
Device Model Name Model

Numbers
Mandatory; Priority A GuidantBSCI-ICDsCRTsAlert-AL08-06-VAWW.pdf

Not
5.11.21 (continued)... FDA CLASS II recall of ...(continued) Attachment 2. This guidance was
(continued) Boston Scientific Corporation’s prepared by Dr. Edmund Keung, Director of the
Cardiac Rhythm Management VA National ICD Surveillance Center, as the best
Division (previously called Guidant) course of action for your patients.
Implantable Cardiac Defibrillators
(ICDs) and Cardiac
Defibrillators (CRT-Ds). (AL08-06) NOTE: Because the incidence rate is very low
and prolongation of charge time and ERI/EOL
can be identified by close monitoring (see
information contained within the Attachments
NOTE: Some models addressed in below), prophylactic replacement of the devices is
this Alert also appear in Patient not recommended.
Safety Alert AL07-07 issued on April
18, 2007. This Alert provides new
information addressing a new battery
problem.
A subset of the following Guidant

ICD and CRT-D device models have
a buildup of internal battery
impedance that may lengthen ICD
and CRT-D charge times and display
the Elective Replacement Indicator
(ERI) or End of Life Indicator (EOL)
even though battery voltage and
capacity remain available. This issue
can result in delayed delivery of
shock therapy.
Device Model Name Model

Numbers
Mandatory; Priority A GuidantBSCI-ICDsCRTsAlert-AL08-06-VAWW.pdf

Not
5.12.1 Implant orientation of Implantable Actions:
Cardioverter Defibrillators (ICDs) and
Cardiac Resynchronization Therapy
Devices (CRT-Ds) manufactured by
Boston Scientific Corporation’s 1. By Close of Business (COB) April 30, 2008,
Cardiac Rhythm Management electrophysiology and/or
Division, previously under the name
Guidant (AL08-08) cardiology staff or other appropriate caregivers
must identify all affected
patients by implementing steps a, b, c and step 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 that patients will not be missed, as they may be
found on one list and not on another.
specific location and in an
uncommon orientation - beneath the a) Retrieve and review a list of your patients 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 device’s ability to deliver
appropriate shock therapy. (https://icdpm.sanfrancisco.med.va.gov, see
Attachment 3 for instructions.
May 12, 2006 Poplation
This list includes all the patients in Guidant’s
Device Model Name database that have implanted
Model Numbers
devices affected by this and previous recalls
Contak Renewal 3 & 3 HE (some devices are affected by
H170/H173/H175/H177/H179
more than one recall).
Contak Renewal 3 AVT & 3 AVT HE
M150/M155/M157/M159 b) Review your patient records for all patients
with implanted Guidant
Contak Renewal 4 & 4 HE
H190/H195/H197/H199
devices affected by this recall.
GuidantBSCIICDsCRTsAlertAL08-07.pdf

Not
5.12.1 (continued)... Implant orientation of ...(continued) identified in steps a and b above, to
(continued) Implantable Cardioverter determine if device’s location and orientation are
Defibrillators (ICDs) and Cardiac verifiable. If device
Resynchronization Therapy Devices
(CRT-Ds) manufactured by Boston location or orientation is not verifiable or a post-
Scientific Corporation’s Cardiac implant CXR is not
Rhythm Management Division,
previously under the name Guidant available then proceed to step d. If device
(AL08-08) orientation is verified as beneath the pectoral
muscle with the serial number facing the ribs then
proceed to Action 2 below.
A subset of the following Guidant d) Contact the patients identified at step c above
ICDs and CRT-Ds models implanted (those with device
in a
orientation or location not verifiable) to have an
specific location and in an Anterior/Posterior (AP)
uncommon orientation - beneath the
pectoral muscle with the serial Chest x-ray to determine/verify specific device
number facing the ribs - may be orientation or to have a
subject to component damage and
device malfunction. This can impact physical examination of the implant area to best
the device’s ability to deliver determine the location of
appropriate shock therapy.
the device.
May 12, 2006 Poplation
Device Model Name

Model Numbers 2. Review and plan appropriate action as
discussed in Attachment 2 prepared by Dr.
Contak Renewal 3 & 3 HE Edmund Keung, Director of the VA National ICD
H170/H173/H175/H177/H179 Surveillance Center.
Contak Renewal 3 AVT & 3 AVT HE

M150/M155/M157/M159
Contak Renewal 4 & 4 HE

Mandatory; Priority A GuidantBSCIICDsCRTsAlertAL08-07.pdf

Not
5.12.2 VistA Anesthesia and Nurse VistA patch TIU*1*236 was subsequently
Interoperative Report patch released on November
TIU*1.0*215, released June 28,
2007. (AL08-08) 15, 2007 to restore the VistA Surgical Notes and
addendum
function to the pre-TIU*1*215 state. As of

A VHA VISN reports that VistA 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 Actions:

Surgery case editors [e.g. OSS
Operation (Short Screen)]. If

changes were made by Surgery 1. By Close of Business (COB) February 15,
2008 review
personnel to surgical data via the
Surgery case editor, such as Attachment 1, the list of facilities that installed
VistA patch
ESU Coagulation Range or
coagulation therapy changes, TIU*1*215.
addended data is not available for a. If your facility/healthcare system is listed in

viewing via the Surgery tab in Attachment 1,
CPRS, resulting in inaccurate execute Actions 2, 3 and 4.

surgery information.
b. If your facility/healthcare system is not on the
list, execute
Action 2 only.
Mandatory; Priority A VistAPatchTIU1215AL08-08.pdf

Not
5.12.2 (continued)... VistA Anesthesia and ...(continued) (or their designees) in a formal
(continued) Nurse Interoperative Report patch letter (see
TIU*1.0*215, released June 28,
2007. (AL08-08) sample letter in Alert Attachment 2).
A VHA VISN reports that VistA 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 must compare Anesthesia notes and Nurse
Surgery case editors [e.g. OSS Intraoperative Reports
Operation (Short Screen)]. If respectively, with CPRS Surgical Note(s). VistA

changes were made by Surgery patch TIU*1*231
personnel to surgical data via the provides software tools to assist with the process.
Surgery case editor, such as If the
ESU Coagulation Range or discrepancy contains significant clinical data,

coagulation therapy changes, facilities must
addended data is not available for reconcile the information and follow
viewing via the Surgery tab in documentation provided within
CPRS, resulting in inaccurate the TIU*1*231 patch description to correct the

surgery information. missing addendums.
If the discrepancy was caused by VistA patch

TIU*1.0*215,
information in the surgical case editors is

probably the most recent
Mandatory; Priority A VistAPatchTIU1215AL08-08.pdf

Not
5.12.3 Baxter - Allergic Reactions to A possible link to severe allergic reactions has
Heparin Sodium (AL08-09) been associated with the use of Baxter multiple
dose heparin vials and single dose vials. 40% of
the cases are estimated as serious, based on
preliminary and ongoing review. The number of
The Food and Drug Administration reports seen in the past two months is a marked
(FDA) announced on February 11, increase from the number of reports associated
2008, that since December 2007, with heparin use normally received. Since the
Baxter and FDA have received 350 January 17, 2008, recall, Baxter has also
reports of adverse reactions to received similar reports of adverse patient
heparin dispensed from Baxter multi reactions occurring in other lots of 1,000 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 hypersensitivity-
type 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)...
Mandatory; Priority A HeparinAlert08-09.pdf

Not
5.12.3 (continued)... Baxter - Allergic ...(continued) Apheresis procedures (photo and
(continued) Reactions to Heparin Sodium (AL08- plasma)
09)
There have been isolated reports of reactions

The Food and Drug Administration with other forms of heparin including premixed
(FDA) announced on February 11, bags.
2008, that since December 2007,
Baxter and FDA have received 350
reports of adverse reactions to
heparin dispensed from Baxter multi Actions:
dose vials. On January 17, 2008,
Baxter issued a recall of 9 specific 1. By close of business (COB) February 20, 2008,
heparin lots (see affected lots listed Pharmacy Chiefs will assure that the following 9
under Action 1 below). The increase lots of Baxter multi-dose heparin vials are
in adverse events was reported in removed from inventory, segregated and
patients receiving high bolus doses returned. Use the following link for information on
of heparin. Adverse events reported returning affected product.
include: allergic or hypersensitivity-
type reactions, with symptoms of oral
swelling, nausea, vomiting, sweating,
shortness of breath, and cases of Recall Update - Baxter HealthCare - Heparin
severe hypotension requiring Inj.doc
treatment. Most events develop
within minutes of heparin initiation,
although the possibility of a delayed
response has not been excluded. 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.
Mandatory; Priority A HeparinAlert08-09.pdf

Not
5.12.4 Expanded Recall of Baxter Heparin This Patient Safety Alert supplements Patient
Products, AL08-10 Safety Alert AL08-09 (PSAT question 5.12.3).
Any future updates relating to the original or
expanded Baxter heparin recalls will be
communicated through the National Center for
Baxter initially recalled nine lots of Patient Safety’s Patient Safety Log.
multi-dose heparin sodium injection
products (e.g., vials, syringes) on
January 17, 2008. This recall has
now been expanded to include the Actions:
following products:
• all remaining lots of Baxter multi-

dose heparin sodium injection By close of business Saturday March 1, 2008:
products,
1. Implement the Actions in Patient Safety Alert
• all lots of Baxter single-dose AL08-09, if not already completed.
heparin sodium injection products,
and
• all lots of Baxter heparin flush 2. Pharmacy Chiefs (or designee) must assure
products. that the following products are removed from
inventory, segregated and returned to the
supplier:
NOTE: This recall does not involve a) all remaining lots of Baxter multi-dose heparin
Baxter's heparin pre-mix IV solutions sodium injection
in bags (heparin sodium in 5%
dextrose injection and heparin products
sodium in 0.9% sodium chloride
injection). b) all lots of Baxter single-dose heparin sodium
Mandatory; Priority A ExpandedBaxterHeparinAL08-10.pdf

Not
5.12.5 STERIS C1160 Universal Flexible STERIS identified this issue internally during
Processing Trays used with the quality control procedures; STERIS indicated
STERIS System 1 Sterile Processing there have been no adverse incidents reported
Systems (AL08-11) from facilities regarding this issue. It is possible,
however, that devices (e.g., endoscopes,
esophageal dilators) sterilized in the STERIS
System 1 with C1160 trays may not have been
STERIS Corporation issued an adequately sterilized. Additional diagnostic cycles
Urgent Recall Notice about the recommended by STERIS will ensure the
design/operation of the C1160 processor is operating within acceptable limits.
universal flexible processing tray that
may compromise the ability of the
STERIS System 1 Sterile Processor
to provide an effective 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)...
Mandatory; Priority A SterisSystemIAlertAL08-11.pdf

Not
5.12.5 (continued)... STERIS C1160 ...(continued) by close of business Friday, March
(continued) Universal Flexible Processing Trays 14, 2008:
used with the STERIS System 1
Sterile Processing Systems (AL08-
11)
1. Reprocessing personnel who utilize the
STERIS System 1 must read this
STERIS Corporation issued an Patient Safety Alert and the attachments.

Urgent Recall Notice about the
design/operation of the C1160 NOTE: Be sure to identify all areas in your facility
universal flexible processing tray that that have STERIS
may compromise the ability of the
STERIS System 1 Sterile Processor System 1 Processing Systems that may include,
to provide an effective sterilization but are not limited
cycle when the C1160 tray is used.
to the following: Ambulatory Surgery, Endoscopy,
GI, GU, OR,
NOTE: This Patient Safety Alert Respiratory, SPD, and Urology.

applies to all STERIS System 1
models and
all serial numbers of C1160 trays. 2. If possible, discontinue the use of STERIS
This Patient Safety Alert does not C1160 trays with the STERIS
apply
System 1 until STERIS is able to correct the
to C1200, C1220, or C1140 trays. 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
Mandatory; Priority A SterisSystemIAlertAL08-11.pdf

Not
5.12.6 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 allergies. Since 2003, ART and CPRS no longer
not generate automatic drug-allergy permit entry of free-text
order checks necessary for effective allergies. In June 2007, a software utility
medication management. Patients (GMRA*4*29) was provided to
with
automate mapping of existing free-text patient
a known allergy may be 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 Manager’s menu to

obtain a list of
free-text allergy entries (see Step 1 of Attachment

2 for
Mandatory; Priority A FreeTextAllergiesAlertAL08-12.pdf

Not
5.12.6 (continued)... Free-text patient ...(continued) facilities must submit an initial
(continued) allergy entries in the Computerized report - even those
Patient Record System (CPRS)
(AL08-12) with negative reports (i.e., those facilities with
zero free-text
allergy entries). If your facility’s report is negative,

Free-text allergy entries in CPRS do no further
not generate automatic drug-allergy
action is required after submitting your negative
order checks necessary for effective report. If your
medication management. Patients
with facility’s report is positive (i.e., contains free-text
allergy
a known allergy may be administered
a medication or served 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:
Mandatory; Priority A FreeTextAllergiesAlertAL08-12.pdf

Not
5.12.7 Improper reprocessing of flexible The caps of the semi-disposable biopsy valves
endoscope biopsy valves (AL08-13) were not opened up (see the figures in Alert
Attachment 1), and hence were not cleaned,
brushed, and disinfected or sterilized according to
the manufacturer’s instructions. This resulted in
A VA medical center noted that their the presence of bioburden on the semidisposable
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-gastro- valves 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
manufacturer’s flexible endoscopes and biopsy

valves, THIS PATIENT
SAFETY ALERT APPLIES TO ALL

COLONOSCOPES, EGD, AND
ULTRASOUND SCOPES THAT HAVE BIOPSY

VALVES,
REGARDLESS OF MANUFACTURER OR
MODEL.
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

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) reprocessed according to the flexible endoscope
manufacturer’s instructions.
A VA medical center noted that their

semi-disposable (i.e., reusable to an Actions:
extent; limited use) biopsy valves
(Olympus part number MB-358) for Chief of SPD (or designee) must ensure the
their colonoscopes (Olympus Model following actions are carried out by close of
CF-180AL) and esophago-gastro- business Tuesday, April 8, 2008:
duodeno (EGD) scopes (Olympus
Model GIF-H180) were not being
reprocessed properly.
1. All personnel who reprocess flexible
endoscopes have read this Patient
Safety Alert and the attachment.
NOTE: Ensure you have identified all areas in

your facility that
reprocess flexible endoscopes, which may

include, but are not
limited to the following: Ambulatory Surgery,

Endoscopy, GI,
GU, OR, Respiratory, SPD, Urology, and Clinics

to include
CBOCs.
2. As requested by VA Central Office, in an email
FlexibleEndoscopeBiopsyValvesAL08-13.pdf

Not
5.12.8 Collimator screws on x-ray systems The manufacturer issued an Urgent Device
manufactured by Philips Medical, Correction
collimator models 9896 010 00612,
9896 010 00614, and 9896 010 (Alert Attachment 1) about collimator screws
00615 used on the Bucky Diagnot, securing the collimator to
Digital Diagnost, Easy Diagnost, and
Thorovision x-ray systems. (AL08- the stand in the models listed above where they
14) may become
loose and fall out. If the screws fall out, there is a

small chance
the collimator could fall from the x-ray stand,

placing patients and
employees at risk, although no incidents of this

type have been
reported.
Philips Medical is upgrading affected systems as

quickly as
possible, to be completed by October 2008.
Actions:
If your facility is affected and you have not

already done so:
Mandatory; Priority A PhilipsCollimatorScrewsAL08-14.pdf

Not
5.12.9 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

Not
5.12.9 (continued)... Topcon IMAGEnet ...(continued) failure that prevents transmission
(continued) DICOM Interface 2 Retinal Image
Acquisition Systems distributed by of images from the local Topcon IMAGEnet
Topcon Medical Systems. (AL08-15) Workstation to the VistA
Imaging gateway, images may reside on the local

Topcon workstation
VA sites report patient identification
errors during image transmission temporarily. Once transmission ability is restored,
from images must be
Topcon IMAGEnet DICOM interface transmitted and deleted. Under no circumstance

2 Retinal Imaging Workstations to should images greater
VistA
than seven days old remain on the Topcon
Imaging. Workstation.
3. All Topcon IMAGEnet devices must be

upgraded to version 2.11 as soon as the software
is released.
Mandatory; Priority A TopconImagenetAL08-15.pdf

Not
5.12.10 Alaris model 8000 infusion pumps; Affected componets are:
Alaris models 8100, 8110, 8120
infusion modules; Alaris models 1. Gray Interface connectors (two per unit) on the
8210, 8220 SpO2 modules. These 8000, 8100, 8110, 8120
devices
and 8220 manufactured before March 16, 2004.
are manufactured by Cardinal
Health. (AL08-16) 2. U9 socketed Integrated Circuit (IC) on the 8110
and 8120 display
boards manufactured before October 25, 2005.

The components on the devices can
fail resulting in a channel 3. U19 socketed IC on the 8100 module logic
boards manufactured before
error that will shut down infusion or
monitoring and activate audio and September 8, 2005.
visual alarms.
Note: Alaris will provide replacements free of

charge. They will also replace the components on
any units they receive for the ongoing Occluder
Spring Recall.
Actions:
1. By close of business June 27, 2008 determine

if affected items are in the
facility inventory. If yes, notify caregivers and

continue using the devices
as necessary but ensure that an appropriate
AlarisComponentsAL08-16.pdf

Not
5.12.10 (continued)... Alaris model 8000 ...(continued) for clinical use.
(continued) infusion pumps; Alaris models 8100,
8110, 8120 infusion modules; Alaris a. Connectors – acquire and replace all affected
models 8210, 8220 SpO2 modules. connectors.
These devices
b. U9 and U19 ICs – acquire and replace all
are manufactured by Cardinal affected circuit boards.
Health. (AL08-16)
The components on the devices can

fail resulting in a channel
error that will shut down infusion or

monitoring and activate audio and
visual alarms.
Mandatory; Priority A AlarisComponentsAL08-16.pdf

Not
5.12.11 Voicemail greetings for mental health Because it is possible to bypass facility
staff’s 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 reach phones for mental health staff that are not
left messages on phones assigned manned 24 hours a
to mental health staff only to day/7days a week. If those phones are not
attempt/complete suicide prior to answered, it is imperative
mental
that the veteran hear instructions for making
health staff’s ability to return the emergency contact with
calls.
either 911 or the Suicide Prevention Hot Line.
Recommendations:
1. VA issued cell phones (including Blackberry)

and desk phones
assigned to mental health staff should include

standard elements
for their activated voice mail message as

illustrated by this example
voicemail greeting:
“You have reached the phone of [insert name,

title]. If this is a
Recommended; Priority A VoiceMailAdvisoryAD08-03.pdf

Not
5.12.11 (continued)... Voicemail greetings for ...(continued) leave a brief message and I will
(continued) mental health staff’s 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 2. Personal cell phone numbers should not be
left messages on phones assigned given to patients. If
to mental health staff only to they have been given out, the standard voicemail
attempt/complete suicide prior to greeting should
mental
be applied until all patients who received the
health staff’s ability to return the number have been given
calls.
more appropriate contact phone numbers
Recommended; Priority A VoiceMailAdvisoryAD08-03.pdf

Not
5.12.12 Monitor ceiling suspensions with There were no injuries and cables prevented it
motorized height movement used from falling to the floor. While Philips believes it is
with X-ray systems manufactured by highly unlikely this will occur again, they will be
Philips Medical Systems. (AL08-17) sending service personnel to sites to eliminate
this risk starting this month. Philips has identified
32 VA facilities affected by this issue; the full
notice is attached to this Alert.
Philips reports that a ceiling mounted
monitor used with an x-ray system
fell from the ceiling suspension
system. Actions:
Until Philips implements the Field Change Order

(FCO),
1. By close of business July 18, 2008 review the

attached list of sites/units
to determine if you are affected. If affected, inform

all users about the
following recommendations.
a. Do not place the monitor over the patient
b. Avoid unnecessary carriage movement
c. Do not stand under or near the carriage.
2. If, during use of the carriage, users find

abnormal carriage behavior
PhilipsMonitorCeilingSuspensionAL08-17.pdf

Not
5.12.13 Power supply on Lionville Systems Although the incident rate is low, Lionville
mobile computing products, iPoint recommends that facilities with units
and iMed, manufactured before May, manufactured before May 2007 contact them for
2007. (AL08-18) a free upgrade to the Lionville Power Solution
(LPS). This upgrade adds a thermal cutoff switch
to the power inverter to prevent the possibility of
overheating.
A VA facility reports overheating of
the medication cart with smoke
emitted from the unit. Action:
1. If your facility is on the list of sites with units

manufactured before
May 2007 (See Alert Attachment 1), contact

Lionville Technical Services by
close of business August 15, 2008.
2. Schedule an upgrade of the LPS for each unit

with the Lionville
Technical Services Manager, Dave Moyer at 1-

800-523-7114,
Extension 253.
Mandatory; Priority A LionvilleCartPowerSupplyAL08-18.pdf

Not
5.12.14 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 If the correct date/time is not manually entered
glucose measurement devices that is into the peripheral measurement device when the
automatically uploaded into the battery is depleted or changed, the device will
Home default to an incorrect date/time that is then
uploaded by the Home Telehealth appliance and
Telehealth appliance. 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:
Mandatory; Priority A CCHTPeripheralDevicesAL08-19.pdf

Not
5.12.14 (continued)... Peripheral Blood ...(continued) ensure data
(continued) Pressure and Blood Glucose
Measurement Devices connected to displayed on vendor websites is verified for
Health Hero, Viterion, VitelNet and accuracy prior to clinical
American Telecare Inc.
decision-making and placement in the CPRS
(ATI) Home Telehealth Appliances medical record.
(AL08-19)
2. If the evaluation by the VISN CCHT Program

Several VA sites report incorrect Manager does not
date/time stamping from peripherally
connected blood pressure result in assurance that appropriate practices are
measurement devices and blood in place to ensure
glucose measurement devices that is
automatically uploaded into the measurements are always verified prior to clinical
Home decision-making and
Telehealth appliance. placement in CPRS, they will suspend use of

automated data collection
from peripheral devices connected to home

telehealth devices. These
VISN CCHT programs will revert to manual data

entry by patients
instead. Manual data entry will ensure correct

time and date stamping of
measurements.
Mandatory; Priority A CCHTPeripheralDevicesAL08-19.pdf

Not
5.12.15 Same syringe used for IV CDC guidelines and general infection control
(intravenous) line heparin flushes for precautions require that any syringe or needle
multiple patients (AL08-20) used on one patient be considered contaminated
and cannot be used on any other patient or be
reintroduced into a multiuse vial.
As routine practice in a VA medical The concern about reuse of syringes applies to

center, the same syringe was used to cardiac catheterization labs, emergency rooms,
administer heparin flushes to patients endoscopy suites, operating rooms, patient
via their IV lines during procedures in treatment areas, radiology, and all other areas
the cardiac cath lab. A multi-dose vial using injectable medications.
of heparin was used to fill a 10 ml
syringe at the beginning of the day’s
procedures, and the same syringe
was used for subsequent patients Actions:
throughout the day.
By Close of Business, Friday, August, 15, 2008,

the facility director, using
available staff and resources will ensure that

notification is provided to all staff who perform
medication injections of the following information:
a). Do not use the same syringe to administer

medications to multiple
patients even if the needle is changed for each

patient. This applies
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
manner.
SameSyringeAL08-20.pdf

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 to fill a 10 ml c). Use fluid infusion and administration sets (i.e.,
syringe at the beginning of the day’s intravenous bags,
procedures, and the same syringe
was used for subsequent patients tubing and connectors) on one patient only and
throughout the day. dispose appropriately after
their use. Consider a syringe or needle / cannula

contaminated once it has
been used to enter or connect to a patient’s

intravenous infusion bag or
administration set.
d). When using multidose vials – both the needle

and syringe used to
access a multidose vial must be sterile.

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.
Mandatory; Priority A SameSyringeAL08-20.pdf

Not
5.12.16 Inpatient Medication Orders for The IMO software functionality enables an
Outpatients (IMO): Inability to enter Outpatient location (i.e. Clinic)
Unit Dose orders beyond midnight for
patients checked in before midnight. to use the Inpatient Meds (Unit Dose) ordering
(AD08-04) program to enter
medication orders that are to be administered in

the clinic setting.
When using IMO for a patient who
was checked into an IMO clinic Potential issues related to this
before appointment/encounter problem are:
midnight and who remains in the • When this problem occurs, a clinician will be
outpatient location after midnight, unable to access the
their
CPRS Unit Dose medication ordering screens.
current encounter no longer CPRS will only
functions for ordering Meds, Inpatient
in permit entry of outpatient prescriptions in this
situation. If
CPRS. This is especially problematic
in a 24 hour Emergency Outpatient orders are entered and the patient has
an active
Department setting as patients’
appointments will often start on one Outpatient prescription for the same dispensed
day drug, the active
and end on the next. Site reports order is discontinued. Providers may forget to
indicate this causes a number of reorder the standing
potential patient safety issues Outpatient medication with the appropriate

relating to medications (see General number of refills. This
Information below). may also lead subsequent staff to misinterpret the

medication
profile and assume that the therapy has been
InpatientMedicationOrdersAD08-04.pdf

Not
5.12.16 (continued)... Inpatient Medication ...(continued) receive
(continued) Orders for Outpatients (IMO):
Inability to enter Unit Dose orders their intended medications when needed. Sites
beyond midnight for patients report delays in
checked in before midnight. (AD08-
04) medication administration for as long as 10 hours.
• If a second unscheduled appointment is created

after midnight in
When using IMO for a patient who
was checked into an IMO clinic order to be able to enter Unit Dose medications,
before then notes and
midnight and who remains in the encounter information may subsequently be

outpatient location after midnight, attached to this
their
encounter instead of the original appointment. All
current encounter no longer the encounter
functions for ordering Meds, Inpatient
in data in the unscheduled encounter is deleted if
this unscheduled
CPRS. This is especially problematic
in a 24 hour Emergency encounter is deleted. The deleted encounter data
may include
Department setting as patients’
appointments will often start on one Diagnosis Codes, Immunizations, Education, and
day Health Factors
and end on the next. Site reports which may be used to trigger Clinical Reminders.
indicate this causes a number of
potential patient safety issues

relating to medications (see General IMO is a medication ordering process for
Outpatient Clinics. Its use
Information below).
enables medication orders to go through order
checks and pharmacist
InpatientMedicationOrdersAD08-04.pdf

Not
5.12.17 J & J Ethicon ENDOPATH ETS Ethicon has started supplying these linear cutters
Endoscopic Linear Cutters (AD- (which do not have pre-loaded cartridges) with a
0805) 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
On September 22, 2008 Ethicon use. Ethicon will exchange affected devices for
Endo-Surgery, LLC issued an MOD Code 02 replacement products with the red
protection covering.
Important Customer Reminder to
users stating that the ENDOPATH
ETS Endoscopic Linear Cutter is not
preloaded with staples. A small Recommendation:
number of incidences have been
reported SPD or other personnel that supply the affected
devices to the
related to the linear cutters being
used without a cartridge causing the operating or procedure rooms where these
instrument to cut tissue without devices are used should label the packaging of
applying a staple, preventing proper the linear cutters to remind clinicians to load the
closure of the incision. cutters with an appropriately sized cartridge
before use until replacement products are
obtained.
The following Product codes and

MOD Code 00 are affected:
• ETS45 (ENDOPATH ETS45

Endoscopic Linear Cutter)
• ATS45 (ENDOPATH ETS-Flex45

Articulating Linear Cutter)
• CTS45 (ETS Compact-Flex 45

Articulating Endoscopic Linear
Cutter)
Recommended; Priority A EndoscopicLinearCuttersAD08-05.pdf

Not
5.12.18 Shower curtains used in locked Many locked mental health units have shower
mental health units (AL09-01) curtains for patient privacy and for patient safety
(e.g., to prevent water from pooling outside the
shower, reducing the potential for a slip and fall
hazard). While the shower curtain involved in this
A VAMC reported that a patient in a event was a vinyl/plastic combination, totally
locked mental health unit used the plastic or totally vinyl shower curtains also
clear plastic, light-weight, bottom present a suffocation hazard.
portion of a shower curtain (see Alert
Figure 1) to attempt suicide by
suffocation. The patient ripped off the
clear plastic portion from the 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
(continued)...
Shower Curtains in Locked MH UnitsAL09-01.pdf

Not
5.12.18 (continued)... Shower curtains used ...(continued) suffocation. Acceptable alternatives
(continued) in locked mental health units (AL09- are products that mitigate or reduce the risk of
01) suffocation and are unlikely to pose any other
hazards to patient or staff in locked units.
Examples include, but are not limited to, the
following:
A VAMC reported that a patient in a
locked mental health unit used the a. Cloth shower curtains - provided that they 1)
clear plastic, light-weight, bottom have a suicide prevention track (i.e., a track that
portion of a shower curtain (see Alert can’t be used as an anchor), 2) are breakaway,
Figure 1) to attempt suicide by attached with Velcro, 3) have Velcro tabs spaced
suffocation. The patient ripped off the at a minimum of approximately 12 inches apart
clear plastic portion from the heavier (e.g., use only 3 Velcro tabs to attach a 24” wide
vinyl portion and wrapped the shower curtain), and 4) have no more than 2
material around their head. square inches of each Velcro tab in contact with
the curtain. Note that meeting these requirements
may require retrofitting commercial cloth shower
curtains. Note also that the small number and
placement of the Velcro tabs will cause the
shower curtain to look saggy, but prevents the
curtain from supporting a patient’s weight.
Additionally, since mold can grow on cloth easily,
be sure to launder and/or replace the shower
curtain as necessary.
b. The Soft Suicide Prevention Door (SSPD)

patented by Sheridan VAMC (see Alert Figure 2
and www.suicideproofing.com). This is a fire
Mandatory; Priority A resistant, foam
Shower Curtains core,MHVelcro-hinged
in Locked UnitsAL09-01.pdf door that has

Not
5.12.19 Bleeding episodes during dialysis VA dialysis centers performed more than 2.5
(AD09-02) million chronic and acute dialysis treatments
during the period of time reviewed. In addition to
the review of RCA and Safety reports, the nurse-
managers of 65 VA dialysis centers were
VA dialysis centers performed more interviewed by telephone as were some Patient
than 2.5 million chronic and acute Safety Managers.
dialysis treatments during the period
of time reviewed. In addition to the
review of RCA and Safety reports,
the nurse-managers of 65 VA All of the significant bleeding events involved
dialysis centers were interviewed by dislodgement of the venous needle or
telephone as were some Patient disconnection of the venous blood line at the
Safety Managers. dialysis catheter connection. In the majority of
these cases, the venous pressure alarm on the
dialysis machine failed to detect the event until
significant blood loss had occurred. There
appeared to be no statistical difference in the
reported adverse bleeding events between the
four brands and multiple
models of dialysis machines involved, although

the number of incidents with each machine may
have been too small to draw any firm
conclusions.
Two major risk factors for bleeding during dialysis

were found: 1) 75% of the most severe bleeds
occurred in patients (continued)...
Recommended; Priority A BleedingEpisodesDuringDialysisAD09-02.pdf

Not
5.12.19 (continued)... Bleeding episodes ...(continued) who were restless, confused,
(continued) during dialysis (AD09-02) agitated, or uncooperative, and 12.5% in patients
who were asleep; 2) approximately 50% of the
severe bleeds occurred outside of the chronic
dialysis unit (in the ICU or in isolation rooms).
VA dialysis centers performed more
than 2.5 million chronic and acute
dialysis treatments during the period
of time reviewed. In addition to the In 50% of the severe bleeds, the access site was
review of RCA and Safety reports, not visible at the time of the event, and in the
the nurse-managers of 65 VA remaining 50%, the visibility of the access site
dialysis centers were interviewed by was not documented in the RCA.
telephone as were some Patient
Safety Managers.
Taping of the access site and restraint policies

and procedures varied across the 65 VA dialysis
centers. Many dialysis machines also lacked an
internal memory for alarms and shutdowns.
In addition to these findings, usability testing of

the Redsense portable alarm—an FDA-approved
device specifically designed to detect venous
needle dislodgement during dialysis—was
performed. Problems were found with the clip and
the sensor connection. The manufacturer is
currently redesigning the clip and problems with
the sensor connection appear to have been
solved.
Recommendations:
Recommended; Priority A BleedingEpisodesDuringDialysisAD09-02.pdf

Not
5.12.20 Methicillin-resistant Staphylococcus Recommendations:
aureus (MRSA) contamination in an
orthopedic clinic room (AD09-03)
1) For joint/bursa injections that involve the

injection of more than one medication from one
Several patients who received syringe, it is strongly recommended to use 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).
4) All sterile supplies in clinic rooms
Methicillin-resistant Staphylococcus aureus (MRSA) AD09-03.pdf

Not
5.12.20 (continued)... Methicillin-resistant ...(continued) are to be kept in closed cabinets,
(continued) Staphylococcus aureus (MRSA) drawers, or closed carts.
contamination in an orthopedic clinic
room (AD09-03)
5) Following any procedure done on an infected

site, such as:
Several patients who received
joint/bursa injections in one aspiration of pus, open drainage, debridement or
orthopedic surgery clinic exam room, obtaining cultures performed in an orthopedic
during a four-day period, developed clinic room, the examination table and horizontal
infections. For those patients who surfaces in the room should be wiped down with
had cultures grown, MRSA was an EPAregistered hospital disinfectant before the
identified as the causative agent. next patient is placed in the room. If there is
Infections may have been caused by visible soilage, an EPA-registered
improper preparation of injections,
cross contamination between disinfectant/detergent should be used for cleaning
multidose vials and/or breach of and disinfecting. In addition, all furniture such as
appropriate practices following the exam tables, chairs, tables, carts, horizontal
collection of a specimen for surfaces in examination/procedure rooms, sinks,
microbiological culture from a patient and floors in the clinics should be cleaned and
who was infected with MRSA. During disinfected on a daily basis using appropriate
the investigation issues related to cleaning agents and an EPA-registered hospital
documentation were also identified. disinfectant or an appropriate EPA-registered
hospital disinfectant/detergent.
6) In accordance with VHA Handbook 1004.1

VHA Informed Consent for Clinical Treatments
and Procedures (link in “Additional
Information” section below), the patient’s

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 space.
Methicillin-resistant Staphylococcus aureus (MRSA) AD09-03.pdf

Not
5.12.22 Medtronic Neuromodulation The intrathecal catheters and intrathecal catheter
Sutureless Connector Catheters revision kits use a sutureless connector for
used with SynchroMed and IsoMed attachment of the catheter to the implanted
implantable infusion pumps: Medtronic SyncroMed II, SynchroMed EL, and
 INDURA One-Piece (1P) IsoMed infusion pumps. The catheter is part of an

Intrathecal Catheters, Model 8709SC infusion system that stores and delivers
parenteral drugs to the intrathecal space.
 Intrathecal Catheters, Model
8731SC Medtronic’s investigation indicates that reported
events have been caused by misalignment or
 Sutureless Pump Connector incomplete connection of the sutureless pump
Revision Kit, Model 8578 connector to the catheter port. Proper alignment
and full engagement of the sutureless pump
 Intrathecal Catheter Pump connector to the catheter port during attachment
Segment Revision Kit, Model is critical to ensure the catheter is properly and
8596SC completely connected to the pump.
(AL09-02)
Actions:
There is a potential for

misconnections of the Medtronic
sutureless connector catheters from 1. By close of business October 31, 2008,
the catheter port on the pump. These physicians responsible for implanting and
misconnections have resulted in a managing patients must do the following:
blockage (occlusion) between the
sutureless pump connector and the a. Read Attachments 1, 2, and 3.
catheter port on the pump and
disconnections from the pump b. Begin to perform the following procedures
connector. Misconnections can result during implantation. Detailed instructions are
in lack of therapeutic effect, clinically provided in Attachments 2 and 3.
significant or fatal drug underdose, or
return of underlying symptoms and/or  verify (continued)...
withdrawal symptoms. Drug
withdrawal from Intrathecal Baclofen
Mandatory; Priority A Medtronic Intrathecal Catheter AL09-02.pdf

Not
5.12.22 (continued)... Medtronic ...(continued) cerebrospinal fluid (csf) backflow
(continued) Neuromodulation Sutureless through the catheter
Connector Catheters used with
SynchroMed and IsoMed implantable  ensure alignment of the sutureless connector
infusion pumps: to the pump
 INDURA One-Piece (1P)  snap the sutureless connector into place

Intrathecal Catheters, Model 8709SC
 tug and rotate to test the connection
 Intrathecal Catheters, Model
8731SC c. Follow recommendations for managing patients
with implanted sutureless “SC” catheters, as
 Sutureless Pump Connector outlined in Attachment 1.
Revision Kit, Model 8578
 Intrathecal Catheter Pump

Segment Revision Kit, Model 2. By close of business October 31, 2008, contact
8596SC your patients who have these devices to educate
them about the signs and symptoms of drug
(AL09-02) underdose and withdrawal.
There is a potential for 3. Effective immediately, all patients that present

misconnections of the Medtronic with an intrathecal pump should be provided with
sutureless connector catheters from education about the signs and symptoms of drug
the catheter port on the pump. These underdose and withdrawal.
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
Mandatory; Priority A Medtronic Intrathecal Catheter AL09-02.pdf

Not
5.12.23 Baxter Single Strength Dosing Card Actions:
for BREVIBLOC Premixed Injection
(esmolol HCl) 2,500 mg/250 mL (10
mg/mL) Ready-to-use-Bags, 250 mL
bags (AL09-03) 1. Chief Nursing Officer (or designee), Chief of
Staff (or designee) and Chief of Pharmacy (or
designee) will ensure that all nurses, physicians,
There is an error in the 121 lb (55 kg) and pharmacists, respectively, are informed of
patient weight setting on the Single this Patient Safety Alert and that clinical
Strength Dosing Card for Baxter's departments under their management control
BREVIBLOC Premixed Injection locate the incorrect dosing cards. The incorrect
(esmolol HCl) 2,500 mg/250 mL (10 dosing cards can be identified by the product
mg/mL) Ready-to-use-Bags, 250 mL number 748762 4/07 on the back of the card as
bags. The Maintenance Infusion shown in the Attachment.
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 Note: Be sure to look in all areas where these
listed on the dosing card are correct. cards may be located in your facility. These cards
The dosing cards often find their way into pharmacists’, physicians’
or nurses’ pockets and are often posted on desks
were distributed to clinicians by or walls in areas such as, but not limited to, cath
Baxter pharmaceutical sales labs, critical care areas, emergency departments,
representatives. operating rooms, pharmacy, post-anesthesia care
units, and telemetry monitoring units.
Using the incorrect maintenance

infusion value (55000 mcg/min) could 2. Under no circumstances may these dosing
cause a patient receiving the infusion cards be used in their current form. Nurses,
to have an adverse clinical outcome. physicians, pharmacists and department
Baxter sent an Important Correction managers must (continued)...
of Drug Information letter to Directors
of Nursing and Directors of
Pharmacy on August 27, 2008, to
inform them of error within
Mandatory; Priority A Baxter BREVIBLOC Inaccurate Dosing Card AL09-03.pdf

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
(esmolol HCl) 2,500 mg/250 mL (10
mg/mL) Ready-to-use-Bags, 250 mL
bags. The Maintenance Infusion
listed under 100 mcg/kg/min for the
mcg/min setting is listed as 55000
(see below); it should read 5500.
Baxter reports that the other rates
listed on the dosing card are correct.
The dosing cards
were distributed to clinicians by

Baxter pharmaceutical sales
representatives.
Using the incorrect maintenance

infusion value (55000 mcg/min) 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
Mandatory; Priority A Baxter BREVIBLOC Inaccurate Dosing Card AL09-03.pdf

Not
5.12.25 Incorrect Patient Information Actions:
Displayed in CPRS v27 (AL09-04)
1. Medical Center Directors are instructed to send

When switching from one patient’s a certification message that a notification process
record to a second patient’s record in has been implemented whereby all clinical staff
the same session of CPRS while and users of CPRS have read and been made
using CPRS v27, the first patient’s aware of this Patient Safety Alert. The
information may still be displayed in certification message is to be sent from the
the second patient’s CPRS display, VAMC Director to the VISN Network Director to
impacting patient care decisions. It is the Office of the DUSHOM (10N). A VISN
not known at this time if data entered certification message must be sent to Megan
for the second patient will be placed Friel, Acting Chief Biomedical
in the incorrect record. This problem
occurs intermittently and has been Engineer, at megan.friel@va.gov, no later than 2
reported when viewing clinical data pm (EST) on Friday, November 7, 2008, which
on the Orders and Notes Tabs. 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)...
Mandatory; Priority A Incorrect Patient Information Displayed in CPRSv27 AL09-04.pdf

Not
5.12.25 (continued)... Incorrect Patient ...(continued) CPRS
(continued) Information Displayed in CPRS v27
(AL09-04) and then log onto CPRS again to continue your
activities.
When switching from one patient’s

record to a second patient’s record in 3. If users experience an “Access Violation”
the same session of CPRS while message or incorrect patient information after
using CPRS v27, the first patient’s switching from one patient’s CPRS record to a
information may still be displayed in second patient’s CPRS record, immediately
the second patient’s CPRS display, report the experience to your facility’s Clinical
impacting patient care decisions. It is Application Coordinator (CAC) or designee.
not known at this time if data entered Clinical Application Coordinators are responsible
for the second patient will be placed for reporting any occurrence to the VA Service
in the incorrect record. This problem
occurs intermittently and has been Desk (1-888-596-4357) or logging a national
reported when viewing clinical data Remedy ™ help ticket.
on the Orders and Notes Tabs.
Mandatory; Priority A Incorrect Patient Information Displayed in CPRSv27 AL09-04.pdf

Not
5.12.26 CPRS v27 - Discontinued orders are Actions:
no longer listed in order of
discontinuation date/time (AL09-05)
1. Medical Center Directors are instructed to send

a certification message that a notification 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
date, instead of the date the order certification message is to be sent from the
was discontinued when viewing VAMC Director to the VISN Network Director to
Active Orders or Recent Activity. In the Office of the DUSHOM (10N). A VISN
addition, the prefix “Discontinue” no
longer appears in the discontinued certification message should be sent to Megan
orders in this view. These changes Friel, Acting Chief
have resulted in reported delays for
stopping continuous infusion orders Biomedical Engineer, at megan.friel@va.gov no
(e.g., stopping IV heparin drips). later than 2 PM (EST) on Friday, November 7,
2008, which certifies that all VA medical centers
in that VISN have completed this notification
process.
2. Effective immediately, at the beginning of each

shift and every four (4) hours thereafter, nursing
staff shall review the BCMA Cover Sheet to
identify any IV’s or PCA’s that may have been
discontinued and are still infusing (see
Attachment 1).
Mandatory; Priority A CPRSv27 Discontinued Orders AL09-05.pdf

Not
5.12.27 Maxi Move patient lifts with lock and Actions:
load system (Combi Hanger):
Manufactured by Arjo between
November 2005 and April 2008.
(AL09-06) 1. By close of business December 2, 2008,
Biomedical Engineering will ensure that
replacement parts are ordered for affected Arjo
patient lift units (see Attachment 1).
There is the potential for the “Lock
and Load” hanger on the patient lift a. Units manufactured from November 2005,
to unintentionally become dislocated through August 4, 2006, require replacement of
when descending upon a rigid the entire T-bar assembly.
surface (e.g., a patient bed, the arm
rest of a chair, the side rails of a toilet b. Units manufactured from August 6, 2006 to
commode chair). If the hanger is April 7, 2008, require replacement of the T-bar
partially dislodged there is a potential bushings.
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 2. Until replacement components are installed,
been reported. Arjo has identified 75 immediately inform users of the reported issue
VA facilities affected by this 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.
Mandatory; Priority A Maxi Move patient lifts with lock and load system Arjo AL09-06.pdf

Not
5.12.28 Improper set-up and reprocessing of Actions:
flexible endoscope tubing and
accessories (AL09-07)
The Facility Director (or designee) will ensure that

all of the following three actions are carried out by
Correct tubing modified with an close of business January 7, 2009:
incorrect connector was used to
attach an Olympus flexible 1. All personnel who perform procedures with
endoscope to its irrigation source flexible endoscopes and/or reprocess
(Olympus Flushing Pump and endoscopes and their tubing and accessories
accessories). This resulted in a have read this Patient Safety Alert.
backflow of body fluids into irrigation
source tubing NOTE: Ensure you have identified all areas in
your facility
(where backflow should not occur)
during an endoscopic procedure. where reprocessing of flexible endoscopes
occurs, which may
include, but are not limited to the following:

Specifically, during some endoscopic Ambulatory
procedures, the facility used an
Olympus Auxiliary Water Tube (MAJ- Surgery, Endoscopy, GI, GU, OR, Respiratory,
855) that was modified to have an SPD, Urology,
Olympus Washing Tube (MH-974)
connector attached instead of the and Clinics to include CBOCs.
connector intended to be used with
the Olympus Auxiliary Water Tube
(MAJ-855). The Auxiliary Water
Tube (MAJ-855) is required to 2. For those facilities using the Olympus Flushing
connect the Auxiliary Water Port on Pump and compatible endoscopes, ensure that:
the endoscope to the Olympus
Flushing Pump (OFP) Filter
(7501335), which is connected to the
OFP Irrigation Tube (7501669). (See a. the set-up shown in Attachment 1 is being
the photograph in Attachment 1, consistently utilized.
which depicts proper set-up of the
Mandatory; Priority A OlympusScopeAL09-07.pdf

Not
5.12.28 (continued)... Improper set-up and ...(continued) modify, create, or enhance
(continued) reprocessing of flexible endoscope manufacturer
tubing and accessories (AL09-07)
tubings and accessories.
Correct tubing modified with an

incorrect connector was used to ii. the Olympus Auxiliary Water Tube (MAJ-855) is
attach an Olympus flexible supplied
endoscope to its irrigation source
(Olympus Flushing Pump and non-sterile, and needs to be reprocessed before
accessories). This resulted in a initial
backflow of body fluids into irrigation
source tubing use and after each patient using steam
sterilization (refer
(where backflow should not occur)
during an endoscopic procedure. to the instruction manual for your particular
endoscope).
Specifically, during some endoscopic

procedures, the facility used an iii. the OFP Filter (7501355) and OFP Irrigation
Olympus Auxiliary Water Tube (MAJ- Tube
855) that was modified to have an
Olympus Washing Tube (MH-974) (7501669) are supplied non-sterile, must be
connector attached instead of the sterilized
connector intended to be used with
the Olympus Auxiliary Water Tube prior to initial use, can be utilized all day, and
(MAJ-855). The Auxiliary Water must be discarded at the end of each day, as per
Tube (MAJ-855) is required to the manufacturer instructions.
connect the Auxiliary Water Port on
the endoscope to the Olympus
Flushing Pump (OFP) Filter
(7501335), which is connected to the iv. the OFP Fluid Container (7501352) is supplied
OFP Irrigation Tube (7501669). (See nonsterile,
the photograph in Attachment 1,
which depicts proper set-up of the
must be sterilized prior to initial use, can be
OlympusScopeAL09-07.pdf

Not
5.12.29 Suicide attempt in the Emergency Recommendations:
Room (ER) (AD09-05)
1. Staff in emergency rooms should be familiar

Holiday seasons can present with the Suicide Risk Assessment Pocket Card
challenges to both patients and staff. (see the Attachment).
For example, holidays can trigger
depression or suicidal ideation in
patients, and staff may experience
increased workload and stress and 2. Patients appearing to ER staff to be at risk for
have added distractions. self-harm should be kept in the line of sight, if
possible, while awaiting their evaluation.
Patients attempt or complete suicide

because they have both the will and 3. During the holidays (e.g., New Years, 4th of
the opportunity to do so. Staff July, Veteran’s Day, Thanksgiving, Winter
vigilance in the ER setting is Holidays, etc), ER staff should be aware of
essential since it is the most common potential risks of holiday decorations (e.g.,
area where these patients first banners, strings of lights, garland) that are not
present. typically in the environment.
Recommended; Priority A Suicide Attempt In ER-AD09-05.pdf

Not
5.13.1 Product Recall: Duragesic® 50 Actions:
mcg/h (Fentanyl Transdermal
System) CII (patch) National Drug
code (NDC) 50458-034-05, Lot #
0817239 (AL 09-08) By close of business January 16, 2009,
Pharmacy Chiefs will:
1) Assure that all remaining products with the

affected lot number
ALZA Corporation is recalling their (#0817239) at the facility are returned to

Duragesic® 50 mcg/h Fentanyl McKesson, the pharmaceutical
transdermal
prime vendor for VA. The product should NOT be
patches. A small number of these returned as instructed
systems may have a cut along one
side of the drug reservoir. The result in the manufacturer/distributor’s product recall
is the possibility of gel being released documents.
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. 2) Determine whether the affected lot number
Exposure to Fentanyl gel may lead to (refer to lot number provided
serious adverse events, including
respiratory depression and possible above) was dispensed to any patient(s). If so,
overdose, which may be fatal. 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.
Mandatory; Priority A DuragesicFentanylPatchAL09.08.pdf

Not
5.13.1 (continued)... Product Recall: ...(continued) breathing need emergency help.
(continued) Duragesic® 50 mcg/h (Fentanyl Family members or caretakers
Transdermal System) CII (patch)
National Drug code (NDC) 50458- should call 911.”
034-05, Lot # 0817239 (AL 09-08)
4) If patients cannot be reached by telephone,

follow-up with a letter. A
ALZA Corporation is recalling their sample letter can be found at:

Duragesic® 50 mcg/h Fentanyl
transdermal http://vaww.national.cmop.va.gov/PBM/Other
%20Documents%20and%2
patches. A small number of these
systems may have a cut along one 0Resources/Recall%20Patient%20Letter
side of the drug reservoir. The result %20Template.doc. This
is the possibility of gel being released
from the gel reservoir into the pouch template can be altered according to site-specific
in which the patch is packaged that needs.
will allow patients or caregivers to be
directly exposed to Fentanyl gel.
Exposure to Fentanyl gel may lead to
serious adverse events, including 5) Report any adverse reactions experienced
respiratory depression and possible
overdose, which may be fatal.
Mandatory; Priority A DuragesicFentanylPatchAL09.08.pdf

Not
5.13.2 Digital Television’s (DTV) transition Recommendations:
and affect on wireless medical
telemetry systems for physiologic
patient monitoring (AD 09-06)
Managing a practical approach to assessing and
mitigating risk associated
On February 17, 2009, all US with these new DTV stations includes the
television stations will stop following important steps.
broadcasting on
analog airwaves and begin

broadcasting only in digital. As a 1. Determine if the wireless medical telemetry
result, some system in the medical
of these new DTV station channels center operates within the 608-614 MHz (Channel
will now broadcast on Channels 36 37) telemetry band.
and
38, which are adjacent to an

authorized Wireless Medical 2. If the wireless medical telemetry system
Telemetry operates within the frequency
Service (WMTS) band (TV Channel band utilized by Channel 37, then:
37), increasing the risk for
interference
and the possibility for disruption of a. Check to determine whether a new station will
patient monitoring. be broadcasting
on Channel 36 or 38 and the proximity of the

transmitter to the
Many VHA medical centers operate
their wireless medical telemetry medical center. This information can be found at
systems within the Channel 37 http://www.fcc.gov/dtv/markets/.

WMTS band. Television stations
Recommended; Priority A DTVTransitionsAffectonMedicalTelemetryAD09-06.pdf

Not
5.13.2 (continued)... Digital Television’s ...(continued) potential risk
(continued) (DTV) transition and affect on
wireless medical telemetry systems and to possibly retune affected transmitters.
for physiologic patient monitoring
(AD 09-06)
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
systems within the Channel 37

Recommended; Priority A DTVTransitionsAffectonMedicalTelemetryAD09-06.pdf
POLICIES, TOOLS AND AIDS - Element 6

Not
Cognitive Aids
6.1.1 Is the Anesthesia Cognitive Aid Safety Staff to talk about implementation of the
provided on all anesthesia aid and give feedback on how the aid was
machines? received by affected staff. Look for aid on
anesthesia machines when walking the OR.
Recommended; Priority C cognitive_aids_anesthesiology.pdf
Cognitive Aids
6.1.2 Are the American Heart Association Safety Staff to talk about implementation of the
Handbooks being used and well aid and give feedback on how the aid was
received on all facility crash carts? received by affected staff. This aid should be
attached to all code carts in the facility.
Communication of Patient Tests Results

6.2.1 Does the facility have a written policy Policy should include: 1) Description of the
for communication of emergent or process for communication of test results to the
abnormal diagnostic findings? requesting providers (or surrogates) and how and
when the documentation of this communication
should occur.
Mandatory; Priority A VHA Directive 2003-043 Test Results.pdf
6.2.1.1 Is there a process to address the Often reports from these entities do not get
receipt of fee basis and outside placed in the electronic record due to limited or
contract diagnostic practitioner no access. However, the facility should
reports? recognize this vulnerability and ensure a process
exists to address situations so these results are
entered with the medical record.
Recommended; Priority B VHA Directive 2003-043 Test Results.pdf
6.2.2 Are all results (positive or negative) Documentation should include appropriate test
documented electronically by the related patient history to assist radiologist,
diagnostic provider in the patients laboratory, or nuclear medicine personnel in
medical record in a timely manner? making a judgment call on critical findings. A
standard process should be in place to handle fee
basis and outside contract reports which often do
not get scanned in the electronic chart.
IL 10-2002-017.pdf
Policies, Tools Aids - 6 Policies, Tools Aids - 6 - Version: 01.30.2009 277 of 578

Not
6.2.3 Are emergent and abnormal Direct communication is defined as face-to-face
diagnostic test results communicated telephone conversation; or via a hand carried
directly from the diagnostic report (electronic communication does not
practitioner to the ordering suffice). This direct communication (from the
practitioner or ordering practitioner’s diagnostic practitioner to the ordering practitioner
appropriate surrogate? or his/her surrogate) and any subsequent change
in care plan must be documented in the VistA
computer system. The test results and care plan
changes must also be communicated to the
patient and/or family by the ordering practitioner
(or surrogate).

Patient Safety Mental Health Concerns
6.3.1 Have suggested strategies in The Information letter recommends the following:
Information Letter IL 10-2006-013 Develop and implement strategies to properly
been implemented to address JC assess, treat, and manage patients identified at
National Patient Safety Goal 15, risk for suicide; document the relevant risk factors
Mitigating the Risk of Suicide? for suicide in each patient's medical record;
document treatment and the treatment setting in
a manner that addresses the presence of (or
absence of) relevant risk factors that increase risk
for suicide and features that may decrease risk
for suicide; provide the appropriate telephone
number(s) for calls during working hours and
other times, in writing, to at-risk patients and/or
significant others (also document this in the
patient’s medical record); instruct patients and
their significant others to call the facility's
Emergency Department or Urgent Care Center if
they have a crisis situation (or local suicide
prevention hotlines if after hours); ensure that the
safety concerns in the design of the inpatient
mental health unit (and its furnishings) are
addressed; and, establish and implement
(continued)...
Mandatory; Priority A USH IL-10-2006-13.pdf

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 that VA patients receive emergency support and
address JC National Patient Safety referral to the VA as soon as possible.
Goal 15, Mitigating the Risk of
Suicide?
Mandatory; Priority A USH IL-10-2006-13.pdf
6.3.2 Has the facility implemented the The primary purpose of the High Risk for Suicide
required actions of VHA Directive PRF is to communicate to VA staff that a veteran
2008-036 Use of Patient Record is at high risk for suicide and the presence of a
Flags to Identify Patient at High Risk flag should be considered when making treatment
for Suicide? 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 patient’s 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)...
Mandatory; Priority A VHA Directive 2008-036 record flags.pdf

Not
6.3.2 (continued)... Has the facility ...(continued) is placed on a patient’s chart, it is
(continued) implemented the required actions of re-evaluated at least every 90 days to ensure that
VHA Directive 2008-036 Use of the PRF is promptly removed when the high risk
Patient Record Flags to Identify status is resolved. (Chief of Staff) 1. Instituting
Patient at High Risk for Suicide? 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.
Mandatory; Priority A VHA Directive 2008-036 record flags.pdf

Patient Safety Environmental Concerns
6.4.1 Is the Domestic hot water "Facility should have a local policy that addresses
temperature controlled via regulating criteria listed in the related VA Directive, such as
hardware and preventative the risk assessment process, search procedures,
maintenance inspections/checks? and staff training plan. Review documents to
verify. Also if a patient is determined missing, the
local law enforcement should be contacted and
the patient put into the National Crime Information
Computer (NCIC) system. These agencies must
also be informed in a timely manner to cancel this
alert when a missing patient is recovered. This
policy should not preclude those Police and
Security Services units from entering this data
themselves provided they have the capability to
do so."
JCAHO_CAMH.pdf /A Page=349
Mandatory; Priority A VHA Directive 2002-073.pdf

Not
Patient Safety Environmental Concerns
6.4.2 Has the facility reviewed the This Information Letter addresses bed bug
information in IL 10-2008-011 Under issues, and is provided to assist staff at Veterans
Secretary for Helath's Information Health Administration (VHA) facilities in
Letter on Bed Bugs, and taken the diagnosing patients presenting with bed bug
detection, intervention, patient care bites, recognizing bed bugs, and preventing and
and prevention strategies into mitigating bed bug infestations at VHA facilities.
consideration? NOTE: Information for use in educating patients
on bed bug infestations in community-based
residences is provided in Att. A of the Directive.
Recommended; Priority A IL 10-2008-011 bed bugs.pdf

Escape & Elopement Prevention
6.5.1 Does the facility have a written plan The facility should have a local policy that
to help prevent wandering and addresses criteria listed in the related VA
missing patient events and a process Directive, such as the risk assessment process -
to manage the events that do occur? 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.
Mandatory; Priority A VHA Directive 2008-057 missing pt.pdf

Not
6.5.2 Are Missing Patient incidents both Actual SAC score of 3 requires an individual
adverse events, and, close calls with RCA to be done. All others should be an
a SAC potential score of 3, aggregated review (twice per FY) focusing on
addressed via the Aggregate Review fixing related processes.
Process?
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.
VHA Directive 2008-057 missing pt.pdf

Mandatory; Priority A VHA Handbook 1050 01 PSI.pdf
6.5.2.1 Does the missing patient event log The Missing Patient Aggregated Review Log
capture the information outlined in should contain the following 17 elements for each
SPOT for each case? event and close call: Case number, Age, Date,
Time & Location reported missing; Length of time
missing; Level of privileges; Previous episodes; if
treatment plan reflects an order of supervision;
primary diagnosis; persons notified (name, date
and time); type of search conducted (general or
grid); date and location found; condition (injuries);
barriers to prevent escape or elopement; and,
activity at time of elopement or escape.
Mandatory; Priority A Agg review criteria.pdf

Not
6.5.2.2 Does the information captured in the The purpose of capturing information in the log is
log used to drive the root causes, for the aggregate team to analyze trends in the
actions and outcomes in the data collected to help determine where there is a
aggregated reports? need to focus, such as a particular facility
location, time of day, patient population, etc.

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.

Not
6.5.4 Is the prevention and effective VHA Directive 2008-057 addresses two areas for
management of wandering and prevention:
missing patient being addressed?
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.

Not
6.5.5 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?

Not
Fall Prevention
6.6.1 Are Fall incidents both adverse Actual SAC score of 3 requires an individual
events, and, close calls with a SAC RCA to be done. All others should be an
potential score of 3, addressed via aggregated review (once per FY quarter) focusing
the Aggregate Review Process? on fixing related processes.
completefallstoolkit.pdf
Mandatory; Priority A VHA PS Handbook.pdf
Fall Prevention
6.6.2 Does the patient falls event log The Patient Falls Aggregated Review Log should
capture the information outlined in contain the following 11 elements for each event
SPOT for each case? and close call: Case number; Age; Sex; Event
(day, date, time); Outpatient/Inpatient status;
functional and cognitive factors; assistive devices
in use or ordered; communication issues (staff to
staff, staff to patient, etc.); environmental factors;
what happened and treatment plan; other
comments.

Fall Prevention
6.6.3 Have facility Physical Therapists Show example via review of SPOT team
been involved as team members for membership data for aggregate review RCAs.
RCA's or Aggregate Reviews Also talk with Physical Therapy Service to
involving Falls? determine their involvement.
Mandatory; Priority A JCAHO 2007 Goals - TIPS Article.pdf
Fall Prevention
6.6.4 Does a process exist to conduct an Review assessment/reassessment process. The
initial assessment, and subsequent assessment methods and/or tools used should be
reassessments as appropriate on all consistent throughout the facility. The
patients for fall risk? reassessment process is determined at the
facility level, can be based on an interval of time
or on patient status change (transfer, medication,
fall incident, etc.).
Mandatory; Priority A JCAHO 2007 Goals - TIPS Article.pdf

Not
Fall Prevention
6.6.4.1 NCPS Falls Toolkit and Fall The Falls Toolkit provides a compendium of
Prevention and Management practical suggestions to improve falls programs
cognitive aid been distributed and and reduce falls and injuries from falls.
used? Templates, successful practices, cognitive aids
and advice on measuring are all included in their
resources. The Fall Prevention an Management
is an older NCPS cognitive aid that can also
helpful to determine assessment and prevention
methods.
Recommended; Priority B completefallstoolkit.pdf

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 Review written plan. The program should
Safety Program? include: The appointment of an MRI Officer; how
to secure MRI areas; a current list of MRI
compatible equipment in the facility; 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

Not
6.7.2 Is there an on going training and Review training materials, plan and training
competency program for all effected records. Check to see if that not only necessary
staff that covers hazard recognition clinical personnel are trained, but that
and policies/procedure? emergency, transport, maintenance,
housekeeping, security, and medical
residents/fellows are included as well. If clinical
or support are not trained they should not be
allowed to work in the direct vicinity of the MR
equipment.
MRI Hazard Summary 2008.pdf

Recommended; Priority B SEA 38 MRI.pdf
6.7.3 Are MR technicians trained and Review training materials, training plan, and
competent in the specifics of MR records. "Specifics of MRI Safety" include items
safety? 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.

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.


Not
6.7.5 Has the MR Hazard Supplement The Hazard Summary published by NCPS in
developed by NCPS been shared 2001 and updated in 2008 can serve as a
with all MR staff and discussed to guideline and a reference for those working in an
determine what barriers are being MR environment. This Hazard summary can be
implemented locally to prevent found on the NCPS intranet and internet
adverse events? websites: vaww.ncps.med.va.gov or
www.patientsafey.gov
Recommended; Priority B MRI Hazard Summary 2008.pdf
6.7.6 Has a plan been developed and Regular code drills should be conducted in the
tested to address patients who need MR environment to help acclimate medical
emergency care (code) within the responders to a consistent approach of removing
MR room? the patient from the magnet area. Codes or drills
should not be conducted in the magnet room.

6.7.7 Has the ventilation system for the Cryogen vent systems should be adequately
cryogenic gas been inspected by a designed, as minimum design requirements have
qualified individual to ensure it is been revised by some MR system suppliers, and
capable of functioning and not the system are to be inspected by qualified
obstructed? individuals at least annually.
Recommended; Priority A MRI Hazard Summary 2008.pdf
Medication Use Process Safety Concerns
6.8.1 Is VHA Quality Directive for Unit- Facility is required to have a written policy within
Dose Packaging and Barcode each inpatient pharmacy; and, all Medication
Labeling being followed? must have machine-readable bar-coded labels.
Mandatory; Priority A Quality unit-dose barcode.pdf

Not
6.8.1.1 Are measurables of this directive BCMA coordinators are responsible for
(VHA 2006-008) being followed up establishing baseline data and measuring the
on? process over time. Also direct observation must
be done to determine the scannability of different
medications for a total of twenty observations per
quarter. Assessor to review related
documentation to verify.
Mandatory; Priority A Quality unit-dose barcode.pdf
6.8.2 Is communication with the patient These strategies should include medication
about medications part of the reconciliation and patient education regarding
adverse-drug event prevention prescribed medication.
strategy?
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
Recommended; Priority A JC- CAMH MM-06-01-03.pdf
6.8.3 Does the facility have contingency Review plan, interview staff.
plans in place for the loss of the
CPRS, POE, BCMA, and VISTA
system?
6.8.3.1 Have these information system It is important to ensure your contingency plans
contingency plans been tested (via a are realistic and workable, it is not ideal to find
drill), which included a faults in the plan at the time of an emergency.
debriefing/critique? After testing, if problems are found the plan
should be adjusted accordingly.

Not
6.8.4 Does the hospital show efforts to The facility Director is responsible for:
manage High-alert medications
appropriately? (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

Mandatory; Priority A VHA Directive 2008-027 The Availablity of Potassuim Chloride for Injection Concentrate USP

Not
6.8.4 (continued)... Does the hospital ...(continued) only,
(continued) show efforts to manage High-alert
medications appropriately? (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 patient’s
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 perfusionist’s cabinet.
IHI 5 Million Lives Kit - Prevent Harm from High-Alert Medications.doc
The Joint Commission MM.01.01.03

Mandatory; Priority A VHA Directive 2008-027 The Availablity of Potassuim Chloride for Injection Concentrate USP

Not
6.8.5 As VA Directive 2008-028 stipulates, The facility Director, or designee, is responsible
If requested by a VA prescriber, does for ensuring written policies are established to
the VA medical center pharmacy address the timely delivery of urgently needed
staff make urgently needed outpatient prescription medications.
outpatient prescription medication
available to patients within 24 hours
of notification, using the most
appropriate means available, The VA prescriber must notify the pharmacy
including CBOCs? when a new prescription or refill is urgently
needed due to a change in the patient’s 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 patient’s
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)...
Mandatory; Priority A VHA Directive 2008-028 urgent outpt meds.pdf

Not
6.8.5 (continued)... As VA Directive 2008- ...(continued) shipping the medication overnight
(continued) 028 stipulates, If requested by a VA 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?
Mandatory; Priority A VHA Directive 2008-028 urgent outpt meds.pdf

6.8.6 Has a anticoagulation therapy See Attachment A of the Draft VHA Directive on
management program been Anticoagulation Therapy Management.
implemented?
Mandatory; Priority A VHA DRAFT Dir Anticoag.DOC
Misidentification Prevention
6.9.1 Is there a SOP for ordering, VHA Directive requires a written Standard
processing, transporting, and Operating Procedure regarding verification of
transfusing blood or blood products patients' identification. Assessor to review SOP.
according to VHA Directive 1200-
029, Transfusion verification and
identification requirements of all
Sites?

Not
Medical/Surgical Resident PS Involvement (ACGME)
6.10.1 Have patient safety topics, exercises, Incorporating patient safety at the prime level of
and educational opportunities been medical training can fulfill some requirements of
incorporated in the resident the Accreditation Council on Graduate Medical
training/curriculum at your facility? 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
Recommended; Priority B http://www.patientsafety.gov/curriculum/index.html

Not
Surgical and Invasive Procedures Safety
6.11.1 Is a surgical policy been developed Policy should address: pre-closing wound
and implemented to meet the criteria exploration for every case; towels, sponges,
in the VHA Directive 2006-030 pads, etc. are not to be cut or used for dressings
Prevention of Retained Surgical and must be detectable by radiograph; counting
Items? methods must comply with AORN standards;
sponges, towels, pads and sharps must be
counted in all applicable cases; if count is
incorrect staff must inform surgeon, conduct a
search, and radiography of the surgical field must
be done with a radiology interpretation with in 30
minutes where applicable; requirement for
divergence from standard practice to be
documented. Policy should also include special
precautions for high risk surgeries, and indicate
the a process in place to locally review all
retained items close calls and adverse events
and require them to be reported appropriately to
NCPS.

6.11.2 Has the Ensuring Correct Surgery To meet the Directive the following must be met:
Directive been fully implemented? (1) A local policy is in place that incorporates the
steps as described on the correct Site Surgery
poster. (2) The execution of these steps is
documented in the patient's record. (3) The
implementation of the steps and conformance to
the local policy are monitored for compliance.
Mandatory; Priority A VHA Directive 2004-028 (2002-070).pdf

Not
6.11.3 Is a written local policy in place that A local written policy can be incorporated into an
address moderate sedation done by overall facility sedation and anesthesia care
non-anesthesia providers? policy. Moderate sedation section should include:
requirement for privileged staff to be involved in
the planning and providing for moderate sedation;
patient chart shall include history and physical
that is done less than 30 days prior to procedure;
all assessments must be signed by a licensed
independent practitioner prior to sedation; a re-
evaluation should occur immediately before
procedure, with vital signs documented;
requirement that sufficient numbers of qualified
staff are present during sedation. Also, the policy
should address staff that administer, monitor,
and/or supervise moderate sedation have had
competency based education, training and
experience that follow criteria required in the
related VHA Directive.
Recommended; Priority A VHA Directive 2006-023.pdf

6.11.4 Is there an effort being made to IHI has recognized four practices that may help to
reduce surgical complications? 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

Recommended; Priority B IHI 5 Million Lives Kit - Prevent Surgical Site Infections.doc

Not
Pressure Ulcer Management
6.12.1 Are pressure ulcers effectively The responsibilities of the medical Center Director
addressed through an assessment, are: a) at risk patients receive appropriate
management and prevention assessment and care; b) a patient with pressure
program that includes delineated ulcers is treated to heal, prevent infection and
responsibilities outlined in VHA prevent new sores; c) a system is in place to be
Handbook 1180.2? 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.
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

Mandatory; Priority A VHA Handbook 1180.2 Assessment and Prevention of Pressure Ulcers

Not
6.12.1 (continued)... Are pressure ulcers ...(continued) at least every 48 hours. Long term
(continued) effectively addressed through an 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

Mandatory; Priority A VHA Handbook 1180.2 Assessment and Prevention of Pressure Ulcers

Not
6.12.2 Is a pressure ulcer risk assessments Risk Factors:
conducted at the time of admission
and are subsequent re-assessments a. Evidence suggests that risk factors include
appropriate and timely in accordance immobility and the associated friction and
with VA Handbook 1180.2? 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)...
Mandatory; Priority A VHA Handbook 1180.2 Pres Ulc.pdf /A Page=9

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 re- integral part of preventing pressure ulcers.
assessments appropriate and timely Factors that have been determined to place
in accordance with VA Handbook patients at an increased risk of pressure ulcers
1180.2? 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 individual’s condition

Not
6.12.2.1 Is the pressure ulcer assessment COMPREHENSIVE ASSESSMENT
comprehensive and include the use
of the Braden Scale? 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 patient’s intrinsic risks, the
patient’s 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)...

Not
6.12.2.1 (continued)... Is the pressure ulcer ...(continued) exposure to moisture
(continued) assessment comprehensive and
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 patient’s 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 individual’s 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).

Not
6.12.2.2 Are required pressure ulcer Doumentation
assessments appropriately
documented? 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)...

Not
6.12.2.2 (continued)... Are required pressure ...(continued) electronic medical record CPRS-
(continued) ulcer assessments appropriately Veterans Health Information Systems and
documented? 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)
Mandatory; Priority A as appropriate.
VHA Handbook 1180.2Only trained
Pres Ulc.pdf Wound Care
/A Page=11

Not
6.12.3 Is the prevention of pressure ulcers PREVENTION
managed by the appropriate
caregivers (interdiciplinary team); a. The first step in prevention is the identification
and is care planning a part of the of the patient at risk of developing pressure ulcers
team's responsiblities including using the Braden Scale risk level (see App. C of
patient/family edcuation? 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)...

Not
6.12.3 (continued)... Is the prevention of ...(continued) Rehabilitation Staff (e.g.,
(continued) pressure ulcers managed by the Occupational Therapist, Physical Therapist), and
appropriate caregivers a Wound Care Specialist.
(interdiciplinary team); and is care
planning a part of the team's (1) The Primary Provider needs to be familiar with
responsiblities including team function and organization with established
patient/family edcuation? 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 patient’s total risk score, the

interdisciplinary team is responsible for the
patient’s care and will review each risk factor and
potential cause(s) individually to:
(1) Identify those factors that increase the
VHA Handbook 1180.2 Pres Ulc.pdf /A Page=11

Not
6.12.4 Does the facility have the required It is VHA policy that all acute care inpatients,
local procedures in place to assess nursing home residents, home care and high risk
and treat patients and residents for outpatients must be screened for risk of skin
sink breakdown; and is the process breakdown, and must receive appropriate
documented in accordance with VHA interdisciplinary management with appropriate
Directive 2006-066 Reporting and documentation to support the review of these
Tracking of Pressure Ulcers? processes.
Mandatory; Priority A VHA Directive 2006-066 Track Pres Ulc.pdf

6.12.4.1 Are organization processes in place The SOARS assessment guide can be found at:
to meet the intent of the System-wide http://soars.vssc.med.va.gov/Assessment
Ongoing Assesssment and Review %20Tools/default.aspx
Strategy (SOARS) assessment guide
for pressure ulcers and the MDS
Pressure Ulcer Quality Indicators for
Nursing Home Residents? 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
Mandatory; Priority A 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?
Mandatory; Priority A JCAHO_CAMH.pdf

Not
Violence Prevention
6.14.2 Has the facility and/or VISN It is VHA policy that all facilities must have
implemented the use of behavioral installed the required patches and initiated
patient record flags (PRFs) into the facility-wide use of Behavioral Patient Record
medical record (CPRS/VIST-A) to Flags (PRFs). Ensure that Category I Behavioral
indicate a potentially violent patient? PRFs are originated and accessible. Individual
Networks and facilities determine whether
optional Category II PRFs are to be used.
Category definitions are found in related VHA
Directive.

Hospital Acquired Infections Prevention
6.15.1 Has the recommendations for the Prevention recommendations are: early
prevention of Norovirus (Norwalk-like identification; implementation of contact
viruses) in VHA Information Letter IL- precautions of infected patients (48-hours post
10-2007-010 been applied? symptoms); infected staff should remain off duty
(48-hours post symptoms); cleaners to wear
masks; patient and staff hand hygiene and
training; and, environment of care cleaning
regimen (outlined in Information Letter) if
contamination of an area has occurred.
noro-factsheet.pdf
Recommended; Priority B IL 10-2007-010 noro.pdf
6.15.2 Have stringent institutional practices The following precautions are recommended in
that minimize the potential for spread the care of patients with C. Difficile: caregiver
and transmission of C. difficile been should use gloves when in contact with the
implemented? patient along with the use of antimicrobial soap
after care is given (alcohol based hand rubs may
not be sufficient); private patient rooms should be
provided and disposable rectal thermometers
should replace electronic devices for affected
patients."
Recommended; Priority B USH IL-10-2005-018.pdf

Not
6.15.3 Has an influenza vaccination It is VHA policy that a program be implemented at
program been implemented? 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
Mandatory; Priority A VHA Directive 2008-057 Flu 08-09.pdf
6.15.4 Has the MRSA Initiative been The Methicillin-Resistant Staphylococcus Aureus
implemented at the facility? (MRSA) Initiative was set forth in the VHA
Directive 2007-002. It includes the
implementation of the following: Active
Surveillance/Screening on unit where the initiative
has been implemented; where patients are found
positive Contact Precautions are required
(defined by CDC) and the patient will become
"flagged" as being positive until testing negative;
the Hand Hygiene program plays an important
role with MRSA-positive patients and should be in
place. The Resources required to fully implement
this Directive are: adequate staffing in the
Laboratory to support the initiative; and the
appointment of an MRSA Initiative Coordinator.
CDC Isolation2007.pdf
IHI 5 Million Lives Kit - MRSA.doc

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

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?

Not
6.15.6 Is there an effort being made to Central venous catheters can disrupt the integrity
reduce the incidence of central line of the skin, making infection with bacteria and/or
infections? fungi possible. Infection may spread to the
bloodstream increasing the changes of sepsis
which can lead to death, and/or prolong
hospitalization. The Institute of Healthcare
Improvement's 100k Lives Campaign gives
detailed guidance on how to help reduce
incidence of occurrence by following the five
components of the "central line bundle." These
components are: 1) Hand hygiene; 2) Maximal
barrier precautions; 3) Chlorhexidine skin
antisepsis; 4) Optimal catheter site selection, with
subclavian vein as the preferred site for non-
tunneled catheters; 5) Daily review of line
necessity, with prompt removal of unnecessary
lines.
Recommended; Priority B IHI 5 Million Lives Kit - Prevent Central Line Infections.doc
6.15.7 Is there an effort being made to VAP is the leading cause of death among
reduce the incidence of Ventilator- hospital-acquired infections. VAP can prolong
Associated Pneumonia (VAP)? time spent on the ventilator, length of ICU stay,
and length of hospital stay after discharge from
the ICU. The Institute of Healthcare
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)
Recommended; Priority B IHI 5 Million Lives Kit - Prevent Ventilator-Associated Pneumonia.doc

Not
6.15.8 Are patients that are high-risk for, Directive 2008-082 stipulates (Exerpts from the
exposed to, diagnosed with, or being Directive):
treated for HIV being managed
appropriately through the
implementation of VHA Directive
2008-082 National HIV Program and Now that HIV can be seen as a treatable chronic
USH IL-10-2005-17? 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

Mandatory; Priority A VHA Directive 2008-082 National HIV Program

Not
6.15.8 (continued)... Are patients that are ...(continued) diagnosis and care of HIV-infected
(continued) high-risk for, exposed to, diagnosed veterans.
with, or being treated for HIV being
managed appropriately through the (2) Reviewing, on an annual basis, the contact
implementation of VHA Directive information for the facility’s HIV Lead Clinician.
2008-082 National HIV Program and Any changes in staffing or the contact information
USH IL-10-2005-17? 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 HIV-
infected 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 to benefit the health of veterans
HIV testing.pdf
Mandatory; Priority A VHA Directive 2008-082 National HIV Program

Not
Fire Prevention for Patient Safety
6.16.1 Has the facility abided by the Actions for this Directive include: Implementation
directions set forth in VHA Directive- of a local policy; and, Implementation of staffing
2004-037 Planning for Fire levels for fire response based on assessed needs
Response? (for overnight patient care buildings not fully
sprinkler-protected the staff to patient ratio is 1
responder to every 2 non-ambulatory patients; or,
overnight patient care buildings fully sprinkler-
protected the ratio is 1 responder to every 4 non-
ambulatory patients.)

6.16.2 Have the appropriate measures been A policy must be written and implemented that
implemented to reduce the fire addresses items below: Each facility must ensure
hazard of smoking when oxygen that smoking is prohibited in patient sleeping
treatment is expected for inpatients rooms; that oxygen cylinders/delivery equipment
as required by VHA Directive 2006- are not permitted within smoking shelters; and
021? 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)...

Not
6.16.2 (continued)... Have the appropriate ...(continued) facility; and high-risk patients are be
(continued) measures been implemented to 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 A policy must be written and implemented that
for home care patients who have addresses items below: A fire risk assessment is
oxygen therapy prescribed as well? conducted for all new oxygen therapy home care
patients with reassessments as directed; contract
serves must require education and/or warning
information for patients and families/caregivers on
the hazards of smoking while oxygen is in use;
vendor's checklist should include inspection for
warning signs, smoke alarm and verification
veteran has been instructed to test alarms
monthly, instructions for oxygen use/shut off, and
verification that veteran/family/cohabitants are
given fire/oxygen hazard educational materials.
Vendors are required to notify clinical staff if
smoke alarms are not present or not functioning.

Not
Other Patient Safety Initiatives
6.17.1 Has a facility assessment of all The 2001 VHA Patient Safety Alert on Bed
patient beds been completed in Entrapment requires an assessment hospital
accordance with 2001 VHA Alert on beds which address two entrapment zones.
Bed Rail Entrapment and 2005 FDA Official FDA guidance was released in March
guidance to reduce entrapments with 2006 which addresses the assessment of 4
appropriate actions taken? zones. Ensure the facility has initiated a hospital
wide assessment with marking of non-compliant
beds and a plan for replacement of these beds.
FDA Guidance to Reduce Entrapments 2006.pdf

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

Not
6.17.4 Has the facility developed and This Directive stipulates implementing a policy
implemented a policy to address the with the componets of this program, which are: A
sterility of non-biological implanable description of the processes and procedures to
devices in accordance with VHA be followed if the non-biological implantable
Directive 2007-001? device is not sterile upon receipt; Who in the
operating room is responsible for: (a) Checking
the integrity of the package appropriate color
change of the external chemical indicator tape,
expiration date, and (b) Documenting this check
prior to use; Who in the facility is responsible for
managing an inventory of all routinely-used non-
biological implants, such as screws or nails or
plates that are needed in sets of assorted sizes
and not on consignment. Relase of statements
that: non-biological implantable devices are not
to be sterilized by flash sterilization; all
sterilization loads containing these non-biological
implantable devices are monitored with the
appropriate biological monitor; and, after
sterilization, non-biological implantable devices
are quarantined in SPD and not released
(continued)...
Mandatory; Priority A VHA Directive 2007-001 Implantable Devices.pdf

6.17.4 (continued)... Has the facility ...(continued) until the spore test is found to be
(continued) developed and implemented a policy negative (48 hours).
to address the sterility of non-
biological implanable devices in
accordance with VHA Directive 2007-
001?
Mandatory; Priority A VHA Directive 2007-001 Implantable Devices.pdf

Not
6.17.5 Has the use of Rapid Response Rapid Response Teams or Pre-code teams can
Teams been implemented? be implemented to help prevent a patient from
reaching code status by systematically employing
a team of individuals as "go to" staff for patients
that show declining status or other causes for
concern. The Institute of Healthcare
detailed guidance on how to help institutions
implement teams by offering recommendations
about how to structure teams, use of SBAR
communication, criteria for calling a code, setting
response times and more.
Recommended; Priority B IHI 5 Million Lives Kit - Rapid Response Teams.doc

6.17.6 Is there an effort being made to Studies have shown that patients with AMI should
improve the treatment and outcomes receive specified components of care in order to
for patients with Acute Myocardial reduce morbidity and mortality. Specificities of
Infraction (AMI)? 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

Not
6.17.7 Is there an effort being made to Numerous studies have established a firm
improve the treatment and outcomes evidence base indicating that specific
for patients with Congestive Heart components of CHF care reduce morbidity and
Failure (CHF)? mortality. IHI has recommended the following
seven key care components be provided to all
CHF patients, in the absence of contraindications
or intolerance: 1. Left ventricular systolic (LVS)
function assessment. 2. ACE-inhibitor or
angiotensin receptor blockers (ARB) at discharge
for CHF patients with systolic dysfunction (Left
Ventricular Ejection Fraction (LVEF) <40%). 3.
Anticoagulant at discharge for CHF patients with
chronic or recurrent atrial fibrillation (AF). 4.
Smoking cessation advice and counseling. 5.
Discharge instructions that address all of the
following: activity level, diet, discharge
medications, follow-up appointment, weight
monitoring, and what to do if symptoms worsen.
6. Influenza immunization (seasonal). 7.
Pneumococcal immunization
Recommended; Priority B IHI 5 Million Lives Kit - CHF.doc

6.17.8 Have the recommendations in the VA clinicians should follow the manufacturer’s
information letter IL 10-2007-018 for instructions for catheter use. Catheters identified
Intermittent Catheterization and the as single-use devices should not be re-used in
use of sterile catheters been any setting. Patients should be provided with an
implemented in that catheters are not adequate number of catheters to use a sterile
reused? catheter each catheterization. Patients, family
members, and attendants need to be informed
that catheters are identified for single-use only.
Recommended; Priority A IL 10-2007-018 inter cath.pdf

Not
Tubing Management
6.18.1 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 Interview staff regarding what tubings are defined
that identifies high risk tubings such as high risk by the organization and what labeling
as epidural or arterial lines and which practice they have standardized across the
requires labeling of such high risk organization.
lines?
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?
Tubing Management
6.18.4 Does the organization have a policy Ask to review policy.
in place prohibiting purchase of non-
intravenous equipment (e.g., blood
pressure devices, oxygen tubing,
etc.) that can physically connect with
or without force with luer slip and luer
lock IV line connectors?


Not
Tubing Management
6.18.5 Do all staff, including housekeeping, Ask to see content used for orientation of new
ancillary staff, transport staff, employees.
volunteers, and students have
content included in their orientation
and annual review about the risks
associated with tubing
misconnections?
Tubing Management
6.18.6 Can the organization describe, as Ask to see staffing measures improvement
part of its staffing measures and documents and identify whether the organization
improvement activities, efforts it has has included staff fatigue as a variable. This
taken to identify and manage risks would be evidenced by things such as controls
associated with staff fatigue and related to overtime, number of days worked in
mistakes such as misconnections? sequence, shift work considerations, etc.

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
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 Facility unit/ward name:

Not
Bed Safety
7.1.1.1 If bed rails are installed/used are Entrapment can result in suffocation. Follow July
they free of entrapment potential (for 2001 NCPS Patient Safety Alert Action items
patients identified as high risk for including: assessing existing beds for horizontal
entrapment): 1) rail to mattress, 2) gap between mattress and bed rail must be less
between split rails, 3) rail to board - than 2 3/8 inches when the mattress is pushed to
either end, 4) board to mattress, or, the opposite side; permanently mark all non-
5) within rail? complying bed assemblies; fill gaps created
between the mattress and bed rail that are equal
or wider than 2 3/8 inches for high risk patients;
reduce the rail to rail openings, and openings with
in rail gaps to less than 4 3/4 inches by using rail
netting, clear padding or retrofit kits; ensure new
beds purchased meet requirements.
FDA Hospital Bed Safety.pdf

BedEntrap.pdf
Mandatory BedEntrapPoster.pdf
Bed Safety
7.1.1.2 When beds and/or mattresses are re- New beds brought into the facility should meet
ordered for purchase or lease are the entrapement criteria.
they reviewed for entrapment risk?
Recommended
Bed Safety
7.1.1.3 Are non-compliant beds clearly All new beds must meet requirement, & existing
marked as to indicate entrapment non-compliant beds marked. Staff should be
risk? knowledgeable about the markings and
requirements.
Mandatory BedEntrap.pdf
Bed Safety
7.1.1.4 Are beds designed to facilitate Bed attributes would include: Stand assistive
patient transfer? devices to assist patients to stand, room for base
of lifting device to fit under the bed, clear area
around bed for staff and lifting equipment access,
variable position capabilities.
Recommended OSHA Guidelines Nursing Homes.pdf
Long Term Care - 7.1 Long Term Care - 7.1 - Version: 01.30.2009 325 of 578

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

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

Not
Code Carts
7.1.2.3.1 Are there post-code, other debriefing Evaluation of codes in key for improving
forms that are filled out to offer performance. Review any documentation that is
feedback on how codes are available regarding code review if any.
preformed to allow feedback
regarding process improvements?
Recommended
Code Carts
7.1.2.4 Is the VHA modified version of the Inspect top of cart and review checklist of
ECC (Emergency Cardiac Care) contents if provided.
AHA (American Heart Association)
Handbook of Cardiovascular Care
Cognitive Aid located on all carts?
Recommended
Code Carts
7.1.2.5 Are CO2 detectors available on code Inspect carts. Adjunctive devices (i.e. 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 VHA Directive 2005-031.pdf
Code Carts
7.1.2.6 Is there a standardized system (e.g. Cart should be locked with an integrity seal, look
checklist) or method used to verify for a valid checklist or equivalent system on the
that code carts are fully stocked and cart, dated with last check/update date. Items
properly equipped before they are such as these should be on the checklist: O2
sent to the units and a daily tank volume; tubing ; CO2 detectors; appropriate
inspection on each unit? medications; AED (or other defibrillators) and
suction machine functionality; laryngoscope with
batteries; cardiac board, etc.
Recommended

Not
Electrical Safety
7.1.3.1 Are electrical receptacles in, or All areas designated as wet locations, or areas
serving, wet areas or behavioral used for behavioral health patients, require (wet)
health areas provided with Ground or recommend (behavioral health) ground-fault
Fault Circuit Interruption (GFCI) protection. These types of receptacles are
protection or an isolated power designed to stop the flow of electrical current,
system? preventing shock or electrocution. For behavioral
health areas, electrical receptacles must be
protected, covered, or completely removed in
patient rooms to protect patients who my try to
harm themselves.
http://vaww.ceosh.med.va.gov/
NFPA 99 ch 4.pdf /A Page=03
Mandatory NFPA 99 ch 4.pdf /A Page=04
Electrical Safety
7.1.3.2 Are electrical receptacles fitted with Observe conditions on unit.
covers, secured, and free of loose or
exposed wiring?
Electrical Safety
7.1.3.3 Are emergency power receptacles Staff should be able to identify emergency
appropriately identified and only receptacles. Assessor should inspect locations of
used for equipment needing to be on these outlets that should be the color red or have
emergency power circuits? a red sticker identifing them.
Electrical Safety
7.1.3.4 Are electrically powered medical Cords are free of physical defects including
devices in good condition and in line cracks, frayed ends, or missing prongs. The
with the facility Preventative presence of a PM sticker to indicate devices are
Maintenance (PM) process? up to date is also important.
NFPA 99 Ch 8.pdf /A Page=03
Mandatory VHA Directive 2008-011 Elect Safety Equip.pdf

Not
Electrical Safety
7.1.3.5 Are there at least 4 receptacles (6 in Inspect patient rooms.
critical care) for each patient bed?
Electrical Safety
7.1.3.6 If used, are power cords and Facilities should strive to eliminate the use of
electrical extension cords placed extension cords for small working spaces such as
where they are free from mechanical the operating room, patient rooms, or exam
damage, properly sized (gauge) to rooms. A plan should be in place to install
prevent overheating, and arranged permanently affixed receptacles supplied by the
so that they do not present a tripping appropriate electrical circuit (emergency or critical
hazard? branch) if cords are being used.
Recommended NFPA 99 Ch 10.pdf /A Page=03
Environmental and Housekeeping Safety
7.1.4.1 Are hot water temperatures taken Temperature should be less than 120 F at the tap
manually using a thermometer before and 110F in baths.
patient use or immersion (including
partial immersion) takes place?

7.1.4.2 Are supply and return air registers Observe conditions on the unit.
clean and free of lint and dust?
Mandatory JC- CAMH EC-02-06-01.pdf
7.1.4.3 Does general housekeeping appear Cleanliness, sanitation, odor, etc.
to be a priority?

Not
7.1.4.4 Are storage rooms neat, organized, Inspect storage areas. Organized, well light
well light and temperature rooms will help prevent mistakes. Ensuring
controlled? Is all storage 18" below extreme temperatures do not occur will uphold
fire sprinklers and off the floor? the integrity of the supplies. Keeping boxes off of
floor keeps supplies sanitary.
Mandatory JC- CAMH LS-02-01-35.pdf
7.1.4.5 Are egress corridors and stairways Observe conditions on the unit by checking for
unobstructed and kept free of blocked doors.
storage?
NFPA 101 ch 7 - 2009.pdf
7.1.4.6 Are patient or resident areas free of All cleaning products, medication, employee food
unlabeled or unattended containers, or drink, etc., should not be left in patient care
such as cleaning products or areas or patient rooms.
medication?
JC- CAMH EC-02-01-01.pdf
7.1.4.7 Are hazards clearly identified and Pre-construction meetings should proactively
properly controlled during address all necessary interventions to remediate
construction and renovation? such issues. However, patient/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


Not
7.1.4.8 Are high hazard areas such as: High hazard areas must be locked to prevent
Roofs, service areas, medication access to patients/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 Infestations can occur, such as myiasis, without
"pests" in the hospital environment? preventative measures or monitors. Special
considerations should be made for sterile
environments.
Mandatory VHA Program Guide 1850.2 Pest Control.pdf /A Page=6
Equipment Safety
7.1.5.1 Is medical equipment being Check inspection tags, or other identifiers on the
inspected in accordance with the equipment that indicates it has been inspected.
Preventative Maintenance Program? Interview staff to determine how to interpret
identifiers.
NFPA 99 CH 8.pdf
Equipment Safety
7.1.5.2 Is back up patient care/monitoring Uninterruptible monitoring and support should be
equipment readily available in the planned for.
event of failure and or emergency?
Recommended JC- CAMH EC-02-04-01.pdf

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

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

Not
Equipment Safety
7.1.5.6 Is the equipment designed such that Should not see post-it notes or permanently
its operation is intuitive to the user posted signs indicating warnings about seemingly
and does not require use of adjunct logical machine operation (i.e. a sign reading
devices to complete the required such messages as: "Don't press 'ENTER' key to
tasks? enter data.") Interview staff and inspect
equipment in area.
Recommended
Equipment Safety
7.1.5.7 Is patient care and monitoring All screens/interfaces are readable and at or near
equipment positioned so that eye level; key pads within reach; equipment is not
caregivers can easily reach and/or blocking each other; adequate space to move
read displays and controls? around, including head clearance on mounted
devices.
Recommended
Equipment Safety
7.1.5.8 Are liquids kept away from medical To prevent spillage which can result in
equipment? malfunctioning.
NFPA 70 Article 110-2008.pdf
Recommended VA Circular 10-90-035.pdf
Equipment Safety
7.1.5.9 Are disposable medical Inspect storage rooms and other stock areas in
devices/supplies stored in a way that the area/unit (e.g. folding supplies like hoses and
the integrity of the devices is kept tubing causes kinking that has prevented them
intact (i.e. not bent or folded)? from functioning properly).
Recommended
Equipment Safety
7.1.5.11 Are locations of AEDs and Placing this equipment in the same location of
defibrillators standardized 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

Not
Equipment Safety
7.1.5.13 Has the facility eliminated sterile Having sterile water for injection available in ward
water (in forms easily confused with stock, either in multi-dose vials or bags, creates
medications) from ward stock? the potential for confusion with intravenous
medication/fluids. Warnings have been published
(ISMP) regarding water being confused with other
medications resulting in fatal hemolysis. If soft
bags are unavoidable, due to equipment, 2 liter
bags are preferred, however they still carry a
potential vulnerability since they can be attached
to intravenous lines. Engineering their use out is
best when new equipment is purchased. If sterile
water is in ward stock for irrigation purposes,
plastic bottles that require tubing that cannot be
connected to intravenous lines are preferred.
FDA PS News_ Show #22 12-03.pdf

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 Look for signage, and ask staff about
devices that can affect monitoring policy/protocols.
and other medical equipment
controlled in applicable areas as
specified in local policy?
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

Not
7.1.6.3 If wander guard systems are in Observe if in use, interview appropriate staff to
place, are they included in the determine if properly maintained - ward staff
preventative maintenance inspection should be able to speak to reliability of system.
program?
Recommended
7.1.6.4 Are annual drills of the full missing Review records of drills or critiques of missing
patient process (grid search) patient searches.
conducted at least annually if the
plan wasn't exercised during a real
event?
Mandatory VHA Directive 2008-057 missing pt.pdf
7.1.6.5 Is a risk assessment for elopement Awareness of the potential for
completed at the time of admission elopement/wandering behavior is the first step in
or transfer and regularly during the prevention. Review documentation or interview
patients stay? staff to verify that the assessment is being
completed. Consider using electronic flags in
CPRS to inform clinicians if the patient is a high
risk. A change in the patients care (i.e., to a new
bed/unit, or new/change in medication) is a key
time for reassessment.

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.

Not
7.1.6.6 Is a processes in place and used to If patient privileges are not clear this often can
keep track of high risk patients when lead to lack of communication on patient status
they are off of the unit? and location. A tracking or documentation
system can be used to help staff know patient
habits, and is a method to communicate this
information at the shift change. Also transport of
patients off the unit should be planned and
scheduled with competent escorts who
understand the potential for a high risk patient to
elope.

Recommended
Fall Prevention
7.1.7.1 Are all patient/resident rooms, Observe conditions on the unit. Patient sleeping
procedure rooms and common areas rooms and private bathrooms should be provided
provided with adequate lighting so with nightlights. Assess for shadows or glare that
that the patients ability to ambulate may adversly impact ambulation.
safely is not impeded?
Fall Prevention
7.1.7.2 Are mechanical assist devices used Have staff show example, and conduct interviews
to lift or transfer patients accessible to determine facility consistency.
and used by staff when needed?
Recommended
Fall Prevention
7.1.7.2.1 Are preventative measures Staff training, proper number of staff present, no
implemented to prevent falls from obstructions in lift area.
manual lifting and/or handling
patients?
http://vaww.ncps.med.va.gov/Tools/CognitiveAids/FallPrev/index.html
Recommended SPHMAlgorithms.pdf

Not
Fall Prevention
7.1.7.3 Are all floors in patient/resident Floors should be free of liquids, electrical cords,
rooms or procedure rooms free of wires, tubes, or other connectors which can
environmental slipping and tripping create fall hazards. Patient/resident/procedure
hazards? rooms should be free of floor clutter or other low
hanging objects that could be a tripping hazard.

Fall Prevention
7.1.7.4 Are shower/bathroom areas provided Inspect areas. Bathrooms should be provided
with adequate lighting, proper with night lights. Assess bathroom flooring
drainage, non-slip floor surfaces, and conditions for excessive moisture and water build
installed handrails? 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.
Fall Prevention
7.1.7.5 Are call buttons within reach of the Inspect all areas.
patient?
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 Sentinel Event Alert #14.pdf
Fall Prevention
7.1.7.7 Does the facility have a Fall Interview staff - protocol should evaluate: 1) A
Prevention & Management Protocol risk screen; 2) Protective device matched to risk
or equivalent? level; 3) First responder assessment to identify
patients for immediate physician evaluation and
4) Treatment plan for follow up, post fall.
Mandatory

Not
Fall Prevention
7.1.7.8 Is a uniform tool used to assess Identifying high risk patients will help care team to
which patients are at high risk for put proactive and preventative measures in place.
falls, and is there criteria to Assessor should look for identifiers and interview
determine: 1) When they are staff.
assessed, and 2) What triggers a
reassessment, including applicable
timeframes?
JC- CAMH PC-01-02-01.pdf
Mandatory JC- CAMH PC-01-02-03.pdf
Fall Prevention
7.1.7.9 Is there at least one patient lift, OR Review equipment, interview staff. Patients
table, radiololgy table, etc. available weighing in excess of 400 pounds are not
that has sufficient lifting/holding uncommon. If equipment cannot support the
capacity to meet the needs of weight of the patient contingency plans should be
bariatric patients? developed to provide care.
Recommended Copyrighted Refs.doc
Fall Prevention
7.1.7.9.1 Is the load carrying capacity of the Labels and warnings are minimal actions and
equipment obvious to care humans often disregard them but they are one
providers? barrier that should be in place. Talk with the care
providers in the area to determine if they know
what the load capacities are. Other cognitive aids
may be necessary depending upon the
knowledge level.
Fire Safety
7.1.8.1 Are staff members familiar with fire Interview staff to determine familiarity.
emergency procedures, and the fire
prevention plan for their service
area?
JC- CAMH EC-02-03-01-pdf.pdf
Mandatory JC- CAMH HR-01-04-01.pdf

Not
Fire Safety
7.1.8.2 Can clinical staff identify smoke and Interview staff to determine familiarity. Staff must
fire walls in their immediate area? be knowledgeable regarding where to move
patients in the event of a fire.
Fire Safety
7.1.8.3 Is the fire alarm signal easily Interview staff to determine familiarity, if alarm is
distinguishable from other alarms not witnessed.
(e.g., equipment, nurse call, etc.)?
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 JC- CAMH EC-02-03-01-pdf.pdf
Fire Safety
7.1.8.5 Are flame retardant pajamas or Smoking risk patients are patients who are known
aprons provided for patients who to routinely violate the "no smoking" rules
smoke and are identified as a established by the facility. They smoke in non
"smoking risk"? designated areas when unsupervised and may
have a physical or mental condition that could
lead them to drop a cigarette, ashes, or match
causing clothing or hair to ignite. Flame retardant
pajamas or aprons can be a preventive measure
for these patients.
VA Circular 10-90-035.pdf
Mandatory VA MP-3 Part III 32.36(b) & (d).pdf /A Page=21

Not
Fire Safety
7.1.8.5.1 If flame retardant pajamas or linens Interview staff, determine if practices are
are used, is a process in place to consistent with policy. If the material has a fire
ensure integrity of the flame retardant applied it will wash out over a period of
retardant agent is maintained on time.
these articles after repeated
laundering?
Recommended VA MP-3 Part III 32.36(c) & (d).pdf /A Page=21
Infection Control
7.1.9.1 Are all linen carts (clean and soiled) Observe conditions on the unit.
kept covered and the bottom of the
cart is a solid surface (without
openings)?
Mandatory JC- CAMH IC-02-02-01.pdf
Infection Control
7.1.9.2 Are sharps containers accessible Observe conditions in unit/area. Patients and
and not over filled? employees are often stuck by sharps not properly
disposed of due to overfilling of these containers.

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

Not
Infection Control
7.1.9.4 Are the VA recommended hand Alcohol-based hand rub (ABHR) disinfectants
hygiene guidelines followed? should be located to promote their use (including
in patient rooms, on carts). Clinicians should also
be offered the small (2-4 oz.) personal containers
of hand gel. In addition to the ABHR gel/foam a
lotion (to prevent skin dryness) should also be
available.
Staff who come in contact with patients or

prepare sterile products (such as IV drugs)
should not have artificial fingernails.

Infection Control
7.1.9.5 Is the integrity of negative/positive Door remains closed if in use, Personal
pressure isolation rooms tested and Protective Equipment used. Signage outside to
maintained (once per day for identify hazard exists.
occupied, monthly for non-
occupied)?
Staff should understand what actions to take if

the room pressures are out of range when they
are checked.
CDC Environment IC Healthcare.pdf

Mandatory 29CFR 1910.145.pdf
Infection Control
7.1.9.5.1 Is there a process in place to Establishing these temporary rooms should be
establilsh temporary part of the facilities Emergency Prepardness
negative/positive pressure rooms if Plan.
they are needed?
Recommended

Not
Medical Gas Safety
7.1.10.1 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 Flow meters are only used for specific treatments,
not in use (for nebulized medication are not required during emergencies and should
treatments)? not be left attached to be confused with O2 flow
meter.
Medical Gas Safety
7.1.10.3 Do staff know where the emergency Staff to demonstrate competency. Also verify that
oxygen shut-off is, and when and labels, warnings or other signage posted at the
how to use it? shut off point in accurate and up to date.
Mandatory NFPA 99 Ch 5.pdf /A Page=17
Medical Gas Safety
7.1.10.4 Does the storage and use of portable If color identifies type, must be the same hue &
medical gas containers appear to be intensity; flammables separated from oxidizers;
in compliance with CGA secured at all times (full or empty); container in
(Compressed Gas Association) good condition; only a limited quantity permitted
Standards? in use area (less than 12 E-cylinders, or 1 H-
cylinder per area).
Mandatory O2CylHazardSumm.pdf

Not
Medical Gas Safety
7.1.10.4.1 Do area/unit personnel know how to Cylinders should not be left standing unsecured,
correctly handle oxygen cylinders? they should not be lifted using the flow meter
assembly.
They should understand the purpose of both the

main cylinder valve and the flow meter valve.
Cylinders not in use must be turned off using the
main cylinder valve.
Cylinders should be opened slowly.
Organic ointments or oils should not be used in or

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

Not
Medication Safety
7.1.11.1 Are all medication refrigerators Check floor refrigerators, ensure correct labeling
maintained appropriately? and appropriate separations from employee
food/drink.
Review temperature log (or electronic

temperature monitoring device/log) and verify that
the thermometer is working.
Staff should know what actions to take if the

temperatures in the refrigerators are out of range.
ISMP_Book.pdf /A Page=30
JC- CAMH MM-03-01-01.pdf
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 JC- CAMH MM-03-01-01.pdf
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.
Medication Safety
7.1.11.4 Are receptacles for medication Door locking mechanism cannot be defeated for
storage locked and are controlled any reason. Door should not be held open.
substances double locked?

Not
Medication Safety
7.1.11.6 Is area stock limited to emergency Review approved floor stock and IV solution list
medication and IV solutions which (e.g. 3% NaCl should not generally be available).
are appropriate to patient care in the
unit?
Recommended JC- CAMH MM-03-01-03.pdf
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 ISMP 9-03 - Preventing Medication Errors.pdf
Medication Safety
7.1.11.8 Have concentrated electrolyte Such as: potassium chloride and potassium
solutions been removed from patient phosphate
floors/care areas?
Sentinel Event Alert #1.pdf
Medication Safety
7.1.11.9.1 Are only standard concentrations of Floor stock of high-alert drugs should be limited
high alert medications kept in the to critically needed medications, with minimal
area/unit to minimize the potential of number of doses, and be pre-made solutions (if
calculation and compounding errors? available).
Medication Safety
7.1.11.10 Is a unit dose medication system Look in patient bins for products that are in the
used including liquids? final pagkage of use. Bulk containers should not
be used.

Not
Medication Safety
7.1.11.13 Is drug preparation done primarily in Interview floor staff. It is safest for mixtures to be
the pharmacy and not on care units? completed in pharmacy areas.

Medication Safety
7.1.11.13.1 Is medication mixing (admixtures) on Interview floor staff. If admixtures are done on
inpatient care units a discouraged units, the area should be a designated area that
practice? is clean and secure. It is safest for mixtures to be
completed in pharmacy areas only.
Recommended
Medication Safety
7.1.11.14 Are procedures in place to prevent Infection control literature documents nosocomial
sterile product use from patient to infections occur irrespective of changing needles
patient (including medications)? or IV tubing's.
ASA December 2000 Newsletter.pdf
Recommended ISMP June 2000 Alert.pdf
Medication Safety
7.1.11.15 Are IV over-wrap bags utilized and The protective over-wrap for some solutions
properly labeled with manufacturers serves to control the amount of water vapor that
instructions? escapes from an IV solution. Once unwrapped it
is best to use the solution right way.

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

Not
Medication Safety
7.1.11.19 Are appropriate reversal agents In the event of an unusual reaction or overdose
(flumazenil, naloxone, protamine, the agents need to be available. Look on the
etc.) available based on the drug code cart drug list.
being administered and clinical
setting?
Medication Safety
7.1.11.19.1 Does the facility track use of reversal Such as reviewing automated dispensing
agents? machine records, which can be used as a tracer
order for adverse drug events. (e.g., reversal
agent s used in Endosocpy, Radiology, Acute
Care, etc., may be a signal to misadministration
or unsafe practices occurring. Tracking may also
alert to anesthesia adverse events occurring.
Other citeria to consider is increased surgical
times, durg interactions, and allergies.
Recommended
Medication Safety
7.1.11.21 Is there a process for monitoring Review monitoring records. To trial BCMA, test 5
BCMA? bar codes scans to ensure process is working,
coding should match the electronic medical
record to the patient, allowing the information on
the patients armband to be matched with the
electronic information.
Recommended ISMP_Book.pdf /A Page=13
Medication Safety
7.1.11.21.1 Is BCMA used to administer Observe staff. An oversight committee (i.e.,
medication without using work BCMA committee) should be monitoring for work
arounds? arounds.
Recommended

Not
Medication Safety
7.1.11.21.2 What is the protocol for handling One of the driving forces to increase medication
medication preparations that are safety within the VA as been to ensure staff are
incorrectly bar coded or labeled, or compliant and are able to scan medications into
have labels that do not scan? BCMA. Pharmacy and or adhoc groups such as
BCMA committee should have a (QA) monitor for
ensuring medications dispensed from pharmacy
are able to be scanned, and secondly QA monitor
for medication scanning on the unit Lastly there
is a greater likelihood for a medication error to
occur when staff are able to administer
medications that have an incorrect/improper
barcode.

Medication Safety
7.1.11.21.3 Is there a helpdesk for BCMA Test hotline number available on all shifts;
available during all shifts? interview off-shift staff if available.
Recommended
Medication Safety
7.1.11.22.1 Do the VISTA modules effectively Show example, if available. Test the software to
alert to potential food/drug/herbal ensure there is not an option for turning off the
interactions and duplicate drug alerts.
therapies? Are users prohibited from
turning them off (the alerts)?
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 JC- CAMH IM-02-02-03.pdf

Not
Medication Safety
7.1.11.26 Are up-to-date facility specific Interview unit staff, show where information is
protocols, guidelines, dosing scales, kept and how it is retrieved. (e.g. use of
and/or checklists readily available for electrolyte replacement, aminoglycoside, and
staff? anti-coagulant guidelines).
Mandatory JC- CAMH IM-02-02-03.pdf
Medication Safety
7.1.11.27 Are specific precautions followed Discuss protocols with staff (such as insulin and
when handling look/sound alike heparin vials; and hydromorphone and
drugs? morphine). In pharmacy, discuss what is being
done with the look alike medication project.

Recommended JC- NPSG-03-03-01.pdf
Medication Safety
7.1.11.28 Is a prohibited abbreviations in For example "u" in unit may be mistaken for "0"
effect? resulting in ten fold over dosage.
Medication Safety
7.1.11.29 If Automated Dispensing Machines Written documents should include which drugs
(ADMs) are used, is staff aware of a are available - including strengths and doses,
written policy, and can they explain how often drugs are inspected for expiration
how the machine works? dates, drugs not used but removed, and content
review.
Medication Safety
7.1.11.32 If ADMs are used, are there Show example reports, where filed on units;
capabilities to run override reports interview Nurse Manger. Have staff reveal how
that track discrepancy and utilization reports are used and acted upon, and if there is a
at least monthly? process to deal with variances.

Not
Medication Safety
7.1.11.34 Are patients educated regarding their Show example.
prescribed medication, as inpatients
and as part of the discharge
process?
Medication Safety
7.1.11.35 Does the care provided by Interview clinicians to determine if Pharmacists
Pharmacists meet the clinical needs are available for consult, and if they participate in
of the patients in scope and rounds or access patient medication history.
frequency?
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?
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 Randomly interview nursing staff on the floor.
cognitive aids available on the floor Look for aids at nurses stations.
for staff to reference (Escape and
Elopement; Fall Prevention, etc.)?
Recommended

Not
7.1.12.3 Are patient/resident records kept Ensure records or computer screens are not left
confidential, including computer unattended and openly visible.
information?
7.1.12.4 Are staff wearing identification Monitor patient care areas. Interview staff about
badges and are unauthorized policies such as the handling of drug
persons kept out of patient care manufacturer representatives that visit
areas? unexpectedly. Patient charts should not be left in
patient rooms where patients are waiting.
7.1.12.5 Are restraints used in accordance Look for restraint devices or alternative devices in
with local policy and are restraint the area that may be in use. Document any
alternative devices available and questionable use. Review patient record where
used when appropriate? restraints were used to determine if appropriate.


Not
7.1.12.6 Are there practices in place to Requires using two patient identifiers for any
decrease the likelihood of patient administrations, draws or procedures/images,
misidentification? and at outpatient pharmacy. Other suggestion
include the use of record and room flags for
same/similar/common names; four or less beds in
patient rooms; special procedure for the
transporting of patients at high risk for
misidentification.
VHA Directive 2005-029 dictates mandatory

patient identification requirements for transfusions
and the handling of blood and blood products,
including "active" identification (patient be asked
to state he/her name and Social Security
Number) and crossmatch with patient arm band
and consent form. Also the verifying staff
member must remain with the patient until
administration or collection begins.
7.1.12.6.1 Upon collection of blood or blood It is a requirement of the reference Directive that
products is a informed consent prior to ordering the blood products for
obtained? transfusion, an informed consent is documented
in the patient's record, ensuring that the patient is
aware of the transfusion to take place.

Not
7.1.12.6.2 Is the labeling of blood samples or When blood collection is completed at the
specimens done at the bedside, bedside or in the clinic the blood container must
rather than in bulk (at the nurses be immediately labeled before leaving the patient
station) to prevent mislabeling? at minimum with the following: patient's full
name, Social Security Number, collector's
identification, and date of collection.

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

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

Not
7.1.12.8 Are handoffs between shifts or A consistent process should exist to update on-
transfer of care between units coming staff or new unit staff of patient status.
standardized? Interview staff and compare answers between
units. Look for use of SBAR or other
communication tool.
Mandatory JC- NPSG-02-05-01.pdf
7.1.12.9 Is the transfer of care between A consistent process should occur during
disciplines for off-unit appointments appointments and when patients are sent back
standardized, including the and forth from units, including patient
continuation of monitoring patient identification means, patient record transfer, and
status and patient medical devices the monitoring of the patient's condition and
such as IV pumps and oxygen level needed medical devices. Stopping and
while the patient is visiting, being resumption of IV medications should be planned
treated/tested, and during transport? and documented. Interview staff in all areas
compare answers to determine standardization.
Recommended USP CAPSLink July 2004.pdf

7.1.12.10 Are patients searched and residents To ensure the safety of the patients/residents and
questioned for contraband upon staff members it is essential to have a rigorous
admission to each applicable search process of each individual patient.
area/unit? 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

Not
7.1.12.12 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?

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 leads and creating loops (i.e., as if when a hand a
on 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 Use manufacturer-approved fiber optic, carbon
optic, carbon fiber or graphic leads fiber or graphite leads instead of conductive leads
and low impedance ECG electrodes on medical devices. Also, use manufacturer-
used on equipment that is brought approved large surface area, low impedance
into the MR scan room? ECG electrodes
Recommended MRI Hazard Summary 2008.pdf

Not
Domiciliary Patient Safety Concerns
7.1.16.1 Is a face to face assessment with a Some residents that enter into the
standardized assessment tool Domiciliary/Hoptel program are those that have or
conducted and documented on each have had Mental Health issues or factors that
potential resident before make them at higher risk for falls, therefore a
acceptance/admission into the specific standardize mechanism needs to be in
Domiciliary (or Hoptel) evaluating for place to assure that residents who are at risk for
falls and suicidal/homicidal risk? 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 It is important to reassess patients on a
there a specific frequency for systematic schedule, to ensure the patient
periodic re-evaluations throughout remains in a safe environment. Each assessment
the stay for falls and mental health? 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 All staff should receive specific training regarding
thoroughly trained on the Falls and assessment programs with emphasis on suicidal
Mental Health assessment program, and homicidal behaviors (i.e., despondent,
including all staff working on off- depressed, agitated, potentially violent.
shifts?
Recommended
7.1.16.2 Has a standard assessment tool These veterans need training to handle difficult
been developed and used to assess situations such as when another veteran, who
the competency of the veterans may be a friend, wants to enter the building with
working at the open domiciliary contraband. They also need to know what action
entrances that monitor access? to take if they believe another veteran is acting
intoxicated or may be harmful to others or
themselves.
Recommended

Not
7.1.16.3 Is amount of time residents have with Current VHA policy requires a minimum of 4
planned activities monitored with the hours per day, 7 days per week of therapeutic
goal of increasing the contact hours activities. If residents are only occupied for 1 to 2
with each resident? hours per day, 5 days per week with no activities
on weekends or holidays the activities should be
increased.
7.1.16.4 Are break room and kitchen The FDA Food code requires all food to
refrigerators monitored periodically to consistanly remain below 41 degrees Farinheight.
assure appropriate temperatures are Therefore it is recommended in gerenal industry
maintained? 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 Per VA policy, see minimum Domiciliary staffing
shifts, holidays and weekends levels. Review staffing versus resident
assessed and modified as needed? population to verify if appropriate.

7.1.16.6 Has the Mental Health Residential The Deputy Under Secretary for Health for
Program Annual Safety and Security Oepration and Management put forth a
Assessment being completed on the Memorandum for residental programs to
directed schedule? 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
BEHAVIORAL HEALTH CARE UNITS (Locked) 7.2 Facility unit/ward name:

Not
Code Carts
7.2.2.1.1 Are code carts secured and If carts are missing items then they could be
inaccessible to patients to prevent ineffective in when needed in an emergency.
tampering where appropriate (i.e., Check that carts are put away in affected areas.
Behavioral Health areas)?
Recommended
Code Carts
Recommended
Code Carts
Service.

to be a priority?
Psych Care - 7.2 Psych Care - 7.2 - Version: 01.30.2009 358 of 578

Not
storage?
NFPA 101 ch 7 - 2009.pdf

environments.

Not
Equipment Safety
identifiers.
NFPA 99 CH 8.pdf
Equipment Safety

Mandatory
Equipment Safety
Equipment Safety
Recommended

Not
correctly?
Recommended
program?
Recommended
event?

Not

elope.

Recommended
Fall Prevention
Fall Prevention

Not
Fire Safety
area?
Fire Safety
Fire Safety
Fire Safety
NFPA 101 Ch 19.pdf

Not
Fire Safety
for these patients.
Fire Safety
laundering?
Fire Safety
7.2.8.6 Are fire equipment cabinets and fire These should be locked to prevent tampering,
alarm pull stations locked? however ALL staff should carry key on their
person at all times for unlocking in an emergency.
Recommended fire prot design man.doc #25

Infection Control
openings)?

Not
Infection Control
IV room.
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
food/drink.



Not
Medication Safety
not in use?
Medication Safety
Medication Safety
Medication Safety
unit?
Medication Safety
be used.

Not
Medication Safety
Medication Safety
arounds? arounds.
Recommended
Medication Safety
barcode.

Medication Safety
Recommended
Medication Safety

Not
Medication Safety
Medication Safety

Medication Safety
Medication Safety
review.
Medication Safety

Not
Medication Safety
process?
Medication Safety
frequency?
Medication Safety
not accepted.
Recommended

Not
information?


Not
misidentification.


Not


in bed as well.
Recommended

Not
communication tool.

Recommended
Recommended

Not
7.2.12.11.1 Is there an assessment used to Review assessment process/documents.
determine if a patient is potentially
violent?
Mandatory; Priority A VA IL-10-97-006 Violent Behavior.pdf
Mental Health Locked Unit Checklist
7.2.13.1 General Criteria
7.2.13.1.1 Are floor coverings free of tripping Floor coverings should be secured to the floor, in
hazards? good repair without tripping hazards, and not
easily torn or dislodged.
Are floor coverings secured to the

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

tamper resistant anchors or
fasteners?
Recommended

Not
7.2.13.1.4 Are wall coverings and paint non- Non-toxic wall paper, glue, and paint should be
toxic? used. Paint and wall paper should not be peeling.
Are wall coverings secured to the

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

walls using tamper resistant screws
or anchors?
Recommended

Not
7.2.13.1.6 Are the number and locations of GFCI-protected outlets, adequate number of
electrical receptacles in the room outlets, short electrical cords. Equipment with
adequate? cords should be located close to the wall outlet;
cords should be too short to loop around the neck
and secure to an anchor point for hanging. Flush
mounted switches reduce the risk of using 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/a-catalog/sec_index_f
s.htm
Are louvers designed so that they

cannot be used to secure any item
that might be used to attempt suicide
by hanging?
Recommended

Not
7.2.13.1.8 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 In older buildings, it is not unusual for wiring to
molding been removed? newer receptacles to be run in surface-mounted
wire molding. Ideally, wire should be run inside of
the wall and out of sight. Surface-mounted
molding could potentially be used as an anchor
point and should be replaced with flush wall-
mounted receptacles. Prior to being replaced,
any surface-mounted wire molding must be
secured tight to the wall with no gaps and
secured with tamper resistant screws.
Recommended
7.2.13.1.11 Corner mirrors are secured with Corner mirrors may be necessary for safety, but
tamper resistant screws and are must not provide an anchor for hanging and must
flush mounted so that they will not be made of non-glass material.
support a rope or material for
hanging.
Recommended

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, Cords should be too short to use to wrap around
even if otherwise considered a safety a neck and hang from any securing point
item, designed so they cannot be (maximum of 12 inches). Wall telephones should
used for harm of self or to harm only be in locations that can be continuously
others? For wall-mounted sprinklers, observed by staff and the cord between the
see sprinkler criteria under Ceilings telephone base and the hand set should be as
section. 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

Not
7.2.13.1.14 Are wall mounted exposed room No wall mounted exposed room thermostat in
thermostats removed from patient patient areas. Use duct mounted temperature
areas? 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 In areas accessible to patients and not
the direct line of sight of the nursing continuously observable by staff (e.g., patient bed
station constructed of solid materials rooms, day rooms), ceilings should be solid or of
such as plaster/lath, gypsum board, a rigid, locking tile. The space above a lay-in
or a metal pan system the requires suspended ceiling will almost always contain
the use special tools for removal? 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
Are ceilings free of hanging objects ingested. There should not be items hanging from
such as plant hangers and wind the ceiling.
chimes?
Recommended
7.2.13.1.16 Are access doors in solid ceilings Access doors are needed to access electrical and
locked using a key or special tool to mechanical equipment above the ceiling.
prevent unauthorized access and Patients having access to this space may harm
secured to the ceiling using tamper themselves or others or use the space for storing
resistant fasteners? 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 break-resistant material so that bulbs cannot be
provided with break-resistant panels accessed. Tamper resistant screws/attachment
or covers and designed so they devices should be used.
cannot serve as an anchor point for
hanging?
Recommended

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-proof. Large box-like projections with
tamper resistant fasteners? 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 Institutional sprinklers should be used for
type that cannot be used as an sprinklers installed on the walls as well as the
anchor point for hanging? 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

Not
7.2.13.1.20 Does the glazing material in windows See below for glazing requirements from VA
comply with VA specifications Master Specification Section 08810, Glass and
(nominal 7/16 inches thick and Glazing. If the unit was designed as a mental
laminated)? health unit it is likely that the glazing meets the
Are windows restricted so that the requirements. If the unit was converted from a
maximum opening is 6 inches or different use, the glazing may not meet the
locked to prevent them from being requirements for mental health units. Consult with
opened by a patient? Do staff know facility Engineering staff regarding use of Section
the location of the key need to unlock 08810.
the window and is it accessible to
them if it is needed?
"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) optional glazing of clear heat
(continued) strengthened glass clad polycarbonate, or clear
Recommended
tempered glass clad polycarbonate for 11 mm
inch (7/16) thick laminated glass."

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 Shades, or blinds inside of window panes are
they cannot be used for hanging? 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
can’t be used to secure a noose. It should also
Is the hardware supporting the be tamper proof to prevent it being removed and
window covering designed and used as a weapon or for self harm.
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.variolight-sonnenschutz.de/eng/produ
kte.html
Recommended

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 room, but if necessary (e.g., patient barricaded
into the corridor? (Only New Units) 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

Not
7.2.13.1.23 ...(continued) to limit the transfer of smoke, so the
(continued) 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.
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
piano hinges or other hardware that are supported by a post at the top and bottom of
reduces the risk of the hardware the door and do not have hinges. Such hardware
being used as an anchor? (Only New is acceptable as long as the gap at the top of the
Units) 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
piano-type hinges that are flush-mounted to the
Are three point hinges designed and door 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?
Recommended

Not
7.2.13.1.26 Is the door latching hardware Hardware should be designed with a taper or a
designed and installed to prevent it lever so a noose would slip off with the weight of
from being used as an anchor point a person Use round edges type.
for hanging?
See http://www.oddballindustries.com/ Click the

link for "Door Lock"
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

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 Any racks must be flush with the wall and
tamper resistant fasteners? 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

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 move; it should be made of wood or study
and thrown or moved to block a plastic; knobs and pulls should be designed to not
door? 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.max-
potential 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 2002-
073, 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

Not
7.2.13.1.32 Is the unit designed to eliminate blind Some older buildings have configurations that
spots? Note: In existing buildings result in hallways that are not visible from the
alternate and equivalent methods nurses station; these areas should have cameras
must be in place (e.g., non breakable or staff assignment that allows for ease of
mirrors) to increase visibility. 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 All chemicals, housekeeping supplies and
housekeeping carts, secured when equipment, and maintenance carts and
not in use? equipment must be secured or have someone in
attendance.
Recommended
7.2.13.1.34 Are devices such as blood pressure Blood pressure cuffs can be placed around the
cuffs and other medical equipment neck and inflated, or the cords and hoses can be
kept inaccessible to patients? 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

Not
7.2.13.1.36 Is the area free of unnecessary If cords are present, they should be 12 inches or
cords? 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 Excluding items such as beds, linens, furniture.
rooms kept to a minimum? Mattresses should be fire-resistant, however.
Recommended
7.2.13.2 Sleeping Rooms

Not
7.2.13.2.1 Are all mounted fixtures designed to "Breakaway rods and sprinkler heads; flush
prevent attachment of devices that mounted vent covers free of louvers; no
could be used to inflict self-harm? attachment points on furniture parts or doors (i.e.,
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 shatter- Mirrors should be stainless steel, not glass.
resistant?
Recommended
7.2.13.2.3 Have electric and manually Platform beds are the safest for an acute
adjustable beds been eliminated psychiatric environment. If electric beds are
unless indicated by clinical need? necessary, power cords should be shortened and
securely fastened.
Recommended
7.2.13.2.4 Are emergency call cords, if used, Inspect ward and patient rooms. Cords should be
shortened and/or permanently made out of plastic bead type materials or
attached to beds? 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

Not
7.2.13.2.5 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/D
ocs/PrivacyCurtainAL07-04.pdf
Recommended
7.2.13.3 Bathrooms
7.2.13.3.1 Are light fixtures securely mounted to Flush mounted fixtures are recommended,
the ceiling by inaccessible fasteners however surface mounted lights are acceptable
or tamper resistant fasteners (or provided they do not provide an anchor point for
equivalent) with non breakable hanging. All energized parts must be secured
lenses? 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

Not
7.2.13.3.3 Are grab rails installed around the The grab rail should be of a design that permits
toilet and shower areas the closed them to be easily grasped while preventing
type that prevent materials from materials from being threaded through that meet
being wrapped around them? 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
Are all grab rails eliminated where slanted design with two anchoring points for top
they are not needed? 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 Toilet paper holders may have metal spring clips
the wall and designed to hold the used to hold the paper roll in place. These clips
paper without providing materials may be used as weapons. Toilet paper holders
that could be used as a weapon? 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

Not
7.2.13.3.7 If electrical receptacles have not Removal of the receptacle is preferred [MET]. If
been removed and covered by a a receptacle must be used, GFCI protection is
plate fastened using a tamper required to reduce the risk of shocks and
resistant fastener, is a Ground Fault electrocutions, and the receptacle cover must be
Circuit Interrupter (GFCI) receptacle fastened with tamper resistant screws
or GFCI circuit breaker provided? [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 Joint Commission requires the call buttons (when
buttons mounted using tamper provided) to be accessible to someone who has
resistant fasteners and located fallen on the floor. If plastic break-away beads
approximately 1 foot above the floor are used the unit should develop a protocol for
level and 38” to 44” above the floor. quickly and easily replacing the beads as they are
Pull cords should be of plastic removed or pulled off by patients.
breakaway beads in lieu of cords.
Recommended

Not
7.2.13.3.9 For new units, are toilets floor Plumbing fixtures should be enclosed to minimize
mounted with no exposed piping that risks. See Yeager et al. Measured response to
could serve as an anchor point for identified suicide risk and violence: What you
hanging and free of removable seat need to know about psychiatric patient safety.
covers? (Only New Units) 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 Porcelain toilets can be broken and the pieces
seclusion, are toilets shatter proof used as a weapon or self harm. See these web-
(e.g. metal)? pages for toilets:
http://www.acorneng.com/acorn_catalog/PDF/cat
alogpdf/p/1440.pdf
And
http://www.eljer.com/
Recommended

Not
7.2.13.3.11 Are privacy dividers angled down at Use electronic sensor for flushing.
least 30 degrees toward the floor to
prevent hanging?
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 Institutional faucets will not provide an anchor
showers institutional type? There point for hanging. Consider using automatic
should be no handheld shower on/off faucets to eliminate the faucet handles.
devices and no temperature Push button controls for the shower are also an
adjusting devices with in the showers acceptable alternative. Break away fixtures are
(unless recessed). Shower heads also permitted but only if they can be tested
should be institutional type. Soap without damaging the fixture.
Holders should be recessed. Floor
drain plates should have tamper-
resistant screws.
Recommended
7.2.13.3.14 Is the water temperature limited to a Check the water by running the faucet in the sink
maximum of 110 degrees F? or shower or install temperature control guard for
all faucet and set temperature to 105-110
degrees F.
Recommended

Not
7.2.13.3.15 Are shower curtains hung from Shower Curtains are important for privacy and to
ceiling mounted tracks with curtains keep water from flooding the floor - causing fall
designed to tear away when a static hazards. It is vital to check that the mounted
load of 15 pounds or more is tracks cannot be used as an anchor point for
applied? Tracks in bathrooms hanging. Break away curtain rods may be used
should be the flush type and not as a weapon and are not recommended. Note:
surface mounted. 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 There is no Life Safety Code requirement for the
the bathroom and not provided with construction of doors to toilets and shower rooms
locks? (Only New Units) (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 Selclusion Rooms

Not
7.2.13.4.1 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 Light switch should be outside of the room and
and are they on a dimmer switch? 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

Not
7.2.13.4.6 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 Consideration should be given to eliminating
glass kept to a minimum – ideally exterior windows in seclusion rooms. If present,
seclusion rooms should not have they should be small, locked, and of a material
windows other than the observation that meets VA requirements for glazing (see
window in the door. There should be discussion under General Criteria). The
no curtains or external window observation window in the door should be only
coverings. 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? The room should be of a size and configuration to
(Only New Units) 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 Hallway cameras should visualize the seclusion
no greater than 11 feet long? (Only room door.
New Units)
Recommended
7.2.13.4.10 Are blind spots eliminated?
Recommended

Not
7.2.13.4.11 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 Ideally the seclusion room should be close to the
the nursing station? (Only New nurses’ station and should be separated from
Units) 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 There should be no furniture other than a bed
psych style box bed, bolted to the that is bolted to the floor or a mattress.
floor?
Recommended

Not
7.2.13.4.16 Are seclusion room beds free of No protrusions, posts, or sharp edges/corners;
potential hazards to patients? head/foot boards removed or secured; bed
secured to the floor.
Recommended
7.2.13.4.17 Are special precautions in place for All fixtures (covers/vents/windows) secured with
seclusion rooms? 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 The Sally Port is the space between two locked
entrance into the unit used by staff, doors that must be traversed to enter the unit.
visitors and patients? 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 It is important for staff to be able to communicate
Port that rings into the nurses emergency situations.
station?
Recommended

Not
7.2.13.5.3 Is there a window into the Sally Port It is important to be able to see inside the Sally
from outside? 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 Having the option of controlling the door from the
electronically controlled, capable of nursing station will save staff time and offers less
being operated from the nursing distractions. However, this should not be
station? 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 Camera surveillance will assist staff in
Port entrance provided and determining who is trying to enter the unit without
monitored at the nursing station? 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 The intent is to provide a secure environment that
forensic unit Dining Rooms fixed to will prevent tables from being moved or
the floor or secured so they cannot overturned. This may be accomplished in several
be moved or overturned? ways. They can be physically secured or too
heavy to move.
Recommended

Not
7.2.13.6.2 Are dining room furnishings (e.g. The intent is to prevent furniture from being
chairs) physically heavy or secured thrown.
to the floor or table?
Recommended
7.2.13.6.3 Is the temperature of food and liquids This is important to prevent patients and staff
being served in the dining room from receiving 3rd degree burns (can occur in 10
monitored to ensure that seconds at 130 degrees F temperature) from
temperatures do not exceed 130 spilled or thrown food/liquids.
degrees F?
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 Nursing Station

Not
7.2.13.7.1 Are nursing stations secured from Walls around nursing stations should be
unauthorized entry? 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 This is particularly important around pass through
kept out of reach of the patients? openings or near counters.
Recommended
7.2.13.7.3 Are panic alarms provided for staff Panic alarms monitored by the VA Police are
use in nursing stations? 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 Utility Rooms

Not
7.2.13.8.1 Are all chemicals stored in a locked It is critical that patients on locked mental health
utility room? 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
Does the utility room have a self- chemicals (due to a variety of reasons) or to think
locking door? 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 It is critical that patients on locked mental health
room such that the door can be units do not have access to cleaning supplies at
locked behind it? 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

Not
7.2.13.8.3 Are cleaning chemicals locked or Consider the use of signs in the utility room and
under direct staff observation at all on the utility cart reminding staff of the need for
times? 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 This helps prevent staff from being locked in with
ability to swing outward from the patient. Important Note: The door swing must
room? (Only New Units) 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 should be able to unlock the office door in case of
in 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

Not
7.2.13.9.3 When a patient is in the office is the Consider the use of interview rooms rather than
door unlocked or left open? 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, Remove all unnecessary paperwork and objects
and is the desk free of objects that from desktop during patient treatment or
could be grabbed by a patient and interview. Unsecured items in the office can be
used to harm themselves or others? 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 Alarms should sound at the nurse station and
offices as needed? Are the panic police. Testing of panic alarms should be done
alarms periodically tested to ensure on a periodic schedule with a frequency as
that they are functioning correctly? 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 Reduce the risk of patients inserting objects in the
secured with a cover and are power outlets. Consider using outlet covers that allow
strips (if used) hidden under the desk appliances to be plugged in then locked down.
and secured on the floor or wall? Use of power strips is not encouraged. If
additional electric outlets are needed, flush wall-
mounted outlets should be installed.
Recommended
7.2.13.10 Outdoor Areas

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

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 the fence area, keep bushes and flower beds
proximity to the fence)? 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

Not
7.2.13.10.4 Are light fixtures out of the reach of Switch for outdoor light must be located inside the
patients? 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 tamper-
resistant screws?
Are the light fixtures and poles

designed to be not easily climbed?
Is there sufficient light for the entire

outdoor area?
Recommended

Not
7.2.13.10.5 Ideally, outdoor areas should be Staff must be train to monitor camera when
monitored by cameras. If cameras patients are outdoors. A procedure must be in
are used: 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 Outdoor furniture must be anchor to concrete pad
too heavy to be easily moved? 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
Is furniture located at a sufficient unsecured.
distance away from the fence to
prevent it being using to get over the
fence?
Recommended

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 self- High hazard areas must be locked to prevent
closing self-locking door, or is there a access to patients and have warning signs and
control switch at the nurses station labels. Generally, only patients assessed at low
that activates the power to the risk for suicide should be allowed in the kitchen
appliances (this control switch can be even under supervision. If there are appliances
on a timer)? 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

Not
7.2.13.11.3 Are laundry rooms secured with a High hazard areas must be locked to prevent
self-closing self-locking door? access to patients and have warning signs and
labels. Generally, only patients assessed at low
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 Self explanatory.
and away from the patients when
they are not being supervised?
Recommended
7.2.13.11.5 Are OT rooms secured and not High hazard areas must be locked to prevent
available to patients when they are access to patients and have warning signs and
not supervised? labels. Generally, only patients assessed at low
risk for suicide should be allowed in the OT room
even under supervision.
Recommended
ACUTE CARE UNITS (Medical/Surgical/Step-Down) 7.3 Facility unit/ward name:

Not
Bed Safety

BedEntrap.pdf
Bed Safety
Recommended
Bed Safety
requirements.
Acute Care - 7.3 Acute Care - 7.3 - Version: 01.30.2009 413 of 578

Not
Bed Safety
CPR, etc.
Recommended
Bed Safety
7.3.1.6 Are beds with built-in weight scales Preventative maintenance tags should be up to
accurate and functioning correctly? date. Scale calibration should be considered and
manufacturer and/or facility policy
recommendations followed.
Recommended
Bed Safety

Code Carts
Mandatory

Not
Code Carts
Recommended
Code Carts
Recommended
Code Carts
Recommended
Code Carts
Service.

Not
Code Carts
Recommended
Electrical Safety
harm themselves.
Electrical Safety
exposed wiring?
Electrical Safety

Not
Electrical Safety
Electrical Safety
Electrical Safety


Not
to be a priority?
storage?
NFPA 101 ch 7 - 2009.pdf
medication?


Not
entrance?

environments.
Equipment Safety
identifiers.
NFPA 99 CH 8.pdf
Equipment Safety

Not
Equipment Safety
Recommended
Equipment Safety

Mandatory
Equipment Safety
Recommended

Not
Equipment Safety
equipment in area.
Recommended
Equipment Safety
devices.
Recommended
Equipment Safety
Equipment Safety
Recommended

Not
Equipment Safety
7.3.5.10 Is a reliable system used to identify Examples are color coding or directional arrows
which tubes and connectors go to for input jacks. Color coding should be used with
which devices? caution and given consideration for color-
blindness, 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.

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?

Not
Equipment Safety
7.3.5.10.2 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 The Joint Commission SEA Issue 36

Not
Equipment Safety
7.3.5.10.2 (continued)... Are staff observed to ...(continued) caregivers). Which also might
(continued) trace tubes and lines back to points include new significant others/visitors coming
of origin in appropriate onto the scene.
circumstances?
Equipment Safety
7.3.5.10.4 Can staff describe how they include Interview and ask to see example of contents
tubing considerations for individual from the plan of care that address tubing
patients when they assess for fall management as a fall risk for patients with
risk? multiple tubings.
Equipment Safety
7.3.5.10.5 As part of the orientation, are the Ask to review anything that represents the
patient and family instructed to get content used for orientation of patients and
help from clinical staff if there is a families. Ask staff what they tell patients relative
real or perceived need to connect or to tubing connections and disconnections and
disconnect any devices or tubings? how they reinforce this each shift.

Equipment Safety
Recommended

Not
Equipment Safety

Equipment Safety
Recommended
correctly?
Recommended

Not
program?
Recommended
event?


Not
elope.

Recommended
Fall Prevention
Fall Prevention
Recommended
Fall Prevention
patients?

Not
Fall Prevention

Fall Prevention
the patient.
Fall Prevention
patient?
Fall Prevention
alarms?
Fall Prevention
Mandatory

Not
Fall Prevention
timeframes?
Fall Prevention
Fall Prevention
knowledge level.
Fire Safety
area?

Not
Fire Safety
Fire Safety
Fire Safety
NFPA 101 Ch 19.pdf
Fire Safety
for these patients.

Not
Fire Safety
laundering?
Infection Control
openings)?
Infection Control

Infection Control
IV room.

Not
Infection Control
available.


Infection Control
occupied)?

are checked.

Infection Control
they are needed?
Recommended

Not
Medical Gas Safety
adaptors.
Medical Gas Safety
meter.
Medical Gas Safety
Medical Gas Safety
cylinder per area).

Not
Medical Gas Safety
assembly.


around oxygen.
Medical Gas Safety
O2CylHazardSumm.pdf
Medical Gas Safety

Not
Medication Safety
food/drink.


Medication Safety
not in use?
Medication Safety
Medication Safety

Not
Medication Safety
unit?
Medication Safety
precaution?
Medication Safety
Medication Safety
be used.
Medication Safety


Not
Medication Safety
Recommended
Medication Safety
Medication Safety

Medication Safety
use)?
Medication Safety

Not
Medication Safety
setting?
Medication Safety
Recommended
Medication Safety
Medication Safety
arounds? arounds.
Recommended

Not
Medication Safety
barcode.

Medication Safety
Recommended
Medication Safety
Medication Safety

Not
Medication Safety
Medication Safety

Medication Safety
Medication Safety
review.
Medication Safety

Not
Medication Safety
process?
Medication Safety
frequency?
Medication Safety
not accepted.
Recommended

Not
information?


Not
misidentification.


Not


in bed as well.
Recommended

Not
communication tool.

Recommended
Recommended

Not
7.3.12.11.1 Is there an assessment used to Review assessment process/documents.
determine if a patient is potentially
violent?
Mandatory; Priority A VA IL-10-97-006 Violent Behavior.pdf

INTENSIVE CARE UNITS 7.4 Facility unit/ward name:

Not
Bed Safety

BedEntrap.pdf
Bed Safety
Recommended
Bed Safety
requirements.
ICU - 7.4 ICU - 7.4 - Version: 01.30.2009 447 of 578


Not
Bed Safety
CPR, etc.
Recommended
Bed Safety
7.4.1.6 Are beds with built-in weight scales Preventative maintenance tags should be up to
accurate and functioning correctly? date. Scale calibration should be considered and
manufacturer and/or facility policy
recommendations followed.
Recommended
Bed Safety

Code Carts
Mandatory


Not
Code Carts
Recommended
Code Carts
Recommended
Code Carts
Recommended
Code Carts
Service.


Not
Code Carts
Recommended
Electrical Safety
harm themselves.
Electrical Safety
exposed wiring?
Electrical Safety


Not
Electrical Safety
Electrical Safety
Electrical Safety



Not
to be a priority?
storage?
NFPA 101 ch 7 - 2009.pdf
medication?



Not
environments.
Equipment Safety
identifiers.
NFPA 99 CH 8.pdf
Equipment Safety
Equipment Safety
Recommended


Not
Equipment Safety

Mandatory
Equipment Safety
Recommended
Equipment Safety
equipment in area.
Recommended
Equipment Safety
devices.
Recommended


Not
Equipment Safety
Equipment Safety
Recommended
Equipment Safety

Equipment Safety


Not
Equipment Safety






Not
Equipment Safety
circumstances?
Equipment Safety
Equipment Safety

Equipment Safety
Recommended
Equipment Safety
7.4.5.12 Are clocks synchronized and During codes the monitoring equipment has a
accurate? clock and the room or unit has a clock and the
times on all clocks should be the same.
Recommended


Not
Equipment Safety

Equipment Safety
Recommended


Not
Recommended
Fall Prevention
Fall Prevention
Recommended
Fall Prevention
patients?
Fall Prevention


Not
Fall Prevention
the patient.
Fall Prevention
patient?
Fall Prevention
alarms?
Fall Prevention
Mandatory
Fall Prevention
timeframes?


Not
Fall Prevention
Fall Prevention
knowledge level.
Fire Safety
area?
Fire Safety
Fire Safety


Not
Fire Safety
NFPA 101 Ch 19.pdf
Infection Control
openings)?
Infection Control

Infection Control
IV room.


Not
Infection Control
available.


Infection Control
occupied)?

are checked.

Infection Control
they are needed?
Recommended


Not
Medical Gas Safety
adaptors.
Medical Gas Safety
meter.
Medical Gas Safety
Medical Gas Safety
cylinder per area).


Not
Medical Gas Safety
assembly.


around oxygen.
Medical Gas Safety
O2CylHazardSumm.pdf
Medical Gas Safety


Not
Medication Safety
food/drink.


Medication Safety
not in use?
Medication Safety
Medication Safety


Not
Medication Safety
unit?
Medication Safety
7.4.11.6.1 If needle-less sytems are used are Example of needle-less systems: blunt tip, pre-
emergency 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
precaution?
Medication Safety
floors/care areas?


Not
Medication Safety
Medication Safety
be used.
Medication Safety
7.4.11.10.1 Are single-dose perenteral For infection control and medication safety
containers (with preference to pre- purposes.
filed syringes) used when possible?
Mandatory JCAHO_CAMH.pdf /A Page=249

Medication Safety

Medication Safety
Recommended


Not
Medication Safety
Medication Safety

Medication Safety
use)?
Medication Safety
Medication Safety
setting?


Not
Medication Safety
Recommended
Medication Safety
Medication Safety
arounds? arounds.
Recommended


Not
Medication Safety
barcode.

Medication Safety
Recommended
Medication Safety
Medication Safety


Not
Medication Safety
Medication Safety

Medication Safety
Medication Safety
review.
Medication Safety


Not
Medication Safety
process?
Medication Safety
frequency?
Medication Safety
7.4.11.39.1 Is there a process to verify contents Safe labeling of medications and solutions
of a syringe or container before drug (including contrast media) in perioperative
administration to patient during a settings, operating rooms, ambulatory surgery,
procedure or code? clinics, cardiac catheterization area, endoscopy,
radiology, dental, or other areas where operative
and invasive procedures may be performed an
independent double check 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


Not
not accepted.
Recommended
information?



Not
misidentification.



Not


in bed as well.
Recommended


Not
communication tool.

Recommended
Recommended


Not

Surgical or Invasive Procedure Precautions
7.4.14.2 Has the VHA OR Self Assessment This self assessment tool provides a relatively
#1: Self-Assessment Tool for quick way to assess local policy compliance with
Observing Steps Required by VHA requirements of related VHA Directives.
Directives 2004-028 (Ensuring
Correct Surgery and Invasive
Procedures) and 2006-030
(Prevention of Retained Surgical
Items, being used?
Mandatory ORSAT 1 In-OR for VAMC Policies 2004-028 & 2006-030_51107.doc

PRE-OP HOLDING OPERATING ROOM & POST ANESTHESIA UNIT Facility unit/ward name:
Not
Code Carts
Recommended
Electrical Safety
harm themselves.
Electrical Safety
exposed wiring?
Electrical Safety
OR - 7.5 OR - 7.5 - Version: 01.30.2009 479 of 578

Not
Electrical Safety
Electrical Safety
Electrical Safety
7.5.3.7 If provided are electrical isolation NCPS has observed increasing number of
transformers and switchgear serving electrical blackouts and brownouts in operating
the operating rooms properly sized to suites due to the increased power demand of new
carry the maximum expected equipment being used in the OR's. Facilities
electrical load; and is there an Engineering should conduct an analysis to verify
assessment done when new the adequacy of these devices/equipment.
equipment is added to the system?
Recommended
to be a priority?
OR - 7.5 OR - 7.5 - Version: 01.30.2009 480 of 578

Not
storage?
NFPA 101 ch 7 - 2009.pdf
medication?

7.5.4.9 Are battery operated lights provided Due to lag time between the loss of power and
in Operating Rooms and any other activation of the emergency generator battery
Anesthetizing Location? operated lights shall be provided.
OR - 7.5 OR - 7.5 - Version: 01.30.2009 481 of 578

Not
environments.
Equipment Safety
identifiers.
NFPA 99 CH 8.pdf
Equipment Safety
Equipment Safety
Recommended
OR - 7.5 OR - 7.5 - Version: 01.30.2009 482 of 578

Not
Equipment Safety

Mandatory
Equipment Safety
Recommended
Equipment Safety
equipment in area.
Recommended
Equipment Safety
devices.
Recommended
OR - 7.5 OR - 7.5 - Version: 01.30.2009 483 of 578

Not
Equipment Safety
Equipment Safety
Recommended
Equipment Safety

Equipment Safety
OR - 7.5 OR - 7.5 - Version: 01.30.2009 484 of 578

Not
Equipment Safety




OR - 7.5 OR - 7.5 - Version: 01.30.2009 485 of 578

Not
Equipment Safety
circumstances?
Equipment Safety
Equipment Safety

Equipment Safety
Recommended
Equipment Safety
7.5.5.12 Are clocks synchronized and During codes the monitoring equipment has a
accurate? clock and the room or unit has a clock and the
times on all clocks should be the same.
Recommended
OR - 7.5 OR - 7.5 - Version: 01.30.2009 486 of 578

Not
Equipment Safety

Equipment Safety
Recommended
OR - 7.5 OR - 7.5 - Version: 01.30.2009 487 of 578

Not
elope.

Recommended
Fall Prevention
Recommended
Fall Prevention
patients?
Fall Prevention
OR - 7.5 OR - 7.5 - Version: 01.30.2009 488 of 578

Not
Fall Prevention
Fall Prevention
knowledge level.
Fire Safety
area?
Fire Safety
Fire Safety
OR - 7.5 OR - 7.5 - Version: 01.30.2009 489 of 578

Not
Fire Safety
NFPA 101 Ch 19.pdf
Infection Control
openings)?
Infection Control

Infection Control
IV room.
OR - 7.5 OR - 7.5 - Version: 01.30.2009 490 of 578

Not
Infection Control
available.


Medical Gas Safety
adaptors.
Medical Gas Safety
OR - 7.5 OR - 7.5 - Version: 01.30.2009 491 of 578

Not
Medical Gas Safety
cylinder per area).
Medical Gas Safety
assembly.


around oxygen.
Medical Gas Safety
O2CylHazardSumm.pdf
OR - 7.5 OR - 7.5 - Version: 01.30.2009 492 of 578

Not
Medical Gas Safety
Medication Safety
food/drink.


Medication Safety
not in use?
Medication Safety
OR - 7.5 OR - 7.5 - Version: 01.30.2009 493 of 578

Not
Medication Safety
unit?
Medication Safety
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
precaution?
OR - 7.5 OR - 7.5 - Version: 01.30.2009 494 of 578

Not
Medication Safety
Medication Safety

Medication Safety
7.5.11.11 Are the sizes of injectable drugs in Helps to prevent overdose and reduces the
vials or ampoules matched to the hazard associated with multi-dose vials. This
clinical situation? may be a future JCAHO PS Goal.
Recommended
Medication Safety
Medication Safety

OR - 7.5 OR - 7.5 - Version: 01.30.2009 495 of 578

Not
Medication Safety
use)?
Medication Safety
Medication Safety
setting?
Medication Safety
Recommended
OR - 7.5 OR - 7.5 - Version: 01.30.2009 496 of 578

Not
Medication Safety
7.5.11.19.2 If naloxone has been used to reverse There have been cases where the anesthesia
the effects of morphine or reversal agent wears off and the anesthesia
meperidine, is the patient observed begins to take effect again after patients have
for a minimum of two hours to ensure been discharged.
that re-narcotization has not taken
place?
Recommended
Medication Safety
Medication Safety
Medication Safety

Medication Safety
OR - 7.5 OR - 7.5 - Version: 01.30.2009 497 of 578

Not
Medication Safety
review.
Medication Safety
process?
Medication Safety
7.5.11.36 Are medications used in surgical Standardization is an important patient safety
cases organized and standardized principle.
per case type to minimize inter-
provider variation?
Recommended
Medication Safety
7.5.11.37 Are chemical products and If appropriate sizes are acquired for each clinical
medications (including contract situation it eliminates the transfer of containers,
media) used in the operative suite, omitting the vulnerability of mislabeling or mis-
treatment areas, pharmacy or clinics administration. Labels are required on all
purchased in sizes appropriate for medications, solutions, etc. on and off the sterile
their clinical situation (single dose, field, even if only one medication/solution is
single patient, individually labeled) given. If pre-made single dose containers are not
and kept in a labeled state to the available for sterile procedures, sterile markers
point of administration? 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 OR - 7.5 - Version: 01.30.2009 498 of 578

Not
Medication Safety
7.5.11.39 Are medications drawn up for use in Eliminate the use of unlabeled sterile basins.
the sterile field accurately and Encourage the use of sterile-packed unit dose
consistently labeled? medications.
JC- CAMH MM.05.01.09.pdf
Medication Safety
Recommended
Medication Safety
7.5.11.40 Do respiratory care professionals Having these individuals give the medication is a
administer respiratory treatments? 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 These cases are rare, however, the medication to
malignant hyperthermia readily treat it can expire before it is needed. There
available? should be mechanism to check the expiration
date and availability on a periodic basis.
MH Medical Professionals FAQs.pdf

OR - 7.5 OR - 7.5 - Version: 01.30.2009 499 of 578

Not
Medication Safety
7.5.11.41.1 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?
Medication Safety
not accepted.
information?
OR - 7.5 OR - 7.5 - Version: 01.30.2009 500 of 578

Not
misidentification.

OR - 7.5 OR - 7.5 - Version: 01.30.2009 501 of 578

Not


Recommended
OR - 7.5 OR - 7.5 - Version: 01.30.2009 502 of 578

Not
7.5.14.1 Is there physical evidence that the Observe a pre-op team "time out"; or interview
VHA Ensuring Correct Surgery clinicians who participate on surgical teams.
Directive is being followed inside OR Look for posters, use of a white board, review
for surgeries and outside the OR for documentation if available. View surgical
other invasive procedures? 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 This self assessment tool provides a relatively
#1: Self-Assessment Tool for quick way to assess local policy compliance with
Observing Steps Required by VHA requirements of related VHA Directives.
Directives 2004-028 (Ensuring
Correct Surgery and Invasive
Procedures) and 2006-030
(Prevention of Retained Surgical
Items, being used?
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

7.5.14.3.1 If an item is missing and radiological Radiographs must be interpreted during normal
interpretation is needed are working hours in real time (i.e., within 30
guidelines of referenced Directive minutes). Teleradioloy can and should be used if
followed? available on off-shifts, if available.
OR - 7.5 OR - 7.5 - Version: 01.30.2009 503 of 578

Not
7.5.14.4 Does each surgical team conduct a Talk with staff to determine if successes are
post-operative debriefing to discuss acknowledged, if miscommunications occurred, or
recently completed surgical cases? improvements are discussed.
Recommended MTTBD_Sep06.pdf
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 Ask staff of protocol; look for use of an insolated
used, is there a standardized holster or device.
protocol of where the unit is placed
during a surgical procedure to
prevent inadvertent fire or burns
when not in active use?
Recommended NFPA 99.8.5.2.3.1.pdf /A Page=03
OR - 7.5 OR - 7.5 - Version: 01.30.2009 504 of 578

Not
7.5.14.8 If ESU, lasers, or other heat An oxygen enriched atmosphere greatly
producing equipment is used during increases the risk of fire and therefore must be
surgical procedures in the lungs, controlled before the heat source is introduced.
throat, or near the nose or mouth is Oxygen can be trapped in body hair and
compressed oxygen turned off and dressings and time is needed for it to dissipate.
oxygen given time to dissipate prior
to activating the equipment?

7.5.14.9 Do guidelines exist for using flash Flash sterilizers are only to be used in an
sterilizers? 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 Interview staff.
are earmarked and prepared for a
specific patient verified (via protocol
for double checks) for type and
cross-match before the surgical
procedure begins?
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

Not
7.5.14.12 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 IHI 5 Milion Lives Kit - Reduce Surgical Complications.doc
7.5.14.13 Is a pre-operative evaluation If patients are determined to be at significant risk,
completed for each patient to it may be necessary to give peri-operative
determine the risk of acquiring a antibiotics. Postpone elective procedures,
Surgical Site Infection (SSI)? remove hair for surgical site by clipping (not
shaving), etc.
Recommended IHI 5 Milion Lives Kit - Reduce Surgical Complications.doc
7.5.14.14 Has a protocol been defined for the Ensure proper fit; keep inflation time and
use of pneumatic tourniquets? 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 Vulnerabilities can exist in the acquiring and
that prosthetic devices are available placement of these devices. Double checks and
in the correct size and properly labeling are inefficient and often ineffective
sterilized prior to surgery? 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

Not
7.5.14.17 Are environmental distractions Radio volume, checking pagers, answering cell
minimized during surgical phones, talking, etc.
procedures?
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 Lasers are an ignition source and can cause fire,
plan address the use of heat explosion and consequently serious burns to
producing equipment in and around patients or staff in an oxygen enriched
oxygen enriched atmospheres and/or environment.
flammable preparations?
NFPA 99 ch 13.pdf
Recommended JC- CAMH EC-02-03-01-pdf.pdf
OR - 7.5 OR - 7.5 - Version: 01.30.2009 507 of 578

RADIOLOGY AREA Facility unit/ward name:

Not
Code Carts
Mandatory
Code Carts
Recommended
Code Carts
Recommended
Code Carts
Recommended
Code Carts
Service.
Radiology - 7.6 Radiology - 7.6 - Version: 01.30.2009 508 of 578


Not
Electrical Safety
harm themselves.
Electrical Safety
exposed wiring?
Electrical Safety
Electrical Safety


Not
Electrical Safety
to be a priority?
storage?
NFPA 101 ch 7 - 2009.pdf


Not
medication?

entrance?

environments.


Not
Equipment Safety
identifiers.
NFPA 99 CH 8.pdf
Equipment Safety
equipment in area.
Recommended
Equipment Safety
devices.
Recommended
Equipment Safety
Equipment Safety
Recommended


Not
Equipment Safety
Equipment Safety

Equipment Safety
Recommended
Equipment Safety
Recommended


Not
elope.

Recommended
Fall Prevention
Fall Prevention
Recommended
Fall Prevention
patients?


Not
Fall Prevention

Fall Prevention
the patient.
Fall Prevention
Fall Prevention
knowledge level.


Not
Fire Safety
area?
Fire Safety
Fire Safety
Fire Safety
NFPA 101 Ch 19.pdf
Infection Control
openings)?


Not
Infection Control

Infection Control
IV room.
Infection Control
available.




Not
Medical Gas Safety
adaptors.
Medical Gas Safety
meter.
Medical Gas Safety
Medical Gas Safety
O2CylHazardSumm.pdf
Medical Gas Safety
Medication Safety


Not
Medication Safety
floors/care areas?
Medication Safety
Medication Safety

Medication Safety

Medication Safety
use)?


Not
Medication Safety
Medication Safety
setting?
Medication Safety
Recommended
Medication Safety


Not
Medication Safety
Medication Safety
Medication Safety

Medication Safety
Medication Safety


Not
Medication Safety
process?
Medication Safety
7.6.11.39 Are medications drawn up for use in Eliminate the use of unlabeled sterile basins.
the sterile field accurately and Encourage the use of sterile-packed unit dose
consistently labeled? medications.
JC- CAMH MM.05.01.09.pdf
Medication Safety
Recommended
Medication Safety


Not
not accepted.
information?



Not
misidentification.



Not




Not
Recommended

7.6.15.1 In Magnetic Resonance (MR) areas, Any objects which contain ferromagnetic
do physical barriers separate the materials (from watches to floor buffers) have the
magnet area from waiting rooms, potential of being drawn into/towards the MR
changing rooms, reception areas, equipment due to the powerful magnets used.
etc. and does adequate signage MR machines are always "on", creating a
exist to warn of associated hazards? 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 SEA 38 MRI.pdf


Not
7.6.15.2 In MR areas, are staff able to explain Before the MR procedure, each patient should be
the patient assessment process to assessed twice (two separate instances) for all
the patient or patient's family before associated risk factors, including an evaluation of
or at the time of scheduling the medical history. There may be different
exam? 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.



Not
7.6.15.2.1 In MR areas, are patients briefed Before the procedure, the patient should be
before the procedure regarding the educated about the MR scan, again asked about
hazards/risk factors, provided with a implants, and instructed to change clothes into a
patient alarm, and offered hearing hospital provided gown. The patient should be
protection? 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).
ACR white paper on MR Safety.pdf /A Page=12



Not
7.6.15.3 Are all devices, equipment, and Each MR machine has a magnet strength rating
products assumed to be unsafe for in Tesla (T), and all equipment/devices should be
the MR environment unless proven tested and found safe for use in your MR
otherwise? 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.



Not
7.6.15.3.1 Are materials and equipment that are A hand-held magnet cam be used to screen
brought into the MR scan room objects on or accompanying patients and other
tested with a hand held magnet or items that need to be brought into the MR
verified in writing by the environment. Note that this has limited
manufacturer to be safe for your MR effectiveness; for example, ferromagnetic springs
environment? within a pillow have gone undetected with a hand-
held magnet.
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



Not
7.6.15.3.2 Does a cognitive aid or other Patients should be positioned to avoid crossing
guidance exist for MR Technicians leads and creating loops (i.e., as if when a hand a
on 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.

7.6.15.3.3 Are manufacturer approved fiber Use manufacturer-approved fiber optic, carbon
optic, carbon fiber or graphic leads fiber or graphite leads instead of conductive leads
and low impedance ECG electrodes on medical devices. Also, use manufacturer-
used on equipment that is brought approved large surface area, low impedance
into the MR scan room? ECG electrodes
Recommended MRI Hazard Summary 2008.pdf
7.6.15.4 In MR areas, does the clinical and Interview staff. Look for use of cognitive aids
technical staff demonstrate (equipment lists, patient checklists, procedure
competency in the facility's policy checklist, etc.). Compare current practices with
requirements (such as: MR written policy. Inquire if emergency drills are
equipment compatibility, identification conducted for fire, medical, and civil
of the MR Safety Officer, associated disturbances.
MR hazards, and emergency
procedures) and are they able to
name the MR Safety Officer
assigned for the facility?



Not
7.6.15.5 Can staff describe contraindications The clinical status, medication history and lab
to using contrast media, and how to results of the patient should be known before the
manage adverse reactions? 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.
Recommended
7.6.15.6 Are policies, guidelines, charts or For example neurotoxic or ionic contrast agents
other cognitive aids available to should not be administered intrathecally (may
inform staff about the proper use, cause death). All contrast media administrations
indication, and routes of each type of should require a redundant check. High alert
contrast agent in use or any other medication administered upon transfer into
drugs administered in radiology radiology require the same standard of care
which require monitoring (e.g., pain regarding monitoring.
medicine, sedation, anti-coagulants)?
Recommended
7.6.15.7 Are different types of contrast media All contrast agents should secured and stored
agents stored separately (ionic and separately based on its use and provided with
non-ionic) from one another in the warning labels such as "not for intrathecal use,"
departments and/or in the pharmacy, or kits should be packaged by pharmacy for
and are they labeled with applicable specific procedures such as myelography.
warnings? 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


Not
7.6.15.9 If the facility uses teleradiology via ACR has criteria recommendations including the
PACS (Picture Archiving and following: display monitors, identification (patient
Communications System) are ACR id, date, facility, body part/side, data
(American College of Radiology) compression, patient history), transmission, data
recommendations being followed? archive and retrieval, data security, system
reliability and redundancy, and licensing. If
equipment does not meet the standards
diagnosis's could be affected.
ACR TS for Dig Im Data Mgt.pdf

Recommended ACR TS for telerad.pdf
7.6.15.10 Are all results (positive or negative) Documentation should include appropriate test
documented electronically by the related patient history to assist radiologist,
diagnostic provider in the patients laboratory, or nuclear medicine personnel in
medical record in a timely manner? making a judgment call on critical findings. A
standard process should be in place to handle fee
basis and outside contract reports which often do
not get scanned in the electronic chart.

7.6.15.11 Are abnormal radiology, laboratory Direct communication is defined as face-to-face
and pathology findings requiring or telephone conversation; or written as
urgent attention communicated customary protocol.
directly?
7.6.15.12 Has the communication process for The issuance of pagers; maintenance of VISTA
contacting treating providers in the contacts; the viewing of alerts in CPRS; and /or
event of an abnormal report been establishment of a system of surrogates for taking
simplified in the facility? responsibility for abnormal results.
Recommended; Priority B VHA Directive 2003-043 Test Results.pdf

PHARMACY AREA Facility unit/ward name:

Not
Code Carts
7.7.2.2 Is there a standard method for Expired medications and equipment could cause
rotating stock in code carts before it delays in code responses.
has expired, or replacing stock after
it has expired?
Code Carts
Recommended
Code Carts
Recommended
Code Carts
Recommended
to be a priority?
Pharmacy - 7.7 Pharmacy - 7.7 - Version: 01.30.2009 534 of 578


Not
Equipment Safety
Recommended
Equipment Safety
Equipment Safety

Infection Control


Not
Infection Control
IV room.
Infection Control
available.




Not
Medication Safety
food/drink.


Medication Safety
not in use?
Medication Safety
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?


Not
Medication Safety
unit?
Medication Safety
Recommended
Medication Safety
precaution?
Medication Safety
floors/care areas?


Not
Medication Safety
7.7.11.9 Are high alert drug IV Facility should have local established standards
solutions/concentrations for IV admixtures and administration of high alert
standardized? medications (look for standardized
concentrations, drip charts or cognitive aids for
titratable or frequently changing drugs, and pre-
made solutions when commercially
available);staff should be able to articulate the
precautions to be taken with these medications.

Medication Safety
be used.
Medication Safety

Medication Safety
7.7.11.11 Are the sizes of injectable drugs in Helps to prevent overdose and reduces the
vials or ampoules matched to the hazard associated with multi-dose vials. This
clinical situation? may be a future JCAHO PS Goal.
Recommended
Medication Safety
7.7.11.12 Has the facility prospectively To reduce the danger of accidental free flow, it is
analyzed which medications can safer to prepare smaller bags.
have smaller total dose bag sizes?
Recommended


Not
Medication Safety

Medication Safety
Recommended
Medication Safety
Medication Safety

Medication Safety
use)?


Not
Medication Safety
setting?
Medication Safety
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


Not
Medication Safety
arounds? arounds.
Recommended
Medication Safety
barcode.

Medication Safety
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


Not
Medication Safety
7.7.11.23 Does the facility have a contingency Review plan, interview staff. Ensure it is common
plan for the loss of the BCMA knowledge what to do in case of a breakdown.
system? Is staff aware and Also review records of last test.
competent in this process?
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
Medication Safety
Medication Safety



Not
Medication Safety
7.7.11.27.1 Is the purpose (indication) of the If the pharmacy staff is told the indication of the
medication order/prescription medication it can serve as another method to
communicated to the pharmacy? minimize confusion between look/sound alike
drugs.
Medication Safety
Medication Safety
review.
Medication Safety
7.7.11.30 If ADMs are used, is there a staff Interview staff.
education and competency review
program?
Recommended
Medication Safety
7.7.11.31 If ADMs are used, do Pharmacists Review policy and interview staff.
check drugs before restocking, is a
bar coding system used?
Recommended
Medication Safety
7.7.11.31.1 If ADMs are used, does the system Review policy and interview staff.
have pharmacy profile interface?
Recommended


Not
Medication Safety
Medication Safety
7.7.11.33 Do prescription labels include both This helps with non-VA medications to alert
the generic and brand names? 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
process?
Medication Safety
frequency?


Not
Medication Safety
7.7.11.37 Are chemical products and If appropriate sizes are acquired for each clinical
medications (including contract situation it eliminates the transfer of containers,
media) used in the operative suite, omitting the vulnerability of mislabeling or mis-
treatment areas, pharmacy or clinics administration. Labels are required on all
purchased in sizes appropriate for medications, solutions, etc. on and off the sterile
their clinical situation (single dose, field, even if only one medication/solution is
single patient, individually labeled) given. If pre-made single dose containers are not
and kept in a labeled state to the available for sterile procedures, sterile markers
point of administration? 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

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 JC- CAMH MM.05.01.07.pdf
Medication Safety
Recommended


Not
Medication Safety
7.7.11.41 Are emergency medications to treat These cases are rare, however, the medication to
malignant hyperthermia readily treat it can expire before it is needed. There
available? should be mechanism to check the expiration
date and availability on a periodic basis.
MH Medical Professionals FAQs.pdf

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?
Medication Safety
not accepted.
information?


Not
misidentification.



Not




Not
7.7.15.7 Are different types of contrast media All contrast agents should secured and stored
agents stored separately (ionic and separately based on its use and provided with
non-ionic) from one another in the warning labels such as "not for intrathecal use,"
departments and/or in the pharmacy, or kits should be packaged by pharmacy for
and are they labeled with applicable specific procedures such as myelography.
warnings? 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

Outpatient Areas Facility unit/ward name:

Not
Code Carts
Mandatory
Code Carts
Recommended
Code Carts
Recommended
Code Carts
Recommended
Code Carts
Service.
Outpatient Areas- 7.8 Outpatient Areas- 7.8 - Version: 01.30.2009 551 of 578

Not
Code Carts
Recommended
Electrical Safety
harm themselves.
Electrical Safety
exposed wiring?
Electrical Safety

Not
Electrical Safety
Electrical Safety

to be a priority?

Not
storage?
NFPA 101 ch 7 - 2009.pdf
medication?


Not
entrance?

environments.
Equipment Safety
identifiers.
NFPA 99 CH 8.pdf
Equipment Safety

Not
Equipment Safety
Recommended
Equipment Safety
equipment in area.
Recommended
Equipment Safety
Recommended
Equipment Safety
Recommended
Fall Prevention

Not
Fall Prevention

Fire Safety
Fire Safety
NFPA 101 Ch 19.pdf
Infection Control

Infection Control
IV room.

Not
Infection Control
available.


Medication Safety
Medication Safety
setting?

Not
Medication Safety
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

Not
Medication Safety
Medication Safety
Medication Safety

Medication Safety
Medication Safety
7.8.11.33 Do prescription labels include both This helps with non-VA medications to alert
the generic and brand names? patients and providers of duplicate therapy. Most
VA facilities dispense only generic medications,
but having the brand names listed can serve this
purpose.
Recommended

Not
Medication Safety
process?
Medication Safety
Recommended
Medication Safety
not accepted.

Not
information?
misidentification.


Not


Recommended

Not

Domiciliary
Not
Electrical Safety
exposed wiring?
Electrical Safety
Electrical Safety
to be a priority?
Domiciliary - 7.9 Domiciliary - 7.9 - Version: 01.30.2009 565 of 578

Domiciliary
Not
storage?
NFPA 101 ch 7 - 2009.pdf
medication?


Domiciliary
Not
entrance?

environments.
Equipment Safety
identifiers.
NFPA 99 CH 8.pdf
Fall Prevention

Domiciliary
Not
Fall Prevention

Fire Safety
NFPA 101 Ch 19.pdf
Infection Control
IV room.
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
Not
Medication Safety
Medication Safety
Medication Safety

information?

Domiciliary
Not
misidentification.

7.9.16.1 Is a face to face assessment with a Some residents that enter into the
standardized assessment tool Domiciliary/Hoptel program are those that have or
conducted and documented on each have had Mental Health issues or factors that
potential resident before make them at higher risk for falls, therefore a
acceptance/admission into the specific standardize mechanism needs to be in
Domiciliary (or Hoptel) evaluating for place to assure that residents who are at risk for
falls and suicidal/homicidal risk? receive appropriate care.
Review admission documentation and mental

health assessment program.

Domiciliary
Not
7.9.16.1.1 If a veteran is accecpted/admited is It is important to reassess patients on a
there a specific frequency for systematic schedule, to ensure the patient
periodic re-evaluations throughout remains in a safe environment. Each assessment
the stay for falls and mental health? should be documented. Review assessment
frequencies in resident records or in care plans.
Mandatory VHA Handbook PRRTP.pdf

7.9.16.1.2 Are appropriate Domiciliary staff All staff should receive specific training regarding
thoroughly trained on the Falls and assessment programs with emphasis on suicidal
Mental Health assessment program, and homicidal behaviors (i.e., despondent,
including all staff working on off- depressed, agitated, potentially violent.
shifts?
Recommended
7.9.16.2 Has a standard assessment tool These veterans need training to handle difficult
been developed and used to assess situations such as when another veteran, who
the competency of the veterans may be a friend, wants to enter the building with
working at the open domiciliary contraband. They also need to know what action
entrances that monitor access? to take if they believe another veteran is acting
intoxicated or may be harmful to others or
themselves.
Recommended
7.9.16.3 Is amount of time residents have with Current VHA policy requires a minimum of 4
planned activities monitored with the hours per day, 7 days per week of therapeutic
goal of increasing the contact hours activities. If residents are only occupied for 1 to 2
with each resident? hours per day, 5 days per week with no activities
on weekends or holidays the activities should be
increased.

Domiciliary
Not
7.9.16.4 Are break room and kitchen The FDA Food code requires all food to
refrigerators monitored periodically to consistanly remain below 41 degrees Farinheight.
assure appropriate temperatures are Therefore it is recommended in gerenal industry
maintained? 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

7.9.16.5 Is staffing in the Domiciliary on all Per VA policy, see minimum Domiciliary staffing
shifts, holidays and weekends levels. Review staffing versus resident
assessed and modified as needed? population to verify if appropriate.

7.9.16.6 Has the Mental Health Residential The Deputy Under Secretary for Health for
Program Annual Safety and Security Oepration and Management put forth a
Assessment being completed on the Memorandum for residental programs to
directed schedule? 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

VISN Patient Safety Program

Not
Leadership/Support
8.1.1 Does the PSO report directly to the It is important that the Patient Safety Program
Network Director? 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
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 VISN leaders (i.e., Network Director, Chief
leaders in the VISN on patient Medical Officer, Deputy Network Director, and
safety? 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 USH memo PSM Job Jar (2).pdf

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 Does each facility in the VISN have The PSO should track and report vacant PSM
a full time PSM? positions to the Network Director. Vacant
positons should be filled in a timely manner (e.g.
6 months).
VISN PS Program VISN PS Program - Version: 01.30.2009 573 of 578


Not
Staffing
8.2.2 Are PSO collateral duties kept to a Collateral duties assigned should fit under the
minimum? 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
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 The PSO serves as a coach and first line
HFMEA training course? resource for VISN facilities when questions arise
on completing proactive risk
Mandatory
Resources
8.3.3 Has the PSO attended the NCPS The PSO serves as a coach and advisor to PSMs
101 RCA training course? on RCA issues. 101 covers the fundamentals of
the VA patient safety program.
Mandatory
Resources
8.3.4 Is the PSO funded to attend As the VISN patient safety expert it is imporant
continuing education patient safety for the PSO to be up to date on developments in
training conferences? the patient safety field.
Recommended


Not
RCA Activities
8.4.1 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 Annually, at least 50% of the minimum required
HFMEA reports completed by the individual RCAs/Aggregated Reviews and at least
facilities reviewed and critiqued with one HFMEAs for each facility should be reviewed
comments being provided to the with comments provided to the PSM. The intent is
PSM? to help the facility improve the end product. The
optimal timeframe to complete and return the
reviews is within 30 days of submission.

RCA Activities
8.4.3 Does the PSO work with the facilities Assistance can be provided in many ways
to improve the quality of RCAs (e.g. including written comments, teleconferences, and
root causes, actions, and outcome formalized training. Documentation that these
measures) and Aggregated Review activities have taken place should be available.
when needed?
RCA Activities
8.4.4 Is guidance and assistance being SPOT data should be continuously reviewed and
provided for facilities that routinely PSOs should have in depth knowledge of what
have RCAs and Aggregated Reviews work is being done and how timely it is being
that exceed 45 days with evidence completed regarding patient safety at each of
that compliance is improving? their facilities. Performance data is available on
the NCPS VA web site.
USH memo PSM Job Jar (2).pdf
Mandatory VHA PS Handbook.pdf


Not
RCA Activities
8.4.5 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.)
8.5.1 Were site visits conducted by the Annual visits to VISN facilities should be
PSO during the past 12 months at conducted with a a written report (that can be
every VISN medical center or followed up) submitted.
hospital using questions from the
ePSAT with a written report being
provided?
Recommended
8.5.2 When requested by leadership, PSM, The PSO is the first line consultant on all patient
etc. does the PSO provide patient safety issues and conducting training on the
safety training within the Network? patient safety program is an appropriate way to
continue to provide support.
8.5.3 Are regularly scheduled (e.g., Each PSO should keep in regular contact with the
monthly) teleconference calls or PSMs and ideas should be shared across the
other means of communication VISN. The recommended way to do this is to
maintained with the PSMs? hold regular calls.
8.5.4 Does the PSO participate in the Staying current on national patient safety
monthly national PSO program issues is vital to the PSO role and
teleconferences and the national necessary to perform the job effecively.
PSM teleconferences?
Recommended


Not
8.5.5 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 At minimum the orientation program should cover
and are visits made by the PSO to SACing events, RCA training, a schedule of
provide assistance and training to pertinent conference calls and introduction to
new PSMs in the VISN? other PSMs in the VISN. Mentoring is
recommend between senior PSMs and new hire
PSMs.
8.5.7 Is there a system in place to verify Use of the VISN 22 web site meets this
that actions specified in Patient requirement.
Safety Alerts are completed and
sustained?
8.5.8 Is there a system in place to verify Use of the VISN 22 web site meets this
that recommendations contained in requirement.
Patient Safety Advisories are
completed or alternate equivalent
measures are implemented?


Not
8.5.9 Are lessons learned and best If outstanding programs or actions have been
practices disseminated and shared implemented it is important to share with others
across the VISN and with NCPS? so that, if applicable and feasible, others can
benefit from success of across the VA. Some
examples are newsletters, conference calls,
formal comments, etc.
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

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Patient Safety Assessment Too

MANAGEMENT AND LEADERSHIP - Element 1

JC- CAMH LD-03-05-01.pdf

Mgt Ldr - 1 Mgt Ldr - 1 - Version: 01.30.2009 5 of 578

MANAGEMENT AND LEADERSHIP - Element 1

JC- CAMH LD-03-01-01.pdf

JC- CAMH LD-03-06-01.pdf

JC- CAMH LD-03-04-01.pdf

Mandatory;Priority A VHA Handbook 1050 01 PSI.pdf /A Page=9

Mgt Ldr - 1 Mgt Ldr - 1 - Version: 01.30.2009 6 of 578

MANAGEMENT AND LEADERSHIP - Element 1

Mgt Ldr - 1 Mgt Ldr - 1 - Version: 01.30.2009 7 of 578

MANAGEMENT AND LEADERSHIP - Element 1

Supporting the Patient Safety Program Memo.pdf

Recommended; Priority C JC- CAMH LD-03-05-01.pdf

JC- CAMH LD-03-06-01.pdf

Mgt Ldr - 1 Mgt Ldr - 1 - Version: 01.30.2009 8 of 578

MANAGEMENT AND LEADERSHIP - Element 1

Mgt Ldr - 1 Mgt Ldr - 1 - Version: 01.30.2009 9 of 578

PATIENT SAFETY PROGRAM MANAGEMENT - Element 2

AggReviewSchedule 09 & 10 11x17.pdf

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

PS Prgm Mgt - 2 PS Prgm Mgt - 2 - Version: 01.30.2009 10 of 578

PATIENT SAFETY PROGRAM MANAGEMENT - Element 2

PS Prgm Mgt - 2 PS Prgm Mgt - 2 - Version: 01.30.2009 11 of 578

PATIENT SAFETY PROGRAM MANAGEMENT - Element 2

PS Prgm Mgt - 2 PS Prgm Mgt - 2 - Version: 01.30.2009 12 of 578

PATIENT SAFETY PROGRAM MANAGEMENT - Element 2

Mandatory; Priority A VHA Handbook 1050 01 PSI.pdf /A Page=13

Mandatory; Priority A VHA Handbook 1050 01 PSI.pdf /A Page=16

PS Prgm Mgt - 2 PS Prgm Mgt - 2 - Version: 01.30.2009 13 of 578

PATIENT SAFETY PROGRAM MANAGEMENT - Element 2

JC- CAMH PI-03-01-01.pdf

PS Prgm Mgt - 2 PS Prgm Mgt - 2 - Version: 01.30.2009 14 of 578

PATIENT SAFETY PROGRAM MANAGEMENT - Element 2

PS Prgm Mgt - 2 PS Prgm Mgt - 2 - Version: 01.30.2009 15 of 578

PATIENT SAFETY PROGRAM MANAGEMENT - Element 2

commitment on the part of the organization to the

Verify via feedback documentation and interview

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

PS Prgm Mgt - 2 PS Prgm Mgt - 2 - Version: 01.30.2009 16 of 578

JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3

JC - 3 JC - 3 - Version: 01.30.2009 17 of 578

JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3

Use at least two patient identifiers

2) Two patient identifiers are used when

3) Two patient identifiers are used when

4) Two patient identifiers are used when providing

2009 NPSGs Chart TIPS (2).pdf

JC - 3 JC - 3 - Version: 01.30.2009 18 of 578

JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3

Use at least two patient identifiers

Wrong-patient errors occur in

2009 NPSGs Chart TIPS (2).pdf

Conduct a verification process before

2009 NPSGs Chart TIPS (2).pdf

JC - 3 JC - 3 - Version: 01.30.2009 19 of 578

JOINT COMMISSION (Comprehensive Accreditation Manual for Hospitals) - Element 3

Eliminate transfusion errors related