VA Health Care
Weaknesses in Policies and Oversight Governing Medical Supplies and Equipment Pose Risks to Veterans' Safety Gao ID: GAO-11-391 May 3, 2011Department of Veterans Affairs (VA) clinicians use expendable medical supplies--disposable items that are generally used one time--and reusable medical equipment (RME), which is designed to be reused for multiple patients. VA has policies that VA medical centers (VAMC) must follow when purchasing such supplies and equipment, tracking these items at VAMCs, and reprocessing--that is, cleaning, disinfecting, and sterilizing--RME. GAO was asked to evaluate (1) purchasing, tracking, and reprocessing requirements in VA policies and (2) VA's oversight of VAMCs' compliance with these requirements. GAO reviewed VA policies and selected two purchasing requirements, two tracking requirements, and two reprocessing requirements. At the six VAMCs GAO visited, GAO interviewed officials and reviewed documents to examine the adequacy of the selected requirements to help ensure veterans' safety. GAO also interviewed officials from VA headquarters and from six Veterans Integrated Service Networks (VISN), which oversee VAMCs, and obtained and reviewed documents regarding VA's oversight.
GAO found that the VA tracking and reprocessing requirements selected for review are inadequate to help ensure the safety of veterans who receive care at VAMCs. GAO did not identify inadequacies in selected VA purchasing requirements that may create potential risks to veterans' safety. GAO found the following: (1) Tracking requirements. Because VA does not require VAMCs to enter information about certain expendable medical supplies and RME in their facilities into VA's inventory management systems, VAMCs may have incomplete inventories of these items. This, in turn, creates potential risks to veterans' safety. For example, in the event of a manufacturer recall involving these items, VAMCs may be unable to readily determine whether the items are in their facilities and should be removed and not used when providing care to veterans. (2) Reprocessing requirements. Although VA requires VAMCs to develop device-specific training for staff on how to correctly reprocess RME, VA has not specified the types of RME for which this training is required. VA has also provided conflicting guidance to VAMCs on how to develop this training. This lack of clarity may have contributed to delays in developing the required training. Without appropriate training on reprocessing, VAMC staff may not be reprocessing RME correctly, which poses potential risks to the safety of veterans. VA headquarters officials told GAO that VA has plans to develop training for certain RME, but VA lacks a timeline for developing this training. GAO also found weaknesses in VA's oversight of VAMCs' compliance with the selected purchasing and reprocessing requirements. These weaknesses render VA unable to systematically identify and address noncompliance with the requirements, which poses potential risks to the safety of veterans. GAO did not identify weaknesses in VA's oversight of VAMCs' compliance with the selected tracking requirements. GAO found the following: (1) Oversight over purchasing requirements. In general, VA does not oversee VAMCs' compliance with the selected purchasing requirements. While VA intends to improve oversight over these requirements, it has not yet developed a plan for doing so. (2) Oversight over reprocessing requirements. Although VA headquarters receives information from the VISNs on any noncompliance they identify as well as VAMCs' corrective action plans to address this noncompliance, VA headquarters does not analyze this information to inform its oversight. According to VA headquarters officials, VA intends to develop a plan for analyzing this information to systematically identify areas of noncompliance that occur frequently, pose high risks to veterans' safety, or have not been addressed across all VAMCs. GAO is making several recommendations for VA to address the inadequacies identified in selected tracking and reprocessing requirements and the weaknesses in its oversight over selected purchasing and reprocessing requirements. VA concurred with these recommendations.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Randall B. Williamson Team: Government Accountability Office: Health Care Phone: (206) 287-4860GAO-11-391, VA Health Care: Weaknesses in Policies and Oversight Governing Medical Supplies and Equipment Pose Risks to Veterans' Safety
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United States Government Accountability Office:
GAO:
Report to Congressional Requesters:
May 2011:
VA Health Care:
Weaknesses in Policies and Oversight Governing Medical Supplies and
Equipment Pose Risks to Veterans' Safety:
GAO-11-391:
GAO Highlights:
Highlights of GAO-11-391, a report to congressional requesters.
Why GAO Did This Study:
Department of Veterans Affairs (VA) clinicians use expendable medical
supplies”disposable items that are generally used one time”and
reusable medical equipment (RME), which is designed to be reused for
multiple patients. VA has policies that VA medical centers (VAMC) must
follow when purchasing such supplies and equipment, tracking these
items at VAMCs, and reprocessing-”that is, cleaning, disinfecting, and
sterilizing”-RME. GAO was asked to evaluate (1) purchasing, tracking,
and reprocessing requirements in VA policies and (2) VA‘s oversight of
VAMCs‘ compliance with these requirements. GAO reviewed VA policies
and selected two purchasing requirements, two tracking requirements,
and two reprocessing requirements. At the six VAMCs GAO visited, GAO
interviewed officials and reviewed documents to examine the adequacy
of the selected requirements to help ensure veterans‘ safety. GAO also
interviewed officials from VA headquarters and from six Veterans
Integrated Service Networks (VISN), which oversee VAMCs, and obtained
and reviewed documents regarding VA‘s oversight.
What GAO Found:
GAO found that the VA tracking and reprocessing requirements selected
for review are inadequate to help ensure the safety of veterans who
receive care at VAMCs. GAO did not identify inadequacies in selected
VA purchasing requirements that may create potential risks to veterans‘
safety. GAO found the following:
* Tracking requirements. Because VA does not require VAMCs to enter
information about certain expendable medical supplies and RME in their
facilities into VA‘s inventory management systems, VAMCs may have
incomplete inventories of these items. This, in turn, creates
potential risks to veterans‘ safety. For example, in the event of a
manufacturer recall involving these items, VAMCs may be unable to
readily determine whether the items are in their facilities and should
be removed and not used when providing care to veterans.
* Reprocessing requirements. Although VA requires VAMCs to develop
device-specific training for staff on how to correctly reprocess RME,
VA has not specified the types of RME for which this training is
required. VA has also provided conflicting guidance to VAMCs on how to
develop this training. This lack of clarity may have contributed to
delays in developing the required training. Without appropriate
training on reprocessing, VAMC staff may not be reprocessing RME
correctly, which poses potential risks to the safety of veterans. VA
headquarters officials told GAO that VA has plans to develop training
for certain RME, but VA lacks a timeline for developing this training.
GAO also found weaknesses in VA‘s oversight of VAMCs‘ compliance with
the selected purchasing and reprocessing requirements. These
weaknesses render VA unable to systematically identify and address
noncompliance with the requirements, which poses potential risks to
the safety of veterans. GAO did not identify weaknesses in VA‘s
oversight of VAMCs‘ compliance with the selected tracking
requirements. GAO found the following:
* Oversight over purchasing requirements. In general, VA does not
oversee VAMCs‘ compliance with the selected purchasing requirements.
While VA intends to improve oversight over these requirements, it has
not yet developed a plan for doing so.
* Oversight over reprocessing requirements. Although VA headquarters
receives information from the VISNs on any noncompliance they identify
as well as VAMCs‘ corrective action plans to address this
noncompliance, VA headquarters does not analyze this information to
inform its oversight. According to VA headquarters officials, VA
intends to develop a plan for analyzing this information to
systematically identify areas of noncompliance that occur frequently,
pose high risks to veterans‘ safety, or have not been addressed across
all VAMCs.
What GAO Recommends:
GAO is making several recommendations for VA to address the
inadequacies identified in selected tracking and reprocessing
requirements and the weaknesses in its oversight over selected
purchasing and reprocessing requirements. VA concurred with these
recommendations.
View [hyperlink, http://www.gao.gov/products/GAO-11-391] or key
components. For more information, contact Randall B. Williamson at
(202) 512-7114 or williamsonr@gao.gov.
[End of section]
Contents:
Letter:
Background:
Selected VA Requirements for Tracking and Reprocessing Are Inadequate
to Help Ensure Veterans' Safety:
VA's Oversight of VAMCs' Compliance with Selected Purchasing and
Reprocessing Requirements Has Weaknesses:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Scope and Methodology:
Appendix II: Comments from the Department of Veterans Affairs:
Appendix III: GAO Contact and Staff Acknowledgments:
Table:
Table 1: Characteristics of VAMCs Selected for Site Visits:
Figure:
Figure 1: Selected Veterans Affairs (VA) Entities' Roles and
Responsibilities for Purchasing, Tracking, and Reprocessing:
Abbreviations:
AEMS/MERS: Automated Engineering Management System/Medical Equipment
Reporting System
GIP: Generic Inventory Package:
HIV: Human Immunodeficiency Virus:
MQAS: Management Quality Assurance Service:
OIG: Office of Inspector General:
RME: reusable medical equipment:
SOP: standard operating procedure:
SPD: Supply, Processing, and Distribution:
VA: Department of Veterans Affairs:
VAMC: Veterans Affairs medical center:
VHA: Veterans Health Administration:
VISN: Veterans Integrated Service Network:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
May 3, 2011:
The Honorable Jeff Miller:
Chairman:
The Honorable Bob Filner:
Ranking Member:
Committee on Veterans' Affairs:
House of Representatives:
The Honorable Charles E. Grassley:
United States Senate:
The Honorable Russ Carnahan:
House of Representatives:
The Department of Veterans Affairs (VA) operates one of the largest
integrated health care delivery systems in the United States,
providing care to over 5.5 million veterans annually. Organized into
21 Veterans Integrated Service Networks (VISN), VA's health care
system includes 153 VA medical centers (VAMC) nationwide that offer a
variety of outpatient, residential, and inpatient services.[Footnote
1] In providing health care services to veterans, clinicians at VAMCs
use supplies and equipment purchased by VA. These include expendable
medical supplies, such as needles and scalpel blades, which are
generally used once and discarded, and reusable medical equipment
(RME), which is designed to be reused for multiple patients and
includes such equipment as endoscopes and some surgical instruments.
Because RME is used when providing care to multiple veterans, this
equipment must be reprocessed--that is, cleaned and disinfected or
sterilized--between uses. VA has established requirements for VAMCs to
follow for purchasing items such as expendable medical supplies and
RME; for tracking--that is, accounting for--these items at their
facilities;[Footnote 2] and for reprocessing RME.[Footnote 3] These
policies are designed, in part, to help ensure the safety of the
veterans who receive care at VAMCs.
Recent press articles have reported lapses in compliance with VA's
reprocessing requirements at some VA medical centers, which may have
put the safety of thousands of veterans receiving care at these
facilities at risk.[Footnote 4] For example, one article reported that
between 2009 and 2010, about 1,800 veterans were potentially exposed
to infectious diseases at the St. Louis VAMC, because they received
care using improperly reprocessed dental instruments.[Footnote 5]
Moreover, in a September 2010 congressional hearing, we presented our
preliminary observations on veterans' safety issues related to
expendable medical supplies and RME. We reported examples of
noncompliance with VA's requirements for purchasing and tracking
certain medical supplies and equipment, which may pose risks to
veterans' safety. In response, a congressional committee and certain
members of Congress have raised questions about the adequacy of VA's
requirements for purchasing, tracking, and reprocessing to help ensure
veterans' safety. In addition, questions have been raised regarding
the adequacy of VA's oversight of VAMCs' compliance with these
requirements. In this report, we examine (1) VA purchasing, tracking,
and reprocessing requirements in VA policies, which were selected
based on their relevance to patient safety incidents, and (2) VA's
oversight of VAMCs' compliance with these selected requirements.
To examine VA purchasing, tracking, and reprocessing requirements, we
reviewed relevant VA policies, and from these policies we judgmentally
selected two purchasing requirements, two tracking requirements, and
two reprocessing requirements that we determined were relevant to
patient safety incidents that were identified at certain VAMCs.
[Footnote 6] After selecting these requirements for our review, we
judgmentally selected six VAMCs from the following locations to visit:
Albany, New York; Cheyenne, Wyoming; Detroit, Michigan; Miami,
Florida; Palo Alto, California; and St. Louis, Missouri. These VAMCs
represent different surgical complexity groups[Footnote 7] and
geographic regions[Footnote 8] and serve veteran populations of
different sizes. At these six VAMCs, we examined the adequacy of the
selected purchasing, tracking, and reprocessing requirements to help
the facilities ensure the safety of veterans who received care at
these facilities. To do this, we examined how the selected
requirements in these policies were implemented and whether or to what
extent the selected requirements directly or indirectly created a
potential risk to the safety of the veterans receiving care at the
VAMCs. We reviewed applicable VAMC committee meeting minutes[Footnote
9] and other documentation on the implementation of these
requirements. We also interviewed VAMC officials who were responsible
for implementing the selected requirements in VA policies to determine
whether the selected requirements are adequate to help ensure
veterans' safety.
To examine VA's oversight of VAMCs' compliance with the purchasing,
tracking, and reprocessing requirements we selected, we reviewed VA's
oversight of these requirements and evaluated whether this oversight
provides VA with adequate information to identify and address
noncompliance. As part of this review, we assessed VA's oversight in
the context of federal standards for internal control for monitoring.
[Footnote 10] The internal control for monitoring refers to an
agency's ability to assure that ongoing review and supervision
activities are conducted, with the scope and frequency depending on
the assessment of risks; deficiencies are communicated to at least one
higher level of management; and actions are taken in response to
findings or recommendations within established timelines. We
interviewed officials responsible for overseeing VAMCs' compliance
with the requirements we selected for review from VA headquarters,
VA's Office of Inspector General (OIG), and six VISNs that are
responsible for overseeing compliance at the VAMCs we visited. In
addition, we obtained and reviewed relevant documents regarding VA
oversight, including internal reports, VAMCs' plans to correct
problems identified through oversight activities, and policy
memorandums.
We conducted this performance audit from March 2010 to May 2011 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives. See appendix I
for more information on our scope and methodology.
Background:
VA is required by law to provide hospital care and medical services to
certain veterans and may provide care to other veterans.[Footnote 11]
In general, veterans must enroll in VA health care to receive VA's
medical benefits package that includes a range of services such as
preventative health care services and inpatient hospital services.
Veterans may receive certain other health care services, such as
dental care, without enrolling.[Footnote 12] VA provides these
services at various types of facilities, including VAMCs. In providing
these services to veterans, clinicians at VAMCs use expendable medical
supplies and RME. VA has established roles and responsibilities within
its system for purchasing, tracking, and reprocessing of these items
and policies that VAMCs are required to follow when purchasing and
tracking these items at their facilities. VA also has policies that
VAMCs are required to follow regarding the reprocessing of RME.
VA Roles and Responsibilities for Purchasing, Tracking, and
Reprocessing:
VA headquarters is responsible for the development of policies related
to purchasing, tracking, and reprocessing and is ultimately
responsible for ensuring that VISNs and VAMCs are in compliance with
these policies. Within VA headquarters, the Office of Acquisition,
Logistics, and Construction and the Procurement and Logistics Office,
are responsible for policies related to the purchasing and tracking of
expendable medical supplies and RME, while the Sterile Processing
Department is responsible for policies related to the reprocessing of
RME.
Each of the 21 regional VISNs is responsible for ensuring compliance
with VA's policies at the VAMCs within its region. VISNs report to the
Deputy Under Secretary for Health for Operations and Management within
VA headquarters. In turn, each of the 153 VAMCs is responsible for
implementing VA's policies. Within each VAMC, the Acquisition
Department is responsible for purchasing expendable medical supplies
and RME, the Logistics Department is responsible for tracking these
items, and the Sterile Processing Department is responsible for
reprocessing RME. (See figure 1 for an overview of VA's organizational
structure.)
Figure 1: Selected Veterans Affairs (VA) Entities' Roles and
Responsibilities for Purchasing, Tracking, and Reprocessing:
[Refer to PDF for image: chart]
VA Headquarters:
VA headquarters is responsible for the development of policies, and
for ensuring that Veterans Integrated Service Networks (VISN) and
Veterans Affairs Medical Centers (VAMC) are in compliance with these
policies.
Top level: Secretary of VA.
* Office of Acquisition, Logistics, and Construction[A].
Second level, reporting to Secretary of VA:
* Deputy Under Secretary for Health for Operations and Management[A].
Reporting to Deputy Under Secretary for Health for Operations and
Management:
* Procurement and Logistics Office[A];
* Sterile Processing Department[A].
VISNs:
There are 21 regional VISNs, each responsible for ensuring compliance
with VA‘s policies at the VAMCs within its region.
VISN Director: Reports to VA Deputy Under Secretary for Health for
Operations and Management.
VAMCs:
Each of the 153 VAMCs is responsible for implementing VA's policies.
VAMC Director: Reports to VISN Director.
Reporting to VAMC Director:
* Logistics Department[A];
* Sterile Processing Department[A].
Reporting to VA Procurement and Logistics Office:
* Acquisition Department[A].
Source: GAO.
[A] Indirect reporting relationship.
[End of figure]
VA Policies for Purchasing, Tracking, and Reprocessing:
VA policies specify how VAMCs can purchase expendable medical supplies
and RME. VAMCs can purchase expendable medical supplies and RME
through their acquisition departments or through their clinical
departments, such as the radiology department. VA's policies include
the following requirements related to veterans' safety that VAMCs must
follow when purchasing expendable medical supplies and RME:
Committee review and approval. A designated VAMC committee must review
and approve proposed purchases of any expendable medical supplies or
RME that have not been previously purchased by the VAMC.[Footnote 13]
The committee, which typically includes administrative staff and
clinicians from various departments, reviews the proposed purchases to
evaluate the cost of the purchase as well as its likely effect on
veterans' care.[Footnote 14] For example, the committee that reviews
and approves proposed RME purchases often includes a representative
from the department responsible for reprocessing RME in order to
determine whether the VAMC has the capability to reprocess the item
correctly and to ensure that staff are appropriately trained to do so.
Proper reprocessing of RME is important to ensure that RME is safe to
use and that veterans are not exposed to infectious diseases, such as
Human Immunodeficiency Virus (HIV), during treatment.
Signatures from two officials. All approvals for purchases of
expendable medical supplies and RME must be signed by two officials,
the official placing the order and the official responsible for
approving the purchase.[Footnote 15] This process helps ensure that
purchases of expendable medical supplies and RME are appropriate to
use when providing care to veterans.
VA has two inventory management systems that it requires VAMCs to use
to track the type and quantity of expendable medical supplies and RME
used in its facilities. VAMCs use information about the items in their
facilities for a variety of purposes, for example to readily determine
whether they have expendable medical supplies or RME that are the
subject of a manufacturer recall or a patient safety alert. VA policy
requires that each VAMC enter information about certain expendable
medical supplies and RME in their facilities into the appropriate
system. Specifically, VA policies include two key requirements related
to veterans' safety that VAMCs must follow for tracking expendable
medical supplies and RME:
Tracking of expendable medical supplies. VAMCs must enter information
on all expendable medical supplies that are ordered on a recurring
basis into the Generic Inventory Package (GIP).[Footnote 16]
Tracking of RME. VAMCs must enter information on all RME that is
classified as nonexpendable equipment by VA's Office of Acquisition,
Logistics, and Construction into the Automated Engineering Management
System/Medical Equipment Reporting System (AEMS/MERS).[Footnote 17]
VA policies include requirements designed to help ensure that VAMCs
reprocess RME correctly,[Footnote 18] in order to help ensure that RME
is safe for use when providing care to veterans. VA's reprocessing
policies include two key types of requirements:
Training requirements. To ensure that RME is reprocessed in accordance
with manufacturers' guidelines, VA requires that each VAMC develop
device-specific training for reprocessing RME. To develop this
training, VA requires VAMCs to create device-specific standard
operating procedures (SOP), which provide step-by-step instructions
for reprocessing. VA also requires VAMCs to assess staff annually on
their competence to reprocess RME in accordance with these SOPs.
Operational requirements. To ensure that reprocessing activities are
performed safely and that RME is reprocessed correctly, VA policies
establish operational requirements for VAMCs, which include that VAMC
staff must monitor sterilizers to ensure that they are functioning
properly, use personal protective equipment when performing
reprocessing activities, and segregate dirty and clean RME.
Selected VA Requirements for Tracking and Reprocessing Are Inadequate
to Help Ensure Veterans' Safety:
We found that both the tracking and reprocessing requirements we
reviewed are inadequate to help ensure the safety of veterans who
receive care at VAMCs. These inadequacies create potential risks to
the safety of veterans who receive care at VAMCs. However, we did not
identify any inadequacies in the purchasing requirements we selected
for review that may create potential risks to veterans' safety.
VAMCs Are Not Required to Track Certain Expendable Medical Supplies
and RME:
VA does not require VAMCs to enter information about certain
expendable medical supplies and RME into their inventory management
systems, and therefore, VAMC inventories have incomplete information
on these items. Specifically, VAMCs are not required to enter into GIP
information on expendable medical supplies purchased on a nonrecurring
basis. Furthermore, VAMCs are not required to enter into AEMS/MERS
information on RME that VA's Office of Acquisition, Logistics, and
Construction does not classify as nonexpendable equipment. RME that is
not classified as nonexpendable equipment includes certain surgical
and dental instruments. As a result, none of the six VAMCs we visited
had complete inventories of all of the expendable medical supplies or
RME in their facilities. Incomplete inventories of these items at
VAMCs can pose potential risks to veterans' safety.
At all six of the VAMCs we visited, we identified examples of
potential risks to veterans' safety that may result from these
inadequacies in VA's tracking requirements. For example:
Limited ability to identify items on which there are alerts or
recalls. In the event of a manufacturer recall or patient safety alert
related to an expendable medical supply item or RME, VAMCs may be
unable to use their inventory management systems to systematically
determine whether the affected item is in their facilities and should
therefore be removed so that it is not used when providing care to
veterans. Rather, VAMC officials would have to rely on a physical
search for the item throughout their facilities--and a physical search
could miss items. As we reported in our 2010 testimony,[Footnote 19]
VAMC officials and officials from the VA OIG told us that in response
to a patient safety alert in December 2008 regarding an auxiliary
water tube--a type of RME that is used with a colonoscope--VAMC
officials checked their inventory management systems and concluded--
incorrectly--that the tube was not used in the facility.[Footnote 20]
However, in March 2009, the VAMC discovered that the tube was in use
in the facility and was not being reprocessed correctly, potentially
exposing 2,526 veterans to infectious diseases such as HIV, hepatitis
B, and hepatitis C.[Footnote 21]
Difficulty maintaining appropriate inventories. Because GIP helps
VAMCs to ensure that they maintain appropriate quantities of supply
items in their facilities, VAMCs with incomplete information in GIP
about the supplies in their facilities may have difficulty ensuring
that they maintain appropriate quantities of these items. This may
result in expendable medical supplies being unavailable for veterans'
care if needed or, alternatively, excess supplies accumulating and
expiring before they can be used. For example, in 2009 and 2010, VA
headquarters officials identified expired expendable medical supplies,
which were not being properly tracked in GIP, at three of the six
VAMCs we visited. Had these VAMCs been properly tracking these supply
items in GIP, they may have been able to maintain appropriate
quantities of items and therefore avoid unavailable or expired
supplies.
Challenges developing required training. VAMCs with incomplete
information about the RME in their inventories face challenges
identifying the equipment for which they must develop device-specific
reprocessing training. None of the six VAMCs we visited relied on
their inventory management systems to systematically determine which
types of RME they had in their facilities. In fact, officials at all
six VAMCs told us that they had to use alternate methods, such as
contacting individual staff members or conducting searches in each
clinical department, to determine if the facility had a specific type
of RME. These methods of searching for RME make it difficult for VAMCs
to ensure that they identify all of the RME in their facilities for
which they must develop device-specific reprocessing training--without
inadvertently missing items--and may have contributed to delays in
developing this training. Approximately 1 year after VA instituted the
requirement for developing device-specific training for reprocessing,
three of the six VAMCs we visited had not yet fully developed this
training. Without appropriate training for reprocessing RME, VAMCs
cannot ensure that staff in their facilities are reprocessing RME
correctly so that these items are safe for use when caring for
veterans.
At the time of our review, VA did not have plans to immediately
address the inadequacies we identified in the tracking requirements by
requiring VAMCs to enter information about all expendable medical
supplies and RME into VA's inventory management systems. VA
headquarters officials told us that they plan to address the
inadequacies we identified in the tracking requirements following
implementation of a new inventory management system--Strategic Asset
Management. However, VA had suspended the implementation of this
system as of March 2011. Although VA did not plan on revising its
tracking requirements immediately, officials from two of the six VAMCs
we visited told us that they have taken steps to improve the
information they maintain on the expendable medical supplies at their
facilities. Officials told us that they are requiring staff to enter
information about all expendable medical supplies at these VAMCs into
GIP, including those that are purchased on a nonrecurring basis.
Selected VA Reprocessing Requirements Are Inadequate:
The VA reprocessing requirements we selected for review are inadequate
to help ensure veterans' safety in two respects: (1) they do not
specify the types of RME for which VAMCs must develop device-specific
training, and (2) VA has provided VAMCs with conflicting guidance on
how to develop this training.[Footnote 22]
Lack of specificity about types of RME that require device-specific
training. The VA reprocessing requirements we reviewed do not specify
the types of RME for which VAMCs must develop device-specific
training. This inadequacy has caused confusion among VAMCs and
contributed to inconsistent implementation of training for RME
reprocessing. While VA headquarters officials told us that the
training requirement is intended to apply to RME classified as
critical--such as surgical instruments--and semi-critical--such as
certain endoscopes,[Footnote 23] officials from five of the six VAMCs
we visited told us that they were unclear about the RME for which they
were required to develop device-specific training.
Officials at one VAMC we visited told us that they did not develop all
of the required reprocessing training for critical RME--such as
surgical instruments--because they did not understand that they were
required to do so. Officials at another VAMC we visited also told us
that they had begun to develop device-specific training for
reprocessing non-critical RME, such as wheelchairs, even though they
had not yet fully completed device-specific training for more critical
RME. Because these two VAMCs had not developed the appropriate device-
specific training for reprocessing critical and semi-critical RME,
staff at these VAMCs may not have been reprocessing all RME properly,
which potentially put the safety of veterans receiving care at these
facilities at risk.
Conflicting guidance on the development of RME reprocessing training.
While VA requires VAMCs to develop device-specific training on
reprocessing RME, VA headquarters officials provided VAMCs with
conflicting guidance on how they should develop this training. For
example, officials at three VAMCs we visited told us that certain VA
headquarters or VISN officials stated that this device-specific
training should very closely match manufacturer guidelines--in one
case verbatim--while other VA headquarters or VISN officials stated
that this training should be written in a way that could be easily
understood by the personnel responsible for reprocessing the RME. This
distinction is important, since VAMC officials told us that some of
the staff responsible for reprocessing the RME may have difficulty
following the more technical manufacturers' guidelines.[Footnote 24]
In part because of VA's conflicting guidance, VAMC officials told us
that they had difficulty developing the required device-specific
training and had to rewrite the training materials multiple times for
RME at their facilities. Officials at five of the six VAMCs also told
us that developing the device-specific training for reprocessing RME
was both time consuming and resource intensive.
VA's lack of specificity and conflicting guidance regarding its
requirement to develop device-specific training for reprocessing RME
may have contributed to delays in developing this training at several
of the VAMCs we visited. Officials from three of the six VAMCs told us
that they had not completed the development of device-specific
training for RME since VA established the training requirement in July
2009. As of October 2010, 15 months after VA issued the policy
containing this requirement, officials at one of the VAMCs we visited
told us that device-specific training on reprocessing had not been
developed for about 80 percent of the critical and semi-critical RME
in use at the facility.
VA headquarters officials told us that they are aware of the lack of
specificity and conflicting guidance provided to VAMCs regarding the
development of training for reprocessing RME, and were also aware of
inefficiencies resulting from each VAMC developing its own training
for reprocessing types of RME that are used in multiple VAMCs. In
response, VA headquarters officials told us that they have made
available to all VAMCS a database of standardized device-specific
training developed by RME manufacturers for approximately 1,000 types
of RME and plan to require VAMCs to implement this training by June
2011. The officials also told us that VA headquarters is planning to
develop device-specific training available to all VAMCs for certain
critical and semi-critical RME for which RME manufacturers have not
developed this training, such as dental instruments. However, as of
February 2011, VA headquarters has not completed device-specific
training for these RME and has not established plans or corresponding
timelines for completing this training.
VA's Oversight of VAMCs' Compliance with Selected Purchasing and
Reprocessing Requirements Has Weaknesses:
VA's oversight of VAMCs' compliance with selected purchasing and
reprocessing requirements has weaknesses, which result in VA not being
able to systematically identify and address noncompliance. We did not
identify any weaknesses in VA's oversight of the tracking requirements
we selected for review.[Footnote 25] Oversight of VAMCs' compliance
with the selected purchasing, tracking, and reprocessing requirements
is important because, at each of the six VAMCs we visited, we
identified examples of noncompliance, which may result in risks to
veterans' safety. VA headquarters officials told us that VA intends to
improve oversight over the selected purchasing requirements, but has
not yet developed a plan for doing so. In addition, VA recently made
changes to its oversight of VAMCs' compliance with selected
reprocessing requirements; however, this oversight continues to have
weaknesses.
VA Has Limited Oversight of VAMCs' Compliance with Selected Purchasing
Requirements:
We found that, in general, VA does not oversee VAMCs' compliance with
the purchasing requirements we selected for review. Specifically,
neither VA headquarters nor the six VISNs that oversee the VAMCs we
visited provided oversight for the committee review and approval
requirement and only one of the six VISNs provided oversight of the
double signature requirement.[Footnote 26] Consistent with the federal
internal control for monitoring, which is applicable to all federal
agencies, we would expect VA to oversee VAMCs' compliance with the
requirements we selected, assess the risk of VAMCs' noncompliance with
these requirements, and ensure that noncompliance is addressed.
[Footnote 27]
Without oversight of the selected purchasing requirements, VA is
unable to identify and address VAMCs' noncompliance with the selected
purchasing requirements. During our site visits to six VAMCs, we
identified examples of noncompliance with these requirements that
created potential risks to veterans' safety.[Footnote 28]
VAMC committee review and approval. Officials from four of the six
VAMCs we visited told us that certain expendable medical supplies--for
example, those used in a limited number of clinical departments--were
sometimes purchased without the required VAMC committee review and
approval. Furthermore, officials from one of those four VAMCs told us
that none of the expendable medical supplies it purchased were
reviewed and approved by a VAMC committee. Without obtaining the
required review and approval, these VAMCs may have purchased
expendable medical supplies without evaluating their cost-
effectiveness or likely effect on veterans' care.
Signatures of purchasing and approving officials. At one of the six
VAMCs we visited, VAMC officials discovered that one staff member
working in a dialysis department purchased expendable medical supplies
without obtaining the required signature of an appropriate approving
official. That staff member ordered the wrong supplies, which
incorrectly allowed blood to pass into dialysis machines. Those
supplies were used for 83 veterans, resulting in potential cross-
contamination of these veterans' blood, which may have exposed them to
infectious diseases, such as HIV, hepatitis B, and hepatitis C.
[Footnote 29]
In January 2011, VA headquarters officials told us that they intend to
develop an approach to oversee VAMCs' compliance with the selected
purchasing requirements, although VA has not yet established a
timeline for developing and implementing this oversight. In addition,
an official from one VISN told us in January 2011 that the VISN
planned to begin overseeing VAMCs' compliance with VA's requirement
that two signatures be obtained for purchases of expendable medical
supplies and RME. However, the official told us that the VISN had not
yet established a timeline for developing and implementing this
oversight.
Despite Changes Intended to Improve Its Oversight of VAMCs' Compliance
with Selected Reprocessing Requirements, VA's Oversight Has Weaknesses:
Beginning in fiscal year 2011, VA headquarters directed VISNs to make
three changes intended to improve its oversight of VAMCs' compliance
with the selected reprocessing requirements at VAMCs.[Footnote 30]
* VA headquarters recently required VISNs to increase the frequency of
site visits to VAMCs--from one to three unannounced site visits per
year--as a way to more quickly identify and address areas of
noncompliance with selected VA reprocessing requirements.
* VA headquarters also recently required VISNs to begin using a
standardized assessment tool to guide their oversight activities.
[Footnote 31] According to VA headquarters officials, requiring VISNs
to use this assessment tool will enable the VISNs to collect
consistent information on VAMCs' compliance with VA's reprocessing
requirements. Before VA established this requirement, the six VISNs
that oversee the VAMCs we visited often used different assessment
tools to guide their oversight activities. As a result, they reviewed
and collected different types of information on VAMCs' compliance with
these requirements.
* VISNs are now required to report to VA headquarters information from
their site visits. Specifically, following each unannounced site visit
to each VAMC, VISNs are required to provide VA headquarters with
information on VAMCs' noncompliance with VA's reprocessing
requirements and VAMCs' corrective action plans to address areas of
noncompliance. Prior to fiscal year 2011, VISNs were generally not
required to report this information to VA headquarters.[Footnote 32]
Despite the recent changes, VA's oversight of VAMCs' compliance with
its reprocessing requirements, including those we selected for review,
has weaknesses in the context of the federal internal control for
monitoring. Consistent with the internal control for monitoring, we
would expect VA to analyze this information to assess the risk of
noncompliance and ensure that noncompliance is addressed. However, VA
headquarters does not analyze information to identify the extent of
noncompliance across all VAMCs, including noncompliance that occurs
frequently or poses high risks to veterans' safety. As a result, VA
headquarters has not identified the extent of noncompliance across all
VAMCs with, for example, VA's operational reprocessing requirement
that staff use personal protective equipment when performing
reprocessing activities, which is key to ensuring that clean RME are
not contaminated by coming into contact with soiled hands or clothing.
Three of the six VAMCs we visited had instances of noncompliance with
this requirement. Similarly, because VA headquarters does not analyze
information from VAMCs' corrective action plans to address
noncompliance with VA reprocessing requirements, it is unable to
confirm, for example, whether VAMCs have addressed noncompliance with
its operational reprocessing requirement to separate clean and dirty
RME. Two of the six VAMCs we visited had not resolved noncompliance
with this requirement. Compliance with this requirement is important
to ensure that clean RME does not become contaminated by coming into
contact with dirty RME.
VA headquarters officials told us that VA plans to address the
weaknesses we identified in its oversight of VAMCs' compliance with
reprocessing requirements. Specifically, VA headquarters officials
told us that they intend to develop a systematic approach to analyze
the information on VAMCs' noncompliance and corrective action plans to
identify areas of noncompliance across all VAMCs, including those that
occur frequently, pose high risks to veterans' safety, or have not
been addressed in a timely manner.[Footnote 33] While VA has
established a timeline for completing these changes, certain VA
headquarters officials told us that they are unsure whether this
timeline is realistic due to possible delays resulting from VA's
ongoing organizational realignment, which had not been completed as of
April 6, 2011.[Footnote 34]
Conclusions:
Weaknesses exist in VA's processes for tracking expendable medical
supplies and RME and reprocessing RME that create potential safety
risks to veterans. Because VA does not require VAMCs to track
information about certain expendable medical supplies and RME in their
inventory management systems, VAMCs may be unaware of the complete
inventory of such items at their facilities. This knowledge is
critical to maintain available supplies on hand to serve veterans, to
properly identify items for which manufacturers have issued recalls,
and to develop training on reprocessing the RME in their inventory.
Moreover, VA's lack of specificity and conflicting guidance for
developing device-specific training for reprocessing RME has led to
confusion among VAMCs about which types of RME require device-specific
training and how VAMCs should develop that training. This confusion
has contributed to some VAMCs not developing training for their staff
for some critical and semi-critical RME. Until these weaknesses are
addressed, the safety of veterans receiving care at VAMCs could
potentially be at risk.
A general lack of oversight of VAMCs' compliance with selected
purchasing requirements makes it difficult for VA to identify and
resolve situations wherein items are purchased without proper review
and approval. A failure to review and approve these purchases poses
safety risks to veterans being treated in VAMCs. In fact, during our
visits to VAMCs, we noted examples of expendable medical supplies that
were purchased without appropriate review and approval. As a result,
some supplies may have been purchased without evaluating the likely
effect on veterans' care, or worse yet, the wrong supplies were
ordered--a mistake that potentially led to some veterans being exposed
to infectious diseases. Furthermore, weaknesses in oversight of VAMCs'
compliance with the selected reprocessing requirements do not allow VA
to identify and subsequently address areas of noncompliance across all
VAMCs, including those that occur frequently, pose high risks to
veterans' safety, or have not been addressed by VAMCs. Providing
effective oversight over purchasing and reprocessing requirements
consistent with the federal standards for internal control would help
VA prevent potentially harmful incidents from occurring.
Recommendations for Executive Action:
To help ensure veterans' safety through VA's purchasing, tracking, and
reprocessing requirements, we are making four recommendations. We
recommend that the Secretary of Veterans Affairs direct the Under
Secretary for Health to take the following four actions:
* Require VAMCs to enter information about all expendable medical
supplies and RME into an appropriate inventory management system.
* Develop and implement an approach for providing standardized
training for reprocessing all critical and semi-critical RME to VAMCs.
Additionally, hold VAMCs accountable for implementing device-specific
training for all of these RME.
* Develop and implement an approach to oversee compliance at all VAMCs
with the selected purchasing requirements.
* Use the information on noncompliance identified by the VISNs and
information on VAMCs' corrective action plans to identify areas of
noncompliance across all 153 VAMCs, including those that occur
frequently, pose high risks to veterans' safety, or have not been
addressed, and take action to improve compliance in those areas.
Agency Comments and Our Evaluation:
VA provided written comments on a draft of this report, which we have
reprinted in appendix II. In its comments, VA concurred with our
recommendations and described the department's planned actions to
implement them. VA also provided technical comments, which we
incorporated, as appropriate.
To address our recommendation that VA require VAMCs to enter
information about all expendable medical supplies and RME into an
appropriate inventory management system, VA stated that it plans to
take several actions that include the following. By September 30,
2011, the department plans to implement a process for tracking
information on certain expendable medical supplies, which are
currently not being tracked in GIP, to ensure that these items can be
identified in the event of a recall. Furthermore, by September 30,
2011, VA plans to implement a pilot program for tracking certain RME,
such as surgical and dental instruments, which are currently not being
tracked in AEMS/MERS.
To address our recommendation that VA develop an approach for
providing standardized training to VAMCs on reprocessing all critical
and semi-critical RME, VA stated that it is taking several actions,
which include revising VA's requirement for developing device-specific
reprocessing training and providing staff training through a
professional organization that specializes in RME reprocessing. In our
report, we stated that VA headquarters is planning to develop device-
specific training available to all VAMCs for certain critical and semi-
critical RME for which RME manufacturers have not developed this
training, such as dental instruments, but had not developed a time
frame for developing this training. VA's comments did not provide an
update on when this training would be developed. To hold VAMCs
accountable for implementing training for critical and semi-critical
RME, VA reiterated that it is strengthening its oversight of VAMCs and
is requiring VAMCs to develop corrective action plans to ensure that
noncompliance with the training requirement is addressed.
To address our recommendation that VA develop and implement an
approach to oversee compliance with selected purchasing requirements
at all VAMCs, VA stated that it plans to oversee VAMCs' purchasing
activities, including VAMCs' compliance with our selected purchasing
requirements. To do this, VA stated that by September 30, 2011, VA
headquarters' Purchasing and Logistics Office will begin requiring
VISN officials to conduct routine site visits to VAMCs to help the
latter develop action plans for addressing noncompliance with the
purchasing requirements. The Purchasing and Logistics Office also
plans to review and approve these action plans and follow up with
VAMCs to ensure that any noncompliance is addressed.
To address our recommendation that VA use information on noncompliance
to identify areas of noncompliance across all VAMCs and take action to
improve compliance in those areas, VA plans to analyze the results of
its oversight activities to identify national concerns and target
future Sterile Processing Department initiatives. In our report we
stated that while VA has established a timeline for conducting this
analysis, certain VA headquarters officials told us that they were
unsure whether this timeline is realistic. In its comments, VA did not
provide information on whether it anticipates meeting its expected
timeline. VA also reiterated changes that it has made that are
intended to improve its oversight of VAMCs' compliance with its
requirements.
We are sending copies of this report to the Secretary of Veterans
Affairs, appropriate congressional committees, and other interested
parties. In addition, the report is available at no charge on the GAO
Web site at [hyperlink, http://www.gao.gov].
If you or your staffs have any questions about this report, please
contact me at (202) 512-7114 or williamsonr@gao.gov. Contact points
for our Offices of Congressional Relations and Public Affairs are on
the last page of this report. GAO staff who made major contributions
to this report are listed in appendix III.
Signed by:
Randall B. Williamson:
Director, Health Care:
[End of section]
Appendix I: Scope and Methodology:
To examine Department of Veterans Affairs (VA) purchasing, tracking,
and reprocessing requirements, we reviewed relevant VA policies
[Footnote 35] and from these policies we judgmentally selected two
purchasing requirements, two tracking requirements, and two
reprocessing requirements that we determined were relevant to
veterans' safety issues that were identified at certain VA medical
centers (VAMC) in 2008 and 2009. Specifically, the purchasing
requirements we selected were relevant to a patient safety incident at
the VAMC in Palo Alto, California, resulting from the improper
purchase and use of dialysis supplies; the tracking requirements we
selected were relevant to a patient safety incident resulting from the
improper reprocessing of endoscopy equipment at the VAMC in Miami,
Florida; and the reprocessing requirements we selected were relevant
to patient safety incidents resulting from the improper reprocessing
of endoscopy equipment at the VAMCs in Augusta, Georgia; Miami,
Florida; and Murfreesboro, Tennessee.
After selecting these requirements for our review, we judgmentally
selected six VAMCs at the following locations to visit: Albany, New
York; Cheyenne, Wyoming; Detroit, Michigan; Miami, Florida; Palo Alto,
California; and St. Louis, Missouri. These VAMCs represent different
surgical complexity groups,[Footnote 36] serve veteran populations of
different sizes, and are located in different Veterans Integrated
Service Networks (VISN). (See table 1.)
Table 1: Characteristics of VAMCs Selected for Site Visits:
VAMC location: Albany, New York;
Surgical complexity group[A]: 2;
Size of patient population served, 2009: Greater than 24,999 and less
than 50,000;
VISN: 2.
VAMC location: Cheyenne, Wyoming;
Surgical complexity group[A]: 3;
Size of patient population served, 2009: Less than 25,000;
VISN: 19.
VAMC location: Detroit, Michigan;
Surgical complexity group[A]: 1c;
Size of patient population served, 2009: Greater than 24,999 and less
than 50,000;
VISN: 11.
VAMC location: Miami, Florida;
Surgical complexity group[A]: 1b;
Size of patient population served, 2009: Greater than 49,999;
VISN: 8.
VAMC location: Palo Alto, California;
Surgical complexity group[A]: 1a;
Size of patient population served, 2009: Greater than 49,999;
VISN: 21.
VAMC location: St. Louis, Missouri;
Surgical complexity group[A]: 1a;
Size of patient population served, 2009: Greater than 49,999;
VISN: 15.
Source: GAO analysis of VA data.
[A] VA assigns each VAMC a complexity score between 1 and 3, with
level 1 being the most complex, using a facility complexity model.
Level 1 is broken down further into 1a, 1b, and 1c. That model uses
multiple variables to measure facility complexity arrayed along four
categories, namely patient population served, clinical services
offered, education and research complexity, and administrative
complexity.
[End of table]
At these six VAMCs, we examined the adequacy of the selected
purchasing, tracking, and reprocessing requirements to help ensure the
safety of veterans who received care. To do this, we examined how the
requirements in these policies were implemented and whether the
requirements indirectly created a potential risk to the safety of
veterans who receive care at VAMCs. Specifically, at each VAMC we
visited, we reviewed applicable VAMC committee meeting
minutes[Footnote 37] and other documentation on the implementation of
these requirements. We also interviewed VAMC officials who were
responsible for implementing the selected requirements to determine
whether the requirements were adequate to help ensure veterans'
safety. At each VAMC, these officials included members of the
executive leadership team, the nurse executive, the chief of the
Sterile Processing Department, the patient safety manager, infection
preventionists, and members of the quality management staff.[Footnote
38]
To examine VA's oversight of VAMCs' compliance with the purchasing,
tracking, and reprocessing requirements we selected, we reviewed VA's
oversight of these requirements and evaluated whether this oversight
provides VA with adequate information to identify and address
noncompliance. As part of this review, we reviewed VA's oversight in
the context of federal standards for internal control for
monitoring.[Footnote 39] The internal control for monitoring refers to
an agency's ability to assure that ongoing review and supervision
activities are conducted, with the scope and frequency depending on
the assessment of risks, deficiencies are communicated to at least one
higher level of management, and actions are taken in response to
findings or recommendations within established timelines.
We then interviewed officials from VA headquarters, including the
Sterile Processing Department, the Infectious Disease Program Office,
and the System-wide Ongoing Assessment and Review Strategy; VA's
Office of Inspector General; and the six VISNs that oversee the VAMCs
we visited who are responsible for overseeing compliance with VA's
requirements, including those we selected for our review. Through our
interviews, we obtained information on the oversight activities
conducted by each of these entities and the extent to which these
entities followed up with VAMCs to ensure that they corrected problems
identified through these oversight activities. In addition, we
obtained and reviewed relevant documents regarding VA oversight,
including internal reports, VAMCs' plans to correct problems
identified through oversight activities, and policy memorandums.
We conducted this performance audit from March 2010 to May 2011 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
[End of section]
Appendix II: Comments from the Department of Veterans Affairs:
Department Of Veterans Affairs:
Washington DC 20420:
April 11, 2011:
Mr. Randall B. Williamson:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Mr. Williamson:
The Department of Veterans Affairs (VA) has reviewed the Government
Accountability Office's (GAO) draft report, VA HEALTH CARE: Weaknesses
in Policies and Oversight Governing Medical Supplies and Equipment
Pose Risks to Veterans' Safety (GA0-11-391). VA generally agrees with
GAO's conclusions and concurs with GAO's recommendations.
The enclosure specifically addresses each of GAO's recommendations and
provides comments on the draft report. VA appreciates the opportunity
to comment on your draft report.
Sincerely,
Signed by:
John R. Gingrich:
Chief of Staff:
Enclosure:
[End of letter]
Enclosure:
Department of Veterans Affairs (VA) Response to Government
Accountability Office (GAO) Draft Report: VA Health Care: Weaknesses
in Policies and Oversight Governing Medical Supplies and Equipment
Pose Risks to Veterans' Safety (GA0-11-391).
GAO recommendation: To help ensure veterans' safety through VA's
purchasing, tracking, and reprocessing requirements, we are making
four recommendations. We recommend that the Secretary of Veterans
Affairs direct the Under Secretary for Health to take the following
actions:
Recommendation 1: Require VAMCs to enter information about all
expendable medical supplies and RME into an appropriate inventory
management system.
VA response: Concur. In accordance with Veterans Health Administration
(VHA) Directive 1761.1, Standardization of Supplies and Equipment,
dated January 26, 2001, and VHA Handbook 1761.0?, VHA Inventory
Management, dated October 20, 2009, the Generic Inventory Package
(GIP) Inventory System is used to maintain inventory of reoccurring
expendable medical supplies used at VA medical centers (VAMC). All
reoccurring expendable medical supplies, except one time use or
specialty items used on a specific patient or procedure, are required
to be maintained in the GIP Inventory System. All VAMCs are required
to utilize GIP and bar code technology to monitor inventory of
expendable medical supplies.
For specialty items that do not meet the criteria established in the
GIP Inventory System, VHA's Procurement and Logistics Office (PLO)
will develop a process to capture information on such items to ensure
that they can be identified in the event of a medical device recall.
The anticipated completion date for development of policy guidance and
implementation is September 30, 2011.
PLO will also develop a plan that will restrict the use of purchase
cards for purchasing clinical items and require all clinical
expendable supplies to be acquired through the Facility Logistics
Program. This will help to ensure that information on purchases of
expendable medical supplies is reported and accounted for accurately.
The anticipated completion date for development of policy guidance and
implementation is September 30, 2011.
Reusable medical equipment (RME) such as surgical and dental
instruments do not have individual identifiers for tracking and are
not maintained in the Automated Engineering Management System/Medical
Equipment Reporting inventory system. In an effort to track individual
instruments in a production management system, a pilot of the Real
Time Location System (RTLS) will be initiated under the auspices of the
Secretary's Major Initiatives. Based on the information gained from
the pilots, the PLO will work closely with the RTLS Program Office for
a broader implementation plan. The anticipated completion date is
September 30, 2011.
In accordance with a February 11, 2011, memorandum from the Deputy
Under Secretary for Health for Operations and Management, Veterans
Integrated Service Network (VISN) Chief Logistics Officers must
validate VAMC compliance with applicable directives and policies
relating to management of expendable and non-expendable inventory by
conducting site visits to each VAMC by April 30, 2011, and providing a
summary report to the PLO that includes action plans to correct any
deficiencies identified during such site visits. These site visits
will be conducted using the revised Management Quality Assurance
Service Checklist, dated October 1, 2010, and include the appropriate
use of the GIP Inventory System and validation of the proper review
and approval of items procured for use at VAMCs. The VISN Chief
Logistics Officers will be required to follow-up and validate that
action plans have been completed and report the results to PLO for
review by June 30, 2011.
Recommendation 2: Develop and implement an approach for providing
standardized training for reprocessing all critical and semi-critical
RME to VAMCs. Additionally, hold VAMCs accountable for implementing
device-specific training for all of these RME.
VA response: Concur. VHA has implemented a new inspection process that
requires a total of nine reviews per year per facility (six performed
by facility officials and three by VISN officials annually). A
standardized inspection tool is being used to verify standardized
operating procedures (SOP) and employee competencies. This
standardized inspection tool has already been released to the field,
is available on the SharePoint site, and is being used by both the
facility and VISN inspection teams. The inspection tool asks questions
targeted to address those issues that are of a higher risk to patient
safety. The results of the inspections will be reviewed, tracked, and
trended nationally.
Facilities that are not in compliance, as identified by the results of
the inspections, are required to develop action plans, which are
reviewed and monitored by the VISN Sterile Processing Department (SPD)
Board and by VA Central Office SPD Operations. According to VHA
Directive 2009-031, Improving Safety in the Use of Reusable Medical
Equipment through Standardization of Organizational Structure and
Reprocessing Requirements, the SPD Board has the "authority and
accountability for ensuring" that reprocessing occurs in accordance
with current manufacturers' instructions and VHA policy.
Training of staff that reprocess RME is accomplished using
standardized SOPs and Tech Ready Documents. VA Directive 7176, Supply
Processing and Distribution, requires facility managers to annually
validate competencies of staff and document this in their training
records. All 153 facilities report through their VISN offices that
initial training is completed and competencies are maintained on
critical and semi-critical equipment used in their facilities. As
staff, equipment, or manufacturer's instructions change, the training
is updated and made available at all facilities through OneSource.
SPD Operations has also partnered with the VHA Office of Clinical
Consultation and Compliance (OCCC) to conduct a standardized,
extensive educational program and maintain records of attendance
through the International Association of Healthcare Central Services
Material Management (IAHCSMM). IAHCSMM is an internationally
recognized professional organization dedicated to the education and
certification of SPD personnel. The IAHCSMM recognizes VHA Level 2
certification as an alternate means of certification. During fiscal
year (FY) 2010, VHA's own Level 2 training was revised to include a
standardized curriculum and certification examination. During FY 2010,
four Level 2 classes were offered and attended by more than 200 SPD
professionals and managers. VA employees are being encouraged to apply
for this alternate IAHCSMM certification.
Training requirements in the current VA Directive 7176 are being re-
written to include extensive requirements for training and
verification of competencies for staff reprocessing RME. This
directive is currently in draft form and being reviewed for content by
a group of field-based and national SPD experts and managers. It will
enter VA's formal concurrence process on or before April 30, 2011,
with an expected publication date of September 30, 2011.
Recommendation 3: Develop and implement an approach to oversee
compliance at all VAMCS with the selected purchasing requirements.
VA response: Concur. GAO selected two specific purchasing requirements
for review. The first requirement establishes processes for committee
review and approval, and the second requires specific signatures for
approval. To address these specific purchasing requirements, as well
as to establish a uniform approach to ensure appropriate review and
approval of all new items utilized at VAMCs, the Deputy Under
Secretary for Health for Operations and Management in January 2011
directed all VISNs to establish Network Commodity Standardization
Committees. The new Committees will ensure that items to be purchased
are first reviewed and approved before they are used at a facility.
PLO also is establishing a Program Executive Office (PEO) that
includes an Operations/Policy Division to provide oversight and
support of VHA facility purchasing activities, including compliance
with appropriate VHA directives and policies, including those selected
by GAO in its review. PLO will develop a compliance review process to
ensure routine site visits are performed at each VAMC by VISN
Logistics Office staff. A site visit report and corresponding action
plan will be developed for each site visit and forwarded to PLO for
review and approval. PLO will perform follow-up reports to ensure all
action items are implemented and closed out. The anticipated
completion date is September 30, 2011.
Further, to ensure VAMC compliance with the use of mandatory national
standardized contracts, the PEO will establish management controls to
ensure that VHA program offices are included in the development of
contract requirements and solutions to improve compliance with
selected purchasing requirements. The anticipated completion date is
September 30, 2011.
Recommendation 4: Use the information on noncompliance identified by
the VISNs and information on VAMC's corrective action plans to
identify areas of noncompliance across all 153 VAMCs, including those
that occur frequently, pose high risk to veterans' safety, or have not
been addressed, and take action to improve compliance in those areas.
VA response: Concur. As noted in the response to Recommendation 2,
facility and VISN officials will conduct an increased number of
inspections to ensure proper reprocessing of RME. The results of these
inspections will be reviewed, tracked, and trended nationally to
identify national concerns and target future SPD initiatives.
The Office of Deputy Under Secretary for Operations and Management, SPD
Operations, is developing a standardized tool to aggregate the
information from the standardized VISN and/or facility inspection
results. This tool will assist in identifying any common deficiencies
or areas nationwide where additional training of staff that performs
reprocessing may be required. This tool will be deployed nationwide on
or before September 30, 2011. VISNs will also be required to identify
specific deficiencies at facilities and develop action plans that will
be tracked by the VISN SPD board in order to improve compliance at the
facility level. The anticipated completion date is September 30, 2011.
Staff from the Office of Deputy Under Secretary for Operations and
Management, SPD Operations, will continue to perform site visits to
provide additional oversight to ensure that annual training and
competency assessments are completed. During FY 2010, a total of 22
site visits were performed, and to date in FY 2011, a total of eight
site visits have been performed with a total of 18 pending visits
prior to the end of FY 2011. The staff from SPD Operations will use
the same standardized inspection tool as the VISN and facility to
ensure equal comparisons of information and deficiencies are
identified.
[End of section]
Appendix III: GAO Contact and Staff Acknowledgments:
GAO Contact:
Randall B. Williamson, (202) 512-7114 or williamsonr@gao.gov:
Staff Acknowledgments:
In addition to the contact named above, Mary Ann Curran, Assistant
Director; David Barish; Kye Briesath; Alana Burke; Melanie Krause; and
Michael Zose made key contributions to this report. Lisa Motley
provided legal support and Krister Friday assisted in the message and
report development.
[End of section]
Footnotes:
[1] The management of VAMCs is decentralized to 21 VISNs.
[2] See, for example, VA Handbook 7176, Supply, Processing, and
Distribution (SPD) Operational Requirements (Aug. 16, 2002) and
Veterans Health Administration (VHA) Handbook 1761.02, VHA Inventory
Management (Oct. 20, 2009).
[3] VA Handbook 7176, Supply, Processing, and Distribution (SPD)
Operational Requirements; VHA Directive 2009-004, Use and Reprocessing
of Reusable Medical Equipment (RME) in Veterans Health Administration
Facilities (Feb. 9, 2009); and VHA Directive 2009-031, Improving
Safety in the Use of Reusable Medical Equipment Through
Standardization of Organizational Structure and Reprocessing
Requirements (June 26, 2009).
[4] According to press articles, patient safety incidents involving
improperly reprocessed RME have also occurred at non-VA hospitals. For
example, a Pittsburgh Tribune-Review article from September 16, 2009,
noted that patients at a non-VA hospital in Pennsylvania were
potentially exposed to infectious diseases due to the improper
reprocessing of surgical instruments. See W.F. Roche, "UPMC's Venango
County facility improperly sterilized equipment," TribLIVE News (Sept.
16, 2009). Accessed on February 16, 2011, at [hyperlink,
http://www.pittsburghlive.com/x/leadertimes/s_643419.html].
[5] See M. Owens, "St. Louis VA Medical Center dental infections:
Nearly 2,000 at risk," KSDK.com (June 29, 2010). Accessed on February
16, 2011, at [hyperlink,
http://www.ksdk.com/news/local/story.aspx?catid=3&storyid=205262].
[6] We reviewed applicable VA policies, including VHA Handbook
1761.02, VHA Inventory Management; VHA Directive 2009-031, Improving
Safety in the Use of Reusable Medical Equipment Through
Standardization of Organizational Structure and Reprocessing
Requirements; VHA Directive 2009-004, Use and Reprocessing of Reusable
Medical Equipment (RME) in Veterans Health Administration Facilities;
VA Handbook 7002, Logistics Management Procedures (July 10, 2009); VA
Handbook 7176, Supply, Processing, and Distribution (SPD) Operational
Requirements; and VA Standard Operating Procedure #AM 5, Inventory of
Equipment in Use Standard Operating Procedure (Feb. 17, 2011).
[7] VA assigns each VAMC a complexity score between 1 and 3, with
level 1 being the most complex, using a facility complexity model.
Level 1 is broken down further into 1a, 1b, and 1c. That model uses
multiple variables to measure facility complexity arrayed along four
categories, namely patient population served, clinical services
offered, education and research complexity, and administrative
complexity.
[8] Each of the six VAMCs we visited is located within a different
VISN.
[9] We reviewed minutes from the following committees: commodity
standards, equipment, medical executive, infection control, and RME.
[10] See GAO, Standards for Internal Control in the Federal
Government, [hyperlink,
http://www.gao.gov/products/GAO/AIMD-00-21.3.1] (Washington, D.C.:
November 1999) and GAO, Internal Control Management and Evaluation
Tool, [hyperlink, http://www.gao.gov/products/GAO-01-1008G]
(Washington, D.C.: August 2001).
[11] 38 U.S.C. §§ 1710(a)(1)-(3), 1701(5), (6). Requirements for VA
health care services are effective in any fiscal year only to the
extent and in the amount provided in advance in appropriations acts
for such purposes. 38 U.S.C. § 1710(a)(4).
[12] See 38 C.F.R. § 17.37 (2010).
[13] Generally, a VAMC's commodity standards committee reviews and
approves purchases of expendable medical supplies and a VAMC's
equipment committee reviews and approves purchases of RME.
[14] See VA Handbook 7176, Supply, Processing, and Distribution (SPD)
Operational Requirements.
[15] VA Handbook 7002, Logistics Management Procedures.
[16] According to VHA Handbook 1730.01, Use and Management of the
Government Purchase Card Program (Aug. 27, 2008), purchases are
defined as recurring if they are made four or more times per year. In
contrast, VHA Handbook 1761.02, VHA Inventory Management, states that
expendable medical supplies that are ordered on a recurring basis must
be entered into GIP but does not specify the number of times per year
a purchase must be made in order to qualify as recurring.
[17] Nonexpendable equipment has a life expectancy of 2 years or more.
See VA Standard Operating Procedure #AM 5, Inventory of Equipment in
Use Standard Operating Procedure and VA Handbook 7002, Logistics
Management Procedures.
[18] See VA Handbook 7176, Supply, Processing, and Distribution (SPD)
Operational Requirements, VHA Directive 2009-004, Use and Reprocessing
of Reusable Medical Equipment (RME) in Veterans Health Administration
Facilities, and VHA Directive 2009-031, Improving Safety in the Use of
Reusable Medical Equipment Through Standardization of Organizational
Structure and Reprocessing Requirements.
[19] See GAO, VA Health Care: Preliminary Observations on the
Purchasing and Tracking of Supplies and Medical Equipment and the
Potential Impact on Veterans' Safety, [hyperlink,
http://www.gao.gov/products/GAO-10-1038T] (Washington, D.C.: Sept. 23,
2010).
[20] Officials from this VAMC also checked with staff responsible for
reprocessing in the gastrointestinal department, which is where
colonoscopies are performed, to determine whether the VAMC possessed
this type of RME. See VA Office of Inspector General, Use and
Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical
Facilities, 09-01784-146 (Washington, D.C.: June 2009).
[21] As of August 17, 2010, the VAMC reported that it has successfully
notified 2,523 of the 2,526 veterans of possible exposure to
infectious diseases and that there were 17 new positive test results.
VA reports that these results are not necessarily linked to RME issues
and it is continuing its evaluation.
[22] According to VA headquarters officials, certain RME are difficult
to reprocess because they need to be fully disassembled in order to be
reprocessed correctly, so developing device-specific training for
reprocessing these items is important to help ensure veterans' safety.
[23] RME is generally categorized into critical, semi-critical, or non-
critical items based on the degree of risk for infection involved in
use of the item. Critical items, such as surgical instruments, are
those that enter sterile tissue or the vascular system and require
sterilization because they confer a high risk of infection. Semi-
critical items, such as certain endoscopes, are those that contact
mucous membranes or non-intact skin and minimally require high-level
disinfection. Non-critical items, such as wheelchairs, are those that
come into contact with intact skin and may be cleaned with low-level
disinfectants.
[24] VA officials stated that manufacturer guidelines for reprocessing
RME may be technically complex and may include steps that VAMCs are
unable to follow. For example, these officials stated that guidelines
from RME manufacturers may require the use of a specific disinfectant
that is not available in the United States. The Food and Drug
Administration has responsibility for overseeing RME, including the
guidelines written by manufacturers for reprocessing these items.
[25] VA headquarters' Management Quality Assurance Service (MQAS)
oversees each VAMC's compliance with the selected VA tracking
requirements approximately once every 7 to 8 years as part of broader
compliance reviews. MQAS uses a standardized checklist to conduct
these reviews. Following each review, VAMCs are required to develop
corrective action plans to address areas of noncompliance. MQAS
subsequently analyzes information on VAMC noncompliance and corrective
action plans to identify the extent of noncompliance across all VAMCs,
including those that occur frequently or have not been resolved.
Although we did not identify any weaknesses in VA's oversight of the
selected tracking requirements, as described earlier in this report,
we did identify inadequacies in those requirements that pose risks to
the safety of veterans.
[26] VA policy requires VISNs to conduct annual audits of some
purchases--those made using purchase cards--which may include
examining whether the two required signatures were obtained. However,
according to a VA headquarters official, these audits are conducted
inconsistently across VISNs. See VHA Handbook 1730.01, Use and
Management of the Government Purchase Card Program.
[27] The federal internal control for monitoring states that an agency
should be able to ensure that ongoing review and supervision
activities are conducted, with the scope and frequency depending on
the assessment of risks, and that actions in response to findings or
recommendations are taken within established timelines. See
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1] and
[hyperlink, http://www.gao.gov/products/GAO-01-1008G].
[28] We previously reported examples of noncompliance with selected VA
purchasing and tracking requirements from five VAMCs we visited. See
GAO-10-1038T. We have since conducted a site visit to a sixth VAMC.
[29] As of June 2, 2010, the VAMC reported that all testing has been
completed and that no veterans have acquired infectious diseases as a
result of this incident. The VAMC found that 1 of the 83 veterans
identified was dialyzed on an uncontaminated machine and therefore
this veteran was not notified or tested for these infectious diseases.
[30] VA headquarters generally delegates responsibility for this
oversight to the VISNs. In addition to oversight conducted by the
VISNs, some entities within VA headquarters conduct oversight of
VAMCs' compliance with VA reprocessing requirements, including those
we selected for review. Specifically, VA's OIG and Sterile Processing
Department conduct site visits to investigate allegations of VAMC
noncompliance with VA reprocessing requirements. In addition, since
around 2005, the System-wide Ongoing Assessment and Review Strategy
has included reviews of the selected VA reprocessing requirements as
part of broader reviews of VAMC compliance with VA policies in
preparation for external accreditation reviews approximately every 3
years. In 2010, VA's OIG also conducted reviews of the selected VA
reprocessing requirements as part of broader ongoing reviews of VAMC
compliance with VA policies.
[31] VA headquarters officials told us that they may refine this
assessment tool over time.
[32] While VISNs were not generally required to report to VA
headquarters information on VAMCs' noncompliance with VA's
reprocessing requirements, VISNs were required to report to VA
headquarters information about noncompliance that may have resulted in
harm to veterans. VA headquarters officials told us that, following a
review of that information and collection of additional information,
as needed, a panel of experts would determine whether the
noncompliance identified in the reviews resulted in risks to veterans'
safety and, if so, whether veterans should be notified. See VHA
Directive 2008-002, Disclosure of Adverse Events to Patients
(Washington, D.C.: Jan. 18, 2008).
[33] VA headquarters officials also told us that a temporary staff
member was assigned in March 2011 to begin reviewing some information
from VISNs' oversight activities. Specifically, that staff member will
be responsible for reviewing whether VAMCs have developed the required
device-specific training for reprocessing RME and the extent to which
VAMCs are utilizing flash sterilization, a sterilization technique
that should be used only in limited circumstances.
[34] As part of this realignment, VA headquarters is establishing a
new position within the Office of the Deputy Under Secretary for
Health for Operations and Management, which will be responsible for
overseeing certain departments, including VA headquarters' Sterile
Processing Department.
[35] We reviewed applicable VA policies, including VHA Handbook
1761.02, VHA Inventory Management (Oct. 20, 2009); VHA Directive 2009-
031, Improving Safety in the Use of Reusable Medical Equipment Through
Standardization of Organizational Structure And Reprocessing
Requirements (June 26, 2009); VHA Directive 2009-004, Use and
Reprocessing of Reusable Medical Equipment (RME) in Veterans Health
Administration Facilities (Feb. 9, 2009); VA Handbook 7002, Logistics
Management Procedures (July 10, 2009); VA Handbook 7176, Supply,
Processing and Distribution (SPD) Operational Requirements (Aug. 16,
2002); and VA Standard Operating Procedure #AM 5, Inventory of
Equipment in Use Standard Operating Procedure (Feb. 17, 2011).
[36] VA assigns each VAMC a complexity score between 1 and 3, with
level 1 being the most complex, using a facility complexity model.
Level 1 is broken down further into 1a, 1b, and 1c. That model uses
multiple variables to measure facility complexity arrayed along four
categories, namely patient population served, clinical services
offered, education and research complexity, and administrative
complexity.
[37] We reviewed minutes from the following committees: commodity
standards, equipment, medical executive, infection control, and
reusable medical equipment (RME).
[38] The patient safety manager is responsible for overseeing the
response to patient safety advisories and alerts from VA headquarters
and for addressing patient safety incidents at the VAMC; infection
preventionists are responsible for helping to ensure that infection
control standards are followed by VAMC staff; and the quality
management staff is responsible for monitoring the quality of care at
VAMCs.
[39] See GAO, Standards for Internal Control in the Federal
Government, [hyperlink,
http://www.gao.gov/products/GAO/AIMD-00-21.3.1] (Washington, D.C.:
November 1999) and GAO, Internal Control Management and Evaluation
Tool, [hyperlink, http://www.gao.gov/products/GAO-01-1008G]
(Washington, D.C.: August 2001).
[End of section]
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