VA Health Care
Weaknesses in Policies and Oversight Governing Medical Equipment Pose Risks to Veterans' Safety Gao ID: GAO-11-591T May 3, 2011This testimony discusses patient safety incidents at Department of Veterans Affairs (VA) medical centers and potential strategies to address the underlying causes of those incidents. 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. In providing health care services to veterans, clinicians at VAMCs use reusable medical equipment (RME), which is designed to be reused for multiple patients and includes such equipment as endoscopes and some surgical and dental 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 when reprocessing RME, which are designed, in part, to help ensure the safety of the veterans who receive care at VAMCs. This testimony, based on our May 2011 report, which is being released today, examines issues related to veterans' safety, including (1) selected reprocessing requirements established in VA policies, based on their relevance to patient safety incidents and (2) VA's oversight of VAMCs' compliance with these selected requirements.
In summary, we found that the VA reprocessing requirements we selected for review are inadequate to help ensure the safety of veterans who receive care at VAMCs. Although VA requires VAMCs to develop devicespecific training for staff on how to correctly reprocess RME, it has not specified the types of RME for which this training is required. Furthermore, VA has provided conflicting guidance to VAMCs on how to develop device-specific training on reprocessing RME. 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 veterans' safety. VA headquarters officials told us that VA has plans to develop training for certain RME, but VA lacks a timeline for developing this training. We also found that despite changes to improve VA's oversight of VAMCs' compliance with selected reprocessing requirements, weaknesses still exist. These weaknesses render VA unable to systematically identify and address noncompliance with the requirements, which poses potential risks to the safety of veterans. 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. To address the inadequacies we identified in selected VA reprocessing requirements, GAO recommends that VA develop and implement an approach for providing standardized training for reprocessing all critical and semi-critical RME to VAMCs and hold VAMCs accountable for implementing this training. To address the weaknesses in VA's oversight of VAMCs' compliance with selected requirements, GAO recommends that VA use information on noncompliance identified by the VISNs and information on VAMCs' corrective action plans to identify areas of noncompliance across all 153 VAMCs and take action to improve compliance in those areas.
GAO-11-591T, VA Health Care: Weaknesses in Policies and Oversight Governing Medical Equipment Pose Risks to Veterans' Safety
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United States Government Accountability Office:
GAO:
Testimony:
Before the Committee on Veterans' Affairs, House of Representatives:
For Release on Delivery:
Expected at 10:30 a.m. EDT:
Tuesday, May 3, 2011:
VA Health Care:
Weaknesses in Policies and Oversight Governing Medical Equipment Pose
Risks to Veterans' Safety:
Statement of Randall B. Williamson:
Director, Health Care:
GAO-11-591T:
Chairman Miller, Ranking Member Filner, and Members of the Committee:
I am pleased to be here today as you discuss patient safety incidents
at Department of Veterans Affairs (VA) medical centers and potential
strategies to address the underlying causes of those incidents. 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 reusable medical equipment (RME),
which is designed to be reused for multiple patients and includes such
equipment as endoscopes[Footnote 2] and some surgical and dental
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 when reprocessing RME,[Footnote 3]
which are designed, in part, to help ensure the safety of the veterans
who receive care at VAMCs.
My testimony today, based on our May 2011 report,[Footnote 4] which is
being released today, examines issues related to veterans' safety,
including (1) selected reprocessing requirements established in VA
policies, based on their relevance to patient safety incidents and (2)
VA's oversight of VAMCs' compliance with these selected requirements.
To examine VA reprocessing requirements, we reviewed relevant VA
policies and from these policies, we judgmentally selected the
following two types of reprocessing requirements that we determined
were relevant to patient safety incidents that were identified at
certain VAMCs.[Footnote 5]
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.
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 6] sizes of veteran populations
served, and geographic regions.[Footnote 7] At these six VAMCs, we
examined the adequacy of the selected 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 were implemented and whether or to what extent these
requirements directly or indirectly created a potential risk to
veterans' safety. We reviewed applicable VAMC committee meeting
minutes[Footnote 8] 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 these requirements are adequate to help ensure veterans'
safety.
To examine VA's oversight of VAMCs' compliance with the selected
reprocessing requirements, 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 9] 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 with the requirements we selected for review 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.
In summary, we found that the VA reprocessing requirements we selected
for review are inadequate to help ensure the safety of veterans who
receive care at VAMCs. Although VA requires VAMCs to develop device-
specific training for staff on how to correctly reprocess RME, it has
not specified the types of RME for which this training is required.
Furthermore, VA has provided conflicting guidance to VAMCs on how to
develop device-specific training on reprocessing RME.[Footnote 10]
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 veterans' safety. VA headquarters officials told us that VA
has plans to develop training for certain RME, but VA lacks a timeline
for developing this training.
We also found that despite changes to improve VA's oversight of VAMCs'
compliance with selected reprocessing requirements, weaknesses still
exist. These weaknesses render VA unable to systematically identify
and address noncompliance with the requirements, which poses potential
risks to the safety of veterans. 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.
To address the inadequacies we identified in selected VA reprocessing
requirements, GAO recommends that VA develop and implement an approach
for providing standardized training for reprocessing all critical and
semi-critical RME to VAMCs and hold VAMCs accountable for implementing
this training. To address the weaknesses in VA's oversight of VAMCs'
compliance with selected requirements, GAO recommends that VA use
information on noncompliance identified by the VISNs and information
on VAMCs' corrective action plans to identify areas of noncompliance
across all 153 VAMCs and take action to improve compliance in those
areas.
Selected VA Reprocessing Requirements Are Inadequate to Help Ensure
Veterans' Safety:
We found that the VA reprocessing requirements we selected for review
are inadequate to help ensure veterans' safety.
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
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 11] 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 RME. This
distinction is important, since VAMC officials told us that some of
the staff responsible for reprocessing RME may have difficulty
following the more technical manufacturers' guidelines.[Footnote 12]
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 their 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 had not completed the development of
device-specific training for these RME and has not established plans
or corresponding timelines for doing so.
Despite Changes Intended to Improve VA's Oversight of VAMCs'
Compliance with Selected Reprocessing Requirements, Weaknesses
Continue to Exist:
We found that VA recently made changes to its oversight of VAMCs'
compliance with selected reprocessing requirements; however, this
oversight continues to have weaknesses. Beginning in fiscal year 2011,
VA headquarters directed VISNs to make three changes intended to
improve its oversight of these reprocessing requirements at VAMCs.
[Footnote 13]
* 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 14] 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 a VAMC, VISNs are required to provide VA headquarters with
information on the facility's 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 15]
Despite the recent changes, VA's oversight of 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 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 and, as a result, are unable 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
oversight information 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 16] 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 17]
In conclusion, weaknesses exist in VA's policies for reprocessing RME
that create potential safety risks to veterans. 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.
Moreover, weaknesses in oversight of VAMCs' compliance with the
selected reprocessing requirements do not allow VA to identify and
address areas of noncompliance across VAMCs, including those that
occur frequently, pose high risks to veterans' safety, or have not
been addressed by VAMCs. Correcting inadequate policies and providing
effective oversight of reprocessing requirements consistent with the
federal standards for internal control is essential for VA to prevent
potentially harmful incidents from occurring.
To help ensure veterans' safety through VA's reprocessing
requirements, we are making two recommendations in our report. We
recommend that the Secretary of Veterans Affairs direct the Under
Secretary for Health to take the following actions:
* 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.
* 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.
In responding to a draft of the report from which this testimony is
based, VA concurred with these recommendations.
Chairman Miller, Ranking Member Filner, this concludes my prepared
statement. I would be happy to respond to any questions you or other
Members of the Committee may have.
Contacts and Acknowledgments:
For further information about this testimony, please contact Randall
B. Williamson at (202) 512-7114 or williamsonr@gao.gov. Contact points
for our Offices of Congressional Relations and Public Affairs may be
found on the last page of this testimony. Individuals who made key
contributions to this testimony include Mary Ann Curran, Assistant
Director; Kye Briesath; Krister Friday; Melanie Krause; Lisa Motley;
and Michael Zose.
[End of section]
Footnotes:
[1] The management of VAMCs is decentralized to 21 VISNs.
[2] An endoscope is a device with a light attached that is used to
look inside a body cavity or organ.
[3] VA Handbook 7176, Supply, Processing, and Distribution (SPD)
Operational Requirements (Aug. 16, 2002); 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] See GAO, VA Health Care: Weaknesses in Policies and Oversight
Governing Medical Supplies and Equipment Pose Risks to Veterans'
Safety, [hyperlink, http://www.gao.gov/products/GAO-11-391]
(Washington, D.C.: May 2011).
[5] We reviewed applicable VA policies, including 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;
and VA Handbook 7176, Supply, Processing, and Distribution (SPD)
Operational Requirements.
[6] VA assigns each VAMC a complexity score between 1 and 3, with
level 1 being the most complex, using a facility complexity model.
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.
[7] Each of the six VAMCs we visited is located within a different
VISN.
[8] We reviewed minutes from the following committees: commodity
standards, equipment, medical executive, infection control, and RME.
[9] 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).
[10] 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.
[11] 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.
[12] VA officials stated that manufacturer guidelines for reprocessing
RME may be technically complex and may include steps that staff at
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.
[13] 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, VA's 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.
[14] VA headquarters officials told us that they may refine this
assessment tool over time.
[15] 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).
[16] 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.
[17] 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.
[End of section]
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