VA Health Care: Weaknesses in Policies and Oversight Governing Medical Supplies and Equipment Pose Risks to Veterans' Safety
Published: 2011-05-03T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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.

section_title: Letter
paragraphs: 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. 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; and for reprocessing RME.  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. 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. 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. 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 and geographic regions 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 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. 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.
subsections: section_title: Background
paragraphs: VA is required by law to provide hospital care and medical services to  certain veterans and may provide care to other veterans. 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. 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.
subsections: section_title: VA Roles and Responsibilities for Purchasing, Tracking, and Reprocessing
paragraphs: 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 fig. 1 for an overview of VA’s organizational structure.)
section_title: VA Policies for Purchasing, Tracking, and Reprocessing
paragraphs: 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.  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. 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.  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).
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).
VA policies include requirements designed to help ensure that VAMCs  reprocess RME correctly, 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.
section_title: Selected VA Requirements for Tracking and Reprocessing Are Inadequate to Help Ensure Veterans’ Safety
paragraphs: 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.
subsections: section_title: VAMCs Are Not Required to Track Certain Expendable Medical Supplies and RME
paragraphs: 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, 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.  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.
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.
section_title: Selected VA Reprocessing Requirements Are Inadequate
paragraphs: 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.
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, 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. 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.
section_title: VA’s Oversight of VAMCs’ Compliance with Selected Purchasing and Reprocessing Requirements Has Weaknesses
paragraphs: 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. 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.
subsections: section_title: VA Has Limited Oversight of VAMCs’ Compliance with Selected Purchasing Requirements
paragraphs: 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. 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.
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.
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.
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.
section_title: Despite Changes Intended to Improve Its Oversight of VAMCs’ Compliance with Selected Reprocessing Requirements, VA’s Oversight Has Weaknesses
paragraphs: 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.
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.  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.
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. 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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  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.
section_title: Appendix I: Scope and Methodology
paragraphs: To examine Department of Veterans Affairs (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 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, serve veteran populations of different sizes,  and are located in different Veterans Integrated Service Networks (VISN).  (See table 1.)
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 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.
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. 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.
section_title: Appendix II: Comments from the Department of Veterans Affairs
section_title: Appendix III: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.