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

Fast Facts:

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

section_title: Letter
paragraphs: 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. 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.
My testimony today, 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.
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.
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, sizes of veteran populations served, and  geographic regions. 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 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.  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.  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.
subsections: section_title: Selected VA Reprocessing Requirements Are Inadequate to Help Ensure Veterans’ Safety
paragraphs: 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, 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. 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 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.
section_title: Despite Changes Intended to Improve VA’s Oversight of VAMCs’ Compliance with Selected Reprocessing Requirements, Weaknesses Continue to Exist
paragraphs: 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.
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 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.
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. 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.
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.
section_title: Contacts and Acknowledgments
paragraphs: 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.
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