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

Letter

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, 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.

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.

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.

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.

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