Selected Facilities Did Not Conduct All Inspections, Follow All Inspection Procedures, or Develop Written Inspection Procedures that Were Fully Consistent with VHA Policy

		Two of Four Selected VA Medical Facilities Did Not Conduct All Required Monthly Inspections

VHA policy requires that facilities inspect multiple patient care areas and  pharmacies on a monthly basis. At the VA medical facility that missed 43 percent (131 of 308) of the  required monthly inspections, we found that most (about 95 percent) of  the facility’s missed inspections were for the facility’s patient care areas,  while the remaining 5 percent of missed inspections at this facility were  for the pharmacy. Controlled Substance Inspections Conducted at Three of Four Selected Medical Facilities Did Not Follow Certain VHA Policy Requirements

We found that three of the four selected VA medical facilities, when  conducting inspections, did not include, or correctly follow, three or more  of the nine VHA requirements we reviewed. At two of the selected VA medical facilities, inspectors did not verify that  controlled substances had been properly transferred from VA pharmacies  to automated dispensing machines in patient care areas. VHA  recommends but does not require that the  coordinators take the online training course for inspectors. Oversight of Controlled Substance Inspection Programs by Selected VA Medical Facilities and Their Networks Is Inconsistent

Facility directors are responsible for reviewing monthly inspection reports  that the coordinators at the facilities submit, and these reports must  provide information on missed inspections and reasons for missed  inspections. We also found that oversight provided by the four networks to which the  four selected VA medical facilities in our review report was inconsistent. Officials from two of the four networks we  interviewed told us they did not review the quarterly trend reports. In addition, we  found that one of two networks that had reviewed the quarterly trend  reports did not take action to ensure that one of the facilities in our review  had completed quarterly trend reports. The inconsistent oversight provided by facility directors and networks of  VA’s controlled substance inspection programs is contrary to federal  internal control standards. Without a  process to ensure consistent monitoring by facility directors and networks  that includes correcting missed inspections and other nonadherence and  holding individuals accountable, VHA  lacks reasonable assurance that  the facilities are meeting the objective of the inspection program. Conclusions

VHA’s controlled substance inspection programs are one of the primary  means VHA uses to reduce the risk of the diversion of controlled  substances at its VA medical facilities. However, we found weaknesses in  the implementation of these programs. As a result, VHA’s ability to detect diversion and  protect its veterans from harm that can result from diversion—such as  depriving them of needed pain medications—is limited. Although our review focused on four selected facilities, the problems we  identified in implementing and overseeing the inspection programs are  consistent with the problems identified by the VA OIG in its reviews of  controlled substance inspection programs at other VA medical facilities in  2009 and again in 2014. These longstanding program implementation  issues and weaknesses in oversight are cause for concern, and VHA has  a responsibility to ensure that all of its controlled substance inspection  programs are being implemented as it intends. Recommendations for Executive Action

To help VHA achieve its objective of reducing the risk of diversion through  effective implementation and oversight of the controlled substance  inspection program, the Secretary of Veterans Affairs should direct the  Under Secretary for Health to take the following six actions: ensure that VA medical facilities have established an additional control  procedure, such as an alternate controlled substance coordinator or  additional inspectors, to help coordinators meet their responsibilities and  prevent missed inspections; ensure that VA medical facilities have established a process where  coordinators, in conjunction with appropriate stakeholders (e.g.,  pharmacy officials), periodically compare facility inspection procedures to  VHA’s policy requirements and modify facility inspection procedures as  appropriate;  improve the training of VA medical facility controlled substance  coordinators by ensuring the training includes the inspection procedures  that VHA requires; ensure that medical facility directors have designed and implemented a  process to address nonadherence with program requirements, including  documenting the nonadherence and the corrective actions taken to  remediate nonadherence or the actions that demonstrate why no  remediation is necessary; ensure that networks review their facilities’ quarterly trend reports and  ensure facilities take corrective actions when nonadherence is identified;  and ensure that networks monitor their medical facilities’ efforts to establish  and implement a review process to periodically compare facility  inspection procedures to VHA’s policy requirements.
Why GAO Did This Study

Diversion of opioid pain relievers and other controlled substances by health care providers has occurred at several VA medical facilities. Such diversions for personal use can pose a threat to patients by depriving them of needed medications. Absent effective practices to mitigate its risk and quickly identify it, diversion can occur undetected. VHA requires each of its facilities to implement a controlled substance inspection program to help reduce the risk of diversion.
GAO was asked to examine VHA's processes to prevent diversion and its oversight of these processes. This report examines VHA's implementation and oversight of controlled substance inspection programs at selected facilities. GAO reviewed VHA policies and interviewed officials from VHA central office and from a nongeneralizable selection of four facilities and the networks that oversee them. Facilities were selected to reflect variation in geography and in the number of opioids dispensed at retail pharmacies in the state in which the facility operates. GAO compared the facilities' implementation and oversight of the programs to VHA's policy requirements and to federal standards for internal control.

What GAO Found

GAO found weaknesses in the way four selected Department of Veterans Affairs (VA) medical facilities were implementing their controlled substance inspection programs. Two of the four did not conduct monthly inspections of controlled substances as required by the Veterans Health Administration (VHA). For example, one facility missed 43 percent of monthly inspections in critical patient care areas and the pharmacy for the period GAO reviewed—January 2015 to February 2016. Further, inspections that three of the four facilities performed did not include or follow three or more of the nine VHA requirements GAO reviewed. At two of the three facilities, for example, inspectors did not properly verify that controlled substances had been transferred from VA pharmacies to patient care areas; nor did inspectors ensure that all controlled substances on hold for destruction were properly documented. The VA Office of the Inspector General identified similar inspection program weaknesses at other VA facilities in 2009 and again in 2014.
GAO found that several factors contributed to nonadherence to VHA policy at selected facilities. First, the two facilities that missed inspections lacked an additional control procedure—such as the use of an alternate controlled substance coordinator—to help prevent missed inspections when inspectors could not conduct them due to professional or other personal responsibilities. Second, while facilities develop their own set of inspection procedures that must follow VHA's policy requirements, three of the four facilities did not ensure their written procedures included the nine VHA program requirements GAO reviewed. Third, VHA relies on coordinators at the facilities to ensure that the inspections are completed appropriately, but GAO found that VHA's training course for the coordinators does not focus on its required inspection procedures. As a result of these weaknesses, VHA cannot ensure that its inspection programs are following all of its requirements.
GAO found inconsistent oversight at the selected facilities of their controlled substance inspection programs by facility directors and the Veterans Integrated Service Networks (network) to which the facilities report. VHA assigns oversight responsibilities to each facility director and network. GAO found that directors at two of the four selected VA medical facilities had not implemented corrective actions to address missed inspections identified in the monthly inspection reports. In addition, two of the four selected networks did not review their facilities' quarterly trend reports, as required by VHA. Such reports identify inspection program trends such as missed inspections and areas for improvement. GAO found that one network that had reviewed the trend reports failed to follow up with a facility to ensure it had submitted missed trend reports. Inconsistent oversight by the directors and networks is contrary to federal internal control standards that state oversight should be ongoing to assess performance and promptly remediate deficiencies in order to achieve objectives, including holding individuals accountable for their responsibilities. Without effective oversight of the inspection programs by directors and networks, VHA lacks reasonable assurance that its programs are being implemented as required to prevent and identify diversion of controlled substances.

What GAO Recommends

GAO is making six recommendations, including that VHA establish procedures to prevent missed inspections, review facilities' inspection procedures, improve coordinator training, and direct facility directors and networks to ensure that facilities correct facility nonadherence to VHA policies. VA concurred with GAO's recommendations.