VA Health Care:

Actions Needed to Ensure Medical Facility Controlled Substance Inspection Programs Meet Agency Requirements

GAO-17-242: Published: Feb 15, 2017. Publicly Released: Feb 15, 2017.

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Contact:

Randall B. Williamson
(202) 512-7114
williamsonr@gao.gov

 

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youngc1@gao.gov

How does VA oversee the distribution of controlled substances?

The Veterans Health Administration requires that its medical facilities have an inspection program to monitor how controlled substances are dispensed by staff. Inspectors check, for example, that opioids removed from dispensing machines by staff have a valid doctor’s order and are administered to patients.

However, we found that some VHA facilities did not follow all required procedures, and some even skipped required inspections. We recommended that the VHA ensure that its inspection program is in line with its policies, and establish procedures to prevent missed inspections.

 

Photo of a nurse administering medication.

Photo of a nurse administering medication.

Additional Materials:

Contact:

Randall B. Williamson
(202) 512-7114
williamsonr@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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.

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 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.

For more information, contact Randall B. Williamson at (202) 512-7114 or williamsonr@gao.gov.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: VA issued a memorandum to its Veterans Integrated Service Network (VISN) directors and medical facility directors on February 22, 2017. The memorandum included a requirement that medical facility directors appoint an alternate controlled substance coordinator (CSC) if one was not already in place, and certify to the VISNs that they had met this requirement. In addition, VA included in its updated directive on the controlled substance inspection program (VHA Directive 1108.02) the requirement that controlled substance inspection programs have an alternate CSC. As of December 2017, all but one of the medical facility directors had certified that an alternate CSC had been appointed, according to VA. The remaining facility was in the process of appointing an alternate CSC, according to VA.

    Recommendation: 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 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.

    Agency Affected: Department of Veterans Affairs

  2. Status: Closed - Implemented

    Comments: VA issued a memorandum to its Veterans Integrated Service Network (VISN) directors and medical facility directors on February 22, 2017. The memorandum included a requirement that medical facility directors must certify to the VISNs that their facility policies on the controlled substance inspection program include all of VA's policy requirements. Medical facility directors were required to perform a multidisciplinary self-assessment of their local inspection procedures using a guide developed by VA and provide an action plan to correct for identified discrepancies between VA's policy requirements and their local procedures. As of February 2018, all of the medical facilities had completed the self-assessment and modified their facility inspection policies and procedures to ensure consistency with VA's policy requirements, according to VA. In addition, VA included in its updated directive on the controlled substance inspection program (VHA Directive 1108.02) a requirement that medical facility policy and procedures must be updated as appropriate whenever there is a change in VA's national requirements.

    Recommendation: 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 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.

    Agency Affected: Department of Veterans Affairs

  3. Status: Closed - Implemented

    Comments: VA issued a memorandum to its Veterans Integrated Service Network (VISN) directors and medical facility directors on February 22, 2017. The memorandum included a requirement that all controlled substance coordinators (CSC) and alternate CSCs complete the controlled substance inspector certification course in addition to the CSC orientation, and medical facility directors were required to certify to the VISNs that they had met this requirement. VA also included in its updated directive on the controlled substance inspection program (VHA Directive 1108.02) the requirement that all CSCs and alternate CSCs must complete the inspector certification course in addition to the CSC orientation. As of December 2017, all but one of the medical facility directors had certified that their CSCs and alternate CSCs had completed this training, according to VA. VA also revised both of its training courses to include updated inspection procedures in its revised directive on the controlled substance inspection program (VHA Directive 1108.02).

    Recommendation: 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 improve the training of VA medical facility controlled substance coordinators by ensuring the training includes the inspection procedures that VHA requires.

    Agency Affected: Department of Veterans Affairs

  4. Status: Closed - Implemented

    Comments: VA issued a memorandum to its Veterans Integrated Service Network (VISN) directors and medical facility directors on February 22, 2017. The memorandum included a requirement that facility directors incorporate the review and evaluation of the controlled substance inspection program monthly and quarterly reports into the facility quality management (QM) committee. That is, VA now requires the QM committee to review and evaluate these reports for adherence with VA's controlled substance inspection program requirements. All corrective actions must be documented and followed through to completion by the QM committee and reported to the medical facility director. VA also required in its memorandum that the medical facility directors certify to the VISNs that they were meeting this requirement. As of December 2017, all medical facility directors had certified that this requirement was being met, according to VA. These new QM requirements were included in VA's updated directive on the controlled substance inspection program (VHA Directive 1108.02).

    Recommendation: 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 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.

    Agency Affected: Department of Veterans Affairs

  5. Status: Closed - Implemented

    Comments: VA issued a memorandum to its Veterans Integrated Service Network (VISN) directors and medical facility directors on February 22, 2017. The memorandum included a requirement that the VISNs review their facilities' inspection program quarterly reports and ensure that facilities take corrective actions when nonadherence is identified. As part of the memorandum, VA required that the VISNs certify that they were meeting this requirement. As of December 2017, all VISNs had certified that this requirement was being met, according to VA. In addition, VA included this VISN requirement in its updated directive on the controlled substance inspection program (VHA Directive 1108.02).

    Recommendation: 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 ensure that networks review their facilities' quarterly trend reports and ensure facilities take corrective actions when nonadherence is identified.

    Agency Affected: Department of Veterans Affairs

  6. Status: Closed - Implemented

    Comments: VA issued a memorandum to its Veterans Integrated Service Network (VISN) directors and medical facility directors on February 22, 2017. The memorandum included a requirement that the VISNs monitor their medical facilities' efforts to establish and implement a review process to periodically compare facility controlled substance inspection procedures to VHA's policy requirements. VA required that the VISNs certify that they were meeting this requirement. As of December 2017, all VISNs had certified that this requirement was being met, according to VA. In addition, VA included this VISN requirement in its updated directive on the controlled substance inspection program (VHA Directive 1108.02).

    Recommendation: 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 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.

    Agency Affected: Department of Veterans Affairs

 

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