VA Health Care: Actions Needed to Ensure Medical Facility Controlled Substance Inspection Programs Meet Agency Requirements
Published: 2017-02-15T00:00:00

Fast Facts:
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.

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

section_title: Letter
paragraphs: The rate of opioid overdose deaths tripled between 2000 and 2014 and  the misuse of opioids such as oxycodone was a contributing factor. One  way that providers and other health care employees misuse opioids—and  other controlled substances that they have ready access to—is by  diverting them from patients for their own personal use. Absent effective  practices to mitigate the risk of diversion and quickly identify it after it  occurs, providers and others can divert controlled substances over time  without anyone knowing. This, in turn, poses a serious threat to patients  by depriving them of needed medications. Although data on the frequency  of diversion in medical facilities located in the United States—including  those run by the Department of Veterans Affairs (VA)—is not available,  diversion can occur anywhere in a facility where employees have access  to controlled substances. Patient care areas may be more vulnerable to  diversion; in these settings, providers can administer and dispose of  controlled substances out of the view of others, making diversion by the  employee easier and detection more difficult, as discussed in the Mayo  Clinic Proceedings.
The Controlled Substances Act and implementing regulations require all  medical facilities, including VA facilities, to have effective controls and  procedures to adequately safeguard against theft and diversion of  controlled substances. To fulfill this requirement, the Veterans Health  Administration (VHA), which operates VA’s health care system, required  that each of its medical facilities with stocks of controlled substances  implement a controlled substance inspection program. VHA requires the  programs to conduct monthly inspections following specified procedures  outlined in VHA policy in all medical facility areas that are authorized to  have controlled substances, such as patient care areas and pharmacies.
In recent years, diversion of controlled substances has occurred at  several VA medical facilities. For example, an investigation in 2012 found  that a former health care employee at the VA medical facility located in  Baltimore, Maryland  had been diverting the opioid fentanyl—an  anesthetic used for patients undergoing surgical procedures—for his own  use. The employee was injecting himself with syringes of fentanyl  intended for patients undergoing surgery and then refilling the empty  syringes with saline solution. Instead of receiving the prescribed dose of  fentanyl with its intended anesthetic effect, patients received saline  solution that was tainted with the Hepatitis C virus carried by the  employee. Another investigation in 2012 found that an emergency room  nurse at a VA medical facility was injecting herself with syringes of  hydromorphone, an opioid pain reliever, intended for patients. After identifying discrepancies in the amounts of hydromorphone the nurse  documented as having administered to patients, VA officials accused the  nurse of diversion. Eventually, the nurse confessed to having diverted  hydromorphone for approximately six months.
VHA has faced challenges implementing its controlled substance  inspection programs. In 2009 and 2014, the VA Office of the Inspector  General (OIG) identified a number of weaknesses in VA medical facilities’  implementation of controlled substance inspection programs. For  example, the VA OIG found that some VA medical facilities had not  conducted the required monthly inspections, and when facilities did  conduct the monthly inspections, the inspections were sometimes  incomplete because they did not follow all of the required VHA  procedures. The VA OIG recommended that VHA, in conjunction with  the Veterans Integrated Service Networks (network) and VA medical  facility directors and other leaders, take action to ensure adherence with  VHA’s requirements.
You requested that we report on VHA’s processes to reduce the risk of  diversion of controlled substances at its medical facilities and VHA’s  oversight of these processes. This report examines:  1.  the extent to which selected VA medical facilities have implemented  controlled substance inspection programs as required by VHA  policies, and  2.  VHA’s oversight of these programs at selected VA medical facilities.
This report also provides information in Appendix I about selected VA  medical facilities’ use of reports available from facilities’ automated  dispensing machines—computer-controlled medication storage and  dispensing cabinets in patient care areas—to help identify diversion of  controlled substances.
To examine the implementation of VHA’s controlled substance inspection  programs at selected facilities, we selected four VA medical facilities to  include in our review. We selected the four facilities to achieve variation in  geography and in the number of prescriptions for opioid pain relievers  dispensed in the states in which the facilities operate. The four VA  medical facilities we selected are located in Washington, D.C.;  Milwaukee, Wisconsin; Memphis, Tennessee; and Seattle, Washington.  We compared the number of controlled substance inspections that each  of the four VA medical facilities reported to us as having been completed  from January 2015 through February 2016 to the number of inspections  that should have been conducted, based on VHA’s policy requirement.  We chose this time frame to include an entire year of the most recently  completed inspections when we conducted our work. For each of the four  selected facilities, we also requested and reviewed a random sample of  documents from completed inspections in order to test the reliability of the  inspection information provided by the VA medical facilities. To determine  the extent to which each VA medical facility’s inspection procedures were  consistent with certain VHA  requirements, we reviewed the inspection  procedures in place at each of the four facilities as described in inspection  program policies, training manuals, and other guidance documents, and  compared these procedures to VHA’s policy requirements. We  interviewed relevant officials from the four selected VA facilities— including the controlled substance coordinator (coordinator), controlled  substance inspectors (inspector), and pharmacists—to discuss the local  operating policies and procedures and how they implemented their  procedures. We also analyzed VHA’s online training course for  coordinators and discussed this course with coordinators in each of the  four VA medical facilities as well as other training they had received about  VHA’s inspection program requirements, including training on the  required inspection procedures. We also evaluated facilities’ processes  for ensuring completion of the inspections, and VHA’s coordinator  training, against federal standards for internal control related to control  activities. Our findings for the four selected VA medical facilities cannot  be generalized to other VA medical facilities.
To examine VHA’s oversight of selected medical facilities’ controlled  substance inspection programs, we reviewed VHA and VA medical facility  policies and other relevant documents, including a 2014 VHA  memorandum (memo), that describe oversight responsibilities. We  compared the oversight responsibilities identified in VHA policies and the  2014 memo to the selected facilities’ oversight activities. As part of this  comparison, we reviewed documents such as monthly and quarterly  inspection reports and interviewed VA medical facility directors and other  facility leadership officials, including the chief of staff at the four selected  facilities about their oversight activities and any information they review  related to the inspection program. We also interviewed officials from  VHA’s central office, and the four networks associated with each of the  four selected VA medical facilities, about their oversight responsibilities  and activities related to the controlled substance inspection programs. In addition, we compared the facilities’ oversight activities and  responsibilities identified in VHA policies and the 2014 VHA memo to  federal standards for internal control related to monitoring and oversight.
We conducted this performance audit from January 2016 to February  2017 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.
subsections: section_title: Background
paragraphs: According to VHA policy on the inspection of controlled substances, each  VA medical facility must establish a controlled substance inspection  program, which is to be overseen mainly by the facility’s director. VHA’s  policy stipulates that the VA medical facility director must 1) ensure that  the facility’s program complies with VHA’s requirements, 2) establish local  medical facility procedures for the controlled substance inspection  program that are consistent with VHA’s requirements, and 3) appoint a  coordinator, who is responsible for managing the program and the  inspectors who conduct the inspections.
The coordinator is responsible for ensuring that inspections are  conducted unannounced and monthly in each area of the VA medical  facility that stores controlled substances. To assist the coordinator, a  team of inspectors is to be assigned from various areas of the medical  facility to conduct the actual inspections. The coordinator is responsible  for ensuring that the inspectors have completed required training and  must document annually an assessment of the inspectors’ competencies.  The coordinator is also responsible for ensuring that the inspections  include all of VHA’s policy requirements. VHA policy requires the  coordinator to develop and submit two reports to the VA medical facility  director—a monthly inspection report and a quarterly trend report.  According to VHA policy, the monthly inspection report is to summarize  the inspection findings. VHA  also requires that these reports include  information on missed inspections for each month and if missed  inspections are identified, the medical facility director is expected to work  with the coordinator to develop an action plan to improve performance  and continue to monitor for additional missed inspections. The quarterly  trend report is to summarize patterns in discrepancies identified through  the inspection program—such as discrepancies between the physical  count of controlled substances and their recorded inventory by patient  care area—problematic trends, and potential areas for improvement in  the program. VHA also requires that networks review the quarterly trend  reports during an annual quality management visit to the medical facility.
VHA’s policy establishes the requirements for the monthly inspection of  controlled substances at VA medical facilities and the procedures that  inspectors must follow to implement these requirements. There are  different procedures for conducting inspections of pharmacies compared  to patient care areas such as inpatient units and clinic areas. See table 1.
section_title: Selected Facilities Did Not Conduct All Inspections, Follow All Inspection Procedures, or Develop Written Inspection Procedures that Were Fully Consistent with VHA Policy
subsections: section_title: Two of Four Selected VA Medical Facilities Did Not Conduct All Required Monthly Inspections
paragraphs: VHA policy requires that facilities inspect multiple patient care areas and  pharmacies on a monthly basis. These inspections are intended to help  mitigate the risk of drug diversion. We found that from January 2015  through February 2016, one of the four selected facilities we reviewed  missed 43 percent of the required monthly inspections, and another  facility missed 17 percent of these inspections. The other two VA  medical facilities we reviewed fully adhered to VHA’s requirement to  conduct monthly inspections.
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. For example, we found that  inspectors missed monthly inspections in the facility’s patient care areas  such as the operating room (all 14 inspections missed), bronchoscopy  laboratory (all 14 inspections missed), and the intensive care units (7 of  14 inspections were missed). The facility’s coordinator told us that the  operating room was not inspected at all during our review period because  the inspectors assigned to inspect the operating room needed to arrive  before or after normal operating room hours to obtain access to the  controlled substances and were unable to conduct the inspections due to  their conflicting work schedules. The bronchoscopy laboratory was not  inspected at all during our review period because it was not identified by  the coordinator as an area having controlled substances.
Inspectors missed inspections in some patient care areas for 2 to 4  consecutive months. These areas included the intensive care units,  cardiac catheter laboratory, and interventional  radiology.
Inspectors also missed inspections of the facility’s pharmacy for 3  consecutive months.
At the VA medical facility that missed 17 percent (118 of 702) of the  required monthly inspections, we found that most (about 95 percent) of  the 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. For example, we found that  inspectors missed monthly inspections in patient care areas such as the  operating room (5 inspections missed), medical intensive care unit (4  inspections missed), and pain clinic (6 inspections missed).
Inspectors missed inspections of some patient care areas for 2 or 3  consecutive months. These areas included the operating room, pain  clinic and inpatient psychiatry.
Inspectors also missed inspections of one of the facility’s four pharmacies  for 2 consecutive months.
We found one factor that contributed to the missed inspections at the two  selected VA medical facilities was the lack of an additional control  procedure to help prevent the medical facility from missing inspections,  such as designating an alternate coordinator or appointing additional  inspectors to fill in for the assigned inspector when needed. The  coordinator and inspector roles are usually collateral duties. The  coordinators and inspectors at the four VA facilities we selected told us  that in addition to their inspection program duties, they had substantive  full-time responsibilities and scheduled their inspection work around their  facility jobs. Both of the VA medical facilities that conducted all of the  required monthly inspections had an alternate coordinator to assist the  coordinator in managing the inspection program, including scheduling the  inspections and following up with inspectors to ensure inspections are  completed. At one of these facilities the alternate coordinator also  conducted inspections when inspectors had unforeseen circumstances  that prevented them from completing the assigned inspections.
In contrast, the two medical facilities that missed inspections during our  review did not have an additional control procedure, such as the use of an  alternate coordinator. The coordinators at these two medical facilities told  us that managing the inspection program was challenging given their  other full-time duties, which included supervising the VA medical facility’s  patient food service and conducting quality improvement activities. One of  the coordinators told us that she had not been informed of the time  commitment related to the coordinator position prior to being appointed.  According to these two coordinators, it is a challenge to re-assign the  inspections when the assigned inspectors cannot conduct the scheduled  inspections due to unforeseen circumstances. For example, the  coordinators at these two facilities explained that some inspectors waited  until the end of the month to conduct their assigned monthly inspections,  and because of competing priorities or unexpected health or personal  issues, the inspections were sometimes not completed. In these cases,  the coordinators told us inspectors may not notify the coordinator in time  to find another inspector to complete the monthly inspections, and the  coordinators may not have time to complete the inspections themselves.  One of the coordinators at these facilities told us that she had requested  an alternate coordinator be appointed to help ensure adherence to the  monthly inspection requirement and that the request was approved for an  alternate coordinator to begin in January 2017.
In VHA’s November 28, 2016 update to its inspection policy, VHA added  a responsibility related to the monthly inspection requirement and made  recommendations regarding the appointment of more than one  coordinator for certain purposes and regarding the coordinator’s time  commitment. First, the update assigns the facility chief of pharmacy  responsibility for ensuring that the coordinator has an accurate listing of  all automated dispensing machines and controlled substance storage  areas. If properly implemented, this update may help ensure that all areas  requiring monthly inspections are identified. Second, the update  recommends that facility directors (a) appoint more than one coordinator  (e.g., an alternate) for the purpose of coverage, program continuity, and  succession planning and (b) discuss the time commitment with the  coordinator and the coordinator’s current supervisor and adjust other  duties as necessary to provide adequate time for the coordinator to  perform the inspection program duties. The update is likely an  improvement as it raises awareness around the time commitment of the  coordinator role and it also might address the identified risks of missing  inspections by recommending the appointment of more than one  coordinator if needed for coverage of program responsibilities. However,  because the update does not make the appointment of an alternate  coordinator mandatory or require another control activity to address its  risk, VHA still might lack reasonable assurance that inspections occur  when the primary inspector is unable to fulfill that responsibility.
Federal internal control standards state that to achieve an entity’s  objective, management should define responsibilities and assign them to  key roles throughout the entity. Further, management should design  control procedures to help fulfill the defined responsibilities and address  any identified risk in not achieving the entity’s objective. If management  learns that the existing control procedures are not operating as designed,  management should review them and analyze and respond to any  associated risks of not meeting the defined objective. The two facilities  that did not adhere to VHA’s requirement to conduct monthly inspections  did not have an additional control procedure in place, such as an  alternate coordinator, to respond to the risk of missed monthly  inspections, which is inconsistent with these internal control standards.
Missed inspections increase the likelihood that VHA may not meet the  objective of the program—to reduce the risk of diversion of controlled  substances. In 2009 and 2014, the VA OIG also found that VA medical  facilities did not always conduct required monthly inspections. For  example, in 2014 the VA OIG reported that of the 58 VA medical facilities  it reviewed, the facilities missed required monthly inspections in 20  percent of patient care areas with controlled substances.
section_title: Controlled Substance Inspections Conducted at Three of Four Selected Medical Facilities Did Not Follow Certain VHA Policy Requirements
paragraphs: 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. The fourth VA medical facility  we reviewed had implemented inspection procedures that followed these  requirements. The following are examples of inspections not following  VHA requirements at these three selected facilities.
At three of the selected VA medical facilities, inspectors did not perform  physical counts of pharmacy emergency caches of controlled substances  as required. Inspectors at one selected facility did not perform the count  at all and at a second facility, inspectors told us that they counted some,  but not all, of the cache, as required. Inspectors at the third facility only  counted the cardboard shipping boxes in which the controlled substances  were shipped and did not count the contents, according to the  coordinator at the facility. However, without opening these shipping  boxes to verify that they actually contained the controlled substances and  counting them, inspectors would not know if any controlled substances  had been removed from the boxes.
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. At one facility,  inspectors verified only a sample of controlled substances dispensed by  the pharmacy on a selected day to confirm that the controlled substances  were actually transferred to patient care areas. According to VHA’s  inspection program policy, inspectors are required to verify that all  controlled substances transferred by a pharmacy on a selected day were  received in these areas. At a second facility, inspectors told us that they  did not conduct this required procedure in one of the facility’s two  pharmacies. Without checking that all controlled substances were  properly transferred from the pharmacy, inspectors may not identify  controlled substances that are dispensed by the pharmacy and  subsequently diverted rather than stocked in the automated dispensing  machines located in patient care areas.
At two selected VA medical facilities, inspectors did not verify that all of  the controlled substances slated for destruction had been documented.  According to VHA’s inspection program policy, facilities’ pharmacies are  to maintain a list of controlled substances that are scheduled to be  destroyed because, for example, the medication is past its expiration  date or has been crushed or damaged in some way. According to VHA’s  inspection program policy, inspectors are required to verify that all  relevant medications are included in this list; however, inspectors at two  of the selected facilities told us they only verified that a sample of the  controlled substances being held for destruction was documented.  Because the inspectors reviewed only a sample of these controlled  substances, the facility lacks assurance that all controlled substances  intended for destruction have been logged into the pharmacy’s computer  system, thereby increasing the risk that controlled substances could be  diverted.
At one selected VA medical facility, inspectors did not count all of the  controlled substances stored in the patient care areas. At this facility,  inspectors did not count the controlled substances stored in all the  automated dispensing machines in the facility’s cardiac catheter  laboratory, interventional  radiology area, and gastrointestinal endoscopy  area, according to a facility official. Although each of these areas had two  machines that dispensed controlled substances, inspectors only counted  the inventory in one of the two machines in each area. In addition,  inspectors did not count any inventory of controlled substances stored in  this facility’s bronchoscopy laboratory. Because the inspectors did not  count controlled substances in these areas, the facility lacks assurance  that the physical inventory matches the recorded inventory.
Similar to our findings, the VA OIG found in 2009—and again in 2014— that VA medical facilities did not always follow VHA’s required procedures  in conducting monthly inspections. For example, in 2014 the VA OIG  reported that in 24 percent of the facilities’ inspections, inspectors did not  verify controlled substances had been properly transferred from the  facilities’ pharmacies to the automated dispensing machines in patient  care areas. Furthermore, the VA OIG reported that in 17 percent of the  inspections, inspectors did not perform physical counts of the emergency  caches. As a result, inspections in these facilities may not have identified  controlled substances that were diverted from their emergency cache or  while in transfer from the pharmacy to patient care areas.
In its 2016 inspection policy update, VHA modified its requirement for  inspectors to verify that controlled substances are properly transferred  from pharmacies to automated dispensing machines. The policy states  that in cases where there was no dispensing of controlled substances to a  specific automated dispensing machine on the day the inspector selected  to review, the inspector should select another day to examine that  machine.
section_title: Three VA Medical Facilities Did Not Develop Written Controlled Substance Inspection Procedures That Were Fully Consistent with VHA Policy
paragraphs: In comparing the written procedures at the four VA medical facilities we  reviewed with selected VHA requirements, we found that three facilities  did not have written inspection procedures that were fully consistent with  VHA’s policy requirements. (See figure 1.) This likely contributed to  inspections not following certain VHA  policy requirements at the three  selected VA medical facilities, as previously discussed. The VA medical  facility directors are responsible for establishing local written medical  facility policies on the inspection of controlled substances and ensuring  that their inspection programs adhere to VHA’s policy requirements,  according to VHA’s inspection program policy. To respond to this  requirement, facilities are to develop inspection program procedures and  guidance documents describing the procedures for inspectors.
The one VA medical facility that had implemented all of the selected VHA- required inspection procedures has an ongoing process to specifically  conduct comprehensive reviews of the facility’s inspection procedures to  ensure they are consistent with VHA’s requirements. At this facility, the  current and prior coordinators had each conducted separate reviews of  the facility’s procedures in coordination with two pharmacy managers,  according to a facility official. Further, the coordinator and two pharmacy  managers at this facility review the procedures anytime there is an update  to VHA’s requirements to ensure that their medical facility is adherent,  according to a facility official. For example, the facility conducted a review  in 2013 when VHA  updated its pharmacy inspection requirements for the  review of hard copy prescriptions. As a result of this review, the facility  updated its local inspection program policy, the written procedures, and  other guidance documents that the inspectors use to conduct the monthly  pharmacy inspections. Moreover, a facility official told us that the  coordinator informs the VA medical facility director of the inspection  program changes so that the facility director is aware of the new  requirements. In contrast, at the other three selected VA medical facilities,  the coordinators’ reviews of the facilities’ inspection procedures were not  as comprehensive. At two of these facilities, the coordinators told us that  they had compared some, but not all, of their facility’s inspection  procedures to VHA’s requirements. At another facility, the coordinator told  us he had compared all of the facility’s procedures to the VHA  requirements, but he did not involve other facility officials, such as  pharmacy managers, to verify the accuracy of his review.
Furthermore, VHA requires that the coordinators have a complete  understanding of VHA’s inspection procedures and ensure that the  inspectors have completed inspections using the required procedures.  However, we found in our analysis of the contents of VHA’s online  coordinator training course that it lacks substantive information about  VHA’s required inspection procedures. VHA  officials told us the  coordinator training course is designed to focus on the management  aspects of carrying out the coordinator role (e.g., recruiting inspectors,  scheduling inspections, and generating required reports) as opposed to  VHA’s inspection procedures. VHA’s online course for inspectors, in  comparison, includes substantive information about the required  inspection procedures. VHA  recommends but does not require that the  coordinators take the online training course for inspectors. While two of  the four coordinators we interviewed told us they were provided helpful  on-the-job training at their medical facilities, which included shadowing  the prior coordinator, three of them told us that additional coordinator  training was needed. In addition to online and on-the-job training,  coordinators have opportunities to discuss various aspects of their VA  medical facilities’ inspection programs on an ongoing basis, for example,  by participating in the voluntary bi-monthly meetings that VHA  officials  facilitate for coordinators. Although VHA officials told us that these bi- monthly meetings often focus on VHA’s required inspection procedures,  two of the four coordinators told us that they did not regularly participate  in these meetings.
In its 2016 inspection policy update, VHA eliminated one of the  requirements that we reviewed—verifying that ordered controlled  substances are placed in inventory—and added a requirement that  coordinators must take the coordinator online training course within 30  days of their appointment. The update also addresses certain other  inspection procedures we reviewed such as verifying the transfer of  controlled substances. However, these changes do not address the lack  of a comprehensive review of medical facilities’ inspection procedures or  the lack of substantive information about VHA’s required inspection  procedures in VHA’s online training course for coordinators. The lack of a  comprehensive review of the medical facilities’ inspection procedures and  the inadequate coordinator training are inconsistent with federal internal  control standards. These standards state that management should  periodically review policies and procedures for continued relevance and  effectiveness in achieving the entity’s objectives or addressing related  risks. Without a process in place to review medical facilities’ local  inspection procedures and modify inspection procedures as appropriate,  VHA cannot ensure that VA medical facilities’ procedures adhere to  VHA’s policy requirements. Federal internal control standards also state  that effective management is essential to achieving results and  operational success depends on personnel being properly trained.  Training is aimed at developing employee knowledge and skills to  achieve organizational goals. While the updated November 2016 policy  mandates coordinators’ training, VHA’s existing training for coordinators  does not focus on VHA’s required inspection procedures. As a result,  VHA cannot ensure that all coordinators have adequate information to  determine if the inspections have been completed as required.
section_title: Oversight of Controlled Substance Inspection Programs by Selected VA Medical Facilities and Their Networks Is Inconsistent
paragraphs: 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. They are also responsible for working with coordinators to  develop and implement corrective action plans if missed inspections are  identified. Medical facility directors are also required to review quarterly  trend reports submitted by facility coordinators, which summarize  information from the controlled substance inspections and may provide  information on problems with the inspection programs and needed  improvements.
We found that medical facility directors did not consistently perform these  duties at two of the four selected VA medical facilities. At the two VA  medical facilities that missed monthly inspections, facility directors did not  implement corrective actions to prevent future missed inspections. These  facility directors told us they reviewed the monthly inspection reports, and  some of these reports that we reviewed showed that inspections were in  fact missed. As discussed earlier, one of the facilities missed 43 percent  of the required inspections, while the other facility missed 17 percent of  the inspections. In addition, one of four medical facility directors did not  receive quarterly trend reports during our review period and did not  implement a corrective action to ensure that he receives future quarterly  trend reports. VHA’s 2016 inspection policy update added the  requirement that corrective actions to prevent missed inspections are to  be documented in the monthly inspection reports that the coordinators  submit to the directors. However, the update does not require corrective  action plans to be documented for other types of inspection program  nonadherence—for example, if an inspection was conducted but did not  include all of the required procedures.
We also found that oversight provided by the four networks to which the  four selected VA medical facilities in our review report was inconsistent.  The networks are responsible for reviewing their facilities’ quarterly trend  reports; VHA included this requirement in the 2014 memo it issued in  response to the VA OIG findings on implementation problems with the  inspection programs. Officials from two of the four networks we  interviewed told us they did not review the quarterly trend reports.  Officials in one of these two networks told us they were unaware of the  requirement. An official in the other network told us the network did not  review their facilities’ quarterly trend reports due to a lack of  communication within the network about the requirement. 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. For example, this network found  during its site-visit review of this facility that the coordinator had not  completed and submitted the quarterly trend reports to the medical facility  director, as required. We also found that this coordinator had not  completed other quarterly trend reports during our 14-month review  period, and the facility’s director did not develop a corrective action plan  to ensure the completion of these reports in the future.
The inconsistent oversight provided by facility directors and networks of  VA’s controlled substance inspection programs is contrary to federal  internal control standards. These standards state that management  should document internal control issues, determine appropriate corrective  actions for deficiencies on a timely basis, and complete and document  these actions. The standards also state that management should  establish and operate monitoring activities to monitor the internal control  system and appropriately remediate identified deficiencies on a timely  basis. Further, the standards state that an oversight body should also  monitor the status of remediation efforts to ensure they are completed on  a timely basis. Management, with oversight from the oversight body,  should take corrective action as necessary to enforce accountability of  individuals performing their internal control responsibilities. 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.
section_title: Conclusions
paragraphs: 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. In particular, because of gaps in  facilities’ local inspection procedures and coordinator training, VHA  cannot ensure its controlled substance inspection programs are being  correctly implemented. 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. Further, without  ongoing program monitoring by the facility directors and networks,  including holding VA medical facilities accountable for identifying  and  correcting nonadherence to program requirements, VHA lacks reasonable  assurance that implementation problems will be corrected on a timely  basis.
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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments
paragraphs: We provided a draft of this report to VA for review and comment.  In its  written comments, reproduced in appendix II, VA concurred with our six  recommendations and described plans to implement them by October  2017. The department also provided technical comments, which we  incorporated as appropriate.
In its comments, VA stated that to address our first recommendation,  VHA will require the medical facility directors to appoint an alternate  coordinator for their controlled substance inspection programs—to  provide back-up support to the coordinator—and add inspectors to ensure  that the monthly inspections are not missed. VA noted that it will  communicate these requirements to the facility directors in a memo that  VHA Central Office will develop. VA also stated that the facilities’ quality  managers will report to the networks on whether the facilities have  appointed alternate coordinators and added inspectors. Facilities that  have not met these requirements will develop action plans for doing so.  The networks, in turn, will monitor the facilities’ implementation of the  requirements and will provide to VHA Central Office any facility action  plans. VA also noted in its comments that officials within VHA Central  Office will meet to decide if additional actions are needed to ensure that  the medical facilities have alternate coordinators and additional  inspectors. To ensure that the actions that VHA  identified for medical  facilities and networks to conduct on a recurring basis are taken, we  encourage VHA  to include them in its inspection program policy.
To address our second recommendation, VA stated that VHA will require  the medical facility directors to compare their current inspection program  policies and procedures with VHA’s inspection program policy using a  self-assessment guide that VHA developed. VA added that a  multidisciplinary group of medical facility staff—including the coordinator  and chief of pharmacy—will be responsible for conducting the  comparison, while each facility’s quality management committee will  review the results. If discrepancies between a facility’s procedures and  VHA’s program requirements are identified, the facility must develop an  action plan for addressing the issue, and the quality management  committees will track the facilities’ progress in correcting discrepancies.  The networks, in turn, will monitor that the facilities have completed the  assessment and corrected any identified discrepancies and will provide  VHA Central Office with any action plans. Furthermore, officials within  VHA Central Office will meet to decide if additional actions are needed to  ensure that the facilities have completed the comparison and corrected  any identified discrepancies. To ensure that all of the actions that VHA  identified for medical facilities and networks to conduct on a recurring  basis are taken, we encourage VHA to include them in its inspection  program policy.
To address our third recommendation, VA stated that VHA will require the  coordinators to complete its online controlled substance training course  for inspectors—which includes detailed information about VHA’s  inspection procedures. VA noted that it will include this requirement in the  memo VHA plans to send to the medical facility directors to address our  first recommendation, as described above. In addition, VA stated that  VHA will update its inspection program policy to include this new training  requirement for coordinators. VA added that the networks will monitor  facilities’ adherence to the training requirement and will provide action  plans to VHA  Central Office for facilities whose coordinators have not  completed the training course. According to VA, officials within VHA  Central Office will also meet to decide if further actions are needed to  ensure that the coordinators have taken the online training course for  inspectors. In addition to including the new training requirement in its  inspection program policy, we encourage VHA to include in policy the  networks’ responsibilities for monitoring facilities’ adherence to the  training requirement.
To address our fourth recommendation, VA stated that VHA Central  Office will develop guidance directing the medical facility directors to  assess adherence with VHA’s inspection program requirements at least  quarterly.  Further, the facilities’ quality management committees will  review the monthly and quarterly inspection reports for adherence with  VHA’s inspection program requirements and will ensure—when  nonadherence is identified—that the facilities have established,  documented, and completed necessary corrective actions. According to  VA, the committees will also report progress on correcting identified  nonadherence to the facility directors. In addition, the networks will  monitor facilities’ progress in correcting nonadherence and will provide to  VHA Central Office any action plans for nonadherent facilities. VA stated  that officials within VHA Central Office will meet to determine if further  actions are needed to ensure that nonadherence is corrected. To ensure  that the actions that VHA identified for medical facilities and networks to  conduct on a recurring basis are taken, we encourage VHA to include  them in its inspection program policy.
To address our fifth and sixth recommendations, VA stated that VHA  Central Office will develop a memo outlining the requirements for  networks to review their facilities’ quarterly inspection reports, ensure  facilities take corrective actions when nonadherence is identified, and  monitor facilities’ efforts to periodically compare their inspection  procedures with VHA’s inspection policy requirements.  VA noted that  VHA Central Office will provide this memo to the network directors who, in  turn, will disseminate the memo to the medical facility directors. VA stated  that the facility quality managers will report to the networks on whether  the facilities have taken corrective actions when nonadherence is  identified in the quarterly reports as well as compared their inspection  procedures with VHA’s policy requirements. VA further stated that the  networks will provide VHA  Central Office with action plans for any  facilities with identified nonadherence, while officials within VHA  Central  Office will meet and decide if further actions are needed to ensure  adherence. To ensure that the actions that VHA identified for medical  facilities and networks to conduct on a recurring basis are taken, we  encourage VHA  to include them in its inspection program policy.
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If you or your staff 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: Use of Automated Dispensing Machine Reports to Identify Diversion of Controlled Substances at Selected VA Medical Facilities
paragraphs: This appendix describes information about the four selected Department  of Veterans Affairs (VA) medical facilities’ use of information available  from their automated dispensing machines that store controlled  substances in patient care areas. Specifically, we present information  about the extent to which facilities we selected used information available  from these machines, the type of information reviewed, and how facilities  used the information to help identify potential diversion.
Veteran Health Administration (VHA) policy states that VA medical facility  staff may use information from electronic reports that facility automated  dispensing machines generate to help identify potential drug diversion.  Automated dispensing machines are computerized drug storage and  dispensing medication cabinets located in medical facility patient care  areas, including surgical and emergency care areas. These machines  track information on medication dispensing activities that can be used to  identify potential diversion, such as the number of times each nurse  removes a controlled substance to administer to a patient, the type and  amount of drug dispensed, and the patients to whom the drug was  administered. Among the types of reports that can be generated from  these machines are the dispensing practices report, which can provide  information about potential drug diversion by identifying the average  number of drug doses dispensed per month by users of the machines in a  given medical facility area, and the transaction report, which provides  details of dispensing activity by date, nurse accessing the medicine, and  patient.
Below are examples of the information from automated dispensing  machines that the four selected VA medical facilities used to help identify  diversion.
In VA medical facility A, a pharmacist reviews dispensing practices  reports monthly and sends them to the nurse managers and head of  anesthesiology for their review, pointing out certain outliers that the  reports automatically flag. A facility official told us that the facility began  reviewing the dispensing practices reports regularly in 2013 after a  pharmacist used a report to investigate a discrepancy in which a  physician’s order for hydromorphone that an emergency room nurse had  dispensed could not be verified. The report showed that the nurse  removed a significantly higher quantity of hydromorphone compared to  his co-workers during a 12-month period. A pharmacist further reviewed  the medical records of 10 patients the nurse treated and found he had  dispensed hydromorphone without a physician’s order for 6 of the  patients. In a state court system the nurse later pled guilty to diverting  hydromorphone.
In VA medical facility B, a pharmacist reviews dispensing practices  reports monthly for the most frequently dispensed controlled substances  to identify potential outliers. The pharmacist explained that the facility  does not use specific criteria to define potential outliers and that the last  time the facility identified a potential outlier was in 2012. In this case the  pharmacist contacted the nurse’s manager, who explained that the nurse  had provided a disproportionate share of the care to patients in that area,  which accounted for the nurse’s higher-than-expected dispensing of  controlled substances.
VA medical facility C does not regularly review dispensing practices  reports to help identify diversion. A pharmacy official from this facility told  us he reviews discrepancy reports and may review controlled substance  dispensing on occasion, for example, to help resolve a discrepancy with  an automated dispensing machine, but that reviewing such data on a  regular basis would be very time consuming.
In VA medical facility D, the inspection program coordinator has identified  four nurse outliers as potential diverters since 2015 by analyzing  dispensing practices reports, and the coordinator told us that she has  provided the results of her analysis to other facility officials for further  investigation. The coordinator focuses her reviews on oxycodone and  fentanyl because they are highly addictive and are most likely to be  diverted, according to the coordinator. The coordinator reviews the total  amount of these drugs that each nurse has removed from the automated  dispensing machines compared to other nurses in the same patient care  areas. After identifying a potential outlier, to determine if the nurse  continues to be an outlier the coordinator reviews additional information.  For example, the coordinator would review the nurse’s dispensing activity  over a different time period as well as the types of patients the nurse has  treated, since some patients (e.g., those with cancer) have higher than  average use of controlled substances.
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, Marcia A. Mann, Assistant  Director; Pamela Dooley, Analyst-in-Charge; Mary Ann Curran-Dozier;  and Carmen Rivera-Lowitt made key contributions to this report. Also  contributing were Muriel Brown, Krister Friday, and Jacquelyn Hamilton.