All facilities should, as a matter of routine, undertake ongoing auditing of controlled substances in all areas where these substances are stored, used, and disposed. Many facilities conduct routine as well as focused audits to assess overall risk or to look for improvement after a specific risk has been identified. While auditors are typically inclined to focus on the search for evidence of diversion, a greater benefit may be achieved by also considering the audit as an opportunity to assess controlled substance handling practices overall and detect any practice issues that may be clouding the data.
Identify Poor Practice
Identifying poor practice is an essential component of the auditing process as poor practice can severely limit the audit’s effectiveness. For example, one common method of diversion is achieved by delaying the waste process. This strategy often involves diverting the waste after administration, and later wasting a different substance such as water or an over-the-counter drug. If it is common for staff on a unit to delay waste, the diverter will remain well hidden amongst their peers. The same is true for delaying administration, failing to stay within the parameters of the order, etc. Because pervasively poor practice can mask diversion, it is crucial that it be identified and addressed to ensure the effectiveness of the auditing program.
Audit Focal Points
To determine audit locations, review all areas where controlled substances are handled. All too often, off-site clinical and procedural settings, air and ground transport services, manual storage locations, and emergency kits that contain controlled substances are overlooked. In terms of focused auditing, some commonly identified high-risk areas include the ER, ICU, OR, orthopedics, and oncology departments.
When auditing anesthesia practitioners, it is important to incorporate all units where anesthesia staff work including IR, cath lab, L&D, endoscopy, and other specialty units. One facility routinely audited anesthesia practitioners within the OR looking for outlier behavior, but did not consider their transactions elsewhere in the facility. This allowed an anesthesiologist to pull fentanyl for his patients from the automated dispensing cabinet (ADC) in the OR, while also pulling a duplicate dose in either the PACU or in Preop. His diversion scheme went undetected for months. During recent health system audits, we have identified increasing risk related to opioid drip accountability, emergency kit management, and controlled substance use in outpatient procedural areas such as outpatient surgery centers. Auditors should consider expanding their focus to these areas as well.
All diversion auditing programs should include risk rounding, which involves visiting areas where controlled substances are used, assessing medication handling practices, speaking with staff to gauge their level of regulatory awareness, and examining inventory. This approach frequently reveals risky practices that may not otherwise be evident through a transaction audit.
With surveillance cameras increasingly common in medication rooms, many facilities provide diversion program staff with access to the system so that they can resolve situations that are otherwise unclear. Camera surveillance can also be used to determine what may have occurred when there is an unresolved discrepancy. Because waste compliance is often lacking (eg, staff do not visually witness the waste process), we have initiated waste transaction audits at several facilities using camera surveillance footage. We pull a random sample of 10% of the waste transactions for the unit in question and review surveillance footage for each transaction, paying close attention to how staff approach and process the waste. This allows us to identify units where staff are generally non-compliant, provide additional education on wasting responsibilities, and then monitor for improvement.
Most facilities consider analytics to be an essential component of the auditing process. There are many analytics programs available with varying levels of sophistication. A good one will reduce the amount of time necessary to audit for diversion, guide auditors to focus on the most important issues so there is an improvement in the return on the time invested, reduce the number of false positives that may otherwise occur (thereby increasing the overall confidence in the auditing program), and provide succinct and easy-to-understand information to the other clinical staff involved in auditing.
Given the variety of analytics programs and the breadth of reports available, it can be challenging to determine which reports should be reviewed and at what intervals. Nevertheless, there are key parameters to include in an ongoing auditing program, such as temporary user transactions, overrides, and cancelled transactions. See TABLE 1 for a list of recommended reports and frequencies. For those facilities that cannot audit all of these parameters, it is important to prioritize the data under review based on their identified areas of risk.
Effective audits follow a consistent method of documentation. Most auditors use a spreadsheet containing a data set of transactions. Key fields to include are:
Include a column for comments to provide further explanation of the findings. This allows for helpful information such as:
To help demonstrate particular findings, auditors commonly highlight concerning transactions. We recommend using yellow highlighting for practice issues and red highlighting for transactions with missing medication, but any consistent and unambiguous color scheme will work. If there are multiple auditors involved, providing a standard template and method for documenting findings will help ensure that the audit results are easily understood by anyone who may review them.
Developing Policies and Procedures
Include specific details in medication handling policies and procedures (P&Ps) to help staff understand what is expected of them. This also helps auditors flag aberrant practices. For instance, many facilities include the expected timeframes for administration, wasting, or returning medications starting from the time the medication is pulled from secure storage. It is also common to prohibit hand-offs of controlled substances except in specific emergent situations. Auditors must have a firm understanding of existing P&Ps in order to undertake a comprehensive audit.
There should be written expectations for the auditing process as well. These can be provided in a guideline or incorporated into a P&P, Standard Operating Procedure (SOP), or other document. While clinical leaders, such as nurse managers, are commonly responsible for auditing their staff, they often are unsure as to what they are supposed to do with the reports they receive. When these managers find the reports confusing, the result is disparate practices; some conduct a detailed review of all staff and document their findings, while others simply skim the report and make mental notes.
To ensure a consistent and meaningful approach, the expectations for regular report review should be fully defined, including what reports will be sent to whom, what the recipients are expected to do when they receive the report, and what they are required to do with abnormal or suspicious findings. Statistical thresholds should be defined, as appropriate. Identify a resource (by job title) who is responsible for explaining reports or providing additional information as needed; this is typically the Diversion Specialist or Diversion Program Manager. To be successful, auditors require training on how to read reports and how to proceed when reports raise suspicion. Care must be taken to ensure that all staff involved in auditing receive the reports for their area of responsibility. Establish a process to flag turnover in the auditing staff and ensure that the incoming auditor receives training and is added to the report distribution list immediately.
As previously discussed, the use of a standardized documentation template is highly recommended. Furthermore, the results should be stored in a location, such as a shared drive, where they can be accessed by authorized staff at any time. All audit results should be retained for a minimum of 2 years even if there was no finding of diversion since they are proof of the considerable effort undertaken to prevent and detect diversion. In addition, facilities should strongly consider adding routine audit findings to their Diversion Program Dashboard; this ensures that the efforts of auditors are recognized and provides leadership with an overview of the facility’s areas of risk as well as areas of strength.
Many problematic practices are only revealed through an audit. Yet, these findings are not always comprehensive; rather, they may simply reveal that an individual is either diverting or uses poor practice. Any time practice issues are identified, it is important to determine the extent of the issues and investigate all potential causes. For instance, at one facility our audit showed that staff on a busy procedural unit had a pattern of delaying administration over an hour after pulling controlled substances, and staff often returned controlled substances hours after pulling them. We visited the unit and learned that the only ADC available to staff was a considerable distance from the patient care site. In response, staff had developed a workaround of pulling patients’ opioids in anticipation of need. As a result of the audit findings, an ADC was placed in the procedural unit, thereby allowing the staff to pull drugs in appropriate quantities at the time of need.
An effective diversion auditing program requires five key elements:
With attention to all of these elements, the auditing program will be effective and efficient; if any of these elements are missing, auditing will require undue time and effort, or it will be ineffective at preventing and detecting diversion.
Kimberly New, JD, BSN, RN, is the founder of Diversion Specialists, LLC, a consulting service providing solutions for all aspects of institutional drug diversion. She is also the cofounder and executive director of the International Health Facility Diversion Association.
Lucas Overmire, MS, a partner at Diversion Specialists, LLC, is a specialist in pharmacy automation and analytics and is also the creative director for the International Health Facility Diversion Association.