A common observation among facilities that have recently implemented a diversion prevention, detection, and response program is that although diversion is evident, they are uncovering fewer incidents than expected.

This may be because the usual impulse is to focus on improving controlled substance auditing and surveillance as the first step toward a more robust program. While comprehensive and effective auditing is certainly an important aspect of a program, developing a uniform process to respond to suspected diversion is one of the most important initial steps. Without an established diversion response protocol that staff are required to follow, an institution risks mishandling suspected diversion and possibly undermining the diversion program.

Create a Diversion Response Policy

To create diversion response workflows, begin by characterizing the situations that warrant a formal response. This may seem intuitive, but in practice it often is more complicated. Many facilities adhere to policies that require behavioral observations, such as signs of impairment, in order for a situation to meet the “reasonable suspicion” or “for cause” standard. This approach may miss the mark, as these indications are typically late signs of diversion. Quite often, diverting staff members are top performers who fail to show any classic behaviors associated with impairment until the diversion scheme has been ongoing for some time. Since the goal of surveillance is to identify diversion early, through data, many institutions must start by reworking their policy to include data-driven suspicion as a reason to begin an investigation (see TABLE 1).

The policy should clearly state that if a suspicion of diversion is based solely on signs of impairment, the issue will be addressed per the institution’s Drug Free Workplace policy. If appropriate, the diversion response team will be notified after the associate has been evaluated and/or treated for impairment.

Many organizations have historically used a standard disciplinary approach when investigating suspected diversion, handling the issue as they would any other potential disciplinary matter. For those institutions that have not discovered significant diversion, it may not be apparent that diversion differs from most other disciplinary issues, and thus requires a different response. Most importantly, there is a considerable chance that patients have been harmed as a result of the diversion. There is also a serious risk that the staff member may be harmed if the intervention is not handled quickly and skillfully. Furthermore, diversion cases are particularly complex because the diverters are usually quite clever; they continually adapt their methods to outwit investigators.

Successfully investigating diversion necessitates expertise in a variety of areas seldom found in a single individual. The required skill set includes:

• A thorough understanding of clinical and pharmacy processes
• Knowledge of ADC reports and analytics data
• Familiarity with regulatory and legal standards as well as the intricacies of labor relations
• Skilled in interviewing techniques
• Experience in the principles of evidence preservation
• Awareness of external reporting requirements

As such, establishing a multidisciplinary team is key to managing the initial response and overseeing the ensuing investigation.

Many organizations rely heavily on the suspected diverter’s manager to handle the situation. While the suspected staff member’s manager should certainly be part of the response process, they may not be in the best position to undertake the investigation on their own, or even to lead it. Managers tend to bond with their staff and are usually aware of their staff’s personal circumstances, which often results in some degree of investigator bias (see CASE STUDY 1).

In addition to the risk of investigator bias, clinical managers may not be the best equipped to handle diversion investigations as they are typically already pulled in numerous directions, and rarely have the time or resources to spend days looking into a diversion case. Instead, managers are best tasked with offering support to their staff during the investigation and clarifying details about workflows and best practices in their clinical setting.

Establish a Diversion Response Team

In order to ensure streamlined and comprehensive oversight, a diversion response team should be in place to respond to all cases of suspected diversion. Ideally a small multidisciplinary group (normally no more than 6 members), the team should be capable of convening both on short notice and after regular business hours. Its membership will be dictated to some degree by the leadership structure and culture of the organization. Typically led by the diversion program manager, the team often includes representation from departments such as pharmacy, human resources (HR), legal or risk management, compliance, public safety, occupational health, and safety/quality. On an ad hoc basis, the supervisor of the suspected diverter should also be part of the team. Others may be added to the team as needed, depending on the nature of the case. For instance, anesthesia leadership would be added to the team in a case involving anesthesia personnel.

A multidisciplinary group can approach diversion issues from a variety of perspectives and can also provide consistency in how cases are handled. As the team develops knowledge and expertise over time, it can apply prior experience to overcome recurrent difficulties; that is not possible when each case is handled by a different individual. The diversion response team can also help support and guide the manager of the suspected employee, since most managers may not be familiar with the process of reviewing and investigating potential diversion.

In order to obtain the support of staff and leadership within the institution, the response team should comprise members appointed by the organization, rather than being a self-appointed group. Self-appointed investigators often have a reason for their interest in participating, which may not be in line with the objectives of the institution (see CASE STUDY 2). The goal is to create an objective team that staff and leaders trust. It is essential that each team member maintain a thoughtful and systematic approach and be open to learning.

Diversion Response Policies

Once membership of the diversion response team is established, identify the circumstances for contacting the team and specify these criteria in the policy. These situations will generally be all instances outside of clear impairment, wherein a diversion-related issue has occurred or is suspected. The policy should also specify how the team will be contacted. A diversion response team email group is recommended to ensure that all members are promptly notified when an issue arises; this approach reduces duplicative communications and eliminates the need to constantly forward messages. Include any additional internal stakeholders outside of the team, who should be notified in cases of suspected diversion and denote those individuals, by title, in the response policy.

Diversion investigations involving medical staff are often referred to a separate department, such as the Office of Medical Affairs. The diversion response team should coordinate in these situations with the investigating department as appropriate, and encourage sharing information and conclusions since the institution’s DEA reporting requirements remain the same for these cases. To facilitate trust and cooperation, the Chief Medical Officer, or their designee, should be included in the diversion oversight committee. This will enable the medical staff officers to understand the mission of the program and develop a level of comfort with how diversion cases are handled. It will also help highlight the regulatory reporting requirements that might otherwise be unknown to medical staff leadership.

Patient and staff safety considerations dictate that time is of the essence when there is suspicion of diversion. At the beginning of each investigation, the team must assess the possibility that patient harm has occurred and also consider whether a suspected staff member is in danger of self-harm. The answers to these questions should guide the team’s actions.

In cases of suspected diversion, the diversion response team should convene in person or via phone or email to establish the appropriate course of action, including steps such as:

• Conduct a review or further audit of high-risk/controlled substance transactions and/or analytics reports
• Sequester and process physical evidence as appropriate (eg, in cases of suspected tampering)
• Interview witnesses and staff with knowledge of the issue
• Assign ongoing monitoring of the situation
• Develop a plan to interview the associate, and if the associate will be interviewed, ensure that the following steps have been taken:
  • The associate is removed from the patient care setting
  • ADC and physical access to high-risk/controlled medications is immediately discontinued

In conjunction with these tasks, each member of the team should be assigned responsibility for a part of the investigation that falls within their area of competence. For example, the pharmacy representative might generate transaction records and determine whether pharmacy staff may have been involved, the supervisor of the suspected staff member may produce staffing assignments and query shift supervisors about their observations, HR might review the work history and look for any prior disciplinary issues involving the suspected staff member, risk management might review medication safety events in the incident management system, and a patient safety/quality representative might interview patients, as necessary. Deadlines for the tasks should be assigned, and the team should convene at least briefly on a daily basis until all tasks are complete. The bulk of most investigations should be finalized within 24 to 48 hours (for solutions to common pitfalls in diversion response, see TABLE 2).

Click here to view a larger version of this Table

Initiating an Investigation

Many response team investigations do not involve a suspected individual. For instance, an investigation might be prompted by a morphine syringe or vial that is found in a staff bathroom. The team might convene because pharmacy staff discovers acetaminophen in place of the oral opioids in an ADC. The locks on the medication cabinets in an ambulatory surgery unit may have been forced. Each of these cases requires a complete investigation, regardless of whether a suspect or group of suspects is immediately apparent.

It is essential that every suspected case of diversion be investigated fully, even if it is clear early on that there will not be sufficient evidence to take action against an individual. The steps taken and subsequent results must be documented and available for future investigations, as this helps identify patterns of behavior. In one institution, a possible case existed of tampering with a patient-controlled analgesia syringe, but the investigation was abandoned when it became clear that necessary evidence had not been preserved. A similar situation occurred shortly thereafter, but the investigation was abandoned yet again because evidence was lacking, and a conclusion could not be drawn. Months later, a pattern of recurrent tampering with PCAs became evident, but the information that might have been gleaned from the early instances was irretrievably lost.

When there is reasonable suspicion of diversion and a suspect has been identified, that individual should be removed from patient contact, and their access to medications suspended until an interview can be conducted and a full investigation completed. The team should notify key personnel when reasonable suspicion is established, including the IT department to halt access to internal email; security/public safety to suspend badge access to relevant buildings, departments, and medication storage areas; and occupational health in anticipation of the need for a fit-for-duty evaluation and drug test.

Plans must be in place for handling after-hours cases. This may be challenging, but absent an established plan, situations are likely to be inappropriately handled. Some organizations have utilized a plan to send the associate across town in a taxi to be drug screened. Another institution enacted a robust “for cause” testing program during the day, but had no plan outside of those hours. For after-hours cases, including those on weekends, the individual would be sent home without explanation with the only follow-up being the expectation that someone would address the situation on the next work day.

Approaching a Suspected Individual

Once the diversion response team has reached a conclusion, the next step is to interview the suspected diverter. The best approach may vary from case to case, but most often, the interview is conducted by a small group, such as the diversion program manager, the suspected staff member’s supervisor (present chiefly to support the suspect and to clarify clinical processes that may contribute to an understanding of the incident), and a representative from HR. Others may be present or nearby; for example, if the suspect is threatening or belligerent, a public safety officer might be present. Some institutions may employ trained public safety officers as investigators, who are well equipped to handle the interview portion of the investigation. Other institutions may have HR or risk management leaders who are attorneys; these experts may be the most adept at conducting the interview. Regardless of who is involved, the interview should be conducted privately and in a non-confrontational manner. The response team may have a role in making arrangements for the interview, evaluation, and drug screen of the staff member.

When diversion is confirmed, reporting may be required to regulatory authorities and professional boards. Diversion is theft, not loss, and, as such, must be immediately reported to the DEA even if the quantity of drug involved is not considered significant. A report should also be made to any relevant professional boards; without this report, there is nothing to prevent a diverter from moving from institution to institution, as has happened with distressing frequency in high-profile, multi-state instances of diversion with serious patient harm. Because professional boards often take considerable time to make a determination of culpability, or there may not be a professional board to report to, strong consideration should be given to reporting to local law enforcement. The response team members may or may not have a role in external reporting, but they should ensure that all required reporting takes place in a timely fashion.

Post-Case Review and Action

In all cases, the diversion response team should undertake a post-case review and recommend process changes where appropriate. Whether diversion is confirmed or not, many diversion investigations uncover issues such as inadequate security, non-compliance in medication handling, and more (see CASE STUDY 3).

The actions to be taken with regard to a person who has been confirmed to be a diverter is a sensitive subject; however, the diversion response team should not be involved in making the determination about the consequences for the staff member. Instead, the response team should present its findings to HR and the staff member’s supervisor and allow them to make that determination. If outcomes of similar cases appear to be inconsistent, the diversion response team may need to raise this concern with the diversion oversight committee or other executive committee equipped to manage the issue.

Every component of the diversion response team investigation, including interviews, transaction review, and other investigatory steps must be documented, and the records preserved for future reference. Developing a diversion investigation template can help ensure that documentation is consistent. There is no specific type of template that must be used, but at a minimum the investigation notes should include:

• Date of each note (as investigations are often conducted over multiple days)
• Author of the note
• Preliminary findings that led to the investigation
• Findings of the investigation
• Next steps and recommendations
• Conclusion of the investigation, including staff member disposition and reporting that was undertaken
• Photos of evidence

Conclusion

A multidisciplinary approach to suspected diversion is essential, but it requires dedication on the part of the institution, including a commitment of staff and resources as well as a consistent, documented manner of investigation. The return for the team’s commitment will inevitably be a safer environment for patients and staff.

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 a specialist in controlled substance security and DEA regulatory compliance, working with health systems across the country to establish and expand drug diversion programs, with the overriding goal of improving patient safety.