Given the unique structure of the OR, identifying and preventing diversion of controlled substances in this environment can be a challenging pursuit. Many factors complicate diversion prevention in the ORs and procedural areas, including disparate workflows in various areas and among various providers, manual documentation systems, EMR systems that are separate from the main EHR, and difficulty in determining an accurate comparison of controlled substance use by providers. The latter issue is particularly challenging; for example, if one anesthesia provider is assigned to an OR for eye surgeries, such as lens replacements, and another provider is in a room doing joint replacements, their opioid usage will differ considerably.

Nevertheless, multiple strategies can be employed to thwart diverters in the ORs, including the following:

• Employ physical rounding and transactional auditing
• Educate perioperative staff about the risks and signs of diversion
• Empower staff to report concerns and ensure they feel empowered and comfortable in doing so
• Ensure that all perioperative and procedural locations, including off-site surgery and procedural centers and clinics, are incorporated into the diversion program

To adopt these strategies, organizations must commit to developing and implementing comprehensive diversion detection and prevention programs in the ORs and procedural areas.

A Gradual Approach

Taking a step-by-step approach to identifying and preventing diversion in the ORs can make the process less daunting. Begin by identifying all perioperative and procedural areas for which the organization is responsible, including both onsite and off campus locations. Consider all clinics and office practices that may be performing procedures, such as a reproductive medicine clinic. Although listing the relevant sites may sound simple, it is often more involved than expected, particularly if the health system is large and complex. Invest the necessary time to create a comprehensive list of all locations, as diversion can occur anywhere.

Once the areas are identified, it is prudent to visit each location to verify the nature of the care rendered and the medications in use. Review policies and procedures and ask staff to explain their workflows, both during regular business hours and after hours, if relevant. The controlled substance dispensing method for each area should be noted, in addition to the method of documentation. Once this information is obtained, identify areas with the greatest risk and prioritize prevention and detection efforts in these areas first.

Standardizing policies, anesthesia dispensing procedures, and perioperative record systems should be a top priority. Anesthesia team members are often assigned to multiple sites within a health system; it is challenging to enforce security and accountability when there is wide variation in practice within the facility, as well and across the health system.

Preoperative Workflows

Although preoperative areas may not utilize many controlled substances, they still require evaluation. Determine whether controlled medications are administered by nursing staff or anesthesia staff in this setting. If anesthesia staff administers controlled medications, there may be an increased risk of diversion if they obtain doses outside of the preoperative area. See CASE EXAMPLE 1 for an example of poor practice in the preoperative area that could lead to diversion.

Preoperative blocks or regional anesthesia may also present a diversion risk. Although blocks are usually relatively benign from a diversion standpoint, I have encountered facilities where a resident or CRNA pulled large quantities of opioids and benzodiazepines for the anesthesiologist performing blocks that day. In one instance, the controlled substances were stored in a drawer at the nurse’s station until they were needed; in another, the drugs were placed on an open cart and wheeled from patient to patient as the blocks were provided. When I questioned the rationale for pre-pulling so much medication, both providers said that efficiency demands prevented them from pulling medication on a patient-by-patient basis.

Efficiency demands are commonly cited as a rationale for controlled substance workarounds in OR and procedural settings. However, safety concerns dictate that staff should slow down enough to follow best practice, which means pulling controlled substances at the time of need on a patient by patient basis. In order to promote this, facilities may need to consider adding ADCs in locations where staff are struggling. Recently in an interventional radiology setting, staff were certain that they could never pull controlled substances on a patient by patient basis. Once an ADC was placed in the anteroom, they found not only that they could do it, but that it was actually a better workflow.

Dispensing Methods

In ORs and procedural areas, diversion risk depends to some degree on the method of dispensing to anesthesia staff. The two most commonly utilized approaches to dispensing should be considered: manual kits and automated dispensing cabinets.

Manual Kits

As a dispensing method, manual kits lack both security and accountability; they increase the number of touch points for controlled substances since they must be assembled, used, reconciled, and broken down. They also necessitate manual auditing, as no automation is involved.

The riskiest approach to dispensing manual kits for anesthesia is the provision of a custom kit each day, as this configuration allows providers access to large amounts of controlled substances throughout the day. Slightly less risky is the use of a standard kit each day, as there are limits placed on what is included in the kit. Next, in order of highest to lowest risk, are use of a custom kit for each case, and finally a standard kit per case. When kits are customized, there is often a tendency to overpull or ask for more medication than is actually needed. The contents of standard kits should be based on actual usage trends, which means providers are given what they need as opposed to extra just in case it is required.

Typically, kits are dispensed by a dedicated OR pharmacy. Pharmacists should be aware that when kits are dispensed in the OR, anesthesia staff may have to carry them a substantial distance to be used in procedural areas; there is no perfect solution for preventing diversion during transport. Therefore, an explicit policy requiring providers to keep the kits in their physical custody at all times during transport should be in place and rigorously enforced.

Lackadaisical kit handling can be identified by reviewing kit dispensing logs. One facility I observed noted four or five instances each month where a kit was pulled in the morning and not returned until the next day, even though the provider finished their work before the OR pharmacy closed. When kits are dispensed from the OR pharmacy, they should be tracked in a log that details who has the kit, the time it was signed out, and when the kit was returned. There should also be a method in place to identify the locations of any outstanding kits at the end of the day, and these kits should be located prior to the time the pharmacy closes. If a surgical case extends past pharmacy hours, there must be a method for returning the kit to a secure location. For example, I have seen after-hours kit depositories that could be readily accessed; one OR pharmacy simply cut a hole in the pharmacy wall and placed a cardboard box beneath the hole on the pharmacy side of the wall to collect after-hours kits.

Returning the kit at the end of the case or shift to the pharmacy is a best practice. This provides the opportunity for immediate reconciliation of the contents and allows for a time stamp indicating when the kit was returned. Another secure option is placing the kit into a small container that can be securely sealed with serialized locks (the lock numbers are recorded on the paperwork inside the container so that staff can verify that the kit has been received intact). When these are used, the containers are typically placed in an area of an automated supply cabinet that has limited access. The kits are retrieved the following day and there is an automated time stamp indicating when the return occurred. A third option is a safe that is placed in a secure location to which there is limited access. Safes should be bolted to the floor and ideally have a revolving depository slot that is large enough to accommodate the kit, yet prevents unauthorized access. Kits must be sealed so that the contents do not empty into the safe, and it is helpful to place a soft barrier at the bottom of the safe to prevent breakage of vials and ampules. If a safe or supply cabinet is used, placing camera surveillance at the return location is strongly recommended.

It is important to note that when kits are returned after hours, there is a significant risk that they will not be returned in a timely fashion. I have spoken with providers who admit that as long as the kit is placed in the depository before it is emptied by pharmacy staff, there will be no repercussions. As a result, these providers regularly engage in extremely risky practices, such as storing kits in unsecured lockers or taking kits home and leaving them in the car overnight.

Facilities should consider making expectations for the return process explicit by stating in the policy and procedure that kits that are kept out after hours must be returned immediately when the case or shift ends. Although it is not a desirable situation, if kits must be kept out after hours (eg, during an on-call shift), ensure that anesthesia providers have a lockable location to temporarily store the kit during their shift.

Manual Kit Auditing

Kit auditing typically involves reconciling the items dispensed and returned against the data recorded by the provider on the usage sheet. While this type of confirmation is no doubt necessary, facilities should recognize that this practice is purely a mathematics exercise, and is often of limited value. For example, if the numbers cannot be reconciled correctly, the provider is notified of the discrepancy and usually just adjusts the record as needed. Facilities should understand that even if they are conducting a 100% reconciliation of anesthesia dispensing compared to usage, this practice alone should not be considered robust diversion auditing. For a meaningful anesthesia audit to occur, transactions must be compared with the anesthesia documentation in the medical record.

Generally, the longer controlled substances are out of secure storage, the higher the risk of diversion or loss. Facilities that use kits may wish to reduce their risk by transitioning to an automated system or, at the very least, adopt a standard kit-per-case approach. Of course, when standard kits are used, facilities may need to prepare more than one type of kit to accommodate different surgical populations, such as pediatrics or open-heart cases.

Central ADC Dispensing

Dispensing from a central ADC in the surgical area or procedural unit where anesthesia providers obtain their drugs on a case-by-case basis introduces a lower risk versus manual kit dispensing. Central ADC dispensing provides additional security, since the system is designed so that providers pull their drugs prior to each case, and do not keep them out of secure storage for extended periods of time. Accountability is also improved as transactions can be reviewed and analyzed electronically. Risk with this method of dispensing arises primarily because providers tend to overpull controlled medications for fear of running out during cases. If a central ADC is used, transactions should be carefully monitored to ensure that staff are not developing a habit of overpulling; a few telltale signs are frequent returns and wasting of complete doses.

Whether utilizing manual kits or central ADC dispensing, the facility must provide a secure method of storing the kit or medications in the OR or procedural area throughout the day. Most facilities offer a manual supply cart for storing medications and supplies, but the security of these carts can vary considerably. Because keys tend to get lost and access codes tend to be predictable and well-known among non-anesthesia staff, I recommend a cart that is accessed via a combination of a badge reader and unique user code. This type of cart usually has one or two secure medication drawers that are accessed via badge and code only, while other drawers are accessible to anesthesia technicians so they can stock supplies. These carts usually give the facility the ability to produce an access report showing who has accessed the secure portion of the cart and when that access occurred.

Secure Anesthesia Cabinets

When used properly, anesthesia cabinets in each OR and procedural area provide a secure and accountable method of dispensing. These cabinets allow providers to access controlled substances at the time they are needed, as opposed to pulling them well in advance, and the automation enables facilities to audit transactions more easily than manual systems allow.

It is critical to note that the security of anesthesia cabinets varies; in fact, anesthesia cabinets in many facilities are not secure. For example, it is not uncommon for these cabinets to be accessed using a predictable universal passcode that has not changed in years, and one that most OR staff know. To improve security and accountability, use an anesthesia cabinet that has a dedicated controlled substance drawer, which is accessed by a badge reader and unique provider code. This type of cabinet maintains drug security and offers the ability to track which staff has accessed it, while still allowing anesthesia technicians to restock supplies in the non-secure cabinet drawers.

Anesthesia cabinets are only as effective as the staff that uses them, so facilities should confirm that these systems are being used as intended. To verify this, best practice is to audit anesthesia transactions for pre-pulling, overpulling, and delayed wasting. In addition, ensure that time-outs on cabinet drawers and screens are limited to a reasonable amount of time. It is not uncommon for providers to leave cabinets live when transporting patients to the post-anesthesia care unit (PACU) or when receiving a patient into the preoperative area. Implementing automatic time-outs in the anesthesia cabinet can be an effective method of reducing the risk of diversion by staff who remain in the OR.

When configuring cabinets, pharmacists should be aware that some practices uniquely available with anesthesia ADCs, such as transferring doses from patient to patient, can increase the complexity of auditing.

Auditing Transactions

Transactional auditing is necessary in all perioperative and procedural areas. Newer analytics programs can help identify unusual or suspicious behaviors, but even without access to these programs, a peer-to-peer comparison of staff in similar roles should be conducted. All providers should be regularly audited, and any discrepancies or undocumented medication should be tracked and trended. When a provider is identified as an outlier for any reason, it is recommended to review that provider’s usage and transactions over several months, to look for evolving trends and any escalation in usage for the drug that is potentially being diverted.

One risky practice to look for in routine diversion auditing is handoffs among providers, which can occur regardless of the type of dispensing method used. Handing off controlled substances from provider to provider diminishes accountability (see CASE EXAMPLE 2 for an example of the dangers of utilizing handoffs in the ORs and procedural areas). Allowing handoffs of controlled substances from one provider to another is strongly discouraged; if this practice does occur, the providers must document the handoff in the medical record, including exactly what was handed off and the time the transition occurred.

Risk Rounding

Risk rounding can help facilities reduce the risk of diversion and improve controlled substance workflows by observing practices in person, with the goal of identifying gaps and risk points in procedures. This practice is essential to the institutional auditing program, because it is the most effective way to identify diversion risks that may not be apparent on a transaction review.

Many high profile diversion cases involving patient harm demonstrate the value of physical auditing. In several cases, the diverter did not have legitimate access to controlled substances, but was able to gain access due to inadequate security or lax handling practices. Transaction reviews cannot identify this type of risk, but physically observing workflows can be effective.

Risk rounding is simple and requires a minimal time commitment. The rounding team should be limited to no more than two individuals. It can be useful to don PPE and check ORs and procedural areas just before cases start, in between cases, and after hours when all cases for the day are finished, as it is not uncommon to find controlled substances left unsecured during these times. In addition, note that because controlled substances are often placed in locked drawers throughout the day, they may be forgotten and remain there at day’s end.

Waste Analysis

Some facilities analyze anesthesia waste as an additional data point for detecting diversion by anesthesia staff. When done properly, anesthesia waste analysis can provide valuable data. Waste analysis requires acquisition of a refractometer or other device that will reliably test for fentanyl. Historically, facilities have used basic handheld refractometers that were not capable of differentiating fentanyl or sufentanil from distilled water, which have refractive indices that are scarcely different. Newer products are available that have the sensitivity to determine when a sample is fentanyl versus water.

In addition, facilities must ensure that there is a strict chain of custody protocol for collected specimens so that results can be deemed reliable. Some steps that may be necessary include:

• Require bagging of all anesthesia waste in serialized, tamper-evident bags prior to placement in the return bin, and have a method for recording each bag number so that it can be verified by the individual performing the testing. Alternatively, have two pharmacy staff members collect all the waste so there is a witness to the pickup.
• Have all specimens immediately delivered to the staff member who will do the testing. This preserves the chain of custody and avoids degradation of specimens.
• Have a witness readily available when testing occurs so that the specimens can be wasted after testing.
• Utilize an outside laboratory to test diluted specimens for verification of in-house results.

When implementing an anesthesia waste analysis program, test at least 10% of all anesthesia waste from procedural and operative areas. Develop a policy for how results will be handled, including what percentage dilution will be considered acceptable and what percentage will be considered a failed result. Furthermore, establish a plan for how to address a provider who has an initial diluted specimen. For example, can they continue working pending verification, or should they be immediately suspended? Should a drug screen of the provider be required? It is important to recognize that a determined diverter can elude detection even if waste is being tested; in a few cases, providers developed a trend of administering all of their medication so waste was never generated.

Education

Providing staff education on diversion issues is as important in the ORs and procedural areas as it is in other areas. OR staff tend to be a close-knit group; consequently, it is common for staff to sincerely believe that no one on their team would divert. Equally common is the belief that diverters appear impaired, and that if a colleague does not appear impaired, they cannot be diverting.

Diversion education should be mandatory at the point of hire, on transfer into operative areas, and annually thereafter. Diversion cases are often reported in the news, and these situations can be used to demonstrate the inherent risks. Maintaining transparency about previous instances of diversion can be an excellent tool to help staff understand an important message: Diversion can happen at this facility, it has happened at this facility, and it will happen again as long as controlled substances continue to be used here. Above all, education should touch upon the scope of the problem, signs that diversion is occurring, and how to report concerns.

Anesthesia Buy-In

Develop an anesthesia workgroup to help maximize buy-in and ensure active communication with anesthesia staff. This group may be a subcommittee of the institutional Diversion Oversight Committee, or it can be an independent group. The workgroup should be composed largely of anesthesia staff, but should also include diversion program staff or other independent stakeholders, such as pharmacists and perioperative nurses.

The workgroup should review workflows and propose performance improvement initiatives. Diversion program stakeholders should also work with the anesthesia workgroup to develop an anesthesia accountability policy that outlines controlled substance handling expectations and describes how noncompliance in controlled substance handling will be addressed.

Noncompliance should result in progressive discipline. Anesthesia staff are unique, however, because they are often given the opportunity to correct errors and omissions in their documentation. Anesthesia concerns identified through rounding and transaction auditing, even those that appear to be isolated cases, should be tracked on a monthly basis and presented to the chief of anesthesia or their designee.

Conclusion

Operative and procedural areas present a tempting target for diverters because of the large quantities of drugs of abuse used in these areas. Appropriate attention, automation, policies and procedures, risk rounding, and auditing can help detect diversion risks in these areas and lead to substantial improvements in patient safety and regulatory compliance.

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.