10 Tips to Identify Compliance Gaps in Your Facility
Note: This is an excerpt from the forthcoming book The AAHA Guide to Safeguarding Controlled Substances by Jack Teitelman and Kelley Detweiler (AAHA Press, 2020).
Because our team has conducted close to 500 compliance inspections for veterinary practices, we have a pretty good idea of what ails you when it comes to adhering to DEA compliance. Compliance gaps in veterinary medicine are not rare and not unique to just the veterinary profession, but to anyone in healthcare who is ordering, storing, dispensing, and prescribing controlled substances. The good news is that, by pinpointing any gaps in compliance, the veterinarians and practice team can take a proactive approach to correct issues and decrease the risk to the business.
Here are our top 10 tips for identifying and preventing compliance gaps in your practice operations.
Achieving controlled substance compliance requires planning, and effective planning begins by conducting a gap analysis. A gap analysis will identify and evaluate any and all issues that require improvement and should be immediately followed by taking steps to remediate all of the problems identified. The AAHA Guide to Safeguarding Controlled Substances will give you and your team all the tools you need to conduct a gap analysis in your practice.
If you don’t have the staff, time, or resources to conduct a compliance gap analysis internally, engage a third-party company to ensure nothing slips through the cracks and daily operations do are not interrupted. Whether a practice completes its own gap analysis or hires a third party to do it, the main goal is to identify compliance risks and fix them so that the practice is protected.
Streamline communication between the purchaser and the veterinarians and team members accessing the drugs.
Don’t forget about potential compliance gaps with your DEA registration. Be vigilant when it comes to registration renewal dates and deadlines, and keep on top of any changing federal requirements for your license. By obtaining a DEA registration, veterinarians also accept full legal responsibility for all aspects of how an entire veterinary practice works with these powerful controlled substances. The DEA can revoke registration from those who fail to meet these legal obligations.
Prioritize a relationship with your controlled substance supply chain and maintain an open line of communication with your sales rep. Don’t assign controlled substance supply chain management to multiple employees, but rather to one seasoned pharmacy technician, and be sure to cross-train two other employees as a safety measure. To make sure things run efficiently, prioritize and maintain solid working relationships with vendors. Having open dialogue with a sales representative can make the difference between obtaining five bottles of a needed drug or none. Maintaining a consistent working relationship with your supply chain vendors also creates the opportunity for better accountability.
Adhere to the DEA Pharmacist’s Manual guidelines but recognize that many specifics are left to the investigator’s subjective interpretation.
Create a dedicated area where controlled substance orders are consistently received and inventoried. Many receiving errors we encounter (such as miscounts) usually occur during the receiving process. Whether you have a loading dock with a full-time inventory manager or not, an excellent way to reduce receiving errors is to prepare your receiving area for incoming inventory.
Implement a diversion-prevention committee to enforce policies for overseeing the security of controlled substances. Your diversion-prevention team takes responsibility for putting diversion response policies and procedures in place to detect and investigate potential threats and incidents promptly. The diversion-response team may be the committee itself, a subset of the committee, committee members by rotation, a diversion specialist with other assistants as needed, or some other arrangement.
Separate your documents! One of the most common compliance gaps that is subject to monetary fines is having all required controlled substance records stored in one file. When it comes to controlled substance recordkeeping, the DEA requires that you separate all schedule II controlled substance records from schedule III, IV, and V records.
Managing your controlled substance inventory is an ongoing process, during which you will likely find gaps in your compliance. When this happens, don’t panic. Stick to the fundamental principles of secure management of your controlled substances.
Want more expert tips on navigating your practice's controlled substances? Coming this December, The AAHA Guide to Safeguarding Controlled Substances provides a road map for all practitioners to stay safe and DEA compliant. Preorder your copy now!