This is Part 3 of our 3-part series about DEA inspections and compliance to help OMS surgeons prepare (if you haven’t seen them yet, be sure to read Part 1 and Part 2 of the series). This article covers what happens and what you can do if DEA inspectors show up at your practice for a surprise inspection.
DEA Investigators may visit your practice for a number of different reasons, including improper licensure, subpar record keeping, suspension of a surgeon or staff member due to theft or substance abuse, or submitting orders for controlled substances that are beyond the scope of practice. Whatever the reason, there are some aspects of the audit that are likely to occur, so planning for these and knowing the process ahead of time may enable you to reduce your risk, lower your stress, and minimize the impact the audit has on your practice’s operations that day.
What happens when the DEA arrives
The DEA investigators will likely identify themselves with their badges, but if not, you should ask to see identification. They will ask you to sign the Notice of Inspection (DEA form 82) to begin the process. Be sure to review your rights in the Statement of Rights section of the notice, as that clarifies what you can and cannot do during the audit. The investigators will ask you and your staff for access to numerous documents, including licenses, purchase and prescription records, and DEA forms from the last 2 years.
The inspection consists of several parts, including:
- The Accountability Audit: This is similar to the self-audit discussed in Part 2 of this series. The investigators will review records of received controlled substances and compare that against records of drugs that have been dispensed or destroyed and that remain on-hand. At a minimum, the investigators will usually audit at least 2 drugs for each schedule, over a 6-month time period. They’ll begin with a recent physical count, usually your biennial inventory (which your self-audit can count as; see Part 2 of this series for details). The inspectors are verifying if any discrepancies show errors in record keeping or possible theft, and there’s really no acceptable margin of error here. This is why it’s good to conduct the self-audit on your own without the DEA present in order to verify the balance or correct any errors immediately.
- Records And Reports Audit: The DEA investigators will also be reviewing records closely to ensure that your practice is maintaining controlled substances records and reports that are accurate, complete, and accessible for the prior 2 years. The investigators will review multiple transactions, comparing report figures against the order forms (DEA form 222) to ensure they were complete, accurate, filed, and filled within 60 days of when the patient completed them. The investigators will also review accuracy and completeness of the Power of Attorney documents, invoices, and packing slips, which can include contacting a sample of vendors and patients to double-check.
- Security Inspection: This step requires physical access to your security system used to manage controlled substances on the premises. The investigators will verify that your safeguards are in line with the types and amounts of controlled substances your practice dispenses. They will inspect your system to make sure it’s functioning appropriately and test the alarm system.
What you can do during the inspection
Although things are mostly in the hands of the investigators at this point, there is plenty you can do:
- First off, be friendly, cooperative, and professional. Make sure your staff knows to do the same.
- Ask for identification and a business card from each of the investigators, if they don’t present them upon arrival.
- Review the notice of inspection and read your rights.
- Request an opportunity to meet with the investigators once they’ve concluded their audits, and take detailed notes.
- Give the DEA a private space to conduct their activities.
- You have the right to contact legal counsel.
- Notify all staff (including at other practice locations) of the investigation and to accommodate requests and answer any questions from the investigators.
- Appoint 1 or 2 staff members to oversee the investigation and provide all documents and building access requested by the DEA. Train them beforehand so they know what to expect and what to do. They will need to have access to the documents that the investigators will request.
- Have the appointed staff member(s) take detailed notes of all observations, comments, and recommendations made by the investigators.
- Allow the prescribing surgeon who is being investigated to be present as a witness.
- Make copies of any documents that the investigators need to take, and make notes of any documents that they question, copy, or scrutinize.
- Make sure you get a receipt (DEA form 12) for any controlled substances or original records that the investigators take off-site.
What happens at the end of the inspection
The investigators won’t be able to give you their final findings right away. In fact, it may be months before you receive the inspection results. But they may be able to give you some feedback to help your practice better comply with regulations. Be sure to get business cards before the investigators leave, if they didn’t already give them to you. Consider implementing any feedback right away, especially if any issues arose—getting ahead of that sooner rather than later can only help your practice.
What you can do now (before an inspection)
If you need support making changes to your processes or re-training staff to improve compliance, OMS Consulting Firm is also available. Our team of experts is ready to not only advise you but also get involved with you and your staff to help implement these improvements to your practice compliance. The best position to be in, of course, is fully compliant before the DEA ever even thinks of visiting your practice.
Thank you for reading this series on DEA compliance and investigations. If you have any feedback or questions, please Contact Us.
OMS Consulting Firm’s team of experts can offer guidance and hands-on improvements for your practice’s compliance program. Contact us for more information.