Tips for keeping your cool during a DEA Audit
Take a deep breath and relax. These folks are just here to do their jobs, and are likely here as a part of a routine random inspection.
The knock at the door – When the DEA investigators arrive, they typically show up in pairs. If they haven’t already, ask them to show you identification. Next ask the reason for their visit. As soon as possible, escort them to a room away from clients and patients. This can be an empty exam room or an administrative office. Be cordial – offer a coffee or water if possible at your facility. Let them know that the person in charge will be with them shortly.
Remember – if you are polite to the inspector, your audit will run 100% smoother.
DEA Form 82 – If the inspector does not off it first, you should ask for a DEA Form 82. This is the Notice of Inspection of Controlled Premises. When you sign, you are giving permission to the DEA to perform the inspection.
Remember – You can refuse to sign, but the likelihood of them returning in a much more aggressive state with an administrative search warrant is high.
DEA Binder – A well prepared facility will bring their DEA binder into the room to review with the inspector. This binder will contain all of the facilities readily retrievable items printed and ready for review tabbed out with a table of contents in the front. This includes:
Current DEA Registration
In addition to these items, they will likely want to review your current logbooks. If paper, bring them in the room, if digital, bring a laptop in (know that they may ask you to print off records for review).
Comparison – The DEA inspectors will review your documentation looking for any items missing, amounts that do not match or add up, incomplete forms, unexplained discrepancies and more. They may ask you questions to clarify something that does not make sense to them. This is where you shine! You know your logbooks. Answer clearly and do not offer information that was not asked for. Short and sweet, we want them in and out.
Typically an investigator will want to see your safe/storage cabinet. They may also want to verify that the amount on hand listed in your logbook accurately reflects what you physically have. If it is tablets/capsules, grab a pill counter and count in front of the inspector. If it is an injectable medication, ask if it would be ok to “eye-ball” the vial. If they say no, pull out an appropriately sized syringe and needle, draw up the medication in front of them, and return it to the vial. Show them the amount of unavoidable hub-loss in the syringe from the draw as
well so they know you understand the concept.
DEA Form 12 – Sometimes an inspector will want to take physical copies of documents with them from the facility.If the inspector insists on taking any original documents instead of accepting copies, take photos of the documents they are taking and request a DEA Form 12, which serves as a receipt for the records removed.
Missing items – If you are missing any items and truly do not have them, make a notes and ask the inspector how they would like the missing items sent to them for verification.
Remember – you can’t make nonexistent items appear out of thin air, but you can show the inspector that you understand the importance of this item by offering to have it to them at a later date. It doesn’t fix the issue, but shows respect and willingness to comply.
Interviews – If the inspector requests to interview employees, and you feel that it would have a negative impact on patient care, ask if the interviews can be scheduled or if the employee can call to speak with the inspector after their shift. It never hurts to ask.
At the end of the inspection, thank them for coming and ask if there is anything else needed on your end. Also ask if they should expect any form of communication back from them after the visit.