Florida Department of Health inspectors are out and about visiting Pain Management Clinics, particularly in south Florida. Here is what you might expect when they come to call.
Likely, you will be visited by two inspectors who may ask for the following:
- Dispensing logs, if you dispense medication from your office
- A List of all patients receiving controlled substances
- A handful of charts of patients receiving controlled substances after October 1, 2010
- During the chart review, they will want to see the most recent prescription; the most recent progress note associated with that prescription; and the initial History and Physical note
- DEA 222 forms for dispensing controlled substances
- All of your licenses and certifications
- A list of your out of state patients
- They also may ask about your advertising methods, whether you have bill boards or do commercials
If you dispense medication from your office, that related documentation likely will be of greater interest. Remember, the purpose of the new law is to shut down ‘pill mills.’
Take special note if you employ physician extenders in your practice. A physician must perform a physical examination of the patient the same day a controlled substance is prescribed or dispensed to the patient. The physician also should sign the medical record documenting the examination.
Our clients tell us that fulfilling these requests is fairly easy to do with electronic medical records.
Once the inspection is complete, you will be asked to sign both a paper and electronic form that documents any violations. The Department is required to make a reasonable attempt to discuss each violation with the owner or designated physician before issuing a formal written notification. If violations are noted, corrective action should be documented in writing to the Department of Health. You should expect follow up visits to verify violations have been corrected.
The best way to handle these visits is to be cordial and professional; assure the inspectors are not kept waiting; and provide them a comfortable and quiet place to work. Have your staff check with them occasionally to see if they need additional information or documentation. And, of course, thank them when they find no deficiencies and finally leave your office.
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Linda A. Keen has over 20 years experience working with Florida’s health care regulating agencies and is a Florida licensed healthcare risk manager with experience developing and implementing robust risk management, quality assurance, and compliance programs. She currently is representing clients before the Board of Medicine on pain management clinic registration issues. She is available to assist your practice in meeting regulatory requirements and addressing other health care legal issues. She can be reached at (850)894-0336 or lkeen850@embarqmail.com. You also can read more about her at www.FloridaHealthcareLawFirm.com.
