Office Surgery Facility Inspections: What does it mean? Part 6

Requirements for Level III Office Surgery

Office surgery facilities in Florida must comply with detailed laws and rules established by the Florida Boards of Medicine and Osteopathic Medicine. These regulations govern patient safety, facility standards, anesthesia levels, and surgeon responsibilities.

When a facility performs Level III office-based surgery—procedures involving general anesthesia, major conduction anesthesia, or deep sedation—additional regulatory requirements apply beyond those for Level I and Level II procedures. A Level III office surgery facility must meet standards comparable to a free-standing ambulatory surgical center (ASC).

The Florida Department of Health (DOH) conducts pre-registration inspections for all new office surgery facility applicants. Annual inspections are required for all registered facilities not accredited by a Board-approved national accrediting organization . Inspections are designed to ensure compliance with general requirements for all office surgeries, Level II requirements (moderate sedation/conscious sedation procedures), and Level III requirements (general anesthesia, deep sedation, or major conduction anesthesia procedures).  Some, but not all, Level III requirements are listed below:

• Compliance with the American Society of Anesthesiologist’s Classifications for appropriate patients for Level III office surgery. Know which classifications require the patient to undergo surgery at a hospital or ASC.
• Compliance with training requirements for the surgeon and assistants to the surgeon, such as Advanced Cardiac Life Support certification.
• Compliance with emergency policies and procedures and ensures the office periodically reviews and updates the emergency policies and procedures, which must be posted in the office in a conspicuous location.
• Compliance with emergency policies and procedures related specifically to airway blockage, allergic reactions, bradycardia, bronchospasm, cardiac arrest, chest pain, hypoglycemia, hypotension, hypoventilation, laryngospasm, local anesthetic toxicity reactions and malignant hyperthermia.
• Compliance with required anesthesia, surgical, and monitoring equipment
• Compliance with anesthesia providers and training. Anesthesia providers cannot function in any other capacity during the procedure.
• Compliance with training requirements for additional assistance in recovery, such as Advanced Cardiac Life Support certification. In addition, registered nurses must have previous post-anesthesia care unit (PACU) experience to perform recovery services in an office surgery setting.

Department inspections are an essential part of maintaining your office surgery facility license. To avoid penalties or enforcement actions, be sure to have all your records ready for the inspector to review on the day of the inspection. Never refuse to allow an Inspector into the office to perform the inspection. Refusal of an inspection could result in severe action against the office surgery facility license.

If you fail an inspection, you must submit a Corrective Action Plan (CAP) to the Department within the required number of days.  Failure to achieve compliance may result in a formal complaint against your facility registration and the designated physician’s license.

Don’t let this happen.  Let the experienced health law attorneys at Howell, Buchan & Strong help. We can help you prepare for the inspection. If you have already failed the inspection and you are wondering what to do, we can assist you in drafting and submitting the CAP.  If you have already received a complaint against the office surgery facility and/or the designated physician’s medical license, we can help defend your registration and medical license. Contact us today for a free consultation.