Office Surgery Registration and Inspections - Florida Board of Medicine - Office Surgery Registration and Inspections

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Q:	Who needs to register with the Office Surgery Registration Program?
A:	Every Florida licensed physician who holds an active Florida license and performs Level II surgical procedures in Florida with a maximum planned duration of five (5) minutes or longer or any Level III office surgery, as fully defined in 64B8-9.009, shall register with the Board of Medicine. It is the physician’s responsibility to ensure that every office in which he or she performs Levels II or III surgical procedures as described above is registered, regardless of whether other physicians are practicing in the same office or whether the office is non-physician owned.

Q:	What are the different levels of office surgery?
A:	Level I office surgery includes, but is not limited to, the following: Minor procedures such as excision of skin lesions, moles, warts, cysts, lipomas and repair of lacerations or surgery limited to the skin and subcutaneous tissue performed under topical or local anesthesia not involving drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient. Liposuction involving the removal of less than 4000cc supernatant fat is permitted. Incision and drainage of superficial abscesses, limited endoscopies such as proctoscopies, skin biopsies, arthrocentesis, thoracentesis, paracentesis, dilation of urethra, cysto-scopic procedures, and closed reduction of simple fractures or small joint dislocations (i.e. finger and toe joints). Pre-operative medications not required or used other than minimal pre-operative tranquilization of the patient; anesthesia is local, topical, or none. No drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient is permitted in level I Office Surgery. Chances of complication requiring hospitalization are remote. Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, thus making intra and post-operative monitoring necessary. Such procedures shall include, but not be limited to: hemorrhoidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000cc supernatant fat. Also, includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. Level III Office Surgery is that surgery which involves, or reasonably should require, the use of a general anesthesia or major conduction anesthesia and pre-operative sedation. This includes, but is not limited to, the use of: Intravenous sedation beyond that defined for Level II office surgery; General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions; or Major conduction anesthesia. Only patients classified under the American Society of Anesthesiologists (ASA) risk classification criteria as Class I or, II, are appropriate candidates for Level III office surgery.

Q:	What additional documents are needed to register with this program?
A:	Office Surgery Registration Form with an original signature for each Surgeon Name and license number of any Surgeon, Physician Assistant (PA), Certified Registered Nurse Anesthetist (CRNA), Advanced Registered Nurse Practitioner (ARNP), or Registered Nurse (RN) at facility Copies of any protocols necessary for the supervision of any PA, CRNA or ARNP. Name and license number of M.D. or D.O. Anesthesiologist, if applicable Transfer agreement from a local hospital or staff privileges with a delineation of procedures from a local hospital (within 30 minutes). Copy of current ACLS Card for Surgeon or at least one assistant BLS cards or ACLS cards for surgeon and staff The Surgeon must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other board approved by the Board of Osteopathic Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training and experience or must provide documentation of staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting. In addition, the surgeon must have knowledge of the principles of general anesthesia. Copy of current accreditation certificate and survey, if applicable.

Q:	If I have staff privileges, do I need a transfer agreement?
A:	No, as long as the staff privileges are at a hospital within reasonable proximity (30 minutes) and are you are able to perform the same procedures as those performed in the office setting.

Q:	What documentation is needed to prove level of training required?
A:	The surgeon must have documented staff privileges at a licensed hospital within reasonable proximity (30 minutes) to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training and experience. In addition, the surgeon must have knowledge of the principles of general anesthesia.

Q:	What if I have a new physician enter my office surgery practice?
A:	Every Florida licensed physician who holds an active Florida license and performs Level II surgical procedures in Florida with a maximum planned duration of five (5) minutes or longer or any Level III office surgery, as fully defined in 64B8-9.009, shall register with the Board of Osteopathic Medicine. It is the physician's responsibility to ensure that every office in which he or she performs Levels II or III surgical procedures as described above is registered, regardless of whether other physicians are practicing in the same office or whether the office is non-physician owned. The new physician must submit a signed office surgery registration form and all required documentation. The physician must immediately notify the Board office, in writing, of any changes to the registration information. Application for Registration with Instructions (pdf - 107kb)

Q:	Are there any exemptions from having to register with this program?
A:	All physicians who perform level 2 procedures lasting more than 5 minutes and all level 3 surgical procedures in an office setting must register the office with the department unless that office is licensed as a facility pursuant to chapter 395. Office surgery is defined as surgery which is performed outside a hospital, an ambulatory surgical center, abortion clinic, or other medical facility licensed by the Department of Health, the Agency for Health Care Administration, or a successor agency.

Q:	Do Pain Management facilities need to register?
A:	The Board of Osteopathic Medicine determined that anesthesia blocks are surgical procedures and would fall under the office surgery rule but the level of sedation would determine the level surgery.

Q:	Am I required to retain a risk manager in my office?
A:	The rule requires physicians performing office surgery to have a risk management program. It does not require retaining a risk manager. However, if an office wishes to consult with a risk manager in the development of the risk management program, it is recommended the office contact the Agency for Health Care Administration who regulates risk managers to obtain a list of licensed risk managers in your area. The contact information is: Agency for Health Care Administration Hospital and Outpatient Services Unit 2727 Mahan Dr, Mail Stop #31 Tallahassee, FL 32308 (850) 487-2717 telephone (850) 921-5459 facsimile www.fdhc.state.fl.us

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