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The Florida Department of Health works to protect, promote & improve the health of all people in Florida through integrated state, county, & community efforts.

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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:

  1. 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.
  2. Liposuction involving the removal of less than 4000cc supernatant fat is permitted.
  3. 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).
  4. 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.
  5. 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:

  1. Intravenous sedation beyond that defined for Level II office surgery;
  2. General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions; or
  3. Major conduction anesthesia.

Only patients classified under the American Society of Anesthesiologist’s (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).

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

Q:

What are the laws and rules regulating office surgery in Florida?

A:

s. 458.309 (3), F.S. - Office Surgery Registration
Rule 64B-4.003 F.A.C. - Office Surgery Registration Fee
Rule 64B-4.002 F.A.C. - Office Surgery Inspection Fee
Rule 64B8-9.009 F.A.C. - Standard of Care for Office Surgery
Rule 64B8-9.0091 F.A.C. - Requirement for Physician Office Registration and Accreditation
Rule 64B8-9.0092 F.A.C. - Approval of Physician Office Accrediting Organizations

Q:

What is office based surgery?

A:

Any surgical procedure performed in the physician's office.  You may also review Rule 64B8-9.009(1)(d), F.A.C. for more information.

Q:

What are the levels of office-based surgery?

A:

The levels of surgery are divided into four categories based on the level of anesthesia administered to the patient.

  • Level I (Rule 64B8-9.009(3), F.A.C.) - No drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient and/or the use of local or oral medication that does not alter the consciousness of the patient.
  • Level II (Rule 64B8-9.009(4), F.A.C.) - Any surgery where the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardio-respiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation.
  • Level IIA (Rule 64B8-9.009(5), F.A.C.) - Any Level II surgery with a maximum planned duration of five minutes or less and in which chances of complications requiring hospitalization are remote.
  • Level III (Rule 64B8-9.009(6), F.A.C.) - Any surgery which involves, or reasonably should require, the use of a general anesthesia or major conduction anesthesia and pre-operative sedation. This includes 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.

Q:

Who must register to perform office surgery?

A:

Physicians who perform Level II and Level III surgical procedures in the office setting must register the facility and each physician performing procedures at that location. You may also review Rule 64B-4.003(1)(a), F.A.C. for more information.

Q:

How do I register to perform office surgery?

A:

Please print and fill out the Office Surgery Registration Application. Mail the completed form, along with the required $150.00 fee, to Department of Health, P.O. Box 6330, Tallahassee, FL 32314-6330.  You may also contact our Communications Center at (850) 488-0595 to have the form mailed to you.

Q:

How much is the office surgery registration fee?

A:

The fee is $150.00.  You may also review Rule 64B-4.003(2), F.A.C. for more information.

Q:

How long does the registration process take?

A:

Most registration applications can be processed and approved within 30 days of receiving a complete application.  Incomplete applications will take longer to process.

Q:

What documents are required with the application?

A:

The following documents are required:

  • Copy of Board certification certificate from American Board Medical Specialties or a Board eligibility letter
  • Staff privileges letter with a copy of the delineation of privileges
  • Transfer agreement (Level II surgery only)        
  • Advanced Cardiac Life Support certification for the physician and recovery personnel
  • Copy of Basic Life Support/Advanced Certified Life Support certification for assistants
  • Copies of all "protocol agreements" between physicians and Advanced Registered Nurse Practitioners and Certified Registered Nurse Anesthetists

Q:

What kind of education, training, and background are required before performing office surgery?

A:

Physicians are expected to perform only those surgeries for which they are competent to perform. Specific education requirements are listed in Rules 64B8-9.009(4)(b)2.a.b. and 64B8-9.009(6)(b)1.a.b., F.A.C..

Q:

Is the physician performing office surgery required to have staff privileges at a hospital?                                                                                                                          

A:  Physicians who perform Level III office-based surgery must have staff privileges to perform the same procedures at a hospital licensed under s. 395, F. S. You may also review Rule 64B8-9.009(6)(b)1.a., F.A.C. for more information.

Q:

When is a transfer agreement required?

A:

A physician performing Level II office surgery needs either staff privileges to perform the same procedures at a licensed hospital or a transfer agreement with a licensed hospital within 30 minutes travel time.  You may also review Rule 64B8-9.009(4)(b)1., F.A.C. for more information.

Q:

Are physicians required to be certified in Advanced Cardiac Life Support (ACLS)?

A:

The surgeon/physician performing surgical procedures and recovery room personnel must be certified in ACLS.  One assistant to the surgeon/physician (if needed) must be certified in Basic Life Support (BLS).  You may also review Rules 64B8-9.009(4)(b)4. and 64B8-9.009(6)(b)4., F.A.C. for more information.

Q:

Who is allowed to provide anesthesia?

A:

The surgeon must be assisted by a qualified anesthesia provider. Licensed health care personnel, such as a physician/anesthesiologist, Certified Registered Nurse Anesthetist (CRNA), Physician Assistant (PA), Anesthesiology Assistant (AA) or Registered Nurse (RN) qualified by training in anesthesiology, may assist the surgeon.  You may also review Rules 64B8-9.009(4)(b)4. and 64B8-9.009(6)(b)4., F.A.C. for more information.

Q:

Can the surgeon administer anesthesia and perform the procedure?

A:

A physician cannot administer the anesthesia and perform the surgical procedure. A qualified anesthesia provider is required to administer the anesthesia and cannot perform any other function in the operation room.  You may also review Rule 64B8-9.009(4), F.A.C. for more information.

Q:

What medication is required to be on the crash cart?

A:

The crash cart must include, at a minimum, the following resuscitative medications:

  • Adenosine 6 mg/2 ml x 3
  • Albuterol Inhaler
  • Amiodarone 150 mg x 2
  • Atropine 0.4 mg/ml; 3 ml
  • Calcium chloride 10%; 10 ml
  • Dextrose 50%; 50 ml
  • Diphenhydramine 50 mg
  • Dopamine 200 mg minimum
  • Epinephrine 1:10,000 dilution; 10 ml
  • Epinephrine 1:1000 dilution; 1 ml x 3
  • Flumazenil 0.1 mg/ml; 5 ml x 2
  • Furosemide 40 mg
  • Hydrocortisone or Methylprednisolone or Dexamethasone
  • Lidocaine 100 mg
  • Magnesium sulfate 1 gm x 2
  • Naloxone 0.4 mg/ml; 3 ml
  • Propranolol 1 mg x 1
  • Sodium bicarbonate 50 mEq/50 ml
  • Succinylcholine 1 vial
  • Vasopressin 20 units x 2
  • Verapamil 5 mg x 2

You may also see Rule 64B8-9.009(4)(b), F.A.C. for more information.

Q:

What equipment is required in the operating room?

A:

Level II office surgeries require the following equipment:

  • Full and current crash cart at the location the anesthetizing is being carried out
  • A Benzodiazepine must be stocked, but not on the crash cart
  • Suction devices, endotracheal tubes, laryngoscopes, etc.
  • Positive pressure ventilation device (e.g. Ambu) plus oxygen supply
  • Double tourniquet for the Bier block procedure
  • Monitors for blood pressure/EKG/Oxygen saturation
  • Emergency intubation equipment
  • Adequate operating room lighting
  • Emergency power source able to produce adequate power to run required equipment for a minimum of two (2) hours
  • Appropriate sterilization equipment
  • IV solution and IV equipment

You may also see Rules 64B8-9.009(2) and 64B8-9.009(4)(b)3., F.A.C. for more information.

Q:

What are the standard dimensions of the operating room?

A:

The rules do not specify standard dimensions for the physical plant of an office surgery facility. It is suggested that you contact your local city and county clerk's office for specific rules and code descriptions and restrictions.

Q:

Who is required to be certified in Basic Life Support (BLS)?

A:

At least one staff person assisting the surgeon/physician during surgery must be certified in BLS.  You may also see Rules 64B8-9.009(4)(b)2.b. and 64B8-9.009(6)(b)1.b., F.A.C. for more information.

Q:

Who can assist the surgeon during the procedure?

A:

The surgeon must be assisted by a qualified anesthesia provider or a registered nurse (RN) may assist with the anesthesia if the surgeon is Advanced Cardiac Life Support (ACLS) certified.  An assisting anesthesia provider cannot function in any other capacity during the procedure.  If additional assistance is required by the specific procedure or patient circumstances, it must be provided by a physician, osteopathic physician, RN, licensed practical nurse (LPN) or an operating room technician. You may also see Rule 64B8-9.009(4), F.A.C. for more information.

Q:

Who can monitor and supervise the recovery of a patient?

A:

Licensed health care providers are required to monitor the recovery of a patient who has been given anesthesia. A physician, osteopathic physician, physician assistant (PA), or a licensed registered nurse (RN) with post-anesthesia training and experience must be available.   You may also see Rule 64B8-9.009(4)(b)4., F.A.C. for Level II office surgery and see Rule 64B8-9.009(6)(b)4., F.A.C. for Level III office surgery.

Q:

How many health care providers are required in the recovery room?

A:

At least two monitors should be in the recovery room, one of which must be certified in Advanced Cardiac Life Support (ACLS).  You may also see Rule 64B8-9.009(2)(h)1., F.A.C. for more information.

Q:

Is a surgical log required?

A:

Yes, a surgical log is required. Copies of the suggested form are available online at the Board of Medicine Web Site.  You may also see Rule 64B8-9.009(2)(c), F.A.C. for more information.

Q:

What should be recorded on the surgical log?

A:

The items required on the surgical log form are:

  • Confidential patient identifier
  • Time of arrival in the operating suite
  • Name of the physician who provided medical clearances
  • Surgeon's name
  • Diagnosis
  • CPT Codes
  • Patient ASA classification
  • Type of procedure
  • Level of surgery
  • Anesthesia provider
  • Type of anesthesia used
  • Duration of the procedure
  • Type of post-operative care
  • Duration of recovery
  • Disposition of the patient upon discharge
  • List of medications used during surgery and recovery
  • Any adverse incidents, as identified in Section 458.351, F.S.

You may also see Rule 64B8-9.009(2)(c), F.A.C. for more information.

Q:

Where can I get a copy of the Sample Surgical Log form?

A:

The suggested surgical log form is available.

Q:

What is an adverse incident?

A:

For purposes of reporting to the department, an adverse incident is an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: 

  • The death of a patient
  • Brain or spinal damage to a patient
  • The performance of a surgical procedure on the wrong patient
  • A procedure to remove unplanned foreign objects remaining from a surgical procedure
  • The performance of a wrong-site surgical procedure; the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and and if one of the listed procedures in this paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient
  • Any condition that required the transfer or a patient to a hospital licensed under s. 395, F.S., from any facility or any office maintained by a physician for the practice of medicine which is not licensed under s. 395, F.S.

You may also see Rule 64B9-9.001(1)(a), F.A.C. for more information.

Q:

Who is required to report an adverse incident?

A:

The report must be submitted by every licensee who was involved in the adverse incident. If multiple licensees are involved in the adverse incident, they may meet this requirement by signing off on one report; however, each signee is responsible for the accuracy of the report. You may also see Rule 64B8-9.001(2) F.A.C. for more information.

Q:

Is there a time limitation on reporting adverse incidents?

A:

Incident reports shall be postmarked and sent by certified mail within 15 calendar days after the occurrence of the adverse incident.

Q:

How can I obtain a copy of the adverse incident reporting form?

A:

You may download and print a copy of the Physician Incident Reporting Form or by calling us at (850) 245-4131.

Q:

Where should I send the adverse incident report?

A:

Mail the completed incident report by certified mail to Department of Health, Consumer Services Unit, 4052 Bald Cypress Way, Bin #C75, Tallahassee, Florida 32399.

Q:

If a death occurs, who should be notified?

A:

The county medical examiner should be notified immediately. You may also see Rule 64B8-9.001(3) F.A.C. for more information.

Q:

What is the pause/time out rule?

A:

The pause/time out rule is intended to prevent wrong site, wrong side, wrong patient and wrong surgeries/procedures by requiring the team to pause prior to the initiation of the surgery/procedure to confirm the side, site, patient identity, and surgery/procedure.You may also see Rule 4B8-9.007, F.A.C. for more information.

Q:

Who is required to perform the pause/time out before surgery begins?

A:

Both the physician office setting and the facilities licensed under s. 395 F. S., (hospitals and ambulatory surgical centers) are required to perform the pause/time out rule.  The physician and surgical team will pause immediately prior to the initiation of any surgical procedure to confirm the patient's identification, the surgical procedure and correct surgical site.  You may also see Rule 64B8-9.007(2)(b), F.A.C. for more information.

Q:

What is the definition of a "pediatric patient"?

A:

A pediatric patient is a child of 13 years of age or younger.  Certification in Pediatric Advanced Life Support is required when treating pediatric patients.  You may also review Rule 64B8-9.009(1)(e), F.A.C. for more information.

Q:

Which nationally recognized accrediting agencies are accepted by the Department of Health?

A:

The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), Accreditation Association for Ambulatory Health Care (AAAHC), and Joint Commission on Accreditation of Healthcare Organizations (JCAHO).  You may also see Rule 64B8-9.0091, F.A.C. for more information.

Q:

I am accredited with a nationally recognized accrediting agency.  What documentation should I submit? 

A:

Submit a copy of your accreditation certificate and a copy of your accreditation survey with your application and after each inspection to Department of Health, P.O. Box 6330, Tallahassee, FL 32314-6330.

Q:

Who is inspected by the Department of Health?

A:

When an application for office surgery registration is completed, the physician chooses either an annual inspection by the Department or to hold current accreditation with a national accrediting organization or an accrediting organization approved by the Florida Board of Medicine.  You may also review Rule 64B8-9.0091, F.A.C. for more information.

Q:

What is the process for the Department of Health inspection?

A:

One of our inspectors will contact the facility office at least one week in advance to make an appointment for the inspection. On the day of the inspection, the physician/representative should be available to accompany the inspector. After the inspection, the inspector will go over the survey with the physician/representative and indicate any deficiencies. The physician/representative is required to submit a corrective action plan to the Board of Medicine within 30 days from the date of the inspection. You may also review Rule 64B8-9.0091, F.A.C. for more information.

Q:

How much is the inspection fee?

A:

The inspection fee is $1500.00 payable after the facility is inspected.  An invoice is generated and mailed to the facility for payment of the inspection fee.  You may also see Rule 64B-4.002, F.A.C. for more information.
Related entities:
The Health Care Clinic Act, s. 400, F.S., and Rule 59A-33, F.A.C., provides for the regulation of certain physician practices that are not wholly owned by physicians or their immediate family.
For information about health care clinics, hospitals and ambulatory surgery centers, please call the Agency for Health Care Administration at (850) 487-2717.