Office Surgery Registration Program
If a death occurs, who should be notified?
The county medical examiner should be notified immediately. See Rule 64B8-9.001(3), F.A.C., for more information.
What are the standard dimensions of a procedure room?
Applicable statutes and 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.
Who can assist a physician/surgeon during a procedure?
A physician/surgeon must be assisted by a qualified anesthesia provider, or a registered nurse may assist with the anesthesia if the physician/surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required due to the specific procedure or patient circumstances, it must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. See Rule 64B8-9.009(4), F.A.C., for more information.
Who can monitor and supervise the recovery of a patient?
Licensed health care providers are required to monitor the recovery of a patient who has been given anesthesia. A physician, osteopathic physician, physician assistant, or registered nurse with an ACLS certification (for Level II procedures) and post-anesthesia training and experience (for Level III procedures) must be available. See Rule 64B8-9.009(4)(b)4., F.A.C., for Level II office surgeries and see Rule 64B8-9.009(6)(b)4., F.A.C., for Level III office surgeries.
How many health care providers are required in the recovery room?
At least two monitors must be in the recovery room at all times, one of whom must be ACLS certified when the patient has undergone a Level II procedure and one of whom must be ACLS certified and have post-anesthesia care training and experience when the patient has undergone a Level III procedure. See Rule 64B8-9.009(2)(h)1., F.A.C., for more information.
Is a surgical log required?
Yes, a surgical log is required. Copies of the suggested form are available online at the Board of Medicine website. See Rule 64B8-9.009(2)(c), F.A.C., for more information.
What should be recorded on the surgical log?
The information required on the surgical log are:
- Confidential patient identifier
- Time of arrival in the procedure room
- 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 postoperative care
- Duration of recovery
- Disposition of the patient upon discharge
- List of medications used during surgery and recovery
- Any adverse incidents as defined in section 458.351, F.S.
See Rule 64B8-9.009(2)(c), F.A.C., for more information.
What is an adverse incident?
For purposes of reporting to the Department of Health, an adverse incident is an event over which a 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 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 section 395, F.S., from any facility or any office maintained by a physician for the practice of medicine that is not licensed under section 395, F.S.
See Rule 64B9-9.001(1)(a), F.A.C., for more information.
Who is required to report an adverse incident?
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. See Rule 64B8-9.001(2), F.A.C., for more information.
Is there a time limitation on reporting adverse incidents?
Adverse incident reports must be postmarked and sent by certified mail or emailed within 15 calendar days after the occurrence of the adverse incident.
How can I obtain a copy of the adverse incident reporting form?
You may download and print a copy of the Physician Office Adverse Incident Report form.
Where should I send the adverse incident report?
Mail by certified mail the completed adverse incident report to
Department of Health, Consumer Services Unit,
4052 Bald Cypress Way, Bin C-75,
Tallahassee, Florida 32399
or send by email to MQA.ConsumerServices@flhealth.gov.
What equipment is required in the procedure room?
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 plus an oxygen supply
- Double tourniquet for the Bier block procedure
- Monitors for blood pressure/EKG/oxygen saturation
- Emergency intubation equipment
- Adequate lighting
- Emergency power source able to produce adequate power to run required equipment for a minimum of two hours
- Appropriate sterilization equipment
- IV solution and IV equipment
See Rules 64B8-9.009(2) and 64B8-9.009(4)(b)3., F.A.C., for more information.
Am I required to retain a risk manager in my office?
The rules require physicians performing office surgery to have a risk management program. It does not require them to retain a risk manager. See Rule 64B8-9.009, F.A.C., for more information
What is the pause/time out rule?
The pause/time out rule is intended to prevent wrong site, wrong side, wrong patient, and wrong surgeries/procedures by requiring the surgical team to pause prior to the initiation of a surgery/procedure to confirm the side, site, patient identity, and surgery/procedure to be performed. See Rule 64B8-9.007, F.A.C., for more information.
Who is required to perform the pause/time out before surgery begins?
Office surgery facilities and facilities licensed under section 395, F.S., (hospitals and ambulatory surgical centers) are required to perform a pause/time out. See Rule 64B8-9.007(2)(b), F.A.C., for more information.
Who is inspected by the Department of Health?
All office surgery facility applicants must undergo a preregistration inspection. Once an application for office surgery registration is approved, the facility chooses either to undergo annual inspections by the Department of Health or to hold a current accreditation with a national accrediting organization or an accrediting organization approved by the Florida Board of Medicine. See Rule 64B8-9.0091, F.A.C., for more information.
How much is the inspection fee?
The inspection fee is $1500 payable after the facility is inspected. Following an inspection, an invoice is generated and mailed or emailed to the facility for payment of the fee. See Rule 64B-4.002, F.A.C., for more information.
Which nationally recognized or board-approved accrediting agencies are accepted under the applicable rule?
QUAD A, Accreditation Association for Ambulatory Health Care, Joint Commission on Accreditation of Healthcare Organizations, and American Accreditation Commission International. See Rule 64B8-9.0092, F.A.C., for more information.
I am accredited with a nationally recognized or board-approved accrediting agency. What documentation should I submit?
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, Post Office Box 6330, Tallahassee, FL 32314-6330 or send by email to PMC_OSR@flhealth.gov.
Am I required to complete the Professional Liability Coverage Disclosure?
Yes. All office surgery facility applicants must complete the Professional Liability Coverage Disclosure, choosing the option(s) that best describe(s) the facility.
If gluteal fat grafting procedures are performed at an office surgery facility, does that facility have additional financial responsibility requirements?
Yes. If gluteal fat grafting procedures are being performed, the office surgery facility applicant must establish and maintain additional liability coverage. See Section 458.328(1)(c), F.S.
Are typed or electronic signatures allowed on the signature page of the application?
No. Only hand-written signatures are acceptable.
Is a physician performing office surgery required to have staff privileges at a hospital?
Unless they are board certified or board eligible and are under a qualifying transfer agreement, physicians who perform Level II or Level III office-based surgeries must have staff privileges to perform the same procedures at a hospital licensed under section 395, F.S. See Rule 64B8-9.009(6)(b)1.a., F.A.C., for more information.
What is office surgery?
Any surgical procedure performed in a physician’s office. See Rule 64B8-9.009(1)(d), F.A.C., for more information.
What are the laws and rules regulating office surgery in Florida?
Section 458.238, F.S. – Office Surgeries
Rule 64B-4.002, F.A.C. – Office Surgery Inspection Fee
Rule 64B-4.003, F.A.C. – Office Surgery Registration Requirements, Fees
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; Inspection or Accreditation
Rule 64B8-9.0092, F.A.C. – Approval of Physician Office Accrediting Organizations
What are the different levels of office surgery?
Level I office surgeries (Rule 64B8-9.009(3), F.A.C.) include, but are 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 preoperative tranquilization of the patient.
- Liposuction involving the removal of less than 1000cc supernatant fat.
- Incision and drainage of superficial abscesses, limited endoscopies such as proctoscopies, skin biopsies, arthrocentesis, thoracentesis, paracentesis, dilation of urethra, cystoscopic procedures, and closed reduction of simple fractures or small joint dislocations (i.e., finger and toe joints).
- Anesthesia is local, topical, or none. There is no drug-induced alteration of consciousness other than minimal preoperative tranquilization of the patient.
- Chances of complications requiring hospitalization are remote.
Level II office surgeries (Rules 64B8-9.009(4) and (5), F.A.C.) include, but are not limited to, the following:
- Procedures during which perioperative medication and sedation are administered intravenously, intramuscularly, or rectally, thus making intra- and postoperative monitoring necessary.
- Hemorrhoidectomies, hernia repairs, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopies, and liposuction involving the removal of up to 4000cc supernatant fat.
- Surgeries 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 (Rule 64B8-9.009(6), F.A.C.) is that surgery which involves, or reasonably should require, the use of general anesthesia or major conduction anesthesia and preoperative sedation. This includes, but is not limited to, the use of:
- Intravenous sedation beyond that defined for Level II office surgery. General anesthesia refers to a 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 Anesthesiologist’s risk classification criteria as Class I or II are appropriate candidates to undergo Level III office surgery procedures.
How do I register to perform office surgery in a physician’s office?
Please print and fill out the Office Surgery Registration Application. Mail the completed application along with the required registration fee and all staff credentials to Department of Health, Post Office Box 6330, Tallahassee, FL 32314-6330.
How much is the office surgery registration fee?
The fee is $150. See Rule 64B-4.003(2), F.A.C., for more information.
How long does the registration process take?
Most registration applications can be processed and approved within 30 days of receiving a complete application. Incomplete applications will take longer to process.
What is required for a physician to serve as the Designated Physician at an office surgery facility?
To serve as a Designated Physician, a physician must have a current, active, and unencumbered license and practice medicine at the physician office where office surgeries are to be performed.
Is a Designated Physician required to perform office surgeries in order to serve as a Designated Physician?
No. However, before a Designated Physician can perform office surgeries, he or she must provide all necessary credentials to the Department of Health to demonstrated that he or she is qualified to be added to an office surgery registration. If a Designated Physician does not intend to perform office surgeries, he or she must provide a letter to the Department stating that he or she will practice medicine at the office surgery facility but will not perform office surgeries.
When should a physician register with the Office Surgery Registration and Inspection Program?
Every Florida licensed physician who holds an active Florida license and performs certain Level I or any Level II or Level III office surgeries in an office surgery facility registered in Florida must register with the Department of Health. It is the physician’s responsibility to ensure that every office in which he or she performs a regulated procedure is registered regardless of whether other physicians are practicing in the same office or whether the office is non-physician owned.
What kind of education, training, and background are required before a physician can perform office surgeries?
Physicians/surgeons are expected to perform only those surgeries 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.
Are there any exemptions from having to register with this program?
All physicians who perform certain Level I or any Level II or Level III surgical procedures in a physician office setting must register the office with the Department of Health unless that office is licensed pursuant to Chapter 390 or 395, Florida Statutes. Office surgery is defined as surgery that 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.
When is a transfer agreement required?
Among other requirements, a physician/surgeon performing Level II or Level III office surgeries needs either staff privileges to perform the same procedures at a licensed hospital or a qualifying transfer agreement with a licensed hospital within 30 minutes travel time. See Rule 64B8-9.009(4)(b)1., F.A.C., for more information.
If I have staff privileges, do I need a transfer agreement?
No, so long as the staff privileges are at a hospital within reasonable proximity (within 30 minutes), and you are able to perform the same procedures with your staff privileges as those performed in the office surgery facility.
Are physicians/surgeons required to be certified in Advanced Cardiac Life Support (ACLS)?
The physician/surgeon performing surgical procedures and recovery room personnel must be certified in ACLS by an approved provider. See Rules 64B8-9.009(4)(b)4. and 64B8-9.009(6)(b)4., F.A.C., for more information.
Who is required to be certified in Basic Life Support (BLS)?
At least one staff person assisting the physician/surgeon during surgery must be certified in BLS by an approved provider. See Rules 64B8-9.009(4)(b)2.b. and 64B8-9.009(6)(b)1.b., F.A.C., for more information.
What is the definition of a “pediatric patient?”
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. See Rule 64B8-9.009(1)(e), F.A.C., for more information.
What documentation is needed to prove level of training required?
A physician/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, must be able to document satisfactory completion of training such as Board certification or Board eligibility 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 comparable background, training, and experience. In addition, the physician/surgeon must have knowledge of the principles of general anesthesia.
What if a new physician/surgeon enters my office surgery practice?
Every Florida licensed physician who holds an active Florida license and performs Level II or Level III office surgery, as fully defined in Rule 64B8-9.009, F.A.C., must 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. The new physician/surgeon must submit a signed office surgery registration form and all required documentation. The physician/surgeon must immediately notify the Board office, in writing, of any changes to the registration information. Office Surgery Registration Application.
Who is allowed to provide anesthesia?
A physician/surgeon cannot provide anesthesia when performing Level II or Level III procedures. In such cases, anesthesia must be provided by a qualified anesthesia provider. Licensed health care personnel, such as a physician/anesthesiologist, certified registered nurse anesthetist, physician assistant, anesthesiologist assistant under the direct supervision of an anesthesiologist, or registered nurse qualified by training in anesthesiology, may assist the physician/surgeon. See Rules 64B8-9.009(4)(b)4. and 64B8-9.009(6)(b)4., F.A.C., for more information.
Can the physician/surgeon administer anesthesia and perform the surgical procedure?
A physician/surgeon cannot administer anesthesia and perform the surgical procedure. A qualified anesthesia provider is required to administer the anesthesia and cannot perform any other function in the procedure room. See Rule 64B8-9.009(4), F.A.C., for more information.
What medication is required to be on the crash cart in an office surgery facility?
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
- Paralytic agent that is appropriate for use in rapid sequence intubation
- A calcium channel blocker class drug
- Intralipid 20% 500 ml solution (only if non-neuraxial regional blocks are performed)
See Rule 64B8-9.009(4)(b), F.A.C., for more information.