Florida Administrative Code
64 - DEPARTMENT OF HEALTH
64B8 - Board of Medicine
Chapter 64B8-9 - STANDARDS OF PRACTICE FOR MEDICAL DOCTORS
Section 64B8-9.009 - Standard of Care for Office Surgery

1. For the purpose of this rule office surgery is defined as surgery which is performed in an office maintained by a physician for the practice of medicine where a surgeon performs procedures as permitted by this rule and is governed pursuant to Rule 64B8-9.0091, F.A.C., and Section 458.328, F.S. The physician's office must be an office at which the surgeon regularly performs consultations with surgical patients, pre-surgical examinations, and post-surgical care related to the surgeries performed at the physician's office, and where patient records are readily maintained and available. Office surgical procedures shall not be of a type that generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin; require major or prolonged intracranial, intrathoracic, abdominal, or major joint replacement procedures, except for laparoscopic procedures; involve major blood vessels performed with direct visualization by open exposure of the major vessel, except for percutaneous endovascular intervention; or are generally emergent or life threatening in nature.

2. A facility that meets the definition of an ambulatory surgical center as defined in Section 395.002(3), F.S., a hospital as defined in Section 395.002(12), F.S., or an abortion clinic as defined in Section 390.011(2), F.S., may not be registered as an office surgery facility under Rule 64B8-9.0091, F.A.C.

1. When combined with abdominoplasty, liposuction may not exceed 1000cc of supernatant fat,

2. When liposuction is associated and directly related to another procedure, the liposuction may not exceed 1000 cc of supernatant fat,

3. Major liposuction in excess of 1000cc supernatant fat may not be performed in a remote location from any other procedure.

1. These standards apply to general anesthetics, regional anesthetics, and monitored anesthesia care (Level II and III as defined by this rule) although, in emergency circumstances, appropriate life support measures take precedence. These standards may be exceeded at any time based on the judgment of the responsible supervising physician or anesthesiologist. They are intended to encourage quality patient care, but observing them cannot guarantee any specific patient outcome. They are subject to revision from time to time, as warranted by the evolution of technology and practice. This set of standards addresses only the issue of basic anesthesia monitoring, which is one component of anesthesia care.

2. In certain rare or unusual circumstances some of these methods of monitoring may be clinically impractical, and appropriate use of the described monitoring methods may fail to detect untoward clinical developments. Brief interruptions of continual monitoring may be unavoidable. For purpose of this rule, "continual" is defined as "repeated regularly and frequently in steady rapid succession" whereas "continuous" means "prolonged without any interruption at any time."

3. Under extenuating circumstances, the responsible supervising physician or anesthesiologist may waive the requirements marked with an asterisk (*); it is recommended that when this is done, it should be so stated (including the reasons) in a note in the patient's medical record. These standards are not intended for the application to the care of the obstetrical patient in labor or in the conduct of pain management.

1. The office must provide at least two (2) monitors, one of these monitors must be certified in Advanced Cardiac Life Support (ACLS), and maintain a monitor to patient ratio of at least 1 monitor to 2 patients. Once the surgeon has signed a timed and dated discharge order, the office may provide only one monitor to monitor the patient. The monitor must be qualified by licensure and training to administer all of the medications required on the crash cart and must be certified in Advanced Cardiac Life Support. The full and current crash cart required below must be present in the office and immediately accessible for the monitors.

2. The surgeon must be reachable by telephone and readily available to return to the office if needed. For purposes of this subsection, "readily available" means capable of returning to the office within 15 minutes of receiving a call.

1. The identification, investigation, and analysis of the frequency and causes of adverse incidents to patients,

2. The identification of trends or patterns of incidents,

3. The development of appropriate measures to correct, reduce, minimize, or eliminate the risk of adverse incidents to patients; and,

4. The documentation of these functions and periodic review no less than quarterly of such information by the surgeon.

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. Anesthesia is limited to minimal sedation. The patient's level of sedation is that of minimal sedation and anxiolysis and the chances of complications requiring hospitalization are remote. Minimal sedation and anxiolysis is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and physical coordination may be impaired, airway reflexes, and ventilatory and cardiovascular functions are unaffected. Controlled substances, as defined in Sections 893.02 and 893.03, F.S., are limited to oral administration in doses appropriate for the unsupervised treatment of insomnia, anxiety or pain.

5. Chances of complication requiring hospitalization are remote.

1. Training Required. Surgeon's continuing medical education should include: proper dosages; management of toxicity or hypersensitivity to regional anesthetic drugs. One assistant must hold current certification in an American Heart Association, American Safety and Health Institute, American Red Cross, Pacific Medical Training approved Basic Life Support course with didactic and skills components, or ACLS Certification Institute Basic Life Support course with didactic and skills components, and the surgeon must hold current certification in an American Heart Association, American Safety and Health Institute, Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components, or ACLS Certification Institute Advanced Cardiac Life Support course with didactic and skills components.

2. Equipment and Supplies Required. Intravenous access supplies, oxygen, oral airways, and a positive pressure ventilation device shall be available in the office, along with the following medications, stored per manufacturer's recommendation:

3. When performing 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, physicans are exempt from subparagraphs (3)(b)1. and 2., above. Current Basic Life Support certification is recommended but not required.

4. Assistance of Other Personnel Required. No other assistance is required, unless the specific surgical procedure being performed requires an assistant.

1. Level II Office Surgery shall include, but not be limited to: hemorrhoidectomy, hernia repair, large joint dislocations, colonoscopy, and liposuction involving the removal of up to 4,000cc supernatant fat.

2. Level II Office surgery includes any surgery in which the patient's level of sedation is that of moderate sedation and analgesia or conscious sedation. Moderate sedation and analgesia or conscious sedation is a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is maintained. Reflex withdrawal from a painful stimulus is not considered a purposeful response.

1. Transfer Agreement Required. The physician, or the facility where the procedure is being performed, must have a transfer agreement with a licensed hospital within reasonable proximity if the physician performing the procedure does not have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity. "Reasonable proximity" is defined as not to exceed thirty (30) minutes transport time to the hospital. The transfer agreement required by this rule must be current and have been entered into no more than five (5) years prior to the date of the inspection. A transfer agreement must affirmatively disclose an effective date.

2. Training Required.

3. Equipment and Supplies Required.

4. Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthesist, or Physician Assistant qualified as set forth in subparagraph 64B8-30.012(2)(b) 6., F.A.C., or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An anesthesiologist assistant may assist the anesthesiologist as set forth in Rule 64B8-31.005, F.A.C. 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, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. A physician licensed under Chapter 458 or 459, F.S., a licensed physician assistant, a licensed registered nurse with post-anesthesia care unit experience or the equivalent, credentialed by an American Heart Association, American Safety and Health Institute, Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components, or ACLS Certification Institute Advanced Cardiac Life Support Couse with didactic and skills components or, in the case of pediatric patients, by an American Heart Association, American Safety and Health Institute, or Pacific Medical Training approved Pediatric Advanced Life Support course with didactic and skills components must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia.

1. The standards set forth in subsection 64B8-9.009(4), F.A.C., must be met except for the requirements set forth in subparagraph 64B8-9.009(4)(b) 4., F.A.C., regarding assistance of other personnel.

2. Assistance of Other Personnel Required. During the procedure, the surgeon must be assisted by a physician or physician assistant who is licensed pursuant to Chapter 458 or 459, F.S., or by a licensed registered nurse or a licensed practical nurse. Additional assistance may be required by specific procedure or patient circumstances. Following the procedure, a physician or physician assistant who is licensed pursuant to Chapter 458 or 459, F.S., or a licensed registered nurse must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia. The monitor must be certified by an American Heart Association, American Safety and Health Institute, Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components, or ACLS Certification Institute Advanced Cardiac Life Support Course with didactic and skills components or, in the case of pediatric patients, by an American Heart Association, American Safety and Health Institute, or Pacific Medical Training approved Pediatric Advanced Life Support course with didactic and skills compenents.

1. Level III Office Surgery is that surgery in which the patient's level of sedation is that of deep sedation and analgesia or general anesthesia. Deep sedation and analgesia is a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. Reflex withdrawal from a painful stimulus is not considered a purposeful response. General anesthesia is a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. The use of spinal or epidural anesthesia shall be considered Level III.

2. 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.

1. Training Required.

2. Emergency policies and procedures related to serious anesthesia complications shall be formulated, periodically reviewed, practiced, updated, and posted in a conspicuous location. Topics to be covered shall include the following:

3. Equipment and Supplies Required.

4. Assistance of Other Personnel Required. An Anesthesiologist, Certified Registered Nurse Anesthetist, Anesthesiologist Assistant, or Physician Assistant qualified as set forth in subparagraph 64B8-30.012(2)(c) 6., F.A.C., must administer the general or regional anesthesia and an M.D., D.O., Registered Nurse, Licensed Practical Nurse, Physician Assistant, or Operating Room Technician must assist with the surgery. The anesthesia provider cannot function in any other capacity during the procedure. A physician licensed under Chapter 458 or 459, F.S., a licensed anesthesiologist assistant, a licensed physician assistant, or a licensed registered nurse with post-anesthesia care unit experience or the equivalent, and credentialed by an American Heart Association, American Safety and Health Institute, Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components, or ACLS Certification Institute Advanced Cardiac Life Support course with didactic and skills components, or in the case of pediatric patients, by an American Heart Association, American Safety and Health Institute, Pacific Medical Training approved Pediatric Advanced Life Support course with didactic and skills components, must be available to monitor the patient in the recovery room until the patient has recovered from anesthesia.