Ga. Comp. R. & Regs. R. 360-41-.02 - Regulations for Facilities and Physicians

(1) Application of rules. These rules apply to physicians practicing independently or in a group setting who perform office based surgery employing one or more of the following levels of sedation or anesthesia:

(a) Moderate sedation/analgesia;

(b) Deep sedation/analgesia;

(c) Major conduction anesthesia; or

(d) General anesthesia.

(2) Accreditation or certification. Physicians who perform any procedures utilizing moderate sedation/analgesia, deep sedation/analgesia, major conduction anesthesia, or general anesthesia must ensure that the procedure is performed in a facility that is appropriately equipped and maintained to ensure patient safety, which may be demonstrated by accreditation by any of the following entities:

(a) The Joint Commission;

(b) The Accreditation Association for Ambulatory Care;

(c) The American Association for Accreditation of Ambulatory Surgery Facilities; or

(d) The Centers for Medicare and Medicaid Services

(3) Competency. When an anesthesiologist or certified registered nurse anesthetist is not present, the physician performing office based surgery using moderate sedation/analgesia, deep sedation/analgesia, major conduction anesthesia, or general anesthesia must be competent and qualified to oversee the administration of intravenous sedation/analgesia through one of the following training pathways:

(a) Completion of a continuing medical education course in conscious sedation;

(b) Training in conscious sedation in a residency program; or

(c) Having privileges for conscious sedation granted by a hospital medical staff.

(4) Separation of surgical and monitoring functions.

(a) The physician performing the surgical procedure must not administer the intravenous sedation or monitor the patient.

(b) The licensed health care practitioner designated by the physician to administer the intravenous sedation and monitor the patient may assist the physician with minor interruptible tasks for short duration once the patient's level of sedation and vital signs have been stabilized, provided that adequate monitoring of the patient's condition is maintained. The licensed health care practitioner who administers intravenous medication under deep sedation/analgesia or general anesthesia must not perform or assist with the procedure.

(5) Sedation assessment and management.

(a) Sedation is a continuum. Depending on the patient's response to drugs, the drugs administered, and the dose and timing of administration, it is possible that a deeper level of sedation will be produced than initially intended.

(b) If an anesthesiologist or certified registered nurse anesthetist is not present, a physician intending to produce a given level of sedation shall rescue a patient that enters a deeper level of sedation than intended.

(c) If a patient enters into a deeper level of sedation than planned, the physician must return the patient to the lighter level of sedation as quickly as possible while closely monitoring the patient to make sure the airway is patent, the patient is breathing, and that oxygenation, heart rate, and blood pressure are within acceptable values.

(d) Instructions to avoid driving, operating machinery, consuming alcoholic beverages, and making important decisions for 24 hours should be provided for patients who undergo deep sedation/analgesia.

(6) Emergency care and transfer protocols. A physician performing office based surgery must ensure that in the event of a life-threatening complication or emergency that:

(a) At least one health care provider certified in advanced resuscitative techniques appropriate for the patient age group (i.e., ACLS, PALS, or APLS) must be present or immediately available with age-size-appropriate resuscitative equipment throughout the procedure and until the patient has met the criteria for discharge from the facility.

(b) All office personnel are familiar with a written, documented plan to timely and safely transfer patients to an appropriate hospital that includes a proven accessible route for stretcher transport of the patient out of the office, arrangement for emergency medical services and appropriate escort of the patient to the hospital, and a compliance process to notify the Board of an adverse event as specified in 360-41-.04; and

(c) Resuscitative equipment is immediately available. Such equipment should be evaluated for functionality every 6 months and records of such evaluations should be maintained within the facility.

(7) Standard of practice. Any licensed physician engaging in surgery in office based surgery must have received appropriate training and education in the safe and effective performance of all procedures performed in the facility. Such training and education shall include:

(a) Indications and contraindications for each procedure;

(b) Identification of realistic and expected outcomes for each procedure;

(c) Selection, utilization, and maintenance of products and equipment;

(d) Appropriate technique for each procedure, including infection control and safety precautions;

(e) Pharmacologic intervention specific to each procedure;

(f) Identification of complications and adverse reactions for each. procedure; and

(g) Emergency procedures to be used in the event of:

(i) Complications;

(ii) Adverse reactions;

(iii) Equipment malfunctions; or

(iv) Any other interruption of a procedure.

(8) Adverse events. Any incident within the facility that results in a patient death or transport of the patient to the hospital for observation or treatment for a period in excess of 24 hours shall be reported to the Board in writing within 10 working days of the death or hospitalization.

(9) Truth in advertising. The credentials, education and training received, specialty board certification, and proficiency evaluations of all personnel involved in performing surgical procedures shall be accurately presented in any form of advertising and shall be readily available inwriting to all patients.

Notes

Ga. Comp. R. & Regs. R. 360-41-.02

O.C.G.A. § 43-34-47.

Original Rule entitled "Regulations for Facilities and Physicians" adopted. F. Apr. 26, 2023; eff. May 16, 2023.