South Carolina Code of Regulations › Chapter 81 - DEPARTMENT OF LABOR, LICENSING AND REGULATION STATE BOARD OF MEDICAL EXAMINERS › Article 9.7 - OFFICE-BASED SURGERY › Section 81-96 - Office Based Surgery

Current through Register Vol. 48, No. 6, June 28, 2024
A. Statement of
			 Intent and Goals
The purpose of this regulation is to promote patient safety in
				the non-hospital office-based setting during procedures that require the
				administration of local anesthesia, sedation/analgesia, or general anesthesia,
				or minor or major conduction block. Moreover, this regulation has been
				developed to provide physicians performing office-based surgery (including
				cryosurgery and laser surgery), that requires anesthesia (including tumescent
				anesthesia), analgesia or sedation, the benefit of uniform professional
				standards regarding qualification of practitioners and staff, equipment,
				facilities and policies and procedures for patient assessment and monitoring.
				Level I procedures as defined in (B)(13) are excluded from this
				regulation.
B. Definitions
For the purpose of this regulation, the following terms are
				defined:
1. "Advanced resuscitative
			 technique" means current certification in Advanced Trauma Life Support (ATLS),
			 Advanced Cardiac Life Support (ACLS), or Pediatrics Advanced Life Support
			 (PALS) as appropriate for the individual patient and surgical situation
			 involved. For example, for those licensees treating adult patients, training in
			 advanced cardiac life support (ACLS) is appropriate; for those treating
			 children, training in pediatric advanced life support (PALS) is
			 appropriate.
2. "Anesthesiologist"
			 means a physician who has successfully completed a residency program in
			 anesthesiology approved by the Accreditation Council of Graduate Medical
			 Education (ACGME) or the American Osteopathic Association (AOA), or who is
			 currently a diplomate of either the American Board of Anesthesiology or the
			 American Osteopathic Board of Anesthesiology, or who was made a Fellow of the
			 American College of Anesthesiology before 1982.
3. "Anesthesiologist's assistant (AA)" means
			 a person licensed by the Board as an anesthesiologist's assistant who is an
			 allied health graduate of an accredited anesthesiologist's assistant program
			 who is currently certified by the National Commission for Certification of
			 Anesthesiologist's Assistants and who works under the direct supervision of an
			 anesthesiologist who is immediately available in the operating suite and is
			 physically present during the most demanding portions of the anesthetic
			 including, but not limited to, induction and emergence.
4. "Board" means the South Carolina State
			 Board of Medical Examiners.
5.
			 "Certified registered nurse anesthetist (CRNA)" means a person licensed by the
			 South Carolina State Board of Nursing as an Advanced Practice Registered Nurse
			 in the category of Certified Registered Nurse Anesthetist.
6. "Complications" means untoward events
			 occurring at any time within 48 hours of any surgery, special procedure or the
			 administration of anesthesia in an office setting including, but not limited
			 to, any of the following: paralysis, malignant hypothermia, seizures,
			 myocardial infarction, renal failure, significant cardiac events, respiratory
			 arrest, aspiration of gastric contents, cerebral vascular accident, transfusion
			 reaction, pneumothorax, allergic reaction to anesthesia, unintended
			 hospitalization for more than 24 hours, or death.
7. "Deep sedation/analgesia" means the
			 administration of a drug or drugs that produce sustained 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.
8. "DHEC" means the S.C. Department of Health
			 and Environmental Control.
9.
			 "General anesthesia" means 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.
10. "Health care
			 personnel" means any office staff member who is licensed or certified by a
			 recognized professional or health care organization such as but not limited to
			 a professional registered nurse, licensed practical nurse, physician assistant
			 or certified medical assistant.
11.
			 "Hospital" means a hospital licensed by the state in which it is
			 situated.
12. "Immediately
			 available" means being located within the office and ready for immediate
			 utilization when needed.
13. "Level
			 I Surgery" means minor procedures in which p.o. preoperative medication and/or
			 unsupplemented local anesthesia is used in quantities equal to or less than the
			 manufacturer's recommended dose adjusted for weight and where the likelihood of
			 complications requiring hospitalization is remote. No drug-induced alteration
			 of consciousness other than preoperative minimal p.o. anxiolysis of the patient
			 is permitted in Level I Office Surgery; the chances of complications requiring
			 hospitalization must be remote.
14.
			 "Local anesthesia" means the administration of an agent that produces a
			 transient and reversible loss of sensation in a circumscribed portion of the
			 body.
15. "Major conduction block"
			 means the injection of local anesthesia to stop or prevent a painful sensation
			 in a region of the body. Major conduction blocks include, but are not limited
			 to, axillary, interscalene, and supraclavicular block of the brachial plexus,
			 spinal (subarachnoid), epidural and caudal blocks.
16. "Minimal sedation" (anxiolysis) means the
			 administration of a drug or drugs that produces a state of consciousness that
			 allows the patient to tolerate unpleasant medical procedures while responding
			 normally to verbal commands. Cardiovascular or respiratory function should
			 remain unaffected and defensive airway reflexes should remain intact.
17. "Minor conduction block" means the
			 injection of local anesthesia to stop or prevent a painful sensation in a
			 circumscribed area of the body (that is, infiltration or local nerve block), or
			 the block of a nerve by direct pressure and refrigeration. Minor conduction
			 blocks include, but are not limited to, intercostal, retrobulbar,
			 paravertebral, peribulbar, pudendal, sciatic nerve, and ankle blocks.
18. "Moderate sedation/analgesia" means the
			 administration of a drug or drugs, which produces depression of consciousness
			 during which patients respond purposefully to verbal commands, either alone or
			 accompanied by light tactile stimulation. Reflex withdrawal from painful
			 stimulation is NOT considered a purposeful response. No interventions are
			 required to maintain a patent airway, and spontaneous ventilation is adequate.
			 Cardiovascular function is usually maintained. This includes dissociative
			 anesthesia, which does not meet the criteria as defined under sustained deep
			 anesthesia or general anesthesia.
19. "Monitoring" means continuous visual
			 observation of a patient and regular observation of the patient as deemed
			 appropriate by the level of sedation or recovery using instruments to measure,
			 display, and record physiologic values such as heart rate, blood pressure,
			 respiration and oxygen saturation.
20. "Office" means a location at which
			 medical or surgical services are performed and which is not subject to
			 regulation by DHEC.
21.
			 "Office-based practice" means procedures performed under this regulation that
			 occur in a physician's office or location other than a hospital or facility
			 licensed by DHEC.
22. "Office-based
			 surgery" means the performance of any surgical or other invasive procedure
			 requiring anesthesia, analgesia, or sedation, including cryosurgery and laser
			 surgery, which results in a necessary patient stay of less than twenty-four
			 consecutive hours and is performed by a physician in a location other than a
			 hospital or a diagnostic treatment center, including free-standing ambulatory
			 surgery centers.
23. "Operating
			 room" means that location in the office or facility dedicated to the
			 performance of surgery or special procedures.
24. "Physical status classification" means a
			 description of a patient used in determining if an office surgery or procedure
			 is appropriate. The American Society of Anesthesiologists (ASA) enumerates
			 classification: I - Normal, healthy patient; II - a patient with mild systemic
			 disease; III- a patient with severe systemic disease limiting activity but not
			 incapacitating; IV- a patient with incapacitating systemic disease that is a
			 constant threat to life; and V- Moribund, patients not expected to live 24
			 hours with or without operation.
25. "Physician" means an individual holding
			 an M.D. or D.O. degree who is authorized to practice medicine in accordance
			 with the South Carolina Medical Practice Act.
26. "Practitioner" means a physician or
			 anesthesiologist assistant, registered nurse or CRNA licensed and practicing
			 within the scope of practice pursuant to South Carolina law.
27. "Recovery area" means a room or limited
			 access area of an office dedicated to providing medical services to patients
			 recovering from surgery or anesthesia.
28. "Special procedure" means patient care
			 which requires entering the body with instruments in a potentially painful
			 manner, or which requires the patient to be immobile, for a diagnostic or
			 therapeutic procedure requiring anesthesia services; for example, diagnostic or
			 therapeutic endoscopy, invasive radiologic procedures, pediatric magnetic
			 resonance imaging; manipulation under anesthesia or endoscopic examination with
			 the use of general anesthetic.
29.
			 "Sufficient knowledge" means a physician holds staff privileges in a South
			 Carolina hospital or ambulatory surgical center which would permit the
			 physician to supervise the anesthesia, or the physician must be able to
			 document certification or eligibility by a specialty board approved by the
			 American Board of Medical Specialties or American Osteopathic Association, or
			 the physician must be able to demonstrate comparable background, formal
			 training, or experience in supervising the anesthesia, as approved by the
			 Board.
30. "Surgery" means any
			 operative or manual procedure performed for the purpose of preserving health,
			 diagnosing or treating disease, repairing injury, correcting deformity or
			 defects, prolonging life or relieving suffering, or any elective procedure for
			 aesthetic or cosmetic purposes. This includes, but is not limited to, incision
			 or curettage of tissue or an organ, suture or other repair of tissue or an
			 organ, extraction of tissue from the uterus, insertion of natural or artificial
			 implants, closed or open fracture reduction, or an endoscopic examination with
			 use of local or general anesthetic. This also includes, but is not limited to,
			 the use of lasers and any other devices or instruments in performing such
			 procedures.
31. "Topical
			 anesthesia" means the effect produced by an anesthetic agent applied directly
			 or indirectly to the skin or mucous membranes, intended to produce a transient
			 and reversible loss of sensation to a circumscribed area.