LAC 46:XLV.7310. Office-Based Surgery Levels

A. Level I 1. Level I office-based surgery includes, but is not limited to: a. minor procedures such as excision of skin lesions, moles, warts, cysts, lipomas, Loop Electrosurgical Excision Procedures (LEEP), laser cone of cervix, laser/cautery ablation of warts or other lesions, 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; b. incision and drainage of superficial abscesses, skin biopsies, arthrocentesis, paracentesis, dilation of urethra, cystoscopy procedures, and closed reduction of simple fractures or small joint dislocations (i.e., finger and toe joints) performed under topical or local anesthesia not involving drug-induced alteration of consciousness; c. other procedures requiring only topical, local, or no anesthesia with no drug-induced alteration of respiratory effort or consciousness. Only minimal or no preoperative sedation should be required or used. Level 1 office-based surgery shall only be performed on patients rated ASA class 1 or 2. 2. Required Training. The physician’s continuing medical education must include management of toxicity or hypersensitivity to local anesthetic drugs and Advanced Life Support Certification. 3. Required Equipment and Supplies. The facility where office-based surgery is to be performed must contain oral airway and positive pressure ventilation device, epinephrine (or other vasopressor), corticosteroids, antihistamines, oxygen, atropine, adequate resuscitative equipment to manage the adverse effects of the anesthesia used, if any type of anesthesia is used. The equipment and skills to establish intravenous access must be available if any other medications are administered. The equipment and supplies must be suitable for and consistent with the potential patient population, i.e., pediatrics, etc. 4. Required Additional Personnel. Unless the specific procedure or conditions dictate otherwise, the presence or assistance of additional personnel is not required for Level I office-based surgery. B. Level II 1. Level II office-based surgery includes: a. any procedure in which perioperative medication and sedation are used orally, intravenously, intramuscularly, or rectally. Such procedures include, but are not limited to: hernia repair, hemorrhoidectomy, reduction of simple fractures, large joint dislocations, breast biopsies, dilatation and curettage, thoracentesis, endoscopies, colonoscopies, hysteroscopies, and cystoscopies and closed reduction of simple fractures or small joint dislocations (i.e., finger and toe joints) performed using drug-induced alteration of consciousness. If perioperative or intraoperative medication is administered, intraoperative and postoperative monitoring is required. b. any procedure in which the patient is sufficiently sedated to allow 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. c. any procedure that has the potential for excessive blood loss. 2. Level of anesthetic for Level II procedures includes local or peripheral nerve block, including Bier Block, plus intravenous or intramuscular sedation, but with preservation of vital signs. 3. Required Transfer Agreement. The physician must have a written transfer agreement from a licensed hospital within reasonable proximity at which the physician has privileges to treat complications. 4. Required Training. The physician must document satisfactory completion of surgical training such as board certification or board eligibility for a board approved by the American Board of Medical Specialties or the American Osteopathic Association Bureau of Osteopathic Specialists. The certification should include training in the procedures performed in the office setting. 5. Required Equipment and Supplies. The location where anesthesia is administered and/or the office-based procedure is being performed must maintain at all times a full and complete crash cart that contains all equipment, medications, and supplies as recommended in current best practices. 6. Required Assistance of Other Personnel a. In addition to the physician at least one assistant certified in Advanced Life Support must be present during any Level II procedure. Unless an anesthesiologist or certified registered nurse anesthetist is present to manage the anesthetic, there must be at least one person certified in Advanced Cardiac Life Support or pediatric advanced life support, if applicable, present during any Level II procedure. b. A registered nurse may only administer analgesic doses of medications on the direct order of a physician. c. An assisting anesthesia provider, including a nurse providing sedation, may not 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 another physician, registered nurse, licensed practical nurse, or operating room technician. C. Level III 1. Level III office-based surgery includes: a. Surgery that involves, or might foreseeably require, the use of general anesthesia or major conduction anesthesia and perioperative sedation. This includes: i. Intravenous sedation beyond that defined for Level II office surgery; ii. General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions; iii. Major Conduction anesthesia, including epidural, spinal, caudal or any block of a nerve or plexus more proximal than the hip or shoulder joint including visceral nerve blocks. iv. Self-controlled auto-administered nitrous oxide machines, such as Pronox. 2. Only patients classified under the American Society of Anesthesiologists’ (ASA) risk classification criteria as Class I, II, or III are appropriate candidates for Level III office surgery. For ASA Class III patients, the surgeon must document in the patient’s record the justification for an office procedure rather than other surgical venues. The record must also document precautions taken that make the office a preferred venue for the particular procedure to be performed. 3. Required Transfer Agreement. The physician must have a written transfer agreement from a licensed hospital within reasonable proximity at which the physician has privileges to treat complications. 4. Required Training and Personnel a. To be eligible to perform office-based surgery, the physician must document satisfactory completion of surgical training such as board certification or board eligibility by a board approved by the American Board of Medical Specialties or American Osteopathic Association Bureau of Osteopathic Specialists. The certification should include training in the procedures to be performed in the office setting. Alternative credentialing for procedures outside the physician’s core curriculum and specialty training must be applied for through the board. b. In addition to the surgeon, at least one assistant certified in Advanced Life Support must be present during any Level III procedure. At least one person certified in Advanced Cardiac Life Support must be present during any Level III procedure unless there is an anesthesiologist or certified registered nurse anesthetist to manage the anesthetic. c. Emergency procedures related to anesthesia complications should be formulated, periodically reviewed, practiced, updated, and posted in a conspicuous location. 5. Required Equipment and Supplies a. Equipment, medication and monitored post-anesthesia recovery must be available in the office. If anesthetic agents include inhaled agents, other than nitrous oxide, medications must include a stock of no less than 12 vials of Dantrolene. b. The facility, in terms of general preparation, equipment, and supplies, must be comparable to a free-standing ambulatory surgical center, including, but not limited to, recovery capability, and must have provisions for proper record keeping. c. Blood pressure monitoring equipment; EKG; end tidal CO2 monitor; pulse oximeter, precordial or esophageal stethoscope, emergency intubation equipment and a temperature monitoring device must be available for all phases of perioperative care. This equipment must be sized to the patient whether adult or pediatric. d. Table capable of Trendelenburg and other positions necessary to facilitate the surgical procedure. e. IV solutions and IV equipment. f. A full and complete crash cart that contains all equipment, medications, and supplies as recommended in current best practices. D. Laser Devices 1. The use of laser, pulsed light or similar devices, either for invasive or cosmetic procedures, is considered to be the practice of medicine in the state of Louisiana and therefore such use shall be limited to physicians, podiatric physicians, and qualified additional personnel directly supervised by physicians, such that a physician is on the premises and would be directly involved in the treatment if required. 2. These rules shall not apply to any person licensed to practice dentistry if the laser, pulsed light, or similar device is used exclusively for the practice of dentistry.