Section 1043.3 - Onsite InspectionsAll offices in which general anesthesia, deep sedation, or moderate sedation is conducted under the terms of this article shall, unless otherwise indicated, meet the standards set forth below. In addition, an office may in the discretion of the Board be required to undergo an onsite inspection. For the applicant who administers in both an outpatient setting and at an accredited facility, the onsite inspection must be conducted in an outpatient setting. The evaluation of an office shall consist of three parts:
(a) Office Facilities and Equipment. All equipment shall be maintained, tested, and inspected according to the manufacturers' specifications. In an office where anesthesia services are to be provided to pediatric patients, the required equipment, medication, and resuscitative capabilities shall be appropriately sized for use on a pediatric population. The following office facilities and equipment shall be available: (1) An operating theatre large enough to adequately accommodate the patient on a table or in an operating chair and permit an operating team consisting of at least three individuals to freely move about the patient.(2) An operating table or chair which permits the patient to be positioned so the operating team can maintain the airway, quickly alter patient position in an emergency, and provide a firm platform for the management of cardiopulmonary resuscitation.(3) A lighting system which is adequate to permit evaluation of the patient's skin and mucosal color and a backup lighting system which is battery powered and of sufficient intensity to permit completion of any operation underway at the time of general power failure.(4) Suction equipment which permits aspiration of the oral and pharyngeal cavities. A backup suction device which can operate at the time of general power failure must also be available.(5) An oxygen delivery system with adequate full face masks and appropriate connectors that is capable of allowing the administering of greater than 90% oxygen at a 10 liter/minute flow at least sixty minutes (650 liter "E" cylinder) to the patient under positive pressure, together with an adequate backup system which can operate at the time of general power failure.(6) A recovery area that has available oxygen, adequate lighting, suction, and electrical outlets. The recovery area can be the operating theatre.(7) Ancillary equipment:(A) Laryngoscope complete with adequate selection of blades and spare batteries and bulb. (This equipment is not required for moderate sedation.)(B) Endotracheal tubes and appropriate connectors. (This equipment is not required for moderate sedation.)(C) Emergency airway equipment (oral airways, laryngeal mask airways or combitubes, cricothyrotomy device).(D) Tonsillar or pharyngeal type suction tip adaptable to all office outlets.(E) Endotracheal tube forceps. (This equipment is not required for moderate sedation.)(F) Sphygmomanometer and stethoscope.(G) Electrocardioscope and defibrillator. (This equipment is not required for moderate sedation.)(H) Adequate equipment for the establishment of an intravenous infusion.(I) Precordial/pretracheal stethoscope.(K) Capnograph and temperature device. Patients receiving moderate sedation, deep sedation, or general anesthesia shall have ventilation continuously monitored during the procedure by two of the following three methods: (i) Auscultation of breath sounds using a precordial stethoscope.(ii) Monitoring for the presence of exhaled carbon dioxide with capnography.(iii) Verbal communication with a patient under moderate sedation. This method shall not be used for a patient under deep sedation or general anesthesia.(b) Records. The following records shall be maintained:(1) Adequate medical history and physical evaluation records updated prior to each administration of moderate sedation, deep sedation, or general anesthesia. Such records shall include, but are not limited to the recording of the age, sex, weight, physical status (American Society of Anesthesiologists Classification), medication use, any known or suspected medically compromising conditions, rationale for sedation of the patient, and visual examination of the airway, and for general anesthesia or deep sedation only, auscultation of the heart and lungs.(2) Moderate sedation, deep sedation, or general anesthesia- records, which shall include a time-oriented record with preoperative, multiple intraoperative, and postoperative pulse oximetry (every 5 minutes intraoperatively and every 15 minutes postoperatively for general anesthesia or deep sedation) and blood pressure and pulse readings, (both every 5 minutes intraoperatively for general anesthesia or deep sedation), drugs, amounts administered and time administered, length of the procedure, any complications of anesthesia or sedation and a statement of the patient's condition at time of discharge.(3) Records shall include the category of the provider responsible for sedation oversight, the category of the provider delivering sedation, the category of the provider monitoring the patient during sedation, and whether the person supervising the sedation performed one or more of the procedures. Categories of providers are defined in Section 1680(z)(3) of the Code.(4) Written informed consent of the patient or, as appropriate, patient's conservator, or the informed consent of a person authorized to give such consent for the patient, or if the patient is a minor, his or her parent or guardian, pursuant to Section 1682(e) of the Code.(c) Drugs. Emergency drugs of the following types shall be available: (2) Vasopressor (other than epinephrine)(4) Muscle relaxant (This is not required for moderate sedation.)(5) Intravenous medication for treatment of cardiopulmonary arrest (This is not required for moderate sedation.)(6) Appropriate drug antagonist(9) Antiarrhythmic (This is not required for moderate sedation.)(10) Coronary artery vasodilator(11) Antihypertensive (This is not required for moderate sedation.)(14) 50% dextrose or other antihypoglycemic(d) Prior to an onsite inspection and evaluation, the dentist shall provide a complete list of his/her emergency medications to the evaluator.Cal. Code Regs. Tit. 16, § 1043.3
1. Amendment filed 4-1-91; operative 5-1-91 (Register 91, No. 18).
2. Editorial correction of subsection (a)(4) (Register 95, No. 16).
3. Amendment filed 2-27-2006; operative 3-29-2006 (Register 2006, No. 9).
4. Amendment filed 8-16-2022; operative 8-16-2022 pursuant to Government Code section 11343.4(b)(3) (Register 2022, No. 33). Note: Authority cited: Section 1614, Business and Professions Code. Reference: Sections 1646.2, 1646.3, 1647.3 and 1647.6, Business and Professions Code.
1. Amendment filed 4-1-91; operative 5-1-91 (Register 91, No. 18).
2. Editorial correction of subsection (a)(4) (Register 95, No. 16).
3. Amendment filed 2-27-2006; operative 3-29-2006 (Register 2006, No. 9).
4. Amendment filed 8-16-2022; operative 8/16/2022 pursuant to Government Code section 11343.4(b)(3) (Register 2022, No. 33).