Cal. Code Regs. Tit. 16, § 1044.5 - Facility and Equipment Standards

All equipment shall be maintained, tested, and inspected according to the manufacturers' specifications. A facility in which oral conscious sedation is administered to patients pursuant to this article shall also meet the standards set forth below.

(a) Facility and Equipment.

(1) An operatory large enough to adequately accommodate the patient and permit a team consisting of at least three individuals to freely move about the patient.

(2) A table or dental chair which permits the patient to be positioned so the attending 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 treatment which may be underway at the time of a general power failure.

(4) An appropriate functional suctioning device that permits aspiration of the oral and pharyngeal cavities. A backup suction device that can function at the time of general power failure must also be available.

(5) A positive-pressure oxygen delivery system capable of administering greater than 90% oxygen at a 10 liter/minute flow for at least sixty minutes (650 liter "E" cylinder), even in the event of a general power failure. All equipment must be age-appropriate and capable of accommodating the patients being seen at the permit-holder's office.

(6) Inhalation sedation equipment, if used in conjunction with oral sedation, must have the capacity for delivering 100%, and never less than 25%, oxygen concentration at a flow rate appropriate for an age appropriate patient's size, and have a fail-safe system. The equipment must be maintained and checked for accuracy at least annually.

(b) Ancillary equipment, which must include the following:

(1) Age-appropriate oral airways capable of accommodating patients of all sizes.

(2) An age-appropriate sphygmomanometer with cuffs of appropriate size for patients of all sizes.

(3) A precordial/pretracheal stethoscope.

(4) A pulse oximeter.

(c) The following records shall be maintained:

(1) An adequate medical history and physical evaluation, updated prior to each administration of oral conscious sedation. Such records shall include, but are not limited to, an assessment including at least visual examination of the airway, the age, sex, weight, physical status (American Society of Anesthesiologists Classification), and rationale for sedation of the patient as well as 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.

(2) Oral conscious sedation records shall include baseline vital signs. If obtaining baseline vital signs is prevented by the patient's physical resistance or emotional condition, the reason or reasons must be documented. The records shall also include intermittent quantitative monitoring and recording of oxygen saturation, heart and respiratory rates, blood pressure as appropriate for specific techniques, the name, dose and time of administration of all drugs administered including local and inhalation anesthetics, the length of the procedure, any complications of oral sedation, and a statement of the patient's condition at the time of discharge.

(d) An emergency cart or kit shall be available and readily accessible and shall include the necessary and appropriate drugs and age- and size-appropriate equipment to resuscitate a nonbreathing and unconscious patient and provide continuous support while the patient is transported to a medical facility. There must be documentation showing that all emergency equipment and drugs are checked and maintained on a prudent and regularly scheduled basis. Emergency drugs of the following types shall be available:

(1) Epinephrine

(2) Bronchodilator

(3) Appropriate drug antagonists

(4) Antihistaminic

(5) Anticholinergic

(6) Anticonvulsant

(7) Oxygen

(8) Dextrose or other antihypoglycemic

Notes

Cal. Code Regs. Tit. 16, § 1044.5

1. New section and new forms OCS-5 and OCS-3 filed 3-14-2000; operative 4-13-2000 (Register 2000, No. 11).
2. Amendment of section and NOTE and repealer of printed forms (this action incorporates applicable forms within article 5.5 by reference) filed 12-13-2007; operative 12-13-2007 pursuant to Government Code section 11343.4 (Register 2007, No. 50).
3. Amendment of first paragraph and subsections (b) and (c)(1) and amendment of NOTE 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 1647.22 and 1647.24, Business and Professions Code.

1. New section and new forms OCS-5 and OCS-3 filed 3-14-2000; operative 4-13-2000 (Register 2000, No. 11).
2. Amendment of section and Note and repealer of printed forms (this action incorporates applicable forms within article 5.5 by reference) filed 12-13-2007; operative 12-13-2007 pursuant to Government Code section 11343.4(Register 2007, No. 50).
3. Amendment of first paragraph and subsections (b) and (c)(1) and amendment of Note filed 8-16-2022; operative 8/16/2022 pursuant to Government Code section 11343.4(b)(3) (Register 2022, No. 33).