21 NCAC 16Q .0505 MINIMAL CONSCIOUS SEDATION CLINICAL REQUIREMENTS AND EQUIPMENT

(a) A permit holder administering minimal conscious sedation or supervising a CRNA employed to administer or RN employed to deliver minimal conscious sedation shall ensure that the facility where the sedation is administered meets the following requirements:

(1) The facility shall be equipped with the following:

(A) an operatory of size and design to permit access of emergency equipment and personnel and to permit emergency management;

(B) a CPR board or a dental chair without enhancements, suitable for providing emergency treatment;

(D) suction equipment as necessary for specific procedures, including non-electrical back-up suction;

(E) positive pressure oxygen delivery system, including full face masks for small, medium, and large patients and back-up E-cylinder portable oxygen tank apart from the central system;

(F) small, medium, and large oral and nasal airways;

(G) blood pressure monitoring device;

(H) pulse oximeter;

(I) automatic external defibrillator (AED);

(J) thermometer;

(K) tonsillar suction with back-up suction; and

(L) syringes as necessary for specific procedures.

(2) The following unexpired drugs shall be maintained in the facility and with access from the operatory and recovery rooms:

(A) epinephrine;

(B) oral antihistamine;

(D) antihypoglycemic agent;

(E) appropriate reversal agents; and

(F) nitroglycerine.

(3) The permit holder shall maintain written emergency and patient discharge protocols. The permit holder shall also provide training to familiarize auxiliaries in the treatment of clinical emergencies.

(4) The permit holder shall maintain the following records for at least 10 years:

(A) patient's current written medical history and pre-operative assessment;

(B) drugs administered during the procedure, including route of administration, dosage, strength, time, and sequence of administration; and

(5) The sedation record shall include:

(A) base line vital signs, blood pressure (unless patient behavior prevents recording), oxygen saturation, pulse and respiration rates of the patient recorded in real time at 15-minute intervals;

(B) procedure start and end times;

(D) documentation of complications or morbidity; and

(E) a consent form, signed by the patient or guardian, identifying the procedure, risks and benefits, level of sedation, and date signed.

(6) During a sedation procedure, the facility shall be staffed with at least two BLS certified auxiliaries, one of whom shall be involved in patient monitoring. This Subparagraph shall not apply if the permit holder is dedicated to patient care and monitoring regarding sedation throughout the sedation procedure and is not performing the surgery or other dental procedure.

(b) During an inspection or evaluation, the applicant or permit holder shall demonstrate the administration of minimal sedation on a patient while the evaluator observes. During the demonstration, the applicant or permit holder shall demonstrate competency in the following areas:

(1) monitoring blood pressure, pulse, pulse oximetry, and respiration;

(2) drug dosage and administration;

(3) treatment of untoward reactions, including respiratory or cardiac depression if applicable;

(4) sterile technique;

(5) use of BLS certified auxiliaries;

(6) monitoring of patient during recovery; and

(7) sufficiency of patient recovery time.

(c) During an inspection or evaluation, the applicant or permit holder shall demonstrate competency to the evaluator in the treatment of the following clinical emergencies:

(1) laryngospasm;

(2) bronchospasm;

(3) emesis and aspiration;

(4) respiratory depression and arrest;

(5) angina pectoris;

(6) myocardial infarction;

(7) hypertension and hypotension;

(8) allergic reactions;

(9) convulsions;

(10) syncope;

(11) bradycardia;

(12) hypoglycemia;

(13) cardiac arrest; and

(14) airway obstruction.

(d) During the evaluation, the applicant shall take a written examination on the topics set forth in Paragraphs (b) and (c) of this Rule. The applicant must obtain a passing score on the written examination by answering 80 percent of the examination questions correctly. If the applicant fails to obtain a passing score on the written examination that is administered during the evaluation, he or she may be reexamined in accordance with Rule .0507(h) of this Section.

(e) A minimal conscious sedation permit holder shall evaluate each patient for health risks before starting any sedation procedure as follows:

(1) The permit holder shall review the patient's current medical history and medication use and, if the permit holder considers it clinically necessary, the permit holder shall consult with the patient's treating medical provider.

(2) A patient who is not medically stable or who is ASA III or higher shall be evaluated further by the permit holder's consultation with the patient's treating primary care physician or medical specialist regarding the potential risks posed by the procedure the permit holder plans to perform.

(f) Post-operative monitoring and discharge:

(1) The permit holder or a BLS certified auxiliary under his or her direct supervision shall monitor the patient's vital signs throughout the sedation procedure until the patient is recovered as defined in Subparagraph (f)(2) of this Rule and is ready for discharge from the office.

(2) Recovery from minimal conscious sedation shall include documentation of the following:

(A) cardiovascular function stable;

(B) airway patency uncompromised;

(D) state of hydration within normal limits;

(E) patient can talk, if applicable;

(F) patient can sit unaided, if applicable;

(G) patient can ambulate, if applicable, with minimal assistance; and

(H) for the special needs patient or patient incapable of the usually expected responses, the pre-sedation level of responsiveness or the level as close as possible for that patient shall be achieved.

(3) Prior to allowing the patient to leave the office, the permit holder shall determine that the patient has met the recovery criteria set out in Subparagraph (f)(2) of this Rule and the following discharge criteria:

(A) oxygenation, circulation, activity, skin color, and level of consciousness are stable and have been documented;

(B) explanation and documentation of written postoperative instructions have been provided to the patient or a person responsible for the patient at the time of discharge; and

History Note: Authority G.S. 90-28; 90-30.1;

Temporary Adoption Eff. December 11, 2002;

Eff. August 1, 2004;

Amended Eff. July 3, 2008;

Readopted Eff. February 1, 2019;

Recodified from 21 NCAC 16Q .0402 Eff. November 9, 2020;

Amended Eff. August 1, 2021.