Current through Register Vol. 39, No. 6, September 16, 2024
(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;
(C) lighting as
necessary for specific procedures and back-up lighting;
(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;
(C) bronchodilator;
(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
(C) a sedation record.
(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;
(C) status of patient
upon discharge;
(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;
(C) patient arousable and protective reflexes
intact;
(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
(C) a person
authorized by the patient is available to transport the patient after
discharge.
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.
