Current through Register Vol. 39, No. 6, September 16, 2024
(a) A dentist
administering moderate conscious sedation or supervising any CRNA employed to
administer or RN employed to deliver moderate 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) EKG
monitor;
(I) pulse
oximeter;
(J) automatic external
defibrillator (AED);
(K) precordial
stethoscope or capnograph;
(L)
thermometer;
(M) vascular access
set-up as necessary for specific procedures, including hardware and
fluids;
(N) laryngoscope with
working batteries;
(O) intubation
forceps and advanced airway devices;
(P) tonsillar suction with back-up
suction;
(Q) syringes as necessary
for specific procedures; and
(R)
tourniquet and tape.
(2)
The following unexpired drugs shall be maintained in the facility and with
access from the operatory and recovery rooms:
(A) Epinephrine;
(B) Atropine;
(C) antiarrhythmic;
(D) antihistamine;
(E) antihypertensive;
(F) bronchodilator;
(G) antihypoglycemic agent;
(H) vasopressor;
(I) corticosteroid;
(J) anticonvulsant;
(K) muscle relaxant;
(L) appropriate reversal agents;
(M) nitroglycerine;
(N) antiemetic; and
(O) Dextrose.
(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 dentist 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, ET CO2 if
capnography is utilized, pulse and respiration rates of the patient recorded in
real time at 15 minute intervals;
(B) procedure start and end times;
(C) gauge of needle and location of IV on the
patient, if used;
(D) status of
patient upon discharge;
(E)
documentation of complications or morbidity; and
(F) consent form, signed by the patient or
guardian, identifying the procedure, risks and benefits, level of sedation, and
date signed; and
(6) The
following conditions shall be satisfied during a sedation procedure:
(A) The facility shall be staffed with at
least two BLS certified auxiliaries, one of whom shall be dedicated to patient
monitoring and recording sedation data throughout the sedation procedure. This
Subparagraph shall not apply if the dentist 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;
and
(B) If IV sedation is used, IV
infusion shall be administered before the start of the procedure and maintained
until the patient is ready for discharge.
(b) During an inspection or evaluation, the
applicant or permit holder shall demonstrate the administration of moderate
conscious sedation on a patient, including the deployment of an intravenous
delivery system, while the evaluator observes. During the demonstration, the
applicant or permit holder shall demonstrate competency in the following areas:
(1) monitoring blood pressure, pulse, ET CO2
if capnography is utilized, 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 permit applicant shall take a written examination on the
topics set forth in Paragraphs (b) and (c) of this Rule. The permit applicant
must obtain a passing score on the written examination by answering 80 percent
of the examination questions correctly. If the permit applicant fails to obtain
a passing score on the written examination that is administered during the
evaluation, he or she may be re-examined in accordance with Rule .0306(h) of
this Section.
(e) A moderate
conscious sedation permit holder shall evaluate a patient for health risks
before starting any sedation procedure as follows:
(1) a patient who is medically stable and who
is ASA I or II shall be evaluated by reviewing the patient's current medical
history and medication use or;
(2)
a patient who is not medically stable or who is ASA III or higher shall be
evaluated by a consultation with the patient's primary care physician or
consulting medical specialist regarding the potential risks posed by the
procedure.
(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 moderate 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) before allowing the patient to leave the
office, the dentist 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.
