Current through Register Vol. 39, No. 6, September 16, 2024
(a) A dentist administering moderate
pediatric 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 following
records are maintained 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;
(C) a sedation record; and
(D) a consent form, signed by the patient or
a guardian, identifying the procedure, risks and benefits, level of sedation,
and date signed;
(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; and
(E)
documentation of complications or morbidity; 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)
when IV sedation is used, IV infusion shall be administered before the
commencement of the procedure and maintained until the patient is ready for
discharge.
(b) During an inspection or evaluation,
applicants and permit holders who use intravenous sedation shall demonstrate
the administration of moderate pediatric conscious sedation on a live patient,
including the deployment of an intravenous delivery system, while the evaluator
observes. Applicants and permit holders who do not use IV sedation shall
describe the proper deployment of an intravascular delivery system to the
evaluator and shall demonstrate the administration of moderate pediatric
conscious sedation on a live patient while the evaluator observes.
(c) During the demonstration, all applicants
and permit holders shall demonstrate competency in the following areas:
(1) monitoring blood pressure, pulse, 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.
(d) During an inspection or evaluation, the
applicant or permit holder shall demonstrate competency 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.
(e) During
the evaluation, the permit applicant shall take a written examination on the
topics set forth in Paragraphs (c) and (d) 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 .0408(h) of
this Section.
(f) A moderate
pediatric conscious sedation permit holder shall evaluate patients 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.
(g) Patient
monitoring:
(1) Patients who have been
administered moderate pediatric conscious sedation shall be monitored for
alertness, responsiveness, breathing, and skin coloration during waiting
periods before operative procedures.
(2) 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 (g)(3) of this Rule and is ready for discharge from the
office.
(3) Recovery from moderate
pediatric 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 a 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.
(4) Before allowing the patient to leave the
office, the dentist shall determine that the patient has met the recovery
criteria set out in Subparagraph (g)(3) 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 a person responsible for the patient at time of discharge;
and
(C) a person responsible for
the patient is available to transport the patient after discharge, and for the
patient for whom a motor vehicle restraint system is required, an additional
responsible individual is available to attend to the patient.
