subchapter 16Q - GENERAL ANESTHESIA AND SEDATION
section .0100 – DEFINITIONS
21 NCAC 16Q .0101 GENERAL ANESTHESIA AND SEDATION
DEFINITIONS
For the purpose of these Rules relative to the
administration of minimal conscious sedation, moderate conscious sedation,
moderate conscious sedation limited to oral routes or nitrous oxide inhalation,
moderate pediatric conscious sedation or general anesthesia by or under the
direction of a dentist, the following definitions shall apply:
(1) "Analgesia" – the diminution or
elimination of pain.
(2) "Anti-anxiety sedative" – a
sedative agent administered in a dosage intended to reduce anxiety without
diminishing consciousness or protective reflexes.
(3) "Anxiolysis" – pharmacological
reduction of anxiety through the administration of a single dose of a minor
psychosedative, possibly in combination with nitrous oxide, to children or
adults prior to commencement of treatment on the day of the appointment which
allows for uninterrupted interactive ability in a totally awake patient with no
compromise in the ability to maintain a patent airway continuously and without
assistance. Nitrous oxide may be administered in addition to the minor
psychosedative without constituting multiple dosing for purpose of these Rules.
(4) "Behavior control" – the use of
pharmacological techniques to control behavior to a level that dental treatment
can be performed effectively and efficiently.
(5) "Behavioral management" – the use
of pharmacological or psychological techniques, singly or in combination, to
modify behavior to a level that dental treatment can be performed effectively
and efficiently.
(6) "Competent" – displaying special
skill or knowledge derived from training and experience.
(7) "Conscious sedation" - an induced
state of a depressed level of consciousness that retains the patient's ability
to independently and continuously maintain an airway and respond appropriately
to physical stimulation and verbal command, and that is produced by
pharmacologic or non-pharmacologic agents, or a combination thereof. In
accordance with this particular definition, the drugs or techniques used shall
carry a margin of safety wide enough to render unintended loss of consciousness
unlikely.
(8) "Deep sedation" – an induced
state of a depressed level of consciousness accompanied by partial loss of
protective reflexes, including the ability to continually maintain an airway
independently or respond purposefully to verbal command, and is produced by
pharmacological agents.
(9) "Direct supervision" – the
dentist responsible for the sedation/anesthesia procedure shall be physically
present in the facility and shall be continuously aware of the patient's
physical status and well being.
(10) "Facility" – the location where a
permit holder practices dentistry and provides anesthesia/sedation services.
(11) "Facility inspection" - an on-site
inspection to determine if a facility where the applicant proposes to provide
anesthesia/sedation is supplied, equipped, staffed and maintained in a condition
to support provision of anesthesia/sedation services that meet the minimum
standard of care.
(12) "General anesthesia" - the
intended controlled state of a depressed level of consciousness that is produced
by pharmacologic agents and accompanied by a partial or complete loss of
protective reflexes, including the ability to maintain an airway and respond
purposefully to physical stimulation or verbal commands.
(13) "Immediately available" – on-site
in the facility and available for immediate use.
(14) "Local anesthesia" – the
elimination of sensations, especially pain, in one part of the body by the
regional application or injection of a drug.
(15) "May" – indicates freedom or
liberty to follow a reasonable alternative.
(16) "Minimal conscious sedation" – conscious
sedation characterized by a minimally depressed level of consciousness, in
which patient retains the ability to independently and continuously maintain an
airway and respond normally to tactile stimulation and verbal command, provided
to patients 13 years or older, by oral or rectal routes of administration of a
single pharmacological agent, in one or more doses, not to exceed the
manufacturer's maximum recommended dose, at the time of treatment, possibly in
combination with nitrous oxide. Minimal conscious sedation is provided for
behavioral management.
(17) "Minor psychosedative/Minor
tranquilizer" – pharmacological agents which allow for uninterrupted
interactive ability in a patient with no compromise in the ability to maintain
a patent airway continuously and without assistance and carry a margin of
safety wide enough to render unintended loss of consciousness unlikely.
(18) "Moderate conscious sedation" –
conscious sedation characterized by a drug induced depression of consciousness,
during which patients respond purposefully to verbal commands, either alone or
accompanied by light tactile stimulation, provided to patients 13 years or
older, by oral, nasal, rectal or parenteral routes of administration of
multiple pharmacological agents, in multiple doses, within a 24 hour period,
including the time of treatment, possibly in combination with nitrous oxide.
Moderate conscious sedation is provided for behavior control.
(19) "Moderate conscious sedation limited to
oral routes and nitrous oxide inhalation" – conscious sedation
characterized by a drug induced depression of consciousness during which
patients respond purposefully to verbal commands, either alone or accompanied
by light tactile stimulation, provided to patients 13 years or older, by oral
routes of administration and nitrous oxide inhalation, of single or multiple
pharmacological agents, in single or multiple doses, within a 24 hour period.
Moderate conscious sedation limited to oral routes and nitrous oxide inhalation
is provided for behavior control.
(20) "Moderate pediatric conscious sedation"
- conscious sedation characterized by a drug induced depression of
consciousness, during which patients respond purposefully to verbal commands,
either alone or accompanied by light tactile simulation, provided to patients
under 13 years of age, by oral, nasal, rectal or parenteral routes of administration
of single or multiple pharmacological agents, in single or multiple doses,
within a 24 hour period, including the time of treatment, possibly in
combination with nitrous oxide. Moderate pediatric conscious sedation is
provided for behavior control.
(21) "Must" or "shall" –
indicates an imperative need or duty or both; an essential or indispensable
item; mandatory.
(22) "Parenteral" - the administration
of pharmacological agents intravenously, intraosseously, intramuscularly,
subcutaneously, submucosally, intranasally, or transdermally.
(23) "Protective reflexes" – includes
the ability to swallow and cough.
(24) "Supplemental dosing" – the oral
administration of a pharmacological agent that results in an enhanced level of
conscious sedation when added to the primary sedative agent administered for
the purpose of oral moderate conscious sedation, and which, when added to the
primary agent, does not exceed the maximum safe dose of either agent,
separately or synergistically.
(25) "Vested adult" – a responsible
adult who is the legal parent or guardian, or designee of a legal parent or
guardian, entrusted with the care of a minor following the administration of
general anesthesia or conscious sedation.
History Note: Authority G.S. 90-28; 90-30.1;
Eff. February 1, 1990;
Temporary Amendment Eff. December 11, 2002;
Amended Eff. July 3, 2008; August 1, 2004.
section .0200 - GENERAL ANESTHESIA
21 NCAC 16Q .0201 GENERAL ANESTHESIA CREDENTIALS AND
PERMIT
(a) No dentist shall employ or use general anesthesia on an
outpatient basis for dental patients unless the dentist possesses a permit
issued by the Board. A dentist holding a permit shall be subject to review and
shall only employ or use general anesthesia at a facility located in the State
of North Carolina in accordance with 21 NCAC 16Q .0202. Such permit must be
renewed annually and shall be displayed with the current renewal at all times
in a conspicuous place in the office of the permit holder.
(b) Any dentist who wishes to administer general anesthesia
to patients must apply to the Board for the required permit on a prescribed
application form, submit an application fee of one hundred dollars ($100.00) and
produce evidence showing that he or she:
(1) Has completed a minimum of one year of
advanced training in anesthesiology and related academic subjects (or its
equivalent) beyond the undergraduate dental school level; or
(2) Has graduated from a program certified by
the American Dental Association in Oral and Maxillofacial Surgery; or
(3) Is a Diplomate of or eligible for
examination by the American Board of Oral and Maxillofacial Surgery; or
(4) Is a Fellow of the American Dental Society
of Anesthesiology; or
(5) Is a dentist who has been administering
general anesthetics in a competent manner for the five years preceding the
effective date of this Rule.
(c) A dentist who is qualified to administer general
anesthesia in accordance with this Section and holds a general anesthesia
permit is also authorized to administer any level of sedation without obtaining
a separate sedation permit.
(d) The dentist involved with the administration of general
anesthesia shall document current, successful completion of advanced cardiac
life support (ACLS) training, or its age-specific equivalent or other
Board-approved equivalent course and auxiliary personnel shall document annual,
successful completion of basic life support (BLS) training.
History Note: Authority
G.S. 90-28; 90-30.1;
Eff. February 1,
1990;
Amended Eff. April 1,
2001; August 1, 2000;
Temporary Amendment
Eff. December 11, 2002;
Amended Eff. February 5, 2008.
21 ncac 16q .0202 EQUIPMENT
(a) A dentist administering general anesthesia is solely
responsible for providing that the environment in which the general anesthesia
is to be administered meets the following requirements:
(1) The facility is equipped with:
(A) An operatory of size and design to permit access of
emergency equipment and personnel and to permit effective emergency management;
(B) A chair or table for emergency treatment, including
chair suitable for CPR or CPR Board;
(C) Lighting as necessary for specific procedures; and
(D) Suction equipment as necessary for specific
procedures, including non-electrical back-up suction;
(2) The following equipment is maintained:
(A) Positive pressure oxygen delivery system, including
full face masks for adults and pediatric patients;
(B) Oral and nasal airways of various sizes;
(C) Blood pressure monitoring device;
(D) Electrocardiograph;
(E) Pulse oximeter; and
(F) Defibrillator;
(3) The following emergency equipment is
maintained:
(A) I.V. set‑up as necessary for specific
procedures, including hardware and fluids;
(B) Laryngoscope with current batteries;
(C) Intubation forceps and endotracheal tubes;
(D) Tonsillar suction with back‑up suction;
(E) Syringes as necessary for specific procedures;
(F) Tourniquet & tape; and
(G) Blood pressure monitoring device;
(4) The following drugs are maintained with a
current shelf life and with access from the operatory and recovery room:
(A) Epinephrine;
(B) Atropine;
(C) Lidocaine;
(D) Antihistamine;
(E) Antihypertensive;
(F) Bronchial dilator;
(G) Antihypoglycemic agent;
(H) Vasopressor;
(I) Corticosteroid;
(J) Anticonvulsant;
(K) Muscle relaxant;
(L) Appropriate reversal agents;
(M) Appropriate anti‑arrhythmic medication;
(N) Nitroglycerine; and
(O) Antiemetic;
(5) Written emergency and patient discharge
protocols and training to familiarize office personnel in the treatment of
clinical emergencies are provided; and
(6) The following records are maintained:
(A) Patient's current written medical history, including
known allergies and previous surgery;
(B) Base line vital signs, including blood pressure and
pulse;
(C) An anesthesia record which shall include:
(i) Periodic vital signs taken at intervals during
the procedure;
(ii) Drugs administered during the procedure,
including route of administration, dosage, time and sequence of administration;
(iii) Duration of the procedure;
(iv) Documentation of complications or morbidity; and
(v) Status of patient upon discharge.
(b) During an inspection or evaluation, the applicant or
permit holder shall demonstrate the administration of anesthesia while the
evaluator observes. During the demonstration, the applicant or permit holder
shall demonstrate competency in the following areas:
(1) Monitoring of blood pressure, pulse, and
respiration;
(2) Drug dosage and administration;
(3) Treatment of untoward reactions including
respiratory or cardiac depression;
(4) Sterilization;
(5) Use of CPR certified personnel;
(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 verbally 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/Hypotension;
(8) Syncope;
(9) Allergic reactions;
(10) Convulsions;
(11) Bradycardia;
(12) Insulin shock; and
(13) Cardiac arrest.
(d) A dentist administering general anesthesia shall ensure
that the facility is staffed with auxiliary personnel who shall document annual
successful completion of basic life support training and be capable of
assisting with procedures, problems, and emergency incidents that may occur as a
result of the general anesthetic or secondary to an unexpected medical
complication.
History Note: Authority G.S. 90-28; 90-30.1; 90-48;
Effective February 1, 1990;
Amended Eff. November 1, 2013; August 1, 2002; August 1,
2000.
21 ncac 16q .0203 TEMPORARY APPROVAL PRIOR TO SITE
EVALUATION
(a) If a dentist meets the requirements of Rule .0201 of
this Section, he shall be granted temporary approval to continue to administer
general anesthesia until a permit can be issued. Temporary approval may be
granted based solely on credentials until all processing and investigation has
been completed. Temporary approval may not exceed three months. An on-site
evaluation of the facilities, equipment, procedures and personnel shall be required
prior to the issuance of a permit.
(b) An evaluation may be made any time it is deemed
necessary by the Board.
(c) Temporary approval shall not be granted to a
provisional licensee.
History Note: Authority G.S. 90-28; 90-30.1;
Eff. February 1, 1990;
Amended Eff. August 1, 2002.
21 ncac 16q .0204 PROCEDURE FOR EVALUATION OR INSPECTION
(a) When an evaluation or on-site inspection is required,
the Board will designate two or more qualified persons, each of which has
administered general anesthesia for at least three years preceding the
inspection, exclusive of his training in general anesthesia. When an on-site
inspection involves only a facility and equipment check and not an evaluation
of the dentist, the inspection may be accomplished by one or more evaluators.
(b) Any dentist-member of the Board may observe or consult
in any evaluation.
(c) The inspection team shall determine compliance with the
requirements of the Rules in this Subchapter, as applicable, by assigning a
grade of "pass" or "fail".
(d) Each evaluator shall report his recommendation to the
Board, setting forth the details supporting his conclusion. The Board is not
bound by these recommendations. The Board shall determine whether the
applicant has passed the evaluation/inspection and shall notify the applicant
in writing of its decision.
(e) At least a 15-day notice shall be given prior to an
evaluation or inspection. The entire evaluation fee of three hundred seventy
five dollars ($375.00) shall be due 10 days after the date of receipt of such
notice. An inspection fee of two hundred seventy five dollars ($275.00) shall
be due 10 days after the dentist receives notice of the inspection of each
additional location at which the dentist administers general anesthesia.
History Note: Authority G.S. 90‑28; 90‑30.1;
90-39;
Eff. February 1, 1990;
Amended Eff. February 1, 2009; December 4, 2002; January
1, 1994.
21 ncac 16q .0205 RESULTS OF SITE EVALUATION AND
REEVALUATION
(a) An applicant who fails an inspection or evaluation
shall not receive a permit to administer general anesthesia, or if the holder
of a permit, shall not have it renewed. An applicant who has obtained
temporary approval from the Board and fails an inspection or evaluation shall
no longer be approved.
(b) An applicant who receives notification of failure of an
inspection may, within 15 days after receiving the notice, request a
reevaluation. Such request must state specific grounds supporting it. The
Board shall require the applicant to receive additional training prior to the
reevaluation. The additional training shall consist of, but not be limited to,
areas of deficiency as determined by the evaluation.
(c) If the reevaluation is granted, it shall be conducted
by different persons, qualified as evaluators, in the manner prescribed in Rule
.0204 of this Section.
(d) No applicant who has received a failing notice from the
Board may request more than one reevaluation within any 12 month period.
History Note: Authority G.S. 90-28; 90-30.1;
Eff. February 1, 1990;
Amended Eff. August 1, 2002.
section .0300 - PARENTERAL CONSCIOUS SEDATION
21 NCAC 16Q .0301 CREDENTIALS AND PERMITS FOR MODERATE
CONSCIOUS SEDATION, MODERATE PEDIATRIC CONSCIOUS SEDATION AND MODERATE
CONSCIOUS SEDATION LIMITED TO ORAL ROUTES OF ADMINISTRATION AND NITROUS OXIDE
(a) Before a dentist licensed to practice in North Carolina
may administer or supervise a certified registered nurse anesthetist (CRNA) to
administer moderate conscious sedation, moderate pediatric conscious sedation
or moderate conscious sedation limited to oral routes of administration and
nitrous oxide to dental patients on an outpatient basis, the dentist shall
obtain a permit from the Board by completing an application form provided by
the Board and paying a fee of one hundred dollars ($100.00). Such permit shall
be renewed annually and shall be displayed with the current renewal at all
times in a conspicuous place in the facility of the permit holder.
(b) For a dentist to employ a certified registered nurse
anesthetist to administer moderate conscious sedation, moderate conscious
sedation limited to oral routes and nitrous oxide or moderate pediatric
conscious sedation, the dentist must demonstrate through the permitting process
that he or she is capable of performing all duties and procedures to be delegated
to the CRNA. The dentist must not delegate said CRNA to perform procedures
outside of the scope of the technique and purpose of moderate conscious
sedation, moderate pediatric conscious sedation or moderate conscious sedation
limited to oral routes and nitrous oxide as defined in Rule .0101 of this
Subchapter.
(c) A dentist applying for a permit to administer moderate
conscious sedation or moderate pediatric conscious sedation must meet at least
one of the following criteria:
(1) Satisfactory completion of a minimum of 60
hours of didactic training, including PALS (Pediatric Advanced Life Support),
and instruction in intravenous conscious sedation and satisfactory management
of a minimum of 10 patients, under supervision, using intravenous sedation; or
(2) Satisfactory completion of a pre-doctoral
dental or postgraduate program which included intravenous conscious sedation
training equivalent to that defined in Subparagraph (c)(1) of this Rule; or
(3) Satisfactory completion of an internship or
residency which included intravenous conscious sedation training equivalent to
that defined in Subparagraph (c)(1) of this Rule.
(d) Notwithstanding the foregoing, a dentist may also
qualify for a permit to administer moderate pediatric conscious sedation by documenting,
with patient names and dates of completion, at least 100 cases of moderate
pediatric sedation procedures successfully completed between July 3, 2006 and
July 3, 2009. A dentist who obtains a pediatric conscious sedation permit
pursuant to this Paragraph may not administer sedation intravenously and such
limitation shall be noted on the dentist's permit.
(e) A dentist may modify his or her moderate conscious
sedation permit to include the privilege of moderate pediatric conscious
sedation by completing a Board approved pediatric dental degree or pediatric
dental residency program or obtaining the equivalent hours of continuing
education program in pediatric dental anesthesia. If said qualifications are
satisfied, it shall be so designated on the dentist's moderate conscious
sedation permit and will be subject to the renewal requirements stated in Rule
.0501(d) of this Subchapter.
(f) To be eligible for a moderate conscious sedation
permit, moderate conscious sedation limited to oral routes and nitrous oxide
inhalation permit or moderate pediatric conscious sedation permit, a dentist
must operate within a facility which includes the capability of delivering
positive pressure oxygen, and is staffed with supervised auxiliary personnel
for each procedure performed. The dentist shall ensure that auxiliary
personnel document annual, successful completion of basic life support (BLS)
training and are capable of assisting with procedures, problems and emergencies
incident thereto.
(g) Prior to issuance of a moderate conscious sedation
permit, moderate conscious pediatric sedation permit or moderate conscious
sedation permit limited to oral routes and nitrous oxide inhalation permit, the
applicant shall undergo an evaluation which includes a facility inspection.
The Board shall direct an evaluator to perform this evaluation. The applicant
shall be notified in writing that an evaluation and facility inspection is
required and provided with the name of the evaluator who shall perform the
evaluation and facility inspection. The applicant shall be responsible for
successful completion of the evaluation and inspection of his or her facility
within three months of notification. An extension of no more than 90 days
shall be granted if the designated evaluator or applicant requests one.
(h) The evaluator shall assign a grade of pass or fail and
shall report his recommendation to the Board, setting out the basis for his
conclusion. The Board is not bound by the evaluator's recommendation and shall
make a final determination regarding whether the applicant has passed the
evaluation. The applicant shall be notified of the Board's decision in
writing.
(i) A dentist who holds a moderate conscious sedation,
moderate conscious sedation limited to oral routes and nitrous oxide inhalation
or moderate pediatric conscious sedation permit shall not intentionally
administer deep sedation although deep sedation may occur briefly and
unintentionally.
(j) A dentist may obtain a moderate conscious sedation
permit limited to oral routes of administration and nitrous oxide inhalation,
including the ability to add supplemental dosing to the techniques set out in
Rule .0101(23) of this Subchapter upon compliance with the following
requirements:
(1) successfully complete 24 hours of didactic
training and manage at least 10 adult case experiences, including at least
three live clinical dental experiences. The live clinical cases shall not be
handled by groups with more than five student participants. The remaining
cases may include simulations, video presentations or both, but must include
one experience in returning/rescuing a patient from deep to moderate sedation;
or
(2) document, with patient names and dates of
completion, at least 100 cases of oral moderate conscious sedation procedures
successfully completed within one year preceding June 3, 2008; and fulfill all
the requirements listed in Rule .0401 of this Subchapter for minimal conscious
sedation.
(k) A dentist who is qualified to administer general
anesthesia, moderate conscious sedation or moderate pediatric conscious
sedation and holds a general anesthesia, moderate conscious sedation permit or
a moderate pediatric conscious sedation permit may administer minimal conscious
sedation without obtaining a separate minimal conscious sedation permit.
(l) Any dentist who holds an active parenteral conscious
sedation permit as of October 1, 2007 shall be deemed to hold an active
moderate conscious sedation permit. Such permits shall be subject to the
renewal requirements set out in Rule .0501 of this Subchapter.
History Note: Authority G.S. 90-28; 90-30.1;
Eff. February 1, 1990;
Amended Eff. April 1, 2001; August 1, 2000; January 1,
1994;
Temporary Amendment Eff. December 11, 2002;
Amended Eff. July 1, 2010, July 3, 2008; August 1, 2004.
21 NCAC 16Q .0302 CLINICAL REQUIREMENTS AND EQUIPMENT
(a) A dentist administering moderate conscious sedation or
moderate pediatric conscious sedation or supervising the administration of
moderate conscious sedation or moderate pediatric conscious sedation by a
certified registered nurse anesthetist shall ensure that the facility in which
the sedation is to be administered meets the following requirements:
(1) The facility is equipped with:
(A) An operatory of size and design to permit access of
emergency equipment and personnel and to permit effective 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
(D) Suction equipment as necessary for specific
procedures, including non-electrical back-up suction.
(2) The following equipment is maintained:
(A) Positive oxygen delivery system, including full face
masks for adults and pediatric patients and back-up E-cylinder portable oxygen
tank apart from the central system;
(B) Oral and nasal airways of various sizes;
(C) Blood pressure monitoring device;
(D) Pulse oximeter; and
(E) Automatic External Defibrillator (AED).
(3) The following emergency equipment is
maintained:
(A) I.V. set-up as necessary for specific procedures,
including hardware and fluids, if anesthesia is intravenous;
(B) Syringes as necessary for specific procedures; and
(C) Tourniquet and tape.
(4) The following drugs are maintained with a
current shelf life and with access from the operatory and recovery area:
(A) Epinephrine;
(B) Atropine;
(C) Appropriate reversal agents;
(D) Antihistamine;
(E) Corticosteroid;
(F) Nitroglycerine;
(G) Bronchial dilator;
(H) Antiemetic; and
(I) 50% Dextrose.
(5) Written emergency and patient discharge
protocols are maintained and training to familiarize office personnel in the
treatment of clinical emergencies is provided; and
(6) The following records are maintained for at
least 10 years:
(A) Patient's current written medical history, including
known allergies and previous surgery;
(B) Drugs administered during the procedure, including
route of administration, dosage, strength, time and sequence of administration;
(C) A sedation record which shall include:
(i) blood pressure;
(ii) pulse rate;
(iii) respiration;
(iv) duration of procedure;
(v) documentation of complications or morbidity; and
(vi) status of patient upon discharge.
(b) During an inspection or evaluation, the applicant or
permit holder shall demonstrate the administration of moderate conscious
sedation on a patient, or where applicable, moderate pediatric conscious
sedation on a patient, including the deployment of an intravenous delivery
system, while the evaluator observes. Practices limited to pediatric dentistry
will not be required to demonstrate the deployment of an intravenous delivery
system. Instead, they will orally describe to the evaluator the technique of
their training in intravenous and intraosseous deployment. During the
demonstration, the applicant or permit holder 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 CPR certified personnel;
(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 verbally 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/Hypotension;
(8) Allergic reactions;
(9) Convulsions;
(10) Syncope;
(11) Bradycardia;
(12) Insulin shock; and
(13) Cardiac arrest.
(d) A dentist administering moderate conscious sedation or
moderate pediatric conscious sedation shall ensure that the facility is staffed
with sufficient auxiliary personnel for each procedure performed who shall
document annual successful completion of basic life support training and be
capable of assisting with procedures, problems, and emergency incidents that
may occur as a result of the sedation or secondary to an unexpected medical
complication.
History Note: Authority G.S. 90-28; 90-30.1; 90-48;
Eff. February 1, 1990;
Amended Eff. August 1, 2002; August 1, 2000;
Temporary Amendment Eff. December 11, 2002;
Amended Eff. November 1, 2013; July 1, 2010; July 3,
2008; August 1, 2004.
21 NCAC 16Q .0303 TEMPORARY APPROVAL PRIOR TO SITE
INSPECTION
(a) If a dentist meets the requirements of Paragraphs (a) –
(e) of Rule .0301 of this Subchapter, he/she shall be granted temporary
approval to administer moderate conscious sedation or moderate pediatric
conscious sedation until a permit can be issued. If a dentist meets the
requirements of Paragraph (j) of Rule .0301 of this Subchapter, he or she shall
be granted temporary approval to administer moderate conscious sedation limited
to oral routes and nitrous oxide inhalation. Temporary approval may be granted
based solely on credentials until all processing and investigation has been
completed. The temporary approval shall expire after 90 days. Extensions
shall not be granted. An applicant who fails to complete the requirements
within the time allowed by this Rule must re-apply for a permit and shall not
be eligible for temporary approval. An on-site evaluation of the facilities,
equipment, procedures, and personnel shall be required prior to issuance of a
permanent permit. The evaluation shall be conducted in accordance with Rules
.0204 - .0205 of this Subchapter, except that evaluations of dentists applying
for moderate conscious sedation permits may be conducted by dentists who have
been issued moderate conscious sedation permits by the Board and who have been
approved by the Board, as set out in these Rules. A two hundred seventy five
dollar ($275.00) inspection fee shall be collected for each site inspected
pursuant to this Rule.
(b) An inspection may be made upon renewal of the permit or
for cause.
(c) Temporary approval shall not be granted to a
provisional licensee or applicants who are the subject of a pending Board
disciplinary investigation or whose licenses have been revoked, suspended or
are subject to an order of stayed suspension or probation.
History Note: Authority G.S. 90-28; 90-30.1;
Eff. February 1, 1990;
Amended Eff. August 1, 2002; January 1, 1994;
Temporary Amendment Eff. December 11, 2002;
Amended Eff. September 1, 2014; February 1, 2009; July 3,
2008; August 1, 2004.
21 NCAC 16Q .0304 Off Site Use of Sedation Permits
(a) Upon request, the holder of a moderate pediatric
conscious sedation or moderate conscious sedation permit may travel to the
office of a licensed dentist who does not hold such a permit and provide
sedation services at the level for which the traveling dentist holds a valid
permit, as well as minimal sedation or moderate conscious sedation limited to
oral routes for the patients of that dentist who are undergoing dental
procedures. The permit holder is solely responsible for providing that the
facility in which the sedation is administered meets the requirements
established by the Board, that the required drugs and equipment are present,
and that the permit holder utilizes sufficient auxiliary personnel for each
procedure performed based on the standard of care who shall document annual
successful completion of basic life support training and be capable of
assisting with procedures, problems, and emergency incidents that may occur as
a result of the sedation or secondary to an unexpected medical complication.
(b) Holders of moderate conscious sedation permits limited
to oral routes and nitrous oxide inhalation may not provide sedation at the
office of a licensed dentist who does not hold an appropriate sedation permit.
History Note: Authority G.S. 90-28; 90-30; 90-48;
Recodified from 21 NCAC 16Q .0302(e)(f), Eff. November 1,
2013.
section .0400 - enteral conscious sedation
21 NCAC 16Q .0401 MINIMAL CONSCIOUS SEDATION
CREDENTIALS, EVALUATION AND PERMIT
(a) Before a dentist licensed to practice in North Carolina may administer or supervise a certified registered nurse anesthetist to
administer minimal conscious sedation, the dentist shall obtain a Board-issued
permit for minimal conscious sedation, moderate pediatric conscious sedation,
moderate conscious sedation or general anesthesia. A permit is not required
for prescription administration of DEA controlled drugs prescribed for
postoperative pain control intended for home use. A dentist may obtain a
minimal conscious sedation permit from the Board by completing an application
form provided by the Board and paying a fee of one hundred dollars ($100.00). Such
permit must be renewed annually and shall be displayed with the current renewal
at all times in a conspicuous place in the office of the permit holder.
(b) Only a dentist who holds a general anesthesia license
may administer deep sedation or general anesthesia.
(c) Application:
(1) A minimal conscious sedation permit may be
obtained by completing an application form provided by Board, a copy of which
may be obtained from the Board office, and meeting the requirements of Section
.0400 of this Subchapter.
(2) The application form must be filled out
completely and appropriate fees paid.
(3) An applicant for a minimal conscious
sedation permit shall be licensed and in good standing with the Board in order
to be approved. For purposes of these Rules "good standing" means
that the applicant is not subject to a disciplinary investigation and his or
her licensee has not been revoked or suspended and is not subject to a
probation or stayed suspension order.
(d) Evaluation:
(1) Prior to issuance of a minimal conscious
sedation permit the applicant shall undergo a facility inspection. The Board
shall direct an evaluator qualified to administer minimal sedation to perform
this inspection. The applicant shall be notified in writing that an inspection
is required and provided with the name of the evaluator who shall perform the
inspection. The applicant shall be responsible for successful completion of
inspection of his or her facility within three months of notification. An
extension of no more than 90 days shall be granted if the designated evaluator
or applicant requests one.
(2) During an inspection or evaluation, the
applicant or permit holder shall demonstrate competency in the following areas:
(A) Monitoring of blood pressure, pulse, pulse oximetry
and respiration;
(B) Drug dosage and administration (by verbal
demonstration);
(C) Treatment of untoward reactions including
respiratory or cardiac depression (by verbal demonstration);
(D) Sterilization;
(E) Use of CPR certified personnel;
(F) Monitoring of patient during recovery (by verbal
demonstration); and
(G) Sufficiency of patient recovery time (by verbal
demonstration).
(3) During an inspection or evaluation, the
applicant or permit holder shall verbally demonstrate competency to the
evaluator in the treatment of the following clinical emergencies:
(A) Laryngospasm;
(B) Bronchospasm;
(C) Emesis and aspiration;
(D) Respiratory depression and arrest;
(E) Angina pectoris;
(F) Myocardial infarction;
(G) Hypertension/Hypotension;
(H) Syncope;
(I) Allergic reactions;
(J) Convulsions;
(K) Bradycardia;
(L) Insulin shock; and
(M) Cardiac arrest.
(4) The evaluator shall assign a grade of pass
or fail and shall report his recommendation to the Board, setting out the basis
for his conclusion. The Board is not bound by the evaluator's recommendation
and shall make a final determination regarding whether the applicant has passed
the evaluation. The applicant shall be notified of the Board's decision in
writing.
(e) Educational/Professional Requirements:
(1) The dentist applying for a minimal
conscious sedation permit shall meet one of the following criteria:
(A) successful completion of training consistent with
that described in Part I or Part III of the American Dental Association (ADA)
Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in
Dentistry, and have documented administration of minimal conscious sedation in
a minimum of five cases;
(B) successful completion of an ADA accredited
post-doctoral training program which affords comprehensive training necessary
to administer and manage minimal conscious sedation;
(C) successful completion of an 18-hour minimal
conscious sedation course which must be approved by the Board based on whether
it affords comprehensive training necessary to administer and manage minimal
conscious sedation;
(D) successful completion of an ADA accredited
postgraduate program in pediatric dentistry; or
(E) is a North Carolina licensed dentist in good
standing who has been using minimal conscious sedation in a competent manner
for at least one year immediately preceding October 1, 2007 and his or her
office facility has passed an on-site inspection by a Board evaluator as required
in Paragraph (d) of this Rule. Competency shall be determined by presentation
of successful administration of minimal conscious sedation in a minimum of five
clinical cases.
(2) All applicants for a minimal sedation
permit must document successful completion of a Basic Life Saving (BLS) course
within the 12 months prior to the date of application.
History Note: Authority
G.S. 90-28; 90-30.1;
Temporary Adoption
Eff. March 13, 2003; December 11, 2002;
Eff. August 1, 2004;
Amended Eff. July 3,
2008.
21 NCAC 16Q .0402 MINIMAL CONSCIOUS SEDATION PERMIT
REQUIREMENTS, CLINICAL PROVISIONS AND EQUIPMENT
(a) Minimal conscious sedation is indicated for use only as
defined in Rule .0101(15) of this Subchapter (relating to Definitions). Minimal
conscious sedation is not indicated for use to achieve deep sedation.
(b) A minimal conscious sedation permit is not required for
minor psychosedatives used for anxiolysis prescribed for administration outside
of the dental office when pre-procedure instructions are likely to be followed.
Medication administered for the purpose of minimal conscious sedation shall
not exceed the maximum doses recommended by the drug manufacturer, sedation
textbooks, or juried sedation journals. Except for nitrous inhalation, drugs
in combination are not permitted for minimal conscious sedation. During longer
periods of minimal conscious sedation, in which the amount of time of the
procedures exceeds the effective duration of the sedative effect of the drug
used, the incremental doses of the sedative shall not exceed total safe dosage
levels based on the effective half-life of the drug used.
(c) Each dentist shall:
(1) adhere
to the clinical requirements as detailed in Paragraph (e) of this Rule;
(2) maintain
under continuous direct supervision any auxiliary personnel, who shall be
capable of assisting in procedures, problems, and emergencies incident to the
use of minimal conscious sedation or secondary to an unexpected medical
complication;
(3) utilize
sufficient auxiliary personnel for each procedure performed who shall document
annual successful completion of basic life support training; and
(4) not
allow a minimal conscious sedation procedure to be performed in his or her
office by a Certified Registered Nurse Anesthetist (CRNA) unless the dentist
holds a permit issued by the Board for the procedure being performed. This
provision addresses dentists and is not intended to address the scope of
practice of persons licensed by any other agency.
(d) Each dentist shall meet the following requirements:
(1) Patient
Evaluation. Patients who are administered minimal conscious sedation must be
evaluated for medical health risks prior to the start of any sedative
procedure. A patient receiving minimal conscious sedation must be healthy or
medically stable (ASA I, or ASA II as defined by the American Society of
Anesthesiologists). An evaluation is a review of the patient's current medical
history and medication use. However, for individuals who are not medically
stable or who have a significant health disability Physical Status III (ASA
III, as defined by the American Society of Anesthesiologists) a consultation
with their primary care physician or consulting medical specialist regarding
potential procedure risk is required.
(2) Pre-procedure
preparation, informed consent:
(A) The patient or
guardian must be advised of the procedure associated with the delivery of the minimal
conscious sedation.
(B) Equipment must
be evaluated and maintained for proper operation.
(C) Baseline vital
signs shall be obtained at the discretion of the operator depending on the
medical status of the patient and the nature of the procedure to be performed.
(D) Dentists
administering minimal conscious sedation shall use sedative agents that he/she
is competent to administer and shall administer such agents in a manner that is
within the standard of care.
(e) Patient monitoring:
(1) Patients
who have been administered minimal
conscious sedation shall be monitored during waiting periods prior to operative
procedures. An adult who has accepted responsibility for the patient and been
given written pre-procedural instruction may provide such monitoring. The
patient shall be monitored for alertness, responsiveness, breathing and skin
coloration.
(2) Dentists
administering minimal conscious
sedation shall maintain direct supervision of the patient during the operative
procedure and for such a period of time necessary to establish pharmacologic
and physiologic vital sign stability.
(A) Oxygenation.
Color of mucosa, skin or blood shall be continually evaluated. Oxygen
saturation shall be evaluated continuously by pulse oximetry, except as
provided in Paragraph (e)(4) of this Rule.
(B) Ventilation.
Observation of chest excursions or auscultation of breath sounds or both shall
be performed.
(C) Circulation.
Blood pressure and pulse shall be taken and recorded initially and thereafter
as appropriate except as provided in Paragraph (e)(4) of this Rule.
(D) AED. Dentists
administering minimal conscious sedation shall maintain a functioning automatic
external defibrillator (AED).
(3) An
appropriate time oriented anesthetic record of vital signs shall be maintained
in the permanent record including documentation of individual(s) administering
the drug and showing the name of drug, strength and dosage used.
(4) If the
dentist responsible for administering minimal conscious sedation must deviate from the requirements set out in this
Rule, he or she shall document the occurrence of such deviation and the reasons
for such deviation.
(f) Post-operative procedures:
(1) Following the operative procedure, positive
pressure oxygen and suction equipment shall be immediately available in the
recovery area or operatory.
(2) Vital signs shall be continuously monitored
when the sedation is no longer being administered and the patient shall have
direct continuous supervision until oxygenation and circulation are stable and
the patient is sufficiently responsive for discharge from the office.
(3) Patients who have adverse reactions to minimal
conscious sedation shall be assisted and monitored either in an operatory chair
or recovery area until stable for discharge.
(4) Recovery
from minimal conscious sedation
shall include:
(A) cardiovascular
function stable;
(B) airway patency
uncompromised;
(C) patient easily
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 patient
who is disabled, or 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.
(5) Prior to allowing the patient to leave the
office, the dentist shall determine that the patient has met the recovery
criteria set out in Paragraph (f)(4) of this Rule and the following discharge
criteria:
(A) oxygenation,
circulation, activity, skin color and level of consciousness are sufficient and
stable and have been documented;
(B) explanation and
documentation of written postoperative instructions have been provided to the
patient or a responsible adult at time of discharge;
(C) responsible
individual is available for the patient to transport the patient after
discharge;
(D) A vested adult
must be available to transport patients for whom a motor vehicle restraint
system is required and an additional responsible individual must be available
to attend to the patients.
(g) The dentist, personnel and facility shall be prepared
to treat emergencies that may arise from the administration of minimal
conscious sedation, and shall have the ability to provide positive pressure
ventilation with 100% oxygen with an age appropriate device.
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.
21 NCAC 16Q .0403 TEMPORARY APPROVAL PRIOR TO SITE
INSPECTION
(a) A dentist whose facility has not been inspected but who
has otherwise met the requirements of Rule .0401 of this Section may seek
temporary approval to administer minimal conscious sedation until a permit can
be issued. Temporary approval may be granted based solely on credentials until
all processing and investigation has been completed. Temporary approval may
not exceed three months.
(b) Temporary approval shall not be granted to a
provisional licensee or to an applicant who is the subject of a disciplinary
investigation or whose license has been revoked or suspended or is the subject
of a probation or stayed suspension order.
(c) A two hundred seventy five dollar ($275.00) fee shall
be collected for each site inspected pursuant to Rule .0401 of this Section.
History Note: Authority G.S. 90-28; 90-30.1.
Temporary Adoption Eff. December 11, 2002;
Eff. August 1, 2004;
Amended Eff. February 1, 2009; July 3, 2008.
SECTION .0500 - RENEWAL OF
PERMITS
21 NCAC 16Q .0501 ANNUAL RENEWAL REQUIRED
(a) General anesthesia and all sedation permits shall be
renewed by the Board annually. Such renewal shall be accomplished in
conjunction with the license renewal process, and applications for permits
shall be made at the same time as applications for renewal of licenses. A one
hundred ($100.00) annual renewal fee shall be paid at the time of renewal.
(b) All sedation permits shall be subject to the same
renewal deadlines as are dental practice licenses, in accordance with G.S.
90-31. If the permit renewal application is not received by the date specified
in G.S. 90-31, continued administration of general anesthesia or any level of
conscious sedation shall be unlawful and shall subject the dentist to the
penalties prescribed by Section .0700 of this Subchapter.
(c) As a condition for renewal of the general anesthesia
permit, the permit holder shall meet the requirements of 21 NCAC 16Q .0202 and
document current, successful completion of advanced cardiac life support (ACLS)
training, or its age-specific equivalent or other equivalent course, and
auxiliary personnel shall document annual, successful completion of basic life
support (BLS) training.
(d) As a condition for renewal of the moderate conscious
sedation permit or moderate pediatric conscious sedation permit, the permit
holder shall meet the requirements of 21 NCAC 16Q .0302 and:
(1) document annual, successful completion of
BLS training and obtain three hours of continuing education each year in one or
more of the following areas, which may be counted toward fulfillment of the
continuing education required each calendar year for license renewal:
(A) sedation;
(B) medical emergencies;
(C) monitoring IV sedation and the use of monitoring
equipment;
(D) pharmacology of drugs and agents used in IV
sedation;
(E) physical evaluation, risk assessment, or behavioral
management;
(F) audit ACLS/Pediatric Advanced Life Support (PALS) courses;
and
(G) airway management; or
(2) document current, successful completion of
ACLS training or its age-specific equivalent, or other equivalent course and
annual successful completion of BLS.
(e) moderate pediatric conscious sedation permit holders
must have current PALS at all times.
(f) As a condition for renewal of the minimal conscious
sedation permit and the moderate conscious sedation permit limited to oral
routes and nitrous oxide inhalation, the permit holder shall meet the
requirements of 16Q .0402 and shall document annual, successful completion of
BLS training and obtain six hours of continuing education every two years in
one or more of the following areas, which may be counted toward fulfillment of
the continuing education required each calendar year for license renewal:
(1) pediatric or adult sedation;
(2) medical emergencies;
(3) monitoring sedation and the use of
monitoring equipment;
(4) pharmacology of drugs and agents used in
sedation;
(5) physical evaluation, risk assessment, or
behavioral management; or
(6) audit ACLS/PALS courses; and
(7) airway management.
(g) Any dentist who fails to renew a general anesthesia or
sedation permit on or before March 31 of each year must complete a reinstatement
application, pay the one hundred dollar ($100.00) renewal fee and a one hundred
dollar ($100.00) penalty and comply with all conditions for renewal set out in
this Rule for the permit sought. Dentists whose anesthesia or sedation permits
have been lapsed for more than 12 calendar months must pass a facilities
inspection as part of the reinstatement process.
History Note: Authority
G.S. 90-28; 90-30.1; 90-48;
Eff. February 1,
1990;
Amended Eff. August
1, 2002;
Transferred and
Recodified from 16Q .0401 to 16Q .0501;
Temporary Amendment
Eff. December 11, 2002;
Amended Eff. November
1, 2013; July 3, 2008; August 1, 2004.
21 NCAC 16Q .0502 PAYMENT OF FEES
A fee of fifty dollars ($50.00) shall accompany the permit
renewal application, such fee to be separate and apart from the annual license
renewal fee imposed by the Board.
History Note: Authority G.S. 90‑28; 90‑30.1;
Eff. February 1, 1990;
Transferred and Recodified from 16Q .0402 to .0502.
21 ncac 16q .0503 INSPECTION AUTHORIZED
Incident to the renewal of an anesthesia or sedation permit,
for cause or routinely at reasonable time intervals in order to ensure
compliance, the Board may require an on-site inspection of the dentist's
facility, equipment, personnel and procedures. Such inspection shall be
conducted in accordance with Rules .0204, .0205, .0303, and .0401 of this
Subchapter.
History Note: Authority
G.S. 90-28; 90-30.1;
Eff. February 1,
1990;
Amended Eff. January
1, 1994;
Transferred and
Recodified from 16Q .0403 to 16Q .0503;
Temporary Amendment
Eff. December 11, 2002;
Amended Eff. August 1, 2004.
SECTION .0600 ‑ REPORTING AND PENALTIES
21 NCAC 16Q .0601 REPORTS OF ADVERSE OCCURRENCES
(a) A dentist who holds a permit to administer general
anesthesia or sedation shall submit a report to the Board within 72 hours after
each adverse occurrence related to the administration of general anesthesia or
sedation which results in the death of a patient within 24 hours of the
procedure.
(b) A dentist who holds a permit to administer general
anesthesia or sedation shall report to the Board, within 30 days after each
adverse occurrence related to the administration of general anesthesia or
sedation, any situation which results in permanent organic brain dysfunction of
a patient within 24 hours of the procedure or which results in physical injury
causing hospitalization of a patient within 24 hours of the procedure.
(c) The adverse occurrence report shall be in writing and
shall include:
(1) The dentist's name, license number and
permit number;
(2) The date and time of the occurrence;
(3) The facility where the occurrence took
place;
(4) The name and address of the patient;
(5) The surgical procedure involved;
(6) The type and dosage of sedation or
anesthesia utilized in the procedure; and
(7) The circumstances involved in the
occurrence.
(d) Upon receipt of any such report, the Board shall make
such investigation as it deems appropriate and shall take such action as it
deems necessary.
History Note: Authority G.S. 90‑28; 90‑30.1;
90‑41;
Eff. February 1, 1990;
Transferred and Recodified from 16Q .0501 to 16Q .0601.
21 ncac 16q .0602 FAILURE TO REPORT
If a dentist fails to report any incident as required by
these Rules, the dentist shall be subject to discipline in accordance with
Section .0700 of this Subchapter.
History Note: Authority
G.S. 90-28; 90-30.1; 90-41;
Eff. February 1,
1990;
Transferred and
Recodified from 16Q .0502 to 16Q .0602;
Temporary Amendment
Eff. December 11, 2002;
Amended Eff. August
1, 2004.
SECTION .0700 ‑ PENALTY FOR NON‑COMPLIANCE
21 NCAC 16Q .0701 FAILURE TO COMPLY
Failure to comply with the provisions of this Subchapter may
result in suspension or revocation of the permit and/or the dentist's license
to practice dentistry in accordance with G.S. 90‑41.
History Note: Authority G.S. 90‑28; 90‑30.1;
90‑41;
Eff. February 1, 1990;
Transferred and Recodified from 16Q .0601 to 16Q .0701.
