Section .0100 – Definitions

Link to law: http://reports.oah.state.nc.us/ncac/title 21 - occupational licensing boards and commissions/chapter 16 - dental examiners/subchapter q/subchapter q rules.html
Published: 2015

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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.