Current through Register Vol. 30, No. 38, September 20, 2024
A. Before
administering oral sedation Oral Sedation in a dental office or dental clinic,
a dentist shall possess a Section 1303 permit Permit issued by the Board. The
dentist may renew a Section 1303 permit Permit every five years by complying
with
R4-11-1307
1. A Section 1301 Permit holder or Section
1302 Permit holder may also administer Oral Sedation without obtaining a
Section 1303 Permit.
2. The
administration of a single Drug for Minimal Sedation does not require a Section
1303 Permit if:
a. The administered dose is
within the Food and Drug Administration's maximum recommended dose as printed
in the Food and Drug Administration's approved labeling for unmonitored home
use;
i. Incremental multiple doses of the
Drug may be administered until the desired effect is reached, but does not
exceed the maximum recommended dose; and
ii. During Minimal Sedation, a single
supplemental dose may be administered. The supplemental dose may not exceed
one-half of the initial dose and the total aggregate dose may not exceed one
and one-half times the Food and Drug Administration's maximum recommended dose
on the date of treatment; and
b. Nitrous oxide/oxygen may be administered
in addition to the oral Drug as long as the combination does not exceed Minimal
Sedation.
B. To
obtain or renew a Section 1303 Permit, a dentist shall:
1. Submit a completed application on a form
provided by the Board office that, in addition to the requirements of
subsections (B)(2) and (3) and
R4-11-1307,
includes:
a. General information about the
applicant such as:
i. Name;
ii. Home and office addresses and telephone
numbers;
iii. Limitations of
practice;
iv. Hospital
affiliations;
v. Denial,
curtailment, revocation, or suspension of hospital privileges;
vi. Denial of membership in, denial of
renewal of membership in, or disciplinary action by a dental organization;
and
vii. Denial of licensure by,
denial of renewal of licensure by, or disciplinary action by a dental
regulatory body; and
b.
The dentist's dated and signed affidavit stating that the information provided
is true, and that the dentist has read and complied with the Board's statutes
and rules;
2. On forms
provided by the Board, provide a dated and signed affidavit attesting that any
dental office or dental clinic where the dentist will administer Oral Sedation:
a. Contains the following properly operating
equipment and supplies during the provision of sedation:
i. Emergency Drugs;
ii. Cardiac defibrillator or automated
external defibrillator;
iii.
Positive pressure oxygen and supplemental oxygen;
iv. Stethoscope;
v. Suction equipment, including tonsillar or
pharyngeal and emergency backup medical suction device;
vi. Pulse oximeter;
vii. Blood pressure monitoring device;
and
viii. Auxiliary lighting;
and
b. Maintains a staff
of supervised personnel capable of handling procedures, complications, and
emergency incidents, including at least one staff member who:
i. Holds a current certificate in
cardiopulmonary resuscitation healthcare provider level;
ii. Is present during the Oral Sedation
procedure; and
iii. After the
procedure, monitors the patient until discharge;
3. Hold a valid license to practice dentistry
in this state;
4. Maintain a
current permit to prescribe and administer Controlled Substances in this state
issued by the United States Drug Enforcement Administration;
5. Provide confirmation of completing
coursework within the two years prior to submitting the permit application in
one or more of the following:
a.
Cardiopulmonary resuscitation healthcare provider level from the American Heart
Association, American Red Cross, or another agency that follows the same
procedures, standards, and techniques for training as the American Heart
Association or American Red Cross;
b. Pediatric advanced life support in a
practice treating pediatric patients; or
c. A recognized continuing education course
in advanced airway management.
C. Initial applicants shall meet one of the
following by submitting to the Board verification of meeting the condition
directly from the issuing institution:
1.
Complete a Board-recognized post-doctoral residency program that includes
documented training in Oral Sedation within the last three years before
submitting the permit application; or
2. Complete a Board recognized post-doctoral
residency program that includes documented training in Oral Sedation more than
three years before submitting the permit application shall provide the
following documentation:
a. On a form provided
by the Board, a written affidavit affirming that the applicant has administered
Oral Sedation to a minimum of 25 patients within the year or 75 patients within
the last five years before submitting the permit application;
b. A copy of the Oral Sedation permit in
effect in another state or certification of military training in Oral Sedation
from the applicant's commanding officer; and
c. On a form provided by the Board, a written
affidavit affirming the completion of 30 hours of continuing education taken
within the last five years as outlined in
R4-11-1306(C)(1)(a)
through (f); or
3. Provide proof of participation in 30 clock
hours of Board-recognized undergraduate, graduate, or post-graduate education
in Oral Sedation within the three years before submitting the permit
application that includes:
a. Training in
basic Oral Sedation,
b.
Pharmacology,
c. Physical
evaluation,
d. Management of
medical emergencies,
e. The
importance of and techniques for maintaining proper documentation,
and
f. Monitoring and the use of
monitoring equipment.
D. After submitting the application and
written evidence of compliance with requirements in subsection (B) and, if
applicable, subsection (C) to the Board, the applicant shall schedule an onsite
evaluation by the Board. After the applicant completes the application
requirements and successfully completes the onsite evaluation, the Board shall
issue a Section 1303 Permit to the applicant.
1. The onsite evaluation team shall consist
of:
a. For initial applications, two dentists
who are Board members, or Board designees.
b. For renewal applications, one dentist who
is a Board member, or Board designee.
2. The onsite team shall evaluate the
following:
a. The availability of equipment
and personnel as specified in subsection (B)(2);
b. Successful responses by the applicant to
oral examination questions from the evaluation team about patient management,
medical emergencies, and emergency medications;
c. Proper documentation of Controlled
Substances, that includes a perpetual inventory log showing the receipt,
administration, dispensing, and destruction of Controlled Substances;
d. Proper recordkeeping as specified in
subsection (E) by reviewing the forms that document the Oral Sedation record;
and
e. For renewal applicants,
records supporting continued competency as specified in
R4-11-1306.
3. The evaluation team shall
recommend one of the following:
a. Pass.
Successful completion of the onsite evaluation;
b. Conditional Approval for failing to have
appropriate equipment, proper documentation of Controlled Substance, or proper
recordkeeping. The applicant must submit proof of correcting the deficiencies
before permit will be issued;
c.
Category 1 Evaluation Failure. The applicant must review the appropriate
subject matter and schedule a subsequent evaluation by two Board Members or
Board designees not less than 30 days from the failed evaluation. An example is
failure to recognize and manage one emergency; or
d. Category 2 Evaluation Failure. The
applicant must complete Board approved continuing education in subject matter
within the scope of the onsite evaluation as identified by the evaluators and
schedule a subsequent evaluation by two Board Members or Board designees not
less than 60 days from the failed evaluation. An example is failure to
recognize and manage more than one emergency.
4. The onsite evaluation of an additional
dental office or dental clinic in which Oral Sedation is administered by a
Section 1303 Permit holder may be waived by the Board staff upon receipt in the
Board office of an affidavit verifying compliance with subsection
(D)(2)(a).
5. A Section 1303 mobile
permit may be issued if the Section 1303 Permit holder travels to dental
offices or dental clinics to provide Oral Sedation. The applicant must submit a
completed affidavit verifying:
a. That the
equipment and supplies for the provision of Oral Sedation as required in
R4-11-1303(B)(2)(a) either travel with the Section 1303 Permit holder or are in
place and in appropriate condition at the dental office or dental clinic where
Oral Sedation is provided, and
b.
Compliance with R4-11-1303(B)(2)(b).
E. A Section 1303 Permit holder shall keep an
Oral Sedation record for each Oral Sedation procedure that:
1. Includes the following entries:
a. Pre-operative, intra-operative, and
post-operative, pulse oximeter oxygen saturation and pulse rate
documentation;
b. Pre-operative and
post-operative blood pressure;
c.
Documented reasons for not taking vital signs if a patient's behavior or
emotional state prevents monitoring personnel from taking vital
signs;
d. List of all medications
given, including dosage and time intervals;
e. Patient's weight;
f. Consent form;
g. Special notes, such as, nothing by mouth
or last intake of food or water; and
h. Time of discharge and status, including
name of escort; and
2.
May include the following entries:
a.
Pre-operative and post-operative electrocardiograph report; and
b. Intra-operative blood pressures.
F. The Section 1303
Permit holder shall utilize supplemental oxygen for patients receiving Oral
Sedation for the duration of the procedure.
G. The Section 1303 Permit holder shall
ensure the continuous supervision of the patient from the administration of
Oral Sedation until oxygenation, ventilation and circulation are stable and the
patient is appropriately responsive for discharge from the dental office or
dental clinic.
H. A Section 1303
Permit holder may employ a health care professional to provide anesthesia
services, if all of the following conditions are met:
1. The physician anesthesiologist or
Certified Registered Nurse Anesthetist meets the requirements as specified in
R4-11-1301(I);
2. The Section 1303
Permit holder has completed coursework within the two years prior to submitting
the permit application in one or more of the following:
a. Advanced cardiac life support from the
American Heart Association or another agency that follows the same procedures,
standards, and techniques for training as the American Heart
Association;
b. Pediatric advanced
life support in a practice treating pediatric patients;
c. A recognized continuing education course
in advanced airway management;
3. The Section 1303 Permit holder ensures
that:
a. The dental office or clinic contains
the equipment and supplies listed in
R4-11-1304(B)(2)(a)
during the provision of anesthesia or sedation by the physician
anesthesiologist or Certified Registered Nurse Anesthetist;
b. The anesthesia or sedation record contains
all the entries listed in R4-11-1304(D);
c. For intravenous access, the physician
anesthesiologist or Certified Registered Nurse Anesthetist uses a new infusion
set, including a new infusion line and new bag of fluid for each patient;
and
d. The patient is continuously
supervised from the administration of anesthesia or sedation until the
termination of the anesthesia or sedation procedure and oxygenation,
ventilation and circulation are stable. The Section 1303 Permit holder shall
not commence with a subsequent procedure or treatment until the patient is in
monitored recovery or meets the guidelines for
discharge.