Ariz. Admin. Code § 4-11-1303

Current through Register Vol. 30, No. 21, May 24, 2024

Section R4-11-1303 - Oral Sedation

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.

Ariz. Admin. Code § R4-11-1303

New Section R4-11-1303 renumbered from R4-11-805 and amended by final rulemaking at 5 A.A.R. 580, effective February 4, 1999 (Supp. 99-1). Former Section R4-11-1303 renumbered to R4-11-1304; new Section R4-11-1303made by final rulemaking at 9 A.A.R. 1054, effective May 6, 2003 (Supp. 03-1). Amended by final rulemaking at 19 A.A.R. 341, effective April 6, 2013 (Supp. 13-1). Amended by final rulemaking at 28 A.A.R. 1885, effective 9/12/2022.