Ariz. Admin. Code § 4-11-1302

Current through Register Vol. 30, No. 50, December 13, 2024

Section R4-11-1302 - Parenteral Sedation

A. Before administering parenteral sedation in a dental office or dental clinic, a dentist shall possess a Section 1302 permit Permit issued by the Board. The dentist may renew a Section 1302 permit Permit every five years by complying with R4-11-1307.

1. A Section 1301 Permit holder may also administer parenteral sedation.

2. A Section 1302 Permit holder shall not administer or employ any agents which have a narrow margin for maintaining consciousness including, but not limited to, ultra-short acting barbiturates, propofol, parenteral ketamine, or similarly acting Drugs, agents, or techniques, or any combination thereof that would likely render a patient deeply sedated, generally anesthetized or otherwise not meeting the conditions of Moderate Sedation.

B. To obtain or renew a Section 1302 Permit, the 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 parenteral sedation by intravenous or intramuscular route:

a. Contains the following properly operating equipment and supplies during the provision of parenteral sedation by the permit holder or General Anesthesia or Deep Sedation by a physician anesthesiologist or Certified Registered Nurse Anesthetist:

i. Emergency Drugs;

ii. Positive pressure oxygen and supplemental oxygen;

iii. Stethoscope;

iv. Suction equipment, including tonsillar or pharyngeal and emergency backup medical suction device;

v. Oropharyngeal and nasopharyngeal airways;

vi. Pulse oximeter;

vii. Auxiliary lighting;

viii. Blood pressure monitoring device; and

ix. Cardiac defibrillator or automated external defibrillator; 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 course completion confirmation in cardiopulmonary resuscitation healthcare provider level;

ii. Is present during the parenteral 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. 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; or

c. A recognized continuing education course in advanced airway management.

C. Initial applicants shall meet one of the following conditions by submitting to the Board verification of meeting the condition directly from the issuing institution:

1. Successfully complete Board-recognized undergraduate, graduate, or postgraduate education within the three years before submitting the permit application, that includes the following:

a. Sixty didactic hours of basic parenteral sedation to include:

i. Physical evaluation;

ii. Management of medical emergencies;

iii. The importance of and techniques for maintaining proper documentation; and

iv. Monitoring and the use of monitoring equipment; and

b. Hands-on administration of parenteral sedative medications to at least 20 patients in a manner consistent with this Section; or

2. An applicant who completed training in parenteral 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 parenteral 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 parenteral sedation permit in effect in another state or certification of military training in parenteral sedation from the applicant's commanding officer; and

c. On a form provided by the Board, a written affidavit affirming the completion of 30 clock hours of continuing education taken within the last five years as outlined in R4-11-1306(B)(1)(b) through (f).

D. After submitting the application and written evidence of compliance with requirements outlined in subsection (B) and, if applicable, subsection (C) to the Board, the applicant shall schedule an onsite evaluation by the Board during which the applicant shall administer parenteral sedation. After the applicant completes the application requirements and successfully completes the onsite evaluation, the Board shall issue a Section 1302 Permit to the applicant.

1. The onsite evaluation team shall consist of:

a. Two dentists who are Board members, or Board designees for initial applications, or

b. One dentist who is a Board member or Board designee for renewal applications.

2. The onsite team shall evaluate the following:

a. The availability of equipment and personnel as specified in subsection (B)(2);

b. Proper administration of parenteral sedation to a patient by the applicant in the presence of the evaluation team;

c. Successful responses by the applicant to oral examination questions from the evaluation team about patient management, medical emergencies, and emergency medications;

d. Proper documentation of Controlled Substances, that includes a perpetual inventory log showing the receipt, administration, dispensing, and destruction of all Controlled Substances;

e. Proper recordkeeping as specified in subsection (E) by reviewing the records generated for the patient receiving parenteral sedation as specified in subsection (D)(2)(b); and

f. 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 Substances, or proper recordkeeping. The applicant must submit proof of correcting the deficiencies before a permit is 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;

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; or

e. Category 3 Evaluation Failure. The applicant must complete Board approved remedial continuing education with the subject matter outlined in R4-11-1306 as identified by the evaluators and reapply not less than 90 days from the failed evaluation. An example is failure to recognize and manage an anesthetic urgency.

4. The onsite evaluation of an additional dental office or dental clinic in which parenteral sedation is administered by an existing Section 1302 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 1302 mobile permit may be issued if a Section 1302 Permit holder travels to dental offices or dental clinics to provide parenteral sedation. The applicant must submit a completed affidavit verifying:

a. That the equipment and supplies for the provision of parenteral sedation as required in R4-11-1302(B)(2)(a) either travel with the Section 1302 Permit holder or are in place and in appropriate working condition at the dental office or dental clinic where parenteral sedation is provided, and

b. Compliance with R4-11-1302(B)(2)(b).

E. A Section 1302 Permit holder shall keep a parenteral sedation record for each parenteral sedation procedure that:

1. Includes the following entries:

a. Pre-operative, intra-operative, and post-operative pulse oximeter documentation;

b. Pre-operative, intra-operative, and post-operative blood pressure and vital sign documentation;

c. A list of all medications given, with dosage and time intervals and route and site of administration;

d. Type of catheter or portal with gauge;

e. Indicate nothing by mouth or time of last intake of food or water;

f. Consent form; and

g. Time of discharge and status, including name of escort; and

2. May include pre-operative and post-operative electrocardiograph report.

F. The Section 1302 Permit holder shall establish intravenous access on each patient receiving parenteral sedation utilizing a new infusion set, including a new infusion line and new bag of fluid.

G. The Section 1302 Permit holder shall utilize supplemental oxygen for patients receiving parenteral sedation for the duration of the procedure.

H. The Section 1302 Permit holder shall continuously supervise the patient from the initiation of parenteral sedation until termination of the parenteral sedation procedure and oxygenation, ventilation and circulation are stable. The Section 1302 Permit holder shall not commence with the administration of a subsequent anesthetic case until the patient is in monitored recovery or meets the guidelines for discharge.

I. A Section 1302 Permit holder may employ a health care professional as specified in R4-11-1301(I).

Ariz. Admin. Code § R4-11-1302

New Section R4-11-1302 renumbered from R4-11-803and amended by final rulemaking at 5 A.A.R. 580, effective February 4, 1999 (Supp. 99-1). Amended 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.