Arizona Secretary of State - Ken Bennett


 
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Supp. 13-2
RULE INTERPRETATION:
The Office of the Secretary of State does not interpret or enforce rules in the Administrative Code. Questions should be directed to the state agency responsible for the promulgation of the rule as provided:
Name: C. Lloyd Vest, Executive Director
Address: 9545 E. Doubletree Ranch Rd.
Scottsdale, AZ 85258
Telephone: (480) 551-2791

TITLE 4. PROFESSIONS AND OCCUPATIONS

CHAPTER 16. ARIZONA MEDICAL BOARD

(Authority: A.R.S. § 32-1401 et seq.)

Editor’s Note: The name of the Allopathic Board of Medical Examiners was changed to the Arizona Medical Board by Laws 2002, Ch. 254, § 9, effective August 22, 2002 (Supp. 03-2).

ARTICLE 1. GENERAL PROVISIONS

Article 1, consisting of Sections R4-16-101 through R4-16-106, adopted effective June 1, 1984.

Former Article 1, consisting of Sections R4-16-01 through R4-16-16, repealed effective June 1, 1984 (Supp. 84-3).

Section

R4-16-101. Definitions

R4-16-102. Continuing Medical Education

R4-16-103. Rehearing or Review of Board Decision

R4-16-104. Recodified

R4-16-105. Recodified

R4-16-106. Recodified

R4-16-107. Recodified

R4-16-108. Recodified

Table 1. Recodified

R4-16-109. Recodified

ARTICLE 2. LICENSURE

Article 2 heading, recodified to Article 3 heading, at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

Article 2, consisting of Sections R4-16-201 through R4-16-205, adopted effective September 22, 1995 (Supp. 95-3).

Section

R4-16-201. Application for Licensure

R4-16-202. Application for Pro Bono Registration

R4-16-203. Application for Locum Tenens Registration

R4-16-204. Licensure by Endorsement

R4-16-205. Fees

R4-16-206. Time-frames for Licenses, Permits, and Registrations

R4-16-207. Time-frames for License Renewal; Expiration

Table 1. Time-frames

ARTICLE 3. DISPENSING OF DRUGS

Article 3 heading, recodified from Article 2 heading, at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

Article 3, consisting of Sections R4-16-301 through R4-16-303, adopted effective February 2, 2000 (Supp. 00-1).

Section

R4-16-301. Registration and Renewal

R4-16-302. Packaging and Inventory; Exception

R4-16-303. Prescribing and Dispensing Requirements

R4-16-304. Recordkeeping and Reporting Shortages

R4-16-305. Inspections; Denial and Revocation

ARTICLE 4. MEDICAL ASSISTANTS

Section

R4-16-401. Medical Assistant Training Requirements

R4-16-402. Authorized Procedures for Medical Assistants

R4-16-403. Renumbered

R4-16-404. Recodified

R4-16-405. Recodified

R4-16-406. Recodified

R4-16-407. Recodified

R4-16-408. Recodified

R4-16-409. Recodified

R4-16-410. Recodified

ARTICLE 5. EXECUTIVE DIRECTOR DUTIES

Article 5, consisting of Sections R4-16-501 through R4-16-505, renumbered by exempt rulemaking at 11 A.A.R. 1056, effective February 18, 2005 (Supp. 05-1).

Article 5, consisting of Sections R4-16-501 through R4-16-505, made by exempt rulemaking at 9 A.A.R. 2274, effective August 12, 2003 (Supp. 03-2).

Section

R4-16-501. Interim Evaluation and Investigational Interview

R4-16-502. Direct Referral to Formal Interview

R4-16-503. Request for Inactive Status and License Cancellation

R4-16-504. Interim Consent Agreement

R4-16-505. Mediated Case

R4-16-506. Referral to Formal Hearing

R4-16-507. Dismissal of Complaint

R4-16-508. Denial of License

R4-16-509. Non-disciplinary Consent Agreement

R4-16-510. Appealing Executive Director Actions

ARTICLE 6. DISCIPLINARY ACTIONS

R4-16-601. Expired

R4-16-602. Expired

R4-16-603. Expired

R4-16-604. Aggravating Factors Considered in Disciplinary Actions

R4-16-605. Mitigating Factors Considered in Disciplinary Actions

ARTICLE 7. OFFICE-BASED SURGERY USING SEDATION

Article 7, consisting of Sections R4-16-701 through R4-16-707, made by final rulemaking at 14 A.A.R. 380, effective January 8, 2008 (Supp. 08-1).

Section

R4-16-701. Health Care Institution License

R4-16-702. Administrative Provisions

R4-16-703. Procedure and Patient Selection

R4-16-704. Sedation Monitoring Standards

R4-16-705. Perioperative Period; Patient Discharge

R4-16-706. Emergency Drugs; Equipment and Space Used for Office-Based Surgery Using Sedation

R4-16-707. Emergency and Transfer Provisions

ARTICLE 1. GENERAL PROVISIONS

R4-16-101. Definitions

Unless the context otherwise requires, definitions prescribed under A.R.S. § 32-1401 and the following apply to this Chapter:

1. “ACLS” means advanced cardiac life support performed according to certification standards of the American Heart Association.

2. “Agent” means an item or element that causes an effect.

3. “Approved medical assistant training program” means a program accredited by any of the following:

a. The Commission on Accreditation of Allied Health Education Programs;

b. The Accrediting Bureau of Health Education Schools;

c. A medical assisting program accredited by any accrediting agency recognized by the United States Department of Education; or

d. A training program:

i. Designed and offered by a licensed allopathic physician;

ii. That meets or exceeds any of the prescribed accrediting programs in subsection (a), (b), or (c); and

iii. That verifies the entry-level competencies of a medical assistant prescribed under R4-16-402(A).

4. “Ausculation” means the act of listening to sounds within the human body either directly or through use of a stethoscope or other means.

5. “BLS” means basic life support performed according to certification standards of the American Heart Association.

6. “Capnography” means monitoring the concentration of exhaled carbon dioxide of a sedated patient to determine the adequacy of the patient’s ventilatory function.

7. “Deep sedation” means a drug-induced depression of consciousness during which a patient:

a. Cannot be easily aroused, but

b. Responds purposefully following repeated or painful stimulation, and

c. May partially lose the ability to maintain ventilatory function.

8. “Discharge” means a written or electronic documented termination of office-based surgery to a patient.

9. “Drug” means the same as in A.R.S. § 32-1901.

10. “Emergency” means an immediate threat to the life or health of a patient.

11. “Emergency drug” means a drug that is administered to a patient in an emergency.

12. “General Anesthesia” means a drug-induced loss of consciousness during which a patient:

a. Is unarousable even with painful stimulus; and

b. May partially or completely lose the ability to maintain ventilatory, neuromuscular, or cardiovascular function or airway.

13. “Health care professional” means a registered nurse defined in A.R.S. § 32-1601, registered nurse practitioner defined in A.R.S. § 32-1601, physician assistant defined in A.R.S. § 32-2501, and any individual authorized to perform surgery according to A.R.S. Title 32 who participates in office-based surgery using sedation at a physician’s office.

14. “Informed consent” means advising a patient of the:

a. Purpose for and alternatives to the office-based surgery using sedation,

b. Associated risks of office-based surgery using sedation, and

c. Possible benefits and complications from the office-based surgery using sedation.

15. “Inpatient” has the same meaning as in A.A.C. R9-10-201.

16. “Malignant hyperthermia” means a life-threatening condition in an individual who has a genetic sensitivity to inhalant anesthetics and depolarizing neuromuscular blocking drugs that occurs during or after the administration of an inhalant anesthetic or depolarizing neuromuscular blocking drug.

17. “Minimal Sedation” means a drug-induced state during which:

a. A patient responds to verbal commands,

b. Cognitive function and coordination may be impaired, and

c. A patient’s ventilatory and cardiovascular functions are unaffected.

18. “Moderate Sedation” means a drug-induced depression of consciousness during which:

a. A patient responds to verbal commands or light tactile stimulation, and

b. No interventions are required to maintain ventilatory or cardiovascular function.

19. “Monitor” means to assess the condition of a patient.

20. “Office-based surgery” means a medical procedure conducted in a physician’s office or other outpatient setting that is not part of a licensed hospital or licensed ambulatory surgical center. (A.R.S. § 32-1401(20)).

21. “PALS” means pediatric life support performed according to certification standards of the American Academy of Pediatrics or the American Heart Association.

22. “Patient” means an individual receiving office-based surgery using sedation.

23. “Physician” has the same meaning as doctor of medicine as defined in A.R.S. § 32-1401.

24. “Rescue” means to correct adverse physiologic consequences of deeper than intended level of sedation and return the patient to the intended level of sedation.

25. “Sedation” means minimum sedation, moderate sedation, or deep sedation.

26. “Staff member” means an individual who:

a. Is not a health care professional, and

b. Assists with office-based surgery using sedation under the supervision of the physician performing the office-based surgery using sedation.

27. “Transfer” means a physical relocation of a patient from a physician’s office to a licensed health care institution.

Historical Note

Former Rule 12. Former Section R4-16-01 repealed, new Section R4-16-101 adopted effective June 1, 1984 (Supp. 84-3). Section repealed, new Section renumbered from R4-16-103 effective September 22, 1995 (Supp. 95-3). Amended by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Amended by final rulemaking at 8 A.A.R. 4270, effective November 18, 2002 (Supp. 02-3). Former Section R4-16-101 recodified to R4-16-102 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). New Section made by final rulemaking at 12 A.A.R. 823, effective February 23, 2006 (Supp. 06-1). Amended by final rulemaking at 14 A.A.R. 380, effective January 8, 2008 (Supp. 08-1).

R4-16-102. Continuing Medical Education

A. A physician holding an active license to practice medicine in this state shall complete 40 credit hours of the continuing medical education required by A.R.S. § 32-1434 during the two calendar years preceding biennial registration. A physician may not carry excess hours over to another two-year cycle. One hour of credit is allowed for each clock hour of participation in continuing medical education activities, unless otherwise designated in subsection (B).

B. A physician may claim continuing medical education for the following:

1. Participating in an internship, residency, or fellowship at a teaching institution approved by the American Medical Association, the Association of American Medical Colleges, or the American Osteopathic Association. A physician may claim one credit hour of continuing medical education for each one day of training in a full-time approved program, or for a less than full-time training on a pro rata basis. In this subsection teaching institutions define “full-time.”

2. Participating in an education program for an advanced degree in a medical or medically-related field in a teaching institution approved by the American Medical Association, the Association of American Medical Colleges, or the American Osteopathic Association. A physician may claim one credit hour of continuing medical education for each one day of full-time study or less than a full-time study on a pro rata basis. In this subsection teaching institutions define “full-time”.

3. Participating in full-time research in a teaching institution approved by the American Medical Association, the Association of American Medical Colleges, or the American Osteopathic Association. A physician may claim one credit hour of continuing medical education for each one day of full-time research, or less than full-time research on a pro rata basis. In this subsection teaching institutions define “full-time”.

4. Participating in an education program certified as Category 1 by an organization accredited by the Accreditation Council for Continuing Medical Education, 515 North State Street, Suite 2150, Chicago, Illinois 60610.

5. Participating in a medical education program designed to provide understanding of current developments, skills, procedures, or treatments related to the practice of medicine, that is provided by an organization or institution accredited by the Accreditation Council for Continuing Medical Education.

6. Serving as an instructor of medical students, house staff, other physicians, or allied health professionals from a hospital or other health care institution with a formal training program, if the instructional activities provide the instructor with understanding of current developments, skills, procedures, or treatments related to the practice of allopathic medicine.

7. Publishing or presenting a paper, report, or book that deals with current developments, skills, procedures, or treatments related to the practice of allopathic medicine. The physician may claim one credit hour for each hour preparing, writing, and presenting materials:

a. Actually published or presented; and

b. After the date of publication or presentation.

8. A credit hour may be earned for any of the following activities that provide an understanding of current developments, skills, procedures, or treatments related to the practice of allopathic medicine:

a. Completing a medical education program based on self-instruction that uses videotapes, audiotapes, films, filmstrips, slides, radio broadcasts, or computers;

b. Reading scientific journals and books;

c. Preparing for specialty board certification or recertification examinations;

d. Participating on a staff or quality of care committee, or utilization review committee in a hospital, health care institution, or government agency.

C. If a physician holding an active license to practice medicine in this state fails to meet the continuing medical education requirements under subsection (A) because of illness, military service, medical or religious missionary activity, or residence in a foreign country, upon written application, shall grant an extension of time to complete the continuing medical education.

D. The Board shall mail to each physician a license renewal form that includes a section regarding continuing medical education compliance. The physician shall sign and return the form certified under penalty of perjury that the continuing medical education requirements under subsection (A) are satisfied for the two-calendar-year period preceding biennial renewal. Failure to receive the license renewal form under subsection (A) shall not relieve the physician of the requirements of subsection (A). The Board may randomly audit a physician to verify compliance with the continuing medical education requirements under subsection (A).

Historical Note

Former Rule 16. Former Section R4-16-02 repealed, new Section R4-16-102 adopted effective June 1, 1984 (Supp. 84-3). Section repealed, new Section renumbered from R4-16-106 effective September 22, 1995 (Supp. 95-3). Amended by final rulemaking at 6 A.A.R. 1881, effective May 3, 2000 (Supp. 00-2). Former Section R4-16-102 recodified to R4-16-103; New Section R4-16-102 recodified from R4-16-101 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-103. Rehearing or Review of Board Decision

A. A motion for rehearing or review shall be filed as follows:

1. Except as provided in subsection (B), any party in a contested case may file a written motion for rehearing or review of the Board’s decision, specifying generally the grounds upon which the motion is based.

2. A motion for rehearing or review shall be filed with the Board and served no later that 30 days after the decision of the Board.

3. For purposes of this Section, “service” has the same meaning as in A.R.S. § 41-1092.09.

4. For purposes of this Section, a document is deemed filed when the Board receives the document.

5. For purposed of the Section, the terms “contested case” and “party” shall have the same meaning as in A.R.S. § 41-1001.

B. If the Board makes a specific finding that it is necessary for a particular decision to take immediate effect to protect the public health and safety, or that a rehearing or review of the Board’s decision is impracticable or contrary to the public interest, the decision shall be issued as a final decision without opportunity for rehearing or review and shall be a final administrative decision for purposes of judicial review.

C. A written response to a motion for rehearing or review may be filed and served within 15 days after service of the motion for rehearing or review. The Board may require the filing of written briefs upon any issues raised in the motion and may provide for oral argument.

D. A rehearing or review of a decision may be granted for any of the following reasons materially affecting a party’s rights:

1. Irregularity in the administrative proceedings by the Board, its hearing officer, or the prevailing party, or any ruling or abuse of discretion, that deprives the moving party of a fair hearing;

2. Misconduct of the Board, its hearing officer, or the prevailing party;

3. Accident or surprise that could have not been prevented by ordinary prudence;

4. Material evidence, newly discovered, which with reasonable diligence could not have been discovered and produced at the original hearing;

5. Excessive or insufficient penalties;

6. Error in the admission or rejection of evidence, or other errors of law that occurred at the hearing;

7. The decision is the result of a passion or prejudice; or

8. The decision of findings of fact or decision is not justified by the evidence or is contrary to law.

E. A rehearing or review may be granted to all or any of the parties and on all or part of the issues for any of the reasons in subsection (D). The Board may take additional testimony, amend findings of fact and conclusions of law, or make new findings and conclusions, and affirm, modify, or reverse the original decision.

F. A rehearing or review, if granted, shall be a rehearing or review only of the question upon which the decision is found erroneous. An order granting a rehearing or review shall specify with particularity the grounds for the order.

G. Not later than 15 days after a decision is issued, the Board of its own initiative may order a rehearing or review for any reason that it might have granted a rehearing or review on motion of a party. After giving the parties notice and an opportunity to be heard on the matter, the Board may grant a timely-served motion for a rehearing or review, for a reason not stated in the motion. In either case, the Board shall specify in the order the grounds for the rehearing or review.

H. If a motion for rehearing or review is based upon affidavits, they shall be served with the motion. The opposing party may, within 15 days after service, serve opposing affidavits. The Board may extend this period for a maximum of 20 days either by the Board for good cause, or by the parties by written stipulation. The Board may permit reply affidavits.

Historical Note

Former Rule 17; Amended effective August 19, 1977 (Supp. 77-4). Former Section R4-16-03 repealed, new Section R4-16-103 adopted effective June 1, 1984 (Supp. 84-3). Section R4-16-103 renumbered to R4-16-101 effective September 22, 1995 (Supp. 95-3). New Section adopted effective May 20, 1997 (Supp. 97-2). Amended by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Amended by final rulemaking at 8 A.A.R. 4270, effective November 18, 2002 (Supp. 02-3). Former Section R4-16-103 recodified to R4-16-204; new Section R4-16-103 recodified from R4-16-102 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-104. Recodified

Historical Note

Former Rule 18. Former Section R4-16-04 repealed, new Section R4-16-104 adopted effective June 1, 1984 (Supp. 84-3). Section repealed effective September 22, 1995 (Supp. 95-3). New Section adopted effective January 20, 1998 (Supp. 98-1). Section recodified to R4-16-206 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-105. Recodified

Historical Note

Former Rule 19. Former Section R4-16-05 repealed, new Section R4-16-105 adopted effective June 1, 1984 (Supp. 84-3). Section repealed effective September 22, 1995 (Supp. 95-3). New Section adopted effective January 20, 1998 (Supp. 98-1). Section recodified to R4-16-207 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-106. Recodified

Historical Note

Former Rule 21. Former Section R4-16-06 repealed, new Section R4-16-106 adopted effective June 1, 1984 (Supp. 84-3). Section R4-16-106 renumbered to R4-16-102 effective September 22, 1995 (Supp. 95-3). New Section adopted by final rulemaking at 6 A.A.R. 1881, effective May 3, 2000 (Supp. 00-2). Section recodified to R4-16-201 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-107. Recodified

Historical Note

New Section adopted by final rulemaking at 6 A.A.R. 1881, effective May 3, 2000 (Supp. 00-2). Section recodified to R4-16-202 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-108. Recodified

Historical Note

New Section adopted by final rulemaking at 6 A.A.R. 1881, effective May 3, 2000 (Supp. 00-2). Section recodified to R4-16-203 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

Table 1. Recodified

Historical Note

Table 1 adopted effective January 20, 1998 (Supp. 98-1). Table 1 recodified to the end of Article 2 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-109. Recodified

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Amended by final rulemaking at 8 A.A.R. 4270, effective November 18, 2002 (Supp. 02-3). Section recodified to R4-16-205 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

ARTICLE 2. LICENSURE

R4-16-201. Application for Licensure

A. For purposes of this Article, unless otherwise specified:

1. “ECFMG” means Educational Commission for Foreign Medical Graduates.

2. “FLEX” means Federation Licensing Examination.

3. “LMCC” means Licentiate of the Medical Council of Canada.

4. “Medical Condition” means the following physiological, mental, or psychological conditions or disorders: (a) chronic and uncorrected orthopedic, visual, speech, or hearing impairments; (b) cerebral palsy, epilepsy, muscular dystrophy, multiple sclerosis, cancer, heart disease, diabetes, mental retardation, HIV disease, or tuberculosis; or (c) specific learning disabilities, dementia, Alzheimer’s, bipolar disorder, schizophrenia, paranoia, or any psychotic disorder.

5. “SPEX” means Special Purposes Examination.

6. “USMLE” means United States Medical Licensing Examination.

B. An applicant for licensure to practice medicine by endorsement, Step 3 of the USMLE, or by endorsement with the SPEX shall submit the following information on an application form provided by the Board:

1. Applicant’s full name, social security number, business and home addresses, business and home telephone numbers, and date and place of birth;

2. Names of the states or provinces in which the applicant has applied for or has been granted a license or registration to practice medicine, including license number, date issued, and current status of the license;

3. Whether the applicant has had an application for medical licensure denied or rejected by another state or province licensing board, and if so, an explanation;

4. Whether any disciplinary or rehabilitative action has ever been taken against the applicant by another licensing board, including other health professions, and if so, an explanation;

5. Whether any disciplinary actions, restrictions, or limitations have been taken against the applicant while participating in any type of training program or by any health care provider, and if so, an explanation;

6. Whether the applicant has been found in violation of a statute, rule, or regulation of any domestic or foreign governmental agency, and if so, an explanation;

7. Whether the applicant is currently under investigation by any medical board or peer review body, and if so, an explanation;

8. Whether the applicant has ever had a medical license disciplined resulting in a revocation, suspension, limitation, restriction, probation, voluntarily surrender, cancellation during an investigation or entered into a consent agreement or stipulation, and if so, an explanation;

9. Whether the applicant has had hospital privileges revoked, denied, suspended, or restricted, and if so, an explanation;

10. Whether the applicant has been named as a defendant in a malpractice matter currently pending or that resulted in a settlement or judgment against the applicant, and if so, an explanation;

11. Whether the applicant has been subjected to any regulatory disciplinary action, including censure, practice restriction, suspension, sanction, or removal from practice, imposed by any agency of the federal or state government, and if so, an explanation;

12. Whether the applicant has had the authority to prescribe, dispense, or administer medications limited, restricted, modified, denied, surrendered, or revoked by a federal or state agency, and if so, an explanation;

13. Whether the applicant, within the last five years, has or had a medical condition that impairs or limits the applicant’s ability to safely practice medicine, and if so, an explanation;

14. Whether the applicant engages in the illegal use of any controlled substance, habit- forming drug, or prescription medication, and if so, an explanation;

15. Whether the applicant has consumed intoxicating beverages resulting in the applicant’s present ability to exercise the judgment and skills of a medical professional, being impaired or limited, and if so, an explanation;

16. Whether the applicant has been found guilty or entered into a plea of no contest to a felony, or misdemeanor involving moral turpitude in any state, and if so, an explanation;

17. A complete list of the applicant’s internship, residency, and fellowship training;

18. Whether the applicant is currently certified by any of the American Board of Medical Specialties;

19. The applicant’s intended specialty;

20. Consistent with the Board’s statutory authority, other information the Board may deem necessary to fully evaluate the applicant;

21. A photograph of passport quality no larger than 2 1/2 x 3 inches taken not more than 60 days before the date of application; and

22. A notarized statement, signed by the applicant, verifying the truthfulness of the information provided, and that the applicant has not engaged in any acts prohibited by Arizona law or Board rules, and authorizing release of any required records or documents to complete application review.

C. In addition to the application form, an applicant for licensure to practice medicine by endorsement, Step 3 of the USMLE, or endorsement with the SPEX shall submit the following:

1. Certified copy of the applicant’s birth certificate or passport;

2. Certified evidence of legal name change if the applicant’s legal name is different from that shown on the document submitted under subsection (B)(1);

3. Complete list of all hospital affiliations and employment for the past five years;

4. Verification of any medical malpractice matter currently pending or resulting in a settlement or judgment against the applicant, including a copy of the complaint and either the agreed terms of settlement or the judgment. The verification must contain the name and address of each defendant, the name and address of each plaintiff, the date and location of the occurrence which created the claim and a statement specifying the nature of the occurrence resulting in the medical malpractice action; and

5. The fee required in A.R.S. § 32-1436.

D. In addition to the requirements of subsections (A) and (B), an applicant for licensure to practice medicine by endorsement, by Step 3 of the USMLE, or by endorsement with the SPEX shall have the following directly submitted to the Board:

1. The following forms must be included with the application and be completed by persons other than the applicant:

a. Medical College Certification,

b. Postgraduate Training Certification,

c. Clinical Instructor Certification,

d. ECFMG certification if applicant is an international graduate,

e. Federation of State Medical Boards Disciplinary Search,

f. American Medical Association Physician Profile, and

g. Verification of American Board of Medical Specialty Certification, if applicable;

2. Examination and Board History Report scores for USMLE, FLEX, and SPEX;

3. Verification of LMCC exam score, state written exam score, or national board exam score;

4. Verification of licensure from every state in which the applicant has ever held a medical license; and

5. Verification of all hospital affiliations and employment for the past five years. This must be submitted by the verifying entity on its official letterhead.

Historical Note

Adopted effective September 22, 1995 (Supp. 95-3). Amended by final rulemaking at 8 A.A.R. 2319, effective May 9, 2002 (Supp. 02-2). Former Section R4-16-201 recodified to R4-16-301; New Section R4-16-201 recodified from R4-16-106 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-202. Application for Pro Bono Registration

A. An applicant for a pro bono registration to practice medicine shall submit an application on a form provided by the Board that provides the information required by R4-16-106(B).

B. In addition to the application, an applicant for a pro bono registration to practice medicine shall submit the following:

1. Certified copy of the applicant’s medical degree diploma;

2. Certified copies of internship, residency, or fellowship certificates;

3. Photocopy of any current license to practice medicine in another state, territory, or possession of the United States or the District of Columbia, along with a letter from the medical board issuing the license, certifying that the license is current and in good standing;

4. Certified copy of ECFMG certificate, if applicable;

5. The fee required in A.R.S. § 32-1436.

C. In addition to the requirements of subsections (A) and (B), an applicant for pro bono registration shall have the following directly submitted to the Board:

1. American Medical Association physician profile;

2. Federation of State Medical Boards disciplinary search; and

3. Verification of licensure from every state in which the applicant has ever held a license.

Historical Note

Adopted effective September 22, 1995 (Supp. 95-3). Amended by final rulemaking at 8 A.A.R. 2319, effective May 9, 2002 (Supp. 02-2). Former Section R4-16-202 recodified to R4-16-302; New Section R4-16-202 recodified from R4-16-107 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-203. Application for Locum Tenens Registration

A. An applicant for a locum tenens registration to practice medicine shall submit an application on a form provided by the Board that provides the information required by R4-16-107(A).

B. In addition to the application, an applicant for a locum tenens registration to practice medicine shall submit the following:

1. Certified copy of the applicant’s medical degree diploma;

2. Certified copies of internship, residency, or fellowship certificates;

3. A statement completed by the sponsoring Arizona-licensed physician giving the reason for the request for issuance of the registration; and

4. Certified copy of ECFMG certificate, if applicable.

C. In addition to the requirements of subsections (A) and (B), an applicant for locum tenens registration shall have the following directly submitted to the Board:

1. American Medical Association physician profile;

2. Federation of State Medical Boards disciplinary search; and

3. Verification of licensure from every state in which the applicant has ever held a license.

Historical Note

Adopted effective September 22, 1995 (Supp. 95-3). Amended by final rulemaking at 8 A.A.R. 2319, effective May 9, 2002 (Supp. 02-2). Former Section R4-16-203 recodified to R4-16-303; New Section R4-16-203 recodified from R4-16-108 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-204. Licensure by Endorsement

A. An applicant for licensure by endorsement may make a written request of the Board, for an extension of the seven-year period provided by A.R.S. § 32-1426(B)(4) to pass one of the combinations of specified examinations. The applicant shall submit the written request to the Board with evidence that:

1. The applicant meets all requirements for licensure and for taking the United States Medical Licensing Examination,

2. The combination of examinations cannot be passed in the time required by law, and

3. The applicant is:

a. A full-time student in an approved school of medicine, as defined in A.R.S. § 32-1401(5);

b. A participant in an approved hospital internship, residency, or clinical fellowship program, as defined in A.R.S. § 32-1401(4); or

c. A full-time student in a recognized medical degree program, as defined in subsection (E), concurrently or consecutively with medical school or postgraduate training.

B. If the Board determines that the applicant satisfies the requirements of subsection (A), the Board shall grant the extension.

C. An extension shall not exceed 10 years from the date on which the applicant successfully completes the first part of the combination of examinations.

D. If the Board denies the request for extension, the applicant may request a hearing by filing a written notice with the Board no later than 30 days after receipt of notice of the Board’s action. A hearing shall be conducted according to A.R.S. Title 41, Chapter 6, Article 10.

E. In this Section, a “recognized degree program” means an education program offered by a college or university approved by the New England Association of Schools and Colleges, Middle States Association of Colleges and Secondary Schools, North Central Association of Colleges and Schools, Northwest Association of Schools and Colleges, Southern Association of Colleges and Schools, or Western Association of Schools and Colleges or accredited by the United States Department of Education, Council on Postsecondary Accreditation, Association of American Medical Colleges, the Association of Canadian Medical Colleges, or the American Medical Association.

F. An applicant for licensure by endorsement under A.R.S. § 32-1426(C) who provides proof of passing an examination specified in A.R.S. § 32-1426(A) more than ten years before the date of filing shall:

1. Hold a current certification in an American Board of Medical Specialty (“ABMS”), or

2. Take and pass the Special Purposes Examination (SPEX).

Historical Note

Adopted effective September 22, 1995 (Supp. 95-3). Amended by final rulemaking at 8 A.A.R. 2319, effective May 9, 2002 (Supp. 02-2). Former Section R4-16-204 recodified to R4-16-304; New Section R4-16-204 recodifed from R4-16-103 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-205. Fees

The Board charges the following fees, which are nonrefundable unless A.R.S. § 41-1077 applies:

1. Application for a license through endorsement, USMLE Step 3, or Endorsement with SPX Examination, $500;

2. Issuance of an initial license, $500, which may be prorated from date of issuance to date of license renewal;

3. Two-year license renewal, $500;

4. Reactivation of an inactive license, $500, which may be prorated from date of reactivation to date of license renewal;

5. Locum tenens registration, $350;

6. Duplicate license, $50;

7. Annual registration of an approved internship, residency, clinical fellowship program, or short-term residency program, $50;

8. Annual teaching license at an approved school of medicine or at an approved hospital internship, residency, or clinical fellowship program, $250;

9. Five-day teaching permit at an approved school of medicine or at an approved hospital internship, residency, or clinical fellowship program, $100;

10. Copy of the annual allopathic medical directory, $30;

11. Initial registration to dispense drugs and devises, $200;

12. Annual renewal to dispense drugs and devises, $150;

13. Penalty fee for late renewal of an active license, $350;

14. Verifying a license, $10 per request;

15. Copies of records, documents, letters, minutes, applications, and files, $1 for the first three pages and 25¢ for each additional page; and

16. Data disk containing public information about licensed physicians, $100.

Historical Note

Adopted effective September 22, 1995 (Supp. 95-3). Amended by final rulemaking at 8 A.A.R. 2319, effective May 9, 2002 (Supp. 02-2). Former Section R4-16-205 recodified to R4-16-305; New Section R4-16-205 recodifed from R4-16-109 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). Amended by final rulemaking 19 A.A.R. 1300, effective July 6, 2013 (Supp. 13-2).

R4-16-206. Time-frames for Licenses, Permits, and Registrations

A. For each type of license, permit, or registration issued by the Board, the overall time-frame under A.R.S. § 41-1072(2) is shown on Table 1.

B. For each type of license, permit, or registration issued by the Board, the administrative completeness review time-frame under A.R.S. § 41-1072(1) is shown on Table 1 and begins on the date the Board receives an application and all required documentation and information.

1. If the required application is not administratively complete, the Board shall send a written deficiency notice to the applicant.

a. In the deficiency notice, the Board shall state each deficiency and the information required to complete the application or supporting documentation. In the deficiency notice, the Board shall include a written notice that the application is withdrawn if the applicant does not submit the additional information within the time provided for response.

b. Within the time provided in Table 1 for response to a deficiency notice, the applicant shall submit to the Board the requested documentation or information specified in the notice. The time-frame for the Board to finish the administrative completeness review is suspended from the date of the notice until the date the Board receives the requested documentation or information from the applicant.

2. Within 30 days after receipt of a deficiency notice, an applicant may submit a written hearing request to the Board.

3. The Board shall schedule and conduct the applicant’s deficiency hearing according to provisions prescribed under A.R.S. § 32-1427(E).

4. In addition to hearing provisions prescribed under subsection (B)(3), the Board shall send the following to the applicant in writing:

a. A notice of a scheduled hearing at least 21 days before the hearing date; and

b. The Board’s decision within 30 days after the hearing that shall include notice of any applicable right of appeal.

C. For each type of license, permit, or registration issued by the Board, the substantive review time-frame under A.R.S. § 41-1072(3) is shown on Table 1.

1. The Board may request additional information from an applicant according to provisions prescribed under A.R.S. § 41-1075 during the substantive review time-frame. In any request for additional information, the Board shall include a written notice that the application is withdrawn if the applicant does not submit the additional information within the time provided for response.

2. In response to a single comprehensive written request from the Board under A.R.S. § 41-1075(A), the applicant shall submit the information identified to the Board within the time to respond specified in Table 1. The time-frame for the Board to finish the substantive review is suspended from the date the Board sends the comprehensive written request for additional information until the date the Board receives the additional information from the applicant.

3. If the Board determines that the applicant does not meet all substantive criteria for a license, permit, or registration as required under A.R.S. Title 32, Chapter 13 or this Chapter, the Board shall send written notice of denial to the applicant. The Board shall include notification of any applicable right of appeal in the denial notice.

4. If the applicant meets all substantive criteria for a license, permit, or registration required under A.R.S. Title 32, Chapter 13 and this Chapter, the Board shall issue the applicable license, permit, or registration to the applicant.

Historical Note

New Section recodified from R4-16-104 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). Amended by final rulemaking at 11 A.A.R. 2944, effective September 10, 2005 (Supp. 05-3).

R4-16-207. Time-frames for License Renewal; Expiration

A. For license renewal, the overall time-frame under A.R.S. § 41-1072(2) is 90 days.

B. For license renewal, the administrative completeness review time-frame described in A.R.S. § 41-1072(1) is 45 days and begins on the date the Board receives the renewal application.

1. If the required application is not administratively complete, the Board shall send a written deficiency notice to the applicant.

a. In a deficiency notice, the Board shall state each deficiency and the information required to complete the application or supporting documentation.

b. Within 60 days after the Board sends a deficiency notice, the applicant shall submit to the Board the requested documentation or information specified in the notice. The time-frame for the Board to finish the administrative completeness review is suspended from the date of the notice until the date the Board receives the requested documentation or information from the applicant.

2. The provisions prescribed under R4-16-206(B)(2) through (B)(4) apply to this Section.

C. For license renewal, the substantive review time-frame under A.R.S. § 41-1072(3) is 45 days.

1. During the substantive review time-frame, the Board may request additional information according to provisions prescribed under A.R.S. § 41-1075.

2. The applicant shall submit to the Board information identified by a single comprehensive written request from the Board for additional information allowed under A.R.S. § 41-1075(A) within 60 days after the Board sends its request.

3. If the applicant meets all license renewal substantive criteria and remits the applicable fee required under A.R.S. Title 31, Chapter 13 and this Chapter, the Board shall issue a license renewal to the applicant.

D. If a person holding an active license does not apply for license renewal according to the biennial renewal requirement or fails to meet time-frame requirements under this Section, the person’s license expires according to provisions prescribed under A.R.S § 32-1430(A) unless the person is under investigation according to provisions prescribed under A.R.S. § 32-3202.

Historical Note

New Section recodified from R4-16-105 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). Amended by final rulemaking at 11 A.A.R. 2944, effective September 10, 2005 (Supp. 05-3).

Table 1. Time-frames

Time-frames (in calendar days)

Type of License

Overall Time-frame

Administrative Review Time-frame

Time to Respond to

Deficiency Notice

Substantive Review Time-frame

Time to Respond to Request for Additional

Information

Initial License by Examination

240

120

365

120

90

Initial License by Endorsement

240

120

365

120

90

Locum Tenens or Pro Bono Registration

120

60

30

60

30

Temporary License

60

30

30

30

30

Teaching License

40

20

30

20

30

Educational Teaching Permit

20

10

30

10

10

Training Permit

40

20

30

20

30

Short Term Training Permit

40

20

30

20

30

One-year Training Permit

40

20

30

20

30

Registration to Dispense Controlled Substances and Prescription-only Drugs and Devices

150

45

30

105

30

Historical Note

Table 1 recodified from Article 1 to end of Article 2 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). Amended by final rulemaking at 11 A.A.R. 2944, effective September 10, 2005 (Supp. 05-3).

ARTICLE 3. DISPENSING OF DRUGS

R4-16-301. Registration and Renewal

A. A physician who wishes to dispense a controlled substance as defined in A.R.S. § 32-1901(12), a prescription-only drug as defined in A.R.S. § 32-1901(65), or a prescription-only device as defined in A.R.S. § 32-1901(64) shall be currently licensed to practice medicine in Arizona and shall provide to the Board the following:

1. A completed registration form that includes the following information:

a. The physician’s name, license number, and field of practice;

b. A list of the types of drugs and devices the physician will dispense; and

c. The location or locations where the physician will dispense a controlled substance, a prescription-only drug, or a prescription-only device.

2. A copy of the physician’s current Drug Enforcement Administration Certificate of Registration for each dispensing location from which the physician will dispense a controlled substance.

3. The fees required in A.R.S. § 32-1436.

B. A physician shall renew a registration to dispense a controlled substance, a prescription-only drug, or a prescription-only device by complying with the requirements in subsection (A) on or before June 30 of each year. If a physician has made timely and complete application for the renewal of a registration, the physician may continue to dispense until the Board approves or denies the renewal application.

C. If the completed annual renewal form, all required documentation, and the fee are not received in the Board’s office on or before June 30, the physician shall not dispense any controlled substances, prescription-only drugs, or prescription-only devices until re-registered. The physician shall re-register by filing for initial registration under subsection (A) and shall not dispense a controlled substance, a prescription-only drug, or a prescription-only device until receipt of the re-registration.

Historical Note

New Section adopted by final rulemaking at 6 A.A.R. 751, effective February 2, 2000 (Supp. 00-1). Former Section R4-16-301 recodified to R4-16-401; New Section R4-16-301 recodified from R4-16-201 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-302. Packaging and Inventory; Exception

A. A physician shall dispense all controlled substances and prescription-only drugs in prepackaged containers or in light-resistant containers with consumer safety caps, that comply with standards specified in the official compendium as defined in A.R.S. § 32-1901(49) and state and federal law, unless a patient or a patient’s representative requests a non-safety cap.

B. All controlled substances and prescription-only drugs dispensed shall be labeled with the following information:

1. The physician’s name, address, and telephone number;

2. The date the controlled substance and prescription-only drug is dispensed;

3. The patient’s name;

4. The controlled substance and prescription-only drug name, strength, and dosage, form, name of manufacturer, the quantity dispensed, directions for use, and any cautionary statement necessary for the safe and effective use of the controlled substance and prescription-only drug; and

5. A beyond-use-date not to exceed one year from the date of dispensing or the manufacturer’s expiration date if less than one year.

C. A physician shall secure all controlled substances in a locked cabinet or room and shall control access to the cabinet or room by a written procedure that includes, at a minimum, designation of the persons who have access to the cabinet or room and procedures for recording requests for access to the cabinet or room. This written procedure shall be made available on demand to the Board or its authorized representatives for inspection or copying. Prescription-only drugs shall be stored so as not to be accessible to patients.

D. Controlled substances and prescription-only drugs not requiring refrigeration shall be maintained in an area where the temperature does not exceed 85° F.

E. A physician shall maintain an ongoing dispensing log for all controlled substances and the prescription-only drug nalbuphine hydrochloride (Nubain) dispensed by the physician. The dispensing log shall include the following:

1. A separate inventory sheet for each controlled substance and prescription-only drug;

2. The date the drug is dispensed;

3. The patient’s name;

4. The dosage, controlled substance and prescription-only drug name, strength, dosage, form, and name of the manufacturer;

5. The number of dosage units dispensed;

6. A running total of each controlled substance and prescription-only drug dispensed; and

7. The signature of the physician written next to each entry.

F. A physician may use a computer to maintain the dispensing log required in subsection (E) if the log is quickly accessible through either on-screen viewing or printing of a copy.

G. This Section does not apply to a prepackaged manufacturer sample of a controlled substance and prescription-only drug, unless otherwise provided by federal law.

Historical Note

New Section adopted by final rulemaking at 6 A.A.R. 751, effective February 2, 2000 (Supp. 00-1). Former Section R4-16-302 recodified to R4-16-402; New Section R4-16-302 recodified from R4-16-202 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-303. Prescribing and Dispensing Requirements

A. A physician shall record on the patient’s medical record the name, strength, dosage, and form, of the controlled substance, prescription-only drug, or prescription-only device dispensed, the quantity or volume dispensed, the date the controlled substance, prescription-only drug, or prescription-only device is dispensed, the medical reasons for dispensing the controlled substance, prescription-only drug, or prescription-only device, and the number of refills authorized.

B. Before dispensing a controlled substance, prescription-only drug, or prescription-only device to a patient, a physician shall review the prepared controlled substance, prescription-only drug, or prescription-only device to ensure that:

1. The container label and contents comply with the prescription, and

2. The patient is informed of the name of the controlled substance, prescription-only drug, or prescription-only device, directions for use, precautions, and storage requirements.

C. A physician shall purchase all dispensed controlled substances, prescription-only drugs, or prescription-only devices from a manufacturer or distributor approved by the United States Food and Drug Administration, or a pharmacy holding a current permit from the Arizona Board of Pharmacy.

D. The person who prepares a controlled substance, prescription-only drug, or prescription-only device for dispensing shall countersign and date the original prescription form for the controlled substance, prescription-only drug, or prescription-only device.

E. For purposes of this Article, “dispensing” means the delivery of a controlled substance, a prescription-only drug, or a prescription-only device to a patient for use outside the physician’s office.

Historical Note

New Section adopted by final rulemaking at 6 A.A.R. 751, effective February 2, 2000 (Supp. 00-1). Amended by final rulemaking at 6 A.A.R. 4585, effective November 14, 2000 (Supp. 00-4). Former Section R4-16-303 recodified to R4-16-403; New Section R4-16-303 recodifed from R4-16-203 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-304. Recordkeeping and Reporting Shortages

A. A physician who dispenses a controlled substance or prescription-only drug shall ensure that an original prescription dispensed from the physician’s office is dated, consecutively numbered in the order in which it is originally dispensed, and filed separately from patient medical records. A physician shall ensure that an original prescription be maintained in three separate files, as follows:

1. Schedule II controlled substances;

2. Schedule III, IV, and V controlled substances; and

3. Prescription-only drugs.

B. A physician shall ensure that purchase orders and invoices are maintained for all controlled substances and prescription-only drugs dispensed for profit and not for profit for three years from the date of the purchase order or invoice. Purchase orders and invoices shall be maintained in three separate files as follows:

1. Schedule II controlled substances only;

2. Schedule III, IV, and V controlled substances and nalbuphine; and

3. All other prescription-only drugs.

C. A physician who discovers a theft or loss of a controlled substance or a dangerous drug, as defined in A.R.S. § 13-3401, from the physician’s office shall:

1. Immediately notify the local law enforcement agency,

2. Provide that agency with a written report, and

3. Send a copy to the Drug Enforcement Administration and the Board within seven days of the discovery.

D. For purposes of this Section, controlled substances are identified, defined, or listed in A.R.S. Title 36, Chapter 27.

Historical Note

New Section recodified from R4-16-204 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-305. Inspections; Denial and Revocation

A. A physician shall cooperate with and allow access to the physician’s office and records for periodic inspection of dispensing practices by the Board or its authorized representative. Failure to cooperate or allow access shall be grounds for revocation of a physician’s registration to dispense a controlled substance, prescription-only drug, or prescription-only device or denial of renewal of the physician’s dispensing registration.

B. Failure to comply with A.R.S. § 32-1491 or this Article constitutes grounds for denial or revocation of dispensing registration.

C. The Board shall revoke a physician’s registration to dispense a controlled substance, prescription-only drug, or prescription-only device upon occurrence of the following:

1. Suspending, revoking, surrendering, or canceling the physician’s license;

2. Placing the physician’s license on inactive status;

3. Failing to timely renew the physician’s license; or

4. Restricting the physician’s ability to prescribe or administer medication, including loss or expiration of the physician’s Drug Enforcement Administration Certificate of Registration.

D. If the Board denies a physician’s dispensing registration, the physician may appeal the decision by filing a request, in writing, with the Board, no later than 30 days after receipt of the notice denying the registration.

Historical Note

New Section recodified from R4-16-205 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

ARTICLE 4. MEDICAL ASSISTANTS

R4-16-401. Medical Assistant Training Requirements

A. A supervising physician or physician assistant shall ensure that a medical assistant satisfies one of the following training requirements before employing the medical assistant:

1. Completion of an approved medical assistant training program; or

2. Completion of an unapproved medical assistant training program and passage of the medical assistant examination administered by either the American Association of Medical Assistants or the American Medical Technologists.

B. This Section does not apply to any person who:

1. Before February 2, 2000:

a. Completed an unapproved medical assistant training program and was employed as a medical assistant after program completion; or

b. Was directly supervised by the same physician, physician group, or physician assistant for a minimum of 2000 hours; or

2. Completes a United States Armed Forces medical services training program.

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Former Section R4-16-401 recodified to R4-16-501; New Section R4-16-401 recodified from R4-16-301 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). Former Section R4-16-401 repealed; New Section R4-16-401 renumbered from R4-16-402 and amended by final rulemaking at 12 A.A.R. 823, effective February 23, 2006 (Supp. 06-1).

R4-16-402. Authorized Procedures for Medical Assistants

A. A medical assistant may perform, under the direct supervision of a physician or a physician assistant, the medical procedures listed in the 2003 revised edition, Commission on Accreditation of Allied Health Education Program’s, “Standards and Guidelines for an Accredited Educational Program for the Medical Assistant, Section (III)(C)(3)(a) through (III)(C)(3)(c).” This material is incorporated by reference, does not include any later amendments or editions of the incorporated matter, and may be obtained from the publisher at 35 East Wacker Drive, Suite 1970, Chicago, Illinois 60601, www.caahep.org, or the Arizona Medical Board at 9545 E. Doubletree Ranch Road, Scottsdale, AZ 85258, www.azmd.gov.

B. In addition to the medical procedures in subsection (A), a medical assistant may administer the following under the direct supervision of a physician or physician assistant:

1. Whirlpool treatments,

2. Diathermy treatments,

3. Electronic galvation stimulation treatments,

4. Ultrasound therapy,

5. Massage therapy,

6. Traction treatments,

7. Transcutaneous Nerve Stimulation unit treatments,

8. Hot and cold pack treatments, and

9. Small volume nebulizer treatments.

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Amended by final rulemaking at 8 A.A.R. 4270, effective November 18, 2002 (Supp. 02-3). Former Section R4-16-402 recodified to R4-16-502; New Section R4-16-402 recodified from R4-16-302 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). Former Section R4-16-402 renumbered to R4-16-401; New Section R4-16-402 renumbered from R4-16-403 and amended by final rulemaking at 12 A.A.R. 823, effective February 23, 2006 (Supp. 06-1).

R4-16-403. Renumbered

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Amended by final rulemaking at 8 A.A.R. 4270, effective November 18, 2002 (Supp. 02-3). Former Section R4-16-403 recodified to R4-16-503; New Section R4-16-403 recodified from R4-16-303 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). Former Section R4-16-403 renumbered to R4-16-402 by final rulemaking at 12 A.A.R. 823, effective February 23, 2006 (Supp. 06-1).

R4-16-404. Recodified

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Section recodified to R4-16-504 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-405. Recodified

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Section recodified to R4-16-505 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-406. Recodified

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Section recodified to
R4-16-506 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-407. Recodified

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Section recodified to
R4-16-507 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-408. Recodified

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Section recodified to
R4-16-508 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-409. Recodified

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Amended by final rulemaking at 8 A.A.R. 4270, effective November 18, 2002 (Supp. 02-3). Section recodified to R4-16-509 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-410. Recodified

Historical Note

New Section made by final rulemaking at 8 A.A.R. 830, February 7, 2002 (Supp. 02-1). Amended by final rulemaking at 8 A.A.R. 4270, effective November 18, 2002 (Supp. 02-3). Section recodified to R4-16-510 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

ARTICLE 5. EXECUTIVE DIRECTOR DUTIES

R4-16-501. Interim Evaluation and Investigational Interview

A. The executive director may require a physician, who is under investigation by the Board, to submit to a mental, physical, oral, or written medical competency examination after the following:

1. Reviewing the allegations and investigator’s summary of findings; and

2. Consulting with and receiving the agreement of the Board’s supervising medical consultant or designee that an examination is necessary.

B. The executive director may request a physician to attend an investigational interview to answer questions regarding a complaint against the physician. Before issuing a request for an investigational interview, the executive director shall review the allegations and facts to determine whether an interview is necessary to provide information the Board needs to adjudicate the case. The executive director shall consult with and receive the agreement of either the investigation supervisor or supervising medical consultant that an investigational interview is necessary before requesting one.

C. The executive director shall report to the Board at each regularly scheduled Board meeting, a summary of the number and type of evaluations ordered and completed since the preceding Board meeting.

Historical Note

New Section made by exempt rulemaking at 9 A.A.R. 2274, effective August 12, 2003 (Supp. 03-2). Former Section R4-16-501 recodified to R4-16-601; New Section R4-16-501 recodified from R4-16-401 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-502. Direct Referral to Formal Interview

The executive director shall refer a case to a formal interview on a future Board meeting agenda, if the medical consultant in cases involving quality of care, the investigative staff, and the lead Board member concur after review of the case that a formal interview is appropriate.

Historical Note

New Section made by exempt rulemaking at 9 A.A.R. 2274, effective August 12, 2003 (Supp. 03-2). Former Section R4-16-502 recodified to R4-16-602; New Section R4-16-502 recodified from R4-16-402 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

Editor’s Note: At the time of publication, A.R.S. § 32-1401(26) (referenced in R4-16-503) was A.R.S. § 32-1401(24). Laws 2003, Ch. 59, § 1, effective 90 days after the close of the First Regular Session of the Forty-sixth Legislature, will change the subparagraph citation to A.R.S. § 32-1401(26) (Supp. 03-2). This Section was subsequently recodified to a different Section in this Chapter. Refer to the historical notes for more information (05-1).

R4-16-503. Request for Inactive Status and License Cancellation

A. If a physician requests inactive status or license cancellation and meets the requirements of A.R.S. §§ 32-1431 and 32-1433, and is not participating in the program defined under A.R.S. § 32-1452, the executive director shall grant the request.

B. The executive director shall provide to the Board at each regularly scheduled Board meeting a list of the individuals granted inactive or cancelled license status since the preceding Board meeting.

Historical Note

New Section made by exempt rulemaking at 9 A.A.R. 2274, effective August 12, 2003 (Supp. 03-2). Former Section R4-16-503 recodified to R4-16-603; New Section R4-16-503 recodified from R4-16-403 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-504. Interim Consent Agreement

The executive director may enter into an interim consent agreement with a physician if there is evidence that a restriction is needed to mitigate imminent danger to the public health and safety and the investigative staff, the medical consultant, and the lead Board member concur after review of the case that a consent agreement is appropriate.

Historical Note

New Section made by exempt rulemaking at 9 A.A.R. 2274, effective August 12, 2003 (Supp. 03-2). Former Section R4-16-504 recodifed to R4-16-605; New Section R4-16-504 recodified from R4-16-404 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-505. Mediated Case

A. The executive director shall close a case resolved through mediation.

B. The executive director shall provide to the Board at each regularly scheduled Board meeting a list of the physicians whose cases are resolved through mediation since the preceding Board meeting.

Historical Note

New Section made by exempt rulemaking at 9 A.A.R. 2274, effective August 12, 2003 (Supp. 03-2). Former Section R4-16-505 recodifed to R4-16-606; New Section R4-16-505 recodified from R4-16-405 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-506. Referral to Formal Hearing

A. The executive director may directly refer a case to a formal hearing if the investigative staff, the medical consultant, and the lead Board member concur after review of the physician’s case that a formal hearing is appropriate.

B. The executive director shall provide to the Board at each regularly scheduled Board meeting a list of the physicians whose cases were referred to formal hearing since the preceding Board meeting and whether the referral is for revocation, suspension or is a result of an out- of-state disciplinary action, or is due to complexity of the case.

Historical Note

New Section R4-16-506 recodified from R4-16-406 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-507. Dismissal of Complaint

A. The executive director, with the concurrence of the investigative staff, shall dismiss a complaint if the review shows the complaint is without merit and dismissal is appropriate.

B. The executive director shall provide to the Board at each regularly scheduled Board meeting a list of the physicians about whom complaints were dismissed since the preceding Board meeting.

Historical Note

New Section R4-16-507 recodified from R4-16-407 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-508. Denial of License

A. The executive director shall deny a license to an applicant who does not meet statutory requirements for licensure if the executive director, in consultation with the investigative staff and the medical consultant concur after reviewing the application, that the applicant does not meet the statutory requirements.

B. The executive director shall provide to the Board at each regularly scheduled Board meeting a list of the physicians whose applications were denied since the preceding Board meeting.

Historical Note

New Section R4-16-508 recodified from R4-16-408 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-509. Non-disciplinary Consent Agreement

The executive director may enter into a consent agreement under A.R.S. § 32-1451(F) with a physician to limit the physician’s practice or rehabilitate the physician if there is evidence that a licensee is mentally or physically unable to safely engage in the practice of medicine and the investigative staff, the medical consultant, and the lead Board member concur after review of the case that a consent agreement is appropriate.

Historical Note

New Section R4-16-509 recodified from R4-16-409 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-510. Appealing Executive Director Actions

A. Any person aggrieved by an action taken by the executive director may appeal that action to the Board. The aggrieved person shall file a written request to the Board:

1. Thirty days after notification of the action, if personally served; or

2. Thirty-five days after the date on the notification, if mailed.

B. The aggrieved person shall provide, in the written request, evidence showing:

1. An irregularity in the investigative process or the executive director’s review deprived the party of a fair decision; or

2. Misconduct by Board staff, a Board consultant, or the executive director that deprived the party of a fair decision; or

3. Material evidence newly discovered that could have a bearing on the decision and that, with reasonable diligence, could not have been discovered and produced earlier.

C. The fact that the aggrieved party does not agree with the final decision is not grounds for a review by the Board.

D. If an aggrieved person fails to submit a written request within the time specified in subsection (A), the Board is relieved of the requirement to review actions taken by the executive director. The executive director may, however, evaluate newly provided information that is material or substantial in content to determine whether the Board should review the case.

E. If a written request is submitted that meets the requirements of subsection (B):

1. The Board shall consider the written request at its next regularly scheduled meeting.

2. If the written request provides new material or substantial evidence that requires additional investigation, the investigation shall be conducted as expeditiously as possible and the case shall be forwarded to the Board at the first possible regularly scheduled meeting.

Historical Note

New Section R4-16-510 recodified from R4-16-410 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

ARTICLE 6. DISCIPLINARY ACTIONS

R4-16-601. Expired

Historical Note

New Section R4-16-601 recodified from R4-16-501 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). Section expired under A.R.S. § 41-1056(E) at 16 A.A.R. 2062, effective September 14, 2010 (Supp. 10-3).

R4-16-602. Expired

Historical Note

New Section R4-16-602 recodified from R4-16-502 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). Section expired under A.R.S. § 41-1056(E) at 16 A.A.R. 2062, effective September 14, 2010 (Supp. 10-3).

Editor’s Note: To conform with the renumbering in A.R.S., the Arizona Medical Board requested (under A.R.S. § 41-1011 et seq.) a subsection reference update in R4-16-603 [R05-85]. Please refer to the historical notes for more details (Supp. 05-1).

R4-16-603. Expired

Historical Note

New Section R4-16-603 recodified from R4-16-503 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). A.R.S. § 32-1401(26) subsection corrected to A.R.S. § 32-1401(27) under a formal written request from the Board, March 22, 2005 (Supp. 05-1). Amended by final rulemaking at 14 A.A.R. 380, effective January 8, 2008 (Supp. 08-1). Section expired under A.R.S. § 41-1056(E) at 16 A.A.R. 2062, effective September 14, 2010 (Supp. 10-3).

R4-16-604. Aggravating Factors Considered in Disciplinary Actions

When determining the degree of discipline, the Board may consider certain factors including, but not limited to, the following:

1. Prior disciplinary offenses;

2. Dishonest or selfish motive;

3. Pattern of misconduct; multiple offenses;

4. Bad faith obstruction of the disciplinary proceeding by intentionally failing to comply with rules or orders of the Board;

5. Submission of false evidence, false statements, or other deceptive practices during the investigative or disciplinary process;

6. Refusal to acknowledge wrongful nature of conduct; and

7. Vulnerability of the victim.

Historical Note

New Section R4-16-604 recodified from R4-16-504 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

R4-16-605. Mitigating Factors Considered in Disciplinary Actions

When determining the degree of discipline, the Board may consider certain factors including, but not limited to, the following:

1. Absence of prior disciplinary record;

2. Absence of dishonest or selfish motive;

3. Timely good faith effort to rectify consequences of misconduct;

4. Interim rehabilitation;

5. Remoteness of prior offenses; and

6. How much control the physician has of processes in the specific practice setting.

Historical Note

New Section R4-16-605 recodified from R4-16-504 at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1).

ARTICLE 7. OFFICE-BASED SURGERY USING SEDATION

R4-16-701. Health Care Institution License

A physician who uses general anesthesia in the physician’s office or other outpatient setting that is not part of a licensed hospital or licensed ambulatory surgical center when performing office-based surgery using sedation shall obtain a health care institution license as required by the Arizona Department of Health Services under A.R.S. Title 36, Chapter 4 and 9 A.A.C. 10.

Historical Note

New Section made by final rulemaking at 14 A.A.R. 380, effective January 8, 2008 (Supp. 08-1).

R4-16-702. Administrative Provisions

A. A physician who performs office-based surgery using sedation in the physician’s office or other outpatient setting that is not part of a licensed hospital or licensed ambulatory surgical center shall:

1. Establish, document, and implement written policies and procedures that cover:

a. Patient’s rights,

b. Informed consent,

c. Care of patients in an emergency, and

d. The transfer of patients;

2. Ensure that a staff member who assists with or a healthcare professional who participates in office-based surgery using sedation:

a. Has sufficient education, training, and experience to perform duties assigned;

b. If applicable, has a current license or certification to perform duties assigned; and

c. Performs only those acts that are within the scope of practice established in the staff member’s or health care professional’s governing statutes;

3. Ensure that the office where the office-based surgery using sedation is performed has all equipment necessary:

a. For the physician to safely perform the office-based surgery using sedation,

b. For the physician or health care professional to safely administer the sedation,

c. For the physician or health care professional to monitor the use of sedation, and

d. For the physician and health care professional administering the sedation to rescue a patient after the sedation is administered to the patient and the patient enters into a deeper state of sedation than what was intended by the physician.

4. Ensure that a copy of the patient’s rights policy is provided to each patient before performing office-based surgery using sedation;

5. Obtain informed consent from the patient before performing an office-based surgery using sedation that:

a. Authorizes the office-based surgery, and

b. Authorizes the office-based surgery to be performed in the physician’s office; and

6. Review all policies and procedures every 12 months and update as needed.

B. A physician who performs office-based surgery using sedation shall comply with:

1. The local jurisdiction’s fire code;

2. The local jurisdiction’s building codes for construction and occupancy;

3. The biohazardous waste and hazardous waste standards in 18 A.A.C. 13, Article 14; and

4. The controlled drug administration, supply, and storage standards in 4 A.A.C. 23.

Historical Note

New Section made by final rulemaking at 14 A.A.R. 380, effective January 8, 2008 (Supp. 08-1).

R4-16-703. Procedure and Patient Selection

A. A physician shall ensure that each office-based surgery using sedation performed:

1. Can be safely performed with the equipment, staff members, and health care professionals at the physician’s office;

2. Is of duration and degree of complexity that allows a patient to be discharged from the physician’s office within 24 hours;

3. Is within the education, training, experience skills, and licensure of the physician; and

4. Is within the education, training, experience, skills, and licensure of the staff members and health care professionals at the physician’s office.

B. A physician shall not perform office-based surgery using sedation if the patient:

1. Has a medical condition or other condition that indicates the procedure should not be performed in the physician’s office, or

2. Will require inpatient services at a hospital.

Historical Note

New Section made by final rulemaking at 14 A.A.R. 380, effective January 8, 2008 (Supp. 08-1).

R4-16-704. Sedation Monitoring Standards

A physician who performs office-based surgery using sedation shall ensure from the time sedation is administered until post-sedation monitoring begins:

1. A quantitative method of assessing a patient’s oxygenation, such as pulse oximetry, is used when minimal sedation is administered to the patient, and

2. When moderate or deep sedation is administered to a patient:

a. A quantitative method of assessing the patient’s oxygenation, such as pulse oximetry, is used;

b. The patient’s ventilatory function is monitored by any of the following:

i. Direct observation,

ii. Auscultation, or

iii. Capnography;

c. The patient’s circulatory function is monitored during the surgery by:

i. Having a continuously displayed electrocardiogram,

ii. Documenting arterial blood pressure and heart rate at least every five minutes, and

iii. Evaluating the patient’s cardiovascular function by pulse plethysmography,

d. The patient’s temperature is monitored if the physician expects the patient’s temperature to fluctuate; and

e. That a licensed and qualified healthcare professional, other than the physician performing the office-based surgery, whose sole responsibility is attending to the patient, is present throughout the office-based surgery.

Historical Note

New Section made by final rulemaking at 14 A.A.R. 380, effective January 8, 2008 (Supp. 08-1).

R4-16-705. Perioperative Period; Patient Discharge

A physician performing office-based surgery using sedation shall ensure all of the following:

1. During office-based surgery using sedation, the physician is physically present in the room where office-based surgery is performed;

2. After the office-based surgery using sedation is performed, a physician is at the physician’s office and sufficiently free of other duties to respond to an emergency until the patient’s post-sedation monitoring is discontinued;

3. If using minimal sedation, the physician or a health care professional certified in ACLS, PALS, or BLS is at the physician’s office and sufficiently free of other duties to respond to an emergency until the patient is discharged;

4. If using deep or moderate sedation, the physician or a health care professional certified in ACLS or PALS is at the physician’s office and sufficiently free of other duties to respond to an emergency until the patient is discharged;

5. A discharge is documented in the patient’s medical record including:

a. The time and date of the patient’s discharge, and

b. A description of the patient’s medical condition at the time of discharge; and

6. A patient receives discharge instructions and documents in the patient’s medical record that the patient received the discharge instructions.

Historical Note

New Section made by final rulemaking at 14 A.A.R. 380, effective January 8, 2008 (Supp. 08-1).

R4-16-706. Emergency Drugs; Equipment and Space Used for Office-Based Surgery Using Sedation

A. In addition to the requirements in R4-16-702(A)(3) and R4-16-703(A)(1), a physician who performs office-based surgery using sedation shall ensure that the physician’s office has at a minimum:

1. The following:

a. A reliable oxygen source with a SaO2 monitor;

b. Suction;

c. Resuscitation equipment, including a defibrillator;

d. Emergency drugs; and

e. A cardiac monitor;

2. The equipment for patient monitoring according to the standards in R4-16-704;

3. Space large enough to:

a. Allow for access to the patient during office-based surgery using sedation, recovery, and any emergency;

b. Accommodate all equipment necessary to perform the office-based surgery using sedation; and

c. Accommodate all equipment necessary for sedation monitoring;

4. A source of auxiliary electrical power available in the event of a power failure; and

5. Equipment, emergency drugs, and resuscitative capabilities required under this Section for patients less than 18 years of age, if office-based surgery using sedation is performed on these patients; and

6. Procedures to minimize the spread of infection.

B. A physician who performs office-based surgery using sedation shall:

1. Ensure that all equipment used for office-based surgery using sedation is maintained, tested, and inspected according to manufacturer specifications, and

2. Maintain documentation of manufacturer-recommended maintenance of all equipment used in office-based surgery using sedation.

Historical Note

New Section made by final rulemaking at 14 A.A.R. 380, effective January 8, 2008 (Supp. 08-1).

R4-16-707. Emergency and Transfer Provisions

A. A physician who performs office-based surgery using sedation shall ensure that before a health care professional participates in or staff member assists with office-based surgery using sedation, the health care professional and staff member receive instruction in the following:

1. Policy and procedure in cases of emergency,

2. Policy and procedure for office evacuation, and

3. Safe and timely patient transfer.

B. When performing office-based surgery using sedation, a physician shall not use any drug or agent that trigger malignant hyperthermia.

Historical Note

New Section made by final rulemaking at 14 A.A.R. 380, effective January 8, 2008 (Supp. 08-1).


Scott Cancelosi
Director
Public Services Division

A.A.C. Table of Contents

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Editor
Arizona Administrative Code