Ariz. Admin. Code § R9-7-727 - Training for Use of Manual Brachytherapy Sources and Training for the Use of Strontium-90 Sources for Treatment of Ophthalmic Disease

A. Except as provided in R9-7-712.01, a licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under Group 400 in Exhibit A, Medical Use Groups of this Article to be a physician who:

1. Is certified by a medical specialty board whose certification process has been recognized by the NRC or an Agreement State, the names of which are specified in the NRC's Medical Uses Licensee Toolkit available through https://www.nrc.gov, and who meets the requirements in subsection (A)(2). To have its certification process recognized, a specialty board shall require all candidates for certification to:

a. Successfully complete a minimum of three years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of the American Osteopathic Association; and

b. Pass an examination, administered by diplomates of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy; or

2. Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:

a. 200 hours of classroom and laboratory training in the following areas:

i. Radiation physics and instrumentation;

ii. Radiation protection;

iii. Mathematics pertaining to the use and measurement of radioactivity;

iv. Radiation biology;

b. 500 hours of work experience, under the supervision of an authorized user who meets the requirements in this Section, R9-7-712.01, or equivalent NRC or Agreement State requirements at a medical institution authorized to use byproduct materials under Group 400 in Exhibit A, Medical Use Groups of this Article, involving:

i. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

ii. Checking survey meters for proper operation;

iii. Preparing, implanting, and removing brachytherapy sources;

iv. Maintaining running inventories of material on hand;

v. Using administrative controls to prevent a medical event involving the use of radioactive material;

vi. Using emergency procedures to control radioactive material;

c. at least three years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in this Section, R9-7-712.01, or equivalent NRC or Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subsection (A)(2)(b); and

d. Obtaining written attestation that the individual has satisfactorily completed the requirements in subsections (A)(2)(a) through (c) and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under Group 400 in Exhibit A, Medical Use Groups of this Article. The attestation must be obtained from either:

i. A preceptor authorized user who meets the requirements in this Section, R9-7-712.01, or equivalent Agreement State or NRC requirements; or

ii. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Section, R9-7-712.01, or equivalent Agreement State or NRC requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subsections (A)(2)(a) through (c).

B. Except as provided in R9-7-712.01, a licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who:

1. Is an authorized user under subsection (A) or equivalent Agreement State or NRC requirements; or

2. Has:

a. Completed at least 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy, including:

i. Radiation physics and instrumentation,

ii. Radiation protection,

iii. Mathematics pertaining to the use and measurement of radioactivity, and

iv. Radiation biology;

b. Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five individuals, including:

i Examination of each individual to be treated,

ii Calculation of the dose to be administered,

iii Administration of the dose, and

iv. Follow up and review of each individual's case history; and

c. Obtained written attestation, signed by a preceptor authorized user who meets the requirements in subsection (A) or (B), R9-7-712.01, or equivalent Agreement State or NRC requirements, that the individual has satisfactorily completed the requirements in subsections (B)(2)(a) and (b) and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.

B.C. A licensee who uses strontium-90 for ophthalmic treatments must ensure that certain activities as specified in subsection (D) are performed by either:

1. An authorized medical physicist; or

2. An individual who:

a. Is identified as an ophthalmic physicist on a:

i. Specific medical use license issued by the Department, the NRC, or another Agreement State,

ii. Permit issued by the Department or an NRC or other Agreement State broad scope medical use licensee,

iii. Medical use permit issued by an NRC master material licensee, or

iv. Permit issued by an NRC master material licensee broad scope medical use permittee;

b. Holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university;

c. Has successfully completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and

d. Has documented training in:

i. The creation, modification, and completion of written directives;

ii. Procedures for administrations requiring a written directive; and

iii. Performing the calibration measurements of brachytherapy sources as detailed in R9-7-726.

C.D. The individuals who are identified in subsection (C)(1) or (2) shall:

1. Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under R9-7-726; and

2. Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures must include the frequencies that the individual meeting the requirements in subsection (A) will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives.

D.E. Licensees shall retain a record of the activity of each strontium-90 source in accordance with R9-7-313.

E.F. The training and experience shall have been obtained within the seven years preceding the date of application or the individual shall have had related continuing education and experience since the required training and experience was completed.

Notes

Ariz. Admin. Code § R9-7-727

New Section R9-7-727 recodified from R12-1-727at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1). Amended by final expedited rulemaking at 25 A.A.R. 3561, effective 12/3/2019. Amended by final expedited rulemaking at 28 A.A.R. 3533, effective 11/2/2022. Amended by final expedited rulemaking at 30 A.A.R. 2681, effective 8/7/2024.