Ariz. Admin. Code § R9-7-721 - Training for Imaging and Localization Studies Not Requiring a Written Directive

Except as provided in R9-7-712.01, a licensee shall require an authorized user of unsealed radioactive material for the uses authorized under Group 200 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. To have its certification process recognized, a specialty board shall require all candidates for certification to:

a. Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for imaging and localization studies as described in subsection (3)(a); and

b. Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control;

2. Is an authorized user under R9-7-723 and meets the requirements in subsection (3)(a)(ii)(7) or equivalent NRC or Agreement State requirements; or

3. Has:

a. Completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience must include:

i. Classroom and laboratory training in the following areas:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Chemistry of radioactive material for medical use; and

(5) Radiation biology; and

ii. Work experience, under the supervision of an authorized user who meets the requirements in this Section; R9-7-712.01; or both subsection (3)(a)(ii)(7) and R9-7-723; or the equivalent requirements of the NRC or another Agreement State. An authorized nuclear pharmacist who meets the requirements in R9-7-712 may provide the supervised work experience for subsection (3)(a)(ii)(7). Work experience must involve:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(3) Calculating, measuring, and safely preparing patient or human research subject dosages;

(4) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;

(6) Administering dosages of radioactive drugs to patients or human research subjects; and

(7) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the elate for radionuclide purity, and processing the elate with reagent kits to prepare labeled radioactive drugs; and

b. Obtained written attestation that the individual has satisfactorily completed the requirements in subsection (3)(a) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under Groups 100 and 200 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 both subsection (3)(a)(ii)(7) and R9-7-723; or equivalent NRC or Agreement State 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 both subsection (3)(a)(ii)(7) and R9-7-723; or equivalent NRC or Agreement State 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 subsection (3)(a).

Notes

Ariz. Admin. Code § R9-7-721

New Section R9-7-721 recodified from R12-1-721at A.A.R. 813, effective March 22, 2018 (Supp. 18-1). Amended by final expedited rulemaking at 24 A.A.R. 2151, effective July 12, 2018 (Supp. 18-3). Amended by final expedited rulemaking at 25 A.A.R. 3561, effective 12/3/2019. Amended by final expedited rulemaking at 30 A.A.R. 2681, effective 8/7/2024.