Current through 2024-51, December 18, 2024
Section 144-220-G-D-290 - Training for imaging and localization studiesExcept as provided in G.57, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under G.200 to be a physician who:
A. Is certified by a medical specialty board whose certification process has been recognized by the Agency, the NRC, or an Agreement State. The names of board certifications which have been recognized by the Agency, the NRC, or an Agreement State, will be posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to: (1) 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 uptake, dilution, and excretion studies that includes the topics listed in paragraphs G.290.C(1)(a) through (2) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control;B. Is an authorized user under G.390 and meets the requirements in G.290.C(1)(b)(vii) or equivalent Nuclear Regulatory Commission or Agreement State requirements; orC.(1) Has completed 700 hours of training and experience, including a minimum of 80 hours 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, at a minimum: (a) 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) Chemistry of radioactive material for medical use; and(v) Radiation biology; and(b) Work experience, under the supervision of an authorized user who meets the definition of an authorized user in Part A.2 for the same uses, or who meets the requirements in G.57, G.290 or G.390 and G290.C(1)(b)(vii) or equivalent Nuclear Regulatory Commission, or Agreement State requirements involving. An authorized nuclear pharmacist who meets the requirements in G.55 or G.57 may provide the supervised work experience for G.290.C(1)(b)(vii). Work experience must involve:(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;(ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;(iv) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;(v) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;(vi) Administering dosages of radioactive drugs to patients or human research subjects; and(vii) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in G.290.C(1) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under G.100 and G.200. The attestation must be obtained from either: (a) A preceptor authorized user who meets the requirements in G.57, G.290, or G.390 and G.290.C(1)(b)(vii), or equivalent Nuclear Regulatory Commission or Agreement State requirements; or(b) 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 G.57, G.290, or G.390 and G.290.C(1)(b)(vii), or equivalent Nuclear Regulatory Commission 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 G.290.C(1) of this section.10-144 C.M.R. ch. 220, § G-D-290