Section 144-220-G-E-390 - Training for use of unsealed radioactive material for which a written directive is requiredExcept as provided in G.57, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under G.300 to be a physician who:
A. Is certified by a medical specialty board whose certification process has been recognized by the Agency, the Nuclear Regulatory Commission, or an Agreement State, and who meets the requirements in G390.B(1)(b)(vii) and G.390.B(2). Specialty Boards whose certification processes 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 be recognized, a specialty board shall require all candidates for certification to:(1) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include 700 hours of training and experience as described in G.390.B(1)(a) through G.390.B(2). Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and(2) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; and clinical use of unsealed radioactive material for which a written directive is required; orB.(1) Has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience must include: (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.390.A, G.390.B or equivalent Nuclear Regulatory Commission, or Agreement State requirements. A supervising authorized user who meets the requirements in G.390.B must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status. The 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 contain spilled radioactive material safely and using proper decontamination procedures; (vi) Eluting generator systems, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and(vii) Administering dosages of radioactive drugs to patients or human research subjects from the three categories in this paragraph. Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under G.1000. This work experience must involve a minimum of three cases in each of the following categories for which the individual is requesting authorized user status: (a) Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for which a written directive is required;(b) Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-1312;(c) Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics or photon energy less than 150 keV for which a written directive is required; and(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs G.390.B(1) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under G.300 for which the individual is requesting authorized user status. The attestation must be obtained from either: (a) A preceptor authorized user who meets the definition requirements in G.57, G.390, or equivalent Nuclear Regulatory Commission or Agreement State requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting user status; 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.390, or equivalent Nuclear Regulatory Commission or Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, 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 paragraph (b)(1) of this section. 2 Experience with at least three cases in Category (vii)(b) also satisfies the requirement in Category (vii)(a).
10-144 C.M.R. ch. 220, § G-E-390