Training for Uptake, Dilution, and Excretion Studies

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 105 CMR 120.544 to be a physician who: (A) Is certified by a medical specialty board whose certification process has been recognized by the Agency, Nuclear Regulatory Commission or an Agreement State. The names of board certifications that have been recognized by the Agency, Nuclear Regulatory Commission or an Agreement State are 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 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies as described in 105 CMR 120.546(C)(1)(a) through (b)6.; and (2) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or (B) Is an authorized user under 105 CMR 120.551 or 120.556, or equivalent Agreement State or Nuclear Regulatory Commission requirements; or (C) (1) Has completed 60 hours of training and experience, including a minimum of eight hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience must include: (a) 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 (b) Work experience, under the supervision of an authorized user who meets the requirements 105 CMR 120.528, 120.546,120.551 or 120.556 or equivalent Agreement State, or Nuclear Regulatory Commission requirements, involving: 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; and 6. Administering dosages to patients or human research subjects; (2) Has obtained written attestation that the individual has satisfactorily completed the requirements in 105 CMR 120.546(C)(1) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 105 CMR 120.544. The attestation must be obtained from either: (a) A preceptor authorized user who meets the requirements in 105 CMR 120.528, 120.546, 120.551, or 120.556, 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 105 CMR 120.528, 120.546, 120.551, or 120.556, 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 105 CMR 120.546(C)(1). SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE NOT REQUIRED