Training for Imaging and Localization Studies

Except as provided in 105 CMR 120.528, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under 105 CMR 120.547 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 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for imaging and localization studies as described in105 CMR 120.551(C)(1)(a) through (b)7.; 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; or (B) Is an authorized user under 105 CMR 120.556 and meets the requirements of 105 CMR 120.551(C)(1)(b)7., or equivalent Agreement State or Nuclear Regulatory Commission requirements; or (C)(1) Has 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, at a minimum: (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; 5. Radiation biology; and (b) Work experience, under the supervision of an authorized user who meets the requirements of 105 CMR 120.528, 120.551, or 120.556 and 120.551(C)(1)(b)7., or equivalent Agreement State, or Nuclear Regulatory Commission requirements. An authorized nuclear pharmacist who meets the requirements in 105 CMR 120.526 or 120.528 may provide the supervised work experience for 105 CMR 120.551(C)(1)(b)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 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 105 CMR 120.551(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 and 120.547. The attestation must be obtained from either: (a) A preceptor authorized user who meets the requirements in 105 CMR 120.528, 120.551, or 120.556 and 120.551(C)(1)(b)7., 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, 120.551, or 120.556 and 120.551(C)(1)(b)7., 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 120.551(C)(1). SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE REQUIRED