Except as provided in Appendix 7P, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under 7.36 to be a physician who:
7F1 Is certified by a medical specialty board whose certification process has been recognized by the NRC or an Agreement State and who meets the requirements in 7F2.1(2)(f). The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To be recognized, a specialty board shall require all candidates for certification to:
7F1.1 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 7F2.1(1) through 7F2.1(2)(e). Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association;
and
7F1.2 Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed radioactive material for which a written directive is required;
or
7F2
7F2.1 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:
(1) Classroom and laboratory training in the following areas:
(a) Radiation physics and instrumentation;
(b) Radiation protection;
(c) Mathematics pertaining to the use and measurement of radioactivity;
(d) Chemistry of radioactive material for medical use; and
(e) Radiation biology;
and
(2) Work experience, under the supervision of an authorized user who meets the requirements of Appendix 7P, 7F, or equivalent Agreement State or NRC requirements. A supervising authorized user, who meets the requirements in 7F2, must also have experience in administering dosages in the same dosage category or categories (i.e., 7F2.1(2)(f)) as the individual requesting authorized user status. The work experience must involve:
(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(c) Calculating, measuring, and safely preparing patient or human research subject dosages;
(d) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;
(e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;
and
(f) Administering dosages of radioactive drugs to patients or human research subjects from the three categories in 7F2.1(2)(f). Radioactive drugs containing radionuclides in categories not included in 7F2.1(2)(f) are regulated under 7.62. 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:
(i) 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;
(ii) Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131;2
(iii) 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
7F2.2 Has obtained written attestation that the individual has satisfactorily completed the requirements in 7F2.1 and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 7.36. The attestation must be obtained from either:
(1) A preceptor authorized user who meets the requirements in 7P, 7F, or equivalent Agreement State requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or
(2) 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 7P, 7F, or equivalent Agreement State or NRC 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 7F2.1.
2 Experience with at least three cases in Category 7F2.1(2)(f)(ii) also satisfies the requirement in Category 7F2.1(2)(f)(i).
6 CCR 1007-1-7F