10 C.F.R. § 35.290 Training for imaging and localization studies.
Title 10 - Energy
Except as provided in §35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under §35.200 to be a physician who— (a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (c)(2) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's 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 that includes the topics listed in paragraphs (c)(1)(i) and (c)(1)(ii) of this section; 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 §35.390 and meets the requirements in §35.290(c)(1)(ii)(G), or equivalent Agreement State 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 byproduct material for imaging and localization studies. The training and experience must include, at a minimum— (i) 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 byproduct material for medical use; (E) Radiation biology; and (ii) Work experience, under the supervision of an authorized user, who meets the requirements in §§35.290, or 35.290(c)(1)(ii)(G), and 35.390, or equivalent Agreement State requirements, involving— (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 byproduct material; (E) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures; (F) Administering dosages of radioactive drugs to patients or human research subjects; and (G) 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, signed by a preceptor authorized user who meets the requirements in §§35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under §§35.100 and 35.200. [67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 69 FR 55738, Sept. 16, 2004; 70 FR 16364, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006]
Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart D—Unsealed Byproduct Material—Written Directive Not Required
§ 35.290 Training for imaging and localization studies.
