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ABR Training in Nuclear Medicine - Compliance with NRC Regulations
Effective with the publication of the final revised version of the new 10 CFR part 35 in March, 2005, the Nuclear Regulatory Commission (NRC) established new guidelines for physicians who wish to achieve the status of Authorized User (AU). The ABR is committed to compliance by:
- providing information about the required components of training and experience;
- requiring from program directors written attestation and case log documentation (for I-131 therapy) that the proper training has been given, and;
- testing knowledge of the required subjects in both its written and oral examinations.
Candidates seeking certification for diagnostic radiology must meet the specific training and experience requirements described in 10 CFR 35.290(c) (1) (i) and (c) (1) (ii) and 10 CFR 35.392(c) (1) and (c) (2). Radiation safety, radionuclide handling and quality control and related topics specified in 10 CFR 35.290 and 10 CFR 35.392 must be covered.
Specifically, each candidate for AU status through the ABR pathway must have completed a minimum of 700 hours of training and experience in imaging and localization studies, including classroom and laboratory training in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies. In addition, each candidate must also meet the training and experience requirements specified in § 35.392 for medical uses of radioiodine I-131 (? 33mCi) that require a written directive. The training and experience must include, at a minimum, the following:
- Classroom and laboratory training in the areas of
- Radiation physics and instrumentation;
- Radiation protection;
- Mathematics pertaining to the use and measurement of radioactivity;
- Chemistry of by-product material for medical use; and
- Radiation biology.
- Work experience for imaging and localization studies under the supervision of an AU, who meets the requirements in § 35.290, or 35.290(c)(1)(ii)(G) and 35.390 or equivalent Agreement State requirements, involving the following:
- ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
- performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
- calculating, measuring, and safely preparing patient or human research subject dosages;
- using administrative controls to prevent a medical event involving the use of unsealed byproduct materials;
- using procedures to safely contain spilled radioactive material and using proper decontamination procedures;
- administering dosages of radioactive drugs to patients or human research subjects; and
- 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.
- Work experience for the oral administration of sodium iodide I-131 requiring a written directive. This experience must be obtained under the supervision of an AU who meets the requirements in § 35.390, 35.392, 35.394 or equivalent Agreement State requirements. A supervising AU who meets the requirements in § 35.390 (b) must also have experience in the oral administration of sodium iodide I-131 for which a written directive is required. This work experience must involve the following:
- ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
- performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
- calculating, measuring, and safely preparing patient or human research subject dosages;
- using administrative controls to prevent a medical event involving the use of unsealed byproduct materials;
- using procedures to safely contain spilled radioactive material and using proper decontamination procedures; and
- administering doses to patients or human research subjects that include at least three cases involving the oral administration of ?33mCi of sodium iodide I-131.
Case experience, including that specified above, must be documented as follows:
Regarding § 35.392, candidates must have completed a minimum of three cases that involved administration of ?33mCi of I-131 for therapy under an AU who meets the requirements in § 35.390, 35.392, 35.394 or equivalent Agreement State requirements. A supervising AU who meets the requirements in § 35.390 (b) must also have experience in the oral administration of sodium iodide I-131 for which a written directive is required. A logbook of these therapies must be kept by the resident and submitted in the following format:
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