§ 35.940 - Training for use of brachytherapy sources.

Except as provided in § 35.57, the licensee shall require the authorized user of a brachytherapy source listed in § 35.400 for therapy to be a physician who—

(a) Is certified in—

(1) Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;

(2) Radiation oncology by the American Osteopathic Board of Radiology;

(3) Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or

(4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

(b) Is in the active practice of therapeutic radiology, has had classroom and laboratory training in radioisotope handling techniques applicable to the therapeutic use of brachytherapy sources, supervised work experience, and supervised clinical experience as follows—

(1) 200 hours of classroom and laboratory training that includes—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity; and

(iv) Radiation biology;

(2) 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes—

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) Checking survey meters for proper operation;

(iii) Preparing, implanting, and removing sealed sources;

(iv) Maintaining running inventories of material on hand;

(v) Using administrative controls to prevent a medical event involving byproduct material; and

(vi) Using emergency procedures to control byproduct material; and

(3) Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes—

(i) Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications;

(ii) Selecting the proper brachytherapy sources and dose and method of administration;

(iii) Calculating the dose; and

(iv) Post-administration follow up and review of case histories in collaboration with the authorized user.