Training for Use of Manual Brachytherapy Sources

Section 335 Section 335.9100  Training for Use of Manual Brachytherapy Sources Except as provided in Section 335.9160, the licensee shall require the authorized user of a manual brachytherapy source under the provisions and requirements of Subpart H to be a physician who: a)         Is certified by a medical specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State.  To have its certification process recognized, a specialty board shall require all candidates for certification to: 1)         Successfully complete a minimum of 3 years of residency training in a radiation oncology program 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 2)         Pass an examination administered by diplomates of the specialty board that evaluates knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy sources; or AGENCY NOTE:  Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website. b)         The physician has: 1)         Completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes: A)        200 hours of classroom and laboratory training in the following areas: i)          Radiation physics and instrumentation; ii)         Radiation protection; iii)        Mathematics pertaining to the use and measurement of radioactivity; iv)        Radiation biology; and B)        500 hours of work experience, under the supervision of an authorized user who meets the requirements in this Section or Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, at a medical facility authorized to use radioactive material under Subpart H.  The work experience shall include: i)          Ordering, receiving and unpacking radioactive materials safely and performing the related radiation monitoring; ii)         Checking survey instruments for proper operation; iii)        Preparing, implanting and removing brachytherapy sources; iv)        Maintaining running inventories of material on hand; v)         Using administrative controls to prevent medical events involving radioactive material; vi)        Using emergency procedures to control radioactive material; and 2)         Completed 3 years of supervised clinical experience in radiation oncology under an authorized user who meets the requirements in this Section or Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements.  The experience shall be obtained as part of a formal training program approved by the Residency Review Committee for Radiation Oncology 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.  This experience may be obtained concurrently with the supervised work experience required by subsection (b)(1)(B); and. 3)         Obtained written attestation that the individual has satisfactorily completed the requirements in subsections (b)(1) and (b)(2) and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources under Subpart H.  The attestation shall be obtained from either: A)        A preceptor authorized user who meets the requirements in this Section, Section 335.9160, or equivalent U.S. 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 this Section, Section 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and concurs with the attestation provided by the residency program director. The residency training program shall 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 shall include training and experience specified in subsections (b)(1) and (b)(2).