NRC Update

  March 2, 2006
RE: NRC recognition for the American Board of Radiology for residency training and experience in the therapeutic administration of unsealed byproduct material for which a written directive is required

To: Radiation Oncology Program Directors

From: Steven A. Leibel, M.D., FACR
President, American Board of Radiology (ABR)

Date: April 4, 2006

Dear Colleagues:

In August 2005, we communicated to you information and procedures to address the changes in the Nuclear Regulatory Commission (NRC) rules that govern the training and experience required to administer the types of radioactive materials commonly used in radiation oncology and nuclear medicine for the treatment of several different malignancies.The final version of these changes was published on March 30, 2005 in the Federal Register. The NRC has in the past accepted ABR certification as evidence that a practitioner is properly trained to safely and effectively use therapeutic radioactive materials.

The ABR wishes to retain this status under the new regulations, and accordingly, is requiring that resident training and experience and the materials on which the ABR examines match the new NRC regulations. These regulations pertain to training and experience in the therapeutic administration of unsealed byproduct material (10 CFR 35.390) as well as the use of manual brachytherapy sources (10 CFR 35.490) and remote after loader units, teletherapy units and gamma stereotactic radiosurgery units (10 CFR 35.690).

Each of these modalities require a written directive as described in 10 CFR 35.40. The ABR and the Radiation Oncology RRC will maintain consistency with these requirements. What follows is an update that incorporates several clarifications of the requirements by the NRC for recognition of the ABR certification process.

1. Beginning with the oral examination of June 2007, the ABR will only admit, for examination, candidates who have a minimum of 700 hours of training in the topics described in 10 CFR 35.390 (b)(1)(i)(A) through 10 CFR 35.390 (b)(1)(i)(E) as well as supervised work experience as outlined in 10 CFR 35.390 (b)(1)(ii)(A) through 10 CFR 35.390 (b)(1)(ii)(G)(2) and (3) (authorized user for the oral administration of I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries) and parenteral administration of any beta emitter or a photon-emitting radionuclide with photon energy of < 150 KeV, for which a written directive is required). The work experience outlined in CFR 35.390 (b)(1)(ii) must be obtained under the supervision of an authorized user who meets the requirements in 10 CFR 35.390 or equivalent Agreement State requirements. A supervising authorized user 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 and the parenteral administration of any beta emitter, or a photon-emitting radionuclide with a photon energy less than 150 KeV, for which a written directive is required. Instruction may take place as part of the RRC required courses in medical physics, radiation and cancer biology and clinical radiation oncology or a rotation in nuclear medicine.
2. This training and supervised work experience must include all NRC-required items related to the safe handling, administration and quality control of the radionuclide doses used in clinical radiation oncology and nuclear medicine. The Federal Register provides a comprehensive list of these items. ABR testing will cover topics that include radiation safety, radionuclide handling, quality assurance, treatment planning, and the clinical use of unsealed byproduct material for which a written directive is required, as well as manual brachytherapy, remote after loading brachytherapy, stereotactic radiosurgery and external beam therapy. Such items will be included on both the written and oral examinations.
3. ABR Certification will include satisfying the requirements for authorized user status as specified in 35.390(b)1(ii)(G)(2) and in 35.390(b)1(ii)(G)(3). To meet the requirements as an authorized user, residents must participate in three cases involving oral administration of > 33 mCi of I-131 and three cases involving the parenteral administration of any beta emitter, or a photon-emitting radionuclide with photon energy of < 150 KeV. Note that this category includes I-131 labeled antibodies and I-131 MIBG.
4. The specific dates on which experiences with oral I-131 and parenteral therapy occur and a case description should be kept in a log by each resident. Click here to download the log .

Because of HIPAA concerns, data that might identify a patient should not be included in the log. This log is to be submitted by the program director along with the other materials that attest to the resident´s oral exam eligibility.

To license an individual as an authorized user of radionuclides
the NRC will require that another authorized user/preceptor - typically this would be an appropriately trained radiation oncologist or nuclear medicine physician - submit a preceptor form to attest to the candidate´s satisfactory completion of the NRC requirements and attainment of competency sufficient to function as an authorized user. The attestation of the residency program director will not be accepted by the NRC unless that program director is also an appropriately-qualified authorized user, and the program director completes the NRC preceptor form.

For admittance to the ABR exam, however, residency program director attestation on an ABR form will suffice.

The ABR recommends that all residency programs reevaluate their training in the use of these agents and add the content elements outlined in this communication and in the NRC Final Regulations .

In this way, residents will be prepared and qualified to take the ABR oral examination.