Compliance with NRC Regulations

 

AU-E Designation Discontinued

In March 2022, the ABR informed the Nuclear Regulatory Commission (NRC) of the Board’s intent to discontinue including Authorized User-Eligible (AU-E) designations on ABR certificates issued after December 31, 2023. To allow time for our candidates to adjust, the ABR announced this change more than 18 months in advance. For residents anticipating board certification by December 31, 2023, no changes are needed in record-keeping or document submission to the ABR. Please review the Frequently Asked Questions for additional information on this transition. You can also view a recording of our March 30, 2022 informational webinar regarding the changes to the AU-E designation.  

NRC Compliance

Please note that the ABR policies and requirements related to Authorized User (AU) eligibility status remain unchanged from the text below, which was sent to radiation oncology program directors in April 2006. 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. The final version of changes in the Nuclear Regulatory Commission (NRC) rules, which 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, was published on March 30, 2005, in the Federal Register. The NRC accepts ABR certification as evidence that a practitioner is properly trained to safely and effectively use therapeutic radioactive materials. The ABR requires that resident training and experience, as well as the materials on which the ABR examines, match 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 afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.690). Each of these modalities requires a written directive as described in 10 CFR 35.40. The ABR and the Radiation Oncology RRC will maintain consistency with these requirements. The following incorporates several clarifications of NRC requirements for recognition of the ABR certification process.

1. 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) training under an Authorized User (AU) for the oral administration of ¹³¹I 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 AU who meets the requirements in 10 CFR 35.390 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 ¹³¹I, 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 afterloading brachytherapy, stereotactic radiosurgery, and external beam therapy. Such items will be included on both the computer-based and oral examinations.
3. ABR Certification will include satisfying the requirements for AU 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 AU, residents must participate in three cases involving oral administration of > 33 mCi of ¹³¹I 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 ¹³¹I-labeled antibodies and ¹³¹I MIBG.
4. The specific dates on which experiences with oral ¹³¹I and parenteral therapy occur and a case description should be kept in a log by each resident. Click here to download the log.

Due to HIPAA concerns, data that might identify a patient should not be included in the log. The program director will submit this log, along with the other materials that attest to the resident´s oral exam eligibility. To license an individual as an AU, the NRC requires that another AU, who is typically 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 AU. The NRC will not accept the attestation of the residency program director unless that program director is also an appropriately qualified AU, and the program director completes the NRC preceptor form. For admission to the ABR exam, however, residency program director attestation on an ABR form will suffice. The ABR recommends that all residency programs evaluate their training in the use of these agents and add the content elements outlined in this communication and in the NRC Final Regulations.  

Frequently Asked Questions

What is “Authorized User-Eligible (AU-E)”? This is an ABR certificate designation that allows a candidate to submit training and experience documentation to the ABR as part of the process for eventually requesting, if needed, the Authorized User designation from the Nuclear Regulatory Commission (NRC). What is an “Authorized User” [of Radioactive Materials]? This is a designation by the NRC for an individual who meets the training and experience requirements and is added to the institution/facility/practice upon request and approval of the required credentials. Many radiologists are not Authorized Users. “A person named as an authorized user on an NRC license is responsible for ensuring that radioactive materials are handled and used safely and in accordance with NRC regulations and the terms and conditions of the NRC license.”  https://www.nrc.gov/about-nrc/radiation/protects-you/hppos/hppos145.html Why has the ABR decided to stop issuing (AU-E) designations?

• It is outside the defined focus of the ABR’s mission.
• It diverts resources from fundamental objectives (e.g., refinement of remote exams, high reliability customer service).
• A direct pathway exists with the Nuclear Regulatory Commission (NRC) and Agreement States. (An Agreement State has signed an agreement with the NRC authorizing the State to regulate certain uses of radioactive materials within the State).
• An individual may be an AU without being board certified. Conversely, an individual may be board certified without being an AU.

When will these changes be implemented? The ABR will discontinue including (AU-E) designations on certificates issued after December 31, 2023. Candidates in all disciplines who receive initial board certification before that date and meet other criteria, such as passing the RISE for DR and IR/DR, will receive AU-E on their certificates. What ABR certificates are impacted by this change? All ABR specialty certificates are impacted. AU-E designations on ABR certificates are diagnostic radiology (AU-Eligible), interventional radiology/diagnostic radiology (AU-Eligible), radiation oncology (AU-Eligible), diagnostic medical physics (RSO-Eligible), nuclear medical physics (RSO-Eligible), and therapeutic medical physics (AMP-Eligible). Where can I find information about becoming an NRC Authorized User? Detailed information about the training, experience, and documentation required to become an NRC Authorized User is available on the NRC website. If a candidate is board eligible but not board certified, can they become an NRC Authorized User?­ Yes. ABR board certification is not a requirement to become an NRC Authorized User. Does the ABR require residency programs to keep NRC-related training records for a certain period of time? ­No. The ABR does not require residency programs to keep NRC-related training records. However, it would be in the best interest of the residents and programs to retain these records to help those interested in becoming an NRC Authorized User. If I’m completing my training this year, but I’m not worried about AU-E, does the ABR require submission of the forms? No. This has never been a requirement for ABR board certification. Is there a change to the required documentation (record keeping) by the residency program? No. For radiation oncology, the Oral I-131 and Parenteral Administration Log will no longer be submitted to the ABR. However, residents and programs should continue to be consistent with meeting RRC and NRC requirements. The graduate may request that the program complete and attest to their training and experience in their NRC Preceptor Statement; the documentation requirements are very similar to what is currently provided to the ABR. The government form looks different, but the information needed for completion is very similar to that needed for completion of the ABR forms.