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ABR Initial Certification NRC Information



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  • 1. ABR Initial Certification NRC Information April 14 , 2006 RE: Nuclear Regulatory Compliance To: Radiology Residency Program Directors Radiology Residency Program Coordinators President, APDR President, SCARD From: Philip O. Alderson, MD, Robert R. Hattery, MD American Board of Radiology (ABR) ABR Oral Examination and NRC Regulations We are writing to provide further clarification about the relationship between completion of the new Nuclear Regulatory Commission (NRC) requirements for Nuclear Medicine and the admissibility of a resident to the ABR examination. Radiology residents will be allowed to take the entire ABR examination including the Nuclear Medicine section whether or not they are NRC-compliant. Residents who are not NRC compliant but pass the examination will become fully ABR-certified. Diplomates who also have fulfilled the NRC requirements will receive a certificate with a special additional designation. That designation will indicate that they are eligible to be an NRC Authorized User (AU) of radionuclides in medicine. The designation will appear near the left lower corner of the certificate as the words "AU-eligible". This designation indicates that the diplomate has fulfilled all the training and experience requirements of the NRC and passed all the ABR examinations. Such a person can apply to the NRC for authorized user status, which allows the diplomate to be listed on the institutional or practice site license and oversee the safe and effective medical uses of radionuclides. ABR diplomates who do not have the designation AU-eligible on their certificate also can apply to the NRC for status as an AU via the so-called alternate pathway, but they will be required to provide detailed information to NRC about their classroom and practical experiences. The AU-eligible designation is an addition to the ABR certificate for those who have completed the appropriate training. Under no circumstances should Program Directors designate as NRC-compliant a candidate who has not completed the full course of study mandated in the NRC curriculum for authorized users. This curriculum is summarized on the ABR website under the side bar symbol "NRC regs." False attestation of completion of training for NRC non-compliant residents would jeopardize the reputation and integrity of the residency program, the ABR and the Residency Review Committee (RRC), and threaten the relationship between these organizations and the NRC. There should not be blanket approval of a resident class if the training and experience in NRC-related 1
  • 2. aspects of Nuclear Medicine varies within the group. The decision to provide attestations should be individualized and linked to completion of the NRC curriculum by individual residents. The ABR recognizes that completion of the NRC-mandated curriculum is perhaps more difficult in this first transition year to the new regulations. Accordingly, the ABR anticipates that only a minority of residents who sit for the examination in June, 2006, will be designated by their Program Directors as compliant with NRC requirements. The ABR reserves the right to further survey or explore with those residents the manner in which they completed the curricular requirements. Whether or not a resident completes the full NRC-mandated curriculum, they must have completed 16 or more clinical weeks of nuclear medicine during the four years of training and will be responsible to answer NRC-related questions on all ABR examinations. We hope that this further clarifies the relationship between the new NRC regulations and the admissibility of residents to the ABR examination. This memorandum will be posted on the ABR website so that Program Directors or others may refer to it in the future. Thank you for your continued support of the ABR. January 30, 2006 RE: Nuclear Regulatory Commission Issues To: Radiology Residency Program Directors Radiology Chief Residents Chairs/Directors of Service From: Philip O. Alderson, MD, Robert R. Hattery, MD American Board of Radiology (ABR) We are writing to provide an update about the status of the interactions between the American Board of Radiology (ABR) and the Nuclear Regulatory Commission (NRC) concerning the training of radiology residents in Nuclear Medicine, and to provide further information about how NRC - related topics will be addressed in the ABR examination to be given in June 2006. As you probably know, the ABR and the Residency Review Committee (RRC) have approved a new 16-week curriculum for Nuclear Medicine, which is to be completed within the four-year residency program. This was done in compliance with the new part 35 of Title 10, Code of Federal Regulations (10 CFR 35), the revised final version of which was published by the NRC March 30, 2005 after nearly 10 years of public comments/negotiations between the NRC and its broad user community. Although the new part 35 CFR is better in a number of ways, it is more restrictive in other ways. All Boards seeking recognition by the NRC, including the ABR, must update their requirements to conform to the new part 35 and must re-apply for approved status. This application process has not been as straightforward as we had hoped. 2
  • 3. The ABR is striving to create a program that fulfills the NRC requirements for training and experience of radiology residents. The ABR is endeavoring to meet those requirements within the context of an overall balanced radiological curriculum and with a set of didactic, laboratory and clinical experiences in nuclear medicine that will ensure safe and effective use of radionuclides by board-certified radiologists. Despite significant efforts by the ABR, ABR and NRC have not yet reached an agreement. We continue to work hard toward this goal and trust that approval will be obtained prior to the coming oral examinations in June 2006. Whether or not agreement with NRC is reached, candidates who take the ABR oral exam in June 2006 and in future years will be tested on NRC items during the examination in Nuclear Medicine. The ABR believes that these items are important components of a responsible education for radiologists and contribute to the safety of medical practice in ways that are broadly supported by organized medicine, regulators and the public. The NRC cases will count towards the pass/fail score in Nuclear Medicine and will constitute approximately 30% of that examination in 2006. Some of the NRC materials will be depictions of situations/scenarios that will allow the examiner and candidate to discuss pertinent NRC principles. Other questions will come from clinical scans and will relate to issues of radiopharmaceutical biodistribution (e.g., critical organ doses), to I-131 therapy or to other relevant issues. Attached is a one-page attestation about NRC-related training that Program Directors must submit for each candidate who wishes to take the oral examination. This form should be submitted when you receive this year's final reference form from the ABR in several weeks. The ABR will keep you informed of its interactions with NRC. Compliance Form cc: Nuclear Medicine Directors August 11, 2005 RE: Nuclear Medicine Training To: Diagnostic Radiology Program Directors Radiology Chief Residents Chairs/Directors of Service From: Philip O. Alderson, MD, President-Elect American Board of Radiology (ABR) Dear Colleagues: Several years ago, the Nuclear Regulatory Commission (NRC) proposed changes in the rules that govern training and experience required to use the types of radioactive materials commonly employed in clinical nuclear medicine. Controversies surrounding the proposed regulations delayed 3
  • 4. implementation, but a revised final version was published March 30, 2005 in the NRC Federal Register. In the past, the NRC has accepted ABR certification as evidence that a practitioner is properly trained to safely and effectively use radioactive materials in nuclear medicine. The ABR wishes to retain as much of this status as possible under the new regulations, and accordingly, is requiring that the length of training and the materials on which it examines match the final new NRC regulations. The ABR also will attempt to maintain consistency with the requirements of the Radiology RRC, which also are being revised at this time. 1. Beginning with the oral examination of June 2006, the ABR will admit candidates who have 700 or more hours of training and experience in nuclear medicine. The ABR will require that four complete months (16 weeks) be spent on clinical nuclear medicine rotations. Time away (e.g., vacations, AFIP, etc.) may not be counted toward the 16-week requirement in nuclear medicine. Didactic instruction will be required to cover the nuclear medicine topics cited in sections 35.290 (imaging and localization studies) and 35.392 (oral administration of I-131 in quantities ≤ 33mCi) of the new NRC regulations. This instruction can be given in classroom/laboratory sessions during the clinical rotations in nuclear medicine, or at other times during the residency. 2. This total training and experience should include all NRC-required items related to the safe handling, administration and quality control of the radionuclide doses used in clinical nuclear medicine. The Federal Register provides a comprehensive list of these items, which is posted on the NRC website. ABR testing will cover selections from subjects such as safe elution and quality control (QC) of radionuclide generator systems, calibration and QC of survey meters and dose calibrators, safe handling and administration of therapeutic doses of unsealed radionuclide sources (i.e., I-131), written directives, responses to radiation spills and accidents, radiation signage, and related materials. Such items may be included on both the written and oral exams. In order to comply with NRC regulations and expected new RRC guidelines related to I-131 therapy with unsealed sources, a resident will have to participate with preceptors in three therapies involving oral administration of ≤ 33mCi of I-131. (Treatment of hyperthyroidism is a frequent indication for therapeutic doses in this range.) Experience with administration of larger doses of I- 131 or other types of radionuclide therapy for cancer is not being required by the ABR for diagnostic radiology at this time. The specific dates on which experiences with I-131 therapy occur should be kept by each resident in a log book, in a format similar to the following. A minimum of participation in three cases involving oral administration of ≤ 33mCi of I-131 is required. Resident Name Program 4
  • 5. Because of HIPAA concerns, no data that might identify a patient are to be included in the log book. This log is to be submitted by the program director along with the other materials that attest to the resident's oral exam eligibility. Our colleagues in radiation oncology are dealing with similar concerns about the therapy-related sections of the new NRC regulations. The ABR will be writing to radiation oncology training program directors in a separate memo to encourage new training content, and to indicate ABR's intention to include new NRC-related materials in future examinations. To license an individual as an authorized user of radionuclides, the NRC will require that another authorized user/preceptor - typically this would be the nuclear medicine chief - 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 also is an 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 nuclear medicine to assure that all the elements listed by NRC and on the ABR website are included. In this way, all residents will be well prepared and qualified to take the nuclear medicine portion of the ABR oral exam, and also will be well prepared to provide nuclear medicine services safely and effectively. 5