Initial Certification for Diagnostic Radiology

Compliance with NRC Regulations

Last verified on August 22, 2017
 

Training in Nuclear Radiology

NRC FAQs

The U.S. Nuclear Regulatory Commission (NRC) has established guidelines for physicians who wish to achieve the status of Authorized User (AU) of unsealed byproduct material (radionuclides). The ABR is committed to compliance by:
  1. providing information about the required components of training and experience;
  2. requiring from program directors a written attestation that the proper training has been given and a case log of sodium iodide I-131 therapy work experience that has been supervised and attested to by appropriate AU-preceptor(s); and
  3. testing knowledge of the required subjects.
The ABR requires a resident training program to fulfill the NRC requirements for training and experience of radiology residents, as does the Diagnostic Radiology Residency Review Committee (see reference to these requirements below). The ABR endeavors to have residents meet those requirements within the context of an overall balanced radiological curriculum and with a set of didactic, laboratory, and clinical experiences in nuclear radiology that ensure safe and effective use of radionuclides by board-certified radiologists. The ABR believes these items are important components of a responsible education for radiologists and that they contribute to the safety of medical practice in ways broadly supported by organized medicine, regulators, and the public.
 

NRC Training and Experience Requirements

Candidates seeking certification in diagnostic radiology or must meet the specific training and experience requirements described in 10 CFR 35.290 (c)(1)(i), (c)(1)(ii), and (c)(3); 10 CFR 35.392 (c)(1), (c)(2), and (c)(3); and 10 CFR 35.394 (c)(1) and (c)(2). Radiation safety, radionuclide handling and quality control, and related topics specified in 10 CFR 35.290, 10 CFR 35.392, and 10 CFR 35.394 must be covered.
Detailed information regarding 10 CFR 35.290, 35.392, and 35.394 may be found via the NRC Electronic Reading Room, which provides access to the NRC Regulations, Frequently Asked Questions, and other pertinent references. That information is available here.
Specifically, each candidate for AU status through the ABR pathway must have completed a minimum of 700 hours of training and experience in imaging and localization studies, which must include 80 hours of classroom and laboratory training in basic radionuclide handling techniques applicable to both the medical use of unsealed byproduct material for imaging and localization studies and the medical use of sodium iodide I-131 for procedures requiring a written directive. In addition, each candidate must also meet the training and experience requirements specified in §35.392 and §35.294 for medical uses of sodium iodide I-131 (≤ 33 mCi and > 33 mCi, respectively) requiring a written directive. The training and experience must include, at a minimum, the following:
Classroom and laboratory training (minimum of 80 hours, or 200 hours for nuclear radiology) under the direction of an Authorized User in the following areas:
  1. Radiation physics and instrumentation
  2. Radiation protection
  3. Mathematics pertaining to the use and measurement of radioactivity
  4. Chemistry of by-product material for medical use
  5. Radiation biology
Work experience for imaging and localization studies (§35.290) under the supervision of a preceptor AU who meets the requirements in §35.57, §35.290, or §35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, involving the following:
  1. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys
  2. Performing quality-control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters
  3. Calculating, measuring, and safely preparing patient or human research subject dosages
  4. Using administrative controls to prevent a medical event involving the use of unsealed by-product material
  5. Using procedures to safely contain spilled radioactive material and using proper decontamination procedures
  6. Administering dosages of radioactive drugs to patients or human research subjects
  7. Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs
  8. Residents must demonstrate hands-on work experience when they perform the supervised work experience requirements. Observation alone is not sufficient.
Work experience for the oral administration of sodium iodide I-131 (§35.392 and §35.394) requiring a written directive: Experience under §35.392 must be obtained under the supervision of an AU who meets the requirements in §35.390, 35.392, 35.394, 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 I-131, for which a written directive is required. This work experience must involve the following:
  1. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys
  2. Performing quality control procedures on instruments  used to determine the activity of dosages and performing checks for proper operation of survey meters
  3. Calculating, measuring, and safely preparing patient or human research subject dosages
  4. Using administrative controls to prevent a medical event involving the use of unsealed byproduct material
  5. Using procedures to safely contain spilled radioactive material and using proper decontamination procedures
  6. Administering to patients or human research subjects dosages that include at least three cases involving the oral administration of ≤ 33mCi and three cases involving the administration of >33 mCi of sodium sodium iodide I-131
 

Authorized User (AU)-eligible Designation

Sodium iodide I-131 case experience documentation

  1. Regarding §35.392, the ABR requires that candidates must have completed a minimum of three cases that involve administration of ≤ 33 mCi of I-131 for therapy under a preceptor Authorized User (AU) who meets the requirements in §35.390, 35.392, 35.394, 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. A logbook of these therapies must be kept by the resident and submitted to the ABR in the format given below.
  2. Regarding §35.394, the ABR requires that candidates must have completed a minimum of three cases that involve the administration of > 33 mCi of I-131 for therapy under a preceptor AU who meets the requirements in §§35.57, 35.390, 35.394, or equivalent Agreement State requirements. A supervising AU who meets the requirements in §35.390(b) must also have experience in administering dosages as specified in §35.390(b)(1)(ii)(G)(2). A logbook of these therapies must be kept by the resident and submitted to the ABR in the format given below.
 

Forms to Be Submitted to the ABR

Two forms are available to document compliance with and completion of the required NRC/Agreement State training and experience. Both completed forms must be submitted on behalf of each candidate for the candidate to be eligible for an ABR Diagnostic Radiology Certificate with the Authorized User (AU)-eligible designation.
  1. ABR Form A (Program Director Attestation)
  2. ABR Form B (Candidate 131I Case Log)
Download printable forms in .pdf format

ABR Form A – Program Director Attestation

This form is intended to assure the ABR (and, thus, the NRC) that each individual candidate has completed the required training. The program director must submit an attestation form. There should not be blanket approval of a resident class because the training and experience in NRC-related aspects of nuclear radiology may vary within the group. The decision to provide attestations should be individualized and linked to completion of the NRC curriculum by individual residents.
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. False attestation of completion of training for NRC-noncompliant residents would jeopardize the reputation and integrity of the residency program, the ABR, and the Residency Review Committee (RRC) and would threaten the relationship among these organizations and the NRC.
The ABR reserves the right to audit the manner in which the residents completed the curricular requirements. Whether or not a resident completes the full NRC-mandated curriculum, the resident must have completed 16 or more clinical weeks of nuclear medicine during the four years of training as required by the Diagnostic Radiology RRC and will be responsible to answer NRC-related questions on all ABR examinations. Time away (e.g., vacations, AIRP, etc.) cannot be counted toward the 16-week requirement in nuclear radiology.

ABR Form B – Candidate I-131 Case Log

Because of HIPAA concerns, no data that might identify a patient are to be included on Form B. Please note that participation in three sodium iodide I-131 administrations in each of the two categories is required. Because patients requiring sodium iodide I-131 therapy in amounts ≤ 33 mCi and > 33 mCi present in very different clinical settings and to assure clinical experience with both levels of sodium iodide I-131 administration, each set of three cases must be discrete and listed in the proper category. Thus, administered amounts of sodium iodide I-131 in each category, ≤ 33 mCi and > 33 mCi, must actually be within the appropriate category in the case log. Administered activity > 33 mCi of sodium iodide I-131 cannot be used in the category designated for ≤ 33 mCi of sodium iodide I-131, or vice versa.
Both Form A and Form B are to be submitted by the program director prior to a resident’s graduation.
 

ABR Examinations and the NRC Curriculum

The NRC/Agreement States accept ABR certification as evidence that a practitioner is properly trained to safely and effectively use radioactive materials in nuclear radiology. Content addressing safety and the handling of radionuclides as specified by the NRC-required curriculum is embedded in the ABR examinations leading to initial certification in diagnostic radiology, including the Core and Certifying examinations.
A candidate’s performances on the NRC-related portions of the Core and Certifying examinations jointly comprise the Radioisotope Safety Exam (RISE). The results of the RISE will be determined after a candidate successfully completes and passes the Certifying Examination.
The ABR recommends that all residency programs ensure that their training in nuclear radiology is compliant with all the elements listed by the NRC and on the ABR website. In this way, all residents will be well prepared and qualified to take the NRC-related portions of the ABR exams, and also will be well prepared to provide nuclear radiology services safely and effectively.
 

The ABR AU-eligible Designation

The preceding ABR forms do not have to be completed for a resident to take the ABR exams. Timely submission of the ABR forms, however, documents completion of the required NRC training and allows candidates who fulfill all the requirements listed above on Forms A and B and who pass all their ABR exams, including the RISE content, to receive an ABR certificate that contains the additional designation of AU-eligible. This designation will appear near the left lower corner of the certificate.
If Forms A and B are not completed and submitted to the ABR for a candidate, AU-eligible certificate designation will not be possible, even though the NRC-required training and experience may have been completed, and the examinations passed by the candidate.
An AU-eligible certificate indicates that the diplomate has fulfilled all the training and experience requirements of the NRC/Agreement State and has passed all the ABR examinations. It means that the diplomate is eligible through the ABR board certification pathway to be approved by the NRC/Agreement State as an Authorized User (AU) of medical radionuclides for imaging and localization studies, and for oral administration of sodium iodide I-131 in amounts ≤ 33 mCi and > 33 mCi requiring a written directive. Such a person can apply to the NRC/Agreement State for Authorized User status, which allows the diplomate to be listed on the institutional or practice site license and to oversee the safe and effective medical uses of radionuclides.
Authorized User status is obtained upon written application to the NRC/Agreement State and also requires submission of an NRC preceptor form that has been completed and signed by the preceptor, who must be an AU. The forms are available on the NRC website.
ABR diplomates who do not have the designation AU-eligible on their certificates may apply to the NRC/Agreement State for status as an AU via the NRC’s alternate pathway, but they will be required to provide detailed information to the NRC about their relevant training and experience.

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