Initial Certification for Diagnostic Radiology

Compliance with NRC Regulations

Last verified on October 25, 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/radiopharmaceuticals). See https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0390.html. The ABR is committed to compliance with the NRC by:
  1. providing information to its candidates and diplomates about the required components of training and experience;
  2. requiring from program directors a written attestation that the proper training and experience have been completed, including case logs of oral sodium iodide 131I therapies, as well as parenteral therapies for subspecialization in nuclear radiology, that have been supervised and attested by appropriate AU-preceptor(s); and
  3. testing knowledge of the required subjects and assessing competence in radiation safety, radionuclide handling, and quality control.
In accordance with the Radiology Residency Review Committee, the ABR requires a radiology residency training program to fulfill the NRC requirements for training and experience. (See https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0390.html.)
The ABR endeavors to have radiology residents meet those requirements within the context of a balanced radiological curriculum and with classroom, laboratory, and clinical experiences in nuclear radiology that ensure the safe and effective use of radionuclides (radiopharmaceuticals) for diagnosis and therapy by board-certified radiologists.
The ABR believes these items are important components of a responsible and comprehensive education for radiologists and that they contribute to the safety of medical practice in ways broadly supported by the profession, organized medicine, regulators, and the public.

NRC Training and Experience Requirements for Diagnostic Radiology or Interventional/Diagnostic Radiology

Candidates seeking specialty certification in diagnostic radiology or interventional/diagnostic radiology must meet all specific training and experience requirements described in 10 CFR 35.290 “Training for imaging and localization studies” (c)(1)(i)-(c)(1)(ii)(G); in §35.392 “Training for the oral administration of sodium iodide 131I requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)” (c)(1)-(c)(2)(vi); and in §35.394 “Training for the oral administration of sodium iodide 131I requiring a written directive in quantities greater than or equal to 1.22 gigabecquerels (33 millicuries)” (c)(1)-(c)(2)(vi). All specified radiation safety, radionuclide handling, quality control, and related topics must be covered.
Each diagnostic radiology or interventional/diagnostic radiology candidate seeking AU eligibility status through the ABR pathway must have completed a minimum of 700 hours of training and experience in imaging and localization studies, including a minimum of 80 hours of classroom and laboratory training in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies.
Each candidate must also meet the training and experience requirements specified in §35.392 and §35.294 for medical uses of oral sodium iodide 131I (≤ 33 mCi and > 33 mCi, respectively) for procedures requiring a written directive.
Under the direction of a qualified AU, this training and experience must include, at a minimum:
A. Classroom and laboratory training 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 byproduct material for medical use
  5. Radiation biology
and
B. 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, must involve all 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
Radiology residents must demonstrate hands-on work experience when they perform the supervised experience requirements. Observation alone is not sufficient.
Detailed information regarding these regulations may be accessed 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.
 

NRC Training and Experience Requirements for Nuclear Radiology

In addition to the above requirements under 10 CFR 35.290, 35.392, and 35.394 for specialty certification in diagnostic radiology, candidates seeking subspecialty certification in nuclear radiology must meet all of the specific training and experience requirements described in §35.390 “Training for use of unsealed byproduct material for which a written directive is required” b(1)(i)-(b)(1)(ii)(G)(4). All specified radiation safety, radionuclide handling, quality control, and related topics must be covered.
Specifically, each nuclear radiology candidate for AU eligibility status through the ABR pathway must have completed a minimum of 700 hours of training and experience in imaging and localization studies, including a minimum of 200 hours of classroom and laboratory training in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies.
Specifically, each nuclear radiology candidate must meet the additional requirements specified in §35.390 for parenteral administration of any beta emitter or photon-emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required, and/or parenteral administration of any other radionuclide, for which a written directive is required.
Detailed information regarding §35.290, §35.390, §35.392, and §35.394 may be accessed 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.
 

Authorized User (AU)-eligible Designation for Diagnostic Radiology or Interventional/Diagnostic Radiology: Oral Sodium Iodide 131I Case Experience Documentation

Work experience for the oral administration of sodium iodide 131I (§35.392 and §35.394) requiring a written directive must be performed 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 dosages of sodium iodide 131I for which a written directive is required in that dosage category.
This work experience must involve the following:
Administering to patients or human research subjects dosages that include at least three cases involving the oral administration of ≤ 33 mCi and at least three cases involving the administration of > 33 mCi of sodium iodide 131I.
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 assures the ABR (and the NRC) that each diagnostic radiology or interventional/diagnostic radiology candidate has completed the required training and experience in keeping with the NRC curriculum for an AU. The program director must submit an attestation form for each resident, not a “blanket approval” for a residency class, because the training and experience in NRC-related aspects of nuclear radiology may vary within the group.
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 an AU. A false attestation of completion of NRC training would jeopardize the reputation and integrity of the residency program, the ABR, and the Radiology 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 submitted curricular requirements. Regardless of whether or not a resident completed the full NRC-mandated curriculum, the resident must have completed 16 or more clinical weeks (approximately four months, 700 hours) of nuclear radiology/nuclear medicine during the four years, as required by the Radiology RRC. Time away (e.g., vacations, AIRP, etc.) cannot be counted toward this requirement in nuclear radiology. The resident will be expected to answer NRC-related questions on all ABR exams.

ABR Form B – Candidate Sodium Iodide 131I Case Log

Because of HIPAA concerns, no patient identifying data should be included on Form B. For diagnostic radiology or interventional/diagnostic radiology candidates, participation in at least three oral sodium iodide 131I administrations in each of the two categories is required. Because patients requiring sodium iodide 131I therapy in dosages ≤ 33 mCi and > 33 mCi present in different clinical settings, and to assure appropriate clinical experience with both levels of sodium iodide 131I administrations, each set of three cases must be discrete and listed in the proper category. Thus, administered dosages of oral sodium iodide 131I in each category, ≤ 33 mCi and > 33 mCi, must actually be recorded within the appropriate category in the case log. That is, administered activity > 33 mCi of sodium iodide 131I cannot be used in the category designated for ≤ 33 mCi of sodium iodide 131I, or vice versa.
Both Form A and Form B are to be submitted by the program director prior to a resident’s graduation.  

Authorized User (AU)-eligible Designation for Nuclear Radiology: Oral Sodium Iodide 131I and Parenteral Case Experience Documentation

Work experience for oral sodium iodide 131I therapies and parenteral therapies requiring a written directive must be performed under the supervision of an AU who meets the requirements in §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 dosages of sodium iodide 131I for which a written directive is required in that dosage category.
This work experience must involve the following:
1. Administering to patients or human research subjects dosages that include at least 10 cases involving the oral administration of ≤ 33 mCi and five cases involving the administration of > 33 mCi of sodium iodide 131I.
2. Administering to patients or human research subjects dosages that include at least five cases involving 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, and/or parenteral administration of any other radionuclide, 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.
 

ABR Exams and the NRC Curriculum

The NRC/Agreement States accept ABR certification as evidence that a practitioner is properly trained to use radioactive materials safely and effectively in the practice of nuclear radiology. Content addressing safety and the handling of radionuclides (radiopharmaceuticals), as specified by the NRC-required curriculum, is embedded in the ABR exams leading to initial certification in diagnostic radiology or interventional/diagnostic radiology, including the Core and Certifying exams.
A candidate’s performances on the NRC-related portions of the Core and Certifying exams jointly comprise the RadioIsotope Safety Exam (RISE). The results of the RISE will be determined after a candidate successfully completes and passes the Certifying Exam.
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 to take the NRC-related portions of the ABR Core and Certifying exams and will be qualified to provide nuclear radiology services safely and effectively.    

The ABR AU-eligible Designation

The preceding ABR forms (Forms A and B) do not need 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 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 or 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 met, and the exams 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 exams, including the RISE. 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) for the medical use of radionuclides (radiopharmaceuticals) for imaging and localization studies, and for the oral administration of sodium iodide 131I in amounts ≤ 33 mCi and > 33 mCi for procedures requiring a written directive.
In addition, nuclear radiology diplomates receive AU for parenteral administration of any beta emitter, or photon-emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required, and/or parenteral administration of any other radionuclide, for which a written directive is required.
Such diplomates can apply to the NRC/Agreement State for AU status, which allows the diplomate to be listed on the institutional or practice site license and to oversee the safe and effective medical use of radionuclides (radiopharmaceuticals).
AU status is obtained upon written application to the NRC/Agreement State and 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 about their relevant training and experience.

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