Initial Certification for Interventional Radiology

Compliance with NRC Regulations

Last verified on April 20, 2022

 

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.

 

The ABR AU-Eligible Designation

The ABR Authorized User-Eligible designation is available for interventional radiology/diagnostic radiology (IR/DR) certificates issued by December 31, 2023. Additional information on how to earn this designation is available below.

   

NRC Training and Experience Requirements for Interventional Radiology/Diagnostic Radiology (IR/DR)

The information below covers NRC §35.290, §35.392 and §35.394.

Training for Imaging and Localization Studies:

Candidates seeking specialty certification in IR/DR must meet all specific training and experience requirements described in:

§35.290 (c)(1)(i) through (c)(2)(ii)(G), “Training for imaging and localization studies”.

Each IR/DR candidate seeking Authorized User (AU) eligibility status through the ABR pathway must have completed, at a minimum:

700 hours of training and experience, 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. This training and experience must include, at a minimum:

Classroom and laboratory training in:

  • Radiation physics and instrumentation;
  • Radiation protection;
  • Mathematics pertaining to the use and measurement of radioactivity;
  • Chemistry of byproduct material for medical use; and
  • Radiation biology;

And

Work experience, under the supervision of a preceptor AU who meets the requirements in §35.57, §35.290, §§35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements. Work experience must involve:
  • Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
  • Performing quality-control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
  • Calculating, measuring, and safely preparing patient or human research subject dosages;
  • Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
  • Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;
  • Administering dosages of radioactive drugs to patients or human research subjects; and
  • 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.

Each IR/DR candidate must demonstrate hands-on work experience in performing the supervised experience requirements. Observation alone is not sufficient.

Training for Oral Administration of Sodium Iodide I-131 Requiring a Written Directive:

Candidates seeking specialty certification in IR/DR must meet all specific training and experience requirements described in:

§35.392 (c)(1)(i) through (c)(2)(vi), “Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)”
and
§35.394 (c)(1)(i) through (c)(2)(vi), “Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries)”.

Each IR/DR candidate seeking Authorized User (AU) eligibility status through the ABR pathway must have successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. This training must include:

  • Radiation physics and instrumentation;
  • Radiation protection;
  • Mathematics pertaining to the use and measurement of radioactivity;
  • Chemistry of byproduct material for medical use; and
  • Radiation biology;

And

Work experience, under the supervision of a preceptor AU who meets the requirements in §§35.57, 35.390, 35.394, or equivalent Agreement State requirements. A supervising AU who meets requirements in §35.390(b) must also have experience in administering dosages as specified in §35.390(b)(1)(ii)(G)(2). The work experience must involve:
  • Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
  • Performing quality-control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
  • Calculating, measuring, and safely preparing patient or human research subject dosages;
  • Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
  • Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;
  • Administering dosages of radioactive drugs to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and
  • Administering dosages of radioactive drugs to patients or human research subjects, that includes at least 3 cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131.

Under the supervision of a qualified AU, each IR/DR candidate must meet all of the training and experience requirements specified in both §35.392 and §35.394 for medical uses of oral sodium iodide I-131 (≤ 33 mCi and > 33 mCi, respectively) for procedures requiring a written directive.  Candidates for AU eligibility via the ABR Pathway must meet all training and experience requirements specified in §35.394.

Each IR/DR candidate must demonstrate hands-on work experience in performing the supervised experience requirements. Observation alone is not sufficient.

Detailed information may be accessed via the NRC Medical Uses Licensee Toolkit (https://www.nrc.gov/materials/miau/med-use-toolkit.html), the NRC Medical Regulations in 10 CFR Part 35 (https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/), and the Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses, Final Report (NUREG-1556, Volume 9, Revision 3 (https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/).

 

Authorized User (AU)-Eligible Designation for IR/DR: Oral Sodium Iodide I-131 Case Experience Documentation

Work experience for the oral administration of sodium iodide I-131 requiring a written directive must be performed under the supervision of an AU who meets the requirements in §35.390,  §35.394, or equivalent Agreement State requirements. A supervising AU who meets requirements in §35.390(b)(1)(ii)(G)(2) must have experience in the oral administration of dosages of sodium iodide I-131 for which a written directive is required in that dosage category or categories.

Work experience must involve administering therapeutic dosages to patients or human research subjects that include, at a minimum:

  • Three cases involving the oral administration of ≤ 33 mCi of sodium iodide I-131;
and
  • Three cases involving the oral administration of > 33 mCi of sodium iodide I-131.

A logbook of these therapies must be kept by the IR/DR candidate and submitted to the ABR in the format given below. 

Candidates for AU eligibility via the ABR Pathway must, at a minimum, meet all training and experience requirements specified in §35.394.

 

Forms to Be Submitted to the ABR

Two forms, contained within one document, are available to document compliance with and completion of the required NRC/Agreement State training and experience. Both completed forms must be submitted by the program on behalf of each IR/DR candidate for the candidate to be eligible for an ABR IR/DR Certificate with the Authorized User (AU)-Eligible designation.

  • ABR Form A (IR/DR Program Director Attestation);
  • ABR Form B (IR/DR Candidate sodium iodide I-131 Case Log).

Download printable forms in .pdf format

ABR Form A – IR/DR Program Director Attestation

This form assures the ABR (and the NRC/Agreement State) that each IR/DR candidate has completed the required training and experience in keeping with the NRC curriculum for AU status. The program director must submit an attestation form for each candidate, not a “blanket approval” for a residency class, because the training and experience in NRC-related aspects 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 and the ABR and would threaten the relationship among these organizations and the NRC.

The ABR reserves the right to audit the manner in which candidates have completed the submitted curricular requirements. Regardless of whether or not a candidate completed the full NRC-mandated curriculum, the candidate must have completed 16 or more clinical weeks (approximately four months, or a minimum of 700 hours) of training and experience during the five years. Time away (e.g., vacations, AIRP, etc.) cannot be counted toward this requirement.

The candidate will be expected to answer NRC-related questions on all ABR exams. The exams will assess knowledge and competence in radiation safety, radionuclide handling, quality control, and related topics including but not limited to radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, chemistry of byproduct material for medical use, radiation biology, applicable to imaging and localization studies as well as applicable to oral sodium iodide I-131 procedures for which a written directive is required in both dosages < 33 mCi and > 33 mCi.

ABR Form B – IR/DR Candidate Sodium Iodide I-131 Case Log

Because of HIPAA concerns, no patient identifying data should be included on Form B. For IR/DR candidates, participation in at least three oral sodium iodide I-131 administrations in each categories is required. Because patients requiring sodium iodide I-131 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 I-131 administrations, each set of three cases must be discrete and listed in the proper category. Thus, the exact administered dosages of oral sodium iodide I-131 in each category, ≤ 33 mCi and > 33 mCi, must be recorded accurately within the appropriate category in the case log. That is, 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.

Candidates for AU eligibility must, at a minimum, meet the training and experience requirements for §35.394.

 

ABR Exams and the NRC Curriculum for Specialty Certification in IR/DR

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 interventional radiology/diagnostic radiology. Content addressing safety and the handling of radionuclides (radiopharmaceuticals), as specified by the NRC-required curriculum, is embedded in the ABR Qualifying (Core) and Certifying exams leading to initial certification in IR/DR.

A candidate’s performances on the NRC-related portions of the Qualifying (Core) and Certifying exams jointly comprise the Radioisotope Safety Exam (RISE). The results of the RISE will be determined only after a candidate successfully completes and passes the Certifying Exam.

The ABR recommends that all IR/DR residency programs ensure that their training is compliant with all elements specified by the NRC as listed on the ABR website. In this way, all candidates will be well prepared to take the NRC-related portions of the ABR Qualifying (Core) and Certifying exams and will be qualified to provide services safely and effectively.

 

The ABR AU-Eligible Designation for Specialty Certification in IR/DR

Timely submission of the ABR forms documents completion of the required NRC training and allows candidates who fulfill all 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 may have been passed by the candidate.

An AU-Eligible IR/DR 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 I-131 in dosages ≤ 33 mCi and > 33 mCi for procedures requiring a written directive.

AU-Eligible diplomates should work with their employer institution to apply to the NRC/Agreement State for AU status. Such AU status allows the diplomate to be listed on the institutional or practice site license in order to oversee the safe and effective medical use of byproduct material (radionuclides/radiopharmaceuticals), including sodium iodide I-131.

ABR diplomates who do not have the designation AU-Eligible on their certificates may have their institution or practice site apply for status as an AU via the NRC’s alternate pathway, for which they will be required to provide detailed information about their relevant training and experience.

 

Non-Authorized User Duties

If a radiologist is not named as an Authorized User (AU) on an NRC license at an institution, what duties may he or she perform at that facility?

The NRC recognizes that it is frequently necessary for an Authorized User (AU) to delegate to other individuals the specific tasks associated with preparing and administering byproduct material (radionuclides or radiopharmaceuticals) for medical use in patients (§35.27). These individuals include technologists and other physicians who may not be AUs.

If the policies and procedures of the institution holding an NRC radioactive materials license allow, the NRC regulations permit delegation of these duties if the individuals performing the duties are properly instructed and supervised. Specifically:

Subpart D – Unsealed Byproduct Material – Written Directive Not Required:

  • 35.100 “Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required”;
  • 35.200 “Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required”;

And

Subpart E – Unsealed Byproduct Material – Written Directive Required:

  • 35.300 “Use of unsealed byproduct material for which a written directive is required”.

The supervising AU need not be physically present for delegated use of byproduct material under subparts D and E. Furthermore, there is no NRC requirement that diagnostic examinations performed using byproduct material must be interpreted by an AU. Thus, the NRC regulations do not restrict who can interpret and report diagnostic imaging or the results of therapeutic procedures (i.e., radiologists who are not AUs may interpret and report such examinations and procedures). However, it is strongly recommended that those non-AU and AU radiologists practicing in NRC Agreement States consult the appropriate state regulatory agency to ensure that the state regulations allow for this delegation.

According to NRC regulations, only an AU can sign a written directive, including those necessary for therapeutic procedures involving unsealed byproduct material (e.g., treatment of hyperthyroidism, ablation of residual functional thyroid tissue, or treatment of functioning thyroid metastases using oral sodium iodide I-131). However, administration of the therapeutic unsealed byproduct dosage specified in the written directive may be delegated if the individuals performing the administration are properly instructed in the written directive procedures and supervised accordingly.

 

Radioisotope Safety Exam (RISE)

How long is the exam?

Exam details, including the number of questions and exam length, are located here.

What material does the exam cover?

Questions on radiopharmaceuticals, including radioiodines, clinically relevant beta emitters, and PET radionuclides should be anticipated. Considerable content regarding radionuclides/radiopharmaceuticals will be included, and the exam will include all NRC-related issues. The exams will assess knowledge and competence in radiation safety, radionuclide handling, quality control, and related topics including but not limited to radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, chemistry of byproduct material for medical use, radiation biology, applicable to imaging and localization studies as well as applicable to oral sodium iodide I-131 procedures for which a written directive is required in both dosages < 33 mCi and > 33 mCi. The candidate will be expected to answer NRC-related questions on all ABR exams.

Does the ABR provide guidelines to facilitate preparation?

The NRC website provides the general areas of training content under §35.290, §35.392, and §35.394, which are pertinent to the exam. The NRC website also provides rules and regulations applicable to the safe use of radiopharmaceuticals and compliance issues that are included on the exam. In addition, a study guide for the exam is available here.

If I need to take a separate RISE, what options/dates will be available to me later?

The separate RISE is given annually in the spring. Registration information is available on this website each year beginning December 1. Candidates are eligible to take the RISE up to seven years from the date of completion of their residency. The 2023 exam application window is from August 1 to September 30, 2022.  Please check back here during this time period for the application form.

What is the fee to take the exam?

The exam fee is located here.

Where can I take the exam?

The separate RISE is administered remotely.

What benefit/rights does AU eligibility give me?

Being AU-Eligible through the ABR gives the potential to more efficiently comply with some of the requirements set forth by the NRC to become an Authorized User. However, the ABR suggests candidates contact their institution/workplace for information regarding its particular AU requirements.

 

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.

As a diagnostic radiologist, may I interpret nuclear medicine/nuclear radiology studies without being an AU?

Yes, if granted practice privileges to do so.

Do DR and IR/DR residents still need to do 700 hours of training in Nuclear Radiology?

Yes. The ACGME (i.e., “residency”) requires 700 hours.

Will the Radioisotope Safety Exam (RISE) still be given as part of the Qualifying (Core) and Certifying exams for DR and IR/DR?

The exam content that makes up the RISE is an integral part of the domain of diagnostic radiology and interventional radiology, so there are no plans to change those in the exams. However, starting in 2024, that part of the exam will not be scored separately. The questions will continue to be scored toward the overall exam score. Pass rates on the Qualifying (Core) and Certifying exams will not be affected by this change.

What is the last date for DR or IR/DR diplomates to take the “make-up” RISE to get AU-E added to their certificates? 

The “make-up” RISE will be offered in January 2023 and December 2023. Thereafter, it will no longer be offered.

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 DR and IR/DR, ABR Forms A and B will no longer be submitted to the ABR as of June 2023. 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.

Is documentation still needed for the ABR 16-Month Nuclear Radiology Pathway or Nuclear Radiology/Nuclear Medicine Fellowship?

Yes. The documentation requirements for the 16-month pathway and the nuclear radiology/nuclear medicine fellowship pathway will be unchanged; however, the documentation will only be used to determine eligibility for the Nuclear Radiology Subspecialty Exam. This documentation will not be used for AU-E designation after 2023.