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)


Date:     March 2, 2006
Re:    Nuclear Regulatory Compliance

ABR Training in Nuclear Medicine – Compliance with NRC Regulations

Effective with the publication of the final revised version of the new 10 CFR part 35 in March, 2005, the Nuclear Regulatory Commission (NRC) established new guidelines for physicians who wish to achieve the status of Authorized User (AU). The ABR is committed to compliance by:

1. providing information about the required components of training and experience;
2. requiring from program directors written attestation and case log documentation (for I-131 therapy) that the proper training has been given, and;
3. testing knowledge of the required subjects in both its written and oral examinations.

Testing applies to the Nuclear Medicine portion of the initial certificate in Diagnostic Radiology and to the certificate of added competence in Nuclear Radiology. The detailed cross-references to 10 CFR 35.290 and 35.392 follow.

Candidates seeking certification for diagnostic radiology must meet the specific training and experience requirements described in 10 CFR 35.290(c) (1) (i) and (c) (1) (ii) and 10 CFR 35.392(c) (1) and (c) (2). Radiation safety, radionuclide handling and quality control and related topics specified in 10 CFR 35.290 and 10 CFR 35.392 must be covered.

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, including classroom and laboratory training in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies. In addition, each candidate must also meet the training and experience requirements specified in § 35.392 for medical uses of radioiodine I-131 (≤ 33mCi) that require a written directive. The training and experience must include, at a minimum, the following:

1. Classroom and laboratory training in the areas of

a) Radiation physics and instrumentation;
b) Radiation protection;
c) Mathematics pertaining to the use and measurement of radioactivity;
d) Chemistry of by-product material for medical use; and
e) Radiation biology.

2. Work experience for imaging and localization studies under the supervision of an AU, who meets the requirements in § 35.290, or 35.290(c)(1)(ii)(G) and 35.390 or equivalent Agreement State requirements, involving the following:

a) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
b) performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
c) calculating, measuring, and safely preparing patient or human research subject dosages;
d) using administrative controls to prevent a medical event involving the use of unsealed byproduct materials;
e) using procedures to safely contain spilled radioactive material and using proper decontamination procedures;
f) administering dosages of radioactive drugs to patients or human research subjects; and
g) 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.

3. Work experience for the oral administration of sodium iodide I-131 requiring a written directive. This experience 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:

a) ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
b) performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
c) calculating, measuring, and safely preparing patient or human research subject dosages;
d) using administrative controls to prevent a medical event involving the use of unsealed byproduct materials;
e) using procedures to safely contain spilled radioactive material and using proper decontamination procedures; and
f) administering doses to patients or human research subjects that include at least three cases involving the oral administration of ≤33mCi of sodium iodide I-131.

Case experience, including that specified above, must be documented as follows:

Regarding § 35.392, candidates must have completed a minimum of three cases that involved administration of ≤33mCi of I-131 for therapy under 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. A logbook of these therapies must be kept by the resident and submitted in the following format:

Printable Forms

FORM B

I-131 Therapy Experience

Because of HIPAA regulations, identifying patient data are to be excluded from 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. To assure the ABR that each candidate has completed the required training, the Program Director must submit an attestation form as follows:

FORM A

American Board of Radiology – Program Director Attestation

COMPLIANCE WITH NRC TRAINING AND EXPERIENCE REQUIREMENTS

More information can be found at the following link:
http://www.nrc.gov/reading-rm /doc-collections/cfr/part035/part035-0290.html

The preceding ABR forms do not have to be completed for a resident to take the ABR exam including the Nuclear Medicine section of the exam. Completing the form documents the training and allows the candidate to receive authorized user (AU)-eligible designation on his/her certificate.

Candidates who fulfill all the requirements listed above on Form A and Form B and who pass all their ABR exams will receive an ABR certificate that contains the additional designation “AU-eligible”. This means that the person is eligible through the ABR pathway to be approved by the NRC as an AU of medical radionuclides for imaging and localization studies and for oral administration of sodium iodide I-131 requiring a written directive (≤33mCi). NRC approval is obtained upon written application to the NRC/Agreement State and also requires submission of an NRC preceptor form which has been completed and signed by the preceptor who must be an AU. The forms are available on the NRC website.

There is a footnote to 10 CFR 35.390(b)(1)(ii)(G)(2) stating that experience with at least three cases in Category (G)(2) also satisfies the the requirement in Category(G)(1). Please note that this goes only one way, i.e., experience with at least three cases in (G)(1) does not satisfy the requirement in (G)(2). The translation is that if residents have experience with higher I-131 doses, that experience will qualify them for AU eligibility related to I-131 doses lower than 33mCi. Low dose experience does not impact in any way on one's eligibility for high dose work.

Also presented on the ABR website are copies of informational memos about the NRC (ABR put hot link to NRC Regs section). These memos are not as specific as the information above regarding the content required in the Nuclear Medicine portion of Diagnostic Radiology training programs. Such memos are simply guidance from the ABR. The sections above delineate the detailed content as required by NRC and also are the most complete compilation of the types of material subject to ABR testing relevant to NRC principles related to Nuclear Medicine. This testing will focus on radiation safety, radionuclide handling, quality control, quality assurance and clinical uses of unsealed by-product materials for which a written directive is required. Such testing will be part of the exam in physics, the part-2 written examination and the oral exam taken by all candidates seeking ABR certification in Diagnostic Radiology.

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