Radiology Training and Certification Requirements

Radiologic Education

Nuclear Medicine/Radiology Training and Certification Requirements: Recent Changes1 Jay Harolds, MD, Michael M. Graham, PhD, MD, Alan Maurer, MD, Milton J. Guiberteau, MD, Tom R. Miller, MD, PhD Kay Vydareny, MD

Rationale and Objectives. There have been many recent changes in governmental regulations affecting nuclear medicine/ nuclear radiology practice and training requirements. This article summarizes the background for these changes, and summarizes the new requirements for residency training, board certification, and authorized user status. Key Words. Radiology residency training; nuclear medicine training; certification in nuclear medicine; certification in radiology; residency training in nuclear medicine; NRC; authorized user; regulations in nuclear medicine. ©

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HISTORY In order to best understand the current status of nuclear medicine training and regulation, it is important to review the history. In 1946, the Atomic Energy Act (AEA) established the Atomic Energy Commission (AEC). In 1954, the AEA was amended to add the medical use of radioisotope licensing and regulation to the authority of the AEC. In 1966, AEC Chairman Seaborg appointed the Radioisotopes Licensing Review Panel, which “will produce better results than detailed regulations”(1). In 1974, the Energy Reorganization Act replaced the AEC with two organizations, the Nuclear Regulatory Commission (NRC) and the Energy Research and Development Agency (with the latter eventually becoming the

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From Integris Baptist Medical Center, 3300 NW Expressway, Oklahoma City, OK 73112 (J.H.); University of Iowa, Iowa City, IA 52242 (M.M.G.); Temple University, Philadelphia, PA 19140 (A.M.); St. Joseph Medical Center, Houston, TX 77002 (M.J.G.); Mallinckrodt Institute of Radiology, St. Louis, MO 63110 (T.R.M.); and Emory University, Atlanta, GA 30322 (K.V.). Received July, 2006; accepted Aug 10, 2006. Address correspondence to: J.H. e-mail: [email protected]

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Department of Energy). The latter was to promote the peaceful uses of nuclear energy. Title 10, Part 35 of the Code of Federal Regulations (CFR), including the medical uses of byproduct material, came into being. In 1959, the U.S. Congress permitted states, called agreement states, to have a regulatory role. The NRC has signed agreements with 34 states that set their own fees and perform a regulatory function. Several other states have applications pending for agreement state status. In most cases, agreement state regulations parallel the NRC, but in some cases, the agreement state training requirements are more stringent than those of the federal government. By one estimate, about 70% of the agreement states have more rigorous requirements than the NRC. The NRC regulates byproduct (reactor-produced) material as well as source and special nuclear materials, and the states regulate the rest of the medical uses of ionizing radiation. The NRC directly, or through agreement state agencies, licenses medical facilities that perform diagnostic and therapeutic procedures using radioisotopes. Individual health care providers who perform these procedures are not licensed but may apply to the NRC or the appropriate state agency to be listed on a facility’s license as “authorized users” (defined below). In 1974, the U.S.

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Food and Drug Administration (FDA) assumed responsibility for the licensing and regulation of radiopharmaceuticals. In 1979, the NRC assumed the authority to step in where necessary when it determined that there was a potentially hazardous situation. In 1987, the NRC set a somewhat arbitrary regulation that I-131 therapy patients could not be released from the hospital until they have less than 30 mCi in their bodies or were emitting less than 5 mrem per hour at 1 m. In 1997, however, as the result of studies showing only minimal exposure of individuals in the population with proper patient management and because of numerous complaints about this regulation, it was changed so that almost all patients treated with I-131 can now be treated as outpatients (2). As a result of a study of the regulatory role of the NRC by the influential National Academy of Sciences, a report was issued that the excessive regulation of byproduct materials had not reduced risk to the public compared to unregulated sources of radiation (3). This report also pointed out there was greatly more regulation for the medical uses of radiation than for chemotherapy and other treatments that were potentially more hazardous. The report proposed that the NRC’s regulatory authority be eliminated; however, the NRC rejected the conclusion of the report. In part as a response to such criticism, the NRC has undergone internal review of its regulatory role and proposed new regulations.

NEW NRC REGULATIONS Over the years, there have been several controversies regarding the amount of training an individual needs to use radiopharmaceuticals. This has been in part over concerns about safety to the public, medical specialty turf battles, and not sacrificing other training needs in a residency program because of the time spent in nuclear medicine. New regulations have been adopted by the NRC (4, 5), some of which are described below. Authorized Users “An authorized user is a licensed physician (medical or osteopathic), dentist or podiatrist who meets specific requirements, and is so identified on the license or permit. Other persons may work with byproduct material under the supervision of an authorized user” (6). Those who were identified as an authorized user before “April 29, 2005 need not comply with the new training requirements

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as long as they perform only those medical uses for which they were authorized on that date” (6). However, if one was board certified by an examining board with NRC-granted deemed status before the effective date of the new regulations but has not already applied and been granted authorized user (AU) status, no grandfathering for AU status is allowed and the individual must meet the new NRC training requirements. AU status is not required for a physician to interpret nuclear medicine studies or inject patients with radiopharmaceuticals, but there must be an AU on an office’s or institution’s NRC/agreement state license for each category of medical byproduct material. The supervising AU has legal and regulatory responsibilities. However, the functioning of the department can continue when an AU is temporarily absent or takes vacation. Radiation Safety Officers The radiation safety officer (RSO) must qualify in all areas of responsibility. There is a single RSO designation on a license, although there can be deputy RSOs as well, if needed to cover all areas of medical isotopic use. Previously certified RSOs will have their status grandfathered. However, there are now new RSO requirements that call for a preceptorship of 1 year and 200 hours of special instruction. There are some concerns that the new regulations may present difficulties for some rural institutions in procuring RSOs and may thus affect patient access to care. Nuclear Pharmacists New training regulations pertaining to nuclear pharmacists will not apply to those who were previously certified.

NRC REQUIREMENTS FOR ACHIEVING AU STATUS The only way one can become an AU is by making an application to the NRC or the appropriate agreement state agency, and having the NRC or its state agent approve the submitted credentials of the individual. Besides grandfathering for existing AUs, there are two separate pathways (at the time of the submission of this article) that can be followed to be eligible for an AU status. The first is through certification by specific specialty boards that have been approved by the NRC (a current list is posted on the NRC Website). The other is by an alternate educa-

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tional pathway, in which a candidate must complete a specified number of hours of didactic training and work experience under an authorized user. Specialty Board Certification Pathway Certification by an NRC-approved board serves as proof that an individual has successfully completed the necessary training to be eligible for AU status. However, this status is not automatic, and the individual must still present this certificate with other required information (a preceptor statement of competency) to the NRC or its state agent for approval. Effective in June 2006, the American Board of Radiology (ABR) was designated by the NRC as an approved specialty board for parts 35.290 (imaging and localization studies) and 35.392 (oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 GBq [ⱕ33 mCi]) of the new regulations (10 CFR, Part 35). Certification by the American Board of Nuclear Medicine (ABNM) is recognized by the NRC as evidence that a diplomate qualifies to be an authorized user under parts 35.190 (uptake, dilution, and excretion studies), 35.290, and 35.390 (uses of byproduct material for which written directive is required). A physician who is not certified by an NRC-approved specialty board may seek to become an AU using the alternative educational pathway. Alternate Educational Pathway To follow this pathway, an applicant must obtain a letter of attestation from an authorized user preceptor that states that “the individual has satisfactorily completed the requirements . . ., and has achieved a level of competency sufficient to function independently as an authorized user.” This means for 35.190 (training for uptake, dilution, and excretion studies) and 35.290 (training for imaging and localization studies), “700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training” are required. To be able to perform limited therapy of hyperthyroid patients, one can qualify under section 35.392 (training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 GBq [ⱕ33 mCi]). This requires 60 hours of classroom and laboratory training, along with “Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 GBq (ⱕ33 mCi) of sodium iodide I-131.” Generally, radiologists will not qualify for other applications of unsealed source therapy (radiolabeled monoclonal antibodies

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(Zevalin or Bexxar), palliation of bone metastases (phosphorus 32, strontium 89, samarium 153, etc . . .) under 35.390 (broad use of unsealed sources for therapy), which requires 200 classroom/laboratory hours applicable to these uses. In addition they will need to get a letter of attestation from an authorized user preceptor that states that “the individual has satisfactorily completed the requirements . . ., and has achieved a level of competency sufficient to function independently as an authorized user.” Under 35.396 radiation oncologist AUs must have 80 hours of didactic training and participate in three cases in order to administer Bexxar and Zevalin. The revised regulations define who can officially be considered to be a preceptor. NRC Form 313A is the necessary preceptor statement, and is currently being revised. The preceptor statement includes the word “competence.” That is causing some controversy as there is currently no accepted method for testing residents for their level of competency in safe handling and administration of radiopharmaceuticals. It may be useful for documentation of the required NRC curriculum for training programs to devise a check off list of various activities in the nuclear medicine department. Such a list could include performing a variety of skills such as performing a wipe test, eluting a generator, performing a variety of scans, etc. Alternatively, some think this may be overly prescriptive and not very flexible if regulations change in the future. It has been proposed that a model curriculum be produced for the NRC regulatory aspects for training programs to consider. In addition there must be an AU in each area of NRC regulation that is being preceptored. Multiple preceptors therefore are not only permitted but may be required in some programs. To be valid for first-time AU status recognition, the preceptor statement must have been obtained within 7 years after the completion of training or “the individual must have related continuing education and experience since the required training and experience was completed” (6).

ABR CERTIFICATION PROCESS The ABR certification process includes testing of every candidate’s knowledge of appropriate aspects of the NRC curriculum through both its written examinations (which address radiation biology, physics and instrumentation, and clinical aspects of radiology and nuclear medicine) and its oral examination. A portion of the oral examina-

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tion in nuclear radiology addresses NRC-related material on radioisotopic safety and handling. These questions are derived in part from the clinical image-related cases and in part from presentation of relevant “depictions of situations/scenarios.” The NRC has approved a plan proposed by the ABR to issue two types of certificates: (a) the traditional one and, (s) a new one that recognizes “AU eligible” status. An “AU eligible” designation on the certificate is only granted to those who have successfully completed the ABR examination process and whose training program directors have attested to the candidate’s successful completion of the NRC-mandated training (7). In order to obtain an “AU eligible” certificate, when applying to take the ABR examination, the candidates must include a form from their radiology training program director indicating that they have completed the required training. In addition, a second form signed by the appropriate authorized users indicating that the applicants have participated in three I-131 therapy cases must also be submitted. (NOTE: More than one resident can participate in a therapy case to get credit for each therapy. Although these cases are generally expected to consist of low-dose I-131 therapy for hyperthyroidism [ⱕ33 mCi], if a resident has participated in a high-dose therapy of I-131 [⬎33.0 mCi] in a thyroid cancer patient, the individual can get credit for one low-dose therapy if the resident needs that credit.) These forms are not the letter of attestation (NRC Form 313A) that the resident is competent. That comes later, when the resident applies to the NRC or its agreement state agent to become an authorized user in a specific state. It should be emphasized that the requirements to become an AU can vary in each agreement state. It is not necessary for all ABR oral examination candidates to have completed the 700 hours of training to sit for the exam. However, they will need 4 months of nuclear medicine clinical experience and must be knowledgeable in NRC-related radioisotope handling and safety issues. Those who want to be “AU eligible” must have documented completion of the 700 hours. All candidates, regardless of their training and intent to become or not become an AU, will be tested on the radiation safety and handling aspects of radioisotopes. It should be noted that it is not sufficient to merely sit in front of a viewbox or PACS reading station during the 4 months to satisfy the NRC’s clinical experience requirement. Rather, the individual needs to spend time in the nuclear medicine department and participate in daily quality control and radiation safety practices. However, provision of this training

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may be handled differently in each residency program to achieve the required results, and there are no universally accepted policies regarding time missed on nuclear medicine while post-call or sick. For these reasons, some residency programs may choose to require 20 weeks in nuclear medicine to insure residents can document the required 700 hours. In addition to formal rotations in nuclear medicine, there are inevitably other relevant educational opportunities during training that do not occur while the resident is officially on a nuclear medicine rotation and that are applicable to the required training. These may consist of lectures on related material or clinical and laboratory experience received while on duty at night and on weekends. In any case, regardless of how the necessary hours are achieved, there must to be an attestation statement by the radiology training program director to the ABR that ensures that each resident seeking an “AU eligible” ABR certificate has completed the NRC-required training for such status. CHANGES IN RESIDENCY REQUIREMENTS Diagnostic Radiology Residency Requirements In April 2006, the Radiology Residency Review Committee (RRC) recommended changes regarding the required training devoted to nuclear medicine in diagnostic radiology programs. As is true for all new program requirements, these must be approved by the ACGME before they are official. No significant objections to these proposals are expected. The Radiology RRC changes may be summarized as follows: 1. Each resident MUST have a minimum of 700 hours of training and experience in Nuclear Medicine under the direction of an authorized user. This can include the 80 hours of classroom and laboratory as noted below. 2. There must be at least 80 hours of didactic (classroom and laboratory training) components under the direction of an AU (authorized user) that address the following subjects: ● Diagnostic radiologic physics, instrumentation and radiation biology as related to nuclear medicine ● Patient and medical personnel safety ● The chemistry of byproduct material for medical use.

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Biologic and pharmacologic actions of materials administered in diagnostic and therapeutic procedures ● Safe handling, administration and quality control of radionuclide doses used in clinical medicine 3. The didactic instruction and work experience must also include ordering, receiving and unpacking radioactive material safely and performing the related radiation surveys; the safe elution and quality control (QC) of radionuclide generator systems; calculating, measuring and safely preparing patient dosages; 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; response to radiation spills and accidents (containment and decontamination procedures); radiation signage and related materials; using administrative controls to prevent medical events involving the use of unsealed byproduct material; administering doses to patients or human research subjects that includes at least three cases involving the oral administration of ⱕ33 mCi of sodium iodide I-131. Nuclear Medicine Residency Requirements The Nuclear Medicine Residency Review Committee recently changed the training requirements for nuclear medicine. Starting in July 2007, the program requirements for entering nuclear medicine residents will include 3 years of training in nuclear medicine if the individual only has completed an internship, 2 years of training if the individual has completed another patient care specialty such as surgery, medicine, or pediatrics, and 1 year if the individual has completed a residency in radiology. The previously established 4-year combined nuclear medicine and internal medicine program will continue. The new requirements also include additional experience in oncology and cross-sectional imaging, especially computed tomography.

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SUMMARY There have been significant recent changes in the nuclear medicine training requirements of the NRC and agreement states, the ABR and ABNM, as well as the Radiology and Nuclear Medicine Residency Review Committees and ACGME. In addition, the processes for converting this revised training into board certification and into official recognition of training completion and NRC AU status have undergone significant alteration. These changes have also caused consternation in many training programs with respect to how best to design, provide, and document the necessary curriculum and practical experience in nuclear medicine required by regulatory, accreditation, and certification entities. The need for decisions by diagnostic radiology training programs on whether or not to provide documentation of training and experience required for their trainees to become NRC AUs and for decisions by trainees themselves whether or not to seek AU status after receiving the appropriate training has added to this uncertainty at many levels. As with all change, as issues become decided and as experience with the new regulations and processes is garnered, comfort levels in these areas should be regained. REFERENCES 1. Siegel JA. Guide for Diagnostic Nuclear Medicine: Nuclear Regulatory Commission Regulation Of Nuclear Medicine. Society of Nuclear Medicine, 1850 Samuel Morse Drive, Reston, VA. 20190-5316, 2001, p 9. 2. Grigsby PW, Siegel BA, Baker S, Eichling JO. Radiation exposure from outpatient radioactive iodine (131I) therapy for thyroid carcinoma. JAMA 2000; 283:2272–2274. 3. Institute of Medicine. Radiation in Medicine. National Academies Press, National Academy of Sciences, 500 Fifth St. NW, Washington, DC 2001, January 1, 1996, ISBN 0309053862. 4. Foens CS, Fairobent LA, Guiberteau MJ. 10 CFR Part 35: Changes to the NRC rule governing the medical use of radioisotopes and implications for radiologic practice. J Am Coll Radiol 2006; 3:96 –101. 5. 10 CRF Part 35: Medical Use of Byproduct Material. Available at http:// www.nrc.gov/reading-rm/doc-collections/cfr/part035/. Accessed August 28, 2006. 6. Mettler FA, Guiberteau MJ. Essentials of Nuclear Medicine Imaging, 5th edition. Philadelphia, WB Saunders, 2006, p 430. 7. http://theabp.org

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