Professional Documents
Culture Documents
Processes for credentialing physicians and criteria used for delineating their practice-specific clinical privileges
vary widely across the United States. The ACR and the ABR have jointly developed this resource document to
define the requisite credentials for specialty board-certified diagnostic radiologists and subspecialty board-
certified nuclear radiologists to be privileged to practice therapeutic nuclear medicine. Through its initial
specialty and subspecialty certification processes and its maintenance of certification programs for practicing
certificate holders, the ABR assures the competence of its professional diplomates for clinical practice. On the
basis of their education, training, and clinical work experience, board-certified radiologists have the qualifica-
tions to supervise and perform therapies using unsealed radioisotopes. Optimum patient care is best served by
a physician with training and expertise in supervising and performing radioisotope therapies in conjunction
with multimodality imaging technologies for initial diagnosis and follow-up.
Key Words: ACR, ABR, credentialing, privileging, radioisotope therapy, diagnostic radiologists, nuclear
radiologists, nuclear medicine
J Am Coll Radiol 2013;10:774-780. Copyright © 2013 American College of Radiology
knowledge base receive initial certification in DR by the §35.394: Training for the oral administration of so-
ABR [6]; those who complete additional training in NM dium iodide I-131 requiring a written directive in
may obtain further certification by the ABR in NR [7]. quantities greater than 1.22 gigabecquerels (33
ABR-certified DRs and NRs have received the requisite mCi) [10].
education, have demonstrated their capabilities, and are §35.396: Training for the parenteral administration
well prepared to provide a high standard of patient care. of unsealed by-product material requiring a written
Their expertise enables a comprehensive assessment of directive [11].
patients in need of radiopharmaceutical treatments, in-
cluding adjunctive clinical evaluation and the multimo- A written directive is essentially a prescription that
dality diagnostic imaging that generally precedes and contains certain elements and which must be signed and
often follows therapeutic intervention. Moreover, their dated by an NRC-approved physician, referred to as an
solid foundation in radioisotopes and radiopharmaceuti- AU, before the administration of the unsealed radioiso-
cals, radiation physics and safety, dosimetry, and radio- tope. To become an AU, a physician must either (1) have
biology positions them well to serve a critical role in completed specified training and experience and have a
multidisciplinary clinical paradigms. In addition, radiol- written attestation of such training from a preceptor who
ogists, who obtain ABR certification in DR and also is an NRC AU, or (2) be board certified by an approved
successfully complete an examination covering the re- medical specialty board, such as the ABR. A physician
quired NRC radioisotope safety curriculum, qualify to may be authorized to perform all of the treatments under
become recognized on hospital and facility radioactive 10 CFR 35.390, or may be qualified for specific therapies
materials licenses as authorized users (AU) of radioiso- addressed in individual subsections.
topes. In the United States, only such AUs are qualified The first 2 subsections (§35.392 and §35.394) regulate
to write prescriptions for the radiopharmaceuticals the most widely employed radioisotope therapy, namely,
needed for patient therapies. the oral administration of I-131 sodium iodide in 2 levels of
activity, often referred to as “low-dose” and “high-dose” for
QUALIFICATIONS OF RADIOLOGISTS WHO
treatment of hyperthyroidism and thyroid cancer, respec-
SUPERVISE AND PERFORM THERAPEUTIC
tively. The third subsection (§35.396) regulates additional
NUCLEAR MEDICINE
radioisotope therapies, and includes the parenteral admin-
istration of any beta emitter, any photon-emitting radioiso-
Nuclear Regulatory Commission Training tope with a photon energy less than 150 kiloelectron volt
Requirements (keV), and/or parenteral administration of any other radio-
Under the Atomic Energy Act of 1954, as amended in isotope requiring a written directive. The following para-
NUREG-0980 and the Energy Reorganization Act of graphs address the subsections of the NRC regulations to
1974, the United States government has authorized the give a more detailed and complete understanding of NRC
NRC to govern the medical use of by-product material. requirements.
The NRC regulations, including training and experience
requirements for the safe use of radioisotopes, are codi- §35.392 [9]. This subsection of the rule directs the use
fied in the Code of Federal Regulations, 10 CFR Part 35. of I-131 sodium iodide for the treatment of hyperthy-
The NRC provides oversight for compliance with these roidism. Authority to perform this level of therapy re-
regulations in some states. However, it also has an agree- quires 700 hours of training and work experience under
ment program that allows individual states to assume the the supervision of an AU and must involve ordering,
regulatory authority to license and regulate by-product receiving, and unpacking radioactive materials safely and
materials within their borders. For all practical purposes, performing the related radiation surveys; performing
state requirements should be virtually identical to those quality control procedures on instruments used to deter-
of the NRC; therefore, this document refers only to mine the activity of dosages and performing checks for
NRC regulations. proper operation of survey meters; calculating, measur-
The NRC stipulates the training and experience re- ing, and safely preparing patient or human research sub-
quirements for the use of unsealed by-product material ject dosages; using administrative controls to prevent a
for which a written directive is required under 10 CFR medical event involving the use of by-product material;
35, Subsection E. The applicable regulations are: using procedures to contain spilled by-product material
safely and using proper decontamination procedures;
§35.390: Training for use of unsealed by-product ma- plus a minimum of 80 hours of classroom and laboratory
terial for which a written directive is required [8] instruction applicable to the medical use of I-131 sodium
and its subsections: iodide, including radiation physics and instrumentation;
§35.392: Training for the oral administration of so- radiation protection; mathematics pertaining to the use
dium iodide I-131 requiring a written directive in and measurement of radioactivity; chemistry of by-prod-
quantities less than or equal to 1.22 gigabecquerels uct material for medical use; and radiation biology; plus
(33 millicuries [mCi]) [9]. personal experience involving the oral administration of
776 Journal of the American College of Radiology/ Vol. 10 No. 10 October 2013
I-131 sodium iodide in an amount less than or equal to icine, or any combination of these specialties, including a
1.22 gigabecquerels (33 mCi) to a minimum of 3 pa- transitional year.
tients or human research subjects. To qualify for AU During the 4 years of DR residency, a trainee must
status, the physician must be certified by a medical spe- complete a minimum of 4 months of clinical training in
cialty board whose certification process includes each of NM, which must include therapeutic applications [2].
these requirements, and must present written attestation New program requirements go into effect on July 1,
of satisfactory completion of these requirements and 2013 [4]. In terms of hours of training, residents will
achievement of a level of competency sufficient to func- continue to complete the NRC-specified requirements to
tion independently as an AU for medical uses. become AU-eligible:
§35.394 [10]. This subsection directs the use of I-131 IV.A.6.b) a minimum of 700 hours (approximately 4
sodium iodide for the ablation of residual thyroid tissue months) of training and experience in clinical nu-
after thyroidectomy for thyroid cancer, or treatment of clear medicine, which may include the required 80
regional or distant functioning metastases. The require- hours of classroom and laboratory instruction; and
ments are essentially the same as for §35.392, with the
exception of personal experience involving the oral ad- IV.A.6.d) at least 80 hours of didactic (classroom and labo-
ministration of I-131 sodium iodide in an amount greater ratory training) training under the direction of an AU.
than 1.22 gigabecquerels (33 mCi) to a minimum of 3 DR residents must continue to learn:
patients or human research subjects.
IV.A.3.b).(1).(c).(i).(c) the chemistry of by-product
§35.396 [11]. This part of the rule addresses the use of material for medical use;
various therapeutic radiopharmaceuticals administered IV.A.3.b).(1).(c).(i).(d) biologic and pharmacologic
parenterally. Although not specifically named in the reg- actions of materials administered in diagnostic and
ulation, examples of therapies covered by this subsection therapeutic procedures; and
currently include I-131 tositumomab (Bexxar), Sm-153
samarium lexidronam (Quadramet), Sr-89 strontium IV.A.3.b).(1).(c).(i).(e) topics in safe handling, ad-
chloride (Metastron), and Y-90 yttrium ibritumomab ministration, and quality control of radionuclide
tiuxetan (Zevalin). One notable difference from §35.392 doses used in clinical medicine.
and §35.394 is that the work experience and the class- Their didactic instruction (or work experience) will
room and laboratory training must be applicable to continue to include the following:
parenteral administrations of any beta emitter, any
photon-emitting radioisotope with a photon energy less IV.A.3.b).(1).(c).(ii) ordering, receiving, and unpacking
than 150 keV, and/or parenteral administration of any radioactive material safely, and performing the related
other radioisotope for which a written directive is re- radiation surveys; the safe elution and quality control
quired. Personal experience involving the administration of radioisotope generator systems; calculating, mea-
of these applicable radiopharmaceuticals to at least 3 suring, and safely preparing patient dosages; calibra-
patients or human research subjects is required. tion and quality control of survey meters and dose
calibrators; safe handling and administration of ther-
Graduate Medical Education and Training
apeutic doses of unsealed radioisotope sources (ie,
Pathways
I-131); written directives; response to radiation spills
DR: Specialty Training. Diagnostic Radiology is a and accidents (containment and decontamination
4-year residency program approved by the ACGME. As procedures); radiation signage and related materials;
defined by the ACGME, using administrative controls to prevent medical
Diagnostic radiology encompasses a variety of diagnostic and image-
events involving the use of unsealed byproduct mate-
guided therapeutic techniques, including all aspects of image-based rial. Observation alone is not sufficient.
diagnosis (radiography, nuclear radiology, diagnostic ultrasound,
magnetic resonance, computed tomography, interventional proce-
With regard to therapies, residents currently “must
dures, and molecular imaging). The residency program in diagnostic participate in at least 3 therapies involving oral adminis-
radiology shall offer a quality graduate medical educational experience tration of I-131 [2].” The new program requirements [4]
in all of these associated disciplines [2,4]. specify not only the minimum number of cases, but also
the specific levels of administered radioiodine activity,
Before entering DR residencies, a preparatory clinical and the associated processes:
post-graduate year is required. However, some DR resi-
dencies may integrate these 12 months of additional clin- IV.A.5.a).(2).(a) Residents must perform under pre-
ical training into the residency. Regardless, this ceptor supervision at least 3 therapies involving oral
accredited clinical training must be in internal medicine, administration of I-131 in quantities less than or
pediatrics, surgery or surgical specialties, obstetrics and equal to 33 mCi and at least 3 therapies in quanti-
gynecology, neurology, family practice, emergency med- ties greater than 33 mCi; and
Brown et al/ACR/ABR Clinical Statement on Credentialing and Privileging of Radiologists for Therapeutic Nuclear Medicine 777
Table 1. Therapeutic Nuclear Medicine in Diagnostic Radiology Residency Programs: Alignment of NRC, ACGME
and ABR
Part 35 Minimum Number Administered Route of
Subsection of Cases Activity (mCi) Radiopharmaceutical Administration
§35.392 3 ⱕ33 I-131 NaI oral
§35.394 3 ⬎33 I-131 NaI oral
NRC ⫽ Nuclear Regulatory Commission; mCi ⫽ millicuries.
IV.A.5.a).(2).(a).(i) Residents must participate in pa- uniformly in the ACGME program requirements for different spe-
tient selection, informed consent, understanding cialties . . . . The purpose of this document is to recommend the
minimum training requirements for therapeutic procedures using
and calculating the administered dose, counseling
radiopharmaceuticals. These requirements should be uniform across
of patients and their families on radiation safety ACGME specialty training requirements. This training must include
issues and patient follow up. independently evaluating and treating, under supervision, a mini-
mum of 10 cases of radioiodine therapy for hyperthyroidism, a min-
Thus, on the basis of their training, DRs have been
imum of 5 cases of radioiodine therapy for thyroid carcinoma, and a
and will continue to be qualified to supervise and per- minimum of 3 cases of parenteral radioisotope therapy. Less training
form patient treatments using oral I-131 sodium iodide. and experience is inadequate to ensure the safety, appropriateness, and
As of July 1, 2013, the ACGME program requirements effectiveness of radioisotope therapy.
will align with the ABR’s existing requirements for DR
trainees, which specify training in accordance with NRC In 2012, Delbeke et al [13] reinforced that there con-
regulations appropriate to recognition of the ABR’s DR tinued to be “a significant difference between nuclear
Certificate with AU Eligibility under the NRC’s specialty medicine and nuclear radiology [in] the amount of train-
board recognition program (Table 1). ing required for therapy with radiopharmaceuticals as
NR/NM: Subspecialty Training. As defined by the described in [the above referenced] conjoint statement
ACGME, on credentialing and delineation of privileges for thera-
peutic procedures using radiopharmaceuticals.”
Nuclear radiology is a clinical subspecialty of radiology involving the With the October 2012 approved revisions to the pro-
diagnostic and therapeutic use of radioactive materials using unsealed
sources. Radiologists select, interpret, and perform procedures, in- gram requirements for NR [5], these concerning differ-
cluding diagnostic imaging by external detection of radioisotopes, ences with regard to radioisotope therapies have been
diagnostic in vivo or combination in vivo/in vitro procedures that eliminated. Moreover, the mutually agreed upon desired
involve the administration and detection of radioactivity by non- harmonization across the NR and NM training programs
imaging means, and therapeutic administration of radioisotopes. . . .
The educational program in nuclear radiology must be 12 months in outlined in the consensus ACR/Society of Nuclear Med-
length. . . . Diagnostic radiology subspecialty fellowship programs are icine Task Force I Report will be achieved; that is, “har-
designed to develop advanced knowledge and skills in a specific clin- monizing or even equalizing the curricula for the Nuclear
ical area [5]. Radiology Fellowship with the 1-year NM residency
available to physicians who are board certified in DR is
Should they choose, physicians who successfully com-
desirable [14,15].” The new program requirements be-
plete DR residencies may obtain additional training in
NR or NM through either of 2 one-year ACGME-ap- came effective on July 1, 2013 and will assure that NRs
proved training pathways available to radiologists: (1) a are equipped to meet the highest standards and safe-
NR fellowship, or (2) a NM residency. Both pathways guards in providing all radioisotope therapies.
provide advanced training in therapeutic NM and both With the revisions to the NR program requirements [5],
fulfill the ABR’s training requirements to qualify for physicians who follow the DR-NR pathway will be offered
ABR subspecialty certification in NR. Acceptance into learning opportunities related to radioisotope therapies
fellowship training in NR requires current or past enroll- equivalent to those in NM programs [16]; the graduates will
ment in an ABR-approved DR program; therefore, most have an equal foundation of knowledge, skills, and experi-
NR trainees have already started or may have even com- ence. Specifically, the new trainees
pleted the steps to AU-eligible status to perform unsealed
IV.A.2.a).(2).(b) must participate in therapeutic ad-
radiopharmaceutical therapy by virtue of their ABR re-
quired training and experience. ministration of radiopharmaceuticals, including
In 2011, a conjoint Society of Nuclear Medicine/ patient selection, informed consent, understanding
American College of Nuclear Medicine/American Board and calculating of the administered dose, counsel-
of Nuclear Medicine position paper [12] noted, ing of patients and their families on radiation safety
issues, and patient follow up after therapy; and
The training requirements for the supervision and administration of
therapeutic procedures using radiopharmaceuticals are not defined they must provide
778 Journal of the American College of Radiology/ Vol. 10 No. 10 October 2013
Table 2. Therapeutic Nuclear Medicine in Nuclear Radiology Programs: Alignment of NRC, ACGME and ABR
Part 35 Minimum Number Administered Route of
Subsection of Cases Activity (mCi) Radiopharmaceutical Administration
§35.392 10 ⱕ33 I-131 NaI oral
§35.394 5 ⬎33 I-131 NaI oral
§35.396 5 any beta emitters or those with parenteral
photons ⬍ 150 keV
NRC ⫽ Nuclear Regulatory Commission; mCi ⫽ millicuries.
high-dose (⬎33 mCi) I-131 sodium iodide oral thera- in an institution with an ACGME-approved NR fellowship
pies. The ABR requires documentation by both the pro- or NM residency as another pathway to ABR subspecialty
gram director and qualified AU that the candidate has certificate eligibility in NR.
successfully completed this training. Specifically, as pre- Currently, the ABR conducts oral examinations to
scribed by the NRC and the ACGME, each candidate for ascertain the qualifications of DRs who have studied NR.
AU status through the ABR pathway must have com- In the near future, this examination will be transitioned
pleted a minimum of 700 hours of training and experi- to a computer-based format while maintaining compre-
ence in imaging and localization studies, and 80 hours of hensive content. “A board-certified nuclear radiologist is
classroom and laboratory training in basic radioisotope one who has demonstrated knowledge, problem-solving,
handling techniques applicable to the medical use of and application of those skills to a degree worthy of the
unsealed byproduct material for imaging and localization public’s and the profession’s trust. This is someone
studies as well as the use of I-131 sodium iodide for deemed capable of working in various sectors of the field
procedures requiring a written directive. safely and effectively.” [7]
The ABR website is an extensive resource for candi-
dates and the residency programs to use in reference to MAINTENANCE OF CERTIFICATION
seeking AU-eligibility for the medical use of radioiso- PATHWAYS
topes for diagnostic and therapeutic uses through the The ABR maintenance of certification program for spe-
ABR certification process [6,17-20]. The ABR require- cialty [20] and subspecialty [21] diplomates includes
ments are aligned with the NRC requirements and the continuing medical education, self-assessment modules,
revised diagnostic radiology program requirements, ef- and practice quality improvement requirements tailored
fective July 1, 2013 (Table 1). The ABR endeavors to to a diplomate’s specific clinical practice, including NM
ensure safe and effective use of radioisotopes by board- therapy using unsealed radioisotope sources. As the ap-
certified radiologists. The ABR believes that these items plications, technologies, and methodologies of the radio-
are important components of a responsible education for logical and therapeutic armamentaria continue to
radiologists and contribute to the safety of medical prac- expand and develop, the ABR understands that lifelong
tice in ways that are broadly supported by organized learning is critical to ensure that new information and
medicine, regulators and the public. knowledge are incorporated into clinical practice to
NR: Subspecialty Certification. Nuclear radiology is a maintain the essentials of quality patient care.
subspecialty of DR that encompasses the use of radio-
pharmaceuticals for dynamic and static imaging of ACR PRACTICE GUIDELINES
pathophysiologic processes and the treatment of a spec- For DRs, including those practicing NM, to achieve
trum of benign and malignant diseases [7]. The ABR consistency in the therapeutic use of unsealed radiophar-
offers radiologists who have achieved certification in DR maceuticals, they need to become familiar with the ACR
the opportunity to achieve further subspecialty certifica- practice guidelines. These are important educational
tion in NR after an additional year of ACGME-approved tools designed to assist practitioners in providing effec-
NR fellowship or NM residency [7]. In the realm of tive, high-quality clinical care. The ACR has developed a
therapeutic NM practice, NR prerequisite training in- collaborative clinical guideline with the American Soci-
cludes oral radioiodine therapies under 10 CFR 35.392 ety for Therapeutic Radiology and Oncology addressing
[9] and 10 CFR 35.394 [10] and, concordant with the the performance of therapy with unsealed radiopharma-
NRC regulations and revised ACGME program require- ceutical sources [22]. Developed from literature review,
ments, parenteral therapies under §35.396 [11] (Table expert opinion, open commentary, and consensus, this
2). The virtual equivalency of training between the NM Practice Guideline outlines recommended conduct in
residency and NR training requirements, accomplished this specific domain of clinical practice.
by recent approval of the revised NR Fellowship Program Through training and lifelong work experience, radi-
Requirements by the ACGME in September 2012 (ef- ologists practicing NM, including radiopharmaceutical
fective beginning July 1, 2013), should lead inevitably to therapies, are able to assist referring physicians in select-
future equivalency of NRC recognition in therapeutic ing and delivering the most clinically appropriate thera-
uses of radioisotopes of both ABR (NR) and American peutic strategy to meet a particular patient’s needs.
Board of Nuclear Medicine (NM) certification processes.
With the recent change to a 36-month core curriculum SPECIALTY AND SUBSPECIALTY PRACTICE
in DR residencies and the increase in permissible months of OF RADIOISOTOPE THERAPY
training in a particular subspecialty from 12 to 16 months On the basis of their education and training pathways,
within a 4-year (48-month) program, the opportunity for initial board certification(s) and maintenance of certifi-
significant additional NM training in DR residencies has cation(s), and NRC AU status, DRs’ participation in
become possible. With this in mind, in 2010, the ABR unsealed source therapies usually follows 1 of 3 common
approved 16 months of NM training within a DR residency practice paradigms:
780 Journal of the American College of Radiology/ Vol. 10 No. 10 October 2013
● Radiologists who are ABR-certified in DR, but do not 8. Nuclear Regulatory Commission. Part 35. Medical Use of Byproduct
Material. Subpart E, Unsealed Byproduct Material – Written Directive
hold AU status: These physicians may participate in Required. 35.390 Training for use of unsealed byproduct material for
the practice of therapy with unsealed radiopharmaceu- which a written directive is required. Available at: http://www.nrc.gov/
ticals under the supervision of an AU of therapeutic reading-rm/doc-collections/cfr/part035/part035-0390.html. Accessed
October 20, 2012.
radioisotopes. Although they may not issue written
directives for the necessary radiopharmaceuticals, they 9. Nuclear Regulatory Commission. Part 35. Medical Use of Byproduct
Material. Subpart E, Unsealed Byproduct Material – Written Directive
may administer such a dose as designated by an AU. Required. 35.392 Training for the oral administration of sodium iodide
● Radiologists who are ABR-certified in DR and hold I-131 requiring a written directive in quantities less than or equal to 1.22
AU status based on that certification: These physicians gigabecquerels (33 millicuries). Available at: http://www.nrc.gov/reading-
rm/doc-collections/cfr/part035/part035-0392.html. Accessed October 20, 2012.
may practice radioisotope therapy consisting of oral
10. Nuclear Regulatory Commission. Part 35. Medical Use of Byproduct
radioiodine at all dosage levels under their own AU Material. Subpart E, Unsealed Byproduct Material –Written Directive
qualifications. Required. 35.394 Training for the oral administration of sodium iodide
● Radiologists who are ABR-certified in DR, with or I-131 requiring a written directive in quantities greater than 1.22 gigabec-
querels (33 millicuries). Available at: http://www.nrc.gov/reading-
without ABR certification in NR, and hold the appro- rm/doc-collections/cfr/part035/part035-0394.html. Accessed October
priate AU statuses: These physicians may practice as 20, 2012.
complete a gamut of oral and parenteral therapeutic 11. Nuclear Regulatory Commission. Part 35. Medical Use of Byproduct
NM as permitted by their own specific training leading Material. Subpart E, Unsealed Byproduct Material –Written Directive
Required. 35.396 Training for the parenteral administration of unsealed
to such AU statuses. byproduct material requiring a written directive. Available at:
http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-
It is recognized that local practice and individual radi- 0396.html. Accessed October 20, 2012.
ologist qualification variations and regulatory require- 12. Delbeke D, Graham MG, Royal H, Segall G, Shulkin BL, Ziessman HA.
ments may, of necessity, dictate site-specific practice Conjoint statement of the SNM, ACNM and ABNM on credentialing
patterns, and radiologists may best participate in practice and delineation of privileges for therapeutic procedures using radiophar-
according to their special interests and qualifications. maceuticals. J Nucl Med 2011;52:323-6.
13. Delbeke D, Royal HD, Frey KA, Graham MM, Segall GM. SNMMI/
ABNM joint position statement on optimizing training in nuclear med-
icine in the era of hybrid imaging. J Nucl Med 2012;53(9):1490-4.
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