NRC Specifies Classroom and Laboratory Training Hours for Alternative Pathwa

Under the final rule, NRC will now specify the minimum number of classroom and laboratory training (CLT) hours that medical users of byproduct material will have to perform through the alternate pathway to be approved as an authorized user. The regulation also discusses issues surrounding: training under the certification pathway; definition of "laboratory training;" and grandfathering criteria.

Minimum Classroom and Laboratory Training Requirements

The NRC will continue to mandate a minimum of 700 hours of training and experience for authorized users under section 35.290 (diagnostic) and 35.390 (therapeutic). However, the commission now specifies that authorized users (35.290) must include 80 hours of classroom and laboratory training among their 700 hours of training and experience. Authorized users (35.390) will be required to complete 200 hours of CLT.

Under its reasons for adopting 80 hours for 35.290, NRC believes that the complexity and level of knowledge required is less than for uses under 35.390 and that the frequency of use of byproduct material should not be considered in evaluating the risk to individuals from uses of byproduct material under 35.290 (Page 16344). Requirements for radiation safety officers (RSO), authorized medical physicists (AMP), authorized nuclear pharmacists (ANP) are outlined on pages 16361-16363.

Also of note, work experience for authorized users in 35.190, 35.290 and 35.390 has been changed to require experience with quality control check of instruments rather than with calibrating instruments. In addition to instrument calibration, quality control procedures commonly include checks of parameters such as linearity, constancy and functionality, including battery checks. (Page 16340)

Clarification of the Definition of "Laboratory Training"

In response to calls for more clarity regarding the definition of "laboratory training," NRC stated that the commission "expects that clinical laboratory hours that will be credited toward meeting the requirements for classroom and laboratory training in Subparts B and D through H will involve training in radiation safety aspects of the medical use of byproduct material. The NRC recognizes, for example, that physicians in training may not dedicate all of their clinical laboratory time specifically to the subject areas covered in these subparts and will be attending to other clinical matters involving the medical use of material under the supervision of an AU (e.g., reviewing case histories or interpreting scans). "

"However, those hours spent on other duties, not related to radiation safety, should not be counted toward the minimum number of hours of required classroom and laboratory training in radiation safety. This type of supervised work experience, even though not specifically required by the NRC, may be counted toward the supervised work experience to obtain the total hours of training (e.g., 700 hours for 35.390). Similarly, the NRC recognizes that clinicians will not dedicate all of their time in training specifically to the subject areas described in Subparts D through H and will be attending to other clinical matters. The NRC will broadly interpret "classroom training" to include various types of instruction received by candidates for approval, including online training, as long as the subject matter relates to radiation safety and safe handling of byproduct material." (Page 16349)

Impact on the Certification Pathway

While NRC has now included a minimum number of hours for CLT, the commission did not add minimum hours to the requirements for recognition of specialty board certifications. In making this decision, NRC states that it is important to provide flexible options for boards to evaluate the adequacy of training and education related to radiation safety. (Page 16343)

Grandfathering Criteria

Finally, of critical note, the commission will grandfather those individuals who have already met NRC or their respective Agreement State licensure requirements. For specific information regarding who would qualify under the new regulations, please see page 16363.

Implementation Date for Agreement States

Under the final rule, Agreement States will be given an additional three years to conform to the "new" NRC requirements. In making this decision, the commission "determined that three years will be allowed for adoption of the Compatibility B final rule to avoid transboundary issues relating to differing standards between states." In addition, the commission believed that because legislative action in some states may be required to adopt the final rule, states should be afforded adequate time to allow for the legislative process, which in some cases can take up to two years. (Page 16354) For a list of both NRC and Agreement States, please consult www.hsrd.ornl.gov/nrc/.

In Agreement states physicians must apply to the appropriate state office for the authorized user license. For a list of the appropriate state officials, please consult www.hsrd.ornl.gov/nrc/asdirectr.htm. Under the new 10 CFR Part 35 the training and experience requirements for diagnostic authorized users in the Agreement states must be "essentially identical" to the NRC requirements. However, Agreement States will now have an additional three years from the implementation date of the final rule (April 29, 2005) to comply with the new compatibility requirement. By April 29, 2008 all agreement states must have training and experience requirements that are "essentially identical" to the NRC standards.

The American Society of Nuclear Cardiology will be working with the agreement states through the mechanism of the Organization of Agreement States to get as many of these 32 states to comply with the new national standards as quickly as possible. The process will vary from state to state depending on whether the state has an Administrative Procedures Act that allows independent agencies to promulgate rules without legislative approval. In some states every new rule must be approved by the legislature, a process that will lengthen the time of compliance.

Changes to the Certification Pathway & Implications for CBNC

The final rule provides more latitude, through establishing less prescriptive criteria under the certification pathway, so that more boards will be able to meet the revised requirements for recognition by the NRC. Once such change eliminates the requirement that boards must have candidates for certification obtain a preceptor attestation as a condition for NRC recognition of certifications. However, the NRC will still require individuals to obtain preceptor attestations and submit them to the commission.

Under the final rule, the Certification Board of Nuclear Cardiology (CBNC) will have to reapply for NRC recognition. In making this decision, the NRC states that, "because of the importance of board certification to establishing the adequacy of training and experience for individuals to serve as RSO, AMPs, ANPs and AUs, a clear regulatory determination must be made that all boards, both new and existing, meet the relevant regulatory criteria. Evaluation of board requirements against revised criteria in the final rule is necessary to make this determination. The NRC notes that, via separate rulemaking, the expiration of Subpart J was extended for 1 year to October 24, 2005 (69 FR 55736, September 16, 2004); this will provide time for boards to apply for recognition under the revised regulation in the final rule. During this period, the NRC will continue to recognize the certifications of boards, including the CBNC's, which are recognized under current regulations." (Pages 16347-16348)

Definition of "Preceptor" Modified

The definition of "preceptor" is modified by NRC by eliminating the word "the" from the phrase "the training and experience" to help clarify that more than one individual may serve as a preceptor. In addition, this new definition will permit verification by a preceptor of required training and/or experience obtained previously or elsewhere. (Page 16347)