American College of Radiology opposes changes to radiation safety rules
The American College of Radiology is expressing opposition to recently proposed changes related to radiation safety in medicine.
Released by the Nuclear Regulatory Commission in July, the administration is seeking to replace the agency’s longstanding “as low as reasonably achievable” standard. Instead, the NRC would move to a new graded approach to radiation dose management, ACR noted in a news update published Thursday.
In one change of concern, the commission is proposing to have providers obtain written consent from patients who received radiopharmaceuticals or brachytherapy before they can be released from the hospital. ACR noted that this change would not be limited to administrations exceeding 5 mSv (0.5 rem) to the patient's caregiver.
“If finalized, such a proposal would create undue compliance and documentation burdens without a risk-based rationale,” ACR CEO Dana H. Smetherman, MD, MBA, MPH, wrote in comments submitted to the commission on Aug. 27. “This new burden would be in direct conflict with NRC’s stated goal of ensuring that existing compliance approaches would be interoperable with the proposed changes.”
In the proposed rule, the NRC said this change would remove the requirement to keep records of dose evaluations for individual releases that meet certain criteria. Instead, providers would need to develop, implement and maintain a written procedure to ensure patients are not likely to exceed established radiation limits. ACR is urging the commission, instead, to limit written consent to to be released from the hospital to scenarios where the radiation dose to a caregiver from the patient was expected to exceed 5 mSv (0.5 rem).
The college also is urging the administration to clarify that consent can be obtained at any time before or after administration, through any mechanism. This could be through the patient portal or electronic check-in process. ACR is concerned that, absent these changes, providers could face situations where patients meet the release criteria but have not yet completed their paperwork.
“In many healthcare settings, unplanned hospitalization/holding for this administrative purpose would be operationally impracticable and create unnecessary burdens, including negative financial impact on the already strained inpatient infrastructure, without providing radiation safety benefits,” Smetherman wrote.
ACR also is concerned the changes do not address situations where a patient or their caregiver might withdraw consent after the treatment has been administered. In this case, the college is recommending that the NRC allow facilities to establish internal process for addressing withdrawn consent.
The college additionally opposes proposed changes, moving from a “per release” to a “per patient administration regimen” framework for evaluating doses to caregivers and patients. Treatment regimens can be modified based on patient response, disease progression or other factors. However, the proposed rule does not clearly address whether such modifications would remain part of the original administration regimen or constitute a new one for purposes of compliance with the revised release criteria.
“This ambiguity would create uncertainty for licensees and unnecessarily complicate patient release determinations,” Smetherman wrote. “Moreover, implementation of a ‘per administration regimen’-based regulatory compliance approach applied to noncaregiver members of the public would require substantial changes to existing workflows, documentation systems and compliance processes and could influence treatment decisions for reasons unrelated to radiation safety or optimal care delivery,” she added later.
ACR is not alone, with others including the New Mexico attorney general also expressing concern with the proposed changes. The college noted that this is part of the NRC’s broader effort to revise regulations to meet the requirements of the 2025 NRC reform executive order.
Read the rest of ACR’s full comments here.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.