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Radiation in Medicine: A Need for Regulatory Reform
Question 2a (N = 21)
How does the current regulatory framework—as it applies to ionizing radiation in medicine—affect the practice of medicine?
In response to this question we received 21 replies: 16 from professional associations, societies, and industry; 3 from states; and 2 from miscellaneous sources. Although there was no singular answer to this question, there seemed to be widespread agreement that the current regulatory structure was, as one association explained, "very expensive, time-consuming and inhibitory" (ABNM). As one commentator explained, "By burdening health care providers with excessive regulation and diverting the time and efforts to highly compensated professionals and technical personnel from patient care to regulatory compliance, health care costs escalate and the delivery of care is impeded" (NYH-CMC). Others asserted that various prescriptive regulations deprived physicians of the flexibility and judgment that they needed to optimize their practice. Another observation was that high licensing fees might inadvertently drive people out of the nuclear medicine business. A commentator from the Illinois Department of Nuclear Safety declared: "Clarification of jurisdictional boundaries and reciprocal recognition of authority between agencies would be a good start in eliminating duplicative paperwork requirements. This would allow medical professionals more time to practice medicine."
Question 2b (N = 30)
What is your opinion of the revised quality management rule for misadministrations and the new reporting requirements? How would you change it? What suggestions would you make regarding tracking/preventing misadministrations? Are the NRC's definitions of misadministrations on target?
In response to this question we received 20 replies: 11 from professional associations, societies, and industry and professional societies; 6 from states; and 3 from miscellaneous sources. In contrast to question 2a, for which there appeared to be a consensus regarding possible overregulation, answers to question 2b revealed a considerable divergence of views. Whereas many respondents expressed a favorable view of the new QM rule and reporting requirements, others were not nearly so sanguine. A similar difference of opinion was generated in response to the question regarding the new definition of misadministration.
Some of the more notable comments were as follows: "The 'new' rules for reporting have downplayed the importance of any errors except those involving iodine and therapy. The result has been to create a 'doesn't matter' atmosphere that leads to a lack of concern for care in other areas of operation" (AANC). "The problem is not in the rule, but the way NRC is enforcing it" (AAPM). "The revision to the quality management rule made the rule a little more palatable but not necessarily acceptable nor necessary. … The approach used by the NRC with its quality management and inspection program is overly prescriptive and