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Radiation in Medicine: A Need for Regulatory Reform
minimal regulations to protect the welfare of the public" (ARRS). "We believe that model QA programs should be developed by professional associations" (ASRT). "The Boards of Medicine and the professional associations, with input solicited from the appropriate state and federal agencies, should bear ultimate responsibility for devising the appropriate quality assurance program" (CORAR). "The responsibility for the development and implementation of quality assurance programs must lie with professional organizations" (HPS). "The ultimate responsibility belongs with the specialty societies. … Federal agencies should adapt these programs when the ultimate authority must reside with government" (RSNA).
As stated above, not all respondents agreed that professional associations were suited to this task, however. NEMA asserted: "We believe a federal agency, or state agencies in agreement with the federal agency, should bear this responsibility. However, in the course of its development, the federal agency in question should rely heavily upon the input from professional associations." NEMA continued: "Professional organizations cannot enforce, therefore they do not fit these [i.e., the need to assure an effective QMP] criteria." This view was reiterated by the Florida Department of Health and Rehabilitative Services: "The state agency must use its own resources as well as those of federal and professional agencies an institutions to field and adequate control program which included a quality assurance/management component."
Question 8 (N = 15)
If applicable, what kind of QA program do you have in place? Upon whose expertise did you rely when devising it? How is it working?
In response to this question we received 15 replies: 14 from professional associations, societies, and industry; and 1 from miscellaneous sources. All 15 respondents acknowledged having a QM program in place. Most stated that their programs were based on a combination of sources including model professional guidelines, JCAHO, in-house expertise, and various state and federal requirements. "We have a continuous QA improvement program patterned on the requirements of JCAHO. We developed it using our in-house expertise" (AAPM). "Most programs have QA programs in place that embody the essential components for the current NRC QM rule. … Expertise used to devise is quite varied and includes internal staff, medical radiation physicists, quality improvement/management personnel, etc." (ABNM). "Our programs are based on several documents and protocols written and published by the AAPM, ACMP, ACR, and ASTRO. The program was devised by the medical physics division and with input from the staff physicians. The person-hours and the required paper work to maintain a good QA/QMP program have certainly increased. We have not seen any noticeable benefit to the patent, staff or members of the general public in terms of reduced risk" (ACNP). "We rely on the expertise of these specialists in establishing, updating and maintaining our radiation safety program.