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Public Meeting Documents

ORGANIZATIONS FORMALLY CONTACTED FOR PUBLIC MEETING PARTICIPATION

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American Academy of Family Physicians

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American Academy of Neurology

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American Academy of Ophthalmology

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American Academy of Otolaryngology-Head and Neck Surgery

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American Academy of Pediatrics

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American Association for Thoracic Surgery

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American Association of Clinical Urologists

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American Association of Dental Examiners

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American Association of Operating Room Nurses

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American Association of Pathologists

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American Association of Physicists in Medicine (AAPM)

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American Association of Retired Persons

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American Board of Internal Medicine

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American Board of Nuclear Medicine (ABNM)

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American Board of Radiology (ABR)

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American Brachytherapy Society

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American Cancer Society

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American College of Cardiology

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American College of Chest Physicians

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American College of Emergency Physicians

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American College of Medical Physics



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Radiation in Medicine: A Need for Regulatory Reform H Public Meeting Documents ORGANIZATIONS FORMALLY CONTACTED FOR PUBLIC MEETING PARTICIPATION 1. American Academy of Family Physicians 2. American Academy of Neurology 3. American Academy of Ophthalmology 4. American Academy of Otolaryngology-Head and Neck Surgery 5. American Academy of Pediatrics 6. American Association for Thoracic Surgery 7. American Association of Clinical Urologists 8. American Association of Dental Examiners 9. American Association of Operating Room Nurses 10. American Association of Pathologists 11. American Association of Physicists in Medicine (AAPM) 12. American Association of Retired Persons 13. American Board of Internal Medicine 14. American Board of Nuclear Medicine (ABNM) 15. American Board of Radiology (ABR) 16. American Brachytherapy Society 17. American Cancer Society 18. American College of Cardiology 19. American College of Chest Physicians 20. American College of Emergency Physicians 21. American College of Medical Physics

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Radiation in Medicine: A Need for Regulatory Reform 22. American College of Nuclear Medicine 23. American College of Nuclear Physicians (ACNP) 24. American College of Obstetricians and Gynecologists 25. American College of Occupational and Environmental Medicine 26. American College of Physicians 27. American College of Radiation Oncology 28. American College of Radiology (ACR) 29. American College of Surgeons 30. American Federation for Aging Research 31. American Gastroenterological Association 32. American Geriatrics Society 33. American Health Decision 34. American Heart Association 35. American Hospital Association 36. American Institute of Ultrasound in Medicine 37. American Medical Association 38. American Medical Women's Association 39. American Nuclear Society 40. American Nurses Association 41. American Orthopaedic Association 42. American Orthopaedic Foot and Ankle Society 43. American Osteopathic Association 44. American Osteopathic College of Radiology 45. American Pediatric Surgical Association 46. American Pharmaceutical Association Foundation 47. American Public Health Association 48. American Radium Society 49. American Roentgen Ray Society (ARRS) 50. American Society for Pharmacology and Experimental Therapeutics 51. American Society for Radiologic Technologists (ASRT) 52. American Society for Therapeutic Radiology and Oncology 53. American Society of Clinical Oncology 54. American Society of Clinical Pathologists 55. American Society of Internal Medicine 56. American Society of Law, Medicine and Ethics 57. American Society of Neuroradiology 58. American Society of Nuclear Cardiologists 59. American Thoracic Society 60. American Urological Association 61. Appalachian Compact Users of Radioactive Isotopes 62. Association of American Medical Colleges 63. Association of Free Standing Radiation Oncology Centers 64. Association of Pediatric Oncology Nurses 65. Association of University Radiologists

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Radiation in Medicine: A Need for Regulatory Reform 66. Bureau of Radiation Health 67. Cancer Care Inc. 68. Center for Devices and Radiological Health 69. Center for Drug Evaluation and Research 70. Center for Information on Internal Dosimetry of Radiopharmaceuticals 71. Committee on Interagency Research and Policy Coordination (CIRRPC) 72. Center for Medical Consumers 73. College of American Pathologists 74. Conference of Radiation Control Program Directors Inc. (CRCPD) 75. Department of Energy 76. Department of Health and Human Services (DHHS) 77. Elekta Instruments, Inc. 78. Environmental Protection Agency (EPA) 79. Food and Drug Administration (FDA) 80. Group Health Association of America, Inc. 81. Health Care Financing Administration 82. Health Physics Society (HPS) 83. Hospice Education Institute, Inc. 84. Joint Commission on Accreditation of Healthcare Organizations (JCAHO) 85. National Coalition for Cancer Survivorship 86. National Committee on Quality Assurance 87. National Consumers League 88. National Council of Radiation Protection and Measurement 89. National Electrical Manufacturers Association Nuclear Section 90. National Institute for Occupational Safety and Health 91. National Institute of Health Radiation Safety Officers 92. National Institutes of Health/National Cancer Institute 93. New York City Department of Public Health 94. Office of Energy Research 95. Office of Legislation and Policy 96. Office of Nuclear Energy 97. Office of Radiation and Indoor Air 98. Office of Radiation Programs 99. Oncology Nursing Society 100. People's Medical Society 101. Physicians for National Health Program 102. Physicians for Social Responsibility 103. Public Citizen Health Research Group 104. Radiation Research Society 105. Radiological Society of North America (RSNA) 106. Society for Pediatric Radiology 107. Society of Cardiovascular and Interventional Radiology 108. Society of Cardiovascular Anesthesiologists 109. Society of Nuclear Medicine (SNM)

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Radiation in Medicine: A Need for Regulatory Reform 110. United Cancer Council 111. Veterans Administration COMMITTEE FOR REVIEW AND EVALUATION OF THE MEDICAL USE PROGRAM OF THE NUCLEAR REGULATORY COMMISSION PUBLIC MEETING ANNOUNCEMENT AND REQUEST FOR WRITTEN TESTIMONY The Institute of Medicine (IOM) Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission (NRC) will hold a public meeting to solicit information from a broad spectrum of organizations and groups regarding the NRC's Medical Use Program and ionizing radiation in medicine. The following is an open invitation to prepare written testimony for submission to the Committee. A limited number of organizations will be invited to give a brief oral statement at the public meeting, which is scheduled to begin at 9 a.m., October 12, 1994, at the National Academy of Sciences, 2001 Wisconsin Avenue, NW, Green Building Room 130, Washington, DC, 20007. Any organization or individual wishing to be considered for oral presentation must submit a written statement to this office no later than September 6, 1994. Please read further for more details. Background The U.S. Nuclear Regulatory Commission (USNRC) is responsible for regulating the medical (diagnostic and therapeutic) use of byproduct materials, especially for protecting the public from undue risk attendant upon their use in health care applications. (Byproduct materials, or radionuclides, include such substances as cobalt-60, iodine-131, and radium-223 used for diagnosis and treatment of cancer and iodine-125 used for the diagnosis of osteoporosis.) This ''medical use" responsibility derives from its more general public health and safety responsibilities for regulating all aspects of nuclear reactor safety. The Nuclear Regulatory Commission has requested from the Institute of Medicine (IOM) a detailed independent review and evaluation of the adequacy of that program as well as recommendations for needed changes. The IOM has established a 16-member committee of experts to conduct a study that will result in a formal report at the conclusion of this study tentatively scheduled for release December 1995.

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Radiation in Medicine: A Need for Regulatory Reform Providing Testimony To respond to this request, the IOM has established a committee of 16 experts representing a wide range of expertise. As part of the committee's activities, written testimony is being solicited from a large number of organizations and groups representing all points of view on the subject. Although a limited number of organizations will be invited to present oral testimony and to respond to the committee's questions, the committee urges you to submit written testimony, which will be given equal consideration to the oral testimony. One invitational session, a day long, will be convened in Washington, D.C. on October 12, 1994. Those organizations and individuals asked to present oral statements will be grouped in panels, asked to confine their remarks to about 5 minutes summarizing their written testimonies, and requested to be prepared to respond to committee members' questions. We can only accommodate a limited number of oral presentations but persons/organizations who wish to be considered for making a brief oral presentation should contact Kate-Louise Gottfried as soon as possible, and no later than August 23, 1994. These sessions will be open to the public for observation. Reporters interested in attending the oral presentation sessions should contact the Office of News and Public Information at 202-334-2138, or through Internet at NEWS@NAS.EDU. This hearing provides an opportunity for the committee members to obtain firsthand an extensive range of opinions on the matters under consideration. Written and oral statements will be summarized by staff for the committee after they are completed. The topics to be addressed in the written testimony are provided in the following Guide to Preparing Testimony. If a particular question(s) is not relevant to your discipline, or you have no knowledge/experience regarding the area identified, please state this and proceed to the next topic. Finally, the committee is eager to hear from you, not only your criticisms and frustrations about the existing system, but also your realistic recommendations and/or proposals on how to improve the existing system. Please bear this in mind throughout your response to the questions presented. Guide to Preparing Testimony First, as background, briefly describe your organization and its activities; existing brochures or publications are acceptable. Then, to the extent possible, please address at least the topics listed below. Your written statement may be as long as you choose. Previously prepared relevant statements may be submitted, but also make sure to respond to the specific questions posed. Please note that all testimony should include a one-to-two page executive summary and a cover letter identifying the name, affiliation, address, and telephone number of the contact person.

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Radiation in Medicine: A Need for Regulatory Reform TOPICS The Committee has created four subcommittees that focus on particular aspects of the study. The following questions are listed according to each subcommittee category: Regulation Does the current regulatory structure pertaining to the medical uses of ionizing radiation provide adequate safeguards to protect the public's health and safety? If not, how might the respective roles of various Federal and State authorities be revised to assure greater patient safety and cost effectiveness? How does the current regulatory framework—as it applies to ionizing radiation in medicine—affect the practice of medicine? 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? The Atomic Energy Act of 1954 as amended requires that the Nuclear Regulatory Commission (NRC) regulate reactor-generated byproduct material. Do you believe the act should be amended to require uniform regulation of all ionizing radiation used in medicine under a single Federal agency? If so, which agency? An existing one (i.e., NRC, FDA)? A new one? What role should this agency have vis-à-vis the states? Data/Risk Do you believe that the current regulatory framework pertaining to the medical uses of ionizing radiation reflects the actual risks associated with the various diagnostic and therapeutic applications? Are your patients informed about the potential risks associated with medical procedures involving ionizing radiation? If yes, how? If not, why not? In your experience, has the evolution of radiation protection standards helped to improve patient safety and welfare? Has it influenced staff safety and welfare? Quality Management/Quality Assurance Who should bear the ultimate responsibility for devising appropriate quality assurance programs? Professional associations such as JCAHO, ACR, AAPM, etc.? State agencies? Federal agencies? 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?

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Radiation in Medicine: A Need for Regulatory Reform Education The 1981 Consumer-Patient Radiation Health Safety Act provides minimum standards by the Federal Government for the accreditation of education programs for persons who administer radiologic procedures and for the certification of such persons. Do you adhere to these standards? Are they effective? What, if any, Federal agency should be responsible for establishing educational standards for accreditation regarding the medical use of ionizing radiation? NRC? FDA? Other? How should the quality of the education programs be judged? What criteria should be applied? How are personnel under authorized users supervised/trained in your facilities? How should they be? How are users trained in applications of new technology? What kind of ongoing training is provided? Should recertification be by test or evidence of continued education? Other What are your other concerns regarding the regulation of ionizing radiation in medicine? Please note that all written statements are to be received no later than September 6, 1994. Feel free to distribute this announcement to others who may wish to submit written testimony. Questions regarding the written statements may be directed to Kate-Louise Gottfried, J.D., M.S.P.H., Study Director, at Institute of Medicine, FO 3105, 2101 Constitution Avenue, NW, Washington, DC 20418. PUBLIC HEARING OCTOBER 12, 1994 ORGANIZATIONS AND INDIVIDUALS SUBMITTING TESTIMONY1 Aldrich, Rita American Association for Nuclear Cardiology (AANC) American Association of Clinical Endocrinologists American Association of Physicists in Medicine American Board of Nuclear Medicine American Board of Radiology American Brachytherapy Society American College of Medical Physics American College of Nuclear Physicians American College of Radiology 1   The organizations in italics presented oral testimony at the public hearing.

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Radiation in Medicine: A Need for Regulatory Reform American Medical Association American Roentgen Ray Society American Society for Therapeutic Radiology and Oncology (ASTRO) American Society of Nuclear Cardiology American Society of Radiologic Technologists Conference of Radiation Control Program Directors Council on Radionuclides and Radiopharmaceuticals (CORAR) & Du Pont Pharmaceutical Diatech Inc. DuPont Merck Health Physics Society Mallinckrodt Medical Inc. McElroy, Norman L. National Electrical Manufacturers Association New York Hospital-Cornell Medical Center (NYH-CMC) North Shore University Hospital (NSUH)-Cornell University Medical College Radiological Society of North America Sloan-Kettering Memorial Cancer Center Society for Nuclear Medicine State of Arizona Radiation Regulatory Agency State of Florida Department of Health and Rehabilitative Services State of Illinois State of Kansas State of Kentucky State of New York Department of Health (NY-DOH) State of North Carolina Department of Environment, Health and Natural Resources State of Texas Department of Health State of Utah Department of Environmental Quality State of Washington Department of Health Syncor Wenatchee Valley Clinic QUESTION SUMMARIES Question 1 (N = 34) Does the current regulatory structure pertaining to the medical uses of ionizing radiation provide adequate safeguards to protect the public's health and safety? If not, how might the respective roles of various Federal and State authorities be revised to assure greater patient safety and cost effectiveness? In response to this question we received 34 replies: 18 from professional associations, societies, and industry; 10 from states; and 6 from miscellaneous

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Radiation in Medicine: A Need for Regulatory Reform sources. There was widespread opinion that the current regulatory structure pertaining to the medical uses of ionizing radiation adequately protects the public's/worker's health and safety (ABNM, NEMA, Syncor, ACR, Mallinckrodt, CORAR, Texas, New York). Some believe it is adequate because "it is incidental to insuring public health and safety. Professional pride, peer pressure and legal implications of errors are more important factors than regulations" (AAPM). Others asserted that the existing regulatory structure protects the public health and safety "with a level and degree of regulation that is often excessive to achieve the desired goal" (RSNA). The Society for Nuclear Medicine stated that the existing structure is not useful for protecting the public. "Excessive regulations are proving unnecessary, prescriptive, expensive and prohibitively burdensome to hospitals and physicians in private practice" (SNM). In view of these statements the American Roentgen Ray Society suggestion appears reasonable: "Validity of regulatory requirements must be re-evaluated and changed as appropriate." The primary concern about the adequacy of the regulations focused on excessive paperwork, cost effectiveness, diagnosis and treatment of disease (ACNP, Illinois, RSNA, North Shore Hospital, Mallinckrodt, SNM). "Licensees are faced with ever increasing regulations that are costly to implement. NRC's licensing and annual fees have increased 1000% since Congress turned over full budget authority to the NRC through the collection of user fees … medical licensees are restricted in their ability to recoup costs" (ACR). "In diagnostic nuclear medicine even a gross error has virtually no practical possibility of inducing a perceptible adverse health effect in the affected patient. The current regulatory structure simply does not reflect this reality. Burdening health care providers with excessive regulation and diverting the time and efforts of highly compensated professional and technical personnel from patient care to regulatory compliance causes health care costs to escalate and impedes the delivery of effective care"(NYH-CMC). "… [O]ften NRC's licensing requirements exceed the regulations promulgated in the CFR [Code of Federal Regulations] and add additional expense … large fees are not commensurate with services rendered" (SNM). The Society of Nuclear Medicine believes that "there is a loophole in the existing requirements under the Administrative Procedures Act that allows the NRC to bypass an accurate cost/benefit analysis for new regulations affecting medical licensees." The distinction between diagnostic and therapeutic applications was noted in several instances. "The regulatory framework is inadequate relative to therapeutic applications"(NYH-CMC). In addition, the American College of Nuclear Physicians noted that the public is adequately protected but the patients are less so. "The patients are not as well protected as is desirable, but the situation is different with different types of ionizing radiation in medicine." Several respondents stated they favored a single federal agency with authority to regulate ionizing radiation in medicine. They argue that a single agency

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Radiation in Medicine: A Need for Regulatory Reform would be more cost effective and would assure greater patient/staff safety (NEMA, ABR, Washington, New York, North Carolina; see synopsis of question #3 for elaboration of this issue). Although some respondents noted inconsistency among the states, several other respondents believed that the regulatory responsibility for ionizing radiation in medicine should be shifted to the states or the states in conjunction with the federal government. "A uniform regulatory structure that would be more cost-effective and assure greater patient/employee safety would be achieved by state regulation and inspection of all sources of ionizing radiation based on conformity with minimum basic national regulatory safeguards" (ABNM). "Federal standards need to be developed in full consultation with the states and involvement by the public and regulated community. [A] State agency should have flexibility to develop a regulatory program consistent with federal standards which reflects local needs and conditions" (New York). A different approach was proposed by the American College of Medical Physics (ACMP). The ACMP suggested that regulatory agencies should revise their programs to require adequate facility design for safe operation, adequate staffing with required qualifications (certification/licensure), and standards of practice following established QA protocols developed by relevant professional/scientific organizations. ACMP proposes that periodic inspections should be performed by a small team of experts to evaluate both physical and clinical aspects of the program and that "the regulatory agency" should require compliance with the recommendations of the site team. ACMP did not specifically identify the regulatory agency. Finally, the ASRT stated that the regulations need to address the credentialing of technologists. A few respondents stated that NRC's scope of control should not be expanded and in certain instances should be reduced (Du Pont Merck, Illinois, Washington, Florida) or that insufficient data are available to justify fundamental changes in the structure (ASTRO). Illinois asserted that the federal agencies should respect efforts of the states and professional societies in regulating the practice of medicine and that the federal government should only require each state to have a radiation regulation program that has all the basic components necessary to implement the equivalent of the model state statutes provided by the CRCPD licensing state program. The American Medical Association recommended that the NRC work in conjunction with the private sector and other government agencies. Various respondents noted the omission of federal requirements for x-ray programs that include linear accelerators (Kentucky). The majority believed that the existing regulatory structure adequately protects the public's health and safety, but there was sentiment that the cost/benefit ratio is disproportionate and should be reevaluated. Opinions varied as to whether a single federal agency should regulate all of ionizing radiation in medicine or whether this responsibility should be transferred to the states under a national set of performance standards (see question #3 for further discussion).

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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

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Radiation in Medicine: A Need for Regulatory Reform does not lend itself well to the concept of quality improvement which should be at the heart of each institution's program" (ACR). NRC's misadministration reporting requirements "seem unreasonable in an area of medicine where the misadminstrations [rate] is less than 0.1%" (ARRS). One of the more insightful comments came from the National Electrical Manufacturers Association (NEMA): "The revised Quality Management Rule did not generate many time-consuming procedures. These procedures were in fact those already found in good operating programs prior to the implementation of the new QM rule. … The new definition of 'misadministrations,' concomitant with the new QM rule, is now more realistic. However, in our view, the Quality Management Rule, even as amended, will not serve to reduce 'misadministrations' since the rate of misadministrations for nuclear medicine is extremely low, and is probably at the lowest rate of any modality." Others explained: "The revised definition for a misadministration is an improvement over the previous one. … The reporting requirements are appropriate [and] the implementation of this [QM] rule was uneventful from a radiation safety perspective at a broad licensed facility" (RSNA). The states were equally divided in their interpretation of the new QM rule and concomitant reporting requirement. "The revised QM rule and reporting requirements for misadministrations are improved by the fact that emphasis is being placed in the more significant events. … NRC's definitions of misadministrations appear to be on target" (Florida). "The quality management (QM) rule was an attempt to fix something that was not broken, and should be repealed" (Illinois). "By deleting the reporting requirement for diagnostic uses of radioisotopes, the regulatory agencies are not able to track trends, such as tracing mislabeled or improper radiopharmaceuticals back to a nuclear pharmacy" (Texas). "While the Quality Management rule codifies a concept that is already fairly well established, it also adds a significant paperwork burden for all licensees, keeps the regulator busy reviewing the accumulated paper rather than evaluating the actual radiation safety practice of the institution, and potentially generates civil penalties which distract the licensee from needed radiation safety improvements. … NRC's definition of misadminstrations is also reflective of the narrow focus of the agency" (Washington). Question 3 (N = 31) The Atomic Energy Act of 1954 as amended requires that the Nuclear Regulatory Commission (NRC) regulate reactor-generated byproduct material. Do you believe the act should be amended to require uniform regulation of all ionizing radiation used in medicine under a single Federal agency? If so, which agency? An existing one (i.e., NRC, FDA)? A new one? What role should this agency have vis-à-vis the states? In response to this question, we received 31 replies: 18 from professional associations, societies, and industry; 8 from states; and 5 from miscellaneous

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Radiation in Medicine: A Need for Regulatory Reform sources. The majority believes that regulation of all ionizing radiation used in medicine should be uniform. However, this is the extent of the agreement among respondents. The proposals for how uniform regulation could be achieved revealed a spectrum of ideas. Three respondents said that a new federal agency should be created (one said a new agency within DHHS and one of the three said a new one or the FDA). Three respondents stated that the NRC should retain jurisdiction, and one stated that the NRC should expand its authority to include discrete NARM (naturally occurring and accelerator-produced materials) and potentially accelerators. Two indicated that they preferred the FDA. Four stated there should be a single agency, but did not identify an existing one or state whether there should be a new one. One respondent said responsibility should be split between the FDA and the NRC, with the FDA regulating electronic product radiation and the NRC regulating all radioactive material used in medicine. Four indicated that the states should assume responsibility, and one of the four said the states should be subject to a national set of performance standards. Two respondents said the NRC should not be the agency regulating ionizing radiation; one said the EPA should not have the responsibility; and one said that FDA should not be the lead agency. Two respondents indicated that a single agency is not needed, and one said that if a need is perceived for a lead agency it should not be the NRC. Finally, one proposed to coordinate all radiation regulations, including NRC regulations, within the Executive Branch (e.g., in the National Science and Technology Council via CIRRPC). Another organization proposed to reestablish the Federal Radiation Council. Thus, it is generally believed that all of ionizing radiation should be regulated by a single agency. "[There are] too many instances in which reactor-generated materials are more stringently regulated than NARM materials" (NEMA). States with adequate resources would have the right to implement and enforce combined regulations under provisions similar to the Agreement State provisions of the NRC. Licensing, inspection and enforcement would come within the authority of these Agreement States, but they would have to adhere more closely to regulations promulgated by the new agency. The new/federal agency would still carry oversight responsibility (NEMA). There was some concern that creating a single agency to address all of ionizing radiation may not be the appropriate solution. For instance, Syncor did not believe that providing the NRC with authority to regulate the medical uses of other forms of ionizing radiation will necessarily improve the quality of regulation, or better effectuate the goal of regulation. "Relative harm to the public should be measured prior to establishing regulations. Existing voluntary efforts should be analyzed and a determination made as to the cost effectiveness of adding further regulations. Fiscal analyses of where the public's money would be best spent to protect the public should be made prior to the adoption of future regulations" (ACR).

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Radiation in Medicine: A Need for Regulatory Reform ''It would be beneficial for one organization to have regulatory power for all sources of internally administered ionizing radiation. Placing all ionizing radiation (external and internal) under one agency would be a mistake. … Issues [surrounding] externally administered radiation are different and tend to be device related far more than internally administered radiation" (RSNA). Finally, one group believed that the regulation should be expanded to incorporate nonionizing radiation. "Have a single agency … include the regulation of practices that involve nonionizing radiation used in medicine, such as ultrasonography and MRI [magnetic resonance imaging" (ASRT). There was a cry for uniformity. What specifically ought to be uniform was not entirely clear. There also appeared to be no consensus as to how that uniformity is to be achieved. Question 4 (N = 28) Do you believe that the current regulatory framework pertaining to the medical uses of ionizing radiation reflects the actual risks associated with various diagnostic and therapeutic applications? In response to this question we received 28 replies: 18 from professional associations, societies, and industry; 7 from states; and 3 from miscellaneous sources. There was widespread consensus that the current regulatory framework is too elaborate, expensive, and time intensive relative to the actual risks associated with diagnostic applications. "Clinical benefits of radiation exposure greatly outweigh the risks" (HPS). Several respondents indicated that the actual risks related to diagnostic applications are many orders of magnitude less than the risks of other treatment modalities, such as administration of drugs, anesthesia, and medical/surgical procedures that are unregulated: "Misadministrations occur at much higher rates in these disciplines, but since these areas do not have attending regulatory agencies the degree of their regulation is much less" (ACR). "Patients perceive that risks that are important enough to get the federal government involved are greater than risks which do not require any government agency oversight or regulation" (ABNM). "Compared with therapeutic and diagnostic interventions in traditional medicine, the adverse events in nuclear medicine are few and of limited medical consequence" (Syncor). Several respondents noted that the regulatory structure should distinguish between the risks of therapeutic and diagnostic applications in ionizing radiation. "Levels of radiation received by a patient undergoing diagnostic procedures are significantly lower than the levels for therapeutic procedures. The current level of regulation, however, is virtually the same" (Syncor). "The current framework reflects the risk associated with therapeutic uses but overestimates and overcontrols diagnostic uses" (ARRS). Risk was also addressed in the context of education and training of personnel involved in performing diagnostic and therapeutic applications of radiation in medicine. It was noted that the existing regulatory framework does not "address

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Radiation in Medicine: A Need for Regulatory Reform risk factors involved in utilizing uncertified individuals to perform diagnostic and therapeutic applications involving radiation" (ASRT). One individual believed that the key risk associated with the medical use of byproduct material is unretrieved brachytherapy sources. Texas and Illinois indicated that accelerators and diagnostic x-ray are unregulated at the federal level. They are not covered under misadministration requirements or in training standards for users. Kansas observed that the rules pertaining to cobalt-60 teletherapy and accelerators are very different despite the fact that both are capable of delivering doses that could cause serious acute injuries. Question 5 (N = 19) Are your patients informed about the potential risks associated with medical procedures involving ionizing radiation? If yes, how? If not, why not? In response to this question we received 19 replies: 15 from professional associations, societies, and industry; 2 from states; and 2 from miscellaneous sources. There was widespread consensus that patients are informed verbally and via a written consent form (requiring their signature) regarding radiation hazards of therapy procedures by the physician and/or other personnel. The same is true in some cases regarding ionic contrast medicine. Regarding diagnostic procedures, patients are often informed verbally by the technologist or physician. "In some institutions, the patient is not informed about potential risks for diagnostic procedures as the risk is judged to be too small" (ABNM, AAPM), "and the anticipated medical benefit is so large as to make such discussion unnecessary and potentially counterproductive" (NYH-CMC). However, particular attention is paid to women of childbearing age who might be pregnant or lactating. Signs about potential risks to the fetus are posted and efforts are made to ascertain a woman's pregnancy status. A few respondents indicated concerns regarding inadequate information. "In general patients are getting limited and sometimes inadequate information to understand the potential risk of radiation" (ARRS). "[We have] no direct patient contact; amount of information provided regarding risk is dependent on medical facility. Our members indicate that patients may not be [getting] adequate information for a variety of reasons that include lack of knowledge that is available. Our philosophy is that all patients deserve to be informed of all risks for any procedure performed on them" (ASRT). Note: Florida stated that its regulations do not require that all patients be informed about the potential risks associated with medical procedures involving ionizing radiation. Information is provided as requested by patients in most cases.

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Radiation in Medicine: A Need for Regulatory Reform Question 6 (N = 27) In your experience, has the evolution of radiation protection standards helped to improve patient safety and welfare? Has it influenced staff safety and welfare? In response to this question we received 27 replies: 18 from professional associations, societies, and industry; 6 from states; and 3 from miscellaneous sources. There was a general sentiment that the evolution of radiation protection standards (as distinguished from regulations) based on recommendations of national (, NCRP) and international (International Commission on Radiological Protection, ICRP) bodies have helped to improve both patient and staff safety and welfare. Requirements regarding training of technologists and other individuals using ionizing radiation have improved patient and worker safety (Illinois). An excellent example of improved patient safety and welfare may be the change in the last 15 years in the practice of mammography (Kansas, Texas, NY-DOH). The incorporation of NCRP recommendations has also influenced the practice of radiation safety procedures (ACMP). In particular, 10 CFR Part 20, relative to staff safety was cited, specifically the ALARA (as low as reasonably achievable) program as one that has "heightened staff awareness of the level of accumulated personal radiation exposure" (NEMA, Syncor). Although it was generally believed that the evolution of radiation protection standards improved both patient and staff safety and welfare, the "regulations promulgated to achieve these standards are collectively excessive" (NYH-CMC). "Efforts to drive down occupational exposure limits have not resulted in improved occupational health but have resulted in substantial increases in compliance costs" (Health Physics Society). "Regulatory agencies may be crossing the line between requirements that result in an increase in paperwork without an actual safety benefit" (Illinois). Question 7 (N = 26) Who should bear the ultimate responsibility for devising appropriate quality assurance programs? Professional associations such as JCAHO, ACR, AAPM, etc.? State agencies? Federal agencies? In response to this question we received 26 replies: 18 from professional associations, societies, and industry; 5 from states; and 3 from miscellaneous sources. Although the response was not unanimous, there appeared to be overwhelming consensus that the various professional associations should be entrusted with the task of devising appropriate quality assurance programs. "I believe a professional organization such as ACR or AAPM should develop guidelines for QA programs with oversight of the programs the responsibility of JCAHO. I do not believe any federal [agency] should devise the programs" (AAPM). "It is essential that quality assurance programs be based within appropriate professional associations … state and federal agencies should establish

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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.

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Radiation in Medicine: A Need for Regulatory Reform The program seems to be working well. In terms of quality assurance within the facility, we utilize a complex of professional standards and programs, JCAHO reviews, and government requirements to ascertain a proper mix for ongoing quality improvement efforts" (ACR). "The institution and department QA programs [are] based upon published guidelines and professional associations and in compliance with state and federal agencies. They were developed by adhering to in-house expertise. They seem to be working well" (ARRS). Question 9 (N = 17) The 1981 Consumer-Patient Radiation Health Safety Act provides minimum standards by the Federal Government for the accreditation of education programs for persons who administer radiologic procedures and for the certification of such persons. Do you adhere to these standards? Are they effective? In response to this question we received 17 replies: 11 from professional associations, societies, and industry; 5 from states; and 1 from miscellaneous sources. Many of the respondents were not aware of act's existence. Of those who were, most seemed to think that, at best, it had a minor impact. As the American Society of Radiologic Technologists explained: The act "laid the groundwork for what could have been a step in the right direction for reducing risks and improving cost effectiveness in the use of ionizing radiation by setting minimum standards for the certification of persons who administer radiologic procedures. However, because the standards set in the Act were made voluntary, this Act became a totally insufficient piece of legislation" (ASRT). Other respondents commented on the volatile political issue regarding certification and licensure: "NRC has been subject to political pressure from various medical lobbying groups whenever it has attempted to rigidly enforce the requirement for certification of education of various professional groups. Exceptions made in the area of nuclear cardiology are but one example" (MS-KCC). Despite this issue, many acknowledge the need for such certification. "In order to assure proper standards, all health practitioners should be licensed, including nuclear medicine technologists. … In New York we have no licensing for technologists in Nuclear Medicine. New York State requires certification when a technologist is responsible for radiopharmaceutical administration. Licensure would assure attainment of an appropriate level of training" (NSUH). Particularly illuminating were the responses from various state radiation agencies: "The State of Florida adheres to the Radiological Technologist Certification Act which we consider effective. It states that all educational programs for certified radiological technologists [must] include documentation of accreditation by the American Medical Association Committee on Allied Health and [must be] currently approved by the United States Department of Education." "Illinois requires minimum standards of education, including continuing education, for persons who perform medical radiography, nuclear medicine technology

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Radiation in Medicine: A Need for Regulatory Reform procedures, or administer radiation therapy. The standards and requirements for training prescribed by Illinois' statute and regulation are certainly equal to, and in most cases exceed, those standards suggested by the Act" (Illinois). The Illinois respondent went on to explain that "there are still 21 states, with regard to medical radiography, that have made no progress during the past 13 years in implementing the minimum standards for training and education described in the Act. In addition, there are still 35 states which have no requirements for technologists who use radioactive materials and perform nuclear medicine procedures. While the Act describes minimum standards, there has been little guidance provided to the states on implementation of these standards." Question 10 (N = 24) What, if any, Federal agency should be responsible for establishing educational standards for accreditation regarding the medical use of ionizing radiation? NRC? FDA? Other? How should the quality of the education programs be judged? What criteria should be applied? In response to this question we received 24 replies: 16 from professional associations, societies, and industry; 5 from states; and 3 from miscellaneous sources. On this question, there was no consensus. Answers typically fell into one of two categories: (1) There should be no federal involvement in this issue. (2) Federal involvement is appropriate but determining which agency is no simple task. Most of the professional associations offered the first response. In place of federal oversight, they argued instead for industry self-regulation. "There is already a complete working mechanism for the review, accreditation and periodic re-review of education programs for radiological technologists, and radiation therapists. All that would be necessary is to require all individuals using ionizing radiation for medical uses to either be a licensed health care professional or a graduate of an accredited program" (AAPM). "Government agencies should not have responsibility for developing educational standards, standards for accreditation of training programs, or certification of qualifications (competence) to practice medicine using ionizing radiation. This should be the responsibility of professional organizations" (ABNM). "We do not think that any Federal agency should be directly responsible for establishing educational standards for accreditation regarding the medical use of ionizing radiation. This should be the assumed responsibility of established professional/educational/scientific organizations. … Educational programs should be evaluated by accreditation bodies which may operate under the auspices of a Federal agency" (ACMP). "No Federal agency should be involved with this. … Professional accrediting organizations exist to accredit programs, and this all that is needed. … For those who do not possess certification by an acceptable professional group, the State can offer an examination, as is done in California" (ACNP). "Neither agency [FDA or NRC] is well-equipped to make this type medical decision and neither should be

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Radiation in Medicine: A Need for Regulatory Reform called on to do so. The states should continue to play the most significant role in determining what are the appropriate education and training criteria for licensed professionals practicing in their states" (ACR). "We believe that there would be no great need for a federal agency to attempt to replace the existing education standards, criterion and judgments already established within the medical radiologic community. Instead, a federal agency should work with private entities involved in curriculum development and certification standards" (ASRT). "The establishment of educational standards for accreditation regarding the clinical use of ionizing radiation is best handled by the educational committees of the various interested professional organizations" (NEMA). "[E]ducational standards should remain the province of the appropriate credentialing bodies for externally administered ionizing radiation for diagnostic purposes and appropriateness of use should be determined by the market place" (RSNA). "No federal agency should establish educational standards for any medical practice. Such standards should be established, supported, and accredited by professional peers. Federal agencies may set minimum standards for recognition of training and experience for entry level professionals based on input from the profession. An effective example of this profession/regulatory interplay is the development of the NRC's proposed Authorized Nuclear Pharmacy Rule" (Syncor). Not all professional societies and medical representatives subscribed to the notion that the federal government should play no role in the accreditation process. "[G]overnmental agencies should defer to national professional organizations in devising educational standards. As in insuring uniform regulation of all ionizing radiation used in medicine, in the area of technical training, I believe a single federal agency, preferably the NRC, should probably be responsible for devising educational standards" (NYH-CMC). "The NRC is the logical regulating body to set minimal federal guidelines for training practitioners regarding radiation and radiation safety. However, the professional associations and accreditation bodies must have responsibility for establishing quality programs and local committees for local implementation" (ARRS). "Minimum standards for education and accreditation regarding the medical use of ionizing radiation can be established by the Nuclear Regulatory Commission. Individual states should have the right to adopt more strict criteria for education and accreditation programs if they so desire" (ASTRO). The state responses differed markedly from the professional associations. Of those who responded, most seemed to think that the Department of Education should play a role in the certification process. "The U.S. Department of Education with appropriate technical input from other agencies such as the NRC and the FDA should be responsible for establishing educational standards for accreditation" (Florida). "The Department of Education, through its Council on Allied Health Education and Accreditation (CAHEA), established an effective means of accrediting such programs. This process has been in place for many years and has been quite effective where it is used. … The standards, and related processes, are well established and their use should be encouraged"

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Radiation in Medicine: A Need for Regulatory Reform (Illinois). "The US Department of Education has considerable experience in credentialing professional bodies to accredit educational programs. It is appropriate for that department to continue this function." Question 11 (N = 16) How are personnel under authorized users supervised/trained in your facilities? How should they be? How are users trained in applications of new technology? What kind of ongoing training is provided? Should recertification be by test or evidence of continued education? In response to this question we received 16 replies: 13 from professional associations, societies, and industry and 3 from the states. The overwhelming number of respondents agreed that continuing education and in-house training were the best means of assuring a competent work force. A smaller number suggested that testing was also important. And an even smaller number argued that there was a role for federal authorities in this broad area. As the AANC representative explained: "Regulatory agencies must look at the documentation of training, even if the training is part of a residency program, and determine that the regulatory requirements have been met" (AANC). The majority of comments, however, were of the following type: "The process of 'recertification' is best accomplished through well documented continued education" (ABNM). "Whenever new technology is introduced a special training is conducted by application specialists supplied by the manufacturer. Further in-house on-the-job training is provided by the medical physicist or equipment specialist who may have attended a special course at the factory" (ACMP). "I believe that recertification should occur by documentation of CME [continuing medical education]" (ACR). "Recertification could best be done as a combination of continuing education and testing'' (ARRS). "We believe that an individual working in any aspect of medical radiologic science should demonstrate minimum certification criteria with regard to an accredited education, practice experience and successful passage of a certification examination" (ASRT). "It is not clear what the optimum approach to re-certification is, but I feel that periodic testing, especially of highly experienced practitioners, would be strongly resisted and may well be unreasonable" (NYH-CMC). "Recertification can be accomplished by either testing or continued education" (Florida). "Illinois believes that the evidence of continuing education is adequate for re-certification of technologists at this time. The Department is aware of no medical profession or allied health occupation that is currently required to pass a test for re-certification" (Illinois). Question 12 (N = 19) What are your other concerns regarding the regulation of ionizing radiation in medicine? In response to this question we received 19 replies: 12 from professional associations, societies, and industry; 6 from states; and 1 from miscellaneous

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Radiation in Medicine: A Need for Regulatory Reform sources. Given the open-ended nature of this question, it was surprising to see that so many answers reflected a similar concern—namely, a preoccupation with what many considered to be overregulation and the duplication of various regulations regarding the uses of ionizing radiation. A smaller number focused on the costs attached to these regulations—particularly the required paperwork. "The cost of regulation of radiation in medicine is high and the benefits are low. Radiation in medicine is over-regulated when the amount of risk to the public is considered" (AAPM). "Under the current system, we divert a tremendous amount of our limited resources to protect ourselves against ionizing radiation. Ultimately, we are less safe because monies are not available to protect ourselves against the much larger risks that affect our health" (ABNM). Relative risk between medical disciplines should be measured and considered prior to adopting rules as should relative harm to the public. Voluntary efforts need to be considered more fully. Unsuccessful regulations should be abolished, and financial analyses should be employed to determine where money is best spent (ACR). "The needless over-regulation of medicine has become cumbersome, difficult for patients, and more expensive at no benefit to the patient or to the regulating agencies beyond the apparent self-serving need to perpetuate multiple agencies with ambiguous role and scope definition, unnecessary redundancy and predictable excessive delays, and increased costs" (ARRS). In addition to comments of this nature, others spoke of the need for a single federal agency to deal with all issues relating to ionizing radiation. "While a 'national coordinating role' such as is provided by the CRCPD is preferred, the formation of a single federal 'public health' agency would be a reasonable approach to effectively resolving the issue" (Washington). And others, still, urged caution: "Although we advocate some changes to the current system, we would caution those that propose changes beware of the 'pendulum' effect, where we go from having too much regulation to having no regulation at all" (Illinois). "The rush to correct a problem has in the past created more problems than it solved. Care needs to be taken that anecdotal data and poor science are not substituted for careful evaluation of real data and development of a sound response" (Kansas). ''We must assure that public safety is not sacrificed in lieu of cost savings" (ASRT).