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INDEX 299 Index A American College of Medical Physics, 268, 274, 275, 277, 279 Access. See Patient access to radiation American College of Nuclear Physicians, medicine 34, 267, 275, 277 Accreditation Council on Graduate Medi- American College of Radiology, 12, 34, cal Education, 127 47, 67-69, 73, 90, 144, 145 , Administrative Procedure Act, 18, 177 165, 267, 269-270, 271, 272, 274, Adverse events. 275, 276, 277-278, 279, 280 See also Misadministration American Medical Association, 268, 276 anesthesia, 123 blood transfusions, 123-124 data availability, 120-121, 153, 171 human error, 117 iatrogenic injury, 117 inappropriate and unnecessary care, 125-127 nonradiological medical interventions, 121-125 prescription drugs, 122-123 rates, 118 n.3, 124-125, 136 reduction strategies, 126-127 Agreement State Program (NRC) administration, 3, 8-9, 19, 42 brachytherapy regulation, 73 costs, 19, 91, 108, 146, 177-178 establishment, 256 and Medical Use Program, 7, 28 and misadministrations, 118, 119 NRC oversight, 6, 8-9, 28, 85-86 participants and nonparticipants, 244-245 performance indicators, 86 and quality management rule, 84, 256 radionuclide regulation, 61 teletherapy regulation, 69-70 American Association for Nuclear Cardi- ology, 279 American Association of Physicists in Medicine, 73, 269, 273, 274, 275, 277, 280 American Board of Nuclear Medicine, 267, 268, 269, 272, 273, 275, 277, 279, 280 American Board of Radiology, 267-268 American Cancer Society, 64
INDEX 300 American National Standards Institute, 73 Prostate cancer; American Radium Society, 249 Radiation oncology American Roentgen Ray Society, 34, 249, cases, by site, 66 267, 270, 272, 273, 274-275, 276, defined, 193 278, 279, 280 radiogenic, 69, 112-113, 134, 136, American Society for Therapeutic Radiol- 287-288 ogy and Oncology, 34, 268, 275, 278 Carter, President, 253 American Society of Radiologic Technol- Cesium-137, 71 ogists, 268, 272-273, 275, 276, 278, Chemotherapy, 124, 193 279, 280 Cholecystogram, 45 Americium-241, 100-101 Code of Federal Regulations, Title 10 Anesthesia, 123, 124 Part 20, 9, 16, 61-62, 100, 161, 174, Angiography, 45-46, 192 202-211, 274 Angioplasty, 45 n.3 Part 30, 101 Appropriateness of care, 125-127 Part 35, 6, 9, 15-16, 17, 61-62, 70, 80, Association of Health Services Research, 81, 83, 105, 108, 144, 14 , 34 174-175, 176, 177, 212-243; Association of University Radiologists, 34 see also Quality Management (QM) Rule Atomic Energy Act of 1954, as amended, Part 50, 286 1, 8, 23-24, 28, 80, 85, 251-252, 256 Parts 170 and 171, 94 Atomic Energy Commission, 6, 27 n.6, recommended revisions, 15-16, 18, 28, 61, 81, 82, 90, 251, 252, 256, 286 176-177 Code of Federal Regulations, Title 21 Part 900, 51-52 B Part 1020, 52 Biologics Act of 1902, 79, 86 Committee on Interagency Radiation Blood transfusions, 123-124 Research and Policy Coordination Boron neutron capture therapy, 6 n.4, 41, , 253, 271 80 n.1, 108 Committee on the Biological Effects of Brachytherapy Ionizing Radiation, 286, 287-288 applications, 40, 64, 65 Committee on the Pathological Effects of defined, 193 Atomic Radiation, 285 dose rates, 71, 72 Computed tomography, 40, 43-44, 45, 47, misadministration, 24-25, 26, 83 48, 57, 90, 193 overview, 70-72 patient outcomes, 68 radionuclides used in, 71-72 regulation and control, 7, 72-73, 84, 89 risks, 273 types of procedures, 72 utilization, 119 Breast cancer, 44, 63, 64, 69, 72 Bureau of Medical Devices, 254 Bureau of the Budget, 253 Byproduct material. See also Radionuclides defined, 23-24 n.3, 193 medical applications, 40, 27 n.7 C Cancer. See also Breast cancer;
INDEX 301 Conference of Radiation Control Program accreditation standards for radiologic Directors personnel, 30 evolution of, 30, 254, 256 authority, 3, 14 funding, 149, 151, 155-156, 166, 175 oversight shifted to, 10, 16-17, 156, 158, Profile of State and Local Radiation 159, 160, 161, 271 Control Programs, 90 recommended role, 16-17, 20, 151, 166, regulations, 52, 90 175 role, 4-5, 12, 16, 17, 18, 19-20, 21, Department of Transportation, 3, 4, 16, 88-89, 143, 145, 149, 150 n.1, 156, 61, 73, 79, 142, 147, 149, 157, 160, 165-166, 170, 172, 177-178, 268, 280 172, 175 Congress Department of Veterans Affairs, 4, 121, hearings on medical radiation regula- 142, 154, 157, 166 tion, 30-31 Diagnostic nuclear medicine. Joint Committee on Atomic Energy, See also Radiopharmaceuticals 251, 285 misadministrations, 118, 119 recommendations to, 15-17, 20-21 radiation doses, 56, 57, 61 Consumer-Patient Radiation Health regulation and control, 61-62 Safety Act, 276-277 types of procedures, 40, 52-55 Coronary artery bypass graft, 125 utilization rates, 55, 57, 118 Cost-benefit analysis, 36-37, 267 Diagnostic uses of ionizing radiation. See Costs of regulation Nuclear medicine; and access to radiation medicine, 269 Radiology in alternative systems, 146, 177-178 Dose. See Radiation dose federalization alternative, 159-160 Drug Amendments of 1962, 86-87 fees, 37, 94-96, 102, 108, 142, 267 DuPont Merck, 268 fines collected, 96, 98, 99, 108 Dynamic conformal radiation therapy, 64 full-time-equivalent employees, 94, 96 Dysprosium-165, 74 misadministration rule, 83 nonfee, 98, 100-102 Nuclear Waste Fund appropriations, 94 E radioactive waste management, 101-102 Education and training recordkeeping requirements, 98, 100 accreditation, 276-279 reforms in, 102-104 savings from deregulation (estimated), 102, 103 security requirements, 100-101 separation of, 18-19 Council of State Governments, 19, 90, 178, 256 Council on Radionuclides and Radiophar- maceuticals, 267, 275 Cyclotrons, 40, 41, 53, 194 D Dana-Farber Institute, 117 de Planque, E. Gail, 124 Department of Defense, 4, 142, 154, 157, 166, 254 Department of Education, 278-279 Department of Energy, 3, 61, 79, 94, 149, 252, 287 Department of Health and Human Services
INDEX 302 health care professionals, 126-127, 152 proposed roles, 145, 147, 149, 156-157, n.2, 255, 272-273 177 patient, 273 radiation dose tables and codes, 42 public, 145, 153 reporting requirements, 120, 122, 145, recertification and ongoing training, 279 153, 294 and risk, 272-273 utilization surveys, 47 Eisenhower, President, 251-252, 253 Embolotherapy, 45 n.3 Energy Reorganization Act of 1974, 28, G 252 Gallium-67, 53, 61 Energy Research and Development Gamma camera, 53, 54-55 Agency, 61, 252 General Accounting Office, 8, 35, 82, 86, Environmental Protection Agency, 3, 4, 120, 257 16, 61, 79, 88, 142, 160, 172, 175, German Roentgen Society, 249 253, 254, 255, 286 GI series, 45 Exposure to radiation. Glenn, John (NRC), 124 See also Radiation dose Glenn, John H., 1, 23, 30, 31 ALARA concept, 105, 115, 172, 274, Gold-198, 72, 74, 82 285, 286 assessment, 112 background, 42, 50 H criteria and standards, 89, 105, 106-107 entrance skin air kerma index, 42, 48, 49 Harvard Medical Practice studies, 117, 122 entrance skin exposure index, 39, 42 Health Care Financing Administration, 5, human studies of, 113-114 123, 142, 147 low-level, 112-113, 115 Health Finance Agency (hypothetical), measures of, 39, 42, 50 n.4 10-11, 161-162, 163-164 occupational, 52 Health Physics Society, 272, 274 unintended, 116-117 Hearings. See Public hearings External beam x-ray therapy, 40 Hodgkin's disease, 69 F I Illinois Department of Nuclear Safety, 269 Federal Food, Drug, and Cosmetic Act of 1938, 86, 145, 255 Illinois, State of, 267, 268, 273, 274, 276-277, 278-279, 279, 280 Federal Radiation Council, 253, 271, 285 Florida State Department of Health and Rehabilitative Services, 268 , 270, 273, 275, 276, 278, 279 Fluoroscopy, 40, 43, 50, 104 n.8, 128, 195 Food and Drug Administration Adverse Drug Reaction Voluntary Reporting Program, 122 authority, 3, 4, 12, 16, 17, 70, 79, 86-89, 142, 146, 172, 175, 271 Bureau of Radiologic Health, 29-30, 254 Center for Biologics Evaluation and Research, 123 Center for Devices and Radiological Health, 17, 29-30, 33, 50 n.4, 159, 175, 254-255 NRC cooperation with, 18, 33, 88, 145, 176
INDEX 303 Indiana Regional Cancer Center, 25 Mammography Quality Standards Act, 37, Indium-111, 61 51-52, 88, 90, 142, 151, 158 , 165, 255 Injury. See Radiation injury Manhattan Project, 61, 196, 250 International Atomic Energy Agency, 73 Manufacture International Commission on Radiological of byproduct material, 13, 16, 151, 152, Protection, 42, 112, 114, 115, 250, 154, 165-166, 175 251, 274, 286 of equipment, 51 Intraluminal thrombolytic therapy, 45 n.3 Medicaid, 4, 147, 161 Intraoperative radiation therapy, 63 Medical Device Amendment, 87, 255. Iodine-123, 53 See also Safe Medical Device Act Iodine-125, 26, 71, 72, 84 Medical Use Program (NRC) Iodine-131, 53, 57, 62, 74, 75, 84 administration, 6, 27-28, 80-81 Ionizing radiation in medicine Agreement States and, 7, 28, 81, 172 benefits/applications, 3, 26-27, 39, elimination of, 4, 15-16, 144-145, 173, 40-41, 52-55, 62-63, 171, 172 -173, 174-175, 296, 297 n.14 291 enforcement, 7, 17, 81, 98-100, 144, 295 defined, 24, 195-196 inspections, 6-7, 81 source-specific regulation, 15, 16, 24, internal review, 1, 31 36, 75, 173-174 Institute of Medicine review, 1, 2, 24, units, 250 27, 30-37 Iridium-192, 25, 71, 72 reporting requirements, 18, 121, 144, Isotopics, 34 176, 294, 295 responsibilities and activities, 28-29, 80 sanctions, 7, 81, 96, 98, 99, 108 J scope, 5-6, 80-81 Joint Commission of the Accreditation of violations, 7; Healthcare Organizations, 18, 20, 50 see also Misadministration n.4, 84, 121, 122, 144, 145, 177, Medicare, 4, 147, 161 274-275, 276 Meetings. See Public meetings Misadministration. See also Adverse events K causes, 83 defined, 1 n.1, 23 n.1, 62, 82, 83, 197, 269 Kansas, State of, 274, 280 examples, 25-26, 84 Kentucky, State of, 268 human error, 117 Indiana, Pennsylvania, incident, 1, 2, 23, L 24-25, 27, 152 investigation, 152 Legislation federal; see individual statutes state, 19-20 Leukemia, 69 Lewis, E. B., 285 Linear accelerators, 26, 29, 37, 40, 41, 63-64, 70, 105, 119, 196, 268, 273 M Magnetic resonance imaging, 41, 43, 44, 45, 47, 48, 57, 196, 272 Mallinckrodt Medical Inc., 267 Mammography, 12, 26, 44, 51, 274
INDEX 304 notification of patients, 295-296 North Carolina State Department of Envi- rates, 17, 18, 37, 39, 83, 104, 117-121, ronment, Health and Natural 136, 143, 270, 272, 292-293 Resources, 267-268 reporting, 8, 70, 73, 82-83, 84, 86, 88, North Shore University Hospital, 267, 276 119 n.4, 153, 269-270, 292 n.5, 294, Nuclear imaging, 53-54 295 Nuclear medicine. rule, 82-84 See also Brachytherapy; Models/modeling Diagnostic nuclear medicine; linear, no-threshold, 112-113, 115, 116, Radiation oncology; 128, 136, 196, 251, 284-288 Teletherapy; linear-quadratic, 287 Therapeutic nuclear medicine tolerance dose, threshold, 114 benefits, 3 Morgan, K. Z., 285 defined, 197 Myelogram, 45 dosage levels, 56, 57, 61 NRC regulation of, 29 therapeutic applications, 40 N Nuclear power, 129, 130, 131-132, 134, Naturally occurring and accelerator- 136, 251-252, 255, 293 produced radioactive materials Nuclear Regulatory Commission (NRC). (NARM) See also Agreement State Program; defined, 2 n.2, 24 n.5, 197 Costs of regulation; jurisdiction over, 28, 36, 89, 90, 92-93, Medical Use Program; 146, 154, 158, 293 Regulation and control medical applications, 40 adequacy of regulation, 290-291 National Advisory Committee on Radia- Analysis and Evaluation of Operational tion, 254 Data, office for, 83 National Bureau of Standards, 250 authority, 3-4, 13, 16, 23-24, 28-29, 30, National Center for Radiological Health, 61, 69-70, 73, 79, 80-86, 141, 142, 254 144, 147, 151, 152, 154, 159, National Council on Radiation Protection 165-166, 175, 256-257, 262 , 297 and Measurements, 34-35, 46, 50, Authorized Nuclear Pharmacy Rule, 278 57, 73, 112, 114, 115, 160, 250, 251, 253, 256, 274, 284, 286 National Electrical Manufacturers Associa- tion, 267-268, 270, 271, 274, 275, 278 National Institute of Standards and Tech- nology, 73 National Institutes of Health, 153 National Physical Laboratory (Great Britain), 250 National Research Council Committee on the Biological Effects of Ionizing Radiation, 112, 115 National Science and Technology Coun- cil, 271 National Transportation Safety Board, 152 Nationwide Evaluation of X-Ray Trends program, 90 New York Hospital-Cornell Medical Cen- ter, 267, 269, 273, 278, 279 New York State Department of Health, 267-268, 274 Nixon, President, 253
INDEX 305 Food and Drug Administration coopera- announcement and request for testi- tion with, 18, 33, 88, 145, 176 mony, 262-263 Final Statement of Principles and Policy elements of, 33 for the Agreement State Program, invited organizations, 259-262 8-9, 86, 257 summaries, 266-280 history, 251-252, 287 topics, 264-265 licensing of health care personnel, Pure Food and Drugs Act of 1906, 79, 86 126-127 Pyelogram, 45 Management Review Board, 85, 256-257 Medical Use Policy Statement, 17, 32, 82, 176, 294 Q Nuclear Medicine Safety and Safe- Quality assurance programs, responsibil- guards division, 28 ity for, 274-275 Office of Nuclear material Safety and Quality Management (QM) Rule Safeguards, 83 in Agreement States, 84, 256 Office of Policy and Planning, 120 costs of, 100, 108 recommendations to, 17-19, 21, 154, intrusion into practice of medicine, 4, 176-178 18, 142, 269, 294-295 request to IOM, 1, 2, 24, 27, 30-37, 262, objectives, 7, 36, 85 290-291 Part 35 provisions, 6, 81, 84-85 program requirements, 62, 70, 73, 84, O 269-270 Oak Ridge National Laboratory, 134, 251 Quality of care, 13, 17, 34 Occupational Safety and Health Adminis- tration, 3, 52, 79, 160-161 Office of Management and Budget, 254 R Oncology. See Radiation oncology Radiation Control for Health and Safety Outcomes. See Patient outcomes Act, 29, 87, 254 Overuse of radiation medicine, 48 Radiation dose annual limit on intake, 100-101 brachytherapy, 71, 72 P calculation, 42 Palladium-103, 71-72 collective, 42, 48, 50-51, 57, 61, 69 Patient access to radiation medicine, 3, defined, 194 147, 173, 269 determinants, 48, 50 n.4 Patient outcomes, 68 dose-response assessment, 112 Performance indicators, 86, 120, 153 n.3, effective dose equivalent, 42, 48, 49, 50, 257, 271 57, 69, 193, 194, 251 Pfahlerm, George, 249-250 Phosphorus-32, 74 Plaques, radioactive, 26 Prostate cancer, 64-65, 68-69, 72 Pollycove, Myron, 124 Positron emission tomography, 53, 198 Prescription drugs, 122-123 Public Health Service, 29, 90, 142, 154, 157, 166, 253-254 Public Law 83-703, 85 Public hearings participants, 265-266 scope of, 33 Public meetings
INDEX 306 maximum permissible, 196, 251, 253, See also Computed tomography; 284 Fluoroscopy; nuclear medicine procedures, 56, 57 Radiography patient-specific, 49-50, 57 benefits, 3, 26-27 radiation oncology, 65, 69 nonhospital-based, 47 radiation protection guides, 253 radiation doses, 48-51 radiology, 46-48 regulation and control, 51-52 roentgens, 250 types of procedures, 43-46 threshold, 114, 115 utilization rates, 46-48 tolerance, 114, 250, 251 Radionuclides utilization and, 51 accelerator-produced, 40, 60-61, 73, 80, Radiation injury. 92-93 See also Misadministration annual limits on exposure, 100-101 acute, 113, 192 biomedical applications, 58-61 iatrogenic, 117 brachytherapy, 71-72 late, 113, 115, 196 defined, 2 n.2, 24 n.5, 199 models of, 114-115 half-life, 54-55, 71, 74 Radiation oncology licensing, 62 dose, 65, 69 reactor-produced, 58-59 defined, 198 regulation and control of, 61-62 examples of clinical use, 64-66 risks from, 14-15, 75 facilities and equipment, 67-68 in therapeutic nuclear medicine, 65, general approach, 62-63 73-74 misadministrations, 118 transportation of, 79 outcomes, 68 Radiopharmaceuticals palliative treatment, 63, 65, 198 applications, 40 Patterns of Care Studies, 67-69 defined, 52-53, 199 regulation and control, 69-70 misadministration, 83 and secondary cancer, 69 regulation, 88 therapeutic nuclear medicine, 74, 119 standards, 91 utilization rates, 65-69, 118, 119 tracer compounds, 53 Radiation Policy Council, 253 Radium, 40, 80 Radiation protection Radium-226, 71 history of, 114-115, 249-257 Radon, 131, 132 private and voluntary involvement in, RAND Corporation, 125 172, 177, 249-251; Reagan, President, 253 see also individual organizations Recommendations standards, 274, 286-287 to Conference of Radiation Control Radiation safety officers, 98, 100-102, 105 Radiation synoviorthesis, 74 Radioactive waste management costs of, 101-102 half-life and, 55 n.5 risk perceptions, 131-132 Radiography, 40. See also Mammography contrast studies, 45-46 conventional examinations, 44 physical principles, 43 utilization rates, 45 Radioimmunotherapy, 74 Radiological Society of North America, 35, 267, 270, 272, 275, 278 Radiology.
INDEX 307 Program Directors, 19-20, 21, 178, 179 Research, radiation medicine, 153 to Congress, 15-17, 20-21, 174-175 Risks from radiation. to NRC, 17-19, 21, 176-178 See also Adverse events; NRC-requested, 32-33 Misadministration to states, 19-20, 21, 178 assessment, 111-116, 127-128, 136 Regulation and control. asymmetry principle, 134 See also Costs of regulation; characterization, 112; Nuclear Regulatory Commission see also Models/modeling adequacy of safeguards, 266-268 coefficients, 51, 199 administrative requirements, 105, 108 communication and trust, 133-134, 163 brachytherapy, 72-73, 84 comparisons, 124-125, 133 chronology, 246-248 dread factor, 129, 136 cobalt teletherapy, 84 education and training and, 272-273 committee concerns, 116 nuclear power, 129, 130, 131-132, 134, diagnostic x-rays, 51 136 fragmentation and disproportionality in, patient education, 273 105, 144, 146, 171 psychometric paradigm, 129 goals, 77-78, 173, 179 public perceptions of, 128-135, 153 of health care delivery, 78-79 radon, 131, 132 professional self-regulation, 249-251 regulation and, 3, 14-15, 16, 24, 31, radiation oncology, 69-70 37-38, 75, 111, 128, 132, 143 , 170, radionuclides and radiopharmaceuticals, 171, 272-273, 279-280, 291-292 61-62 ''signal value" of events, 133 report premises, 170 source of exposure and, 130-131 and risks from radiation, 14-15, 16, 24, unintended exposures, 116-117, 127 31, 37-38, 75, 111, 128, 132, 143, unknown factor, 129, 136 170, 171, 272-273, 279-280, 291-292 x-rays, 129, 130, 132 therapeutic nuclear medicine, 75, 84 Riverside Methodist Hospital, 82 Regulations. See Code of Federal Regula- tions Regulatory systems. See also Regulation and control alternative, 9-14, 143-167 assessment of, 162-167 criticism of, 104-108, 141-142 evolution of, 29-30 federal limited authority, 12, 156-158, 165 federal centralized authority, 11, 158-161, 164, 270-272 framework (current), 3-9, 78-91 Health Finance Agency approach, 10-11, 161-162, 163-164 market-based (laissez faire) approach, 9-10, 146-148, 163 overlapping jurisdictions, 88 sources of ionizing radiation and, 15, 16, 24, 36, 75, 173-174 state regulation exclusively, 11-12, 148-151, 164-165 state regulation with federal guidance, 12-14, 15-22, 151-156, 165 -167, 174-180, 296-298 status-quo alternatives, 10, 143-146, 163
INDEX 308 S radionuclides used for, 74-75 regulation and control, 7, 75, 84, 89 Safe Medical Device Act, 29, 70, 88, types of procedures, 74 156-157 utilization, 118 Selin, Ivan, 31 Three Mile Island accident, 132, 136 Single photon emission computed tomog- Tracer principle, 53 raphy, 54 Sloan-Kettering Memorial Cancer Center, 279 U Society for Nuclear Medicine, 35, 267 Society of Medical Physics, 35 Ultrasound, 41, 43, 45, 47, 48, 272 State regulation. United Nations Scientific Committee on See also Agreement State Program the Effects of Atomic Radiation authority and responsibility, 88-91, 170 , 115, 284-285, 288 brachytherapy, 73 United States Pharmacopoeia, 91, 118 n.2 federal assistance to, 152 University of Chicago Hospital, 117 fees, 91 Utilization rates framework, 79-80 dose and, 51 history, 255-257 nuclear medicine procedures, 55, 57, 118 legislative authority for licensing and Patterns of Care Studies, 67-69 registration, 92-93 radiation oncology, 65-69, 118 proposed roles, 147, 148-158, 164-165, radiology, 45, 46-48, 51 167 radiography, 51, 52 W radiation health programs, 30 recommendations to, 19-20, 21, 178-179 Washington Hospital Center, 84 teletherapy, 69-70 Washington State Department of Health, Stereotactic radiosurgery, 63-64, 65 267-268, 280 Strontium-89, 74 Waste disposal. See Radioactive waste Strontium-90, 72 management Suggested State Regulations for the Con- trol of Radiation, 4-5, 12, 16, 19, 52, 90, 149, 150, 152, 154, 156, 157, X 165, 170, 172, 178, 256 Xenon-133 Syncor, 267, 271, 272, 274, 278 X-ray defined, 200 equipment, 51, 52, 200, 250 T procedures, 27 n.7, 40 Taylor, Lauriston, 250 risk perceptions, 129, 130, 132 Technetium-99m, 53, 55 standards, 89, 255, 273 Teletherapy applications, 40 cobalt, 68, 70, 82, 84, 273 defined, 200 general approach, 63, 72 misadministration, 25-26, 82, 83 regulation, 7, 69-70, 84, 89, 273 utilization, 119 Texas Department of Health, 267, 270, 273, 274 Thallium-201, 53, 61 Therapeutic nuclear medicine misadministrations, 118, 119 overview, 73-74
