A

Access. See Patient access to radiation medicine

Accreditation Council on Graduate Medical Education, 127

Administrative Procedure Act, 18, 177

Adverse events.

See also Misadministration

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 Cardiology, 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

American College of Medical Physics, 268, 274, 275, 277, 279

American College of Nuclear Physicians, 34, 267, 275, 277

American College of Radiology, 12, 34, 47, 67-69, 73, 90, 144, 145 , 165, 267, 269-270, 271, 272, 274, 275, 276, 277-278, 279, 280

American Medical Association, 268, 276

American National Standards Institute, 73

American Radium Society, 249

American Roentgen Ray Society, 34, 249, 267, 270, 272, 273, 274-275, 276, 278, 279, 280

American Society for Therapeutic Radiology and Oncology, 34, 268, 275, 278

American Society of Radiologic Technologists, 268, 272-273, 275, 276, 278, 279, 280

Americium-241, 100-101

Anesthesia, 123, 124

Angiography, 45-46, 192

Angioplasty, 45 n.3

Appropriateness of care, 125-127

Association of Health Services Research, 34

Association of University Radiologists, 34

Atomic Energy Act of 1954, as amended, 1, 8, 23-24, 28, 80, 85, 251 -252, 256

Atomic Energy Commission, 6, 27 n.6, 28, 61, 81, 82, 90, 251, 252, 256, 286

B

Biologics Act of 1902, 79, 86

Blood transfusions, 123-124

Boron neutron capture therapy, 6 n.4, 41, 80 n.1, 108

Brachytherapy

applications, 40, 64, 65

defined, 193

dose rates, 71, 72

misadministration, 24-25, 26, 83

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;

Prostate cancer;

Radiation oncology

cases, by site, 66

defined, 193

radiogenic, 69, 112-113, 134, 136, 287-288

Carter, President, 253

Cesium-137, 71

Chemotherapy, 124, 193

Cholecystogram, 45

Code of Federal Regulations, Title 10

Part 20, 9, 16, 61-62, 100, 161, 174, 202-211, 274

Part 30, 101

Part 35, 6, 9, 15-16, 17, 61-62, 70, 80, 81, 83, 105, 108, 144, 14 , 174-175, 176, 177, 212-243;

see also Quality Management (QM) Rule

Part 50, 286

Parts 170 and 171, 94

recommended revisions, 15-16, 18, 176-177

Code of Federal Regulations, Title 21

Part 900, 51-52

Part 1020, 52

Committee on Interagency Radiation Research and Policy Coordination , 253, 271

Committee on the Biological Effects of Ionizing Radiation, 286, 287 -288

Committee on the Pathological Effects of Atomic Radiation, 285

Computed tomography, 40, 43-44, 45, 47, 48, 57, 90, 193

Conference of Radiation Control Program Directors

evolution of, 30, 254, 256

funding, 149, 151, 155-156, 166, 175

Profile of State and Local Radiation Control Programs, 90

regulations, 52, 90

role, 4-5, 12, 16, 17, 18, 19-20, 21, 88-89, 143, 145, 149, 150 n.1, 156, 165-166, 170, 172, 177-178, 268, 280

Congress

hearings on medical radiation regulation, 30-31

Joint Committee on Atomic Energy, 251, 285

recommendations to, 15-17, 20-21

Consumer-Patient Radiation Health Safety Act, 276-277

Coronary artery bypass graft, 125

Cost-benefit analysis, 36-37, 267

Costs of regulation

and access to radiation medicine, 269

in alternative systems, 146, 177-178

federalization alternative, 159-160

fees, 37, 94-96, 102, 108, 142, 267

fines collected, 96, 98, 99, 108

full-time-equivalent employees, 94, 96

misadministration rule, 83

nonfee, 98, 100-102

Nuclear Waste Fund appropriations, 94

radioactive waste management, 101-102

recordkeeping requirements, 98, 100

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 Radiopharmaceuticals, 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

accreditation standards for radiologic personnel, 30

authority, 3, 14

oversight shifted to, 10, 16-17, 156, 158, 159, 160, 161, 271

recommended role, 16-17, 20, 151, 166, 175

Department of Transportation, 3, 4, 16, 61, 73, 79, 142, 147, 149, 157, 160, 172, 175

Department of Veterans Affairs, 4, 121, 142, 154, 157, 166

Diagnostic nuclear medicine.

See also Radiopharmaceuticals

misadministrations, 118, 119

radiation doses, 56, 57, 61

regulation and control, 61-62

types of procedures, 40, 52-55

utilization rates, 55, 57, 118

Diagnostic uses of ionizing radiation. See Nuclear medicine;

Radiology

Dose. See Radiation dose

Drug Amendments of 1962, 86-87

DuPont Merck, 268

Dynamic conformal radiation therapy, 64

Dysprosium-165, 74

E

Education and training

accreditation, 276-279

health care professionals, 126-127, 152 n.2, 255, 272-273

patient, 273

public, 145, 153

recertification and ongoing training, 279

and risk, 272-273

Eisenhower, President, 251-252, 253

Embolotherapy, 45 n.3

Energy Reorganization Act of 1974, 28, 252

Energy Research and Development Agency, 61, 252

Environmental Protection Agency, 3, 4, 16, 61, 79, 88, 142, 160, 172, 175, 253, 254, 255, 286

Exposure to radiation.

See also Radiation dose

ALARA concept, 105, 115, 172, 274, 285, 286

assessment, 112

background, 42, 50

criteria and standards, 89, 105, 106-107

entrance skin air kerma index, 42, 48, 49

entrance skin exposure index, 39, 42

human studies of, 113-114

low-level, 112-113, 115

measures of, 39, 42, 50 n.4

occupational, 52

unintended, 116-117

External beam x-ray therapy, 40

F

Federal Food, Drug, and Cosmetic Act of 1938, 86, 145, 255

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

proposed roles, 145, 147, 149, 156-157, 177

radiation dose tables and codes, 42

reporting requirements, 120, 122, 145, 153, 294

utilization surveys, 47

G

Gallium-67, 53, 61

Gamma camera, 53, 54-55

General Accounting Office, 8, 35, 82, 86, 120, 257

German Roentgen Society, 249

GI series, 45

Glenn, John (NRC), 124

Glenn, John H., 1, 23, 30, 31

Gold-198, 72, 74, 82

H

Harvard Medical Practice studies, 117, 122

Health Care Financing Administration, 5, 123, 142, 147

Health Finance Agency (hypothetical), 10-11, 161-162, 163-164

Health Physics Society, 272, 274

Hearings. See Public hearings

Hodgkin's disease, 69

I

Illinois Department of Nuclear Safety, 269

Illinois, State of, 267, 268, 273, 274, 276-277, 278-279, 279, 280

Indiana Regional Cancer Center, 25

Indium-111, 61

Injury. See Radiation injury

International Atomic Energy Agency, 73

International Commission on Radiological Protection, 42, 112, 114, 115, 250, 251, 274, 286

Intraluminal thrombolytic therapy, 45 n.3

Intraoperative radiation therapy, 63

Iodine-123, 53

Iodine-125, 26, 71, 72, 84

Iodine-131, 53, 57, 62, 74, 75, 84

Ionizing radiation in medicine

benefits/applications, 3, 26-27, 39, 40-41, 52-55, 62-63, 171, 172 -173, 291

defined, 24, 195-196

source-specific regulation, 15, 16, 24, 36, 75, 173-174

units, 250

Iridium-192, 25, 71, 72

Isotopics, 34

J

Joint Commission of the Accreditation of Healthcare Organizations, 18, 20, 50 n.4, 84, 121, 122, 144, 145, 177, 274-275, 276

K

Kansas, State of, 274, 280

Kentucky, State of, 268

L

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

Mammography Quality Standards Act, 37, 51-52, 88, 90, 142, 151, 158 , 165, 255

Manhattan Project, 61, 196, 250

Manufacture

of byproduct material, 13, 16, 151, 152, 154, 165-166, 175

of equipment, 51

Medicaid, 4, 147, 161

Medical Device Amendment, 87, 255.

See also Safe Medical Device Act

Medical Use Program (NRC)

administration, 6, 27-28, 80-81

Agreement States and, 7, 28, 81, 172

elimination of, 4, 15-16, 144-145, 173, 174-175, 296, 297 n.14

enforcement, 7, 17, 81, 98-100, 144, 295

inspections, 6-7, 81

internal review, 1, 31

Institute of Medicine review, 1, 2, 24, 27, 30-37

reporting requirements, 18, 121, 144, 176, 294, 295

responsibilities and activities, 28-29, 80

sanctions, 7, 81, 96, 98, 99, 108

scope, 5-6, 80-81

violations, 7;

see also Misadministration

Medicare, 4, 147, 161

Meetings. See Public meetings

Misadministration.

See also Adverse events

causes, 83

defined, 1 n.1, 23 n.1, 62, 82, 83, 197, 269

examples, 25-26, 84

human error, 117

Indiana, Pennsylvania, incident, 1, 2, 23, 24-25, 27, 152

investigation, 152

notification of patients, 295-296

rates, 17, 18, 37, 39, 83, 104, 117-121, 136, 143, 270, 272, 292-293

reporting, 8, 70, 73, 82-83, 84, 86, 88, 119 n.4, 153, 269-270, 292 n.5, 294, 295

rule, 82-84

Models/modeling

linear, no-threshold, 112-113, 115, 116, 128, 136, 196, 251, 284-288

linear-quadratic, 287

tolerance dose, threshold, 114

Morgan, K. Z., 285

Myelogram, 45

N

Naturally occurring and accelerator-produced radioactive materials (NARM)

defined, 2 n.2, 24 n.5, 197

jurisdiction over, 28, 36, 89, 90, 92-93, 146, 154, 158, 293

medical applications, 40

National Advisory Committee on Radiation, 254

National Bureau of Standards, 250

National Center for Radiological Health, 254

National Council on Radiation Protection and Measurements, 34-35, 46, 50, 57, 73, 112, 114, 115, 160, 250, 251, 253, 256, 274, 284, 286

National Electrical Manufacturers Association, 267-268, 270, 271, 274, 275, 278

National Institute of Standards and Technology, 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 Council, 271

National Transportation Safety Board, 152

Nationwide Evaluation of X-Ray Trends program, 90

New York Hospital-Cornell Medical Center, 267, 269, 273, 278, 279

New York State Department of Health, 267-268, 274

Nixon, President, 253

North Carolina State Department of Environment, Health and Natural

Resources, 267-268

North Shore University Hospital, 267, 276

Nuclear imaging, 53-54

Nuclear medicine.

See also Brachytherapy;

Diagnostic nuclear medicine;

Radiation oncology;

Teletherapy;

Therapeutic nuclear medicine

benefits, 3

defined, 197

dosage levels, 56, 57, 61

NRC regulation of, 29

therapeutic applications, 40

Nuclear power, 129, 130, 131-132, 134, 136, 251-252, 255, 293

Nuclear Regulatory Commission (NRC).

See also Agreement State Program;

Costs of regulation;

Medical Use Program;

Regulation and control

adequacy of regulation, 290-291

Analysis and Evaluation of Operational Data, office for, 83

authority, 3-4, 13, 16, 23-24, 28-29, 30, 61, 69-70, 73, 79, 80-86, 141, 142, 144, 147, 151, 152, 154, 159, 165-166, 175, 256-257, 262 , 297

Authorized Nuclear Pharmacy Rule, 278

Food and Drug Administration cooperation with, 18, 33, 88, 145, 176

Final Statement of Principles and Policy for the Agreement State Program, 8-9, 86, 257

history, 251-252, 287

licensing of health care personnel, 126-127

Management Review Board, 85, 256-257

Medical Use Policy Statement, 17, 32, 82, 176, 294

Nuclear Medicine Safety and Safeguards division, 28

Office of Nuclear material Safety and Safeguards, 83

Office of Policy and Planning, 120

recommendations to, 17-19, 21, 154, 176-178

request to IOM, 1, 2, 24, 27, 30-37, 262, 290-291

O

Oak Ridge National Laboratory, 134, 251

Occupational Safety and Health Administration, 3, 52, 79, 160-161

Office of Management and Budget, 254

Oncology. See Radiation oncology

Outcomes. See Patient outcomes

Overuse of radiation medicine, 48

P

Palladium-103, 71-72

Patient access to radiation medicine, 3, 147, 173, 269

Patient outcomes, 68

Performance indicators, 86, 120, 153 n.3, 257, 271

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

announcement and request for testimony, 262-263

elements of, 33

invited organizations, 259-262

summaries, 266-280

topics, 264-265

Pure Food and Drugs Act of 1906, 79, 86

Pyelogram, 45

Q

Quality assurance programs, responsibility for, 274-275

Quality Management (QM) Rule

in Agreement States, 84, 256

costs of, 100, 108

intrusion into practice of medicine, 4, 18, 142, 269, 294-295

objectives, 7, 36, 85

Part 35

provisions, 6, 81, 84-85

program requirements, 62, 70, 73, 84, 269-270

Quality of care, 13, 17, 34

R

Radiation Control for Health and Safety Act, 29, 87, 254

Radiation dose

annual limit on intake, 100-101

brachytherapy, 71, 72

calculation, 42

collective, 42, 48, 50-51, 57, 61, 69

defined, 194

determinants, 48, 50 n.4

dose-response assessment, 112

effective dose equivalent, 42, 48, 49, 50, 57, 69, 193, 194, 251

maximum permissible, 196, 251, 253, 284

nuclear medicine procedures, 56, 57

patient-specific, 49-50, 57

radiation oncology, 65, 69

radiation protection guides, 253

radiology, 46-48

roentgens, 250

threshold, 114, 115

tolerance, 114, 250, 251

utilization and, 51

Radiation injury.

See also Misadministration

acute, 113, 192

iatrogenic, 117

late, 113, 115, 196

models of, 114-115

Radiation oncology

dose, 65, 69

defined, 198

examples of clinical use, 64-66

facilities and equipment, 67-68

general approach, 62-63

misadministrations, 118

outcomes, 68

palliative treatment, 63, 65, 198

Patterns of Care Studies, 67-69

regulation and control, 69-70

and secondary cancer, 69

therapeutic nuclear medicine, 74, 119

utilization rates, 65-69, 118, 119

Radiation Policy Council, 253

Radiation protection

history of, 114-115, 249-257

private and voluntary involvement in, 172, 177, 249-251;

see also individual organizations

standards, 274, 286-287

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.

See also Computed tomography;

Fluoroscopy;

Radiography

benefits, 3, 26-27

nonhospital-based, 47

radiation doses, 48-51

regulation and control, 51-52

types of procedures, 43-46

utilization rates, 46-48

Radionuclides

accelerator-produced, 40, 60-61, 73, 80, 92-93

annual limits on exposure, 100-101

biomedical applications, 58-61

brachytherapy, 71-72

defined, 2 n.2, 24 n.5, 199

half-life, 54-55, 71, 74

licensing, 62

reactor-produced, 58-59

regulation and control of, 61-62

risks from, 14-15, 75

in therapeutic nuclear medicine, 65, 73-74

transportation of, 79

Radiopharmaceuticals

applications, 40

defined, 52-53, 199

misadministration, 83

regulation, 88

standards, 91

tracer compounds, 53

Radium, 40, 80

Radium-226, 71

Radon, 131, 132

RAND Corporation, 125

Reagan, President, 253

Recommendations

to Conference of Radiation Control

Program Directors, 19-20, 21, 178, 179

to Congress, 15-17, 20-21, 174-175

to NRC, 17-19, 21, 176-178

NRC-requested, 32-33

to states, 19-20, 21, 178

Regulation and control.

See also Costs of regulation;

Nuclear Regulatory Commission

adequacy of safeguards, 266-268

administrative requirements, 105, 108

brachytherapy, 72-73, 84

chronology, 246-248

cobalt teletherapy, 84

committee concerns, 116

diagnostic x-rays, 51

fragmentation and disproportionality in, 105, 144, 146, 171

goals, 77-78, 173, 179

of health care delivery, 78-79

professional self-regulation, 249-251

radiation oncology, 69-70

radionuclides and radiopharmaceuticals, 61-62

report premises, 170

and risks from radiation, 14-15, 16, 24, 31, 37-38, 75, 111, 128, 132, 143, 170, 171, 272-273, 279-280, 291-292

therapeutic nuclear medicine, 75, 84

Regulations. See Code of Federal Regulations

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

Research, radiation medicine, 153

Risks from radiation.

See also Adverse events;

Misadministration

assessment, 111-116, 127-128, 136

asymmetry principle, 134

characterization, 112;

see also Models/modeling

coefficients, 51, 199

communication and trust, 133-134, 163

comparisons, 124-125, 133

dread factor, 129, 136

education and training and, 272-273

nuclear power, 129, 130, 131-132, 134, 136

patient education, 273

psychometric paradigm, 129

public perceptions of, 128-135, 153

radon, 131, 132

regulation and, 3, 14-15, 16, 24, 31, 37-38, 75, 111, 128, 132, 143 , 170, 171, 272-273, 279-280, 291-292

''signal value" of events, 133

source of exposure and, 130-131

unintended exposures, 116-117, 127

unknown factor, 129, 136

x-rays, 129, 130, 132

Riverside Methodist Hospital, 82

S

Safe Medical Device Act, 29, 70, 88, 156-157

Selin, Ivan, 31

Single photon emission computed tomography, 54

Sloan-Kettering Memorial Cancer Center, 279

Society for Nuclear Medicine, 35, 267

Society of Medical Physics, 35

State regulation.

See also Agreement State Program

authority and responsibility, 88-91, 170

brachytherapy, 73

federal assistance to, 152

fees, 91

framework, 79-80

history, 255-257

legislative authority for licensing and registration, 92-93

proposed roles, 147, 148-158, 164-165, 167

radiography, 51, 52

radiation health programs, 30

recommendations to, 19-20, 21, 178-179

teletherapy, 69-70

Stereotactic radiosurgery, 63-64, 65

Strontium-89, 74

Strontium-90, 72

Suggested State Regulations for the Control of Radiation, 4-5, 12, 16, 19, 52, 90, 149, 150, 152, 154, 156, 157, 165, 170, 172, 178, 256

Syncor, 267, 271, 272, 274, 278

T

Taylor, Lauriston, 250

Technetium-99m, 53, 55

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

radionuclides used for, 74-75

regulation and control, 7, 75, 84, 89

types of procedures, 74

utilization, 118

Three Mile Island accident, 132, 136

Tracer principle, 53

U

Ultrasound, 41, 43, 45, 47, 48, 272

United Nations Scientific Committee on the Effects of Atomic Radiation , 115, 284-285, 288

United States Pharmacopoeia, 91, 118 n.2

University of Chicago Hospital, 117

Utilization rates

dose and, 51

nuclear medicine procedures, 55, 57, 118

Patterns of Care Studies, 67-69

radiation oncology, 65-69, 118

radiology, 45, 46-48, 51

W

Washington Hospital Center, 84

Washington State Department of Health, 267-268, 280

Waste disposal. See Radioactive waste management

X

Xenon-133

X-ray

defined, 200

equipment, 51, 52, 200, 250

procedures, 27 n.7, 40

risk perceptions, 129, 130, 132

standards, 89, 255, 273