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Improving Breast Imaging Quality Standards
IMPROVING BREAST IMAGING QUALITY STANDARDS
Sharyl Nass and John Ball, Editors
Committee on Improving Mammography Quality Standards
National Cancer Policy Board
INSTITUTE OF MEDICINE AND NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C. www.nap.edu
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THE NATIONAL ACADEMIES PRESS
500 Fifth Street, N.W. Washington, DC 20001
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
This study was supported by Contract No. 223–01–2460-T16 between the National Academy of Sciences and the Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for this project.
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Library of Congress Control Number: 2005929662
Additional copies of this report are available from the
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For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.
Copyright 2005 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America.
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THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J.Cicerone is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A.Wulf is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V.Fineberg is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J.Cicerone and Dr. Wm. A. Wulf are chairman and vice chairman, respectively, of the National Research Council.
www.national-academies.org
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COMMITTEE ON IMPROVING MAMMOGRAPHY QUALITY STANDARDS
JOHN R.BALL, M.D., J.D. (Chair), Executive Vice President,
American Society for Clinical Pathology, Chicago, IL
PATRICIA A.CARNEY, Ph.D., Cancer Control Program Director,
Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH
HOWARD FORMAN, M.D., M.B.A., Vice Chairman and Associate Professor of Diagnostic Radiology,
Yale University School of Medicine, New Haven, CT
JANE E.HENNEY, M.D., Senior Vice President and Provost for Health Affairs,
University of Cincinnati, OH
MARIA CAROLINA HINESTROSA, M.P.H., Executive Vice President,
Programs and Planning, National Breast Cancer Coalition, Washington, DC
BRADLEY HUTTON, M.P.H., Director,
Cancer Services Program, New York State Department of Health, Albany, NY
CATHERINE PARSONS, R.T., Administrative Director of Medical Imaging,
Cumberland Medical Center, Crossville, TN
ETTA D.PISANO, M.D., Professor of Radiology and Biomedical Engineering, Director,
Biomedical Research Imaging Center, University of North Carolina School of Medicine, Chapel Hill
EDWARD SALSBERG, M.P.A., Director,
Center for Workforce Studies, Association of American Medical Colleges, Washington, DC
ROBERT A.SMITH, Ph.D., Director of Cancer Screening,
American Cancer Society, Atlanta, GA
STEPHEN TAPLIN, M.D., M.P.H., Senior Scientist,
Applied Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD
Liaison for the National Cancer Policy Board
TIMOTHY EBERLEIN, M.D., Bixby Professor and Chairman,
Department of Surgery, Washington University School of Medicine, St. Louis, MO
Consultants
Volunteers for the Duration of the Study:
PRISCILLA F.BUTLER, M.S., Senior Director,
Breast Imaging Accreditation Programs, Department of Quality and Safety, American College of Radiology, Reston, VA
BARBARA MONSEES, M.D.,
Mallinckrodt Institute of Radiology, St. Louis, MO
LAWRENCE N.ROTHENBERG, Ph.D.,
Department of Medical Physics, Memorial Sloan-Kettering Cancer Center, New York, NY
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EDWARD A.SICKLES, M.D.,
Department of Radiology, University of California, San Francisco Medical Center
Short-Term Volunteers:
MARTIN L.BROWN, Ph.D.,
Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD
DIONE FARRIA,
Mallinckrodt Institute of Radiology, St. Louis, MO
Paid Consultants:
JONATHAN SUNSHINE, Senior Director for Research,
American College of Radiology, Reston, VA
PAUL WING, Deputy Director,
Center for Health Workforce Studies, State University of New York (SUNY) School of Public Health, Rensselaer
Study Staff
SHARYL J.NASS, Ph.D., Study Director
ROGER HERDMAN, M.D., Director,
National Cancer Policy Board
KATHRYN BARLETTA, Research Assistant
MARY ANN PRYOR, Senior Project Assistant
ANIKE JOHNSON, Administrative Assistant
JULIE WILTSHIRE, Financial Associate
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NATIONAL CANCER POLICY BOARD
JOSEPH V.SIMONE, M.D. (Chair), President,
Simone Consulting, Dunwoody, GA
BRUCE W.STILLMAN, Ph.D. (Vice-Chair), Director,
Cold Spring Harbor Laboratory, Cold Spring Harbor, NY
ELLEN STOVALL (Vice-Chair), Executive Director,
National Coalition for Cancer Survivorship, Silver Spring, MD
JILL BARGONETTI, Ph.D., Associate Professor,
Department of Biological Sciences, Hunter College, New York, NY
TIMOTHY EBERLEIN, M.D., Bixby Professor and Chairman,
Washington University School of Medicine, St. Louis, MO
KATHY GIUSTI,
The Multiple Myeloma Research Foundation, New Canaan, CT
KAREN HERSEY, J.D., Senior Intellectual Property Counsel,
Massachusetts Institute of Technology, Cambridge, MA
JIMMIE HOLLAND, M.D., Chair,
Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY
WILLIAM KAELIN, M.D., Professor of Medicine,
Harvard Medical School, Boston, MA
WILLIAM W.MCGUIRE, M.D., Chairman and CEO,
United Health Group, Minnetonka, MN
JOHN MENDELSOHN, M.D., President,
University of Texas, M.D. Anderson Cancer Center, Houston
KATHLEEN HARDIN MOONEY, Ph.D., Professor,
University of Utah College of Nursing, Salt Lake City
PATRICIA NOLAN, M.D., Director,
Rhode Island Department of Health, Providence
DAVID PARKINSON, M.D., Vice-President of Oncology,
Amgen, Inc., Thousand Oaks, CA
JOHN D.POTTER, M.D., Ph.D., Program Head,
Cancer Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA
LOUISE RUSSELL, Ph.D., Research Professor of Economics,
Rutgers University, New Brunswick, NJ
THOMAS J.SMITH, M.D., F.A.C.P., Professor,
Medical College of Virginia at Virginia Commonwealth University, Richmond
ED WAGNER, M.D., M.P.H., F.A.C.P., Director,
MacColl Institute for Healthcare Innovation at the Center for Health Studies, Seattle, WA
SUSAN WIENER, Ph.D., President,
The Children’s Cause, Silver Spring, MD
ROBERT C.YOUNG, M.D., President,
American Cancer Society and Fox Chase Cancer Center, Philadelphia, PA
National Cancer Policy Board Staff
ROGER HERDMAN, M.D., Director
JILL EDEN, M.P.H., M.B.A., Senior Program Officer
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HELEN GELBAND, M.H.S., Senior Program Officer
MARIA HEWITT, Dr.P.H., Senior Program Officer
SHARYL NASS, Ph.D., Senior Program Officer
JUDY WAGNER, Ph.D., Scholar-in-Residence
PENNY SMITH, M.P.H., Research Associate
KATHRYN BARLETTA, Research Assistant
ELIZABETH BROWN, Research Assistant
MARY ANN PRYOR, Senior Project Assistant
ANIKE JOHNSON, Administrative Assistant
JULIE WILTSHIRE, Financial Associate
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Reviewers
This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s (NRC’s) Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:
Robert H.Brook, M.D., Sc.D., Professor of Medicine and Health Services, UCLA Center for Health Sciences; Vice President of RAND and Director, RAND Health, RAND Corporation, Santa Monica, CA
Judy Destouet, M.D., Chief of Mammography, Comprehensive Breast Cancer Center, Greater Baltimore Medical Center, Baltimore, MD
Edward Hendrick, Ph.D., Director of Breast Imaging Research and Research Professor, Northwestern Memorial Hospital, Worthington, OH
Elizabeth D.Jacobson, Ph.D., JK Consultants, Hagerstown, MD
Carol H.Lee, M.D., Professor of Diagnostic Radiology, Department of Diagnostic Radiology, Yale University School of Medicine, New Haven, CT
Allen S.Lichter, M.D., Newman Family Professor of Radiation Oncology and Dean, University of Michigan Medical School, Ann Arbor
Carol Mount, RT, Supervisor of Mammography, Department of Diagnostic Radiology, Mayo Clinic, Rochester, MN
Deborah E.Powell, M.D., Dean, Assistant Vice President for Clinical Sciences, and McKnight Presidential Leadership Chair, University of Minnesota Medical School, Minneapolis
Rebecca Smith-Bindman, M.D., Associate Professor in Residence, Department of Radiology, University of California, San Francisco
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Dr. Howard Rabinowitz, M.D., Professor of Family Medicine, Thomas Jefferson University, Department of Family Medicine, Jefferson Medical College, Philadelphia, PA; and Dr. Harold C.Sox, M.D., Editor, Annals of Internal Medicine, American College of Physicians of Internal Medicine, Philadelphia, PA. Appointed by the National Research Council and Institute of Medicine, they were responsible for
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making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
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Acknowledgments
The Committee members all gave generously of their time to form a conscientious and hard-working collaborative team. Although the Committee was solely responsible for decisions regarding the content, conclusions, and recommendations of the report, four consultants and a liaison to the National Cancer Policy Board also attended the committee meetings and provided invaluable insight and information during the study process.
At the first Committee meeting, five working groups were established to take the lead in addressing specific charges put before the Committee in our statement of task. Etta Pisano chaired the “Mammography Quality Standards Act (MQSA) Regulations” working group and led her team (Priscilla Butler, Timothy Eberlein, Jane Henney, Carolina Hinestrosa, Lawrence Rothenberg) through a detailed examination of the current MQSA regulations and inspections. Patricia Carney chaired the “Interpretation” working group (Brad Hutton, Barbara Monsees, Edward Sickles, Robert Smith, Stephen Taplin), which took the lead on drafting Chapter 2 of the report. Edward Salsberg led the “Workforce” working group (Timothy Eberlein, Howard Forman, Barbara Monsees, Catherine Parsons, Etta Pisano), which took primary responsibility for Chapter 4. Robert Smith chaired a working group (Jane Henney, Carolina Hinestrosa, Catherine Parsons, Lawrence Rothenberg, Edward Salsberg) that was charged with examining issues that extended beyond MQSA, which led to Chapter 5 of the report. Howard Forman led the “Data” working group (Priscilla Butler, Patricia Carney, Brad Hutton, Edward Sickles, Stephen Taplin), which made important contributions to Chapters 2 and 4.
The Committee is grateful to many individuals who provided valuable input and information for the study, either through formal presentations or through informal communications with study staff, Committee members, and consultants, including William Barlow, Helen Barr, Craig Beam, Rebecca Belsaas, C.S.Bernstein, Mythreyi Bhargavan, Jonathon Bibb, Jennifer Bitticks, Jim Brice, Jerry Britt, Martin Brown, Cathy Coleman, Janet Corrigan, Harriet Crawford, Richard Ellis, Joann Elmore, Dione Farria, Charles Finder, Beatrice Gairard, Kaye Goss-Terry, Tim Haran, Richard Harris, John Hayes, Kelly Hecht, Pam Kassing, Kellee Kemp, Shukri Khuri, Dan Kopans, Joseph Levitt, Rebecca Lewis, Michael Linver, Sharon-Lise Normand, Bill Page, John Patti, Nicholas Perry, John Pila, Peggy O’Kane, Rhonda Richards, John Sandrik, Phillip Scott, Brigitte Seradour, Janet Shaefer, Lillie Shockney, Rebecca Smith-Bindman, Jeanette Spencer, Richard Suberman, Jonathan Sunshine, Helene Toiv, Anna Tosteson, Dan Trammell, Steve Tucker, Judy Wagner, Richard Wagner, Deb Wiggins, Paul Wing, Martin Yaffe, and Bonnie Yankaskas.
The Committee is also indebted to the IOM study staff. Special thanks go to the study director, Dr. Sharyl Nass, for epitomizing the best of that role. She was extremely knowledgeable, very efficient, and captured the essence of the Committee’s deliberations superbly. Kathryn Barletta provided dedicated and exceptional research support and was directly involved in the development, writing, and production of the report. Mary Ann
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Pryor provided outstanding administrative support and took primary responsibility for organizing the logistics of Committee meetings and communications. In addition, Maria Hewitt, Judy Wagner, Jill Eden, and Janet Joy, current and former members of the staff of the National Cancer Policy Board, provided invaluable insight and input to the study. Alison Mack and Margie Patlack, consulting writers, were also instrumental in keeping the study report on schedule and on target. Both prepared written background material for the report, and Alison took the lead in drafting Chapter 4.
John Ball
Committee Chair
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Acronyms
AAFP
American Academy of Family Physicians
AAMC
American Association of Medical Colleges
ACCME
American Council for Continuing Medical Education
ACoS
American College of Surgery
ACR
American College of Radiology
ADEMAS
Association pour le Dépistage des Maladies du Sein
AHRQ
Agency for Healthcare Research and Quality
AIUM
American Institute of Ultrasound in Medicine
AOCR
American Osteopathic College of Radiology
ARDMS
American Registry of Diagnostic Medical Sonographers
ASRT
American Society of Radiologic Technologists
AUC
Area Under the Receiver Operating Curve
BCCMPA
Breast and Cervical Cancer Mortality Prevention Act
BCSC
Breast Cancer Surveillance Consortium
BIQSA
Breast Imaging Quality Standards Act
BI-RADS
Breast Imaging Reporting and Data System
CAD
Computer-Aided Detection
CEJA
American Medical Association’s Council on Ethical and Judicial Affairs
CLIA
Clinical Laboratory Improvement Amendments
CME
Continuing Medical Education
CMS
Centers for Medicare and Medicaid Services
CPT
Current Procedural Terminology
CSR
Center for Survey Research (University of Virginia)
CT
Computerized Tomography
DCIS
Ductal Carcinoma in Situ
EUSOMA
European Society of Mastology
FDA
Food and Drug Administration
FFDM
Full-Field Digital Mammography
FP
False Positive
FTE
Full-Time Equivalent
GAO
Government Accountability Office, formerly General Accounting Office
GPCI
Geographic Practice Cost Index
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HCFA (now CMS)
Health Care Financing Administration
HELP
Senate Committee on Health, Education, Labor, and Pensions
HHS
Department of Health and Human Services
HIPAA
Health Insurance Portability and Accountability Act
HRSA
Health Resources and Services Administration
IOM
Institute of Medicine
LCIS
Lobular Carcinoma in Situ
MISA
Mammography Interpretive Skills Assessment
MQSA
Mammography Quality Standards Act
MQSRA
Mammography Quality Standards Reauthorization Act of 1997
MRI
Magnetic Resonance Imaging
NBCCEDP
National Breast and Cervical Cancer Early Detection Program
NCI
National Cancer Institute
NEXT
1985 Nationwide Evaluation of X-Ray Trends
NHSBSP
National Health Service Breast Screening Program
NHSC
National Health Service Corps
NMQAAC
National Mammography Quality Assurance Advisory Committee
NPV
Negative Predictive Value
NSQIP
National Surgical Quality Improvement Program
OPPS
Outpatient Prospective Payment System
PFQ
Pay for Quality
PIAA
Physician Insurers Association of America
PPV
Positive Predictive Value
RA
Radiologist Assistant
RADIUS
Routine Antenatal Diagnostic Imaging with Ultrasound
RBRVS
Resource-Based Relative Value Scale
ROC
Receiver Operating Curve
RT
Radiologic Technologist
RVU
Relative Value Unit
SBI
Society of Breast Imaging
SCARD
Society for the Chairmen of Academic Radiology Departments
SEER
Surveillance, Epidemiology, and End Results
SOSS
Scheduled On-Site Survey
US
Ultrasound
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Contents
EXECUTIVE SUMMARY
1
1
INTRODUCTION
16
A Brief History of MQSA,
17
Committee Charge,
20
Methods,
20
Framework of the Report,
22
References,
22
2
IMPROVING INTERPRETIVE PERFORMANCE IN MAMMOGRAPHY
24
Current State of Knowledge Regarding Appropriate Standards or Measures,
24
Factors Affecting Interpretive Performance of Both Screening and Diagnostic Mammography,
35
Double-Reading Methods and Technical Tools Designed to Improve Performance,
45
The Impact of Residency/Fellowship Training and CME on Interpretive Skills,
47
The Influence of Skills Assessment and Feedback on Performance,
49
Challenges to Using Medical Audit Data to Improve Interpretive Performance in the United States,
53
Limitations of Current MQSA Audit Requirements,
61
Strategies to Improve Medical Audit of Mammography,
63
Breast Imaging Centers of Excellence,
64
The Need for a Supportive Environment to Promote Quality Improvement,
67
Summary and Conclusions,
70
References,
71
3
MQSA REGULATIONS, INSPECTIONS, AND ENFORCEMENT
82
Regulations Overview,
82
Suggested Changes to FDA Regulations,
85
National Quality Standards,
109
The Costs and Benefits of MQSA,
112
Summary and Conclusions,
113
References,
114
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4
ENSURING AN ADEQUATE WORKFORCE FOR BREAST CANCER SCREENING AND DIAGNOSIS
117
Current Status: Is Access to Mammography Endangered?,
121
Future Projections: Workforce Demand Outstrips Supply,
128
Addressing Underserved Communities,
137
Factors Limiting the Supply of Interpreting Physicians,
143
Strategies to Ensure an Adequate Mammography Workforce,
150
Summary and Conclusions,
156
References,
157
5
BEYOND MQSA
164
Reminder Systems,
164
Medicolegal Liability and the Quality of Care,
165
Oversight of Other Breast Imaging Modalities,
174
Summary and Conclusions,
179
References,
180
APPENDIXES
A
ACR Survey Methods and Analysis
189
Analyses and Reports on Radiologists Performing Mammography,
192
B
Society of Breast Imaging Survey
200
C
Workforce Projection Methods
202
GLOSSARY
211
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Boxes, Tables, and Figures
BOXES
ES-1
Summary of Recommendations to Improve Breast Imaging Quality,
2
1–1
Committee Statement of Task,
21
2–1
Mammography Self-Assessment Programs,
55
2–2
Models of Integrated Breast Care,
66
2–3
Paying for Quality,
68
3–1
MQSA Regulations Overview,
83
3–2
Examples of Preemptive National Standards,
111
4–1
The Mammography Workforce,
118
4–2
Key U.S. Mammography Workforce Statistics,
120
4–3
Reimbursement,
148
4–4
CLIA Regulation of Pap Testing,
154
5–1
Reminder System Models and Comparisons,
166
5–2
The Malpractice Claims Process,
168
5–3
Tort Reform Legislation,
172
TABLES
2–1
Terms Used to Define Test Positivity/Negativity in BI-RADS 1st and 4th Editions,
25
2–2
Possible Results for a Screening Test,
27
2–3
Recent Reports of Measures on Interpretive Performance of Screening and Diagnostic Mammography,
36
2–4
Summary of Recent Studies That Examine the Impact of Interpretive Volume and Experience on Accuracy,
39
3–1
Suggested Changes to MQSA Regulations,
86
3–2
Self-Reported Estimate of the Cost of MQSA Compliance,
112
4–1
Number of Interpreting Physicians by Year,
121
4–2
American College of Radiology (ACR) Mammography Accreditation Program: Reason for Facility Closures Since April 2001 (as of October 2004),
125
4–3
Fees for Screening Mammograms Vary by Insured Status,
127
4–4
Projected FTE Supply of Radiologists Performing Mammography,
130
4–5
Full-Time Equivalent (FTE) Supply of Radiologic Technologists Performing Mammography: Status Quo Projections for the United States, 2004 to 2025,
132
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4–6
Estimate of Workforce Burden Subsequent to Screening Mammography,
134
4–7
Medicare Reimbursement for Selected Radiology Procedures, 2005,
136
4–8
Percentages of Radiologists Interpreting Mammograms and Mammograms by Type of Location, 2003,
137
4–9
Estimated Numbers of New Radiologists Needed to Implement Double Reads on All Mammograms, Assuming Constant Average Volume for Interpreting Physicians,
138
C-1
Details of Calculations for Constant Rate Scenario for FTE RTs Performing Mammography,
205
C-2
Involvement of RTs in Mammography by Age Group, 2004,
207
C-3
Estimated RTs Working in Mammography by Age Group, 2004,
207
C-4
Estimates of Radiologists Performing Mammography by Age Group, 2003,
208
C-5
Mammography Certification Rates for a Sample of RTs Practicing Mammography in New York State, 2004,
209
FIGURES
1–1
A history of MQSA,
19
2–1
Ideal (A) and actual common (B) distribution of mammography interpretation,
33
2–2
ROC analysis,
34
2–3
Results of statistical modeling for unadjusted (Line A) and adjusted (Line B for patient characteristics, C for radiologist characteristics, and D for both patient and radiologist characteristics) false-positive rates for 24 radiologists in a community setting,
50
2–4
Radiologists’ perceived 5-year risk of breast cancer for a vignette of a 41-year-old woman whose mother had breast cancer, who had one prior breast biopsy with atypical hyperplasia, and who was age 40 at first live birth,
53
3–1
Full Field Digital Mammography (FFDM) growth,
106
3–2
Percentage of facilities by highest violation level,
108
4–1
Estimated radiologists interpreting mammograms and percentage of total mammograms, by volume, United States, 2003,
123
4–2
Simplified screening mammogram outcome pyramid,
135
4–3
Percentage of radiologists who interpret mammograms in different community settings, by degree of urbanness,
139
4–4
Number of radiologists who interpret mammograms per 10,000 women aged 40 and older in different communities, by degree of urbanness,
140
C-1
Schematic diagram of age-cohort flow projection method,
204
