Visit the National Academies Press online, the authoritative source for all books from the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, and the National Research Council: • Download hundreds of free books in PDF • Read thousands of books online for free • Explore our innovative research tools – try the “Research Dashboard” now! • Sign up to be notified when new books are published • Purchase printed books and selected PDF files Thank you for downloading this PDF. If you have comments, questions or just want more information about the books published by the National Academies Press, you may contact our customer service department toll- free at 888-624-8373, visit us online, or send an email to feedback@nap.edu. This book plus thousands more are available at http://www.nap.edu. Copyright © National Academy of Sciences. All rights reserved. Unless otherwise indicated, all materials in this PDF File are copyrighted by the National Academy of Sciences. Distribution, posting, or copying is strictly prohibited without written permission of the National Academies Press. Request reprint permission for this book. ISBN: 0-309-55003-3, 240 pages, 8 1/2 x 11, (2005) This PDF is available from the National Academies Press at: http://www.nap.edu/catalog/11308.html http://www.nap.edu/catalog/11308.html We ship printed books within 1 business day; personal PDFs are available immediately. Improving Breast Imaging Quality Standards Sharyl Nass and John Ball, Editors, Committee on Improving Mammography Quality Standards, National Research Council I MPROVIN G BREAST I M AGIN G Q UALITY S T A N DARDS Sharyl Nass and John Ball, Editors Committee on Improving Mammography Quality Standards National Cancer Policy Board Copyright © National Academy of Sciences. All rights reserved. Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html 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. International Standard Book Number 0-309-09648-0 (Book) International Standard Book Number 0-309-55003-3 (PDF) Library of Congress Control Number: 2005929662 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334- 3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. 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. Copyright © National Academy of Sciences. All rights reserved. Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html 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 Copyright © National Academy of Sciences. All rights reserved. Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html Copyright © National Academy of Sciences. All rights reserved. Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html v 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 Copyright © National Academy of Sciences. All rights reserved. Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html vi 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 Copyright © National Academy of Sciences. All rights reserved. Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html vii 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 Copyright © National Academy of Sciences. All rights reserved. Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html viii 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 Copyright © National Academy of Sciences. All rights reserved. Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html ix 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 Copyright © National Academy of Sciences. All rights reserved. Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html [...]... reserved Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html 2 IMPROVING BREAST IMAGING QUALITY STANDARDS BOX ES-1 Summary of Recommendations to Improve Breast Imaging Quality Improve mammography interpretation 1 Revise and standardize the required medical audit component of MQSA 2 Facilitate a voluntary advanced medical audit with feedback 3 Designate specialized Breast Imaging. .. Academy of Sciences All rights reserved Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html 8 IMPROVING BREAST IMAGING QUALITY STANDARDS C) Designated centers should be encouraged to serve as training centers for breast imaging and as regional readers of mammograms to alleviate access problems in underserved areas D) Ideally these Breast Imaging Centers of Excellence should... © National Academy of Sciences All rights reserved Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html 12 IMPROVING BREAST IMAGING QUALITY STANDARDS ENSURING AN ADEQUATE WORKFORCE FOR BREAST CANCER SCREENING AND DIAGNOSIS Results from surveys conducted by the American College of Radiology (ACR), the Society of Breast Imaging, and the American Society of Radiologic Technologists,... skilled practitioners, even for part-time work, could be a cost-effective way to maintain access to high -quality breast imaging Copyright © National Academy of Sciences All rights reserved Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html 14 IMPROVING BREAST IMAGING QUALITY STANDARDS services For example, interpreting physicians who wish to work part-time often find it difficult... rights reserved Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html 6 IMPROVING BREAST IMAGING QUALITY STANDARDS • Test different methods of delivering audit results to improve interpretive performance • Undertake studies of randomly selected facilities using required basic audit procedures to ascertain the impact of these new measures on interpretive quality • Protect... Published reports provide conflicting evidence regarding the relationship between Copyright © National Academy of Sciences All rights reserved Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html 10 IMPROVING BREAST IMAGING QUALITY STANDARDS reader volume and interpretive accuracy, and there is no basis for specifying a higher level of reader volume A variety of approaches... adequate workforce for breast cancer screening and diagnosis 7 Collect and analyze data on the mammography workforce and service capacity 8 Devise strategies to recruit and retain highly skilled breast imaging professionals 9 Make more effective use of breast imaging specialists Improve breast imaging quality beyond mammography 10 Mandate accreditation for nonmammography breast imaging methods that are... of such Category 0 assessments should be given final assessments within 30 days Copyright © National Academy of Sciences All rights reserved Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html 4 IMPROVING BREAST IMAGING QUALITY STANDARDS D) Audit data collection and analysis should be verified at FDA inspection, but not collected by FDA E) Reimbursement rates for mammography... Productivity will be maximized if radiologic technologists focus their efforts on imaging procedures and if breast imaging physicians focus on image interpretation and performing interventional breast imaging procedures Ancillary personnel could Copyright © National Academy of Sciences All rights reserved Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html EXECUTIVE SUMMARY 15 make... radiology imaging interpretation Note that an FTE radiologist is not necessarily an FTE breast imager For example, a full-time radiologist who devotes 40 percent of practice time to breast imaging could be equivalent to a radiologist who works 40 percent of the time and devotes all of his or her practice to breast imaging Copyright © National Academy of Sciences All rights reserved Improving Breast Imaging . reserved. Improving Breast Imaging Quality Standards http://www.nap.edu/catalog/11308.html Copyright © National Academy of Sciences. All rights reserved. Improving Breast Imaging Quality Standards. immediately. Improving Breast Imaging Quality Standards Sharyl Nass and John Ball, Editors, Committee on Improving Mammography Quality Standards, National Research Council I MPROVIN G BREAST. 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