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MEDICARE A Strategy for Quality Assurance VOLUME I! Sources and Method Committee to Design a Strategy for Quality Review and Assurance in Medicare Division of Health Care Services INSTITUTE OF MEDICINE Kathleen N. Lohr, editor NATIONAL ACADEMY PRESS Washington D.C. 1990

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NOTICE: The project that is the subject of this report and its technical appendices 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 this report were chosen for their special competencies and with regard for appropriate balance. Volume I of the report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal goverrunent and its own initiative in identifying issues of medical care, research, and education. This study was supported by the Health Care Financing Administration, U.S. Department of Health and Human Services, under Cooperative Agreement No. 17-C-99170/3. Publication IOM-90-02 Library of Congress Cataloging-ln-Publication Data Institute of Medicine (U.S.). Division of Health Care S. educes. Medicare: a strategy for quality assurance. (Publication IOM; 90-02) "Committee to Design a Strategy for Qualtiy Review and Assurance in Medicare"-P. following t p. vcrso. "This study was supported by the Health Care Financing Administration, U.S. Dept. of Health and Human Services, under cooperative agreement no. 17-C-991/3"-T.p. verse. Includes bibliographical refercaces and indexes. 1. Medical care-United States~uality control. 2. Medicare. I. Lohr, Kathleen N., 1941 II. Institute of Medicine (U.S.) Committee to Design a Strategy for Quality Review and Assurance in Medicare. m. United States. Health Care Financing Administration. IV. Title. V. Series: IOM publication: 90-02 [DNLM: 1. Health Insurance for Aged and Disabled, Title 18. 2. Quality Assurance, Health Care-United States. WT 30 I591m] RA395.A3I56 1990 362.1'0973 90-5787 ISBN 0-309-04230-5 (`,.1) ISBN 0-309-04238-0 (Y.2) Volumes I and II of this report Mascara: A Strategy for Quality Assurance are available from the National Academy Press, 2101 Constitution Avenue, N.W., Washington, D.C. 20418. An Executive Summary of Volume I of the report is available from the Institute of Medicine, Division of Health Care Services, 2101 Constitution Avenue, N.W. Washington, D.C. 20418. Copyright 1990 by the National Academy of Scicncce No part of this book may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use, without wntton permission from the publisher, accept for the purpose of official use by the United States Go~cmmcnt. Printed in the United States of America

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Committee to Design a Strategy for Quality Review and Assurance in Medicare STEVEN A. SCHROEDER,* Chair, Division of General Internal Medicine, University of California at San Francisco, San Francisco, California MARK R. CHAS SIN, Value Health Sciences, Santa Monica, California (formerly of The RAND Corporation) LEO M. COONEY, Yale University School of Medicine and Yal - New Haven Hospital, New Haven, Connecticut ROBERT B. COPELAND,* Georgia Heart Clinic, LaGrange, Georgia CHARLES J. PAHEY,* Third Age Center, Fordham University, New York, New York PAUL F. GAINER,* University of Rochester Medical Center and Strong Memorial Hospital, Rochester, New York WILLIAM S. HOFFMAN, Social Security Department, International Union, United Auto Workers, Detroit, Michigan ROBERT L. KANE, School of Public Health, University of Minnesota, Minneapolis, Minnesota HAROLD S. LUFT,* Institute for Health Policy Studies, University of California at San Francisco, San Francisco, California MAXWELL MEHLMAN, The Law-Medicine Center, Case Western Reserve University School of Law, Cleveland, Ohio MARIE MICHNICH, American College of Cardiology, Bethesda, Maryland MARILYN MOON, Policy Research Institute, American Association of Retired Persons, Washington, DC (until October 1989~; The Urban Institute, Washington, DC JAMES D. MORTIMER, Midwest Business Group on Health, Chicago, Illinois ALBERT G. MULLEY, Jr., General Internal Medicine Unit, Massachusetts General Hospital, Boston, Massachusetts EDWARD B. PERRIN,* Department of Health Services, University of Washington, Seattle, Washington MARGARET D. SOVIE,* Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania LORING W. WOOD, NYNEX Corporation, White Plains, New York *destitute of Medicine Member . . IN

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STUDY STAFF Division of Health Care Services KARL D. YORDY, Director KATHLEEN N. LOHR, Study Director MOLLA S. DONALDSON, Associate Study Director JO HARRIS-WEHLING, Stay Officer ALLISON J. WALKER, Research Associate MICHAEL G. H. MCGEARY, Senior Stuff Officer DONALD TILLER, Administrative Assistant THELMA COX, Secretary DENISE GRADY, Secretary THERESA NALLY, Secretary IV

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Contents 1 OVERVIEW Ol? THE STUDY TO DESIGN A STRATEGY FOR QUALITY REVIEW AND ASSURANCE IN MEDICARE 1 Kathleen N.Lohr Study Committee and Technical Advisory Panel, 2 Conduct of the Study, 3 Concluding Remarks, 6 2 ORAL AND WRITTEN TESTIMONY FROM THE PUBLIC HEARINGS . ~ e e e ~ e ~ ~ ~ e e ~ e e e e e e e ~ ~ e e ~ e e e e ~e e e e ~ e ~ e Jo Harris-Wehling Methods, 7 Findings, 10 Concluding Remarks, 27 APPENDIX A Guidelines for Written Testimony, 27 APPENDIX B Organizations Submitting Testimony, 30 RESULTS OF TlIE MEDICARE BENEFICIARY AND PH YSICIAN FOCUS OR O UPS 35 Allison J. Walker 7 Benefits and Limitations of Focus Groups, 35 Study Methods, 36 Findings of the Beneficiary Focus Groups, 41 Findings of the Physician Focus Groups, 59 Concluding Remarks, 73 v

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v! CONTENTS APPENDIX A Moderator's Guide for the Beneficiary Focus Groups, 76 APPENDIX B Moderator's Guide for the Physician Focus Groups, 81 APPENDIX C Recruiting Screener: Medicare Beneficiary Focus Groups, 86 APPENDIX D Recruiting Screener: Physician Focus Groups, 88 4 SITE VISITS ~ eeeeeeeeeeeeeeee-ee--e~eeeeeeeeee91 Molla S. Donaldson and Kathleen N. Lohr Methods, 92 Issues, 97 Problems of Quality and Quality Assurance, 99 Concluding Remarks, 104 APPENDIX A Confirmation Letter Regarding Site Visit, 106 APPENDIX B Guide for Site Visitors, 109 5 DEFININ G Q UALITY OF CARE .......................... Jo Harris-Wehling Methods, 116 Key Dimensions Used by Several Groups in Defining Quality, 118 The Committee's Definition, 128 Concluding Remarks, 129 APPENDIX Examples and Sources of Definitions of Quality, 130 6 A QUALITY ASSURANCE SAMPLER: METHODS, DATA, AND RESOURCES ................................ Molla S. Donaldson and Kathleen N. Lohr Introduction, 140 Hospital, 145 Ambulatory Care, 193 lIome Health Care, 236 Concluding Remarks, 260 APPENDIX Mercy Health Services Survey of Quality Management Programs, Staff, and Resources, 273 7 MEDICARE CONDITIONS OF PARTICIPATION AND ACCREDITATION FOR HOSPITALS........... Michael G. H. McGeary Hospital Standards: Origin and Development, 296 Medicare Certification and Joint Commission Accreditation Standards and Procedures for Assuring Quality of Patient Care in Hospitals, 311 116 140 292

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CONTENTS Conclusions, Issues, and Options, 331 Concluding Remarks, 336 . . vie 8 THE UTILIZATION AND QUALITY CONTROL PEER REVIEW ORGANIZATION PROGRAM 343 Kathleen N. Lohr and Allison J. Walker Introduction, 343 PRO Legislation and Regulations, 344 PRO Organizational Characteristics, 346 PRO Contacts, 346 PRO Scopes of Work, 348 First PRO Scope of Work (1984-1986 Contract Cycle), 351 Second Scope of Work (1986-1988 Contact Cycle), 354 Third PRO Scope of Work (1988-1990 Contract Cycle), 344 Responses to Quality or Utilization Problems: Notifications, Corrective Actions, and Sanctions, 365 Costs, 380 Quality Review in Medicare Risk-Con';ract Plans, 382 Current and Future Initiatives of the PRO Program, 388 Evaluating PRO Activities, 399 Data Collection, Management, and Reporting Requirements, 404 Controversial or Problematic Aspects of PRO Quality-Relate Activities, 408 Concluding Remarks, 429 INDEX . e e ~ e e e e e e e ~ e e e e ~ e e e ~ ~ e e ~ ~ ~ e ~ ~ The contents of Volume I are listed below Preface Introduction to the Volume Summary . . .......... 439 ......... 1X . . . ........ X111 Chapter 1. Chapter 2. Chapter 3. ,..~,~_^,,.v~..~,~...................... Chapter 4. The Medicare Program ...................... Chapter 5. Hospital Conditions of Participation in Medicare....... Chapter 6. Federal Quality Assurance Programs for Medicare ..... Chapter 7. Quality Problems and the Burdens of Harm ............ Chapter 8. Settings of Care and Payment System Issues for Quality Health, Health Care, and Quality of Care Concepts of Assessing, Assuring, and Improving Quality. . . T1~^ Fl~lv P^ - l`1oti~n Assurance ~ ..... 45 ..... 69 ..... 96 ....... 119 .... 138 .... 207 .. 238 Chapter 9. Methods of Quality Assessment and Assurance 265 Chapter 10. Critical Attributes of Quality-of-Care Criteria and Standards 303 Chapter 11. Needs for Future Research and Capacity Building 343 Chapter 12. Recommendations and a Strategy for Quality Review and Assurance in Medicare 368

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~- dEDICARE

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