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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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