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I. INTRODUCTION AND SUMMARY The United States has begun an experiment, unique to worth experience, that attempts to assure quality in medical care. Many nations have sought to assure access to care, but none has established a national system of quality assurance. This national goal of quality assurance is worthy, but its full achievement lies beyond the present capabilities of either the health professions or society at large. The Pro- fessional Standards Review Organizations (PSROs)';, the mecha- nisms created by Federal legislation to establish programs of quality assurance, constitute an important initial step to- ward the goal. Expectations for PSROs, however, must be re- a~istic if major disappointments are to be avoided and the future development of PSROs as rigid and oppressive regulatory mechanisms is to be prevented. The long-range importance of quality assurance in health care and the immediacy of the problems attending development of PSROs prompted the Institute of Medicine to appoint a com- mittee to examine the "policy issues involved in the estab- lishment of professional standards review organizations or other publicly sanctioned mechanisms for the review of pro- fessional standards for medical care." This committee has concluded that the most important needs are for appropriately limited immediate expectations of PSROs and for the establish- ment of a set of principles to guide their development and as- sist in the future evaluation of any quality assurance mechanisms. Different groups have different-specific goals for the PSRO program: reducing the cost of medical care, improving the allocation of health resources, easing access to needed care, decreasing depersonalization of care, punishing rascals, or improving performance of health workers through education. None of these goals excludes the others, but neither can any single program of quality assurance fulfill them all. In the committee's view, the primary goad of a quality assur- ance system should be to make health care more effective in bettering the health status and satisfaction of a population, within the resources that society and individuals have chosen '; The establishment of PSROs was authorized by Public Law 92-603. These organizations of physicians will be established in areas designated by the Secretary of Health, Education, and Welfare. They will review the appropriateness and quality of institutional health care financed under the Federal Medicare, Medicaid, and Child Health programs. For a specific comparison of the recommendations of this policy statement with the pro- visions of the PSRO legislation, see Section IV. 1

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to spend for that care. To achieve this goal we would have to improve our ability to relate the processes of care to the outcomes of care, ascertain whether,the population is getting the care it needs, assess the response by providers to the health care requirement of the population, and use that assess- ment to improve the performance of providers to the satisfac- tion of consumers. One consequence of such a quality assurance process could be greater efficiency in the use of resources leading to re- ductions in the cost of care. But another couth be the iden- tification of shortcomings in care, which would call for more resources. Quality assurance also could give rise to minimum standards of performance and punishment of providers who threaten the safety of the population by consistently fail- ing to meet those standards. The committee, however, be- lieves that the punitive aspect of quality assurance will contribute little to achievement of the system's primary goal's. The main body of this report is long and detailed, re- flecting the complexity of quality assurance in its develop- mental stage. Some of the issues and conclusions deemed most important by the committee are contained in the following summary. The reasoning behind the committee's conclusions will be found in the body of the report. Summary of Major Conclusions . Quc~Zity should be measured by results. There is a great need in the gauging of quality to move beyond structure and process and toward the measurement of outcomes of care. The committee believes strongly that the goal of quality assurance can only be achieved by relating assessments of quality to the measurement of results, recognizing that methods of measuring outcomes are not now well advanced, and that many 'factors other than health care affect health status. Present methods of quality measurement, Phi be rudimentary, are a us e fuZ beginning. Further development of methods is badly needed, but much can be done today. Medical records can be improved, community-wide data systems can be developed, and evaluation of new quality assurance programs can be carried out while the necessary research to improve methods continues. Technology and methods are available to begin the task of quality assessment, based on measurement of a judicious com- bination of structural aspects of care, processes of care, and outcomes of that care. Quc~Zi ty assessment data should mover an entire popuZation. Most reviews of health care traditionally have been 'concerned with individuals receiving care from an institution or group 2

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of providers. But a quality assurance- pro-gra~:also should take into account the health of the total population in its . area. The base of judgment should broaden as a quality assur- ance system expands. Present law stipulates review of care by professional peers. This emphasis on peer review is suit- able on an individual case basis, in order to maintain confi- dentiality for the patient and relationships between providers. We believe, however, that there should be some participation by consumers and providers who are not professional peers in quality review at all levels, beginning with a minor role at the local level and increasing the role as quality assurance programs establish higher levels of administration and review to deal with aggregates of patients, providers, and institutions. Q us Z i by as s uran oe p ro grams s ho u Z ~ h ave cr Z cr age r s ~ o p e . Although the PSRO system's initial concern is with review of acute hospital care, the committee urges a rapid expansion of scope to include ambulatory and custodial care. The elements of review should quickly be enlarged beyond concern with the site of care to encompass episodes of illness and health problems that affect a large share of the population outside the hospital. Quality assurance pi ZZ tees t work as a positive concept. The committee strongly believes that provider performance will be changed for the better by education and fis Cal in- centives- based on feedback of quad ity assurance data, and not so much by primary reliance on sanctions and punishment of providers . A purpose of quality as surance should be to improve the performance of all rather than merely enforcing minimum standards of performance. Quiddity crssuranoe 408 ts shouZ~ be bc`Zc~noed against the ~ en e fi ts a Many increment s of improved health care quality im- pose an increment in cost. Part of the added cost stems from the review- process itseJ f but further cost may attend provider conformity with standards of care. Those responsible for review systems should consider whether an increase in costs can be expected to result in an appropriate increase in quality. Care fug p tanning should minimize unexpected consequences . Introduction of qua] ity assurance programs in a fie] ~ as com- plex as health care is certain to produce some unanticipated side effects. A thorough examination of possible consequences of quality as surance methods, experimentation with methods, and careful implementation can reduce surprises . 3

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The caveats and concerns notwithstanding, the committee believes that the beginning steps to assure quality of medi- cal care are important and worthy of the nation's best efforts for improvement. The committee believes that most providers, given better information, will seek to improve their performance, and, through partnership with the consumer, will accomplish an overall improvement in health care. The PSRO is a step along the way to better quality of health care and better health of the population. But the PSRO approach requires a deliberate implementation and careful evaluation to permit realization of its potential. The discussion and recommendations in this report repre- sent the committee's present analysis and judgment.; The con- cept of quality assurance, however, is evolving rapidly, and we believe that it should be re-examined periodically as tech- nica] progress and public policy developments warrant. The Context of the Conclusions .. . . . . The committee reached its conclusions in a context of assumptions and observations about the future of the nation's health care system and the appropriate role of a quality assur- ance program: --the United States will continue to have a variety of arrangements for the provision of health care; --social pressures will increase for equitable, ef- fective, and efficient health care for the entire population; --demands will grow for broader public participation in all aspects of health, including the financing, organization, distribution and evaluation of services; --the health professions increasingly will be re- quired to account to consumers, fiscal intermedi- aries, and governments for prudent use of resources. --many aspects of health care can now be qualita- tively measured only with great difficulty--com- forting, caring, the practitioner-patient rela- tionship, the "placebo effect" among others--but can have a strong effect on a patient's perception of well-being. The importance of "caring" to the whole process and outcome of medical care is re- cognized by this committee even though this report discusses more fully the impersonal aspects of as- sessing medical services. ; See comment and dissent by Mildred Morehead, page 53. 4

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--the present focus of quality advancement is on personal health services because of their identi- fiable benefits and costs, but the committee is well aware that other factors--air and water pol- lution, occupational hazards, accidents, stress, and the like--may have a more profound influence on health status of the population. Historical Development of Regulation of the Quality of Health Care Public and private efforts to assure quality in health care have a long history, some of whose highlights can con- tribute to understanding the committee's considerations of the current situation and the possibilities for change. Regulation for quality.assurance has entailed both pro- fessionally instituted measures and governmental actions, al- though the two are often mixed in their application. Measures adopted and implemented by professionals themselves include peer review committees (such as perinatal mortality review conferences) and tissue committees. Examples.of regulation imposed by government include state health manpower licensing and Federal licensure of drugs. A mixture of public and pro- fessional regulation is exemplified by state licensure, which, although codified by statute in all the states, leaves enforcement to the professions by stipulating that most mem- bers of licensing boards also be members of the profession to be regulated. The early phase of quality regulation in the U.S. was in- formal and private self-regulation, overridden only by medical malpractice litigation, which is quasi-public in nature. After formal professional organizations emerged, the regulatory func- tion devolved upon them and upon provider units such as hospita Because the government did not then finance the purchase of care, its regulatory role was limited. Later, the states en- acted health. manpower Jicensure laws. These represented the first formal public intervention in the performance of the medical care system and began the next phase of quality regu- lation, characterized by an ever-enlarging role of government. Most of the regulatory legislation prior to PSRO was in- tended either to establish minimum standards protecting the health. and safety of the public from abuses, or to control un- necessary utilization of medical facilities and services. Only recently has there arisen a concern for the ratio- nality of decisions made by the practitioner, a concern directed more to upgrade the quality of care by all practitioners than to eliminate substandard practitioners. The new emphasis on rationality of practitioner decis ions accompanies a growing perception of the scientific aspect of health care. Better 5 Pals .

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application of scientific reasoning in decision making is seen as one way to achieve a better correspondence between the pro- cesses used in health care and the outcome for the patient. To some extent, the consumer's exercise of choice has al - ways imposed on the practitioner to increase the qua] ity of care . Increas ing s ophis tication and fragmentation of the health care system would appear to reduce consumer influence; cons umers have to know much more than b efore . But the emer- gence of more sys tematic approaches to the regulation of quality can enlarge the consumer influence; consumers can be informed of the relative effectiveness of various heal th providers and make their choices accordingly . The committee regards PS ROs as having the potential to encourage the trend in quality assurance toward a concern for general improvements in practitioner decis ion making and a more informed role for consumer choice. In our view, we stand at a point in the historical development of regulation of quality when key choices can encourage this trend. This per- spective influences all that fold ows in this report. If the positive potential of PSROs can be fulfill ed, some fears should be assuaged for providers concerned about the his- torical progression of regul ation of: quality toward deeper gov- ernmenta] invo] vement. But we cannot assume that PSRO develop- ment will take the positive course. Specific decisions will need to be guided by principles that are based on the perspec- tive and goals that we have indicated. This report outlines maj or principal es, which in the committee' s view can achieve the desired goal in the development of PSROs and succeeding generations of quality assurance programs. 6