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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
Representative terms from entire chapter:
professional standards
