Assuring the Quality of Care
To this point, the committee has had two key messages: (1) Health care reform proposals must aim to maintain and improve the health and well-being of the entire population, including groups with special health or access problems; and (2) reform planners must design and organize policies and programs to strengthen the value of health care expenditures—that is, what we can achieve, in terms of the health and well-being of individuals and populations, through health care spending. It has also stated that reform must be implemented so that expanding access and containing costs does not lead to unintended reductions in the quality of health care.
Reform plans can achieve these objectives only with explicit attention to quality, which includes defining, measuring, assuring, and improving the quality of care. Therefore, the committee proposes a set of quality-related principles and policies for health care reform proposals and advances an argument for greater attention to clinical practice guidelines.
By way of context, two major changes in medical care should be noted. First, care is being evaluated increasingly on the basis of its processes and outcomes, rather than on its structural aspects, such as the credentials of health care professionals. Second, with the advent of better research methods and computer technology, clinical medicine is becoming more science-and information-based. These two shifts should yield better and more cost-effective care in the future. In the committee's view, health policies and reform packages should not create incentives that retard these very positive and promising developments.
Quality of health care has recently been defined by an IOM committee (1990h) as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. The key concepts in this definition involve a broad view of health services; a focus on both individuals and populations; an expansive concept of health outcomes; a demonstrated link between processes of care (services) and outcomes; and an acknowledgment of the responsibilities of health professionals to stay abreast of their fields and to share with patients information about all reasonable alternative options in their care. This definition draws attention to a link between the processes of health care and the end results or outcomes of that care, in terms of both personal and social well-being and welfare. Additionally, it implies that individuals need to be well-informed about alternative health care interventions and their expected consequences (as well as about the expected damaging effects of decisions to pursue unhealthy lifestyles) and that, when making decisions about health care, clinicians need to take their patients' preferences and values into account.
Desired health outcomes are an especially important element for the quality of care dimensions of health reform proposals. In considering such outcomes, reform proposals should provide for the use of a wide range of health-related quality of life measures; the array of tasks that might require such measures includes determining core benefits, assessing the effectiveness of health are technologies, and monitoring and improving the quality of care over time (IOM, 1989c,f, 1990a,b,f,g,h; Lohr, 1989, 1992). The focus should not be on just the effect of health care on survival and life expectancy or various symptom, physiologic, and biologic states. Rather, quality assessment and assurance programs, and thus solid reform proposals, should also give attention to the impact on aspects of health that often matter most to patients, and about which they can give accurate reports; these include physical and cognitive functioning, role performance, emotional and mental well-being, and factors such as pain, energy, and vitality. Reform proposals should, finally, include measures of how people perceive their own health and of satisfaction with health care as
important adjuncts to the outcomes related to health, functioning, and well-being. Proposals need not extend the scope of outcomes to the more expansive notions of quality of life. These involve the physical environment in which we live and work, the economic environment in which we labor, the skills we bring to coping with life's challenges, and the ethical, moral, and spiritual aspects of our lives. These factors, in many respects, are less appropriate as measures of health care outcomes than as indicators of circumstances that may limit or reinforce the impact of medical care.
QUALIFY MEASUREMENT AND IMPROVEMENT
Simply asserting the benefits of quality assurance and improvement efforts will not suffice in an increasingly resource-constrained health care environment. To demonstrate the value of health spending, including spending for quality assurance and improvement activities to maintain high-quality health care services and good outcomes, reform proposals will need to proceed from several basic principles.
First, reform plans should explicitly acknowledge three central issues that quality assurance and improvement efforts should address: (1) use of unnecessary or inappropriate care, as well as overprovision of otherwise appropriate services; (2) underuse of needed, effective, and appropriate care; and (3) lapses in technical and interpersonal aspects or care (IOM, 1990h). These issues might be more simply characterized, respectively, as:
''too much care''—the unnecessary or inappropriate care provided in this country costs money that could be put to more productive use and makes patients vulnerable to harmful side effects;
"too little care"—necessary and appropriate services are often unused or unavailable, not only when people lacking health insurance delay seeking care or receive no care at all but also when even those
with insurance face geographic, cultural, attitudinal, or other barriers that limit their abilities to receive, for example, proper well-baby or well-child care, prenatal care, ongoing care for chronic illnesses, emergency care, rehabilitative services, or palliative care; and
"inferior care"—health care professionals are expected to be able to diagnose and treat our ailments with competence and compassion, but not all clinicians have full mastery of their specialties, and not all can communicate with their patients with grace and empathy; these problems remain significant challenges to quality assurance and improvement efforts.
Criteria for a Strategy
Second, proposals for reform should define an approach to quality assurance that will be meaningful, efficient, and acceptable to those with a stake in the process. This includes patients and families, institutional providers and clinical practitioners, payers, and policymakers. For clinicians and patients, a participatory approach in which continuous improvement is the goal may be an important component of any quality assurance effort. One approach, for example, advances 15 criteria for judging the success of quality assurance or quality improvement programs (IOM, 1990h). It states that the program should:
address poor technical or interpersonal quality, overuse of unnecessary or inappropriate services, and underuse of needed services;
intrude only minimally into the patient-clinician relationship;
be acceptable to health care professionals and provider organizations;
foster improvement throughout the health care organization and system;
identify and intervene to remedy demonstrably substandard performance (the so-called outlier or "bad apple" problem);
invoke positive and negative incentives for change and improvement;
provide well-motivated people with timely information to improve performance;
possess face validity for the public and for professionals (i.e., be understandable and relevant to clinical decisionmaking);
be scientifically rigorous (i.e., meet requirements for reliability, validity, and generalizability);
improve patient well-being and outcomes in ways that can be measured and evaluated over time or that can be inferred from the process-of-care elements assessed;
address both individual patient and population-based outcomes;
document improvement in quality and progress toward excellence;
be easily implemented and administered;
be affordable and cost-effective; and
include participation by patients and the public.
The committee recognizes, as did the original IOM committee for the Medicare study, that some of these attributes may be mutually exclusive and need to be traded off against each other. Furthermore, not all will be fully appropriate for different settings and types of practitioners or institutions, and in any case some cannot realistically be achieved in the short term. These are, nonetheless, the characteristics of a successful quality assurance and quality improvement effort toward which the system ought to move, even as reform plans are being put into effect.
Individual and System Perspectives
Third, the committee draws attention to the different perspectives that health care reform proposals need to reflect. On the one hand, proposals will need to be concerned with the quality of are that individual plans and providers deliver; this is a more traditional and familiar realm of assessing and improving the processes and outcomes of care given to individual patients and to persons enrolled in specific insurance programs. On the other, proposals will need to attend to the quality of care across the entire system, for instance, determining
whether particular reforms do improve access to needed and appropriate services for all underserved populations.
Roles and Responsibilities
Fourth, health care reform proposals must be clear about organizational structures, procedures, and divisions of responsibility and make explicit provisions for both internal and external monitoring of quality of care. Specifically, they should set in place conditions that will help health organizations, provider groups, and practitioners act on their own to measure and improve quality. Two goals are sought. The first is to reinforce steps toward quality improvement at the local institution or plan level without introducing intrusive micromanagement programs from the outside; the second is to strengthen the performance of the system by rewarding exemplary performance and promoting continuous improvement of the average quality of care, not just by eliminating severely substandard practitioners or institutions. Reform plans will also need to involve existing or new regulatory programs to maintain outside surveillance on quality of care, and they may wish to provide for quality review activities by entities concerned with financing or consumer affairs. The committee wishes to emphasize, however, the importance of avoiding the external micromanagement of health care providers and of fostering self-evaluation, innovation, and internal quality improvement.
Fifth, the quality assurance and improvement program outlined in health reform proposals ought to include specific responsibilities for identifying and overcoming system and policy barriers to improved performance. As suggested by the tenets of continuous quality improvement, wasteful and inefficient systems, as well as unduly complicated or contradictory policy environments, may contribute more to poor processes and outcomes of care than do the behaviors and practices of health professionals and institutions. The quality assurance
efforts embodied in reform proposals should be designed to help surmount these problems, and they should do this in conjunction with the information-gathering efforts of stronger national surveys and the use of computer-based data files discussed in the section on infrastructure; progress will also depend somewhat on the generation of better evidence about the effects of practice guidelines on quality of care, as the evidence to date is preliminary and soft.
CLINICAL PRACTICE GUIDELINES
If advances in the nation's ability to measure and improve quality of care, as well as enhance value, are serious goals of reform, then proposals must explicitly endorse the development, dissemination, implementation, and evaluation of science-based guidelines for clinical practice. Clinical practice guidelines are "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances" (IOM, 1990c; 1992b). The emphases in the IOM's view of guidelines are clear: assistance of clinician and patient decisionmaking, a focus on specific clinical circumstances, an insistence on systematic development, and an adherence to the best possible scientific base or, when data are not sufficient, the greatest possible consensus among health care professionals.
Practice guidelines are in a relatively embryonic state of development, especially insofar as cost containment, design of basic benefit packages, and other endeavors key to health care reform are concerned. Thus, as the committee has already suggested in its discussions of access and cost containment, health care reform proposals should not place more burdens on guidelines for solving problems of cost control, benefit package design, rationing, competition, administration, or quality than they, at their present stage of development, can sustain. Their emphasis should be on credible, accountable processes for developing and applying guidelines and, as noted in the Conclusion, on explicit support for the effectiveness and outcomes research needed to provide the scientific base for guidelines.
In the meantime, proposals can acknowledge that, with respect to quality assessment and assurance, thoughtfully designed and applied guidelines will help in four ways: (1) by improving patients' informed consent, their participation in decisionmaking, and their satisfaction with both the processes and outcomes of care; (2) by identifying important patient outcomes to incorporate in patient satisfaction surveys and other instruments designed to assess or improve performance; (3) by identifying possible quality problems arising from underuse, overuse, or incompetent provision of care; and (4) by determining priorities for improving or standardizing specific patterns of clinical care and sorting out competing claims for funding of biomedical and outcomes or effectiveness research. With respect to cost management, proposals can also recognize that those who pay for health care services and their agents can use guidelines in various ways, including (1) determining health insurance coverage and as screens to avoid paying for unnecessary or inappropriate care; (2) selecting or credentialing practitioners for participation in various health plans or institutions; and (3) tailoring other economic incentives to affect practitioner or patient behavior. The committee has, however, already cautioned against excessive expectations about the use of guidelines to control costs.
The IOM has proposed eight attributes by which the soundness of practice guidelines might be assessed and has developed a provisional assessment instrument based on those attributes (IOM, 1992b). Although judging the caliber of practice guidelines is not directly germane to health care reform, proposals ought to acknowledge that the quality of guidelines will be very relevant to quality measurement and improvement; consequently, the committee calls on reform advocates to provide for systematic evaluation of guidelines and similar tools, such as medical review criteria, that are produced in the coming years. Advances in this field will hinge, to some degree, on the headway made in related areas such as information systems and outcomes and effectiveness research, as discussed in the section on infrastructure.
The committee's positions stated in the previous sections on access and cost containment have specific implications for the quality measurement and improvement program of any health care reform proposal. In particular, proposals should mandate that one responsibility of a quality assurance and improvement mechanism is to track health status and the use of services for identified, insured populations. Collectively, those populations will comprise all (or virtually all) people in this country.
Specific attention then needs to be given to services used (whether or not appropriate and necessary) and services not used that should have been (e.g., preventive care, prescription drugs). Note that the services not used that should have been cannot adequately be tracked by studying only those who use the health care system. Furthermore, special consideration must be directed at previously uninsured, vulnerable populations to see that appropriate outreach is mounted and that discrimination does not exist or persist.
Intersecting with these recommendations are those related to cost control. The committee recommends that reform proposals mandate that a quality assurance and improvement program track the effects of certain cost containment processes. This charge includes monitoring the impact of geographic global budgets and caps, if such are proposed. The aims are to ensure that necessary services are not curtailed excessively and that inappropriate queue-jumping does not occur. The charge also involves tracking the effects of increased use of health maintenance organizations, preferred provider organizations, and health insurance purchasing cooperatives that constrain the choice of physicians, other types of clinicians, hospitals, and the like. Such ongoing evaluation is necessary to be certain that continuity of care is not significantly eroded, that use of specialty care is not inappropriately restricted, and that outreach programs are maintained for special populations that face especially difficult barriers to access.
Finally, a formal, nonjudicial mechanism by which individuals can voice grievances and obtain assistance should be available to all as the nation moves through the next few years of experimentation and change. For example, even if certain reforms are enacted, such as
amendments to the Employee Retirement Income Security Act (ERISA) and elimination of preexisting condition exclusions and waiting periods, situations may still arise in which certain kinds of plans may erect barriers to initial or continued health coverage or may link coverage in unacceptable ways to health status or social or demographic factors. These problems demand timely attention and resolution. Thus, the committee recommends that health care reform proposals mandate an additional responsibility of a quality assurance and improvement program—namely, to serve as a focus for consumer complaints or as an ombudsman. The committee does not envision the quality assurance mechanism suggested here as a substitute for reformed structures and processes to deal with patient allegations of malpractice.
Like access and cost containment, the commitment to quality of care—and the means by which it is assessed and improved—has implications for numerous other aspects of the health care system. For example, a common database (or common elements in multiple databases) able to track use and identify nonuse of services by enrolled populations will be needed; consequently, some provision needs to be made in reform proposals for defining and setting standards for databases that can be used in quality assessment and improvement programs.
ASSURING THE QUALITY OF CARE Key Statements
Reform plans should explicitly acknowledge three central issues that quality assurance and improvement efforts should address: (1) use of unnecessary or inappropriate care, as well as overprovision of otherwise appropriate services; (2) underuse of needed, effective, and (3) appropriate care; and lapses in technical and interpersonal aspects of care.
Proposals for reform should define an approach to quality assurance that will be meaningful, efficient, and acceptable to those with a stake in the process.
In considering outcomes, reform proposals should provide for the use of a wide range of health-related quality of life measures.
Reform proposals will need to reflect both concern with the quality of care provided by individual plans and practitioners and attention to the quality of care across the entire system.
Health care reform proposals should be clear about organizational structures, procedures, and divisions of responsibility and make explicit provisions for both internal and external monitoring of quality of care.
The quality assurance and improvement program outlined in health reform proposals ought to include specific responsibilities for identifying and overcoming system and policy barriers to improved performance.
Reform proposals should mandate that a quality assurance and improvement program track the effects of certain cost containment processes.
Practice guidelines are in a relatively embryonic state of development, especially insofar as cost containment, design of basic benefit packages, and other endeavors key to health care reform are concerned. Thus, as the committee as already suggested in its discussions of access and cost containment, health care reform proposals should not place more burdens on guidelines for solving problems of cost control, benefit package design, rationing, competition, administration, or quality than they, at their present stage of development, can sustain.
A formal, nonjudicial mechanism by which individuals can voice grievances and obtain assistance should be available to all as the nation moves through the next few years of experimentation and change. This committee recommends that health care reform proposals mandate an additional responsibility of a quality assurance and improvement program—namely, to serve as a focus for consumer complaints or as an ombudsman.