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II. THE PRINCIPLES OF QUALITY ASSURANCE The nation is presently committed by the PSRO legislation to particular mechanisms for regulating the quality of care but the Jaw leaves some leeway for administratively determined policies and specific approaches to be developed by individual PSROs. The committee has chosen not to limit its concern to the provision of detailed guidance for implementation of PSROs within the bounds of existing law. Such an approach, while perhaps of immediate use to those implementing the legislation, would belie the long-range potential of a quality assurance program to achieve the goal we have enunciated. And a limited approach also would imply that all the techniques are now in hand to achieve our goa1. The committee finds no existing definitive method for assessing and regulating the quality of health care. But we can postulate the principles that are fundamental to any such method and that can guide the future evolution of the program, including desirable legislative changes. In the following dis- cussion these principles are grouped under seven general head- ings: scope, methods and data requirements, standards, sanctions and behavior, management and control, costs and evaluation, and research. The final section of this report compares these prin- ciples to the present legislation. Scope three issues are raised by consideration of a program's scope. There is the jurisdiction of a quality assurance scheme, the population base for assessment, and the type of providers to be judged and employed in the review process. Jurisdiction. Determining the jurisdiction of a quality assurance system entails a number of considerations: the den- sity and demographic composition of the general population served in the review area; the types and numbers of practi- tioners in the area; the validity of measures of performance, which for infrequent diseases or procedures require coverage of a substantial population; the degree to which quality assur- ance systems should be compatible and geographically coexten- sive with political jurisdictions in the area; the possibili- ties for economies of size; the extent to which practitioners participating in the review should be known to each other; and the amount of responsibility to be given providers for the ini- tial review. Thene are two principal models of jurisdiction. One would establish a quality assurance scheme at the level of the health care organization, such as a group practice, a single hospital or a hospital chain, or a clinic. Examples of such provider organizations are the Kaiser-Permanente health plans, the Mayo 7
Clinic, or the New York City Health and Hospitals Corporation. The system would be established coextensive with the organiza- tion or with several organizations if one alone lacked a suf- ficient population of consumers or practitioners to provide valid statistical analyses. The "Commission on Quality Health Care Assurance," proposed in a recent Senate bill, follows this format.* A second model, similar to the PSRO approach, has population- based geographic areas of review. It would cover many different medical care organizations in a geographic area and review the care provided to the entire population of the area. Although in each model some review of cases would take place within the medical care organization, the first places more reliance on the initial internal review while the second requires an external mechanism to review the care provided by a number of organizations and individuals. The committee believes that geographically defined popu- lation bases offer advantages of a large enough general popu- lation to permit valid statistical comparisons,-and reviews that are less subject to influence by organizational pressures and professional relationships. Defining a population within a geographic area on the basis of enrollment in a financing plan (such as Medicare) can offer the same advantages and could extend to the entire population if mandatory national health insurance is enacted. On the other hand, an institu- tional basis for review offers some possible advantage in feedback of the review to influence individual provider be- havior and institutional policy. On balance, the committee considers the geographic area advantages to be greater. The committee recommends that quaZity assurance programs be estabZished initiaZZy to encompass a total population in a geographic area rather than a partio~Zar health mare organiza- tion. In view of the Limited experience with either system, however, experimentation is justified with different schemes or quality assurance review at the ZeveZ of the health mare organization. Recent debate over the criteria to be used by HEW in des- ignating geographic areas for PSROs indicates that the issues of jurisdiction are more likely to be resolved on the basis of political factors than of information and experience. An early example of political pressure is the push by state medical so- cieties for the designation of each state as a single PSRO. The committee believes that the designation of jurisdiction on political grounds without consideration for the patterns of re- lationship among health care providers will tend to create a " S.14, 93rd Congress, January 1973. 8
perception of the quality assurance system as a remote bureau- cracy concerned primarily with miscreants rather than a group that is intimately concerned with the overall improvement in the quality of care provided in a general population or com- munity. the committee recommends that the jurisdiction for a quaZity assurance program not extend beyond a natural "medioaZ trade" area which foZZo~s existing referral patterns. Population base. in which the focus of inquiry is on the people to be served, has two distinct varieties. Quality assurance could be limited to an examination of those services actually delivered to pa- tients or it could take into account the health status of all persons living in a geographic area or eligible for a health benefit program. The matter of general population base. The committee emphasizes the importance of comparing pa- tient services actually delivered with the health care needs of all persons in the region served or of all persons in a de- fined segment of that population. However, we recognize prob- lems inherent in that approach. Medical record abstract information for persons receiving health services can be compared to survey information that mea- sures health care needs of general populations to establish the relationship between health care need, demand, use and perfor- mance. The measurement of health status might be attempted Ja- ter but it is affected by many variables other than medical care and its measurement is much more difficult. Apparent discrepancies between need and the receipt of medical care should not imply that it is the sole responsibility of individual providers serving the area to correct deficits. An overburdened rural physician, for instance, should not bear the primary responsibility for the Jack of access to medical care in his area. Removing inequities may require action by the entire community or broader groups of professionals to pro- vide additional or reorganized services. Comparable terms, definitions, and classifications must be used in collecting data about both persons receiving and per- sons not receiving health services, otherwise valid comparisons are likely to be impossible or meaningless. the committee recommends that quality assurance programs use information both about patients receiving services and about the genera Z population, most of whom fizz not be receiving serv- ioes during a specific period. Providers of medioaZ care Fizz be reviewed primarily in regard to persona, health ware services provided, but paraZZeZ survey information should be empZoyed to assess the heaZth needs and demands of aZZ persons in the review area, including those not receiving services during the period under consideration, using terms, definitions, and oZassifioations oomparabZe to those used for the patient record information. 9
corollary: The problem of responsibility for meeting the health serv- ices needs of those not being served is beyond the scope of this report, involving issues of access, financing, and indi- vidua~ behavior. In a later section (p. 41) she committee recommends that Special project support be proffered to quality assurance programs that agree to undertake assessments of the relative health needs and health status of the general and un- derserved populations. It is clear that initially only a few areas will have the requisite trained manpower to do population surveys. Also, population surveys are costly, and the benefits from a particular survey design must be weighed against the costs. It is the committee's intention that only periodic and selected sample population studies be conducted by persons ex- perienced in this field. Provid are to be ino bud ed . The PSRO legislation seems to place primary emphasis on review of decisions by physicians, who also dominate the administrative mechanisms established. But providers other than physicians are responsible, in prac- tice if not by law, for the provision of services* either in- dividually or as part of a health care team. Consequently a system of quality assurance directed only to services rendered by physicians would be deficient in several respects: some services not easily traceable to a given physician might es- cape review; some services, judged inadequate, might be attri- buted to a physician who neither assumed the responsibility nor supervised the encounter. Moreover, there are providers such as dentists, clinical psychologists, and optometrists whose practice is independent of the physician but who should be subject to review the same as physicians. The committee recommends that aZZ persons who make inde- pendent, Zisorete judgments affecting the provision of serv- ioes be subject to review by quality assurance programs. This recommendation necessitates, in all fairness, a The committee recommends that at: health ware praoti- tioners subject to review participate in the setting of stan- Zards for the review process and in the performance review itself. i; The reason for the distinction of the types of providers is that the law, in general, does not recognize the "indepen- dence" of other health personnel such as nurses, physician's assistants, dental hygienists and technicians. The concept of an "independent" provider of services is evolving and should be re-examined at frequent intervals. 10
The engagement of all health care practitioners in standard-setting and review will make unnecessary the estab- lishment of separate standards for each professional group, and the separate audit or separate review of practitioner performance.* The committee believes that proliferation of different standards for different professional groups engaged in the same care process should be discouraged, as should the development of separate auditing and review systems. Ino fusion o f ambu Zatory care . Review only of hospital care is insufficient for an assessment of cost and quality of health care generally. Unless ambulatory care is also con- sidered, there is no way to determine the natural history of an episode of illness. In addition, adequate ambulatory care can sometimes prevent hospitalization. Finally, many ill- nesses that do not require hospitalization but do cause dis- abiJity, suffering, or even death would not be subject to quality review that only covered hospitals. Different prob- lems are involved in reviewing ambulatory care, such as the smaller number of discrete services per visit or the frequent difficulty in specifying the diagnosis or problem. However, the development of coding schemes for problems is helping to overcome the difficulties. The importance of covering ambu- latory care in quality assurance programs warrants its inclu- sion as soon as possible. the committee recommends that review be made of ambu Za- tory mare series as me ZZ as services provided in hospit~Zs. Methods and Data Requirements The PSRO legislation does not specify the methods to be used in reviewing care, and its references to date require- ments are quite general. This lack of specificity may re- flect an understanding that the state of the art is quite rudimentary and that groups of strong proponents are forming around the various methods aimed at quality assurance. The committee does not believe that clear superiority has been established for any one method; we have chosen to concentrate on generic principles that should guide the development of specific methods and data requirements and their evaluation in the future. Because an understanding of the state of the art is fundamental to our recommendations, both for immediate actions and long-range development of the field, we present in the following sections considerable detail on methods and data. We recognize that there will have to be separate cri- teria for certain health professions such as dentistry. 11
Methods Many different methods have been employed to assess the quality of medical care. This section presents a matrix for classifying these methods, discusses some principles, and raises problems associated with some of the methods. A de- tailed discussion of each method is beyond the scope of this report but discussions can be found in some of the articles listed in the annotated bibliography attached to the report as Appendix A. Quality assurance methods differ mainly in two regards: the type of data to be used and the source from which the data are obtained. Figure ~ presents a summary of the possible interrelationships among these two matters. Some definitions will facilitate consideration of the figure. Type of data to be ooZZeoted Struo ture data describe a variety of characteristics of health facilities, including the size of institu- tiQn, equipment in a hospital or safety and hygiene standards in a nursing home, experience or creden- tials of health practitioners in the institution, such as whether a physician is "board certified" or how many years a nurse has been invo~ved-in direct patient care, the characteristics of patients, and the case mix. Prooess data describe what physicians and other health providers do to and for a patient e Outoome data describe the end result for the patient or population, reckoned by such factors as longevity, change in symptoms, dependency, and functional capacity. Methods for ooZZeoting data Resource and organization data, gathered by a vari- ety of agencies, include the number of hospital beds in a community, vital statistics, and the ratio of physicians to population. Hos pi ta Z discharge abs tract includes a uniform ba- sic set of data collected for all patients dis- charged from all hospitals and expressed in standardized terms, definitions, and classifica- tions. This basic data set can be augmented by problem or disease-specific information. 12
Figure 1 Quality of Care Assessment: Possible relationships between the type of data by which the assessment of the quality of care will be made and method by which that data will be collected. Type of Data Method- and Sources Routinely Reported Data about Population, Resources, and Organizations Hospital Discharge Abstract Claims Form Encounter Form Source-Oriented Medical Record Problem-Oriented Medical Record Direct Observation of Physicians Simulation Techniques Patient Interview Tracer Disease Strategy Population Survey Combination of Above Structure Process Outcome Combination X X X X X X X This type of data can be collected by this method. 13 X
Claims form includes basic data used by a physi- cian or health facility in billing insurance in- termediaries for reimbursement. By employing uniform terms, definitions, and classifications, it can be linked to or incorporated with the Hos- pital Discharge Abstract. Encounter f orm includes a uniform basic data set as part of the record for each patient visit; a statement of the patient's problems, diagnosis, procedures such as laboratory tests, services provided and disposition of the patient is in- cluded. It can be linked to a claims form and in some instances to a hospital discharge abstract Souroe-oriented medical record is the traditional manner in which the medical record is kept. Each provider participating in the care, such as nurses and physicians, initiates data, usually in differ- ent parts of the record. ProbZem-orienbed mesa? record is a recent inno- vation in medical record keeping. The record sys- tem is basically time-sequential; the patient's salient problems are defined, and the record clearly links each problem to its clinical investigation and management. Such records provide a clear indication of the physician's clinical logic and differ from source-oriented records in that for any given en- counter all the data relating to the encounter are found in one place in the chart, regardless of who entered them and arm redated to the appropriate problem. Direot observation of practitioners is data acquisi- tion by trained observers who watch and record in- formation about what a health professional actually does in practice. Simu Z ation technique s employ actors, computers, and other means to simulate clinical situations which enable an assessment of a health professional's re- sponse. Patient interview is the collection of data by in-- terviewing patients (face-to-face, by telephone, or by mailed questionnaire) who sought services from a give-e health provider.
Tracer disease s trategy is an approach to selecting and using indicators to assess the 'qualify of medical care. It relies on sampling sets of discrete units of process for which-o~t'come can be identified'. Analysis of the sample data provides a basis for generalizing about the effectiveness of medical processes, provider performance, and organizational management at a collection site. Pop u Cation survey is the collection of data by means of household interviews or health examination surveys from properly selected random samples of a defined population or an entire population, both those who have and those who have not actually used health services during a speci- fied time period, such as two weeks or a year. Criteria for the app Ligation of data After the types of data and methods of data collection have been determined, criteria must be established for apply- ing the data to the assessment of the quality of care. Evi- dence suggests that the results of qualify 'of care assessment will vary with the purpose 'for which the criteria were estab- lished, who determined the criteria, and the methods used in the establishment of criteria. The broad range of possible approaches illustrates the complexity of attempting to assess quality on a uniform and objective basis: The purpose for establishing criteria can be ad- ministrative alone, or designed to serve an inte- gral role in the care of the patient. Criteria can be set by groups of providers external to the provider group whose care is being reviewed, or established by the group subject to review. The manner in which criteria are established can be explicit (predetermined and understood by the group in ' advance) or implicit (judgments relying on the subjective opinion of the individual judge). Explicit criteria can be normative judgments based on the opinions of an individual or a group of ap- propriate experts, or empirical judgments based upon data obtained from objective assessments, evaluations, or analyses. The way in which criteria are set may help determine the degree of compliance. Local physicians may be less coopera- tive with criteria established at the national or state levels than those established locally, but local criteria may not re- flect the most desirable practice of health care based on more objective analysis. 15
A later section of this report (see p. 28) discusses the setting of standards, which are defined as the expected level of compliance with criteria. The setting of standards raises many of the same issues involved in establishing criteria. Although the issues are similar, the setting of standards is considered separately because, in the context of this report, standards represent a regulatory decision which may involve many factors other than the technical criteria, whereas the establishment of criteria is a technical task based on profes- sional competence. Examination of Figure ~ suggests that the choice of a method of quality assurance is a complex undertaking. Yet even this figure oversimplifies the task. Other variables to be considered in developing a method to assess quality of care include the extent of concern about availability, accessibility and cost of care; the costs of the method; whether criteria for adequate care will be set externally or internally; and whether the criteria will be derived administratively by a public agency. The committee recommends that the process of setting ori- teria for the use of data in a system of quality assessment be kept fLexibZe so that the system may combine, as appropri- ate, the values of various techniques in criteria setting. StruoturaZ, prowess, and outcome data Any method of assessing the quality of health care should either measure improvements in the health of the population served by the system as well as in the population not served, or should measure a set of variables that have a highly pre- dictable and reproducible correlation with changes in health status. In addition, a quality assurance system should assist in efforts to understand the relative effect of personal health care services on health status as against the effect of other influences such as the environment. In Figure 1, the ''type of data to be used" is arranged so that proceeding down any column yields categories in which in- creasingly more direct measurements of' health can be made. But the categories in the left-hand columns--'~process" and ·r structure"--provide insufficient data by any collection method to serve as the sole basis for assessing medical care quality. In most cases, research has not substantiated the relationship between these categories and health status. A number of commonly accepted structural indicators of good quality, such as the extent of a provider Is training, have not been consistently shown to account for all the differences in quality of medical care, although structural factors may make measurable improvements in the processes of care. Such fac- tors as class rank and grades in medical school, a physician r S 16
board certification status, the place of physician training, the presence of a full-time radiologist or pathologist on the staff of a hospital, and the percentage of patients autopsied may have some relationship to measurable quality, but they are not sufficient factors by themselves. Such factors as the number of journals read, participation in continuing edu- cation as it is currently practiced in most situations, and membership in medical societies have no identifiable relation- ship to outcomes of health care. Inherent unreliability notwithstanding, certain struc- tural and process information that can be related to outcome of care is useful in assessing the quality of care. An exam- ple is standards for safety in electrical equipment used in care. Many other structural aspects of care need to be assessed in terms of effects on outcomes. When it can be con- clusively shown that a process or structural factor is causally related to outcomes, greater reliance can be placed on it. Data source, 408 t, and re Ziabi Zi by Possible sources of data are displayed along the vertical axis of Figure 1. In general, unless sampling of data is per- formed, data obtained from the sources listed toward the bottom of this axis are more expensive than data obtained from sources toward the top. However, except for data derived from hospital case fatality rates or complication rates, which can be obtained from a hospital abstract or medical record, patient outcome data are generally available only from patient interviews and popu- lation surveys. Such outcome data are usually expensive, al- though methods recently tested suggest that under certain cir- cumstances functional capacity or disability and distress levels can be assessed Reliably and collected at the time of and during hospitalization.; Only through the use of a community survey or survey of a registered population can information be obtained from a prop- erly selected random sample of those in a population who used services as well as those who did not. To assess the effective- ness of health services, users have to be compared with nonusers. Besides content, there are q~e*stions about data with re- spect to reliability and validity and to the amount of pro- fessional time needed for its acquisition. Data abstracted ... Rosser and Watts: 1972. ~ ''Reliable" data give the same result in successive usages. "Valid" means that the data are appropriate to the . . ~ ~ enc In view. 17
from the medical record may have more to do with the quality of data recorded by the physician than with the quality of care provided. If the medical record is not kept in a neat, legible, problem-oriented format, mistakes.made.in abstract- ing or judging the record may be so numerous that the informa- tion is less useful. On the other hand, data obtained from claim forms, encounter forms, or hospital discharge abstracts may not be sufficiently detailed to judge fairly all aspects of the performance of an individual provider, or the care of a particular patient. Observations of a practitioner's work -require a great amount of time and are difficult to standard- ize. Finally, no matter what source is used, the.volume of primary data collected on individual cases is likely to be large. Detailed and accurate data, such as those contained in the medical record, are often necessary for the delivery of good quality medical care. But if the data are used in the review of all care in a region or large institution, the quantity be- comes unmanageably large. An accurate abstract of pertinent data can reduce the quantity and enable data aggregation for Statistical profiles. And the development of aggregated sta- tistics can be further simplified, reduced in cost, and fre- quently made more accurate, by sampling. Simpler data to begin with, such as that contained in an abstract, are more likely to retain their accuracy when handled successively in data processing. Specific methods in quality assessment Recent research in quality assurance and the relationships indicated by Figure 1 prompt the committee to make the follow- ing observations on the application of specific methods: --Because so few of the persons who have developed quality assurance.methods have worked collabora- tively, or have tested alternative methods, there is little consensus on an optimal method or set of methods. Available comparisons of different methods to assess the quality of care show wide variations among methods in the levee of acceptable care found.; The comparisons suggest that assess- ment of quality of care is affected by the method used to measure it. They also suggest that the use of explicit process criteria to assess medical care may foster a dramatic increase in the number of services without a corresponding improvement in the health of the population. Brook, R.H., 1973. 18
--Other important issues are raised by the trade-offs be- tween the use of explicit or implicit and normative or empirical judgments in the formulation of criteria. Ex- plicit judgments are more reliable and involve less phy- sician time. But implicit judgments permit the review of all aspects of a case because predetermined criteria-- essential for explicit judgments--are seldom available for every relevant aspect of a patient's condition and treatment. Reoommendoctions about me thods The implementation of the PSRO program will afford an op- portunity to test the validity of some of the committees ob- servations. An examination of a number of the predecessor programs, such as some of the EMCROs,* QUAP,** TAPER* and some material developed by the Foundations for Medical Care, has led the committee to believe that it is probable that the method chosen by most of PSROs will be based on explicit judg- ments of process data derived from a modified type of hospital claim form. There are a number of problems with this approach. First, as indicated before, this type of review is likely to result in increased costs without corresponding improvement in health status. Second, innovation may be stifled. As long as correla- tions are lacking between process and outcome, there will be a tendency to formalize lists of procedures to be employed in given diseases and regard noncompliance as inadequate care. No* all practitioners, however, agree on a "proper" procedure. In the treatment of myocardial infarction, for instance' there is some evidence to indicate that suitable patients treated at ]iV'1tC =~ ~ =O ~ ~ ^= ~ y L~ 'V' =O Lll~= ]tU~p ~ Ld ~ locus Yet current practice dictates protracted hospitalization, and if that were made a standard practice under the PSRO program effi- cacious alternatives could be discouraged or even proscribed. ~ ~~ ~ ~ ~ ~ ~ ~1 ~ . 1_ A ~ ~ 7 ~ A ~ ~ ~ ~ ~ ~ _ ._ ~ t~ _ _ ~ ]~ ~ ~ _ ~ _ _ _ ~ X X * * * Experimental Medical Care Review Organizations, sup- ported by the Federal Government as experimental quality re- · ~ view programs. * The Quality Assurance Program, sponsored by the American Hospital Association as a model for hospital-based quality review ........ ^^^ Trustees, Administrators, and Physicians Institutes of the Joint Commission on Accreditation of Hospitals. * ......... ^~^ Mather, H.G., et al., 1971. .19
A third problem is the potential for increased hazard to the patient. Prescriptions of lengthy hospital stays, more drugs, more x-rays, and the like increase the risk to the pa- tient--a risk that needs to be balanced by demonstrable bene- fits. And increased demand for tests adds to the demand for manpower, and ultimately to the cost of care. The preceding examination of data requirements and methods of review leads to two recommendations for initiating a quality assurance system. The committee recommends that data for ~ quaZity assurance program be based on the universaZ use of decentralized and re- gionaZized hospitaZ Zisoharge abstract systems that employ a uniform basin data sets Each abstract contains data on the patient's place of residence, demographic characteristics, procedures, diagnosis, length of stay and health status at time of discharge. In all, fifteen basic items have been recommended, including one for the total of charges of the hospital stay. The hospital discharge abstract data set is so constructed that it can be linked to similar uniform basic data sets of claims review and encounter forms. Regional or institutional comparisons of items contained in this data set such as the utilization rate for a specific operation or death rates in myocardia~ infarction would be useful to quality as- surance systems as a first step. If the current PSRO legis- lation does not permit the use of this approach, comparisons should be made between the PSRO approach and the recommended approach. Use of the abstract puts the emphasis where it should be at the initiation of a quality assurance program on both pro- cess and outcome measurements. As more experience is gained with understanding information from the abstract, the Uniform Hospital Discharge Abstract data set could be augmented by the inclusion of data about those medical care processes which have been shown to be correlated with beneficial patient outcome. The committee acknowledges that this data set allows only a beginning assessment of outcome and alone will not be suffi- cient to analyze case mix differences among hospitals. We ... The U.S. National Committee on Vital and Health Statis- tics of the National Center for Health Statistics has promul- gated a Uniform Hospital Discharge Abstract Data Set which has been tested and implemented in many hospitals across the coun- try. The "Abstract" has been endorsed by the Federal govern- ment, most major medical organizations and financers of hospital care. See "Uniform Hospital Abstract: Minimum Basic Data Set. fir Vital Health Statistios, Series 4, No. 14, U.S. Government Printing Office' Washington, D.C., 1972. 20
believe, however, that the Uniform Hospital Discharge Abstract data set is the simplest,.most acceptable, and reliable uni- form data set that can be utilized by the entire hospital com- munity immediately. the committee recommends that processes of medical care for which information is lacking to correlate them with benefioiaZ patient outcomes not be inoZuded in a quality assurance program except on a speoiaZ study basis, even though the processes constitute usual and customary practices. Once it is under way, a quality assurance program can add data from ambulatory care and disease-specific studies of the outcomes of care for patients who have visited.a health pro- vider as well as data on the health status of people who have not. An example of such a study would be a population survey that determined the characteristics as rates for those in the population who have hypertension but have either not been diag- nosed or, having been diagnosed, have not been properly treated. Summary of eonoZusions about methods What conclusions can be drawn from the current knowledge about methods that can be useful for both the initiation of PSROs and the longer range developments of quality assurance mechanisms? Informed opinions differ on the validity and re- liability of any one method of collecting and evaluating data for a quality assurance program but a few propositions are at- tracting some consensus. --Any method should be oriented, to the extent possible, to establishing and utilizing reliable relationships between structural characteristics and processes of care, and the achievement of desired outcomes of that care. Establishing these relationships is not so much a quality assurance method as it is a clinical research technique that should form a Jogi- cal underpinning for application in any method. The PSRO pro- gram should and can be oriented around this fundamental emphas --The use of explicitly predetermined criteria should be avoided unless they are grounded in objective studies showing beneficial patient outcome. The use of explicit criteria based on norms of current practice or even consensus of experts, without reference to patient outcome, can stifle innovation, increase costs, increase demand for scarce manpower resources, and increase the risk of harm to the patient from the care it- self. --The importance of the medical record in organizing decision-making processes is gradually being recognized. How- ever, medical records have been arranged more for the conveni- ence of those entering the data than of those using the record for care. Increasing complexity of records is forcing their reorganization to simplify and expedite the clinical inter- pretation of the information and reflect the clinical logic of 21 IS .
the physician. The problem-oriented record represents an im- portant example of this development. --The use of any method poses cost-benefit questions. Some methods, such as observing practitioners at work, are valuable but very expensive. These trade-offs must be openly discussed and costs and benefits analyzed before major commitments are made to specific methods. --None of these methods is definitive and none is fully proved. Quality assurance on a major scale is a new enter- prise and experimentation should be the rule rather than the exception. In spite of the lack of a definitive method, there is sufficient information available about certain approaches and methods to establish a first-generation quality assurance system as described above. The committee recommends that earefuZZy designed research studies be oonduoted to reZate process and struoturaZ factors oausaZZy to outcomes. Unti Z such time as this research provides reZiabZe information, quaZity assurance shouZ~ be based on a judicious combination of struoturaZ, prowess, and outcome fao- tors. Experimentation in methods shouZ~ be the ruZe and not the exception. In sum, concerning methods, the committee recommends that a quality assurance program should buiZ~ initiaZZy on the "Uni- form BospitaZ Discharge Abstraot Basio Data Set." As the pro- gram develops beyond this initial data sets both process and outcome measurements shouZ~ be used, attempting always to relate mare to outcomes and empZoying only those process measures for which research has demonstrated a definite oorreZation with patient outcome. Any quaZity assurance program, including PSRO, shouZ~ expand to cover ambulatory mare as soon as possible. Data Requirements The data requirements for a quality assurance program might seem to be a technical detail to some policymakers. But the committee believes that the nature of data requirements has fun- damental implications for the effectiveness of a quality assur- ance system and deserves treatment as important policy principles. Two basic agreements form the framework for the committee's specific recommendations. First, the committee agrees that the data system for quality assurance should allow evaluation of care to be integrated into the delivery system. Implicit in that con- cept is that selected patient data should be quickly retrievable, related to patient problems, compatible with other data require- ments related to patient care or health planning, susceptible to continual revision, and frequently compared to existing standards that are in turn periodically reviewed when new data are available.
Second, the committee agrees that any data system of quality assurance should aim toward coverage of all providers, patients receiving services,- and persons not receiving serv- ices. Once these data are available, the sole purpose of data collection should be to facilitate the framing of the ques- tions about the derivation of relationships or correspondences between what is done when health care is provided--the pro- cesses used in the provision of care--and patient outcome. It is then possible to divide outcome data into categories for in- dividual patients and for out-populations of various catego- ries of patients. Within this framework, the remaining issues to be covered are the kind of data to be collected, the uniformity of basic data sets, methods for collecting and retrieving data, the compatibility of the data-with other health data collection systems, and the patient's medical record. Kinds o f data Specific requirements for health data can be defined through the use of seven terms.* Health data should be prob Zem-oriented, i.e., data should be focused on the probe ems that patients and populations present to providers. A health information system should also be person-reZated, so persons can be identified through the use of sociodemographic indicators with due regard for confidentiality. As a corollary, data must be available about all providers of care. The data should be popuZation- based so that denominators--either enrolled populations or geo- graphically defined populations--will allow demographic stan- dardization of the data for purposes of making comparisons. Additionally, all data should be period-expZioit and pZa~e- speoifio. In other words, the system should identify the time periods and the place of the services, or, in the case of popu- lations not in receipt of services, the area in which the popu- lation resides. Finally, a data system should be characterized by parsimony; only that data should be routinely collected for which there is a definite use envisioned in making decisions. To sum up: The committee recommends that data for the purposes of qua City assurance be probZem-oriented, specific to recipients of mare and proviZers, popuZation-based, period-expZioit, and pZa~e-speoifio. The data must make possible analyses of those patients aotuaZZy served and those potentiaZZy served and the ready identification of demographic and soetoe~onomio oharao- teristios of persons inoZuded. ~ ~~ This conceptualization is borrowed from an article by Kerr White, M.D., "Priorities for Health Services Information," Health Servioes Reports, 88: No.2, February 1973. 23
Uniformi by of data If the terms, definitions, classifications, and time pe- riods employed by a data system for quality assurance in Arizona are different from those used in Delaware, it would be difficult if not impossible to make comparisons of the quality of services between those two states. Similarly, if data collected for hospital discharge purposes are not com- patible with data collected for ambulatory care, comparisons between patients served by various parts of the system, as well as linkages between inpatient and ambulatory data will be impossible. Medicine and dentistry no longer are expected to have substantial deviations in performance from place to place in the U.S., except to the extent that there are geographic varia- tions in diseases and social and environmental factors. Com- parisons among providers can be made only if there is a uniform system for collecting performance data. It is essential that all terms, definitions and classifications within the data system be uniform. Information systems wilt continue to be established in support of quality assurance programs. But this is only one function of health data, which are collected about many as- pects of health care, including manpower, facilities, and costs. Data systems are proliferating in both the public and private sectors. Some states are moving to participate in the "Cooperative Federal-State-Local Health Statistics System"* that involves coordinated Federal, state and local statistical efforts. The National Center for Health Statistics has been developing contractual arrangements for state and local com- portents of this system. The use of comparable terms, defini- tions and classifications by these systems and quality assur- ance programs is essential. Unless all of the Federal programs promulgating standards for data collection (PSRO, National Center for Health Statistics, Social Security Administration, Social Rehabilitation Service, and Health Maintenance Organi- zations) use a common approach, confusion will be compounded and costs expanded. Uniformity of data terms, definitions and classifications are equally important in the private sector. By 1973, re- gional, voluntary health care data systems had been established in twelve states. In addition, many state Blue Cross plans have created other data systems. Although present laws cannot compel these systems to adopt terms, definitions and classifi- cations in common with systems supporting quality assurance, ... `' Authorized by Section 305(b) of the Public Health Service Act, as amended. 24
they should be strongly encouraged to do so. This adoption is the only way to facilitate the exchange of comparable data be- tween the public and private systems. As a step in this direc- tion, the members of the American Association of Health Data Systems, representing fifteen regional data systems, have al- ready adopted the uniform basic data set for hospital discharge abstracts. The committee recommends that basin patient identifioa- tion Satan services, and diagnostic categories be stated in uniform terms, definitions and oZassifioations and that oom- patibiZity between public and private data systems be enoourageZ. The recommended uniformity will make unnecessary a uni- form configuration for data collection instruments or forms, since the data derived from any instrument or form can be readily processed by computers, although common data collection forms may be useful to the provider. The uniform data set we recommend is a minimum requirement. It is important to allow for additional data elements that reflect local initiatives and permit the development of new ideas and innovations. Me thod s f or oo Z be sting and re trio sing da ta The technology of collection and retrieval of data is undergoing rapid change, largely because of increasing use of computers. The committee has limited its recommendations pri- marily to characteristics of data rather than detailed techni- Cal advice on data collection and processing systems. The committee is of the opinion that the computer's great capaci- ties for storing, retrieving, and analyzing data should be used whenever possible. Regardless of the degree of compu- terization, the data will be more valid if practitioners re- sponsible for generating and assembling the primary data, particularly concerning diagnosis, are responsible for their accurate entry into the data collection system. This respon- sibility can be assumed by the practitioner directly or through supervision of personnel, as long as the practitioner maintains the ultimate responsibility for the validity of the data generated. The committee recommends the use of computer teahnoZogy whenever feasible in the assembling of data for qua Zity assur- ~ gnizes, however, that the nature of the teeknoZogy a Zone does not assure vaZid data. Therefore it recommends that providers, who are responsible for the initial generation of diagnostic and other data about patients, be responsible for the oorreot entry of that data in the record system. ~ . . ... ~ ante programs. The committee redo teeknoZogy a Zone doe The committee wishes to emphasize the importance of the quality of the input data and the competence of the computer 25
management for the successful use of computers in quality as- surance programs. Compatibi Zity of aZZ health care data Because information is needed to measure the performance of the health care system as well as to develop programs for improved delivery of health care, providers are continually faced with increased requests for data. These requests can be minimized by assuring compatibility between the data system for quality assurance and other data systems. Several measures can help assure this compatibility. Pro- viders and other suppliers of data must be able to record such data only once to serve many purposes--quality assurance, health planning, manpower planning, requirements of Federal and state agencies, and the like. It is technologically feasible to de- sign data collection instruments that will serve multiple pur- poses. This should be done at the Federal, state, regional and local levels. Responsibility could be assigned to the National Center for Health Statistics to formulate uniform terms, defi- nitions and classifications and to collect, collate and dissemi- nate standards for the collection of health care information. The NCHS should approve Federal systems for gathering data, and also the standards for population survey data to be gathered through the Federal, state, and local cooperative health sta- tistics systems. At state and regional levels there should be a central health data processing center for each medical care area, developed by a consortium of interested public and pri- vate users and providers of data. This center would be a single entry point for data from the medical care area and could be re- garded by all parties as a neutral source of data, free from parochial interests and able to supply health data for a variety of purposes, including those of the quality assurance program. Several of these consortium data centers are already coming into being. They are usually constituted as nonprofit corporations whose trustees represent the major health interests and the public. The commi ttee recommends that qua Zity assurance data, as eZZ as other data, be recorded only once; that aZZ data be uniform with respect to terms, definitions of terms, and cZas- sifioations; and that, in order to faoi Zitate the uniformity and parsimony of data and to minimize demands upon the pro - viders, the National Center for Health Statistios be assigned responsibi City Hi thin HEW to formulate uniform terms, defini- lions of terms, and classifications, and to formulate data co Z Zeotion systems in aooordanoe with this recommendation. In " Examples include data centers established in Maryland, Rhode Island, and Massachusetts. 26
addition, the NCHS should formulate specifications and stan- dards for processing and aggregating the data to be coZZeoted, including speolfioations for the appropriate release of ag- gregated data to authorized users in aZZ oases, respecting the needs for protecting the oonfidentiaZity of individual pa- tients. Independent centers for health services data, in- oorporated by a consortium of the users and providers of such data, shouZ~ be established for each medical mare area to ant as a single entry point for health services data and a pro- oessor and distributor of that data for aZZ purposes., inoZud- ing quality assurance. ConfidentiaZity of patient data The PSRO legislation requires that patient profiles be collected by each PSRO. The committee can understand the use- fuiness of these profiles in assisting providers to improve patient care, an example being the reduction of duplicate or contraindicated prescriptions. However, the committee be- lieves strongly in the importance of maintaining the confiden- tiality of individual patient data; this is a logical exten- sion to the health information system of the practitioner- patient relationship of trust, and is subject to the same code of ethics. At the local review level, patients will occasion- ally be identified by name to those entities to know. But those data will be aggregated for use at higher levels and patient identification is not crucial to disclosure of infor- mation about provider performance. Data analyses to be per- formed by organizations such as the National Center for Health Statistics and other national, state and regional organizations and agencies, as well as authorized research workers, can be accomplished without identification of patients by name. This is a deceptively simple point to state, but the committee stresses its importance because of the potential for abuse. The committee recommends that data ooZZeoted on individual patients in the course of quaZity assurance be kept striotZy confidentiaZ at the topaz review ZeveZ and that only aggre- gated or anonymous individuaZ statistioaZ data be made gener- aZZy avaiZabZe. The patient's medioaZ record A number of instruments are likely to be used for data collection purposes, but the patient's medical record will con- tinue to be an indispensable instrument. Because of the com- plexity of the health care delivery system and the high mobility of the population in the United States, however, a patient's medical record is rarely a single document but rather is a com- posite of data about the patient collected from a number of providers. Information exchange among providers should con- tinue to increase, facilitated by electronic record-keeping and communication. Nevertheless, the time should come when all 27
patients can be given possession of a copy of most of his or her own medical records in addition to records to be main- tained by providers. The committee recognizes that both pro- vider and patient attitudes and practices will have to change significantly and that there are limits to the amount and type of information to be given to patients. the committee recommends that means be deve loped and evaZ~ated for entrusting most aspects of the patient's medioaZ rectory to the patient. Standards'; Whatever methods are used by a PSRO or future quality as- surance program, some standards will have to be employed against which to measure provider performance. There formula- tion is certain to create controversy. Questions of unifor- mity and stringency arise, as well as the questions of who wild formulate the standards and for what purpose. Neverthe- Jess, a few principles seem incontrovertible. Uniformity of standards is a desirable principle. The patient's right to expect good treatment wherever he lives would be sacrificed if a provider in one state were held to different standards than one similarly situated in another state. There are, however, practical justifications for de- viations from uniform standards. Ability to meet uniform stan- dards may be beyond the control of the individual practitioner. An isolated rural family practitioner with a heavy patient load may not be able to follow all standards that would apply to an urban practitioner with a normal work load. Rigid adherence to uniform standards in this rural situation could result in denying some patients access to any care at all. Other depar- tures from standards may be justified in terms of different patient characteristics, such as a tendency not to follow medi- cal instructions, poor-nutrit~onal habits, or drug abuse. De- viations from standards should not, however, be made on a subjective basis, such as the practitioner's relative compe- tence or lack of knowledge, but should reflect differences in available resources and population characteristics. Although medical care standards should be related to the desired changes in health outcome of the population being served, it must be recognized that medical care is often not the most important variable affecting health status. ^ It may be useful at this point to reiterate the committee's distinction between "criteria" and "standards" (see p. 16~. "Cri- teria" are identifiable elements of care used to judge the appro- priateness of that care; a tt standard tl iS the degree of adherence to the defined criteria. Sometimes "norm" is used interchangeably with "standard." However, the committee defines "norm" as merely a statistical average, whereas a "standard" is set by a decision which may involve many factors other than statistical averages. 28
Another principle is that providers subject to review should not be wholly responsible for formulating the criteria by which they will be reviewed. Epidemiological and statisti- cal skills should also be employed in setting criteria, with providers participating in the establishment of standards, particularly at the local level. The technology of quality assurance is in its infancy. The formulation and application of standards will have to be an evolutionary process. One way to encourage evolution is to provide some flexibility permitting local initiative in the initial establishment of most standards. The PSRO legislation provides this flexibility. Local initiative must be balanced, however, by the need for a reasonable degree of uniformity to ensure the equitable treatment of providers. Any future Jegis- lation enabling quality assurance must not only permit but also require some local setting of standards and the constant re- formulation of standards on the basis of both field experience and the results of evaluative research. (The Federa] function in collecting and analyzing this experience is discussed in more detail under the recommendation for Federal management. See p. 40.) The committee recommends that standards be formuZated ini- tiaZZy at the topaz review ZeveZ, and the FederaZ activity fo- ous on the reties, comparison and approvaZ of Zo~aZZy developed standards. After some experience is gained with standards and more knowledge is acquired concerning the relationship of ware processes to outcomes, seZeoted standards should be promulgated as national Guidelines, but not with the regulatory forge that coup pre~Zude further goof innovation. Both the formuZation and appZioation of standards should be subject to periodic modification as the methods evolve to assure qua City of health mare. The Costs of Quality Assurance Some activities now exist to enhance quality in the health care delivery system. But the establishment of a quality assur- ance program, such as PSRO, that requires the participation of essentially all providers of care will add substantially to cur- rent expenditures for the effort. The increases can be attri- buted to acquiring data, establishing quality assurance systems, maintaining them, and possibly to effects on the provision of care itself, which may become more costly as a result of im- posing a quality assurance system. Some additional costs can be justified in terms of the value received from the assurance of the quality of care. Whether these costs are offset by de- creases in the overall costs of care as a byproduct of the quality assurance program remains to be seen. In any event, the committee assumes that there will be a decreasing rate of 29
return from the use of more elaborate and expensive quality assurance methods. Therefore, continuous attention should be given to the analysis of costs of alternative methods compared with the effectiveness of the method for enhancing quality of care. Qua City assurance costs. Most of the studies and esti- mates on health care data suggest that costs of quality assur- ance will be high. In the New Mexico and San Joaquin medical care foundations, which use complex data for review of hospital and ambulatory care, preliminary estimates of the costs are two to five percent of the overall care cost. These costs, however, also cover the collection of some information that would be needed in any process of third-party claims review. Because of the methods of cost accounting currently used in the health care field, it is very difficult to develop re- liable cost estimates. But the potential for substantial data collection and analysis costs argues for maximum use of sam- pling techniques which will minimize not only the burden on providers but the purchasers of care as well. The minimal requirements for quality assurance will be substantial in quantity and cost. The apparently inexorable expansion of demands for data will only increase that cost. The Committee recommends that health information systems be designed so that quality assurance data are oompatibZe with those ooZZeoted for other purposes in order to restrain the normal tendency of bureaucracies to ooZZeot more data than man be justified by a oZear expression of need or use; and that sampling techniques be used wherever they are appropriate to the purpose. Costs of establishing quality assurance systems. Costs of starting a quality assurance system (planning, design, de- velopment and installation of hardware and software, and ini- tial staffing) can be covered at the outset by either of two sources but the eventual result is the same: the consumer- taxpayer pays the bill. If providers, who are required to participate in quality assurance programs, also have to bear the cost of those programs, they will pass it on to the con- sumers. Since consumers of health care services include government, and government's revenue comes from taxation, the taxpayer would support the government's consumer role as well as his own. If government assumes all or part of the start- up costs for quality assurance, as is the case with PSROs, the money could come from general tax revenues or Social Se- curity tax funds. Whichever formula is applied will occasion some redistribution of income among the population. Thorny as the issue is, it is not an integral part of this committee's 30
considerations. We merely emphasize that it is an important issue, and point out that general revenues come from a more progressive tax base than does the Social Security. trust fund. The committee recommends that the Federal government bear the total costs of estabZishing quality assurance programs by nonprofit organizations with assurances that topaz sources Fizz be able to bear their share of the costs of maintenance. The costs of maintenance. The line between start-up and maintenance expenses is not clearcut but is sometimes drawn arbitrarily by legislation as a means of limiting the Federal role. The PSRO legislation is not clear when, if at all, a direct Federal subsidy will cease.~ The committee believes that users of data from a quality assurance program, such as providers, third-party payers, educational programs, and plan- ning agencies, will have a greater motivation to participate in the implementation of that system if they are asked to par- ticipate in its operating costs. The committee recommends that aZZ users of data from the quaZity assurance program shouZ~ participate substantiaZZy in the operating costs of the program. The overeat costs of health mare. There is an interde- pendent relationship in health care among the factors of access, cost, and quality. Changing one usually affects the other two. In a real worId of constrained resources, a reasonable balance has to be struck among the three factors. The difficulties in achieving that balance are substantial. It is often assumed that if a quality assurance program has a lean administrative apparatus and modest data require- ments it will save resources by controlling overutilization. But this assumption may be valid only if the system is con- cerned solely with overutilization. If the system were con- cerned with both under- and overutilization, it might increase costs. If the quality assurance program relies heavily on process criteria, the standards for practice may require more procedures or units of care than current practice, especially if many new developments in the technology of medicine are ac- cepted uncritically; thus compliance with standards could ne- cessitate more costly care than good medical practice would dictate. A balance among access, cost, and quality also can be thrown out of kilter by a wrongly placed concern about the quality factor. Quality assurance systems can make practi- tioners so concerned, even preoccupied, with the criteria of care that have been set that they practice defensive medicine or overtreat their patients--a response that diminishes treat- ment resources for the rest of the population. If a quality 31
assurance system is to minimize unnecessary increases in costs of care, it must be designed for the benefit of the population as a whole' not only the population receiving health care.- Improving Performance: Education and Sanctions A function of quality assurance should be to change both provider and consumer behavior, using a minimum of coercion and punishment. Education of the provider is the keystone in achieving the quality assurance goals agreed on by this commit- tee. The basis of any set of sanctions against providers must be the transformation of behavior toward improved quality. Inadequate performance by a provider can be more than a matter of individual error. There also can be failure in the health care system as well, in which case system changes can improve performance. Often it is assumed that inadequate per- formance on the part of practitioners is due to the actions of just a few. The corollary then is that regulation of perfor- mance can be expediently accomplished by "rascal-hunting." While it is undoubtedly true that some practitioners of health care are error-prone and incompetent, it is also true that the health care system can enhance rather than diminish error by even the most well-intentioned. This concept lies at the root of the committee's recommendations in this section. To the maximum extent feasible, the quality assurance system should serve as an educational device to improve provider performance, although state licensing bodies and existing con- tinuing education programs will continue to play a role. The purpose of quality assurance is the elevation of performance of all providers, not the detection and punishment of a few of- fenders or incompetents. The failure of an organization or institution, such as a hospital, to meet the requirements of quality assurance can be due to poor management, insufficient feedback, and the like. In these circumstances, the isolation of individual failure may not only be difficult but also inappropriate and mislead- ing. Failure of the health system may be as much a factor in providing poor health care as individual failure of health professionals. There also must be sanctions designed to change the behavior of the system, as distinct from the behavior of individuals in it. These sanctions might include the imposing of technical assistance, close monitoring of performance for a probationary period, or reducing reimbursement to an institu- tion under Medicare and Medicaid, although we recognize that the current Jaw requires an "all-or-none'' response. Positive incentives should be used as much as possible. Methods must be developed to reward satisfactory--and more 32
important, exemplary--performance. This effort can be en- hanced by publicizing the results of quality assurance serv- ices, awarding special commendations, and offering merit awards for innovation and high quality performance. When sanctions must be applied, they should be appropri- ately selected from a graduated schedule of possible actions. There is sufficient evidence--from nursing home regulation or physician licensure, for example--that when only a severe sanc- tion is available, its imposition is rare. WhiJe not wishing to encourage frequent imposition of sanctions, the committee believes that a set of sanctions graded in severity will pro- vide a more flexible means of securing provider compliance. Examples of possible sanctions include mandatory continuing education, dissemination of information about performance, fiscal penalties (particularly in the form of reduced reim- bursement, either per procedure or against total reimburse- ment payable), restrictions on practice, and suspension of licensure. Provider profiles developed through quality assurance should be made available to appropriate state licensure bodies and specialty boards. It has been established that state Ji- censure bodies under provider control seldom initiate disci- plinary action on the grounds of medical incompetence.'; This is due largely to the fact that licensure statutes, which were enacted at the behest of providers, do not include either oc- casional or recurrent incompetence as a basis for discipline. Nonetheless, action against a provider's license could serve as a potentially effective sanction. For specialty boards, evidence of continued failure of any provider to meet quality assurance standards should be the basis for withdrawal or modi- fication of specialty qualifications. A substantial amount of information about provider perfor- mance will be amassed by quality assurance systems. This in- formation, in statistically aggregated form and checked for validity and reliability, should be digested and disseminated to the public in a manner reasonably calculated to be construc- tive and understandable. This should help improve choices by consumers and provide incentives for improved practitioner per- formance. But there are a number of precautions to be recognized in implementing public information about provider performance: ~d; Derbyshire, R.C., 1969. 33
--The relative crudeness of quality assurance methods implies that health care institutions should be the initial subjects of information disclosure. Attribu- tion of error among individual practitioners is often difficult and could be misleading. And for diseases of infrequent incidence, individual practitioners will not process enough patients to enable an assess- ment of their performance. However, where a valid basis does exist for describing facts relevant to the performance of individual practitioners, the committee believes that dissemination of information identifying practitioners by name is justified. --Education and changes in behavior being the prime objectives of quality assurance, information about provider performance should contribute to those ob- jectives. Hence, in addition to public dissemina- tion, and in most cases prior to it, providers should be given information about performance. --Any provider named in information planned for public dissemination should be given a reasonable period of time to' review the information and offer suggestions for correction and explanation. All information to be disseminated should be placed in context. Public dis- semination of information about individual practition- ers' performance should be applied only after less stringent measures fail to improve performance. --Information to be publicly disseminated should be re- Jeased in sequence according to its potential for individual onus. The first to be red eased would be aggregate statistical data describing the frequency of events an their outcomes by institutions and serv- ices; next would be data relating to specific health care processes and their objectively established ef- ficacy; and finally, as a last resort, data about the performance of individual practitioners. --Information designed for the public should be readily accessible to the public and not buried in obscure reports. Dissemination of it should be handled by the officially designated 'qualify review agency in an authorized report available to anyone. Management and Control Management of a quality assurance program is not neces- sarily the same as control of it, the latter entailing formu- lation of policy that is implemented by management. The PSRO legislation emphasizes the rode of physicians in both functions. 34
The committee believes, however, that providers and consumers both are concerned with quality assurance. The relative par- ticipation and responsibilities of each must be explored, as must the Federal role in administration. The following discussion and recommendations address the degree of professional expertise required for participation at the several levels of the quality assurance system--the initial review level and the supervisory level--and the appro- priate participation of consumers in the management and con- trol of the program. Expertise : review Zeve Z . At the initial review Reveal, ex- pertise is most important. It is possible for consumers to understand the issues in quality assurance but the judgments to be made require both technical knowledge and professional commentary. This is not to say that the initial review pro- cess must be the exclusive province of the professional. Con- sumers can play at least two important roles at this level. The history of self-regulation in all fields suggests that there is an inherent constraint, arising out of identification with one's peers, upon members of a profession who review the performance of a fellow member. The presence of consumers during the review process, far from compromising the expertise of the professional, can enhance it by fostering objectivity. The consumer's other function is self-education. Patients who have little knowledge of health care and its limitations expect far too much of the provider. They can react with hos- tility when the healing arts don't heal. But it is in the quality assurance process that the capacities and limits of health care are best revealed. Consequently, participation by consumers in quality assurance, particularly perceptive consu- mers who play leadership roles in the community, will ulti- mately help to close the gap between public expectations and provider performance. The committee recognizes that consumer participation may be more effective for some questions than others, particularly at the beginning of a quality assurance program. There are four general categories of inquiry that will arise at various levels of quality assurance review. The first is whether the given process of health care is one of established efficacy. The second is whether the care provided by a given practitioner-to a given patient meets the standards of quality. The third is the performance of * The committee uses the term "consumers" to include all those who receive or are potentially in receipt of health services. 35
certain providers (individuals and institutions) compared with others. The fourth, based on information obtained in the other three, is to decide on an optima] allocation of resources. In the committee's view, consumer participation is more Jikely to be appropriate and effective in the proportions il- lustrated in Figure 2. Expertise : supervisory Zeve Z. The committee's examina- tion has been Jimited to publicly authorized quality assurance systems, such as PSROs, in which it is understood that non- providers will assume some supervisory responsibilities in the inevitable bureaucracies. But, it is essential that providers seek and be accepted for supervisory positions so that their expertise will be available to the government in its adminis- tration of quality assurance programs. Contro Z. In its technical definition, control refers to the formal composition of the governing body of a legal entity. For example, comprehensive health planning agencies are puta- tively controlled by nonproviders because the enabling legis- lation mandates their majority. But because of the expertise, interest, and resolve of providers, the effective control of many CHP agencies rests with providers. In the case of quality assurance, control of the program at the Federal level will ultimately rest with nonproviders through the government. Control is exercised more directly at the bureaucratic level by the nonproviders who dominate HEW. The remaining question is the form of control at the in- termediate supervisory Jevels and at the local review level. At the local review Jevel, the importance of expertise makes it necessary to place majority control with providers. Consumers should constitute less than a majority for reasons that already have been stated. At the supervisory level, foreseen as state or regional advisory councils, consumers should participate extensively. Whether they should control the entity should be the subject of experimentation. Enabling legislation should not require either provider or consumer control but should permit the de- velopment of both forms for comparison as to effectiveness. The same opportunity to experiment with various forms should be permitted any Federal advisory body. Management. Effective management is not usually related to whether the manager is a provider or consumer. This implies that the most skillet managers should be sought for a quality assurance program irrespective of their status. Nevertheless, managers with experience as providers are possibly the most suitable at the review level where frequent interaction with 36
Figure 2 Relative Rot .es of Providers and Consumers in Review of Care and Supervision of Quality Assurance Systems Level of Participation Federal policy setting State review Area review Review of care by local quality assurance system or institution ~ / 1' '''' - / . . ~ Proportion of Cons t 1mer Participation Proportion of / Provider Participation 37
other providers is essential. At the supervisory level, the situation is less clear and the probable result will be a mixture. She committee recommends that the review process at the Zo~aZ Level be oontroZZeZ and preferably managed by providers with a minority of consumers participating. At the supervi- sory and advisory bevels, control should rest various by with providers and consumers, and management should include non- providers, such as statisticians, epidemiologists, and systems analysts. Quality assurance is sufficiently important that the frag- mentation characteristic of public administration of health programs should be minimized. This can be achieved in a num- ber of ways; the committee offers only a few general recommendations: - --A single Federal agency should have the fuZZ responsi- biZity of supporting and monitoring ZocaZ qua Zity as- suranoe programs. The National Center for Health Statistios should have responsibility for determin- ing uniform terms, definitions, oZassifioations and standards for data processing functions. Foous of Federal responsibility Ritz ensure that the agency is visible and responsible to providers, which can be enhanced by having the agency report direotZy to the Assistant Seoretary-for HeaZth, HEW. Many problems can be avoided by focusing Federal respond bilities in a single.agency. The current confusion surround- ing the administration of the PSRO programs at the Federal level illustrates the importance of this point. The Federal health bureaucracy is fragmented, and it is unclear who bears the responsibility for the administration of quality assurance programs. There is an office charged with responsibility for the PSRO programs but it is in jurisdictional conflict with other agencies that have a.role in quality assurance activities. The structure makes unclear to providers the source of rules and regulations and technical assistance. --In order to ensure the pertinence and availability of research and development findings, the agency responsible for quality assurance should have the authority to expend funds for applied research and development in quality assurance methods and prao- tioes. The evaluation of programs should be shared between the bureau having operational responsibility and another evaZuation function located outside the operating bevel. Other agencies should be mandated to fund basic research related to quality assurance. 38
One of the keys to the success of quality assurance is a research program to help develop the technology of quality as- surance. If one agency administers a program and another ad- ministers research and development funds, it is unlikely that the research results will meet all the needs of the administer- ing agency. This problem can be addressed by fusing the quality assurance research and development responsibility with responsibility for its administration. The evaluation of the quality assurance program should be carried out both by the operating bureau for those operational matters where a direct feedback to management is desirable and by an evaluation function at a different administrative level to examine those issues which relate to the basic nature of the program. By this split of the evaluative function, both ongoing managerial response and objectivity concerning major program changes should be served. Some additional responsibility to support fundamental re- search into new methods of quality assurance should be given to an agency that is not responsible for day-to-day operational problems. The Bureau of Health Services Research and Evaluation would seem to be an appropriate location for this fundamental re- search support. --The Federal agency with the responsibi Zity for ad~mini- s Oration o f qua Zi by as surance s hou Zig a is o pos s e ss the authority to determine the needs for data about pro- viZer performance and control application of that data to qua Zi by as suranoe . The committee has recommended that the National Center for Health Statistics be designated to collect and interpret data with respect to the delivery of health care services. Having no operational authority, NCHS should be responsive to the re- quirements of the quality assurance program. Additionally, NCHS should be governed by the decisions of the quality assur- ance agency with respect to the use of the data bearing on that aspect of health care. --The agency responsible for quality assurance at the FeZeraZ [eye Z should have the power to assure that poZioles for payment to providers under aZZ Federal health mare financing programs support the actions of quality assurance programs in administering sanctions. To make effective the sanctions that the quality assurance programs choose to administer, they must have the authority to impose fiscal sanctions. The Social Security Administra- tion, or any successor agency for financing health care, should accept, implement, and, if necessary, delegate authority for any fiscal sanctions imposed by the quality assurance agency. 39
A Federat oZearinghouse should be estabZished for (1) information related to standards for quality assurance and f2J analyses and information respeot- ing provider performances as measured by qua City assurance systems other statistical Fatal and speoiaZ studies. this function shouter be assigned to the FederaZ bureau charged with responsibility for quality assurance programs rather than those agencies concerned primariZy with the financing of services. The committee has recommended that standards for quality assurance be formulated initially at the local level. This implies a passive role for the Federal government in the early stages, one of monitoring performance of local review agencies. Data needs at the various levels of the quality assurance system will vary, and each level will wish to abstract data as appropriate. The performance of quality assurance at the local levee will require retrievability of data at that level. Data are also needed at the national level in order to facili- tate comparisons and contrasts across the country. This is particularly true of information about standards. There are at least three types of information that should be centralized. Because the development and application of quality assurance standards are decentralized, each local re- view unit should forward information about local standards to a central repository for comparison and analysis. Also, ag- gregated statistical data on provider performance within re- gions across the country should be centralized, at least on a sample basis, so that comparisons can be made between provider performance in various regions. And the central repository should serve as a clearinghouse for literature, studies and analyses on the quality of care in this country or elsewhere. At present, if a group of providers in one part of the country wishes to establish a quality assurance program, they must rely largely on their own ability to learn about other experiences. Research, Development' and Evaluation By means of the PSRO program, this nation is beginning a major innovative social experiment that the committee would like to see committed to a goal of improving the effectiveness of health care. Little is known about the varying quality of provider performance and its relation to this goal or the ap- propriate methods to assess that performance. The committee has noted earlier that the quality of care has been a matter of public and professional concern for decades but that only in the past few years has sufficient public interest developed to establish a formal program for quality assurance. In part, this interest arises from the expansion of the governmental 40
role in financing health care. But it also manifests an in- creasing conviction among providers and consumers that a bet- ter job must be done in health care. The effectiveness of present methods for quality assurance are not sufficient. A substantial continuing program of research is needed. Results of that research must be rigorously evaluated before they are deployed in the operation of the quality assurance system. In addition, every quality assurance system should have an evalua- tion design available--and resources to conduct the evaJuation-- before it becomes operational. Every local quality assurance program should have a minimal level of evaluation activity that feeds back to management of the system. But recognizing that prospective evaluations are costly in time and money, some pro- grams should have more complex evaluation protocols to estab- Jish definitively the value of particular techniques. The overall program evaluation responsibility should be assigned to a group that is not directly responsible for operation of the quality assurance program in order to assure objectivity. We also recognize that sufficient evaluation expertise does not exist currently and needs to be developed. Research requirements go beyond the methods of quality as- surance. There is need for investigation of provider and con- sumer behavior, alteration of which is part of quality advance- ment. Ways must be found to encourage innovation in quality assurance methods. Special funds could help programs undertake and analyze promising projects, such as a survey of the health status and health needs of that portion of a population that was not utilizing health services. Project grants for these purposes should be made available in addition to sums paid to quality assurance programs for start-up and maintenance costs. The committee recommends that a substantial research and development program be launched to augment and improve the teehnoZogy of qua City assurances inoZuding data ooZZeotion and analysis, and that, before quality assurance systems become operational, designs and tease Line data for their evaZuation Size be developed and ready for impZementation. Some plans for evaluation must be developed for the nation as a whole for those aspects which need larger numbers than are available Zo~aZZy. Moreover, provision should be made in the design of any quality assurance system for the systematic feeZ- baok of evaluation resuZts and fief experience to faoiZitate the periodic re-e~amination and retoo Zing of quality assurance programs. In addition, R & D programs should be developed to design methods of aZtering provider and consumer behavior, and for innovative quality assurance projects. 41
