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-IV. TEE IMPLICATIONS OF THE PRINCIPLES FOR THE PSRO PROGRAM While the recommendations in the preceding sections of this policy statement deal with generic principles of any quality assurance system, PSRO is the quality assurance pro- gram of today. To assist in understanding the immediate im- plications of the committee's recommendations for the PSRO program in its early stage of development, this section com- pares and contrasts the PSRO legislation with the recommenda- tions of the committee. The Jocations of the recommendations in the report are noted. Recommendations are summarized when necessary to indicate more specifically the comparison with the PSRO legislation. Geographic Scope, Recommendation, page 8 The PSRO program is to be established.on a "regional" basis. The review process, therefore, embraces many providers. The committee recommends a similar geographic area approach at this time. The committee, however, feels that a final conclu- sion is unwarranted and recommends experimentation with schemes of quality assurance review established on other than a re- gional basis, such as programs coextensive with provider or- ganizations or institutions. Size of Geographic Area, Recommendation, page 9 The PSRO legislation refers only to the establishment of professional standards review organization in an "area" to be determined by the Secretary. The committee recommends that no quality assurance program be established which extends be- yond a natural ''medical trade" area. ation-Based Data, Recommendation, page 9 The PSRO legislation provides for review of care provided only to patients receiving care. The committee, however, has recommended that data be gathered both on patients receiving services and the rest of the population not receiving services as well. Providers Subject to Review, Recommendation, Page 10 The PSRO legislation limits the scope of review to "phy- sicians and other health care practitioners and institutional and noninstitutional providers of health care services in the provision of health care services and items for which payment may be made..." The committee's recommendation would extend review to all those who make independent judgments in the pro- vlslon 01 services. 47

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page 10 Participation of All Types of Prac'ti't'i'on'e'rs',''Re'c'ommendation, ~ . The PSRO legislation does not specify which health care practitioners should participate in standard-setting and re- view of performance. The most likely interpretation, however, is that physicians would dominate the process. The committee recommends that all types of health care practitioner subject to review participate in standard-setting and in the review of performance. Review of Ambulatory Services, Recommendation, Page 11 - The PSRO legislation leaves to the option of individual PSROs the review of ambulatory services. The committee recom- mends that ambulatory services be reviewed by every quality assurance program. Initial Methods for Quality Assessment, Recommendation, Pages 20 and 21 The PSRO legislation does not specify the methods to be used in assessing professional performance. The committee recommends that (a) the ''Uniform Hospital Discharge Abstract" be used as an initial source of data for quality assurance and that (b) "processes" of medical care which cannot be correlated with beneficial patient outcomes be excluded from quality assur- ance review. Relating Processes to Outcomes, Recommendation, Page 22 The PSRO legislation does not deal with the relationship between processes and outcomes in a quality assurance program. The committee recommends that carefully designed research studies be fostered to causally relate process and structural factors to outcome. , Recommendation? Page 23 The PSRO legislation refers to maintenance by professional standard review organizations of 'types and kinds of cases," 'idiagnoses involved," and "profiles of care and services re- ceived and provided." No other references are made in the legislation to the data to be collected. However, the commit- tee recommends specific characteristics for the data support- ing the quality assurance system indicated in this and the following four recommendations. 48

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The committee recommends that the data should be problem- oriented, person-specific, available as to all providers, population-based, period-explicit, place-explicit, and charac- terized by parsimony. In addition, the committee recommends that the individuals in the population covered by the quality assurance system be readily identifiable on the basis of demo- graphic and socioeconomic indicators. Uniform Terms, Definitions and Classifications, Recommendation, The committee recommends that basic patient identification data plus services and diagnostic categories be expressed on a common structural basis. At a minimum this requires uniform terms, definition of terms, and classifications. The PSRO legislation does not specify such uniformity. Use of Computer Technology, Recommendation, Page 25 The committee recommends that computer technology be de- ployed whenever feasible and that providers responsible for the initial generation and assembly of data about patients, par- ticularly diagnostic data, also bear the responsibility for putting that data into the collection system. The PSRO legis- lation does not deal with those matters. Compatibility with Other Health Care Data, Recommendation, pages 26 and 27 The committee recommends that (a) data for use in quality assurance activities as well as other purposes be recorded only once; (b) all health data be uniform with respect to terms, definition of terms, and classifications; and (c) to facilitate the uniformity of data and its parsimony and to minimize demands upon providers, the National Center for Health Statistics be assigned the responsibility to formulate uniform terms, definitions of terms, and classification, and to con- struct data collection systems in accordance with this recom- mendation and the other recommendations of the committee. The legislation is silent on these points. PSRO legislation is compatible with the committee's recom- mendation with respect to the confidentiality of patient data. 49

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Entrusting the Patient with his Record, Recommendation, Page 28 . . . . The PSRO legislation is silent about the access of the patient to the patient's medical record. The committee recom- mends that the means be developed and tested to entrust most aspects of the patient's medical record to the patient. Develooment of Norms and Standards, Recommendation, Page 29 _ . . The PSRO legislation requires that professional standards review organizations apply 1/professionally developed norms of care, diagnosis and treatment based on typical patterns of practice in its regions as principle points of evaluation and review..." The National Professional Standards Review Council and the Secretary of HEW, in addition, may provide technical assistance to organizations in the development of such norms of care, diagnosis and treatment. Moreover, those professional standards review organizations which have developed "signifi- cantly different norms of care, diagnosis and treatment stan- dards" shall be so informed; and in the event that "appropriat consultation and discussion" indicate a reasonable basis for usage of other norms than those applied, "the professional standards review organization may apply such norms in such areas as are approved by the national professional standards review council." e The committee recommends that standards be initially for- mulated at the local review level in a manner consistent with PSRO legislation. Similarly, the Federal role, in the commit- tee's view, should be limited initially to the review and com- parison of local standards. The committee suggests further that once experience is gained and specific correlations be- tween processes and outcomes are identified, equity in the care of patients calls for some standards to be promulgated as guide- lines for national application. The committee also recommends that the formulation and application of standards should be subject to periodic modification as the technology of quality assurance evolves. Bearing the Costs of Quality Assurance, Recommendations, Page 31 . 5 It is clear from the PSRO legislation that the start-up expenses of quality assurance will be borne by the Federal government, but it is not entirely clear when the Federal sub- sidy will terminate, if at all. The committee recommends that the Federal government bear the total cost of establishing quality assurance systems, but that local users, such as pro- viders, third-party payers, and planning agencies be required to share substantially in the operating costs of the program. 50

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The PSRO legislation has provided only two sanctions: termination of reimbursement programs and monetary fines. The committee believes that the question of compliance with quality assurance legislation requires a far broader range of responses in seeking performance improvement. The committee recommends that quality assurance legislation serve primarily an educa- tional purpose to improve provider performance rather than as a device to punish professional behavior not in compliance with the legislation. The committee also stresses the importance of positive incentives and the use of graduated sanctions. In addition, the committee suggests that failure to comply with quality assurance programs may not always be the result of the errors of individuals but may rather be due to systemic failure such as poor management, insufficient feedback, poor communica- tion and the like. Finally, the committee stresses the impor- tance of the dissemination of information to the public about provider performance. Under specified circumstances, the com- mittee believes that consumers of care should be given infor- mation about provider performance as a means of improving pro- vider performance as well as a means of informing consumer choice. Consumer Participation' Recommendation, Page 38 The PSRO legislation requires provider control of profes- sional standards review organization activities. The only ex- ception is with respect to "Statewide Professional Standards Review Councils." In those states in which councils are re- quired, minority representation on such councils may be com- posed of "persons knowledgeable of health care," not necessarily physicians. In all other respects, physicians maintain full control under the PSRO legislation. The committee's recom- mendations differ from the legislation in the following re- spects: (a) the committee recommends that the review process be controlled at the local level by providers but with consumer participation short of a simple majority and be managed to the extent feasible by providers as well; (b) that the supervisory and/or advisory levels (comparable to Statewide Professional Standards Review Councils) should be a mixture of providers and consumers with no specification for provider and/or consumer control. Federal Management, Recommendations, Pages 38-40 The PSRO legislation does not specify what agency or bu- reau within the Federal government will carry out Federal re- sponsibilities for the program. However, because of the 51

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fragmentation that customarily characterizes public administra- tion of health programs, the committee offers some general recommendations for administration. First, the committee recom- mends that a single Federal agency be given full responsibility for supporting and monitoring PSRO programs. The National Cen- ter for Health Statistics should be given the responsibility to determine uniform terms, definitions of terms and classifications, and standards for data processing functions. Second, the agency responsible for quality assurance should possess the authority to expend funds for applied research and development in quality assurance. Other Federal agencies should fund basic research related to quality assurance. Third, the committee recommends that the Federal agency with the responsi- bilaty for quality assurance possess the authority to determine the needs for and control the use of data about provider per- formance and that such agency also possess the power to assure that policies for payment to-providers under all Federal.health care financing programs support the actions of quality assur- ance programs in administering sanctions. Finally, the commit- tee recommends that the agency in charge of quality assurance serve as a Federal clearinghouse for the collection and dissemi- nation of (disinformation related to the standards for quality assurance; and (2) analyses and information respecting provider performance as measured by quality assurance systems, other statistical data, and special studies. Research, Development, and Evaluation, Recommendation, Page 41 The PSRO legislation gives authority to the National Pro- fessional Standards Review Council to "...make available or arrange for such technical and professional consultative assist- ance as may be required to carry out its functions," and "make or arrange for the making of studies and investigations with a view to developing and recommending to the Secretary and the Congress measures designed to more effectively accomplish the purpose and objectives Lof the legislation]." In all other re- spects, the PSRO legislation is silent as to research and de- velopment. The committee, however, recommends that a substantial research and development program be launched to augment and im- prove the technology of quality assurance, including data col- lection and analysis, and further that prospective evaluation designs be developed for the evaluation of quality assurance systems. Finally, F ~ D programs should also be developed to design methods of altering provider and consumer behavior and for the establishment of innovative quality assurance projects. 52