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12
Quality Assessment and Assurance

The OBRA 1987 legislation asked the IOM to address "the quality of care provided to end-stage renal disease beneficiaries, as measured by clinical indicators, functional status of patients, and patient satisfaction." This charge cannot be fully addressed using existing data.

However, quality assessment and assurance are very important in the ESRD program, and this chapter responds to Congress in the following way: First, the principles of quality assessment and quality assurance are briefly discussed. Second, the management of ESRD quality assurance by the federal government is described. Finally, a strategy for quality in the ESRD program is suggested that is oriented to the treatment-unit level and to improving patient management.

This report refers to both quality assessment and quality assurance. Quality assessment deals with the measurement of quality and with the development of instruments and measures; it implies a need for research to develop, validate, and interpret these measures. Quality assurance (QA) typically involves the monitoring of care (usually through discharge abstracts, chart reviews, or patient reports) to identify instances of poor-quality care by physicians and institutions; providing feedback of information to the appropriate physicians and health care institutions; devising remedies for identified problems, including the education of providers or the application of sanctions; and reviewing issues to see if they have been solved or that no new ones have been created.

All of medicine is being asked for evidence that patients are receiving medical care of good quality. Nephrology confronts this same demand, but formidable obstacles exist to the use of QA in the ESRD setting. First, like many physicians, nephrologists resent the loss of public trust in their ability and willingness to deliver good-quality care (Starr, 1982). Second, neither



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Kidney Failure and the Federal Government 12 Quality Assessment and Assurance The OBRA 1987 legislation asked the IOM to address "the quality of care provided to end-stage renal disease beneficiaries, as measured by clinical indicators, functional status of patients, and patient satisfaction." This charge cannot be fully addressed using existing data. However, quality assessment and assurance are very important in the ESRD program, and this chapter responds to Congress in the following way: First, the principles of quality assessment and quality assurance are briefly discussed. Second, the management of ESRD quality assurance by the federal government is described. Finally, a strategy for quality in the ESRD program is suggested that is oriented to the treatment-unit level and to improving patient management. This report refers to both quality assessment and quality assurance. Quality assessment deals with the measurement of quality and with the development of instruments and measures; it implies a need for research to develop, validate, and interpret these measures. Quality assurance (QA) typically involves the monitoring of care (usually through discharge abstracts, chart reviews, or patient reports) to identify instances of poor-quality care by physicians and institutions; providing feedback of information to the appropriate physicians and health care institutions; devising remedies for identified problems, including the education of providers or the application of sanctions; and reviewing issues to see if they have been solved or that no new ones have been created. All of medicine is being asked for evidence that patients are receiving medical care of good quality. Nephrology confronts this same demand, but formidable obstacles exist to the use of QA in the ESRD setting. First, like many physicians, nephrologists resent the loss of public trust in their ability and willingness to deliver good-quality care (Starr, 1982). Second, neither

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Kidney Failure and the Federal Government the tradition nor the formal systems of QA are well developed in nephrology: Many nephrologists are skeptical that quality can be measured, the design and development of ESRD-specific QA measures and instruments has been minimal, and few good examples of ESRD QA exist. Third, many nephrologists see QA as a requirement imposed on treatment units by the federal government, which is to be delegated to a QA coordinator for paper compliance and shielding the unit from adverse effects. Fourth, the conceptual expertise regarding quality assessment generally resides in the health services research community, not in medical specialties. If effective ESRD QA systems are to be developed, the nephrology community will need to avail itself of this expertise. Notwithstanding these obstacles, the committee is persuaded that more systematic approaches to QA are needed and possible in the ESRD arena. To be successful, however, QA systems will have to be seen by physicians, patients, and other ESRD clinicians as a way to improve routine, everyday patient management and patient outcomes at the treatment-unit level. PRINCIPLES OF QA A recent IOM report, Medicare: A Strategy for Quality Assurance, requested by Congress in OBRA 1986, presents a comprehensive picture of quality assessment and assurance in health care, especially for the Medicare program (Lohr, 1990). It deserves careful review by all. The IOM Quality committee defined quality of care as "the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge" (Lohr, 1990, p. 4). Building on that definition, "health services" in the ESRD context includes the full spectrum of medical, social, and rehabilitative services used in the care of the ESRD patient; "desired health outcomes" include reducing mortality and morbidity and maintaining and improving the health status and well-being of ESRD patients; and ''consistent with current professional knowledge" implies that physicians remain abreast of changing clinical knowledge, that they not be expected to exceed that knowledge in their practice, that they be judged only on the basis of what is known and can be done, and that medical research contribute strongly to the clinical knowledge base. The purposes of QA programs, as they have evolved over time, have been (1) to identify providers whose care is so substandard that immediate sanctions are needed to remove them from practice or to ensure that third-party payers no longer reimburse them; (2) to identify providers whose practices are unacceptable, but who may respond to information and education to correct their problems; (3) to improve the average level of quality of care provided by a community of providers; and (4) to motivate and assist

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Kidney Failure and the Federal Government providers to achieve high levels of quality. In recent years, the emphasis has shifted to the latter two objectives. For the Medicare program, Congress has authorized the creation of external review bodies—first, the Professional Standards Review Organizations (PSROs) in 1972 and later the Utilization and Quality Control Peer Review Organizations (PROs). These efforts have been intended, in part, to guarantee that Medicare beneficiaries receive care of acceptable quality and, in part, to control costs. However, the QA orientation of the PSRO and PRO programs has been primarily to policing poor-quality care. The Joint Commission on Accreditation of Healthcare Organizations, formerly the Joint Commission on Accreditation of Hospitals, fulfills a QA role that is broader in scope than that of Medicare-certified facilities, but its activities intersect strongly with Medicare. It has moved beyond its survey-based accrediting function within the past 5 years, mainly through its "Agenda for Change," which embraces the improvement of care, the motivation of physicians, and an emphasis on clinical indicators (JCAHO, 1987, 1988). In response to these external efforts, many providers have created internal QA systems for monitoring their own performance. As these systems have developed, a tension has emerged between meeting regulatory requirements and improving patient-care management at the treatment-unit level. Not surprising, these tensions also exist in the ESRD setting. The purposes of ESRD QA systems vary considerably across four levels of potential users. First, the federal government agencies of the Public Health Service (PHS), Centers for Disease Control (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH), and the Agency for Health Care Policy Research (AHCPR) are engaged in public health and safety, education, and research; the Health Care Financing Administration (HCFA) is involved in provider oversight. Second, at the regional level, state survey agencies perform regulatory oversight of providers. ESRD networks, on the other hand, support medical care review and collect data from providers in order to establish regional and national norms for providers. At the third level of users, nephrologists and other ESRD clinicians comply with federal ESRD regulatory requirements, provide data through ESRD networks at HCFA, and independently deal with quality in their treatment facilities. The need for compliance with HCFA requirements shapes the view that many ESRD clinicians have of QA. However, partly in response to the IOM quality study, ESRD providers have begun recently to recognize the significance of continuous quality improvement oriented to systematically raising the average quality of care on a continuing basis at the treatment-unit level (RPA, 1990). Fourth, ESRD patients are also potential users of QA information. Such information can indicate how their care compares to regional and national norms and can help them participate in decision making about their own

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Kidney Failure and the Federal Government care. This participation can provide valuable expression of patient preferences and important guidance for physicians and other clinicians. In addition, some evidence exists that patient involvement in clinical decision making actually results in better health outcomes (Kaplan and Ware, 1989; Kaplan et al., 1989). In any event, the ultimate "guarantors" of quality care are the members of the clinical team. It is they who can make QA systems serve patient management and who implement practices to improve patient outcomes. Physicians must exercise QA leadership consistent with their professional duties to patients. Nurses, technicians, social workers, and dietitians must join them as members of a clinical team and reflect a corresponding commitment to patient well-being. THINKING ABOUT QUALITY Many years ago, Donabedian (1966) articulated the basic framework for assessing the quality of medical care in terms of structure (or resource inputs), processes, and patient outcomes. The Medical Outcomes Study offers a graphic interpretation of this framework as shown in Figure 12-1 (Tarlov et al., 1989). Structure Structure, or the basic inputs to care, consists of system, provider, and patient characteristics. System characteristics include the organization of the provider community (as described in Chapter 6). Provider characteristics are those of physicians and facilities. Physician characteristics include education, experience, and credentials, including board certification. Treatment-unit characteristics include the numbers, training, experience, and roles of nurses, technicians, social workers, and nutritionists; physical equipment and treatment technology (machines, dialysate, membranes, and software); and amenities. Patient characteristics include demographic, clinical, and functional status. Baseline measures, against which processes and outcomes are later judged, should include primary diagnosis (and its severity), comorbid conditions (and their severity), functional status (physical, social, and mental functioning) patient perceptions of their own health, and patient preferences. Process The processes of care include both the technical and the interpersonal aspects of care. In dialysis, these involve the diagnosis, prescription, and delivery of treatment to the patient by physicians and other clinicians;

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Kidney Failure and the Federal Government FIGURE 12-1 Conceptual Framework of the Medical Outcomes Study SOURCE: Tarlov et al. (1989). Copyright, 1989, American Medical Association. Used with permission. the biological interactions of the patient with the technology of vascular access, membrane, dialysate, machine, and prescription; the technical support of water purification and monitoring, dialysate concentrate handling, reprocessing of dialyzers and blood tubing, infection control, and equipment maintenance; and the vital personal interactions between patients and clinicians. The actual use of the dialysis system for purifying the blood, usually three treatments per week, involves the following: pretreatment patient as-

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Kidney Failure and the Federal Government sessment; initiation of needle placement or other vascular connection; monitoring during dialysis; review of the dialysis prescription to confirm or alter it; termination of the dialysis session; and end-of-treatment assessment. Patient care also involves periodic chemistry and hematology monitoring, patient instruction, correction of identified problems, and periodic complete evaluations (physical examination, x rays, electrocardiogram, echocardiogram, and other tests). This complex array of processes requires, at minimum, the treatment of complications and related conditions such as hypertension, anemia, infection, and bone disease. For patients treated by continuous ambulatory peritoneal dialysis (CAPD), special infection-control procedures associated with fluid exchange are required. The validity of process measures, however, is often unsupported in the literature (Audet et al., 1990); they bear a presumed but seldom documented relationship to outcomes. The effectiveness of many tests, procedures, medications, and even counseling has not been critically demonstrated in medicine. For chronically ill patients with complex medical and social conditions, the relationships between process and outcome measures are even less well understood than for acute-care patients. Dialysis is no exception, despite the limited scope and recurring nature of most processes. Even the optimal prescription of dialysis treatment, for example, is far from agreed upon in the renal community. Outcomes The IOM quality study emphasizes patient-care outcomes (Lohr, 1990), as does this study. Outcomes of care may be categorized in terms of mortality; proximate or intermediate clinical outcomes (e.g., infection rates, hematocrit levels, clinical and laboratory values, results of hypertension control, and results of prescription dialysis); morbidities (e.g., abnormal observed clinical signs, physiological laboratory measurements, and patient-reported symptoms, such as complications or adverse treatment effects); disease-specific and general functional-status effects; and patient well-being, satisfaction, and quality of life. Several comments about these outcome measures are warranted. First, although ESRD patient mortality is essential (and has received much attention in recent years), other outcome measures are needed to assess patients with a complex clinical conditions (such as ESRD) who undergo treatment that extends over long periods of time and involves numerous prolonged contacts with many medical care providers.

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Kidney Failure and the Federal Government Second, proximate clinical outcome measures guide patient management decisions as much as any other outcomes and are easily linked as endpoints to the relevant process measures. They include such measures as blood chemistries, hematocrit, and blood urea nitrogen. Third, validated measures of functional status (physical, mental, and social functioning, including rehabilitation, general well-being, and patient satisfaction) have been developed at a brisk pace in the past decade, largely within the health services research community (Lohr, 1989). These measures have been used mainly for research purposes but are now being adapted for use in clinical practice (Patrick and Bergner, 1990). Unfortunately, this literature is not widely known to practicing physicians. Outcomes and Process and Structure In recent years, quality assessment and assurance have shifted from an emphasis on structure and process to widespread agreement that such measures are important only as they are related to outcomes (Lohr et al., 1988; Lohr, 1988). Although this increased emphasis on outcomes has led some to reject process and structural measures of quality as unimportant, it is important to underscore at both the conceptual and the practical levels the need to link outcome measures to process measures (Lohr, 1990). Nor should structural measures of quality be ignored, especially if no other measures exist, as the discussion of personnel in the previous chapter suggests. Structure provides the institutional, physical, and human framework that influences the range of possible outcomes and the nature and scope of the processes of care. Proximate Clinical Indicators Proximate clinical indicators include both process and outcomes. Outcomes, resulting from the patient-provider encounters, include, for example, infection rates, hematocrit levels, and the outcomes of prescription dialysis. Many factors affect such outcomes, including the initial functional and health status of the patient. The task of QA, and the supporting assessment function, is to identify those aspects of medical care that are under the control of providers, as distinct from other factors that affect outcomes, such as patient characteristics. The criteria for selecting a proximate outcome measure include the following: the time interval between the receipt of care and the measurement of outcome must be chosen carefully to measure a cause-effect relationship; comorbidities must be acknowledged in the indicator or measure, minimally by their presence and preferably by their severity; the indicator or measure must be related to standards or norms of care, based on the literature, data aggregation, direct observation, or other means of ascertaining expert opinion; and the indicator must pertain to treatable medical factors.

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Kidney Failure and the Federal Government Process statements, or instructions about diagnostic and treatment intervention, codify knowledge from the medical literature, expert judgment, and direct observation of patients into norms of practice, guidelines, indications for appropriate use, or algorithms (Audet et al., 1990). These statements guide physician and nurse behavior in the appropriate management of individual patients. Although these process measures must be validated, they provide a reasonable way to critically assess patient conditions and to improve the quality of practice. There are at least three criteria for selecting a process measure. First, the measure must bear a putative relationship to outcomes that is supported by clinical studies of efficacy or, at least, by expert opinion. Second, its use must be feasible, that is, data about it can be found in the medical chart. Third, the measure must have a high degree of specificity regarding application; for example, it specifies that a patient with a temperature of 102 degrees F, due to an identified infection, should be treated in a particular way. Proximate clinical indicators combine outcome and process measures. Typically, a discussion of one leads to a discussion of the other, since the two interact continuously in the clinical setting. For example, a low hematocrit, say, less than 20 percent, is an outcome (or perhaps an initial baseline measure); the administration of EPO under various protocols is a process; and a high hematocrit following treatment is a resulting outcome. The treatment of anemia, as an example of a proximate clinical indicator, is presented in Appendix I of this chapter for consideration by renal providers. This candidate indicator has been developed from the literature and from informally solicited expert opinion. Although empirical research is needed to validate it so that it can be used to distinguish between good and bad care, it illustrates the meaning of this section. Functional-and Health-Status Assessments Proximate clinical indicators are necessary but not sufficient for assessing quality of care. More important than the presence or absence of signs, symptoms, or laboratory test values is the patient's response to how treatment affects his or her life. Thus, functional-and health-status assessments are also necessary. Functional status refers to how well patients function. Health status, sometimes referred to as health-related quality of life, concerns itself not only with the health-related physical, social, and psychological functioning of patients but also with how patients perceive their well-being. It focuses attention on what the patient brings to the treatment situation, including his or her financial, social, family, and emotional resources-factors that powerfully affect the outcome of care of chronic-disease patients. That baseline status influences all subsequent internal and external assessments.

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Kidney Failure and the Federal Government Health status assessment has developed strongly within the past decade. Several important summaries of the field have been published recently (Katz, 1987; Lohr, 1989; Lohr and Ware, 1987). The major conclusions emerging from that literature are the following: First, substantial progress in measurement has occurred in the past decade. Second, measures of the health status of pediatric patients need to be developed (Lewis et al., 1989), a need of ESRD pediatric patients also (Evans et al., 1990a). Third, generic health status measures,1 when supplemented by disease-specific measures, permit comparisons across groups and sites of care and are sensitive to the changes in the clinical status of patients that are of interest to physicians (Patrick and Deyo, 1989; Temkin et al., 1989). Generic measures have been used in research on ESRD patients (Hart and Evans, 1987; Julius et al., 1989). ESRD-specific measures have yet to be developed. Thus, a direct comparison of generic and ESRD-specific measures has not been made. Fourth, health status assessment has begun to be used in clinical research, most extensively by pharmaceutical firms for clinical trials of new drugs and biologicals (Kazis et al., 1989; Luce et al., 1989). Both U.S. and Canadian clinical trials of erythropoietin (EPO) used such measures (Canada Erythropoietin Study Group, 1990; Evans et al., 1990b). Fifth, health status research has shown that the physician-patient interaction affects the health status of patients. Ascertaining patient preferences has become a central concern, especially where the choice between two treatments does not turn clearly on scientific knowledge or the clinical skill of the physician but on how patients assess the different probable outcomes (Kaplan, et al., 1989; Kaplan and Ware, 1989). Finally, health status assessment has only begun to be used in clinical practice. For such use to proceed further, the clinical utility of health status information must be demonstrated and then shown to have an effect on patient outcomes (Nelson and Berwick, 1989). Patrick and Bergner (1990) argue that two major challenges of clinical application must be confronted in the next decade. First, short, reliable, self-administered comprehensive measures that are sensitive to variations in health care organization and medical practice must be developed. Second, disease-specific health status measures must be developed to supplement generic ones. The development of short patient survey instruments is necessary to adapt research instruments to patient management use by clinicians. The Medical Outcomes Study 36-item short-form Health Survey, for example, has been validated, takes 6 minutes to complete, can be self-administered by a patient or easily administered by a nurse (Tarlov et al., 1989). These short forms will need to be validated for use on special populations. Anecdotal reports suggest that, for the most part, patients are pleased at the attention implied by a survey. As short instruments are developed, their high infor-

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Kidney Failure and the Federal Government mation content and usefulness to clinicians for patient management and improving patient outcomes can become clear. Patient Satisfaction Mention of ''patient satisfaction" in the OBRA 1987 ESRD legislation reflects recognition by Congress that a critical test of quality is how patients assess the care they receive. Patient satisfaction constitutes an important way to assess the amenities and interpersonal aspects of care and whether patients believe that they are treated with dignity and respect (Davies and Ware, 1988). It can be validly and reliably measured. Quality of Life The literature regarding the quality of life of ESRD patients intersects strongly with health status assessment (Evans et al., 1990a; Quevedo, 1991). Evans and his colleagues (1985, 1987, 1989, 1990b) have conducted three major quality-of-life studies in dialysis and kidney transplantation from 1981 to the present; other studies are in progress. These studies have focused on modality-specific quality of life and on longitudinal studies of the same patient group. All the studies have involved objective2 (functional ability, employment, and health status) as well as subjective3 (well-being, life satisfaction, psychological affect, and happiness) measures of quality of life. Case-mix adjustment was based on sociodemographic characteristics of patients and medical characteristics (primary diagnosis, the presence and number of comorbid conditions, duration of current treatment modality, and percentage with failed transplant). The major findings are these: Transplant patients generally have greater functional ability, are in better health, are more likely to return to work, and have higher levels on all scales than patients on any form of dialysis. A failed transplant may adversely affect the quality of life of an ESRD patient, but most such patients continue to prefer transplantation to dialysis. Diabetes adversely affects the quality of life of transplant recipients. Longitudinal studies show that the quality of life of transplant recipients, diabetic or not, improves over time. Among dialysis patients, home hemodialysis patients generally enjoy a higher quality of life than in-center hemodialysis or CAPD patients. External observers, using "objective" measures, tend to rate the quality of life of dialysis patients relatively low. Dialysis patients themselves, however, report satisfaction with their lives. Studies of EPO have shown that it enhances the quality of life of dialysis patients (Evans et al., 1990b). Although, in the 10 months they were studied, these patients were no more likely to return to work than other dialysis

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Kidney Failure and the Federal Government patients, it would be premature to weigh these findings too heavily, since other factors affect employment. Bremer and colleagues (1989) basically confirm the findings of Evans and colleagues in rank-ordering successful transplantation, home hemodialysis, CAPD, and in-center hemodialysis relating to quality of life, but found that a failed transplant reduces quality of life in objective as well as subjective terms. Julius and colleagues (1989) found that transplant patients fared better than dialysis patients on activities of daily living (ADL) Sickness Impact Profile when scores were adjusted by analysis of covariance for all factors in the analyses. Similarly, in-center hemodialysis patients did better than CAPD patients. The only statistically significant differences were between living-donor-transplant recipients and CAPD patients. The strongest explanatory factors for both high dependency in ADL and high physical dysfunction were older age, diabetes as primary cause of ESRD, and a greater number of comorbid conditions. Finally, the objective-subjective distinction in these ESRD quality-of-life studies raises the question of what clinicians are to do when patients evaluate their own quality of life more highly than do "objective" observers. This is basically the same issue as that discussed in Chapter 3 regarding the initiation or termination of treatment. The appropriate response is that health-status and quality-of-life measures can provide useful information to clinicians for assessing individual patients. Such information may predict treatment outcomes, but it should be discussed with the patient and his or her family when major treatment decisions are being made. ESRD quality-of-life studies have been used for research about the effectiveness of different treatment modalities. They have not been used for improving patient management. However, they have laid an important foundation for the future use of functional-and health-status measures in nephrology. Adjustment for Patient Complexity Adjustment for patient differences serves several purposes. For reimbursement issues, case-mix control or severity adjustment is done to predict resource use (Cretin and Worthman, 1986; Jencks and Dobbins, 1987). In quality assessment, it is used to compare treatment outcomes across institutions, as in the HCFA use of hospital mortality data (Green et al., 1990). For patient management purposes, adjustment for patient complexity is required to evaluate variation in outcomes by modality of treatment, site of care, length of treatment in years, and other factors, as well as to predict resource needs. This report uses patient complexity, a comprehensive term, to encompasses both case mix and severity. Case-mix control, as used in the ESRD program, is limited to age, gender, race, and reported primary diagnosis leading to ESRD. Severity-of-illness measures specific to ESRD have yet to be developed,

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Kidney Failure and the Federal Government NOTES 1.   Generic instruments for assessing the functional and health status of individuals include the Sickness Impact Profile, the Quality of Well-Being Scale, Functional Limitations Index, the General Health Ratings Index, the Medical Outcome Study 36-item short form, the Health Utility Index, and the Patient Utility Measurement Set. 2.   Objective refers to the assessment of patients by external observers. 3.   Subjective refers to the patient's own assessment of his or her quality of life. 4.   The ESRD networks were created in 1974, established by regulation in 1976, authorized by law in 1978, and consolidated by law in 1985 and 1986. Their development during the 1970s is described by Rettig and Marks (1980). 5.   The screens, developed by a panel of nephrologists, are described as "clinical measures of quantifiable aspects of patient care to guide professionals in monitoring and evaluating patient care quality and appropriateness." Screens are not standards but, rather, triggers for identifying areas of patient care needing further evaluation. 6.   It is uncertain whether this observed variation for one cross-sectional snapshot is volatile or stable over time. The factual situation should be easily determined by HCFA and analyses of quality adjusted accordingly by using multiyear data. REFERENCES Alter MJ, Ahtone J, Maynard JE. 1983a. Hepatitis B virus transmission associated with a multiple-dose vial in a hemodialysis unit. Ann Intern Med 99:330–333. Alter MJ, Favero MS. 1988. National Surveillance of Dialysis-Associated Disease in the United States. Atlanta, Ga.: Centers for Disease Control. Alter MJ, Favero MS, Petersen SM, Doto IL, Leger RT, Maynard JE. 1983b. National surveillance of dialysis-associated hepatitis and other diseases: 1976 and 1980. Dialysis Transplant 12:860–865. Alter MJ, Favero MS, Maynard JE. 1986. Impact of infection control strategies on the incidence of dialysis-associated hepatitis in the United States. J Infect Dis 153:1149–1151. Alter MJ, Favero MS, Miller JK, Coleman PJ, Bland LE. 1988. Reuse of hemodialyzers: Results of nationwide surveillance for adverse effects. JAMA 260:2073–2076. Audet A-M, Greenfield S, Field M. 1990. Medical practice guidelines: Current activities and future directions. Ann Intern Med 113:709–714. Bataldan PB, Buchanan ED. 1989. Industrial models of quality improvement. In: Goldfield N, Nash DB (eds.). Providing Quality Care: The Challenge to Physicians. Philadelphia, Pa.: American College of Physicians. Berwick DM. 1988. Measuring health care quality. Pediatr Rev 10: 11–16. Berwick DM. 1989. Continuous improvement as an ideal in health care. N Engl J Med 320:53–56, 1424–1425. Bremer BA, McCauley CR, Wrona RM, Johnson JP. 1989. Quality of life in end-stage renal disease: A reexamination. Am J Kidney Dis 13:200–209. Canada Erythropoietin Study Group. 1990. Association between recombinant human erythropoietin and quality of life and exercise capacity of patients receiving haemodialysis. Br Med J 300:573–578. Cretin S, Worthman L. 1986. Alternative Systems for Case Mix Classification in Health Care Financing. R-3457-HCFA. Santa Monica, Calif.: The RAND Corporation. Davies AR, Ware JE Jr. 1988. Involving consumers in quality of care assessment. Health Affairs 7(1):33–48. Donabedian A. 1966. Evaluating the quality of medical care. Milbank Memorial Fund 44(July, Pt 2):166–203.

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Kidney Failure and the Federal Government Evans RW, Manninen DL, Garrison LP Jr, et al. 1985. The quality of life of patients with end-stage renal disease. N Engl J Med 312:553–559. Evans RW, Garrison LP, Jr, Hart LG, Manninen DL. 1987. Health Care Financing Special Report: Findings from the National Kidney Dialysis and Kidney Transplantation Study. Baltimore, Md.: Health Care Financing Administration. Evans RW, Manninen DL, Thompson C. 1989. A Cost and Outcome Analysis of Kidney Transplantation: The Implications of Initial Immunosuppressive Protocol and Diabetes. Seattle, Wash.: Battelle Human Affairs Research Centers. Evans RW, Manninen DL, Dugan MK, et al. 1990a. The Kidney Transplant Health Insurance Study. Seattle, Wash.: Battelle Human Affairs Research Centers. Evans RW, Rader B, Manninen DL, and the Cooperative Multicenter EPO Clinical Trial Group. 1990b. The quality of life of hemodialysis recipients treated with recombinant human erythropoietin. JAMA 263:825–830. Garwin R. 1986. A Note on Quality: The Views of Deming, Juran, and Crosby. 9-687-001 (Rev. 6/87). Boston, Mass.: Harvard Business School. Gordon SM, Tipple M, Bland LE, Harvis WR. 1988. Pyrogenic reactions associated with the reuse of disposable hollow-fiber hemodialyzers. JAMA 260:2077–2081. Green J, Winfield N, Sharkey P, Passman LJ. 1990. The importance of severity of illness in assessing hospital mortality. JAMA 263:241–246. Hart LG, Evans RW. 1987. The functional status of ESRD patients as measured by the Sickness Impact Profile. J Chronic Dis 40 (Suppl 1): 117S–130S. HCFA (Health Care Financing Administration. 1990a. National Medical Review Criteria Screens. Health Standards and Quality Bureau. Baltimore, Md. March. HCFA. 1990b. Medical Case Review Procedures. Health Standards and Quality Bureau. Baltimore, Md. March. JCAHO (Joint Commission on the Accreditation of Healthcare Organizations). 1987. Agenda for Change. Update 1: 1,6. JCAHO. 1988. Agenda for Change. Update 2:1,5. Jencks SF, Dobbins A. 1987. Refining case-mix adjustment: The research evidence. N Engl J Med 317:679-686. Julius M, Hawthorne VM, Carpentier-Alting P, Kneisley J, Wolfe RA, Port FK. 1989. Independence in activities of daily living for end-stage renal disease patients: Biomedical and demographic correlates. Am J Kidney Dis 13:61–69. Kaplan SH, Ware JE, Jr. 1989, The patient's role in health care and quality assessment. In: Goldfield N, Nash DB (eds.). Providing Quality Care: The Challenge to Clinicians. Philadelphia, Pa.: American College of Physicians. Kaplan SH, Greenfield S, Ware JE, Jr. 1989. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. Med Care 27(3, Suppl):S110–S127. Katz S (ed.). 1987. The Portugal conference: Measuring quality of life and functional status in clinical and epidemiological research. J Chronic Dis 40:459. Kazis LE, Anderson JJ, Meenan RF. 1989. Effect sizes for interpreting changes in health status. Med Care 27(3, Suppl):S178–S198. Kravitz RL, Greenfield S, Rogers WH. 1991. Patient-mix in the practices of general internists, family physicians, cardiologists, and endocrinologists: results from the Medical Outcomes Study. In process. Laffel G, Blumenthal D. 1989. The case for using industrial quality management science in health care organizations. JAMA 262:2869–2873. Levin N, Keshaviah P, Gotch FA. 1990. Effect of reimbursement on innovation in the ESRD program. Paper prepared for the Institute of Medicine ESRD Study Committee. New York: Beth Israel Medical Center. Lewis CC, Pantell RH, Kieckhefer GM. 1989. Assessment of children's health status: Field test of new approaches. Med Care 27(3, Suppl):S54–S65.

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Kidney Failure and the Federal Government Lohr KN. 1988. Outcome measurement: concepts and questions. Inquiry 25(Spring):37–50. Lohr KN (ed.). 1989. Advances in health status assessment: Conference proceedings. Med Care 27(3, Suppl). Lohr KN (ed.). 1990. Medicare: A Strategy for Quality Assurance. Washington D.C.: National Academy Press. Lohr KN, Ware JE, Jr (eds.). 1987. Proceedings of the advances in health assessment conference. J Chronic Dis 40(Suppl 1). Lohr KN, Yordy KD, Thier SO. 1988. Current issues in quality of care. Health Affairs 7(1):5–18. Luce BR, Weschler JM, Underwood C. 1989. The use of quality-of-life measures in the private sector. In: Mosteller F, Falotico-Taylor J (eds.). Quality of Life and Technology Assessment. Washington, D.C.: National Academy Press. Nelson EC, Berwick DM. 1989. The measure of health status in clinical practice. Med Care 27(3, Suppl):S77–S90. Patrick DL, Bergner M. 1990. Measurement of health status in the 1990s. Ann Rev Public Health 11:165–183. Patrick DL, Deyo RA. 1989. Generic and disease-specific measures in assessing health status and quality of life. Med Care 27(3, Suppl):S217–S232. Quevedo S (ed.). 1991. Proceedings of the American Kidney Fund Consensus Conference on "Quality of Life." Seminars in Dialysis (in press). Rettig RA, Marks EL. 1980. Implementing the End-Stage Renal Disease Program of Medicare. R-2505-HCFA. Santa Monica, Calif.: The RAND Corporation. Roper WL, Winkenwerder W, Hackbarth GM, Krakauer H. 1988. Effectiveness in health care: An initiative to evaluate and improve medical practice. N Engl J Med 319:1197-1202. RPA (Renal Physicians Association). 1990. Improving Patient Care: A Quality Agenda. Washington, D.C. September. Starr P. 1982. The Social Transformation of American Medicine. New York: Basic Books, Inc. Tarlov AR, Ware JE, Jr, Greenfield S, Nelson EC, Perrin E, Zubkoff M. 1989. The Medical Outcomes Study: An application of methods for monitoring the results of medical care. JAMA 262:925–930. Temkin NR, Dikmen S, Machamer J, McLean A. 1989. General versus disease-specific measures: Further work on the Sickness Impact Profile for head injury. Med Care 27 (3, Suppl):S44–S53. USRDS (U.S. Renal Data System). 1990. Annual Data Report. National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md.

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Kidney Failure and the Federal Government APPENDIX 1 QUALITY OF CARE IN ESRD: AN EXAMPLE OF A PROXIMATE CLINICAL INDICATOR The control of anemia is presented here as an example of a proximate clinical indicator. The clinical literature is briefly summarized as to its acceptance or rejection of this formulation as a quality indicator. The discussion includes the acceptable rates or levels of treatment; appropriate time intervals between measurement; the validity (or sensitivity-specificity) of the indicator relative to prior treatment; and pertinent modifying or adjusting factors. Treating Anemia in Dialysis Patients1 Anemia is nearly universal in ESRD and results primarily from impaired erythropoietin production by diseased kidneys (Haley et al., 1989; Paganini, 1989). Anemia appears to be responsible for many of the symptoms that patients, nurses, and physicians associate with kidney failure despite apparently adequate dialysis. Over the past 25 years, the initial treatment of anemia in dialysis patients has included increased dialysis, diagnosis and repair of iron and vitamin deficiencies, and diagnosis and treatment of aluminum intoxication (Korbet, 1989; Paganini, 1989). Patients who remain unacceptably anemic (the threshold varies from patient to patient and from physician to physician) have been treated with androgens. There is substantial variability in the efficacy of androgen therapy reported by different investigators; this variation may reflect differences in the patient populations studied (Korbet, 1989). Androgens clearly do not work for all patients, perhaps not even for most. Furthermore, their administration is accompanied by frequent adverse effects, including virilization and hepatic toxicity. In some patients, side effects prompt discontinuation of androgen treatment. Until recently, nearly one-quarter of dialysis patients required red cell transfusion as treatment for anemia (Eschbach et al., 1987). Transfusion carries risks of acute transfusion reactions, of infection with viruses causing hepatitis and with retroviruses, of iron overload, and of immunologic sensitization of individuals who are or may become transplant candidates. There is evidence that repeated red cell transfusion can suppress residual endogenous erythropoietin production, making the patient transfusion-dependent (Watson, 1989). On June 1, 1989, the Food and Drug Administration licensed recombinant human erythropoietin (rHuEpo) for treatment of anemia associated with chronic renal failure (FDA, 1989). With the advent of rHuEpo, the

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Kidney Failure and the Federal Government routine treatment of anemia in dialysis patients has changed dramatically. The results of three clinical trials suggest that rHuEpo reverses uncomplicated anemia of renal failure within months, with predictable dose-response curves (Casati et al., 1987; Korbet, 1989; Winearls et al., 1986). However, superimposed red cell destruction or loss, marrow suppression by inflammation, aluminum toxicity, poorly controlled hyperparathyroidism, and inadequate iron or folate stores will counter or even overcome the therapeutic effect of rHuEpo. Absent one of these comorbid conditions, rHuEpo raises the hematocrit to 30–35% in more than 95% of patients (Eschbach et al., 1989). The dose of rHuEpo required to achieve this goal varies substantially from patient to patient. The requirement for transfusion wanes correspondingly. Within 3 months of beginning rHuEpo, transfusion frequency drops almost a factor of 10; within the subsequent 3 months, transfusion frequency declines more than 40-fold (Mohini, 1989). The benefits of rHuEpo treatment include elimination of the adverse effects associated with androgens and transfusion, and potentially a long-term reduction in cardiovascular morbidity and mortality. One study of dialysis patients has shown an inverse correlation between hemoglobin and left ventricular mass index as estimated by echocardiography (Silberberg et al., 1989). Other studies have shown improved exercise tolerance and decreased left ventricular volume in patients whose anemia was treated with rHuEpo (Lundin, 1989). Exercise testing before and after one year of rHuEpo treatment of 10 hemodialysis patients showed that as the average hematocrit rose from 19.8% to 34.3%, duration of exercise increased in all patients, maximum oxygen consumption increased in 7, and the anaerobic threshold increased in 8 of 9. Before treatment, 8 of the 10 electrocardiograms had some areas of ST depression; 7 of 8 normalized. Left ventricular mass, as measured by echocardiography, decreased significantly (Macdougall et al., 1990a). Long-term studies will be required to determine whether, as seems almost certain, these changes outweigh the consequences for vascular disease of the increase in blood pressure associated with rHuEpo treatment. The most prominent immediate consequence of rHuEpo treatment appears to be on the quality of life of dialysis patients. The recent open-label study of 333 patients concluded that rHuEpo "greatly enhances the quality of life of anemic patients who receive maintenance hemodialysis" (Evans et al., 1990). Areas of improvement included energy, activity, functional ability, sleep and eating, disease symptoms, health status, satisfaction with health, sex life, well-being, psychological affect, and happiness. This conclusion supports a widespread clinical impression. On the other hand, a double-blind, placebo-controlled study found that fatigue and physical symptoms and exercise tolerance were substantially

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Kidney Failure and the Federal Government improved in patients receiving rHuEpo, but that ''the effect on psychosocial function was less impressive'' (Canadian Erythropoietin Study Group, 1990). A questionnaire tailored to the problems of patients with ESRD showed some improvement, but psychosocial scores on the Sickness Impact Profile were not significantly different. Patient utilities, as measured by the time trade-off techniques, were not different on rHuEpo. Important adverse effects of rHuEpo treatment include development or exacerbation of hypertension (about 30-50% of patients) and seizures that sometimes appear to be related to severe hypertension. Iron deficiency can impair the effectiveness of treatment if iron stores are not monitored closely and repleted orally or parenterally. Serum potassium rises slightly (Eschbach et al., 1989). Although any diminution in hemodialyzer clearance that has occurred is unlikely to be clinically important (Eschbach et al., 1989: FDA, 1989), reports regarding a possible increase in the rate of venous access thrombosis are inconsistent (Canadian Erythropoietin Group, 1990; Eschbach et al., 1989; FDA, 1989). Further investigation will be required to identify and measure the long-term consequences of erythropoietin treatment. These may influence conclusions regarding therapeutic goals. In particular, it will be important to determine the form of the relationships between (1) functional status and red cell mass and (2) improvement in cardiopulmonary function and red cell mass. Are these functions continuous? Where are their maxima? Further investigations of the optimal frequency and route of rHuEpo delivery are also indicated. Some studies suggest that daily subcutaneous administration may achieve the same increment in red cell mass with a smaller total weekly dose (Macdougall et al., 1990b). Potential Use as an Outcome Indicator Using rHuEpo or androgens, maintain mean hematocrit equal to or greater than 30% in the absence of causes of anemia other than ESRD. Use transfusion only to replace acute blood loss or for immunologic modulation before transplantation. Potential Use as Process Indicators In patients who do not achieve or maintain a mean hematocrit equal to or greater than 30%, exclude other causes of anemia. These should include blood loss, hemolysis, aluminum toxicity, uncontrolled hyperparathyroidism, vitamin deficiency, inflammatory states, and other causes of bone marrow disease. Measure iron stores before rHuEpo therapy and at regular intervals during treatment.

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Kidney Failure and the Federal Government Attain a mean diastolic blood pressure of 95 mmHg or lower before beginning rHuEpo treatment; reevaluate antihypertensive regimen weekly during treatment until stable rHuEpo dose, red cell mass, and blood pressure are achieved. Note 1.   Prepared by Klemens B. Meyer, M.D., and Sheldon Greenfield, M.D., New England Medical Center, Boston, Mass., 1990. References Canadian Erythropoietin Study Group. 1990. Association between recombinant human erythropoietin and quality of life and exercise capacity of patients receiving haemodialysis. Br Med J 300:573–578. Casati S, Passerini P, Campise MR, et al. 1987. Benefits and risks of protracted treatment with human recombinant erythropoietin in patients maintained by chronic hemodialysis. Br Med J 295:1017–1020. Eschbach JW, Egrie JC, Downing MR, et al. 1987. Correction of anemia of end-stage renal disease with recombinant human erythropoietin. N Engl J Med 316:73–78. Eschbach JW, Abdulhadi MH, Browne JK, et al. 1989. Recombinant human erythropoietin in anemic patients with end-stage renal disease: Results of a phase III multicenter clinical trial. Ann Intern Med 111:992–1000. Evans RW, Rader B, Manninen DL, et al. 1990. The quality of life of hemodialysis recipients treated with recombinant human erythropoietin. JAMA 263:825–830. FDA (Food and Drug Administration). 1989. Summary Basis of Approval: Drug License name: Epoetin alfa; Brand name: EPOGEN. June 1. Haley NR, Adamson JW, Schneider GL, Eschbach JW. 1989. There are no uremic inhibitors to erythropoietin (EPO) in chronic renal failure (CRF). Abstract 319A, American Society of Nephrology. Korbet SM. 1989. Comparison of hemodialysis and peritoneal dialysis in the management of anemia related to chronic renal disease. Semin Nephrol 9(Suppl 1):9–15. Lundin AP. 1989. Quality of life: Subjective and objective improvements with recombinant human erythropoietin therapy. Semin Nephrol 9(Suppl 1):22–29. Macdougall IC, Lewis NP, Saunders MJ, et al. 1990a. Long-term cardiorespiratory effects of amelioration of renal anaemia by erythropoietin. Lancet 335:489–493. Macdougall IC, Hutton RD, Cavill I, Coles GA, Williams JD. 1990b. Treating renal anaemia with recombinant human erythropoietin: Practical guidelines and a clinical algorithm. Br Med J 300:655–659. Mohini R. 1989. Clinical efficacy of recombinant human erythropoietin in hemodialysis patients. Semin Nephrol 9(Suppl 1): 16–21. Paganini EP. 1989. Overview of anemia associated with chronic renal disease: primary and secondary mechanisms. Semin Nephrol 9(Suppl 1):3–8. Silberberg JS, Rahal DP, Patton DR, Sniderman AD. 1989. Role of anemia in the pathogenesis of left ventricular hypertrophy in end-stage renal disease. Am J Cardiol 64:222–224. Watson AJ. 1989. Adverse effects of therapy for the correction of anemia in hemodialysis patients. Semin Nephrol 9(Suppl 1):30–34. Winearls CG, Oliver DO, Pippard MJ, et al. 1986. Effect of human erythropoietin derived from recombinant DNA on the anemia of patients maintained by chronic hemodialysis. Lancet 2:1175–1178.

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Kidney Failure and the Federal Government APPENDIX 2 EXAMPLES OF ESRD QUALITY ASSURANCE Dialysis Clinic, Inc., Cincinnati (DCI-C) DCI-C, affiliated with the University of Cincinnati Medical Center (UCMC), opened in July 1977. It has 24 to 27 stations, a home training program (since 1978), a CAPD training program (since 1980), and a strong commitment to transplantation. Its stated philosophy is: Excellent patient care requires an able concerned team of professional staff, who function as independent professionals, and are well informed about their patients and the details of their medical condition(s). Patients should be as well informed as possible and be encouraged to participate as actively as possible in their care. Central to implementing the unit's philosophy is a patient-centered electronic Medical Information and Quality Assurance System (MIS), introduced in March 1976 when the unit was still part of UCMC. This provides a clinical data base that is available to staff on each patient at all times. The MIS staff interact on a daily basis with physicians, nurses, and other professionals to provide relevant clinical information for decisions about patient care. For medical as well as administrative purposes, these information professionals are counted as patient-care staff. The MIS links medical information with administrative, cost, and billing data. This has enabled DCI-C to examine the safety of dialyzer reuse during 1978–79, investigate the effect of reuse on patient well-being and the costs of supplies, and study the enhanced safety and cost-effectiveness of automated dialyzer reprocessing. Patient-specific, dialyzer-specific analysis permitted an increase of average dialyzer uses from 6 to 12, and subsequently to 36. Each improvement in number of uses was accompanied by an improvement in patient well-being. A key benefit of the MIS is the capacity to analyze many types of patient medical information with very little delay. This has facilitated the incorporation into individual patient care of an iterative, day-by-day or month-by-month, sequential process of action, feedback, and correction, which is the essence of continuous quality improvement. In individual patients, the MIS is used daily to assess hypotension during dialysis and to modulate "target weight" and blood pressure; it is used monthly to evaluate adequacy of dialysis, nutrition, calcium and phosphate control, and anemia and its response to treatment; and it is used yearly to examine survival rates. Applied to groups of patients, the MIS is used regularly to assess dialyzer performance, to detect infection and pyrogenic reactions, and to monitor the quality of the water supply. It is also used to transmit full knowledge about the patient's condition whenever an unexpected event occurs, such as admission to hospital

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Kidney Failure and the Federal Government or consultation with other physicians. This process has had a favorable effect on patient well-being and survival. Greenfield Health Systems Greenfield Health Systems (GHS), a division of Henry Ford Health System, Detroit, operates 10 dialysis facilities in three states. Since 1978, a clinical management computer system has been in place to monitor and evaluate the dialysis therapy and clinical status of ESRD patients. Data elements of the QA program include dialysis treatment, medications, routine laboratory studies, urea kinetic modeling results, and dialyzer reprocessing parameters. The QA program involves a monthly review of "key results" for established outcome measures by the multidisciplinary team of each treatment unit. The program generates summary data about patients who fail to meet established outcome targets. The clinical team can then modify treatment for those patients as appropriate. The standard for hyperphosphatemia, for example, is that the mid-week predialysis serum phosphorous level be less than 6.0 milligrams per deciliter. Corrective action for patients falling below this would include nutrition and medical counseling and review of phosphate binders. Parameters measured against a target outcome include dialysis efficacy (Kt/V, protein catabolic rate); a wide range of intradialytic symptoms and signs (nausea, vomiting, cramps, hypotension); calcium; phosphorus; ferritin; potassium; blood urea nitrogen; interdialytic blood pressure control; interdialytic weight gains; and treatment problems (poor blood flow, clotted needles, clotted dialyzers). Mortality and morbidity are monitored monthly; direct causes of hospitalization are reviewed. The QA program also involves a "discipline audit" of everyday practice for consistency of performance of routine procedures. The results may lead to education of personnel or reevaluation of a procedure. On a quarterly basis, the GHS Medical Advisory Board reviews trends within and across treatment units. The program provides a monitoring capability that is used for outcome-oriented patient management, that supports clinical research, and that creates a setting for formal discussion of unit and system performance. The system has provided the data for numerous publications, book chapters, abstracts, and presentations. It has also been adapted for use by the Division of Nephrology and Hypertension of the Beth Israel Medical Center in New York City. National Medical Care, Inc. (NMC) NMC, the largest proprietary dialysis chain in the country with over 300 units, has quality assurance programs both for its manufacturing division,

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Kidney Failure and the Federal Government regulated by the FDA's Good Manufacturing Practices, and its health services (dialysis) division. For several years, NMC has collected summaries of laboratory test values; these have allowed unit medical directors to assess a unit's performance against the averages for the entire organization, and to compare the values for an individual patient against those for both the unit and the entire patient population. Recently, prompted by data showing a relationship between dialysis time and mortality and by laboratory data implicating serum albumin (as a nutrition marker) and other clinical variables in mortality, a program of testing and monitoring of urea reduction and the effective dialysis prescription (expressed as urea reduction ratio) has been introduced. A pre-and postdialysis blood urea nitrogen test is made monthly of each patient, concurrent with monthly chemistries, to measure the fractional reduction of urea during a dialysis procedure. Quarterly summaries of data on each patient are being provided to units on serum albumin and selected clinical variables as well as urea reduction ratio. NMC requires that these reports be reviewed as part of unit QA meetings. The purpose of this NMC action is to provide a clinical management tool to assist physicians and medical teams with the routine evaluation of treatment intensity, both for the assessment of individual patients and for the evaluation of treatment patterns within and between facilities. NMC officials expect that the testing, reporting, and summarizing of URR and Kt/V values will help achieve that goal (Lowrie and Lew, 1991). Forthcoming steps in the NMC quality assurance effort will involve calculating risk-adjusted mortality, and using clinical and laboratory data as specific quality indicators. Reference Lowrie EG, Lew NL. 1991. The urea reduction ratio (URR): a simple method for evaluating hemodialysis treatment. Contemporary Dialysis and Nephrology 12(2):13–20.

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