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Kidney Failure and the Federal Government (1991)

Chapter: Quality Assessment and Assurance

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Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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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

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

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

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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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

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

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

  1. the diagnosis, prescription, and delivery of treatment to the patient by physicians and other clinicians;

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

FIGURE 12-1

Conceptual Framework of the Medical Outcomes Study SOURCE: Tarlov et al.

(1989). Copyright, 1989, American Medical Association. Used with permission.

  1. the biological interactions of the patient with the technology of vascular access, membrane, dialysate, machine, and prescription;

  2. the technical support of water purification and monitoring, dialysate concentrate handling, reprocessing of dialyzers and blood tubing, infection control, and equipment maintenance; and

  3. 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-

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

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

  1. mortality;

  2. proximate or intermediate clinical outcomes (e.g., infection rates, hematocrit levels, clinical and laboratory values, results of hypertension control, and results of prescription dialysis);

  3. morbidities (e.g., abnormal observed clinical signs, physiological laboratory measurements, and patient-reported symptoms, such as complications or adverse treatment effects);

  4. disease-specific and general functional-status effects; and

  5. 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.

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

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.

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

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.

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

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-

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

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

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

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,

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

but severity is often used synonymously with case mix. Patient complexity refers to the following patient characteristics: demographic status, primary diagnosis, clinical severity of illness, as well as socioeconomic, social support, and functional and health status. Validated measures may exist for some variables and may need to be developed for others in the ESRD setting; similarly, data may be available for some measures and need to be collected for others. However, if outcome data are to be interpreted in a way that avoids the inappropriate attribution of causality, then the more comprehensive the basis for adjusting for differences among patients, the better. The measurement of patient complexity, then, represents a hoped-for future state, not a present reality.

In the development of measures of patient complexity, the most immediate practical need of clinicians is to develop adjusters for the clinical severity of ESRD patients. The simplest approach to this task uses patient-specific case-mix data found in Medicare data bases. A second approach builds on this data base with additional data about the accuracy of the primary diagnosis and the frequency of comorbid conditions. To this end, the USRDS is analyzing a retrospective sample of 2,500 patient abstracts (USRDS, 1990). The USRDS Scientific Advisory Committee has recommended to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) that a prospective study be done.

A third approach, not yet attempted in the ESRD patient population, reflects that used by the Medical Outcomes Study (Kravitz et al., 1991). A scaling and scoring approach was developed to assess the severity of the primary diagnosis in clinical-as well as functional-status terms for office-practice patients. This approach was extended to assess the severity of comorbid conditions in the same way. Severity scores for primary diagnosis as well as for comorbid conditions were then combined into a scale that has been shown to differentiate among patients and can be used to adjust for outcomes in terms of the baseline clinical severity of patients. This allows patients to be compared within units, across units, and across modalities. This group provides an example of this approach applied to diabetes mellitus (Kravitz, 1991).

In the ESRD population, disease severity and comorbidities affect health status so strongly that they must be assessed at the baseline in a systematic way. Only then can they be used for predicting outcomes of care. Developing means to adjust for clinical severity is a necessary first step toward creating a full set of measures of patient complexity.

RESPONSIBILITIES OF FEDERAL AGENCIES

The U.S. Department of Health and Human Services (DHHS) exercises responsibility for quality assessment and assurance in the ESRD program through both the PHS and HCFA.

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×
Public Health Service

Within the PHS, CDC, FDA, NIH, and AHCPR, respectively, exercise broad authorities related to infection control, equipment and device safety, basic and applied medical research, health services research, technology assessment, and practice guidelines. Relative to ensuring the quality of care delivered to ESRD patients, their contributions are indicated below.

Centers for Disease Control

The CDC surveys dialysis facilities for dialysis-related problems, including hepatitis infection (Alter et al., 1983a,b; 1986), hepatitis vaccination, AIDS infection, extent of dialyzer reuse (Alter et al., 1988), and prevalence of pyrogenic reactions (Gordon et al., 1988). The survey, first conducted in 1976, has been done annually since 1982, being included with the annual HCFA facility survey since 1981. Although compliance with this survey is voluntary, CDC achieves a very high response rate. Results are reported annually within the DHHS (Alter and Favero, 1988) and in the clinical literature.

CDC, through its infection control program, investigates problems of water treatment and contamination as well as dialyzer reuse. These detailed, professional inquiries, often in cooperation with HCFA and FDA, permit rapid analysis of poorly understood but dangerous problems and allow appropriate remediable action by providers. However, their scope is limited. The multiagency efforts sometimes become disconnected, and the reports to the provider community are not systematically or widely distributed. Nonetheless, the agency has a well-earned reputation for scientific integrity, and most providers acknowledge the utility of the information that CDC collects.

Food and Drug Administration

The FDA responsibilities related to ESRD include ensuring the safety and efficacy of drugs and biologicals, medical devices, food additives, and manufacturing process standards. Basically, all currently used dialysis equipment resembles devices that existed before enactment of the 1976 Medical Device Amendments. Consequently, recent innovations in dialysis-related medical devices have been granted FDA approval under the ''grandfather" clause of the 1976 amendments, and manufacturers have not been required to generate clinical trial evidence of efficacy.

FDA authority for the safety and efficacy of dialysis equipment and supplies includes devices such as the dialyzer membrane; proportioning and monitoring machines; subsystems for water purification and dialysate concentrate labeling and handling; and dialyzers and blood tubing.

However, FDA has gone beyond these regulatory limits to develop, with

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

the renal provider community, educational material's—videotapes on human factors in dialysis treatment, infection control, water processing, and dialyzer reuse. It has also prepared a water treatment manual. These materials have been uniformly well received.

In addition, FDA contracted in 1990 with Dialysis Management, Inc., to produce a report, "A Quality Assurance Program for Hemodialysis Facilities." That report, expected in early 1991, will deal with water treatment, delivery systems (e.g., dialysate proportioning, temperature control, conductivity control, and monitoring), dialysate, dialyzers, other supplies and equipment, anticoagulation in dialysis, vascular access devices, hemodialyzer reuse, infection control, and toxic chemicals handling. It is expected to review the pertinent literature regarding risks and hazards, existing standards, routine and long-term monitoring, preventive maintenance, staff training, and patient education.

Hemodialysis equipment and systems are becoming more sophisticated and require more monitoring and maintenance. ESRD patients are also presenting with greater disease severity. Therefore, it may become appropriate in the future for FDA, or another agency, to assess the implications for safety and efficacy of the education and skill levels of technicians.

National Institutes of Health

NIH is seldom seen as a quality assessment or assurance agency. This view overlooks the critical role of clinical research and clinical trials in providing the scientific underpinnings of clinical practice. It also ignores the standard-setting role that academic investigators often exercise for a much larger group of practitioners.

NIH, through the National Institute of Allergy and Infectious Diseases (NIAID) and the NIDDK, supports transplant immunology and kidney disease research. Early in the 1980s, as indicated in Chapter 10, NIDDK terminated the Artificial Kidney Chronic Uremia contract research program in clinical dialysis and transplantation, which had existed since 1965. Since then, the agency has not supported the clinical study of dialysis to any appreciable extent (Levin et al., 1990). Thus, little was done in the 1980s, for example, to deepen scientific knowledge about the adequacy of dialysis, a critical treatment issue during a time when facilities were under increasing reimbursement-related pressures. The committee believes that the resumption of active support of clinical dialysis research by NIDDK would contribute greatly to the quality of clinical practice.

Agency for Health Care Policy and Research

OBRA 1989 created a new PHS organization, AHCPR. The new agency subsumes the health services research and technology assessment functions

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

of the National Center for Health Services Research and adds new functions related to the dissemination of research results, the development of practice guidelines, and data base development. AHCPR administers the DHHS Medical Treatment Effectiveness Program (MEDTEP), which consolidates outcomes and effectiveness research. If adequately funded over the long term, AHCPR will provide an important focus of research addressed to what works in clinical practice.

Health Care Financing Administration

HCFA is responsible to the public for prudently managing the resources it administers, including ensuring that acceptable quality of care is delivered to Medicare beneficiaries. The HCFA responsibility for QA has been addressed historically through the PSROs and, more recently, the PROs. Since 1987, it has issued periodic hospital mortality reports, attempted to make Medicare data more accessible to researchers and practitioners, and advocated during 1987–89 an Effectiveness Initiative (Roper et al., 1988). This latter effort provided one major impetus for the creation of AHCPR and its MEDTEP program.

These general QA efforts provide the context for this committee's recommendations regarding the responsibility of HCFA for quality assessment and assurance of the ESRD program. The ESRD QA function has been exercised by the Health Standards and Quality Bureau (HSQB), primarily through the conditions of coverage, state survey agencies, and the ESRD networks.4

Conditions of Coverage

The 1976 regulations set forth conditions of coverage for renal transplantation centers and renal dialysis facilities and centers as requirements for participation in Medicare (41 Fed. Reg. 22502-22522, June 3, 1976). These are listed in Table 12-1. Several of these conditions may be considered indicators of quality because they stipulate standards that represent structural measures and some process measures of quality.

The most important conditions for QA purposes in dialysis facilities are 405.2137, 405.2138, 405.2161, 405.2162, and 405.2163. Condition 405.2137 requires that each treatment facility maintain a written long-term program and long-term patient care plan "to ensure that each patient receives the appropriate modality of care and the appropriate care within than modality." The patient, or his or her parent or guardian, is to be involved in planning that care. Condition 405.2138 requires that each facility establish a written statement of patients' rights and responsibilities and inform patients of this statement.

Condition 405.2161 specifies the responsibilities of a medical director, who must be a qualified physician. The most important are:

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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TABLE 12-1 Conditions of Coverage for ESRD Providers

405.2131

provider status: renal transplantation center or renal dialysis center

405.2132

fulfillment of service needs in network

405.2133

furnishing data and information for ESRD program administration

405.2134

membership in a network

405.2135

compliance with federal, state, and local laws and regulations

405.2136

governing body and management

405.2137

patient long-term program and patient-care plan

405.2138

patients' rights and responsibilities

405.2139

medical records

405.2140

physical environment

405.2160

affiliation agreement or arrangement

405.2161

director of a renal dialysis facility or renal dialysis center

405.2162

staff of a renal dialysis facility or renal dialysis center

405.2163

minimal service requirements for a renal dialysis facility or renal dialysis center

405.2170

director of a renal transplantation center

405.2171

minimal service requirements for a renal transplantation center

NOTE: Encoded at Title 42, Part 405 of the Code of Federal Regulations.

  • participating in the selection of a suitable treatment modality for all patients;

  • ensuring adequate training of nurses and technicians in dialysis techniques;

  • ensuring adequate monitoring of the patient and the dialysis process;

  • ensuring the development and availability of a patient-care policy and procedures manual and its implementation; and

  • when self-dialysis training is offered, ensuring that patient teaching materials are available for patient use during training and at times other than during the dialysis procedure.

This statement is the most extensive ESRD QA requirement set forth in federal regulations.

Condition 405.2162 deals with standards for registered nurses, on-duty personnel, and self-care dialysis training personnel. Condition 405.2163 stipulates standards for laboratory services, social services, dietetic services, self-care dialysis support services, and participation in a recipient registry. The most important of these standards are:

  • Registered nurse. At least one full-time qualified nurse must be responsible for nursing services.

  • On-duty personnel. Whenever patients are undergoing dialysis, other than self-care dialysis, one currently licensed health professional (e.g., physician, registered nurse, or licensed practical nurse) experienced in ESRD care is to be on duty to oversee ESRD patient care. An adequate number of personnel

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

must be present to meet patient needs and medical and non-medical emergencies.

  • Social services. To support the patient's social functioning and adjustment, social services are to be provided to patients and their families. These services are to be furnished by a qualified social worker responsible for psychosocial evaluations, team review of patient progress, and recommendation of treatment changes based on the patient's current psychosocial needs. In addition, the social worker is to identify community social agencies and assist patients and families in using them.

  • Dietetic services. Patients are to be evaluated for nutrition needs by the attending physician and by a qualified dietitian. The dietitian, in consultation with the attending physician, is responsible for assessing the nutrition and dietetic needs of each patient, recommending therapeutic diets, counseling patients and their families on prescribed diets, and monitoring adherence and response to diets.

These conditions do not establish staffing requirements; instead they specify the types of personnel with given training who are to provide treatment. Some state health codes prescribe staffing patterns in much greater detail. These federal standards represent structural measures of quality and have never been related to either process or outcome measures. They are based on the judgments of health professionals about necessary services, not on a demonstrated relationship to outcomes.

HCFA reimbursement policies reinforce staffing patterns that have the lowest economic cost (e.g., one licensed practical nurse and the rest technicians, with special training for each shift) without regard for patient complexity. Pressures from Medicare ESRD reimbursement, as discussed in Chapter 10, have led treatment units to depart from these Medicare-specified staffing standards. With respect to social services, HCFA announced in 1990 its intention to issue a Notice of Proposed Rulemaking that would move away from input standards and focus on outcomes. This outcome orientation is commendable, and presumably it will be accompanied by proposed outcome measures. HCFA should also relate these outcomes to the structural and process requirements to achieve them.

State Survey Process

HCFA contracts with state health departments to survey all Medicare-certified facilities, including ESRD treatment units. Although these state surveys have potential for measuring structural and some process measures of quality in dialysis units, providers frequently complain about the inconsistency of the surveys from state to state and the variability in the level of training of surveyors. The present system is characterized by poor support, inadequate

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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training, and inconsistent oversight. It produces surveys that vary widely in approach, thoroughness, and perceived fairness. Consequently, they are seldom accepted as valid by clinicians.

Several simple steps can be taken to address these issues (personal communication, Douglas L. Vlchek, January 12, 1990). First, HCFA should rewrite the "Interpretive Guidelines" manual for surveyors to conform with the current conditions of coverage of End-Stage Renal Disease Services (42 CFR Part 405, Subpart U) and describe the context of its use. Second, all ESRD facility surveyors should be required to attend a training program that uses a standard curriculum. Third, all surveyors should be required to pass a certifying examination after completing the training program. Fourth, all surveyors should be required to attend a periodic refresher course, followed by an examination. Finally, HCFA should consider putting in place a broader, more effective quality control method than it currently uses.

The committee endorses efforts to strengthen the competence of state survey agencies to fulfill their responsibilities. The committee also believes that an effective ESRD QA program requires the integration of the state surveys with other QA activities. State surveys can make an important contribution to QA, but they cannot be the centerpiece of a QA system.

HSQB and the ESRD Networks

Quality assurance within the ESRD program derives from the 1972 statute that vested authority in the Secretary to regulate reimbursement and included the requirement of "a medical review board to screen the appropriateness of patients for the proposed treatment procedures." Regulations of 1976 (41 Fed. Reg. 22052, June 3, 1976) required that each ESRD network have a medical review board to monitor the effectiveness of the patient long-term program; oversee the evaluation of the performance of physicians, nonphysicians, and facilities; coordinate the medical care evaluation studies of network facilities (at minimum, one annually for each facility); and provide written recommendations to physicians and facilities about possible improvements in the care of patients.

The ESRD network medical care review function has been performed with varying degrees of effectiveness by different networks. As originally conceived, it was to depend on data from an ESRD medical information system that did not exist until several years after HCFA was created in 1977. Furthermore, networks struggled for survival during much of the 1980s, fending off repeated but unsuccessful attempts by HCFA to eliminate them. The circumstances were hardly suitable for putting together a sound QA system at the ESRD network level.

In OBRA 1985 and OBRA 1986, Congress directed the Secretary of DHHS to consolidate the 32 existing ESRD networks into 17 networks,

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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later increased to 18. Under OBRA 1986, each network was to include a medical review board whose functions were to include "reporting on facilities and providers that are not providing appropriate care" and "conducting on-site reviews of facilities and providers ... utilizing standards of care established by the network organization." Networks existed in administrative limbo until the issue of their liability for medical review was resolved in 1989. Since then, they have followed the lead of HSQB in QA efforts.

In March 1990, HSQB centralized the design of the medical review function. It distributed the "National Medical Review Criteria Screens" and "Medical Case Review Procedures" for public comment to implement Sections 9335(d)-(h) of OBRA 1986 regarding the establishment of criteria and standards related to the quality and appropriateness of patient care (HCFA, 1990a,b). The proposed review process requires ESRD networks to use screens5 to review, through the Network Medical Review Boards, a random sample of medical records. Records that fail the screens are then reviewed by network personnel with the local facility personnel. Opportunities are provided to the facility for discussion, written comment, the development of a Corrective Action Plan, specific educational activities, or sanctions.

HSQB began pilot testing the review process during 1990–91, focusing on "validity and meaningfulness of screens, availability and ease of collection of data elements, sensitivity and specificity of data elements as flags, and controllability of underlying causes of variances from indicators." It plans to review the screens periodically and modify them to reflect evolving clinical knowledge.

The HSQB effort clearly represents one plausible approach to QA in the ESRD program. However, it reflects several problems. First, the objectives of the endeavor remain unclear. Although characterized as a pilot program designed to improve care, the plan also refers to sanctions, which are surely premature for a pilot effort. The approach further presumes that the provision of high-quality, comprehensive, and appropriate medical care to patients in ESRD facilities can best be ensured by a top-down monitoring system as opposed to QA activity rooted at the treatment-unit level.

Second, the HSQB proposal was designed rapidly by a small number of professionals drawn exclusively from the nephrology community without benefit of any expertise from the quality assessment community. A broader group, augmenting the expertise of the nephrology community with that of the quality assessment community appears warranted. The current initiative appears to underestimate the need for an investment in QA design. Third, allowing only one year for design and pilot testing may be too ambitious both technically and for the wide-scale learning that must accompany effective implementation. Adequate time is needed for system design, training and education of the provider community, and review and redesign. Although uniformity on a national scale for a common set of data elements is desirable,

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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several competing approaches using these common elements might be considered in the pilot-test phase as a way to identify the appropriate elements of a national system.

Fourth, the effort imposes financial costs on providers and networks. The requirements of random chart review are labor intensive, expensive, and exceed the number of experienced ESRD reviewers.

Fifth, the random chart review methodology depends on criteria sets and exceptions that have yet to be validated. It represents a flagging system that is more likely to reveal the quality of documentation than the quality of care. Moreover, it overlooks more readily available flags such as mortality and hospitalization and appears to overlook the fact that existing data could guide focused case review.

The random chart review method also assumes that an individual patient record can be meaningfully evaluated against an untested universal clinical indicator of quality. Also important, this review strategy does not assess the quality of treatment units; facilities characterized by high mortality, low transplant referral, low home dialysis referral, and other measures of unit performance, for example, are completely overlooked. In this context, it does little to move outlier units toward the average level of quality and little to improve performance for those grouped around the mean.

Finally, the HSQB approach misses an important opportunity to QA oversight functions that it could exercise in concert with the Bureau of Policy Development (BPD) and the Office of Research and Demonstrations (ORD) using existing Medicare data bases. These opportunities are discussed below.

Opinion is divided in the renal community about the usefulness of ESRD networks. Defenders tout their potential; others tolerate their existence on the grounds that some institutional framework is better than none; still others argue that they should be eliminated. The utility of the networks can be realized if they implement a well-designed QA strategy and develop the supporting data systems. Responsibility for the articulation of such a strategy resides with HCFA.

Bureau of Policy Development

In Part IV, this report has examined ESRD reimbursement policies, the effects that such policies have had on quality, and several controversial reimbursement issues. Indirectly, all these chapters show that ESRD reimbursement policies have been developed without sufficient attention to their implications for quality. The atypical service intensity criterion for reimbursement rate exception requests, for example, is a category for classifying requests and not a decision rule (or criterion) in the technical sense of that term.

On the other hand, the HCFA coverage and reimbursement decisions regarding the use of EPO for the treatment of anemia in dialysis patients

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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offer an interesting alternative perspective. The coverage decision was made promptly in 1989 within weeks of FDA approval of the compound. The reimbursement policy, although criticized by many providers, has clearly been transitional.

Congress, in OBRA 1990, modified Medicare policy on EPO to provide for self-administration of EPO by home dialysis patients and dose-related reimbursement for inpatients. HCFA, before this legislation, had initiated a review of EPO, the equivalent of a Phase IV trial protocol, that involved collecting data on EPO dosage and hematocrit response. It recently awarded a contract to evaluate these data to the Johns Hopkins University School of Public Health. The review may provide the basis for a dosage-related payment policy that is related, in turn, to proximate clinical outcome data—the effect of EPO on hematocrit levels. Outcome measures may perhaps be expanded to include measures of energy, employability, employment, functional and health status, and quality of life. The HCFA attempt to relate reimbursement to an observed proximate clinical outcome, then, suggests a QA approach for the entire ESRD program.

The committee believes that ESRD reimbursement policy has reached the point where it is essential that HCFA establish adequate measures, data, and systems to predict and monitor the consequences of all future reimbursement policy changes. The EPO experience may point in the appropriate direction.

Office of Research and Demonstrations

Within ORD, the Office of Research (OR) has established a basis for contributing to ESRD QA functions. It has been instrumental, with the Bureau of Data Management and Strategy (BDMS), in developing the ESRD data bases now widely used by the research community, including this committee. It has supported ESRD quality-of-life studies. Its staff have conducted many cost and epidemiologic analyses, prepared an annual ESRD Research Report since 1984, contributed to the literature, and conducted numerous internal analyses. Eggers (unpublished data, 1990), for example, analyzed ESRD ambulance use and showed that ESRD patients accounted for 8 percent of all Medicare ambulance expenditures, and that three-quarters of this 8 percent were generated by one percent of the ESRD patients. (Good functional status measures might predict such use.)

OR has an increasing capability to conduct analyses that link quality and cost data. It also has the technical capability to generate facility-specific ESRD mortality and other data on a time-series basis. Investigating the high-and low-mortality outliers among treatment units would be useful in its own right and might stimulate a demand by providers for development of validated measures, methods, and data in this area.

OR has not supported external research related to ESRD severity adjust-

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

ment or health status assessment to any appreciable degree. Nor has it dealt with adapting generic functional-and health-status assessment instruments and measures for use in ESRD clinical practice. In short, OR has the data base and the analytical capability to enter more forcefully into the ESRD QA function, but it needs to do so with a coherent research agenda and in concert with other HCFA organizational units.

Coordination Within HCFA

Much greater coordination is needed within HCFA to develop a coherent agenda for QA in the ESRD program. Such an agenda would involve:

  • relating major conditions of coverage to patient outcomes;

  • developing measures of patient complexity to guide state surveys, assist network-based medical review, and help facilities with QA efforts;

  • standardizing state surveys and integrating them within a broader QA strategy;

  • distinguishing between oversight efforts to identify poor-quality providers and the aggregation of regional and national data to help develop norms of practice and improve the quality of care;

  • assessing its QA efforts for their financial burden on facilities;

  • analyzing reimbursement policy for its effects on quality; and

  • supporting QA-related research.

Operationally, such coordination would require that the major bureaus within HCFA—BPD, HSQB, ORD, and BDMS—cooperate to develop such an agenda and pursue it in a systematic and credible way. In this context, the question asked by OBRA 1987 about the effects of reimbursement on quality is a very important question. How might it be answered? The EPO case suggests one way; that is, reimbursement policy could be analyzed in terms of patient outcomes. Not all aspects of dialysis or transplantation offer the opportunity to relate inputs and patient outcomes so directly. But the EPO case points in an appropriate direction.

HCFA might also consider the following issues, which join reimbursement and quality:

  • The HCFA cost data analyzed in Chapter 11 indicate substantial variation among facilities on the basis of reported costs, audited costs, and ''margins."6 HCFA could easily identify the low-and high-cost outlier facilities (say, at the 10th and 90th percentiles of the audited-cost distribution), or those with high-and low-revenue margins, and devise a "quality audit" (that included mortality) to clarify the relationships between resources and quality.

  • Available data permit HCFA to examine mortality on a facility-specific basis. It could identify low-and high-mortality treatment units and

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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conduct a ''quality audit" that included payment and cost data to determine what factors might account for differences among units.

  • If patient-complexity adjusters were developed, they could clarify the relationships among payment, treatment characteristics, and patient characteristics. Results could be analyzed for high-and low-cost units to clarify the utility of mortality as a quality measure.

  • Hospital-based and independent outpatient dialysis units report quite different costs per treatment. Hospitals argue that these differences reflect greater patient severity. No compelling data have been presented, however, to support that claim. HCFA should design a pilot effort to examine prospectively the complexity differences between a random sample of patients drawn from hospital-based units and a random sample drawn from independent facilities as a way to resolve this decade-long issue.

Although none of the above proposals can be implemented immediately, all could be done soon if preceded by an appropriate investment in research design. Although existing data bases can provide substantial assistance in addressing these questions, some new data will be required. Most important, an agenda that includes the above issues would require a commitment from both HCFA and the provider community to engage these issues in a cooperative way. Absent such cooperation, the future is likely to be as fractious as the recent past.

Quality Assessment and Assurance Data Needs

The OBRA 1986 legislation authorized the creation of a National End-Stage Renal Disease Registry, discussed at length in Chapter 13. The registry has three identifiable functions: epidemiologic research, cost analyses linked to epidemiologic data, and data acquisition and analysis related to quality. Regarding the last function, the registry is "to assemble and analyze the data reported by network organizations, transplant centers, and other sources on all end stage renal disease patients" and determine "patient mortality and morbidity rates, and trends in such rates, and other indices of quality of care."

NIDDK established the USRDS on a contract basis in 1988, in a manner consistent with the OBRA 1986 legislation. USRDS receives the core of its data from HCFA; this includes all of the ESRD Program Management and Medical Information System (PMMIS) data and selected data on transplant follow-up and Medicare Parts A and B services. The ESRD networks are instrumental in collecting and processing PMMIS data and, through several consultative mechanisms, USRDS, HCFA, and the networks cooperate in data collection policies and procedures.

The committee attaches great importance to the establishment of an ef-

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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fective QA system for the ESRD program. What is needed is a system to collect data on selected measures of quality from treatment units. These data could then be aggregated to generate regional and national norms. National, regional, and facility-specific data should then be fed back promptly to individual treatment units by HCFA, on a non-punitive basis, for unit review and evaluation. Where unit behavior deviates sharply from such empirically derived norms, HCFA mechanisms for investigating this variation can be established.

Given the establishment of the USRDS and its strong initial performance, it is essential that DHHS find a satisfactory way to facilitate the development of an effective QA data system implied by the OBRA 1986 legislation. This will undoubtedly require cooperative working relationships among NIDDK, HCFA, the ESRD networks, and the USRDS in the collection and analysis of quality-related data. Data support for ESRD QA is presently more of a hope than a reality. This situation should not be permitted to continue.

In addition to the data acquisition and analysis capability described above, a separate capability for the design of a QA system, including instruments, measures, and data elements, is needed. HCFA should be responsible for this capability, although it could be established either within the government or through a contractor. In any case, it requires an expert advisory group reflecting clinical, measurement, and quality assessment expertise and support for a staff that includes clinical and quality assessment professionals.

CONTINUOUS QUALITY IMPROVEMENT

Within the past 5 years, a literature has emerged dealing with the application of industrial quality control concepts to medicine and health. This nascent effort, known as the continuous quality improvement (or QI) model of quality assessment and assurance, has already gained many adherents. This section summarizes very briefly this literature. [A more extend summary can be found in Lohr (1990).]

The model originates with quality improvement in manufacturing and has been variously described as "total quality control," "total quality improvement," "quality improvement process,'' and "continuous improvement.'' In medicine, it is a facility-level approach to QA that represents an alternative to the top-down approach of HCFA. The best top-down system always risks becoming a paper compliance system and overloading treatment units with costly data requirements.

A facility-level approach is justified, however, as a way to incorporate the commitment to quality care into the unit philosophy and to focus on improving patient management and outcomes. Effective QA systems at the treatment-unit level can also help providers analyze the effects of reim-

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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bursement policies on patient management and outcomes. In fact, top-down and facility-unit-level QA approaches can be complementary, if HCFA and the provider community agree on the shared values and common purposes of QA.

The QI literature in health includes, first, by reference, the extensive literature on management and statistical quality control principles and applications, in which W. Edwards Deming and Joseph M. Juran are prominent (Garwin, 1986). Second, it includes the writings of a number of physicians regarding the attractiveness of the QI model for application in health (Berwick, 1988, 1989). Bataldan and Buchanan (1989), for example, provide an overview of the principles that have guided Hospital Corporation of America as it has pioneered in this area. Third, an applications literature has begun to emerge, much of which is still found in handbooks, conference notebooks, and applications manuals.

There are four core assumptions of continuous improvement. First, the individuals who deliver health care work mainly in organizations and QI, and therefore must use the energy and lines of accountability of these organizations to accomplish the purposes of QI. Second, health care workers—from physicians to technicians—wish to perform to the best of their ability, and QI challenges them to do so. It seeks to create a supporting environment and a progressively advancing set of quality benchmarks. Third, the failure of workers to perform at their best is usually a function of organizational systems, not of personal motivation. Fourth, the interactions among individuals, organizations, and systems of service delivery create situations that can always be improved.

The major principles that underlie the philosophy and rationale of the QI model are these. First, successful continuous improvement requires the commitment to quality of the highest leadership of a treatment unit or organization. This commitment must permeate the values and behavior of the entire organization. QI cannot be delegated to a peripheral "QA unit" or to a "QA professional," but must be primary to how the unit understands its clinical objectives and strategy.

Second, QI objectives are defined by an organization's orientation to its several "customers "—patients, employees, external payers, and policymakers. The patient is clearly the primary "customer" for health organizations, including ESRD treatment units, although not the only one.

Third, the commitment of a QI system is to continuous quality improvement, not to meeting static standards of care typical of traditional QA systems.

Fourth, QI emphasizes the systems or processes of care—how care gets delivered. All structures and processes of the organization that occur before the delivery of benefit to the patient must be engaged in a systematic, cooperative search to improve care. The QI activities of "planning, doing,

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
×

checking, acting," therefore, are cyclic and iterative, and improvement occurs by integrating customers' views and the processes of care into the regular redesign of service and care.

Fifth, QI uses practical statistical techniques developed for industrial quality control to facilitate the search for improved quality. The instruments used for data collection and analysis follow from the organizational leadership's commitment to quality; they do not precede it. These include flow charts, fishbone diagrams, and run charts. Finally, the organizational commitment to continuous improvement is consistent with the professional values of physicians and the other clinicians who care for ESRD patients. It also provides the framework for integrating the clinical, technical support, administrative, and financial management aspects of a treatment unit.

The Dialysis Facility: Practical Considerations

Treatment units seeking to implement a QA system will have to address several practical problems. First, the unit philosophy of quality assessment and assurance must result from the careful deliberation and endorsement of the organization's board of directors, CEO or administrator, and medical director. These individuals must invest enough time to understand their QA strategy and adopt it in a deliberate, not superficial, way.

Second, relationships between medical directors and attending physicians should be clearly stated, preferably in writing, regarding adherence to unit or organization practices, including QA policies. Similarly, relationships between the medical director, the head nurse, and other professional members of the clinical team should be clearly articulated. These written statements should be the subject of training and education regarding both philosophy and implementation. They should state the organization's commitment to quality as a primary function, not as a delegated task of a QA professional.

Third, a commitment to QA underlines once again the importance of the careful monitoring of the dialysis prescription for the adequacy of treatment. The importance of monitoring water quality, dialysate concentrate, and dialyzer reprocessing is also emphasized by this orientation. Finally, a serious facility-level approach to QA must link process data to a critical review of patient outcome data, as discussed above.

Examples of ESRD Quality Assurance

In the ESRD context, the QI model has great potential applicability, both for clinical care and for the "industrial substrate" of dialysis. Although the committee is unaware of specific examples where individual ESRD providers have formally adopted the QI model, as defined by its foremost advocates,

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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many providers have undoubtedly incorporated aspects of this model into their unit's routine practice and procedures. The principles of this model should be seriously considered by all ESRD providers.

Appendix 2 describes three ESRD provider organizations currently engaged in QA efforts that approximate some elements of the QI model, although none has explicitly characterized its efforts in this way. The examples are Dialysis Clinic, Inc., Cincinnati; Greenfield Health Systems, a division of Henry Ford Health System; and National Medical Care, Inc. They include not-for-profit and for-profit, independent and hospital-based organizations, ranging from a single unit to a large corporation.

What they have in common is a leadership commitment to quality and to using quality assessment and assurance for improved patient care and outcomes. They also rely extensively on strong data and measurement systems that are integral to the management of patient care and costs. The critical review of such data leads to process alterations and follow-up. These QA systems are not paper compliance efforts responding to the federal government. Presently, all focus on proximate clinical indicators, both process and outcome. None has yet to introduce measures of patient functional status and well-being to assess quality.

The committee has no systematic data about the extent of similar treatment-level QA systems within the ESRD provider community. These examples are hardly exhaustive and not necessarily representative. They do suggest the future direction of quality assessment and assurance for ESRD providers.

CONCLUSIONS AND RECOMMENDATIONS

Are quality assessment and assurance feasible and desirable within the ESRD program? The committee believes that they are. Substantial progress has been made on conceptual and measurement issues related to quality assessment, and the renal community should take advantage of that progress. The evolution of computer technology has made large-scale data collection, manipulation, and analysis feasible.

The challenge in the ESRD context is threefold. First, it is necessary to develop meaningful process and outcome indicators that are valid for ESRD patients in the ESRD treatment setting. Second, it is necessary to demonstrate to physicians that these measures have value for patient management and that they will benefit from incorporating them into their clinical practice. Third, it is essential that practicing clinicians adopt effective treatment-unit QA systems that reduce the QI philosophy to useful practice. The committee believes that the clinical community is prepared to engage in QA that permits them to do their jobs better and that genuinely helps patients.

Currently, a disjunction exists between federal QA systems, which are

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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regulatory in character, and treatment-level systems that physicians and other clinicians use to improve patient care. This disjunction must be bridged in a mutually satisfactory manner if the maximum benefit of both approaches is to be realized.

As long as national and regional QA systems emphasize regulatory objectives, however, the medical community will respond with ambivalence. Providers generally accept the need to police those few among them who willfully trade quality for financial gain or simply disregard quality standards. They also value the opportunity to compare their own performance against national or regional norms. But they resent burdensome paperwork, are skeptical of the quality of QA programs, and remain suspicious of government motives.

The specific recommendations made by the committee are recapitulated here. They are that HCFA:

Improve the Medicare ESRD state survey system by developing uniform training and certification requirements for surveyors and by integrating the state system with other ESRD QA efforts.

Evaluate all policies, including reimbursement policies, for their quality effects on patients.

Provide adequate financial support to facilities for QA by incorporating facility QA costs in reimbursement for both dialysis and transplantation.

Coordinate the efforts of the Health Standards and Quality Bureau, the Bureau of Policy Development, and the Office of Research and Demonstrations; link existing data bases for the development and operation of ESRD QA oversight systems, and integrate the ESRD networks and state surveys into a coherent national QA strategy.

Establish an advisory group of nephrology professionals and experts in QA to design and develop ESRD-specific QA systems.

Support the regional and national data systems necessary for an effective QA system.

Modify the patient data intake to provide a basis for assessing patient complexity.

Support a continuing program of ESRD QA research.

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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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.

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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.

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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.


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Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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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.

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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.


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Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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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

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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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

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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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
  1. 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.

  2. Measure iron stores before rHuEpo therapy and at regular intervals during treatment.

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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  1. 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.

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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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

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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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,

Suggested Citation:"Quality Assessment and Assurance." Institute of Medicine. 1991. Kidney Failure and the Federal Government. Washington, DC: The National Academies Press. doi: 10.17226/1818.
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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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Next: Part V: Data and Research, Data Systems »
Kidney Failure and the Federal Government Get This Book
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Since 1972, many victims of endstage renal disease (ESRD) have received treatment under a unique Medicare entitlement. This book presents a comprehensive analysis of the federal ESRD program: who uses it, how well it functions, and what improvements are needed.

The book includes recommendations on patient eligibility, reimbursement, quality assessment, medical ethics, and research needs.

Kidney Failure and the Federal Government offers a wealth of information on these and other topics:

  • The ESRD patient population.
  • Dialysis and transplantation providers.
  • Issues of patient access and availability of treatment.
  • Ethical issues related to treatment initiation and termination.
  • Payment policies and their relationship to quality of care.

This book will have a major impact on the future of the ESRD program and will be of interest to health policymakers, nephrologists and other individual providers, treatment site administrators, and researchers.

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