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Quality Assessment and Assurance
Pages 274-312

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From page 274...
... 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.
From page 275...
... 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.
From page 276...
... 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~.
From page 277...
... 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.
From page 278...
... the technical support of water purification and monitoring, dialysate concentrate handling, reprocessing of dialyzers and blood tubing, infection control, and equipment maintenance; and (4) the vital personal interactions between patients and clinicians.
From page 279...
... 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)
From page 280...
... 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, 19884. 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~.
From page 281...
... 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.
From page 282...
... 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, 19891. Finally, health status assessment has only begun to be used in clinical practice.
From page 283...
... Quality of Life The literature regarding the quality of life of ESRD patients intersects strongly with health status assessment (Evans et al., 1990a; Quevedo, 19911. Evans and his colleagues ~ 1985, 1987, 1989, 1990b)
From page 284...
... In quality assessment, it is used to compare treatment outcomes across institutions, as in the HCFA use of hospital mortality data (Green et al., 19901. 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.
From page 285...
... exercises responsibility for quality assessment and assurance in the ESRD program through both the PHS and HCFA.
From page 286...
... 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
From page 287...
... 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.
From page 288...
... 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)
From page 289...
... 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.
From page 290...
... State Survey Process HCFA contracts with state health departments to survey all Medicarecertified 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.
From page 291...
... 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.
From page 292...
... . The proposed review process requires ESRD networks to use screens5 to review, through the Network Medical Review Boards, a random sample of medical records.
From page 293...
... 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.
From page 294...
... 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.
From page 295...
... 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.
From page 296...
... 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 EndStage Renal Disease Registry, discussed at length in Chapter 13.
From page 297...
... [A more extend summary can be 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.
From page 298...
... The patient is clearly the primary "customer" for health organizations. including ESRD treatment units, although not the only one.
From page 299...
... 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.
From page 300...
... 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.
From page 301...
... 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.
From page 302...
... 1990. Association between recombinant human erythropoietin and quality of life and exercise capacity of patients receiving haemodialysis.
From page 303...
... 1987. The functional status of ESRD patients as measured by the Sickness Impact Profile.
From page 304...
... 1990. Improving Patient Care: A Quality Agenda.
From page 305...
... On June 1, 1989, the Food and Drug Administration licensed recombinant human erythropoietin (rHuEpo) for treatment of anemia associated with chronic renal failure (FDA, 19891.
From page 306...
... 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.
From page 307...
... functional status and red cell mass and (2) improvement in cardiopulmonary function and red cell mass.
From page 308...
... 1989. Clinical efficacy of recombinant human erythropoietin in hemodialysis patients.
From page 309...
... This has facilitated the incorporation into individual patient care of an iterative, day-by-day or month-bymonth, 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.
From page 310...
... 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.
From page 311...
... 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.


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