Introduction to quality improvement

QUALITY IMPROVEMENT

Introduction to Quality Improvement Jay B. Wish, MD Chairman

‘‘I

T IS TIME to establish an advisory group of nephrology professionals and experts in quality assessment and design to develop ESRD-specific quality-assessment and qualityassurance systems.’’1 ‘‘The Federal government needs to develop a far more comprehensive and coordinated strategy for quality improvement in the ESRD program than it has to date.’’2 ‘‘Experts agree that changes in the American system of dialysis are essential. After almost a quarter century of government influence over treatment, the mortality rates and poor health of patients demonstrate a need for an overhaul that will allow the lifesaving treatment to meet its promise.’’3 ‘‘In consultation with representatives of providers of services and renal dialysis facilities, patients of such providers and facilities, and quality improvement experts, the Secretary, with the assistance of the Network administrative organizations, shall establish and operate a quality improvement program for providers of services and renal dialysis facilities. . . .’’4 WHAT IS ALL THE FUSS ABOUT?

● The mortality of end-stage renal disease (ESRD) patients in the United States is greater than that in Europe, Japan, and Australia, but comorbidity among patients with ESRD in the United States is higher, mortality rates among patients with ESRD in the United States are decreasing, and data from other parts of the world may be flawed or otherwise noncomparable.5 ● There are significant regional variations in process and outcome for patients with ESRD in the United States, as shown by the Health Care Financing Administration’s (HCFA’s) ESRD Core Indicators Project, suggesting significant opportunities for improvement, but such variation is decreasing among the ESRD Networks, and national outcomes, particularly with regard to the treatment of anemia and adequacy of dialysis, are progressively improving.6

● For-profit dialysis chains, alleged to be concerned only with growth and stock performance, are accused of sacrificing quality of care and are said to need more regulation, but only patients who don’t die or become hospitalized provide an income stream to the proprietary dialysis facilities. DRIVING FORCES FOR INCREASED ACCOUNTABILITY IN THE ESRD PROGRAM

In the early 1990s, HCFA shifted its focus from individual medical case review of performance outliers (quality assurance) to a continuous quality improvement (CQI) philosophy embodied in its health care quality improvement program (HCQIP).7 Two national projects directed at the ESRD program were developed as part of the HCQIP: The National Anemia Cooperative Project and The ESRD Core Indicators Project. The National Anemia Cooperative Project focused on the treatment of anemia in patients with ESRD, using anemia as a model for the development of CQI activities that could address any process or outcome at the facility level. The National Anemia Cooperative Project provided every dialysis facility in the United States with an algorithm for the evaluation and treatment of the anemic patient with ESRD; a quality improvement manual that presented in detail the strategies for the implementation of a CQI program at the facility level; and facility-specific profiles, including mean hematocrit, percentage of patients with hematocrit less than 30%, and mean erythropoietin dosages based on HCFA billing data, with regional and national comparatives. As part of the National Anemia Cooperative Project, each ESRD Network conducted intervenFrom the Department of Medicine, Case Western Reserve University, Cleveland, OH. Address reprint requests to Jay B. Wish, MD, Division of Nephrology, University Hospitals of Cleveland, 11100 Euclid Ave, Cleveland, OH 44106. E-mail: jaywish @earthlink.net

娀 1998 by the National Kidney Foundation, Inc. 0272-6386/98/3206-0430$3.00/0

American Journal of Kidney Diseases, Vol 32, No 6, Suppl 4 (December), 1998: pp S161-S164

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tion activities, including facility-site visits, regional workshops, and the development of enduring materials to promote the application of CQI tools to the treatment of anemia at the facility level. The ESRD Core Indicators Project was developed as part of the HCQIP to examine regional and national trends for certain quality-of-care indicators in the ESRD program. These indicators were chosen based on a consensus of the renal community and do not constitute scientifically validated clinical performance measures derived from evidence-based practice guidelines. Rather, the choice of these core indicators, which address anemia, adequacy of dialysis, blood pressure, and nutritional status, was based on the recognition that these are important intermediate outcome parameters and the provision of national and regional performance data for these parameters could show opportunities for improvement in the processes of care related to these outcomes. The ESRD Core Indicators Project has fulfilled its promise of providing a snapshot of national and regional performance for anemia treatment, adequacy of dialysis, nutritional status, and blood pressure control, and the four iterations of the ESRD Core Indicators Project Annual Report (1994, 1995, 1996, 1997) published to date have shown consistent improvement with regard to outcomes for anemia management and adequacy of dialysis. Not surprisingly, nutrition and blood pressure outcome parameters have not shown the same improvement, most likely because there is no consensus regarding the appropriate intervention activities for these clinical parameters. By providing Network-specific profiles for the core indicators, the ESRD Core Indicators Project can allow Networks to focus their intervention activities where the greatest opportunities for improvement exist. However, the ESRD Core Indicators Project does not provide for accountability at the facility level, and this has led to the development of a number of legislative and regulatory initiatives to increase accountability at the provider level in an effort to improve clinical outcomes. These include the following: ● The 1997 Balanced Budget Act (BBA) enacted by Congress includes a provision requiring the Secretary of Health and Human Services to

JAY B. WISH

develop and implement a method to measure and report on the quality of dialysis services provided under Medicare. Although Medicare could have responded to this mandate with the ESRD Core Indicators Project alone, it has chosen to contract for the development of scientifically validated clinical performance measures, derived from the National Kidney Foundation Dialysis Outcomes Quality Initiative Clinical Practice Guidelines, that will ultimately be integrated into the ESRD Core Indicators Project, expanded to include facility-specific data collection and facility-specific profiling. Although the major purpose of this clinical performance measures initiative will be to drive CQI activities at the facility level, it is anticipated that there will be a subset of clinical performance measures that will be used to increase provider accountability and perhaps be linked to reimbursement, and a further subset of performance measures that may enter the public domain to assist in consumer choice. The BBA requires that the first phase of clinical performance measure development be completed by the end of 1998, and that the pilot testing and validation phase of the clinical performance measures be completed by the end of 1999. ● In response to the President’s Reinventing Government initiative, HCFA published a notice of their Initiative Involving Facilities that Furnish Hemodialysis Treatments in the Federal Register, April 29, 1997 (volume 62, no. 82). This HCFA initiative was to show the feasibility of collecting, collating, analyzing, and distributing facility-specific data for the treatment of hemodialysis patients to drive CQI. This initiative has evolved into the Vital Information System to Improve Outcomes in Nephrology (VISION) Project, which will eventually electronically link every dialysis facility in the United States with a data collection, validation, and analysis infrastructure, maintained through each facility’s respective ESRD Network, that will provide facility-specific reports to drive CQI activities, as well as replacing the current required paper forms and reports that each facility must submit to HCFA as part of its conditions of coverage. ● The final report of the Advisory Commission on Consumer Protection and Quality in the Health Care Industry (commissioned by Presi-

QUALITY IMPROVEMENT INTRODUCTION

dent Clinton and published in March 1998) states that a ‘‘key element of improving health care quality is the nation’s ability to measure quality of care and provide easily understood, comparable information on the performance of the industry.’’ This report outlines a number of key implementation strategies that are being adopted by HCFA and the ESRD Networks to improve quality of care, accountability, and outcomes in the ESRD program. A key component of this initiative with regard to ESRD will be the development of the data management infrastructure that will allow for the generation of facilityspecific outcome profiles to drive CQI and the improved ability of the ESRD Networks to identify opportunities for improvement to better focus their intervention activites. ● HR 2972, the ESRD Quality Improvement Act of 1998, was introduced into the congressional record by Representative Pete Stark4 and proposes to establish a facility-based information system to transfer process and outcome data to the Networks, which will produce comparative profiles, and also to increase physician accountability by linking patients to Universal Physician Identification Numbers (UPIN). This draft bill has not received the unanimous support of the key stakeholders in the renal community, who would prefer to pursue the national ESRD quality agenda through a nonlegislative mechanism that promotes accountability while allowing for evolution as systems change. As a result, it is unlikely that this draft legislation will be introduced during the current legislative session. However, should current and anticipated nonlegislative vehicles to promote quality improvement and accountability fail, this draft legislation may be introduced in the future. ● The 1997-2000 ESRD Networks Scope of Work developed by HCFA requires the Networks to collect core indicators of care from facilities and to conduct pattern analysis to identify indicators or care processes that should be monitored for opportunities to improve. Such activities may include the implementation of quality improvement projects at the Network level to foster improvement in specific processes of care, the generation of provider (facility or physician)specific profiles with regional and national comparatives to foster accountability and drive CQI, and the use of benchmarking whereby facilities

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achieving more desirable outcomes are encouraged to share their processes of care with other facilities, so that the variability in processes is decreased and the aggregate outcomes for all facilities are improved. ● The conditions of coverage, which specify how a dialysis facility must operate to be approved for Medicare reimbursement and provide a template for state surveyor activities, have not been revised in more than a decade. Substantial revisions in these conditions of coverage have been proposed by Medicare and await legislative approval. These revisions include, for the first time, outcome measures by which facilities will be evaluated, as well as data collection and submission specifications that will increase the ability for Networks to generate facility-specific outcome profiles to drive quality improvement activities and increase accountability. The 1997 Annual Report of the ESRD Core Indicators Project6 reports an increase in the percentage of adult incenter hemodialysis patients with a mean urea reduction ratio (URR) of 65% or greater: 43% in the fourth quarter of 1993, 49% in the fourth quarter of 1994, 59% in the fourth quarter of 1995, and 68% in the fourth quarter of 1996. Furthermore, the percentage of adult incenter hemodialysis patients receiving hemodialysis with a mean URR of 65% or greater continues to vary significantly among the 18 ESRD Networks from a low of 56% to a high of 80%. One of the fundamental principles of CQI is that variations in outcomes, as shown among the 18 ESRD Networks for URR, represent variations in process, and there exist opportunities for improvement in process whenever such outcome variability exists. The progressive improvement in the national sample achieving URRs of 65% or greater suggests that opportunities for improvement continue to exist even among the better performing levels of analysis, be they Networks or individual facilities. What are our nephrologist counterparts in Europe, Japan, and Australia doing to achieve lower mortality rates among their ESRD patients than we achieve in the United States? Although differences in case mix and comorbidity probably exist, the variability in intermediate outcomes and, by implication, process within the United States, show that opportunities exist for patients with ESRD in the United States to achieve case-adjusted mortality rates

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similar to those in other parts of the world. How we best develop the information management infrastructure and quality oversight activities to identify those opportunities for improvement and promote accountability is the subject of the four articles that follow. Inevitably, however, only the buyin and implementation of these initiatives by all stakeholders in the ESRD community will result in the outcomes improvement that our patients deserve. REFERENCES 1. Levinsky NG, Rettig RA: The Medicare end-stage renal disease program. A report from the Institute of Medicare. N Engl J Med 234:1143-1148, 1991 2. Schrier RW, Burrows-Hudson S, Diamond L, Lundin AP, Michael M, Patrick DL, Peters TG, Powe NR, Roberts

JS, Sadler JH, et al: Measuring, managing and improving quality in the end-stage renal disease setting: Committee statement. Am J Kidney Dis 24:383-388, 1994 3. Eichenwald K: Mismanaged care: The perils of dialysis. New York Times, Dec 4-6, 1995 A1 4. Stark P: Draft legislature HR 2972, 1998 5. United States Renal Data System: USRDS 1997 Annual Data Report. Bethesda, MD, National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases, April 1997 6. Health Care Financing Administration. 1997 Annual Report, End Stage Renal Disease Core Indicators Project. Department of Health and Human Services, Health Care Financing Administration, Office of Clinical Standards and Quality, Baltimore, MD, December, 1997 7. McClellan WM, Helgerson SD, Frederick PR, Wish JB, McMullan M: Implementing the health care quality improvement program in the Medicare ESRD program: A new era of quality improvement in ESRD. Adv Ren Replace Ther 2:89-94, 1995