As the federal end-stage renal disease (ESRD) program enters its third decade, it continues to grow both in terms of patient enrollment and cost. High visibility as well as patient, physician, and societal concerns regarding ESRD treatment outcomes and expenditures make the development of improved and expanded quality assurance and improvement (QA/QI) mechanisms for the ESRD program vital. The purpose of a QA/QI program is to identify and apply techniques for assessing and improving ESRD care quality to achieve the best possible outcome for all patients who can benefit medically, within the expenditure constraints set by society. Current QA knowledge and methods are reviewed in this article and are judged to be useful but of limited value. Limitations of current quality assessment tools, provider resistance, and inadequate governmental support are substantial barriers to implementation of a QA program. An ESRD QA/QI program should develop improved QA tools at the same time that available tools are cautiously put to work. Such a program would be based in individual treatment units, using existing network and US Renal Data System structures and a new national ESRD QA committee for support and oversight. As additional ESRD QA data become available, providers would incorporate the new information into decision making at all levels to enhance patient outcome. Substantial financial support from the government will be needed to implement such a quality program. A comprehensive ESRD QA program could serve as a model for QA for the national health care system. © 1994, National Kidney Foundation. All rights reserved. All rights reserved.