Continuous quality improvement (CQI) has been described as a methodology to continually improve the processes associated with providing a product or service to meet or exceed customer expectations.1 In reality, the CQI process is a collection of techniques borrowed from the fields of systems theory, statistics, engineering, psychology, and others and is based on the work of pioneers in industrial management such as Deming and Juran.2 As a management philosophy, CQI is an organized, scientific process for evaluating, planning, improving, and controlling quality. Simply stated, the goal of CQI is to reduce variation and improve overall performance. Positive experiences in other industries lead to the application of CQI methods in healthcare in the hope that reduced variation and better performance would improve patient outcomes and result in cost savings. This is fundamentally different than the earlier quality assurance (QA) process used in healthcare, which was geared to identify and eliminate “low-end performers or outliers,” leaving only the acceptable performers. The CQI approach in healthcare has been promoted by individuals such as Donabedian,3 Berwick et al,4 and Jencks and Wilensky.5 It builds on traditional QA methods to develop programs that will reduce variation and improve overall performance. Article p 814 CQI efforts in cardiovascular care have shown benefits such as attaining a high level of adherence to evidence-based performance and process measures in the management of acute coronary syndromes. More importantly, CQI, through an improvement in patient care processes, has an association with better clinical outcomes with emerging data demonstrating decreased mortality.6,7 However, large confirmatory randomized clinical trials are still lacking. An important question is whether large-scale randomized trials are really necessary in this circumstance. Is it necessary to have direct evidence that you have saved lives, or is it enough to show that you …