Continuous Quality Improvement in the Cardiac Catheterization Laboratory: Are the Benefits Worth the Cost and Effort?
C ontinuous 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,
... 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 have improved processes that have a strong link with out-comes? That will be a very important question in the future as there is a greater emphasis on improving the quality of medical care. The core of most CQI programs includes the following: (1) the collection of data containing clinically relevant patient variables that allow assessment of clinical processes, performance, and outcomes; (2) feedback of this performance and outcomes data to the clinicians, ideally with risk adjustment and benchmarking of the data; and (3) implementation of appropriate interventions to promote reduction in wasteful and inefficient variation in care while simultaneously improving performance. These interventions might include the development of evidenced-based clinical guidelines and then dissemination of this information through grand rounds, "pocket guides" of critical pathways, and other reminder tools such as preprinted order sheets. The actual "key ingredients" from the smorgasbord of potential tools to best ensure successful CQI programs are still not fully understood. We also have much to learn regarding the context of how these "key ingredients" are applied. We do know that there are several known predictors of success for CQI programs, invariably focusing on the presence or absence of local physician champions in conjunction with an administrative and financial commitment from the parent organization. 8, 9 In this issue, Moscucci and colleagues 10 describe a substantial effort to implement a statewide CQI initiative in Michigan, specifically devised for the cardiac catheterization laboratory. Their program, designed to examine and reduce outcome variation in the performance of percutaneous coronary intervention (PCI), documents the positive effects of a CQI program. This topic is both relevant and important as Ϸ1 million PCI procedures are now performed annually in the United States. The potential for improvements in PCI outcomes attained through a CQI program could have a major impact, as measured by lives saved and a decrease in hospital costs through a reduction in prolonged hospitalizations that are associated with procedural complications, such as contrast nephropathy, vascular injury, bleeding, stroke, and myocardial infarction. The authors, recognized leaders in the cardiovascular outcomes and quality community, are to be congratulated for their vision and effort in developing this program and, more importantly, in evaluating the impact of this CQI program. Through this documentation, the quality and outcomes community can better understand the importance of CQI implementation in the cardiac catheterization laboratory and its potential for improving care. The Michigan PCI CQI program used a wide range of concurrent and reinforcing strategies directed throughout the