Quality Management for the Laboratory

Abstract

This is the first article in a four-part bimonthly series on laboratory quality systems. Upcoming articles will address the following topics: the documentation pyramid, writing standard operating procedures, and the assessment and improvement of laboratory operations.-EDS A quality revolution has, by necessity, taken hold in this country's manufacturing, business, and service sectors. The health care industry is no exception. The quality of laboratory information has improved steadily because the industry has used quality control (QC) procedures for test methods, first implemented decades ago. Today, hospital administrators, physicians, payers, and patients expect more for their health care dollars. When you combine this expectation with the reality of dwindling resources, down-sizing, and relaxed testing personnel standards, you have to ask: "Is quality suffering?" If we were to apply a manufacturing analogy to the laboratory, the laboratory's product would be information: a surgical pathology report, a compatibility tag for a blood component, or a value for an analyte. Quality control procedures within the organization help ensure the validity of that information. But QC alone does not address the efficiency and effectiveness of laboratory processes-two attributes of quality that have become more important in today's lean times. During the past decade, laboratories have monitored quality by looking only at isolated, randomly chosen aspects of the laboratory's structure, processes, or outcomes. The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) has urged facilities to select high-volume, high-risk, problematic procedures and processes against which to measure performance, find weaknesses, and implement improvements. While this approach broadened the laboratory's activities from monitoring test method and equipment QC to a more interdisci-plinary view, it is selective and incomplete. Quality in laboratory practice must be viewed with the same "systems thinking" that is used in business. We need a system for monitoring quality in laboratory medicine that ensures accuracy, efficiency, and effectiveness of services for customers.