Since the publication of the Centers for Medicare and Medicaid Services’ (CMS) Clinical Laboratory Improvement Amendments (CLIA) final rules in January 2003, many in the clinical laboratory community have questioned the amount of quality control (QC) needed in labs today. Based on the improved performance of new analytical systems, some laboratorians might be misled into thinking that less QC is required for such devices. However, in order to determine the appropriate amount of QC, the question that needs to be answered is: How does an instrument’s analytical performance relate quantitatively to QC?
The emergence of Six Sigma Quality Management as a laboratory quality management tool provides the framework for addressing the issues surrounding what has become known as equivalent QC (EQC). While much has been written about the complexities of Six Sigma, laboratorians can actually use a simple calculation to determine a sigma metric that characterizes the level of quality required for a test and the precision and accuracy observed for the measurement procedure. This metric can then be related to the rejection characteristics of QC procedures in order to select the appropriate control rules and the number of control measurements for an individual lab test.
This article will both describe the relationship of Six Sigma to QC, as well as provide a practical QC planning tool that will allow laboratorians to apply this approach in their own labs.
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