Application of a six sigma model to evaluate the analytical performance of urinary biochemical analytes and design a risk-based statistical quality control strategy for these assays: A multicenter study.

ABSTRACT

BACKGROUND: The six sigma model has been widely used in clinical laboratory quality management. In this study, we first applied the six sigma model to (a) evaluate the analytical performance of urinary biochemical analytes across five laboratories, (b) design risk-based statistical quality control (SQC) strategies, and (c) formulate improvement measures for each of the analytes when needed. METHODS: Internal quality control (IQC) and external quality assessment (EQA) data for urinary biochemical analytes were collected from five laboratories, and the sigma value of each analyte was calculated based on coefficients of variation, bias, and total allowable error (TEa). Normalized sigma method decision charts for these urinary biochemical analytes were then generated. Risk-based SQC strategies and improvement measures were formulated for each laboratory according to the flowchart of Westgard sigma rules, including run sizes and the quality goal index (QGI). RESULTS: Sigma values of urinary biochemical analytes were significantly different at different quality control levels. Although identical detection platforms with matching reagents were used, differences in these analytes were also observed between laboratories. Risk-based SQC strategies for urinary biochemical analytes were formulated based on the flowchart of Westgard sigma rules, including run size and analytical performance. Appropriate improvement measures were implemented for urinary biochemical analytes with analytical performance lower than six sigma according to the QGI calculation. CONCLUSIONS: In multilocation laboratory systems, a six sigma model is an excellent quality management tool and can quantitatively evaluate analytical performance and guide risk-based SQC strategy development and improvement measure implementation.