BACKGROUND: The Six Sigma approach is a new technique to manage process quality performance in clinical laboratory, aligning quality and cost reduction targets. OBJECTIVES: The aim of this study was to evaluate the viability and the impact of the Six Sigma concepts in the clinical laboratory technical processes management. METHODS: It was made a study to compare 14 serum anilities in two automated chemistry systems, Bayer ADVIA 1650 and Ortho-Clinical Diagnostics VITROS 950, using sigma-metrics. Sigma-metrics was calculated using different performance specifications. Results: The highest metrics were found in uric acid and triglycerides assays in both analyzers using Clinical Laboratory Improvement Amendments (CLIA) and biological variation based specifications. The lowest metrics were found in AST and ALT assays on ADVIA 1650 analyzer and chloride on VITROS 950 analyzer. DISCUSSION: The results showed a tendency to higher sigma-metrics in anilities processed on VITROS 950 than ADVIA 1650. The specification limits definition showed to be an important step to a reliable performance evaluation using sigma-metrics. CONCLUSIONS: The use of sigma-metrics as an index of technical process quality performance allow the laboratory to design a cost-effective quality control system, aligning quality and cost goals, keeping the custumer satisfaction in a high level and the focus on financial condition of the organization.
Six sigma; Sigma metrics; BIAS; Accuracy; Precision; Quality; Process control; Costs management
