Abstract

The focus of the Six Sigma quality management methodology is on finding and eliminating errors to raise operational quality. The use of Six Sigma in laboratory procedures makes it possible to identify errors and use cutting-edge ways to save costs without compromising quality. In order to analyse the study biochemical laboratory’s performance and to design and choose the best strategy for enhancing the performance of problematic analytes, the laboratory set out to assess the process performance of commonly examined parameters on a sigma scale. Methods: Retrospective data collection for quality control was conducted between June and September 2022. Sigma metrics were derived using “Total Allowable Error (TEa),” “Coefficient of Variation (CV),” and “Average Bias” for six biochemical parameters measured on the Analyser following the Clinical Laboratories Improvement Act (CLIA). To determine the root of the fault, the Quality Goal Index(QGI) of the problematic analytes were generated. Results: The first three of the following parameters—cholesterol, amylase, HDL, triglycerides, SGOT, and SGPT—produced good sigma values, while triglycerides, SGOT, and SGPT fared badly. Finally, the Quality Goal index was determined for the parameters if the issue is brought on by imprecision, inaccuracy, or both. Conclusion: The study’s conclusions indicate that sigma metrics is a useful tool for assessing the analytical performance of a clinical biochemistry laboratory and that strong internal Quality Control (IQC) requirements are not required for parameters with Sigma between 3-6. However, prior to routine usage, root cause investigation and technique performance improvement should be carried out for a problem analyte with a sigma metric below 3.

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