Application of Six Sigma tool as Quality Indicator for evaluation of analytical phase of sample processing

Abstract

Introduction:In a Clinical Biochemistry Laboratory (CBL), the measures used to assess the QC are Internal QC (IQC) and EQAS. For Quality assessment in an objective and quantitative manner, sigma metrics have been used. Higher Sigma metric values represents few analytical; i.e. 3.4 defects per million opportunities. Based on the sigma metrics, appropriate QC rules are applied. The present study intends to evaluate the performance of Analytic phase of testing at Laboratory Services, GMERS Medical College & General Hospital Vadnagar in terms of Sigma metrics, and Quality Goal index for routine biochemical parameters.Material Method:We calculated (A) Sigma (σ) value and (B) Quality goal Index of 14 parameter. Sigma metrics were calculated using Total allowable goals as per i) Clinical Laboratory Improvement Amendments (CLIA) guidelines from US(2019) and ii) the biological variation database specifications. Microsoft Excel spreadsheet version 2016 was used for statistical analysis. Bias, CV, QGI and sigma metrics were calculated using the above formulae. Bias and CV were presented as percentages.Result:For 2 parameters; Urea and ALT sigma metrics was more than 6, which is a marker of world class quality. The lower performance of Total Bilirubin, Creatine, Cholesterol, HDL, Uric acid, Total Protein, Albumin in was however attributable to both lack of accuracy while for IQC norm and path.Conclusion:Sigma metrics is an excellent self-assessment tool for performance analysis of various test parameters in the laboratory. On applying the same to our routine biochemistry laboratory at Laboratory Services.