Evaluation of the Analytical Performance of Biochemistry Assays in a Private Hospital Laboratory in the United Arab Emirates Using Sigma Metrics

Six Sigma metrics are quality evaluation tools that are continuously being applied in many different industries globally. These metrics can be utilized by the clinical laboratory to improve the internal quality control (IQC) protocols, address poor analyte performance and evaluate the efficiency of the current laboratory processes. The study aimed to assess the analytical performance of biochemistry assays in a private clinical laboratory. IQC data of 16 analytes were collected from January 2022 to August 2022 from a biochemistry laboratory in a private hospital. Sigma values were calculated using total allowable error (TEa), Bias% and the coefficient of variation (CV%) in the formula (TEa-Bias%)/CV%). The quality goal index (QGI) was calculated, and the sources of errors were identified. Out of the 16 analytes, 31.25% and 56.25% of the analytes from IQC level 1 and level 2, respectively, showed world-class performance (Sigma value ≥6). Analytes from IQC level 1 (62.50%) and level 2 (31.25%) showed acceptable performance (Sigma value <6–≥3). Analytes from IQC level 1 (6.25%) and level 2 (12.50%) showed poor performance (Sigma value of <3). Analytes from EQC level 1 (43.75%) and level 2 (62.50%) respectively showed world- class performance. Analytes from EQC level 1 (31.25%) and level 2 (12.50%) showed acceptable performance. Analytes from EQC level 1 (25%) and level 2 (25%) showed poor performance. In conclusion Six Sigma metrics can be used as a laboratory’s self-evaluation tool for analyte performance. Its utilization improves efficiency, cost-effectiveness and ultimately better healthcare quality.