The Analytical Performance Evaluation of Routine Clinical Chemistry Parameters by Six Sigma Approach: An Effective Tool for Laboratory Quality Management

Background: Clinical laboratories errors can impose serious adverse effects on patient management. Clinical laboratories can evaluate their analytical performance by effective quality management tool i.e. Six Sigma metrics.Objectives: To evaluate the analytical performance of routine chemistry parameters by Six Sigma approach.Methods: Cross sectional study carried out from July 2022 till February 2024 in the Chemical Pathology section of University of Lahore Diagnostic Lab and Research Center, Lahore. Analytical performance of nineteen routine chemistry parameters were evaluated by using the external and internal quality control material. Only those parameters were selected who enrolled in External Quality Assurance Scheme. Inclusion criteria for IQC following West gard rule +/- 2 SD while for EQAS results follow +/- 2 Z score. Sample size for 19 parameters analyzed in EQAS from July 2022 till December 2023 was 342. 2700 IQC samples were analyzed from August 2023 till February 2024. All control values were entered in Microsoft Excel 2013 and calculated manually by conventional equations.Results: Most of our laboratory parameters showed satisfactory analytical performance in between 3-6 when evaluated by six sigma metrics.Conclusion: Control frequency for parameters showed score > 6 can be reduce for saving laboratory resources whereas parameters with sigma score around 3 needs more vigilant monitoring. Health care and laboratory outcome need high quality results to improve patient health. Six sigma tool allows laboratory to identify the right method, right rule, run controls at right frequency to enable the right patient outcome.