SIX SIGMA FOR EVALUATION OF QUALITY CONTROL IN CLINICAL LABORATORY

Abstract

ABSTRACT

Background: Quality control in the haematology laboratory is intented to ensure reliable test results with the necessary degree of precission and accuracy. The purpose of the quality control system is to monitor analytic processes, detect analytic error during analysis, and prevent the reporting of incorrect patient value. Six Sigma is a widely-accepted quality management system with statistical methode to find and eliminate defects and variation. The purpose of this research was to evaluate the analytical performance of our hematology parameters using sigma metric.

Materials and Methods: The study was conducted in Clinical Pathology Laboratory Airlangga Hospital. Internal quality control (IQC) data of 5 analytes were analyzed retrospectively over a period 2 month from December 2017 to January 2018 using Sysmex XT-1800i. The analytics assessed were red blood cell (RBC), haemoglobin (HGB), hematocrit (HCT), platelet (PLT) and white blood cell (WBC).

Result: The highest CV (%) value is 3.88 for PLT and the lowest value is 0.68 for HGB. The highest Bias % value is 2.67 for PLT and the lowest value is 0.70 for HGB and WBC. The higest sigma value is 9.30 for HGB, and  the lowest sigma value is 5.52 for RBC. The criteria sigma value for haematology test is good to exellent to world class performance

Conclusion: Sysmex XT 1800i assay for haematology is exellent raging from 5 to > 6 sigma. Good sigma value, acceptable imprecison, the accuracy performance are suitable for routine examination.

Keywords: Six Sigma, imprecision, laboratory, quality control, hematology