Effectiveness of six sigma score analysis of clinical biochemistry parameters in a newly installed automated analyser– Retrospective analysis in a tertiary cancer care centre

Abstract

Quality assurance is need of the hour in a laboratory. Clinician’s decision regarding treatment modality is based on the laboratory results on most occasions. So to ensure accuracy of results reported periodic evaluation as per standard criteria and audit is necessary. Six sigma is one such tool to apply in day to day practice for monitoring and enhancing performance of a laboratory. A new machine is a new challenge for a laboratory from validation to reporting of quality result with assurance for which six sigma is invariably a necessary method. So this study was taken up to check for month wise status of six sigma and performance of clinical chemistry analyser for 20 different analytes.: It was a retrospective study and data required for the study were collected from March 2020 to November 2020 in clinical biochemistry laboratory of Tata Medical Centre Kolkata, West Bengal. Test parameters were analysed on Vitros 7600 automated analyser. Data collected were IQC-coefficient of variation percent (CV %) and proficiency test -Bias%. Six sigma score were analysed monthly using standard formula applicable. We obtained an excellent performance (> 6 sigma) for test parameters CK, Urea, Creatinine, Uric acid, albumin, Calcium, Phosphorus, Magnesium, AST, ALTV, ALKP, GGT, Lipase, LDH in both level of IQC and for sodium and amylase in level 2 IQC. However we noticed poor performance (<3 sigma) for test parameters Glucose, potassium, chloride, TP in both level IQC and for sodium and amylase in level 2 IQC.QGI score analysed to find out root cause and corrective action. Monitoring IQC and EQAS with six sigma method helps evaluation and improvement of performance of a laboratory even with a new machine. It supports root cause analysis and necessary corrective and preventive action.