SIGMA METRICS ASSESSMENT AS QUALITY IMPROVEMENT METHODOLOGY IN A CLINICAL CHEMISTRY LABORATORY

Background:The concept of sigma metrics & lean six sigma is well known in the field of healthcare. However not many labs utilize the six sigma metrics for maintenance of high quality laboratory performance. A minimum value of 3 σ is desired in any clinical laboratory & values of σ≥6 are regarded as gold standard for obtaining high quality lab reports. Aims &Objectives: To calculate bias, cv & sigma metrics from the IQC & EQC data in order to ascertain extent of quality management in our lab. Materials M PGIMER D from Feb 2020 to July 2020. The IQC used(both level I & level II) were from Biorad Laboratories India (lyphochek assayed chemistry control) & the EQC used was from Randox Laboratories, UK. All the controls were run on Beckman Coulter clinical chemistry analyser AU 680. Total 14 clinical parameters were analysed & subsequently; Mean, S.D., CV, bias & σ were calculated through their respective formulas. Results:Sigma level was more than 6 for both levels of IQC was observed for Amylase. It indicates world class performance. Total bilirubin, AST, Triglyceride & HDL depicted σ values between 3.1 to 6 for both L1 & L2. Iron showed σ value of 5.5 in L1 whereas it was 3.78 in L2. Conclusion:-:- Sigma metrics in clinical laboratory is an essential technique to ascertain poor assay performance, along with assessment of the efficiency of existing laboratory process.