Evaluation of The Total Quality Performance of Our Clinical Laboratory With Six-Sigma Method

Abstract

Aim: In order to evaluate the performance of the clinical laboratories, a quality measurement method, The Six-Sigma Methodology, is used. We aimed to evaluate the analytical performance of our clinical laboratory by using the internal and external quality control data of 28 analytes, and by calculating their process sigma values. Methods: Sigma values of 28 analytes of our laboratory were determined from coefficient of variation (CV %) and bias for 3 subsequent months from December 2018 to January 2019. If the sigma values are gt;6, between 3 and 6, and lt;3, they are classified as »world-class«, »good« or »un-acceptable«, respectively. Results: 6 (21%) analytes; T Protein, Creatinin, Ca, Na, Cl, HbA1c; provided lt;3 sigma value, 1 (04%) analyte; lipase; provided between 3-6 value and 11 (39%) analytes; amylase, GGT, ALT, LDH, CRP, Lactate, BUN, Direct Bil., T Bil., CK and CK-MB; provided gt; 6 sigma value for both IQC1 and IQC2 levels for three consecutive months, respectively. Conclusions: In terms of Six-Sigma Metrics; our results were generally found as world-class or good. An appropriate quality control scheduling should be carried out for each test by using Six-Sigma Methodology in all clinical chemistry laboratories.

Keywords

• internal quality control
• external quality control
• six sigma
• variation coefficient
• standard deviation
• bias