The use of six sigma methodology to evaluate the analytical performances of clinical chemistry analyzers

Abstract

Introduction: In our study, we aimed to evaluate the analytical process performances of the biochemistry tests in the analysis systems that were widely used in the clinical laboratories by using the six-sigma methodology. Methods: The analytical performances of four different analytical platforms (Beckman Coulter-Olympus AU2700, Abbott-Architect C8000, Roche-Cobas 8000, and Siemens-ADVIA 2400) running 18 biochemical tests (urea, creatinine, uric acid, total bilirubin, AST, ALT, ALP, LDH, HDL-C, Ca2 +, cholesterol, TG, glucose, total protein, albumin, Na+, K+, and Cl-) were evaluated. Biases and CV were obtained from internal quality control programs. The performance of each instrument was assessed using the σ scale; the benchmark performance was < 3 σ (improvement needed); "world-class" quality was six sigma. Results: The parameters that have σ ≥ 6 which means in world class are HDL-C and ALP in all four systems, while only Na + has σ < 3 which point out the need to develop. Similarities and differences were found between systems for analytical process sigma values of all tests except these. Discussion and conclusion: To improvement and monitoring of the analytical process performance as a part of total quality of a clinical laboratory to provide continuous improving, sigma levels can be used as it is a reliable method.