2. Using Six Sigma method in assessment and comparison analytical process performance of two biochemistry analyzers cobas c702
Main Article Content
Abstract
Six Sigma is an analysis method for quality management that integrates measurement accuracy and precision, error identification, and process improvement. The objective of the study was to evaluate and compare the analytical performance of two automated biochemistry machines using the Six Sigma scale. Internal quality control (IQC) data of routine biochemistry analytes for 3 months in two Cobas C8000 analyzers (Roche) were extracted to determine the mean, standard deviation, CV%, and Bias%. Sigma values were calculated for 18 biochemistry analytes. The results indicated that in both analysers, 2 levels IQC sigma values of GGT is the best, and the levels of iron, total bilirubin, calcium, LDL-cholesterol, total cholesterol, creatinine, glucose, uric acid, aspartate aminotransferase, alanine aminotransferase were determined to be within acceptable range of 3 - 6. The values for direct bilirubin, HDL-cholesterol, triglyceride are very good with sigma values > 6 in only one analyze. Two levels IQC Sigma values of sodium, chloride, urea were < 3, while potassium has sigma level < 3 only at level 2. Six Sigma is a very good method to evaluate the performance of the analytical process in clinical laboratory. By examining the sigma values, the laboratory can design the appropriate internal control program, ensuring the most effective control of the analysis process.
Article Details
Keywords
Six Sigma, quality control, laboratory
References
2. Mao X, Shao J, Zhang B, Wang Y. Evaluating analytical quality in clinical biochemistry laboratory using Six Sigma. Biochem Med (Zagreb). 2018;28(2).
3. Westgard JO, Klee GG. Quality Assurance. In: Fundamentals of Clinical Chemistry. 2nd ed, Burtis K, ed., WB Saunders Company, Philadelphia. 1996.
4. RiliBÄK. Guidelines of the German medical association for the quality assurance of laboratory medical examinations. Available at: http://www.westgard.com/rilibak.htm. Accessed Oct 30, 2017.
5. CLIA proficiency testing criteria. Available at: https://www.westgard.com/2019-clia-requirements.htm. Accessed Aug 03, 2022.
6. Berte LM. Laboratory quality management: A roadmap. ClinLab Med. 2007; 27(4): 771-790.
7. Cano EL, Moguerza JM, Redchuk A. Six Sigma with R: Statistical engineering for process ımprovement. New York, NY: Springer Science + Business Media, 2012.
8. N. T. L. Hoa. 6 Sigma lý thuyết và thực hành. Viện năng suất Việt Nam; 2015.
9. Nanda SK, Ray L. Quantitative application of sigma metrics in medical biochemistry. J Clin Diagn. 2013;7(12):2689-91.
10. Ganji SB, Revupalli S. Evaluation of quality assurance in a new clinical chemistry laboratory by six sigma metrics. J Clin Diagn. 2019; 13(3): BC04-BC07.
11. Medina PA, Matibag J, Datay-Lim SJ, Arcellana-Nuqui E. A pilot study on the evaluation of clinical chemistry laboratory test performance using Six Sigma Metrics. PJP. 2019; 4(2): 31-36.
12. Zhou B, Wu Y, He H, Li C, Tan L, Cao Y. Practical application of Six Sigma management in analytical biochemistry processes in clinical settings. J Clin Lab Anal. 2020; 34(1): e23126.
13. Kumar BV, Mohan T. Sigma metrics as a tool for evaluating the performance of IQC in a clinical chemistry laboratory. J Lab Physicians. 2018; 36(4): 301-8.
14. Maksane SN, Parikh R, Vaswani L. Quantitative assessment of analytical phase quality of clinical biochemistry parameters using Sigma Metrics. IJML. 2017; 4(2): 81-90.