EVALUATION OF ANALYTICAL PERFORMANCE OF BIOCHEMICAL TESTS BY USING SIX-SIGMA METHODOLOGY AT HANOI HEART HOSPITAL IN 2022

Thị Nga Đặng1,, Thị Ngọc Hà Bùi1, Thị Thu Hà Nguyễn1, Huy Đông Nguyễn1, Tài Thời Nguyễn2, Thị Yến Hoàng2
1 HUPH
2 Hanoi Heart Hospital

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Abstract

Objective: To evaluate the biochemical methods performance by using Six Sigma methodology. Subjects and methods: A cross-sectional study was conducted by using Roche Cobas C501 and C702 analysers for 20 routine biochemistry parameters between February and July 2022 at the Department of Laboratory, Hanoi Heart Hospital. Results: 14 of 21 parameters studied had sigma values showed acceptable performance above > 3σ for both normal and pathological levels of IQC. Conclusion: Six Sigma methodology can be used to monitor and evaluate the biochemical methods performance, to compare the analytical performance between analyzers, which is fundamental for assurance and quality improvement.

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References

1. Llopis M.A., Trujillo G., Llovet M.I., et al. (2011). Quality indicators and specifications for key analytical-extranalytical processes in the clinical laboratory. Five years’ experience using the Six Sigma concept. Clin Chem Lab Med, 49(3), 463–470.
2. Dung H.T.P., Lộc L.H., and Việt N.Í. (2022). Áp dụng Six Sigma trong đánh giá và so sánh hiệu năng phân tích của hai máy hóa sinh cobas c702. Tạp Chí Nghiên Cứu Học, 159(11), 10–19.
3. Westgard S., Bayat H., and Westgard J.O. (2018). Analytical Sigma metrics: A review of Six Sigma implementation tools for medical laboratories. Biochem Medica, 28(2), 020502.
4. Desirable Biological Variation Database specifications - Westgard. , accessed: 06/17/2023.
5. Keleş M. (2022). Evaluation of the clinical chemistry tests analytical performance with Sigma Metric by using different quality specifications - Comparison of analyser actual performance with manufacturer data. Biochem Medica, 32(1), 010703.
6. CLIA Requirements for Analytical Quality - Westgard. , accessed: 06/17/2023.
7. Mao X., Shao J., Zhang B., et al. (2018). Evaluating analytical quality in clinical biochemistry laboratory using Six Sigma. Biochem Medica, 28(2), 020904.
8. Hens K., Berth M., Armbruster D., et al. (2014). Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target. Clin Chem Lab Med CCLM, 52(7), 973–980.