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KMID : 1100820210110010011
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Laboratory Medicine Online
2021 Volume.11 No. 1 p.11 ~ p.16
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Evaluating the Performance of an Automated Chemistry Analyzer Using Sigma Metrics
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Kim Sang-Wook
Cho Yun-Jung
Yun Seung-Gyu
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Abstract
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Background: Quality control (QC) is important for producing reliable test results in the clinical laboratory. Sigma metrics is used to evaluate the performance of laboratory instruments. It calculates the sigma value and determines the number of quality control material and strategy for the internal QC of the laboratory according to the sigma value.
Methods: This study was conducted in the clinical laboratory of Korea University Anam Hospital for 6 months. We evaluated internal quality control data of 37 analytes on the automated chemistry analyzer. By Sigma metrics, we calculated the sigma value by (TEa-bias%)/coefficient of variance.
Results: The analytes that exceeded the 6 sigma value were haptoglobin, ALP, AST High level, ALT, amylase, direct & total bilirubin, CK, Fe, Mg High level, GGT, lipase, LD, HDL-cholesterol High level, protein High level, triglyceride, TIBC High level, ferritin High level, and uric acid. IgA, RF High level, protein Low level, and TIBC Low level showed 5?6 Sigma values. RF Low level, AST Low level, creatinine, Cl, K, Na, Mg Low level, glucose, HDL-cholesterol Low level, and ferritin Low level showed 3?5 sigma values. Sigma values below 3 at both Low and High level QC materials were Ca, LDL-cholesterol, total cholesterol, BUN, and total CO2.
Conclusions: In clinical laboratories, sigma metrics should be used as a basis for adopting different Westgard rules for each test and for efficient quality control operations. Also, in the case of analytes with sigma values below 3, improvement in the overall test process is needed.
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KEYWORD
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Sigma metrics, Westgard rule, Bias, Quality control
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