Abstract：Objective Using the Westgard sigma (σ) rule of analytical batch length to set up a reasonable quality control strategy for the indoor quality control of enzymology.Methods Data of Panjin Liaoyou Baoshihua Hospital participating in the national laboratory quality evaluation center in 2020 and data of laboratory indoor quality control were collected as bias and coefficient of variation.The allowed total error provided by the Quality Index of Routine Item Analysis of Clinical Biochemical Tests issued by the National Health Commission (health industry standard WS/T403-2012) was used as the criterion to calculate the σ measure,select the quality control strategy according to the Westgard σ rule of analytical batch length,calculate the quality objective index,and evaluate the analytical performance of enzymology.Results Among all enzymology items,2 items had a σ≥6;the 13s rule was selected,and the analytical batch length was 1000.The σ levels of 2 items were 6＞σ≥5;the quality control rule was 13s/22s/R4s,and the quality control was conducted every 450 tests.The σ levels of 2 items were 5＞σ≥4;the quality control rule was 13s/22s/R4s/41s,and the quality control was conducted every 200 tests.The σ level of 1 item was 4＞σ≥3;the quality control rule was 13s/22s/R4s/41s/6x,and the quality control was conducted every 45 tests.Conclusion The analytical batch length Westgard σ rule is a patient-risk-based quality control strategy that optimizes quality control strategies,improves quality programs,and improves laboratory testing capabilities.
Nevalainen D，Berte L，Kraft C，et al.Evaluating laboratory performance on quality indicators with the six sigma scale[J].Arch Pathol Lab Med，2000，124（4）：516-519.
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