医学检验实验室应用西格玛度量值建立适当的室内质控方案

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Abstract Objective In order to avoid the possible lack of control or over-control in the design of internal quality control (IQC) scheme, an appropriate IQC scheme based on critical sigma value and meeting the quality control (QC) performance objectives was established for the Medical laboratory. Method By using QC software and office software, the probability of error detection (P_ed) and the probability of false rejection (P_fr) of common QC rules were calculated when the system error ranged from 0 to 4.50s. The sigma metric graph and the operational process specifications (OPSpecs) charts were drawn. Results The critical sigma value was obtained when P_ed was 90% and P_fr was less than 5%, and the appropriate QC scheme was obtained. The standardized OPSpecs charts were drawn when the analysis quality assurance was 90%. Conclusion The IQC scheme based on the critical sigma value can effectively ensure the P_ed of the QC scheme and maintain a low P_frfor the Medical laboratory, so as to prevent lack of control or over-control. It is not recommended to use only one level of QC material, which is not conducive to the use of QC rules, and can not provide quality assurance for low-medium sigma level tests.

Key words： medical laboratory sigma metric graph operation process specification charts internal quality control

Received: 21 September 2023

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R446

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	Articles by authors
	JIAO Fangyan
	ZHANG Yu
	ZOU Guoying
	JIANG Weiping
	XU Fei

Cite this article:

JIAO Fangyan,ZHANG Yu,ZOU Guoying等. Medical testing laboratories applying critical Sigma value to establish appropriate internal quality control schemes for quantitative tests[J]. HuNan ShiFan DaXue XueBao(YiXueBan), 2024, 21(2): 139-142.

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http://yxb.hunnu.edu.cn/EN/ OR http://yxb.hunnu.edu.cn/EN/Y2024/V21/I2/139

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