目的: 为避免在设计室内质控方案时可能出现的控制不足或过度控制,为医学检验实验室建立一套基于临界西格玛度量值且满足质控性能目标的适当室内质控方案。方法: 利用质控软件和办公软件,计算系统误差从0至4.50 s时,常用质控方案的误差检出概率和假失控概率,并以此绘制西格玛度量值图和标准化操作过程规范图。结果: 分析得出在使用1~3个浓度水平质控物时,满足90%误差检出概率及小于5%的假失控概率时的临界西格玛度量值,以及此时适合的质控方案,并绘制出达到90%分析质量保证时的标准化操作过程规范图。结论: 基于临界西格玛度量值的室内质控方案可有效保证医学检验实验室质控方案的误差检出概率并维持较低的假失控概率,防止控制不足或过度控制;不建议使用一个浓度水平质控物,因其不利于质控规则的使用和无法提供中低西格玛检验水平项目的质量保证。
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 (Ped) and the probability of false rejection (Pfr) 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 Ped was 90% and Pfr 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 Ped of the QC scheme and maintain a low Pfrfor 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.
关键词
医学检验实验室 /
西格玛度量值图 /
操作过程规范图 /
室内质控
Key words
medical laboratory /
sigma metric graph /
operation process specification charts /
internal quality control
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参考文献
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基金
长沙市自然科学基金“枇杷叶提取物调控TGFBR3影响PI3K-AKT通路抑制肺癌的转移”（kq2202486）
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