[1]张诗诗,王薇,王治国.临床检验质量控制程序的性能验证[J].现代检验医学杂志,2016,31(06):150-153，157.[doi:10.3969/j.issn.1671-7414.2016.06.045]
　ZHANG Shi-shi,WANG Wei,WANG Zhi-guo.Performance Verification of Quality Control Procedures in Clinical Laboratory Medicine[J].Journal of Modern Laboratory Medicine,2016,31(06):150-153，157.[doi:10.3969/j.issn.1671-7414.2016.06.045]
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临床检验质量控制程序的性能验证()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第31卷
期数:
2016年06期
页码:
150-153，157
栏目:
质量控制·实验室管理
出版日期:
2016-12-20

文章信息/Info

Title:
Performance Verification of Quality Control Procedures in Clinical Laboratory Medicine
作者:
张诗诗; 王薇; 王治国
北京医院 国家老年医学中心卫生部临床检验中心,北京 100730
Author(s):
ZHANG Shi-shi; WANG Wei; WANG Zhi-guo
National Center for Clinical Laboratories, Beijing Hospital,National Center of Gerontology,Beijing 100730,China
关键词:
质量控制;  失控状态;  质量控制性能评估;  质控策略
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2016.06.045
文献标志码:
A
摘要:
随着实验室质量控制(QC)计划的发展和风险管理的引入,许多不同类型的QC可用于操控分析过程的性 能并及时准确地检出可能发生的任意误差。因此,进一步验证这些QC程序的有效性对于提升实验室管理水平 是至关重要的。针对给定的质量控制策略,实验室需要确认其合理性并定义性能度量。通过指定一个区分结 果可接受或不可接受的质量规范,结合允许总误差(TEa)表明分析过程的固有不精密度; 运用西格玛(σ)指 标评价分析系统在控操作期间产生不可靠结果的概率并判断分析过程对于失控条件的耐受程度; 用 ΔPE反映失控和在控状态产生不可靠结果的概率差; 以及用Ped表示质控规则的误 差检出概率; 实验室可以评估因失控而产生的不可靠患者结果预期数(E[Nu]),验证质量控制程 序的性能,并判断产生及报告不可靠患者结果的风险是否可以接受。对于符合实验室风险标准的质量控制策 略,在将失控状态判断为失控之前,先于和后于最终可接受的质控活动所报告的不可靠患者结果的预期数可 以用作设计标准,分别用E(Nuf)和E(Nuc)表示。通过计算最大的E (Nuf)和E(Nuc)值以及确定其是否被实验室接受,进一步验证临床实验室的质控策 略是否合理。
Abstract:
With the development of laboratory Quality Control(QC)plans and the introduction of risk management,numerous different types of quality control measures were applied to handle the performance of analytical processes and to timely and accurately detect any errors that may occur.Therefore,it is of critical importance to improve the level of laboratory management by further verifying the effectiveness of quality control procedures in theclinical laboratories.For a given QC strategy,the clinical laboratory should validate its rationality and define the performance indicators.By designating aquality specification which can distinguish acceptable and unacceptable results,combining the allowable total error(TEa)to demonstrate the inherent imprecision of analytical processes,applying the sigma indicator to evaluate the probability of producing unreliable results in-control state by the analytical systemand determine the degree of tolerance for out-of-control conditions in analysis,using ΔPE to reflect the discrepancy of probabilities about producing unreliable results between out-of-control and in-control states,and expressingwith Ped to indicate the probability of error detection capability by theQC rules,the clinical laboratory can estimate the expected number of unreliablepatient results(E[Nu])produced because of out-of-control conditions,verify the performance of QC procedures,and decide whether the risk of producingand reporting unreliable patient results can be accepted.For the QC strategiesup to the laboratory risk standards,before the determination of out-of-control conditions,the expected number of unreliable patient results produced before and after the last accepted QC estimation can be used as the design criteria,abbreviated as E (Nuf)and E(Nuc)respectively.Then the clinical laboratory can further validate the rationality of a QC strategy by computing the maximum E(Nuf)and E (Nuc)values and determining if they are acceptableto the laboratory.

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备注/Memo

备注/Memo:
基金项目:北京市自然科学基金(基金编号:7143182),北京医院资助课题 (BJ-2015-025)。 作者简介:张诗诗(1991-),女,在读硕士研究生,研究方向:实验室质量管理,E-mail:Athena0915@163.com。 通讯作者:王治国,硕士,研究员,主要从事临床检验质量控制方法研究和室间质量评价工作,E- mail:zgwang@nccl.org.cn。
更新日期/Last Update: 2016-12-20