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医学实验室的外部质量控制:1994 - 1996年12次室间比对试验的评估

[External quality control in the medical laboratory: evaluation of 12 ring trials 1994-1996].

作者信息

Hänseler E, Fried R, Savoca R

机构信息

Institut für Klinische Chemie, Universitätsspital Zürich.

出版信息

Schweiz Med Wochenschr. 1997 Sep 13;127(37):1519-27.

PMID:9411709
Abstract

The regulations for reimbursement of laboratory tests provide that such tests will be paid for by social insurance institutions only if the laboratories participate in internal and external quality control schemes. Twelve surveys of the external quality assessment scheme of MQ Zürich (Association for Medical Quality Control) were evaluated. We analyzed the imprecision and inaccuracy of the participant results depending on the analytical system or methods used. Furthermore, the number of participants who met the quality criteria published by FKGRAL (Expert Committee for Overall Revision of Analysis List) was determined. The deviations from the internationally recommended or reference methods respectively were within +/-33% for the metabolites and enzymes if native plasma was used as control sample. If lyophilized samples were used, 5 deviations observed were > +/-33% (maximum +99%). For hematologic parameters the deviations were in the range of +/-10%. The CV's were 5.7-17.6% for wet chemistry methods used by the participants and 4.5-15.1% for the other methods. (Cobas Ready, Ektachem, Reflotron, Vision). For hematologic parameters we found CV's between 4.5 and 14.0%. 69-83% of the participants using wet chemistry methods met the FKGRAL criteria, while 86-98% of participants using one of the other system obtained adequate results. The corresponding figure for the hematologic parameters was 83-93%. The nature of the control samples (native samples or lyophilizate) did not influence the number of participants who successfully passed the survey. The study showed that the surveys are an adequate tool for determining participants with inadequate analytical performance, and in many cases the survey results make it possible to propose the necessary educative measures.

摘要

实验室检测报销规定指出,只有当实验室参与内部和外部质量控制计划时,社会保险机构才会为这些检测付费。对苏黎世MQ(医学质量控制协会)外部质量评估计划的12次调查进行了评估。我们根据所使用的分析系统或方法分析了参与者结果的不精密度和不准确度。此外,确定了符合FKGRAL(分析清单全面修订专家委员会)公布的质量标准的参与者数量。如果使用天然血浆作为对照样品,代谢物和酶与国际推荐方法或参考方法的偏差分别在+/-33%以内。如果使用冻干样品,观察到的5个偏差> +/-33%(最大+99%)。对于血液学参数,偏差在+/-10%范围内。参与者使用的湿化学方法的变异系数为5.7-17.6%,其他方法(Cobas Ready、Ektachem、Reflotron、Vision)的变异系数为4.5-15.1%。对于血液学参数,我们发现变异系数在4.5%至14.0%之间。使用湿化学方法的参与者中有69-83%符合FKGRAL标准,而使用其他系统之一的参与者中有86-98%获得了满意结果。血液学参数的相应数字为83-93%。对照样品的性质(天然样品或冻干物)不影响成功通过调查的参与者数量。该研究表明,这些调查是确定分析性能不足的参与者的合适工具,并且在许多情况下,调查结果使得能够提出必要的教育措施。

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