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欲赢战,先识敌:免疫血液学外部质量评估结果中的错误率

To Win the Battle, First Know Your Enemy: Error Rates in Immunohematology External Quality Assessment Results.

作者信息

Buchta Christoph, Coucke Wim, Mayr Wolfgang R, Müller Mathias M, Körmöczi Günther F

机构信息

ÖQUASTA, Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests, Vienna, Austria.

Sciensano, Quality of Laboratories, Brussels, Belgium.

出版信息

Transfus Med Hemother. 2020 Feb;47(1):80-87. doi: 10.1159/000499941. Epub 2019 May 17.

Abstract

BACKGROUND

As some errors in pretransfusion testing remain unrecognized, error rates and the resulting need for corrective measures are probably underestimated. External quality assessment (EQA) schemes could provide valuable input for identifying error-prone laboratory tests because they are designed to monitor test performance and errors. So far, however, there are only limited published data on error rates in such schemes.

METHODS

The types and incidence of incorrect results in an EQA scheme for red cell immunohematology with 187 participating laboratories were examined. The results of 58 distributions between 1999 and 2017 were evaluated, considering also the employed determination methods.

RESULTS

Out of a total of 58,726 results, 563 (0.96%) were incorrect. Error rates were 5.45% for antibody identification, 1.39% for Rh phenotyping, 0.83% for serologic cross-match, 0.60% for direct antiglobulin test, 0.20% for Kell phenotyping, 0.16% for antibody screening, and 0.14% for ABO phenotyping. During the observation period, 53 participants reported error-free results, while 37 reported one incorrect result and 97 repeatedly reported incorrect results for one or more analytes. Error rates obtained by manual methods significantly surpassed those obtained by automated methods (1.04 vs. 0.42%). The introduction of double testing with two different systems reduced error rates in Rh phenotyping from 1.55 to 0.50%.

CONCLUSION

Risk assessment should consider that error rates in pretransfusion test results vary. These data delineate the error risk potential of individual laboratory tests and thus should aid in tailoring appropriate improvement measures.

摘要

背景

由于输血前检测中的一些错误仍未被识别,错误率以及由此产生的纠正措施需求可能被低估。外部质量评估(EQA)计划可为识别易出错的实验室检测提供有价值的信息,因为它们旨在监测检测性能和错误。然而,到目前为止,关于此类计划中错误率的已发表数据有限。

方法

对一个有187个参与实验室的红细胞免疫血液学EQA计划中错误结果的类型和发生率进行了检查。评估了1999年至2017年间58次分发的结果,同时也考虑了所采用的测定方法。

结果

在总共58726个结果中,有563个(0.96%)是错误的。抗体鉴定的错误率为5.45%,Rh血型分型为1.39%,血清学交叉配血为0.83%,直接抗球蛋白试验为0.60%,Kell血型分型为0.20%,抗体筛查为0.16%,ABO血型分型为0.14%。在观察期内,53名参与者报告无错误结果,而37名报告了一个错误结果,97名反复报告了一种或多种分析物的错误结果。手动方法获得的错误率显著超过自动方法获得的错误率(1.04%对0.42%)。采用两种不同系统进行双重检测使Rh血型分型的错误率从1.55%降至0.50%。

结论

风险评估应考虑到输血前检测结果的错误率各不相同。这些数据描绘了各个实验室检测的错误风险潜力,因此应有助于制定适当的改进措施。

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Proficiency testing in immunohaematology in Ontario, Canada, 1977-1979.
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