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即时检验中的质量错误率。

Quality error rates in point-of-care testing.

机构信息

Clinical Chemistry Laboratory, Altnagelvin Hospital, Western Health and Social Care Trust, Londonderry, Northern Ireland.

出版信息

Clin Chem. 2011 Sep;57(9):1267-71. doi: 10.1373/clinchem.2011.164517. Epub 2011 Jul 22.

DOI:10.1373/clinchem.2011.164517
PMID:21784764
Abstract

BACKGROUND

Although a theoretical consideration suggests that point-of-care testing (POCT) might be uniquely vulnerable to error, little information is available on the quality error rate associated with POCT. Such information would help inform risk/benefit analyses when one considers the introduction of POCT.

METHODS

This study included 1 nonacute and 2 acute hospital sites. The 2 acute sites each had a 24-h central laboratory service. POCT was used for a range of tests, including blood gas/electrolytes, urine pregnancy testing, hemoglobin A(1c) (Hb A(1c)), blood glucose, blood ketones, screening for drugs of abuse, and urine dipstick testing. An established Quality Query reporting system was in place to log and investigate all quality errors associated with POCT. We reviewed reports logged over a 14-month period.

RESULTS

Over the reporting period, 225 Quality Query reports were logged against a total of 407 704 POCT tests. Almost two-thirds of reports were logged by clinical users, and the remainder by laboratory staff. The quality error rate ranged from 0% for blood ketone testing to 0.65% for Hb A(1c) testing. Two-thirds of quality errors occurred in the analytical phase of the testing process. These errors were all assessed as having no or minimal adverse impact on patient outcomes; however, the potential adverse impact was graded higher.

CONCLUSIONS

The quality error rate for POCT is variable and may be considerably higher than that reported previously for central laboratory testing.

摘要

背景

虽然理论上认为即时检验(POCT)可能特别容易出现误差,但关于 POCT 相关质量错误率的信息却很少。此类信息有助于在考虑引入 POCT 时进行风险/效益分析。

方法

本研究包括 1 个非急症和 2 个急症医院场所。这 2 个急症场所均设有 24 小时中央检验科服务。POCT 用于一系列检测,包括血气/电解质、尿液妊娠试验、糖化血红蛋白(Hb A(1c))、血糖、血酮、滥用药物筛查和尿液干化学检测。建立了一个既定的质量查询报告系统,用于记录和调查与 POCT 相关的所有质量错误。我们回顾了在 14 个月期间记录的报告。

结果

在报告期内,共记录了 225 份针对总共 407704 次 POCT 检测的质量查询报告。近三分之二的报告由临床用户记录,其余由实验室人员记录。质量错误率从血酮检测的 0%到 Hb A(1c)检测的 0.65%不等。三分之二的质量错误发生在检测过程的分析阶段。这些错误均被评估为对患者结果无影响或影响极小,但潜在影响被评为更高。

结论

POCT 的质量错误率是可变的,可能比以前报告的中央检验科检测的错误率高得多。

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