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关于质量控制系统的思考:一位检验技师的视角

Thoughts on quality-control systems: a laboratorian's perspective.

作者信息

Cembrowski G S

机构信息

GSC Consulting, Edina, MN 55424, USA.

出版信息

Clin Chem. 1997 May;43(5):886-92.

PMID:9166258
Abstract

State-of-the-art prospective quality-control systems entail the use of medically relevant, analyte-specific quality control limits. With analyte-specific limits broader than those generally used in the clinical laboratory, there will be fewer false rejections, fewer unnecessary reanalyses, and shorter delays in run reporting. If the analyte-specific limits are narrower than those used in the laboratory, more errors will be detected, but the user is at risk of identifying errors over which s/he and the manufacturer have little control. The use of various patient data quality-control algorithms is described. Conservatism is stressed in adopting manufacturers' guidelines for surrogate, nondestructive quality-control testing. A simple, optimized approach is suggested for the systematic retrospective review of proficiency data. Finally, an approach is presented for converting from older, previously accepted quality control procedures to more efficient analyte-specific quality control.

摘要

最先进的前瞻性质量控制系统需要使用与医学相关的、针对特定分析物的质量控制限。当针对特定分析物的限值比临床实验室通常使用的限值更宽时,将有更少的错误拒收、更少的不必要重新分析以及运行报告中的延迟更短。如果针对特定分析物的限值比实验室使用的限值更窄,将检测到更多错误,但用户有可能识别出其本人和制造商几乎无法控制的错误。文中描述了各种患者数据质量控制算法的使用。在采用制造商关于替代、非破坏性质量控制测试的指南时强调了保守性。文中提出了一种简单、优化的方法用于对能力验证数据进行系统的回顾性审查。最后,文中介绍了一种从较旧的、先前接受的质量控制程序转换为更高效的针对特定分析物的质量控制的方法。

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