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质量控制(QC)绩效指标与质量控制规划流程。

Quality-control (QC) performance measures and the QC planning process.

作者信息

Parvin C A

机构信息

Department of Pathology, Washington University School of Medicine, St. Louis, MO 63110, USA.

出版信息

Clin Chem. 1997 Apr;43(4):602-7.

PMID:9105260
Abstract

Numerous outcome measures can be used to characterize and compare the performance of alternative quality-control (QC) strategies. The performance measure traditionally used in the QC planning process is the probability of rejecting an analytical run when a critical out-of-control error condition exists. Another performance measure that naturally fits within the total allowable error paradigm is the probability that a reported test result contains an analytical error that exceeds the total allowable error specification. In general, the out-of-control error conditions associated with the greatest chance of reporting an unacceptable test result are unrelated to the traditionally defined "critical" error conditions. If the probability of reporting an unacceptable test result is used as the primary performance measure, worst-case QC performance can be determined irrespective of the magnitude of any out-of-control error condition that may exist, thus eliminating the need for the concept of a "critical" out-of-control error.

摘要

许多结果指标可用于描述和比较替代质量控制(QC)策略的性能。质量控制规划过程中传统上使用的性能指标是在存在关键失控误差情况时拒绝分析运行的概率。另一个自然适用于总允许误差范式的性能指标是报告的测试结果包含超过总允许误差规范的分析误差的概率。一般来说,与报告不可接受测试结果的最大可能性相关的失控误差情况与传统定义的“关键”误差情况无关。如果将报告不可接受测试结果的概率用作主要性能指标,则可以确定最坏情况下的质量控制性能,而不管可能存在的任何失控误差情况的大小如何,从而消除了“关键”失控误差概念的必要性。

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