为可靠性性能特征设定质量规范的一般策略。
General strategies to set quality specifications for reliability performance characteristics.
作者信息
Fraser C G
机构信息
Directorate of Biochemical Medicine, Ninewells Hospital and Medical School, Dundee, Scotland.
出版信息
Scand J Clin Lab Invest. 1999 Nov;59(7):487-90. doi: 10.1080/00365519950185210.
PMID:10667685
Abstract
Many strategies have been promulgated for the setting of quality specifications in laboratory medicine. Based on the analysis of the effect of error on clinical decision making, general quality specifications for precision, bias, the allowable difference between two analytical methods, drugs, fixed limits for use in external quality assessment and reference methods seem best derived from components of biological variation.
摘要
针对检验医学中质量规范的设定，已出台了许多策略。基于对误差对临床决策影响的分析，精密度、偏倚、两种分析方法之间的允许差异、药物、用于外部质量评估的固定限值以及参考方法的一般质量规范似乎最好从生物学变异的组成部分中推导得出。
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