Limonard C B
Clin Chim Acta. 1979 Jul 16;95(2):353-67. doi: 10.1016/0009-8981(79)90378-4.
An external quality control program is described which, apart from documenting the routine performance of clinical chemistry laboratories with respect to accuracy and precision, also indicates the control efficiency of intra-laboratory quality control procedures. Participants are supplied with a large lot of stable control serum to be used in their intra-laboratory quality control program during a prolonged period of time. The statistical analysis of the submitted data consists of an analysis of variance scheme in order to separate systematic from random errors. The systematic laboratory errors are thereafter graded according to a scoring system independent of the standard deviation. The control efficiency of intra-laboratory quality control procedures is derived from a modified version of the measurability and controllability rules of Van der Grinten (1968) Stat. Neerl. 22, 43--63). Application of these rules in clinical chemistry laboratories is a first step towards a dynamic system of process deviation control. Merits of such an approach are discussed. Principles of the analysis of variance technique are dealt with. A graphical procedure to display its results is shown. Testing procedures to justify application of the analysis of variance technique are discussed and several features are illustrated.
本文描述了一个外部质量控制程序，该程序除了记录临床化学实验室在准确性和精密度方面的常规表现外，还能显示实验室内部质量控制程序的控制效率。为参与者提供大量稳定的质控血清，以便他们在较长时间内用于实验室内部质量控制程序。对提交数据的统计分析采用方差分析方案，以区分系统误差和随机误差。此后，根据一个独立于标准差的评分系统对系统实验室误差进行分级。实验室内部质量控制程序的控制效率源自范德格林滕（1968年，《荷兰统计学》第22卷，43 - 63页）的可测性和可控性规则的修改版本。在临床化学实验室应用这些规则是迈向过程偏差动态控制系统的第一步。讨论了这种方法的优点。阐述了方差分析技术的原理。展示了一种用于呈现其结果的图形化程序。讨论了证明方差分析技术适用性的测试程序，并举例说明了几个特点。
