Ricós Carmen, Fernandez-Calle Pilar, Perich Carmen, Westgard James O
External Quality Programs Committee and Analytical Quality Commission, Spanish Society of Laboratory Medicine (SEQCML), Barcelona, Spain.
Department of Laboratory Medicine, La Paz University Hospital, Madrid, Spain.
Adv Lab Med. 2022 May 23;3(3):243-262. doi: 10.1515/almed-2022-0029. eCollection 2022 Oct.
This paper offers an historical view, through a summary of the internal quality control (IQC) models used from second half of twentyth century to those performed today and wants to give a projection on how the future should be addressed.
The material used in this work study are all papers collected referring IQC procedures. The method used is the critical analysis of the different IQC models with a discussion on the weak and the strong points of each model.
First models were based on testing control materials and using multiples of the analytical procedure standard deviation as control limits. Later, these limits were substituted by values related with the intended use of test, mainly derived from biological variation. For measurands with no available control material methods based on replicate analysis of patient' samples were developed and have been improved recently; also, the sigma metrics that relates the quality desired with the laboratory performance has resulted in a highly efficient quality control model. Present tendency is to modulate IQC considering the workload and the impact of analytical failure in the patent harm.
This paper remarks the strong points of IQC models, indicates the weak points that should be eliminated from practice and gives a future projection on how to promote patient safety through laboratory examinations.
本文通过总结20世纪下半叶至今所使用的内部质量控制（IQC）模型，呈现一种历史视角，并希望对未来的应对方式做出预测。
本研究中使用的材料均为收集到的参考IQC程序的论文。所采用的方法是对不同的IQC模型进行批判性分析，并讨论每个模型的优缺点。
最初的模型基于对控制材料进行检测，并使用分析程序标准偏差的倍数作为控制限。后来，这些限值被与检测预期用途相关的值所取代，这些值主要源自生物学变异。对于没有可用控制材料的被测量物，开发了基于对患者样本进行重复分析的方法，并且这些方法最近得到了改进；此外，将期望质量与实验室性能相关联的西格玛度量已形成了一种高效的质量控制模型。当前的趋势是在考虑工作量和分析失败对患者危害的影响的情况下对IQC进行调整。
本文阐述了IQC模型的优点，指出了实践中应消除的缺点，并对如何通过实验室检查提高患者安全性做出了未来预测。
