Internal quality control – past, present and future trends

Abstract

Abstract Objectives 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. Methods 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. Results 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. Conclusions 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.