The implementation of a system for managing analytical quality in networked laboratories

Abstract

Background In a network of laboratories analytical variability between instruments, even of the same type, may exist for reasons beyond the control of laboratory staff. Controlling variability is a prerequisite for the application of shared reference ranges and for ensuring the transferability of patient test results. Controlling variability requires a robust, non-conventional quality system to detect poor performance of analysers that are geographically distant. Essential to this quality system is a set of well-defined quality specifications. Methods The approach used in our study started with (1) selection of a model for quality specifications based on biological variation; the ‘three-level model’ (TLM) was selected on the basis of its flexibility to accommodate various levels of analytical performance; (2) determination of the performance characteristics of the 71 analytes measured in core biochemistry in terms of imprecision and bias; (3) defining quality requirements in the form of imprecision, bias and total error for 71 analytes measured routinely in core biochemistry; and (4) developing software to assist a consistent wide application of the quality specifications and to monitor analytical indices to the common quality specifications. Results In this paper we describe how we have implemented this model across our network. Forty-six of the 71 analytes in our core laboratory repertoire were allocated to the TLM. We were able to demonstrate equivalence of results on all analysers, for 42 out of 46 analytes allocated to this model. Conclusions We propose that other networked laboratories should investigate the suitability of this quality system for use in their network.