The management of external quality assurance

The term “External Quality Assurance (EQA)” has a variety of possible definitions.¹ Perhaps the most all embracing definition of quality in healthcare is one of the earliest from Donabedian²: “The managed process whereby the comparison of care (in the present context, laboratory results) against predetermined standards is guaranteed to lead to action to implement changes, and ensuring that these have produced the desired improvement”.

Donabedian’s definition by implication outlines the cyclical nature of quality improvement. This paper aims to describe the cycles of EQA as they affect patient results and care and to outline possible pathways to greater public accountability from the perspective of clinical biochemistry.

“Management can have measurable effects on performance—an aspect that is usually only appreciated when things go wrong”

We need to apply the broadest use of this definition to laboratory practice to ensure that its benefits are passed on to patient care in the form of more reliable results. The traditional subdivision of laboratory practice into its service elements of preanalytical, analytical, and postanalytical phases is insufficient to describe laboratory practice as influenced by EQA. The substance and style of laboratory management will have influence beyond these phases on the ability of the laboratory to deliver a reliable service to patients. Management can have measurable effects on performance—an aspect that is usually only appreciated when things go wrong.

Any interpretation of such a definition implies an audit cycle of continuous improvement. Each stage in the process of EQA can be held to have its own cycle. The cycles that are described here are principally, but not exclusively: scheme performance as overseen by steering groups (fig 1), current EQA practice where specimens are circulated and the results are reviewed within laboratories (fig 2), and the work of the …