Commutability and traceability in EQA programs

Abstract

Objectives: The concept of commutability of samples has focused laboratories on the importance of traceability. However, the critical role of External Quality Assurance (EQA) in achieving the primary role of traceability (i.e. facilitating comparable patient results in different laboratories) has largely been lost. The aim of this paper is to review the role of EQA in achieving traceable/commutable results.

Design and methods: The role of commutability and traceability in EQA and Internal Quality Control (IQC) are discussed. Examples of commutable EQA samples are given to highlight the problem of assuming EQA material does not behave like patient samples.

Results: We provide the conventional traceability chain (top down) and the role of EQA in a "bottom up" model using conventional EQA samples.

Conclusions: The quest for commutable samples has compromised the value of EQA without an understanding that some EQA materials are commutable for some measurands. EQA plays a key role in performance improvement, but laboratories need to understand the importance of using a range of values appropriate to the assay to identify areas of quality need. Traceability and EQA using conventional samples are not mutually exclusive concepts.

Keywords: Analytical bias; External Quality Assurance; Patient sample commutability; Reference material; Traceability.