How to conduct External Quality Assessment Schemes for the pre-analytical phase?

Gunn B B Kristensen,Ann Helen Kristoffersen,Kristin Moberg Aakre,Sverre Sandberg

doi:10.11613/bm.2014.013

Gunn B B Kristensen, Ann Helen Kristoffersen + Show 2 more

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https://doi.org/10.11613/bm.2014.013

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Abstract

In laboratory medicine, several studies have described the most frequent errors in the different phases of the total testing process, and a large proportion of these errors occur in the pre-analytical phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades concerning the analytical phase by External Quality Assessment (EQA) organizations operating in most countries. The aim of the paper is to present an overview of different types of EQA schemes for the pre-analytical phase, and give examples of some existing schemes. So far, very few EQA organizations have focused on the pre-analytical phase, and most EQA organizations do not offer pre-analytical EQA schemes (EQAS). It is more difficult to perform and standardize pre-analytical EQAS and also, accreditation bodies do not ask the laboratories for results from such schemes. However, some ongoing EQA programs for the pre-analytical phase do exist, and some examples are given in this paper. The methods used can be divided into three different types; collecting information about pre-analytical laboratory procedures, circulating real samples to collect information about interferences that might affect the measurement procedure, or register actual laboratory errors and relate these to quality indicators. These three types have different focus and different challenges regarding implementation, and a combination of the three is probably necessary to be able to detect and monitor the wide range of errors occurring in the pre-analytical phase.

Highlights

IntroductionSeveral studies have described the most frequent errors in the different phases of the total testing process (TTP) [1,2,3,4,5,6,7,8,9,10,11,12], and a large proportion of these errors occur in the preanalytical phase [2,5,13,14,15,16,17].The first step in improving the quality of the preanalytical phase is to describe potential errors and to try to estimate which errors are most dangerous for the outcome of the patient [13,18,19,20,21,22]
The aim of this paper is to present an overview of different types of External Quality Assessment (EQA) schemes for the pre-analytical phase and to give examples of existing schemes
Very few EQA organizations have focused on the pre-analytical phase, compared to the analytical phase, even if the pre-analytical phase is more prone to errors

Summary

Introduction

Several studies have described the most frequent errors in the different phases of the total testing process (TTP) [1,2,3,4,5,6,7,8,9,10,11,12], and a large proportion of these errors occur in the preanalytical phase [2,5,13,14,15,16,17].The first step in improving the quality of the preanalytical phase is to describe potential errors and to try to estimate which errors are most dangerous for the outcome of the patient [13,18,19,20,21,22]. Several studies have described the most frequent errors in the different phases of the total testing process (TTP) [1,2,3,4,5,6,7,8,9,10,11,12], and a large proportion of these errors occur in the preanalytical phase [2,5,13,14,15,16,17]. Existing pre-analytical procedures should be compared to existing recommendations and thereafter improved to minimize the risk of errors. Schemes for recording of errors and subsequent feedback to the participants have been conducted for decades concerning the analytical phase by External Quality Assessment (EQA) organizations operating in most countries. An important challenge, when developing EQAS for the extra-analytical phases, is the variety of locations and staff groups involved in the total testing process, of which several are outside the laboratory’s direct control.

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