Spanish society of laboratory medicine external quality assurance programmes: evolution of the analytical performance of clinical laboratories over 30 years and comparison with other programmes.

Carmen Perich,Rubén Gómez-Rioja,Margarita Simón,Xavier Tejedor,Joana Minchinela,Beatriz Boned,Antonia Ma Llopis,Marià Cortés,Zoraida Corte,Fernando Marqués,Sandra Bullich,Carmen Ricós,Elisabet González-Lao,Pilar Fernández-Fernández,Jorge Díaz–Garzón ,Montserrat Carbonell Ventura ,Ángel Hermoza Salas ,Francisco Ramón,José Vicente García Lario ,Cecília Martínez-Brú ,Ricardo González‐Tarancón ,Pilar Fernández–Calle

doi:10.1515/almed-2020-0019

Carmen Perich, Rubén Gómez-Rioja + Show 20 more

Open Access

https://doi.org/10.1515/almed-2020-0019

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Abstract

The purpose of this study is to understand the evolution of the analytical performance of the laboratories participating in the Spanish society of laboratory medicine (SEQCML) external quality assurance (EQA) programmes during its 30 years of operation and to compare it with the performance of other EQA programmes to establish whether the results are similar. The results obtained during this period are evaluated by applying the biological variability (BV) and state of the art-derived quality specifications. In addition, the results are compared with those obtained by other EQA programme organisations. It is noted that the laboratories participating in the EQA-SEQCML programmes have improved their performance over 30 years of experience and that the specifications derived from biological variation are achievable. It is difficult to compare EQA programmes, due to lack of accessibility and the differences in the design of these programmes (control materials, calculations used and analytical specifications established). The data from this study show that for some biological magnitudes the results obtained by the programmes are not yet harmonised, although efforts are being made to achieve this. Organisers of EQA programmes should also join the harmonisation effort by providing information on their results to enable comparison.

Highlights

External quality assurance (EQA) programmes are a key component of laboratory quality management
The purpose of this study is to understand the evolution of the analytical performance of the laboratories participating in the Spanish society of laboratory medicine (SEQCML) external quality assurance (EQA) programmes during its 30 years of operation and to compare it with the performance of other EQA programmes to establish whether the results are similar
It is noted that the laboratories participating in the EQA–SEQCML programmes have improved their performance over 30 years of experience and that the specifications derived from biological variation are achievable

Summary

Introduction

External quality assurance (EQA) programmes are a key component of laboratory quality management. Their involvement enables the laboratory to evaluate and monitor its analytical performance, compare the reliability of measurement procedures and understand the degree of harmonisation of analytical results. The Spanish Society of Laboratory Medicine (SEQCML) launched its first EQA programme in 1981, including 20 biochemical serum magnitudes and with 147 participants [1]. The information to be provided by an EQA programme according to the Task Group on Performance Specifications for EQAS of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM-TG-EQA) created at the 1st Strategic Conference in Milan in 2014 [2], in order to allow participants to correctly interpret their results [3] involves: the control material distributed, the target value to which the laboratory result is compared, how the analytical performance of the participant is expressed and the evaluation criterion used

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