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Clin Chim Acta. 2014 May 15;432:90-8. doi: 10.1016/j.cca.2013.11.003. Epub 2013 Nov 14.

A category 1 EQA scheme for comparison of laboratory performance and method performance: An international pilot study in the framework of the Calibration 2000 project.

Author information

1
Dutch Foundation for Quality Assessment in Medical Laboratories (SKML), Nijmegen, The Netherlands. Electronic address: office@skml.nl.
2
Department of Clinical Biochemistry, Harrogate District Foundation Trust, Harrogate, UK.
3
WEQAS Quality Laboratory, Cardiff and Vale University Health Board, Cardiff, UK.
4
Spanish Society of Clinical Chemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Spain.
5
Instituto Nacional de Saude, Portugal.
6
Blood Sciences, Old Medical School, Leeds Teaching Hospitals Trust, Leeds, UK.
7
Dutch Foundation for Quality Assessment in Medical Laboratories (SKML), Nijmegen, The Netherlands.
8
Department of Clinical Chemistry, Leiden University Medical Center, Leiden, The Netherlands.
9
Department of Clinical Chemistry and Hematology, Amphia Hospital, Breda, The Netherlands.

Abstract

INTRODUCTION:

In the modern healthcare service, patients receive care in multiple hospitals and healthcare settings. Therefore, harmonization of results from different methods and instruments, both between and within laboratories, is of the utmost importance. The present pilot study aims to test the use of a Category 1 EQA scheme across four European countries by assessing the current level of equivalence of test results.

METHOD:

This work was led by the Dutch External Quality Assurance Scheme SKML and involved 28 laboratories from three regions in the UK, Spain and Portugal, and 120 laboratories from The Netherlands. A set of six commutable samples, targeted with reference methods, were circulated and 18 biochemistry analytes were tested.

RESULTS AND CONCLUSIONS:

The Total Error (TE) score, defined as the probability (%) that results are within the Total Error Acceptable (TEA) limits, for the eighteen analytes was calculated. Our data show that there is a need for further harmonization of laboratory data, in particular for electrolytes (calcium, chloride, magnesium, sodium), enzymes (ALT, amylase, AST, LDH), lipids (HDL-cholesterol), and for substrates (creatinine, total protein). Lack of performance consistency between instruments was seen for most analytes. The lack of harmonization is still present despite manufacturer claims of established traceability.

KEYWORDS:

Biological variation; Commutability; External quality assessment; Harmonization; Reference method; Traceability

PMID:
24240021
DOI:
10.1016/j.cca.2013.11.003
[Indexed for MEDLINE]
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