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OPINIONI - Opinions

Volume:

Biochimica Clinica 2019; 43(2) 168-172

Pubblicato on-line:

Aprile 16, 2019

DOI:

10.19186/BC_2019.035

Scarica in PDF:
Autenticazione richiesta

La valutazione delle prestazioni analitiche dei laboratori mediante programmi di valutazione esterna di qualità: una analisi multifattoriale

AUTORI

Sandra Secchiero, Laura Sciacovelli, Massimo Baldon, Mario Plebani
Centro di Ricerca Biomedica per la Qualità in Medicina di Laboratorio, Azienda Ospedaliera-Università, Padova

ABSTRACT

The evaluation of laboratories’ analytical performance through external quality assessment programs: amultifaceted analysis

The Italian accreditation body, Accredia, requires that clinical laboratories obtained positiveanalytical performances in the last four External Quality Assessment (EQA) surveys in order to undertake theaccreditation with flexible scope (document RT-26).
In addition to the choice of acceptability limits (AL), other factors contribute to define the analytical performance:nature and commutability of control materials, definition of target value (TV), homogeneous group classification, dataelaboration, procedures for outliers exclusion.
In this study, the creatinine performances of 106 participants, obtained in the last four surveys of the year 2017 ofthe Centre of Biomedical Research (CRB) EQA program, have been evaluated using two different AL and TV: the ALproposed by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and by the RegionalReference Centre of the Azienda Ospedaliera Universitaria “Careggi” of Firenze (Italy) (CRRVEQ); the TV assignedwith the reference method (RV) and as consensus value, i.e. median of the results obtained with the same method(AV).
The percentage of laboratories satisfying the RT-26 requisite was different on the basis of the AL and TV considered:with the EFLM-AL, 68.8 % laboratories complied the requisite if AV was used and 60.4% if RV was applied; with theCRRVEQ-AL, 50.0% and 48.1%, respectively.
These data demonstrate that harmonized criteria and procedures for evaluation of EQA results are needed to obtainhomogeneous classification of laboratories’ performance.
In order to support the laboratory professionals in accreditation processes and, above all, to guarantee theirperformance reliability, time has come that the Scientific Societies of Laboratory Medicine promote the merging of thedifferent Italian EQA schemes in a consolidated network of EQA providers.

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