External quality assessment of serum indices: Spanish SEQC-ML program.


Por: Gómez Rioja R, Ventura M, Llopis MA, Bauça JM, Caballero Garralda A, Ibarz M, Martinez D, Gómez C, Salas Gómez-Pablos P, García Del Pino I, Delgado J, Puente JJ and Marzana I

Publicada: 26 ene 2022 Ahead of Print: 21 oct 2021
Resumen:
OBJECTIVES: Serum indices included in clinical chemistry instruments are widely used by laboratories to assess the quality of samples. Instruments that report quantitative results allow an evaluation of their diagnostic performance in a similar way to other biochemical tests. The Spanish Society of Laboratory Medicine (SEQC-ML) launched a monthly External Quality program of serum indices in 2018 using three lyophilized materials of simultaneous annual distribution. We present the results of the first three years of the program. METHODS: The use of four different quality control materials with different concentrations in three alternate months allows an annual evaluation of the participant's accuracy. Assigned values are established by consensus among homogeneous groups, considering necessary at least 10 participants for a comparison at instrument level. The average percentage difference results per instrument allow the assessment of bias among groups. RESULTS: The imprecision of the three indices ranges between 3 and 9%, with no major differences among instruments. Significant differences were observed in all indices among instruments with more than 10 participants (Roche Cobas, Abbott Architect, Abbott Alinity and Siemens Advia). The 90th percentile of the distribution of percentage differences was used as the analytical performance specification (APS). An improvement in performance was observed in the first three years of the program, probably due to the learning curve effect. In 2020, APS of 7.8, 12.2 and 9.7% were proposed for hemolytic, icteric and lipemic indices, respectively. CONCLUSIONS: Serum indices have a great impact on the quality and the reliability of laboratory test results. Participation in proficiency testing programs for serum indices is helpful to encourage harmonization among providers and laboratories.

Filiaciones:
Gómez Rioja R:
 Laboratory Medicine, La Paz - Cantoblanco - Carlos III University Hospital, Madrid, Spain

Ventura M:
 Spanish Society of Laboratory Medicine, Barcelona, Spain

:
 Laboratory Medicine, Hospital Universitari Germans Trias i Pujol, Badalona, Spain

Bauça JM:
 Servei d'Anàlisis Clíniques, Hospital Universitari Son Espases, Palma de Mallorca, Illes Balears, Spain

Caballero Garralda A:
 CORE Laboratory, Laboratorio Echervarne SA, Castelldefels, Catalunya, Spain

Ibarz M:
 Labortory Medicine, Hospital Universitari Arnau de Vilanova, Lleida, Catalunya, Spain

Martinez D:
 Laboratory, Clínica Universidad de Navarra, Navarra, Spain

:
 Laboratory Medicine, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

Salas Gómez-Pablos P:
 CORE Laboratory, Catlab, Viladecavalls, Barcelona, Spain

García Del Pino I:
 Area Laboratory, Complexo Hospitalario Universitario A Coruña, A Coruña, Spain

Delgado J:
 Department of Laboratory Medicine, Hospital Universitari Son Espases, Palma, Mallorca, Spain

Puente JJ:
 Servicio Bioquímica, Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain

Marzana I:
 Unidad Extraanalítica, Laboratorios Hospital Universitario Cruces, Baracaldo (Vizcaya), Spain
ISSN: 14374331





Clinical Chemistry and Laboratory Medicine
Editorial
Walter de Gruyter GmbH, GENTHINER STRASSE 13, D-10785 BERLIN, GERMANY, Alemania
Tipo de documento: Article
Volumen: 60 Número: 1
Páginas: 66-73
WOS Id: 000727730300017
ID de PubMed: 34670030

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