Abstract
Objetivos
El objetivo de este estudio es conocer la evolución de la prestación analítica de los laboratorios participantes en los programas EQA de la SEQC
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durante los 30 años de ...funcionamiento y compararla con la prestación obtenida en otros programas EQA para saber si los resultados son similares.
Métodos
Se evalúan los resultados obtenidos durante este periodo, aplicando las especificaciones de la calidad derivadas de la VB y del estado del arte. Además, se realiza una comparación con los resultados obtenidos por otras organizaciones de programas EQA.
Resultados
Se observa que los laboratorios participantes en los programas EQA-SEQC
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han mejorado su prestación durante los 30 años de experiencia y que las especificaciones derivadas de la variación biológica son alcanzables. La comparación entre programas EQA es difícil, debido a: la falta de accesibilidad y a las diferencias en el diseño de estos programas (materiales control, cálculos empleados y especificaciones analíticas establecidas).
Conclusiones
Los datos de este estudio ponen de manifiesto que para algunas magnitudes biológicas los resultados obtenidos en los programas todavía no están armonizados, aunque se estan realizando esfuerzos para alcanzar la armonización. Los organizadores de programas EQA deberían sumarse al esfuerzo de armonización, facilitando la información sobre sus resultados para permitir su comparación.
The objective of the present study was to examine the evolution of the analytical performance specifications (APS) used in External Quality Assurance (EQA) schemes, as well as the efficacy of a ...category 1 EQA scheme in monitoring the harmonization of clinical laboratory results in Spain.
A review of the literature on the types of quality specifications used in schemes in other countries and their evolution was performed. In addition, a comparative analysis of the potential impact that different APS from eight countries had on clinical decision-making was made based on three measurands: sodium, thyroid-stimulating hormone (TSH), and activated partial thromboplastin time (aPTT).
Harmonization of analytical methods was demonstrated by assessing whether average results deviated from the certified reference value of control materials within the APS derived from biological variation (BV). The APS used in EQA have evolved from state-of-the-art models to BV. Poor clinical decision-making would occur if the results accepted by some APS were applied.
In Spain, only 2 of the 18 measurands studied are considered to be well harmonized. Closer collaboration between laboratories and analytical system providers would be required to resolve discrepancies.
Interpretation oflaboratory test results requires comparison to some type of reference value or reference interval. These comparisons can be cross-sectional (population-based reference interval and ...cut-off values) or longitudinal (reference change value). Quality specifications for cross-sectional comparison have been established by determining the influence of analytical bias and imprecision on the percentage ofthe healthy population falling outside the reference limits, when sharing population-based reference intervals in a Gaussian distribution ofresults. Quality specifications for longitudinal comparisons are equally important and are often overlooked, since less work has been done in this area. Some criteria suggest that a difference between consecutive results designates a true change in a patient health status when the difference is higher than the within-subject biological variation plus the within-laboratory analytical variation. In this chapter we discuss the clinical considerations and laboratory-related factors that must be considered when quality specifications are applied to sharing reference comparisons. Real life experience shows that different analytical methods can produce comparable results when common quality goals are established, and quality can be achieved through a willingness to work together. Within the existing organization, the current specifications for analytical quality and a dedication to quality health care makes it possible to achieve transferability between laboratories within a geographic area.
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