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Resumen Objetivos la mayor parte de los errores en medicina del laboratorio se producen durante la fase preanalítica y postanalítica del proceso analítico total (PAT). En 2014, la Sociedad Española de Medicina de Laboratorio (SEQCML) lanzó el Programa de Garantía Externa de la Calidad (EQA) de Preanalítica, con el propósito de ofrecer una herramienta para mejorar la calidad de la fase preanalítica. El objeto del presente estudio es evaluar la evolución de los indicadores de calidad (IC) y la comparabilidad de las especificaciones de calidad de la fase preanalitica (EC) con otros programas EQA. Métodos en el programa de la SEQCML, los participantes registraron el número de rechazos por cada tipo de muestra y por causa de rechazo. El cálculo de los percentiles se realizó a partir de los datos obtenidos en el periodo 2014–2017. Posteriormente, se revisaron dichos percentiles con los datos obtenidos en los años 2018 y 2019. Se calcularon los percentiles 25, 50, 75 y 90 de cada serie, estableciendo las medias como especificaciones. Estas especificaciones se compararon con los resultados de otros programas. Resultados en general las especificaciones con respecto a los IC se mantuvieron estables o mejoraron en el periodo 2018–2019, por ejemplo, se produjo un descenso significativo en el número de muestras de suero con un índice hemolítico ≥0,5 g/L. Sin embargo, este descenso no se observó en el manejo de muestras de EDTA y citrato, posiblemente debido a una mejor capacidad de detección de la hemólisis. Las especificaciones para los IC del grupo de trabajo Laboratory Errors and Patient Safety de la IFCC y del programa Key Incident Management and Monitoring System (KIMMS) de la RCPA mostraron resultados comparables, lo que confirma la validez de las especificaciones establecidas. Conclusiones las especificaciones obtenidas son una herramienta útil para la intercomparación, así como para identificar aquellos procesos de la fase preanalítica que son prioritarios mejorar.

Resumen Introducción El objetivo de este estudio es comprobar la evolución de las especificaciones de la prestación analítica (EPA) utilizadas en programas de garantía externa de la calidad (EQA) y el papel de un programa de categoría 1 en la vigilancia de la estandarización de la prestación de los laboratorios clínicos en España. Métodos Se ha revisado la bibliografía sobre tipos de especificaciones de la calidad usados en programas de otros países y se ha comprobado su evolución; se ha comparado el posible impacto de distintas EPA empleadas en ocho países en la toma de decisiones clínicas con tres ejemplos de magnitudes: sodio, tirotropina (TSH) y tiempo de tromboplastina parcial activado (TTPA). Resultados Se ha evidenciado la estandarización entre métodos analíticos comprobando si los resultados medios se desvían respecto al valor de referencia certificado del control dentro de las EPA derivadas de la variación biológica (VB). Las EPA usadas en EQA han evolucionado desde el estado del arte hacia la VB. Si se aplican los resultados que se aceptarían con algunas EPA se podrían producir decisiones clínicas erróneas. Conclusiónes En España, solo 2 de las 18 magnitudes biológicas estudiadas se pueden considerar bien estandarizadas. Sería necesaria una colaboración más estrecha entre los laboratorios y proveedores de sistemas analíticos para resolver las discrepancias.

Background 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. Methods 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). Results 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. Conclusions 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.

Background: The results of 5 years of experience (2004–2008) with process-based quality management using quality indicators for key laboratory processes (analytic and extra-analytic) in a group of clinical laboratories affiliated with the Catalan Health Institute are presented. Our purpose was to analyze the evolution of the indicators, identify processes that require corrective measures, and obtain specifica tions that are more robust than the preliminary ones proposed in a previous study by the same group. Methods: The yearly average was recorded for each indicator in each laboratory, the yearly interlaboratory median was calculated, and the changes occurring were studied to determine their continuity in the 5-year period. For each indicator, the average of the yearly medians was calculated and the results transformed to the Six Sigma scale to estimate the degree of control over the related process. It was suggested to establish the yearly interlaboratory median as the desirable specification for each indicator. Results: The medians for most indicators were stable during the period studied. Thus, the specifications proposed in the first study were considered robust in these cases. The Six Sigma statistic provided added value in this study because it enabled detection of processes that should be improved, in which case the specifications proposed were considered provisional despite their stability. After identifying processes that have the greatest impact on patient safety, the group set a specification of 0%, regardless of the actual specification obtained, although the members are conscious of the difficulty in attaining this level of quality. Certain processes that are in a period of change obtained specifications that are considered in a phase of consolidation. Conclusions: The results for indicators related with sample collection indicate that the process is stable and well controlled. However, based on the results for Hemolyzed serum sample, the group saw the need for installing centrifuges in all phlebotomy centers and established a recommendation to unify the system for measuring hemolysis. The indicator External control exceeds acceptance limit clearly highlighted the need to rigorously monitor the analytic phase of the clinical laboratory. The values obtained for the indicator Reports from referred tests exceed delivery time show that there is considerable deviation regarding the expected report delivery time, whereas for in-house laboratory reports, delivery time is satisfactory.

Background: Quality specifications for indicators of the key analytic processes have been defined by international consensus. However, only preliminary specifications for laboratory-related strategic and support processes have been developed. The present study attempts to increase the robustness of the preliminary proposed specifications. Methods: Recovering records and incidences occurred over a 4-year follow-up period, for 12 indicators, used in all laboratories from this group regarding strategic and support processes. Results and conclusions: The results obtained indicate that it is better to establish an interval rather than a fixed value for the majority of indicators. Longer studies are needed to properly assess some quality specifications, and data recording system must be standardized in others. Additional, multicenter studies are needed to establish more robust specifications and determine the state of the art of laboratories in other settings. Clin Chem Lab Med 2010;48:1015–9.