Carmen Ricós, Pilar Fernández-Calle, Fernando Marqués, Joana Minchinela, Ángel Salas, Cecília Martínez-Bru, Beatriz Boned, Rubén Gómez-Rioja, Marià Cortés, Elisabet González-Lao, JV García-Lario, Xavier Tejedor-Ganduxé, Sandra Bullich, Montse Ventura, Margarida Simón, Carlos Vilaplana, Ricardo González-Tarancón, Mª Pilar Fernández-Fernández, Francisco Ramón-Bauzá, Zoraida Corte, Mª Antonia Llopis, Jorge Díaz-Garzón, Carmen Perich
March 19, 2020
Article number: 20200008
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.