Implementación de la variabilidad biológica como objetivo de la calidad en un laboratorio clínico

Abstract

Introduction Various criteria have been developed to establish the quality that laboratories must achieve. At the Stockholm Conference a hierarchical model was established for analytical quality specifications. The aim of this study was to evaluate the biological variability in multiple biochemical parameters over one year. Materials and methods Every month, each parameter, was calculated for imprecision, systematic error (SE) and total error (TE), as well as calculating the relative variation coefficient (RVC). Results A total of 29 parameters were evaluated for routine and 31 for emergencies. For routine, the imprecision criteria, SE and TE were fulfilled in 80%, 81% and 97%, respectively; and for emergencies in 84%, 90% and 100% respectively. The sodium ion was the only parameter that did not fulfil any of the three criteria. The worst results were registered by those parameters with low biological variability. For the relative variation coefficient (RVC), only the sodium ion did not conform. There were no significant differences found between the results when comparing the quality specifications obtained between routine and emergency analyses. Discusion Even though the results obtained are acceptable, the analytical quality cannot be guaranteed for some parameters and should be reviewed. The best results were obtained using TE. Therefore, the Stockholm model for quality specifications should be implemented in both routine and emergencies laboratories.