Evaluación de los indicadores de la calidad analítica en un laboratorio clínico

Abstract

IntroductionQuality specifications need to be defined using indicators that are adapted to needs and current technology, as well as to establish the limits of acceptability based on national and international consensus. The aim of this study is to evaluate compliance with various quality indicators for different analytes. Materials and methodsThe following statistical values were calculated monthly for each analyte: coefficient of variation ratio, standard deviation index, total error based on biological variability, sigma level and total analytical error (%). ResultsPercentage compliance of imprecision indicator (coefficient of variation ratio) in serum was 97%, while the systematic error indicator (standard deviation index) was 98%. For urine, compliance of imprecision was 88%, and for systematic error it was 95%. As regards to compliance with ET based on biological variability, serum was 85%, urine was 93%, and troponin I (TpI) was 75%. As for sigma quality specifications, it was 72% for serum and for urine was 85%, and in the case of TpI was 57%. For total analytical error, the compliance rate was 97% for serum and 88% for urine. ConclusionsSpecifications based on biological variability should be adopted whenever possible, and if not, the minimum consensus specifications. Goals based on the sigma level are far from being met with current technology.