Evaluación del Sistema de Calidad ISO 15189:2012 en los Procesos Preanalíticos, Analíticos y Postanalíticos en un Laboratorio Clínico Privado

Abstract

Abstract: Health quality represents care managed by standards, which allow health services to be evaluated, to obtain lower error rates. The main objective of this research was To evaluate the quality system applied in a private clinical laboratory in contrast to the ISO 15189:2012 standard in the pre-analytical, analytical and post-analytical processes for which a cross-sectional descriptive study was conducted. The ISO 15189:2012 standard was taken as a standard, a checklist was used as a measurement instrument, which was generated by the author based on the ISO 15189:2012 standard, from which the numerals concerning the pre-analytical processes were taken., analytical and post-analytical. In the analysis, 155 items were found, the institution complies with 67.10% (104 items), non-compliance represents 20% (31 items), partial compliance of 7.74% (12 items) and 5.16% (8 items) corresponding to items of the standard that do not apply in the institution, the majority percentage of non-compliance was found in the pre-analytical processes, which represented 11.61% (18 items), based on the results an analysis of causes was carried out and through the non-conformities detected, possible improvement actions were established to address these non-conformities, which were proposed as a suggestion within the improvement plan.