Análisis del sistema de gestión documental de calidad de laboratorios clínicos privados de la ciudad de Cuenca

Abstract

Introduction: Document management is a crucial aspect of the functioning of clinical laboratories, as it ensures the quality and compliance of clinical results following national and international regulations. Objective: To analyze the compliance of quality indicators in the document management systems of private clinical laboratories in Cuenca following ISO 15189 standards and the guidelines of the Ministry of Public Health (MSP, by its Spanish acronym). Methodology: The applied study was qualitative and cross-sectional, including surveys in low-complexity laboratories to evaluate document quality indicators. Results: The clinical laboratories demonstrate high levels of compliance in permission control (91.7%) and quality records (100%) according to regulations but moderate compliance in non-conformity management and corrective actions (58%). The main limitations include insufficient resources and training, inadequate infrastructure, and low adherence to non-priority indicators. Conclusion: The document management indicators of clinical laboratories were analyzed, showing notable compliance with several parameters of ISO 15189 standards and MSP guidelines. Although quality and technical records achieved 100% adherence, areas for improvement were identified in detecting non- conformities and in corrective and preventive actions. The main limitations include insufficient resources and training, inadequate infrastructure, and low adherence to non-priority indicators.