Análisis del sistema de gestión de calidad técnica en fase preanalitica, en laboratorios clínicos privados de la ciudad de Cuenca.

Abstract

Introduction: It is important to implement a technical quality management system in the pre-analytical phase of private clinical laboratories to reduce and avoid errors and guarantee reliable and efficient results in laboratory tests. Objective: This research aimed to analyze the technical quality management systems of private clinical laboratories in the city of Cuenca. Methodology: To develop this thesis, a qualitative, observational, descriptive- explanatory research design is used, conducted through quality management audits of private clinical laboratories in Cuenca that have an operating permit granted by the ACESS (Agency for Quality Assurance in Health Services and Prepaid Medicine). Results: It was observed that 70% of the intervened laboratories comply with the technical quality standards, although the majority of laboratories comply with the standardized request and sample handling, only 80% correctly follow the identification procedures, and none keeps a daily record of sample entry. Conclusion: The analysis of the technical quality management systems in the private clinical laboratories of Cuenca shows general compliance with the ISO 15189:2012 Standard, although areas for improvement persist. The least met indicators are related to traceability and internal control. In addition, limitations were identified such as lack of resources, insufficient training and difficulties in updating procedures. It is essential to implement continuous improvement strategies to optimize technical and operational quality in the city's laboratories.