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

Abstract

Introduction. Quality management in clinical laboratories is essential to ensure the reliability, safety, and validity of the results. This system includes a documental and technical component and is divided into three phases: pre-analytical, analytical, and post-analytical. The first phase is the most prone to errors. Objective. This research aimed to evaluate the compliance of private laboratories in Cuenca with the Quality Management System, focusing on the pre-analytical phase in accordance with ISO 15189 standards. Methodology. Non-probabilistic sampling was conducted, selecting 14 laboratories in the city to be audited. Descriptive statistics were applied for frequency analysis to obtain qualitative data. Results. Seventy-three percent (73%) of the laboratories complied with the parameters of the pre-analytical phase, while Document Management achieved 100% compliance, and Technical Management showed a compliance rate of 64%. The primary limitations found in these laboratories were a lack of personnel (28%), knowledge (44%), and resources (28%). Conclusion. The pre-analytical phase was the most problematic in terms of inaccuracies among the phases of analysis in Cuenca’s laboratories. The most significant challenges were the lack of personnel, scarcity of resources, and considerable lack of knowledge. Improvement in these areas could reduce errors and increase the accuracy of results in the city's clinical laboratories.