Calidad de los procesos pre-analíticos en un laboratorio clínico según la normativa ISO 15189:2022, 2025.

Abstract

Abstract: Implementing standardized processes in the clinical analysis of biological samples becomes an important priority to ensure the quality of results and patient care. The objective of this study was to evaluate the quality of the pre-analytical processes of a clinical laboratory in the Complementary Health Network of the City of Portoviejo, using the standards established in ISO 15189:2022. The evaluation was conducted based on the technical criteria of ISO 15189:2022 and the application of a prioritized nonconformity survey to clinical laboratory staff with prior informed consent. The methods used in this study were descriptive and deductive approaches, applying observation and document review techniques. The main tool is a checklist for data collection that follows this standard. Internal laboratory records related to patient preparation, sampling, identification, transportation, and proper sample storage will be examined. The information collected will help detect nonconformities and critical aspects in the pre-analytical process. Based on this diagnosis, an improvement plan will be proposed to strengthen staff training, standardize procedures, and improve quality management. This study aims to contribute to strengthening patient safety and the effectiveness of diagnostic services, fostering a culture of continuous improvement in the healthcare sector.