Aseguramiento de la calidad en la fase analítica del laboratorio clínico de un hospital de tercer nivel de la ciudad de Guayaquil 202

Abstract

Abstract: The study describes the implementation of a quality assurance improvement plan for the analytical phase of a clinical laboratory at a tertiary care hospital in Guayaquil during 2024. This plan was based on four strategies: ISO 15189:2022 requirements, process optimization, good clinical laboratory practices, and Six Sigma evaluation, a demanding error reduction metric whose minimum acceptable performance ranges between 3 and 4. The results of the implementation in the clinical biochemistry area showed an improvement in 39% of the analytes. Direct bilirubin reached a 5 sigma, alkaline phosphatase 6, alanine aminotransferase 4, iron 6, and triglycerides 6. These six sigma values showed an increase in the precision and accuracy of the results, demonstrating the effectiveness of the methodology applied and concluding that there is a permanent need for continuous improvement, provided there is commitment from the clinical laboratory and hospital management, as well as strong motivation and training for the technical staff performing the procedures in the analytical phase to ensure sustainability over time.