Unique training and compliance with ISO 15189 technical requirements in hospital clinical laboratories in Ecuador

Abstract

Introduction: ISO 15189 accreditation guarantees technically valid and comparable analytical results, which are essential for patient safety and quality of life. However, not many clinical laboratories have achieved accreditation. Objective: To evaluate compliance with ISO 15189 technical requirements following a single training programme in a clinical laboratory at a primary hospital in Ecuador in 2023. Methodology: A qualitative, longitudinal, empirical, analytical study was conducted before and after a single training session on the general accreditation compliance checklist of the Ecuadorian Accreditation System, in accordance with ISO 15189:2012. The following technical requirements were measured for compliance: pre-analytical, analytical, quality assurance of analytical results, post-analytical, notification of results, communication of results and management of laboratory information. Results: Compliance percentages measured before and after the training session increased for all technical requirements. Quality assurance showed the lowest percentage change in compliance (from 29.41% to 41.18%), while communication of results showed the highest (from 33.33% to 100%). Conclusions: Training has proven to be an effective tool in meeting the ISO 15189 requirements. However, special attention is still required for some technical requirements to achieve accreditation. This is because multiple factors beyond training and the implementation of quality management systems intervene in the current ISO 15189:2022 process.