Introduction: The pre-analytical phase is a crucial step in the workflow of medical laboratories, as errors during this stage can significantly impact the subsequent analytical and post-analytical phases.
Aim: This study provides a comprehensive analysis of the causes of pre-analytical non-conformities and the corrective procedures implemented in the Parasitology-Mycology Central Laboratory of the Ibn Sina University Hospital Center in Rabat.
Methods: Over a 30-month period, we evaluated compliance with ISO 15189:2022 standards using a self-assessment grid to identify areas for improvement. Non-conformities were categorized based on their root causes to gain insight into the underlying issues. We conducted a Pareto analysis to identify the most significant problems in the pre-analytical phase. Additionally, we employed Failure Modes and Effects Analysis (FMEA) to assess potential risks associated with these non-conformities.
Results: The most frequent non-conformities identified included delays in sample transportation, reagent shortages, and identification-prescription errors. The FMEA categorized these non-conformities as high-risk, leading to several proposed corrective actions: enhancing transport protocols, implementing automated alerts for reagent shortages, improving staff training, and establishing better communication between departments and the laboratory.
Conclusion: This study emphasizes the need for a comprehensive approach to managing non-conformities in the pre-analytical phase. Involving everyone in the process and creating a culture of quality and responsibility are essential for improving laboratory efficiency and ensuring better patient outcomes. Additionally, continuous monitoring and evaluation through established quality indicators will support ongoing improvements in laboratory practices.
Keywords: Medical laboratory; Parasitology; Pre-analytical phase.