Risk Management in a Clinical Biochemistry Laboratory.

Introduction: To ensure compliance with new laboratory standards, it is imperative to adopt risk-based thinking, which involves a systematic examination of the functions, procedures, and activities associated with risks and opportunities. This article aims to explore the implementation of risk-based thinking in medical biology laboratories and to highlight the challenges inherent in this approach. Materials and Methods: This descriptive study was conducted in the biochemistry laboratory of the Main Military Teaching Hospital of Tunis during the first half of 2024. A risk analysis was performed by a working group to identify failures by analyzing non-conformities recorded during the study period. The group adopted the Failure Mode and Effects Analysis (FMEA) methodology, an inductive approach well-suited to process analysis and mastered by all participants. Subsequently, a corrective action plan was developed for each process phase. Results: Across the entire laboratory workflow, 33 distinct failure modes were identified and cataloged for each step, followed by a criticality analysis. The distribution of these failures was 36.36% in the pre-analytical phase, 33.34% in the analytical phase, and 30.3% in the post-analytical phase. A review of the severity of their effects revealed that a significant portion constituted major risks. Conclusion: In response to the major risks identified at each stage of the laboratory workflow, a corrective action plan has been proposed. This plan outlines specific actions designed to reduce the criticality of these risks and enhance patient safety and quality of service.