Volume 9 Number 1 2025
Assessment of Risk Management Practices in Clinical Laboratories and Their Impact on Patient Safety
Alaa Mosfer Eid Alotaibi 1, Mohammed Houssain Hamdi 2, Abdullah Mohammed Alomi 2, Abdulrahman Yahya Masmali 2, Ahmed Saleh Ahmed Alzahrani 2, Mohammed Ahmed Ibrahim Alshaikhi 3, Ibrahim Abdu Aljabri 3, Ali Saleh Alghamdi 3
Integrative Biomedical Research (Journal of Angiotherapy) 7(1) 1-8 https://doi.org/10.25163/angiotherapy.7110327
Submitted: 01 May 2023 Revised: 14 June 2023 Published: 15 June 2023
Abstract
Background: Clinical laboratories play a crucial role in healthcare, influencing up to 70% of medical decisions. However, errors in pre-analytical, analytical, and post-analytical phases can compromise patient safety. Risk management practices are essential to minimize these errors and enhance diagnostic accuracy. This article evaluates risk management strategies in clinical laboratories and their impact on patient safety, focusing on standardized frameworks, error reduction, and compliance with international guidelines. Methods: The study reviews existing literature, guidelines from the Clinical and Laboratory Standards Institute (CLSI) and ISO 15189, and empirical case studies. Tools such as Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and Corrective and Preventive Actions (CAPA) are analyzed for their effectiveness in risk mitigation. Results: Structured risk management reduces laboratory errors significantly, particularly in the pre-analytical phase, which accounts for over 50% of errors. Implementation of automated systems, staff training, and continuous monitoring improves accuracy and turnaround times. Laboratories adhering to ISO 15189 and CLSI guidelines report lower error rates and better compliance. Conclusion: Effective risk management enhances patient safety by minimizing diagnostic errors. Future directions include adopting predictive analytics, improving interdisciplinary collaboration, and fostering a non-punitive safety culture.
Keywords: Risk management, clinical laboratories, patient safety, FMEA, ISO 15189, diagnostic errors.
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