Biosafety and Risk Management Protocols in Clinical Laboratories: Review of Historical Challenges and Future Directions in the Context of Emerging Infectious Diseases

Abstract

Background: Clinical laboratories are essential for patient care and public health, particularly during infectious disease outbreaks. The 2014 Ebola outbreak highlighted significant deficiencies in biosafety protocols within clinical laboratories, which adversely affected patient outcomes. This study explores the challenges and current state of biosafety and risk management in clinical laboratories, particularly in light of recent pandemics.

Methods: A comprehensive review of literature and guidelines related to laboratory biosafety was conducted, focusing on incidents during the Ebola and COVID-19 outbreaks. The analysis included regulatory frameworks, existing biosafety protocols, and case studies demonstrating lapses in safety measures.

Results: Findings indicate that many clinical laboratories operate under minimal regulatory oversight, particularly those with a CLIA Certificate of Waiver. A lack of standardized biosafety practices has been identified, leading to increased risks of laboratory-acquired infections (LAIs). The review also revealed that public health laboratories, while better equipped, still face challenges in maintaining biosafety standards due to resource constraints and the rapid emergence of new infectious agents.

Conclusion: The study underscores the urgent need for enhanced biosafety protocols and regulatory frameworks in clinical laboratories to mitigate risks associated with emerging infectious diseases. Collaborative efforts among healthcare professionals, regulatory bodies, and laboratory experts are essential to develop comprehensive strategies that ensure the safety of laboratory personnel and the reliability of diagnostic testing.