Clinical Laboratory Biosafety Gaps: Lessons Learned from Past Outbreaks Reveal a Path to a Safer Future

Area of Science:

• Clinical Laboratory Science
• Public Health Microbiology
• Biosafety and Biosecurity

Background:

• Clinical laboratory professionals often lack knowledge of infectious agents in patient specimens, complicating biosafety measures.
• The 2014 Ebola outbreak underscored the critical need for robust biosafety in clinical laboratories, as concerns led to diagnostic delays and adverse patient outcomes.

Purpose of the Study:

• To evaluate the capability of clinical laboratories to manage biosafety risks and safely test patient specimens.
• To identify gaps and opportunities for improving biosafety practices within diverse clinical laboratory settings.

Main Methods:

• A collaborative review involving subject matter experts from various laboratory types and the federal government.
• Retrospective analysis of biosafety gaps and successful strategies, including case studies from real-world outbreak scenarios.

Main Results:

• Current biosafety guidance, often based on research laboratory practices, may not adequately address the unique complexities of clinical laboratory environments, equipment, and processes.
• Identified gaps span risk assessment, laboratory disciplines, specimen handling, equipment safety, disinfection, personal protective equipment, waste management, training, accreditation, and ethical considerations.

Conclusions:

• Significant gaps in knowledge and practice exist, necessitating collaborative and comprehensive solutions to enhance clinical laboratory biosafety.
• Improved biosafety measures are essential for effectively managing emerging infectious disease threats and ensuring patient and public health.