Biosafety and Biosecurity in Diagnostic Laboratories: Strengthening Risk Management, Containment Strategies, and Global Regulatory Compliance
Dr. Harsh Vardhan¹ | Mrs. Komal Sharma² | Mr. Manish Samyal³
¹Tutor/Senior Resident, Department of Microbiology, Saraswathi Institute of Medical Sciences, Hapur
²Assistant Professor, Child Health Nursing (CHN), Saraswathi College of Nursing, Hapur
³Assistant Professor, Department of Pharmaceutical Chemistry, Saraswathi College of Pharmacy, Hapur
Abstract
Diagnostic laboratories are essential components of modern healthcare systems, supporting clinical diagnosis, disease surveillance, and epidemiological monitoring. These laboratories routinely handle infectious biological materials that may pose risks to personnel, healthcare systems, and surrounding communities if proper biosafety and biosecurity measures are not implemented. The increasing global burden of infectious diseases, expansion of high-containment laboratories, and growth of molecular diagnostic technologies have intensified the need for comprehensive biosafety and biosecurity frameworks. This cross-sectional analytical study evaluates biosafety and biosecurity practice implementation in diagnostic laboratories and analyses their effectiveness in reducing laboratory-associated risks across 214 laboratory biosafety audit records and safety programme reports. Biosafety protocol compliance demonstrated the strongest association with laboratory-associated risk reduction (F=7.24, p=0.001), followed by staff training frequency (F=6.47, p=0.002) and containment equipment maintenance (F=5.93, p=0.003). AI-powered risk monitoring, digital biosafety management systems, and comprehensive regulatory compliance frameworks significantly reduce laboratory-associated infection and biosecurity risks. The study provides evidence-based recommendations for strengthening laboratory biosafety governance in clinical and research settings.
Keywords: Biosafety, biosecurity, diagnostic laboratories, laboratory-associated infections, containment, AI risk monitoring, regulatory compliance, biorisk management.
