Evaluating Biological Risks in Biomedical Laboratories of Primary Health Care
Abstract
Biomedical laboratories in primary health care centers play a critical role in disease detection, diagnosis, and management. However, the handling of diagnostic samples presents significant biological risks, particularly when biosafety measures are insufficient. This study focuses on analyzing the biological risks in 35 BSL-2 biomedical laboratories within health facilities in Athens, Greece, by examining compliance with biosafety regulations, personnel safety awareness, and biorisk management practices. A cross-sectional survey was conducted combining a customized checklist and a structured health and safety questionnaire, both developed based on the existing literature, including the international biosafety guidelines (BMBL 6th ed., WHO Biosafety Program Management, 2020). On-site evaluations were performed by a certified biorisk management advisor, and 158 laboratory professionals anonymously completed questionnaires on biosafety practices. The collected data were analyzed qualitatively, and where possible, quantitatively, by using SPSS software and p-values from the McNemar test. The results revealed widespread deficiencies in biosafety culture and risk management. Key gaps were identified in all layers of engineering controls, administrative controls, personal protective equipment (PPE), and emergency preparedness. Many laboratories failed to meet international biosafety standards set by organizations such as the WHO, CDC, and ECDC, as well as Greek legislation, highlighting the need for urgent improvements. To address these issues and mitigate the observed gaps, the implementation of comprehensive Biorisk Management Systems, enhanced biosafety training, and stricter enforcement of national and European biosafety regulations is strongly recommended. These measures are essential to protect laboratory personnel, the surrounding community, and the environment from lab-acquired infections and other biological threats.
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2. Blacksell, S. D., Dhawan, S., Kusumoto, M., Lě, K., Summermatter, K., O’Keefe, J., Kozlovac, J. P., Almuhairi, S. S., Sendow, I., Scheel, C. M., Ahumibe, A., Masuku, Z. M., Bennett, A., Kojima, K., Harper, D. R., & Hamilton, K. (2023). Laboratory-acquired infections and pathogen escapes worldwide between 2000 and 2021: a scoping review. The Lancet Microbe. https://doi.org/10.1016/s2666-5247(23)00319-1
3. Brown, C.S., Zwetyenga, J., Berdieva, M., Volkova T., Cojocaru R., Costic, N., Ciobanu, S., Hasanova, S., van Beers, S., & Oskam, L. (2015). New policy-formulation methodology paves the way for sustainable laboratory systems in Europe. Public Health Panor. 2015; 1(1):41-7.
4. Centers for Disease Control and Prevention (CDC) (2020). U.S. Department of Health and Human Services. Public Health Service. National Institutes of Health. Biosafety in Microbiological and Biomedical Laboratories. 6th ed. Available at: https://www.cdc.gov/laboratories/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf (Accessed: 23 March 2025)
5. Centers for Disease Control and Prevention (CDC) & National Institute for Occupational Safety and Health (NIOSH) (2021). Hierarchy of Controls. Available at: https://www.cdc.gov/niosh/learning/safetyculturehc/module-3/2.html (Accessed: 23 March 2025)
6. Directive 2000/54/EC (2000). Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC). Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32000L0054&from=EN (Accessed: 23 March 2025)
7. Federal Select Agent Program (FSAP), Division of Regulatory Science and Compliance (DRSC) at the Centers for Disease Control and Prevention (CDC). Inspection Checklists. Available at: https://www.selectagents.gov/compliance/preparing.htm (Accessed: 23 March 2025)
8. Gribble, L.A., Tria, E.S., & Wallis, L. (2015). ‘The AMP Model,’ in Salerno, R.M. and Gaudioso, J. (ed.) Laboratory Biorisk Management: Biosafety and Biosecurity, Boca Raton: CRC Press, Taylor & Francis Group, pp. 31-42.
9. International Organization for Standardization (ISO) (2019). ISO 35001:2019. Biorisk management for laboratories and other related organizations. Available at: https://www.iso.org/standard/71293.html (Accessed: 23 March 2025)
10. International Organization for Standardization (ISO), (2020). ISO 15190:2020. Medical laboratories – Requirements for safety. Available at: https://www.iso.org/standard/72191.html (Accessed: 23 March 2025)
11. International Organization for Standardization (ISO), (2022). ISO 15189:2022. Medical laboratories – Requirements for quality and competence. Available at: https://www.iso.org/standard/76677.html (Accessed: 23 March 2025)
12. National Institutes of Health (NIH) (2024). NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health. Available at: https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf (Accessed: 23 March 2025)
13. Presidential Decree 102/2020 (Government Gazette 244/A’/07.12.2020) (2020). Available at: https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20200100244 and https://www.gov.gr/sdg/work-and-retirement/health-and-safety-at-work/independent-authority-labour-inspectorate/obligations-of-companies (Accessed: 23 March 2025)
14. Tun, T. A. (2017). Biomedical Laboratory: its safety and risk management. Journal of Experimental & Biomedical Sciences/Biomedical Science Letters, 23(3), 155–160. https://doi.org/10.15616/bsl.2017.23.3.155
15. Tziaferi, S., Sourtzi, P., Kalokairinou, A., Sgourou, E., Koumoulas, E., & Velonakis, E. (2011b). Risk assessment of physical hazards in Greek hospitals combining staff’s perception, experts’ evaluation and objective measurements. Safety and Health at Work, 2(3), 260–272. https://doi.org/10.5491/shaw.2011.2.3.260
16. World Health Organization (WHO) (2004). Laboratory Biosafety Manual. 3rd ed. Available at: https://www.who.int/publications/i/item/9241546506 (Accessed: 23 March 2025)
17. World Health Organization (WHO) (2020). Laboratory Biosafety Manual. 4th ed. Available at: https://www.who.int/publications/i/item/9789240011311 (Accessed: 23 March 2025)
18. World Health Organization (WHO) (2020). Laboratory biosafety manual, 4th edition: Biosafety programme management. Annex 2 (Biosafety risk assessment template). Available at: https://www.who.int/publications/i/item/9789240011434 (Accessed: 23 March 2025)
19. Wurtz, N., Papa, A., Hukić, M., Di, A., Leparc-Goffart, I., Leroy, E. M., Landini, M., Sekeyová, Z., Dumler, J. S., Bădescu, D., Busquets, N., Calistri, A., Parolin, C., Palù, G., Christova, I., Maurin, M., La Scola, B., & Raoult, D. (2016). Survey of laboratory-acquired infections around the world in biosafety level 3 and 4 laboratories. European Journal of Clinical Microbiology & Infectious Diseases, 35(8), 1247–1258. https://doi.org/10.1007/s10096-016-2657-1
Copyright (c) 2025 Dionysios Vourtsis, Efstathia Papageorgiou, Anastasios Kriebardis, Gijsbert van Willigen, Kostas Kotrokois, Petros Karkalousos

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