Combining Biosafety Experts’ Evaluations and Workers’ Perceptions to Disclose Biological Risks in Biomedical Laboratories

  • Dionysios Vourtsis Department of Biomedical Sciences, University of West Attica, Athens, Greece
  • Efstathia Papageorgiou Department of Biomedical Sciences, University of West Attica, Athens, Greece
  • Anastasios Kriebardis Department of Biomedical Sciences, University of West Attica, Athens, Greece
  • George Albert Karikas Department of Biomedical Sciences, University of West Attica, Athens, Greece
  • Gijsbert van Willigen Medical Center, Leiden University, Leiden, Holland
  • Kostas Kotrokois Department of Public Health Policies, University of West Attica, Athens, Greece
  • Georgios Dounias Department of Public Health Policies, University of West Attica, Athens, Greece
  • Petros Karkalousos Department of Biomedical Sciences, University of West Attica, Athens, Greece
Keywords: Biorisk management, Biosafety, Biological risk assessment, Biomedical laboratories, Laboratory personnel awareness, Biosafety legislation

Abstract

Objectives: This paper focuses on examining the biological risks in biomedical laboratories of public hospitals in Athens, Greece, by combining expert evaluations and laboratory workers’ perception. It also aimed to review how personnel managed biological materials, assess the level of safety awareness and training of workers, and propose hazards mitigation actions according to local legislation and international biosafety guidelines. Materials and Methods: A total of 36 biosafety level 2 (BSL-2) laboratories in 20 hospitals were evaluated for biosafety containment specifications and adherence to biosafety procedures. The study was conducted as a cross-sectional survey using a checklist and a detailed health and safety (H&S) questionnaire, focusing on biosafety and biorisk management. An expert biosafety officer inspected and completed a checklist for each laboratory (n=36) across the 20 hospitals. Additionally, 415 lab professionals completed a biosafety-specific health and safety questionnaire. Results: Both the checklists and questionnaires revealed that, although some positive findings were observed, a significant percentage of laboratories lacked effective management of biological agents and materials overall. The main deficiencies identified included restricted access, safety equipment, standard operating procedures (SOPs), biorisk management systems, risk assessments, biosafety manuals, biosafety officers, accident reporting, and biosafety training programs. Conclusion: The significant shortcomings in some areas of engineering and administrative controls, as well as in the implementation of Greek and European biosafety legislation, demonstrate that the laboratories do not fully comply with  internationally accepted BSL-2 standards. Therefore, there is an urgent need for more comprehensive and proactive measures, adequate biosafety training for workers, and stricter enforcement of existing laws and directives to ensure the safety of laboratory professionals, the community, and the environment.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

PlumX Statistics

References

1. Bathula, S. R. & Rakhimol, A. (2017). Global Trends in biorisk Management. BioRisk, 12, 1–23. https://doi.org/10.3897/biorisk.12.12156
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: 27 July 2024)
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: 27 July 2024)
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: 27 July 2024)
7. Farr, J.M. & Shatkin, L. (2004). Best jobs for the 21st century. JIST Works. p. 460. ISBN 978-1-56370-961-6.
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: 27 July 2024)
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: 27 July 2024)
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: 27 July 2024)
12. Kessel, M. (2014). Neglected diseases, delinquent diagnostics. Science Translational Medicine, 6(226). https://doi.org/10.1126/scitranslmed.3008194
13. 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: 27 July 2024)
14. Pike, R.M. (1976). Laboratory-associated infections. Summary and analysis of 3921 cases. Health and Laboratory Science vol 13, page 105-114.
15. 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: 27 July 2024)
16. Raafat, H. & Sadhra, SS. (1999). In: Sadhra SS, Rampal KG, editors. Occupational health: risk assessment and management. 4th ed. Oxford (UK): Blackwell Science Ltd; 1999. pp. 177–193.
17. Salerno, M.R. & Gaudioso, J. (2015). ‘Introduction: The Case for Biorisk Management,’ in Salerno, M.R. and Gaudioso, J. (ed.) Laboratory Biorisk Management: Biosafety and Biosecurity, Boca Raton: CRC Press, Taylor & Francis Group, pp. 1-23.
18. Sandia National Laboratories (2014). Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document. Available at: https://internationalbiosafety.org/wp-content/uploads/2019/08/Laboratory-Biosafety-and-Biosecurity-Risk-Assessment.pdf (Accessed: 27 July 2024)
19. Sewell, D. L. (1995). Laboratory-associated infections and biosafety. Clinical Microbiology Reviews, 8(3), 389–405. https://doi.org/10.1128/cmr.8.3.389
20. 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
21. 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
22. Vourtsis, D., Papageorgiou, E., Kriebardis, A., Karikas, G. A., Van Willigen, G., & Karkalousos, P. (2022). A swift risk analysis for COVID-19 testing facilities using rapid tests. One Health & Risk Management, 3(4), 48–66. https://doi.org/10.38045/ohrm.2022.4.05
23. Weinstein, R. A. & Singh, K. (2009). Laboratory-acquired infections. Clinical Infectious Diseases, Volume 49, Issue 1, 1 July 2009, Pages 142–147,. https://doi.org/10.1086/599104
24. World Health Organization (WHO) (2004). Laboratory Biosafety Manual. 3rd ed. Available at: https://www.who.int/publications/i/item/9241546506 (Accessed: 27 July 2024)
25. World Health Organization (WHO) (2005). International Health Regulations, Joint external evaluation tool – third edition. Available at: https://www.who.int/publications/i/item/9789240051980 (Accessed: 27 July 2024)
26. World Health Organization (WHO) (2010). Responsible life sciences research for global health security, A guidance document. Available at: https://www.who.int/publications/i/item/WHO-HSE-GAR-BDP-2010.2 (Accessed: 27 July 2024)
27. World Health Organization (WHO) (2011). Laboratory Quality Management System: handbook, Available at: https://www.who.int/publications/i/item/9789241548274 (Accessed: 27 July 2024)
28. World Health Organization (WHO) (2014). Training Report, Hands-on Training Workshop on Cell Culture Techniques for the Laboratory Diagnosis of Polio/Enteroviruses and Measles/ Rubella in the Western Pacific Region. Available at: https://apps.who.int/iris/bitstream/handle/10665/208735/RS_2014_GE_11_HOK_eng.pdf?sequence=1 (Accessed: 27 July 2024)
29. World Health Organization (WHO) (2016). Development of national laboratory policies, Best practices document and facilitators’ guide. Available at: https://www.who.int/europe/publications/i/item/WHO-EURO-2017-5659-45424-65013 (Accessed: 27 July 2024)
30. World Health Organization (WHO) (2020). Laboratory Biosafety Manual. 4th ed. Available at: https://www.who.int/publications/i/item/9789240011311 (Accessed: 27 July 2024)
31. World Health Organization (WHO) (2020). Laboratory biosafety manual, 4th edition: Biosafety programme management. Available at: https://www.who.int/publications/i/item/9789240011434 (Accessed: 27 July 2024)
32. 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
Published
2025-01-15
How to Cite
Vourtsis, D., Papageorgiou, E., Kriebardis, A., Karikas, G. A., van Willigen, G., Kotrokois, K., Dounias, G., & Karkalousos, P. (2025). Combining Biosafety Experts’ Evaluations and Workers’ Perceptions to Disclose Biological Risks in Biomedical Laboratories. European Scientific Journal, ESJ, 21(37), 68. https://doi.org/10.19044/esj.2025.v21n37p68

Most read articles by the same author(s)