Managing Biological Risks in Biomedical laboratories of Public Hospitals in Athens, Greece, based on the Biosafety requirements
Keywords:
Biosafety, Biorisk Management, Risk Assessment, Biosafety legislation, Biomedical laboratories
Abstract
Objectives: The aim of the present study was to review the laboratory workers’ perception on the biological risks in Biomedical laboratories of Public Hospitals in Athens, Greece, to evaluate how they are managing the biological materials and to propose mitigation measures according to the existing risk, the local legislations and the international Biosafety guidelines.
Materials and Methods: The study was designed as a cross-sectional study with a detailed health and safety (H&S) questionnaire focused on biosafety and biorisk management. A total of 36 biomedical laboratories Biosafety Level-2 in 20 public hospitals were assessed for their biosafety containment and compliance with biosafety practices. Laboratory staff (medical laboratory doctors, medical laboratory technologists, laboratory assistants, biologists and biochemists) (n = 415) completed the questionnaire.
Results: The results showed, that a significant percentage of laboratories lacked proper management of the biological agents and biological materials in general, thus more specific: restricted access 48.9%, controlled and independent ventilation 36.6%, use of BSCs 31.8%, biorisk management system in place 31.6%, risk assessments 28.4%, biosafety manuals 21.4%, SOPs 35.9%, assigned biosafety officers 10.8%, occupational Doctor 34.9%, accidents reporting 25.5%, emergencies plan 34.2% and biosafety training programs 28.2%.
Conclusion: There are marked deficiencies in containment and administrative controls, as well as in the implementation of the Greek and EU biosafety legislation. This emphasize the urgency of addressing critical gaps in biosafety and in emergency preparedness in Greek biomedical laboratories. Therefore a Biorisk Management System, risk assessments, SOPs, assignment of a Biosafety Officer, staff trainings and emergency response plans should be developed, applied and enforced, in compliance with the local and European legislation and guidelines.
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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. 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.
3. 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 œLancet Microbe. https://doi.org/10.1016/s2666-5247(23)00319-1
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/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf (Accessed: 7 May 2024)
5. Centers for Disease Control and Prevention (CDC), (2015). Hierarchy of Controls. Available at: https://www.cdc.gov/niosh/topics/hierarchy/ (Accessed: 7 May 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: 7 May 2024)
7. European Committee for Standardization, (2011). CEN Workshop Agreement. CWA 15793:2011, Laboratory Biorisk Management Standard. Available at:
https://internationalbiosafety.org/wp-content/uploads/2019/08/CWA-15793-English.pdf (Accessed: 7 May 2024)
8. Farr, J.M., Shatkin, L. (2004). Best jobs for the 21st century. JIST Works. p. 460. ISBN 978-1-56370-961-6.
9. Gaudioso, J. M., & Zemlo, T. (2007). Survey of Bioscience Research Practices in Asia: Implications for Biosafety and Biosecurity. Applied Biosafety, 12(4), 260–267. https://doi.org/10.1177/153567600701200408
10. Gribble, L.A., Tria, E.S., and 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.
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: 7 May 2024)
12. International Organization for Standardization (ISO), (2020). ISO 15190:2020. Medical laboratories – Requirements for safety. Available at: https://www.iso.org/standard/72191.html (Accessed: 7 May 2024)
13. 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: 7 May 2024)
14. Kaufman, S. G., Mathews, H., & Alderman, L. M. (2007). Biosafety officers, behavioral compliance strategies, and their effects on laboratory practices. Applied Biosafety, 12(2), 75–78. https://doi.org/10.1177/153567600701200202
15. Kessel, M. (2014). Neglected diseases, delinquent diagnostics. Science Translational Medicine, 6(226). https://doi.org/10.1126/scitranslmed.3008194
16. 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: 7 May 2024)
17. Pike, R.M. (1976). Laboratory-associated infections. Summary and analysis of 3921 cases. Health and Laboratory Science vol 13, page 105-114.
18. 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: 7 May 2024)
19. Salerno, M.R. and 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.
20. 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: 7 May 2024)
21. 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
22. 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
23. 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
24. 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
25. Weinstein RA., 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
26. World Health Organization (WHO), (2004). Laboratory Biosafety Manual. 3rd ed. Available at: https://www.who.int/publications/i/item/9241546506 (Accessed: 7 May 2024)
27. 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: 7 May 2024)
28. 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: 7 May 2024)
29. World Health Organization (WHO), (2011). Laboratory Quality Management System: handbook, Available at: https://www.who.int/publications/i/item/9789241548274 (Accessed: 7 May 2024)
30. 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: 7 May 2024)
31. 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: 7 May 2024)
32. World Health Organization (WHO), (2020). Laboratory Biosafety Manual. 4th ed. Available at: https://www.who.int/publications/i/item/9789240011311 (Accessed: 7 May 2024)
33. World Health Organization (WHO), (2020). Laboratory biosafety manual, 4th edition: Biosafety programme management. Available at: https://www.who.int/publications/i/item/9789240011434
(Accessed: 7 May 2024)
34. 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
2. 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.
3. 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 œLancet Microbe. https://doi.org/10.1016/s2666-5247(23)00319-1
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/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf (Accessed: 7 May 2024)
5. Centers for Disease Control and Prevention (CDC), (2015). Hierarchy of Controls. Available at: https://www.cdc.gov/niosh/topics/hierarchy/ (Accessed: 7 May 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: 7 May 2024)
7. European Committee for Standardization, (2011). CEN Workshop Agreement. CWA 15793:2011, Laboratory Biorisk Management Standard. Available at:
https://internationalbiosafety.org/wp-content/uploads/2019/08/CWA-15793-English.pdf (Accessed: 7 May 2024)
8. Farr, J.M., Shatkin, L. (2004). Best jobs for the 21st century. JIST Works. p. 460. ISBN 978-1-56370-961-6.
9. Gaudioso, J. M., & Zemlo, T. (2007). Survey of Bioscience Research Practices in Asia: Implications for Biosafety and Biosecurity. Applied Biosafety, 12(4), 260–267. https://doi.org/10.1177/153567600701200408
10. Gribble, L.A., Tria, E.S., and 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.
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: 7 May 2024)
12. International Organization for Standardization (ISO), (2020). ISO 15190:2020. Medical laboratories – Requirements for safety. Available at: https://www.iso.org/standard/72191.html (Accessed: 7 May 2024)
13. 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: 7 May 2024)
14. Kaufman, S. G., Mathews, H., & Alderman, L. M. (2007). Biosafety officers, behavioral compliance strategies, and their effects on laboratory practices. Applied Biosafety, 12(2), 75–78. https://doi.org/10.1177/153567600701200202
15. Kessel, M. (2014). Neglected diseases, delinquent diagnostics. Science Translational Medicine, 6(226). https://doi.org/10.1126/scitranslmed.3008194
16. 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: 7 May 2024)
17. Pike, R.M. (1976). Laboratory-associated infections. Summary and analysis of 3921 cases. Health and Laboratory Science vol 13, page 105-114.
18. 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: 7 May 2024)
19. Salerno, M.R. and 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.
20. 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: 7 May 2024)
21. 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
22. 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
23. 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
24. 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
25. Weinstein RA., 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
26. World Health Organization (WHO), (2004). Laboratory Biosafety Manual. 3rd ed. Available at: https://www.who.int/publications/i/item/9241546506 (Accessed: 7 May 2024)
27. 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: 7 May 2024)
28. 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: 7 May 2024)
29. World Health Organization (WHO), (2011). Laboratory Quality Management System: handbook, Available at: https://www.who.int/publications/i/item/9789241548274 (Accessed: 7 May 2024)
30. 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: 7 May 2024)
31. 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: 7 May 2024)
32. World Health Organization (WHO), (2020). Laboratory Biosafety Manual. 4th ed. Available at: https://www.who.int/publications/i/item/9789240011311 (Accessed: 7 May 2024)
33. World Health Organization (WHO), (2020). Laboratory biosafety manual, 4th edition: Biosafety programme management. Available at: https://www.who.int/publications/i/item/9789240011434
(Accessed: 7 May 2024)
34. 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
2024-05-20
How to Cite
Vourtsis, D., Papageorgiou, E., Kriebardis, A., Karikas, G. A., Willigen, G. van, Kotrokois, K., Dounias, G., & Karkalousos, P. (2024). Managing Biological Risks in Biomedical laboratories of Public Hospitals in Athens, Greece, based on the Biosafety requirements. European Scientific Journal, ESJ, 29, 438. Retrieved from https://eujournal.org/index.php/esj/article/view/18151
Section
ESI Preprints
Copyright (c) 2024 Dionysios Vourtsis, Efstahia Papageorgiou, Anastasios Kriebardis, George Albert Karikas, Gijsbert van Willigen, Kostantinos Kotrokois, Georgios Dounias, Petros Karkalousos
This work is licensed under a Creative Commons Attribution 4.0 International License.
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