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Biorisk Management in High-Containment Laboratories: Assessment of Certification Systems and Need for Global Standardization.

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Τίτλος: Biorisk Management in High-Containment Laboratories: Assessment of Certification Systems and Need for Global Standardization.
Συγγραφείς: Garbuglia AR; Laboratory of Virology and Laboratories of Biosafety, National Institute for Infectious Diseases 'Lazzaro Spallanzani'-IRCCS, 00149 Rome, Italy., Zulian V; Laboratory of Virology and Laboratories of Biosafety, National Institute for Infectious Diseases 'Lazzaro Spallanzani'-IRCCS, 00149 Rome, Italy., Pauciullo S; Laboratory of Virology and Laboratories of Biosafety, National Institute for Infectious Diseases 'Lazzaro Spallanzani'-IRCCS, 00149 Rome, Italy., Lapa D; Laboratory of Virology and Laboratories of Biosafety, National Institute for Infectious Diseases 'Lazzaro Spallanzani'-IRCCS, 00149 Rome, Italy.
Πηγή: Pathogens (Basel, Switzerland) [Pathogens] 2026 Sep 07; Vol. 15 (9). Date of Electronic Publication: 2026 Sep 07.
Τύπος έκδοσης: Journal Article; Review
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: MDPI AG Country of Publication: Switzerland NLM ID: 101596317 Publication Model: Electronic Cited Medium: Internet ISSN: 2076-0817 (Electronic) Linking ISSN: 20760817 NLM ISO Abbreviation: Pathogens Subsets: MEDLINE
Imprint Name(s): Original Publication: Basel, Switzerland : MDPI AG, 2012-
Ιατρικοί όροι (MeSH): Containment of Biohazards*/standards , Containment of Biohazards*/methods , Laboratories*/standards , Laboratory Infection*/prevention & control , Certification*, Humans
Περίληψη: Laboratory-acquired infections (LAIs) and accidental pathogen escape from laboratory settings (APELS) are still a significant concern, even with biosafety guidelines and manuals in place. The actual number of these events is probably underestimated because there are no mandatory reporting systems or standard surveillance frameworks. In this review, a clear overview is given about the evolution of biosafety, the worldwide distribution and governance of high-containment laboratories (BSL-3 and BSL-4), and the key factors that lead to laboratory incidents. The focus is specifically on human error, inadequate training, and differences in standard operating procedures as primary causes of biosafety failures. Furthermore, current regulatory frameworks are described, pointing out the lack of consistency in laboratory practices, infrastructure needs, and national policies, especially the variances in biosafety level recommendations for high-risk pathogens. Certification systems as potential tools to improve standardization and consistency in operations are discussed. Among these, ISO 35001 is a detailed standard for managing biorisks, including risk assessment, staff training, incident reporting, and processes for ongoing improvement. However, its use is still limited, and certification is not mandatory for laboratory licensing everywhere. Additionally, existing standards do not fully cover structural aspects and national differences in how pathogens are handled. This review also highlights the limitations of current certification systems and proposes recommendations to strengthen and harmonize standardization procedures across high-containment laboratories. Overall, this work highlights the need for greater global consistency in biosafety practices, suggesting the establishment of an independent international auditing body as an important step toward enhancing global health security and laboratory readiness.
References: Health Lab Sci. 1976 Apr;13(2):105-14. (PMID: 946794)
Am J Public Health Nations Health. 1947 Apr;37(4):431-40. (PMID: 20292057)
Bull World Health Organ. 2025 Jun 1;103(6):383-391. (PMID: 40511402)
Science. 2024 Sep 13;385(6714):1152. (PMID: 39265006)
Infect Dis Poverty. 2016 Jun 23;5(1):62. (PMID: 27333890)
Health Secur. 2015 Sep-Oct;13(5):345-8. (PMID: 26348927)
Biosecur Bioterror. 2007 Mar;5(1):75-85. (PMID: 17437355)
Bacteriol Rev. 1961 Sep;25:210-6. (PMID: 14005531)
Nature. 2008 Sep 18;455(7211):290-1. (PMID: 18800118)
PLoS Negl Trop Dis. 2021 Mar 15;15(3):e0009280. (PMID: 33720942)
Epidemiol Infect. 2026 Jan 02;154:e16. (PMID: 41480662)
J Clin Microbiol. 2020 Mar 25;58(4):. (PMID: 32024724)
Appl Biosaf. 2025 Mar 07;30(1):4-10. (PMID: 40151385)
F1000Res. 2021 Aug 4;10:752. (PMID: 35903214)
Emerg Infect Dis. 2024 May;30(5):864-873. (PMID: 38666553)
Clin Infect Dis. 2022 Nov 14;75(10):1845-1847. (PMID: 35675697)
Risk Anal. 2024 Aug;44(8):1896-1906. (PMID: 38488186)
Ann Med. 2022 Dec;54(1):1859-1866. (PMID: 35786155)
MMWR Suppl. 2015 Apr 10;64(2):47-53. (PMID: 25856538)
Euro Surveill. 2016;21(11):30169. (PMID: 27020766)
Biosaf Health. 2025 Jul 10;7(4):209-217. (PMID: 40918204)
Public Health Rep (1896). 1964 Jul;79:619-33. (PMID: 14177793)
Appl Biosaf. 2024 Mar 1;29(1):45-56. (PMID: 38434103)
Health Secur. 2016 Sep-Oct;14(5):323-30. (PMID: 27559843)
Rev Sci Tech. 2018 Dec;37(3):857-883. (PMID: 30964462)
Am J Public Health Nations Health. 1953 Nov;43(11):1428-37. (PMID: 13104703)
Presse Med. 2026 Sep;55(3):104277. (PMID: 40188869)
Nature. 2008 Oct 23;455(7216):1012. (PMID: 18948912)
Am J Public Health Nations Health. 1951 Jul;41(7):769-81. (PMID: 14846999)
Lancet Microbe. 2024 Feb;5(2):e194-e202. (PMID: 38101440)
J Gen Virol. 2016 Nov;97(11):2799-2808. (PMID: 27667586)
Appl Biosaf. 2021 Sep;26(Suppl 1):S34-S42. (PMID: 36032652)
PLoS One. 2017 Sep 8;12(9):e0182315. (PMID: 28886039)
Grant Information: 101132215 European Union
Contributed Indexing: Keywords: BSL-3; BSL-4; accreditation; biorisk; biosafety; biosecurity; certification; high-containment laboratories; standardization
Entry Date(s): Date Created: 20260926 Date Completed: 20260926 Latest Revision: 20260929
Update Code: 20260929
PubMed Central ID: PMC13609949
DOI: 10.3390/pathogens15090951
PMID: 42796719
Βάση Δεδομένων: MEDLINE
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  Data: Laboratory-acquired infections (LAIs) and accidental pathogen escape from laboratory settings (APELS) are still a significant concern, even with biosafety guidelines and manuals in place. The actual number of these events is probably underestimated because there are no mandatory reporting systems or standard surveillance frameworks. In this review, a clear overview is given about the evolution of biosafety, the worldwide distribution and governance of high-containment laboratories (BSL-3 and BSL-4), and the key factors that lead to laboratory incidents. The focus is specifically on human error, inadequate training, and differences in standard operating procedures as primary causes of biosafety failures. Furthermore, current regulatory frameworks are described, pointing out the lack of consistency in laboratory practices, infrastructure needs, and national policies, especially the variances in biosafety level recommendations for high-risk pathogens. Certification systems as potential tools to improve standardization and consistency in operations are discussed. Among these, ISO 35001 is a detailed standard for managing biorisks, including risk assessment, staff training, incident reporting, and processes for ongoing improvement. However, its use is still limited, and certification is not mandatory for laboratory licensing everywhere. Additionally, existing standards do not fully cover structural aspects and national differences in how pathogens are handled. This review also highlights the limitations of current certification systems and proposes recommendations to strengthen and harmonize standardization procedures across high-containment laboratories. Overall, this work highlights the need for greater global consistency in biosafety practices, suggesting the establishment of an independent international auditing body as an important step toward enhancing global health security and laboratory readiness.
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  Data: Health Lab Sci. 1976 Apr;13(2):105-14. (PMID: <searchLink fieldCode="PM" term="%22946794%22">946794)</searchLink><br />Am J Public Health Nations Health. 1947 Apr;37(4):431-40. (PMID: <searchLink fieldCode="PM" term="%2220292057%22">20292057)</searchLink><br />Bull World Health Organ. 2025 Jun 1;103(6):383-391. (PMID: <searchLink fieldCode="PM" term="%2240511402%22">40511402)</searchLink><br />Science. 2024 Sep 13;385(6714):1152. (PMID: <searchLink fieldCode="PM" term="%2239265006%22">39265006)</searchLink><br />Infect Dis Poverty. 2016 Jun 23;5(1):62. (PMID: <searchLink fieldCode="PM" term="%2227333890%22">27333890)</searchLink><br />Health Secur. 2015 Sep-Oct;13(5):345-8. (PMID: <searchLink fieldCode="PM" term="%2226348927%22">26348927)</searchLink><br />Biosecur Bioterror. 2007 Mar;5(1):75-85. (PMID: <searchLink fieldCode="PM" term="%2217437355%22">17437355)</searchLink><br />Bacteriol Rev. 1961 Sep;25:210-6. (PMID: <searchLink fieldCode="PM" term="%2214005531%22">14005531)</searchLink><br />Nature. 2008 Sep 18;455(7211):290-1. (PMID: <searchLink fieldCode="PM" term="%2218800118%22">18800118)</searchLink><br />PLoS Negl Trop Dis. 2021 Mar 15;15(3):e0009280. (PMID: <searchLink fieldCode="PM" term="%2233720942%22">33720942)</searchLink><br />Epidemiol Infect. 2026 Jan 02;154:e16. (PMID: <searchLink fieldCode="PM" term="%2241480662%22">41480662)</searchLink><br />J Clin Microbiol. 2020 Mar 25;58(4):. (PMID: <searchLink fieldCode="PM" term="%2232024724%22">32024724)</searchLink><br />Appl Biosaf. 2025 Mar 07;30(1):4-10. (PMID: <searchLink fieldCode="PM" term="%2240151385%22">40151385)</searchLink><br />F1000Res. 2021 Aug 4;10:752. (PMID: <searchLink fieldCode="PM" term="%2235903214%22">35903214)</searchLink><br />Emerg Infect Dis. 2024 May;30(5):864-873. (PMID: <searchLink fieldCode="PM" term="%2238666553%22">38666553)</searchLink><br />Clin Infect Dis. 2022 Nov 14;75(10):1845-1847. (PMID: <searchLink fieldCode="PM" term="%2235675697%22">35675697)</searchLink><br />Risk Anal. 2024 Aug;44(8):1896-1906. (PMID: <searchLink fieldCode="PM" term="%2238488186%22">38488186)</searchLink><br />Ann Med. 2022 Dec;54(1):1859-1866. (PMID: <searchLink fieldCode="PM" term="%2235786155%22">35786155)</searchLink><br />MMWR Suppl. 2015 Apr 10;64(2):47-53. (PMID: <searchLink fieldCode="PM" term="%2225856538%22">25856538)</searchLink><br />Euro Surveill. 2016;21(11):30169. (PMID: <searchLink fieldCode="PM" term="%2227020766%22">27020766)</searchLink><br />Biosaf Health. 2025 Jul 10;7(4):209-217. (PMID: <searchLink fieldCode="PM" term="%2240918204%22">40918204)</searchLink><br />Public Health Rep (1896). 1964 Jul;79:619-33. (PMID: <searchLink fieldCode="PM" term="%2214177793%22">14177793)</searchLink><br />Appl Biosaf. 2024 Mar 1;29(1):45-56. (PMID: <searchLink fieldCode="PM" term="%2238434103%22">38434103)</searchLink><br />Health Secur. 2016 Sep-Oct;14(5):323-30. (PMID: <searchLink fieldCode="PM" term="%2227559843%22">27559843)</searchLink><br />Rev Sci Tech. 2018 Dec;37(3):857-883. (PMID: <searchLink fieldCode="PM" term="%2230964462%22">30964462)</searchLink><br />Am J Public Health Nations Health. 1953 Nov;43(11):1428-37. (PMID: <searchLink fieldCode="PM" term="%2213104703%22">13104703)</searchLink><br />Presse Med. 2026 Sep;55(3):104277. (PMID: <searchLink fieldCode="PM" term="%2240188869%22">40188869)</searchLink><br />Nature. 2008 Oct 23;455(7216):1012. (PMID: <searchLink fieldCode="PM" term="%2218948912%22">18948912)</searchLink><br />Am J Public Health Nations Health. 1951 Jul;41(7):769-81. (PMID: <searchLink fieldCode="PM" term="%2214846999%22">14846999)</searchLink><br />Lancet Microbe. 2024 Feb;5(2):e194-e202. (PMID: <searchLink fieldCode="PM" term="%2238101440%22">38101440)</searchLink><br />J Gen Virol. 2016 Nov;97(11):2799-2808. (PMID: <searchLink fieldCode="PM" term="%2227667586%22">27667586)</searchLink><br />Appl Biosaf. 2021 Sep;26(Suppl 1):S34-S42. (PMID: <searchLink fieldCode="PM" term="%2236032652%22">36032652)</searchLink><br />PLoS One. 2017 Sep 8;12(9):e0182315. (PMID: <searchLink fieldCode="PM" term="%2228886039%22">28886039)</searchLink>
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