Biorisk Management Research Articles

Implementing an Organizational Culture of Biosafety and Biosecurity in the ŞAP Institute.

An organizational culture of biosafety and biosecurity is critical for effective management of transboundary animal diseases. One essential aspect of this work is keeping important pathogens studied in veterinary laboratories under control. Türkiye is among the countries that are both endemic and disease-free for foot-and-mouth disease (FMD) virus, and it has a unique institute dedicated to FMD diagnosis, control, and vaccine production. To build an organizational safety culture within this institute and strengthen awareness of the importance of safe and secure handling of FMD, 4 staff members previously trained in biorisk management developed and provided trainings to all institute staff. The institute's 173 personnel were divided into 3 groups by job description based on direct or indirect work with FMD virus. All 3 groups received training that addressed biosecurity, biosafety, biorisk awareness, and insider threat; the trainings varied in length by group. Three-quarters (n=130, 75%) of all institute staff completed their training and were asked to complete knowledge surveys using a Likert scale survey before and after their training. A majority (n=104, 80%) of those participants completed both the pretraining and posttraining surveys. All 3 training groups' posttraining surveys showed improved awareness above baseline scores, and all 3 groups scores reached the targeted threshold goal. Group 2 demonstrated a realization that some of the knowledge and habits they had acquired through experience were incorrect. Scores for several individual questions decreased at posttraining, and these results will need further evaluation. The overall training results prompted the institute to provide periodic updates to employees to sustain the organizational safety culture. With this study, the institute now has a dedicated group of biorisk management representatives. This work serves as a wake-up call for established institutions that rely on staff experience to foster an organizational culture of biosafety and biosecurity.

Combining biosafety expert’s evaluation and workers’ perception regarding the Biological Risks in Biomedical laboratories of Public Hospitals in Athens, Greece

Objectives: The aim of the present study was by combining an expert’s evaluation and laboratory workers’ perception, to review the biological risks in biomedical laboratories of public hospitals in Athens, Greece. It was also to evaluate how they are managing the biological materials, the level of safety awareness and training of the personnel, and to propose mitigation measures according to the existing risks, based on the local legislation and the international Biosafety guidelines. Materials and Methods: A total of 36 biosafety level-2 (BSL2) biomedical laboratories in 20 public hospitals were assessed for their biosafety containment specifics and compliance with biosafety practices. The study was designed as a cross-sectional study, with a checklist and a detailed health and safety (H&S) questionnaire, focused on biosafety and biorisk management. An expert biosafety officer observed and filled in a checklist for each biomedical laboratory (n=36) of the 20 hospitals. Laboratory staff (medical laboratory doctors, medical laboratory technologists, laboratory assistants, biologists and biochemists; n = 415) filled in a specific to biosafety H&S question­naire in each of these laboratories. Results: Both the results from the checklists and the questionnaires showed that in a significant percentage of laboratories there are the following deficiencies: restricted access and signage at the entrance, autoclaves in the laboratory area, ability to use the washbasins hands-free, biorisk management system, written risk assessments, biosafety manuals, standard operating procedures (SOPs), assigned biosafety officers, protocols about the use of Personal Protective Equipment (PPE), insufficient biosafety training programs, accidents reporting, eyewash emergency shower system, first aid kits and emergency telephone numbers. On the positive site laboratory procedures are separated from management, sanitary and rest areas, laboratory surfaces and floors are easy to clean and disinfect, good laboratory Practices followed for all procedures, waste management is in compliance with the current Greek legislation and there are sufficient PPE available. Conclusion: In the laboratories studied there are significant shortcomings in containment and administrative controls, in the application of Greek and EU biosafety legislation, and in the proper management of biological agents and materials in general. This emphasizes the importance of closing key gaps in biosafety and emergency preparedness, in the biomedical laboratories. Using the results of this study, actions should be developed, applied and enforced, in compliance with the local and European legislation and guidelines. This could enhance the safety of these facilities, and the laboratory professionals, the community and the environment could be better protected from possible harmful biological agents and the possibility of Laboratory acquired infections (LAIs). This study also demonstrated the value of the laboratory workers participation in the risk evaluation, despite their propensity to over or under-estimate the risk level of the possible hazards. That fact should be considered in future studies when enhancing hospital staff.

Bio-Risk Management Systems: Biosafety Assessment in COVID-19 Referral Hospitals in Indonesia

Numerous hospital laboratories in Indonesia need to implement improved bio-risk management (BRM) systems. There are many potential biohazards in laboratory activities that can impact health and the environment, leading to laboratory incidents. To minimize the impact and occurrence of such incidents, it is necessary to evaluate the implementation of BRM in every hospital laboratory that uses biological agents. This study was conducted in eight COVID-19 reference hospitals in Indonesia in the regions of Sumatra, Kalimantan, and Java, which have committed to implementing BRM systems in their laboratory activities. This research employed a descriptive study design and quantitative methods, with the aim of analyzing and evaluating the implementation of BRM systems in laboratories by assessing the achievements and gap analysis obtained from each laboratory. This research utilized primary data in the form of checklist forms referencing ISO 35001:2019 for the laboratory BRM system. Then, the assessments were based on virtual interviews conducted by the researcher with laboratory personnel as the primary data. The evaluation conducted on gap analysis from the seven clauses in ISO 35001:2019 across all hospitals revealed large gaps, particularly in three clauses: leadership, support, and performance. However, the aspects concerning organization, improvement, and performance evaluation were relatively satisfactory. Hence, there is a need for further improvement in leadership, support, and performance evaluation clauses. Additionally, it is essential to highlight the importance of comprehensive performance assessment, including proactive audits and continuous enhancements to achieve optimal bio-risk management.

Biosecurity Risk Assessment for the Use of Artificial Intelligence in Synthetic Biology.

The integration of Artificial Intelligence (AI) with synthetic biology is driving unprecedented progress in both fields. However, this integration introduces complex biosecurity challenges. Addressing these concerns, this article proposes a specialized biosecurity risk assessment process designed to evaluate the incorporation of AI in synthetic biology. A set of tailored tools and methodology was developed for conducting biosecurity risk assessments of AI language models used for synthetic biology. These resources were developed to guide risk management professionals through a systematic process of identifying, evaluating, and mitigating potential risks. The tools and methodology provided offer a structured approach to risk assessment, enabling risk management professionals to comprehensively analyze the biosecurity implications of AI applications in synthetic biology. They facilitate the identification of potential risks and the development of effective mitigation strategies. An example of a risk assessment performed on the large language model "ChatGPT 4.0" is provided here. AI's role in synthetic biology is rapidly expanding; thus, establishing proactive and secure practices is crucial. The biosecurity risk assessment tools and methodology presented here are the first provided in the literature and will be instrumental steps toward the responsible integration of AI in synthetic biology. By adopting these resources, the biorisk management community can effectively navigate and manage the biosecurity challenges posed by AI, ensuring its responsible and secure application in the field of synthetic biology.

Training the Next Generation of Infectious Disease Researchers: A Biorisk Management Module Embedded in a European Master Program.

The current global situation with increasing zoonotic transmissions of pathogens, rapidly changing ecosystems due to the climate change and with it the distribution of potential vectors, demands new ways of teaching and educating students in the field of infectious disease research. The international master program "Infectious Diseases and One Health-IDOH" started its second application period in 2019. Biosafety is an integral part of IDOH, exemplified by a biosafety level 3 hands-on training at the Animal Health Research Center IRTA-Centre de Recerca en Sanitat Animal (CReSA), Barcelona. At Hanover Medical School, biosafety is expanded to a comprehensive biorisk management approach with focus on risk assessment, bioethics, and training in a mobile containment laboratory. This article illustrates in depth the intention and the individual teaching units of the biorisk management module within the third semester of the IDOH master. Risk assessment is taught based on the new WHO Laboratory Biosafety Manual 4th edition, which represents a paradigm shift toward a risk-based approach instead of a prescriptive definition of biosafety levels. This methodology will enable the international IDOH students to cope with different national legislations and to provide guidance on biosafety in their home countries. In the final unit, the students operate a mobile containment laboratory and simulated a viral hemorrhagic fever outbreak in Africa. In sum, this module combines theoretical risk assessment and its practical implementation in the mobile laboratory as a future direction for training infectiologists. In addition, our report may serve as a blue print for others to amend their education with the herewith mentioned pillars of biosafety teaching.

Mentorship of the next generation of One Health workers through experiential learning: A case of students of Makerere University

Abstract Multiple zoonotic disease outbreaks occurred in Uganda over the past two decades and have needed operationalization of the One Health (OH) Approach to respond effectively. Between 2016 and 2018, the African One Health University Network (AFROHUN) supported 61 students (25 females, 36 males) to join multisectoral and multidisciplinary government national and district task force disease response teams. The goal of joining these teams was to build and strengthen the students’ disease investigation and response skills in real time using a One Health approach. Qualitative methods were used to collect student and partner responses on their field experiences. The AFROHUN project identified the experiential knowledge and skills that the students gained. Student project reports were reviewed by the joint technical teams from the university and the national/district task forces. These included training materials and disease outbreak investigation and response reports. Partnerships and collaboration between the university One Health networks and the government enabled 35 graduate and 26 undergraduate students to receive joint mentorship from the national or district task force outbreak response teams. Most participants were from degree programs in Public Health, Epidemiology, Environmental Health, Veterinary, Wildlife Sciences, and Infectious Disease Management, while few students were from social sciences. Students were mentored in seven competency-based areas of disease management: (1) biorisk management, (2) community engagement and coordination, (3) epidemiology, (4) leadership, (5) outbreak investigation and response, (6) risk communication, and (7) surveillance. In conclusion, zoonotic outbreaks provided real-life learning opportunities for students in disease outbreak investigation and response using a multidisciplinary and multisectoral approach. The identified skills can be incorporated into educational materials such as curricula and present an ideal opportunity to build partnerships for workforce development. One Health impact statement The next generation of One Health workers, those capable of working across sectors and disciplines to improve the health of animals, humans, plants, and the environment, need soft and technical skills to guarantee optimal preparedness, prevention, and response to disease outbreaks and understand the animal to human transmission dynamics of disease. In countries where emerging, re-emerging, and endemic zoonoses and hemorrhagic fevers are prevalent, it is crucial to provide these real-life or experiential training opportunities for university students, working closely in multidisciplinary teams. The “real-time” joint mentorship by the government’s multidisciplinary and multisectoral outbreak response teams, during disease outbreaks, provides an opportunity to build and strengthen student skills in biorisk management, community engagement and coordination, epidemiology, leadership, outbreak investigation and response, risk communication, and surveillance.

Frequency of Leaks from Conical Centrifuge Tubes.

Threaded conical centrifuge tubes are ubiquitous in biological laboratories and are frequently used for the storage/transport of potentially biohazardous samples. However, limited data are available on how frequently and from where these tubes leak. These data are valuable for laboratory biorisk management and to inform future studies on risks arising from the routine use of laboratory consumables. The frequency of leaks from threaded conical centrifuge tubes was tested using a Glo Germ solution as a tracer. Conical tubes (15 and 50 mL) from several brands were filled, inverted, and placed on their side on the benchtop. After 1 h, the presence or absence of leaks on the benchtop surface, tube threads, and exterior was recorded. We observed that liquid leaked out of tubes that were apparently properly threaded in 2% of 15 mL tubes (confidence interval [95% CI] 1.4-2.6) and 1.4% of 50 mL tubes (95% CI 0.2-1.5). After opening, liquid was found on the threads on the outside of the tube in 20% of 15 mL tubes (95% CI 10-31) and 14% of 50 mL tubes (95% CI 1-28). We did not find sufficient evidence that differences in leak rates among brands were practically significant. The fact that leaks were not uncommonly observed from conical centrifuge tubes suggests that mitigations for any hazard posed by a leak should be a component of every biorisk management strategy for protocols involving the manipulation of hazardous substances in these tubes. Further research should be conducted on other activities that could cause tubes to leak (such as centrifugation or vortexing) and should be completed to understand the risks associated with this consumable. Research into the costs and benefits of mitigating the risk of leaks from conical tubes is recommended.

Cyberbiosecurity in high-containment laboratories.

High-containment laboratories (HCLs) conduct critical research on infectious diseases, provide diagnostic services, and produce vaccines for the world's most dangerous pathogens, often called high-consequence pathogens (HCPs). The modernization of HCLs has led to an increasingly cyber-connected laboratory infrastructure. The unique cyberphysical elements of these laboratories and the critical data they generate pose cybersecurity concerns specific to these laboratories. Cyberbiosecurity, the discipline devoted to the study of cybersecurity risks in conjunction with biological risks, is a relatively new field for which few approaches have been developed to identify, assess, and mitigate cyber risks in biological research and diagnostic environments. This study provides a novel approach for cybersecurity risk assessment and identification of risk mitigation measures by applying an asset-impact analysis to the unique environment of HCLs. First, we identified the common cyber and cyberphysical systems in HCLs, summarizing the typical cyber-workflow. We then analyzed the potential adverse outcomes arising from a compromise of these cyber and cyberphysical systems, broadly categorizing potential consequences as relevant to scientific advancement, public health, worker safety, security, and the financial wellbeing of these laboratories. Finally, we discussed potential risk mitigation strategies, leaning heavily on the cybersecurity materials produced by the Center for Internet Security (CIS), including the CIS Controls®, that can serve as a guide for HCL operators to begin the process of implementing risk mitigation measures to reduce their cyberbiorisk and considering the integration of cyber risk management into existing biorisk management practices. This paper provides a discussion to raise awareness among laboratory decision-makers of these critical risks to safety and security within HCLs. Furthermore, this paper can serve as a guide for evaluating cyberbiorisks specific to a laboratory by identifying cyber-connected assets and the impacts associated with a compromise of those assets.

Knowledge, skills, and performance in biorisk management among allied health educators in the University of Perpetual Help System Jonelta

This descriptive-correlational study determined the relationship between the health educators’ knowledge, skills, and performance in biorisk management in the University of Perpetual help System Jonelta. The study probed the predictive ability of knowledge and skills of the health educators’ performance in biorisk management. The results of the study served as basis in developing a training program on biorisk management that was common and applicable to all allied health educators. The study, which was conducted from November 2022 to April 2023, involved 199 health educators of the University as respondents. The study results revealed that the respondents’ level of knowledge on biorisk management was very high (x̅ = 3.27); level of skills was high (x̅ = 2.93), and level of performance was high (x̅ = 3.08). Significant relationships were found between the respondents’ level of knowledge and level of skills; between level of knowledge and level of performance; and between level of skills and performance in biorisk management along principles and policies, assessment, safety measures, waste management, and personnel protective equipment (p<0.01). Further, knowledge along safety measures (p=.007<.05), waste management (p=.0071<.05), and level of skills along personal protective equipment(p=.029<.05), and the combination of all skills (p=.007<.05) were found to be significant predictors of performance in biorisk management. It was concluded that the allied faculty members of UPHSL are highly cognizant of the effective management of risks posed by working with infectious agents and toxins; they are competent, trained, and experienced in various aspects of biorisk management in health education settings; and they enforce the use of personal protective equipment (PPE) in a health education setting and are skilled in managing the proper disposal of biological waste, among others. Likewise, the higher is their level of knowledge, the higher the level of skills on biorisk management and level of performance in biorisk management; and the higher their level of skills, the higher is the level of performance in biorisk management. Moreover, knowledge on safety measures and waste management; and skills on personal protective equipment and the combination of all the skills on principles and policies, assessment, safety measures, waste management, and personal protective equipment are predictors of performance in biorisk management

The Biosafety Research Road Map: The Search for Evidence to Support Practices in Human and Veterinary Laboratories.

Lack of evidence-based information regarding potential biological risks can result in inappropriate or excessive biosafety and biosecurity risk-reduction strategies. This can cause unnecessary damage and loss to the physical facilities, physical and psychological well-being of laboratory staff, and community trust. A technical working group from the World Organization for Animal Health (WOAH, formerly OIE), World Health Organization (WHO), and Chatham House collaborated on the Biosafety Research Roadmap (BRM) project. The goal of the BRM is the sustainable implementation of evidence-based biorisk management of laboratory activities, particularly in low-resource settings, and the identification of gaps in the current biosafety and biosecurity knowledge base. A literature search was conducted for the basis of laboratory design and practices for four selected high-priority subgroups of pathogenic agents. Potential gaps in biosafety were focused on five main sections, including the route of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. Categories representing miscellaneous, respiratory, bioterrorism/zoonotic, and viral hemorrhagic fever pathogens were created within each group were selected for review. Information sheets on the pathogens were developed. Critical gaps in the evidence base for safe sustainable biorisk management were identified. The gap analysis identified areas of applied biosafety research required to support the safety, and the sustainability, of global research programs. Improving the data available for biorisk management decisions for research with high-priority pathogens will contribute significantly to the improvement and development of appropriate and necessary biosafety, biocontainment and biosecurity strategies for each agent.

The Biosafety Research Road Map: The Search for Evidence to Support Practices in the Laboratory-SARS-CoV-2.

The SARS-CoV-2 virus emerged as a novel virus and is the causative agent of the COVID-19 pandemic. It spreads readily human-to-human through droplets and aerosols. The Biosafety Research Roadmap aims to support the application of laboratory biological risk management by providing an evidence base for biosafety measures. This involves assessing the current biorisk management evidence base, identifying research and capability gaps, and providing recommendations on how an evidence-based approach can support biosafety and biosecurity, including in low-resource settings. A literature search was conducted to identify potential gaps in biosafety and focused on five main sections, including the route of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. There are many knowledge gaps related to biosafety and biosecurity due to the SARS-CoV-2 virus's novelty, including infectious dose between variants, personal protective equipment for personnel handling samples while performing rapid diagnostic tests, and laboratory-acquired infections. Detecting vulnerabilities in the biorisk assessment for each agent is essential to contribute to the improvement and development of laboratory biosafety in local and national systems.

Improved understanding of biorisk for research involving microbial modification using annotated sequences of concern.

Regulation of research on microbes that cause disease in humans has historically been focused on taxonomic lists of 'bad bugs'. However, given our increased knowledge of these pathogens through inexpensive genome sequencing, 5decades of research in microbial pathogenesis, and the burgeoning capacity of synthetic biologists, the limitations of this approach are apparent. With heightened scientific and public attention focused on biosafety and biosecurity, and an ongoing review by US authorities of dual-use research oversight, this article proposes the incorporation of sequences of concern (SoCs) into the biorisk management regime governing genetic engineering of pathogens. SoCs enable pathogenesis in all microbes infecting hosts that are 'of concern' to human civilization. Here we review the functions of SoCs (FunSoCs) and discuss how they might bring clarity to potentially problematic research outcomes involving infectious agents. We believe that annotation of SoCs with FunSoCs has the potential to improve the likelihood that dual use research of concern is recognized by both scientists and regulators before it occurs.

Biorisk Management Features of a Temporary COVID-19 Hospital.

Yale University designed and constructed a temporary field hospital for 100 COVID-19 symptomatic patients. Conservative biocontainment decisions were made in design and operational practices. Objectives of the field hospital included the safe flow of patients, staff, equipment and supplies, and obtaining approval by the Connecticut Department of Public Health (CT DPH) for opening as a field hospital. The CT DPH regulations for mobile hospitals were used as primary guidance for the design, equipment, and protocols. References for BSL-3 and ABSL-3 design from the National Institutes of Health (NIH) and Tuberculosis isolation rooms from the United States Centers for Disease Control and Prevention (CDC) were also utilized. The final design involved an array of experts throughout the university. Vendors tested and certified all High Efficiency Particulate Air (HEPA) filters and balanced the airflows inside the field hospital. Yale Facilities designed and constructed positive pressure access and exit tents within the field hospital, established appropriate pressure relationships between zones, and added Minimum Efficiency Reporting Value 16 exhaust filters. The BioQuell ProteQ Hydrogen Peroxide decontamination unit was validated with biological spores in the rear sealed section of the biowaste tent. A ClorDiSys Flashbox UV-C Disinfection Chamber was also validated. Visual indicators were placed the doors of the pressurized tents and spaced throughout the facility to verify airflows. The plans created to design, construct and operate the field hospital provide a blueprint for recreating and reopening a field hospital in the future if ever needed at Yale University.

Rate of Splashes When Opening Microfuge Tubes with Various Methods.

Snap-cap microcentrifuge tubes are ubiquitous in biological laboratories. However, limited data are available on how frequently splashes occur when opening them. These data would be valuable for biorisk management in the laboratory. The frequency of splashes from opening snap-cap tubes using four different methods was tested. The splash frequency for each method was measured on the benchtop surface and on the experimenter's gloves and smock, using a Glo Germ solution as a tracer. Splashes occurred very frequently when opening microcentrifuge snap-cap tubes, no matter which method was used to open the tube. The highest rate of splashes on all surfaces was observed with the one-handed (OH) opening method compared with two-handed methods. Across all methods, the highest rate of splashes was observed on the opener's gloves (70-97%) compared with the benchtop (2-40%) or the body of the researcher (0-7%). All tube opening methods we studied frequently caused splashes, with the OH method being the most error-prone but no two-handed method being clearly superior to any other. In addition to posing an exposure risk to laboratory personnel, experimental repeatability may be affected due to loss of volume when using snap-cap tubes. The rate of splashes underscores the importance of secondary containment, personal protective equipment, and good protocols for decontamination. When working with especially hazardous materials, alternatives to snap-cap tubes (such as screw cap tubes) should be strongly considered. Future studies can examine other methods of opening snap-cap tubes to determine whether a truly safe method exists.

Assessment of laboratory capacity in conflict-affected low-resource settings using two World Health Organization laboratory assessment tools.

Laboratory diagnostic services are essential to drive evidence-based treatment decisions, manage outbreaks, and provide population-level data. Many low- and middle-income countries (LMICs) lack sufficient diagnostic capacity, often further exacerbated in conflict-affected areas. This project assessed laboratory services in conflict-affected LMICs to understand gaps and opportunities for improving laboratory capacity. The World Health Organization Laboratory Assessment Tool Facility Questionnaire (WHO Laboratory Tool) and Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) checklist were used to assess five laboratories in Eastern Democratic Republic of the Congo (DRC) and five in Gaza, Palestine. Total scores and percentage outcomes by indicator were calculated. Average WHO Laboratory Tool score across all facilities was 41% (range 32-50%) in DRC and 78% (range 72-84%) in Gaza. Lowest scoring indicators in DRC were Biorisk management (13%, range 8-21%), Documentation (14%, range 6-21%), and in Gaza, were Facilities (59%, range 46-75%) and Documentation (60%, range 44-76%). Highest scoring indicators in DRC were Facilities (70%, range 45-83%) and Data and Information Management (61%, range 38-80%), and in Gaza were Data Information and Management (96%) and Public Health Function (91%, range 88-94%). In DRC, no laboratory achieved a SLIPTA star rating. In Gaza, two laboratories had a 3-star SLIPTA rating, one had a 2-star rating and two had a 1-star rating. Laboratory systems in conflict-affected LMICs have significant gaps. Implementating improvement strategies in such settings may be especially challenging.

Motivating Proactive Biorisk Management.

Scholars and practitioners of biosafety and biosecurity (collectively, biorisk management or BRM) have argued that life scientists should play a more proactive role in monitoring their work for potential risks, mitigating harm, and seeking help as necessary. However, most efforts to promote proactive BRM have focused on training life scientists in technical skills and have largely ignored the extent to which life scientists wish to use them (ie, their motivation). In this article, we argue that efforts to promote proactive BRM would benefit from a greater focus on life scientists' motivation. We review relevant literature on life scientists' motivation to practice BRM, offer examples of successful interventions from adjacent fields, and outline ideas for possible interventions to promote proactive BRM, along with strategies for iterative development, testing, and scaling.

Understanding Biosafety and Biosecurity in Ukraine.

The Russian invasion of Ukraine in February 2022 was accompanied by unfounded Russian allegations of bioweapon activities in Ukraine conducted by the United States and its allies. While false, such allegations can cause substantial damage to disarmament efforts and international cooperation for strengthening disease surveillance and global health security. The purpose of this article is to describe Ukraine's biosafety, biosecurity, and dual-use policies and to provide important context for understanding the unwarranted Russian allegations. Moreover, the analysis of Ukraine's biorisk management system highlights some of the international efforts underway to ensure that life sciences research across the world is conducted safely, securely, and responsibly. With the help of international partners, Ukraine has strengthened its biorisk management governance, as well as identified areas for improvement that it is working to address.

Évaluation des capacités du système de laboratoires biologiques pour la détection des menaces infectieuses au Bénin

Background : International Health Regulations require countries to establish laboratory systems for rapid and safe confirmation of public health emergencies.Objective : This study assessed the capacity of the National Laboratory System for the detection of infectious threats to global health security in Benin.Method : The study was descriptive, cross-sectional, and evaluative. The targets were laboratories performing the confirmation of infectious threats. The sampling method was non-probabilistic with the reasoned choice of 74 laboratories. Four collection tools were used. The World Health Organization’s laboratory assessment tool for health facilities was used to assess the national public health laboratory. The assessment was based on the capacities of peripheric laboratories and of the national reference laboratory. The capacity was rated good if at least 80% of peripheric laboratories met at least 80% of the criteria and if the national public health laboratory had an average indicator of at least 80%. Otherwise, the capacity was rated insufficient.Results : The national laboratory system capacity was insufficient. Only 54% of peripheric laboratories had good capacity. The national reference laboratory had an average indicator of 71%. In this reference laboratory, specimen collection and transport, laboratory testing performance, consumables and reagents, and public health functions had the best scores, above 80%. Biorisk management, organization and management, and documents had the lowest scores. In peripheric laboratories, the testing performance was the only domain with good capacity.Conclusion : To ensure effective Global Health Security in Benin, a National Laboratory System capacity improvement strategic plan need to be developed and implemented.

WHO Laboratory Biosafety Manual: A New Approach to Security.

The paper aims to highlight the new indications introduced in the 4th edition of the "Laboratory Biosafety Manual" of World Health Organization. The authors propose a new vision to improve biosafety and biosecurity in the laboratory aligned with the technical standards ISO 35001:2019 "Biorisk management for laboratories and other related organizations" and ISO 45001:2018 "Occupational health and safety management systems-Requirements with guidelines for use" framework. The current edition has a more innovative approach compared to the previous ones, more attention is given to training awareness and providing skills, to promote the culture of safety by adopting an approach based on risk analysis, rather than the prescriptive approach that has been used previously.

Strengthening Biorisk Management Capacities in Burkina Faso: Contribution of the Global Health Security Agenda.

The Global Health Security Agenda and the International Health Regulations (2005) recommend that countries strengthen the capacity of their national laboratory systems to comply with the International Health Regulations. To efficiently and effectively direct these efforts, the US Centers for Disease Control and Prevention-in collaboration with the Ministry of Health Directorate of Laboratories, the African Society for Laboratory Medicine, and Integrated Quality Laboratory Service-assessed Burkina Faso's national laboratory system using the World Health Organization Laboratory Assessment Tool. Based on gaps observed in biorisk management, the Biosafety and Biosecurity Laboratory Assessment Tool (BSS LAT) was developed to assess 10 public laboratories handling dangerous pathogens. This tool uses a specific scoring matrix with quantitative output. Composite assessment scores for the 9 primary modules (capacity areas) were reported, with the highest scores reported in cleaning, disinfection, sterilization, waste management (42%), and good laboratory practices (40%), and the lowest scores in biosecurity/biosafety (33%), documents/regulations (18%), emergency management (16%), and risk management (5%). To address challenges identified in the assessments, a set of activities was planned with a focus on biorisk management. Results from an evaluation conducted 1 year later, using the BSS LAT, showed an increase in the average score of all indicators from 25% to 45% and an increase in the biorisk management module score from 5% to 35%. This evaluation process was a decisive step toward strengthening the capacity of the laboratory system in Burkina Faso. Global Health Security Agenda investments and activities have made a lasting impact on improving biosafety and biosecurity in public health laboratories. To ensure sustainability, a strong laboratory quality management program based on a mentorship system is greatly needed.