Evaluation of animal biosafety webinar series for professionals working in animal facilities across Pakistan during the COVID-19 pandemic

Experimental research with animals can help the prevention, cure, and alleviation of human ailments. Animal research facilities are critical for scientific advancement, but they can also pose a higher risk than other biomedical laboratories. Zoonosis, allergic reactions, bites, cuts, and scratches by animals are all substantial concerns that can occur in animal facilities. Furthermore, human error and unexpected animal behavior pose a risk not just to humans, but also to the environment and the animals themselves. The majority of biosafety and biosecurity training programs focus on clinical and biomedical laboratories dealing with human safety factors, with little emphasis on animal biosafety. The current virtual training was designed to improve biosafety and biosecurity capabilities of animal laboratory personnel, researchers, and veterinarians from different regions of Pakistan. The results revealed that understanding was improved regarding triggers for risk assessment in addition to annual and regular reviews (56% to 69%), biosecurity (21% to 50%), decontamination (17% to 35%), safe handling of sharps (21% to 35%), Dual Use Research of Concern (DURC) (17% to 40%), Personal Protective Equipment (PPE) usage by waste handlers (60.9% to 75%), waste management (56% to 85%), animal biosafety levels (40.57% to 45%), and good microbiological practices and procedures (17% to 35%). To bring human and animal laboratories up to the same level in terms of biosafety and biosecurity, it is critical to focus on areas that have been overlooked in the past. Training programs focusing on animal biosafety should be conducted more frequently to strengthen bio risk management systems in animal research facilities.Copyright © 2021

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

Introduction: 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. Methods: 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. Results: 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.

Effectiveness of international virtual training on biorisk management in the context of COVID-19.

Introduction: The COVID-19 pandemic has resulted in enormous increases in laboratory activities to keep pace with diagnostic testing and research efforts. However, traditional training, technical assistance, and capacity-building approaches were disrupted by the travel and movement restrictions put in place to control the spread of the disease. To address the needs of laboratorians and managers to conduct laboratory activities safely and securely during the pandemic, a highly interactive virtual training (IVT) workshop on biorisk management during COVID-19 was conducted through active learning strategies that connected speakers with participants. The objective of the training was to increase the basic knowledge and standards of biosafety and biosecurity practices, risk assessment, and control measures with reference specifically to the context of the COVID-19 pandemic and apply a rigorous evaluation methodology to assess the effectiveness of the IVT. The training covered a broad range of topics and encompassed national to international guidelines. Methods: Participants were selected through official channels at the national level, focusing on institutions within Pakistan. The sessions included lectures from international experts in biorisk management concepts, and incorporated poll questions as well as pre- and post-tests and feedback on the speakers' knowledge and presentation skills, to increase interactivity. The pre- and post-test comprised similar multiple-choice questions and provided to every participant to ascertain the impact of the training on awareness and knowledge of biorisk management topics and concepts, and results were compared using paired t-tests. For feedback on the speakers, participants were asked to submit their ratings measured on a five-point Likert scale. The reliability of the Likert scale was estimated using Cronbach's alpha. Analyses were performed using Microsoft Excel and SPSS version 23. Results: In total, 52 individuals from different laboratories across Pakistan and Pakistani students from abroad (China) as well participated in at least one session of the IVT. The participants' pre- and post-test scores showed a significant increase in knowledge and awareness (p < 0.001). The obtained Cronbach's alpha score was >0.8, indicating high reliability of the generated feedback on the IVT approach and speakers. Conclusion: The IVT on biosafety and biosecurity in the context of the COVID-19 pandemic proved beneficial for laboratory professionals and could be a useful model to continue in the future for raising awareness and knowledge.

Biorisk Management for SARS-CoV-2 Research in a Biosafety Level-3 Core Facility.

The emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presents hazards to researchers and other laboratory personnel in research settings where the live virus is stored and handled. The Biosafety Level-3 (BSL-3) Core Facility (CF) at Yong Loo Lin School of Medicine in National University of Singapore (NUS Medicine) has implemented a biorisk management (BRM) system to ensure that biorisk to employees, the public, or the environment are consistently minimized to an acceptable level while working with SARS-CoV-2. This chapter summarizes how a BRM system can be implemented in academic institutions based on international standards in the context of existing local legislations/regulations and institutional policies/guidelines to minimize the risk of laboratory-acquired infections and deliberate misuse of the newly emerged virus, SARS-CoV-2 in BSL-3 laboratories. The BRM programs prioritize performing risk assessments prior to implementation of work processes and reassessing the risk portfolio of the facilities from time to time, determining root causes and prevention of recurrences. Focusing on awareness-raising and educating the laboratory users in biosafety and biosecurity, and identifying opportunities for improvement are the other key factors for a sustainable and successful BRM system in the NUS Medicine BSL-3 CF.

Strengthening Biorisk Management in Research Laboratories with Security-Sensitive Biological Agents Like SARS-CoV-2.

In this chapter, we discuss potential incidents associated with SARS-CoV-2 experimental work in high containment research laboratories. The risk landscape in high containment laboratories is changing due to the strong innovation drive of the life sciences research. Thus, the WHO has recommended life sciences organizations to incorporate good research practices and ethical principles into a risk-based approach of the biorisk management (BRM). Currently, BRM systems in high containment laboratories are predominantly steered by operational personnel and laboratory professional. It is well known that without having a systematic approach and leadership support from the organization, the BRM system in the high containment laboratory will not be sustainable. Even though the roles of organizations and their leadership in establishing the BRM system are spelt out in many international standards, guidance documents and national legislations, operational aspects of these roles are rarely discussed.It is therefore important for everyone to understand about their roles in organizational processes (communication, decision, and performance evaluation) involved in implementation of BRM related operational activities. In this chapter, discussion is based on operational activities of four main organizational behaviors that are considered to have strengthened BRM systems in high containment laboratories: (1) displaying a visible commitment and support to the BRM system from different levels of management, (2) developing a competent and responsible workforce with BRM technical skills and problem identification/solving skills, (3) integrating learning and improvement principles into the BRM system, and (4) enhancing the continuous motivation of laboratory personnel to avoid complacency. The categorization of these organizational behaviors is based on the International Atomic Energy Agency's principles and guidance for strengthening the safety and security culture in nuclear facilities. Furthermore, we encourage the laboratory management to identify gaps in processes and activities related to those organizational behaviors so that one could rapidly address biosafety and biosecurity vulnerabilities in high containment laboratories.

It's the Wrong Virus: Rapid Adaptation of Operations Inside a Highly Pathogenic Avian Influenza Select Agent Laboratory in Response to the 2019 SARS-CoV-2 Pandemic.

Background: The Animal Biosafety Level 3 Enhanced (ABSL-3+) laboratory at St. Jude Children's Research Hospital has a long history of influenza pandemic preparedness. The emergence of SARS-CoV-2 and subsequent expansion into a pandemic has put new and unanticipated demands on laboratory operations since April 2020. Administrative changes, investigative methods requiring increased demand for inactivation and validation of sample removal, and the adoption of a new animal model into the space required all arms of our Biorisk Management System (BMS) to respond with speed and innovation. Results: In this report, we describe the outcomes of three major operational changes that were implemented to adapt the ABSL-3+ select agent space into a multipathogen laboratory. First were administrative controls that were revised and developed with new Institutional Biosafety Committee protocols, laboratory space segregation, training of staff, and occupational health changes for potential exposure to SARS-CoV-2 inside the laboratory. Second were extensive inactivation and validation experiments performed for both highly pathogenic avian influenza and SARS-CoV-2 to meet the demands for sample removal to a lower biosafety level. Third was the establishment of a new caging system to house Syrian Golden hamsters for SARS-CoV-2 risk assessment modeling. Summary: The demands placed on biocontainment laboratories for response to SARS-CoV-2 has highlighted the importance of a robust BMS. In a relatively short time, the ABSL-3+ was able to adapt from a single select agent space to a multipathogen laboratory and expand our pandemic response capacity.

Dual-Use Quickscan: A Web-Based Tool to Assess the Dual-Use Potential of Life Science Research.

Research on pathogenic organisms is crucial for medical, biological and agricultural developments. However, biological agents as well as associated knowledge and techniques, can also be misused, for example for the development of biological weapons. Potential malicious use of well-intended research, referred to as "dual-use research", poses a threat to public health and the environment. There are various international resources providing frameworks to assess dual-use potential of the research concerned. However, concrete instructions for researchers on how to perform a dual-use risk assessment is largely lacking. The international need for practical dual-use monitoring and risk assessment instructions, in addition to the need to raise awareness among scientists about potential dual-use aspects of their research has been identified over the last years by the Netherlands Biosecurity Office, through consulting national and international biorisk stakeholders. We identified that Biorisk Management Advisors and researchers need a practical tool to facilitate a dual-use assessment on their specific research. Therefore, the Netherlands Biosecurity Office developed a web-based Dual-Use Quickscan (www.dualusequickscan.com), that can be used periodically by researchers working with microorganisms to assess potential dual-use risks of their research by answering a set of fifteen yes/no questions. The questions for the tool were extracted from existing international open resources, and categorized into three themes: characteristics of the biological agent, knowledge and technology about the biological agent, and consequences of misuse. The results of the Quickscan provide the researcher with an indication of the dual-use potential of the research and can be used as a basis for further discussions with a Biorisk Management Advisor. The Dual-Use Quickscan can be embedded in a broader system of biosafety and biosecurity that includes dual-use monitoring and awareness within organizations. Increased international attention to examine pathogens with pandemic potential has been enhanced by the current COVID-19 pandemic, hence monitoring of dual-use potential urgently needs to be encouraged.

Evaluation of animal biosafety webinar series for professionals working in animal facilities across pakistan during the covid-19 pandemic

Experimental research with animals can help the prevention, cure, and alleviation of human ailments. Animal research facilities are critical for scientific advancement, but they can also pose a higher risk than other biomedical laboratories. Zoonosis, allergic reactions, bites, cuts, and scratches by animals are all substantial concerns that can occur in animal facilities. Furthermore, human error and unexpected animal behavior pose a risk not just to humans, but also to the environment and the animals themselves. The majority of biosafety and biosecurity training programs focus on clinical and biomedical laboratories dealing with human safety factors, with little emphasis on animal biosafety. The current virtual training was designed to improve biosafety and biosecurity capabilities of animal laboratory personnel, researchers, and veterinarians from different regions of Pakistan. The results revealed that understanding was improved regarding triggers for risk assessment in addition to annual and regular reviews (56% to 69%), biosecurity (21% to 50%), decontamination (17% to 35%), safe handling of sharps (21% to 35%), DURC (17% to 40%), PPE usage by waste handlers (60.9% to 75%), waste management (56% to 85%), animal biosafety levels (40.57% to 45%), and good microbiological practices and procedures (17% to 35%). To bring human and animal laboratories up to the same level in terms of biosafety and biosecurity, it is critical to focus on areas that have been overlooked in the past. Training programs focusing on animal biosafety should be conducted more frequently to strengthen bio risk management systems in animal research facilities.

Considerations for Laboratory Biosafety and Biosecurity During the Coronavirus Disease 2019 Pandemic: Applying the ISO 35001:2019 Standard and High-Reliability Organizations Principles.

Background: Risk assessment is a critical tool for evaluating emerging pathogens such as severe acute respiratory syndrome coronavirus 2 because of the limited available information about pathogens and the diseases they cause. Industries adopt unique frameworks for risk assessment, for example, the ISO 35001:2019 biorisk management for laboratories and other related organizations provide tools to identify, assess, control, and monitor risks associated with hazardous biological materials. Industries such as aerospace are known as high-reliability organizations (HROs) because these must balance high-risk operations with minimal catastrophic outcomes. HROs focus on five core principles: preoccupation with failure, reluctance to simplify, sensitivity to operations, resilience, and deference to expertise to evaluate and manage risk. Results: In the present discussion, practices described in the ISO 35001 standard and the HRO model are applied to the current challenges faced by laboratories worldwide. Laboratories processing known or unknown coronavirus disease 2019 (COVID-19) samples, testing COVID-19 vaccine candidates, propagating severe acute respiratory syndrome-associated coronavirus-2, or validating diagnostic assays benefit from implementing such practices. Principles extrapolated from the HRO also help illustrate the importance of the end-to-end processes to ensure successful outcomes. Summary: Workplace safety is enhanced by the involvement of all stakeholders, from top leadership to front-line workers. High-quality outcomes as measured by a lack of incidents, accidents, injuries, or near misses are the positive consequences of strictly following standard operating procedures and timely communication of risks and pitfalls. Adopting a systematic framework to identify and manage risks posed by emerging pathogens results in increased workplace safety and higher quality processes and products.

COVID-19 and Beyond: Safety and Design Considerations for the Development of a Mobile Biocontainment Laboratory.

Introduction: An infectious disease outbreak like the current COVID-19 pandemic can lead to particularly high infection rates in areas where diagnostic laboratory support is limited. The deployment of mobile laboratories can help to detect pathogens, monitor the presence in a population, and inform public health authorities to take measures aimed at reducing pathogen spread. Materials and Methods: Available layouts and operational descriptions of mobile laboratories were analyzed for their suitability for the envisioned purpose and to assure high standards of biosafety and biosecurity. Recent media coverage on creative solutions for the diagnostics of SARS-CoV-2 (drive-through test centers, self-swab, inverse gloveboxes to protect health care workers) from various countries were considered. Results: A minimalistic and optimized design to construct a multifunctional laboratory on the chassis of a regular-sized box truck is proposed and can serve as a blueprint to rapidly develop additional diagnostic capacities. Discussion: For acute health threats including the current COVID-19 outbreak, rapid diagnosis of infection is key to recommend measures aimed at preventing the spread of the pathogen. Laboratory layouts that are similar to the one proposed here are used in stationary setups, and mobile laboratories have been built on varying platforms (trailers, shipping containers, etc).