Introduction: Infectious disease research conducted in the Duke Regional Biocontainment Laboratory, a biosafety level-3 facility, often includes work with mice. Infected carcasses must be properly decontaminated at the completion of each study and prior to removal from the facility. Working with Select Agents requires validated methods for complete inactivation of the agent before carcasses can be removed from registered spaces. Methods: Biological indicators were implanted into the abdomen of unfrozen mouse carcasses, then autoclaved using different cycle parameters and packaging strategies to determine the best approach to ensure complete sterilization. Results: Both 20-min and 30-min autoclave cycles at 122°C, with three pre-vacuum pulses, failed to consistently sterilize unfrozen mouse carcasses. A 45-min autoclave cycle with the same parameters did result in the successful sterilization of carcasses when packaged at two or four carcasses in an 8” × 12” autoclave bag. Conclusions: This study supports the utilization of an autoclave cycle (122°C sterilization temperature, 45-min sterilization time, three pre-vacuum pulses) to sterilize unfrozen mouse carcasses, up to four per bag.

Introduction: Public health logic models divide interventions into three categories: inputs, activities, and outcomes. Similarly, biosafety programs can be described using this same logic model by describing inputs in the form of program staffing and budget; program activities in the form of risk assessments, routine surveillance, training, incident response, and other services; and outcomes in the form of reported exposures, injuries, compliance, finances, and client satisfaction. Methods: Described here is a systematic means of collecting and displaying biosafety program activity data monthly so that the organizational leadership and associated safety committees can readily grasp the scope of various activities undertaken by the biosafety program to support the broader organizational goals. Discussion: The simplified public health logic model affords guidance on inputs, activities, and outcomes that biosafety programs can use to their advantage. The importance of succinctly reporting the data describing activities can inform and educate upper management and other stakeholders regarding the resources needed to avoid injuries and illnesses and maintain compliance. Conclusion: Within the biosafety profession, on a good day, “nothing bad happens,” so conveying the message of the value of prevention can be challenging. By capturing and readily presenting data that describes the efforts of a biosafety program, individual programs can articulate their needs for staffing and resources more successfully, and the profession stands a better chance of maintaining strong administrative and stakeholder support.

Introduction: Effectively managing biological risk in a research setting requires a strong organizational commitment to promoting safe practices and adhering to established protocols, a concept known as a “culture of biosafety.” Although a sound culture of biosafety is critical for responsible conduct of research, its assessment remains challenging, relying on self-reporting and qualitative and subjective evaluations. Methods: To determine if a laboratory’s culture of biosafety could be evaluated objectively, we examined historical biosafety violation data at three U.S. universities, including biosafety cabinet recertification violations at one university and a range of violations at two other universities. These data were analyzed to determine the distribution of violations among investigators. Results: At all three institutions, we found that a majority of investigators operate laboratories with low rates of biosafety violations and few repeat violations; however, a minority of investigators operate laboratories that are repeatedly in violation of established biosafety guidelines and standards. Repeat violations were unequally distributed amongst laboratories, with only 20% of laboratories accounting for 70–90% of total repeat violations. Discussion: We found that a vast majority of investigators operate laboratories with commendable cultures of biosafety that manifest as low rates of violations and repeat violations. Conclusion: This research establishes metrics for evaluating a laboratory’s culture of biosafety with an objective evidence basis and transparent approach, laying the foundation for future research to understand the drivers of biosafety culture, create interventions to improve biosafety culture, and creating a near-term mechanism to promote biosafety culture at institutions via data-driven retention and recruitment strategies.

Introduction: The safe and compliant transportation of infectious substances and biological specimens is critically essential for public health, scientific research, and disease diagnostics. With its global implications, this study aims to evaluate the International Transportation Association (IATA) regulations for shipping infectious substances and biological specimens in Pakistan. It explores the current level of awareness of IATA regulations and identifies existing gaps and challenges. Objectives: Develop and implement training modules that comply with IATA regulations and the Global Biorisk Management Curriculum (GBRMC). Methods: To promote the adoption of IATA regulations in Pakistan, the Association for Biorisk Management and Health Security Partners collaborated with experts, including certified IATA developed a project in partnership with experts and certified IATA professionals in Pakistan to start a series of workshops in Pakistan focused on IATA regulations. The project comprised two initial phases: a survey to assess the gaps in the existing regulations and their implementation for shipping infectious substances and a series of workshops based on the training of trainers concept. The project was spread over 2 years. Results: Only 1.29% of institutions surveyed offer training in this domain. There is a pressing need to enhance the IATA and local regulations governing the shipment of infectious substances from laboratories. Drawing on international regulations and experiences, we can bolster Pakistan’s capacity to manage the shipping of infectious agents based on national requirements and priorities.

Universities were challenged during the COVID-19 pandemic to continue providing quality education for their students while navigating the uncertainties of the SARS-CoV-2 virus. The goal of this article is to describe strategies used by Colorado State University (CSU) to mitigate SARS-CoV-2 transmission among faculty, staff, and students and to describe procedures used in microbiology teaching laboratories. Information concerning CSU's pandemic response was gathered via email communications to the CSU community, town hall meetings, and interviews with leaders, researchers, and staff who spearheaded public health initiatives. To date, there have been no known cases of transmission of SARS-CoV-2 in the classroom. Early strategies that contributed to this success included social norming of safe public health behaviors, development of low-cost, rapid screening and surveillance methods, an online COVID-19 reporting system, contact tracing and quarantine, rearranging classrooms to reduce the capacity by 50%, increasing air flow, enhanced cleaning and production of sanitizer, and flexible instructors who quickly changed their courses for remote delivery or launched extra risk management procedures for face-to-face delivery of laboratory, performance, or studio classes. Intense collaboration among the CSU community, open and frequent communication, coordination of efforts, flexible instructors, and the willingness to follow safe public health behaviors allowed CSU to continue face-to-face teaching in courses that required hands-on learning or demanded in-person instruction. It is the hope of the authors that this information can provide both a historical account and useful information for others dealing with the COVID-19 pandemic.

The National Biodefense Analysis and Countermeasures Center (NBACC) is a national resource established to understand the scientific basis of the risk posed by biological threats, and to analyze evidentiary material from bioterror or biocrime events. Like many other U.S. research institutions, the emergence of the SARS-CoV-2 virus, and rapid development of the COVID-19 pandemic allowed only a few short weeks of preparations before infectious disease controls could be implemented. Due to the nature of its mission, the NBACC must be available on a 24/7 readiness posture to support bioforensic casework from the Federal Bureau of Investigation (FBI). It also serves to provide the Department of Homeland Security (DHS) with key scientific data to assess the hazard from biological agents, especially in this instance to inform the national response to COVID-19. These factors caused the operational tempo to significantly increase. To accomplish our mission during a national emergency, laboratory staffing levels needed to be maintained at prepandemic levels. As a result, the Battelle National Biodefense Institute (BNBI) leadership took significant actions to prevent COVID-19 exposure and transmission within the workforce. These multiple actions included engineering changes to the facility, stockpiling of personal protective equipment and consumable products, educating the staff on the signs and symptoms of COVID-19, reducing the population of the nonlaboratory staff, and the completion of a comprehensive risk assessment to quantify the risk of COVID-19 infection for all NBACC staff. These early actions, used in tandem, were successful in maintaining a healthy and stable workforce so that BNBI's research objectives could be met.

Healthcare organizations are complex systems where healthcare professionals, patients, biological materials, and equipment constantly interact and provide feedback with highly consequential outcomes. These are the characteristics of a complex adaptive system. Healthcare delivery requires coordination but it necessarily relies on delegation of essential functions. It is thus essential to have an engaged workforce to ensure optimal outcomes for patients. Thus human performance factors play a key role in ensuring both the presence of excellent healthcare provision and the absence of outcomes that must be avoided-"never events." The commitment of management was a precondition for the implementation of the high-reliability organization (HRO) principles. A team from middle management was engaged and provided with appropriate management tools for identifying, prioritizing, assessing, and applying solutions for the safety concern in their operating systems. This article documents efforts at the National Institute of Health (NIH) to adapt the principles of HROs to diagnostic laboratories and vaccine production facilities at its campus in Islamabad, Pakistan, and seeks to draw some lessons for how this approach can be usefully replicated in such facilities elsewhere. Public health institutes such as NIH deliver vital products and services that are inherently risky to produce, where the consequence of failure can be catastrophic. Adopting the HRO principles is an approach to improving not just safety, but also the overall organizational performance in any setting, including low-resource settings, and can serve as an implementable process for other institutions.

Background: As the pharmaceutical industry advances its understanding of biological processes and how they relate to (the causes and treatments of) disease, many new modalities such as protein therapeutics (PTs) are emerging as breakthrough therapies to treat both rare and common diseases. As PTs become more prevalent, occupational health and safety professionals are challenged with identifying potential occupational exposure risks, health hazards, and assessing best practice recommendations for workers who develop, manufacture, and administer PTs. Methods: To characterize airborne exposures to PTs, we conducted a retrospective analysis of industrial hygiene (IH) data for PTs spanning >15 years. This information was used to support the development of an occupational exposure control banding system designed for and applicable to biologically derived PTs (produced in living cells). Overall, 403 IH samples were evaluated that included exposure data for monoclonal antibodies, fusion proteins, PEGylated proteins, and surrogates. Results: Our evaluation of historical IH PT sample data indicated low exposure potential across manufacturing activities with >99% (400/403) being below an airborne concentration of 1 μg/m3. Processes with the highest potential for airborne exposure included high-energy operations (e.g., homogenization) and maintenance activities (e.g., cleaning and repairs). Conclusion: The observed low exposure potential is expected given that many biological manufacturing activities are closed to maintain product sterility. This evaluation indicated that the banding systems historically utilized for small molecules could benefit from being revisited for PTs.