Applied Biosafety最新文献

Introduction: The US regulatory environment is evolving to accommodate a boom in gene therapy research. The 2019 version of the National Institutes of Health (NIH) Guidelines on Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) lacks an appendix providing specific guidance for Institutional Biosafety Committee (IBC) review of clinical trials.

Discussion: As the field matures, the burden of Federal oversight for clinical trials of investigational products containing recombinant or synthetic nucleic acid molecules is shifting toward the Food and Drug Administration (FDA). This report summarizes recent FDA guidance documents on shedding and considerations for environmental impact assessments highlighting key points pertinent to IBC review.

Conclusion: This report helps biosafety professionals understand the evolving regulatory framework for gene therapy products. Knowledge of the guidance documents discussed in this report will assist biosafety professionals in addressing issues pertaining to shedding and environmental impact during IBC review of clinical trials.

Introduction: With the onset of the COVID-19 pandemic, a rapid adjustment of work tasks was necessary for many biosafety programs (and other safety programs) to address drastic shifts in workload demands amid pandemic-related shutdowns and subsequent needs for supporting COVID-19-related safe work protocols, diagnostic testing, research, vaccine development, and so forth. From a program management standpoint, evaluating and understanding these tasks were critically important to ensure that appropriate support and resources were in place, especially during such unprecedented times of rapid change and significant impact to normal life and routine.

Methods: Described here are examples of how the biosafety program at The University of Texas Health Science Center at Houston (UTHealth Houston) addressed these challenges.

Results: As part of this required pivot, key services and tasks emerged into three distinct categories: (1) those that were temporarily diminished, (2) those that had to continue despite COVID-19 and the associated shutdowns for safety or compliance purposes, and (3) those that dramatically increased in volume, frequency, and novelty.

Conclusion: Although the adjustments described were made in situ as the pandemic evolved, the cataloging of these tasks throughout the experience can serve as a template for biosafety programs to plan and prepare for the next pandemic, which will inevitably occur.

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.

Introduction: 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.

Methods: 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.

Conclusion: These early actions, used in tandem, were successful in maintaining a healthy and stable workforce so that BNBI's research objectives could be met.

Introduction: Over the past decade, there have been outbreaks associated with high consequence infectious diseases such as Ebola virus disease, Lassa fever, and Monkeypox. The proper handling of clinical waste from patients infected with such pathogens is critical to ensure healthcare personnel and community safety.

Methods: Mock clinical waste bags were created to simulate four distinct waste streams: personal protective equipment (PPE), dry linens, wet linens, and solidified liquids. Pressure and temperature data loggers were buried in the middle of simulated waste loads to record time at a sterilization temperature of 132°C (270°F) to reduce sterilization time. We also validated super rapid biological indicators (BIs) by embedding standard BIs (48 h), rapid BIs (3 h), and super rapid BIs (24 min) within each load. Cycles were validated over a 2-day period, using a total of 36 simulated waste bags (6 bags each for PPE, dry linen, and wet linen, and 18 bags for solidified liquids).

Results: All waste bags achieved the target sterilization temperature, all BIs passed and cycle times were substantially decreased. For PPE waste processing, an estimated 15 h was saved for a 24-h period.

Discussion: Default factory settings are inadequate to disinfect Category A clinical waste. Reliance on autoclave temperature readings may overestimate time at goal sterilization temperature for actual waste loads.

Conclusions: The data provided by within bag data loggers and BIs allow for the optimization of autoclave parameters to increase throughput and enhance staff safety.

A recent series of widespread infectious disease outbreaks has highlighted commonalities and differences between three key professions that operate on the front lines of response in support of research and/or direct healthcare providers: biosafety, infection prevention, and public health. This assessment, which builds upon previous study by the authors, examines the stated professional competency categories for these three areas, highlighting similarities and differences. This assessment is important as these professions are being drawn together in an operational environment driven by the current pandemic and inevitably future disease outbreaks. Cross-training opportunities for the various professions are proposed.

Background: Burkholderia pseudomallei is a Tier 1 overlap select agent and subject to the select agent regulations (42 CFR §73 and 9 CFR §121). It is a gram-negative, motile, soil saprophyte, and the etiologic agent of melioidosis. B. pseudomallei infection can produce systemic illness and can be fatal in the absence of appropriate treatment. Laboratory exposures involving this organism may occur when appropriate containment measures are not employed. Current disease treatment inadequacies and the risk factors associated with melioidosis make this an agent of primary concern in research, commercial, and clinical laboratory environments.

Results: This study presents data reported to Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins for releases involving B. pseudomallei in 2017-2019 that occurred in Biosafety Level (BSL)-2 and BSL-3 laboratories. Fifty-one Animal and Plant Health Inspection Service (APHIS)/CDC Form 3 release reports led to the medical surveillance of 275 individuals. Entities offered post-exposure prophylaxis to ∼76% of the individuals impacted in the presented events.

Summary: Laboratory safety can be improved by implementing appropriate safety precautions to minimize exposures. Most of the incidents discussed in this evidence-based report occurred during work conducted in the absence of primary containment. None of the releases resulted in illness, death, or transmission to or among workers, nor was there transmission outside of a laboratory into the surrounding environment or community. Effective risk assessment and management strategies coupled with standard and special microbiological policies and procedures can result in reduced exposures and improved safety at facilities.

Aim: This study aimed to validate the efficacy of hydrogen peroxide vapor (HPV) decontamination technology set up in a biosafety level 3 (BSL-3) laboratory on surrogates and hazard group 3 (HG3) agents.

Methods and results: The HPV decontamination system (Bioquell) was assessed with both qualitative and quantitative methods on (1) spore surrogates (Geobacillus stearothermophilus, Bacillus atrophaeus, and Bacillus thuringiensis) in the BSL-3 laboratory and in the material airlock and on (2) HG3 agents (Bacillus anthracis; SARS-CoV-2, Venezuelan equine encephalitis virus [VEE], and Vaccinia virus) in the BSL-3 laboratory. Other HG3 bacteria likely to be handled in the BSL-3 laboratory (Yersinia pestis, Burkholderia mallei, Brucella melitensis, and Francisella tularensis) were excluded from the HPV decontamination assays as preliminary viability tests demonstrated the total inactivation of these agents after 48 h drying on different materials.

Conclusions: The efficacy of HPV decontamination was validated with a reduction in viability of 5-7 log₁₀ for the spores (surrogates and B. anthracis), and for the enveloped RNA viruses. Vaccinia showed a higher resistance to the decontamination process, being dependent on the biological indicator location in the BSL-3 laboratory.

Introduction: 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."

Methods: 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.

Results: 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.

Conclusion: 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.

Introduction: COVID-19 diagnosis was one of the most pressing needs during the early stages of the pandemic. Its entire procedure has inherent biosafety risks that if not properly managed and mitigated can be life threatening. Cognizant of this vital aspect, the Department of Health (DOH) imposed a biosafety training requirement to all laboratories and institutions before they could perform COVID-19 diagnostic testing. But with the mandatory lockdown, conventional face-to-face training could not be conducted. To address this need, the Biosafety Education and Awareness Training COVID-19 Online Program was offered by the National Training Center for Biosafety and Biosecurity of the University of the Philippines Manila.

Methods and materials: This online training program implemented a distance learning approach made available through the Canvas Learning Management System. It consisted of seven modules on biosafety that were sufficient enough to capacitate the participants with information for them to effectively implement a biorisk management system. The participants were evaluated based on quiz, examination, and case analysis. Certificates of completion were awarded to participants who passed all evaluation methods.

Results: A total of 3371 trainees from various medical professions passed and obtained the certificate. This resulted in >100 DOH-accredited COVID-19 testing laboratories by the end of 2020.

Discussion and conclusion: The online availability of this program proved to be an effective innovative solution to a unique problem. Therefore, this training program demonstrated that biosafety training can be effectively conducted online and in a distance learning approach.