November 16, 2019
Juan Osorio, IE, World BioHazTec Corporation, Rockville, MD
Theodore Traum, PE, CCP, DGCP, World BioHazTec Corporation, Rockville, MD
Brynte Johnson, RBP(ABSA), CBSP(ABSA), SM(NRCM), World BioHazTec Corporation, Rockville, MD
Proactive biosafety professionals need to be involved and knowledgeable in the operation, maintenance, and certification of their containment facilities and building systems. The biosafety professional may be called upon to participate in the planning, design, and validation of a new biocontainment laboratory or renovation of an existing facility. The biosafety professional’s training and experience is usually limited to the sciences and they often lack the knowledge of basic engineering principles. This course is intended to fill the gap by providing basic engineering principles that are useful in the planning, design, construction, maintenance, and operation of a BSL-3 or high- containment facility. In order for the biosafety professional to participate in these activities; a foundation of engineering fundamentals, a developed set of skills to ask questions in engineering terms, and the confidence to question the answers are needed. There will be step-by-step slide presentations on planning, design, and quality assurance. Some of the exercises will require calculations (calculator recommended).
- Discuss engineering principles, design, and construction process of a BSL-3 laboratory in order to identify potential problems before construction begins
- Identify the phases and strategies of BSL-3 laboratory design and construction
- Describe the elements of a BSL-3 laboratory quality assurance program
Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals, Facilities Personnel
Chad Austin, PhD, CBSP(ABSA), SM(NRCM), University of Texas Health Science Center—Houston, Houston, TX
Anne-Sophie Brocard, PhD, RBP(ABSA), CBSP(ABSA), University of Texas Medical Branch—Galveston, Galveston, TX
Brandon Hatcher, PhD, GlaxoSmithKline, Vaccines R&D, Rockville, MD
In this advanced and interactive course, participants will evaluate a variety of challenging scenarios based on actual research protocol submissions and real world events from multiple risk perspectives. Participants will work in teams to conduct risk assessments on a diverse selection of scenarios that will include multiple systems used in research as a research project progresses from discovery, to cell culture, to small animal models using recombinant materials, and human clinical trials. Risk assessments will focus on the likelihood of exposure and the severity of consequences from exposure to the multitude of hazards encountered in increasingly complex research as well as the surprises that may come across the biosafety officer’s desk. Participants will be challenged to consider additional risks aside from infection and how best to mitigate them. Participants should have a thorough understanding of pathogenic microorganisms, rDNA principles, other infectious substances and the link between biosafety, risk assessment, and risk mitigation for this advanced course. There is an emphasis on the interactive nature of the risk assessment process and differing views of risk tolerance will be considered; participants should be prepared to participate in discussions and bring interesting or difficult examples of interest to them to discuss with the class.
- Prioritize risks based on the likelihood and consequences of an occurrence
- Identify risks requiring mitigation and mitigation strategies to minimize the unacceptable risks
- Identify institutional and external partners to help implement mitigation strategies
- Evaluate mitigation strategies for effectiveness, adjust strategies as warranted
Suggested Background: Fundamentals of Biosafety, Risk Assessment, Micro/Molecular Biology 101, Principles & Practices of Biosafety
Target Audience: Experienced Biosafety Professionals, Laboratory Workers
Althea Treacy, PhD, National Institutes of Health, Bethesda, MD
Antony Schwartz, PhD, CBSP(ABSA), SM(NRCM), Duke University, Durham, NC
This course will provide biosafety professionals with a strong foundation in disinfection, sterilization, and inactivation that will directly benefit them in carrying out their responsibilities. Course discussion will be on the history and current regulatory context of disinfection, sterilization, inactivation, validation strategies, quality assurance tests for each topic, and analysis of the factors that influence the effectiveness and potency of different treatment methods will be given. Subsequent material will cover the mechanisms of disinfection, sterilization, and inactivation, including chemical structures and classes of disinfectants sterilants and inactivation agents. Further discussion will describe the selection of appropriate methods and identification of associated safety hazards. Utilizing proven practices and procedures, participants will be led through a facilitated discussion leading to the development of standard operating procedures for executing sterilization, disinfection, or inactivation at their institution. Throughtout the course, participants will participate in didactice modules and hands-on exercises in small groups.
- Identify and restate mechanisms of disinfection, sterilization, and inactivation
- Select appropriate disinfectants and sterilants and appropriately evaluate inactivation methodologies
- Choose the appropriate validation and quality assurance test for method of disinfection, sterilization, or inactivation
Suggested Background: Fundamentals of Biosafety, Micro/Molecular Biology 101, Principles and Practices of Biosafety
Target Audience: All Biosafety Professionals, Laboratory Workers
09 – Emerging Technologies in Agricultural and Plant Sector: Biosafety and Biosecurity Challenges and Risk Management
Aparupa Sengupta, PhD, RBP(ABSA), University of California—Merced, Merced, CA
Luis Alberto Ochoa Carrera, MS, Institute for Epidemiological Diagnosis and Reference (InDRE), Mexico City, Mexico Global food security and enhancement of food quality has been a pressing issue worldwide. Recent advent of powerful technologies like gene editing tool CRISPR/Cas9 have the potential of bringing unprecedented global impact in different industries starting from novel bioenergy production, new therapeutic intervention in medical world to biodiversity conservation. In the agricultural sector, these technologies have contributed significantly towards food security, reduction in pesticide use and greenhouse gas emissions, and in improvement of occupational safety in both industrialized and developing countries over the last two decades. Although extremely beneficial, these technologies are certainly not risk-free. They could be used for nefarious acts, such as bioweapon development to create new pathogenic organisms to render vaccines ineffective. These technologies may also have off-target effects, such as tumor suppressor gene silencing during cell culture experiment, or potential of changing biodiversity and invasion and disruption of local agricultural system by exotic or transgenic species. Since, outbreak of diseases, bioweapons, and emerging technology transfer of knowledge knows no borders, the beneficial use of the technology can become challenging in terms of biosafety and biosecurity, if the risks are not understood and addressed appropriately. The course will also include new emerging technologies, applicable to the agricultural and plant biotechnology field, where an appropriate risk assessment and communication strategies are imperative for preventing accidents from occurring or re-occurring.
- Identify and implement the different regulations related to agricultural and plant biosafety/biosecurity when reviewing institutional research protocols
- Evaluate and conduct a risk assessment of the potential impact of using emerging technologies and gene editing in agriculture and plant projects
- Identify and manage risk with the fast-evolving scope of research, especially with the use of CRISPR/Cas9 technology
Suggested Background: Fundamentals of Biosafety, Risk Assessment, Micro/Molecular Biology 101
Target Audience: All Safety Professionals, Experienced Biosafety Professionals, Laboratory Workers
Amy Vogler, PhD, RBP(ABSA), Northern Arizona University, Flagstaff, AZ
Shelley Jones, MS, RBP(ABSA), Northern Arizona University, Flagstaff, AZ
Keeping a Select Agent program going can be difficult, especially in the face of ever-changing regulatory requirements and limited resources. Long-established procedures may suddenly become unacceptable, interrupting research, and frustrating laboratorians. Likewise, a single unexpected adverse event can put an entire program at risk. Being prepared to deal with such changes and events is critical to maintaining a robust program. Anticipating future challenges can prove even more advantageous, elevating a good program to a great program. A proactive approach can minimize the impact of new requirements and reduce duration and frequency of “crises” sparked by sudden, unexpected requirements or events. This course will explore strategies for maintaining and improving an existing Select Agent program, including strategies for anticipating and responding to new requirements. Strategies will be based on the instructors’ experience with their institution’s program with additional input solicited from class participants during open discussions. Topics will include the history of the Select Agent program; effective oversight practices; efficiently meeting ongoing requirements; reporting, responding to, and analyzing incidents; a series of suitability program case studies; implementation of the recent inactivation requirements, including strategies for investigating inactivation “failures;” and inspection preparation and response. The course will consist of topical presentations followed by group discussions aimed at facilitating application of presented strategies to participants’ individual programs and providing a platform to capitalize on participants’ collective experience.
- Identify strategies for efficiently maintaining a Select Agent program in good standing with ongoing requirements
- Review a series of suitability program case studies and identify strategies for dealing with potential suitability concerns in accompanying exercises
- Summarize new inactivation requirements and identify successful strategies for compliance
Suggested Background: Building a Select Agent Program: Safety, Compliance, and Efficiency
Target Audience: All Safety Professionals, Select Agent Program Safety Professionals
11 – Building and Sustaining a Biohazard Accident Investigation Program in the Microbiology Laboratory
Sharon Master, PhD, Masthead Lab Solutions, Albuquerque, NM
Biohazard risk management is critical to a safe workplace. Conducting an investigation after a biohazard event is critical for effective risk management. However, there is limited guidance on this within the realm of biosafety. This course will educate participants on how to appropriately conduct all stages of an accident investigation, including root cause analysis, thus enabling them to build an effective investigation program at their laboratory. Through the use of real life scenarios and workbook exercises, participants will be able to identify a lab accident, a near-miss, and an exposure. Through the use of examples and real life scenarios from a clinical microbiology setting, participants will also learn tips and tricks to recognize laboratory-acquired infections. This course will help reinforce concepts, build, establish, and strengthen laboratory investigation programs resulting in more robust risk management programs.
- Develop and establish an accident investigation program
- Differentiate, using scenarios, between a near miss and an exposure
- Recognize a laboratory-acquired infection
Suggested Background: None
Target Audience: All Biosafety Professionals, Laboratory Workers
David Harbourt, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM), U.S. Army Medical Research Institutes of Infectious Diseases, Fort Detrick, MD
It is important that biosafety professionals understand how to respond to emergency response situations that could affect operations in containment laboratories. Biosafety professionals need to be able to understand how their facility and personnel function during normal operations to aid in preparation for significant events. It is also vital for biosafety professionals to know who the key decision makers are in their facility for situations that could potentially result in disruptions to operations. By understanding how their facility is intended to function, who the key decision makers are and the critical information that is needed during emergency scenarios, biosafety professionals can help ensure that they are prepared when situations arise in the future. This course is intended to cover some basics of emergency response situations along with the features of a containment laboratory that may be affected during an emergency. This course will go over important questions that biosafety and safety professionals need to be able to answer about their facility to help prepare them for emergencies. The course will be separated into two sections with the first covering the key questions of each of the facility components to include HVAC, plumbing, electrical failures, and potential occupational exposures. The second part of the course will cover a series of case studies based on real world emergency response situations in biocontainment laboratories. Individuals will be expected to work in groups to help solve each of the case studies and at the end of the course, the instructor will discuss how the emergency was handled in real time along with lessons learned.
- Restate the basics of emergency response and how they relate to biocontainment laboratory operations
- Identify potential system vulnerabilities in a biocontainment laboratory
- Summarize lessons learned from case studies and apply them to their own facility if applicable
Suggested Background: Fundamentals of Biosafety, Risk Assessment, BSL-3 Design and Operations, Principles and Practices of Biosafety
Target Audience: All Biosafety Professionals, All Safety Professionals
Daniel Eisenman, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM), Advarra, Research Triangle Park, NC
The clinical setting poses a different environment than research laboratories. This course provides foundations for applying biosafety concepts in the clinical setting. Topics covered include common issues and lessons learned pertaining to: clinical facilities including pharmacies, laboratories, clinics, infusion areas, ORs and waste disposal facilities; PPE, disinfection, risk assessments and safety practices in the clinical setting; speaking biosafety to doctors, nursing staff, pharmacy staff, infection prevention and control, diagnostic microbiology lab personnel and hospital EHS staff; applying NIH Guidelines and the BMBL to the clinical setting; gaps in oversight of research safety for clinical trials. The course will close with a focus on clinical trials including: the role of an IRB and how it can overlap with an IBC; the process for investigational products to obtain FDA approval to be deemed as safe and effective therapeutics; and the evolving regulatory environment in the U.S. for biologics such as vaccines, regenerative medicines and gene therapy. The course is designed to be highly interactive with discussions, surveys, and team exercises.
- Apply biosafety principles in the clinical setting
- Perform risk assessments and identify gaps in occupational safety in the clinical setting
- Discuss the regulatory oversight for clinical trials and the developmental process for investigational products
Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, Laboratory Workers, Research Administrators, Clinical Professionals
Lisa Orloff, World Cares Center—Resiliency Advisors, New York, NY
Traumatic events have the power to overwhelm normal coping abilities of individuals and groups. Emotionally charged, high-stress jobs can have a negative impact on individuals if they are not aware of the risks or coping skills. Research shows that training can reduce the impact that disasters, disaster work and high-stress environments have on those that function within them. Fortunately, resiliency is not a trait that is inherited, each person has the ability to build their own resiliency. This course is the first step on your road to resilience and building resilient teams. As a result of participating in this interactive course, participants will take part in role play activities demonstrating the objectives of the course.
- Identify the emotional risks related to disaster and high-stress work environments
- Recognize the signs and symptoms of disaster and high-stress work environment related stress
- Increase the ability to respond safely and effectively in disaster response and high-stress work environments
- Describe the techniques to address emotional stress
Suggested Background: None
Target Audience: All Safety Professionals