60th Annual Biosafety and Biosecurity Conference

Professional Development Courses

October 13-15, 2017

Professional Development Courses
Scientific Program | Abstracts (PDF 324KB)
Posters | Poster Abstracts (PDF 782KB)
Photos | Preliminary Program (PDF 1MB)

(Abstracts are on locked PDF documents. Password will be distributed by the ABSA office.)

October 13, 2017

1701 – Articulating the Value of Your Biosafety Program

A recurrent challenge for biosafety professionals is the ability to garner necessary program resources. The basis for this difficulty is that on a good day in the world of biosafety “nothing happens,” so upper management may not fully appreciate or understand all of the effort that went into making “nothing happen.” Biosafety professionals experience difficulty in this regard because many in the profession have received intensive training in the biological sciences, but little or no training in the area of program management. This course will focus on key management techniques that can be used within biosafety programs to help improve stakeholder understanding of the program and activities, which can result in the provision of necessary programmatic resources. Numerous real-world examples of successful applications of the techniques discussed will be displayed for review and discussion.

Objectives:

Identify biosafety programmatic measures and metrics that can be easily captured and communicated
Recall techniques used for displaying biosafety data in ways that others can readily understand and value
Describe how basic safety and biosafety programs work together to avoid duplication of efforts and improve safety and client satisfaction levels

Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals
Audience Level: Intermediate

1702 – Advanced Risk Assessment

In this advanced and interactive course, participants will evaluate research projects as they evolve over time from basic to multifaceted in vitro and in vivo scenarios based on actual research protocol submissions. Participants will work in teams to conduct risk assessments on scenarios that will include multiple systems used in research as it progresses from cell culture to small animal models using recombinant materials and 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. Participants should have a thorough understanding of rDNA principles 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; participants should be prepared to participate in discussions and bring interesting or difficult examples from their entities to share with the class.

Objectives:

Prioritize risks based on the likelihood and consequences of an occurrence
Assess the overall risk and determine mitigation strategies to minimize the risk
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
Audience Level: Advanced

1703 – Disinfection, Sterilization, and Inactivation: A Practical Guide for the Biosafety Professional

This course will provide biosafety professionals with a strong foundation in the topics of disinfection, sterilization, and inactivation that will have a direct benefit in carrying out their responsibilities. The course discussion will be on the history and current regulatory context of disinfection, sterilization, and inactivation, validation strategies and 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.

Objectives:

Identify and restate the 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, Risk Assessment, Principles & Practices of Biosafety
Target Audience: All Biosafety Professionals, Laboratory Workers
Audience Level: Intermediate

1704 – BSL-3 Operations and Management

This course will review the important aspects of the daily operation of a BSL-3 facility from two points of view—management of the facility and the daily operations. This assumes that you already have a facility built and have all required authorizations to work in it. The course will cover the different aspects you need to consider to operate a BSL-3 facility, such as: approval and training of a worker; maintenance support; occupational health issues; managing waste; maintenance of the HVAC and physical facility; periodic checks on the facility’s systems; and emergencies of different types. Daily operations in a BSL-3 will be discussed such as: understanding when it is safe to enter and when you need to evacuate; what to do when the ventilation fails; practical aspects of entry and exit procedures; practical tips on selection and use of personal protective equipment (PPE); safety considerations within the experimental SOPs; waste handling; facility cleaning; and how to have equipment repaired or serviced. This course will be conducted in a way that allows for interaction and exchange of experiences between participants and instructors. This course will not cover regulatory aspects from any specific country.

Objectives:

Describe the elements of annual verification, emergency response, etc.
Recognize institutional responsibilities from management to user
Summarize the methods used to develop manuals, SOPs, and training

Suggested Background: Basic Risk Assessment and Biosafety Knowledge
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Basic

1705 – Exercising Training: Making Biosafety Education Great Again

If it doesn’t fit—you must uplift! As training has moved online, those working in laboratories and related settings are getting more directed teaching from sitting, reading, and listening, which is associated with less biosafety training in live sessions. Whether online or live, periodic biosafety retraining also challenges trainers to create updated and effective programs for returning students. This course has been designed to provide those responsible for providing biosafety training an opportunity to explore a variety of training activities designed to enhance student engagement and information retention while emphasizing the foundational elements of biosafety. A variety of exercises will be utilized to provide each participant a solid library of training ideas and activities. Sample activities will be shared and shown along with a discussion of how they may be modified to fit alternative situations or venues. Exercises and drills will utilize old and new ideas; low-tech and high-tech materials; brief and detailed learning opportunities; light-hearted and serious case studies; and just plain fun. Opportunities to share lessons learned between trainers will be provided throughout the course. Join in learning how to make biosafety education great again.

Objectives:

Summarize the biosafety exercises used to design high-impact educational training activities
Examine and enhance engagement into existing trainings by intercalating the exercises and drills shown
Identify proven drills and techniques to promote interactions in biosafety training

Suggested Background: Fundamentals of Biosafety, Risk Assessment
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Basic

October 14, 2017

1706 – Gene Editing and Risk Assessment: Application to IBC Protocol Review

Gene editing technologies have been used for decades by scientists in the field of molecular genetics and recombinant DNA technology. Recently, with the discovery of CRISPR-Cas 9 gene editing, this field has expanded, and the ease to manipulate genes has changed significantly. It is important to understand that many times RNAi work uses viral vectors and CRISPR/Cas 9 and CRISPR/Cas9 sometimes is driven by common viral vectors (such as lentiviral vector), which could present additional risks. This is especially crucial since this technology is very quickly evolving and the risks are changing accordingly, a scientific background of the technology is a must have for all biosafety professionals. This course is designed to provide a brief overview of basic gene editing technologies such as plasmid based systems, RNA interference, viral vectors, CRISPR Cas9 technology, and the use of these technologies to create gene drives. After brief discussion of these technologies, participants will review a model IBC protocol application form (includes in vitro, in vivo, and human gene therapy applications) and review, discuss risks and benefits, and potentially propose alternative ways for the research to be conducted in a safer manner. The goal of this course is to provide participants with comprehensive background knowledge of various gene editing and recombinant DNA technologies in common use. Participants will be able to assess the risk of the proposed work and biosafety-related information that must be provided by the faculty members writing the protocol. The instructors come from an institution with many gene editing projects in place with multiple applications and have seen a wide variety of applications for this type of research.

Objectives:

Describe the different types of gene editing technologies including viral vectors, RNAi, and CRISPR/Cas9
Explain why and how these technologies are used together in a research project
Recall the topics and questions needed to assess the risks of gene editing research proposals

Suggested Background: Risk Assessment, Micro/Molecular Biology 101
Target Audience: All Biosafety Professionals
Audience Level: Intermediate

1707 – Engineering for the Biosafety Professional—Part I

Proactive biosafety professionals need to be involved and knowledgeable in the operation, maintenance, and certification of 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. Participants will be equipped with the basic knowledge to understand the process for planning, design, construction, maintenance, and operation of a high-containment laboratory. For the biosafety professional to participate in these activities, it’s important to understand engineering fundamentals, develop skills to ask engineering type questions, and have the confidence to question the answers. Information will be provided relevant to BSL-3 facilities to determine air change rates, define HVAC containment boundaries, interpret design drawings, understand HEPA filtration, provide an introduction in determining room heat loads and ventilation rates, directional airflow concepts and room pressure differentials, and an introduction to HVAC components (e.g., isolation valves, control valves, fast acting actuators, etc.). Building on this information, there will be a step-by-step presentation on planning, design, construction oversight, commissioning, certification/validation/ANSI Z9.14 standard, maintenance, and operation. Participants will be able to formulate informed questions, interact with maintenance personnel, and integrate facility operations with the biosafety program.

Objectives:

Recognize engineering issues within the various development phases of a biocontainment facility
Analyze a laboratory layout to establish its HVAC boundaries
Explain HEPA filters operation, decontamination, and testing

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Basic

1708 – Shipping infectious Substances Certification Course

This course is appropriate for those who have some experience with infectious substance handling or shipping, but may not have been certified within the past three years. The course utilizes group discussions and interactive exercises focused on the essential areas of infectious substance shipping. Participants will have the opportunity to mark, label, package, and complete documentation for a variety of infectious substances shipments (Category A, Category B, and Exempt Patient Specimens). Participants will review applicable regulations with a focus on IATA. This course is appropriate for those responsible for packaging, marking, and labeling shipments of all categories of infectious substances, dry ice, and liquid nitrogen. A final written certification exam will be administered—participants must score at least 80% in order to be certified.

Objectives:

Using principles of risk assessment to classify biological materials for shipping purposes as either Category A, Category B, Exempt, or not regulated
Demonstrate how to package, mark, label, and document shipments for infectious substances, Category A, Category B, and dry ice
Complete a written exam to qualify for infectious substance shipping certification

Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals
Audience Level: Basic

1709 – Building a Select Agent Program: Safety, Compliance, and Efficiency

A successful Select Agent Program depends on ensuring personnel safety and maintaining regulatory compliance in an efficient manner. In the absence of efficiency, research can be unnecessarily hindered and regulatory compliance may become overly burdensome, which could lead to lapses that affect the success or failure of an entity’s Select Agent Program. This course will explore strategies for implementing a successful Select Agent and/or Tier 1 Select Agent Program based upon the instructors’ experience with their institution’s Select Agent (including Tier 1) BSL-3 Program. Topics will include identifying site-specific needs; developing and reviewing plans and SOPs; promoting a safety and compliance culture; organizing and tracking inventory; training methods and recordkeeping; providing effective oversight; and preparing for, facilitating, and responding to inspections. Strategies presented will focus on organization, resource management, flexibility, and efficiency. This course will consist of presentations, group discussions, and exercises to assist participants in applying the strategies to the needs of their entities.

Objectives:

Design and implement effective and efficient policies, plans, and procedures compliant with the current CDC/USDA Select Agent Regulations
Identify strategies for streamlining and integrating required documentation
Describe inventory management techniques to ensure current and accurate inventory records

Suggested Background: None
Target Audience: Safety Professionals Working with Select Agent Programs
Audience Level: Basic

1710 – Institutional Biosafety Committee (IBC) Basics

This course will present the function and administration of the Institutional Biosafety Committee (IBC). Delivered by expert staff from the National Institutes of Health (NIH) Office of Science Policy (OSP), IBC Basics will promote the professional development of those associated with IBC by providing an opportunity to learn about the NIH OBA, the content of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines), and understand the range of responsibilities that the IBC has under the NIH Guidelines.

Objectives:

Summarize the content of the NIH Guidelines and the requirements for the IBC under the NIH Guidelines
Recognize the partnership between NIH OBA, IBC, and Recombinant DNA Advisory Committees (RAC) and
learn about the NIH OBA IBC site visit program
Describe how to implement an effective program of oversight for research subjects to the NIH Guidelines

Suggested Background: None
Target Audience: New Biosafety Professionals, IBC Members/Staff
Audience Level: Basic

1711 – Biocontainment Laboratory Operations

This interactive and discussion-based course will discuss key insights and shared expertise in biocontainment facility start-up and operations from an operator’s point-of-view. We often hear from some of the best of architects and engineers on how to build or renovate a biocontainment laboratory, but what about their competency—have they ever operated a laboratory to evaluate their own design process? Where did they learn their craft? We will discuss details of the questions to ask the design/construction team, the steps to follow, and lessons learned during all the stages of building or renovating a biocontainment facility. This course will focus on establishing the need for high-containment to include the level needed; the long-term need and ideas for flexibility; selecting the right architect and engineer for the project; selecting a construction manager that understands the design and purpose of the facility; how to choose the proper operations staff; selecting the right commissioning agent; and the initiation of scientific operations to allow for safe biocontainment operations.

Objectives:

Summarize lessons learned in the design/construction and start-up process of a biocontainment facility
Restate the questions to ask when selecting the facility design/build and operations teams
Describe what plans are needed to initiate scientific operations

Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, Laboratory Operations Management
Audience Level: Basic

1712 – Introduction to Unique Biocontainment Challenges in Agriculture Research

Agriculture research laboratories must conduct work on important pathogens to develop technologies that reduce economic losses due to disease. Experiments including pathogens must be contained and prevented from introduction to the community, including spread to local agriculture production sites and habitats of native species. Topics covered will focus on assessing risk for agricultural disease agents and developing multi-layered containment procedures for implementation to protect agriculture, public health, and the worker as well as a discussion about the need to continually monitor the adequacy of controls using a robust diagnostic testing and surveillance. Specific emphasis will be placed on aquatic species, poultry, cattle, and small ruminants.

Objectives:

Restate the difference in worker protection, public health risks versus agricultural risks, and the need for a
risk assessment process prior to working with agents that impact agriculture only
Explain the importance of instituting an animal health monitoring program
Identify and develop a basic understanding of operational and infrastructure challenges related to veterinary research activities related to endemic and transboundary animal diseases of agricultural significance

Suggested Background: None
Target Audience: All Biosafety and Biorisk Professionals, Animal Caretakers
Audience Level: Basic

1713 – Human Gene Transfer—Biosafety Considerations

Recent advances in molecular biology have produced ground-breaking new technologies that are now making their way to the clinic with increasing frequency. Oncolytic viruses, CRISPR technology, CAR-T Cell therapy, and gene therapy for rare diseases are just some of the high-profile applications currently under study in Human Gene Transfer (HGT) clinical trials. This course will provide an overview of the latest advances in HGT research, review the risk assessment considerations for biosafety professionals and Institutional Biosafety Committees, and outline the regulatory environment for human gene transfer research. With successes and failures along the way, the HGT field has accumulated a truly significant resource of information regarding real and perceived risks—information that the biosafety professional can use when assessing individual trials. The course will review the new requirements for HGT study startup under the 2016 revised NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and discuss practical experience with RAC review. It will also review the regulatory requirements for clinical research with gene transfer agents after they have been approved by the FDA as drugs. Case studies and group discussion will be used to amplify the take home messages.

Objectives:

Restate the risks and challenges associated with human gene transfer
Identify the categories and risk groups of biological agents used in human gene transfer
Summarize the key NIH regulatory requirements for gene transfer research

Suggested Background: None
Target Audience: All Biosafety Professionals
Audience Level: Intermediate

1714 – Handling Critical Situations in Laboratories

Emergencies and critical situations will occur regardless of the workplace, institution, or country. Laboratories that have a biological risk assessment are not immune to accidents or emergencies. The handling of critical situations ensures responsiveness by the members of a laboratory and minimizes the potential negative impacts of an emergency. Preparing and responding effectively to emergencies are among the most pressing challenges that occur in a laboratory. Several specific situations that institutions must consider are: fire and medical emergencies: weather-related emergencies; spill emergencies; human conflicts; intrusion; and others. Specific procedures need to be created and evaluated on how to handle these situations. This course establishes basic procedures for planning, preventing, and responding to accidents and possible ways to prevent them from occurring as well as understanding the advantages and disadvantages of incident management for coordination, communication, and capacity for the care of critical situations in laboratories. Proper hazard evaluations and risk assessments are the primary responsibility of the person performing the experiment and the laboratory supervisor. Knowledge of basic concepts regarding accidents, incidents, emergencies, and critical situations will be discussed and how this understanding and the sources of information are used to assess the risks associated with potential hazards. A practical guide for trained laboratory personnel engaged in these activities will be provided.

Objectives:

Identify and categorize the various scenarios and critical situations that may be encountered by users during
the development of activities
Develop a risk assessment of activities and specific processes of each laboratory
Evaluate the technical competence of each lab worker and identify potential risks of each lab and activity

Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals
Audience Level: Basic

October 15, 2017

1715 – Advanced Laboratory Design Principles and Practices

This course will provide participants with an in-depth examination of key principles and practices for designing safe and efficient laboratories. It is intended for architects, designers, and biosafety professionals desiring a more comprehensive analysis of the laboratory design process. Participants are expected to have some experience with laboratory facility design and/or have previously attended the ABSA preconference course entitled Laboratory Facility Programming and Design Best Practices. Participants will engage in guided discussions and analyze laboratory plans with respect to the design principles and practices under consideration.

Objectives:

Illustrate methods of design and analysis that promote good laboratory design
Identify examples of good design solutions for laboratory room and laboratory building layouts
Summarize how good design practices work to enhance both biosafety and biosecurity

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Principles & Practices of Biosafety, Laboratory Design Best Practices
Target Audience: Experienced Biosafety Professionals, Architects, Engineers, Facility Maintenance Personnel
Audience Level: Advanced

1716 – Leadership, Training, and Culture Development in Biosafety

Leadership prepares, protects, and promotes the workforce and safety officer. Training not only prepares the workforce, it protects them and promotes safety throughout the organization. Blending the workforce, safety officer, and leadership with a common set of risks, rules, and rituals creates a ONESAFE culture. This course will provide participants with a chance to practice public speaking, behavioral, and cognitive training strategies aimed at delivering more effective biosafety training programs. The second part of the course will provide participants with leadership strategies; increasing the ability of participants to prepare, protect, and promote the workforce. Participants apply several leadership techniques including personality typing, appreciative inquiry, and behavioral techniques to increase compliance to safety policies. The course will provide participants with strategies aimed to blend the workforce, safety officer, and leadership—creating a ONESAFE culture under a common set of risks, rules, and rituals.

Objectives:

Demonstrate effective cognitive and behavioral training strategies in biosafety
Describe leadership strategies in biosafety
Discuss a ONESAFE culture

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Principles & Practices of Biosafety
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Basic/Intermediate/Advanced

1717 – Integrating Biosecurity into Laboratory Biorisk Management Systems

Biorisk management programs should be inclusive of well-developed biosafety and biosecurity elements. Many organizations with robust biosafety programs may not recognize a need to thoroughly integrate biosecurity into their existing biosafety programs. This course aims to provide biosafety professionals and program managers with a strategic and tactical approach to building their biosecurity programs as a functional complement to existing biosafety and physical security programs. It is designed to provide detailed information on the functional components of an effective biosecurity program and how to integrate biosecurity into existing biorisk management programs. This course is comprised of the following sections: understand the inherent differences between risk-based (biosafety) and threat-based (biosecurity) programs where exploration of the fundamentals of threat assessments and vulnerability analyses; examine the Five Pillars of Security (physical security, personnel reliability, material control and accountability, transportation safeguards, and information security) as a framework for an Integrated Security Program (ISP) to be aligned with existing safety and security management systems. The resulting integrated model of biosafety and biosecurity management systems will be augmented using case studies from both academic and industrial examples; participants will be challenged by tabletop exercises that will simulate potential biosecurity threats. A package of biosecurity program documentation will supplement workshop content, including materials specific to conducting threat assessments and vulnerability analyses, models for creating a biosecurity program, checklists to initiate development of biosecurity programs, and strategies for integrating biosecurity functionality into biosafety programs. Participants will leave with practical advice on biosecurity program design and implementation as well as ideas on the initial steps that may be taken to the participant’s respective institutions to build or improve their biosecurity program and integrate it into existing biosafety and management systems. Participants will conclude the session by initiating a draft of their own next action steps for use upon returning to their institutions.

Objectives:

Restate the fundamental elements of risk-based and threat-based programs
Recognize threats and vulnerabilities to consider when protecting laboratory materials from unauthorized access, loss, theft, misuse, diversion, or intentional release
Utilize Five Pillars of Biosecurity as a framework for recognizing gaps and opportunities for improvement

Suggested Background: Fundamentals of Biosafety, Risk Assessment
Target Audience: All Biosafety and Biosecurity Professionals, Lab/Institutional Management
Audience Level: Intermediate

1718 – Naturally Occurring Biotoxins

This course will review the various types and classification of naturally occurring biotoxins. The course will discuss factors affecting health and exposure and the increasing evidence linking exposure to environmental biotoxins to neurodegenerative disease.

Objectives:

Classify the various types and classifications of naturally occurring biotoxins
Summarize factors that affect the susceptibility of individuals to naturally occurring biotoxins
Restate the environmental conditions can affect the prevalence of naturally occurring biotoxins and the
evidence that exists linking biotoxins to disease

Suggested Background: Fundamentals of Biosafety
Target Audience: Experienced Biosafety Professionals, All Safety Professionals
Audience Level: Intermediate/Advanced

1719 – Introduction to ANSI Z9.14: Testing and Performance Verification of BSL-3/ABSL-3 HVAC System

ANSI Z9.14: “Testing and verification of the ventilation system of laboratories that operate at Biosafety Level 3 (BSL-3)/Animal Biosafety Level 3 (ABSL-3) are necessary processes for ensuring that the performance and operation of the systems consistently maintain a safe environment for human occupants, research animals, and the internal and external environment.” Each facility is unique; testing and verification acceptance criteria will differ among facilities. Therefore, a risk-based approach to testing and verification of the ventilation system is recommended. It is highly encouraged that each facility develops and maintains standard operating procedures (SOPs) that address testing and verification of the ventilation system and associated components. Risk assessments should be performed initially and at regular periods throughout the life cycle of the facility. ANSI Z9.14 provides recommendations for testing methodologies, guidance on the ventilation system components that should be inspected visually, and what is needed to verify that the system components operate such that the overall system’s performance (i.e., directional inward airflow, response to failures, minimizing leakage, etc.) can be verified to ensure safe operation of the facility’s ventilation system. This course will introduce the ANSI Z9.14 standard and the recommendations for HVAC system testing and verification.

Objectives:

Discuss common types of equipment found in BSL-3 laboratories and their impact on ventilation systems
Restate key factors in performing an initial “pre-validation” and “post-validation” risk assessment
Describe testing methodologies and discuss course of action for failure scenarios

Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, Operation and Maintenance, Architects, Engineers
Audience Level: Basic

1720 – Practical Biosafety and Infection Control Considerations for Human Gene Transfer Studies

This course will outline regulatory and safety challenges in conducting human gene transfer research and offer strategies to address them. The course will cover basic regulatory review and risk assessment for human gene transfer studies and expand on the practical aspects of conducting such studies including identifying key stakeholders such as the IBC, IRB, Infection Control, and Pharmacy, and how to coordinate safety activities between each group. The course will outline some of the differences between biosafety, infection control, and hazardous drug safety and how each can work together to achieve desired outcomes. The course will also examine case studies that will highlight some of the challenges one might encounter in the real world.

Objectives:

Summarize the regulatory framework and basic risk assessment for human gene transfer research
Identify key stakeholders for conduct of human gene transfer research
Describe strategies to coordinate activities between them

1721 – How to Respond to Emergency Scenarios in Biocontainment Laboratories

It is important for biosafety professionals to understand how to respond to emergency response situations that could affect operations in containment laboratories. Emergency situations can affect a wide range of facility operations (electrical failures, plumbing, heating/ventilation/air conditioning [HVAC], etc.) and often occur with little or no warning to the biosafety professionals, scientific staff, or support staff. Biosafety professionals need to be able to thoroughly understand how their facility and personnel function during normal operations in order to aid in preparation for significant events. In addition to understanding their facility and personnel, 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 short- or long-term disruptions to operations. By understanding the critical information that is needed for the key decision makers during emergency scenarios, biosafety professionals can help ensure that they are prepared when situations arise in the future. This course is intended to cover basic information of emergency response situations along with the key features of a containment laboratory that may be affected during an emergency situation. This course will go over the key aspects of an HVAC, building electrical design, and plumbing systems. This is not an engineering course—it is intended to be a brief overview so that biosafety professionals understand the right questions to ask during emergency situations. The course will be separated into five sections covering critical information that needs to be understood: basics of emergency response; HVAC; plumbing; electrical failures; and potential occupational exposures. A series of case studies based on real-world emergency response situations and potential occupational exposures in biocontainment laboratories will be conducted.

Objectives:

Describe the basics of emergency response and its relation to the decision-making process during an emergency response situation affecting biocontainment laboratory operations
Restate the key decision makers in your facility and who can authorize decisions that will make an impact
Identify lessons learned after action reviews from case studies and potential occupational exposures and apply them to an incident response plan, if applicable

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate

1722 – Best Practices in Teaching Technical Topics

Studies show that nearly 75% of the population fears public speaking. An HR salary study has determined that employees who make presentations earn an average of $9,000 per year more than employees who are not responsible for making presentations. Do you provide training on difficult compliance subjects to your employees? In a recent survey of those who provide technical training, we found that the number one problem was “How to make the training interesting.” Four of the top five issues for trainers involved not technical issues, but how to be a better, more polished speaker (without getting so nervous). This course will reveal easy-to-implement ideas that will help you become more comfortable in front of the room and make your message more impactful. Whether a new trainer or a seasoned veteran, you will find this training presentation helpful. We share cutting-edge ideas that will help you easily explain difficult ideas and help you get your message across to your audience.

Objectives:

Recall the use of a participatory-based training experience (PTE) to encourage retention and change employee behavior
Describe how to handle the “disruptive,” “know it all,” or otherwise “difficult” student
Explain the use of real-time polling, digital quizzes, and other online tools to improve your message

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate

1723 – Contemporary Topics Affecting Biosafety Program Operations

The practice of biosafety is actually the convergence of a variety of professional disciplines, thus changes and developments that affect the field can emerge from various sources. This course is designed to address four contemporary issues confronting biosafety program operations: biosafety’s role in mitigating insider security risks; ethical decision making and the link to safety culture; anticipating and adapting to change within your organization; and the promise and peril of “citizen science.”

Objectives:

List examples of signs and symptoms of insider threat risk behavior
Identify three examples of ethical dilemmas biosafety professionals encounter
Discuss strategies for adapting to organizational change

Suggested Background: None
Target Audience: All Safety Professionals, Experienced Biosafety Professionals, Laboratory Workers
Audience Level: Intermediate

1724 – Commissioning for the Containment Laboratory

Commissioning and/or the resulting documentation from the commissioning process of the biocontainment laboratory are not always clearly understood by the biosafety personnel. The biosafety officer will benefit by having a fundamental understanding of the commissioning process and the resulting documentation. This would allow them to articulate the data required from their commissioning agent and assure the needs are met for the Federal Select Agent Program. Instructors will review the phases of the commissioning process: design; construction; acceptance; and warranty. This knowledge base will allow the biosafety professional to understand how commissioning assists in providing a properly operating facility and the risk when it does not. The knowledge gained will allow the professional to check the containment spaces’ performance should there be any questions. The biosafety officer can then observe (or actively participate) in the commissioning process and fully understand the methodology, tools, and data results. This course will review the common biocontainment guidelines, including BMBL, NIH, and ANSI used for containment commissioning. This interactive course will review the standard tools used to collect data, demonstrate compliance, and document the results. Participants will use the tools to gain a full understanding of the process and tools and are invited to bring questions or scenarios as to how we may perform a test. The instructors will present some of the commonly encountered issues observed in the field, demonstrating how the issues are identified and present specific means and methods to mitigate the issues. The understanding of the commissioning process, the commissioning report, and the tools used will assist the biosafety professional to confidently respond to the Select Agent inspector’s questions regarding the commissioning results of their facility.

Objectives:

Describe the commissioning process and commissioning report
Recognize the tools used in commissioning and the data outputs and their meaning
Identify and resolve commonly encountered issues

Suggested Background: None
Target Audience: All Safety Professionals, New Biosafety Professionals, Facility Operations and Maintenance Personnel
Audience Level: Basic

1725 – Speaking TIPS to Avoid Presentation Disaster

This course is designed to provide biosafety professionals with proven tools for preparing, organizing, and presenting effective presentations to a variety of audiences. Through a combination of lecture and participatory exercises, participants will gain confidence and enhance their speaking skills. Instructor presentations will provide TIPS for preparing, organizing, and presenting effectively with an emphasis on successfully connecting with the audience. Participants will gain valuable communication tips and experience that will benefit them in successfully connecting with customers and managers. An emphasis will be placed on how to connect with your audience in a meaningful and interesting manner. Participants will have the opportunity to engage in a variety of discussions and exercises focused on biosafety-related topics and Q&A. Participants will have an opportunity to practice in front of the group using a series of biosafety-related questions.

Objectives:

Restate how to prepare, organize, and present effective talks that connect with a variety of audiences
Design and present effective PowerPoint slides to support their message
Describe the methods used to assist in thinking quickly and effectively to respond to questions

Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, Animal Caretakers
Audience Level: Basic/Intermediate

1726 – Clinical Laboratory Testing for High Consequence Pathogens in the Front Line, Assessment or Hospital Setting

Availability of clinical laboratory testing is critical for patient care with a Risk Group 4 high-consequence pathogen. The recent development of highly-specialized facilities in the United States to assess and treat patients with a highly-infectious disease has led to the design of dedicated laboratories to safely test specimens that might contain one of these pathogens. This course will identify the regulatory agencies that govern human testing. Participants will recognize the training necessary to perform clinical laboratory testing. Exploration of the process for determining what tests are already available for testing in the frontline and other acute care facilities. Each tier will be assessed using the risk identification and assessment process. Case studies will be used to practice this determination. Safety practices will be reviewed to include the pre-analytical (specimen collection and processing), analytical (specimen testing), and post-analytical (specimen disposal/waste management and reporting) processes. Levels of practice within a BSL-2 or BSL-3 facility will be examined with possible modifications. Participants will simulate practice with quality control, inventory management, packaging and sample shipping for a high-consequence pathogen. Construction of a test menu will be produced and cost analysis of each of the items will be reviewed. Participants will predict the cost of the sustainability of instrumentation for a bioemergency that may never happen.

Objectives:

Compare Clinical Laboratory Improvement Amendments to College of American Pathology regulations
Describe the three complexity levels of testing and requirements for Clinical Laboratory
Improvement Amendments
Practice risk assessment for testing processes that include pre-analytical, analytical, and post-analytical

Suggested Background: Fundamentals of Biosafety, Micro/Molecular Biology 101
Target Audience: Laboratory Workers, All Biosafety Professionals
Audience Level: Intermediate

1727 – OSHA Regulations and Guidance Applicable to Laboratories: What’s Current and in Development?

An institution’s biosafety office often focuses on ensuring adherence to guidance documents such as the NIH Guidelines, Biosafety in Microbiological and Biomedical Laboratories (BMBL), and the CDC/USDA APHIS Regulations for Biological Select Agents and Toxins (BSAT). There may not be the same level of awareness of which Occupational Safety and Health Administration (OSHA) regulations pertain to the laboratories at their institutions. A number of OSHA regulations apply to laboratories that handle biohazardous materials including: the Bloodborne Pathogens (BBP) Standard (29 CFR 1910.1030); the Laboratory Standard (29 CFR 1910.1450); various personal protective equipment (PPE) standards (29 CFR 1910 Subpart I) including the Respiratory Protection Standard (29 CFR 1910.134); and the General Duty Clause. There are also some standards relevant to laboratories that have been developed by State OSHA plans, notably CalOSHA’s Aerosol Transmissible Diseases Standard. In addition to regulations, OSHA has developed various guidance documents that describe methods to protect workers in laboratory environments. Although the BBP Standard has proven very effective at protecting workers from infectious agents transmitted via the bloodborne route, it does not address infectious diseases transmitted by other routes (e.g., contact, droplet, airborne). OSHA is considering development of an infectious diseases (ID) rule that would cover diseases transmitted by routes other than bloodborne. This course will provide a summary of laboratory OSHA regulations and guidance as well as an update on OSHA’s ID rulemaking.

Objectives:

Restate the existing OSHA regulations and guidance that are applicable to laboratories
Evaluate how OSHA regulations and guidance complement and interact with other federal regulations
and guidance
Summarize forthcoming OSHA regulations and guidance that affects laboratories

Suggested Background: None
Target Audience: All Safety Professionals, Institutional Management, Lab Workers, Animal Caretakers and Facility Staff
Audience Level: Basic

1728 – Strategies to Customize and Streamline the Institutional Biosafety Committee (IBC)

Strategies to customize and streamline the Institutional Biosafety Committee (IBC) is intended to provide a deeper understanding and tools to assist experienced biosafety professionals, those new to the field, and research administrators tasked with interfacing or overseeing the IBC. An updated survey will be completed by the instructor of all IBCs, which will be reviewed and dissected by participants. A discussion of best practices from the instructor’s experiences along with the participants will delve beyond recombinant DNA registrations the NIH Office of Biotechnology Activities requires and form additional options for participants to apply at their institution. As IBCs are increasingly tasked with oversight beyond recombinant DNA, this course will provide participants with methods to streamline IBC operations, increase IBC member participation, and provide the IBC as a resource to the research community. Sources and methods include the latest research and literature on IBC oversight, best practices, and the instructor’s experience.

Objectives:

Describe and demonstrate techniques for administering an effective IBC
Explain methodologies to annually benchmark the IBC internally and externally
Quantify the time and effort of regulatory impact on the role of the biosafety office and research office

Suggested Background: Fundamentals of Biosafety, Risk Assessment
Target Audience: All Biosafety Professionals, Research Administrators
Audience Level: Intermediate