Industry Insights

World BioHazTec has been a leader in biosafety and biosecurity since its inception in 1995. Over the years, we have successfully completed numerous groundbreaking projects and received prestigious awards, showcasing our dedication to excellence and innovation.

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The Critical Role of a Commissioning Agent in BSL-3 Laboratory Design and Operation

The commissioning agent plays a vital role in ensuring the BSL-3 laboratory operates safely, effectively and meets the design intent. This subject matter expert is responsible for rigorously challenging a new or renovated laboratory's critical MEP systems and other containment features. A commissioning agent's expertise goes beyond just testing equipment; they ensure that all systems work together as intended under real-world operating conditions. By simulating potential failures through Integrated Systems Functional Performance Tests (ISFPTs), conducting performance verification tests, and ensuring compliance with biosafety standards, the commissioning agent confirms that the facility is ready for safe operation. It is ideal to involve the BSL-3 commissioning agent as early as possible in the programming/design phases of the laboratory. Early engagement ensures that critical building systems and operational requirements are seamlessly integrated into the design, reducing the likelihood of costly modifications or delays later in the project. As a rule of thumb, the commissioning agent should consist of a multidisciplinary team of engineers and biosafety professionals. This combination of expertise ensures not only a deep understanding of critical building systems, such as HVAC, pressure controls, and decontamination systems, but also the ability to translate scientific and biosafety requirements into practical, effective design solutions. By incorporating their insights from the outset, the project team can align the laboratory's design with its functional and safety goals, paving the way for a smooth commissioning process and long-term operational success. The commissioning process involves detailed documentation, culminating in a comprehensive report that extends beyond a simple compilation of test results. This report includes ISFPT (Integrated Systems Functional Performance Testing) sheets, detailed risk assessments, graphical depictions of directional airflow and laboratory layout, validation checklists, calibration verification, differential pressure readings under normal and abnormal conditions, annotated photographs, quality improvement recommendations, and certificates for the equipment used during data collection. Serving as both a record of compliance and a valuable resource, the report provides critical guidance for future maintenance, certification/recertification, and continuous quality improvement. Choosing an experienced commissioning agent is essential to the success of your BSL-3 laboratory project. The ideal candidate should have a strong background in biosafety, engineering, and regulatory compliance, along with a proven track record of commissioning high-containment facilities. Collaborating with a knowledgeable third-party commissioning agent ensures that your laboratory is not only operationally sound but also fully compliant with all relevant guidelines and regulations. It’s important to select a commissioning agent who routinely visits BSL-3 laboratories for annual HVAC verification and validation testing. This hands-on experience provides critical insights into how laboratories operate over time, which can be applied during design, construction, and of course commissioning. A seasoned commissioning agent understands these lessons learned to optimize your laboratory’s functionality, safety and sustainability. Their expertise ensures your facility is built to meet both current and future demands. Investing in the right BSL-3 commissioning expert is a crucial step toward achieving a successfully laboratory project, ensuring that the facility meets its design intent, safeguarding both personnel and the environment while supporting the laboratory’s research objectives. To learn more about World BioHazTec’s commissioning approach, contact us for a free consultation.

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Outsourcing Training for Work in Critical Environments

When managing a high-containment facility, such as a BSL-3 lab, safety is paramount. Training staff to handle biological hazards properly and operate within stringent protocols can literally be a matter of life and death. A critical question many organizations face is whether to develop training programs in-house or outsource this training to a specialized provider. We’ll explore barriers to in-house development and delivery of quality training and why outsourcing your training for high-consequence workplaces could be the best option for your organization. What are your barriers to faster learning design and development? A recent survey conducted by the Association for Talent Development (ATD), which has supported instructional developers of employee training programs worldwide for over 80 years, identified eight top barriers to faster learning design and development.[1] The top three barriers are: Adapted from DeFelice, R. 2021. ATD Blog. Rounding out the top eight barriers include lack of availability of Subject Matter Experts (SMEs) or stakeholders at 37%. In our experience, SMEs and stakeholders have many hats they wear, and their time is limited. Often, SMEs are outside of the organization and pose an additional expense to the development of in-house training, initially and annual updates to the curriculum. World BioHazTec uses the Successive Approximation Model (SAM) approach to instructional design. SAM is a three-phase process: Preparation Phase, Iterative Design Phase, and Iterative Development Phase.[2] SMEs and stakeholders are brought in at the initial outlining phase and then only as needed for review. Because this is an iterative process, by the time the final phase is reached, SMEs and stakeholders have agreed to the plans and there should be very few revisions, or scope creep, to the design and plans. This saves time for these busy professionals and reduces costs by managing time and scope. Limited learning infrastructure—such as access to dedicated systems, authoring tools, and networks—accounts for 35% of the barriers. Authoring tools and resources, such as licensed images, add to the expense. Additionally, online self-paced (asynchronous) learning modules require authoring tools to create interactive content with feedback, as well as a learning management system to deliver the modules effectively. The final three barriers are a lack of learning and development skills within the talent development team (25%), lack of accountability (when the talent development team or SMEs do not fulfill responsibilities or meet deadlines) (23%), and insufficient leadership or management support (19%). These barriers indicate that staff are often occupied with other duties, with training development frequently becoming a lower priority. How much extra time does your staff have? Developing in-house training programs takes time—far more than many organizations realize. According to ATD in its most recent survey, creating one hour of new classroom training can take anywhere from 112 to 367 hours to develop.[3] That means developing just a half-day session could consume weeks of work by several employees. Time that could be better spent on other critical functions of your lab. Also, think of the breadth of knowledge and skills required to operate and maintain a high-containment laboratory, both for inside and outside, from construction to cybersecurity, from environmental protection to personal safety. Biosafety professionals not only require training in performing their jobs safely, they are also involved in risk assessments and compliance with applicable regulations daily, and appropriate emergency response. Frequently, the biosafety professional is called upon to participate in the planning, design, and validation of a new biocontainment laboratory or renovation of an existing facility. “Biosafety professionals should have a foundation in all aspects of working in and around a high-containment laboratory and develop skills to ask questions in specific terms and have the confidence to question the answers.” -World BioHazTec Course Development Guide. [Internal Communication] Developing meaningful, high-quality training that addresses all necessary components typically requires more SMEs and stakeholders than a single facility may have available for training development.  Outsourcing training development strengthens course quality by bringing together SMEs with various expertise for only the time that is necessary under the management of a proven training development team. Also, the development team can use resources already developed to tailor to the specific needs of your facility and staff, which saves time and resources. If you’re thinking of transitioning your existing training into an online format, the time investment can be even greater. Converting a course into effective web-based training requires expertise in instructional design, an investment in e-learning tools, an understanding of e-learning platforms, and the ability to ensure that virtual training still delivers the same level of engagement and effectiveness as in-person sessions. Just as with any training, online training and learning management systems must be monitored regularly and reports generated to stakeholders. Outsourcing this process to specialists not only saves your team countless hours but also ensures the training is designed by professionals with experience in biosafety, biosecurity, and online learning. A Fresh Perspective and Unbiased Assessment One of the key benefits of outsourcing your BSL-3 training is gaining access to an external team of experts who can offer a fresh perspective. When organizations develop their own training programs, there’s often a risk of becoming too close to the material, potentially missing gaps or risks that an SME might spot, offering a fresh perspective. An external provider can objectively assess your current protocols, highlight potential areas for improvement, and suggest best practices based on up-to-date industry standards. “Things change quickly …, so job responsibilities must evolve. If companies evolve their strategy and expect employees to expand their skill sets, offering a team continuous learning will help prevent them from falling behind.” [2] In high-stakes environments like BSL-3 labs, where even minor oversights can have serious consequences, having an unbiased third-party review can add an additional layer of safety. Expert consultants are experienced in tailoring their training programs to meet both your specific operational needs and strict regulatory requirements, ensuring your staff is fully equipped to handle emergencies and day-to-day challenges. CEUs and Professional Development Incentives Professional development is also a tool for employee retention. “About 80 percent of employees rank professional development and continuous learning as high priorities when job hunting. And 94 percent of employees say if an employer invested more in learning and development, they would stay longer at an organization.” [3] Another significant advantage of outsourcing BSL-3 training is the ability to offer Continuing Education Units (CEUs). If your training provider is accredited, they can award CEUs to participants which can be used to maintain certification with professional organizations. This ensures your team remains compliant with the latest industry developments and ongoing certification requirements. It also provides an added incentive for staff to engage in the training. CEUs enhance the perceived value of the training, as they provide tangible career benefits to employees. By outsourcing, you can integrate this offering into your program without the burden of navigating the lengthy accreditation process yourself. Outsourcing Offers Expertise, Efficiency, and Compliance The decision to outsource BSL-3 training boils down to efficiency and safety. By partnering with an experienced external provider, you’re investing in expert insights, saving substantial time, and ensuring your team has access to accredited, top-tier training. Not only does this free up your internal resources, but it also offers peace of mind knowing your staff is receiving the most current and comprehensive training available. So, should you outsource your BSL-3 training? For most organizations, the answer is a resounding yes. World BioHazTec provides extensive professional development training. Schedule a free consultation to learn more about our customized training offerings.   [1] DeFelice, R. 2021. ATD Blog. Retrieved from https://www.td.org/content/atd-blog/how-long-does-it-take-to-develop-training-new-question-new-answers [2] Allen, M. (2012). Leaving ADDIE for SAM – An agile model for developing the best learning experiences. Washington DC: American Society for Training and Development. [3] Based on survey average module length of 23 minutes, the variance was 43 to 141 hours with an average of 67 hours. These results were used to calculate times to develop a one-hour module. [4] Rozensweig, F. 2022. Retrieved from https://www.td.org/atd-blog/shift-from-onboarding-to-everboarding. [5] Rosenzweig, F. 2022. ATD blog. Retrieved from https://www.td.org/content/atd-blog/shift-from-onboarding-to-everboarding

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Handling Animals in ABSL-3 Labs During a Storm

In ABSL-3 labs that work with animals, ensuring their safety and well-being during a storm is a critical part of your emergency preparedness plan. Hurricanes and severe weather can pose significant risks to both the animals and the personnel responsible for their care. Proper planning and clear protocols are essential to minimize these risks and protect the integrity of ongoing research. 1. Pre-Storm Preparations Before a storm hits, take proactive steps to secure the animals and their environments: Relocation Plan: If possible, identify a safer location within the facility where animals can be relocated during the storm. This area should be structurally sound, away from windows, and equipped with backup power to maintain essential functions like ventilation and temperature control. The relocated area should be able to maintain containment by existing services or by a temporary containment enclosure on a higher floor if animals are at ground or basement level. Supply Stockpile: Ensure that there is an adequate stockpile of food, water, bedding, and any necessary medications to last through the duration of the storm and potential aftermath. Consider stocking additional supplies in case the storm disrupts access to regular deliveries. Securing Enclosures: Verify that all animal enclosures are secure and capable of withstanding the conditions of a severe storm. Reinforce cages, pens, or aquariums as necessary to prevent injury or escape during high winds or flooding. 2. During the Storm During the storm, maintaining the safety and comfort of the animals is a priority: Minimal Personnel Presence: Limit the number of personnel in the facility to only those essential for monitoring the animals. Ensure that those present are trained in emergency procedures and are aware of potential risks. Continuous Monitoring: If safe to do so, continue monitoring the animals and their environments throughout the storm. Use remote monitoring systems if available to reduce the need for personnel to be physically present. Backup Systems: Ensure that backup power systems, such as generators, are operational to maintain critical environmental controls, such as temperature, humidity, and air filtration. 3. Post-Storm Recovery After the storm passes, it’s crucial to assess the animals and their environments for any damage or health issues: Health Assessment: Conduct a thorough assessment of all animals to check for signs of stress, injury, or illness. Address any health concerns immediately to prevent further complications. Environmental Inspection: Inspect the animals’ enclosures and surrounding areas for any structural damage or hazards, such as broken glass, water intrusion, or compromised ventilation. Repair or replace damaged equipment promptly. Reinstate Routine Care: As soon as it is safe, return to normal care routines and environmental conditions. Ensure that all supplies are replenished and that the animals are monitored closely for any delayed effects of the storm. 4. Review and Update Animal Care Protocols Finally, after the storm, review the effectiveness of your animal care protocols and make any necessary updates: Debriefing: Hold a debriefing session with all involved personnel to discuss what went well and identify areas for improvement. Document any lessons learned and incorporate them into your emergency preparedness plan. Plan Revisions: Update your animal handling protocols based on the experiences and outcomes from the storm. Ensure that all changes are communicated clearly to the relevant staff. Conclusion Handling animals during a storm in an ABSL-3 lab requires careful planning, swift action, and ongoing vigilance. By taking these steps, you can help protect the animals under your care and ensure the continuity of your research, even in the face of severe weather. If you operate a BSL-3 lab, be sure to read our other blog on how to prepare your BSL-3 lab for hurricane season. World BioHazTec is here to support your lab with expert advice and services, ensuring that your high-containment laboratory remains safe and operational, even during the most challenging conditions. Schedule a free 30-minute consultation or send us an email. Our services to support you include: Risk assessment Lab inspection Certification including testing emergency backup power Emergency response training and drills Writing and/or reviewing emergency response plans

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IACET Accredited Provider logo

World BioHazTec is an Accredited Provider (AP) of the International Association for Continuing Education and Training (IACET). As an IACET Accredited Provider, World BioHazTec offers IACET CEUs for its learning events that comply with the ANSI/IACET Continuing Education and Training Information.

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Accredited Auditing Organization

World BioHazTec is recognized under the Auditing Organisation (AO) scheme by the Singapore Accreditation Council (SAC) to perform the following services:
• Certification of BSL-2, BSL-3, and ABSL-3 facilities worldwide*
• Engineering Verification
• Gap Analysis
*For BSL-3/ABSL-3 facilities in Singapore, World BioHazTec is the Auditing Organization, accredited by the SAC.