The Challenge

OLS aimed to meet the specific needs of facilities operations and maintenance staff by developing a course tailored to personnel managing high containment facilities at the FDA. The FDA mandated a comprehensive review of high containment maintenance and operations, with a focus on adapting to changes brought about by the COVID-19 pandemic, newly published guides, and regulations such as the BMBL, 6th ed. This also included considerations for renovations to existing laboratories and the introduction of new laboratories.

As a result of the pandemic, numerous workers were compelled to operate remotely. World BioHazTec had to redesign the training program, initially designed for instructor-led classroom sessions, with hands-on skills checks and facility walk-throughs for online delivery. The challenges posed by the pandemic also limited access to facilities for photographing systems, impacting the visual components of the training presentation.

The Solution

World BioHazTec conducted a comprehensive evaluation of the FDA BSL-3 laboratory safety training program, aiming to introduce instructional design and planning for the creation of a two-day training program. A needs assessment, including a survey of FDA Operations and Maintenance as well as OLS staff, was carried out to prioritize training content. This prioritization was based on firsthand knowledge, emphasizing the relevance of the content to real-world operations.

The Result

Incorporating stakeholder input and recommendations from World BioHazTec’s subject matter experts, the site-specific content for the training program included High Containment Laboratory Planning and Design, Construction and Renovation, Laboratory Systems, Utilities and Maintenance, Building Automation and Equipment Redundancy, Commissioning and Annual Certification, and Continuity of Operations Planning. The course, delivered online over two days, allowed ample time for breaks, enabling learners to attend to messages and meet their work demands.

The pre-course knowledge assessment yielded an average score of 63%, while all learners successfully completed all modules. Following the course, the average score on the post-course knowledge assessment improved to 91%, with a minimum passing score of 80%. Learners received certificates for thirteen contact hours.

To facilitate ongoing learning, learners were provided with contact information for instructors to answer post-course questions. World BioHazTec implemented a one-year reach-back policy to accommodate queries and follow-ups, recognizing that learners may have questions after the conclusion of the course. The philosophy is that learning extends beyond the course itself, continuing as learners apply knowledge and skills in their work environment.