The Power of Perspective: Using Gap Assessments to Strengthen Biosafety

 
Biosafety programs are a cornerstone of safe and effective operations in the life sciences industry. Yet even organizations with the best intentions can struggle to implement biosafety best practices when financial constraints, competing priorities, and internal silos get in the way.

Biosafety best practices are more than “nice-to-have” additions; they are essential strategies that help prevent employee injury and illness, as well as mitigating operational, financial, and reputational risks. For instance, if staff lack a clear understanding of proper cleaning and disinfection protocols, it can result in product contamination; therefore, wasted resources and delayed timelines. Such breakdowns also can erode confidence among employees and stakeholders, causing reputational damage and loss of trust.

The Challenge: Securing Organizational Buy-in

For those responsible for managing biosafety programs, the hurdle isn’t just knowing and understanding best practices, it’s gaining organizational buy-in and resources needed for a strong biosafety program. Managers frequently face resistance within the organization when safety-related changes are viewed as too expensive or even as something that could slow progress. That perspective typically only shifts after a crisis occurs and the repercussions are already in motion.

A gap assessment provides the outside, expert validation needed to identify potential pitfalls in your program and amplify internal recommendations, helping EHS and biosafety managers secure the buy-in and resources essential for a robust biosafety program.

The Value of Biosafety Gap Assessments

A well-executed biosafety gap assessment is constructive, not punitive, and it does far more than list deficiencies. It delivers a prioritized roadmap for strengthening your program. By evaluating current practices against regulatory requirements and industry best practices, the gap assessment identifies areas of vulnerability and ranks findings from high-to-low priority. This allows organizations to direct limited time, budget, and staffing toward the areas of greatest impact.

Beyond identifying gaps, these assessments also point to opportunities to improve efficiency, reduce complexity, and prevent future issues, saving time, reducing risk, and supporting long-term operational success.

Biosafety needs rarely are static. Frequently, decisions regarding biosafety resources are made early in an institution’s development. But as the institution grows and changes, so too should its biosafety program. A gap assessment can provide much-needed perspective and benchmarking when determining “how much” biosafety program you need and whether your biosafety staff has the tools and training they need to perform their jobs effectively.

For EHS and biosafety managers, biosafety gap assessments also are a powerful tool for overcoming internal barriers. Having a report or recommendations from an independent biosafety expert brings a fresh outside perspective and added validation to internal concerns. Institutional leadership or other departments may also be more open to ideas validated by a qualified outsider.

While every organization is unique, robust biosafety programs typically leverage a few recognized best practices. We’ll review a few of them now.

The Holistic Approach: Bridging Knowledge Gaps

The most effective biosafety programs integrate resources from all levels of research program management. Facilities and building management, employee occupational health and environmental safety, research and technical staff, institutional oversight committees, and research leadership all serve distinct, vital roles in biosafety. By involving stakeholders in biosafety-related decision-making early and soliciting their input throughout the process, you encourage institution-wide ownership of biosafety culture and can more easily identify concerns or program gaps.

This cross-functional collaboration serves as a strategic guardrail. By soliciting input from all stakeholders, you prevent the EHS and biosafety teams from heading down the wrong road without proper input, avoiding costly “backtracking” later to resolve issues.

For example, when designing a new biosafety level 2 laboratory, research and technical staff provide detailed information about the biological materials that will be used in the space. Biosafety professionals ensure that an appropriate risk assessment has been performed and help determine what engineering and administrative controls must be in place to conduct the work. And involving facilities engineering is crucial, because they can speak to whether existing mechanical systems can support the required containment equipment and operations.

Institutional Biosafety Committee: Strengthening Risk Management through Oversight

Institutional Biosafety Committees (IBCs) provide consistent oversight of work with biological materials and ensure that a thorough biological risk assessment is conducted for each process. An IBC should have documented policies and procedures, and its membership should include experts in the type of work being performed, as well as stakeholders from the institution and local community.

If your site receives government funding or resides in a municipality with biotechnology regulations, you may be required to have an IBC. However, even if your site doesn’t meet those criteria, institutional oversight of work with biological materials is an industry best practice. Establishing a structured IBC allows you to meet and document this best practice, as well as ensuring that your institution is ready if an IBC is required in the future.

Readiness for Unplanned Events: Planning and Testing

Preparation and training may not prevent the loss of utilities, a medical emergency, or other unplanned events, but knowing what to do in an emergency impacts how safely and quickly your organization recovers. A contingency plan gives your organization structured tools to plan for and work through emergency situations.

Tabletop exercises, communication with stakeholders, and frequent review and revision of written plans based on current information will ensure that your institution is prepared to handle disruptive events.

Building the Case for a Stronger Biosafety Program

A biosafety gap assessment serves as a practical first step by providing an objective, prioritized view of vulnerabilities alongside clear, actionable recommendations. This allows organizations to focus resources where they matter most while building a tailored roadmap for improvement. Ultimately, a robust biosafety program does more than protect employees and the community. It provides the stability needed for your institution to focus fully on its research mission.

Ready to take the first step toward a stronger biosafety program? Contact us today to schedule your gap assessment.

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