Picture a BL2 lab setting, such as a tissue culture lab, where personnel are rushing to complete their work and take a few shortcuts. Perhaps they fail to decontaminate their work surfaces at the end of their workday or place a pipet tip in the incorrect waste stream. When questioned about the shortcuts by another colleague, their response is: “It’s not a big deal, this is how we’ve always done it,” or “No one cares, as long as I get the work done.” 

What does this say about the organization’s biosafety culture? “Minor oversights” such as these can pose real risks with potentially severe consequences, especially in biotech and pharma labs. Such behaviors are also indicative of the health of the organization’s safety culture.

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Establishing a lab culture of biosafety

Before you can improve your lab’s safety culture, you need to understand what it actually means to do so. The term “safety culture” refers to the shared attitudes, values, and practices that emphasize its importance in an organization or lab. A strong safety culture is not just a single person’s responsibility but rather involves ingrained behaviors and a collective commitment to safety at every level of the organization. When safety is a collective priority, individuals understand not just its importance but also the value of raising concerns, freely exchanging information, and taking proactive measures.

Effectively managing biological risks necessitates a robust organizational safety culture that prioritizes all aspects of biosafety, including but not limited to understanding and assessing the risks of the biohazards, biosecurity, and containment of infectious agents and/or toxins. This also involves practicing responsible science, adhering to all applicable laws, regulations, guidelines, and policies with regulatory bodies (local, federal, etc.).

Failing to prioritize biosafety can lead to severe consequences such as laboratory-acquired infections due to exposure, accidental releases of hazardous agents, and reputational damage. Integrating biosafety into the core of an organization’s operations therefore is not just a regulatory necessity but also an ethical imperative.

In this article, we’ll explore strategies to build a safety-first mindset and integrate biosafety practices seamlessly into lab operations.

Comprehensive training programs for biosafety

Effective training is the cornerstone of a safety-first mindset. Employees need to understand the risks associated with their work and be equipped with the knowledge and skills to mitigate them. This is especially important when working with potentially infectious biohazardous materials. By promoting proper procedures and practices, training helps protect lab workers, the broader community, and the environment from exposure to infectious agents. Here are a few key elements of effective lab safety training:

Customized training modules: Develop programs tailored to specific roles and risks within the lab. There are core training elements that need to be addressed based on the types of biohazardous materials being used and applicable regulations ( e.g. human blood or other potentially infectious materials and the Bloodborne Pathogens Standard [29 CFR 1910.1030] (BBP standard). Work with non-human primate samples or lentiviral vectors will require additional training due to their risk profile. In addition to training on the risks associated with these agents, it is equally important to provide role-based training. Developing user groups with role-based training that goes beyond the standard lab-based vs non-lab-based employees is critical in assigning and delivering effective training. For example, lab visitors would need a different level of training than employees regularly working with biohazardous materials. Support staff or other lab-adjacent roles would need to be trained in biosafety awareness at a minimum along with other training as applicable, depending on what level of contact they have with biohazardous materials. Most eLearning platforms/learning management systems have the capability to create role-based curricula or customized training modules, but it is critical to develop role-based training regardless of the training platform.

Regular refresher courses: Scheduled refresher training helps employees retain awareness of proper safety practices and stay updated on evolving protocols and emerging risks. Many regulatory authorities (e.g. OSHA) mandate safety refreshers on an annual basis and/or re-training when new hazards are identified.

Scenario-based training: Simulated scenarios, such as spill response training, allow employees to practice responses in a controlled environment.

How to conduct effective safety audits in pharmaceutical laboratories 

Routine lab inspections and safety audits play a vital role in maintaining and improving biosafety standards. These audits help identify potential vulnerabilities and ensure compliance and safety.

• Internal audits: Foster accountability through self-audits by lab teams. At a minimum, lab inspections should include the biosafety officer, chemical hygiene officer, emergency coordinator, and other members of the safety team. Having a member of the leadership or management team reinforces the importance of safety. 
• External eudits: External audits provide an unbiased perspective and uncover overlooked issues. In a biosafety setting, audits are commonly done when working with agents with a higher risk profile, select agents or USDA-regulated materials, and as part of the regulatory permitting process for a biosafety or recombinant DNA permit. 
• Audit follow-up: Having clear action items and owners enables teams to address findings or deficiencies promptly and provide overall awareness to stakeholders. Audit follow-up items and response times indicate the overall health of the biosafety program. 

The role of leadership in establishing biosafety standards

Leadership commitment is the bedrock of a strong biosafety culture. Leaders set the tone for the organization and influence how safety is perceived and prioritized. They are ultimately responsible for the safety program. Here’s how lab leaders can show their commitment to a strong safety culture:

• Lead by example: Management modeling behaviors, such as wearing PPE, participating in lab inspections, regularly reviewing potential biosafety risks, and serving as a member of the Institutional Biosafety Committee (IBC) or IACUC sends a powerful message.
• Allocate resources: Funding for training, equipment, and facility upgrades reflects genuine commitment. 
• Setting safety goals or objectives: Creating safety goals or objectives that weave into organizational goals indicates management commitment to safety. Further, setting clear expectations regarding adherence to biosafety policies at the management level is crucial.

Fostering open communication to strengthen lab biosafety culture

A culture of safety thrives in an environment where employees feel comfortable reporting concerns without the fear of reprisal.

•  Reporting mechanisms: Systems for confidentially reporting incidents, accidents, safety violations, or near-misses.
• Safety committees: Representatives from various departments (e.g. lab staff, EHS professionals, and operational stakeholders) can address biosafety issues collaboratively. Specialized committees like the IBC help oversee the implementation and monitoring of biosafety research and practices. Their duties include evaluating proposed research activities for biosafety considerations, authorizing the use of biological agents, and ensuring adherence to biosafety standards.
• Clear communication: Regular updates through daily stand-ups, all-hands meetings/town halls and newsletters reinforces safety importance and bringing awareness to safety initiatives.

Measuring the success of biosafety culture in pharma labs

Establishing a strong biosafety culture is an ongoing process that requires regular evaluation or benchmarking to gauge the overall health of where an organization is in its safety culture journey. Such benchmarking can be done by tracking key performance indicators (KPIs), which include metrics like incident frequency and type of incidents. For instance, has there been a particular type of incident that has occurred more often in multiple labs or locations, or have there been near misses that indicate potential failure points? Other examples include good catches, training completion rates, as well as tracking not just audit findings but also action item closure. Tracking these KPIs can really help measure what “good” looks like. 

Employee feedback is critical to understand the strengths and weaknesses of your biosafety program. This can be done through employee surveys, which can help gauge perceptions of biosafety practices and identify areas for improvement. Other specific ways include one-on-one interviews during safety walkthroughs, audits to share experiences or concerns, and group discussions to evaluate the climate of safety.

Overcoming challenges

Building a strong biosafety lab culture is not without its challenges and can be considered a journey. In this journey there can be multiple roadblocks. Common obstacles can include resistance to change, resource constraints, and complacency. Strategies to address these challenges include:

Change management: By communicating the rationale behind changes and involving employees in the decision-making process, implementing change will be a more collaborative process with buy-in from stakeholders. For example, when implementing new safety procedures or work practices, it always helps to have employees review the procedures prior to going live. 

Continuous improvement: Complacency is another major obstacle to a strong safety culture and can be addressed by adopting a continuous improvement mindset. This can be accomplished by performing periodic risk assessments of hazards, reviewing existing biohazards to ensure no changes in work or program-level risk reviews such as gap analysis and monitoring of KPIs. This also serves as internal benchmarking year over year to identify trends.

Proactively self-identifying areas of improvement and ensuring end-user buy in are useful strategies to overcoming potential challenges. 

Empower pharma labs for a safe future

Building a robust biosafety culture demands continuous commitment and collaboration, ensuring safety remains at the forefront of every decision. By investing in tailored training, conducting proactive safety audits, and fostering leadership-driven initiatives, labs can embed safety into their everyday practices. Open communication and strong partnerships further ensure that biosafety becomes second nature across all operations. A safety-first mindset not only protects people, products, and the environment, but also fosters trust, compliance, and long-term success.