5 Keys Areas Where Biosafety Programs Fall Short
Anthony Troiano | October 22, 2019
Institutions of all sizes and types share common challenges when it comes to the implementation of an effective and efficient biosafety program, as evidenced by a recent analysis conducted by EH&E. Looking beyond compliance with basic regulatory requirements, the analysis identified five key areas where biosafety programs fall short that are vital to making a program really function and ensuring safety.
Biosafety programs for multiple institutions, encompassing over 400 individual laboratories, were evaluated for industry best practices and compliance with Centers for Disease Control and Prevention (CDC), United States Department of Agriculture (USDA), National Institutes of Health (NIH) and Occupational Safety and Health Administration (OSHA) regulations. The institutions represent various types including research and development, commercial and clinical manufacturing.
The five problem areas uncovered by the analysis are revealed here along with tips for improvement that can be implemented by any size institution.
Commissioning is Critical to Validating Containment in the Biosafety Level-3 (BSL-3) Environment
There is a lack of clear, consistent communication between environmental health and safety (EHS), biosafety and scientific staff – and among departments. These silos often result in misalignment of policies between the individual groups, creating inefficiencies and slowing laboratory operations.
EHS should work to bring laboratory, administrative and operations staff as well as technical decision makers to the table to align policies in a meaningful way. Establishing a formalized safety committee is a great way to do this. The committee should include representation from all lab support services including facilities, operations, chemical safety, biological safety, site leadership and scientists.
Newsletters, regular updates and posters are effective methods for communicating biosafety related issues and maintaining visibility. But nothing works better than face-to-face interaction. To encourage these direct interactions and to make your biosafety team and program visible, establish and communicate regular office hours to allow for “drop ins”.
2. Training – Evidence of Competency
Not surprisingly many biosafety programs rely heavily on online training methods because it makes it easy to train a large number of staff with varying schedules and locations. The danger is that if online training is not paired with a process to re-enforce training and ensure competency, it can result in critical knowledge gaps. Hands-on training is needed to verify competency for some skills such as spill response, PPE donning and doffing, and incident response. Don’t let the wrong didactic platform lure your program into a false sense of compliance and safety.
3. Overall Program Management
The analysis revealed a few problem areas within the framework of program management. Again, not surprisingly, many biosafety managers and directors wrestle with how to maximize limited resources including personnel, time and budget. Whether it is a new start-up or a well-developed company outgrowing its EHS capacity, the common denominator is a lack of personnel to adequately handle the workload. This means functions essential to safety and risk management are bogged down and delayed such as onboarding new lab procedures, conducting risk assessments and training new staff.
It is also evident that for many institutions roles and responsibilities are not well defined and communicated. (Remember, communication is number one on the list.) Without proper defined roles, inefficiency and miscommunication is rampant. Each person involved in the program must understand their responsibilities.
Poor information management is another common struggle. This includes items such as proper training records, document reviews, communication of policies and risk assessments. Important program information needs to be properly managed. If not, should your facility be audited, it can lead to chaos and potential deficiencies and citations.
Limited resources and poor information management are contributors to the fact that many programs do not track or have ready access to important program metrics in order to know where program vulnerabilities lie and where to focus resources.
A centralized document management system and compliance calendar are well worth the investment and will go a long way in improving information management and compliance. Something as simple as a permit dashboard that can be run on basic computer software can help establish a baseline for a compliance calendar as well.
Best Practices for a Highly Functioning, Compliant Institutional Biosafety Committee
4. Institutional Biosafety Committee (IBC) Management
Many programs do not have, or have an inadequate, risk assessment process which is key to IBC management. It is important to note that some do not have an IBC because their institution is not subject to the regulatory requirements. However, it is also important to consider that an IBC is a fundamental best practice that provides much needed structure to the program. An IBC helps facilitate Standard Operating Procedure (SOP) reviews, risk assessments, as well as provides transparency within an organization.
IBCs should be formalized with dedicated resources such as an IBC coordinator or chairperson. Occupational health representation is also necessary. Be sure that risk assessments are conducted by qualified individuals. This is another area where a document management system provides efficiency by streamlining the SOP review and risk assessment processes.
Good IBC practices help to keep a pulse on the various permit programs applicable to your institution as well as keep you ahead of the curve for inspection readiness.
Engineering controls, whether primary or secondary containment, form the foundation for safe work practices in biosafety. Yet, we have found that many programs have inadequate engineering controls and that heating, ventilation, and air conditioning (HVAC) system maintenance is not conducted routinely. Once again, this is where a compliance calendar becomes an invaluable tool. The calendar ensures routine preventative maintenance is performed on a systematic basis to ensure optimal operation.
Additionally, we often see infrastructure loads such as supply and exhaust air that feed these labs are often maxed out meaning that they are already at their capacity limits. These limits do not allow for any expansion to the lab and often make renovation/reconfiguration projects difficult to execute. Lastly, equipment such as biosafety cabinets (BSCs) are improperly used or in some instances lacking altogether. Without the ability to add additional engineering controls, laboratory operations are inflexible, limiting the capability of your research programs and making risk assessments more difficult to perform.
Emerging Biotechs: 6 Tips for Designing a Safe Laboratory
Frequently, when a new space is being designed, EHS and biosafety personnel are not included in the process. This results in a space that is less effective to the occupants and directly impacts safety and productivity. When designing a new space be sure to include your EHS and biosafety personnel early during the design phase. This will enable them to provide valuable input on items such as equipment location (e.g., BSCs), workflow and waste streams.
Every research institution is different, whether it’s public or private, academic or pharmaceutical. Yet all industries face common issues with establishing and maintaining an efficient and effective biosafety program. There is never a one size fits all solution to ensuring your program’s success, and every organization struggles with limited resources to address problems. Proactiveness and positivity are two performance factors that require little to no resources and help to foster a greater culture of safety. Proactive measures such as conducting self-audits and tracking key program metrics will provide valuable data needed to highlight critical program vulnerabilities and that can be used to present a stronger case to leadership for the need for additional resources to resolve program deficiencies.
If you’re looking to make improvements to your biosafety program, contact us to learn how we can provide expert support to help you achieve your goals.