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Laboratory Planning and Preparedness to Mitigate Risk

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Considerations to Ensure Biosafety and Laboratory Operations 

During the COVID-19 pandemic, the general public’s familiarity with the concept of risk assessment increased dramatically. For many of us, what had once been routine activities were abruptly scrutinized to determine whether and how they could be performed safely. Consider the act of buying groceries. Probably for the first time, you and other able-bodied, independently mobile individuals had to consciously consider many factors to determine whether the risk of going out into a large public store was worth risking their health. Many of us asked ourselves:  

  • Do I need the groceries now or can I wait a few days until I can address more needs in one trip? 
  • Do I go during peak hours when it’s more convenient for me even though I am more likely to encounter lines and crowds?  
  • When will my online order of KN95 face masks finally arrive?  
  • Do any older adults, infants, or immunocompromised family members at home influence whether or not I go shopping?  
  • Should I use a grocery delivery service so I can avoid the crowds myself?  
  • What if my designated shopper is not good at choosing produce or meat?  
  • What if my preferred brands are out and I won’t be there to choose a substitute?  

Shoppers used these and other questions to help evaluate the risks of essential tasks like grocery shopping and identify how to accomplish their goals in a manner that only exposed themselves and their loved ones to a level of risk they were comfortable with assuming. 

Biosafety is Risk Management
At its core, biosafety follows a similar risk assessment-based approach, but is focused on reducing the risk of people, animals, and the environment being accidentally exposed to dangerous biological materials such as viruses and bacteria. More formally, biosafety is a risk assessment-based approach to identifying and mitigating the risks posed by dangerous biological materials with the goal of reducing those risks to a level that is considered acceptable by the relevant stakeholders. 

In biosafety, we begin by gathering information, including information about the specific biological materials of concern, the planned activities to be performed, what else will be occurring in those spaces at the same time, and aspects of how the facility itself is designed, such as room finishes and details about the HVAC system.  

Once we’ve collected this relevant information, we evaluate and prioritize possible risks, develop a risk control strategy, select and implement appropriate control measures, and assess how successful we believe our risk control measures will potentially be to then help determine what additional improvements may be made. 

If you work for an organization certified to ISO 9001 or that has specific programs that are ISO certified or accredited, this cycle probably sounds very familiar. When using ISO 9001 and related quality management standards, the equivalent process begins with risk identification and progresses through risk analysis, risk response planning, risk mitigation, and risk monitoring, which in turn informs the next round of risk identification. Read about how biosafety also applies in non-laboratory settings in “Biosafety and the Workplace.”  

As Risk Management Applies to Biosafety
In biosafety, the risk mitigation and control measures implemented are based on the National Institute for Occupational Safety and Health’s (NIOSH) hierarchy of controls.  

  • Eliminating – The most effective type of mitigation is eliminating the risk entirely; during the COVID-19 pandemic, this would be typified by having staff work from home, thereby eliminating the likelihood of transmission in the workplace.  
  • Substitution – The next most effective type of control is substitution, which involves replacing a hazard with a less risky option; this is more likely to be possible in a laboratory setting than a community setting.  
  • Engineering – Next up are engineering controls, which include the facility features and infrastructure and the specific equipment that can be used to reduce the risk of an activity; workplace examples could include increasing the number of air changes per hour to prevent the buildup of infectious aerosols in a space, erecting cough barriers between and in front of desks, and installing automatic faucets and toilets to reduce the number of potentially contaminated touch points in a restroom. 
  • Administrative – Administrative controls modify how people perform a given task or operate in a given environment. Well-known community examples from the pandemic include the implementation of social distancing practices and vaccination requirements, as well as changes to sanitation and housekeeping practices in the workplace. 
  • Personal Protective Equipment – Finally, the use of personal protective equipment (PPE). The use of face masks, surgical masks, and respirator masks are prime examples of this. 

 

Interested in learning more about risk mitigation and preparedness planning for laboratory and non-laboratory spaces? Our experts have prepared this “Enhancing Laboratory Operations: Best Practices for Risk Mitigation and Preparedness Planning” webinar just for you.

Considerations for Laboratory Operations
Biosafety planning must extend beyond the office and its staff and into their laboratories, where employees don’t necessarily have the luxury of working from home, as that work has to continue and can only be performed in a laboratory. Effective contingency planning requires such organizations to also consider the impact of factors such as possible materials shortages, infrastructure limitations, and their internal capacity for project review, approval, and oversight.  

Additionally, it can be difficult for leadership to take a risk-based approach to identifying and mitigating issues associated with biosafety and biosecurity. Each member of your team – researchers, lab managers, administrative staff, and others – may have unique behind the scenes challenges. Understanding those challenges is important to cultivate problem solving and find solutions that are appropriate to their needs.  

As an example, management may propose frequent changes to types of PPE required, causing frustration for researchers. Although there may be cost savings in switching a product like a disinfectant, that may result in increased time for the person responsible for making that change in the laboratory. Further, the chosen product may be lower in quality or untested by the laboratory team, which may result in increased safety risks.  

Beyond another pandemic, this planning can help maintain operational continuity through any number of disruptive scenarios. By understanding which of these many diseases, natural disasters, and otherwise disruptive challenges may impact your operational continuity, you can be better prepared to mitigate those impacts. Read more about potential disruptions that could impact your business and the supply chains you may depend on in “Looming Challenges to Continuity.”  

Stockpiling Laboratory Necessities
When we did make a trip to the grocery store or order online for delivery, we all remember having to deal with shortages of household necessities like toilet paper and flour. These shortages extended to PPE and laboratory necessities like N95 masks and pipet tips. Even though vendors had increased their production, demand often outpaced supply, which potentially resulted in safety issues and disruptions for laboratory teams. To prepare for addressing such issues for the future, it is important to think through possible supply chain disruptions like those we saw during the COVID-19 pandemic. Some of those issues might include:  

  • Most laboratory gloves are produced in Malaysia, so shipping disruptions may cause an issue; 
  • With hand sanitizer, we saw stockpiling and price gouging; 
  • Cotton swabs are an example of common laboratory equipment that is needed for many different competing uses;  
  • Products such as disinfectants that have expiration dates and a limited shelf life may not be cost effective to stockpile;  
  • Many laboratories are not designed with the storage space necessary to stockpile necessary materials, so laboratory managers must get creative;  
  • If an item like gloves is used often, it may need to be purchased with greater frequency or in higher quantities than an item that isn’t used with such turnover, like lab coats;  
  • Operationally, certain items like waste bags are needed day-to-day for all projects, while others are niche items needed for a limited term project; 
  • If a vendor is challenged with maintaining their supply chain, you will need other vendors available to secure necessary supplies; and,  
  • Some institutions have complex supply management systems to address these concerns, while others do so by hand or using a simple spreadsheet.  

Further agility will be necessary in varied aspects of your operations, like:  

  • IBC/IACUC protocol review;  
  • Researcher training;  
  • Space/facility modifications; and,  
  • Manual and SOP development and review. 

As an example, let’s say you have a protocol that that now requires additional safety precautions beyond what you usually implement at BSL-2, but it has been several years since you have had to implement such precautions. How long will it take to make this protocol functional? You may have already created SOPs for what requirements are necessary to enhance your safety operations, while medical requirements for N95 respirators have been identified and programs are in place, so staff only need to be trained. Maybe you also have a BSL-3 laboratory so do you have cross-trained staff? How are you going to don and doff enhanced PPE and are there designated spaces for this or will they need to be created?  

While every detail does not need to be defined in advance, a general understanding of what it will take to pivot as necessary can be very useful. Many of us had to answer these questions and define new protocols urgently during the pandemic, so advance preparation for the future is beneficial. Additional considerations to ensure operational continuity include:  

  • Some may think of redundancy as a bad thing, but not having it will be detrimental if a person in a critical role gets sick or cannot make it to an onsite workspace if necessary, making cross-training critical;  
  • Programmatic agility is also important, including the identification of key equipment or skills that will need to be scaled up in response; 
  • Abnormal operations may impact everyone differently, so their personal situations – like whether they live on the other side of a bridge, have farm animals, are pregnant, or have a personal risk tolerance – should be considered;  
  • Communication tools like Zoom, Teams, Slack, and others should be established for teams to stay in touch. Many of us learned to use these effectively during the pandemic and now continue to rely upon them;  
  • Understand the limitations of your facility, such as whether there are enough electrical outlets if new equipment is added? Can you anticipate what equipment would need to be added? Are there limitations to the types of waste you can manage? Are there certain pathogens you cannot work with because of specialized infrastructure requirements? What are backups for waste treatment if, for example, an autoclave broke? 

The COVID-19 pandemic posed a significant challenge to the resiliency of laboratory institutions’ contingency plans at all levels of operation. To be prepared for whatever is next requires advance planning. By applying what we learned during the pandemic, we can be better prepared for maintaining operational continuity through future disruptions.  

GETTING STARTED AT MRIGLOBAL
Contact MRIGlobal for further information about our work in biosafety preparedness. With more than 100 years of combined experience in clinical and research laboratories at all containment levels and in more than a dozen countries, our team can support the start-up of your biosafety program, facility audit and inspection, security and biorisk assessment, and staff training.  

To discuss how we can help your project be successful, contact us today. 

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