Successful biosafety management combines progressive training programs with an operations and maintenance structure that creates a culture of cooperation, resulting in less downtime during required or emergency maintenance. This, in turn, increases researchers’ productivity and saves millions of dollars in grant money that can otherwise be lost during maintenance breaks.
Barbara Johnson, owner of Biosafety Biosecurity International, a company that provides a full range of biosafety, biosecurity, and biocontainment consulting services, says a recent benchmarking exercise she conducted shows that research institutions with efficient biosafety management programs—regardless of their size—share common practices:
- Establishing a single point of contact between the researchers (primary investigators or PIs), maintenance, and safety officers.
- Training all staff who might need to enter biocontainment facilities with programs that emphasize safety and specific technical craftwork, and also provide an understanding of the overall mission, creating a sense of ownership and team pride.
- Using tool kits and stockpiling spare parts for the most important pieces of equipment, especially those for which replacement orders can take weeks to arrive.
“What we were looking for in this benchmarking exercise is how different organizations have achieved minimizing their downtime so researchers can be more productive, but at the same time working in sync with the people in maintenance, operations, and compliance. How do they become a team and work through the process?” explains Johnson. “The specifics may vary among institutions, but common themes came to the surface.” The information that follows focuses on three of the six organizations included in the study.
Bringing Together Separate Entities
Biosafety compliance necessitates coordination between distinct entities at a research institution—research, operations, and maintenance—as well as various compliance and administrative personnel. Culturally, each entity tends to operate in its own sphere, notes Johnson.
Operations oversees the tasks needed to run a facility, such as scheduling work with the PIs, practicing emergency response, providing staff and visitor training, ensuring that safety/security features are verified and working, and backing up and maintaining a functional IT system.
The function of maintenance, a subset of operations, is to keep facilities in proper condition so research can proceed safely and securely. Scheduling preventive maintenance, repairs, and equipment certification, as well as ordering parts and scheduling in-house labor/contractors, fall under this department.
There are institutional compliance entities that require coordination before maintenance can occur or operations are scheduled for specific spaces. These may include, but are not limited to, the institutional biosafety committee, biosafety officer, responsible official, animal care and use committee, and security office.
Management Strategies: Three Case Studies
Johnson interviewed personnel from all aspects of the biosafety program at three research institutions with BSL-3 and/or BSL-4 facilities: the Cornell University College of Veterinary Medicine (Cornell CVM), University of Texas Medical Branch (UTMB), and the Regional Biocontainment Laboratory (RBL) at Duke University. Their total biocontainment areas vary in size from 10,000 sf to 300,000 sf, but they use conceptually similar management strategies to handle biosafety.
At Cornell, where there are several buildings and shared maintenance, a biosafety engineer who is both a professional engineer (PE) and a registered biosafety professional (RBP) serves as the point person coordinating between PIs and campus facilities staff. He works with campus safety personnel to assess PIs’ needs and also the associated biosafety risks, and communicates them to facilities staff, who in turn schedule the repairs.
“This process can happen in minutes,” says Johnson. “It can be as direct as picking up a phone and getting the information you need.”
This type of response time is not only due to flattening of the communication process, but also because the biosafety engineer has placed specialized tool kits in the biocontainment areas and strategically stocked long-lead-time parts. Some replacement parts for critical equipment (e.g., effluent decontamination systems and autoclaves) are kept in the space housing the equipment. By having everything pre-staged, maintenance staff are not entering and exiting containment for another tool or part.
Johnson reports, “This has cut maintenance time in some instances from days to hours, preventing the loss of valuable research time. It becomes increasingly important to be prepared when an institution has a mix of new and older laboratory facilities, some of which periodically require unscheduled maintenance.” This level of enhanced service has been noticed by PIs and helps to foster an atmosphere of teamwork between science, engineering, and safety.
UTMB encompasses 300,000 sf of BSL-3 and BSL-4 facilities spread out in different buildings. Their management strategy also utilizes a point person, a BSL3/4 lab director who coordinates PIs’ needs and wants. He coordinates with biocontainment engineering (BE), a support group of the Environmental Health and Safety (EHS) Department, which houses a four-person staff. BE consists of a leader, a deputy, an NSF/ANSI-49-accredited tech for certification of biosafety cabinets and building HEPAs, and one “jack-of-all-trades maintenance person.” The third leg in the management strategy is campus maintenance, which has a subset of highly trained staff dedicated to serve high-containment areas.
“Does it pay to have someone on your staff who is an accredited NSF-49 certifier? In this case it does, as UTMB has about 250 HEPA filters and over 100 biosafety cabinets in just one building,” says Johnson.
It is important to note that UTMB’s lead biosafety engineer is an agricultural engineer with more than 20 years of experience in design, construction, and operation of biosafety laboratories, and has a science background, so, as in the case of Cornell, understands the research processes and inherent risks as well as the engineering. He, along with a deputy who has more than 25 years of experience in facility maintenance, can reach back to campus maintenance to objectively assess maintenance solutions.
Johnson adds that safety trumps laboratory operations. “If the BE leader or deputy believes the maintenance solution requires refinement to ensure safety, there is no conflict of interest in them going back to maintenance and saying, ‘I think we really need to look at whether this is ready to go online. Is it functioning properly?’”
The BE group’s main role, besides ensuring safe operation of the laboratories, is to mediate and maintain harmony between the user group and the campus maintenance group, says Johnson. They coordinate with the lab directors and maintenance managers, the lab directors coordinate with the PIs, and the maintenance managers coordinate with their maintenance staff. BE does not coordinate directly with PIs or maintenance staff.
“Campus maintenance is there for the entire campus, but they have a highly trained staff dedicated for the maintenance of the high and maximum containment labs. So the BE is making sure work gets done as a priority, but maintenance is allowed to do its work uninterrupted,” she says. “No maintenance people enter a space until it has been coordinated. So we have a smooth transition, which increases the efficiency between these two groups.”
At the RBL at Duke University, the director of safety and operations is the focal point. He serves as liaison between the PIs, the head of campus maintenance, and campus EHS. The safety and operations department has three staff and shares an administrative support position with the RBL. Safety and operations also shares with maintenance a senior mechanic dedicated to BSL-3.
The director of safety and operations is a certified biosafety professional (CBSP) with a research background who also has the authority to run lab operations, thereby streamlining the process, notes Johnson. He coordinates laboratory availability for PIs, all compliance documentation, maintenance, preparation for inflow of animals, reagents, equipment, and decontamination operations.
This person has core staff to help him streamline his duties, as well. A safety officer oversees day-to-day operations, and does orientation, training, lab audits, and room decontaminations. The safety officer also handles shipping. A senior lab assistant does the day-to-day repairs, stocks supplies, and even does light upkeep like mopping the floors.
The shared administrative assistant takes care of paperwork involved with the safety, compliance, maintenance, training, and hiring aspects. The shared maintenance staff person, on call 24/7, is a jack-of-all-trades, but his specialty is HVAC.
Duke employs a “campaigning” strategy, meaning more than one research project may be ongoing at a given time. At the end of a project, or campaign, the reagents/materials are removed, the lab is cleaned and gas decontaminated, equipment is tested as needed, and the space is prepared to support the next project. As in the case of Cornell, long-lead and critical spare parts are stocked at the RBL to prevent maintenance delays.
“They’ve got a shared facility, so it is imperative they turn these labs around quickly, and that each PI is allowed to start work in their space at their designated time,” says Johnson.
Training the Staff
Equally important to a coordination strategy is proper training of all personnel who will enter biosafety areas. Training not only ensures that the various repairs and processes are conducted properly and safely, but also helps everyone involved gain an appreciation and understanding of the research program.
“You’re not just saying, ‘It’s important to change the gasket on the sink.’ It’s also about, ‘This is what researcher A is doing,’” says Johnson. “Maintenance gains an appreciation for the program. By gaining an appreciation for the research, they actually become part of the program, and this is part of team building.
“Training is also psychological. The Cornell biosafety engineer has found that when he explains why the work is going on, and what has been done to mitigate the risk to people who are entering, the maintenance people have higher motivation and less fear. You won’t change everybody but you will change certain key people. That is the buy-in we are looking for.”
Training for craftspeople should include respirator training, so they are pre-cleared for use. At Cornell, the campus provides training to its employees. However, when outside contractors are hired, the contractors’ organization is responsible for the respirator fit test, respirator training, and issuing the respirator to outside contractors, consultants, or certifiers.
The Cornell biosafety engineer also provides what he calls “toolbox training.” This training covers the specific hazards and risks associated with a task, where equipment is located, decontamination specifics, personal protective equipment (PPE), and emergency procedures.
“He does that toolbox training with people before they go in, and explains why this training is important.”
At UTMB, because the research program is large, campus maintenance has mechanical, electrical, and plumbing people, as well as general maintenance staff who are trained in containment.
“They’ve looked at what would be research showstoppers—biosafety cabinets, HEPA filters, and autoclaves—and decided they want staff who are trained in those areas,” says Johnson.
The institute works with biological select agents and toxins, so it has to comply with specific codes and federal regulations. The BE staff and the maintenance people who specialize in biocontainment have security risk assessments that have been approved by the CDC, says Johnson. The members of the biocontainment engineering group have complete access to all the labs, but entry into the labs is coordinated with the lab directors. EHS provides powered air-purifying respirators and emergency response training. These are all campus employees.
Similar to toolbox training from Cornell, UTMB provides ongoing “entry training.” It includes risk mitigation, contents of the labs, signs and symptoms, and emergency egress.
At Duke University, the shared maintenance person has specialized training, says Johnson.
“He has attended the Primus autoclave school, so he is now one of their certified technicians. He can work on their autoclaves, and if there is a problem beyond his capability, because he is a certified technician, it doesn’t invalidate the warranty. This is important not only in terms of reduced cost to the RBL, but also reduces significant downtime that would be incurred in scheduling and travel for a contract technician.”
Important Equipment to Have on Hand
When it comes to equipment, Johnson found common ways these research institutions reduce down time. The most common was utilizing a central storage area for spare parts for equipment that either breaks frequently or takes a long time to fix if parts need to be ordered. Stored parts include valves, sensors, door hardware, switches, and light fixtures. These storage areas often include blueprints and manuals, too.
Having on-campus craftsmen trained in specialty equipment also reduces down time, because the nearest repairperson is sometimes hours away. A new type of incubation media for biological indicators product called Releasat can reduce the time required for the gas decontamination verification process from five days to one, notes Johnson.
Pre-placed equipment kits containing standard equipment and certain specialty equipment based on the lab are also the norm. It is recommended the toolkits be locked up so PIs don’t borrow the tools and forget to return them, says Johnson.
“The toolkits allow for unplanned work, and by having them in the containment envelope, you don’t have to decontaminate all your tools to exit. They stay there. You don’t have to search for tools, reschedule the work, or interrupt the PI even for a few hours. Maintenance makes one trip into the lab and decreases downtime from days to a matter of hours.”
Many research facilities use computerized recordkeeping systems to document their biosafety practices, which also helps them more easily pinpoint records needed to meet compliance requirements. Planning annual shutdowns a year in advance is another common practice that reduces downtime and makes the transition smoother and easier.
By Taitia Shelow
This report is based on a presentation Johnson made at Tradeline’s 2013 International Conference on Biocontainment Facilities.
