“I would recommend doing this during the programming phase, so that your final program document will include the risks and what you plan to do to mitigate them,” says Michael Connor, principal of X-nth Inc., in Alpharetta, Ga.

X-nth has taken the Hazard Analysis Critical Control Point Data process required of chemical manufacturing plants, paired it with the definitions of severity and likelihood found in the Military Standard 882B (see below), and adapted them for biocontainment facilities.

“If we utilize these techniques at the beginning of projects, it will avoid a lot of problems down the road, and the construction estimate will have a lot more validity to it,” he says.

Worst-Case What-If’s

The first step in conducting a PHA is to gather all the possible stakeholders—including users, supervisors, facilities planners, environmental health and safety officials, security personnel, maintenance people, and engineers—who at many institutions never have the opportunity to be in the same room at the same time.

“All these folks bring a different perspective to this process,” says Connor. “It’s amazing what comes out of this once you get these people together.

“You need a facilitator who understands a little bit about everyone’s action,” he adds.

To get the discussion going and break the ice, Connor begins these meetings by starting a “what-if” list that, in the end, should include everything that can go wrong in the facility. He encourages the team to suggest anything they can think of, no matter how unlikely or far-fetched it may sound. The list includes not only mechanical failures—what if this valve locks or that pipe leaks—but the almost limitless possibilities for human error—what if the person pushes the wrong button or leaves a door open.

“The power of this process is when you finally get these people talking,” says Connor. “It’s the humanistic element.”

The next step is to look critically at each item on the list and judge how serious each problem would be if it occurred, and how often it is likely to happen. To quantify that information, the stakeholders use the Military Standard 882B definitions of severity and likelihood. Each level of severity is assigned a “consequence factor” from four (the most serious) to one (the least serious), and each level of likelihood is assigned a similar “probability factor.”

Severity:
4–Death or system loss
3–Severe injury, severe illness, or major system damage that would put the system out of commission for a number of hours or days
2–Minor injury, minor occupational illness, or minor system damage that can be repaired quickly or bypassed immediately with a back-up system
1–Less than minor injury, occupational illness, or system damage

Likelihood:
4–Likely to occur frequently (“You want to avoid these,” says Connor.)
3–Will occur several times during the life of a system
2–Likely to occur sometime in the life of an item
1–Unlikely, but possible to occur
0--So unlikely, assumed impossible

The Next Step

“The ‘what-if’ discussion is supposed to be qualitative,” explains Connor. “You can’t eliminate an action item based on cost.”

All of the data is input into an off-the-shelf software application that generates charts and graphs of each actionable item, its risk rating, and the metrics behind it. Discussion then turns to mitigating each item, and then the costs become apparent. In a recent exercise, a PHA effort for a BSL-2 enhanced facility uncovered a significant oversight in a construction project.  Unfortunately, the PHA process occurred at an advanced stage in the planning and design process.

The facility was designed as a BSL-2 with the potential to convert to BSL-3 if needed. Planners there were just about to go out to bid with 95 percent contract documents when they contacted X-nth.

“They had a sense that things weren’t going well in the design, and they needed a way to quantify the basis of any required changes.” says Connor.

The facility uses BSL-2 agents, and the original designs conformed to all BMBL and NIH guidelines for BSL-2, which did not require installation of a thermal waste treatment system. Those guidelines, however, are meant for research volumes of an agent, which usually means quantities of about 250 ml.

If 250 ml accidentally spilled on the floor, it could be absorbed before it made it to the floor drain. Even if it spilled down the drain, it would be captured by the drain trap and decontaminated.

“Commercial quantities of BSL-2 agents present a different set of challenges” says Connor.

Dealing with commercial volumes can cause the planning process to consider features associated with BSL-3 facilities even though the agents are BSL-2. Having done a PHA review on the front end would have led to making those kinds of considerations earlier in the design process, no doubt.

“The design effort in response to the BMBL was that special attention needed to be paid to the HVAC, so there was no focus on the additional risk inherent in the waste treatment,” he says. “The PHA lets you see what’s really risky and make decisions based on that risk assessment.”

The PHA process, which generated 87 recommendations for the facility, is as likely to produce better standard operating procedures (SOP) as it is to alter the design of the physical space.

“This facility had to be designed around the SOP,” says Connor. “A lot of times these facilities are designed, and then the SOPs are written to the facility, which is backwards. The institution should be developing its SOPs, and the building should be designed to accommodate these SOPs.”

The University of Washington, Seattle, went about it the right way when it designed a 50,000-sf facility with space for BSL-2, BSL-3, ABSL-3, and aerobiology. The hazard review team, which was on board at the earliest planning stage, examined 29 systems, including wastewater treatment.

For example, one person asked what would happen if someone incorrectly input the automation setpoints that control the decontamination temperature. The consequences are that the waste wouldn’t be treated properly and the tanks might overfill.  The severity was assigned a 3 and the likelihood was assigned a 2, resulting in a risk rating of 6. The team then brainstormed possible safeguards: password protection to limit access to the control system; program the control software to limit setpoints and reject ones that outside of a reasonable range; and generate printed records.

“The team documented the safeguards, and this was before any design begins,” says Connor. “There are a lot of things to think about when you are planning one of these facilities.

“The most important thing is how you get all the important people together,” he concludes. “That avoids so many problems.”

The University of Washington project won grant funding from the NIH, as well as high praise for its comprehensive application, which included the PHA. The facility was never constructed, however, because of a lack of matching state funding.

By Lisa Wesel