“CL-3 labs are very expensive and very complicated, in both their mechanical and electrical systems and their operational processes and standard operating procedures,” says Lach. “So a design approach that focuses on operational planning lets you create custom designs that account for the uniqueness of every single facility, rather than taking a template or cookie-cutter approach. However, that means you have to think through all of the operational processes in order to do things right.”

Planning Tools

To ensure that all operational processes are incorporated into the design, operational-based planning relies upon a process flow analysis illustrated by a process flow graphic, a diagram providing an overview of all laboratory components, how those components fit together, and how resources flow among them.

“For example,” says Lach, “if you analyze how a biological sample comes and goes, you ask, how does it arrive? Where does it go first? Is a decontamination process involved? How is it used in the lab? How is it disposed of?”

By “walking through” every key operational process on paper, the design team creates a diagram that can be used not only by the team in designing the facility, but also by the regulatory agency in granting acceptance of the design, and by the operator of the facility when the laboratory is actually in use.

“A containment laboratory is designed to create a safe environment to work with dangerous pathogens, so how staff arrive is very important. You need security doors, you need to change into protective equipment, you need to make sure anything that’s possibly contaminated is disposed of properly. All of these procedures are very strictly defined and need to be enforced. Without an overall logic diagram, there’s a greater risk of making a mistake in the design and creating a hazard.”

To design a laboratory that truly addresses all operational processes, an integrated design process that includes all stakeholders—architects, engineers, owner’s representatives, user groups, administrators, and other building staff—is critical to project success.

“Say you don’t include the maintenance guy in your design team,” says Lach. “You design the building, it looks good, everyone’s happy, and then the maintenance guy comes and says, ‘I need to get to this piece of equipment twice a day, and I can’t get into the lab and climb up a ladder and open a hatch.’ Any lab operator will tell you that this actually does happen, a lot. With controlled environments in particular, you can’t just walk into a lab and do service work.

“If your integrated design process does include the maintenance guy, your building will run better, because the maintenance staff will be able to do their jobs. The integrated process also results in greater user satisfaction with the finished product, because everyone has participated, and they understand why certain decisions or compromises might have been made.”

The Abbotsford Agriculture Centre

Operational-based planning guided the entire design process for a CL-3 laboratory at the Abbotsford Agriculture Centre. This Centre, built in 1995, consolidates four offices of British Columbia’s Ministry of Agriculture and Lands in one location, just across the U.S.-Canada border from Seattle. It also includes the Animal Health Centre which provides pathology and laboratory diagnostic services to the province’s agriculture sector.

In partial response to a large 2004 outbreak of avian influenza, the government of British Columbia elected to add the CL-3 laboratory to the Abbotsford facility to expedite response to future outbreaks by enabling diagnostic work with CL-3 (indigenous and non-indigenous) pathogens in the region. (The 2004 outbreak—of the H7N3 type, not the H5N1 type seen in Asia—was rapidly controlled.)

The 12,500-gsf CL-3 laboratory, encompassing 2,050 nsf of laboratories, 7,300 nsf of mechanical and service space, and 3,150 nsf of other non-laboratory space, includes bacteriology, virology, and polymerase chain reaction (PCR) areas. The facility was built in compliance with Canadian Food Inspection Agency (CFIA) and Health Canada (HC) regulations.

After a feasibility study and government approval, the project team met to determine how the facility would be used and how it would achieve compliance with government regulations. CFIA and HC regulations and checklists provided direction, dictating requirements for standard operating procedures for entry and exit of staff and specimens, waste handling, and other process flows.

The top operational considerations for the Abbotsford CL-3 addition were the entry, processing, and disposal of biological samples; staff entry and exit; emergency exits; and entry and exit of equipment. All of these factors proved integral in planning the new laboratory’s location.

“We decided to connect the new lab to the existing sample entry necropsy area,” says Lach. “That’s the main receiving point for all samples, so once they’ve identified a CL-3 contaminant, they have to move it into the new lab. The choices were to walk it around the block, put it next door, or simply walk ten feet and put it through a pass-through. It was the efficiency of that connection that drove that decision.”

The process of receiving animal specimens into the existing CL-2 necropsy room, however, was in clear need of revision. Specimens were received through one set of large doors that opened directly to the outdoors, allowing outside air to flow in when doors were opened and depressurizing the area. In addition, no provision was made for quick handling of CL-3 agents or for cleaning up potentially hazardous spills outside the doors.

A new receiving area consisting of a covered loading dock was attached to the existing necropsy room, with an anteroom in between as an airlock. To enable the quick sending off of specimen samples judged to potentially contain a CL-3 agent, a small room in the necropsy area is dedicated to handling of specimens. CL-3 specimens are transported directly to the CL-3 laboratory through the link attached to the necropsy room.

People entering the CL-3 lab proceed from a corridor into a positively pressurized clean change room and then into the negatively pressurized soiled change room for access to the lab. Interlocked doors allow only one door to be opened at once, maintaining pressure within the CL-3 laboratory. People exit the CL-3 lab via the same route, through a shower from the soiled change room into the clean change room.

Exit protocols and a special emergency exit were developed to enable potentially contaminated personnel in the CL-3 laboratory to leave in case of fire or other emergencies. After proceeding through a vestibule stocked with disinfectant and containment bags, workers move outdoors to a marshaling area, where they remove CL-3 outer garments, bag them, and disinfect themselves to the extent possible.

Large pieces of equipment such as biological safety cabinets, centrifuges, and refrigerators are decontaminated in a large room equipped with VHP (vaporized hydrogen peroxide) decontamination, as well as a dual biocontainment barrier, interlocked doors to maintain pressurization, and a dedicated air supply and exhaust system. Other decontamination measures include two side-by-side autoclaves, serviceable from outside the containment barrier, and a decontamination pass-through allowing one-way movement of reagents and equipment. Standard operating procedure for transporting isolated viruses or bacteria specimens to outside reference laboratories consists of packing the specimens in plastic dangerous-goods canisters, completely disinfecting the canisters, disinfecting the pass-through with a chemical disinfectant, and removing the canisters from the other side.

During the operational-based planning process, some processes evolved from what they were in the original process flow analysis.

“Originally they wanted to bring the samples into the necropsy area, perform their first analysis, break the samples down, transfer them into the CL-3 lab by walking them down a corridor, and perform a secondary necropsy inside the new containment lab,” says Lach. “After a lot of discussion, they realized that performing open benchtop dissection in the new lab would require it to be designed to a higher, more expensive standard. So we ended up changing the premise. They got agreement from the regulatory agency that the samples could be dissected in the existing necropsy area, broken down into smaller components, and simply transferred through a pass-through, so that no open-bench dissection would have to happen in the new CL-3 lab, and they could design it to a less expensive standard. That saved a lot of money.

“That was probably the piece of process work that took the most time, not just with the user group but also with the regulatory agencies,” he continues. “We had to ensure the safety of these samples, how they would be received and handled, what personal protective equipment people would need, and design the building accordingly. At the end of the day, it’s all about safety--safety for staff and for the public.”

By Deborah Kreuze

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ISSN: 1096-4894