"We are the only facility that currently houses Level 4 and high-containment Level 3 laboratories both on the large animal side and the human health side," says Dr. Stefan Wagener, scientific director for biosafety and environment, and chief administration officer for the CSCHAH. Wagener notes that this is the equivalent of combining into one building the USDA's Plum Island Animal Disease Center (now run by the Department of Homeland Security) in New York with the CDC's Level 4 facility in Atlanta.

The 30,000-gross-square-meter (322,917-gsf) facility opened in 1998. Jointly developed by two federal departments& #151;the Canadian Food Inspection Agency (CFIA) and Health Canada—the facility houses labs for two major programs: the National Microbiology Laboratory (NML) and the National Centre for Foreign Animal Diseases (NCFAD). [The U.S. equivalent of the NML is the Centers for Disease Control (CDC), while the U.S. equivalent to NCFAD is the Animal Plant Health Inspection Service (APHIS).]

Total lab space is around 30 percent. The facility houses 132 Level 2 laboratories; at Level 3 there are 32 laboratories and 14 large suites (or approximately ten percent). Level 4 space (four Level 4 laboratories and one Level 4 large animal suite) accounts for one percent of the total building space. The rest of the facility is used for support, logistics, and administrative issues associated with NML and NCFAD.

To maintain and operate a safe facility that can meet ongoing recertification requirements, Wagener and the staff rely on internal and external teamwork, training, and good community relations, as well as paying attention to the needs of the operations and maintenance (O&M) staff.

Annual Recertification

Since the CSCHAH works with zoonotic agents—which can be transmitted between humans and animals—both the Health Canada Office of Laboratory Security and the CFIA's Biocontainment and Facility Services Division (BCFSD) recertify the CSCHAH annually. To avoid doubling up on the associated workload for the lab, Canadian regulators assign one of the two agencies a lead role, depending on the nature of the research being conducted.

"This is part of their 'I'm from the government, I'm here to help you' approach," says Wagener. "It's a very helpful system."

The lead agency issues the letter of certification, which is also signed by the other agency. Any overlapping issues are worked out between them.

"It has been one of the most pleasant experiences in my professional career working with a regulatory site. There is a wonderful exchange of information, a wonderful exchange of knowledge."

Teamwork

Wagener notes that teamwork at the CSCHAH has two components, internal and external. Both are essential for a successful certification program.

Internally, the CSCHAH emphasizes a close integration of scientific, O&M, security, safety, and animal care staff.

"You have to have all the players working together on the package that you send to the external agency for review," Wagener says. "You don't want to have your right hand saying one thing to a regulator and your left hand saying something different. You put a system in place that lets you know that you can rely on each other and trust each other because any one part of it can make or break a successful certification."

Wagener notes that integrating the different teams at the CSCHAH is made easier by having everyone in one facility.

"Our operations staff knows the folks on the science side. There is very close cooperation. It also helps us that we are a relatively autonomous facility."

Externally, in addition to establishing a good working relationship with regulators, Wagener says the concept of transparency has to be highlighted.

"The point of a certification is to make sure a laboratory meets or exceeds certain criteria. To this end, it is imperative that the certifying office makes their standards and criteria available to the facilities. I need to know what kind of documentation they want to see, what kind of tests they want to have performed, and what the pass and fail criteria are," says Wagener.

"In the end, it is in the interest of both parties. The certifier wants a safe facility and the facility staff also wants to be safe."

Training

Training at the CSCHAH also involves a teamwork approach that goes beyond the facility by working very closely with regulatory groups at the CFIA and Health Canada.

"We got together with them to work out how we could train people in the operational, safety, and maintenance aspects of Level 3 and Level 4 facilities, on a national as well as an international level," says Wagener.

This led to the establishment of the Canadian Centres for Applied Biosafety and Research, which produces the International High Containment Biosafety Workshop annually. The workshop provides employees with hands-on training in containment. For example, a biosafety officer or a facility manager can actually learn how to do a pressure-decay test of a room, or how to certify a filter.

"This is not because we want them to do certifications later on," says Wagener. "But how can a facility manager assess the quality of work being done if he or she has no idea how to certify a filter?"

Wagener notes that, much to his surprise, the scientific staff at CSC also expressed an interest in the workshop. As a result, training is available for Level 3 and Level 4 scientists, technicians, and the animal care staff.

"It gives them a new appreciation not only of the complexity of the facility, but also of the value that the operations and maintenance staff provides," says Wagener. "It is also important that they know the big picture, that if they enter a room, there is a response by the ventilation system or that directional airflow might change."

Helping Out O&M Staff

Wagener stresses the importance of O&M staff in maintaining a safe and effective facility.

"They need to have a work environment they like," says Wagener "This will make for a very happy employee. If they don't like their work environment, you might have problems with the quality of work they perform."

Wagener notes that one unique advantage of building the CSCHAH as a federal facility was being able to integrate the O&M staff early on in the design, construction, and commissioning phases. For non-federal facilities, he recommends giving serious thought to hiring O&M staff in advance.

"You may spend a couple hundred thousand in salary costs but you will gain this money back during the process of building and commissioning the facility. You will need these experienced people later on to make your facility operational and secure the maintenance of the facility."

The CSCHAH has a dedicated staff whose ongoing job is certifying the hundreds of HEPA filters in the facility. Rather than requiring them to move air bubbles or compressed air generators to the HEPA floor, a compressed-air line was added.

"This allows the power tools and DOP (dioctyl phthalate) systems to work," says Wagener. "There are significant benefits associated with it."

If you have significant pieces of equipment, Wagener suggests putting in catwalks, rather than requiring O&M personnel to use a large ladder.

Tagging systems and valves is also important, because it allows the O&M staff to work much more efficiently and safely with those systems.

"You can never have enough information," says Wagener.

Communication

Early on in the operation of the CSCHAH, pre-treated waste was accidentally released into the sanitary sewer. The release was not infectious and local authorities were notified. The public however, was not notified of the incident and in the follow-up investigation federal ministers directed the CSCHAH to set up a Community Liaison Committee (CLC) to enhance public trust and provide for public input.

"It was the best thing that ever happened to us," says Wagener. "I believe the Canadian Science Centre right now is an excellent example of community relations, public relations, and transparency."

Working with the CLC, the CSCHAH established an incident communication system. The system divides incidents into types: people, environment, property, social/psychological, and opinion. Depending on the severity of the incident, notification is sent to 14 specific groups inside and outside the CSCHAH.

For example, one of the categories is the environment external to the building. An incident would be classified according to the following scheme:
1. No threat or harm to the external environment.
2. Threat or harm to the external environment is easily managed or restored.
3. Restoration or management of the external environment requires significant measures (threat or harm remediation).
4. No short-term restoration or management of the risk or harm is possible.

"This allows us to specifically target groups that need to know, not because they need to respond or are even involved in managing the incident, but because they need to know about it," says Wagener, adding that these groups are receiving regular email updates.

The CSCHAH has around 7,000 electronically monitored control points, resulting in what Wagener describes as "an alarm every hour."

"There is a tremendous amount of notification that can go out," says Wagener. "There may be a system to check or a fan or a belt to be replaced. In many cases we inform the community about this. As a result, they have been our best allies."

By Lee Ingalls