Strategies in Commissioning for Bio-Safety

The world is now more than ever aware of the threat posed by bio-terrorism and emerging and re-emerging infectious diseases. No wonder so many bio-safety laboratories are being constructed. But many of these facilities are for owners who have never before built, operated or maintained a bio-safety laboratory.

The commissioning process can serve as a useful tool for all owners to verify and document that the building design, construction and operation meets their performance requirements and the standards set forth in publications such as Biosafety in Microbiological and Biomedical Laboratories (BMBL).

BMBL defines a BSL-3 area as a clinical, diagnostic, teaching, research or production facility in which work is done with indigenous or exotic agents that may cause serious or potentially lethal disease as a result of exposure by inhalation. All procedures involving manipulations of infectious materials within a BSL-3 laboratory must be performed in personal protective clothing, a biological safety cabinet or some other containment device.

Many owners are looking to their commissioning authorities to provide BMBL-required verification and documentation for their biological safety laboratories. However, the commissioning process helps the owner do much more than simply document and verify the laboratory's operation. The process helps ensure that the laboratory's design, construction and operational parameters meet the owner's specific requirements.

Other tools provided by the commissioning authority have been proven to be beneficial to laboratory owners. For instance, the biological safety officer and other staff are provided with necessary information regarding the design and operational parameters of the lab in the commissioning report. This information allows laboratory staff to write appropriate laboratory protocols and procedures. Without information on how the lab actually functions, comprehensive procedures cannot be developed.

The commissioning process is generally considered to be made up of five phases: planning, design, construction, acceptance and warranty. Because BSL-3 laboratories require an annual verification of laboratory operation, the warranty phase can be thought of as “warranty and beyond.” Each phase of the commissioning process presents tools and opportunities.

The commissioning process also requires a strong foundation, made up of the owner's performance requirements (OPR) and the commissioning plan. OPR is defined by ASHRAE Guideline 0 as a written document detailing the functional requirements of the project and the expectations of how the project will be used and operated. Representatives from all groups of people that will occupy, operate, maintain and otherwise be affected by the building must be involved in the creation of the OPR.

Bio-safety laboratories present unique requirements in the creation of the OPR since the facility must comply with the containment and safety protocols related to the agents that will be present in the laboratory.

The commissioning plan is defined by ASHRAE Guideline 0 as a document that outlines the organization, schedule and allocation of resources and documentation requirements of the commissioning process. Communication protocols should be clearly defined within the commissioning plan. The commissioning plan is a living document that will evolve as the project evolves.

OPR and commissioning plan can be developed at any stage of the project. However, in order for them to be most useful, they should be developed early in the planning phase so that the designers have a documented record of the owner's requirements for the project.

Commissioning-focused reviews of the basis of design documentation, schematic design documents and final design documents are performed by the commissioning authority. The OPR can be used as a tool by the design team when preparing the basis of design document (BOD) and other design documents. In its most basic form, the BOD defines the assumptions made in the development of the project design that achieves the requirements of the OPR. For a biological safety laboratory, it is important the laboratory design parameters meet the requirements of regulating agencies such as the Centers for Disease Control and the National Institute of Health. These requirements should be outlined in the BOD and listed as requirements in the OPR. A complete BOD has the following components:

• Descriptions of systems and components
• Descriptions of how systems and equipment are intended to be maintained
• Descriptions of applicable standards and codes
• Description of fire/life safety systems
• Listing of design assumptions
• Manufacturer's equipment information.

When designing a biological safety laboratory, the design team must address all issues. If a sealed containment space is required by the OPR, the design team must provide details on how containment boundary penetrations are to be sealed. It is not enough to simply say “seal all containment zone penetration points.” System and equipment control sequences must be clearly defined, and sensor performance requirements must be specified. An off the shelf sensor may not be appropriate for a BSL application. The design team must also keep maintenance accessibility at the forefront of their design considerations. Equipment requiring maintenance should not be installed above BSL-3 ceilings. The number of equipment access panels in the containment zone is to be minimized.

These access panels will likely become points of failure in the containment boundary. If an appropriate OPR was created during the project-planning phase, these types of requirements will have already been documented. In the design phase the commissioning authority will simply verify that the OPR requirements have been met.

The commissioning team performs other tasks during the design phase that add value to subsequent phases of the building. Examples of these tasks are as follows:

• Update commissioning plan based on design phase input
• Develop commissioning specifications to be included in the design documents
• Develop draft construction checklists and functional performance test procedures
• Assist in the development of training and O&M manual requirements.

The design is complete and meets the requirements of the OPR. The following is a list of commissioning activities performed during the construction phase:

• Update the commissioning plan
• Commissioning focused review of manufacturer's equipment submittals
• Commissioning focused review of contractor's shop drawings
• Finalize construction checklists and provide to appropriate contractors
• Track progress of construction checklist completion
• Verify construction is in accordance with OPR requirements
• Develop finalized functional performance test procedures
• Verify that O&M documentation meets the requirements of the OPR.

By having access to the OPR, the contractor will have an understanding of what the owner expects of the project. The commissioning authority will document the building construction and verify that it meets the OPR. This task is often performed through the use of construction checklists or site observations by the commissioning authority.

These checklists are not intended to take the place of manufacturer's startup procedures. Their purpose is to document that the building construction and equipment installation meets the requirements of the OPR. The construction checklists should be created and approved by all members of the commissioning team. These checklists are completed by the contractor and provided to the commissioning authority for review and verification. The completed checklists are provided as part of the commissioning report. The checklists also inform the commissioning authority that the equipment and systems are ready for functional testing.

Training and functional testing activities are considered part of the construction phase by ASHRAE Guideline 0. These activities are most effective when they are performed after construction is complete. Therefore, many commissioning services providers make these tasks part of a separate phase called the building acceptance phase.

The observation and documentation of equipment and system functional performance testing is an important acceptance phase commissioning activity for any project. However, for a BSL-3 laboratory this activity is vital. The BMBL requires that the laboratory's design and operational parameters be verified and documented prior to making the laboratory fully operational. If this requirement is not met, the lab cannot be certified as a BSL-3. Operation of laboratory systems and the lab as a whole should be documented for normal and emergency modes of operation. A thorough commissioning authority will challenge the lab systems by writing test procedures for “what if” scenarios. Operation of the laboratory during all conceivable equipment line-ups should be documented. With documentation of how the lab operates during every imaginable operational scenario, the bio-safety staff can write specific protocols of action to minimize the spread of contamination and exposure to personnel in other areas of the building.

Other activities performed by the commissioning authority during the acceptance phase include the following:

• Review of training plans including agendas, schedules and handouts
• Verify training meets OPR requirements
• Update commissioning plan
• Review final O&M manuals
• Test & balance verification spot checks
• Provide draft final commissioning report.

The warranty phase of a building begins when the contract specifies that equipment warranties are to start (often at substantial completion) and continues throughout the contractual warranty period. The commissioning objectives are as follows:

• Complete seasonal testing of systems and equipment
• Document and track warranty callbacks and investigate any systemic issues
• Document lessons learned for application on the next project
• Document and verify the accomplishment of continuing owner training
• Interview the end users, operators and maintenance staff to identify issues prior to the end of warranty
• Complete the final commissioning report.

For an owner with little or no experience operating and maintaining a BSL-3 laboratory, the BSL-savvy commissioning authority can be an invaluable tool.

ASHRAE, 2005. ASHRAE Guideline 0-2005. The Commissioning Process. American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc., Atlanta.

CDC, NIH, 2007. Biosafety in Microbiological and Biomedical Laboratories, 5th ed. Centers For Disease Control And Prevention, National Institutes of Health, Washington.

Richmond, Jonathon Y., PHD., Editor. 2004. Anthology of Biosafety. Vol. VII, Biosafety Level 3.

Biological Safety Assn., Mundelein, Ill.