Containment Talk

In this column, three of ABSA International’s experts—“The Containment Guys”—in the areas of containment equipment and facility operations answer questions about a variety of containment topics. Please e-mail questions related to biocontainment facility design, operations, maintenance, and biosafety to J. Paul Jennette at [e-mail].

Key Elements for the Successful Establishment of a Containment Laboratory: Initiating Operations and Forming an Operations Team

To conclude our series of articles in which we discuss the “key elements for the successful establishment of a containment laboratory,” we would like to touch on the last 3 points from our column in volume 20, number 1: how to initiate scientific operations, how to promote safe operations, and how to assemble the right team to develop programs and documentations for registering with the Centers for Disease Control and Prevention or the US Department of Agriculture, Animal and Plant Health Inspection Service, and to manage staffing and training. All of these topics will be covered from the facility operations point of view.

We often say that successful facility operations are composed of 3 elements: biosafety/biocontainment staff, operations staff to keep the facility working safely, and scientific staff to keep the research active and up-to-date. These 3 elements need to work in synchronization. Communication is very important. A facility cannot contain biohazards if the scientific operations and biosafety/biocontainment personnel do not work together to effectively manage biological risk. For example, the equipment in biocontainment laboratories is composed of intricate mechanical systems. Normal operations could be affected by environmental conditions (winds, pressures, temperatures), ventilation equipment shutdowns (proper directional airflow not maintained), electrical issues (power outages, bumps, and brownouts), room temperature and humidity changes (critical for vivaria), information technology modifications, general equipment maintenance (autoclaves, effluent decontamination systems), communication system failures, building automation system modifications, or loss of access to the building automation system, fire safety testing, and so on.

Depending on the size of your facility, one option for enhancing communication is to create a Building Owners Group (BOG). What is a BOG? In a broad sense, it is a communications tool that facilitates the efficient and safe operations of a biocontainment facility. It really is a group of people who care about the facility, have an interest or stake in its operation, and ultimately are owners in the effort that leads to successful operations. Who makes up a BOG? The core group should consist of the following: maintenance management, the institution’s project manager/engineer, the laboratory operations manager/coordinator, the biological safety officer, and a research scientist representative. Ultimately, maintenance management has the responsibility to carefully document decisions, changes, and updates that occur as a result of all the owners providing input to operations. Having accurate minutes of the meetings and documentation of assigned responsibilities is beneficial to the entire group and, again, to safe facility operations. Each group member has a responsibility to the group to provide input on his or her expertise. By setting up these channels of communication early in a project, addressing new issues as the project progresses to full operating status is very easy.

The BOG functions separately from a laboratory construction team. Even when the facility is fully operating, continuing to have BOG meetings provides significant benefits to operations by facilitating good communication among stakeholders. Since all of the BOG members are very familiar with the project and know their roles, a long learning process is avoided when the facility is ready to operate. Regardless of the phase of the project the BOG is making decisions as a group, all the key owners are involved and aware of the details of those decisions. This helps to avoid last-minute and costly changes, right at the time of turnover to operations. Long discussions about why the initial decisions were made are avoided, as every meeting is well documented. Biosafety professionals should make every effort to ensure that this type of communication is used, especially when constructing, renovating, and then operating a biocontainment facility. Staff will be easier to train if they are already aware of management’s commitment to operations and the effort to maintain a BOG for the facility. This will make your job much easier too. However, although operations and scientific staff use BOG meetings to stay on track with the original research plan, they may have to conduct additional planning meetings as the project comes closer to completion.

Daily communication among the scientific program group, facility operations and maintenance group, and the biosafety/biocontainment group is key for the successful operation of biocontainment laboratories. An approach taken by one institution was to create and follow a communications standard operating procedure (SOP), to allow the biosafety/biocontainment group to perform equipment and facility risk assessments, to coordinate maintenance shutdowns with the scientific and maintenance group, to perform validations and certifications of the laboratory facility and equipment, and also to provide adequate, well-planned solutions to issues as they arose. Figure 1 shows an example of this communication protocol approach.

Figure 1.

Example Communication Approach.

How to Initiate the Scientific Program

In previous articles, we identified 5 questions about establishing the need for a biocontainment facility. The topics included the need for new construction versus collaboration with existing facilities, which pathogens to study, the laboratory’s purpose, scientific activities, and financial support. The right answers to those questions not only justify the start of the project but also provide the base guidelines for the scientific program. So, if you started early in the project and kept good notes, a lot of the initial work is already done. We believe that keeping the program as flexible as possible early on will allow some leeway in scientific capabilities when the facility is ready to operate. For example, when laying out the initial laboratory design, the thought might be that 6 animal holding rooms are needed for the planned research. In making these plans, the team adds 6 additional electrical outlets to the room, giving it versatility in case the room is needed for other work. Two years later, as the project is completing, the BOG finds out that 2 rooms will be needed for a containment diagnostic laboratory. Everything is easily and quickly changed in those 2 rooms, as all that is required is to roll in the correct equipment and plug it into existing outlets. The major discussion point for the group at this time is simply deciding which rooms to use.

Initiating the scientific program is truly a shared responsibility between the scientific staff and the biosafety/biocontainment officer or responsible official. From a facility operations point of view, starting with low-consequence pathogens is better while the scientific staff is becoming comfortable working in the facility and the operations staff can make the necessary adjustments to the control systems and alarms. Even though the facility may have gone through an endurance test and final commissioning, the real events do not begin to happen until the scientific staff start work. The early months of operations are critical for fine-tuning the facility, which, if successful, provides extended and safe operations.

For select agent facilities, the BOG is often the main player in putting together all the documentation and information needed for the responsible official to submit an application to register the facility with Centers for Disease Control and Prevention and/or US Department of Agriculture, Animal and Plant Health Inspection Service. Evidence of a well-maintained facility that has written maintenance SOPs and maintenance records is essential for laboratory registration. Well-written operation SOPs and plans may also originate from the BOG. These may include the facility biosafety manual, as it covers the scientific operations and facility emergency responses, the facility maintenance plan, facility security plan, and a facility training plan.

Finally, let’s take a closer look at the staffing and training of people needed to support the operations of a biocontainment laboratory. Several elements must be included in a training plan.

First, the plan should identify who needs to be trained and to what level. Certainly, everyone who enters a biocontainment facility needs some sort of training, but the type and level of training will differ, for contractors who enter the facility only with an escort, and for facility safety personnel to full-time scientific staff who routinely enter the facility unescorted. Prerequisites, such as other trainings, medical surveillance, and respirator fit tests, need to be identified for each type of worker entering the containment facility, and, of course, all of this should be documented.

Specific training for working in biosafety level 3 (BSL-3) typically includes both didactic (lecture) and hands-on (in-facility) components. The content of these components varies depending on the trainee. For example, full-time BSL-3 personnel will probably receive much more of each type of training than a maintenance contractor who enters the facility only one time. For situations like the latter, entry into an active or “hot” BSL-3 is not typically allowed without an escort, so the BSL-3-specific training for the maintenance contractor may consist only of a brief “toolbox training” given immediately prior to the entry. For full-time BSL-3 personnel, the training often includes a mentoring period when the trainee works with an experienced user for a set period, and a proficiency demonstration or other form of test is typically used to assess the trainee’s readiness for working unsupervised in the BSL-3. The training plan should use or reference documents such as a biosafety manual, laboratory-specific SOPs, a security plan, and an emergency response plan. Also, having a secure location to store training documents and records, defining the required training intervals for the laboratory staff, and having a memo from upper management giving the trainers authority to carry out their tasks also may be wise. When establishing prerequisites for laboratory use, remember that any staff performing basic routines in the laboratory should be required to read, understand, and sign off on all applicable SOPs and the biosafety manual. In addition, staff may be required to have hands-on training for specific tasks. Other prerequisites may include annual medical surveillance, spirometry, and respirator fit tests, as well as bloodborne pathogen training.

When contractors, service representatives, and other outside personnel must enter BSL-3 facilities, decontaminating the BSL-3 before they enter is certainly preferable. That is not always possible, however, and the way that institutions handle respiratory protection requirements for outside personnel when they must enter active, or “hot,” BSL-3 facilities merits careful consideration. Some institutions simply give outside personnel the same type of respirator used by the full-time BSL-3 personnel without verifying their compliance with the Occupational Safety and Health Administration (OSHA) respiratory protection standard. We think this is a very bad idea! The OSHA standard clearly places the requirement for medical clearance, training, and fit testing on employers. There are ways to safely address this issue. For example, some institutions may require outside personnel to bring their own respirators and verify that these meet the requirements of the OSHA standard. Other institutions may decide that if outside personnel provide documentation from a medical professional that they are medically fit to wear a respirator, the institution may consider training them to wear a powered air-purifying respirator (PAPR) that it provides since this respirator does not require a fit test. But if an institution decides to do this, it is important that it: (1) keep a copy of a visitor’s fitness document; (2) maintain the ability/certification to officially train the visitor on the PAPR; (3) have the visitor sign off on the PAPR training (ie, as completely understanding the respirator’s use and the risks involved); and (4) properly maintain and test all PAPR equipment before use. This can be a lot of extra work.

This wraps up our series on establishing a containment laboratory. We realize that there can and will be much more to laboratory startup than what we have covered in these last columns, but hopefully we have elucidated a place to start. We look forward to discussing new details in the future, and until then, please write to us with your comments or questions and stay connected.