Hello, everybody and welcome back to this series of modules on biorisk management. This is the first of several modules where we will start looking at how you control biorisk in your facility. We will start by first looking at administrative controls (or work practice controls). These are changes in work procedures such as written safety policies, rules, supervision, schedules, and training with the goal of reducing the duration, frequency, and severity of exposure to hazardous biologicals, chemicals, or situations. If you recall they are the second to last most powerful control in our hierarchy of controls.

Examples of administrative controls are: guidance documents, program management, defining roles and responsibilities, risk assessment, written safety manuals, selection of staff, practices and techniques, education and training, use of committees, registration and inventory control, signs and labelling, inspections and audits, medical surveillance, and of course documentation. Although administrative controls can (and should) always be used to control employee exposure, they are prone to human error and cannot be relied upon to reduce exposure all the time, which is why they are the next to last most powerful control.

Since there are so many different types of administrative controls, we will just cover roles and responsibilities, guidance documents, program management, written manuals, and standard operating procedures (SOPs) in this module. We will cover all the other administrative controls in the modules to come.

First, we will start with roles and responsibilities. Stop here for a minute and think about biorisk management in your laboratories. I want you to think about all the job functions and titles of the people that are involved and responsible for biorisk management at your facilities. What is the role of the laboratory manager, the technician, the animal care staff, and others? Write down their job function and then write down their roles and responsibility they have for biorisk management.

Here are a few job titles that you may or may not have in your facility. You can see all these people have a role in biorisk management with overlapping and shared responsibilities. How does this list compare to yours? Senior management, has the responsibility to establish, support, fund and enforce the biorisk management program. The biosafety officer or someone who is specifically appointed to oversight biorisk is often empowered by senior management to ensure the biorisk management program is working. They play an important role in training, reviewing programs, ensuring regulations and laws are being followed and establishing policy. The principal investigators or laboratory managers, play a vital role, as they oversee the daily operations for the areas, they are responsible for. They are often held accountable for errors or accidents because they are the closest supervisor to the bench activity. The laboratory technicians or clinical staff, doing the work clearly are responsible for implementing the biorisk management policies and procedures. This can include the animal care and laboratory support personnel, such as the cleaning, transportation and sample receiving staff. The facilities engineering, operations and maintenance staff also play a role in biorisk management because the facilities support biocontainment and biosafety. Finally, the security personnel also play a role in biorisk management because they ensure biosecurity and physical security of the facility. Therefore, a lot of different people, with somewhat overlapping roles and responsibilities must work together to achieve optimal biorisk management.

This graphic shows you at a very high level, some of the different biorisk management policies, procedures, laws, regulations that may exist. If you look at the very top and, in the middle, there is international guidance documents from WHO and from the USA. In addition to these very large international guidance documents, there are also international and legal frameworks. If you took one of the earlier modules we talked about the biological weapons convention, UN resolution 1540, the international health regulations and several others. Then there’s international standards and consensus agreements like the international standards organization. For example, ISO 19001, which is a quality management standard and ISO 35001 (formerly CWA 15793), which is an international biorisk management standard. While these do not direct your work or provide oversight, they do give you some guidance and a framework within which you create your administrative controls. If you look to the top of this pyramid, you see your national laws and regulations. You should be aware of these and what is written about the work you do at your facility. Below that, we have national guidance and national standards. These may or may not be binding in law, but parts of them may be regulatory by inference to national regulations. Then below that, at the lower part of the pyramid, we have facilities-specific policies, facilities-specific biosafety manuals and security manuals. We will talk more about those in a few minutes. Finally, at the very base of the pyramid, which forms the strength of the pyramid are the laboratory-specific operating procedures, work instructions and other documents that are very detailed, very specific to your laboratory and very specific to the work that you do. Therefore, you can see that there are a lot of guidance documents that you should be aware of or have written. These are all considered administrative controls.

This graphic shows a biosafety program layout, describing what kind of documents you may see at your working level. It begins with an organizational vision, which is a very short statement that talks about your facility, the organization that you work for and the vision for the biorisk management program. Under that there may be a mission statement and program goals. These are a little bit broader statements and underneath that we get down to the more detailed documents, such as the biosafety and biosecurity policies. These provide a definite course of action by stating commitment and intent. However, the policy statement is not a plan. The policy statement just provides the strategy, the commitment and intent from which the plans are developed. The responsibility to the commitment and intent remains, even if the plan fails.

For each facility you should have a biosafety manual, a biosecurity manual, a facility operation manual, and an incident response manual. These are all bigger documents that describe in more detail how you manage biorisk at your facility. In addition, you may have training and assistance visits from various organizations and groups. Then finally, program assessments to see how all of this is working.

In review. There are a wide variety of people that have various job functions who all contribute to establishing and running a biorisk management program. Everybody must work together as a team under and within the international and national guidance documents, policy, vision and mission statements. Establishing a biorisk management program driven by key individuals is the cornerstone of operating a safe and secure biomedical facility.