Now, let us turn our attention to the biorisk management manuals and documents that should be at your facility. The basic ones that most facilities should have are, a biosafety manual, a biosecurity manual, an incident and emergency response manual, and a facilities operation and maintenance manual. In addition, if you work with animals at your facility, you will also need to have an animal biosafety manual. Each one of these addresses different parts of what you are doing in the laboratory, but there are definite overlaps between them and all are administrative controls. These four or five manuals can be put together into one document or kept separate, but should cross-reference each other. All these manuals are living documents. They are reviewed once per year and changed as needed to reflect the current operating conditions. Remember, every safety manual must be site-specific and no one size fits all. There may be parts that are generic, but much must be customize to your facility.

First let us address the biosafety manual. This is an important document that describes how you operate your facility. Key topics that should be addressed within the biosafety manual are: the scope of the document, how biosafety is organized at your facility, roles and responsibilities of the different people involved in the biorisk management program; forms and registrations that you need to do your work; entry and exit procedures to the building and laboratory; laboratory specific biosafety procedures for the various biosafety levels that you might have, such as BSL1, 2 or 3 including descriptions of specific procedures such as waste disposal, equipment use, material storage and transport. You should also describe the medical surveillance program, how people are trained and documentation. Additional descriptions of these will be required if operating high or maximum containment facilities. You may want to address all of these or more, depending on your facility.

Now we will look at the components and topics that should be addressed in a biosecurity manual. Topics that should be covered are: How biosecurity is organized at your location and who are the key personnel; physical security, access control and monitoring; personnel management – how you hire, fire and monitor people; pathogen inventory and accountability; information security; material transport of biological materials; what to do if there’s an accident, injury or incident that compromises the security of your facility; reporting and communication; training and practice for security drills and documentation. Be sure this is specific to your institute and addresses the needs that you have for biorisk program management.

Next let us look at the Incident and Emergency response manual. This manual needs to describe policies and procedures for unplanned events such as incidents and accidents. The manual should address the following topics: scope of the document; organizational structure of the people involved in the program, the roles and responsibilities of these individuals; call and reporting procedures; response procedures in the event of a fire, earthquake, illness or injury, hazardous spill, power failure, inclement weather or a building evacuation. You should also describe, training and record keeping. All personnel need to be aware and trained on the procedures, so that when something goes wrong the correct response is initiated.

Next, every facility should have an operation and maintenance manual. The more complex the facilities the more important this becomes. The manual needs to describe the scope, the people involved in the activities and their roles and responsibilities, the facility equipment that needs monitoring, the maintenance involved and the frequency, equipment failure response, sourcing of supplies, record keeping and training. High and maximum containment facilities rely heavily upon engineering controls and therefore require more attention to operation and maintenance.
If you or your facilities use animals in the work you do, you will also require an Animal Biosafety manual. This manual can be facility or location specific to the animal rooms and describe safety, security, and facility maintenance for that specific location. Topics that need to be address are: scope of the document, roles and responsibilities of the senior people involved in operating that area; specific operating conditions of the various animal biosafety levels (ABSL1-3); potential hazards and exposures; special occupational health issues, waste disposal including carcasses, necropsy procedures, training and record keeping.

These manuals are large, overarching documents that talk in general about how you operate your facility. Therefore, all the manuals need to be supported by standard operating procedures (SOPs) which are more specific and detailed. Many SOPs are therefore, referred to in the manuals. In part 3, we will look at SOPs and how to write them.