The Biosafety Plan has been developed to provide guidance and enforce policies and procedures of the Biosafety Committee to microbiological and biomedical practices at Wake Forest University’s (WFU) laboratories. These policies and procedures apply to any research involving recombinant or synthetic nucleic acid molecules inserted into cells/organisms and potentially pathogenic microorganisms. In addition, the policies and procedures specify safety practices and the safe handling of biological materials.
The Centers for Disease Control (CDC) have also published Biosafety in Microbiological and Biomedical Laboratories 5th Edition, in conjunction with NIH, for working with all potential biohazards in the lab. Laboratories must follow the guidelines as described, and are encouraged to call the EHS Department for guidance and assistance.
The Laboratory Biosafety Training is required for individuals working in labs with biohazards. The Biosafety Training Certification must be completed after the course. In addition, those working with human blood, cells, or tissue are required to complete the Bloodborne Pathogen Exposure Control Plan training.
Individuals or laboratories planning on using recombinant DNA in research must first file an application with the Wake Forest University Institutional Biosafety Committee (IBC). The IBC establishes and maintains a control system for the use and management of biohazards within all campuses of the University. A copy of the approved application must be kept within the laboratory where research is performed.
The National Institutes of Health (NIH) have published NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, to be followed when using recombinant or synthetic DNA or RNA in research. The IBC uses these guidelines during the application approval to ensure all requirements are met.
Work with infectious agents must follow the same IBC approval process as research with recombinant DNA. Risk Group Classification for Infectious Agents.
Prior to working with human blood or bodily fluids, lab personnel must be trained in the WFU Bloodborne Pathogen Exposure Control Plan (BBP ECP). The ECP is designed to eliminate or minimize occupational exposure to Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV), and other bloodborne pathogens.
Persons working with human blood or bodily fluids and those who are reasonably expected to be potentially exposed must take the BBP ECP Training, complete the BBP ECP Certification and Quiz, and complete the Hepatitis B Vaccination documentation and return to EHS.
In addition, researchers working with human blood or bodily fluids should complete the Bloodborne Pathogen Checklist prior to beginning research and review with the EHS Department.
Prior to shipping any biological material, the PI or designee must be trained in the packaging, labeling, marking and documenting of hazardous goods for shipment. The Department of Transportation regulates the shipment of hazardous materials. This training must be completed and the quiz completed at least once every three years. The shipper must also complete the WFU Hazardous Material Shipping Form and submit to EHS prior to shipment.
If a particular laboratory will be handling large quantities of biohazard materials, a “BIOHAZARD” sign must be placed on the door.
An annual review must be made of sharps by each PI where sharps are employed to identify opportunities where safer devices may be used.