BL-2 Audits and ABL-2 Audits
Biosafety Level 2 Audit Overview
Laboratory biosafety level criteria provide guidance for containment and practices for research projects and are verified through Institutional Biosafety Committee (IBC) registration. Standard microbiological practices are common to all laboratories. Special practices enhance worker safety and environmental protection and address risks associated with handling agents requiring increased levels of containment.
When is an Audit Required?
The IBC requires a Biosafety Level 2 audit of all rooms where Biosafety Level 2 (BL-2) work is done or where BL-2 materials are stored. Audits are performed every five years to correspond with IBC approval. Additional audits may be done for updates or when new BL-2 space is added to an IBC registration.
Who Should Attend?
The principal investigator (PI) and laboratory personnel overseeing the project should attend to ensure that all required safety practices are met. Representatives from the Division of Research Safety (DRS) will be present to lead the audit process and discuss established biosafety practices.
What is Covered?
Biosafety level criteria are published in the BMBL, 5th Ed. Section IV-Laboratory Biosafety Level Criteria. The DRS uses a BL-2 checklist based on these criteria.
After completing the audit, the PI will receive a report summarizing action items. The PI will be asked to send a written response within two weeks of receiving the report that explains how the action items were addressed. The PI may request more time to complete action items. IBC approvals and/or updates are contingent upon satisfactory responses the audit action items.
Animal Biosafety Level 2 Audit Overview
Animal biosafety level criteria provide guidance for the use of experimentally infected animals housed in indoor research facilities. In general, biosafety levels in vivo are comparable to in vitro. However, research with animals presents unique hazards. For example, animals may generate aerosols, bite, or scratch. Therefore, it is necessary to assure that all parties involved in the research are aware of potential hazards as they relate to specific procedures or duties (e.g., the administration of infectious materials by researchers and animal husbandry procedures performed by animal facility personnel). Animal biosafety level containment and practices are verified through Institutional Biosafety Committee (IBC) registration.
When is an Audit Required?
The IBC requires an Animal Biosafety Level 2 audit for all animal rooms where Animal Biosafety Level 2 (ABL-2) work is done. Audits are performed every five years to correspond with IBC approval. Additional audits may be done for updates or when new animal space is assigned to a principal investigator (PI) by the Division of Animal Resources (DAR).
Who Should Attend?
It is critical that researchers and animal facility personnel are aware of their roles and responsibilities for ensuring that all safety concerns and institutional compliances are met. To accomplish this, the following individuals should be present at the audit:
The PI and laboratory personnel overseeing the project;
Representatives from the DRS to discuss biosafety practices and lead the audit;
Representatives from the DAR to discuss animal husbandry and animal care issues;
The occupational health specialist to ensure that occupational exposures to other experimental hazards are addressed.
What is covered?
With all parties present, the PI or senior lab member gives a brief overview of the experiments and specifies any special practices or equipment requirements. This allows each representative to ask questions and ensure that all aspects of the research are addressed.
Animal biosafety level criteria are published in the BMBL, 5th Ed. Section V-Vertebrate Animal Biosafety Level Criteria for Vivarium Research Facilities. The DRS uses an ABL-2 checklist based on these criteria.
After completing the ABL-2 audit, the PI will receive a report summarizing action items discussed during the audit along with a standard operating procedure (SOP) and PI summary. Because ABL-2 rooms may be shared, each room has a SOP to assure that all users abide by basic practices to maintain containment within that facility. The ABL-2 PI Summary outlines project-specific information for the PI and any variations or special practices required. IBC approvals and/or updates are contingent upon satisfactory responses the audit action items.
Last Update: 5/9/2014