Biosafety Laboratory Manual Requirements
The Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (pages 33, 37, 44, 52) requires a “safety manual specific to the facility is prepared or adopted…” and that the manual is “available, accessible, and periodically reviewed and updated as necessary.” This requirement applies to laboratories at all biosafety levels. The BMBL also states that the manual:
- “contains sufficient information to describe the biosafety and containment procedures for the organisms and biological materials in use, appropriate agent-specific decontamination methods, and the work performed.”
- “contains or references protocols for emergency situations, including exposures, medical emergencies, facility malfunctions, and other potential emergencies. Training in emergency response procedures is provided to emergency response personnel and other responsible staff according to institutional policies.”
At a minimum, the Biosafety Laboratory Manual must include:
- Lab contact information (PI name, phone number, including after hours number);
- Copy of current IBC approval letter;
- Copy of the current, approved IBC Registration document;
- Copies of the last three years of laboratory inspection report(s) for the specified space. Copies of the last 3 years of the inspection reports for the specified space may requested from Research Compliance.
- Relevant sections of the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition, (e.g. Section IV pertaining to standard BL1 and BL2 practices, Appendix A, pertaining to Biological Safety Cabinets (applicable sections only), Appendix H, pertaining to work with human cells and tissues if applicable);
- A list of approved agents and agent summary statement(s) (BMBL, Section VIII) or MSDS for each agent stored and/or used in the lab;
- Project-specific written procedures (SOPs);
- Laboratory-specific biosafety requirements including:
- PPE required for working in the lab
- Occupational health requirements for working in the lab (not required for BL1)
- Biohazardous agent specific decontamination and waste disposal procedures including disinfectant preparation and use and autoclave operation for:
i. Liquids
ii. Sharps
iii. Solids
iv. Research animals (if applicable)
v. Mixed waste (fi applicable) - Biohazardous spill clean-up procedures;
- Contains or references protocols for
- emergency situations, including exposures,
- medical emergencies,
- facility malfunctions, and
- other potential emergencies
- Training records for PI and institutional supplied biosafety training (topic and date of attendance).