- The biosafety team performs biosafety inspection(s) at least annually for all research area(s) with an approved biological research registration.PIs and research staff can prepare for biosafety inspection(s) using this self inspection checklist.
- Biosafety will contact and schedule inspection(s) at least annually and concomitantly with continuing review and/or amendment of biological research registration(s). Here is a sample checklist we may use during the inspection.
- Biosafety inspection(s) are specific to Biosafety Level 1, 2, and 3 laboratories and research area(s) and are implemented in accordance with
- Northeastern University’s Biosafety Manual,
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules,
- Biosafety in Microbiological and Biomedical Laboratories (BMBL),
- Boston Public Health Commission, and the
- OSHA Bloodborne Pathogens Standard.
- Biosafety provides assistance with inspection(s) and audit(s) from outside regulatory agencies.
- Inspection report(s) will be sent to the Principal Investigator (PI) and designated safety representative(s). Non-compliance will be reported and escalated to the IBC, department chairs, CSOs, DSOs and OARS leadership.
Biosafety Risk Assessments, Permits and Consultations
- Biosafety performs research, site risk assessments, and consultation(s) for new Principal Investigator(s) working with biological materials, or for current Principal Investigators, as needed, for renovation(s) to facilities or modification(s) to existing experimental procedures that may pose an increased risk. Contact email@example.com for more information or a consultation.
- Biosafety provides guidance and technical expertise on regulations, guidelines, and best practices pertaining to hazardous biological materials to the NU community including: NIH Guidelines, OSHA Bloodborne Pathogens, CDC BMBL, Boston Public Health Commission.
- Biosafety can assist in the development of Standard Operating Procedures (SOP) for biological material(s), Bloodborne Pathogen Exposure Control Plan (BBP-ECP) or other compliance or report documentation(s) as needed.
- Biosafety provides assistance with authorizations, regulatory permits, material transfer agreement(s) and other documentation(s) and report(s) for biological material(s).
- Training is assigned as per the job activities in your research laboratory. Visit the OARS Training page for more info. Minimum Biosafety training(s) for work at Biosafety Level 2 (BSL-2) include:
- Fundamentals of Laboratory Safety (and its annual refresher)
- Biosafety I
- Biosafety II
- Regulated Medical Waste
- Other safety training(s) may be required depending on research procedures and should be listed on your approved biological research registration(s). Specialized trainings may include shipping biologicals, select agents, viral vectors, animal research etc.
- Hands-on training(s) for biological material procedure(s) are required by the PI or delegated experienced staff for new laboratory workers, new procedure(s), and at least annually. Supervision by experienced staff is required for students. Proficiency in research procedures should be evaluated by PI or delegated staff.
- Specialized agent-specific training, spill response training or other training(s) are available upon request from our team.
- Biosafety responds to any reports of incidents or injuries involving biological materials, research animals, sharps, or recombinant or synthetic nucleic acid materials. Reporting may be required to NIH, CDC, BPHC or other regulatory agencies and the Biosafety team will assist researchers in that process.
- All injuries, incidents, or near-misses should be reported to the PI and OARS for safety and further investigation. The IBC reviews all incidents or injuries involving biological material(s).
- This lab exposure response sticker jpeg must be prominently displayed in every lab.
- Call OEHN for guidance on occupational exposure response or post exposure guidance – 866-360-8100.