Annual Inspections
Annual IBC Inspections are performed yearly by members of the IBC. Inspections are conducted in accordance with requirements stated in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the Biosafety in Microbiological and Biomedical Laboratories, 6th edition and the USA Biosafety Manual. Annual inspections ensure that BSL-2, ABSL-2, BSL-3, and ABSL-3 laboratories follow the practices and guidelines set forth by federal regulations and institutional policies. Annual Inspections occur each December.
The IBC office notifies investigators and laboratory staff one month in advance of the annual inspections. They are provided with the following forms of communication:
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- PIs and research personnel are informed via email that they will be sent an electronic
Pre-Inspection Survey, which they are required to complete. This survey supplies the
IBC office with essential details regarding the research protocol, such as protocol
personnel, biological hazards handled, and the biosafety level of containment. Additionally,
pre-inspection survey data is utilized to develop the internal inspection checklists
for IRB inspectors in REDCap.
- An email is sent to PIs and research personnel detailing the day, date, and time of
the scheduled inspections for their department.
- A 2nd email is sent to PIs and research personnel 2 days prior to scheduled department
inspections.
- Post-inspection, PIs are issued an inspection letter. This letter will inform the PI if they have been cited or not cited. If a PI has deficiencies, they are required to submit a Corrective Action Plan (CAP) to the Institutional Biosafety Committee (IBC) office within ten (10) days of receipt of the letter.
- PIs and research personnel are informed via email that they will be sent an electronic
Pre-Inspection Survey, which they are required to complete. This survey supplies the
IBC office with essential details regarding the research protocol, such as protocol
personnel, biological hazards handled, and the biosafety level of containment. Additionally,
pre-inspection survey data is utilized to develop the internal inspection checklists
for IRB inspectors in REDCap.
- Some things to expect during inspections include but are not limited to observations
for biohazard signage, if equipment is tagged with biohazard stickers, autoclave records,
eyewash records, ECP training records, liquid waste log records, training records,
an up-to-date copy of the Biosafety. Inspection teams will observe and have an interactive
dialog with the Investigator and/or their designated lab personnel during inspections.
- Post-inspection, Investigators are emailed results from inspections within a week
of their inspection. Investigators with minor or significant findings are given ten
(10) days to respond with a corrective action plan (CAP) regarding minor and/or significant
deficiencies. The IBC office will follow up with the Investigator’s lab until all
deficiencies have been addressed.
- The IBC committee meets to discuss inspection outcomes. Reporting results allows the IBC to assess that the appropriate practices and procedures are in place for all registered work.
Download the laboratory inspection checklists below for preparation for annual inspections.
Laboratory Inspection Checklists [download links]