Biosafety inspections are typically conducted once a year, along with occasional unscheduled inspections from State and Federal agencies. The following guidelines will help you to understand what these inspections involve, and to keep your lab prepared for when the inspections occur.
Unscheduled, Unannounced Federal/State Inspections
Inspectors from the Hawaiʻi Department of Agriculture (and other State Agencies), Federal Aviation Administration, USDA, or CDC may occasionally conduct inspections of the University Labs. The inspections may not be announced. Should an inspector come to your lab, you may ask them to wait for you to contact someone at our office or your Principal Investigator. Be sure to have all the proper documentation available for them.
What to Expect
The inspectors may ask you to provide the documentation related to importation of biological commodities, including the waybill, Dangerous Goods Declaration (Shipping Papers) and the Training Records. It is a good idea to keep all the documents on importation and exports of any biological commodities organized in an area that is easily accessible, with the Dangerous Goods Declaration and Training Records separated and easily reviewed by an inspector.
The inspectors may also ask to see the physical inventory. It is a good idea to have your physical records log organized in a binder in an easily accessible location.
University of Hawaiʻi Biosafety Inspections: FAQ
- How long will the inspection take?
A typical inspection takes approximately one hour.
- Who should be present?
The PI should be present during the inspection. If he/she is not available, the Lab manager or lab representative who is knowledgeable on the daily operations and standard operating procedures should be present.
- What will happen during the inspection?
Please see the general biosafety inspection checklist for an idea of what to expect. Other guidance sources include:
- BMBL (Biosafety in Microbiological and Biomedical Laboratories, 5th edition)
- NIH Guidelines Involving recombinant DNA Molecules
- A Practical Guide to Containment: Greenhouse Research with Transgenic Plants and Microbes
- Hawaiʻi Department of Agriculture Permit Conditions, Administrative Rules
- Who will be present during the inspection?
Typically the inspection will be scheduled by a staff member in the Research Compliance Office and may include an Institutional Biosafety Committee member or Biosafety Program member who is trained in biosafety and in conducting lab inspections.
- I was notified during my inspection that I have deficiencies that need to be corrected; what do I do now?
If you were verbally informed of a deficiency, you may make the corrective measures immediately. Your inspector will send you an inspection report with the deficiencies within 30 days of the inspection and will inform you of the return visit to see that the corrective measures have been taken 30-60 days after the inspection report.
- I haven’t received an inspection report what should I do?
Notify the Research Compliance officer, email@example.com.
- How often should we expect an inspection?
Inspections are typically scheduled once a year unless there is a non compliance/deficiency issue that is being addressed. You may receive a general lab facility inspection in addition to an Institutional Biosafety Committee inspection in the same calendar year.
- Will the inspections be announced?
The University of Hawaiʻi Research Compliance and IBC inspections will always be scheduled with the PI and/or lab manager.