Biosafety
Laboratory Inspections
Laboratory inspections are a requirement for all research and teaching activities involving Biosafety Level 2 (BSL-2) and Biosafety Level 3 (BSL-3) containment. These experiments and teaching activities may include work with recombinant DNA, infectious organisms, and/or biologically-derived toxins.
The purpose of the inspections is not to create a restrictive environment but rather to assist in ongoing safety education of ±«Óãtv's students, staff and faculty. The goal is to facilitate the safe conduct of research and teaching activities involving biohazardous materials; to maintain safe working conditions by eliminating/mitigating the individuals' risks of exposure to biohazards; and to ensure compliance with federal, state and local regulations.
Laboratories that register with the Institutional Biosafety Committee (IBC) and intend to conduct work under BSL-2 or BSL-3 must have satisfactorily completed a Biosafety lab inspection prior to obtaining initial research/teaching approval from the IBC. An inspection of a BSL-2 laboratory is valid for a period of three years. Activities requiring BSL-3 containment and/or using select agents require inspections on a more frequent basis such as quarterly or monthly based on risk assessment or as mandated by federal requirements.
Laboratory inspections may also be required as part of the research granting agency's stipulations. For example certain Department of Defense (DOD) grants and/or contracts require the institution to provide assurance that the laboratories are inspected on certain schedules.
Additionally, laboratory inspections may also be required prior to setting up accounts and receiving biological specimens from certain vendors/institutions. These include but are not limited to American Type Culture Collection (ATCC), BEI resources, national repositories or private organizations, etc. The vendors/organizations require that the institution provide assurance from the Institutional Biosafety Officer (IBO) for the safe use and disposal of the agent prior to their shipment. This can be in the form of a materials transfer agreements (MTA) for example. Prior to securing the IBO's signature to establish an ATCC /BEI account or an MTA with an institution, the PI must schedule a laboratory inspection with the Institutional Biosafety Officer (IBO) and/or the IBO's designee if using biohazardous materials at a BSL-2 or BSL-3 containment facility.
Regulatory Agency Inspection
On occasion the university may be visited by federal or state regulatory inspectors. Some of these groups may contact our office to initiate an inspection, but others may just present themselves at a lab or building. Notify Research Integrity and Compliance/Biosafety Program staff if an official of a regulatory federal/local agency (such as USDA, CDC, DOT, OSHA, etc.) attempts to inspect your laboratory. Please contact our office if an agency has informed you that an inspection is required. For your protection, it is highly recommended that inspections by federal/state regulators be accompanied by a Biosafety Program representative.
Preparing for an Inspection
All Biosafety laboratory audits will be performed in accordance with requirements published by the CDC/NIH in the Biosafety In Microbiological and Biomedical Laboratories, 5th edition (BMBL) for the required Biosafety containment level for the biohazardous materials utilized. The ±«Óãtv BSL-2 Checklist (MS Word) used for inspections is a resource that investigators can use to prepare for the site visit of their laboratory. Investigators are encouraged to consult these sources to ensure that their laboratories meet the required standards for sound Biosafety. In addition here are some general guidelines about the recent "standouts" at our various site visits & recent inspections:
- Take time to sort through your biological materials, including biological samples,
cultures, biologically-derived toxins, plasmid, vectors, etc. and verify that all
samples are properly identified and stored correctly.
- Ascertain that all laboratory staff has access to Biosafety Lab Manual which should
be available on site. A printed copy of the ±«Óãtv Institutional Lab Manual (PDF) with
an addendum which includes your laboratory specific Standard Operating Procedures
(SOPs)/protocols involving the agent requiring BSL-2 containment will satisfy this
requirement. There must be an "I have read and understood this manual and SOPs..." sign-off sheet at the beginning of the manual that all personnel listed on the application
sign-off on [Print Name, Signature, and Date columns]. An SOP would basically be a
"recipe" for your current on-going lab processes involving the cell lines, viral vectors
etc.
- Ascertain that the appropriate door signage is mounted for your laboratory. BSL-2
requires a "biohazard" sign, a lab information/emergency contact sheet and a "Persons who are immunocompromised or immunosuppressed may be at increased risk of
acquiring infections" sign on the lab entry door. (The biosafety staff will provide the biohazard signage).
- Ascertain that a Biohazardous Spill Cleanup Kit is available in your laboratory. Here
is a link to our spill kit reference web page: Biohazardous Spill Kit and the kits
location in the lab should be indicated with a sign such as "Biohazardous Spill Kit"
on the cabinet door it is behind or if it sits out "Biohazardous Spill Kit" should
be plainly marked on the side of the bucket (container).
- Post a copy of the Biological Spill Response (PDF) in the laboratory, preferably near the spill kit.
- If aspirating biological specimens or infectious agents, ascertain that the aspiration
apparatus has a disinfectant trap or an in-line HEPA filter in the vacuum line between
the waste flask and the vacuum source. (Vacuum System Protection) (PDF) See Protection of Vacuum Systems webpage.
- If centrifugation is involved in research/teaching activities, please ascertain that
the centrifuge(s) have safety caps (bucket style) or sealed rotors to contain aerosolized
agent in case of spill/leak/accident during centrifugation.
- Ascertain that all personnel listed on the IBC application have current and up-to-date biosafety training. For example: training completed within the current calendar year is considered current and up-to-date.
Scheduling an Inspection
To schedule an inspection, contact the Biosafety Program staff or call (813)-974-5110. Investigators/laboratory staff are encouraged to contact Biosafety Program staff prior to official inspection in an effort to answer questions, provide guidance and address any items of concern.