Biosafety Level 2 Laboratory Audit

• Biosafety Level 2 Laboratory Inspection

• Principal Investigator

• Building and room numbers

• Lab Representative

• Department

• Conducted on

  Date

• Campus Location

  Select Main UTK Campus UT Institute of Agriculture College of Vet Medicine Graduate School of Medicine

  • Main UTK Campus
  • UT Institute of Agriculture
  • College of Vet Medicine
  • Graduate School of Medicine

• Prepared by

Facilities signage and practices

• Is access to lab area restricted (i.e., controlled by lab supervisor)?

  Yes

  No

  N/A

• Is the current version of the biohazard signage present at entrances to BSL-2 areas?

  Yes

  No

  N/A

• Is there evidence of food or drink in laboratory area?

  No

  Yes

  NA

• Is the current version of the Infectious Material Exposure Response Procedures posted?

  Yes

  No

  N/A

• Are personnel familiar with the information in the exposure response procedure?

  Yes

  No

  N/A

Housekeeping

• Are there Biosafety related housekeeping concerns?

  No

  Yes

  NA

• Is there evidence of unattended spills?

  No

  Yes

  NA

• Are personnel familiar with the spill procedure?

  Yes

  No

  N/A

Shared facilities or equipment housekeeping

• Are there any shared freezers or refrigerators?

Freezers

• Is the equipment clean and free of housekeeping concerns?

  Yes

  No

  N/A

• Are there any shared cold rooms?

Cold rooms

• Is equipment clean and free of housekeeping concerns?

  Yes

  No

  N/A

• Are samples properly labeled and stored in leak-proof containers?

  Yes

  No

  N/A

• Responsible group or PI?

• Is equipment in a common area that is unrestricted?

  Yes

  Not Applicable

• Is there a placard on the front of the equipment indicating who is responsible for the contents?

  Yes

  No

  N/A

• Is the equipment locked?

  Yes

  No

  N/A

• Responsible group or PI?

• Notes:

Sharps and biological waste disposal practices

• Are needles and other sharps disposed of in appropriate sharps container?

  Yes

  No

  N/A

• Do needles appear to be intentionally bent, broken, or recapped without a formal exemption in place?

  No

  Yes

  NA

• Notes:

• Are biological waste containers properly labeled, leak proof, lined with a biohazard bag and equipped with a closure?

  Yes

  No

  N/A

• Are items that could puncture the autoclave bag in the biohazardous waste containers (i.e., pipette tips) secured in such a way as to minimize the puncture potential?

  Yes

  No

  N/A
Autoclaves

• What is the validation expiration date for the autoclave?

  Date

Hygiene and Primary containment measures

• Is a hand washing sink including soap and hand towels available?

  Yes

  No

  N/A

• Eyewash stations

Station

• Is the station free of obstructions and easily accessible?

  Yes

  No

  N/A

• Does the eyewash have any functional issues (i.e., uneven pressure from the spray heads, pressure too high or low, missing caps)<br>

  No

  Yes

  NA

• Is there documentation to indicate the station has been flushed weekly or monthly (depending on campus policy)?

  Yes

  No

  N/A

• Date of last test/flush

  Date

• BSCs

Cabinet

• Type of cabinet

  Select Clean Bench Class I Class IIa Class IIb1 Class IIb2 Class III

  • Clean Bench
  • Class I
  • Class IIa
  • Class IIb1
  • Class IIb2
  • Class III

• Unless otherwise noted as "not intended for use with BSL-2 materials", has the BSC been certified within the last year?

  Yes

  No

  N/A

• Date of last Certification

  Date

• Is the BSC located away from doors, high traffic areas, and other airflow disruptions?

  Yes

  No

  N/A

• Is there a bunsen burner being used inside the BSC hooked to a dedicated gas line?

  Yes

  No

  N/A

• Are vacuum lines equipped with liquid waste decontamination traps properly housed in spill proof container?<br>

  Yes

  No

  N/A

PPE

• Are gloves worn to protect the hands from infectious or hazardous materials?

  Yes

  No

  N/A

• Are gloves changed when contaminated, glove integrity is compromised, or when otherwise necessary?

  Yes

  No

  N/A

• Are gloves removed and hands washed when work with hazardous or infectious materials has been completed and before leaving the laboratory?

  Yes

  No

  N/A

• Are disposable gloves re-used that are worn for protection from infectious or hazardous materials?

  No

  Yes

  NA

• Are lab coats or other body/clothing coverings worn while working with hazardous or infectious materials?

  Yes

  No

  N/A

• Are protective coverings removed before leaving for non-laboratory areas?

  Yes

  No

  N/A

• How are lab coats cleaned?

  Select Central Sanitation at Vet School Contract cleaner Take home to wash Building/Dept. W&D Other

  • Central Sanitation at Vet School
  • Contract cleaner
  • Take home to wash
  • Building/Dept. W&D
  • Other

• Describe "Other":

• Is eye and face protection used for anticipated splashes or sprays of infectious or other hazardous materials when the materials must be handled outside the BSC or containment device?

  Yes

  No

  N/A

BSL-2 practices

• Are all procedures that may generate aerosols conducted in BSC?

  Yes

  No

  N/A

• Are procedures carried out outside containment designed to minimize the generation of aerosols and/or splashes?

  Yes

  No

  N/A

• Are personnel familiar with the proper decontamination strategies for biological waste (e.g., cultures, stocks) prior to disposal?

  Yes

  No

  N/A

• What kind of disinfectant do you use?

  Select 10% Bleach 70% Ethanol Other

  • 10% Bleach
  • 70% Ethanol
  • Other

• Describe "Other":

• At what frequency is the bleach freshly prepared?

  Daily

  Weekly

  Monthly

  Before use

  Other

• Are personnel aware of how to properly store and transport samples (i.e., capped leak-proof primary container, with leakproof secondary)?

  Yes

  No

  N/A

Biosafety Resources and Documentation

• Have all lab personnel completed initial biosafety training?

  Yes

  No

  N/A

• Are refresher training records available and/or are there plans for completing refresher training in this audit cycle for all personnel working with BSL-2 materials?

  Yes

  No

  N/A

• Is the Biosafety manual readily available?

  Yes

  No

  N/A

• Location?

• Is the biological spills procedures accessible?

  Yes

  No

  N/A

• Is site specific training documented?

  Yes

  No

  N/A

• Does laboratory use a shipping designee?

  Yes

  no

  NA

• Responsible personnel?

• Permit Review

Permit

• Do you hold any regulatory permits?

  Yes

  No

  N/A

• What type of permit is it?

  Select USDA CDC Import Other

  • USDA
  • CDC Import
  • Other

• Describe "Other":

• When is the expiration date?

  Date

• Have permits been shared with the Biosafety Office?

  Yes

  No

  N/A

• Would laboratory personnel like additional information regarding risk management during field work or experiential learning?

  Yes

  No

  N/A

Blood Borne Pathogens

• Are laboratory personnel working with human derived tissues, bodily fluids or cell lines that would require BBP training?

  No

  Yes

  NA

• Is the exposure control plan accessible either in hard-copy or online?

  Yes

  No

  N/A

• Are there any new personnel that require BBP training?

  No

  Yes

  NA

• Are there personnel that have not been informed of their right to vaccination for Hepatitis B ?

  No

  Yes

  NA

• Name and UT NetID?

Summary information

• Results

  Pass

  Provisional Pass

  Fail

• Comments

• Mandatory Corrections

• Deficiencies must be corrected by

• Signature of laboratory representative

  Sign

• Use this space for drawing if needed.

  Drawing

• This Biosafety Level 2 (BSL-2) Inspection is in accordance with requirements outlined in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories 5th ed document (BMBL) and/or other applicable regulatory standards per Institutional Biosafety Committee and Biosafety Office policy.
  Additional Information on the BMBL, BSL-2 requirements, applicable regulatory standards, and lab inspection parameters can be found at http://www.biosafety.utk.edu. Please contact the Office of Biosafety if you have any questions or concerns regarding this evaluation. Thank you in advance for your cooperation in ensuring biological safety and research compliance.

• Legend:
  
  Pass: Score >85% No, or minor deficiencies were noted that were resolved at the time of inspection. Remedial actions are not required at this time.
  
  Provisional Pass: Score >85% Deficiencies were noted; one or more requiring prompt remedial action (Noted under Mandatory Corrections). A mandatory correction is issued when: 1) there is a violation of a U.S. Federal, state, or local regulatory standard; and/or 2) the biosafety inspector has deemed it a risk to personnel safety or biological containment. Remedial action must be taken (or arranged) by the date indicated. Failure to comply will result in a 'FAIL'. Contact the Biosafety Office if you would like further explanation or guidance in resolving the noted issues.
  
  FAIL: Score <85% Numerous or significant deficiencies were noted. Remedial actions must be taken (or arranged by) the date indicated. If corrections have not been taken by that date, the department head and IBC will be consulted to determine the appropriate disciplinary action. Contact the Biosafety Office if you would like further explanation or guidance in resolving the noted issues.