UTS PC2 Laboratory (GMO) Annual Inspection Checklist

• Document No.

• Conducted on

  Date

• Area to be inspected

  BIOSAFETY.committee

  TEST.test

• Specific Location and OGTR identifier number.

• Name of person completing the checklist

• Email of person submitting checklist (for email notification)

• Names of personnel involved in inspection

• Based on the usual conditions of certification as detailed in the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 2 Laboratory Version 3.2 – 1 March 2013.
  • If answering ‘No’ to a condition for which there is no exemption or variation, please make a comment about the reason for the non-compliance and any actions being taken to rectify the situation. A request for a variation may be necessary.

Facility and fitting conditions

• Check if this category is NOT applicable.

• Is facility a fully enclosed space bounded by walls, doors, windows, floors and ceilings?

  Yes

  No

  N/A

• Request refurbishment to fully enclose space.

• Are surfaces smooth, impermeable to water, cleanable and resistant to damage by cleaning agents used in the facility (includes furnishings, benches, walls, floors etc.)?

  Yes

  No

  N/A

• Request that surfaces be repaired.

• Decontamination of hands - Are hands-free washbasin fitted OR other means of decontamination of hands (eg: dispensers containing decontaminant solution)?

  Yes

  No

  N/A

• Install hands free basin or other means of decontamination.

• Are open spaces under benches and equipment accessible for decontamination?

  Yes

  No

  N/A

• Clear under benches to allow decontamination.

• Is eyewash equipment provided and maintained?

  Yes

  No

  N/A

• Install eyewash equipment.

• Aerosol containment - Is a BSC (or other equipment specifically approved in writing) present for any dealings involving Risk Group 2 PC2 GMOs that produce aerosols?

  Yes

  No

  N/A

• Install aerosol containment equipment.

• Aerosol containment - If BSC Class I or II used to contain the aerosols, BSC is inspected and tested at least once within last 12 months?

  Yes

  No

  N/A

• Organise inspection and testing of BSC.

• Aerosol containment - If BSC Class I or II used to contain the aerosols, certificate of test results and date of next test affixed to side of cabinet?

  Yes

  No

  N/A

• Affix certificate of test results and date of next test to side of cabinet.

• Is heat based decontamination equipment validated monthly?

  Yes

  No

  N/A

• Implement process for monthly validation of autoclave.

• Is heat based decontamination equipment calibrated annually?

  Yes

  No

  N/A

• Implement process for annual decontamination of autoclave.

• Backflow prevention (if installed) is maintained and tested annually (if testable)?

  Yes

  No

  N/A

• Request Building Services that backflow prevention RPZ is tested annually.

• Backflow prevention - Any changes to or new connections made to the water supply have initiated risk assessment?

  Yes

  No

  N/A

• New risk assessment required and backflow protection is working as expected.

• Are there any significant structural changes to facility that may affect containment?

  Yes

  No

  N/A

• Request refurbishment to fully enclose space.

General conditions

• Tick if this category is NOT applicable.

• Ownership of facility - Does certification holder own or has authority to maintain facility and fittings?

  Yes

  No

  N/A

• Obtain authority to maintain facility.

• Signs - Are OGTR signage and biohazard signs affixed to access door/s (signs are on or near access door/s and able to be clearly seen by persons entering facility)?

  Yes

  No

  N/A

• Affix the current OGTR signs to doors.

• Is disinfectant supply available and suitable for use against the GMOs dealt with in the facility?

  Yes

  No

  N/A

• Provide suitable disinfectant for GMOs dealt with.

• Is pest control strategy in place?

  Yes

  No

  N/A

• Request Building Services that pest control strategy be implemented.

Behavioural Requirements

• Tick if this category is NOT applicable.

• Authorised persons - Is facility access restricted to authorised persons (as described in Part B, conditions 1 to 9, of the Guidelines for Certification of Physical Containment Facilities PC2 Laboratory Version 3.2 – issued 1 March 2013)?

  Yes

  No

  N/A

• Restrict access to authorized persons.

Obligations of the certification holder in respect to the users of the facility

• Tick if this category is NOT applicable.

• Training - Have persons conducting dealings with GMOs in the facility been trained in the behavioural requirements (as listed in Part C of Guidelines for Certification of Physical Containment Facilities PC2 Laboratory Version 3.2)?

  Yes

  No

  N/A

• Provide induction training based on Part C of OGTR Guidelines for Certification of Physical Containment Facilities PC2 Laboratory.

Person completing this inspection

• Name:

• Signature:

  Sign