Introduction

Introduction

  • This form has been developed by the Biosafety Team to meet The Gene Technology Regulator's Requirements for the Containment of Exempt Dealings and the Australian/New Zealand Standard 2243.3 Safety in laboratories Part 3: Microbiological aspects and containment facilities applies

  • The inspection responses should specify actions required and therefore should be considered as the inspection report and action plan. Please report rectification of issues back to the Biosafety team once they have been actioned.

Instructions

Instructions

  • Fill in the inspection checklist as you go, recording your findings and observations.

  • Corrective actions, responsible person/s and due dates must be assigned, in consultation with relevant stakeholders, to address areas of compliance.

  • If you answer No or Not applicable to any of the following questions you must provide an explanation in the details section allocated.

  • If you require more space, please add to notes section or attach the information and indicate that you have added an attachment.

  • Please indicate if the level of risk for issues and require actions as Low, Moderate, High or Extreme.

  • Completed inspections are to be forwarded to Facility Manager & Team Leader.

1.0 Facility Research Information

1.0 Facility Research Information

  • 1.1 Is there a complete list of researchers undertaking GMO activities in the facility available. (Listed in facility manual?)

  • 1.2 is there a complete list of GMO dealings undertaken in the facility available. (Listed in facility manual?)

2.0 Compliance to Certification Requirements

2.0 compliance to Certification Requirements

  • 2.1 Demonstrated capacity to comply with conditions of certification that will generally be applied to a certified PC2 animal facility

  • 2.2 Are all requirements for a PC2 animal facility specified in the Certification Instrument issued by the Regulator complied with at all times, even if the work being performed in the facility involves animals that are not GMOs?

    (If this inspection is carried out prior to certification of the facility, do you intend to comply with the above mentioned requirements? Please provide an explanation in 'details' section below).

  • 2.3 Is the facility and equipment in the facility maintained so that the facility meets the "Guidelines for Certification of a Physical Containment Level 2 Animal Facility version 3.1" requirements?


  • http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/certifications-1

  • 2.4 Are all facility personnel trained in the requirements of the OGTR "Guidelines for Certification of a Physical Containment Level 2 Animal Facility version 3.1"?


  • http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/certifications-1

  • 2.5 Do all facility personnel indicate to the certification holder that they fully understand their training in OGTR requirements by signing a record of their training after completion and is record of those trained kept and available if requested?

3.0 Facility Signage

3.0 Facility Signage

  • 3.1 Is the facility labelled with the following signs:

  • 3.1a Is a biohazard symbol on the outside of facility access door(s)?

  • 3.1b Is a Facility Containment level sign present on the outside of the facility access door(s)?

  • 3.1c Is there a facility Work Practice sign promiently displayed at the entry of the facility

  • 3.1d Are all facility emergency exit signs in working condition?

  • 3.1e Is all safety equipment appropriately signed (e.g. showers, eye wash stations, fire extinguishers/equipment, emergency stop buttons, spill kits)?

4.0 Facility & Fitting Requirements

4.0 Facility & Fitting Requirements

  • 4.1 Is the facility access restricted to authorised persons? (as described in part B, condition 8 to 16, of the Guidelines)


  • http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/PC2-4/$FILE/PC2ANv3-1.pdf

  • 4.2 Is the facility locked when facility personnel are not in attendance?

  • 4.3 Is the facility a fully enclosed let space contained within the walls, doors, windows, floors and ceilings?

  • 4.4 Are all walls, floors, windows, ceilings and benches smooth, impermeable to water, cleanable, and resistant to the cleaning agents and/or disinfectants used in the facility?

  • 4.5 Are all joints between structural components sealed and impenetrable to GMOs being contained in the facility?

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

  • 4.7 Are the facility boundaries designed to prevent the escape of GM animals or GM animals infected with GMOs?

  • 4.8 Does the facility have an anteroom?

  • 4.8a Is entry into the facility via the anteroom?

  • 4.9 Are self closing door(s) installed, which are capable of preventing the escape of the GMOs and invertebrates being contained in the facility?

  • 4.10 Are drainage exits, including hand basins fitted with barriers (e.g screens & water traps) to prevent the movement of invertebrates and animals either in or out of the facility via the drains?

  • 4.11 Are the open spaces between and under benches, cabinets and equipment accessible for decontamination?

  • 4.12 Is the facility furniture, including seating, washable?

  • 4.13 Are fixtures, fittings and equipment including under-bench cupboards supported in such a manner to facilitate cleaning of the floor?

  • 4.14 Is a wash basin, fitted with a basin mixer of the hands-free operation type, provided for hand washing within the facility or other means of decontamination of hands (e.g dispensers containing decontaminant solution)?

5.0 Aerosol Containment

5.0 Aerosol Containment

  • 5.1 Are there dealings in the facility involving Group 2 PC2 GMOs?

  • 5.1a Are all procedures that generate aerosols containing GMOs performed in a biological safety cabinet, or other equipment designed to contain aerosols specifically approved in writing by the Regulator?

  • 5.1b Does the facility contain a biological safety cabinet, or other equipment specifically approved in writing by the Regulator that is designed to contain aerosols? (Only applicable if procedures that generate aerosols containing GMOs are to be performed in the facility.)

  • 5.1b (i) Is a biological safety cabinet being used in another facility? (Please outline details of the location of the biological safety cabinet - i.e. room and facility certification number)

  • 5.1c Is the biological safety cabinet inspected and tested at least once with the last 12 months by a NATA accredited organisation

  • 5.1d Is a certificate of test results and date of next test affixed to side of cabinet?

  • Add media

6.0 Backflow Prevention

6.0 Backflow Prevention

  • 6.1 Is the water supplied to the laboratory provided with back flow prevention (i.e complies with AS/NZS 2243.3)?

  • 6.1a If installed at time of certification is it maintained and tested annually (if applicable)?

  • 6.1b Where no backflow prevention device is in place are there risks assessments documented and available?


  • http://infostore.saiglobal.com/store/Details.aspx?ProductID=372933

7.0 Emergency Equipment

7.0 Emergency Equipment

  • 7.1 Are eye wash facilities provided within the facility? (either a plumbed eye wash facility or single-use packs of sterile eye irrigation fluids)

  • 7.1a Are eye wash facilities used and maintained in accordance with the manufacturer's instructions (i.e. Flushed and tested at least monthly)?

  • 7.2 Does the facility contain a biological spill kit appropriate to render biological material within the facility non-viable?

  • 7.3 Are spill procedures documented and in place to decontaminate a spill that occurs either within or outside of the facility?

  • 7.4 Are fire extingugishers or fire blankets provided within the facility?

  • 7.5 Is fire fighting equipment used and maintained in accordance with the manufacturer's instructions?

  • 7.6 Is the facility first aid kit stock and is the stock in-date?

8.0 Personal Protective Clothing & Equipment

8.0 Personal Protective Clothing & Equipment

  • 8.1 Is there designated storage or hanging provisions for protective clothing available within the facility i.e. are hanging provisions being utilised?

  • 8.2 Is designated storage or hanging provisions used by facility users?

  • 8.3 is protective clothing, to protect the front part of the body, worn by all persons performing procedures in the facility?

  • 8.4 Do all persons performing procedures in the facility wear closed footwear?

  • 8.5 Is protective clothing always removed after completing laboratory procedures and before leaving the facility? (This requirement does not apply if entering another containment facility, certified to PC2 by the Regulator that is directly connected to the facility.)

9.0 Centrifuge Equipment

9.0 Centrifuge Equipment

  • 9.1 Does the facility contain centrifuges or have access to centrifuges for facility users?

  • 9.1a If centrifuges are not located in the facility, please outline details of the location

  • 9.1b Are centrifuges maintained at least every 12 months by an external accredited organisation?

  • 9.1c Are centrifuges used and maintained in accordance with the manufacturers instructions (local area maintenance including daily, weekly or monthly)?

  • 9.1d Are notices posted on, or adjacent to, the centrifuge indicating maintenance results and the date of the test?

  • 9.1e Are centrifuge log books for usage located near the machine?

  • 9.1f Do the centrifuges have aerosol containment devices (e.g. rotor lid or bucket caps)?

10.0 Pest Control

10.0 Pest Control

  • 10.1 Are there any pests or insects (dead or alive) present on the floor of the facility?

  • Add media

  • 10.2 Are there any spiders webs present on window frames or in corners of facility?

  • Add media

  • 10.3 Are strategies in place to ensure that the facility is free of pests and is a record of the program and dates of specific activities kept and available if requested?

11.0 Heat Based Decontamination Equipment

11.0 Heat Based Decontamination Equipment

  • 11.1 Does the facility contain a pressure steam steriliser (autoclave) or have access to an autoclave?

  • 11.1a If autoclave is not located in the facility, please outline details of the location. (It is preferable that the autoclave be located within the same building as the facility)

  • Add media

  • 11.2 Where pressure steam steriliser (autoclave) is used for decontamination:

  • 11.2a Is the autoclave calibrated including thermocouple and safety valve annually by a qualified person and the results of the test available

  • 11.2b Are provisions made to allow for the penetration of steam into the container during auto leaving?

  • 11.2c Is the coldest part of the load exposed to a minimum temperature of 121 C for at least 15 minutes?

  • 11.2d Are measures taken to ensure that loads that have been processed can be differentiated from loads that have not? (e.g. autoclave tape)

  • 11.2e Is the temperature of each cycle monitored by use of one of the following means: a thermocouple and recorder; a maximum thermometer; a chemical indicator; spore strips; or readings from the autoclave panel?

  • 11.2f Is the effectiveness of decontamination by the pressure steam steriliser (autoclave) used by the facility tested at least every month?

  • 11.2g Is a notice posted on, or adjacent to, the autoclave indicating the result of the above-mentioned test and the date of the test?

12.0 Management of Facility Cleanliness

12.0 Management of Facility Cleanliness

  • 12.1 Are the air conditioner exhaust inlets and outlets clean and free of dust build-up?

  • 12.2 Are the windows and window frames clean and free of dust and dirt build-up?

  • 12.3 Is the facility floor clean from dirt and dust build-up?

  • 12.4 Are hand basins clean and tidy?

  • 12.5 Is there an appropriate amount of paper towelling provided for drying hands after washing?

  • 12.6 Was the facility generally clean and tidy?

  • 12.7 Other facility cleanliness issues?

13.0 Decontamination Procedures

13.0 Decontamination Procedures

  • 13.1 Are all liquid and solid wastes containing GMO's, decontaminated by steam sterilisation (autoclaving), chemical treatment, incineration or any other method approved in writing by the Regulator?

  • 13.2 Is there a supply of disinfectants for decontamination purposes available in the facility?

  • 13.3 Are the disinfectants clearly labelled with the contents and, where necessary, the expiry date or preparation date?

  • 13.4 Are the chemical disinfectants mentioned above in accordance with Appendix E of "Australian/New Zealand Standard 2243.3 Safety in laboratories - Part 3: Microbiological aspects and containment facilities"?


  • http://www.saiglobal.com/online/AutoLogin.asp?url=/online/Script/Details.asp?DocN=AS362637424995

  • 13.5 If incineration is performed does it occur in a high temperature, high efficiency, EPA-approved incineration facility

  • 13.6 Are all work benches, surfaces and equipment where procedures have taken place decontaminated immediately after any spills and when laboratory procedures are completed?

  • 13.7 Are all work surfaces and equipment, in relevant areas of the facility, decontaminated before maintenance is carried out?

  • 13.8 Are equipment, pens, cages or bedding contaminated decontaminated before being removed from the facility?

  • 13.9 Is protective clothing contaminated or suspected to be contaminated removed as soon as practicable and decontaminated prior to reuse?

  • 13.10 Are GMO's rendered non-viable prior to disposal?

14.0 Work Practices

14.0 Work Practices

  • 14.1 Are all facility personnel trained in PC2 requirements and aware of OGTR Containment requirements?

  • 14.2 Are windows closed while laboratory procedures are in progress? (Not applicable to the windows that are fitted with intact flyscreens)

  • 14.3 Are procedures in place to report any unintentional release of GMOs from the facility to the Regulator as soon as practicable?

  • 14.4 Are all cultures clearly identified?

  • 14.5 Can GMO and non-GMO material be clearly differentiated?

  • 14.6 Are reading/writing material and computers essential to procedures performed within the facility the only such items used on work benches where procedures are performed?

  • 14.7 Is eating, drinking, smoking, shaving and applying cosmetics prohibited in the facility?

  • 14.8 Is food or drink intended for human consumption prohibited from being brought into or stored in the facility?

  • 14.9 Is long hair tied back or covered with a hair net at all times to avoid contamination?

  • 14.10 Is mouth pipetting prohibited in the facility?

15.0 Storage of GMO's

15.0 Storage of GMO's

  • 15.1 Are GMO's or organisms infected with GMO's stored inside the facility in a storage unit (freezer, fridge, controlled temperature room or other controlled temperature container)? (Note: storage also includes GMO's currently involved with active research work).

  • 15.2 Does the facility contain an easily retrievable inventory of all GMO's approved for the facility?

  • 15.3 Does the inventory contain the following:

  • 15.3a IBC reference number?

  • 15.3b GMO dealing classification? (e.g. Exempt dealing, NLRD or DNIR)

  • 15.3c Location of the GMO dealing in the facility? (e.g. Room, fridge or freezer)

  • 15.3d Location of the GMO dealing in the storage device? (i.e. shelf number, box number or site)

  • 15.4 Can facility researchers demonstrate that storage records are accurate and GMO's are located where indicated on the inventory list?

  • 15.5 Are GM animals or GM material stored clearly identified?

  • 15.6 Are GM animals or GM animals infected with GMOs stored outside the facility in a storage unit? (e.g. freezer, fridge, controlled temperature room or other controlled temperature container)

  • 15.6a If yes, a "GMO Containment: Storage Location Outside of a Facility Inspection Checklist" must be completed for the storage location.

  • 15.7 A re there local procedures in place to ensure control, and easy identification of GM animals or GM material if facility personnel leave the organisation?

16.0 Transport of GMO's

16.0 Transport of GMO's

  • 16.1 Are GMO's being transported out of the facility (to storage location, other certified facilities or organisations)?

  • 16.1a Are standard operating procedure's in place that comply with IATA standards?

  • 16.2 Is waste potentially contaminated with viable GMOs, being transported out of the facility transported in accordance with the "Guidelines for the Transport of GMOs version 2.1"?


  • http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/gmotransportJuly2007-htm

  • 16.3 Are viable GMO's being transported out of the facility to other buildings or organisations transported in accordance with the "Guidelines for the Transport of GMO's version 2.1"?

  • 16.4 Are viable GMO's transported out of the facility to other buildings or organisations double contained and appropriately labelled with contact details?

  • 16.5 Are notices or logs sheets available for GMO's being transported out of the facility to other buildings or organisations? (does it also contain information on arrival at destination?)

17.0 GM Animal Practice Requirements

17.0 GM Animal Practice Requirements

  • 17.1 When not handled are GM animals infected with GMOs kept in containers or cages designed to prevent escape?

  • 17.2 Are all animals in the facility clearly identified so as to distinguish between GMO and non-GMO material?

  • 17.3 Are animal cages or containers labelled to enable identification of GM animals or GM animals infected with GMOs and the number of animals being contained in the container?

  • 17.4 Are large GM animals or GM animals infected with GMOs marked with a tattoo, permanent tag, microchip or permanent brand?

  • 17.5 Are procedures in place to ensure there is no mixing of non-GMO and GMO animals or GM animals infected with GMOs?

  • 17.6 Are GM animals rendered non-viable prior to disposal and is disposal appropriate?

  • 17.7 Are the experimental procedures and handling of GM animals carried or GM animals infected with GMOs carried out in a way that minimises the chance of escape?

18.0 Other Health & Safety Requirements

18.0 Other Health & Safety Requirements

  • 18.1 Are there any electrical safety issues (e.g. testing & tagging of power boards or extension leads)?

  • 18.2 Air current tube tests results

  • Add media

  • 18.3 Are items in the facility being stored appropriately?

  • 18.4 Is waste being appropriately segrated and correct waste vessels used?

  • 18.5 Are emergency exits clear and easily accessible?

  • 18.6 Are there any machinery safety issues?

  • 18.7 Any other health and safety issues noted at the time of inspection?

19.0 Corrective Actions

19.0 Corrective Actions

  • 19.1 Notes/Enter any corrective actions that will be undertaken

20.0 Sign Off

20.0 Sign Off

  • On site representative:

  • Auditor:

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