Information

  • Audit Title

  • Document No.

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

General

  • What biological work is undertaken within the facility?

  • Are risk group 2 microorganisms used in the facility?

  • is Genetically Modified material in use or stored within the facility?

The Facility

  • Secure from entry of unauthorized personnel

  • Is there signage outside the facility indicating the containment level?

  • Are biohazard stickers attached to all entries to the facility?

  • Maintained so that it is a fully enclosed space, bound by walls, doors, windows, ceilings.

  • Surfaces are maintained so that they continue to be smooth, impermeable to water, cleanable and resistant to damage by cleaning agents and/or disinfectants in use:<br>- walls, floors and benches<br>- any other surface where decontamination is likely or decontamination is required.

  • Open spaces between and under benches, cabinets and equipment are accessible for decontamination.

  • Window furnishings are not located next to major sources of heat or potential fire hazards, such as hot plates or Bunsen burners

  • Bench tops can withstand the heat generated by general laboratory procedures, e.g flaming loops and heating of media

  • Is benchcoat used?

  • Is benchcoat replaced after spills?

  • Does the facility have a pest control system in place?

  • Furniture appropriate for the laboratory and the safety of laboratory users, and containment of microorganisms, e.g height adjustable stool with smooth, impervious seat covering to facilitate cleaning?

  • Are office areas outside the facility?

Equipment

  • Handwash basin, with hands free operation, or suitable alternate available.

  • Eye wash facilities available (plumbed or single use) maintained and flushed regularly.

Biological Safety Cabinets

  • Are BSC class I or II cabinets present for the containment of aerosols?

  • Have BSC been tested within the last 12 months?

  • Are the last test records available?

Decontamination

  • Are disinfectants effective against GMOs available in the facility for decontamination?

  • What decontaminants are being used?

  • Are the decontaminants suitable for the work undertaken?

  • Is there appropriate labeling such as volumes and expiration dates?

  • Are the decontaminants within the expiry date?

  • Are autoclaves used for the decontamination of waste prior to disposal?

  • - are autoclaves calibrated annually and are records for last 5 years available?

  • - what validation methods are used?

  • - are autoclaves validated monthly and are records for the last 12 months available?

  • Staff are trained to perform decontamination.

  • Benches are decontaminated at the end of work

  • Are items that are frequently touched (fridges, door handles, keyboards etc) decontaminated frequently?

  • Equipment decontaminated before removal from the facility.

Waste

  • How is waste disposed of?

  • Is waste adequately segregated?

  • Are GMO waste bins available?

  • How is GMO waste disposed of?

  • Are there GMO waste decontamination records available?

Backflow prevention

  • Does the facility have backflow protection?

  • Has the backflow prevention device been tested annually and are records available?

Behaviour Requirements

  • The preparation, storage or consumption of food and drink, smoking, shaving, chewing gum, inserting items into mouths, and the application of cosmetics or contact lenses is prohibited within the laboratory

  • Mouth pipetting is prohibited

  • Long hair (below shoulders) is tied back

  • Personal devices (e.g. earphones, mobile phones) are not handled with gloves and are not used in locations where they could become contaminated.

  • Where contamination is suspected, does decontamination occur prior to items leaving the laboratory?

  • Facility doors are closed while dealings are in progress.

  • Procedures are in place to ensure non-GMO work is not cross contaminated and procedures are documented.

  • Personal protective clothing is worn at all times inside the laboratory

  • Lab coats appropriately stored (ie. not on chairs/benches).

  • Windows are closed when work with GMOs is being conducted.

  • Production of aerosols is minimized, particularly when work is carried out on an open bench

  • Dissemination of microbiological material shall be minimized while flamming a wire loop, by drawing from cooler to hotter parts of the flame or by using disposable loops

  • Microbial cultures are clearly labeled, dated and transferred to a dedicated storage location when not in use

  • Diagnostic kits, control sera, and products manufactured from microbiological sources are handled using appropriate safety measures to avoid contact and spread of infectious microorganisms

  • Cultures of spore-producing microoragnisms are covered and sealed to prevent dispersal.

Storage

  • All cultures of GMO's are clearly labelled.

  • Are there records onsite for all GMOs

  • Storage of GMOs outside of facility are doubled contained.

  • Fridges/Freezers used for storage external to facility are labelled with biohazard symbol.

  • GMO signage with storage details on fridges/freezers

Transport

  • Is any biological material transported out of the facility?

  • If so, provide details

Centrifuges

  • Is there any centrifugation of infectious material?

  • If so, are rotors or buckets sealed?

Sharps

  • Is the use of sharps minimized?

  • Are sharps containers available?

  • Are sharps handled safely?

  • Do they comply with AS4031?

Emergency procedures

  • Spill kits/appropriate spill containment material available.

  • Spill procedures documented and available.

  • Are biohazardous spill kits available and in date

Records

  • Staff laboratory training (PC1, Chemical Safety modules)

  • Onsite induction

  • Staff handling GMOs completed the Biosafety module

  • Risk management

  • Laboratory procedures

  • Emergency procedures

More

  • Other comments

  • Add further photos

Sign Off

  • Auditor's signature

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