"UBC Laboratory Inspection Checklist"

Information

Document No.
Audit Information
Client / Site
Conducted on
Prepared by
Location
Personnel

Introduction & Instruction

Introduction

This checklist has been developed by the Biosafety Team to meet The Gene Technology Regulator's Requirements, the Quarantine approved premises (QAP) Conditions of Approval under section 46A of the Quarantine Act 1908 and the Australian/New Zealand Standard 2243.3 Safety in laboratories Part 3: Microbiological aspects and containment facilities.
The inspection responses should specify identified issues and actions required to rectify where possible and therefore should be considered as the inspection report and action plan. The purposes of the checklist is to enable a comprehensive facility inspection to be undertaken and clear identification of any issues that must be rectified to achieve and maintain a certification/standard and a safe working environment.
Inspections scheduled by the UBC will be scheduled through the GSafe Audit tool as a 'Manual Biosafety Upload' audit and will specify an auditee, auditor, corrective actions person and an audit approver. Identified persons will receive an email with a link to the GSafe audit. Once the inspection has been completed checklists will be uploaded to GSafe in sections for follow up by auditee, corrective actions person/s and when corrective actions are completed the audit will be approved by the Team Leader - Biosafety, Chemicals and Rdiation.

Instructions

Fill in the inspection checklist as you go, recording your findings and observations.
Where appropriate provide an explanation in the text section associated with each question. Tap on the question to activate a text box if one does not appear.
If you require more space, please activate a text box and add information or add media to the question most relevant or the corrective action section of the checklist.
Completed UBC inspections will be uploaded to GSafe by the auditor and the assigned auditee and corrective actions coordinator will facilitate rectification of identified issues as soon as practicable. All issues must be rectified within a reasonable timeframe and these corrective actions then be updated to GSafe as they are completed. The Audit Approver will then authorise the UBC inspection process successfully completed by approving the GSafe audit.

1.0 Facility Information

1.1.A What is the facility space type?
- Animal facility
- Chemical Laboratory
- Cold room/freezer
- Constant temperature room
- Laboratory
- OGTR certified facility
- OGTR containment facility
- Storage
- GMO storage
- Studio
- Workshop
- Autoclave/dishwash room
1.1.B What is the facility containment level?
- N/A
- PC1
- PC2
- PC3
1.1.C If applicable, what is the quarantine containment level?
- N/A
- Disposal/Autoclave
- QC1 (criteria 5.1)
- QC1 (criteria 7.5 live rodent)
- QC1 (criteria 7.6 live xenopus)
- QC1 (criteria 7.7 live fish)
- QC2 (criteria 5.2)
- QC2 (criteria 7.2 insectary)
- QC3 (criteria 5.3)
1.1.D Does the facility have any certifications or approvals?
1.1.D (i) Is there an OGTR Certified Physical Containment Level sign on the outside of facility access door(s)?
1.1.D (ii) Is a Facility Work Practice sign prominently displayed on the outside of the facility access door(s)? N.B: The Facility Work PRactice sign should incorporate a biohazard symbol & physical containment level sign on the outside of facility access door(s)?
1.1.D (iii) Is there a quarantine approved premise sign, which also identified the quarantine containment level, posted on the outside of each access door?
1.1.D (iv) Does the facility contain any other specialised signage (e.g. radiation, etc.)

1.2 Research Material

1.2.A What type(s) of samples are utilised within this facility?
1.2.B Please advise of any additional sample types not listed below:
1.2.C If applicable, what type of OGTR/UBC projects are approved to be undertaken within the facility
- Exempt dealings
- Notifable Low Risk Dealings
- DNIR
- DIR
- N/A
1.2.C If applicable, what type of quarantine material is stored/used within the facility?
- Soil or water
- Biological products (in vitro only)
- Other

1.3 High Risk Biological Work (other than GM)

1.3 A Are any of the following activities being or planned to be undertaken in this facility:
1.3.A (i) Risk group 2 microorganisms* cultured in large volumes (10L or greater)?
1.3.A (ii) Risk group 2 microorganisms which require special precautions*?
1.3.A (iii) Risk group 3 or 4 microorganisms*?
1.3.A (iv) Infectious/potentially infectious animals, tissues or fluids (involving microorganisms of the categories mentioned above)?
1.3.A (v) Unscreened specimens? i.e. human tissue or body fluids that are known to contain microorgnanisms listed above, or have not been screened for infectious disease; animal tissues or body fluids that could contain zoonoses or have tot been screened for such.
1.3.A (vi) Poisonous or venomous animals? e.g. snakes, spiders, cone-shells.
1.3.A (vii) Biological toxins (excluding toxoids)?
1.3.A (viii) Biological material on the Defence Strategic Goods List (DSGL)?
1.3.A (ix) Security sensitive biological material (SSBA's)?
1.3.A (x) Other;
Please provide full details:

2.0 Administration

2.1 Research Information

2.1.A Is a Facility Manager or Research Technical Support Officer assigned to this facility?
2.1.B Is a list of researchers including students who access the facility known & readily available? (Provide evidence)
2.1.C Are all activities/projects undertaken in the facility known? (Provide evidence)
2.1.D Is there evidence of documented risk assessments for activities/projects being undertaken within the facility?
2.1.E Are researchers undertaking activities/projects that involve regulated material(s) within the facility? i.e. In this context regulated materials refers to OGTR licences, UBC approved projects, quarantine material and anything identified in Section 1.3
2.1.E (i) Where activities/projects involve quarantine material, is a "Responsible Person" assigned & readily identified within the facility?
2.1.E (ii) Is a designated folder for activities/projects involving regulated material(s) readily available within the facility? i.e: There shall be a folder for UBC projects and/or quarantine activities approved to be undertake within the facility, which should contain all relevant documents.
2.1.E(ii)(i) Where goods are subject to quarantine, are copies of entries/directions and transfer approvals kept within the folder?
2.1.E(ii)(ii) Where there is a transfer approval(s) for quarantine goods, is a transfer SOP developed and available within the folder?
2.1.E(ii)(iii) Are copies of past audits (internal & external) kept within the folder? N.B: Copies of past audits shall be kept for 18 months, and must be readily available on request.
2.1.E (iii) Is there a list of researchers undertaking activities/projects involving regulated material(s)?
2.1.E (iv) Are copies of all the approvals, permits and/or licences readily available within the facility?
2.1.E (v) Are relevant written approvals readily available within the facility? e.g. Written approvals may include: UBC approval memo; AQIS written approval to move QM between facilities that are notbco-located; or written approval from the OGTR to use specific equipment to complete GMO activities/projects.
2.1.E (vi) Where relevant, is there a scale drawing of the facility? N.B: A scale drawing of the facility is required where activities/projects involve quarantine goods.
2.1.E (vii) Where relevant, is there a plan of the ventilation system readily available within the facility? N.B: the plan of the ventilation system is required where activities/projects involve quarantine goods.

2.1 Training & Induction

2.1.A Are laboratory safety inductions conducted for all facility users (e.g. staff, researchers & students)?
2.1.B Are all facility personnel trained and aware of the facility requirements and other regulatory requirements (e.g. OGTR & AQIS)?
2.1.C Have facility personnel completed and been deemed competent in the 'Genetic and General Biosafety Training'?
2.1.D Have facility personnel undertaken & gained competency in the Learning@Griffith 'Laboratory & Workshop Safety' training?
2.1.E Are there any special OHS, induction and/or PPE requirements for persons visiting the facility?
2.1.F Where activities/projects involve regulated material are undertaking within the facility, are all personnel aware of the conditions for such activities/projects? N.B: Most activities/projects that involve regulated material will have specific approvals and conditions imposed by the regulating body (OGTR and/or AQIS) and the UBC. All facility personnel (weather or not they are apart of the research group(s) undertaking activities/projects subject to specific approval and conditions) should be informed of these conditions, and sign a record (or training log) to indicate that they have been informed of such conditions and understand the specific conditions. This should occur
2.1.G Where goods are subject to quarantine, are copies of the current QAP accredited person training certificates readily available?
2.1.H Where applicable, have the QAP accredited persons read the relevant documents, and indicated their understanding with a signature? (Provide evidence of training records)

3.0 Facility Fitting & Infrastructure

3.1 Facility Infrastructure

3.1.A Is the facility a fully enclosed space bounded by walls, doors, windows, floors and ceiling?
3.1.B Are facility doors and windows lockable or otherwise able to be secured?
3.1.C Are all surfaces within the facility smooth, impermeable to water, easily cleanable, and resistant to damage by cleaning agents and/or decontamination agents? N.B: All surfaces include (a) walls, floors, doors, windows and benches; (b) furniture and seating; and (c) any other surfaces, where containment is likely to occur or where decontamination is required.

3.2 Facility Fittings

3.2.A Is the facility access restricted to authorised persons?
3.2.B Are open spaces between and under benches, cabinets and equipment accessible for decontamination/cleaning?
3.2.C Is all facility furniture & equipment washable/cleanable?
3.2.D Is a wash basin fitted with hands-free operation or an alternative method of decontaminating hands available?
3.2.E Are openings to the facility (ie. floor drains) suitably screened?

3.3 PC2 Animal or Invertebrate Facilities

3.3.A Is this a PC2 Animal Facility?
3.3.A (i) Does the facility have an anteroom?
3.3.A (ii) Are facility boundaries (walls, floors, doors, ceiling, etc) designed to prevent the escape of animals being contained? e.g. doors shall be fitted with door skirts.
3.3.A (iii) If the facility has drainage exits, including hand basins, are they fitted with barriers? n.b. These barriers must be of a suitable size to prevent the movement either in or out of the facility via the drains e.g. screens, water traps.
3.3.A (iv) Are openings in the walls, ceilings and roof filtered or screened to prevent the entry or exit of animals? n.b. the filter or screen must be of a material mechanically strong to withstand any airflow load, remain undamaged with regular cleaning, and resistant to corrosion/penetration by animals.
3.3.B Is this a PC2 Invertebrate Facility?
3.3.B (i) Is entry/exit to the facility via a dedicated anteroom?
3.3.B (ii) Are facility access doors self closing?
3.3.B (iii) Are the facility doors designed to prevent the escape of animals contained therein? e.g. by the use of seals on the edges of all doors.
3.3.B (iv) Are all joints between structural components sealed and impenetrable to animals contained in the facility?
3.3.B (v) Are measures in place for monitoring and controlling the escape of invertebrates out of the facility? i.e. measures for monitoring and controlling invertebrates may include using traps, visual inspections, use of mirrors/visual aids, accounting procedures for live and trapped invertebrates and methods for attracting invertebrates away from the door.
3.3.B (v)(i) Is there a documented SOP for these monitoring measures available on request?
3.3.B (v)(ii) Are records/logs of measures undertaken available on request?

3.4 Environmental and Ventilation Requirements

3.4.A Is there an inward flow of air into the facility?
3.4.A (i) Air current tube tests results
3.4.B Do users indicate any concerns with the facility environment? e.g. noise levels, lighting relevant to tasks undertaken, temperature, ventilation.

3.5 Backflow Prevention

3.5.A Is the water supplied to the laboratory provided with back flow prevention?
3.5.A (i) If installed at time of certification is it maintained and tested annually (if applicable)?
3.5.A (ii) Where no backflow prevention device is in place, are there risk assessments documented and available?

3.6 Pest Control

3.6.A Are there any pests, insects or evidence of, present within the facility? (Provide evidence)
3.6.B 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?

3.7 Management of Facility Cleanliness

3.7.A Are all surfaces within the facility free of dirt, dust and mould? n.b. this includes air vents.
3.7.B Are hand basins clean and tidy?
3.7.C Is paper towelling provided for drying hands after washing?
3.7.D Is the facility generally clean, tidy and free of nonessential material? i.e. unused/old/damaged equipment, stored items, rubbish. n.b. this includes all areas of facility; constant temperature rooms, storage devices, under benches, etc.
3.7.E If quarantine activities are undertaken: is there a SOP for ensuring floor drains have a disinfectant placed in the traps?
3.7.E (i) Is there a regular schedule of replenishing the disinfectant in the floor drainage traps?
3.7.E (ii) Are these maintenance records kept (& sighted)?
3.7.F Other facility cleanliness issues? (Provide evidence)

4.0 Equipment

4.1 Aerosol Containment Equipment

4.1.A Are there activities or proposed activities with regulated material that produce aerosols? i.e. In this context regulated refers to OGTR licences, UBC approved projects, quarantine material and anything identified in Section 1.3 n.b. deliberate action include; theft, sabotage, protest, human and/or mechanical intervention.
4.1.A (i) Are these activities performed in a BSCII, or other aerosol containment equipment specifically approved in writing by the Regulator?
4.1.A (ii) Does the facility contain a BSCII, or other aerosol containment equipment specifically approved in writing by the Regulator?
4.1.A (ii)(i) Has the BSCII or other equipment approved in writing by the Regulator been serviced & tested within the last 12 months? (Provide evidence) i.e. evidence required includes a copy of the of latest test report & the certificate of compliance incl. date of next test (affixed to unit) n.b. the service must check for containment efficiency and safety, which is to be completed by a NATA accredited organisation. n.b. service shall be conducted prior to use, after any modification including change of HEPA filters, relocation and on an annual basis.
4.1.A (ii)(ii) Are used filters disposed of through the appropriate waste stream i.e. CRW, cytotoxic or quarantine waste stream.
4.1.A (ii)(iii) Is a BSCII or other equipment approved in writing by the Regulator being used in another facility? (Provide facility certification/location & BSCII last test label)
4.1.A (iii) Is there an SOP for operation and decontamination of the BSCII or other equipment approved in writing by the Regulator?
4.1.A (iv) Is reading and writing material prohibited from being used inside a BSCII?
4.1.A (v) Are gloves worn for work undertaken in a BSCII?
4.1.A (v)(i) Is a documented SOP and risk assessment completed for these activities?
4.1.A (iv) If centrifugation or vortexing is undertaken, is it carried out in sealed containers? e.g. sealed containers may include tubes, buckets or rotors
4.1.A (vi)(i) Are centrifuge containers only opened in a BSC?

4.2 Pressure Steam Sterilizer

4.2.A Does the facility contain a pressure steam steriliser (autoclave) or have access to an autoclave?
4.2.A (i) If an autoclave is utilised and located elsewhere please provide details:
4.2.A (ii) Is there evidence that users are trained in the safe use and loading of the autoclave?
4.2.A (iii) Is protective clothing, including heat-insulating gloves, readily available? i.e. for use when loading and unloading sterilisers.
4.2.A (iv) If required, are sterilisation facilities fitted with local exhaust ventilation that include air capture vents or extraction systems for the removal of heat, steam and odours?
4.2.A (v) Are wire racks or perforated metal shelving as well as adequate space provided nearby the heat steriliser? i.e. in order to cool the sterilised material and to allow movement of large loads/trolleys.
4.2.A (vi) Is the coldest part of the load exposed to a minimum temperature of 121 C for at least 15 minutes?
4.2.A (vii) Are visual indicators, such as autoclave tape, used to differentiate between processed and unprocessed loads?
4.2.A (viii) Is the temperature of each cycle monitored? i.e. through use of a thermocouple and recorder; a maximum thermometer; chemical indicator or readings from the autoclave panel?
4.2.A (ix) Is the effectiveness of decontamination tested at least every month, by both chemical and biological indicators?
4.2.A (ix)(i) Is the date and result of the above-mentioned test documented and readily available?
4.2.A (x) Are detailed records of each sterilisation load maintained? n.b. these records should include temperature, duration, load contents including regulatory material, cycle type and if successful completion.
4.2.A (xi) Is the autoclave used to decontaminate regulated material?
4.2.A (ix)(i) Can it be demonstrated that relevant conditions/requirements of a licence, permit or other regulated documented are adhered to?

4.3 Centrifuge Equipment

4.3.A Does the facility contain centrifuges? N.B: generates force in excess of 2G, and as such presences a greater risk to health and safety.
4.3.A (i)If centrifuges are used and not located in the facility, please outline details of the location.
4.3.A (ii) Are centrifuges, including rotors, tubes and buckets, periodically inspected before use, and are damaged goods appropriately labelled and withdrawn from service? n.b. damage includes; cracking, corrosion, pitting, etc.
4.3.A (iii) Do users indicate that rotors and/or buckets are checked for evidence of leaks or breakage before being opened?
4.3.A (iv) Do users indicate that bowls, rotors and buckets are decontaminated with appropriate disinfectants on a regular basis and before servicing?
4.3.A (v) Are centrifuges used and maintained in accordance with the manufacturers instructions? i.e. local area maintenance including daily, weekly and/or monthly requirements. i.e. regular testing and servicing by an external accredited organisation, or similar requirement. i.e. loaded tubes and buckets balanced prior to centrifuging.
4.3.A (vi) Are log books for usage located near instrument and do they indicate maintenance dates/results?

4.4 Equipment, Machinery and Electrical Installations

4.4.A Is equipment free from obstruction?
4.4.B Is equipment and machinery suitably decontaminated before being removed from the facility?
4.4.C Are there any machinery safety issues? (Provide evidence)
4.4. D Are there any electrical safety issues? (Provide evidence) e.g. testing & tagging of power boards or extension leads.

5.0 Animal Work

5.1 Animal Practice Requirements

5.1.A Is animal work undertaken in the facility?
5.1.A (i) Are animal ethics approvals in place?
5.1.A (ii) Are animals held, handled, experimented upon and disposed of in accordance with the animal ethics approval/s?
5.1.A (iii) Is there a documented system of accounting for the number of animals in the facility?
5.1.A (iv) Are animals and associated activities prohibited in the anteroom other than for the purposes of transport?

5.2 GM Animal Practice Requirements

5.2.A Is GM animal work undertaken in the facility?
5.2.A (i) When not handled are GM animals kept in containers or cages designed to prevent escape?
5.2.A (ii) Are animal cages or containers labelled to enable identification of GM animals and the number being contained therein?
5.2.A (iii) Are the experimental procedures and handling of GM animals carried out in a way that minimises the chance of escape and exposure of people to GMOs?
5.2.A (iv) Are documented procedures in place to ensure accountability of GM animals when transported between facilities?
5.2.A (v) Are large animals clearly marked so that they can be readily identified (e.g. with a tattoo, permanent tag, microchip or permanent brand)?
5.2.A (vi) Are users able to demonstrate the process undertaken when a GM animal or animal containing GMOs escapes within the facility? n.b. Process must include capture followed by return to containment or euthanasia.
5.2.A (vii) Are users able to demonstrate the process undertaken when a GM animal or animal containing GMOs escapes outside the facility? n.b. Process must include efforts implemented as soon as practicable to locate and/or retrieve the GMOs and return the GMOs to containment or render them nonviable; and the incident must be reported to the UBC.
5.2.A (viii) Are GM animals and animals containing GM micro-organisms rendered non-viable prior to disposal and is disposal appropriate?

5.3 Quarantine Animal Practice Requirements

5.3.A Is animal work subject to quarantine approvals undertaken in the facility?
5.3.A (i) Are all quarantine activities involving animals conducted a quarantine approved premises (QAP)?
5.3.A (ii) Where post mortem examinations are undertaken, are separate areas for other activities provided, and adequate precautions taken to prevent cross-contamination?
5.3.A (iii) Are secure housing and/or caging provided?
5.3.A (iv) Is a write-up area(s) provided inside the quarantine approved premises?
5.3.A (iv)(i) Does the write-up area have minimal horizontal surfaces? e.g. minimal shelving
5.3.A (iv)(ii) Are generic office functions prohibited from being undertaken at the write-up area?
5.3.A (iv)(iii) Does the write-up area only hold essential reference material? e.g. technical equipment manuals.
5.3.A (v) Are the key(s) or other locking mechanisms for animal enclosures the responsibility of person who holds a current QAP Accredited Training?
5.3.A (v)(i) Is the name, designation/position title and contact details of this person(s) readily accessible?
5.3.A (vi) Is there a recorded system in place for daily monitoring of animals undergoing in vivo trials involving imported biologicals?
5.3.A (vii) Can animals subjected to quarantine easily identified? e.g. by tattoo, microchip, permanent branding or through cage labelling system.
5.3.A (viii) Where animal(s) are inoculated with QM are cages and racks labelled to indicate the details of the inoculation given? i.e. identity and date of innoculation.
5.3.A (ix) Where it is necessary to transport animals (alive or dead) from the QAP containment facility, is there a documented procedure in place? N.B: This documented procedure should detail the type of pen/cage required to be used for transport and the decontamination of these with a DAFF approved broad-spectrum disinfectant?
5.3.A (x) Is there a documented procedure in place for unexpected animal mortalities or incidence of disease? N.B: This documented procedure should include: report event to UBC immediately; the animal(s) should be labelled with day/date; and where possible preserve for appropriate post mortem and examination by DAFF Officer.

6.0 TSDs & Traceability

6.1 Transport

6.1.A Are regulated materials transported external to the facility? i.e. In this context regulated materials refers to OGTR licences, UBC approved projects, quarantine material and anything identified in Section 1.3
6.1.A (i). When in transport, is regulated material(s) packed in a primary container inside a unbreakable secondary container (e.g. double contained, and the outer most container is unbreakable)?
6.1.A (ii). When in transport, does the outer most container identify the type of material contained within; and the contact details of the sender?
6.1.A (iii). When in transport, are procedure in place to account for all regulated material(s) (e.g. Is the quantity or weight of the material logged or otherwise recorded when being removed from one facility and received in another facility)?
6.1.A (iv). When in transport, are regulated material(s) kept secured and transported by an appropriate trained person? i.e. the outer moustache container could be lockable, and kept in the possession of an appropriate trained person.
6.1.A (v). Is there a procedure in place to appropriately decontaminate the the external surface of the primary and any secondary container? N.B: The external surface of the primary and any secondary container shall be appropriately decontaminated prior to being transported, and again when received at its destination.
6.1.B Are documented SOPs in place that comply with IATA standards?
6.1.C Where material(s) subject to quarantine are being transported between the boarder and QAP, has a detailed transport plan been developed? N.B: The transport plan will need to ensure the following requirements are: (i) the most direct route between the two sites; and (ii) the route taken is on sealed roads only.

6.2 Storage

6.2.A Is regulated material(s) stored "inside" the facility?
6.2.A (i) Does the facility contain an easily retrievable inventory of all regulated material approved to be stored within the facility?
6.2.A(ii) Where a inventory of all stored regulatory material(s) exists, does it contain the required information? i.e.: The inventory shall include: date; UBC project number, licence number, import permit number and/or quarantine entry number (if applicable); description of material(s) (including the batch number for goods subject to quarantine); quantity/amount used; quantity/amount remaining; research activity undertaken on material; disposal date; waste disposal method; and name of researcher/operator.
6.2.A (iii) Can facility researchers demonstrate that storage records are true and accurate? N.B: Researchers' should demonstrate the accuracy of their storage records by locating regulated material within a storage device.
6.2.A (iv) Is stored regulated material(s) clearly labelled?
6.2.B Is regulated material(s) stored "outside" the facility?
6.2.B (i). Is there a documented transport SOP available?
6.2.B (ii). Is there a schematic diagram of the most direct route between the facility and outside storage location/facility?
6.2.C Is the storage device labelled as containing regulated materials? e.g. Is there a label on the outside of the storage device that state: "Contains GMOs" or "Quarantine".

6.3 Waste Disposal

6.4.A Are waste management procedures (or SOPs) in place?
6.4.B Are rubbish bins provided within the facility emptied regularly and not overfilled?
6.4.C Is waste being appropriately segregated and correct waste vessels used?
6.4.D Is the outside of the waste vessel(s) appropriately labelled?
6.4. E Is waste generated within the facility from activities involving regulated material? i.e. In this context regulated materials refers to OGTR licences, UBC approved projects, quarantine material and anything identified in Section 1.3
6.4.E (i) Are users aware of the steps required for clinical and related waste (CRW) bin collection?
6.4.E (ii) Are users familiar with safe handling processes when dealing with clinical and related waste?
6.4.E (iii) Is there a documented SOP(s) in place for waste disposal of regulated material(s)?
6.4.E (iv) Is there a record/log for waste disposal of regulated material(s) (if not included in the sample use register)?
6.4.E (iv)(i) Does the waste disposal record/log contain the required information? N.B: The waste disposal record/log shall include: date of disposal; description of material (including batch number if relevant); quantity/amount being disposed; method of disposal; responsible person; and relevant UBC project, permit opened/or licence details (for quarantine waste, the quarantine entry number, and import permit number must be indicated).
6.4.E (v) Is regulated material(s) waste rendered non-viable prior to disposal?
6.4.E (vi) Is regulated material(s) waste transported out of the facility prior to being rendered non-viable? e.g. Regulated material waste may be transported from one facility to another facility to be autoclaved before being disposed of in a waste vessel.
6.4.E (vi)(i) Where viable regulated material(s) waste is being transported out of the facility, is there a documented SOP in place? N.B: This SOP should clearly outline specific procedures on the movement of waste; how the waste should be safely transported; identify the most direct route; and any administration (e.g. record/log movement of waste).
6.4.E (vi)(ii) Where viable regulated material(s) waste is being transported out of the facility, are records/logs maintained and readily available?
6.4.E (vi) (iii) Where viable regulated material(s) waste is being transported out of the facility, is it bagged and placed in an unbreakable container with a secured lid?
6.4.E (vii) Is regulated material(s) waste disposed of immediately (i.e. disposed of same day it is generated)?
6.4.E (vii)(i) Where waste cannot be disposed of immediately, is a separate storage device/area for the temporary holding of goods provided? N.B: The separate device/area must be approved (by UBC or DAFF) and be within an approved facility to prevent loss, spillage or unauthorised access.
6.4.E (vii)(ii) Where waste cannot be disposed of immediately, is it stored in lidded bins/containers of an appropriate size which are lack and pest proof?
6.4.E (viii) Where relevant, is regulated material(s) waste doubled-bagged prior to disposal into the appropriate bins? N.B: All quarantine waste shall be double bagged.
6.4.E (ix) If water waste is sewerable, are documents indicating this in the SOP?

6.4 Decontamination

6.4.A Is there a documented SOP in place for all decontamination practices?
6.4.B Are decontamination procedures only carried out by trained personnel?
6.4.C Is all waste including equipment, protective clothing and liquid and solid wastes, decontaminated by an appropriate/approved method(s)? N.B: In this context, appropriate/approved methods include: pressure steam sterilisation (autoclaving); chemical treatment; or any other method approved in writing by the relevant governing body.
6.4.D Are equipment, pens, cages or bedding contaminated with or suspected to be contaminated with regulated material(s) decontaminated before being removed from the facility?
6.4.E Is there a supply of disinfectants for decontamination purposes available in the facility?
6.4.E (i) Are disinfectants clearly labelled with contents and expiry or preparation date/s (if necessary)?
6.4. (ii) Are the disinfectants mentioned above in accordance with Appendix E of AS/NZS2243.3?
6.4.F Are all work benches, surfaces & equipment where procedures have taken place decontaminated immediately after any spills and when work is completed?
6.4.G Is personal protective equipment/clothing regularly (i.e. monthly) washed using normal laundry methods?

7.0 Chemicals

7.1 Chemicals & Hazardous Substances

7.1.A Does this facility contain chemicals, hazardous substances, gases, drugs, poisons, corrosives, solvents, carcinogens or other restricted substances?
7.1.A (i) Is there an up to date inventory of all chemicals / hazardous substances stored in the laboratory?
7.1.A (ii) Are in date Safety Data Sheets (SDS) available for all hazardous chemicals and solvents stored or used in the facility?
7.1.A (iii) Are all chemicals & containers clearly labelled & in good working order?
7.1.A (iv) Is PPE available within the facility for safe handling of chemicals?
7.1.A (v) Are chemicals stored in manner that prevents or contains unintentional leakage?
7.1.A (vi) Are chemical spill kits available with documented SOP and located nearby in a clearly identified location?
7.1.A (vii) Do users indicate that chemical working stock quantities kept to a minimum?
7.1.A (viii) Is there any evidence of drugs, poisons or other restricted substances in stock?
7.1.A (viii)(i) Are drugs, poisons, carcinogens, etc stored separately and where necessary in locked cabinets?
7.1.A (ix) Have any chemical issues or concerns been identified? e.g. Gas cylinder secured safely and within cylinder test date? Fume cupboards clear of chemicals and equipment when not in use, last test date within 6 months? Flammable/corrosive safely segregated and stored?

8.0 Work Practices

8.1 Work Practices

8.1.A Are all facility doors closed at all times?
8.1.B Are non-essential effects prohibited from being taken into the facility? e.g. hand bags, personal mobiles.
8.1.C Where possible does the facility provide and use dedicated reading/writing areas?
8.1.C (i) 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?
8.1.C (ii) Are these kept clean and tidy and with minimal reference material only?
8.1.D Are only trained personnel permitted to clean contaminated equipment or surfaces, or handle hazardous material?
8.1.E Are manual handling tasks &/or awkward/fixed postures adopted frequently or over long periods?
8.1.F If applicable, how is the physical isolation of regulated material attained in the facility?
8.1.F (i) Is isolation through timing of regulated material work used in the facility?
8.1.G Are procedures in place to report any unintentional release of GMOs from the facility to the Regulator as soon as practicable?

8.2 Personal Protective Clothing & Equipment

8.2.A Do all persons entering the facility wear PPE/C, including:
8.2.A (i) Protective clothing, lab coat or gown, whilst performing procedures in the facility? n.b. long sleeved back-opening gowns or coveralls should be used as these give better protection than laboratory coats.
8.2.A (ii) Closed footwear?
8.2.A (iii) Gloves whilst undertaking activities? n.b. where allergic reactions such as dermatitis or hypersensitivity are reported alternatives such as nitrile or vinyl should be made available.
8.2.A (iv) Protective eyewear (dependent on a documented risk assessment)? n.b. protective eyewear shall be worn unless a documented risk assessment can justify a lessor requirement.
8.2.A (v) Are aprons worn over gowns or laboratory coats where there is a risk for spillage of chemicals or biological materials?
8.2.A (vi) Is respiratory equipment used when carrying out hazardous procedures with material that is transmissible by respiratory route? i.e. spill clean up, handling of animals infected with zoonotic agents, etc.
8.2.B Is protective clothing always removed after completing laboratory procedures and before leaving the facility?
8.2.B (i) Is soiled clothing and PPE decontaminated before laundering?
8.2.B (ii) Is dirty protective clothing laundered before reuse?
8.2.C Is there designated storage or hanging provisions for protective clothing within the facility nearby the access door?
8.2.C (i) Is the designated storage or hanging provisions used by facility users? i.e. lab coats must be hung in such a way to prevent cross-contamination.
8.3.D Is this an invertebrate facility?
8.2.D (i) Do personnel indicate that they check their clothing, hair and exposed skin for any invertebrates prior to exiting the facility?

9.0 Emergency Procedures & Equipment

9.1 Emergency Procedures

9.1.A Is signage of emergency plans with "You are here" indicators, direction to safe exits from the floor/building and written instructions prominently displayed?
9.1.B Are users aware of the building and floor wardens for this facility? (Provide names)
9.1.C Are all exits and corridors clear and easily accessible?
9.1.D Are exit doors unlocked and prohibited from being locked by any means?
9.1.E Are exit signs illuminated and clearly visible?
9.1.F Is there a qualified First Aid Officer/s on site?
9.1.G Is there an accident / incident reporting system in place and utilised by facility users?

9.2 Emergency Equipment - General

9.2.A Is firefighting equipment (extingugishers or blankets) provided within the facility?
9.2.A (i) Is equipment used and maintained in accordance with the manufacturer's instructions every 6 months (check tags attached)?
9.2.B Is there access to a nearby first aid kit?
9.2.B (i) Is the kit stocked?
9.2.B (ii) Are the kit contents within expiry?
9.2.C Are eye wash provisions provided within the facility? (indicate if plumbed or single-use packs are in use)
9.2.C (i) Are eye wash facilities used & maintained in accordance with the manufacturer's instructions (i.e. flushed and tested at least monthly)?
9.2.D Is all safety equipment signed (e.g. showers, eye wash stations, fire extinguishers/equipment)?

9.3 Emergency Procedures - Biosafety

9.3.A Has a documented risk assessment been completed for the escape of any regulated biological material in an emergency event (e.g. natural disaster, deliberate action, accident or fire)? i.e. In this context regulated refers to OGTR licences, UBC approved projects, quarantine material and anything identified in Section 1.3 n.b. deliberate action include; theft, sabotage, protest, human and/or mechanical intervention.
9.3.A (i) If a greater than negligible risk of escape was determined has a Risk Management Plan been established?
9.3.B Has a documented Contingency Plan been developed for any unintentional release of regulated biological material through accident, deliberate action, natural disaster or fire? n.b. deliberate action include; theft, sabotage, protest, human and/or mechanical intervention.
9.3.C Is a documented SOP(s) in place to manage biological spills both inside or outside a containment facility?
9.2.C (i) Are the decontamination agents referenced in the SOP appropriate for the biological material present (i.e. as per the import permit, licence, legislation and/or AS2243.3)? n.b. QM material decontamination agents must meet the import permit and be approved by the relevant authority (e.g.DAFF Bio) for use. n.b. DNIR licences material decontamination agents must meet the disposal, decontamination and destruction requirements in the licence.

9.4 Emergency Equipment - Biosafety

9.4.A Does the facility contain a biological spill kit?
9.4.B Are spill kits in visible locations with clear signage and are they readily accessible?
9.4.C Are the contents of the spill kit, including decontamination agents, reflective of the relevant SOP?
9.4.C (i) Are the decontamination agents within their expiry date?
9.4.D Are facility users able to locate and demonstrate correct usage of the contents within the biological spill kit/s?

10.0 Compliance

Compliance

10.1.A Did the findings from this inspection determine that the facility infrastructure, fittings and work practices comply with the relevant requirements set out in AS/NZS:2243.3:2010, Safety in laboratories Part 3: Microbiological safety and containment?
10.1.A (i) If no, please indicate what areas need addressing/attention to achieve compliance with AS/NZS:2243.3:2010, Safety in laboratories Part 3: MIcrobiological safety and containment?
10.1.B If applicable, did the findings from this inspection determine that the facility infrastructure, fittings and work practices complies with the relevant OGTR guidelines?
10.1.B (i) If no, please indicate what areas need addressing/attention to achieve compliance with the relevant OGTR guidelines.
10.1.C Where a facility is certified with the OGTR, did the findings from this inspection determine that all conditions outlined in the certification instrument are complied with at all times?
10.1.C (i) If not, please indicate what conditions of the OGTR certification instrument need to be addressed/improved to achieve compliance?
10.1.D Where a facility is a QAP, did the findings from this inspection determine that all conditions of approval are upheld at all time?
10.1.D (i) If no, please indicate what QAP conditions need addressing/improving to adhere to the QAP approval?
10.1E Where activities/projects involve regulated material(s), did the findings of this inspection determine that all conditions outlined in the projects approvals, permits and/or licences are followed at all times?
10.1.E (i) If no, please indicate what condition(s) of the certain projects approvals, permits and/or licences need to be addressed/improve to achieve compliance?

11.0 Sign Off

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"UBC Laboratory Inspection Checklist"

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Introduction

Instructions

1.0 Facility Information

1.2 Research Material

1.3 High Risk Biological Work (other than GM)

2.1 Research Information

2.1 Training & Induction

3.1 Facility Infrastructure

3.2 Facility Fittings

3.3 PC2 Animal or Invertebrate Facilities

3.4 Environmental and Ventilation Requirements

3.5 Backflow Prevention

3.6 Pest Control

3.7 Management of Facility Cleanliness

4.1 Aerosol Containment Equipment

4.2 Pressure Steam Sterilizer

4.3 Centrifuge Equipment

4.4 Equipment, Machinery and Electrical Installations

5.1 Animal Practice Requirements

5.2 GM Animal Practice Requirements

5.3 Quarantine Animal Practice Requirements

6.1 Transport

6.2 Storage

6.3 Waste Disposal

6.4 Decontamination

7.1 Chemicals & Hazardous Substances

8.1 Work Practices

8.2 Personal Protective Clothing & Equipment

9.1 Emergency Procedures

9.2 Emergency Equipment - General

9.3 Emergency Procedures - Biosafety

9.4 Emergency Equipment - Biosafety

Compliance

11.0 Sign Off

Related checklists

"UBC Laboratory Inspection Checklist"

Free "UBC Laboratory Inspection Checklist" Checklist

Go digital today!

Convert your paper checklists into digital forms

Introduction

Instructions

1.0 Facility Information

1.2 Research Material

1.3 High Risk Biological Work (other than GM)

2.1 Research Information

2.1 Training & Induction

3.1 Facility Infrastructure

3.2 Facility Fittings

3.3 PC2 Animal or Invertebrate Facilities

3.4 Environmental and Ventilation Requirements

3.5 Backflow Prevention

3.6 Pest Control

3.7 Management of Facility Cleanliness

4.1 Aerosol Containment Equipment

4.2 Pressure Steam Sterilizer

4.3 Centrifuge Equipment

4.4 Equipment, Machinery and Electrical Installations

5.1 Animal Practice Requirements

5.2 GM Animal Practice Requirements

5.3 Quarantine Animal Practice Requirements

6.1 Transport

6.2 Storage

6.3 Waste Disposal

6.4 Decontamination

7.1 Chemicals & Hazardous Substances

8.1 Work Practices

8.2 Personal Protective Clothing & Equipment

9.1 Emergency Procedures

9.2 Emergency Equipment - General

9.3 Emergency Procedures - Biosafety

9.4 Emergency Equipment - Biosafety

Compliance

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