baw auditing template - agriculture...

BAW Auditing Template

Coversheet Auditor name:

Audit schedule:Date Contact Location Audit part Ph/email

Audit details:Licence name & no.

Licence nominee:

Nominated AEC name(s):

Other licences using same AEC:AEC Chair:

Executive Officer:

Date of last audit:

Date this audit commenced:

RELEVANT PRE-AUDIT INFORMATION RECEIVED:

All licence details, including special conditions (ie. copy of licence)

Previous audit/inspection reports (including interstate report requests)

Last year’s annual return statistics: any ‘DAEP’ procedures any ‘particular procedures’ significant number of surplus specified animals from breeding

Any other relevant background information from BAW:

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Part 1: Institution / AEC audit Date: / / Name of AEC and person assisting with this section of the audit:

SummaryCommendations

Non-compliances

If exit interview conducted with licence delegate, record main points:

C CWR NC Recommendations/Commendations

LICENCE HOLDERResponse to previous audit findings?

Compliant with any special conditions on licence?

Induction / refresher training in legal obligations for animal users? Compulsory?

Information provided to researchers on what does / doesn’t need AEC approval accurate?

Intranet information available to researchers?Training in animal handling and basic procedures?

Seek comment from AEC on animal facilities?

Adequate resources for AEC – budget for operations / catering / training?

Reimbursement of expenses / sitting fees paid?

Complaints handling processes for complaints about – AEC / animal users / animal use in institution?Is there an AWO or other compliance monitoring position?

Any compliance issues referred to institution by AEC since last audit? How were they dealt with?

AECPeriod & number of AEC meeting minutes

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Part 1: Institution / AEC audit Date: / / C CWR NC Recommendations/Commendations

inspectedResponse to previous audit findings?Info for new members: Confidentiality FOI legislation Legal requirements Privacy policy Commercial-in-confidence Orientation for new members?

Ongoing training for all members?

TOR (compliant with 2.2.1 & 2.2.10 and accepted by members)

Non-compliance procedure 2.2.48 signed-off by institution 2.1.1(v)

delegation to inspect remote sites

resolution of conflict of interest definition of Executive 2.2.11 adverse incident procedure grievance procedure 2.2.14 signed-off by institution 2.1.1(xii)

Records of all projects/programs applications assessed? Number considered (per year of audit) Number rejected(not for resubmission)

‘Library’ of research procedure SOPs (reviewed regularly – at least every 3 years?)

Who does the AEC report to?

Does the AEC provide an annual report to the Institution?

Is there an annual meeting between AEC chair and governing body of institution?

Communication:

a. With executive of institution and licence nominee(s)

b. With investigators/ teachers

c. With animal care staff

d. With the Bureau, as required

Skills / competency register?

Other (please specify)

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Part 1: Institution / AEC audit Date: / / C CWR NC Recommendations/Commendations

REVIEW OF MINUTES Number of inquorate meetings

Inquorate meetings conducted as Executive, ratified at next meeting? (Comments received after the meeting from missing member/s do not make a meeting quorate)

4 meetings per year?

Circulation of agendas & papers in time/ BAW reports, info/ other material

Chair effective (refer 2.2.9 Code)

Voting according to 2.2.22?

Confidentiality and Conflict of Interest declared

Membership participation (especially C and D members)

Encouragement of the 3Rs (give brief egs.)

Annual reports received? 2.2.37

Final project reports received? 2.2.39

Approved modifications filed with originals?

Attendance of investigators at meetings?

Request for further information, expert advice, other?

Fieldwork notifications completed and forwarded to BAW

Any DAEP projects- forwarded to BAW after AEC?

Site inspectionsa. Annual inspection of animal facilities?b. Independent AEC member participationc. Records of inspections (dates, locations etc) 2.2.29d. Follow-up mechanisms

Other comments

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Part 2: Project audit Date: / /C CWR NC Recommendations/Commendations

PROJECT APPLICATIONApplication form accords with Code?

Note date of first submission and date of final approval (no. of resubmissions)

Clear and precise decision relayed to applicant?

Expected Commencement and completion dates provided?

Information re maximum time individual animals involved in Project?

Personnela. All personnel nominated?b. Experience/Training needs/Supervision stated?c. Link between Animal House and Researchers recorded?

Source and location of animalsa. Source identified and compliant-reg 92(15)?b. Location identified?c. Permits/special arrangements notified?

Potential benefit of projecta. Clarity of lay summaryb. Outline of benefits clear

Overview of projecta. Is AEC informed on link between the animal use and expected benefits?b. Is the project well designed in relation to its aims?

Reductiona. Provision of details on number, species and strain of animal(s)?b. Justification re number and (teaching) use ratio?c. Check statistical support - institutional resources?

d. Repeat of earlier work? If so, justified?e. Identification for tissue sharing?

Replacementa. List of any potential alternatives?b. Type of search, key words, websites, years c. Other resourcesd. Explanation of why not use alternatives

RefinementJustification of species?Is it possible to determine a timeline of procedures for each animal / cohort?

Does the project clearly outline step-by-step the potential impact on the animals and mitigations including:

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a. Transportation (if applicable)?b. Acclimatisation, housing & handling?c. Monitoring of animals pre-experiment?d. Experimental treatments and surgical procedures defined?e. Anaesthesia:

Method conforms to accepted vet standards (recovery surgery)?

Personnel Intra-op and immediate post-op monitoring

described? Dose rates and routes defined?

f. Analgesia for painful procedures? Justification if not? Method Personnel Monitoring Dose rates and routes defined?

g. Administration of other substances defined?h. Are expected adverse events/ side effects defined (including cumulative experimental burden)?i. Post-procedural monitoring

Does monitoring method match expected impacts on animals?

Personnel listed / roles defined? Emergency procedures and contacts Special Care Needs Identified?

j. Endpoints Scientific endpoints clearly defined? Are monitoring methods sensitive enough

to detect endpoints? Management of expected impacts -

personnel, actions, humane endpoints Management of unexpected impacts -

personnel, actions, humane endpointsk. Fate and Humane Killing?

Method (acceptable to COP?) Personnel Intention to share tissues / whole

animalsl. Special considerations identified and justified?

unrelieved pain and distress special housing issues / isolation variation to standards death as the end-point prolonged confinement monoclonal antibody production non human primate use repeat use of animals other?

m. Justification Clarity of scientific or educational value

of project weighed against welfare impact on animals

Special considerations (above)n. Standard operating procedures

Standard operating procedures contemporary (<3 yrs old)?

Standard operating procedures approved by AEC

Standard operating procedures specific to this application

o. Special Risks Identification of specific risks to

animals/humansp. Declaration (s)

That adequate resources available to undertake project

That investigator/teacher will comply

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with legislation, code involving all personnel

Other- specify

PROJECT ANIMAL USEAllocation of animals and personnel responsibilitiesa. Source of animals compliant?b. Initial receipt of animals including transportationc. Allocation/Receipt Records available? Count-down from total approved number?d. Animal I/D system satisfactory?e. Housing (Animal House Inspection Pro-forma) f. Special facilitiesg. Check (Code Section 2.2.26) transfer of responsibility from animal facility to researcher.h. Check out of hours procedures and responsibilities.

Pre-intervention animal monitoring records (if animals held by researchers)a. Monitoring of animal behaviour?b. Monitoring of signs of pain / distress?c. Record system satisfactory?d. Action(s) recorded?

Procedure records should include:a. Date and Personnel involved (check dates match those approved)b. Animals used (total number, id and species)c. Administration of drugs and treatmentsd. Anaesthestic monitoring - 'all OK' at least; must include parameters indicated on applicatione. Surgeryf. Post-operative monitoring at agreed intervalsg. Any adverse events or effectsh. Training of inexperienced personnel

End-pointsa. Check records of post-procedural monitoring of level of pain and distress in relation to AEC agreed end-point of experiment.b. Check other endpoints tally with those approved (eg, CS, tumour size)c. Numbers actually died as a result of ‘death as an end-point’

Adverse effectsa. Did expected adverse effects occur?b. Did unexpected adverse effects occur?c. Were they adequately managed?d. Did they require investigation? e. Advice to AEC?f. Notification to BAW?

Records of humane killing and euthanasia of animalsa. Animal ID, dateb. Methods usedc. Personnel

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Other fate of animalsa. Records of animals delivered to another scientific institution?b. Other- please describe

Standard operating proceduresa. Were standard operating procedures available and apparently used?b. Recipes for stock solution anaesthetics available?

Were the anticipated benefits achieved and demonstrated? For example:a. Journal articleb. Reportsc. Other? Please describe

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Part 3: Audit of animal holding areas Date: / /ANIMAL HOUSE FACILITIES

C CWR NC Recommendations/CommendationsANIMAL FACILITY GENERALAre facilities centrally managed?Emergency plans & alarm systems

Alarm systems present for:- Plant (chillers, boilers etc)- Room temperature - Power interruption- Fire / smoke

Alarms tested regularly, notifying correct people?

Essential services backup tested regularly (generator switchover; chiller switchover)

Fuel present for generator, UPS (uninterrupted power supply) for alarm systems?

Emergency plan in place?

Handling and basic procedures Training provided to animal house

personnel and investigators? Training register? Contemporary practices? Note any retro-

orbital bleeding without GA, using animals for m Abs production, etc.

Health monitoring Appropriate monitoring program. Use of

sentinels should be covered by AEC approval

AEC-approved procedures for prevention, diagnosis and treatment of disease and for quarantine.

Appropriate biosecurity/ biohazard containment (radiation, GM, infectious disease etc)

TransportationCheck AEC-approved SOP for domestic/internal and external transportation plus check transport containers/vehicles where possible.

EuthanasiaAre the general principles of the Australian Code adopted in the euthanasia method/ policy?

Humane method Competent persons Quiet, clean, isolated environment and

death confirmed Appropriate euthanasia or care for

dependent neonates Appropriate method for developmental

stage and confirmation of death prior to disposal

Note any unacceptable methods

RecordsSystem of recording of animal breeding implemented? Nb. SOPs- are they regularly reviewed by the AEC?Check that breeding of new GM lines are approved by AEC

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Part 3: Audit of animal holding areas Date: / /C CWR NC Recommendations/Commendations

Check that AEC approves transfer from new GM to stock line

4yr retention of animal recordsRecords and SOPs readily accessible for auditStock monthly inventory for licence conditions (reg 92 (21))

ANIMAL ROOMSC CWR NC Recommendations/Commendations

Maintenance and hygieneAnimal rooms/yards/stables clean, tidy, vermin-proof, in good repair to facilitate effective cleaning (see also Reg 93)Animal bedding appropriately changed so animals kept dry, comfortable, clean unless contraindicated

Nutritiona. Suitable diet (species, age, stage, intervention level)b. Food storage (cool, vermin-proof)c. Communication re supplementationd. Condition score suitable

Watera. Potable and available at all timesb. Flooding prevented

Animal enclosuresa. Materials and Design

Durable, comfortable, good repair, escape-proof

Safe, comfortable, withstand cleaning agents

Easy monitoring enabled Nesting box for breeding animals If wire floor, solid mat also

b. Space requirements Adequate space and stocking density for

exercise, social stability or single animals, breed, age, growth stage

See appendix 1 Lab animal code- note exemption for short-term housing of post-weaned/pre-issue animals – note any welfare concerns.

c. Social requirements Social housing for social species,

justification if not? Mitigation of isolation or deprivation

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d. Furniture Bedding material provided and

appropriate Nesting material for breeding animals Materials –safe, absorbent, low

allergenic,non-toxic, non-injurious, free from contaminants and vermin

e. Labelling Special care needs Experimental vs stock animals Responsible researcher / AEC # Emergency contacts (per room or project)

f. Animals able to perform species-specific activities including sufficient exercise?

Temperature Room temp recording- daily, Max & Min Room temperature alarms regularly

tested? Special conditions clearly displayed

Relative Humidity within acceptable range 40-70%

Ventilation and air quality Draught free, fresh or conditioned air in

rooms (approx. 10-20 ACH) or IVCs HVAC systems regularly serviced,

alarmed and tested?

Light Opportunity to withdraw to lower light

intensities- tunnels, darkened areas/nesting box etc

Periods of daily light and dark provided- photoperiods?

Access to daylight for non-human primates? (not mandatory unless NHMRC)

EXPERIMENTAL ROOMS TEMPORARILY HOUSING ANIMALS

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Maintenance and hygieneRoom/facilities clean, tidy, vermin-proof, in good repair to facilitate effective cleaning (see also Reg 93)Floor clear of:

trip hazards Places for escaped animals to hide

Appropriate hygiene practices and sterile techniques/facilities availableSOPs or equivalent for room maintenance availableRoom secure to avoid escapesRoom/facilities booking history available

Temperature Room temp recording- daily, Max & Min Room temperature alarms regularly

tested? Special conditions clearly displayed

Relative Humidity within acceptable range 40-70%

Ventilation and air quality Draught free, fresh or conditioned air in

rooms (approx. 10-20 ACH) or IVCs HVAC systems regularly serviced,

alarmed and tested?

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baw auditing template - agriculture...

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