DPI, BUREAU OF ANIMAL WELFARE SCIENTIFIC …agriculture.vic.gov.au/__data/assets/word_doc/0019/228601/SPFL... · Web viewAUDIT TEMPLATE for SPFL–(ie. no premises ordinarily used

AUDIT TEMPLATE for SPFL–(ie. no premises ordinarily used for Scientific Procedures). Animal use, care, housing and equipment used for Scientific Procedures remain the responsibility of the licensee.

AUDITOR DETAILS:

AUDITOR NAME:

ARRANGEMENTS FOR AUDIT: meeting, visits:Date Contact Location Audit

partPh/email

AUDIT DETAILS

LICENCE NAME:

LICENCE NOMINEE:

NOMINATED AEC(S) NAME:

AEC CHAIR:

EXECUTIVE OFFICER:

DATE OF LAST AUDIT:

DATE THIS AUDIT COMMENCED:

RELEVANT PRE-AUDIT INFORMATION ACQUIRED:

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’

Any other relevant background information from BAW:

Version 3. Last updated 12.01.09

Notes:


Part 1- AUDIT OF THE ANIMAL ETHICS COMMITTEE

This component of an institutional audit is intended to evaluate whether the AEC is operating effectively and in accordance with the Australian Code of Practice. Legislative Reference: Regulation 95(2),(3),(4),(5),(9),(15)& (16), Australian Code section 2

1. Name of AEC (and person assisting with this section of the audit):

2. Licences with which AEC affiliated (and any relevant ‘additional conditions’). Note external applicants (*):

3. Date of AEC audit:

4. Attendance at an AEC meeting- Y/N, Location and Date:

5. Period and number of AEC meeting minutes inspected:

6. Total number of projects considered:

7. Any previous issues from the last audit. Were they adequately addressed? If interstate AEC- request other regulatory agency reviews.

Summary Outcomes :

Commendations:#Reg’n or Item COMMENTS SPECIFIC FOLLOW-UP advice / recommendations

OVERALL: Compliant (C) or Non-compliant (NC)


ITEM DESCRIPTION Evidence (y/n) and type C NC Comments/ Recommendations1. Membership (numbers on committee in each category):

A: B: C: D: +/- E:2. Minutes from meetings held (*inquorate):

3. Meeting procedures:

a. Quorum (each and every meeting. * if not)

b. Contingencies for inquorate meetings

c. Frequency of meetings

d. Circulation of agendas/ BAW reports, info/ newsletters..

e. Voting and Consensus

f. Membership participation (especially C and D members)

g. Encouragement of the 3Rs (give brief egs.)

4. Operating procedures and Policies:

a. TOR (compliant with Code and accepted by members)

b. Chair effective (refer 2.2.9 Code)

c. Executive composition and powers defined

d. Confidentiality and Conflict of Interest declared

e. System for record keeping and tracking decisions

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

g. Any special conditions on licence?ITEM DESCRIPTION Evidence (y/n) and type C NC Comments/ Recommendations5. Register of applications and approvals:

Version 3. Last updated 12.01.09 4

a. Records of all projects/programs of teaching activities assessed

b. Annual review of long term projects/programs and animal use.

c. Final project reports

d. Approved modifications6. Site inspections and monitoring of animal facilities and animal

use during Projects:a. Type and frequency

b. AEC member participation

c. Records of inspections (dates, locations etc)

d. Follow-up mechanisms

Take particular note- re special conditions and monitoring of interstate research locations. Note method of monitoring- proxy, digital photos/video, reports etc

7. Application assessment process:a. Application form (accords with the Code, user friendly)

b. Consideration of issues- debate and consensus (C and D member input adequate?)

c. Conflict of interest relevant / declared

d. Attendance of investigators

e. Request for further information, expert advice, other?

f. Decision relayed to applicant, authorities, record kept.

g. Fieldwork notifications completed and forwarded to BAW

h. Any DAEP projects- forwarded to BAW after AEC?ITEM DESCRIPTION Evidence (y/n) and type C NC Comments/ Recommendations8. Does the AEC provide an annual report to the Institution?

9. Member support/ training: type and frequency


10. Communication:

a. With executive of institution and licence holder

b. With investigators/ teachers

c. With animal care staff

d. With the Bureau, as required11. Grievance / Complaint procedures:

a. Are they documented

b. Are they effective in responding to and investigating complaints and reporting non-compliance

12. Housing and Care of Animals policy:

a. Involvement and planning / policy

b. Recommendations for improvement / corrective action

c. Refinement and environmental enrichment

13. a. Adverse events: policy of management, register of events?

b. Skills / competency register?

c. Other (please specify)

Please note (*) if any projects involve ‘death as an end point’ were considered. Were they sent to BAW for approval according to Regulation 12 (2)?


PART 2a,b,c- AUDIT OF PROJECT INFORMATION PROVIDED TO AEC

This part covers the items to be reviewed during audit of project applications assessed by the AEC in accordance with Regulations 95(2),(8),(14),(15) & (16). As such, the Part 2 template includes all items in Section 2.2.15 and 2.2.16 of The Australian Code. The aim of this component of a licence audit is to establish whether a satisfactory process is in place at the institution to enable members of the AEC to make an informed decision about a project application. If a project has a number of component parts, each of these parts must be considered according to the criteria listed below.

This process is repeated during the audit for at least 3 project applications submitted to the AEC- hence parts 2a,b,c

1. Project Title:

2. Identified parts of project (if applicable):

3. Name of Licence(s) under which project conducted –note * if collaborative or ** external project:

4. AEC Reference Number:

5. Chief/Principal(s) Investigator(s) –note * if collaborative project:

6. Location of Animal Use Activity:

NB. Regulation 95(16) pertains to projects involving ‘death as an end point’ as defined by the Australian COP.

Summary Outcomes :

Are the records and documents compliant with the above-mentioned regulations and Australian Code?OVERALL: Compliant or Non-compliant

Commendations:#Reg’n or Item Comments Specific follow-up advice / recommendations


ITEM-Aust code reference § 2.2.16

DESCRIPTION EVIDENCE (y/n) and type

C NC Comments/ Recommendations

(ii) ExpectedCommencement andCompletion dates

a. Dates provided?

b. Information re maximum time individual animals involved in Project ?

(iii) Personnel a. All personnel nominated?b. Experience/Training needs/

Supervision statedc. Access to training register?d. Link between Animal House and Researchers recorded?

(iv) Source and location of Animals

a. Source identified and compliant-reg 14I?b. Location identified?c. Permits/special arrangements notified?

(v) Potential benefit of Project

a. Clarity of lay summaryb. Outline of benefits clear

(vi) Overview of Project a. Is AEC informed on link between the animal use and expected benefits?

b. Is the project well designed in relation to its aims?

(vii) Reductiona. Provision of details on number, species and strain of

Animal(s)?b. Justification re species?c. Justification re number and use ratio (teaching) d. Check statistical support and any repeat use- institutional

resources?e. Identification for tissue sharing?

(viii) Replacement a. List of any potential alternatives?b. Type of search, key words, websites, yearsc. Other resourcesd. Explanation of why not use alternatives


ITEM-Aust code reference § 2.2.16



(ix) Refinement Does the project clearly outline step-by-step the potential impact on the animals including:a. Transportation (if applicable)?b. Acclimatisation and housing?c. Experimental procedures and handling? d. Surgical or painful procedures defined?e. Analgesia?

Method Personnel Monitoring Dose rates and routes defined?

f. Administration of other substances defined?g. Anaesthesia?

Method Personnel Monitoring Dose rates and routes defined?

h. Time Sequence of Procedures?i. Special considerations identified (see xi)? j. Special Care Needs Identified?k. Are expected adverse events/ side effects defined?l. Is any proposed toxicity testing with death as an end

point legal?m. Fate and Humane Killing?

Method (acceptable to COP11) Personnel Intention to share tissues / whole animals

Does the project consider how all of the above impacts on the animal can be minimised by:n. Refinement of procedures?o. Humane end-point for Involvement of Animalp. Management of expected impacts

Action Personnel

q. Management of unexpected impacts Action Personnel

1 Code of Practice for the Housing and Care of Laboratory Mice, Rats, Guinea Pigs and RabbitsVersion 3. Last updated 12.01.09 9

ITEM- Aust. code reference § 2.2.16



(x) Monitoring of Animals a. Provision information/method/frequency of routine monitoring

b. Does monitoring method match expected impacts on animals

c. Post-procedural monitoring Personnel listed / roles defined? Emergency procedures and contacts Clear criteria for intervention

Nb- consider carefully if interstate AEC

(xi) Justification a. Clarity of scientific or educational value of project weighed against welfare impact on animals

b. Special considerations unrelieved pain and distress special housing issues variation to standards death as the end-point2

prolonged confinement monoclonal antibody production non human primate use repeat use of animals other?

(xii) Standard operating procedures

a. Standard operating procedures contemporaryb. Standard operating procedures approved by AECc. Standard operating procedures specific to this application

(xiii) Special Risks a. Identification of specific risks to animals/humans

(xiv) Declaration (s) a. That adequate resources available to undertake projectb. That investigator/teacher will comply with legislation,

code involving all personnelc. Other- specifiy

2 NB. Prevention of Cruelty to Animals Regulation 95(16) pertains to projects involving ‘death as an endpoint’.


PART 3a,b,c-AUDIT OF PROJECT ANIMAL USE

This part covers the items to be reviewed during audit of projects and animal use as approved by the AEC. The aims of this component of a licence inspection are to establish whether the project was carried out in accordance with the protocol approved by the AEC (Regulation 95(10)) and according the Australian Code of Practice (sections 2,3,4,5 and 6) to actually ensure that the agreed welfare of the animals was maintained. If a project has a number of component parts, each of these parts must be considered according to the criteria listed below.

This process is repeated during the audit for at least 3 project applications submitted to the AEC- hence parts 3a,b,c

1 Project Title:

2 Identified parts of project (if applicable):

3 Name of Licence under which project conducted (CI works under this licence):

4 AEC Reference Number:

5 Chief/Principal Investigator:

6 Investigator present at audit, work book sighted?

7. Location of animals during the project:

8. AEC Approved commencement date:

9. AEC approved finish date:

10. Any relevant annual or completion of project reports?

11. AEC Conditions Set:

Summary Outcomes:Are the records and condition of animals, facilities compliant with the AEC approved protocol and the Australian Code of Practice?OVERALL: Compliant (C) or Non-compliant (NC)

Commendations:#Reg’n or Item Comments Specific follow-up advice / recommendations


ITEM DESCRIPTION EVIDENCE (y/n) and type


1. Allocation of Animals and personnel responsibilities

a. Source of animals compliant?b. Initial Receipt of Animalsc. Allocation/Receipt Records available?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.

2. Pre-intervention animal monitoring records

a. Monitoring of– Animal Behaviour?b. Monitoring of – Signs of pain / distress?c. Record system satisfactory?d. Action(s) recorded?

3. Procedure records should include:

a. Date and Personnel involvedb. Total Animals used (number and species)c. Administration of drugs and treatmentsd. Anaesthesia and Analgesia usee. Surgeryf. Other invasive procedures- describe

4. Pain Management Plan

a. Personnel Responsible- Researcher - Housing facility

b. Anaesthesia/sedation and Analgesia- Dose Rates- Preparation- Administration- Monitoring

c. Post anaesthetic recoveryd. Post procedural monitoring


ITEM DESCRIPTION EVIDENCE (y/n) and type


5. Pain and Distress end-point

a. Check records of post-procedural monitoring of level of pain and distress in relation to AEC agreed end-point of experiment.

b. Numbers actually died as a result of ‘death as an end-point’2

6. Adverse effects a. 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 required?

7. Humane Killing and euthanasia of animals

a. Methods used3

b. Personnelc. Records

8. Other fate of animals

a. Records of animals delivered to another scientific institution?

b. Other- please describe

9. Standard operating procedures

a. Were standard operating procedures available and apparently used?

10. Were the anticipated benefits of the project achieved?

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

2 Prevention of Cruelty to Animals Regulation 12(2) pertains to projects involving ‘death as an endpoint’.3 Code of Practice for the Housing and Care of Laboratory Mice, Rats, Guinea Pigs and RabbitsVersion 3. Last updated 12.01.09 13

PART 4- AUDIT OF ANIMALS AND ANIMAL HOUSING –as applicable to SPFL (i.e. no premises ordinarily used for Scientific Procedures). Animal care, housing and equipment used for scientific procedures remain the responsibility of the licensee.

The aim of this part of the audit is to ensure that animal care, equipment and housing comply with the Regulations 95(2),(11),(13),(14),(17) and Regulation 96, Appendix 8 of the Code of Practice for the Housing and Care of Laboratory Mice, Rats, Guinea Pigs and Rabbits and NHMRC Policy for the care and use of non-human primates for scientific purposes as applicable. Compliance with the Minimum Standards of the Laboratory Animals Code is required unless proposed variations to these Standards, as part of an experimental or breeding protocol are justified and approved by an AEC. The same requirements also provide a checklist guide for species not referred in the Laboratory Animal Code.

Licence(s) under which animal facilities pertain:

Name of Animal Facility Manager (if applicable):

Contacts of Animal Facility Manager:

Name of Animal Welfare Officer (if applicable):

Contacts of Animal Welfare Officer:

Date visited Animal Use site- Name/ID Location of fieldwork Contact Animals-species

Summary Outcomes:

Commendations:

Are the facilities, animal care and records compliant with the above-mentioned regulations and mandatory Codes?OVERALL: Compliant (C) or Non-compliant (NC)#Reg’n or Item Comments Specific follow-up actions / recommendations

Use NA if not applicable to SPFL.Version 3. Last updated 12.01.09 14

ITEM-code reference § 3

DESCRIPTION EVIDENCE (y/n) and species


1.1 Nutrition

Non-Lab Code species

i Suitable diet (species, age, stage)ii Food storage (cool, vermin-proof)iii Communication re supplementationiv Vit C and E requirements for GPs metv Feeding consideration for handicapped/young animals

Other- ie. condition score suitable

1.2 Water


I.Potable and available at all timesii. Flooding preventediii. GPs and Vit C water provision- non-copper water

delivery

Other?

2. Animal Enclosures


i. Min Space- see Appx 1 ii. Compatible with known animal needsiii. Durable, comfortable, good repair, escape-proof

Other?

2.1 Materials and Design


i.Safe, comfortable, withstand cleaning agentsii. Easy monitoring enabledii. Nesting box for breeding animalsiv if wire floor, solid mat alsov vectors of rabbit contagious diseases prevented

Other-ie. suitable and safe flooring and restraint facilities- yards, crush etc

ITEM DESCRIPTION EVIDENCE (y/n) and species


2.2 Space requirements

i and ii Adequate space and stocking density for exercise, social stability or single animals, breed, age, growth stage



iii. See appendix 1*- note exemption for short-term housing of post-weaned/pre-issue animals – note any welfare concerns. note- breeding mice pair- 300 cm2 floor space per pair note- upright postures enabled for M,R,Rabbits

Other?2.3 Social

requirementsi. group-housed, justification if not?

2.4 Bedding and nesting

i. Bedding material provided and appropriateii. Nesting material for breeding animalsiii. Rabbit nesting material and containment appropriateiv. Materials –safe, absorbent, low allergenic, free from contaminants and vermin

2.4 Special requirements


i. animals with special requirements present, identified?ii. note if albino, GM, cloned, immunocompromised (nude mice etc), post-surgery, disease or drug affectedii. provision of cage ‘enrichment’ if barrier requirements (eg. IVCs, social isolation etc)

Other- for indoor housed livestock, metabolic/experimental cages, poultry housing….

3.1 Temperature


i. Room temp recording- daily, Max & Minii. Room temp range- see Appx 1iii. Special conditions for very aged, young, thermoregulatory impaired animals

Other- ie. sprinklers for dairy, pigs required, appropriate shade/shelter

Room thermometers ?



3.2 Relative Humidity

i.Within acceptable range 40-70%

3.3 Ventilation and i. Draught free, fresh or conditioned air in rooms (approx. NB BAW Instantaneous Ammonia


Air quality


10-20 ACH) or IVCsii. Room-Instantaneous nor average ammonia concentration < 25 ppmiii. Smallest unit animal housing- Instantaneous nor average ammonia concentration < 25 ppm . NB consider temperature, RH. (note- recommendations for rabbits)iv. ventilation systems regularly serviced

Other- nb housed sheep, calves, poultry…..

meter

3.4 Noise No Minimum Standards- see Recs where necessary3.5 Light


i. Max light intensity at 1 m is 350 lux, except albino animals (light meter)ii. Opportunity to withdraw to lower light intensities- tunnels, darkened areas/nesting box etciii. Periods of daily light and dark provided- photoperiods?

Other- poultry, other birds, crepuscular/ nocturnal animals

NB. BAW Light Meter

3.6 Emergency plans & Alarm systems


i. Able to detect fire or breakdown of essential systems (ventilation, temp control etc- especially IVCs)?ii. Emergency plan in place? (eg. battery back up or generators, emergency contact to engineer etc)

Other- fire evacuation plan?4.1 Behavioural requirements


i. Animals able to perform species specific activities including opportunity for sufficient exercise (note Appx 10-promote for phenotype reporting)ii. provision of nest boxes if intend to breed breeding animalsiii. monitoring for abnormal behaviour, stereotypies & effects (during experimental protocols)

Other?ITEM DESCRIPTION EVIDENCE (y/n)

and speciesC NC Comments/ Recommendations

4.2 Environmental ‘enrichment’/ complexity

i. Items or management to facilitate natural behaviours provided?ii. Above provision- safe, practical and actually fulfil animal needs? See also examples in recommendations



Other- nb sheep in experimental cages or group housed,housed poultry, etc

5. Maintenance and Hygiene


i. Animal Rooms- clean, tidy, vermin-proof, in good repair to facilitate effective cleaning (see also Reg 16)ii. Animal Bedding appropriately changed so animals kept dry, comfortable, clean

Other- check livestock yards, races, crush etc

Cleaning/ repair policy/SOP?

6. Handling and Basic Procedures


i.Training provision or access for animal house personnel and investigators for competent handling, basic procedures and AEC approved procedures as required.ii. Procedures appropriate for age and state of animalsNB- note I retro-orbital bleeding without GA, using animals for m Abs production, can promote saphenous, facial bleeding, ear notch, buccal cell genotyping refinements

Other- nb farming code compliant mulesing, dehorning/disbudding, identification etc

Training register?

7. Health Monitoring


i. Appropriate animal health monitoring program (nb also appropriate for annual interpretation of disease/ death assessment)ii. Appropriate animal health policyiii. Apropriate health monitoring re negative impact project activitiesiv. Appropriate biosecurity/ biohazard containment (nb also radiation, GM, infectious disease etc)

Other-check teaching or research farm management plans for husbandry schedule, veterinary contacts etc

SOPs?



8. Transportation


i-v. Check SOP for domestic/internal and external transportation plus check transport containers where possible- nb specially for local transport

Other- care transport of pregnant animals (refer to Farm codes for guidance)

SOPs, BAW IATA guidelines


9. Euthanasia


i. Are the general principles of the Australian Code adopted in the euthanasia method/ policy? Humane method- see nb. Competent persons Quiet, clean, isolated environment and death

confirmed Appropriate euthanasia or care for dependent

neonates Apropriate method for developmental stage and

confirmation of death prior to disposalii. Refer to Appx 2 – note any not acceptable methods

Other?

NB. Consideration of CO2 use, promote alternatives where possible with OHS covered.

10. Monitoring and Records

i. System of recording of animal breeding implemented? Nb. SOPs- are they regularly reviewed by the AEC?ii. 4yr retention of animal recordsiii. Records and SOPs readily accessible for auditiv. Project monitoring responsibilities recorded- ie. who monitored noted on monitoring sheet

Please note (take photocopy where possible) of any good examples of monitoring sheets. NB also examples in Lab Code

Appx 8 Stock monthly inventory for licence conditions

See Appx 8- Nb especially Z – re surplus breeding and potential animal wastage

Discuss any surplus breeding/ animals- ways to minimise, also ETHITEX (www.ethitex.com) for tissue/animal sharing. Also able to apply to OGTR for exemption to release non-GM surplus animals from a GM breeding program/project.


Documents

DPI, BUREAU OF ANIMAL WELFARE SCIENTIFIC …agriculture.vic.gov.au/__data/assets/word_doc/0019/228601/SPFL... · Web viewAUDIT TEMPLATE for SPFL–(ie. no premises ordinarily used