Most Frequent Findings During AAALAC Site Visits. Harry van Herck, D.V.M., Ph.D., DipECLAM Member, Council on Accreditation AAALAC International

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2 Most Frequent Findings During AAALAC Site Visits Harry van Herck, D.V.M., Ph.D., DipECLAM Member, Council on Accreditation AAALAC International

3 Trends Data Data were extracted from letters to European institutions prepared by the Council on Accreditation during the period letters were reviewed

4 Proportion of European Accredited Institutions by Industry Sector Pharma Companies CROs Not for Profit Academ ic Other Private Commercial Breeders

5 The Animal Care and Use Programme: Institutional policies & responsibilities Institutional Commitment Animal Care and Use Oversight Body (IACUC responsibilities/ethical review) Javier Guillen Occupational Health & Safety Programme Bryan Howard/Richard Fosse Animal Environment, Housing and Management Veterinary Medical Care Physical Plant

6 Combined Total Number of Mandatories and Suggestions for Improvement (SFIs) Institutional Commitment Animal Care and Use Oversight Body (IACUC) Occupational Health and Safety Animal Environment Veterinary Care Physical Plant

7 Total Number of Mandatories and SFIs Mandatory Suggestion Institutional Commitment Animal Care and Use Oversight Body (IACUC) Occupational Health and Safety Animal Environment Veterinary Care Physical Plant

8 Category and Areas of the Recommendations Majority of Recommendations = Suggestions Most Frequent Mandatory findings (in decreasing frequency of recommendations): 1. Occupational Health & Safety issues 2. Physical Plant 3. Animal Care and Use Oversight Body (IACUC) 4. Veterinary Care 5. Animal Environment 6. (Institutional Commitment) Suggestions: Animal Environment!

9 Institutional Commitment Each institution should establish and provide resources for an animal care and use programme that is managed in accordance with the Guide and in compliance with applicable laws and regulations. To implement the Guide and applicable laws and regulations a system or body must be in place to oversee and evaluate the programme. (IACUC functions must be covered) The institution is responsible for maintaining records of the activities of the animal care and use oversight body and for conducting an OSHP.

10 Total Combined Findings Physical Plant Ceilings, Floors, Walls, Doors Facilities for Aseptic Surgery Functional Areas HVAC Temperature and Humidity Ventilation Power & Lighting Storage Areas

11 Physical Plant Ceilings, Floors, Walls, Doors In disrepair Peeled and chipped paint Holes in walls Wood surface deteriorated/unsealed Rusted metal surfaces Adequate sanitation impeded; surfaces should be impervious.

12 Physical Plant HVAC HVAC Performance data not provided, not in correct format, incomplete or outdated Not capable of maintaining temperature / RH according to recommendations Strong animal/ammonia odors due to inadequate performance of the HVAC and/or inadequate sanitation or fully occupied rooms aerosols and potentially toxic gases should be effectively exhausted from room

Physical Plant Storage Areas Inappropriate storage of cages and equipment outside on floor corridors animal/hvac rooms Ensure caging and equipment

13 Physical Plant Storage Areas Inappropriate storage of cages and equipment outside on floor corridors animal/hvac rooms Ensure caging and equipment are stored appropriately to prevent contamination and to keep animal housing and work area free of extraneous materials that would impede sanitation

14 Total Combined Veterinary Medical Care Findings Adequate Veterinary Care Programme Pain, Analgesia, Anesthesia Preventive Medicine - Surveillance, Diagnosis, Treatment & Control Preventive Medicine - Quarantine, Stabilization and Separation Euthanasia

15 Veterinary Medical Care Preventive Medicine - Surveillance, Diagnosis, Treatment & Control Intensity of surveillance, diagnosis and treatment of animals not sufficient for the needs of the programme veterinary staff not notified about ill animals and unexplained animal deaths appropriate veterinary care not provided to all clinically ill animals ensure personnel conform with health surveillance policies and procedures inadequate documentation of evaluation or care provided Excerpt from a Council letter: Someone other than a veterinarian can make observations of animals; however, direct and frequent communication concerning timely and accurate information on problems in animal health, behavior, and well-being must occur between the veterinarian and the observer.

16 Veterinary Medical Care Veterinary Care Programme Inadequate intensity of veterinary care programme and/or involvement of the veterinarian Inadequately coordinated or intensity to ensure routine veterinary care monitoring Unresolved veterinary medical concerns Veterinarian unaware/uninformed of activities, issues Inadequate coordination between the attending veterinarian and other veterinarians (study directors, PI s) Attending Veterinarian's multiple roles may impact veterinary care (risk of conflict of interest )

17 Veterinary Medical Care Preventive Medicine Quarantine, Stabilization, and Separation Inadequate quarantine procedures to prevent contamination among animals No health monitoring of newly arrived animals (macaques, goats, swine, dogs, sheep)

18 Considerations Veterinary Medical Care The Guide Emphasizes importance of effective communication between animal care staff, veterinarians and investigators The Attending Veterinarian [or another qualified professional] must have direct or delegated program authority for all activities involving animals (this must be supported by the senior administration Institutional Official) Ensure timely communication regarding animal health, behavior and well-being

19 Total Combined Number of Findings Animal Environment, Housing and Management Behavioral Management, Structural & Social Environment Housing Husbandry Food Emergency, Weekend & Holiday Care Sanitation/Maintenance Vermin Control Water Illumination

20 Animal Environment, Housing and Management Behavioral Management, Structural and Social Environment Enrichment programme does not meet animal s behavioral and social needs Social animals singly housed Abnormal behaviors not addressed through behavioral management plan

21 Animal Environment, Housing and Management Sanitation and Maintenance Cage sanitation schedule or procedures not conform with the Guide: Solid-bottom caging, bottles, and sipper tubes weekly Enclosures and accessories, such as tops, every 2 weeks [Less often for some type of caging, IVCs, large cages, low density] [More frequent for static microisolators and high density housing] review and approve performance standards for assessing the effects of cage types on bedding change frequency (ammonia levels, biomass, etc.) with consideration of the animals wellbeing

22 Animal Environment, Housing and Management Sanitation and Maintenance No adequate system in place to monitor the effectiveness of sanitation, such as visual inspection, water temperature monitoring, microbiological monitoring Excerpt from Council letter: There were no action parameters defined for interpretation of RODAC plates used to assess the effectiveness of sanitation. The efficacy of sanitation should be monitored and include a plan for interpreting results of microbiological monitoring of sanitized surfaces.

23 Animal Environment, Housing and Management Housing Cracked, crazed, or clouded cages obscure observation of animals and impede sanitation Replace cages Ensure all animals can be readily observed Verify effectiveness of sanitation

24 Thank You

Standard Operating Procedure (SOP) APPROVING SATELLITE HOUSING FACILITIES

University of Pittsburgh Institutional Animal Care and Use Committee May 2014 Standard Operating Procedure (SOP) APPROVING SATELLITE HOUSING FACILITIES I. DEFINITIONS Satellite Housing Area: Any building