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1 of 102
 
Speakers and topics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Hilton J. Klein,  M.S., V.M.D. Overview and introduction
What is a program?
Rising costs of research and research trends …
Rapidly increasing R&D costs
New targets from genomics
Flexibility and adaptability ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Flexibility and adaptability  (Cont’d) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Facilities operation and design ,[object Object],[object Object],[object Object],[object Object],[object Object]
Building considerations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Operation and design tools (Some examples) ,[object Object],[object Object],[object Object]
Information and management ,[object Object],[object Object],[object Object],Conclusion:  renovations or construction will require systems for information management access and retrieval for effective colony and facility management.
Design and  operational considerations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Performance standards
"Performance standards define an outcome in   detail and provide criteria for assessing that   outcome, but do not limit the methods by   which to achieve that outcome."
Standards used ,[object Object],[object Object],[object Object],[object Object],[object Object]
 
 
Hager Hauler
Summary and conclusions ,[object Object],[object Object]
Summary and conclusions  (Cont’d) ,[object Object],[object Object]
Summary and conclusions  (cont’d) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Kathryn A. L. Bayne,  M.S., Ph.D., D.V.M. Review of commonly cited facility problems
Over 640 accredited institutions ... … in 18 countries
Proportion of accredited units By facility size (sq. feet)
Animal care and use program deficiencies
Facilities  mandatory deficiencies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The top three deficiencies ,[object Object],[object Object],[object Object]
HVAC mandatories (Ranked in order of most common) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Common HVAC findings ,[object Object],[object Object],[object Object],[object Object]
 
HVAC purposes  ( Guide ) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Space, temperature  and humidity criteria ,[object Object],[object Object],[object Object],[object Object]
Space, temperature  and humidity criteria ,[object Object],[object Object],[object Object]
HVAC purposes (NIH Ventilation Design Handbook) ,[object Object],[object Object]
Factors ,[object Object],[object Object],[object Object],[object Object],[object Object]
Factors ,[object Object],[object Object],[object Object]
 
www.aaalac.org/connection_1su1998.htm
Contains: ,[object Object],[object Object],[object Object],Available in CD ROM or Spiral Bound book.
James F. Taylor,  D.V.M., M.S. Design of facilities –  the AAALAC perspective
Critical elements for success ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Program needs   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Separation of functions  ,[object Object],[object Object],[object Object],[object Object]
Operational adjacencies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Horizontal vs. vertical design  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Traffic flow vs. efficiency of design ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Facility integrity considerations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Institutional infrastructure ,[object Object],[object Object],[object Object],[object Object],[object Object]
Facility maintenance ,[object Object],[object Object],[object Object],[object Object]
Mechanical systems ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Floor drains ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Ventilation characteristics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Floors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Walls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Ceilings ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],Fit and finish protection
Critical dimensions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Doors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Electrical system ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Illumination ,[object Object],[object Object],[object Object]
Cage wash ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Critical elements for success ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Stephen T. Kelley,  M.S., D.V.M. Performance standards and facility design and operation
AAALAC International uses recognized references for performance standards…   www.aaalac.org/resources
Examples of references which  address facility design and operation ,[object Object],[object Object],[object Object]
References  (Continued)   ,[object Object],[object Object]
References  (Continued) ,[object Object],[object Object]
References  (Continued) ,[object Object],[object Object]
Evaluation criteria ,[object Object]
Evaluation responsibility ,[object Object],[object Object],[object Object]
Operational considerations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Facility location and traffic patterns
Security ,[object Object],[object Object],[object Object]
Traffic - reduce potential for contamination
Personnel areas ,[object Object],[object Object],[object Object]
Animal species ,[object Object],[object Object],[object Object]
Support functions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Maintenance  ,[object Object],[object Object],[object Object],[object Object]
Surfaces ,[object Object],[object Object],[object Object],[object Object]
Heating ventilation and air conditioning ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Heating ventilation  and air conditioning Special requirements ,[object Object],[object Object],[object Object]
Plumbing ,[object Object],[object Object],[object Object],[object Object]
Illumination ,[object Object],[object Object],[object Object],[object Object]
Noise ,[object Object],[object Object],[object Object]
Storage facilities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sanitation facilities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Standard operating procedures and training
The key element necessary to assure high levels of performance standards: Well trained and dedicated personnel
Case studies
Case Study #1 HVAC Observation Site visitors conducted a site visit at a respected, small research institute conducting infectious disease studies involving Biosafety Level 2 agents.  There were a total of six (6) animal rooms housing either rats or mice.  The HVAC report below was provided as an attachment to the program description.
    Room No.   Filtration   Air Exchanges Air Pressure Differential 1101 HEPA 11.8/hr (fresh) Negative 1202 HEPA 8.2/hr (fresh) Negative 1303 HEPA 7.8/hr (fresh) Negative 1404 HEPA 10.4/hr (fresh) Negative 1505 HEPA 12.0 (fresh) Negative 1606 HEPA 8.0 (fresh) Negative Surgery/Necropsy HEPA 14.0/hr (fresh) Negative
Follow up All rooms were sanitized at weekly intervals by wet-mopping the floor and wiping the walls down with an appropriate mild quaternary ammonium disinfectant.  Cages were sanitized appropriately twice weekly.  Bedding was also changed once in a hood between cage sanitation cycles.  Upon entering the rooms, site visitors observed the following cage and stocking densities …
Follow up ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Suggestion for improvement …
Case Study #2   Elevator access Observation A site visit to a large university biomedical research program indicated that a small colony (n=25 adults) of macaques was housed in the top floor of a “satellite” building.  The research involved behavioral testing and brain imaging which was conducted in separate laboratories within the same building.  The behavioral test lab and the imaging lab were accessible only by an elevator which was also used to transport non-laboratory personnel.  Cage washing facilities were located in the basement of the building.
Findings ,[object Object],[object Object],[object Object]
Suggestions for improvement ,[object Object]
Case Study #3 After-hours monitoring Upon careful review of the written Program Description, site visitors concluded that after-hours monitoring of the animal rooms in a 45 year old animal facility consisted of: a) recording the high-low temperature readings in the room on a log sheet by the animal caretaker, and b) the security guard making rounds to ensure the corridor and hallway doors are closed.  This process was confirmed during the site visit.   more…
Case Study #3   After-hours monitoring  (cont’d) Additional background information revealed a steam injector valve in the room humidification control system had stuck in the open position overnight six months prior to the site visit.  This room housed 50 rats on a respiratory/inhalation study at the time.  Animal care staff realized the room temperature had reached 105ºF overnight because of the steam valve defect.  Fifteen animals were found dead the next morning.  Within two days, the study was terminated because of twenty (80%) percent mortality in the controls and test animals.  Excessive respiratory problems were observed in the remaining animals which invalidated the study.
Suggestions for improvement ,[object Object]
Suggestions for improvement ,[object Object]

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Facilities & operations

  • 1.  
  • 2.
  • 3. Hilton J. Klein, M.S., V.M.D. Overview and introduction
  • 4. What is a program?
  • 5. Rising costs of research and research trends …
  • 7. New targets from genomics
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 16. "Performance standards define an outcome in detail and provide criteria for assessing that outcome, but do not limit the methods by which to achieve that outcome."
  • 17.
  • 18.  
  • 19.  
  • 21.
  • 22.
  • 23.
  • 24. Kathryn A. L. Bayne, M.S., Ph.D., D.V.M. Review of commonly cited facility problems
  • 25. Over 640 accredited institutions ... … in 18 countries
  • 26. Proportion of accredited units By facility size (sq. feet)
  • 27. Animal care and use program deficiencies
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.  
  • 33.
  • 34.
  • 35.
  • 36.
  • 37.
  • 38.
  • 39.  
  • 41.
  • 42. James F. Taylor, D.V.M., M.S. Design of facilities – the AAALAC perspective
  • 43.
  • 44.
  • 45.
  • 46.
  • 47.
  • 48.
  • 49.
  • 50.
  • 51.
  • 52.
  • 53.
  • 54.
  • 55.
  • 56.
  • 57.
  • 58.
  • 59.
  • 60.
  • 61.
  • 62.
  • 63.
  • 64.
  • 65. Stephen T. Kelley, M.S., D.V.M. Performance standards and facility design and operation
  • 66. AAALAC International uses recognized references for performance standards… www.aaalac.org/resources
  • 67.
  • 68.
  • 69.
  • 70.
  • 71.
  • 72.
  • 73.
  • 74. Facility location and traffic patterns
  • 75.
  • 76. Traffic - reduce potential for contamination
  • 77.
  • 78.
  • 79.
  • 80.
  • 81.
  • 82.
  • 83.
  • 84.
  • 85.
  • 86.
  • 87.
  • 88.
  • 90. The key element necessary to assure high levels of performance standards: Well trained and dedicated personnel
  • 92. Case Study #1 HVAC Observation Site visitors conducted a site visit at a respected, small research institute conducting infectious disease studies involving Biosafety Level 2 agents. There were a total of six (6) animal rooms housing either rats or mice. The HVAC report below was provided as an attachment to the program description.
  • 93.     Room No.   Filtration   Air Exchanges Air Pressure Differential 1101 HEPA 11.8/hr (fresh) Negative 1202 HEPA 8.2/hr (fresh) Negative 1303 HEPA 7.8/hr (fresh) Negative 1404 HEPA 10.4/hr (fresh) Negative 1505 HEPA 12.0 (fresh) Negative 1606 HEPA 8.0 (fresh) Negative Surgery/Necropsy HEPA 14.0/hr (fresh) Negative
  • 94. Follow up All rooms were sanitized at weekly intervals by wet-mopping the floor and wiping the walls down with an appropriate mild quaternary ammonium disinfectant. Cages were sanitized appropriately twice weekly. Bedding was also changed once in a hood between cage sanitation cycles. Upon entering the rooms, site visitors observed the following cage and stocking densities …
  • 95.
  • 96. Case Study #2 Elevator access Observation A site visit to a large university biomedical research program indicated that a small colony (n=25 adults) of macaques was housed in the top floor of a “satellite” building. The research involved behavioral testing and brain imaging which was conducted in separate laboratories within the same building. The behavioral test lab and the imaging lab were accessible only by an elevator which was also used to transport non-laboratory personnel. Cage washing facilities were located in the basement of the building.
  • 97.
  • 98.
  • 99. Case Study #3 After-hours monitoring Upon careful review of the written Program Description, site visitors concluded that after-hours monitoring of the animal rooms in a 45 year old animal facility consisted of: a) recording the high-low temperature readings in the room on a log sheet by the animal caretaker, and b) the security guard making rounds to ensure the corridor and hallway doors are closed. This process was confirmed during the site visit. more…
  • 100. Case Study #3 After-hours monitoring (cont’d) Additional background information revealed a steam injector valve in the room humidification control system had stuck in the open position overnight six months prior to the site visit. This room housed 50 rats on a respiratory/inhalation study at the time. Animal care staff realized the room temperature had reached 105ºF overnight because of the steam valve defect. Fifteen animals were found dead the next morning. Within two days, the study was terminated because of twenty (80%) percent mortality in the controls and test animals. Excessive respiratory problems were observed in the remaining animals which invalidated the study.
  • 101.
  • 102.