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1、 奇跡單機版,Speakers and topics,Hilton J. Klein, M.S., V.M.D. Overview and introduction Kathryn A. L. Bayne, M.S., Ph.D., D.V.M. Review of commonly cited facility problems James F. Taylor, D.V.M., M.S. Design of facilities - the AAALAC perspective Stephen T. Kelley, M.S., D.V.M. Performance standards and

2、 facility design and operation,Hilton J. Klein, M.S., V.M.D.Overview and introduction,What is a program?,Rising costs of researchand research trends ,Rapidly increasing R Europe,Flexibility and adaptability (Contd),Future Regulation of rats, mice, birds - space? Operational issues Energy Maintenance

3、 New technologies Transgenics and new species Genomics and proteomics Other drivers for the way animals are used Social,Facilities operation and design,Scientific programs Laboratory animals Veterinarians Engineers Community,Building considerations,Research objectives New construction Renovation Fle

4、xibility and adaptability Utilities use Adjacencies Operational costs,Operation and design tools(Some examples),Information sharing - network Computer aided design Computational fluid dynamics,Information and management,An Integrated Database for Managing Animal Study Proposals and Animal Inventory

5、for the Small Animal Facility. T. Calzone, J. S. Montijo, M. B. St.Claire, and E. Lamoreaux. 2001. Lab Animal 30(2):28-31. A Comprehensive, Bar Coded System for the Management of Animal Information in a Research Facility. C. Pryor, D. Frankenfield, H. Klein, W. Terpeluk, S. Washington, N. T. Mourad.

6、 2001. Lab Animal 30(2):36-38. Software for Lab Animal Facilities. G. Novak and T. Schub. 2001 Lab Animal 30(2):39-43.,Conclusion: renovations or construction will require systems for information management access and retrieval for effective colony and facility management.,Design and operational con

7、siderations,Qualification Performance standards approach Factory acceptance testing (FAT) Dirty cage set up Microbiology tests Physical testing Installation qualification (IQ) Operational qualification (OQ),Performance standards,Performance standards define an outcome in detail and provide criteria

8、for assessing that outcome, but do not limit the methods by which to achieve that outcome.,Standards used,Guide for the Care and Use of Laboratory Animals (NRC 1996) EEC 86/609 CoE Convention National legislation Reference resources (“Ag Guide,” AVMA Panel on Euthanasia, etc.),Hager Hauler,Summary a

9、nd conclusions,As demand for animal space changes, we must design, construct, and operate facilities in a flexible and adaptable manner. The use of R research staff Maintenance/service staff; Visitors Access to support spaces (offices, training) Horizontal versus vertical construction,Facility integ

10、rity considerations,Seismic Vibration External water - vertical trench vs. surface Obviously should be low point of room Cap drains in infrequently used rooms Consider installed but capped as contingency,Ventilation characteristics,Computational fluid dynamics Air supply diffusers Exhaust grilles -

11、number and location Room exhaust filters to protect HVAC Pressure differentials Stability of temp and RH control,Floors,Chemical and wear resistance Life cycle cost - maintenance burden Epoxy, seamless vinyl, MMA, terrazzo, tile Surface preparation and cure times! Provide continuous cove Installer e

12、xpertise is paramount,Walls,Structural requirements (caging systems) Space (and renovation) costs of CMU versus RFP Noise control Life cycle cost - maintenance burden Epoxy, tile, RFP Surface preparation and cure times!,Ceilings,Bottom of floor above or suspended Access requirement Sanitizability In

13、tegrity impact upon pest control program,Wall guards - bumpers Door jamb guards Corner guards Interior curbs,Fit and finish protection,Critical dimensions,Door heights and widths (net clearances) Cage wash equipment chamber (H surgery/ICU areas Animal holding; outlets for equipment Perimeter and int

14、ernal security Assure sufficient distribution, placement and number of outlets,Illumination,Dual light levels Fixture placement relative to rack positions to maximize cage level illumination Light-cycle automation minimizes inadvertent lighting errors,Cage wash,Consider automation for large faciliti

15、es Consider equipment throughput capacities versus manpower costs Solid waste management - soiled bedding Ergonomics of cage wash tasks deserve priority treatment Personnel safety and comfort deserve priority consideration Assure adequate space around machines for maintenance and repair!,Critical el

16、ements for success,Define what the facility needs to accomplish Provide flexibility to accommodate future needs Knowledgeable users and A&E/planners Plan, program, design, and construct Define decision making matrix Consider operational and life-cycle costs Review, review, review! Constantly focus o

17、n Achilles heels Include commissioning/validation,Stephen T. Kelley, M.S., D.V.M.Performance standards and facility design and operation,AAALAC International uses recognized references for performance standards /resources,Examples of references which address facility design and operati

18、on,Guide for the Care and Use of Laboratory Animals, 1996, National Research Council, National Academy of Sciences. Animal Welfare Act - 9 CFR Chapter 1, Subchapter A, Animal Welfare. Biosafety in microbiological and biomedical laboratories, 4th Ed., 1999, HHS Publication No. (CDC) 93-8395.,Referenc

19、es (Continued),Occupational Health and Safety in the Care and Use of Research Animals, 1997. National Research Council, National Academy of Sciences. Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, Federation of Animal Science Societies, First Revised Editio

20、n, January 1999.,References (Continued),Guide to the Care and Use of Experimental Animals, Canadian Council on Animal Care. Vol. 1, 1993. Guide to the Care and Use of Experimental Animals. Canadian Council on Animal Care. Vol. 1, 1993.,References (Continued),European Convention for the Protectionof

21、Vertebrate Animals Used for Experimentaland Other Scientific Purposes. Council of Europe (Convention ETS 123), 1985. Council Directive on the Approximation of Laws, Regulations and Administrative Provisions of the Member States Regarding the Protection of Animals Used for Experimental and Other Scie

22、ntific Purposes. European Union (Directive 86/609/EEC), 1986.,Evaluation criteria,Performance vs. engineering,Evaluation responsibility,Institutional Animal Care and Use Committee Facility management Engineering,Operational considerations,Size of the program Nature of animal use Species Flexibility

23、requirements Geographical location & environment Facility type and construction,Facility locationand traffic patterns,Security,Public access Signs Locks and other measures,Traffic -reduce potentialfor contamination,Personnel areas,Clerical / office areas Rest rooms / locker rooms Eating areas,Animal

24、 species,Species requirements Microbiological status Containment,Support functions,Surgery Dedicated? Procedure Necropsy Cage Wash Receiving Laboratories,Maintenance,Identification of deficiencies Prioritization of repair Conducting repairs Documentation of the maintenance program,Surfaces,Walls, ce

25、ilings, floors Frequency Space Materials and methods,Heating ventilationand air conditioning,Monitoring Personnel Manual / automatic Temperature & humidity Air flow direction Evidence of animal abnormalities Frequency Maintenance Operational aspects,Heating ventilation and air conditioningSpecial re

26、quirements,Biosafety and fume hood maintenance and certification Necropsy Inhalant anesthetics,Plumbing,Monitoring Drinking water systems Sanitation water systems Drains,Illumination,Light timers (timer overrides) Light intensity Natural light Observational conditions,Noise,Animal issues Personnel s

27、afety issues Operational issues,Storage facilities,Adequacy Appropriate for use or separation Food Bedding Clean cages Chemicals,Sanitation facilities,Prevent cross contamination Control aerosols - personnel protection Monitoring effectiveness Maintenance Use of vacuums Use of chemicals,Standard ope

28、ratingprocedures and training,The key element necessaryto assure high levels of performance standards:Well trainedand dedicated personnel,Case studies,Case Study #1HVAC,Observation Site visitors conducted a site visit at a respected, small research institute conducting infectious disease studies inv

29、olving 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.,Follow up,All rooms were sanitized at weekly intervals by wet-mopping the floor and wiping the walls down with an a

30、ppropriate 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,Room 1101 rats-4 plastic cag

31、es (2/box) Room 1202 rats-8 plastic cages (2/box) Room 1303 mice-15 plastic cages (3/box),Room 1404 mice-12 plastic cages (2/box) Room 1505 mice-10 plastic cages (4/box) Room 1606 rats-8 shoebox cages (2/box),Suggestion for improvement ,Case Study #2 Elevator access,Observation A site visit to a lar

32、ge 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 te

33、st 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,The macaques were specific pathogen free and were known to be CHV-1 (Herpes “B” virus) negative by

34、ELISA and Western Blot. Cages were covered by Tyvek shrouds for transport to and from cage wash. Soiled cages were sprayed with povidine-iodine solution prior to transport to the cage wash area. Elevators were “l(fā)ocked out” to personnel when transport to and from the labs was performed and the elevat

35、ors were sanitized after use. Review of documents revealed no problems.,Suggestions for improvement,Suggest a security review to assure the potential for escaped animals is minimized in the elevator, the behavioral testing lab, and the imaging lab. Suggest the labs be evaluated for wearing adequate

36、PPE and whether human patients were imaged in the imaging lab, as well as any health risks to personnel and patients.,Case Study #3After-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 a

37、nimal 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 (contd),Additional background information revealed a steam injector v

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