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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 facility design and operation

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


 Research trends of animal use
Dog and monkey use - USDA reports show decline Rodent use
Institution dependent Academic vs. industry NIH/PHS funding increases

Overall/general animal use

 Animal regulations
Dog, monkey space and care - U. S.; Europe

Flexibility and adaptability


 Future
Regulation of rats, mice, birds - space? Operational issues
Energy Maintenance

(Contd)

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 Flexibility 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 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. 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 considerations


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 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 and conclusions


 As demand for animal space changes, we must design, construct, and operate facilities in a flexible and adaptable manner.  The use of R&D resources is rising as new therapeutic targets are identified.

Summary and conclusions

(Contd)

 Animal research resources are coupled to R&D and we must determine strategies to address operational issues through facility design and automation-performance standards.  Team approaches are highly effective for scientists, administration, engineers, lab animal to address and solve space and operational issues.

Summary and conclusions


 Certain future areas in lab animal facilities opportune for change include:
Room design and layout Facility design and layout New technological advances Automation

(contd)

Kathryn A. L. Bayne, M.S., Ph.D., D.V.M.

Review of commonly cited facility problems

Over 640 accredited institutions ...


in 18 countries

<1 00 0 1, 00 09, 99 9

10 ,0 00 ,0 00 ,0 00 -9 9, -4 9, 99 9 -2 4, 99 9 25 50 10 00 999 -1 20 99 0, ,9 00 99 049 9, 99 9 >5 00 ,0 00 0, 0

By facility size (sq. feet)

100 90 80 70 60 50 40 30 20 10 0

Proportion of accredited units

Percen of oa

Animal care and use program deficiencies


13%
Ins ona Po c es

12% 5% 70%

abora ory nima Medicine Ve erinary Care P ysica P ant

Facilities mandatory deficiencies


1. Facility HVAC 2. Facility safety 3. Facility maintenance 4. Facility sanitation 5. Facility design 6. Facility illumination 7. Facility storage 8. Facility security

The top three deficiencies


 IACUC function  Occupational health and safety program  Heating, ventilation and air conditioning system performance

HVAC mandatories
(Ranked in order of most common)

1. Data not available at site visit 2. Not maintaining temperature range 3. Not maintaining air changes (ventilation) 4. Not maintaining humidity range 5. Not meeting recirculated air standards 6. Animal room temperature and humidity not monitored

Common HVAC findings


    Air exchange rate (10-15 ach) Relative humidity levels Air recirculation/filtration Air pressure differentials

HVAC purposes
(Guide)

    

Supply adequate oxygen Remove thermal loads Dilute gaseous and particulate contaminants Adjust moisture content Create static-pressure differentials

Space, temperature and humidity criteria


 Dry bulb temperature
Adjustable +/- 2 Fixed, minimum 66F or 68F Individual room or zone

Space, temperature and humidity criteria


 Relative humidity
Adjustable or fixed, 30-70% RH Individual room or zone

HVAC purposes
(NIH Ventilation Design Handbook)

 Balance air quality, animal comfort and energy efficiency to provide cage environments that optimize animal welfare and research efficiency.  Provide a healthy and comfortable environment for researchers and animal caregivers.

Factors
     Room size Air change rates Pressurization Type and location of diffusers Type and location of racks/cages

Factors
 Species  Bedding type  Cage change frequency

www.aaalac.org/connection_1su1998.htm

Contains:
 Details on codes, regulations and standards.  Laboratory animal facilities planning and design including architectural finishes and costs issues.  Overview of equipment and mechanical systems.

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


 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 on Achilles heels  Include commissioning/validation

Program needs
        Animal procedures - vivarium or laboratories Surgical or diagnostic radiography suites In-house diagnostic needs Need for floor drains Containment/contamination control Imaging requirements Sizing major installed equipment Impact of design on labor costs

Separation of functions
    Animal ops from personnel areas Disease-status separation Species conflicts/incompatibilities Noise

Operational adjacencies
       Established colonies vs. new arrivals Cage sanitation Cage storage/cage staging Procedure rooms Surgical suite and associated support spaces Loading dock and associated in/out functions Indirect adjacencies requiring accommodation

Horizontal vs. vertical design


       Elevators Stairways Security Windows/external light Mechanical systems distribution Support columns Security

Traffic flow vs. efficiency of design


        System of corridors Containment/contamination control Safety and security (emergency egress) Personnel entering or using facility Animal resource staff; research staff Maintenance/service staff; Visitors Access to support spaces (offices, training) Horizontal versus vertical construction

Facility integrity considerations


      Seismic Vibration External water - vertical & horizontal Inherent insulation Acoustic control Floor loading considerations

Institutional infrastructure
     Electrical Central steam & chilled water Water and sewage systems Communications Security

Facility maintenance
 Interstitial space = max. flexibility  Avoid maintenance devices above animal room drop ceilings  Consider space/access for repair of all installed equipment!

Mechanical systems
      Design HVAC for worst case Dedicate to animal facility Provide component redundancy Ductwork integrity (minimal leakage) Air pressure differential control needs RH control (none, zone, room-by-room)

 Additional exhaust needs

Floor drains
 Drain diameter/grating critical  Location
Center vs. side; 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 - 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 expertise 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 Integrity impact upon pest control program

Fit and finish protection


    Wall guards - bumpers Door jamb guards Corner guards Interior curbs

Critical dimensions
Door heights and widths (net clearances) Cage wash equipment chamber (H&W) Elevator door heights Autoclave height, width and depth Corridor widths + turning radiuses at corners, elevator lobbies, etc.  Corridor devices & other protuberances (signs, fire extinguishers, telephones, etc.)     

Doors
       Avoid hollow doors (pest management) Door hardware - long-term integrity is critical Hinges Door closures Door handle design Security (electric strike) Metal versus fiberglass versus wooden

Electrical system
        Early identification of high-demand equipment Emergency (stand-by power) needs HVAC Emergency lighting Emergency egress; surgery/ICU areas Animal holding; outlets for equipment Perimeter and internal 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 facilities  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 elements for success


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

 Constantly focus on 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


www.aaalac.org/resources

Examples of references which address facility design and operation


 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.

References

(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 Edition, 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 Protection of Vertebrate Animals Used for Experimental and 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 Scientific 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 requirements

 Geographical location & environment  Facility type and construction

Facility location and traffic patterns

Security
 Public access  Signs  Locks and other measures

Traffic reduce potential for contamination

Personnel areas
 Clerical / office areas  Rest rooms / locker rooms  Eating areas

Animal 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, ceilings, floors
Frequency Space Materials and methods

Heating ventilation and air conditioning


 Monitoring
Personnel Manual / automatic Temperature & humidity Air flow direction Evidence of animal abnormalities

 Frequency  Maintenance  Operational aspects

Heating ventilation and air conditioning


Special requirements  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 safety 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 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. 1101

Filtration HEPA

Air Exchanges 11.8/hr (fresh)

Air ressure Di erential 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 wetmopping 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
 Room 1101 rats-4 plastic cages (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 or 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
 The macaques were specific pathogen free and were known to be CHV-1 (Herpes B virus) negative by 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 locked out to personnel when transport to and from the labs was performed and the elevators 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 PPE and whether human patients were imaged in the imaging lab, as well as any health risks to personnel and patients.

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

(contd)

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 105F 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


 There were no after hours monitoring mechanism for monitoring HVAC system performance in the facility and for alerting responsible personnel for malfunctions. To minimize the risk to animal health and control variables that might confound research and testing data, a process whereby appropriate personnel are notified when environmental variables fall outside Guide recommended ranges should be implemented.

Suggestions for improvement


 AAALAC International must be notified of such events under the recent changes in the by-laws for accredited institutions. The institution was reminded of the requirement to notify OLAW as well as AAALAC.