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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.

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speakers and topics
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
flexibility and adaptability
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 cont d
Flexibility and adaptability (Cont’d)
  • Future
    • Regulation of rats, mice, birds - space?
    • Operational issues
      • Energy
      • Maintenance
    • New technologies
      • Transgenics and new species
      • Genomics and proteomics
      • Other drivers for the way animals are used
    • Social
facilities operation and design
Facilities operation and design
  • Scientific programs
  • Laboratory animals
  • Veterinarians
  • Engineers
  • Community
building considerations
Building considerations
  • Research objectives
  • New construction
  • Renovation
  • Flexibility and adaptability
  • Utilities use
  • Adjacencies
  • Operational costs
operation and design tools some examples
Operation and design tools(Some examples)
  • Information sharing - network
  • Computer aided design
  • Computational fluid dynamics
information and management
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
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)
slide16

"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
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...)
summary and conclusions
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 cont d
Summary and conclusions (Cont’d)
  • 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 cont d1
Summary and conclusions (cont’d)
  • Certain future areas in lab animal facilities opportune for change include:
    • Room design and layout
    • Facility design and layout
    • New technological advances
    • Automation
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

Facilities mandatory deficiencies
the top three deficiencies
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
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
Common HVAC findings
  • Air exchange rate (10-15 ach)
  • Relative humidity levels
  • Air recirculation/filtration
  • Air pressure differentials
hvac purposes guide
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
Space, temperature and humidity criteria
  • Dry bulb temperature
    • Adjustable +/- 2°
    • Fixed, minimum 66°F or 68°F
    • Individual room or zone
space temperature and humidity criteria1
Space, temperature and humidity criteria
  • Relative humidity
    • Adjustable or fixed, 30-70% RH
    • Individual room or zone
hvac purposes nih ventilation design handbook
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
Factors
  • Room size
  • Air change rates
  • Pressurization
  • Type and location of diffusers
  • Type and location of racks/cages
factors1
Factors
  • Species
  • Bedding type
  • Cage change frequency
contains
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.

critical elements for success
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
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
Separation of functions
  • Animal ops from personnel areas
  • Disease-status separation
  • Species conflicts/incompatibilities
  • Noise
operational adjacencies
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
Horizontal vs. vertical design
  • Elevators
  • Stairways
  • Security
  • Windows/external light
  • Mechanical systems distribution
  • Support columns
  • Security
traffic flow vs efficiency of design
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
Facility integrity considerations
  • Seismic
  • Vibration
  • External water - vertical & horizontal
  • Inherent insulation
  • Acoustic control
  • Floor loading considerations
institutional infrastructure
Institutional infrastructure
  • Electrical
  • Central steam & chilled water
  • Water and sewage systems
  • Communications
  • Security
facility maintenance
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
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
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
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
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
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
Ceilings
  • Bottom of floor above or suspended
  • Access requirement
  • Sanitizability
  • Integrity – impact upon pest control program
fit and finish protection
Fit and finish protection
  • Wall guards - bumpers
  • Door jamb guards
  • Corner guards
  • Interior curbs
critical dimensions
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
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
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
Illumination
  • Dual light levels
  • Fixture placement relative to rack positions to maximize cage level illumination
  • Light-cycle automation minimizes inadvertent lighting errors
cage wash
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 success1
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
aaalac international uses recognized references for performance standards www aaalac org resources
AAALAC International uses recognized references for performance standards…www.aaalac.org/resources
examples of references which address facility design and operation
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
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 continued1
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 continued2
References (Continued)
  • European Convention for the Protectionof 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 Scientific Purposes. European Union (Directive 86/609/EEC), 1986.
evaluation criteria
Evaluation criteria
  • Performance vs. engineering
evaluation responsibility
Evaluation responsibility
  • Institutional Animal Care and Use Committee
  • Facility management
  • Engineering
operational considerations
Operational considerations
  • Size of the program
  • Nature of animal use
    • Species
    • Flexibility requirements
  • Geographical location & environment
  • Facility type and construction
security
Security
  • Public access
  • Signs
  • Locks and other measures
personnel areas
Personnel areas
  • Clerical / office areas
  • Rest rooms / locker rooms
  • Eating areas
animal species
Animal species
  • Species requirements
  • Microbiological status
  • Containment
support functions
Support functions
  • Surgery
    • Dedicated?
  • Procedure
  • Necropsy
  • Cage Wash
  • Receiving
  • Laboratories
maintenance
Maintenance
  • Identification of deficiencies
  • Prioritization of repair
  • Conducting repairs
  • Documentation of the maintenance program
surfaces
Surfaces
  • Walls, ceilings, floors
    • Frequency
    • Space
    • Materials and methods
heating ventilation and air conditioning
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 conditioning special requirements
Heating ventilation and air conditioningSpecial requirements
  • Biosafety and fume hood maintenance and certification
  • Necropsy
  • Inhalant anesthetics
plumbing
Plumbing
  • Monitoring
    • Drinking water systems
    • Sanitation water systems
    • Drains
illumination1
Illumination
  • Light timers (timer overrides)
  • Light intensity
  • Natural light
  • Observational conditions
noise
Noise
  • Animal issues
  • Personnel safety issues
  • Operational issues
storage facilities
Storage facilities
  • Adequacy
  • Appropriate for use or separation
    • Food
    • Bedding
    • Clean cages
    • Chemicals
sanitation facilities
Sanitation facilities
  • Prevent cross contamination
  • Control aerosols - personnel protection
  • Monitoring effectiveness
  • Maintenance
  • Use of vacuums
  • Use of chemicals
slide90
The key element necessaryto assure high levels of performance standards:Well trainedand dedicated personnel
case study 1 hvac

Case Study #1HVAC

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.

slide93

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
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 up1
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)

Follow up

Suggestion for improvement …

case study 2 elevator access
Case Study #2Elevator 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
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
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
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 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
Case Study #3After-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 improvement1
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 improvement2
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.