Speakers and topics

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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

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Hilton J. Klein, M.S., V.M.D.Overview and
introduction
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What is a program?
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Rising costs of researchand research trends
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Rapidly increasing RD costs
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New targets from genomics
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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

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Flexibility and adaptability (Contd)

• 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

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Facilities operation and design

• Scientific programs
• Laboratory animals
• Veterinarians
• Engineers
• Community

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Building considerations

• Research objectives
• New construction
• Renovation
• Flexibility and adaptability
• Utilities use
• Adjacencies
• Operational costs

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Operation and design tools(Some examples)

• Information sharing - network
• Computer aided design
• Computational fluid dynamics

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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.
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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)

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Performance standards
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"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."
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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...)

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Hager Hauler
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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 RD resources is rising as new
  therapeutic targets are identified.

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Summary and conclusions (Contd)

• Animal research resources are coupled to RD 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.

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Summary and conclusions (contd)

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

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Kathryn A. L. Bayne, M.S., Ph.D., D.V.M.Review
of commonlycited facility problems
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Over 640 accredited institutions ...

• in 18 countries

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Proportion of accredited unitsBy facility size
(sq. feet)
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Animal care and useprogram deficiencies
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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

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The top three deficiencies

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

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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

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Common HVAC findings

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

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HVAC purposes (Guide)

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

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Space, temperature and humidity criteria

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

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Space, temperature and humidity criteria

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

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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.

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Factors

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

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Factors

• Species
• Bedding type
• Cage change frequency

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www.aaalac.org/connection_1su1998.htm
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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.
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James F. Taylor, D.V.M., M.S.Design of
facilities the AAALAC perspective
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Critical elements for success

• Define what the facility needs to accomplish
• Provide flexibility to accommodate future needs
• Knowledgeable users and AE/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

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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

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Separation of functions

• Animal ops from personnel areas
• Disease-status separation
• Species conflicts/incompatibilities
• Noise

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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

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Horizontal vs. vertical design

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

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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

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Facility integrity considerations

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

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Institutional infrastructure

• Electrical
• Central steam chilled water
• Water and sewage systems
• Communications
• Security

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Facility maintenance

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

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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

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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

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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

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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

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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!

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Ceilings

• Bottom of floor above or suspended
• Access requirement
• Sanitizability
• Integrity impact upon pest control program

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Fit and finish protection

• Wall guards - bumpers
• Door jamb guards
• Corner guards
• Interior curbs

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Critical dimensions

• Door heights and widths (net clearances)
• Cage wash equipment chamber (HW)
• 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.)

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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

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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

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Illumination

• Dual light levels
• Fixture placement relative to rack positions to
  maximize cage level illumination
• Light-cycle automation minimizes inadvertent
  lighting errors

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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!

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Critical elements for success

• Define what the facility needs to accomplish
• Provide flexibility to accommodate future needs
• Knowledgeable users and AE/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

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Stephen T. Kelley, M.S., D.V.M.Performance
standards and facility design and operation
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AAALAC International uses recognized references
for performance standards www.aaalac.org/res
ources
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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.

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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.

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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.

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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.

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Evaluation criteria

• Performance vs. engineering

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Evaluation responsibility

• Institutional Animal Care and Use Committee
• Facility management
• Engineering

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Operational considerations

• Size of the program
• Nature of animal use
• Species
• Flexibility requirements
• Geographical location environment
• Facility type and construction

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Facility locationand traffic patterns
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Security

• Public access
• Signs
• Locks and other measures

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Traffic -reduce potentialfor contamination
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Personnel areas

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

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Animal species

• Species requirements
• Microbiological status
• Containment

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Support functions

• Surgery
• Dedicated?
• Procedure
• Necropsy
• Cage Wash
• Receiving
• Laboratories

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Maintenance

• Identification of deficiencies
• Prioritization of repair
• Conducting repairs
• Documentation of the maintenance program

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Surfaces

• Walls, ceilings, floors
• Frequency
• Space
• Materials and methods

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Heating ventilationand air conditioning

• Monitoring
• Personnel
• Manual / automatic
• Temperature humidity
• Air flow direction
• Evidence of animal abnormalities
• Frequency
• Maintenance
• Operational aspects

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Heating ventilation and air conditioningSpecial
requirements

• Biosafety and fume hood maintenance and
  certification
• Necropsy
• Inhalant anesthetics

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Plumbing

• Monitoring
• Drinking water systems
• Sanitation water systems
• Drains

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Illumination

• Light timers (timer overrides)
• Light intensity
• Natural light
• Observational conditions

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Noise

• Animal issues
• Personnel safety issues
• Operational issues

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Storage facilities

• Adequacy
• Appropriate for use or separation
• Food
• Bedding
• Clean cages
• Chemicals

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Sanitation facilities

• Prevent cross contamination
• Control aerosols - personnel protection
• Monitoring effectiveness
• Maintenance
• Use of vacuums
• Use of chemicals

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Standard operatingprocedures and training
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The key element necessaryto assure high levels
of performance standardsWell trainedand
dedicated personnel
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Case studies
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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.

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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
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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 for improvement
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Case Study 2 Elevator access
Observation A site visit to a large university
biomedical research program indicated that a
small colony (n25 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.
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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.

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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.

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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
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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/inhalati
  on 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.

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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.

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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.