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 researchand 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 (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

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 considerationsQualification 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 (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’d)

Certain future areas in lab animal facilities opportune for change include:– Room design and layout

– Facility design and layout

– New technological advances

– Automation

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

Review of commonlycited facility problems

Over 640 accredited institutions ...… in 18 countries

Proportion of accredited unitsBy facility size (sq. feet)

0102030405060708090100

<1000

1,000

-9,99

9

10,00

0-24

,999

25,00

0-49

,999

50,00

0-99

,999

100,0

00-1

99,99

9

200,0

00-4

99,99

9

>500,0

00

Percent ofTotal

Animal care and useprogram deficiencies

5%

12%

13%

70%

Institutional Policies

Laboratory AnimalMedicineVeterinary Care

Physical Plant

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 66°F or 68°F– 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

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&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 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

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 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

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 locationand 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 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 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 operatingprocedures and training

The key element necessaryto assure high levels of performance standards:

Well trainedand 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 PressureDifferential

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 upAll 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 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 …

Case Study #2 Elevator accessObservationA 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 (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 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.