AAALAC International: Process and Expectations
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Transcript of AAALAC International: Process and Expectations
AAALAC International: Processand Expectations
James R. Swearengen, DVM, DACLAM, DACVPMSenior Director
Topics
Overview of AAALAC and the accreditation process
Benefits of accreditation Expectations for ACUCs Common misconceptions
What is AAALAC? The Association for Assessment and
Accreditation of Laboratory Animal Care International ...
Enhances life sciences by promoting theresponsible treatment of animals usedin research, teaching and testingthrough voluntary accreditationand assessment programs.
Origins
During the post-World War II science boom, leading veterinarians and researchers saw the need for an independent organization to encourage high standards for humane animal care and use in science.
AAALAC was created to meet this need, and was incorporated as an independent nonprofit [501(c)(3) corporation in 1965.
Organization
“Member Organizations” govern AAALAC, and are represented on the Board of Trustees (>65)
The “Council on Accreditation” carries out the accreditation program (45 members)
190+ “Ad hoc Consultants” help conduct program evaluations
Council CoordinatorMs. Sandy Dexter
Council onAccreditation
Senior Director & Director of
Pacific Rim ActivitiesDr. Kathryn Bayne
Executive DirectorDr. John G. Miller
Program AnalystMs. Darlene Brown
Marketing/CommunicationsMs. Lori Wieder
Program AssistantMs. Anne Hottinger
Ad HocsCouncil
SecretaryMs. Carmen Wallin
Program AssistantMs. Sara Levy
Program AssistantMs. Gretchen Hill
Director of European Activities
Dr. Egil Berge
Board of Trustees
Executive Committee
Senior DirectorDr. James Swearengen
Operations ManagerMr. Dave Maurey
Financial ManagerMr. Jacob Meesarapu
Program AnalystMs. Heather Breighner
AAALAC InternationalOrganizational Chart
500
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650
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750
1994
1996
1998
2000
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2006
Number ofAccreditedUnits
Over 735 Accredited Units in 30 Countries
Countries with Accredited Units
Africa Austria Belgium China Canada Denmark Egypt England France Germany Hungary India Indonesia Israel Italy Japan
Korea Netherlands Norway Peru Philippines Russia Scotland South Africa Spain Sweden Switzerland Taiwan Thailand USA
Proportion of Accredited Units by Industry Sector
6%10%
19%
35%
30% Academic
Commercial
Government
Non-Profit
Hospital
The Accreditation ProgramCornerstones
voluntary
peer-review process
performance-based
completely confidential
Voluntary Participation
Commitment to principles of the Guide
High standards set and maintained
Accountability to science & the public
Peer Review Process
Evaluation by independent experts in the field
Collegiality NOT an inspection Peer review is a form of quality control A process of evaluating, critiquing and
improving
Evaluation or Inspection?
“… the accreditation process is a communication-intensive program of evaluation and support, stressing application of performance standards and professional judgment rather than inspection and enforcement of engineering standards.”
Ronald M. McLaughlin, D.V.M.Past Chair, Board of Trustees
The Use of Performance Standards
"requires that users, IACUCs, veterinarians, and producers use professional judgment in making specific decisions regarding animal care and use."
Completely Confidential
Full disclosure
Free, open communications
Accreditation Process Prepare the Program Description Site Visit
Review Program Description in depth Tour facilities Meet with IACUC members Meet with senior officials Executive session for site visitors Exit briefing
clarifications preliminary findings recommendations to Council
Possible Outcomes
New Applicants
Award Full Accreditation Provisional Status Withhold Accreditation
Site Revisits
Continued Full Accreditation Continued Full w/ Condition Deferred Accreditation
administrative deficiencies short-term resolution
possible Probationary Accreditation Revoke Accreditation
The “AAALAC” Standard
Not a single document Encompasses the entire animal program Based on internationally recognized standards
Science-based
Collective professional judgment of experts Science-driven
Applied through in-depth peer review process Science-based
Standards for Accreditation
National requirements as baseline (e.g. U.S.) Animal Welfare Act Public Health Act
Guide is principal standard AAALAC Reference Resources as applicable Expert professional judgment Peer review process
*ALL PRINCIPLES OF GUIDE MUST BE MET
Why is there International Interest in Accreditation?
Global nature of science and scientific exchange: International meetings have animal care standards Peer-reviewed journals have animal care standards Most funding sources have animal care standards Cross fertilization of ideas through AAALAC site visits AAALAC accreditation is an internationally recognized
symbol of quality
Benefits of AAALAC Accreditation
Provides confidential peer-review
Concentrates on promoting continued improvement
Incorporates standardized and consistent outcome measures allowing to determine performance, best practices and to monitor progress
Represents quality
Accreditation by AAALAC International is a valuable and integral component of any quality assessment and control program
- Requires an extensive internal review- Provides a comprehensive external review
Benefits of AAALAC Accreditation Harmonization of standards used allows for
comparison in effeciency of ethical and animal welfare management
Keeps you knowledgeable and in step with best practices
Incites to adopt high standards and helps to raise the global benchmark for animal well-being in science
Provides the public with a positive image
Benefits of AAALAC Accreditation
Conveys a high level of professionalism to the scientific community
Promotes scientific validity Minimizes experimental variables Promotes reproducible quality data
Recognized by funding sources and research partners AAALAC is the ONLY animal care accreditation body
that is world-wide
Accreditation Promotes Harmonization
Single AAALAC standard Flexibility of performance standards Sensitivity to legal, cultural issues Cross fertilization through site visits Highlighting of best practices Benchmarking of quality
Expectations for the Most Frequently Found Deficiencies Institutional policies
IACUC Protocol review
Review of potential pain and distress (The most frequent source of mandatory findings for protocol review issues)
Occupational health and safety Hazard identification and risk assessment
Veterinary care
Physical plant
Potential for Pain or Distress
What the Guide says should be included in protocol development and review….
Appropriate sedation, analgesia, and anesthesia Criteria and process for timely intervention (e.g.,
administering analgesics), removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated
An integral component of veterinary medical care is prevention or alleviation of pain associated with procedural and surgical protocols
What Council May Say….
Council must be assured that the IACUC reviews protocols for the appropriate use of pain relieving agents; considers the criteria and determines a process for timely intervention, removal of animals from study, or euthanasia if painful or distressful outcomes are anticipated; and documents such deliberations
Review of Pain and Distress: Preventing Deficiencies Emphasize prevention of pain and distress
during protocol review Procedures that cause pain or distress must be
performed with appropriate sedation, analgesia, or anesthesia
Withholding relief must be justified for scientific reasons, and in writing
IACUC should have enough information to determine how and why withholding relief would interfere with the study The sentence, “Analgesics will interfere with the study” is not
considered to be a sufficient justification by itself
Review of Pain and Distress: Preventing Deficiencies (cont.)
A detailed plan for use of humane endpoints should be included in the protocol if pain or distress is expected
Evaluate effectiveness and thoroughness of program during the semiannual facilities inspection and program review
Ensure amendments to protocols with potential for pain or distress have had opportunity for appropriate committee review
Hazard Identification
OHS, Hazard Identification:Preventing Deficiencies Keys to effectively identifying hazards
Staff conducting hazard identification qualified to assess the dangers
Review of animal protocols with potential safety issues
Review of institutional job safety data Accident reports Manufacturer’s safety bulletins MSDS’s, chemical inventories Safety committee or safety audit reports
OHS, Hazard Identification: Preventing Deficiencies (cont.)
Regularly scheduled walk-through reviews of animal facilities and investigator laboratories by environmental health and safety professionals Involve an EHS professional trained in hazard
identification and control Enhanced by involvement of animal care and
research personnel Conduct review when work/research in progress Discuss with workers, get their opinions
Identify both experimental and non-experimental hazards
Risk Assessment
OHS, Risk Assessment: Preventing Deficiencies Risk assessment
No longer based only on substantial animal contact
Includes evaluation of both job related and individual health related risks
Involve trained professionals Inclusion in an OHS program MUST be
offered to all at-risk employees
OHS, Risk Assessment: Preventing Deficiencies
“Health and safety specialists…should be involved in the assessment of risks associated with hazardous activities and in the development of procedures to manage such risks.”
Veterinary Medical Care
Veterinary Medical Care
The most frequent deficiency in veterinary care identified during site visits is that clinical monitoring, reporting, and provision of veterinary care are not sufficient to meet the needs of the program
Veterinary Medical Care: Preventing Deficiencies
Must have an effective system for reporting and timely delivery of care
Ensure good communication between research staff, veterinary staff, husbandry staff, and veterinarian
Physical Plant
Top Three Mandatory Physical Plant Issues
Floors in state of disrepair (most frequent for both mandatory and SFI)
HVAC performance data not provided, incomplete, or outdated
Relative air pressure inappropriate for use of area
Physical Plant: Preventing Deficiencies Have an active program of ongoing preventive
maintenance Don’t wait until last minute to obtain HVAC
performance data for the Program Description Data must be within 12 months from when PD is
submitted
Regular monitoring of air pressure differentials for critical areas (e.g., surgery, ABSL-2/3/4, necropsy, rodent barriers, etc.)
What AAALAC International Doesn’t Expect An inflexible program AAALAC does not require shiny and new, but
does expect clean, sanitized, and functional What are NOT typically issues for agricultural
programs? Older facilities in good repair Unpainted wood Natural ventilation Non-controlled photoperiod (open barns) Dirt floors in sheds/pens/shelters Cold housing (no temperature control) Rust on corral panels/fences
Questions?
For more information….
AAALAC International5283 Corporate DriveFrederick, MD 21703
USA301.696-9626 phone
800.926.0066 toll-free301.696.9627 fax
[email protected]://www.aaalac.org