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AAALAC International: Process and Expectations. James R. Swearengen, DVM, DACLAM, DACVPM Senior Director. Topics. Overview of AAALAC and the accreditation process Benefits of accreditation Expectations for ACUCs Common misconceptions. What is AAALAC?.

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slide1

AAALAC International: Process

and Expectations

James R. Swearengen, DVM, DACLAM, DACVPM

Senior Director

topics
Topics
  • Overview of AAALAC and the accreditation process
  • Benefits of accreditation
  • Expectations for ACUCs
  • Common misconceptions
what is aaalac
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
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
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
slide6

Board of Trustees

AAALAC International

Organizational Chart

Executive Committee

Executive Director

Dr. John G. Miller

Senior Director &

Director of

Pacific Rim Activities

Dr. Kathryn Bayne

Senior Director

Dr. James Swearengen

Director of

European Activities

Dr. Egil Berge

Council on

Accreditation

Council Coordinator

Ms. Sandy Dexter

Program Analyst

Ms. Darlene Brown

Program Analyst

Ms. Heather Breighner

Ad Hocs

Program Assistant

Ms. Anne Hottinger

Council

Secretary

Ms. Carmen Wallin

Program Assistant

Ms. Sara Levy

Program Assistant

Ms. Gretchen Hill

Financial Manager

Mr. Jacob Meesarapu

Marketing/

Communications

Ms. Lori Wieder

Operations Manager

Mr. Dave Maurey

countries with accredited units
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
the accreditation program cornerstones
The Accreditation ProgramCornerstones
  • voluntary
  • peer-review process
  • performance-based
  • completely confidential
voluntary participation
Voluntary Participation
  • Commitment to principles of the Guide
  • High standards set and maintained
  • Accountability to science & the public
peer review process
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
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

slide14

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
Completely Confidential
  • Full disclosure
  • Free, open communications
accreditation process
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

Possible Outcomes
the aaalac standard
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
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
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
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
slide22

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 accreditation1
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 accreditation2
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
AccreditationPromotes 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
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
what the guide says should be included in protocol development and review
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
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
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
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
ohs hazard identification preventing deficiencies
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
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
ohs risk assessment preventing deficiencies
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 deficiencies1
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 care1
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
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
top three mandatory physical plant issues
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
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
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
for more information
For more information….

AAALAC International

5283 Corporate Drive

Frederick, MD 21703

USA

301.696-9626 phone

800.926.0066 toll-free

301.696.9627 fax

accredit@aaalac.org

http://www.aaalac.org

jswearengen@aaalac.org