1. AAALAC International: Process and Expectations James R. Swearengen, DVM, DACLAM, DACVPM Senior Director

2. Topics  Overview of AAALAC and the accreditation process  Benefits of accreditation  Expectations for ACUCs  Common misconceptions

3. What is AAALAC?  The Association for Assessment and Accreditation of Laboratory Animal Care International... Enhances life sciences by promoting the responsible treatment of animals used in research, teaching and testing through voluntary accreditation and assessment programs.

4. 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.

5. 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

6. Council Coordinator Ms. Sandy Dexter Council on Accreditation Senior Director & Director of Pacific Rim Activities Dr. Kathryn Bayne Executive Director Dr. John G. Miller Program Analyst Ms. Darlene Brown Marketing/ Communications Ms. Lori Wieder Program Assistant Ms. Anne Hottinger Ad Hocs Council Secretary Ms. Carmen Wallin Program Assistant Ms. Sara Levy Program Assistant Ms. Gretchen Hill Director of European Activities Dr. Egil Berge Board of Trustees Executive Committee Senior Director Dr. James Swearengen Operations Manager Mr. Dave Maurey Financial Manager Mr. Jacob Meesarapu Program Analyst Ms. Heather Breighner AAALAC International Organizational Chart

7. Over 735 Accredited Units in 30 Countries

8. 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

9. Proportion of Accredited Units by Industry Sector

10. The Accreditation Program Cornerstones  voluntary  peer-review process  performance-based  completely confidential

11. Voluntary Participation  Commitment to principles of the Guide  High standards set and maintained  Accountability to science & the public

12. 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

13. 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

14. The Use of Performance Standards "requires that users, IACUCs, veterinarians, and producers use professional judgment in making specific decisions regarding animal care and use."

15. Completely Confidential  Full disclosure  Free, open communications

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. Potential for Pain or Distress

28. 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

29. 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

30. 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

31. 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

32. Hazard Identification

33. 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

34. 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

35. Risk Assessment

36. 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

37. 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.”

38. Veterinary Medical Care

39. 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

40. 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

41. Physical Plant

42. 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

43. 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.)

44. 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

45. Questions?

46. 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