Welcome!

2. Welcome! Moderator: James R. Swearengen, DVM, DACLAM, DACVPM Senior Director, AAALAC International • The Peer Review Process: What Happens After the Exit Briefing?Kathryn Bayne, MS, PhD, DVM, DACLAM, CAAB, Senior Director and Director of Pacific Rim Activities, AAALAC International • Animal Environment, Housing and Management Dale G. Martin, DVM, PhD, DACLAM, DACVPM, DECLAM, Senior Director, Laboratory Animal Science and Welfare, sanofi-aventis • Training and OHS ProgramsDennis M. Stark, DVM, PhD, DACLAM, Executive Director, Veterinary Sciences, Pharmaceutical Research Institute, Bristol-Myers Squibb • PPE and HVAC IssuesJames J. Elliott, DVM, DACLAM, Director, Department of Laboratory Animal Resources, University of Texas Health Science Center at San Antonio

3. The Peer Review Process: What Happens After the Exit Briefing? Kathryn Bayne, MS, PhD, DVM, DACLAM, CAAB Senior Director and Director of Pacific Rim Activities

4. The Accreditation Program • is a peer-review process • is performance-based • is completely confidential

5. What is Peer Review? • a process of subjecting an author's scholarly work or ideas to the scrutiny of others who are experts in the field (Wikipedia) • a process by which something proposed (as for research or publication) is evaluated by a group of experts in the appropriate field (Merriam-Webster)

6. Reasons for Peer Review • “showing work to others increases the probability that weaknesses will be identified, and with advice and encouragement, fixed.” • “since the reviewers are normally selected from experts in the fields discussed … the process of peer review is considered critical to establishing a reliable body of research and knowledge.”

7. Criticism of Peer Review • Reviewers tend to be especially critical of conclusions that contradict their own views, and lenient towards those that accord with them

8. The AAALAC International process is one of layersof peer review i.e., there is peer review of the peer review…

9. The First Step in the Peer Review Process • AAALAC International Rules of Accreditation • All accreditable units shall be initially evaluated by a team of not less than two site visitors chosen by AAALAC International from among the members of and consultants to the Council

10. Methods to Ensure High Quality Peer Review • Composition of the site visit team • Tailored to the institution; Senior Director makes site visit assignments • Avoidance of conflict of interest • Annual declaration • Site visit specific declaration • Both real and perceived taken into account • Limit to the number of times a Council member may take out a particular ad hoc Consultant • Avoids “cronyism” • Office assigns ad hoc Consultants

11. Who is the Council on Accreditation? • Veterinarians • 10 DVMs; 24 DVM plus graduate degree • Researchers • Research administrators • From 8 countries (including U.S.) • Represent academia, industry, government, private sector • Experience on Council ranges from 1-12 years

12. Quality Assuranceof the Peer Reviewers • New Council members undergo an orientation program and are assigned a mentor • Council members receive ongoing feedback from institutions, other Council members, and Council Officers • Council members receive site visit specific continuing education

13. Who are the ad hoc Consultants/Specialists? • Formal application and selection/election process • More than 200 ad hocs on the roster • Consultants and Specialists from 23 countries and 36 of the 50 states • Expertise includes barrier operations, biosafety, toxicology, agricultural animals and other species-specific knowledge (e.g., nonhuman primates, aquatics, transgenic rodents), surgery, infectious disease, IACUC function, etc.

14. Quality Assuranceof the Peer Reviewers • Annual ad hoc orientation program offered at national AALAS meeting and other venues • Performance is evaluated by Council member after each site visit by use of a standardized form • Contribution to the site visit, inclusive of ability to elicit, assess and communicate information and understand issues and their significance

15. The Second Step in the Peer Review Process • Review of the Site Visit Report (including the post site visit communication from the institution) • Pre-meeting electronic review and comment/discussion • Minimum of two Council Officers and two other Council members, initially • Site visit team members can respond to queries and provide clarifications, additional detail

16. The Second Step in the Peer Review Process • Review of the Site Visit Report (including the post site visit communication from the institution) • Council meeting deliberations • Face-to-face, real-time • Discussion by Council section (10-11 members) • Any Revoke or Withhold actions discussed by full Council

17. Council Structure • Full Council – 43 members • North American Section (32) • European Section (10) • Council Officers • President (belongs to both NA and EU Sections) • Vice President • Leads one section • Section Leader (3) • Each leads a section • Assistant Section Leaders (4) • Official record keeper of the deliberation results

18. Council Officers’ Meetings • Meetings held immediately prior to the Council meetings (Jan, May, Sept) • Evaluate Council operations to ensure sound functioning of the peer review process • Identify topics of more intense discussion in each section • Work to establish an approach to resolve • Perhaps establish a committee to evaluate further

19. Council Committees • Convened in response to an identified need; examples include: • Special topics • Use of alcohol as a disinfectant (http://www.aaalac.org/publications/newsletter.cfm) • Quality control through assurance of appropriate degrees of flexibility and consistency in the application of standards • Consideration of new Reference Resources or deletion of existing Reference Resources

21. Council Deliberations • Guide and AAALAC Reference Resources available to each Council Section • A staff member is available as an administrative resource in each Council Section • The President of Council moves among Sections to ensure consistency in the review process • A formal vote is taken for each accreditation status recommendation; records are maintained of the votes

23. The Third Step in the Peer Review Process • Review of the letter to the institution • Post Council meeting review by Section Leader or Vice President • Content, clarity • Post Council meeting review by President • Content, clarity, consistency • Post Council meeting review by Senior Director and other staff • Content, clarity, consistency, grammatical, matches records from Section

24. Institutional Responses • Correspondence from institutions that had a mandatory item for correction identified in the animal care and use program • Undergoes similar process as a site visit report • Review by site visit team • Pre Council meeting electronic discussion • Council meeting deliberations in assigned section • Post Council review by Officers and AAALAC staff

25. Definitions of “Peer” • 1: one that is of equal standing with another :EQUAL; especially: one belonging to the same societal group (Merriam-Webster) • Colleagues who share the same experiences you do in your animal care and use programs

26. Animal Environment, Housing and Management Dale G. Martin, DVM, PhD, DACLAM, DACVPM, DECLAM, Senior Director, Laboratory Animal Science and Welfare, sanofi-aventis

27. The content of the Exit Briefing coupled with how you respond in the post site visit communication (PSVC) may result in vast differences in programmatic outcomes to the same observation.

28. Example…..Site Visitor’s Observations: • Rats were singly housed on wire-bottom caging. Some mice had nestlets, however, some mice on similar studies did not

29. Exit Briefing Discussion: • Site visitors: suggested that the Unit evaluate the environmental enrichment program for all species

30. The Guide States • “some evidence suggests that solid-bottom caging is preferred by rodents. Solid bottom caging, with bedding, is therefore recommended for rodents…… IACUC review of this aspect of the animal care program should ensure that caging enhances animal well-being consistent with good sanitation and the requirements of the research project.” • “Wherever it is appropriate, social animals should be housed in pairs or groups, rather than individually,…” • “Depending on the species and use, the structural environment should include…..”

31. Post site visit communication (PSVC)=States binding commitment by the Unit to AAALAC International:

32. Unit Response: • No response submitted

33. Unit Response in PSVC: • The IACUC convened a committee of investigators and the attending veterinarian. A comprehensive environmental enrichment program for all species was developed and a policy was developed rodent housing consistent with the Guide.

34. Other Unit Response(s) in PSVC: • A. Rats are now housed on wire only when the investigator requests and the IACUC approves housing rats on wire. B. The Attending Veterinarian recommended and the IACUC endorsed that all breeding mice will be provided nestlets. C. Environmental enrichment is encouraged, a policy is in development which should address species specific needs for all rodents.

35. Unit Response in PSVC: • “As AAALAC demanded all rats will be group housed in solid bottom caging. All rodents will be provided nestlets. Nestlets will be changed as soon as they become damaged”Obviously, there was a failure to communicate, what was observed by the site visitors, and discussed, was not interpreted or communicated effectively to the unit. An undesirable outcome may result.

36. AAALAC, International’s Response: • No responsesubmitted AAALAC may say in a Suggestion for Improvement (SFI): Many of the rodents were housed on wire-bottom cages for both short and long term studies. While wire-bottom caging may enhance sanitation, there is evidence that suggests rodents prefer bedded solid-bottom cages. In addition, pressure neuropathy may result when animals are housed on wire-bottom cages for extended periods of time. The IACUC should review the use of wire-bottom caging for rodents and ensure that caging enhances animal well-being consistent with good sanitation and the requirements of each research project.The structural environment for rodents did not include items that increase the opportunity for expression of species-typical postures and activities and enhance the animals’ well being. These behavioral management needs should be reviewed to conform with recommendations of the Guide.

37. Programmatic result from PSVC: • no change in housing arrangement to………………all rats group housed in solid bottom cages with nestlets being used (perhaps overused)..and because AAALAC International required it??!!!

38. Animal Environment, Housing and Management (Example 2)

39. Example…..Site Visitor’s Observations: • Animal facility had many rabbits, Guinea Pigs and dogs. • The facility did not have a rack washer. • Rabbit cages, Guinea Pig cages and all racks were sprayed with hot water and soap in a wash-down area of the cagewash. • There was excess mineral deposits on the Rabbit and GP caging. • Dog runs were washed down in place on a routine basis, however, there was visible dirt and grime build-up in several of the dog runs. • There was no monitoring of the effectiveness of the sanitation practices.

40. Exit Briefing Discussion: • Site visitors: • expressed concern about the effectiveness of sanitation of the dog runs. • noted that an optimal washing regiment may not be in place for GP and Rabbit caging.\ • Suggested that the Unit implement a program/procedures to effectively sanitize dog runs and all caging. • Suggested the Unit monitor the effectiveness of their sanitation program/ procedures.

41. The Guide States: • “For pens and runs, frequent flushing with water and periodic use of detergents or disinfectants are usually appropriate to maintain sufficiently clean surfaces.” • “Rabbits and some rodents, such as GP and hamsters, produce urine with high concentrations of proteins and minerals. Minerals and organic compounds in the urine from these animals often adhere to cage surfaces and necessitate treatment with acid solutions before washing.”

42. The Guide States: • “Washing and disinfection of cages and equipment by hand with hot water and detergents can be effective but require attention to detail. It is particularly important to ensure that surfaces are free of residual chemicals and that personnel have appropriate equipment to protect themselves from exposure to hot water or chemical agents used in the process.” • “Monitoring of sanitation practices should be appropriate to the process and materials being cleaned; it can include visual inspection of the materials, monitoring of water temperatures, or microbiologic monitoring.”

43. Post site visit communication (PSVC)=States binding commitment by the Unit to AAALAC International:

44. Unit Response: • No response submitted

45. Unit Response in PSVC: • The facility manager and attending veterinarian stated that they would evaluate their overall sanitation program and would implement a program to monitor the effectiveness of sanitation.

46. Other Unit Response(s) in PSVC: • A. Rabbit caging is now treated with Urid for 15 minutes, then sanitized with hot water and quatricide. B. Dog runs are scrubbed every 3 months to eliminate all visible dirt. A program of microbiological monitoring is now in place to monitor the effectiveness of sanitation of the dog runs. C. RODAC plate testing is performed on 10% of dog runs after sanitation, if 50 or more colonies grow on more that 2 of the plates, then the entire room is re- sanitized and retested.

47. Unit Response in PSVC: • “As the Site Visitors recommended, the University spent $200,000 on a new rack washer. This brought great hardship on the investigators as the per diems were increased four-fold.”Obviously, there was a failure to communicate.Or perhaps the Unit wanted to use the AAALAC “Club.”

48. AAALAC International’s Response: • No response submitted AAALAC may say in a Suggestion for Improvement (SFI): Hand washing of animal runs and cages can provide effective sanitation but requires attention to detail. Uniform procedures and practices should be implemented for ensuring consistent sanitation of animal cages and equipment. It is particularly important to ensure that surfaces are rinsed free or residual chemicals and that personnel have appropriate equipment to protect themselves from exposure to hot water or chemical agents used in the process. If hand washing is used, monitoring should be instituted to ensure effective sanitation.

49. AAALAC International’s Response: • No response submitted AAALAC may say in a Suggestion for Improvement (SFI): Although the dog runs were flushed twice a day with water, they were only cleaned with detergent once per year. Consequently, many runs had algae growth on the concrete. The runs should be cleaned and disinfected regularly. The timing of pen or run cleaning should take into account normal behavioral and physiological processes of the animals.Mineral deposits were present on many of the cages in Rooms X,Y,Z>. Minerals and organic compounds in the urine from animals often adhere to cage surfaces and necessitate treatment with acid solutions before washing. Cage washing practices should be improved to minimize animal waste accumulations and provide proper sanitation.

50. Programmatic result from PSVC: • Implementing slight changes in procedures, to spending hundreds of thousands of dollars……. • At times units may use AAALAC International inappropriately as a “Club.”