Presentation on theme: "Preparing for an AAALAC International Site Visit"— Presentation transcript:
1 Preparing for an AAALAC International Site Visit Jim Swearengen, D.V.M., DACLAM, DACVPMSenior Director, AAALAC International
2 Topics Covered AAALAC International site visits: Myth vs. Fact AAALAC speakPurpose of a site visitWhat to expect during a site visitTips on preparing for a site visit
3 Let’s Start With a Little Psychoanalysis Which of the following pictures best represents your impression of an AAALAC International site visit?
4 A: AAALAC puts its nose in places it shouldn’t; AAALAC sniffs around in the bowels of our facility to find problemsOrB: AAALAC is a valuable partner in helping us in reach our goal of an developing the best animal care and use program possibleA.B.OR
5 Accreditation = Partnership For accreditation to work there must be a totally open and honest relationship between the accredited site and the Council on Accreditation. It is a partnership, with both sides working to provide the best animal care and use program possible. Want to know what AAALAC thinks? Give us a call!
6 Myth vs. Fact Myth: AAALAC International is a regulatory agency. Fact: AAALAC International is a private, nonprofit organization.AAALAC International is not a government agency. It is a private, nonprofit organization promoting the humane treatment of animals in science through an accreditation program.
7 Myth vs. FactMyth: AAALAC International conducts inspections of laboratory animal care and use programs.Fact: AAALAC International evaluates laboratory animal care and use programs through a voluntary, peer-review process.That’s right. An AAALAC International evaluation (site visit) is conducted at the request of your institution to demonstrate that standards exceed federal requirements for the humane care and use of laboratory animals.
8 Myth vs. FactMyth: AAALAC International establishes policies and regulations.Fact: AAALAC International evaluates animal care and use programs based on recommendations in the Guide for the Care and Use of Laboratory Animals (Guide), NRC 1996 and other widely accepted guidelines.Although some are federal regulations, all others are from the peer-reviewed scientific literature.i.e. the research community establishes the standards
9 What Else Might Apply to Us? PHS Policy would apply if you have a PHS AssuranceAnimal Welfare Regulations would apply to regulated speciesAgriculture Guide would apply to agricultural research programs
10 Want a Heads Up on Other References that Site Visitors Use? There is a complete resource list available on the AAALAC Web siteIt is subdivided into resources for the United States, Canada, and Europe.
11 Myth vs. FactMyth: AAALAC International uses the same standards to evaluate animal programs outside the U.S.Fact: Because each country has its own set of laws and regulations, AAALAC International site visitors use a customized approach for evaluating the programs.Although some are federal regulations, all others are from the peer-reviewed scientific literature.i.e. the research community establishes the standards
12 They also evaluate the extent to which the program conforms with the principles outlined in the Guide for the Care and Use of Laboratory Animals, and other international standards including the European Union’s Directive 86/609/EEC.As you can see, the Guide is now available in seven different languages, Russian, Spanish, Chinese, English, French, Japanese and Portuguese. AAALAC is spearheading an effort to have the Guide translated and published in German and Arabic. The German version is currently in the process of being translated and the Arabic version was translated word-for-word many years ago, but will be translated so that it is easier to comprehend.
13 Myth vs. FactMyth: AAALAC International evaluates animal care and use programs that only use animals regulated under the Animal Welfare Act.Fact: AAALAC International accreditation covers all vertebrate animals. Many programs using non- regulated species, such as rats and mice, participate in the accreditation program.As well as other programs using nontraditional research animals such as fish or birds. In addition, if invertebrate animals are a significant part of the research mission at an institution, they will be included in the evaluation.Also, AAALAC includes agricultural animals used in food and fiber research.
14 Myth vs. FactMyth: An institution’s evaluation and report is available to the general public.Fact: AAALAC International’s accreditation process is confidential. The evaluation and its results are known solely by the institution and AAALAC International, even if deficiencies are found.They are not subject to the Freedom of Information Act (FOIA).Council members, ad hoc Consultants, members of the Board of Trustees, and AAALAC staff are all required to sign confidentiality agreements. In addition, Conflict of Interest statements are signed by each site visitor.Now, if your institution chooses to publicize or share the results of their AAALAC evaluation, they are welcome to do so.
15 AAALAC - Speak PD Program Description PE Program Evaluation PSVC Post Site Visit CommunicationCoACouncil on AccreditationSVSite VisitMustReally Means MustShouldGood Idea
16 Purpose of the Site Visit Gain thorough understanding of yourprogram of animal care and useCollect evidence of good performance!Serve as Council’s eyes and earsGather sufficient quantities of informationto serve as advocate before Council
17 Before the Site Visit The Council member is assigned Setting the date with the institutionThe Co-Visitors are selectedShared information is confidentialSame team never returns to same site
18 What do ‘They’ Know? Have read the current PD Have reviewed history of the institutionHave previous evaluations
19 Site Visit Coordination Make hotel reservationsAssure they know how to get whereLocal transportation to institution may be neededIntroductory meeting at the institution commonlyat 8:00 a.m. (arrival usually 7:30-7:45 am)Be on time!!!!Gracious collegial support is always the rightthing to do
20 Entrance Briefing Meet with institutional leaders (looking for evidence of institutional support)Introduce AAALAC, InternationalExplanation of the accreditation processExplanation of the proposed daily activitiesExplanation of possible final outcomes of SVOffer an Exit briefing at conclusion of the SV
21 Program Review Review/clarification of aspects of program Clarification of Program DescriptionSite visitors may request additional supportinginformation to gain additional information aboutthe programSite Visitors may ask for protocols and otherdocuments for later review during the SV
22 Program Review Pre-Review: On Site Review: Questions (and responses) before handSupplemental documentation before handOn Site Review:Page by page clarification(Abbreviated versus Long)Some site visitors may submit questions before the day of the site visit and provide a list of supplemental documentation they would like to review during the site visit in order to help expedite the program review.
23 Meeting with the IACUC Set aside some time to meet with IACUC Luncheon works wellDescribe accreditation processDiscuss issues and talk with lay representativesProblem cases … IACUC solutionsVERY important for site visitors to “get a feel” ifIACUC is engagedAlthough meeting with the IACUC is not required, it is highly suggested as a mechanism for Council members to “get a feel” for the level of engagement of your IACUC.
24 Meeting the Husbandry Staff Can set aside a prescribed time …Can have hallway meetings …Staff should be ‘familiar’ with the accreditationprocessDiscuss their areas of activityDon’t let Site Visitors do dumb things …Do be around and working
25 Meeting the Research Staff Facility walk-through evaluationsHealth of animalsCondition of facilities (Sanitation)Emergency Contacts and after hours vetsupportContract and satellite facilitiesPI laboratory visits
26 Review of Documentation USDA Inspection ReportsCompliance RecordsSelected IACUC ProtocolsPHS AssuranceIACUC meeting minutesStanding Operating Procedures (SOPs)These are some of the more typical documents that site visitors may request to see. Other documentation may be requested as needed.
27 Executive Session Site Visitors time to prepare for Exit Briefing Discuss issues and prepare notesCommendations for unitMandatory deficiencies and SFI’sSite Visitors recommendations to Council
28 Exit Briefing Provide unit with preliminary findings and impressions Opportunity to correct misinterpretations orerrorsWhen appropriate encourage PSVC within 10daysVerbal, not written
29 Exit Briefing Conducted by Council member Summary of program strengths andweaknessesCommendations of personnel whenappropriateRe-emphasize - Independent opinions ofsite visitors
30 Exit Briefing Discuss issues that are not clear Unauthorized research and procedures –MandatorySignificant health and safety issues forpersonnel and animals - MandatorySFI’s - Suggestions for improvement - e.g.,more intense microbiological monitoringMay have off line comments too.
31 Exit Briefing – Potential Outcomes If already accredited:If a new application:CFACFA w/ conditionDAProbationAFAProvisionalWithholdRevoke AccreditationCFA: Continued Full AccreditationDA: Deferred AccreditationAFA: Award Full Accreditation
32 Preparing for a Site Visit DoMaintain program in “inspection-ready” stateSelf-identify and resolve deficienciesKeep administration involved and educatedMake sure practices and PD matchDon’tPractice “management by AAALAC”Management by AAALAC is the passive practice of only addressing animal care and use issues when identified through the AAALAC site visit. Animal care and use programs should actively identify problems and resolve them in a timely manner.
33 Preparing the IACUC Train and educate Keep informed of national issues and debates that may be applicable to your programDiscuss and develop policies on relevant issues where clear guidance is lackingDocument activitiesFollow deficiency reporting requirementsIssues where clear guidance may be lacking: wire-bottom cages, toe clipping, restraint, orbital bleeding, housing animals in laboratories, etc.
34 Preparing the OHS Program MUST be part of an overall animal care and use programEvaluate extent and level of participationRisk assessment performedJob related risksPersonal health risksAre all at-risk employees offered participation in an OHS program?Evaluate extent and level of participation: Are people evaluated on the frequency, duration, and intensity of exposure and risk of exposure, versus simply evaluating if they have “substantial animal contact”? For example: Are maintenance personnel and non-affiliate members who enter animal rooms considered?
35 Preparing the OHS Program (Cont) Are declinations of participation documented?Hazard Identification performed routinelyWaste anesthetic gas exposureAllergy awareness and preventionZoonoses awareness and prevention
36 Preparing the Husbandry Program Keep areas clean and unclutteredFollow sanitation schedulesCage sizes adequateMonitor effectiveness of sanitation proceduresHave exemptions documented and approved by IACUC
37 Preparing the Husbandry Program (cont) If SOPs in place, are they followed?Condition of cagingBreeding coloniesChecklists completedand currentDoes PPE make sense and procedures followed?
38 Preparing the Veterinary Care Program Have an effective method for identifying, treating, and following up on sick animalsALL sick animals identifiedDocumentation of Tx and resolutionPart-time veterinarian visits documentedFrequency of rounds sufficient for facilityAnesthesia/analgesia: current, documented
39 Preparing the Veterinary Care Program (cont) Is environmental enrichment considered for all species?Is aseptic technique followed for rodent survival surgeries?OR
40 Preparing the Physical Plant Doesn’t have to be newDoes need to be in good repair, clean and sanitizableMUST have HVAC performance data, current within 12 months of site visitTemperature and humidity monitoredContingency plans for power lossRackwash safety!!I
41 Preparing the Staff Don’t shut down, we need to see daily operations Let PIs, technicians, caregivers know site visitors may ask questionsLet staff know that a lot of writing is normalSite visitors take extensive notes to detail not only what they observe, but to document locations of places they visit and the activities performed. A lot of writing does not necessarily mean that they are finding numerous problems. They also write down the commendable things they see as well.