Preparing for an AAALAC International Site Visit AAALAC

Preparing for an AAALAC International Site Visit

AAALAC Mission AAALAC International is a voluntary accrediting organization that enhances the quality of research, teaching, and testing by promoting humane, responsible animal care and use. It provides advice and independent assessments to participating institutions and accredits those that meet or exceed applicable standards.

AAALAC International § Chartered 1965 § Non-governmental § Non-profit

Accreditation § Confidential § Performance-based § Peer-review process üCurrent Accredited Institutions: >1, 000 in 49 countries

Presentation Topics § vs. Fact § Site Visit (SV) Purpose & Preparation § The Site Visit § Program Preparation

vs. Fact § : AAALAC International is a regulatory agency. § Fact: AAALAC International is a private, nonprofit organization.

vs. Fact § : 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.

vs. Fact § : AAALAC International establishes policies and regulations. § Fact: AAALAC International evaluates animal care and use programs based on recommendations in their Three Primary Standards, applicable legislation and other approved references.

vs. Fact § : 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 programs.

vs. Fact § : In the U. S. , AAALAC International evaluates animal care and use programs that only use animals regulated under the Animal Welfare Act. § Fact: AAALAC International accreditation covers all animals* used or to be used in research, teaching or testing at accredited programs. *Rules of Accreditation: Definition/Animals - This includes traditional laboratory animals, farm animals, wildlife, and aquatic animals. Nontraditional animals, inclusive of invertebrate species, are also included where they are relevant to the program’s mission.

Site Visit Purpose & Preparation § Gain thorough understanding of the program of animal care and use to prepare a site visit report and serve as a program advocate. § Collect evidence of best practices § Serve as Council’s eyes and ears

Before the Site Visit § The Council on Accreditation (COA) or Emeritus member is assigned § The date is set with the institution § The co-visitors* are selected *Conflict of Interest (COI) avoided.

SV Team Preparation Reads and reviews: ü Program Description (PD) ü Program history ü Previous evaluations Shared information remains confidential.

Site Visit Coordination § Typically* program makes hotel reservations** § Confirm directions to institution and § Transportation to the site as needed § Entrance Briefing at the institution, commonly starts at 8: 00 am (with arrival about 7: 30 am) *Arrangement coordination may depend on site visit logistics. **AAALAC pays for the hotel.

The Site Visit Entrance Briefing Program Description Review Meeting with the IACUC/OB Facility Walk-through Document Review Executive Session Exit Briefing Other meetings may be scheduled at the discretion of the Council member.

Entrance Briefing § Make introductions § Explain the accreditation process § Review proposed itinerary § Explain outcome options

Program Description Review § Review/clarify aspects of program § Additional supporting information may be requested § PD may be reviewed with the program prior to the visit* or on-site *In extenuating circumstances

Meeting with the IACUC/OB § May occur at anytime, typically over lunch § Describe accreditation process § Discuss issues and speak with lay representatives § Review complex cases & IACUC/OB resolutions § Assess IACUC/OB training and continuing education opportunities

Facility Walk-through § Appearance of animals § Research and care staff engagement § Condition of facilities (repair & sanitation) § Emergency contacts and after-hours veterinary support § Satellite facilities and research laboratories § Support and procedure areas

Animal Care Technicians Should be able to articulate: § the assessment and accreditation process § their areas of program activity and engagement § and their training and continuing education expectations and opportunities

Document Review Examples: § Regulatory inspection reports & records § Selected IACUC/OB protocols, meeting minutes, semiannual reports… § Standard operating procedures (SOPs) § Training records On-site translator can be available.

Executive Session § Site visitor’s time to prepare for Exit Briefing § Discuss issues and prepare notes* § Commendations for program § Mandatory deficiencies and SFI’s § Recommended status to Council** *A program contact should be available to respond to questions. **See slide #26

Types of Site Visit Findings* Suggestion for Improvement (SFI): encouraged to consider an upgrade or enhancement to an already acceptable or even commendable program Mandatory (M): a deficiency that must be corrected for Full Accreditation to be awarded or continued *Initial findings during Exit Briefing; final decision made during COA deliberation

Exit Briefing § Conducted* by Council/Emeritus member § Summary of program strengths and weaknesses § Commendations of participants as appropriate § Recommended Status: Initial opinion of site visit team *An Exit Briefing is conducted at the discretion of the Council member.

Exit Briefing (cont’d) § Provides preliminary findings and impressions § Opportunity to correct misinterpretations or errors § Exit Briefing is provided verbally* § Post Site Visit Communication (PSVC) requested within 14 business days *May also be provided in writing in certain situations

Exit Briefing – Potential Outcomes Revisit Accredited Program § § § CFA w/Condition DA Probation Revoke NEW Applicant § AFA § Provisional § Withhold Recommended Status: CFA = Continued Full Accreditation, DA = Deferred Accreditation and AFA = Award Full Accreditation.

Accreditation Process After the Site Visit § Draft site visit report prepared § Report reviewed by designated Council Members § Council deliberations § Notification of accreditation status

Program Preparation Do § § Maintain program ‘review-ready’ at all times Self-identify and resolve deficiencies Keep administration involved and informed Make sure practices and PD match Do not § Practice ‘management by AAALAC’

Site Visit Resources § § § Three Primary Standards* Reference Resources** Position Statements*** FAQs**** Applicable Legislation AAALAC International’s: FAQ - *Three Primary Standards, **Reference Resources, ***Position Statements, and ****FAQs

IACUC/OB* § Take part in initial training & continuing education § Stay informed of national issues and discussions that may apply to the program § Develop policies on relevant issues where clear guidance is necessary § Document activities § Follow deficiency reporting requirements** *The following eight (8) slides provide general guidance but are not all inclusive. Refer to slide #29 for SV Resources. **See AAALAC International FAQ: Reporting Requirements

OHS Program* § Part of an overall animal care and use program § Extent and level of participation evaluated § Hazard identification and risk assessment performed § Job related risks § Personal health risks § All at-risk employees must be offered participation in an OHS program *See AAALAC International Position Statement: Occupational Health & Safety Program

OHS Program (cont’d) § Documentation of participation declinations § Waste anesthetic gas exposure assessed § Allergy* & zoonoses risk assessment and management *FAQs: Allergy prevention and Respirator Use

Animal Environment § § Areas clean and uncluttered Sanitation schedules followed Cage sizes/space adequate* Effectiveness of sanitation procedures monitored § Exceptions documented and approved by IACUC/OB** *AAALAC International’s Position Statement: Cage and Pen Space **FAQ: Program-wide IACUC/OB exceptions

Animal Environment (cont’d) § Social Housing* and Environmental Enrichment** considered for all species § SOPs in place and being followed § Breeding colony management assured*** § Log sheets completed and current § PPE reasonable and procedures obeyed AAALAC International's Position Statement: *Social Housing and FAQs: *Social Housing and Social Experience and **Environmental Enrichment. FAQ: ***Trio Breeding

Veterinary Medical Care* § An effective method for identifying, treating, and following up on ill animals § Documentation of treatment and resolution § Part-time veterinarian visits documented § Frequency of rounds sufficient for facility *AAALAC International’s Position Statement: The Attending Veterinarian and Veterinary Care

Veterinary Medical Care** (cont’d) § Aseptic survival surgery technique followed*** § Anesthesia/analgesia: current, documented § Euthanasia: procedures and equipment assessed **AAALAC International's five (5) FAQs under Veterinary Medical Care ***FAQ: Surgery in investigator laboratories

Physical Plant § Maintenance: repair, clean and sanitizable § HVAC system summary, current within 12 months of PD submission* § Temperature and humidity** monitored § Contingency plans for power failure § Cage wash safety practices*** *Program Description and Instructions: **HVAC System Summary and FAQ: Humidity Control. **AAALAC International’s Position Statement: Safety Requirements for Walk-In Cage/Rack Washers and Bulk Sterilizers and FAQ: Instructional Signage for Cage/Rack Washers

Preparing the Staff § Review daily operations, training and recordkeeping practices § Let participants know that site visitors will ask questions and take notes to ensure understanding as your advocates to Council.

Affirmation The site visit should be a positive experience and an opportunity to demonstrate that your program is remaining diligent, staying current with regulatory requirements and evolving industry standards, while maintaining a high level of excellence.

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