AAALAC International: Accreditation Overview

AAALAC International:
Accreditation Overview
John F Bradfield, DVM, PhD, DACLAM
Senior Director, AAALAC International
Agenda
 History/ demographics
 Standards of accreditation
 Accreditation process
History of AAALAC
Animal Care Panel – 1950
 1959 – ACP committee on ethical considerations in the care
of laboratory animals
 Renamed the Professional Standards Committee
 1960 - Animal Facilities Certification Board (establish
standards of care)
 1963 – renamed Animal Facilities Accreditation Board (AFAB
- define condition to promote sound animal research)
 Accreditation by the Board – voluntary (Pilot tested - Indiana
U Medical College, UCLA, UCSF, USC)
 An advisory Council (NAC) was appointed to assist the
Board (ACP, ADA, AHA, AMA, AAMC, AAVMC, PMA)
 1964 - Initiated the formation of a non-profit organization to
administer the accreditation program
History of AAALAC
 Incorporated in 1965 (American)
 NAC become the AAALAC BOT
 AFAB became the Council on
Accreditation
 1996 – Name change (International)
AAALAC International
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Board of Trustees
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Council on Accreditation - 57
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scientists, veterinarians (19 countries/ 22 states)
Ad Hoc Consultants/Specialists - 368
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68 Member Organizations
scientific, professional societies
scientists, veterinarians, program specialists (27 countries/ 42 states)
Executive Office Staff
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Frederick, Maryland
Pamplona, Spain
Bangkok, Thailand
928 Institutions - 39 Countries
79%
8%
11%
1%
Proportion of Accredited Units by
Industry Sector
Standards of Accreditation
Standards of Accreditation
Reference Resources
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General
Biosafety
Education
Euthanasia
Health Monitoring
OHSP
Research related
Species specific
Performance Standards
 Engineering standards dictate how a goal
is achieved
 Performance standards allow for a variety
of methods to reach a goal
 Precise, detailed, definition of the goal
 Criteria to determine that the goal is met (what
to measure)
 How to evaluate that the goal is met (process or
how to measure)
Myth
Program
Components
 AAALAC
accredits
facilities
 Institutional Administration
 Animal Environment
Fact
 OHSP
 AAALAC
 accredits
IACUC Programs (all facets of the
animal care
use at the
institution)
 and
Veterinary
Care
• Organizational structure
• Authority Physical Plant
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Responsibility
Management
Practices/ procedures
Outcomes
Safeguards
Facilities
Site Visit Process
 3 Phases
1) Before the visit
2) The site visit
3) After the site visit
The Program Description
 The program description may be the
single most valuable portion of the site
visit!
 Accurate
 Detailed
 Complete
The Program Description
1) Introduction
 Mission
 Organizational Structure
2) Description
 All chapters of the Guide
3) Appendices
 Forms, Rosters, HVAC data, Protocols, etc
The Program Description
 Submission deadlines
 April 1st (May – August site visits)
 August 1st (September – December visits)
 December 1st (January- April visits)
Site Visit Planning - Logistics
AAALAC
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Assign the Council member
Set the date with the institution
Select Co-visitors Institution
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All information is confidential
Same team rarely returns to the same site
Institution
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Make sure key personnel will be there – IO, IACUC
members & chair, AV, occ health and safety,
maintenance staff, etc.
Site Visit Coordination
 Hotel reservations
 Travel logistics (local transportation?)
 Coordinate an efficient site visit schedule:
entrance-briefing, PD review, facility tours, meet
IACUC, document review, executive session, exitbriefing
 Gracious collegial, support is always
appreciated
What do ‘They’ Know?
 Have read the current Program
Description
 Have reviewed the history of the institution
 Accreditation history
 Correspondence
 Annual Reports
 Have reviewed evaluations from previous
site visits
Phase 2 – The site visit
Purpose of the Site Visit

Gain a thorough understanding of your program of
animal care and use
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Evaluate your program for conformity with AAALAC’s
three Primary Standards as well as national regulations
and Reference Resources
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Serve as Council’s eyes and ears
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Gather information
Entrance Briefing
 Introductions
 Meet with institutional leaders
(institutional support?)
 Explanation of:
 the accreditation process
 the proposed daily activities
Program Review
 Review/clarify aspects Program Description
 Interact with administrative personnel (IO,
OHSP, maintenance staff, security,
operations management, etc)
 Request additional supporting information
(e.g. SOP’s)
 Request protocols and other documents for
later review during the site visit
Meeting with the IACUC/OB
 Set aside some time to meet with the
Committee
 Luncheon works well
 Describe accreditation process
 Discuss issues and talk with lay representatives
 Problem cases … Committee solutions
 Important for site visitors to develop a sense of
Committee engagement
Meet the Husbandry Staff
 Can set aside a prescribed time …
 Can have hallway meetings …
 Staff should be ‘familiar’ with the
accreditation process
 Discuss their areas of activity
 Do be around and working
Meeting the Research Staff
 PI laboratory visits
 Facility tours
Facility Tours
 Facility walk-through (holding rooms,
procedure areas, support space, sx, nx,
etc)
 Health of animals
 Condition of facilities (sanitation, function)
 Emergency contacts and after hours vet
support
 Contract and satellite facilities
 PI laboratory visits
Review of Documentation
 USDA Inspection Reports, PHS
Assurance in the U.S.
 Compliance Records
 Selected IACUC/OB Protocols (files)
 IACUC/OB meeting minutes
 Standing Operating Procedures (SOPs)
 Disaster Plan, Enrichment Program, etc.
Executive Session
 Site Visitors’ time to prepare for Exit
Briefing
 Discuss issues and prepare notes
 Commendations for unit
 Issues
 Mandatory items
 Suggestions for improvement (SFI’s)
 Preliminary recommendations to Council
Exit Briefing
 Conducted by Council member
 Summary of program strengths and
weaknesses
 Independent opinions of site visitors
Exit Briefing
 Preliminary findings and impressions
 Opportunity to correct misinterpretations or
errors
 Discuss issues that are not clear
 Discuss the post site visit communication
(PSVC)
 Within 10 days when appropriate

Verbal, not written (so take careful notes)
Mandatory finding
Serious deviation from the
recommendations of the Guide, Ag Guide
or ETS 123 (depending on the specifics of
the institution) that must be corrected to
achieve or continue accreditation.
Suggestion for improvement
 A suggestion the Council believes will
improve the program
 Although a recommendation, there is no
obligation for institutions to make program
changes based on suggestions for
improvement
Phase 3 – After the site visit
Post Site Visit Activities
 Post site visit – Unit:
 Prepares post site visit
communication
(if applicable)
 Work out correcting
deficiencies
 Wait for Council
decision
 Post site visit – AAALAC:
 Prepares program
evaluation
 Program evaluation goes
out to reviewers
 Questions and comments
are addressed
 Council meets and status
decision is made
 Unit is notified by letter
Post Site Visit Responses
 Unless you agree with findings, DO NOT
make changes or spend money on fixes until
final letter arrives - findings may change
 Final letter will include:
 Commendations
 Acknowledgement of any items already
addressed through PSVC
 Any mandatory items and/or suggestions for
improvement
Potential Outcomes
 If already accredited:
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Continued Full
Accreditation (CFA)
CFA w/ condition
Deferred
Accreditation
Probation
Revoke Accreditation
 If a new application:
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Award Full
Accreditation (AFA)
AFA w/ condition
Provisional
Withhold
Accreditation site visit - Summary
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Accurate, complete PD
Well organized site visit schedule
Don’t shut down
Prepare staff – let them know that site
visitors ask questions and take a lot of notes
 Self identify deficiencies, maintain readiness
and avoid “management-by-AAALAC”
Trends Findings – 2011 Guide
Program Components - Findings
Animal Environment
14%
10%
OHS
10%
26%
18%
22%
IACUC
Veterinary Care
Physical Plant
Institutional
Administration
Animal Environment - Findings
Behavioral/ Social
Management
Husbandry
Sanitation
Microenvironment
Mandatory
SFI
Macroenvironment
0%
10%
20%
30%
40%
50%
60%
Occupational Health & Safety Findings
Personnel protection
Job risk/ safety assessment
Personnel risk assessment
Hazard usage
Mandatory
SFI
Medical sevice
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
IACUC-Related Findings
Protocol Review
Considerations
Policies
Protocol review process
Program Review/ Facilities
Inspections
Oversight/ PAM
Mandatory
SFI
Committee Composition/
Participation
0%
5%
10%
15%
20%
25%
30%
35%
40%
Vet Care Findings
Veterinary Medical Care
Euthanasia
Pain & distress
Surgery & post op
Preventive medicine/biosecurity
Mandatory
Transportation
SFI
Procurement
0%
10%
20%
30%
40%
50%
60%
Institutional Administration - Findings
Documentation/Records
Training
Program Description
Disaster plan
Authority/Responsibility
Annual Report
Mandatory
Organizational Structure
SFI
Commitment
0.00%
10.00%
20.00%
30.00%
40.00%
Physical Plant Findings
HVAC
Construction/maintenance
Satellites
Special facilities
Power
Mandatory
Design/ layout
SFI
Security
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
The Value of Accreditation?
12.4%
Findings corrected by PSVC
87.6%
Findings retained in the
letter
Thank You!
AAALAC International
5283 Corporate Dr., Suite 203
Frederick, MD 21702 USA
301.696.9626 (ph)
301.926.9627 (fax)
www.aaalac.org
[email protected]