AAALAC International: Processand Expectations

James R. Swearengen, DVM, DACLAM, DACVPMSenior Director

Topics

Overview of AAALAC and the accreditation process

Benefits of accreditation Expectations for ACUCs Common misconceptions

What is AAALAC? The Association for Assessment and

Accreditation of Laboratory Animal Care International ...

Enhances life sciences by promoting theresponsible treatment of animals usedin research, teaching and testingthrough voluntary accreditationand assessment programs.

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.

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

Council CoordinatorMs. Sandy Dexter

Council onAccreditation

Senior Director & Director of

Pacific Rim ActivitiesDr. Kathryn Bayne

Executive DirectorDr. John G. Miller

Program AnalystMs. Darlene Brown

Marketing/CommunicationsMs. Lori Wieder

Program AssistantMs. Anne Hottinger

Ad HocsCouncil

SecretaryMs. Carmen Wallin

Program AssistantMs. Sara Levy

Program AssistantMs. Gretchen Hill

Director of European Activities

Dr. Egil Berge

Board of Trustees

Executive Committee

Senior DirectorDr. James Swearengen

Operations ManagerMr. Dave Maurey

Financial ManagerMr. Jacob Meesarapu

Program AnalystMs. Heather Breighner

AAALAC InternationalOrganizational Chart

500

550

600

650

700

750

1994

1996

1998

2000

2002

2004

2006

Number ofAccreditedUnits

Over 735 Accredited Units in 30 Countries

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

Proportion of Accredited Units by Industry Sector

6%10%

19%

35%

30% Academic

Commercial

Government

Non-Profit

Hospital

The Accreditation ProgramCornerstones

voluntary

peer-review process

performance-based

completely confidential

Voluntary Participation

Commitment to principles of the Guide

High standards set and maintained

Accountability to science & the public

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

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

The Use of Performance Standards

"requires that users, IACUCs, veterinarians, and producers use professional judgment in making specific decisions regarding animal care and use."

Completely Confidential

Full disclosure

Free, open communications

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

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

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

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

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

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

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

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

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

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

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

Potential for Pain or Distress

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

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

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

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

Hazard Identification

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

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

Risk Assessment

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

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.”

Veterinary Medical Care

Veterinary Medical Care

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

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

Physical Plant

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

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.)

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

Questions?

For more information….

AAALAC International5283 Corporate DriveFrederick, MD 21703

USA301.696-9626 phone

800.926.0066 toll-free301.696.9627 fax

accredit@aaalac.orghttp://www.aaalac.org

jswearengen@aaalac.org