Rules of Accreditation
Before you apply for AAALAC accreditation, take a moment to make sure your institution qualifies by reviewing the list of rules below ...
All animals used or to be used in research, teaching or testing at accreditable units are to be included and evaluated in accordance with the standards set forth in Section 2 of these Rules. 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 unit's mission.
Criteria for Accreditation
The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) accredits active animal care and use programs. An active animal care and use program includes: animals; facilities; equipment; professional, technical, and administrative support; and policies and programs for institutional responsibilities, animal husbandry and veterinary care. Additionally, for a unit to be accreditable it must have a reasonable activity level relative to the space available for animal holding and use.
For new applicants, an active animal care and use program must be in place and operational prior to application for accreditation. AAALAC International will not conduct a site visit to new applicants that do not meet the criteria of an accreditable unit and that do not have an active animal care and use program. Accredited units must have all components of an active animal care and use program at the time of a site revisit. Accreditation shall be at the sole discretion of AAALAC International.
If an accredited unit fails to meet the criteria of an active animal care and use program, as defined above, the unit must notify the AAALAC International Executive Office at 5283 Corporate Drive, Suite 203, Frederick, MD 21703-2879. AAALAC International will inform the unit that in order to maintain accreditation, an active animal care and use program must be resumed within twelve months. After failing to meet the criteria of an active animal care and use program for twelve consecutive months after notification by AAALAC International, accreditation of the unit will be revoked. If the unit resumes an active animal care and use program after revocation, a new application for accreditation must be submitted.
Any public or private institution, organization, or agency maintaining, using, importing, or producing animals for purposes of scientific research, teaching, or testing may be accredited. The appropriate administrative entity making application is the accreditable unit, and its animal care and use programs and facilities are evaluated to determine accreditation status. All animal programs and facilities of the accreditable unit must be included in the application and evaluated. An animal resource is an administrative and functional department, division, or section of the accreditable unit. A large organization, such as a university, may have several central animal resources as well as satellite resources. Large commercial organizations having separate divisions, especially when located in different geographical areas, may submit separate applications for each division or geographic location. This definition of an accreditable unit is interpreted as follows:
(1) Academic institutions: In academic institutions, resource organizations that provide animal care and related services are not permitted to seek accreditation independently of academic units such as schools, colleges, independent research components, or other academic units. If such a resource unit serves a school, college, etc. that is seeking accreditation, then the resource must be included in the application and evaluated. Such a resource may also serve other units that are not accredited.
(2) Private organizations: In nonacademic institutions (e.g., commercial organizations, animal vendors, hospitals, and private laboratories), major divisions or units are eligible to seek accreditation provided they have independent local administration and are clearly autonomous in terms of facilities, personnel, policies, and funding from other divisions or units of the same organization.
(3) Change of accreditable unit: During the period immediately prior to determination of accreditation status or during provisional accreditation, probationary accreditation, proposed revocation of accreditation, or appeal, institutions may not change their organizational structure, as defined in the Application for Accreditation or as amended in annual reports, so as to remove deficient facilities from evaluation. However, facilities previously used for animal care and use may be permanently abandoned for such purposes at any time.
(4) Contiguous facilities: On occasion, programs being evaluated by AAALAC International have contiguous animal care and use facilities (same floor or building) which are assigned to other units not participating in the AAALAC International accreditation program. The extent to which contiguous facilities are evaluated is at AAALAC International's discretion and depends mainly on whether facilities and practices within the contiguous facilities have an effect on the facilities and programs under primary AAALAC International review. AAALAC International will require information on contiguous facilities prior to a site visit. It is advantageous for personnel who represent the contiguous facilities to be available to provide additional information during an AAALAC International site visit.
(5) Separated facilities/satellites: Institutions seeking accreditation from AAALAC International may have animal care and use activities conducted at one or more institutionally owned facilities located away from the primary site. If the oversight, management and operation of the animal care and use activities in the separate (satellite) facilities are dependent upon the main animal care and use program, e.g., they share administration, mission, personnel, budget, equipment, etc., then they are considered part of the accreditable unit and must be site visited. If the separate facilities are located some distance apart, the time required to travel between them will be considered in determining the category of the institution and the annual fee. If the oversight, management and operation of the satellite facilities are not integral to the primary unit, they may be considered as separate programs and AAALAC International accreditation extended to each of them individually.
(6) Contract facilities: Institutions may have contractual arrangements for certain aspects of their animal care activities with other animal care agencies/facilities. In some situations, an accreditable unit may issue a comprehensive contract whereby the contractor provides most or all specified facilities, services, personnel, animals, etc., and the animals are owned by the contractor. In this situation, AAALAC International accreditation does not extend to the contracted facilities and their associated animal care programs. However, the accredited unit may have a more limited contract in which the accredited unit owns the animals. In this latter situation, AAALAC International considers those facilities to be an integral part of the institution's animal care program. The services and facilities provided by the contractual arrangement must be included in the application and annual reports, and the facilities will be visited as a part of the institution's original and periodic site visits to determine compliance with AAALAC International standards. Contractual agreements made by AAALAC International accredited institutions or applicants must provide for the inspection of the contracted facilities by AAALAC International site visit teams. If the contract facility is separately accredited by AAALAC International and is currently fully accredited, it will not be necessary to visit that facility during the site visit.
The Board of Trustees of AAALAC International, or its designee, shall establish the specific standards and requirements for accreditation of laboratory animal care and use programs. In doing so, the rule-setting entity shall be governed by the following general principles:
- The care and management of laboratory animals should be directed by qualified persons.
- All animal care personnel should be suitably qualified by training and experience in the care of laboratory animals.
- Physical facilities and the methods of care and use for animals should permit their maintenance in a state of well-being and comfort.
- The Guide for the Care and Use of Laboratory Animals (Guide), Eighth Edition (National Research Council 2011), shall serve as a basic guide to the establishment of specific standards for accreditation. AAALAC International may establish standards based on prevailing directives, conventions and guidelines of the country in which the accreditable unit is located.
- The accreditable unit shall observe any and all statutes and governmental regulations which bear upon animal care and use including, but not limited to, the prevailing standards of sanitation, health, labor and safety of the jurisdiction(s) in which it is located.
- The accredited unit shall submit an annual report which describes elements of the animal care and use program as specified by AAALAC International. In addition, the accredited unit shall promptly notify AAALAC International (e.g., through copies of correspondence) of adverse events relating to the animal care and use program. Examples include investigations by the USDA or OLAW, as well as other serious incidents or concerns that negatively impact animal well-being.
- Membership in an association or organization for laboratory animal care and use or in an association of persons dedicated to the care and use of laboratory animals or membership in any association or organization shall not be required as a condition for gaining or maintaining accredited status under the AAALAC International accreditation program.
Fees and Procedure
- AAALAC International shall receive applications for accreditation from accreditable units accompanied by reasonable fees pursuant to a schedule to be established and promulgated by the Board of Trustees. In addition to the application fee, each fully accredited unit and each unit on less than fully accredited status shall be charged a reasonable annual fee pursuant to a schedule established and promulgated by the Board of Trustees. The fee schedules thus established may be amended from time to time. Revocation of accreditation may occur if a unit is more than 12 months in arrears in payment of fees. Any institution presented with a final notice may be provided an extension of 30 days.
- If additional or supplemental site visits are required prior to determination of accreditation status, or interim or follow-up visits are required after accreditation, supplemental fees may be required, when justified, and as determined by AAALAC International. Routine site revisits will not require additional application fees, except that such fees may be imposed when necessary for the economic security of AAALAC International.
- Before adopting any new standard or requirement for accreditation, or changes therein, AAALAC International shall publish the text of any proposed new or changed standard or requirement together with a notice that any interested person can submit to AAALAC International written comments, data, views, arguments in opposition to or in support of such proposals within thirty (30) days from the publication of the notice. AAALAC International shall consider all such written submissions before adopting the new or changed standard or requirements.
- AAALAC International, acting through the Council on Accreditation (Council), shall adopt uniform application and follow-up report forms and shall establish a standard system by which the results of site visits are reported to Council.
Site Visits and Site Visitors
- 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 except that one site visitor may be used at the option of the Council for periodic or special site visits after the initial site visit has been concluded, or in the event of a small and or remote facility.
- All qualified applicant units are initially site visited. Accredited units and those on provisional status are routinely revisited at 3 year intervals. Additional interim or follow-up visits may be required to confirm correction of deficiencies or if there are major changes in programs or facilities.
- The Council shall neither employ nor utilize to evaluate an accreditable unit any visitor who (1) is employed or retained by the accreditable unit; (2) is employed or retained by the same person or institution or agency which owns, manages or operates the accreditable unit ("agency" shall be interpreted as the immediate government or private entity which has administrative authority over the site visitor, e.g., Department of Army, Department of Health and Human Services, State University System, Company, Corporation, Foundation, etc.); (3) is employed or retained by, or the owner of, another accreditable unit which is in direct commercial competition with the accreditable unit to be evaluated; or (4) is employed or retained by, or the owner of, another organization which has a financial interest in the outcome of the site visit to the accreditable unit.
- AAALAC International must have sufficient information to evaluate adequately an applicant's program and facilities. In general, this will require that site visitors be permitted to enter any and, if deemed necessary, all animal holding rooms, laboratory or use areas, and support areas. Further, the site visitors must be provided all relevant programmatic information including that regarding use protocols, particularly information regarding the use of potentially hazardous agents or compounds. AAALAC International will not accredit units that cannot be thoroughly evaluated. Access to facilities and information is essential to assess all aspects of husbandry, sanitation, animal well-being, and safety procedures. There may be instances in which an accreditable unit may wish to restrict or prohibit site visitor access to certain program information or facilities. In such cases, AAALAC International representatives and the applicant may mutually agree that certain areas do not need to be physically entered. Construction features designed to provide ample visibility without the physical entrance to a facility may assist in this determination. Site visitors will respect and adhere to any reasonable and justifiable policies and procedures such as showering, wearing protective clothing, or personal quarantine for specified time periods ordinarily not to exceed 72 hours. Proprietary information will be kept confidential. Applicants must inform AAALAC International at the time the site visit is scheduled if there are restricted areas or information and what the terms and conditions of access will be.
- No Council member or consultant to the Council shall have authority to perform or conduct on behalf of AAALAC International an evaluation of any accreditable unit except upon and in accordance with an assignment made by AAALAC International. No site visitor shall disclose any of his findings to any person or agency except AAALAC International.
Granting or Denying Accreditation
- The Council shall review all applications and site visit reports received by AAALAC International and shall determine the accreditation status of individual accreditable units subject to confirmation and approval by the Board of Trustees, and subject to the rights to appeal otherwise provided for in these Rules.
- The Executive Committee of the Board of Trustees may act on behalf of the Board of Trustees in confirming the actions of the Council relative to granting accreditation.
- Accreditation may be granted, withheld or revoked by AAALAC International. Once granted, accreditation may be revoked in the event of a change in the nature, structure, location or operation of an accredited unit, which in the opinion of AAALAC International is sufficient to warrant such revocation. Any unit previously accredited shall be evaluated as often as deemed necessary by AAALAC International.
- Accreditation may be revoked by AAALAC International at any time for due cause. A previously accredited unit cannot be reverted to Provisional Status. In lieu thereof, the Council may advise an accredited unit of proposed reasons for revoking accreditation, that it has been placed on Probation and that if the specific deficiencies are not corrected within a specific period at the discretion of the Council, not to exceed 12 months, accreditation will be revoked. If all Probationary deficiencies have been satisfactorily corrected at the time of the site revisit but additional deficiencies of a serious nature are noted, an additional Probationary period, not to exceed 12 months, may be granted to correct the new deficiencies. Notice of Probation shall be made known only to the unit and to AAALAC International.
- Provisional Status may be granted by AAALAC International for a period to extend not more than 24 months if, in the opinion of the Council, such extension is justified. At the first meeting of the Council after the expiration of that period, accreditation must be either withheld or granted.
- The Council at its option and based upon the circumstances of each case shall decide whether an additional site visit is needed before taking action on a unit on Provisional Status or Probationary Accreditation.
Hearings and Appeals
Before rendering any decision to Withhold or Revoke accreditation, AAALAC International shall notify the unit in writing of the proposed decision of the Council and the factual findings and reasons supporting the proposed decision. AAALAC International shall also indicate in such notice that all reports, documents, and records considered by the Council in reaching its proposed decision and factual findings will be made available promptly or supplied to the unit or its representative upon receipt of a written request. Such notice shall be sent to the unit utilizing a return receipt mechanism which confirms delivery and indicates the date of delivery (e.g., registered mail, certified mail, etc.). Within 30 days after receipt of such notice, the unit may offer written evidence or argument tending to refute or overcome the factual findings and proposed decision of the Council and, in addition, or in the alternative, may apply in writing for an oral hearing. AAALAC International shall hold such hearing at the next scheduled meeting of Council after receipt of such request, and the unit shall be given an opportunity at such hearing to present evidence or argument tending to refute or overcome the factual findings and proposed decision of the Council and may be represented by counsel. Within 30 days after its meeting, the Council shall render its decision after considering all the facts and matters before it, and shall send its decision to the unit utilizing a return receipt mechanism which confirms delivery and indicates the date of delivery. In the event of the failure of the unit to make timely submission of evidence or argument, the decision of the Council shall be final.
If the decision of the Council is to Withhold or Revoke accreditation, the unit shall be entitled to an appeal of Council's decision to the Board of Trustees. Such appeal shall be initiated by a written request to the Board of Trustees within thirty (30) days after receipt of the decision of the Council. The hearing, notice, and decision provisions of an appeal to the Board of Trustees shall be the same as noted above regarding an appeal to the Council, provided that an appeal to the Council shall be a prerequisite to an appeal to the Board of Trustees.
AAALAC International shall issue a certificate of accreditation to each accredited unit. If a unit shall have its accreditation revoked, the certificate of accreditation shall be returned to AAALAC International. Units that are on Provisional Status are not entitled to receive certificates of accreditation.
All files and records of this corporation shall be held in confidence by AAALAC International and its members, and no such confidential data shall be released by AAALAC International except pursuant to direction by the Board of Trustees or as provided in Section 7 above.
If you have any questions about the information contained within the AAALAC International Rules of Accreditation, please contact the AAALAC International office at 301.696.9626.
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