Instructions for completing and submitting the Program Description
- Program Description Format
- Introduction/Description (Exceptions, Contract Facilities, Animal Use Areas)
- Supplemental Information
- General Information
- Instructions for Submitting the Program Description
to the AAALAC International Executive Office
Appendix 1: Animal Facility Square Footage/Metres Compilation
The following instructions are to assist you in completing your Institutional Animal Care and Use Program Description for AAALAC International. The completed Program Description is comprised of three parts: Introduction; Description; and Appendices. If more than one administrative unit is responsible for animal care, each item in the Program Description must be addressed for each animal care program. This may be done by describing the largest program and noting the exceptions as they apply to other programs. Do not reference appendices in lieu of providing a brief description directly in the Program Description. For example, reference to a copy of Standard Operating Procedures in the Appendix should not be used as a substitute for describing the cage and room sanitation program. An accurate Program Description is necessary to provide Council with sufficient information to make an objective judgment concerning accreditation of a unit. Representatives from AAALAC International will review the Program Description and, at the time of the site visit, evaluate the program and facilities for conformance with AAALAC International's Three Primary Standards: the Guide for the Care and Use of Laboratory Animals (Guide), NRC 2011; the Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag Guide), FASS 2010; and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, Council of Europe (ETS 123). In the Introduction, the institution should describe how the Three Primary Standards are used. Note that the outline of the Program Description basically follows that of the Guide. If you are in doubt about certain questions, you should refer to the Guide for clarification.
There have been instances when institutions have had information from their AAALAC Program Descriptions requested by the public through the Freedom of Information Act (FOIA) or a Public Records Request. Institutions are encouraged to contact their legal counsel for guidance since access to public information varies among states. If your institution deems that parts of the information requested by AAALAC International are of a particularly sensitive or confidential nature (e.g., building floor plans, building security features, proprietary research information, personnel names, room numbers, vendor identification, etc.), this information can be omitted from the Program Description and provided to the site visitors by other means. For example, codes may be used for buildings such as Building A, B, and C or 1, 2, and 3, etc. The same can be applied for housing and procedure rooms or laboratories, such as Room a, b, c, or i, ii, iii. Titles alone may be used for key institutional representatives whose identity is not already publicly available such as Facility Manager, Building A; Animal Care Supervisor, Building B; Nonaffiliated Member; and Scientific Member. Please contact the AAALAC International office for additional guidance in these cases.
Throughout the text, "IACUC/OB" will be used to indicate the Institutional Animal Care and Use Committee (IACUC) or comparable Oversight Body of the unit, and should be considered synonymous with Animal Welfare Body, Animal Care Committee (ACC), Ethics Committee (EC), or other local oversight group.
Program Description Format
- To complete the Program Description:
- Download and save the Program Description to your computer. (Save as a .doc file - Word 97-2003 Document is preferred).
- Complete the Program Description. Insert your cursor in the box designated for your response to each question. This will assist reviewers of the document in easily determining each response. You may type information in these spaces or copy and paste* information from another document (e.g., older version of the Program Description).
*Please note that if you “cut & paste” from a different document there may be embedded formatting, which may interfere with the information pasting into the boxes (For example, the text will paste outside of the box). To solve this issue, please use the following steps.
If using Office 2007:
- “Copy” selected text
- Insert curser in box where you want to “Paste” the text”
- Go to the “Home” tab and click the drop-down arrow under Paste and select “Paste Special” (see arrow below)
- Select “unformatted text,” click OK. This will remove any formatting that may be embedded within the text.
- Update the Table of Contents once the document is complete. This is accomplished by “right clicking” on the Table of Contents to highlight, selecting “Update Fields” and selecting “Update Page Numbers Only."
- Save document as you are working in it. When complete, mail to email@example.com.
- For each stated heading/subheading, responses should be succinct yet provide sufficient detail so that AAALAC International reviewers can understand and assess the program. Each question of the Program Description should be completed. It is imperative to respond to all items. If items are not applicable, please so indicate. Please do not alter the Program Description by deleting questions that are not applicable. In such cases, the Program Description will be returned for completion, which may result in a delay of your on-site assessment.
- Appendices and references to other sections in lieu of an accurate Program Description are not acceptable. An accurate, concise overall Description is dependent, in part, on the completeness of information.
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Introduction/Description (Exceptions, Contract Facilities, Animal Use Areas)
- A. Please note that any IACUC/OB-approved program-wide exception(s) to the Guide and/or other applicable guidelines or regulations must be described in detail. In each appropriate section of the Program Description (e.g., sanitation, animal housing density), state the approved program-wide exception. In addition:
- Provide the rationale for why the program-wide exception to the Guide and/or applicable regulations is necessary.
- Provide a summary of the basis for IACUC/OB approval of the program-wide exception, including references, data and other relevant considerations. Please note that it is not necessary to supply detailed data with the Program Description; however, the site visitors may wish to see evidence at the time of the site visit.
- Summarize the procedural details of the ongoing IACUC/OB monitoring of all approved program-wide exceptions.
- Contract Facilities. According to the AAALAC International Rules of Accreditation, if the care of animals owned by an AAALAC International accredited institution or an institution applying for accreditation is contracted for, then AAALAC International considers the contractor's animal care programs and facilities to be an integral part of the institution's animal care and use program. Examples may include contracted research laboratories, breeding services, diagnostic/imaging facilities, quarantine facilities, etc.
If the contract facility is not separately accredited, the animal care and use program and facilities of the contractor that relate to the animals owned by the institution seeking accreditation must be included and identified as contractor-provided in the Program Description. All elements of the contract facilities' animal care and use program (personnel training, IACUC/OB review of protocols, programs and facilities, occupational health and safety program, veterinary care, etc.) that potentially impact those animals will be evaluated as a part of the institution's site visit to determine conformance with AAALAC International standards. The institution must make arrangements for the site visit of the contractor's facilities and for review of relevant elements of the animal care and use program provided by contract. If, based on the AAALAC International Rules of Accreditation, a review of contract programs and facilities is going to be required, the AAALAC International office must be informed as soon as possible so a decision may be made regarding the length of the site visit. If your institution does not own the animals, but owns the data (or intellectual property) that results from studies or procedures conducted using those animals, AAALAC will not visit the non-accredited site.
In those cases where a contractor provides personnel for the animal care and use program within the accredited institution's facility, the occupational health and safety program and employee training program will be evaluated to determine conformance with AAALAC International standards.
If the contractor's facilities are fully accredited by AAALAC International, a description of the contractor's programs and facilities is not required, and the contractor's facilities may be exempt from the associated institution's site visit at the discretion of AAALAC International.
- If not provided within the Program Description, the Site Visitors may request a list of all animal use areas outside central holding areas, indicating the type of procedures performed there, to facilitate laboratory review.
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The following information is to be appended as a supplement to the Program Description. Please provide the information requested in Items 1-6 and 10-13 in English. Items 7-9 may be provided in the primary language used at the host institution. A summary of pertinent information contained in the appendices should be incorporated into the Program Description under appropriate headings.
- Organizational Chart(s). Include an organizational chart or charts of institutional management structure and of key staff for the accreditable unit and reporting line for the IACUC/OB.
- Animal Usage Form. Included are two options (Form A or Form B) for providing a tabulated summary of animal use at the institution. Please choose one or provide the information in a similar format. If you use Form A, please note that you will need to remove the included examples, and the site visitors may request additional information on-site regarding animals which may be used or housed in laboratories outside the animal care facility.
- Summary of Animal Housing and Support Sites. Briefly summarize the animal facility(ies) or housing sites, noting the building name (coded, if confidential) and acronym, number of areas in which animals are housed (buildings, floors, farms, etc.), the total square feet/meters (or acreage) for animal housing*, the total square feet/meters (or acreage) for necessary animal care and use support* (service corridors, and other areas enumerated in the Guide), and the individual responsible for each facility/site.
If the program includes more than one facility/site, note the approximate distance (yards/miles or meters/kilometers) each facility is from a reference point, such as from the largest animal facility. A campus/site map (with a distance scale) may be included as an Appendix to provide this information.
Provide for each facility the species used and approximate daily census for each species. These numbers do not need to be exact, but are useful for gauging animal program size and complexity.
A blank form denoting the information requested is included.
*See Appendix 1 - Animal Facility Square Footage/Meters Compilation for guidance in calculating the size of your animal care and use program.
- Line Drawing(s). Line drawing(s) (plans) of animal facilities should be provided on 8-1/2" x 11" or A4 paper (do not include blueprints). Campus/site map(s) indicating all animal housing and use locations should be included, if applicable.
- Medical Evaluation Form. Provide a blank copy of the institution's individual risk assessment/medical evaluation form.
- IACUC/OB Membership Roster. This roster should indicate names, degrees, membership role (e.g., scientist, nonaffiliated member) and affiliation, if not provided in Part II, Description.
- IACUC/OB Protocol Form. Provide a blank copy of institution's animal protocol form and, if different, the annual renewal/review form.
- IACUC/OB Minutes. Include the minutes of the last two IACUC/OB meetings; the past 3 years' meeting minutes should be available during the site visit.
- IACUC/OB Periodic Report. Include the most recent report of the IACUC/OB review of the animal care and use program and facilities inspections; the past 3 years' reports should be available during the site visit.
- HVAC Summary. Summarize the heating, ventilation, and air conditioning (HVAC) system(s) for all animal facility areas and satellite animal holding areas outside of the facility. Current (measured within the last 12 months), detailed (by room) HVAC system performance data are to be provided, as indicated on the enclosed HVAC form. A sample and blank form denoting information requested are included.
- Aquatic Systems Summary. Provide species-specific water management and monitoring programs for each aquatic animal facility, including all satellite/rooms/enclosures. A blank form denoting information requested is included.
- Primary Enclosures and Animal Space Provisions. Complete the table describing primary enclosures and documenting the institution's standard space allocation for each species of animal. Provide performance criteria and guiding documents (e.g., Guide, Ag Guide, ETS 123, and/or applicable regulations) used by the IACUC/OB to assess the adequacy of space provided for all research animals, including traditional laboratory animal species, agricultural animals, aquatic species and wildlife when reviewing biomedical, field, and agricultural research studies.
- Cleaning and Disinfection of the Micro- and Macro-Environment. Describe the institution's cleaning and disinfection methods for both the micro- and macro-environment. Note the washing/sanitizing/cleaning frequency and method for each of the areas and types of equipment. A blank form denoting information requested is included.
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The following information for the past 3 years, if available, should be provided for review at the site visit:
- Copies of pertinent government or other oversight agency (i.e., U.S. Department of Agriculture (USDA), Agri-Food and Veterinary Authority (AVA), National/Regional Competent Authority, Canadian Council on Animal Care (CCAC), etc.) inspection reports and responses (if applicable). Although the Rules of Accreditation (Section 2.f) require accredited institutions to promptly report adverse events relating to animal care and use programs and other serious incidents or concerns that negatively impact animal well-being, any reports not previously forwarded to AAALAC should also be available for review.
- Copies of annual or other periodic reports submitted to government or other regulatory bodies (e.g., Public Health Service (PHS) Assurance and annual reports, USDA Annual Reports), if applicable.
- Other information relevant to the animal care and use program, such as policies, procedures, or plans relating to canine exercise and environmental enrichment.
- Copy of the Disaster Plan that outlines specific actions and procedures related to the animal facility and the welfare of animals and staff.
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Board and Council members, ad hoc Consultants/Specialists, and staff representing AAALAC International are required to execute a "Confidentiality Agreement." Conflict of Interest statements are also declared by each site visitor. AAALAC International representatives agree to treat all materials as privileged and safeguard material in their possession. Blank copies of these agreements are available on request.
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Instructions for Submitting the Program Description to the AAALAC International Executive Office
- A cover letter should accompany the Program Description addressing specific remarks or requests pertinent to the site visit (e.g., specific dates that would be inconvenient, entry requirements, etc.).
- Please submit one hard copy of completed materials, unless it can be provided electronically with no more than four attachments.
- If submitted electronically, please use your six digit file number in the e-mail subject line (not applicable to new applicants).
- Submit in Microsoft Word or Portable Document Format (pdf) to firstname.lastname@example.org.
- Do not embed attachments as links within the main document.
- If submitted by hard copy, the document should be two-sided to reduce both volume and mailing costs. Please do not staple, bind, or otherwise assemble your materials.
Mail: AAALAC International
5205 Chairman's Court, Suite 300
Frederick, MD 21703
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Animal Facility Square Footage/Metres Compilation
Reportable Animal Housing Square Footage/Metres:
Outdoor pens for primates, dogs, cats and birds*
Environmentally-controlled domestic animal housing buildings
Reportable Support Square Footage/Metres:
Food and bedding storage rooms
Cage storage rooms
Supply and equipment storage areas
Treatment and procedure rooms
Incinerator rooms (calculated on the amount of use dedicated to the animal facility)
Diagnostic rooms (i.e., pathology, x-ray, necropsy)
Waste storage areas
Restrooms (within the animal facility)
Employee lounge areas
Laboratories within the facilities related to animal research
Offices within the animal facilities associated with the animal care and use program
Loading docks (calculated on the amount of use dedicated to the animal facility)
Elevators (calculated on the amount of use dedicated to the animal facility)
*Special Square Footage/Metres Calculations:
Barns, sheds, and pasture acreage are calculated according to the numbers of buildings and the size of the program. Please contact the office at 301.696.9626 or email@example.com if you have any questions for calculating these spaces.
Square Footage/Metres Not Included:
Investigator's laboratories outside of the animal facilities
Ancillary laboratories outside of the animal facility