**Office of Research Oversight\
Laboratory Animal Welfare Checklist**

**May 7, 2007**

This Office of Research Oversight (ORO) Animal Welfare Checklist is
provided to assist you in ensuring compliance with the regulations, i.e.
the Public Health Service Policy on Humane Care and Use of Laboratory
Animals, and VA policies.  It is intended to help your facility take
measures to carry out the Principles for the Utilization and Care of
Vertebrate Animals Used in Testing, Research, and Training found in the
United States Public Health Service Policy. This checklist is used by
ORO to guide its reviews at VA facilities and will help you identify
areas that may be assessed by ORO staff.  Checklist items reflect
requirements in regulations, VA policies, and those from other sources
encompassed by VA policies. There are in addition, many useful guidance
documents with which you may need to become familiar not cited herein. 
These include, for example, interpretive guidance from the Public Health
Service in the form of "Dear Colleague Notices"; Office of Laboratory
Animal Welfare (OLAW), Office of Extramural Research (OER), National
Institutes of Health (NIH) Notices; United States Department of
Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS),
Animal Care (AC) policies; the 2000 Report of the American Veterinary
Medicine Association on Euthanasia; and the Association for Assessment
and Accreditation of Laboratory Animal Care International (AAALAC)
standards.  A list of acronyms used in the checklist is included in
Appendix A.  Appendix B provides excerpts from the ORO "What to Report
to ORO" memorandum of September 8, 2005, as a reminder of the
requirement to report various animal welfare issues to ORO and other
agencies.  Please direct questions about the checklist to your ORO
Regional Office or to the ORO Chief Veterinary Medical Officer.

SOURCES OF DOCUMENTATION/EVIDENCE: Prior to conducting the review of
this checklist, it would be helpful to assemble the following documents:

1.  Institutional Animal Care and Use Committee (IACUC) Minutes for the
    past 12 months

2.  IACUC Membership Roster (include credentials, representative
    capacity, and voting status)

3.  List of current approved animal research protocols with USDA
    category designations noted (C, D, or E)

4.  Standard Operating Procedures

5.  Last two semi-annual Program Reviews and Animal Research Facility
    Inspections

6.  AAALAC Accreditation Letter and Program Description

7.  DHHS Animal Welfare Assurance and most recent annual report to OLAW

8.  USDA Annual Report

9.  Annual Report to VA Central Office

10. Animal Facility Health Monitoring Reports

11. Training Records for all Animal Users & Care Staff

12. Occupational Health Records of all Animal Care Staff

13. Maintenance Records for HVAC, Cage Washers, Autoclaves, etc.

In 1985, Congress enacted two laws that contained provisions related to
the care and use of animals in research, testing and education: the
Health Research Extension Act (Public Law 99-158) and the Food Security
Act (Public Law 99-198). The Health Research Extension Act made
compliance with PHS Policy on Humane Care and Use of Lab Animals a
matter of law for all PHS funded research. The Food Security Act
extensively amended the Animal Welfare Act (AWA) (7 USC 2131-2156).
Regulatory authority under the AWA is vested in the Secretary of
Agriculture and codified in the Code of Federal Regulations Title 9
Chapter 1, Subchapter A Parts 1,2,3,& 4.

**ORO CHECKLIST FOR LABORATORY ANIMAL WELFARE**

**Determine whether the following items in the Animal Welfare Checklist
are appropriately and sufficiently described and mark either\
"Yes," "No," "Partial," or "N/A". Any deficiencies or features of
exceptional merit should be described in the final column.**

<table>
<colgroup>
<col style="width: 43%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 0%" />
<col style="width: 3%" />
<col style="width: 0%" />
<col style="width: 12%" />
<col style="width: 0%" />
<col style="width: 12%" />
<col style="width: 17%" />
</colgroup>
<thead>
<tr class="header">
<th><h3 id="section"></h3></th>
<th></th>
<th></th>
<th colspan="2"></th>
<th colspan="2"></th>
<th colspan="2"><p><strong>Regulations/</strong></p>
<p><strong>PHS Policy</strong></p></th>
<th><p><strong>Guide/</strong></p>
<p><strong>VA Policies</strong></p></th>
<th></th>
</tr>
<tr class="odd">
<th></th>
<th><strong>Yes</strong></th>
<th><strong>No</strong></th>
<th><strong>Partial</strong></th>
<th colspan="2"><strong>N/A</strong></th>
<th colspan="4"><strong>Source</strong></th>
<th><h4 id="documentationevidence">Documentation/Evidence</h4></th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td><h3 id="a.-institutional-policies-responsibilities">A. INSTITUTIONAL
POLICIES &amp; RESPONSIBILITIES</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><h2 id="monitoring-care-use-of-animals">1. Monitoring Care &amp; Use
of Animals</h2></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><h1 id="section-1"></h1></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>a. There is a functional IACUC of record at or for the
facility.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.37</td>
<td><p>The Guide Pg. 8-9;</p>
<p>1200.7.8</p></td>
<td></td>
</tr>
<tr class="even">
<td>b. The IACUC is responsible for the oversight and evaluation of the
institution's Animal Care &amp; Use Program (ACUP).</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.31(c);</p>
<p>PHS IV, A.3.a</p></td>
<td><p>The Guide Pg. 9;</p>
<p>1200.7.8.d;</p>
<p>1200.7.8.a.1</p></td>
<td></td>
</tr>
<tr class="odd">
<td>c. The Institutional Official (IO) appoints VA members to the IACUC
in writing for renewable terms.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.31(a);</p>
<p>PHS IV.A.3a</p></td>
<td><p>The Guide Pg. 9;</p>
<p>1200.7.8.a</p></td>
<td></td>
</tr>
<tr class="even">
<td>d. The Institutional Official (IO) appoints the Chair for a 1 year
renewable term.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8a(6)(a)</td>
<td></td>
</tr>
<tr class="odd">
<td><p>e. The IACUC has at least five members that include:</p>
<ol type="1">
<li><p>a veterinarian</p></li>
<li><p>a scientist</p></li>
<li><p>a non-scientist</p></li>
<li><p>an unaffiliated non-lab animal user, and</p></li>
</ol>
<p>(5) a member of the R&amp;D Committee.</p></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(b)(3)(i) &amp; (ii); PHS IV.A.3b</td>
<td><p>The Guide Pg. 9;</p>
<p>1200.7.8.a.(1)</p></td>
<td></td>
</tr>
<tr class="even">
<td>f. The IACUC reports to the R&amp;D Committee and the IO.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>PHS IV. B.5;</p>
<p>9 CFR 2.31(c)(5)</p></td>
<td><p>The Guide Pg. 9;</p>
<p>1200.7.8.d.1.e</p></td>
<td></td>
</tr>
<tr class="odd">
<td>g. The institution devotes sufficient administrative and secretarial
resources for IACUC to conduct prescribed duties.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 8;</p>
<p>1200.7.8</p></td>
<td></td>
</tr>
<tr class="even">
<td>h. The IACUC conducts semi-annual evaluations of the ACUP as well as
the Animal Facility, associated animal use labs where animals are housed
more than 12 hours, and other procedure areas at the VA medical
center.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.31(c)(1) &amp; (2);</p>
<p>PHS IV.B1&amp;2</p></td>
<td><p>The Guide Pg. 9;</p>
<p>1200.7.8.d.1</p></td>
<td></td>
</tr>
<tr class="odd">
<td>i. The VA IACUC either 1) conducts oversight and evaluation of the
ACUPs and facilities at other institutions that house VA animals, or 2)
reviews and evaluates the semi-annual reviews of another IACUC in lieu
of its own review of those programs.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.b.1(a)</td>
<td></td>
</tr>
<tr class="even">
<td>j. The IACUC reviews and approves (withholds approvals) of all
animal protocols.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(c)(6)&amp;(7) PHS IV.B.7</td>
<td>1200.7.8.d(2)</td>
<td></td>
</tr>
<tr class="odd">
<td>k. The ACOS/R&amp;D and/or the AO do not serve as voting members of
the IACUC.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.c(1)</td>
<td></td>
</tr>
<tr class="even">
<td>l. No IACUC member may participate in the IACUC review or approval
of a research project in which the member is personally involved.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.c.</td>
<td></td>
</tr>
<tr class="odd">
<td>m. IACUC members should not participate in the IACUC review or
approval of a research project in which the member has a financial
conflict.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.c.</td>
<td></td>
</tr>
<tr class="even">
<td>n. The facility is AAALAC accredited.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.7.e</td>
<td></td>
</tr>
<tr class="odd">
<td>o. The IACUC reviews and approves animal protocols annually.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.e</td>
<td></td>
</tr>
<tr class="even">
<td>p. The IACUC meets as often as needed, but not less than once<br />
every 6 months.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(c)(1) &amp; (2)</td>
<td><p>The Guide Pg. 9;</p>
<p>1200.7.8.d</p></td>
<td></td>
</tr>
<tr class="odd">
<td>q. Appropriate training or continuing education programs exist for
IACUC members.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.32 (c)</td>
<td><p>The Guide pg. 9;</p>
<p>1200.7.8.k</p></td>
<td></td>
</tr>
<tr class="even">
<td><h1 id="iacuc-records-reporting-requirements">2. IACUC Records &amp;
Reporting Requirements</h1></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>a. Reports to the IO include the Semi-Annual Program Review and
Facility Inspection Reports.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(c)(3)</td>
<td><p>The Guide Pg. 9;</p>
<p>1200.7.8.d.(1)(e)</p></td>
<td></td>
</tr>
<tr class="even">
<td><blockquote>
<p>(1) Significant deficiencies are distinguished from minor
deficiencies.</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(c)(3); PHS IV.B.3</td>
<td><p>1200.7.8.d(1)(d)<u>3</u>;</p>
<p>1200.7.8g</p></td>
<td></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>(2) If facility or program deficiencies are reported, the Semi-Annual
Report contains a specific plan of action with a timeline to correct the
deficiency.</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(c)(3); PHS IV.B.3</td>
<td>1200.7.8.d(1)(d)<u>2</u></td>
<td></td>
</tr>
<tr class="even">
<td><blockquote>
<p>(3) Minority IACUC opinions and views are included.</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(c)(3); PHS IV.F.4</td>
<td>1200.7.8.d(1)(d)<u>4</u></td>
<td></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>(4) Departures from the Guide or PHS Policy are detailed, and reasons
for the departure are provided.</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.g(1)(a)</td>
<td></td>
</tr>
<tr class="even">
<td>b. Semi-Annual Reports approved by the IACUC majority are reviewed
during a meeting among the Institutional Official (IO), VMO/VMC, IACUC
Chair, and one or more research administrators, then signed by the IO
indicating he/she reviewed.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.d.(1)(e)</td>
<td></td>
</tr>
<tr class="odd">
<td>c. As part of the Program review, the IACUC randomly reviews IACUC
records representing at least 5 percent of the total active projects (a
minimum of five).</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.d(1)(b)</td>
<td></td>
</tr>
<tr class="even">
<td>d. IACUC Semi-Annual Report is not altered by any local official
once a majority of voting IACUC members has voted to approve the
report.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7, 8.d(1)(f) &amp; (g)</td>
<td></td>
</tr>
<tr class="odd">
<td>e. Semiannual Reports are submitted to the CVMO (ORD) within 60 days
of review.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.d(1)(e)</td>
<td></td>
</tr>
<tr class="even">
<td>f. Minutes of IACUC meetings (including records of attendance, IACUC
activities and deliberations) and semiannual reports are maintained for
3 years.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.35(f);</p>
<p>PHS IV. E.2</p></td>
<td>1200.7.8.h.</td>
<td></td>
</tr>
<tr class="odd">
<td>g. IACUC minutes are written and published within 3 weeks of meeting
date.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.f(1)</td>
<td></td>
</tr>
<tr class="even">
<td>h. Minutes of IACUC meetings are submitted to R&amp;D Committee and
IO.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.f(2)</td>
<td></td>
</tr>
<tr class="odd">
<td>i. A USDA Annual Report of Research Facility is completed and
submitted by December 1 each year using the USDA website. [Submission is
no longer part of RDIS report.]</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.36</td>
<td>1200.7.8.j(1)</td>
<td></td>
</tr>
<tr class="even">
<td>j. An AAALAC Program Description is submitted triennially to
AAALAC.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.j(2)(a)</td>
<td></td>
</tr>
<tr class="odd">
<td>k. The AAALAC Annual Report and other correspondence to and from
AAALAC are sent to the CVMO (ORD).</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.j(2)(b)</td>
<td></td>
</tr>
<tr class="even">
<td>l. An annual VA Veterinary Medical Unit (VMU) report, which includes
mice and rats, is submitted to the CVMO (ORD).</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.j(1) &amp; 1200.7.8.j(4)</td>
<td></td>
</tr>
<tr class="odd">
<td>m. Regardless of funding sources, a PHS Assurance is maintained, and
the Assurance, annual updates, and correspondences to and from OLAW sent
to CVMO (ORD) and ORO.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.j(4) &amp; 8.j(6) &amp; as00.7.4.6.(4)(a)</td>
<td></td>
</tr>
<tr class="even">
<td>n. The IACUC maintains the following records:</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>(1) Proposed activities involving animals</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.35(a)(2); PHS IV.E.1</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><blockquote>
<p>(2) Any changes in activities involving animals</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.35(a)(2);</p>
<p>PHS IV.E.1.c</p></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>(3) IACUC determination of approval or disapproval</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.35(a)(2); PHS IV.E.1.c</td>
<td>The Guide Pg. 9</td>
<td></td>
</tr>
<tr class="even">
<td><blockquote>
<p>(4) IACUC semi-annual reports and recommendations including minority
views, are prepared in accordance with regulatory requirements.</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.35(a)(3); PHS IV.E.1.d</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>o. Records are maintained disclosing required information on each
live dog or cat purchased/acquired by the facility.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.35(b)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>p. ACUC documents, including all PHS, USDA, AAALAC, other reports
and correspondence related to the animal care and use program are
maintained at least three years, and IACUC records of individual
protocols are kept at least 3 years after the end of the study.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.35(f) ;</p>
<p>PHS IV.E.2</p></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>q. Original IACUC documents associated with Good Laboratory Practice
(GLP) studies that are considered to be original data are returned to
the appropriate Study Director to be archived.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">21 CFR 58.195</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>r. IACUC has procedures in place to protect “Whistle-blowers" from
discrimination or reprisal for reporting regulatory violations within
the animal facility or ACUP.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.32(c)(4)</td>
<td><p>1200.7.Appendix E.2.a(18);</p>
<p>1200.7.6.d.</p></td>
<td></td>
</tr>
<tr class="odd">
<td>s. There are procedures in place for internal and external
allegations of improper animal care and use to be promptly investigated
by the IACUC.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.31(c)(4);</p>
<p>PHS IV.B.4</p></td>
<td>1200.7.8.i</td>
<td></td>
</tr>
<tr class="even">
<td>t. IACUC notifies ACOS/R&amp;D, IO, ORO, CVMO, USDA, PHS, and AAALAC
within 15 business days of finding instances of non-compliance.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.31(d)(6)&amp;(7);</p>
<p>PHS IV.F.3</p></td>
<td>1200.7.8.g(5)</td>
<td></td>
</tr>
<tr class="odd">
<td>u. IACUC promptly notifies ACOS/R&amp;D, IO, ORO, CVMO, USDA, PHS,
and AAALAC within 15 business days of suspensions of protocols.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.31(d)(7);</p>
<p>PHS IV.F.3</p></td>
<td><p>1200.7.8.g(5);</p>
<p>1200.7 Appendix E.2.b(10)</p></td>
<td></td>
</tr>
<tr class="even">
<td>v. IACUC notifies ACOS/R&amp;D, IO, ORO, CVMO, USDA, PHS, and AAALAC
within 15 business days of failure to correct major deficiencies.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.31(d)(7)</p>
<p>&amp; (8);</p>
<p>PHS IV.F.3</p></td>
<td><p>1200.7.8.g(5);</p>
<p>1200.7 Appendix.E.2.b(11)</p></td>
<td></td>
</tr>
<tr class="odd">
<td><h1 id="animal-use-protocols">3. Animal Use Protocols</h1></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>a. No request for animal procurement may be approved or initiated
until the VMO or VMU supervisor determines that: (1) the source of
animals is appropriate; (2) adequate and appropriate housing is
available upon arrival; and (3) the animals are going to be used on an
approved Animal Component of Research Protocol (ACORP).</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.7.b(2)</td>
<td></td>
</tr>
<tr class="odd">
<td>b. Procedures are in place for review and approval of all VA-funded
research regardless of performance location.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.4.c</td>
<td></td>
</tr>
<tr class="even">
<td>c. Procedures in place for review and approval of all research
performed at the VA, regardless of funding source.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.4.c.</td>
<td></td>
</tr>
<tr class="odd">
<td>d. Prior to the third anniversary, the IACUC must conduct a complete
re-review of protocols and the most recent ACORP is used by the IACUC to
evaluate VA funded projects involving animal research.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">PHS IV.C.5</td>
<td>1200.7.8.e.2</td>
<td></td>
</tr>
<tr class="even">
<td>e. The IACUC reviews, approves, modifies, or withholds approval of
all animal use protocols.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9CFR2.31(c)(6)&amp;(7) PHS IV.B.7</td>
<td><p>The Guide -Appendix D, pg. 116</p>
<p>1200.7.8.d(2)</p></td>
<td></td>
</tr>
<tr class="odd">
<td>f. Prior to approving any protocol, the IACUC must ensure that all
staff listed on the protocol have been adequately trained.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.32 (a);</p>
<p>PHS Principle VIII</p></td>
<td>1200.7.8.k(1)</td>
<td></td>
</tr>
<tr class="even">
<td>g. Special consideration and justification have been made for the
following:</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>(1) Prolonged physical restraint <em>(How is prolonged restraint
monitored?)</em></p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td rowspan="2"><p>The Guide Pg. 11;</p>
<p>1200.7.8.d(2)(a)<u>3</u></p></td>
<td></td>
</tr>
<tr class="even">
<td><blockquote>
<p>(2) Multiple major survival surgeries <em>(major surgery exposes a
body cavity or produces significant physical or physiologic
impairment)</em></p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(d)(1)(x)</td>
<td></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>(3) Food or fluid restriction.</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 12;</p>
<p>1200.7.8.d(2)(a)<u>5</u></p></td>
<td></td>
</tr>
<tr class="even">
<td>h. There is an SOP manual for operating the ACUP that is reviewed by
the VMO and approved annually by the IACUC.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.7.c</td>
<td></td>
</tr>
<tr class="odd">
<td>i. Special procedures are in place for use of hazardous agents in
animal research.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 16-17;</p>
<p>1200.7 Appendix E, 2.a(16)</p></td>
<td></td>
</tr>
<tr class="even">
<td>j. IACUC has procedures in place for suspension of animal
activities.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.h.</td>
<td></td>
</tr>
<tr class="odd">
<td><h2 id="personnel-qualifications-training">4. Personnel
Qualifications &amp; Training</h2></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>a. All personnel involved with the animal research program are
trained to the level of their positions, and they participate in
continuing education courses to perform their duties related to animal
research.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>PHS IV.A.1g;</p>
<p>9 CFR 2.32(a), (b) &amp; (c)</p></td>
<td><p>The Guide P.13-14;</p>
<p>1200.7.6.c (4 ) &amp; 1200.7.8.d(2)(a)<u>4</u></p></td>
<td></td>
</tr>
<tr class="odd">
<td>b. The training program includes:</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.8.k.1 – 4</td>
<td></td>
</tr>
<tr class="even">
<td><ol type="1">
<li><p>Humane practices of animal care (housing, husbandry, and
handling)</p></li>
</ol></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.32(c)</td>
<td rowspan="3"><p>The Guide Pg. 13-14;</p>
<p>1200.7.6.c(4)</p>
<p>The Guide Pg. 10</p></td>
<td></td>
</tr>
<tr class="odd">
<td><ol start="2" type="1">
<li><p>Humane practices of animal use (research procedures, anesthesia,
analgesia, euthanasia, surgery, pre- and post-operative care)</p></li>
</ol></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.32(c)(1) &amp; (3)</td>
<td></td>
</tr>
<tr class="even">
<td><ol start="3" type="1">
<li><p>Testing methods that minimize the number of animals used to
obtain valid results</p></li>
</ol></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.32(c)(2)</td>
<td></td>
</tr>
<tr class="odd">
<td><ol start="4" type="1">
<li><p>Testing methods that minimize animal pain and distress</p></li>
</ol></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.32(c)(2)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><ol start="5" type="1">
<li><p>The safe use of hazardous agents and access to OSHA hazard
notices.</p></li>
</ol></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.Appendix E.2.d(3)</td>
<td></td>
</tr>
<tr class="odd">
<td>c. The institution has established and implemented a formal or on
the job-training program for the animal care staff/research staff.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9CFR 2.32(a) &amp; (b); PHS IV.A.1g</td>
<td>The Guide Pg. 13</td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="occupational-health-safety-of-personnel">5. Occupational
Health &amp; Safety of Personnel</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>a. There is a functional Occupational Health &amp; Safety Program
(OHSP) administered as part of the overall ACUP.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 14;</p>
<p>1200.7.10.c</p></td>
<td></td>
</tr>
<tr class="even">
<td>b. Human diagnostic, treatment/monitoring areas and/or equipment are
used for animal studies only with IACUC approval and/or appropriate
administrative approval.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.7.m(2)</td>
<td></td>
</tr>
<tr class="odd">
<td>c. Zoonosis surveillance is appropriate for the species housed
(e.g., Q-fever, LCMV, parasites, etc.)</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.Appendix C.10.b &amp; c.</td>
<td></td>
</tr>
<tr class="even">
<td>d. The OHSP program is based upon hazard identification and risk
assessment. Inherent dangers are identified and evaluated, i.e., bites,
scratches.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 14;</p>
<p>1200.7Appendix C.4.a&amp;b</p></td>
<td></td>
</tr>
<tr class="odd">
<td>e. The OHSP covers all personnel working in the animal
facility.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg.14;</p>
<p>1200.7 Appendix C. 4.a</p></td>
<td></td>
</tr>
<tr class="even">
<td>f. Personnel training is provided as is appropriate for the species
and/or hazardous agent(s) used (e.g., zoonoses, hazards, special
precautions).</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7Appendix C. 4.a(2)(d)</td>
<td></td>
</tr>
<tr class="odd">
<td>g. The OHSP covers personnel hygiene procedures (i.e. work clothing,
eating, drinking, smoking policies.)</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 15;</p>
<p>1200.7 Appendix C. 7.f.1-2</p>
<p>1200.7.10.a</p></td>
<td></td>
</tr>
<tr class="even">
<td>h. Signs are posted instructing personnel of eating, drinking, and
smoking prohibitions.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 15;</p>
<p>1200.7. Appendix C. 7.f</p></td>
<td></td>
</tr>
<tr class="odd">
<td>i. A separate break room is available for eating and drinking.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg.73</td>
<td></td>
</tr>
<tr class="even">
<td>j. Procedures are in place for proper use, storage, and disposal of
hazardous materials.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix C. 8.c.(2)</td>
<td></td>
</tr>
<tr class="odd">
<td>k. Appropriate hazard signs are in plain view where
appropriate.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix C. 8.h(1)</td>
<td></td>
</tr>
<tr class="even">
<td>l. Procedures are in place to provide appropriate personnel
protective equipment such as masks, respirators, gowns, eye protections,
boots, etc.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix C. 8.h(2)(c)</td>
<td></td>
</tr>
<tr class="odd">
<td>m. Scavenging systems are used for waste anesthetic gasses.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td rowspan="2"><p>The Guide pg. 17;</p>
<p>1200.7.7.k.1</p></td>
<td></td>
</tr>
<tr class="even">
<td>n. Explosive agents are not used unless justified scientifically and
approved by the IACUC and the SRS (Subcommittee on Research
Safety.)</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td><h3
id="o.-safety-equipment-is-properly-maintained-and-calibrated.">o.
Safety equipment is properly maintained and calibrated.</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide, Pg. 15</td>
<td></td>
</tr>
<tr class="even">
<td><h3
id="p.-material-safety-data-sheets-msds-are-available-for-all-chemical-agents.">p.
Material Safety Data Sheets (MSDS) are available for all chemical
agents.</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">29CFR 1910.1200(g)</td>
<td>1200.7. Appendix C. 8.f(2)</td>
<td></td>
</tr>
<tr class="odd">
<td><h3
id="q.-the-facility-provides-laundry-service-uniforms-and-all-personal-protective-equipment-necessary.">q.
The Facility provides laundry service, uniforms, and all personal
protective equipment necessary.</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 15; 17</p>
<p>1200.7,10.b. &amp;</p>
<p>Appendix E. 2e.(1)</p></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="medical-evaluation-preventive-medicine-for-personnel">6.
Medical Evaluation &amp; Preventive Medicine For Personnel</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>a. Personnel undergo an annual medical evaluation and/or
questionnaire review, and there is an appropriate preventive medicine
program.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg. 17; 1200.7. Appendix C. 4.a(1)</td>
<td></td>
</tr>
<tr class="even">
<td>b. Protective immunizations are given at appropriate intervals
(e.g., tetanus, rabies.)</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 18;</p>
<p>1200.7. Appendix C. 4.a(2)(b)</p></td>
<td></td>
</tr>
<tr class="odd">
<td>c. Personnel are provided the opportunity of receiving vaccines,
free of cost, in accordance with current CDC recommendations.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 18;</p>
<p>1200.7.10.c(2)</p></td>
<td></td>
</tr>
<tr class="even">
<td>d. A pre-employment physical exam is offered and health history
taken to ensure the workplace does not pose unnecessary risks.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix C. 4.a.(2)(a)</td>
<td></td>
</tr>
<tr class="odd">
<td>e. Reporting and treatment procedures exist for those personnel who
have been scratched, bitten, or otherwise injured by an animal.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 18;</p>
<p>1200.7. Appendix C. 4.b</p></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="primate-facilities-only">7. Primate Facilities
Only</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>a. T.B. screening is routinely conducted and includes all
potentially exposed personnel.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix C. 10.b(2)(b)</td>
<td></td>
</tr>
<tr class="even">
<td>b. Training and implementation of procedures are in place for
reporting and responding to bites and scratches involving nonhuman
primates, including procedures and supplies to immediately treat
potential human exposures to <em>C. herpesvirus</em> (Herpes B).</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>1200.7. Appendix C. 4.b;</p>
<p>The Guide Pg. 18;</p>
<p>1200.7. Appendix C. 10.b(1)</p></td>
<td></td>
</tr>
<tr class="odd">
<td>c. There is an educational program on <em>C. herpesvirus</em>
infections when susceptible nonhuman primates are housed or used in the
animal program.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix C. 4.a.(2)(d)</td>
<td></td>
</tr>
<tr class="even">
<td>d. A compliant nonhuman primate enrichment program exists when
appropriate.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.81</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="b.-animal-environment-housing-management">B. Animal
Environment Housing &amp; Management</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="physical-environment">1. Physical Environment</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>a. Wall, ceiling, and floor surfaces within animal holding areas,
along with furniture fixtures, are constructed of materials that allow
them to be cleaned and sanitized.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.1(c)(1)</td>
<td>1200.7. Appendix E. 3.b(13)</td>
<td></td>
</tr>
<tr class="even">
<td>b. Interior surfaces of animal holding areas are free of excessive
rust and jagged edges. Paint on animal housing units is intact and not
chipped or cracked.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.1(c)(1)(i, ii)</td>
<td>1200.7. Appendix E. 3.b(14)</td>
<td></td>
</tr>
<tr class="odd">
<td>c. Ceiling tiles and plaster ceilings that experience water damage
are replaced in a timely fashion to prevent mold growth.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix E. 3.b(15)</td>
<td></td>
</tr>
<tr class="even">
<td>d. Primary enclosures, cages, or shelters are appropriate for the
species housed.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix E. 3.b(20)</td>
<td></td>
</tr>
<tr class="odd">
<td>e. Primary enclosure space for dogs and cats is designed and
constructed in accordance with the Animal Welfare Regulations.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.6(a)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>f. Animals have enough space to turn around and express normal
postural positioning and space available for each species is consistent
with the recommendations of The Guide and the Animal Welfare
Regulations.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.6(a)(2)(xi)</td>
<td>The Guide Pg. 25</td>
<td></td>
</tr>
<tr class="odd">
<td>g. Animals have ready access to appropriate food and potable
water.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.1(d) &amp; 3.6(a)(2)(viii)</td>
<td>The Guide Pg. 39-40</td>
<td></td>
</tr>
<tr class="even">
<td>h. Primary enclosures housing cats contain resting surfaces that are
large enough to hold the occupants comfortably.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.6(b)4)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>i. Animals are housed in compatible groups where appropriate.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.7</td>
<td>The Guide Pg. 37</td>
<td></td>
</tr>
<tr class="even">
<td>j. Primary enclosures for dogs and cats are cleared of excreta and
food waste on a daily basis and cages are sanitized every 2 weeks</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.11(a)</td>
<td>The Guide Pg. 42-43</td>
<td></td>
</tr>
<tr class="odd">
<td>k. Procedural laboratories that house animals for more than 12 hours
meet minimal housing standards.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix E.3.b(1)</td>
<td></td>
</tr>
<tr class="even">
<td>l. All rooms and laboratories in which animal procedures occur are
tracked by the IACUC during review for inclusion in the semi-annual
facilities review.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 2.31(c)(2)</p>
<p>PHS IV.C.1d</p></td>
<td>1200.7. 8.d(1)(a)</td>
<td></td>
</tr>
<tr class="odd">
<td><h1 id="temperature-humidity-ventilation">2. Temperature, Humidity
&amp; Ventilation</h1></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>a. Air changes per hour in animal rooms meet standards.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg. 30-34; 1200.7. Appendix E.3.b(10)</td>
<td></td>
</tr>
<tr class="odd">
<td>b. Directional air flow is proper to ensure a safe working
environment and control of infectious agents.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix E.3.b(11)</td>
<td></td>
</tr>
<tr class="even">
<td>c. Air is flowing into the animal facility from outside areas to
reduce allergen and pathogen exposure outside the facility.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.Appendix E. 3.b(12)</td>
<td></td>
</tr>
<tr class="odd">
<td>d. The facility has a functional Heating, Ventilation, and Air
Conditioning (HVAC) system and in the event of an HVAC failure, systems
are designed to supply facility needs at a reduced level.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 32-34 &amp; Pg. 75-76;</p>
<p>1200.7. Appendix E.3.b(8)</p></td>
<td></td>
</tr>
<tr class="even">
<td>e. Temperature and humidity in animal rooms are monitored to ensure
they stay within acceptable ranges.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix E.3.b(18)</td>
<td></td>
</tr>
<tr class="odd">
<td>f. Temperature and humidity in animal rooms stay within normal
ranges and extremes outside this range are not tolerated for an extended
amount of time.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 3.3(a)&amp;(b)</p>
<p>9 CFR 3.2(a)</p></td>
<td><p>The Guide Pg. 75;</p>
<p>1200.7.7.a</p></td>
<td></td>
</tr>
<tr class="even">
<td>g. HVAC reheat units serving animal rooms are designed so that they
fail in the "off" position preventing over-heating of animals</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.7.a(2)(a)</td>
<td></td>
</tr>
<tr class="odd">
<td>h. HVAC performance is regularly monitored and documented.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 34 &amp; 75;</p>
<p>1200.7.7.a(2)(b)</p></td>
<td></td>
</tr>
<tr class="even">
<td>i. HVAC motors, belts, and equipment are on a regular preventative
maintenance program.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix E.3.b(7)</td>
<td></td>
</tr>
<tr class="odd">
<td>j. Odors, ammonia levels and/or drafts are kept within acceptable
limits. If not, appropriate steps are taken to eliminate them.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.2.b;</td>
<td>The Guide Pg. 33-34</td>
<td></td>
</tr>
<tr class="even">
<td>k. Exhaust air is HEPA (“High Efficiency Particulate Air “) filtered
to remove airborne particles before recycling, when appropriate.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg. 33</td>
<td></td>
</tr>
<tr class="odd">
<td>l. Emergency power is available to power HVAC equipment in the
animal research facility in the event of an electrical outage, or an
effective plan exists to provide supplemental cooling or other measures
to maintain temperatures within acceptable ranges.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix E.3.b.8</td>
<td></td>
</tr>
<tr class="even">
<td>m. The ability of facilities management personnel to properly detect
and respond to elevations in animal room temperatures must be tested at
least once every fiscal year and reported to the IACUC. If the response
to excessive temp is not adequate, corrective action must be immediately
taken by the Medical Center.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>1200.7.7.a.(2)(c);</p>
<p>1200.7.7.a.2(c)(1)</p></td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="illumination-noise">3. Illumination &amp; Noise</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>a. The following factors have been considered with regard to
lighting:</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>(1) Length of lighting period</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.2(c)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><blockquote>
<p>(2) Lighting intensity; and,</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg. 34-35</td>
<td></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>(3) Quality of light</p>
</blockquote></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>b. Timers are used to control lighting periods.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>c. Normal operations are conducted to minimize noise which may
affect animals.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg. 36</td>
<td></td>
</tr>
<tr class="even">
<td>d. Excessively loud or extended duration noise levels are
controlled.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7. Appendix E.3.b(19)</td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="social-environment-husbandry">4. Social Environment &amp;
Husbandry</h3></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>a. There are environmental enhancements to promote the well being of
the animals.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.81</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>b. Primary enclosures are structured to support the social and
psychological well being of the animals.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg. 36-38</td>
<td></td>
</tr>
<tr class="even">
<td>c. Dogs are given the opportunity for additional exercise where
necessary.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.8</td>
<td>The Guide Pg. 38</td>
<td></td>
</tr>
<tr class="odd">
<td>d. The daily oversight of husbandry and other animal care duties
have been assigned to a single individual (Lab Animal Supervisor).</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.6.c</td>
<td></td>
</tr>
<tr class="even">
<td>e. The Lab Animal Supervisor has at least 1 year of experience as a
lab animal care technician, animal health technician, or vet technician
with lab animal experience.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>1200.7.6.c(1)(b)</td>
<td></td>
</tr>
<tr class="odd">
<td>f. Animal handling is appropriate for the species housed.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg. 46</td>
<td></td>
</tr>
<tr class="even">
<td>g. Species-appropriate food is used.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide P. 38-40</td>
<td></td>
</tr>
<tr class="odd">
<td>h. Food is of high quality and contaminant free and is rotated and
used before the expiration date.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>i. Food is protected from vermin and stored in areas free of trash,
waste, and weeds.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 3.1(b)</p>
<p>9 CFR 3.1(e)</p></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>j. The feed is stored off the floor and away from walls to allow
cleaning underneath and around it.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.1(e)</td>
<td>The Guide Pg. 38-40</td>
<td></td>
</tr>
<tr class="even">
<td>k. When special autoclave diets are used, the autoclave date is
recorded so that food is rotated and quickly used.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>l. Transfer of feed-storage containers between areas that pose
different contamination risks is avoided.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>m. Open food supplies are kept in leak-proof containers with tightly
fitting lids to prevent contamination.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.1(e)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>n. Facility, cage, and equipment sanitation methods and standards
meet or exceed those recommended in the Guide.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><p>The Guide Pg. 42-44</p>
<p>1200.7. Appendix E.3.b(20)</p></td>
<td></td>
</tr>
<tr class="even">
<td>o. Feed storage containers are regularly cleaned.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg. 40</td>
<td></td>
</tr>
<tr class="odd">
<td>p. Watering devices are checked daily.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg. 40-41</td>
<td></td>
</tr>
<tr class="even">
<td>q. If water bottles are refilled, they are returned to the same
cage.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>r. Bedding materials are stored to prevent contamination and vermin
infestation.</td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.1(e)</td>
<td>The Guide Pg. 41</td>
<td></td>
</tr>
<tr class="even">
<td>s. Bedding is changed as necessary to keep animals clean and dry
<em>(typically varies from daily to weekly).</em></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td>The Guide Pg. 42</td>
<td></td>
</tr>
<tr class="odd">
<td>t. Excreta and food waste must be removed from pens and runs daily,
and sanitation of these primary enclosures should occur at least once
every 2 weeks.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p>9 CFR 3.1(c)(3) &amp; 3.11(a);</p>
<p>9 CFR 3.11(b)(2)</p></td>
<td colspan="2">The Guide Pg. 42-43</td>
<td></td>
</tr>
<tr class="even">
<td>u. Cages and accessories, e.g., tops, should be sanitized at least
once every 2 weeks.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td>v. Solid bottom cages are sanitized at least once a week.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>w. Bottles and sipper tubes are sanitized at least once a week.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 42-44</td>
<td></td>
</tr>
<tr class="odd">
<td>x. Automatic watering systems are flushed periodically.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>y. Autoclaves are monitored by sanitation verification systems.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td>z. Monitoring of sanitation effectiveness is conducted by monitoring
cage wash and autoclave temperatures to meet applicable standards in The
Guide.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>aa. Room care records document that husbandry staff observe animals
on a daily basis and clean and water animals as appropriate.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7.Appendix E. 3.b(22)</td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="waste-disposal-pest-control">5. Waste Disposal &amp; Pest
Control</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>a. All waste disposal meets facility, municipal, and federal
policies and regulations.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7. Appendix C.8.i(1)</td>
<td></td>
</tr>
<tr class="odd">
<td>b. Conventional, biological and hazardous waste is removed and
disposed of regularly and safely.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.1(f)</td>
<td colspan="2">The Guide Pg. 44</td>
<td></td>
</tr>
<tr class="even">
<td>c. Waste containers are cleaned often and regularly.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td>d. Standard Operating Procedures (SOPs) exist for the safe handling
and disposal of hazardous waste, and staff that might be exposed to
these agents are properly trained to follow the SOPs to minimize risk of
exposure.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>The Guide Pg. 44-45;</p>
<p>1200.7. Appendix C.8.c(2)</p></td>
<td></td>
</tr>
<tr class="even">
<td>e. Soiled bedding disposal procedures are appropriate.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>1200.7. Appendix</p>
<p>C. 8.i(1)</p></td>
<td></td>
</tr>
<tr class="odd">
<td>f. There is a documented program for regular pest control that is
adequate.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.11(d)</td>
<td colspan="2"><p>The Guide</p>
<p>Pg. 45 1200.7.</p>
<p>Appendix E. 3.b(25)</p></td>
<td></td>
</tr>
<tr class="even">
<td>g. Steps have been taken to eliminate areas where vermin can enter
the facility, and/or breed and thrive.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td>h. If vermin control methods are used, they are done in consultation
with investigators to ensure they do not unnecessarily compromise animal
and/or human health or scientific studies, and their use is
documented.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="c.-veterinary-medical-care">C. VETERINARY MEDICAL
CARE</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="attending-veterinarian">1. Attending Veterinarian</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>a. The attending Veterinarian has experience in lab animal
medicine.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.33</td>
<td colspan="2"><p>The Guide Pg. 56;</p>
<p>1200.7.6.b(1) &amp; 1200.7.7.f</p></td>
<td></td>
</tr>
<tr class="odd">
<td>b. The attending Veterinarian has authority to provide medical
treatment at his/her discretion.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.33(a)(2)</td>
<td colspan="2">The Guide Pg. 12-13; and Pg. 60</td>
<td></td>
</tr>
<tr class="even">
<td>c. The attending Veterinarian can access all animals and animal
procedure areas as needed.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7. Appendix E.2.f(3)</td>
<td></td>
</tr>
<tr class="odd">
<td><h3
id="d.-the-attending-veterinarian-monitors-the-surveillance-diagnosis-treatment-and-prevention-of-disease-and-oversees-controlquarantine-programs.">d.
The attending Veterinarian monitors the surveillance, diagnosis,
treatment, and prevention of disease and oversees control/quarantine
programs.</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>The Guide Pg.58</p>
<p>1200.7.6.b(5)(b)</p></td>
<td></td>
</tr>
<tr class="even">
<td><h3
id="e.-the-attending-veterinarian-provides-guidance-on-handling-sedating-anesthetizing-and-euthanizing-of-animals.">e.
The attending Veterinarian provides guidance on handling, sedating,
anesthetizing, and euthanizing of animals.</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.33(b)(4)</td>
<td colspan="2">The Guide Pg. 56</td>
<td></td>
</tr>
<tr class="odd">
<td>f. The attending Veterinarian provides guidance in surgery and
pre/post-surgical care.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(d)(1)(iv)(B)</td>
<td colspan="2">The Guide Pg. 56</td>
<td></td>
</tr>
<tr class="even">
<td>g. The attending Veterinarian provides oversight/guidance for
analgesia.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7. Appendix E.2.f(6)(d)</td>
<td></td>
</tr>
<tr class="odd">
<td>h. The attending Veterinarian is a voting member of the IACUC.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.33(a)(3)</td>
<td colspan="2">1200.7.8.a(1)</td>
<td></td>
</tr>
<tr class="even">
<td>i. The PI consults the Veterinary Medical Officer (VMO) during the
planning stages of a project.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(d)(1)(iv)(B)</td>
<td colspan="2">1200.7.6.b(5)(b)</td>
<td></td>
</tr>
<tr class="odd">
<td>j. Visits by veterinarians who are not FTEs are recorded with the
date/time of visits.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7.6.b(8)(c)</td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="emergency-weekend-care">2. Emergency &amp; Weekend
Care</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td>a. Procedures are in place for weekend animal care.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.33(b)(3)</td>
<td colspan="2">The Guide Pg. 46</td>
<td></td>
</tr>
<tr class="even">
<td>b. Animals are cared for by trained and qualified personnel on the
weekend.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.33(b)(2)</td>
<td colspan="2">The Guide Pg. 46</td>
<td></td>
</tr>
<tr class="odd">
<td>c. Weekend, holiday, emergency, and back up veterinary care is
available.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.33(b)(2)</td>
<td colspan="2">The Guide Pg. 46</td>
<td></td>
</tr>
<tr class="even">
<td>d. Measures have been implemented to prevent the entry of
unauthorized personnel into the facility.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7.7.j</td>
<td></td>
</tr>
<tr class="odd">
<td><h3
id="a-disaster-plan-that-includes-personnel-and-animals-is-available.">A
disaster plan that includes personnel and animals is
available.</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>The Guide, Pg. 46;</p>
<p>1200.7.7.a(3)</p></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="population-management">3. Population Management</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td>a. All animals are identified, including the following as
appropriate:</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 46</td>
<td></td>
</tr>
<tr class="even">
<td>(1) Source of animals</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.35</td>
<td colspan="2">The Guide Pg. 46</td>
<td></td>
</tr>
<tr class="odd">
<td>(2) Strain or stock</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.35</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>(3) Name and location of PI</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.35</td>
<td colspan="2">The Guide Pg. 46-48</td>
<td></td>
</tr>
<tr class="odd">
<td>(4) Pertinent dates</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.35</td>
<td colspan="2">The Guide Pg. 46-48</td>
<td></td>
</tr>
<tr class="even">
<td>(5) Protocol number</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.35</td>
<td colspan="2">The Guide Pg. 46-48</td>
<td></td>
</tr>
<tr class="odd">
<td>(6) Number of animals</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 46-48</td>
<td></td>
</tr>
<tr class="even">
<td>(7) Age or weight; <u>and/or</u>,</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 46-48</td>
<td></td>
</tr>
<tr class="odd">
<td>(8) Sex</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.35</td>
<td colspan="2">The Guide Pg. 46-48</td>
<td></td>
</tr>
<tr class="even">
<td>(9) Individual Identification methods, such as tattoos, ear tags,
neck chains, etc.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 46-48</td>
<td></td>
</tr>
<tr class="odd">
<td>b. Genetics/nomenclature of species is accurate on protocol forms
and on cage or pen cards.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 46-48</td>
<td></td>
</tr>
<tr class="even">
<td>c. Medical and surgical records are readily accessible, and in close
proximity to the animal in question.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 46</td>
<td></td>
</tr>
<tr class="odd">
<td>d. The number of animals produced in breeding colonies is recorded
and reported, including animals bred and not used for study
purposes.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 47-48; 1200.7</td>
<td></td>
</tr>
<tr class="even">
<td>e. Breeding colony records are maintained.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 46-48</td>
<td></td>
</tr>
<tr class="odd">
<td><strong>4. Animal Procurement &amp; Transportation</strong></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>a. All animals are obtained lawfully.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 57; 1200.7.7.b(1)</td>
<td></td>
</tr>
<tr class="odd">
<td>b. Vendors are evaluated for quality of the animals they
supply.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 57; 1200.7.7.b(2)</td>
<td></td>
</tr>
<tr class="even">
<td>c. Transportation is consistent with USDA regulation and humane
practices.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.15</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td>d. Transport of animals is conducted to minimize the spread of
disease and stress to the animals.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.15(a)</td>
<td colspan="2">The Guide Pg. 57</td>
<td></td>
</tr>
<tr class="even">
<td>e. Animal shipments are inspected for compliance with procurement
specifications and signs of clinical disease.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 57</td>
<td></td>
</tr>
<tr class="odd">
<td>f. The ordering and receiving of animals is coordinated with the
appropriate animal care personnel to assure that the appropriate
facilities are available for housing.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>The Guide Pg. 57;</p>
<p>1200.7.7.b(3)</p></td>
<td></td>
</tr>
<tr class="even">
<td>g. Animal transportation inside the facility is discreet and
compliant with institutional policy.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7.10.c(3)</td>
<td></td>
</tr>
<tr class="odd">
<td>h. Animal transportation between facilities is in climate-controlled
vehicles when appropriate and is compliant with institutional
policy.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7. Appendix E.3.a(16)</td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="preventive-medicine-surgery">5. Preventive Medicine &amp;
Surgery</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td>a. There is a preventive medicine program related to the quarantine,
stabilization and the separation of animals by species, source, and
health status.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>The Guide Pg. 57-58;</p>
<p>1200.7. Appendix E.2.f</p></td>
<td></td>
</tr>
<tr class="even">
<td>b. There is a program for the surveillance, diagnosis, treatment,
and control of sub-clinical and natural disease conditions.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>The Guide Pg. 59-60;</p>
<p>1200.7.7.d(2); 1200.7.7.f</p></td>
<td></td>
</tr>
<tr class="odd">
<td>c. All research animals should be as free as possible of infectious
agents.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7.7.e.</td>
<td></td>
</tr>
<tr class="even">
<td>d. There is a program for aseptic surgery, where applicable.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>The Guide Pg. 60-64</p>
<p>1200.7.7.f(3)</p></td>
<td></td>
</tr>
<tr class="odd">
<td>e. Use of animals in more than one major operative procedure from
which they are allowed to recover is justified scientifically in
writing.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(d)(1)(x)</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>f. Surgical training is provided as needed.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(d)(1)(viii)</td>
<td colspan="2">The Guide Pg. 60-64</td>
<td></td>
</tr>
<tr class="odd">
<td><strong>6. Pain, Distress, Analgesia &amp; Anesthesia</strong></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>a. All procedures that cause more than momentary/slight pain or
distress involve consultation with the attending Veterinarian.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(d)(1)(iv)(B)</td>
<td colspan="2">The Guide Pg. 64-65; 1200 7.7.f(4)</td>
<td></td>
</tr>
<tr class="odd">
<td>b. The PI provides written assurance that the research activities do
not unnecessarily duplicate previous experiments.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(d)(1)(iii)</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>c. Personnel caring for and using animals are trained in and are
responsible for assessing pain and distress in the animals.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 64-65</td>
<td></td>
</tr>
<tr class="odd">
<td>d. "End point" criteria exist that define when an animal should
undergo euthanasia or be removed from the study <em>(protocols clearly
stipulate these end points.)</em></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>The Guide Pg. 65-66</p>
<p>1200.7. Appendix D.6.m(4)</p></td>
<td></td>
</tr>
<tr class="even">
<td>e. Guidelines exist for assessing and categorizing pain.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 64-65</td>
<td></td>
</tr>
<tr class="odd">
<td>f. Withholding sedatives, analgesics or anesthetics in experiments
that cause pain or distress is justified scientifically by the PI in
writing and approved by the IACUC.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(d)(1)(iv)(A)</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>g. Compliant drug control and storage procedures are in place,
including secure storage and tracking of controlled substances.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7. Appendix D.1.w(1)</td>
<td></td>
</tr>
<tr class="odd">
<td>h. All controlled substances must be ordered by the local VA
pharmacy, and also received by the pharmacy for disbursement to research
personnel.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7.7.n.</td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="euthanasia">7. Euthanasia</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td>a. Euthanasia methods are consistent with the AVMA recommendations
and are appropriate to the species <em>(A waiver may be approved by the
IACUC.)</em></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">PHS IV.C.1.g 9CFR2.31(d)(1)(xi)</td>
<td colspan="2"><p>The Guide Pg. 65-66;</p>
<p>1200.7.7.g</p></td>
<td></td>
</tr>
<tr class="even">
<td>b. The Veterinarian and the IACUC evaluate compliance with the AVMA
euthanasia guidelines for every protocol submitted.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"><p>1200.7.7.g;</p>
<p>1200.7.6.b(5)(a)</p></td>
<td></td>
</tr>
<tr class="odd">
<td>c. All relevant individuals are trained in the method of euthanasia
to be used.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">PHS IV.C.1.f</td>
<td colspan="2"><p>The Guide Pg. 65-66</p>
<p>1200.7. Appendix D.1.t(3)</p></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="d.-physical-plant">D. PHYSICAL PLANT</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="functional-areas">1. Functional Areas</h3></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>a. Security measures in the animal facility are implemented.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7.7.j.</td>
<td></td>
</tr>
<tr class="odd">
<td>b. Facility maintenance problems are reported and corrected in a
timely manner.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7. Appendix E.3.b(5)</td>
<td></td>
</tr>
<tr class="even">
<td>c. Washrooms and sinks are provided for animal caretakers and are
readily accessible.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 3.1(g)</td>
<td colspan="2"><p>The Guide Pg. 73;</p>
<p>1200.7. Appendix C.4.c(1)</p></td>
<td></td>
</tr>
<tr class="odd">
<td>d. A dedicated, central area for sanitizing cages and ancillary
equipment is provided.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 77</td>
<td></td>
</tr>
<tr class="even">
<td>e. Animal rooms are separated from personnel areas such as offices,
conference rooms and eating rooms.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 71-79</td>
<td></td>
</tr>
<tr class="odd">
<td>f. Doors and frames are sealed to prevent vermin entry or
harborage.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>g. Light fixtures, timers, switches, and outlets are properly sealed
to prevent vermin harborage.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td><p>h. Additional space is provided for:</p>
<ol type="1">
<li><p>Animal housing, care and sanitation</p></li>
<li><p>Receipt, quarantine, and separation of animals</p></li>
<li><p>Separation of species or isolation of individual projects when
necessary</p></li>
<li><p>Storage.</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">The Guide Pg. 72</td>
<td></td>
</tr>
<tr class="even">
<td>I Specialized space (e.g., barrier, surgery, quarantine, necropsy)
is maintained properly and safely utilized.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7. Appendix E.3.b(3)</td>
<td></td>
</tr>
<tr class="odd">
<td>j. Compressed gas cylinders in procedural areas are properly
immobilized.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p>29 CFR 1910.101(b) &amp;</p>
<p>29 CFR 1910.253(b)(2)</p></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>k. Support facilities (e.g., cold storage, restrooms) are properly
maintained and safely utilized.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2">1200.7 Appendix.E.3.b(4)</td>
<td></td>
</tr>
<tr class="odd">
<td><strong>2. Facilities for Aseptic Surgery</strong></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td>a. Non-rodent survival surgery is conducted in a dedicated
room.</td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(d)(1)(ix)</td>
<td colspan="2">The Guide Pg. 78-79</td>
<td></td>
</tr>
<tr class="odd">
<td>b. Instruments used in survival surgeries are sterilized by steam,
gas or approved chemicals. <em>(Alcohol is not an approved chemical
sterilant.)</em></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="2">9 CFR 2.31(d)(1)(ix)</td>
<td colspan="2">Guide Pg. 62</td>
<td></td>
</tr>
</tbody>
</table>

**[Appendix A]{.smallcaps}**

AAALAC Association for Assessment and Accreditation of Laboratory Animal
Care, International

ACORP Animal Component of Research Protocol

ACOS/R&D Associate Chief of Staff for Research and Development

ACUP Animal Care and Use Program

AO/R&D Administrative Officer for Research and Development

APHIS Animal and Plan Health Inspection Service (USDA)

AVMA American Veterinary Medical Association

AWA Animal Welfare Act

CDC Centers for Disease Control and Prevention

CFR Code of Federal Regulations

CO Central Office (Department of Veterans Affairs)

COS Chief of Staff

CRADO Chief Research and Development Officer, VHA

CVMO Chief Veterinary Medical Officer

FTE Full Time Employee

GLP Good Laboratory Practices

GUIDE "Guide for the Care and Use of Laboratory Animals"

HEPA High Efficiency Particulate Air

HVAC Heating, Ventilation, and Air Conditioning

IACUC Institutional Animal Care and Use Committee

IO Institutional Official

LCMV Lymphocytic Choriomeningitis Virus

MSDS Material Safety Data Sheet

NIH National Institutes of Health

OSHA Occupational Safety and Health Administration

OHSP Occupational Health and Safety Program

OLAW Office of Laboratory Animal Welfare (NIH)

ORD Office of Research and Development

ORO Office of Research Oversight

PHS Public Health Service

R&D Research and Development

RDIS Research Development Information System

RO Regional Office (RO)

SOP Standard Operating Procedures

SRS Subcommittee on Research Safety (of R&D Committee)

TB Tuberculosis

USDA United States Department of Agriculture

VAMC Veterans Affairs Medical Center

VHA Veterans Health Administration

VMC Veterinary Medical Consultant

VMO Veterinary Medical Officer

VMU Veterinary Medical Unit

**[Appendix B]{.smallcaps}**

"What to Report to ORO"

Lab Animal Welfare in VA Research

The following identifies issues that VHA facilities must report to ORO
as required by applicable Federal regulations and VHA policies:

1.  Any incident that seriously affects the health or safety of
    laboratory animals.

2.  Any loss of animal life due to physical plant deficiencies and/or
    engineering failures or mishaps.

3.  Any work-related injury to personnel working within an animal
    facility that requires more than minor medical intervention or leads
    to serious complications or death.

4.  Any for-cause suspension or termination of VA animal research by the
    Institutional Animal Care and Use Committee (IACUC).

5.  Any serious or continuing noncompliance with the Public Health
    Service (PHS) Policy on Humane Care and Use of Laboratory Animals or
    VHA Handbook 1200.7 on Use of Animals in Research.

6.  Any serious deviation from the requirements of the Animal Welfare
    Act under 9 CFR Parts 1, 2, or 3.

7.  Any serious deviation from the Guide for the Care and Use of
    Laboratory Animals.

8.  Any findings of noncompliance in laboratory animal care from the VHA
    Office of Research and Development (ORD) or other VA office. NOTE:
    The report to ORO should include a copy of the official findings.
    The facility should promptly provide ORO with copies of all
    subsequent correspondence between the office and the facility until
    the issue is resolved.

9.  Any findings of noncompliance in laboratory animal care from
    external oversight agencies such as the US Department of Agriculture
    (USDA) Animal and Plant Health Inspection Service (APHIS), the
    National Institutes of Health (NIH) Office for Laboratory Animal
    Welfare (OLAW), etc. NOTE: The report to ORO should include a copy
    of the official findings. The facility should promptly provide ORO
    with copies of all subsequent correspondence between the agency and
    the facility until the issue is resolved.

10. Any change in the facility's accreditation status from a
    VA-recognized accreditation organization for laboratory animal
    welfare, such as the Association for Assessment and Accreditation of
    Laboratory Animal Care International (AAALAC), or in the
    accreditation status of an affiliate institution or other VA
    facility upon which the facility relies.

11. Any change in the facility\'s Animal Welfare Assurance status as
    filed with OLAW, or in the Animal Welfare Assurance status of an
    affiliate institution or other VA facility upon which the facility
    relies.

12. Any significant change in the facility\'s Memorandum of
    Understanding (MOU) with an affiliate institution or other VA
    facility regarding animal care and use arrangements. NOTE: Report
    such changes directly to ORO Central Office and simultaneously copy
    the ORO Regional Office.

**This information addresses reporting requirements to ORO only.** VHA
facilities may also be required to report information to other entities,
for example, the VHA Office of Research and Development (ORD), the VHA
Network Director, and/or the National Institutes of Health (NIH) Office
of Laboratory Animal Welfare (OLAW).

**Guiding Principles**

1.  **Report in Writing. ** Although ORO staff is available for
    consultation regarding the content and scope of reports, each VA
    facility must provide the required information to ORO in a **written
    report from the facility Director.  Reports should first be sent by
    FAX or e-mail [and]{.underline} then promptly forwarded in hard
    copy.**

2.  **Report Promptly.  **Reports should be provided to ORO as soon as
    possible, but no later than 10 working days after the issue has come
    before the responsible facility official or oversight committee
    (e.g., Institutional Animal Care and Use Committee), unless
    otherwise indicated in the following material. If the facility has
    not made a final determination as to disposition of the issue within
    this 10 day period, the facility Director should provide ORO with a
    preliminary report and with follow up reports as needed until the
    issue is resolved.

3.  **Report to ORO Regional Office.** Reports should be addressed to
    the ORO Regional Office Director for the region in which the
    facility is located, unless otherwise indicated.

4.  **Report Descriptive Information and Actions.** Reports should
    include:

    a.  The name and any relevant Assurance number of the reporting VA
        facility.

    b.  The title of the research project(s) involved.

    c.  The name of the principal investigator(s) involved (except for
        animal research).

    d.  The number(s) used by the facility's Institutional Animal Care
        and Use Committee (IACUC), and/or Research Service to identify
        the project(s) involved.

    e.  The name of any external sponsor(s) of the project(s) involved.

    f.  The funding source(s) for the project(s) involved.

    g.  A detailed description of the issue being reported.

    h.  A detailed description of the actions the facility is taking, or
        plans to take, to address the issue.