The IACUC must conduct inspections of facilities at least once every six months. This may be accomplished by assigning specific facilities to sub-ommittees, which must consist of at least two IACUC members (AWRs). No IACUC member should be excluded should she or he wish to partici-pate in an inspection. Ad hoc consultants may be used although the IACUC remains responsible for the evaluations and reports. The inspec-tion team should have a working knowledge of the Guide and AWRs in order to fully evaluate the facilities that are being inspected. Section B.2. of this Guidebook also provides general guidance in this regard.
Categories to be Inspected It is helpful for the inspection team to use a list of categories such as:
knowledge of applicable rules and regulations, and
The IACUC may determine whether the supervisory personnel of various facilities should be notified of the date and time of an inspection. Advance notification allows individuals to be available to answer questions; an unexpected visit may show the facility during usual operations but also may result in a visit having to be rescheduled if key individuals are not available.
Performing Inspections Adherence to the following recommendations will assist the IACUC in performing inspections:
An updated list of all facilities to be inspected should be maintained by the IACUC.
All proposals submitted to the IACUC should specify locations where animal procedures will be performed.
It is helpful to maintain a list of all facilities including room number, function of the room, species and deficiencies identified during the previous inspection.
For satellite areas, a contact person is useful.
For facilities with multiple rooms, a floor plan can assist the inspectors.
If a subcommittee is performing the inspection, a blend of Committee members who last inspected the area with members who did not can bring both continuity and a fresh perspective to the inspection process.
Notes should be taken throughout the visit to assist in preparation of the final report.
Apparent deficiencies should be discussed with the person in charge of the facility to ensure that the team's perception of the situation is accurate. In some cases an apparent deviation will be due to the experiment in progress, e.g., withholding of food prior to surgery.
Use of a checklist provides consistency and helps document that all categories were assessed.
While the inspection of each facility must occur semiannually, there is no regulatory requirement that all facilities at an institution must be inspected at the same time (e.g., during the same month). Therefore, IACUCs at large institutions can stagger these inspections throughout the year, as long as each animal area is inspected at least every six months.
Use of AAALAC Activities as Program Evaluation
Provisions permitting use of ad hoc consultants may be invoked by IACUCs to make use of either of the two AAALAC assessment programs (Program Status Evaluation or Accreditation), or pre-assessment preparation activi-ties, to meet the requirements for an IACUC semiannual program evaluation and subsequent report. In order to utilize one of these AAALAC related activities as a semiannual evaluation, the IACUC must ensure that the report complies with IV.B.3. of the PHSPolicy, and officially endorse the report and submit it to the IO. If an institution is covered by the AWRs, the report must comply with §2.31(c) of the AWRs, at least two IACUC mem-bers must participate, no member wishing to participate may be excluded, and the report must be signed by a majority of the IACUC members and include any minority views.
A written report of the semiannual program review and facility inspection must be prepared. The AWRs require the report to be signed by a majority of the IACUC. The report must describe the institution’s adherence to the AWRs, PHS Policy, and the Guide, and identify specifically any deviations from these documents.
Any deficiencies identified in these reviews must be designated by the IACUC as minor or significant. A significant deficiency is defined as a situation that is or may be a threat to animal health or safety. The IACUC, through the IO, must promptly report to OLAW any serious or continuing noncompliance with the PHSPolicy or any serious deviation from the provisions of the Guide. For both categories of deficiencies, a reasonable and specific plan and schedule with dates for correction must be included in the final report. All individuals to be involved in the corrections should be consulted to ensure that the plan is realistic. If the institution is unable to meet the plan, the IACUC, through the IO, must inform Animal and Plant Health Inspection Service (APHIS) officials within fifteen business days of the lapsed deadline (AWRs). If the activity is federally funded, the relevant funding agency also must be informed.
The report should indicate whether or not any minority views were filed, and minority views must be included in the final document. A copy of the report is sent to the IO and must be kept on file for a minimum of three years. It is often useful for the report to be delivered in person in order to emphasize the findings and plans for action. The institution must notify OLAW of the dates of the semiannual program evaluations and facility inspections in an annual report.
References OPRR. 1991. The Public Health Service Responds to Commonly Asked Questions. ILAR News 33(4): 68-70.
Potkay, S., N. Garnett, J. Miller, C. Pond, and D. Doyle. 1997. Frequently Asked Questions about the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Contemporary Topics 36(2): 47-50.
NIH Guide for Grants and Contracts. December 12, 1999. Notice OD-00-007.