Handbook of Policies and Procedures (IACUC/HOPP)
Section 7: Semiannual Program Review and Facility Inspections
- 7.0 Semiannual Reviews
- 7.1 Program Review
- 7.2 Facility Inspections
- 7.3 Deficiency Correction Schedule
- 7.4 Documentation
The PHS Policy and Animal Welfare Regulations (AWRs) stipulate that the IACUC must review the program for humane care and use of animals at least once every six months, using the Guide as the basis for evaluation. Federal requirements also state that the IACUC must inspect all institutional animal facilities at least once every six months
The animal care and use program review includes an evaluation of institutional policies and responsibilities (lines of authority and reporting channels), IACUC membership and functions, and IACUC record keeping and reporting procedures. It also includes a review of the adequacy and appropriateness of the veterinary medical care program, the training program for personnel, and the occupational health and safety program.
The IACUC will review at least once every six months the University’s program for humane care and use of animals, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual program reviews are as follows:
- During the regular convened meetings of the IACUC in May and November of each year, the IACUC reviews the University’s animal care and use program using a Program Review Worksheet (PRW). The PRW is designed to evaluate occupational health and safety; training for IACUC members, research staff, and husbandry staff; the institutional disaster plan; sanitation and cleaning practices; surgical support and post-operative analgesia; compliance with approved protocols; procedures for reporting allegations of inappropriate animal care or use; and accessibility to veterinary care during and after typical working hours. Each area of evaluation is evaluated and any deficiencies are categorized as minor or significant. No member is involuntarily excluded from participating in any portion of the program review.
- Findings from the Program Review, including a Deficiency Correction Schedule (See Section 7.3), are compiled and prepared for IACUC review and discussion at a regular, convened IACUC meeting following the Program Review, usually in June and December. The IACUC Program Coordinator requests additional comments and minority views from all members present.
The facility inspections are a physical inspection of all buildings, rooms, areas, enclosures and vehicles (including satellite facilities in which animals are housed for more than 24 hours) that are used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation. The Animal Welfare Regulations apply to animal study areas where animals are maintained for more than 12 hours (applicable only to USDA-covered species).
Laboratories in which routine procedures, such as immunization, dosing, and weighing, are conducted may be evaluated by other means such as random inspections. The institution, however, through the IACUC, is responsible for all animal-related activities regardless of where animals are maintained or the duration of the housing. The IACUC must have reasonable access to these areas for the purpose of verifying that activities involving animals are being conducted in accordance with the proposal approved by the IACUC.
The IACUC inspects, at least once every six months, all of the University's animal facilities, including satellite facilities, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual facility inspections are as follows:
- Every six (6) months, usually during April and October, the IACUC Program Coordinator organizes the inspection schedule of the animal facilities located on campus and any satellite facilities. These inspections are conducted using the Guide, the PHS Policy on Humane Care and Use of Laboratory Animals, and as applicable, 9 CFR Chapter I, subchapter A, as a basis for evaluation. Inspections are conducted during the first three weeks of May and November. Deficiencies are categorized as minor or significant. All IACUC members are invited, and encouraged, to attend the facility inspections. At a minimum, two (2) members are present for each inspection. No member is involuntarily excluded from participating in any portion of the facility inspections.
- A responsible party (e.g., Principal Investigator, hereinafter referred to as PI) is notified, in writing, of any minor or significant deficiency identified in their laboratory, facility or designated space. Responsible parties are required to promptly provide a response to the deficiency notification with a description of how the deficiency has been corrected or to submit a written plan with a timeline outlining how the deficiency will be corrected.
- Findings from the Facility Inspections, including a Deficiency Correction Schedule (see Section 7.3), are compiled by the IACUC Program Coordinator and prepared for IACUC review and discussion at a regular, convened IACUC meeting following the inspections, usually in June and December. The IACUC Program Coordinator requests additional comments and minority views from all members present.
The IACUC must conduct inspections of facilities at least once every six months. This may be accomplished by assigning specific facilities to subcommittees, which must consist of at least two IACUC members. No IACUC member should be excluded should she or he wish to participate in an inspection. Ad hoc consultants may be used although the IACUC remains responsible for the evaluations and reports. The inspection team should have a working knowledge of the Guide and AWRs in order to fully evaluate the facilities that are being inspected.
It is helpful for the inspection team to use a list of categories such as:
- Food and water provisions,
- Animal identification,
- Waste disposal,
- Animal health records,
- Controlled and/or expired drugs,
- Environmental control,
- Occupational health and safety concerns,
- Staff training,
- Knowledge of applicable rules and regulations, and security.
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. Although advance notification is not required, the IACUC usually provides reasonable notice to investigators of the dates, times, and locations of 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 participate in the last review, can improve the process.
- 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.
All deficiencies identified in during the Facility Inspection and/or Program Review are 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, is obligated to promptly report to OLAW any serious or continuing noncompliance with the PHS Policy or any serious deviation from the provisions of the Guide (See Section 8.5).
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, will inform Animal and Plant Health Inspection Service (APHIS) officials within fifteen business days of the lapsed deadline (AWRs). Federally funded projects will have their relevant funding agency informed.
A written report of the semiannual program review and facility inspection is prepared. The AWRs require the report to be signed by a majority of the IACUC members at a convened meeting. The report describes the institution’s adherence to the AWRs, PHS Policy, the Guide, and identifies specifically any deviations from these documents.
The report will indicate whether or not any minority views were filed, and minority views will be included in the final document. A copy of the report is sent to the IO and is kept on file for a minimum of three years in the Office of Research Support. The University notifies OLAW of the dates of the semiannual program evaluations and facility inspections in the annual report to OLAW.