IACUC Procedure 002: Semiannual Facility and Program Review

1. Purpose: In order to comply with government regulations, set forth by PHS and USDA, the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC), and the Guide for the Care and Use of Laboratory Animals, Ohio University’s Institutional Animal Care and Use Committee (IACUC) has implemented a policy (IACUC Policy 003: Semiannual Program Review) and procedure regarding semi-annual program review and facility inspections. 

2. Scope: Semiannual facility and program reviews consist of a programmatic review and an inspection of all animal housing facilities (5.1).

3. Procedure: 

3.1 Animal Care & Use Program Review Procedure-

3.2 The IACUC may use Sample Semiannual Program and Facility Review Checklist as the basis for evaluating The Animal Care & Use Program. Relevant sections of the Guide must also be consulted where necessary.

3.3 The review of the Animal Care & Use Program begins at the Program Review meeting that follows the semiannual facility inspection(s). The IACUC must work collaboratively to ensure that the program description, and all supporting documents accurately reflects programmatic practices and aligns with applicable OHIO, NIH-OLAW, and USDA-APHIS policies.

3.4 The IACUC will strive to hold an in-person program review meeting, to include as many members as possible.  If there are extenuating circumstances that prohibit an in-person meeting, this can be accomplished virtually, in real time. It’s also possible to break the meeting into several smaller duration meetings, provided that they occur no more than two weeks following the date of the semiannual facility inspection. 

3.5 NOTE: This timeline ensures that each semiannual Program Evaluation is completed comprehensively and timely. The IACUC Coordinator is responsible for arranging this meeting and any subsequent meetings that are needed to complete the evaluation within the given timeframe.

3.6 NOTE: The IACUC may elect to use resources such as OneDrive or other collaboratively filing sharing tools to review the Program Description and supporting documents prior to the Semiannual Program Evaluation Meeting.

3.7 ORC staff share materials with IACUC members at least two weeks in advance of the meeting.

3.8 Updated versions of the Animal Care & Use Program are archived by year in the following shared drive location: R:\vpr-iacuc\Animal Care Program and Inspection Reports. The Office of Research Compliance is responsible for this archival task.

3.9 Facility Inspection Procedure- 

3.10 Two or more members of the IACUC must inspect each location that meets criteria for inspection. An inspection team composed of more than two members may elect to split up and inspect different locations simultaneously.

3.11 Inspection observations are to be recorded in detail at the time of observation. The designated note-taker must ensure that the following information is captured: The building name, room number, a description of the deficiency(ies) along with the severity, and the study team responsible for the area (denoted by the name of the PI). The note-taker must also note when an area is LAR maintained area or shared space.

3.12 Corrective Action Assignment- At the Program Review meeting that follows the facility inspection, the IACUC must: one, confirm the severity of the deficiencies noted, two, determine the corrective actions needed to address the deficiency(ies). Three, assign a due date for the corrective actions. The following linked OLAW FAQ resource can be used to assist the IACUC with assessing the severity of a deficiency (5.7).

3.13 NOTE: Significant deficiencies require immediate action to address the threat to the health or safety of animals. 

3.14 Communication- Following the assignment of corrective actions, the requested action items are to be communicated in writing to the PI or person(s) responsible for the area (e.g. LAR Director, multiple PI’s using a shared space, etc.). The communication must include a description of the deficiencies, a clear description of the requested corrective action, and a due date for completion. 

3.15 Follow-up- One or more members of the IACUC may elect to visit the inspection location(s) shortly after the correction due date to verify completion or verify completion via photograph, however, at least one visual confirmation method must be used. In most cases confirmation from the PI (in writing) that the action was completed and supporting documentation (e.g. certificates, training logs, pictures, etc.) may be sufficient. 

3.16 NOTE: The PHS Policy requires that Assured institutions comply with the regulations (9 CFR, Subchapter A) issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act, as applicable. Any failure to adhere to the plan and schedule that result in a significant deficiency remaining uncorrected is required by USDA to be reported in writing within 15 business days by the IACUC, through the IO, to the Animal and Plant Health Inspection Service (APHIS) and any Federal agency funding that activity (5.4) .

3.17 NOTE: PHS Policy requires prompt reporting to Office for Protection from Research Risks (OPRR) of serious or continuing noncompliance with the PHS Policy or serious deviations from the provisions of the Guide (see Semiannual Program Review IV. Endnotes).

3.18 NOTE: Per AAALAC International’s Rules of Accreditation any significant, unexpected, adverse event occurs resulting in negative consequences to animal welfare or human health must be promptly reported (5.8).

3.19 Completed facility inspection reports are archived by year and month in the following shared drive location: R:\vpr-iacuc\Animal Care Program and Inspection Reports. The Office of Research Compliance is responsible for this archival task.

3.20 Tracking and Trending- The Office of Research Compliance is responsible for maintaining a facility inspection trends spreadsheet. This spreadsheet is to identify trends over time and achieve the supporting documentation for the corrective actions alongside a description of the associated deficiencies. The spreadsheet can be found in the shared drive at the following location: "R:\vpr-iacuc\Animal Care Program and Inspection Reports\Semiannual Inspections\Semiannual Inspection Trends & Proof Action Item Completion.xlsx"

3.21 Semiannual Reports to the IO- A written report of the semiannual program review and facility inspection is prepared for each cycle and submitted to the IO for review. This report is to be submitted to the IO within two weeks of completing the Semiannual Program Review. The NIH-OLAW template linked below is used to prepare the report (5.2).

• PDF Version 

• MS Word Version

3.22 Record Retention- A copy of the report is sent to the IO and must be kept on file for a minimum of three years. The Office of Research Compliance is responsible for this archival task. The report is stored in the Research Division shared drive under R:\vpr-iacuc\Animal Care Program and Inspection Reports

3.23 Note, semiannual reports to the IO should only be submitted to OLAW if requested, or if the institution is submitting a new or renewal Animal Welfare Assurance to OLAW(5.2).

3.24 Flexibilities-

3.25 Scheduling- Facility inspections can include flexibility of within 30 calendar days of the six-month interval from the last inspection, provided there is no forward drift of the date from year to year (5.6). 

3.26 The IACUCs may choose to conduct either an announced or unannounced inspection (5.6).