I. IACUC Operations

This standard operating procedure outlines the procedures to be used when the IACUC conducts its semiannual inspections of approved animal housing facilities or any other locations in which animals are being held at the time of the inspection and/or used under a current protocol. Field site inspection is not included in this process.

DEFINITIONS AND REFERENCES

Animal Facility – any approved College of Charleston facility where animals are housed or used, i.e., holding areas, animal care support areas, storage areas, procedure areas, and laboratories where animal manipulations are conducted. 

Guide - The Guide for the Care and Use of Laboratory Animals

IO – Institutional Official

Minor Deficiency – a deficiency that is not a potential threat to animal health or safety or to the health and safety of persons caring for or utilizing the animals

Significant Deficiency – A significant deficiency is one that is or may be a threat to the health and safety of the animals or personnel.

Approved animal housing areas- contain features germane to the health and well-being of the species being housed, i.e.: air handlers, floor drains, temperature and humidity controls for mammals, salt water tanks for marine species.

Animal housing -any enclosure that holds animals for longer than12 hours. Animal testing area - any enclosure that holds animals for less than 12 hours.

INSPECTION GUIDELINES

At least once every six months the IACUC will visit all of the institute's facilities where animals are housed or used, i.e., holding areas, animal care support areas, storage areas, procedure areas, and laboratories where animal manipulations are conducted. Equipment used for transporting of the animals is also inspected. The IACUC may inspect any facility at any time if it receives report of a deficiency.

The Committee uses the Guide as a basis for the review. To facilitate the evaluation, the Committee will use a checklist based adapted from the facility review checklist from the OLAW website.

If deficiencies are noted during the inspection, they will be categorized as Significant or Minor.

The Committee will develop a reasonable and specific plan and schedule for correcting each deficiency. No member will be excluded from participating in any portion of the inspections.

REPORTING

Individual IACUC members will convey their observations to the IACUC Chairperson, or individual designated by the Chair, who, in turn, will draft the report using the sample OLAW Semiannual Report to the Institutional Official format from the OLAW website.

The report will contain a description of the nature and extent of the institution's adherence to the Guide and the PHS Policy, identify specifically any departures from the provisions of the Guide and the PHS Policy, and state the reasons for each departure. 

The report will distinguish significant deficiencies from minor deficiencies.

If facility deficiencies are noted, the report will contain a reasonable and specific plan and schedule for correcting each deficiency.

The draft report will be reviewed, revised as appropriate, and approved by the Committee.

The final report will be signed by a majority of the IACUC members and will include any minority opinions. If there are no minority opinions, the report will reflect such.

The completed report will be submitted to the Institutional Official within 30 days following the evaluation.

CORRECTIVE ACTION

The IACUC Chair, the Research Compliance Coordinator, and/or the IACUP Director will contact the Protocol PI if any deficiencies in locations where animals are used are noted. The Protocol PI will be requested to submit a corrective action plan within a reasonable specified period of time in consultation with the IACUP Director. A corrective action plan for facility deficiencies that are independent of individual protocols shall be submitted by the IACUP Director.

Should significant protocol-related deficiencies be found that immediately and seriously jeopardize the health and safety of the animals, the IACUC may, as necessary, suspend the protocol and assign full responsibility for care of the animals to the IACUP Director.

Should significant facility deficiencies be found that are immediately and seriously jeopardizing the health and safety of the animals, the Protocol PI shall be contacted immediately about alternative housing or other action as deemed necessary.

Corrections of minor deficiencies shall be reported to the IACUC at a convened meeting and documented in the minutes. Correction of significant deficiencies shall be reported immediately to the IO.