Facility Inspections

IACUC conducts physical inspections of all areas where live animals are housed or used. The PHS Policy states that the inspection should include 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.

Note: The list of laboratory locations is generated directly from proposals. It is important that researchers review proposals to ensure that all locations are correct. 

Several aspects of the facility are reviewed during the inspection, including but not limited to:

• Appropriateness of facilities, personnel and equipment to provide adequate care to animals
• Cleanliness of facilities, lab areas and equipment
• Training of individuals in the laboratory.
  • All individuals working with animals should be listed on the IACUC-approved protocol.
  • All individuals working with animals should have documentation to support they are qualified and have completed all training requirements
  • All individuals working with animals should have documentation of current Occupational Health Enrollment
• The storage and expiration dates of pharmaceuticals
• Appropriate euthanasia methods
• Adherence to aseptic techniques
• Personnel and animals safety issues
• Appropriate lab signs are posted
• Appropriate record-keeping, including animal logs
• Ensuring the number of animals procured, bred, and used do not exceed animals numbers listed on approved IACUC protocol
• General laboratory maintenance

The PI will be notified by the IACUC office of an upcoming scheduled inspection. However, some inspections may be conducted “unannounced” in which the PI will not be notified until the morning of the inspection.

The inspection will be conducted using the Facility Inspection checklist.  Deficiencies will be characterized as either minor or significant with an applicable corrective action plan.

A report describing each observation/deficiency will be sent to the PI to address. The report will also include the due dates for required response(s) to any deficiency noted. The PI must respond by the due date by listing the reasons the deficiencies occurred and providing a corrective action plan for each deficiency. It is the responsibility of the PI to ensure that all deficiencies identified during the inspection are corrected in a timely manner.

The IACUC and the IO will be notified of any significant deficiencies and take appropriate actions, as needed. Any significant deficiency involving USDA-covered species that is not corrected by the specified date will be reported to the USDA within 15 business days following the date of proposed correction. Any minor deficiency that is not corrected by the specified date will be reviewed by the IACUC and necessary action(s) will be determined on a case-by-case basis.

The completed inspection report will be submitted for review and approval by the IACUC. The PI will be provided access to the IACUC approved inspection report. A final copy of the report will be included in the Semi-Annual Program Evaluation and will be available to the Office of Laboratory Animal Welfare (OLAW) upon request.

Be sure that all spaces where you work with live animals are clean, neat and orderly (this includes your lab areas and your animal housing/procedure rooms in the vivarium). Benchtop areas where animal procedures are performed should be cleared of all clutter and debris.

Make sure all labels and cage cards are completed and legible. This includes any special designation cards (e.g. biohazard, chemical hazards, food/water restriction, etc.). Cards should list the agents being administered, start/end dates, and contact details.

Make sure that all experimental and therapeutic agents, special/medicated feed, and all medical materials used in animals are within their printed expiration date. Most drugs and many medical materials (such as sutures and sterile gloves) have an expiration date printed on them by the manufacturer. Expired drugs - such as anesthetics, sedatives, analgesics, and euthanasia solutions - CANNOT be used for any procedure with live animals, including terminal surgeries. They must either be 1) discarded or 2) appropriately labeled "Not for Use in Live Animals" and stored separately from "in date" materials.

Make sure that all Controlled Substances are securely stored. Federal law requires that controlled substances be kept under double lock (e.g., in a locked box that is stored in a locked drawer or cabinet), accessible only to personnel authorized to use them. An updated, complete log of all use of controlled drugs must be kept within the laboratory as well.

Maintain training records for all members of the laboratory staff, including any training done by other lab members for specific animal procedures that are performed under your approved protocols. Make sure the training log is easy to locate for the inspection team and easy to read.

Animal care logs should be readily accessible and easy to read. Make sure all data points are completed. Handwriting should be legible.  

Make sure you are following the IACUC-approved protocol on the frequency in which animal husbandry activities are being recorded.

According to the Guide (NRC 2011) the following animal husbandry activities must be performed at a regular and appropriate frequency, as applicable:

• Animal Health Check (daily)
• Food and Water Check (daily)
• Water Quality Check for Aquatic Animals
• Food quality maintenance
• Room Temperature Check
• Room Ventilation Check
• Bedding Change
• Cage Change
• Room Cleaning/Sanitation (including floors, walls, ceiling, fixtures, etc.)

      Template: Animal Care Log 

Nearly identical definitions of a significant deficiency are found in the USDA AWA Regulations and PHS Policy. The two definitions are shown below:

USDA Animal Welfare Act Regulations, 9 CFR Part 2, Subpart C, Section 2.31, par. (c)(3): “A significant deficiency is one which, with reference to Subchapter A, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals.”

Public Health Service Policy on Humane Care and Use of Laboratory Animals, IV. Implementation by Institutions, paragraph B.3: “A significant deficiency is one which, consistent with this Policy, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency.”

After the committee has inspected your animal areas, the IACUC will communicate any deficiencies found, along with regulatory background to explain why the correction is needed and in some cases how you can meet the regulatory and institutional requirements moving forward. Your lab is responsible for implementing a plan of correction and you must respond to the IACUC at least 2 weeks following the initial notice. The response should confirm that:

• The item(s) noted have been corrected. Include the date of correction and how they were corrected.
• The item(s) noted will be corrected. Include the anticipated date of correction and a written plan for how they will be corrected.

The IACUC staff will follow up with your lab until all deficiencies have been addressed and finalized. Some areas may be revisited to confirm the deficiencies have been corrected.