Procedure for Semiannual Facility Inspections

• All buildings, rooms, study areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation where animals are used or housed for 12 hours or more is inspected every six months by the IACUC
• For areas housing non-Animal Welfare Act (AWA)-regulated species, the IACUC may use as few as one qualified individual or ad hoc consultant, who need not be an IACUC member or institutional employee, to conduct the facility inspections. Qualified individuals should have training and a working knowledge of the PHS Policy, Guide, and the AWRs to appropriately evaluate the facilities and identify deficiencies and animal welfare issues.
• For areas housing AWA-regulated species, the IACUC uses subcommittees composed of at least two committee members and may also invite ad hoc consultants to assist in conducting the inspections. IACUC members involved in these inspections are not required to inspect together and may each inspect different parts of the facility.

Exceptions

• Remote aquaculture units (please contact the IACUC office for a complete list) will be required to maintain NC State housing standards and/or research protocols, but the IACUC will inspect these facilities once every two years. In lieu of semiannual inspections, these facilities will complete self-evaluation checklists annually for IACUC review, except for the year when the IACUC will perform an on-site inspection.
• Agriculture Animal units will be inspected once a year by the IACUC. In lieu of a second semiannual inspection, these facilities will complete self-evaluation checklists for IACUC review.
  These exceptions will not apply if any of these facilities are AAALAC accredited, plan to use USDA regulated species or if investigators receive any PHS (including DoD, NSF or VA) funding for research or testing conducted.

• Maintain schedule to ensure that visits are conducted at appropriate intervals.
• Maintain list of facilities (including satellite areas), each unit’s attending veterinarian(s) and other contacts as appropriate
• Maintain list of laboratories with animal use and contact
• For inspections:
  • Begin planning inspection scheduling with facility contact/ appropriate unit personnel and UAV at least one month in advance of due date of inspection. Note: All IACUC members should be notified of all inspection schedules at least two weeks in advance in order to allow them to participate if desired.
  • Provide to the inspection team: list of inspection sites, contacts, laboratories, previous inspection report(s), and checklists
  • Arrange for transportation
• Take notes during the inspection and prepare inspection reports:
  • Share any potential deficiencies (A significant deficiency is one that is or may be a threat to the health or safety of the animals) with the facility manager or lab contact at the time of the inspection. Discuss to ensure the deficiency is clearly defined.
  • Work with them to ensure a plan for correction is in place and note that for the inspection report.
  • Use the IACUC approved format for drafting the inspection report. Each unit should have a separate report, although laboratories in the same building may be covered along with the central animal housing unit. Each deficiency or comment should be numbered, and the checklists should be attached.
  • Deficiencies are separated into significant vs. minor by the inspection subcommittee performing the visit. A significant deficiency is one that is or may be a threat to the health or safety of the animals.
  • For each deficiency, include a description of the deficiency (what was seen and where), and explanation of why it’s a deficiency (e.g., failure to satisfy specific regulation or guideline). The report may refer to group of common problems, as long as detailed on the attached checklist. For example, “There was chipped and peeled paint on walls and floors of several animal rooms (see attached).”
  • Suggestions for Improvement (SFIs) may be used to document observations noted during the inspection which if uncorrected could become a minor or significant deficiency. These are intended to improve the animal care program at the facility. The IACUC may recommend corrections and provide reference to regulations as to why this finding may lead to a deficiency if not corrected. Repeated suggestions for the same finding may be escalated to a deficiency. This section should include updates on previously noted deficiencies
• Distribute prepared reports to unit managers and other contacts, copying appropriate administrators, and ensure that responses are received as appropriate;
  • If minor deficiencies are noted in the report, the recipient will be instructed to provide a response using the appropriate form within two weeks of receipt of the report.
  • If a significant deficiency has been noted in the report, the plan as discussed at the time of inspection with resolution date will be included in the report to the recipient. If further response is required, the recipient will be required to provide us with a response within 5 working days.
  •  Responses are received from the unit contact and the report is finalized.
• Distribute final reports to full committee for review by email with this instruction: “The attached inspection report has been prepared for your review. Please respond by (insert date here – 5 working days) regarding your review of the attached document. If you wish to request discussion of this report at the next convened quorum, please indicate this in your response.”
• If reports are flagged for discussion at a convened quorum, place on the agenda for the next scheduled meeting.
• Assemble final approved reports and responses. Forward to the IACUC Director to be included in the Semiannual Program Review Report to the Institutional Official

Please prepare to give the inspection team an overview of live animal work performed in the laboratory space & answer questions related to the approved protocol and procedures performed. Please ensure your lab safety plan and signage is current, an updated whistleblower sheet is posted. Incubators have a daily log.   

Additionally, the inspection team will need to see the following:

• All areas where live animals are used in the PI managed lab space
• Areas euthanasia is performed
• Areas animal procedures are performed
• Anywhere live animal records are kept (within past 6 months)
• Personnel Training records for personnel trained in procedures with live animals
• Drug logs/cabinet(s)/controlled drug box- (anesthesia, analgesia, and injectable euthanasia agents)
• Any drugs used in animals maintained by the lab.
• Monitoring records (if monitoring is described in IACUC approved protocol)
• Animal health records – (if applicable) including Veterinary Care as requested.
• Breeding records if applicable Animal use records (how does the lab track animal numbers used?)
• Equipment Maintenance records (i.e anesthesia machine, guillotine maintenance, etc.)
• Personnel vehicle used for animal transport (if applicable)