IACUC SOP 401

Semi-Annual Facility Inspections

  1. PURPOSE
    1. The Institutional Animal Care and Use Committee (IACUC) conducts semi-annual inspections of all animal housing facilities and areas where animal research, testing or teaching is being conducted in accordance with federal and institutional regulations and policies.
    2. This describes the procedure for conducting those inspections and reporting the findings from those inspections.
  1. APPLICABLE REGULATIONS
    1. TAMU 15.03.99.M0.01 Use of Animals in Research, Teaching and Testing
    2. AWAR 9 CFR Ch. 1, §1.1 and §2.31(c) (2)
    3. PHS Policy 111.8
  2. PROCESS OVERVIEW
    1. Frequency – The IACUC inspects each animal housing facility, animal study areas, and animal transport vehicles at least semi-annually, but may inspect any facility at any time.   In accordance with Animal Welfare Act Regulations (AWR) Section §1.1 and §2.31.c.2, and Public Health Service (PHS) Policy 111. 8, the IACUC defines an animal housing facility as any location where animals are housed for more than 12 hours.
    2. The IACUC may occasionally defer inspection of animal study locations if animal activities are not currently planned at the site; however, an inspection within the previous six months is required before the location can be used for animal activities. The IACUC defines an animal procedure or study area as an area where live animals are held or utilized. In accordance with the Animal Welfare Act  (AWA) §2143 (b)(3)(8) an exception to the requirement for semiannual inspection may be made for study areas if animals are studied in their natural environment and the study area is prohibitive to easy access.
    3. Inspection Teams – Facility inspections are conducted by at least two voting members of the IACUC, however, any IACUC member may participate in any facility inspection.
    4. Facility Inspection Reports – Facility inspection reports are submitted by the inspectors and are prepared by the Research Compliance staff for review at a convened IACUC meeting. Reports must be approved by a majority vote of a quorum of the voting members for submission to the Institutional Official in the semi-annual report. The reports will describe any deficiencies noted, and will categorize deficiencies in accordance with AWAR §2.31.c.3 and IACUC policy. The inspection reports will contain a timetable for correction of deficiencies.
    5. Deficiency categories include:
      1. Significant Deficiencies- as defined by Animal Welfare Act Regulations§2.31(c) (3) is one that, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health and safety of the animals.
      2. Minor Deficiencies- as defined by the IACUC is one that, in the judgment of the IACUC, is not a threat to the health and safety of animals, but should be corrected to ensure that the care and use of animals is conducted in accordance with all federal and institutional regulations and standards.
      3. If facility deficiencies are noted, the report must contain a reasonable and specific plan for correction and a schedule with due dates for correcting each deficiency.  Failure to correct a significant deficiency according to the plan and schedule will be reported by the IACUC, through the Institutional Official (IO), to OLAW and any federal agency funding the activity. The report must be submitted no later than 15 business days after the scheduled due date.
      4.  If deficiencies are noted that would affect the conduct of animal activities involving a biohazard requiring BSL2 containment, as defined by the Institutional Biosafety Committee (IBC), a copy of the report will be sent by the Research Compliance office to the IBC. No animal activities involving biohazards may be conducted at a site without current IBC approval.
    6. Scheduling and Notifications – The Research Compliance coordinator in conjunction with the IACUC schedules facility inspections according to member availability.
    7. Inspection team members are reminded one week in advance via e-mail.
    8. Conduct of Inspections:
      1.  Research Compliance staff provides each inspector a copy of the previous inspection report for the facility plus a copy of the response received from that facility.
      2. IACUC members arrange transportation needed to conduct the inspection. Research Compliance staff provides support as needed.
      3. Inspectors are provided inspection checklists appropriate for the type of facility evaluated.
      4. Inspectors will evaluate animal wellbeing and the suitability of the facilities for housing or study of animals. Animal records and/or procedure documentation records may be requested and examined.  Inspectors may visit with animal care staff or other laboratory personnel regarding the research or teaching activities involving animals.
    9. Post Inspection Procedures
      1.  If, in the conduct of an inspection, a significant deficiency is noted that may be a threat to the health or safety of the animals, the inspection team will immediately inform the  facility representative and the Attending Veterinarian (or designee) for an immediate corrective action. The IACUC chair and Research Compliance office will be informed within 24 hours of the deficiency and corrective actions taken to ensure the animals’ wellbeing.
      2. All deficiencies are reported to the IACUC via an inspection report presented at the monthly meetings. A quorum of members must be present to discuss and vote on the report. Deficiencies are discussed and classified as significant, major or minor by the committee.  A corrective action plan and timeline for correction are determined.
      3. Inspection reports with a corrective action plan and timetable for correction are sent to the facility management and PIs (if the deficiency is specific to their lab or animals) from the Research Compliance office.
      4. The Research Compliance coordinator or manager will follow up with the facility/Pl at least five (5) business days before the correction deadline to ensure the timeline has been followed and deficiencies were corrected. All uncorrected deficiencies will be reported to the IACUC.
      5. The Research Compliance staff will maintain documentation of all facility inspections and responses.

4. REVISION HISTORY

00 -This is an original procedure.

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