Semiannual Program Review and Inspection

Semiannual Program Review and Facility Inspection Checklist

This checklist is a tool to help you conduct thorough semiannual reviews. It covers the major topics of the Guide and the requirements of the PHS Policy. The checklist does not replace the Guide, but you should use it along with the Guide. The Guide provides the standards, recommendations, and descriptions of desired outcomes necessary to evaluate and inspect an animal care and use program.

You are not required to use the checklist, but we encourage you to amend it as necessary to reflect institutional programs and needs, or develop your own checklist. If the checklist is modified, periodic review of the checklist is recommended to ensure relevant topics are considered as the animal care and use program changes.

Suggestions or comments about this checklist should be e-mailed to: [email protected]

Summary of Contents

I. Semiannual Program Review Checklist

This is the program review section. It consists of two parts:

• Institutional Policies and Responsibilities: A comprehensive multi-part section covering important topics in the animal care and use program
  • Animal care and use program
  • Disaster planning and emergency preparedness
  • The IACUC, including protocol review and special considerations, membership and functions, training, records and reporting
  • Veterinary care (see also below, expanded in a separate section)
  • Personnel qualifications and training
  • Occupational health and safety of personnel
  • Personnel security
  • Investigating and reporting animal welfare concerns
• Veterinary Medical Care: A thorough breakdown of components of the veterinary medical program and medical care
  • Clinical cate and management
  • Animal procurement and transportation/ preventative medicine
  • Surgery
  • Pain, distress, anesthesia, and analgesia
  • Euthanasia
  • Drug storage and control

II. Semiannual Facility Inspection Checklist

This is the facility inspection section. It covers the following topics:

• Terrestrial animal housing and support areas
• Aquatic animal housing and support areas
• Cagewash
• Aseptic surgery
• Special facilities, such as procedure areas, non-survival surgeries, laboratories, rodent surgeries, imaging, whole-body irradiation, hazardous agent containment, and behavioral studies

III. Semiannual Program Review and Facility Inspection Deficiencies Table

This table is provided as a format for the IACUC to organize and track information regarding deficiencies and plans and schedules for correction. IACUCs may choose to attach the table to the Semiannual Report to the Institutional Official, but it is not a substitute for the Semiannual Report to the IO.

IV. Endnotes

This section provides references to specific USDA regulatory requirements that differ from the PHS Policy. The endnotes are also available in a standalone html format.

Download the Sample Checklist

If you wish to use the sample checklist as a template, click one of the formats below to download.

• Sample Checklist (PDF)
• Sample Checklist (MS Word)

Semiannual Report to the Institutional Official

The PHS Policy requires the IACUC to prepare and submit a report of their semiannual evaluation to the Institutional Official (IO). The IACUC may determine the best means of conducting an evaluation of the institution's programs and facilities and is responsible for the evaluation and report. Final reports of the semiannual evaluations and inspections are considered full committee actions and should be reviewed and endorsed by a majority of the IACUC.

Semiannual reports should be submitted to the IO regularly, but they should only be submitted to OLAW upon request. If the institution is submitting a new or renewal Assurance and is not accredited by AAALAC International, OLAW will request the most recent semiannual report along with the Assurance.

You must include the following information in your report to the IO:

• Description of the nature and extent of the institutions adherence to the Guide for the Care and Use of Laboratory Animals (Guide) and the PHS Policy, including any departures and reason for each departure
• Identification of any deficiencies in the program or facility, including classification as either significant or minor
• Reasonable and specific plan and schedule for correction of deficiencies
• Identification of facilities accredited by AAALAC International
• Any minority views submitted by IACUC members
• Signature of a majority of the IACUC members, if applicable

Regarding signatures, NOT-OD-24-075 and NOT-OD-24-076 explain that "Digital and scanned signatures are acceptable. Alternatively, an email acknowledgement from the member(s) may serve as their acceptance with the semiannual report...These emails should be retained for the record by the IACUC."

If you wish to use the sample semiannual report as a template, click one of the formats below to download. Instructions and information in [italics] should be deleted from the final document.

• Sample semiannual report template (PDF)
• Sample semiannual report template (MS Word)

Laws, Policies, and Guidance

Laws and Policies

• Health Research Extension Act of 1985 Sec. 495 (b)(3)(A): "Each animal care committee of a research entity shall review the care and treatment of animals in animal study areas and facilities of the research entity at least semiannually to evaluate compliance with applicable guidelines established under subsection (a) for appropriate animal care and treatment;"
• PHS Policy IV.A.2:"Each institution must assure that its program and facilities are in one of the following categories:
  • Category 1- Accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated and accredited by AAALAC, or another accrediting body recognized by the PHS...All of the institution's programs and facilities (including satellite facilities) for activities involving animals have also been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months, in accordance with IV.B.1. and 2. of this Policy, and reports prepared in accordance with IV.B.3. of this Policy.
  • Category 2 - Evaluated by the Institution. All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC. These programs and facilities will be reevaluated by the IACUC at least once every six months, in accordance with IV.B.1. and 2. of this Policy, and reports will be prepared in accordance with IV.B.3. of this Policy. The most recent semiannual report of the IACUC evaluation shall be submitted to OLAW with the Assurance.​"
• PHS Policy IV.B.:"As an agent of the institution, the IACUC shall with respect to PHS-conducted or supported activities:
  • 1. review at least once every six months the institution's program for humane care and use of animals, using the Guide as a basis for evaluation;
  • 2. inspect at least once every six months all of the institution's animal facilities (including satellite facilities) using the Guide as a basis for evaluation
  • 3. prepare reports of the IACUC evaluations conducted as required by IV.B.1. and 2. of this Policy, and submit the reports to the Institutional Official" (IO)
    "(The reports must meet the following criteria:
    • a. The reports shall be updated at least once every six months upon completion of the required semiannual evaluations.
    • b. The reports shall be maintained by the institution and made available to OLAW upon request.
    • c. The reports must contain a description of the nature and extent of the institution's adherence to the Guide and this Policy and must identify specifically any departures from the provisions of the Guide and this Policy, and must state the reasons for each departure.
    • d. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one that, 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.
    • e. If some or all of the institution's facilities are accredited by AAALAC or another accrediting body recognized by the PHS, the report should identify those facilities as such.)"
• PHS Policy IV.E.1.d.: "The awardee institution shall maintain... records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official"
• PHS Policy IV.F.1.d.: "At least once every 12 months, the IACUC, through the Institutional Official, shall report in writing to OLAW... notice of the dates that the IACUC conducted its semiannual evaluations of the institution's program and facilities and submitted the evaluations to the Institutional Official." (Note: this refers to submitting dates of semiannual evaluation in the institution's Annual Report to OLAW)

Guidance

FAQs

Semiannual Facility Inspections & Program Review:

• A.9. Does the PHS Policy apply to animals that are not directly involved in research, research training, experimentation, or biological testing or for related purposes?
• D.8. What are the institution’s responsibilities during collaborations involving animal activities?
• E.1. Should the IACUC inspect laboratories or other sites where investigators use animals?
• E.2 How does the IACUC distinguish between significant and minor deficiencies?
• E.3. May the IACUC use an AAALAC International site visit as its semiannual evaluation?
• E.4. Is the IACUC required to inspect field study sites?
• E.5. Are investigators required to be present during the semiannual facility inspections of animal and satellite facilities?
• H.6. Are there flexibilities available to IACUCs regarding the conduct of semiannual facility inspections when faced with a disaster or emergency?
• H.7. Are there flexibilities available to IACUCs regarding the conduct of the semiannual program reviews due to a disaster or emergency?