Semi-Annual and Post Approval Visits

What does the IACUC expect of my Laboratory during Semi-annual Inspections?

The Institutional Animal Care and Use Committee is mandated by federal law (PHS Policy IV.B 1-5 and AWAR §2.31 [c][1]) to review the Institution's animal facilities (including individual laboratories where animals are taken). This document is intended to assist laboratories in understanding the expectations of the IACUC during these visits.

General: A representative of the lab or facility familiar with the activities of the lab or facility should be present to meet with IACUC representatives.

Research: The visitors will ask about the research that occurs in the lab. This allows the inspection team to focus their questions in a more precise manner.

Anesthesia and other drugs: If a gas vaporizer is used within the lab, the IACUC will look to ensure the vaporizer has an in-date calibration sticker. If other drugs are used the IACUC will examine them to ensure they are in-date, pharmaceutical grade, and if they are controlled substances that logs are being maintained and drugs are stored in a double-locked cabinet.

Rodent surgery: Recovery surgery conducted in the lab must be approved on the IACUC protocol. Surgical space is available in the CCMR and should be used unless there is a valid scientific reason to conduct survival surgery in the lab. A clean area or separate room is acceptable for rodent survival surgery. If a clean area of the lab is used, procedures must be in place to minimize traffic in the area. This area should be free of clutter, have an impervious surface, and not be used for any other purpose during the surgical time. An SOP for cleaning the area may be required if it is a mixed use space. Be prepared to describe your aseptic technique, and your pre-op , operative and post-op routine.

Euthanasia: Briefly describe your Euthanasia procedure to ensure that what was written on the protocol is what is being performed in the laboratory. All euthanasia procedures need to comply with the AVMA Panel on Euthanasia. For physical methods of euthanasia equipment (scissors, decapitation instruments) must be clean, and a service and sharpness test log must be maintained and presented to the IACUC inspection team for visual inspection. If CO2 is used a flow meter must be present and flow must be induced at the appropriate flow-rate.

Post Procedural Care: The committee representatives will want to briefly discuss what monitoring takes place immediately after a procedure and also several days after the procedure.

Record Keeping: Please be prepared to show any of the following: Protocol Files; Procedure records,  Anesthesia Records, Controlled Substances Log, other records as applicable.

Personnel: Anyone with any animal contact related to the protocol must be listed on the protocol and have completed all required training.

Occupational Health: Be prepared to discuss any hazards posed by the animals and materials/compounds used in animals.  All personnel on protocol (s) should be enrolled in the Occupational Health Program.

Hazardous Materials: The IACUC may ask to discuss storage and disbursement of materials, dosage preparation and waste management and disposal practices.

Compressed gas cylinders (tanks) must be secured to protect them from falling over

Expired drugs and materials: Expired drugs and materials cannot be used in animals or in some instances may be used in terminal procedures. Expired anesthetic agents and analgesics can never be used in animals including terminal procedures.


What does the IACUC expect of my Laboratory during Post-Approval Monitoring Visits?

Post-Approval Monitoring (PAM) is required for animal related activities. This effort is independent of the IACUC semi-annual inspection and serves to ensure that the activities described on the protocol are being conducted as-written. A PAM visit consists of two parts: the review of an approved protocol and possibly viewing of selected procedures in that protocol.

During these meetings key components of a protocol (personnel, study procedures, anesthesia and analgesia, surgery, post-surgical/procedural care, euthanasia, record keeping, satellite facility, and laboratory) are discussed to ensure that current laboratory practices are consistent with the protocol as written. These visits typically last an hour and do not require advanced preparation on the part of the investigator or the laboratory. All staff working with animals are encouraged to attend the session.

During the PAM meeting, deviations from the approved protocol are sometimes discovered. Any deviations found will be discussed during the meeting, and then are sent formally to the investigator in writing. The investigator is asked to adhere to the approved protocol until modifications to address the departures from the protocol are submitted and approved. The investigator is asked to address these concerns within a month’s time.