citation_inspection: 49

Pertaining to IACUC approved Protocol 200794: The proposal for animal use was reviewed along with the medical records for 13 rabbits on the study. The following instances of the laboratory staff implementing significant changes in an ongoing activity without prior review and approval by the IACUC and instances of the laboratory staff not following the approved protocol were identified. The deviations with the IACUC approved protocol were identified by the IACUC during the November 2023 semi-annual facility inspection. 1. According to the research facility’s IACUC Acclimation Policy that investigators are to follow for all IACUC approved protocols, the acclimation period for all non-rodents is a minimum of 7 days. Review of facility records for the 6 rabbits delivered on 11/16/23 revealed that the 6 rabbits underwent a procedure requiring anesthesia on 11/17/23 (1 day of acclimation) and 1 rabbit delivered on 12/7/23 underwent a procedure requiring anesthesia on 12/12/23 (5 days of acclimation). Shortening of the acclimation period is a significant change regarding the use of animals in an ongoing activity that was not reviewed or approved by the IACUC committee. 2. Protocol states that two injections of the study compound will be administered to the rabbits. The first injection will be administered on study day 0 and the second injection of the study compound will be administered three days later on study day 3. Review of the medical record of rabbit #448 revealed that the study day 0 injection was administered on 12/29/23 and the second injection was administered 6 days later on 1/4/24. Doubling the time interval between study compound injections is a significant change regarding the use of animals in an ongoing activity that was not reviewed or approved by the IACUC committee. 3. Protocol states that the intra-articular injection will be performed under general anesthesia (acepromazine followed by inhalant agent). There was no documentation noted in the review of the medical records of 10 animals that the inhalant agent was administered during the injections as described in the approved protocol. 4. Protocol states that laboratory staff will monitor the rabbits “5 days per week until the prescribed study endpoint” following the intra-articular injections and following the major operative procedure. There was no documentation noted in the review of the medical records of at least 10 animals that the monitoring of the animals was performed as described in the approved protocol. 5. Protocol states that rabbits undergoing a major operative procedure will receive antibiotics for 3 days post-operatively. There was no documentation noted in the review of the medical records of 5 animals that underwent surgery that antibiotics were administered as described in the approved protocol. 6. Protocol states that acepromazine will be administered prior to procedures either as the sole agent or in addition to an inhalant agent, and the protocol includes an approved range for the dose. The dose of acepromazine administered to the rabbits was not documented in the medical records and it could not be determined if the dose of the medication was as described in the approved protocol. 7. Protocol states that “no more than 10 ml of blood at each bleeding”. The volume of blood taken was not documented in the medical records for the majority of the blood draws and it could not be determined if the volume of blood taken was as described in the approved protocol. Per this Section, with respect to activities involving animals, the IACUC shall review and approve, require modifications to secure approval, or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities prior to implementation by the investigator. Principal investigators are to follow the IACUC approved proposals and any proposed changes shall be reviewed and approved by the IACUC prior to implementation. The IACUC needs to address the deviations with the IACUC approved protocol that were identified for this proposal for animal use and ensure that all significant changes regarding the care and use of animals in ongoing activities are reviewed and approved prior to implementation. Correct by 3/1/24. This inspection and exit briefing were conducted with facility representatives. *END OF REPORT* n