citation_inspection: 104

The IACUC protocol PRA after an investigation revealed that 50% of the cranial implants performed by the principal investigator had a negative outcome resulting in euthanasia due to infection from environmental contaminates. Three Rhesus macaques had surgical implants performed by the principal investigator and the surgical sites subsequently became infected despite daily cleaning of the site post-operatively. Samples of the implants and margins were taken, and laboratory results revealed various environmental contaminates. Other study animals that had established head implants also had a history of chronic implant infections. Upon further investigation by the IACUC and veterinary staff, it was determined that there was a consistent break in aseptic technique when the surgeries were being performed. The principal investigator had an improper understanding of how to maintain a sterile surgical field. This resulted in chronic antibiotic resistant infections of the surgical sites and significant neurological symptoms that required the animals to be euthanized. The research facility did not have appropriate procedures in place to ensure the principal investigator was adequately trained in aseptic surgical methods and procedures. The research facility must conduct training and reviews that provides guidance that will ensure all person conducting surgeries are able to appropriately perform aseptic technique. The facility implemented an appropriate corrective action plan that included training of all study personnel on aseptic techniques and suspending surgical privileges until demonstrated ability to perform such procedures. During the inspection of the Traylor Laboratory, expired compounds were noted. The compounds identified were approved for use in the protocol, but they were expired. There were two bottles of Heparin that expired in 2017 and 2018 in a container on the workbench. There were also two bags sodium chloride on the workbench that expired in 2019. The lab technician voluntarily informed the inspector that the Heparin and the sodium chloride were currently being used for the two study rabbits in the laboratory. The use of expired compounds several years out of date should not be used. All expired drugs shall be discarded or marked 'expired' and stored separately from in date drugs. It is the responsibility of the research facility to ensure all scientist, research technicians, animal technicians and other personnel involved in animal care are qualified to perform their duties. The research facility must conduct training and reviews that provides guidance that will ensure all person are able to appropriately use study compounds. Correct by: August 31, 2021