The USDA Veterinary Medical Officer (VMO) was justified in issuing a noncompliant item (NCI) citation because Amici's research technician failed to document that the analgesic was administered as outlined in the approved animal use protocol; therefore, protocol noncompliance has occurred. USDA Animal Care Policy #3 states, “Appropriate post-operative records should be maintained in accordance with professionally accepted veterinary procedures,”1 which in general means all medications administered and treatments performed should be documented in a written form. Amici's controlled substances log book documenting that buprenorphine had been withdrawn on a daily basis and the absence of clinical signs of pain and distress in the dogs during veterinary rounds are not a substitute for appropriate documentation in the dogs' medical records of when the buprenorphine was administered and by whom it was administered.

Amici has a good track record with the IACUC and appears to be a conscientious investigator, which may account for why the Attending Veterinarian came to his defense. However, a lack of documentation has put Amici and the Attending Veterinarian in a weak position to sway the VMO from issuing an NCI. The VMO does have some discretion about when to cite a NCI. The USDA Animal Care Inspection guide states the following:

“For NCIs corrected prior to the inspection: The inspector may decide, using his/her own discretion, whether or not to cite the NCI. If cited, add 'Ensure corrective actions are properly followed', and do not give a correction date.”2

In light of the above, Amici and the Attending Veterinarian could have made a stronger case for not citing the NCI, if the following had happened prior to the VMO's visit: (1) Amici had informed the IACUC of his research technician's failure to document the administration of buprenorphine in the dogs' medical records, (2) Amici had provided documentation to the IACUC that the buprenorphine doses were withdrawn and recorded, (3) Amici had documented when and how he retrained his research technician, (4) and the Attending Veterinarian had provided a report to the IACUC indicating clinical signs of pain and distress in the dogs were absence during veterinary rounds.

Had these steps been taken, the IACUC could have reviewed and potentially accepted the corrective actions. Apparently, there was no previous history of noncompliance by the Amici lab and if the actions outlined above had taken place and were presented to the VMO, they may have elected to not issue the NCI.

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