Tissue and cell surveillance in Catalonia two and half years after start up

Abstract

Surveillance was inserted in the current legislation as a tool to guarantee quality in all the processes which make tissues and cells viable for transplantation. In Catalonia, surveillance took off in June 2008 with the creation of the Catalonian Transplant Organization’s Surveillance Register. The objective of this Register is to gather relevant events observed at each performance level: donation and retrieval, tissue bank procedures and transplantation. During the first two and a half years of this Register there were 63 notifications: 22 out of 54 were serious adverse events (SAEs) interfering with the process. 32 out of 54 of SAE were detected before allocation. 7 were serious adverse reactions, 3 of them in living donors and 4 of them in recipients. In all cases they recovered without any complications. The other 2 were medical alerts. We conclude that the professional involvement in quality systems established under current law is essential to guarantee quality control in all the processes involved and to ensure the final viability of tissues and cells.