Introduction of a Central Documentation of Blood Products according to §§ 14 and 17 Transfusionsgesetz (TFG) by a Computerized Blood Bank Data System

Abstract

Background: Since July 1998 a patient- and product-related documentation of medical products is required by law in Germany. This law (TFG) applies to blood and plasma derivatives which are utilized in the treatment of anemia and thrombocytopenia as well as for recombinant plasma proteins that are used for the treatment of complex coagulation disorders. Methods: In September 1999 a central computer-based patient- and product-related documentation of cellular blood products and fresh frozen plasma (FFP) was introduced at the Department of Transfusion Medicine, University of Aachen. Results: Over a period of 1 year from September 1999 until the end of August 2000 – referring to 28,303 blood products delivered – 98.1% of the transfusion reports (unique for each blood component) returned and central documentation could be achieved. Conclusions: The central patient- and product-related documentation of blood components meets the legal requirements of §§ 14 and 17 TFG and guarantees an immediate and detailed follow-up of every blood product registered. This central computerized registration of relevant data lightens the tasks of the responsible transfusing physician, especially in the case of look-back procedures.