Case Reports

The Food and Drug Administration (FDA) requires all hospitals and blood collectors to document and investigate all adverse reactions to transfusion, including cases of possible recipient transfusion transmitted infections (Section 606.170 (a) of Title 21, Code of Federal Regulations).

The regulations specify that “a written report of the investigation…including conclusions and follow-up, shall be prepared…” and “when it is determined that the product was at fault in causing a transfusion reaction, copies of all such written reports shall be forwarded to... the… collecting facility.” This requirement for you to report possible transfusion reactions and recipient transfusion transmitted infection cases to the Red Cross is included in your contract for obtaining blood and blood products.

Forms for reporting possible recipient complications for infectious disease and transfusion reactions are below.

Reactions to Transfusion Caseroports