Section Summary

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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Current Good Manufacturing Practices for Transfusion Services (online CE course)
Section Summary

Key Points
  1. Infectious disease testing is required by the CFR including HIV types 1 and 2, Hepatitis B virus, Hepatitis C virus, Human T-lymphotropic virus types 1 and 2, and Syphilis.
  2. Lookback or traceback procedures are required to ensure patients are notified of the possibility that their previous transfusion exposed them to an infectious disease because the donor now has a positive marker for the disease.
  3. The dating period of components and reagents is defined by the FDA and may change based on the storage temperature.
  4. Red Cells and thawed plasma must be stored between 1 and 6°C.