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. Written standard operating procedures must include all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for transfusion.
  2. The FDA has defined the font sizes, colors, and contents of the information that must be on a blood component label at the time of issue.
  3. The FDA requires that the Donation Identification Number (DIN), the Product Code, and the ABO/Rh on the blood label be machine readable.
  4. There are specific blood component labeling requirements for autologous units.
  5. The compatibility testing requirements are defined to include the age of the specimen and methods used for collecting and identifying the blood samples of recipients.
  6. Reporting of events that potentially affect the safety, quality, and/or purity of a blood component is required for all facilities—exempt, registered, and licensed facilities.