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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.

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Section Summary

Key Points
  1. The minimum standards that must be met for a product to be labeled leukocyte-reduced are defined by the FDA and they vary with the production method of the component.
  2. Segments are required to be shipped with the product.
  3. The requirements for reissue of blood including storage temperatures for transport 1-6° C and storage 1-10° C are defined.
  4. There are specific requirements for Red Blood Cells, Platelets, Plasma, and Cryoprecipitated AHF production.
  5. The process for requesting a deviation from the requirements is define.