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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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Red Blood Cells

The regulations in Subpart B Red Blood Cells that apply to transfusion services are:

  • Storage. Immediately after processing, the Red Blood Cells shall be placed in storage and maintained at a temperature between 1 and 6°C.
  • Inspection. The product shall be inspected immediately after separation of the plasma, periodically during storage, and at the time of issue. The product shall not be issued if there is any abnormality in color or physical appearance or if there is any indication of microbial contamination.
  • One or more segments shall be provided with each unit of Whole Blood or Red Blood Cells when issued or reissued.
  • Final containers used for Red Blood Cells shall be the original blood containers unless the method of processing requires a different container.
  • If a different container is used, it shall be marked or identified by number or other symbol so as to relate it to the donor of that unit of red cells.