All blood products must be labeled appropriately prior to issue, by federal regulation. As noted elsewhere, all of the required information regarding indications, risks, etc. could not possibly fit on a blood unit label, so transfusion services are required to make the Circular of Information available to all personnel involved in transfusion. However, there are certain things that ARE required to be on the actual final blood label for allogeneic units:

  • Blood component name
  • Unique donation identification number
  • Anticoagulant/preservative solution
  • Sedimenting agent used (if applicable)
  • Approximate volume
  • Facility that collected component
  • Facility that modified component (if applicable)
  • Storage temperature
  • Expiration date (with specific time, if applicable)
  • ABO/Rh type (Rh not required for cryoprecipitate)
  • Specificity of unexpected red cell antibody/ies (if applicable)
  • Specific instructions to the transfusionist:
    1. “See Circular of Information for the Use of Human Blood and Blood Components
    2. “Properly identify intended recipient”
    3. “This product may transmit infectious agents”
    4. “Rx only”
  • Either “Volunteer Donor” or “Paid Donor”, as applicable
  • “CMV seronegative”, if applicable
  • Indication that the unit is low volume, and the actual volume, if applicable
  • If units are pooled, the number of units in the pool, and ABO/Rh of units in the pool (this may be attached with a tie tag)
  • Red cell antigens (non-ABO and Rh, if applicable)

Source: Standards for Blood Banks and Transfusion Services, AABB.

In addition, blood banks cannot simply put the above items wherever they choose on the label. A specific format, known as ISBT 128, is required. This format, approved for use in the U.S. by the FDA in a guidance dated September 22, 2006, standardizes blood labels across donor and transfusion facilities worldwide.

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