Red Cells, Leukocyte Depleted

  • UK has universal leukodepletion
    • >90% should have <1×106 leukocytes
    • >95% should have <5×106 leukocytes
  • Should take place before the end of D2 (D0 = day of collection)
  • If components are removed from their designated storage temperature to undergo leukodepletion, they must be returned to their storage temp asap (within 3h)
  • Hemolysis measurements performed at the end of the shelf life
    • <0.8% of the red cell mass in >75% of components with a min of 20 components tested
    • Revalidation of the red cell prep process for red cell hemolysis performed at least annually and after alteration to production method
  • Production advice
    • Secure system necessary if components are transferred from the original pack
    • Expiry dates of the new component (that has undergone further processing or irradiation) must not exceed that of the primary component/ or exp date limitations conferred by the process
      • If components are pooled, expiry date = that of shortest dated component used
  • Labeling:
    • Type of product and volume
    • Producer’s name
    • Donation number
    • ABO group
    • RhD group
    • Name, composition and volume of anticoagulant solution
    • Date of collection
    • Expiry date
    • Temperature of storage
    • Blood pack lot number
    • INSTRUCTION: always check patient / component compatibility / identity/ Inspect pack and contents for signs of deterioration or damage. Risk of adverse reaction / infection, including vCJD.
  • Storage: maximum of 35 days at 4±2°C
  • Exceptionally, i.e. due to equipment failure at a Blood Centre or hospital, for temperature excursions where the core temperature has not exceeded 10°C or fallen below 1°C, components may be released for transfusion provided that:
    • The component has been exposed to such a temperature change on one occasion only
    • The duration of the temperature change has not exceeded 5 hours
    • A documented system is available in each Blood Centre or hospital to cover such eventualities
    • Adequate records of the incident are compiled and retained.
  • Removal from and return to 2-6°C controlled storage within hospitals
    • Restrict to <30min if possible
    • If 30 min exceeded, should not be returned to the issue location, but to the transfusion lab or quarantined remotely using electronic blood tracking.
    • Up to 60 min out of controlled temp is acceptable, provided the unit is then quarantined by placing in a secure refrigerator for at least 6h (to allow the unit to return to 2-6°C)
    • These units need to be identified such that they are not out of controlled temp storage for between 30-60 min on more than three occasions.
  • Transfusion should be completed within 4 hours of issue out of a controlled temperature environment
  • Should be transfused through a 170–200 µm filter.

Red cell for intrauterine transfusion / neonates / infants

  • Only produced from donors who have:
    • At least one donation in last two years which is negative for all mandatory markers
    • Negative mandatory markers with current donation

Washed RBCs

  • As for leukodepleted RBCs, except washed with 0.9% sodium chloride or other validated solution, then suspended in approved solution.
  • Storage
    • Use ASAP if produced in an open system
    • If produced in a closed system, store at  4±2°C and used within 24 hours of production

RBC, Thawed and Washed, Leukocyte Depleted

  • Frozen in the presence of a cryoprotectant (preferably within 5 days of collection)
    • Cryoprotectant to provide appropriate protection of red cells at intended storage temperature
  • Wash before use with chilled saline or other validated solution for suspension
  • Suspend in approve additive solution after thawing
  • Storage
    • Constant storage temperature is important:
      • High-glycerol cryoprotectant system:  –60°C to –80°C if stored in an electrical freezer
      • Low-glycerol cryoprotectant system:  –140°C to –150°C if stored in vapour phase liquid nitrogen
    • Storage may be extended to 30 years if the correct storage temperature is guaranteed 
    • Use as soon as thawed if produced in open system
    • Use within 24 hours (and store at  4±2°C) if produced in closed system

Whole Blood Leukocyte Depleted

  • 450ml ±10% of blood plus 63ml of anticoagulant
  • Labeling:
    • Type of product and volume
    • Producer’s name
    • Donation number
    • ABO group
    • RhD group
    • Name, composition and volume of anticoagulant solution
    • Date of collection
    • Expiry date
    • Temperature of storage
    • Blood pack lot number
  •  Storage: maximum 35 days at 4±2 °C
  • Transport time should not exceed 12 hours and temperature 2-10°C