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
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