Update notice: text HIGHLIGHTED has changed following the issue of Change Notification 07 - 2009
8.6 Red Cells in Additive Solution, Leucocyte Depleted
A red cell component containing less than 5 x 106 leucocytes and suspended in an approved additive solution.
A red cell component prepared by removing a proportion of the plasma from leucocyte depleted whole blood and suspending in an approved additive solution. Leucodepletion may be carried out on either the whole blood starting material or on the final component.
Red Cells in Additive Solution, Leucocyte Depleted should be transfused through a 170–200µm filter.
May be produced by remanufacture of 8.21, Red Cells for Exchange Transfusion, Leucocyte Depleted, up to 6 days after donation.
Labelling (for general guidelines see Section 7.5)
The following shall be included on the label:
(* = in eye-readable and UKBTS approved barcode format.)
red cells in additive solution, Leucocyte Depleted* and volume
the blood component producer's name*
the donation number*
the ABO group*
the RhD group stated as positive or negative*
the name, composition and volume of the additive solution*
the date of collection
the expiry date*
the temperature of storage
the blood pack lot number.*
In addition, the following statements should be made:
Always check patient/component compatibility/identity
Inspect pack and contents for signs of deterioration or damage
Risk of adverse reaction/infection
Storage (for general guidelines see Section 7.6)
The component may be stored for a maximum of 42 days at a core temperature of 4°C±2°C.
Variation from the core temperature of 4°C±2°C must be kept to a minimum during storage and restricted to any short period necessary for examining, labelling or issuing the component.
Exceptionally, i.e. due to equipment failure at a Blood Centre, red cell components which have been prepared in a closed system and exposed to a core temperature not exceeding 10°C and not less than 1°C may be released for transfusion provided:
that the component has been exposed to such a temperature change on one occasion only
that the duration of the temperature change has not exceeded five hours
that a documented system is available in each Blood Centre to cover such eventualities
that adequate records of the incident are compiled and retained.
In addition to the mandatory and other tests required for blood donations described in Chapter 10, and leucocyte counting (see Sections 7.2. and 8.1.), a minimum of 75% of those components tested for the parameters shown in Table 8.3 shall meet the specified values.
Table 8.3 Red cells in additive solution, leucocyte depleted – additional tests
|Parameter ||Frequency of test||Specification|
|Haemoglobin content||1%||>40 g/unit|
|Haemolysis||As per Section 8.2||<0.8% of red cell mass|
|Leucocyte Count*||As per Sections 7.2 and 8.1||<5 x 106/unit|
* Methods validated for counting low numbers of leucocytes must be used.
Transportation (for general guidelines see Section 7.10)
For red cell components, transit containers, packing materials and procedures should have been validated to ensure the component surface temperature can be maintained between 2°C and 10°C during transportation. Additionally:
the validation exercise should be repeated periodically
if melting ice is used, it should not come into direct contact with the components
dead air space in packaging containers should be minimized
as far as is practicable, transit containers should be equilibrated to their storage temperature prior to filling with components
transport time normally should not exceed 12 hours
in some instances it is necessary to issue red cell components that have not been cooled to their storage temperature prior to placing in the transit container. The transport temperature specified above is not applicable for such consignments.