Update notice: text HIGHLIGHTED has changed following the issue of Change Notification 1 - 2010
8.23 Red Cells in Additive Solution for Neonates and Infants, Leucocyte Depleted
A red cell component suitable for top-up or large volume transfusion of neonates and
infants under one year containing less than 5 x 106 leucocytes (per starting
component). The red cells are suspended in an additive solution and may be divided
into approximately equal volumes using a closed system.
The component should be free from clinically significant irregular blood group antibodies including high titre anti-A and anti-B and should be negative for antibodies to CMV.
Red cells in additive solution for neonates and infants, Leucocyte Depleted should be transfused through a 170–200µm filter.
Unless the Blood Centre recommends screening is unnecessary, the component should be Haemoglobin S screen negative.
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 for neonates and infants, Leucocyte Depleted* and volume
the blood component producer's name*
the donation number and, if divided, sub-batch 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)
Red cells in additive solution, Leucocyte Depleted for top up transfusion of neonates and infants under 1 year may be stored for a maximum of 35 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.
For large volume transfusion of neonates and infants under 1 year, the component must be used by the end of day 5.
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 5 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), the component shall be free from clinically significant irregular blood group antibodies and high titre anti-A and/or anti-B, and antibodies to CMV. Furthermore, a minimum of 75% of those components tested for the other parameters shown in Table 8.18 shall meet the specified values.
Table 8.18 Red cells in additive solution for neonates and infants, leucocyte depleted – additional tests*Methods validated for counting low numbers of leucocytes must be used.
|Parameter||Frequency of test||Specification|
|Volume||1% or 10 per month, whichever is greater|
If less than 10 per month, every component
|Within locally defined nominal volume range|
|Haemoglobin content||Locally defined|
|Haemolysis (only required if produced as a primary >component)||As per Section 8.2||<0.8% of red cell mass|
|Leucocyte Count*||As per Sections 7.2 and 8.1||<5 x 106/starting component|
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.