A3.5: Red Cells for Neonates and Infants, Leucocyte Depleted, Washed

A red cell component (≥250 mL) suitable for neonates and infants under 1 year that contains less than 1×10⁶ leucocytes (per starting component), which has been washed with a validated solution. The Red Cells for Neonates and Infants, Leucocyte Depleted (LD), Washed will be divided into approximately equal volumes using a closed system.

A3.5.1: Technical information

• The amount of residual protein will depend on the washing protocol. Washing can be performed by interrupted or continuous flow centrifugation.
• The use of validated closed system washing procedures that incorporate chilled validated solution for suspension is recommended. This will minimise the risk of bacterial growth and help to produce a component that meets the transit temperature requirements.
• If the washing process results in the transfer of the final component into a pack that was not part of the original pack assembly, a secure system must be in place to ensure the correct donation identification number is put on the component pack of Red Cells, Washed, LD.
• Section 7.7 provides general guidance on the requirements for components for use in neonates and infants under 1 year.
• 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 for Neonates and Infants, LD, Washed should be administered through a CE/UKCA/UKNI marked transfusion set.
• Unless the Blood Centre recommends screening is unnecessary, the donor should be Haemoglobin S screen negative.

A3.5.2: Labelling

For general guidelines, see chapter 6.6.

The following shall be included on the label:

(* = in eye-readable and UKBTS approved barcode format)

• Red Cells for Neonates and Infants, Leucocyte Depleted, Washed* 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 anticoagulant 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:

"INSTRUCTION
Always check patient/component compatibility/identity
Inspect pack and contents for signs of deterioration or damage
Risk of adverse reaction/infection"

A3.5.3: Storage

For general guidelines, see chapter 6.7.

For top-up transfusions of neonates and infants under 1 year, where the component has been produced in a closed system and storage is required, the component should be stored at a core temperature of 4 ±2°C and used up to 14 days if stored in SAGM. Where alternative additive solutions are used, storage will be defined through validation.

A3.5.4: Testing

In addition to the mandatory and other tests required for blood donations described in chapter 9, and leucocyte counting (see chapter 6.3 and chapter 7.1.1), the component shall be free from clinically signficant irregualr 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 parameters shown in Table A3.5 shall meet the specified values. Provided the component is prepared from a process that is validated for leucocyte removal, testing of washed red cells for residual leucocytes is not required.

Table A3.5: Red Cells for Neonates and Infants, LD, Washed – additional tests

Parameter	Specification	Frequency of test
Parameter Volume	Specification Within locally specified volume range	Frequency of test 100% unless the process capability by statistical process control demonstrates otherwise
Parameter Haemoglobin content	Specification Locally defined	Frequency of test 100% unless the process capability by statistical process control demonstrates otherwise
Parameter Haematocrit (1)	Specification 0.50–0.70	Frequency of test 100% unless the process capability by statistical process control demonstrates otherwise
Parameter Haemolysis at end of storage	Specification 0.8% of red cell mass	Frequency of test 100% unless the process capability by statistical process control demonstrates otherwise
Parameter Residual protein (2)	Specification <0.5 g/starting component	Frequency of test 100% unless the process capability by statistical process control demonstrates otherwise
Parameter Leucocyte count (3,4)	Specification <1×10⁶/starting component	Frequency of test As per chapter 6.3 and chapter 7.1.1

A3.5.5: Transportation

For general guidelines, see chapter 6.11.

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 minimised
• 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 from the blood supplier to hospitals 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.