JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

7.23: Whole Blood for Exchange Transfusion, Leucocyte Depleted

A component for exchange or large-volume transfusion of neonates, containing less than 1 × 106 leucocytes per unit.

7.23.1: Technical information

  • The component must be prepared and used for exchange transfusion by the end of Day 5, should be free from clinically significant irregular blood group antibodies including high-titre anti-A and anti-B (see Chapter 12) and should be negative for antibodies to CMV.
     
  • The component should be irradiated and transfused within 24 hours of irradiation. See the BCSH ‘Transfusion guidelines for neonates and older children’.5
     
  • Unless the Blood Centre recommends screening is unnecessary, the donor should be Haemoglobin S screen negative.
     
  • Whole Blood for Exchange Transfusion, Leucocyte Depleted should be transfused through a 170–200 µm filter.
     
  • If not required for exchange transfusion, the component may be remanufactured into Red Cells in Additive Solution, Leucocyte Depleted (see section 7.6), up to 6 days after donation, with a shelf life of up to 35 days in total.

7.23.2: Labelling

For general guidelines, see section 6.6.

The following shall be included on the label:

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

  • Whole Blood for Exchange Transfusion, 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 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, including vCJD

7.23.3: Storage

For general guidelines, see section 6.7.

  • The component may be stored for a maximum of 5 days at a core temperature of 4 ±2°C.
     
  • The component should be used within 24 hours of irradiation and within the overall maximum 5-day shelf life.
     
  • Variation from the core temperature of 4 ±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
    • the duration of the temperature excursion has not exceeded 5 hours
    • a documented system is available in each Blood Centre to cover such eventualities
    • adequate records of the incident are compiled and retained.
       
  • If Whole Blood for Exchange Transfusion, Leucocyte Depleted is unused within its specified shelf life, the Blood Centre may return the component to stock provided that:
    • the component was stored within specification
    • the component is appropriately relabelled as Whole Blood Leucocyte Depleted and, if necessary, ‘irradiated’
    • the storage restrictions of irradiated red cells are observed, i.e. use within 14 days of irradiation.

7.23.4: Testing

In addition to the mandatory and other tests required for blood donations described in Chapter 9, and leucocyte counting (see sections 6.3 and 7.1), 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 7.18 shall meet the specified values.

Table 7.18 Whole Blood for Exchange Transfusion, Leucocyte Depleted – additional tests

Parameter Frequency of test Specification

Volume

1% or as determined by statistical process control
(if ≤10 components produced per month then test every available component)

Within locally defined nominal volume range

Haematocrit

0.4–0.5

Haemoglobin content

≥40 g/unit

Leucocyte count*

As per sections 6.3 and 7.1

<1 × 106/unit

* Methods validated for counting low levels of leucocytes must be used

7.23.5: Transportation

For general guidelines, see section 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 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.