7.5.1: Fresh Frozen Plasma, Leucocyte Depleted

Plasma that has been obtained from whole blood or by apheresis. The plasma contains less than 1 × 10⁶ leucocytes per component and has been rapidly frozen to a temperature that will maintain the activity of labile coagulation factors.

7.5.1.1: Technical information

• Donations of whole blood where the bleed time exceeded 15 minutes are not suitable for the production of plasma components for direct clinical use.
   
• Plasma should be selected from male donors or consideration should be given to screening female donors for HLA/HNA antibodies, as a TRALI risk reduction measure.
   
• The plasma should be separated before the red cell component is cooled to its storage temperature. Greater FVIII yields will be obtained when the plasma is separated as soon as possible after venepuncture and rapidly frozen to –25°C or below.
   
• The method of preparation should ensure the component has the maximum level of labile coagulation factors with minimum cellular contamination. The production process should be validated to ensure that components meet the specified limits for FVIII concentration.
   
• Component samples collected for the quality monitoring assessment of FVIII should be from an equal mix of group O and non-O donations due to the difference in FVIII levels between ABO blood groups.
   
• Fresh Frozen Plasma, Leucocyte Depleted should be administered through a CE/UKCA/UKNI marked transfusion set.

7.5.1.1: Labelling

For general guidelines, see section 6.6.

The following shall be included on the label:

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

• Fresh Frozen Plasma, 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 date of collection
• the expiry date of the frozen component*
• the temperature of storage
• the blood pack lot number*
• a warning that the component must be used within 4 hours of thawing if maintained at 22 ±2°C, or up to a maximum of 120 hours of thawing if stored at 4 ±2°C, depending on indication
• the name, composition and volume of the anticoagulant.

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

7.5.1.3: Storage

For general guidelines, see section 6.7.

• The component should be stored at a core temperature of –25°C or below for a maximum of 36 months.
   
• Although a storage temperature below –25°C improves the preservation of labile coagulation factors, lower temperatures increase the fragility of plastic. Particular care must be taken when handling such packs.
   
• The component should be thawed in a waterbath or other equipment designed for the purpose, within a vacuum-sealed overwrap bag according to a validated procedure. The optimal temperature at which the component should be thawed is 37°C; temperatures between 33°C and 37°C are acceptable.
   
• Protocols must be in place to ensure that the equipment is regularly cleaned and maintained to minimise the risk of bacterial contamination. After thawing, and at the time of administration, the content should be inspected to ensure that no insoluble precipitate is visible and that the container is intact. If to be stored thawed for an extended period (>24 hours from thawing), thawing methods that do not directly expose units to water must be used to minimise bacterial contamination.
   
• Once thawed, the component must not be refrozen and should be transfused as soon as possible. If delay is unavoidable, the component may be stored and should be used within 4 hours if maintained at 22 ±2°C or up to a maximum of 120 hours if stored at 4 ±2°C, but it should be borne in mind that extended post-thaw storage will result in a decline in the content of labile coagulation factors.
   
• Pre-thawed FFP that is out of a controlled temperature environment (4 ±2°C), can be accepted back into temperature controlled storage if this occurs on one occasion only of less than 30 minutes. Transfusion of FFP should be completed within 4 hours of issue out of a controlled temperature environment.
   
• For indications other than unexpected major haemorrhage, the component should be used within 24 hours of thawing.

7.5.1.4: 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 7.1.1), a minimum of 75% of those components tested for the parameters shown in Table 7.5.1 shall meet the specified values.

Table 7.5.1 Fresh Frozen Plasma, Leucocyte Depleted – additional tests

Parameter	Frequency of test	Specification
Volume 1	1% or as determined by statistical process control (if ≤10 components produced per month then test every available component)	Stated volume ±10%
Total protein		≥50 g/L
Platelet count 2,3		<30 × 109/L
Red cell count 3		<6 × 109/L
FVIII 4,5		Mean ≥0.70 IU/mL
Leucocyte count 3,6	As per sections 6.3 and 7.1.1	<1 × 106/unit
1 Units measured and found to be <200 mL or >340 mL should only be issued for transfusion under concessionary release
2 Units with residual platelet count >100 × 109/L should only be issued for transfusion under concessionary release
3 Pre-freeze in starting component
4 Units measured and found to have <0.30 IU/mL should only be issued for transfusion under concessionary release
5 A minimum of 90% of those components tested should have ≥0.50 IU/mL
6 Methods validated for counting low numbers of leucocytes must be used

 

7.5.1.5: Transportation

For general guidelines, see section 6.11.

Every effort should be made to maintain the core storage temperature during transportation. Unless the component is to be thawed and used straightaway it should be transferred immediately to storage at the recommended temperature.