Update notice: text HIGHLIGHTED has changed following the issue of Change Notifications 1 and 2 - 2012
8.13 Fresh Frozen Plasma, Leucocyte Depleted
Plasma that has been obtained from whole blood or by apheresis from a previously tested donor (as defined in Section 8.3). The plasma contains less than 5 x 106 leucocytes per component and has been rapidly frozen to a temperature that will maintain the activity of labile coagulation factors.
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.
Ideally the plasma should be separated before the red cell component is cooled to its storage temperature.
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:C concentration.
Greater FVIII:C yields will be obtained when the plasma is separated as soon as possible after venepuncture and rapidly frozen to –25°C or below.
Component samples collected for the Quality Monitoring assessment of FVIII:C should have approximately the same ABO group distribution as issued components.
Fresh Frozen Plasma, Leucocyte Depleted should be transfused through a
170–200µm filter.
Labelling (for general guidelines see Section 7.5)
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 four hours of thawing if maintained at 22°C±2°C, or 24 hours of thawing if stored at 4°C±2°C
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
Storage (for general guidelines see Section 7.6)
The component should be stored at a core temperature of –25°C or below for a maximum of 24 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 – 37 °C are acceptable. Protocols must be in place to ensure that the equipment is cleaned daily and maintained to minimize the risk of bacterial contamination. After thawing, the content should be inspected to ensure that no insoluble cryoprecipitate is visible and that the container is intact.
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°C±2°C or 24 hours if stored at 4°C±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.
Testing
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 8.10 shall meet the specified values.
Table 8.10 Fresh frozen plasma, leucocyte depleted – additional tests| Parameter | Frequency of test | Specification |
|---|
| Volume | 1% | Within locally defined nominal volume range |
| Total Protein | 1% | >50g/L |
| Platelets | 1% | <30 x 109/L** |
| Red Cells | 1% | <6 x 109/L** |
| FVIII:C | 1% | >0.70 IU/mL |
| 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.
** Prefreeze in starting component.
Transportation (for general guidelines see Section 7.10)
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.