Annexe 5:

Blood Components for Contingency Use

This section contains specifications for blood components used for contingency for a limited time, which will be posted here for the applicable period.  Use will be at the discretion of each UK Blood Service.

Guidance notes for use when implementing components for contingency use

This guidance has been produced in order to provide Blood Establishments with a checklist of items to be considered before implementing components for contingency use, or reactivation of components after they have been archived.

The findings may then inform any further validation work that is required prior to activation of a component.

Guidance

Before implementing or reactivating a component, the following should be considered:

• Any changes that individual Blood Establishments have since made to the way blood or blood components have been collected, including by whole blood or component donation. This must include blood bag material/plasticiser and anticoagulant etc.
   
• Any changes that individual Blood Establishments have since made to their manufacturing processes, as these may impact on component quality
   
• A review of any new scientific or clinical data in the context of the specification
   
• A review of the original validation data and output report, including any caveats or stipulations around use or application
   
• A review of the specification to ensure that the content remains current and accurate (this might also include a comparison with a similar or relevant component in Chapter 7)
   
• A review of any other, or new, specific clinical indications for use
   
• Approval from JPAC for use of the component in the context of the relevant situation (i.e. subject to a case by case review).

• A5.1 Red Cells in Additive Solution, Leucocyte Depleted, Extended Shelf Life
• A5.2 Platelets, Apheresis, Leucocyte Depleted, at Reduced Dose as a Contingency