Unsatisfactory performance – action criteria

Participants are contacted by mail or email following two unsatisfactory performances in a given parameter. This could be within the same trial; an example of this is Factor VIII where two samples are tested at the same time. Alternatively as with for example, fibrinogen, unsatisfactory performance in two individual trials out of four, i.e. intervention before a fifth trial and possible third unsatisfactory performance. Non return is assessed as an unsatisfactory performance.

The Scheme, where possible, prompts investigation into likely problem areas and the centre is asked to report any corrective action(s) taken. Advice is given when a participant contacts the Scheme for assistance following an unsatisfactory performance.  A participant can request samples with consensus mean values to verify any correctiveaction taken and report results to the Scheme to review.

We would like to emphasize that participants are notified of unsatisfactory performancesas soon as possible so that any problem may be swiftly addressed. In this way, we have found persistent unsatisfactory performance can be avoided.