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Coagulation factors VIII and IX are the coagulation factors most regularly tested by haemostasis laboratories, in part because Haemophilia A (FVIII deficiency) and Haemophilia B (FIX deficiency) represent the most common bleeding disorders, and in part because of their known associations with bleeding risk. The Royal College of Pathologists Australasia Quality Assurance Programs (RCPAQAP) is an international QAP with over 100 laboratories enrolled in the Coagulation Factors VIII and IX Program. The aim of the work presented here is to evaluate the assessment criteria for FVIII and FIX over a six-year period (2013–2018) and identify areas of benefit and weakness, in part resulting from a recent (2016) change in criteria (from assessment against factor deficient plasma reagent to plasma calibrator, as this was felt to be more relevant for determination of factor level). We identified an ongoing improvement [reduction in numbers of laboratories outside the RCPAQAP Analytical Performance Specifications (APS)] for both FVIII and FIX over this period of change in assessment criteria. FVIII outliers almost halved from 43 to 23 laboratories, and FIX outliers reduced by over 60% from 36 to 14 laboratories. It is hypothesised that the change in assessment criteria contributed to this improvement in Coagulation Factors program performance by laboratories, although other elements may have also contributed.

Ongoing improvements in laboratory performance of coagulation factors VIII and IX: recent experience from the RCPAQAP