Assessing quality in the specialized hemostasis laboratory: review and critique of external quality assurance (EQA) programs in the US

In 1999 the National Committee for Clinical Laboratory Standards (NCCLS, now known as Clinical & Laboratory Standards Institute) introduced the concepts of quality practice for clinical laboratories, with the notion to improve the pre-analytical, analytical and post-analytical phases of laboratory testing. Hemostasis testing is particularly sensitive to pre-analytical issues, but most quality assurance measures are specific for the analytical phase of hemostasis testing. The external quality assessment (EQA) program is typically a bi-annual assessment using blinded samples that are intended to improve laboratory practice. We review the current EQA options in the US for specialized hemostasis laboratories to assess whether (I) they address all three phases of testing, and whether (II) the testing platforms are providing optimal assessment of hemostasis testing.