4.4 Article

Quality Control in Coagulation Testing

Journal

SEMINARS IN THROMBOSIS AND HEMOSTASIS
Volume 34, Issue 7, Pages 642-646

Publisher

THIEME MEDICAL PUBL INC
DOI: 10.1055/s-0028-1104542

Keywords

Internal quality control; external quality assessment programs; bias; imprecision; biological variability

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The term quality control in laboratory medicine refers to all the procedures commonly used in clinical laboratories to monitor the routine performance of testing processes, to detect possible errors, and to correct problems before test results are reported. In particular, internal quality control (IQC) and external quality assessment (EQA) programs are used to evaluate and improve quality in laboratory, medicine. Laboratory testing is necessary for the diagnosis and treatment. of patients with hemostatic disorders. However, whereas the benefits of quality control and quality assessment in hemostasis have been demonstrated many times and are well documented, available scientific evidence is significantly less than that in clinical chemistry and in other fields of laboratory medicine. Currently available data on analytical quality in coagulation testing not only demonstrates that quality is often unsatisfactory, but also highlights the need for more objective establishment of performances goals. This should be useful for better addressing both IQC and EQA programs. New challenges to EQA schemes for coagulation testing derive from the introduction of innovative tests, genetic analysis, and the need to assess not only analytical procedures but also all steps included in the total testing process.

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