SEP 09, 2019 8:00 AM PDT

Challenges in hemostasis test standardization

Sponsored by: Diagnostica Stago, Inc.
C.E. Credits: P.A.C.E. CE Florida CE
  • Medical Director, UHS Pathology Services, University Health System; Professor, Clinical Pathology and Laboratory Medicine, University of Texas Health Science Center at San Antonio
      Russell A. Higgins, MD is a Clinical Professor of Pathology and Laboratory Medicine at the University of Texas Health San Antonio. He received his undergraduate degree from the New Mexico Tech in 1996 and his medical degree from the University of New Mexico School of Medicine in 2002. He completed a residency in Anatomic and Clinical Pathology in 2006 and a fellowship in hematopathology at the University of Texas Health San Antonio in 2008. Dr Higgins is the Medical Director of University Hospital System Pathology Services and the Section Chief of the Hematology and Coagulation Laboratory at University Hospital in San Antonio. Dr. Higgins has developed expertise in laboratory quality issues in hemostasis. He has been a member and chair of the CAP Coagulation Resource Committee, CAP liaison to the International Society for Thrombosis and Hemostasis (ISTH) and External Quality Assurance in Thrombosis and Hemostasis (EQATH), member of the CAP Pharmacogenetics Subcommittee, co-Chair of the North American Specialized Coagulation Laboratories (NASCOLA) Platelet Committee, and a contributor to the FDA Network of Experts.


    Standardization and harmonization of coagulation testing methods have come a long way in the last 3 to 4 decades; however, standardization is imperfect.  Laboratory professionals need to recognize the limitations of some of our most commonly used coagulation tests.  The INR system has harmonized prothrombin time across methods and platforms for the purpose of monitoring warfarin, but the system does not harmonize very high INR values nor does it harmonize INR values in the setting of liver disease.  Many hospital-based laboratories perform a one stage factor VIII assay to support a wide range of clinical indications.  In the last decade, important biases have been demonstrated between one stage assays and chromogenic assays when diagnosing hemophilia A patients or monitoring new hemophilia therapies.  Finally, quantitative D-dimer assays have excellent negative predictive value to exclude venous thromboembolism.  Unfortunately, there is a lack of standardization, and even a lack of a standardized unit of measure.  Implementation of D-dimer requires careful attention to both the unit of magnitude and the unit type, especially when using different instrumentation across a laboratory system.

    Learning Objectives:

    • Recognize limitations of INR system
    • Choose appropriate factor VIII and factor IX assays for various clinical indications
    • Identify potential safety issues created by nonuniform D-dimer units and lack of standardization



    LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.  CE credits are available for this webinar up to 2 years from the date of the live broadcast

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