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Semin Thromb Hemost 2007; 33(3): 250-258
DOI: 10.1055/s-2007-971811
Copyright © 2007 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA.

Quality Assurance in Hemostasis: The Perspective from the College of American Pathologists Proficiency Testing Program

Mark T. Cunningham1 , John T. Brandt2 , Wayne L. Chandler3 , Charles S. Eby4 , Timothy E. Hayes5 , Jayashree Krishnan6 , Jerry B. Lefkowitz7 , John D. Olson8 , Christopher J. Stasik1 , Jun Teruya9 , Elizabeth M. Van Cott10
  • 1Department of Pathology, University of Kansas Medical Center, Kansas City, Kansas
  • 2Eli Lilly Corporate Center, Indianapolis, Indiana
  • 3Department of Laboratory Medicine, University of Washington, Seattle, Washington
  • 4Department of Pathology, Washington University School of Medicine, St. Louis, Missouri
  • 5Department of Pathology and Laboratory Medicine, Maine Medical Center, Portland, Maine
  • 6Department of Pathology, Washington Hospital Center, Washington, District of Columbia
  • 7Department of Pathology, University of Colorado Health Sciences Center, Aurora, Colorado
  • 8Department of Pathology, University of Texas Health Sciences Center, San Antonio, Texas
  • 9Department of Pathology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas
  • 10Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts
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Publication History

Publication Date:
10 April 2007 (online)

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ABSTRACT

External quality assurance (EQA) is an important component of the total quality assurance program of a clinical hemostasis laboratory. The College of American Pathologists (CAP) helps meet this requirement by providing a proficiency testing program that evaluates a broad range of hemostasis methods and analytes. This article reviews the published experience of the CAP proficiency testing program in hemostasis. The purpose is to formulate general conclusions about the benefits of EQA. Between 1963 and 2006, the performance characteristics of a variety of tests have been evaluated, including the prothrombin time, activated partial thromboplastin time, coagulation factor activity assays (e.g., fibrinogen, factor [F] VIII, FIX, FXI), von Willebrand factor assays, unfractionated heparin monitoring, lupus anticoagulant testing, and platelet function. Based on the results of these evaluations, the major benefits of EQA are to (1) enhance patient care and safety through improved laboratory testing; (2) characterize test accuracy and precision across multiple methods; (3) correlate specific method variables with accuracy and precision; (4) identify interfering substances and quantify their effects across multiple methods; (5) identify clinical laboratories that are at risk for poor performance so that their performance can improve; and (6) satisfy accreditation and regulatory requirements.

KEYWORDS

Coagulation - hemostasis testing - proficiency testing - quality assurance - quality control

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Mark T CunninghamM.D. 

Department of Pathology, University of Kansas Medical Center

3901 Rainbow Blvd, Mail Stop 4049, Kansas City, KS 66160

Email: mcunningham@kumc.edu