Semin Thromb Hemost 2007; 33(3): 243-249
DOI: 10.1055/s-2007-971810
Copyright © 2007 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA.

Emerging Technologies and Quality Assurance: The United Kingdom National External Quality Assessment Scheme Perspective

Ian Jennings1 , Dianne P. Kitchen1 , Timothy A.L Woods1 , Steven Kitchen1 , Isobel D. Walker1
  • 1United Kingdom National External Quality Assessment Scheme (UK NEQAS) for Blood Coagulation, Sheffield, United Kingdom
Further Information

Publication History

Publication Date:
10 April 2007 (online)

ABSTRACT

The pattern of tests employed and technologies developed within hemostasis laboratories has changed considerably within the last 10 years. These changes have presented challenges to external quality assessment (EQA) providers, including the United Kingdom National External Quality Assessment Scheme (NEQAS). EQA for point-of-care devices used for monitoring oral anticoagulant therapy has focused on provision of suitable material to assess performance of devices designed for capillary blood testing, and on education of a user group not usually trained in laboratory quality control procedures. Development of novel therapeutic agents for hemophilia has presented challenges regarding standardization of assays for monitoring treatment, whereas advances related to laboratory testing and automation have not always been accompanied by improved accuracy and precision. EQA provision has also been shown to be of value in molecular genetic screening tests for thrombophilia, and in highlighting standardization issues related to D-dimer measurement in the exclusion of deep vein thrombosis. The increasing prevalence of screening tests of global hemostasis, such as thrombin generation tests and thromboelastography, presents additional challenges to EQA providers in the attempt to standardize these new and potentially beneficial technologies.

REFERENCES

  • 1 Jennings I, Greaves M, Mackie I J, Kitchen S, Woods T A, Preston F E. Lupus anticoagulant testing: improvements in performance in a UK NEQAS proficiency testing exercise after dissemination of national guidelines on laboratory methods.  Br J Haematol. 2002;  119 364-369
  • 2 Jennings I, Kitchen S, Woods T A, Preston F E. Multilaboratory testing in thrombophilia through the United Kingdom National External Quality Assessment Scheme (Blood Coagulation) Quality Assurance Program.  Semin Thromb Hemost. 2005;  31 66-72
  • 3 Kitchen S, Jennings I, Woods T A, Kitchen D P, Walker I D, Preston F E. Laboratory tests for measurement of von Willebrand factor show poor agreement among different centers: results from the United Kingdom National External Quality Assessment Scheme for Blood Coagulation.  Semin Thromb Hemost. 2006;  32 492-498
  • 4 Favaloro E J, Bonar R, Kershaw G et al.. Reducing errors in identification of von Willebrand disease: the experience of the Royal College of Pathologists of Australasia Quality Assurance Program.  Semin Thromb Hemost. 2006;  32 505-513
  • 5 Johnson P R. The contribution of proficiency testing to improving laboratory performance and ensuring quality patient care.  Clin Leadersh Manag Rev. 2004;  18 335-341
  • 6 Fitzmaurice D A, Gardiner C, Kitchen S, Mackie I, Murray E T, Machin S J. British Society of Haematology Taskforce for Haemostasis and Thrombosis. An evidence-based review and guidelines for patient self-testing and management of oral anticoagulation.  Br J Haematol. 2005;  131 156-165
  • 7 Medical Devices Agency .Device Bulletin MDA DB2002(03) March 2002. London; Medical Devices Agency of UK Department of Health 2002
  • 8 Kitchen S, Kitchen D P, Jennings I, Woods T AL, Walker I D, Preston F E. Point of Care International Normalised Ratios: UK NEQAS experience demonstrates necessity for proficiency testing of 3 different monitors.  Thromb Haemost. 2006;  96 590-596
  • 9 Murray E T, Kitchen D P, Kitchen S et al.. Patient self-management of oral anticoagulation and external quality assessment procedures.  Br J Haematol. 2003;  122 825-828
  • 10 Pipe S W, Saenko E L, Eickhorst A N, Kemball-Cook G, Kaufman R J. Hemophilia A mutations associated with 1-stage/2-stage activity discrepancy disrupt protein-protein interactions within the triplicated A domains of thrombin-activated factor VIIIa.  Blood. 2001;  97 685-691
  • 11 Bertina R M, Koeleman B PC, Koster T et al.. Mutation in blood coagulation factor V associated with resistance to activated protein C.  Nature. 1994;  369 64-67
  • 12 Poort S R, Rosendaal F R, Reitsma P H, Bertina R M. A common variation in the 3′-untranslated region of the prothrombin gene is associated with elevated plasma prothrombin levels and an increase in venous thrombosis.  Blood. 1996;  88 3698-3703
  • 13 Lutz C T, Foster P A, Noll W W et al.. Multicenter evaluation of PCR methods for the detection of factor V Leiden (R506Q) genotypes.  Clin Chem. 1998;  44 1356-1358
  • 14 Preston F E, Kitchen S, Jennings I, Woods T AA. UK National External Quality Assessment scheme (UK NEQAS) for molecular genetic testing for the diagnosis of familial thrombophilia.  Thromb Haemost. 1999;  82 1556-1557
  • 15 Tripodi A, Peyvandi F, Chantarangkul V, Menegatti M, Mannucci P M. Relatively poor performance of clinical laboratories for DNA analyses in the detection of two thrombophilic mutations-a cause for concern.  Thromb Haemost. 2002;  88 690-691
  • 16 Hertzberg M, Neville S, Favaloro E J, MacDonald D. External quality assurance of DNA testing for thrombophilia mutations.  Am J Clin Pathol. 2005;  123 189-193
  • 17 Gray E, Hawkins J R, Morrison M et al.. Establishment of the 1st International Genetic Reference Panel for Factor V Leiden, human gDNA.  Thromb Haemost. 2006;  96(2) 215-219
  • 18 Jennings I, Kitchen S, Woods T AL, Preston F E, Greaves M. Clinically important inaccuracies in testing for the lupus anticoagulant: An analysis of results from three surveys of the UK NEQAS for Blood Coagulation.  Thromb Haemost. 1997;  77 934-937
  • 19 Arnout J, Meijer P, Vermylen J. Lupus anticoagulant testing in Europe: an analysis of results from the first European Concerted Action on Thrombophilia (ECAT) survey using plasmas spiked with monoclonal antibodies against human B2-glycoprotein 1.  Thromb Haemost. 1999;  81 929-934
  • 20 Jennings I, Mackie I, Arnout J, Preston F E. Lupus anticoagulant testing using plasma spiked with monoclonal antibodies; performance in the UK NEQAS proficiency testing programme.  J Thromb Haemost. 2004;  2 2178-2184
  • 21 Tripodi A, Biasiolo A, Chantarangkul V, Pengo V. Lupus anticoagulant (LA) testing: performance of clinical laboratories assessed by a national survey using lyophilized affinity-purified immunoglobulin with LA activity.  Clin Chem. 2003;  49 1608-1614
  • 22 Gardiner C, Pennaneac'h C, Walford C, Machin S J, Mackie I J. An evaluation of rapid D-dimer assays for the exclusion of deep vein thrombosis.  Br J Haematol. 2005;  128 842-848
  • 23 Stevens S M, Gregory Elliott C, Woller S C et al.. The use of a fixed high sensitivity to evaluate five D-dimer assays' ability to rule out deep venous thrombosis: a novel approach.  Br J Haematol. 2005;  131 341-347
  • 24 Goodacre S, Sampson F C, Sutton A J, Mason S, Morris F. Variation in the diagnostic performance of D-dimer for suspected deep vein thrombosis.  QJM. 2005;  98 513-527
  • 25 Dempfle C E. D-dimer: standardization versus harmonization.  Thromb Haemost. 2006;  95 399-400
  • 26 Jennings I, Kitchen S, Kitchen D P, Woods T AL, Walker I D. Laboratory D-dimer measurement in the exclusion of DVT: any nearer agreement?.  Br J Haematol. 2006;  133(Supp 1) 47
  • 27 Coakley M, Reddy K, Mackie I, Mallett S. Transfusion triggers in orthotopic liver transplantation: a comparison of the thromboelastometry analyzer, the thromboelastogram, and conventional coagulation tests.  J Cardiothorac Vasc Anesth. 2006;  20 548-553
  • 28 Luddington R J. Thrombelastography/thromboelastometry.  Clin Lab Haematol. 2005;  27 81-90

Dr. I. Jennings

UK NEQAS for Blood Coagulation, Rutledge Mews

3 Southbourne Road, Sheffield S10 2QN, United Kingdom

Email: i.jennings@coageqa.org.uk

    >