Semin Thromb Hemost 2008; 34(7): 647-653
DOI: 10.1055/s-0028-1104543
© Thieme Medical Publishers

Quality Assessment in Point-of-Care Coagulation Testing

Dianne P. Kitchen1 , Steve Kitchen1 , Ian Jennings1 , Tim Woods1 , Isobel Walker1
  • 1UK NEQAS Blood Coagulation, Sheffield, United Kingdom
Further Information

Publication History

Publication Date:
15 December 2008 (online)

ABSTRACT

Point-of-care (POC) testing in the field of hemostasis is rapidly expanding in many countries. This includes use of global tests of hemostasis in operating theaters and especially use of POC monitors for determination of the international normalized ratio (INR) for monitoring oral anticoagulant therapy. Issues related to internal quality control and external quality assessment for these devices are reviewed. Data from external quality assessment exercises involving users of several different POC-INR devices is described, and use of split samples where a patient sample is analyzed by both a POC device and by a conventional laboratory method is described.

REFERENCES

  • 1 ISO/FDIS 17593 .Clinical Laboratory Testing and In Vitro Diagnostic Systems–In Vitro Monitoring Systems for Oral Anticoagulant Therapy. Geneva, Switzerland; International Standards Organization 2006
  • 2 Tripodi A, Bressi C, Carpenedo M, Chantarangkul V, Clerici M, Mannucci P M. Quality assurance program for whole blood prothrombin time-international normalized ratio point-of-care monitors used for patient self-testing to control oral anticoagulation.  Thromb Res. 2004;  113 35-40
  • 3 Kitchen S, Kitchen D P, Jennings I, Woods T AL, Walker I D, Preston F E. Point of care INRs: UK NEQAS experiences demonstrates necessity for proficiency testing of three different monitors.  Thromb Haemost. 2006;  96 590-596
  • 4 Poller L, Keown M, Ibraham S A et al.. Quality assessment of Coaguchek Point-of-Care Prothrombin Time Monitors. Comparison of the European Community-approved procedure and conventional external quality assessment.  Clin Chem. 2006;  52 1843-1847
  • 5 Murray E T, Kitchen D P, Kitchen S et al. Patient self-management of oral anticoagulation and external quality assessment.  Br J Haematol. 2003;  122 825-828
  • 6 Murray E T, Jennings I, Kitchen D, Kitchen S, Fitzmaurice D A. Quality assurance for oral anticoagulation self management: a cluster randomized trial.  J Thromb Haemost. 2008;  6 464-469
  • 7 Kitchen D P, Murray E T, Jennings I et al.. Comparison of Coaguchek S INRS with hospital laboratory citrated plasma INRs. What is the truth?.  Br J Haematol. 2005;  129(Suppl) S1-S18
  • 8 Expert WHO Committee on Biological Standardization .Guidelines for thromboplastins and plasma used to control oral anticoagulation therapy. Geneva, Switzerland; World Health Organ Tech Rep Serr 1999 889: 64-93
  • 9 Watson C, Kitchen S, Woolley A M, Young L, Malia R G. Recombinant and tissue extract thromboplastins for determination of INR.  Br J Biomed Sci. 1999;  56 123-127
  • 10 Perry D J. Factor VII deficiency.  Br J Haematol. 2002;  118 689-700
  • 11 Solvik U O, Stavelin A, Christensen N G, Sandberg S. External quality assessment of prothrombin time: the split-sample model compared with external quality assessment with commercial control material.  Scand J Clin Lab Invest. 2006;  66 337-349
  • 12 Kitchen D, Murray E T, Kitchen S et al.. External quality assessment for prothrombin time/international normalized ratio using point-of-care devices: split-sample or conventional external quality assessment using control samples?.  Scand J Clin Lab Invest. 2007;  67 673-675
  • 13 Kitchen S, Walker I D, Woods T AL, Preston F E. Thromboplastin related differences in the determination of international normalized ratio: a cause for concern?.  Thromb Haemost. 1994;  72 426-429
  • 14 Baglin T, Luddington R. Reliability of delayed INR determination: implications for decentralized anticoagulant care with off-site blood sampling.  Br J Haematol. 1997;  96 431-434
  • 15 Leeming D R, Craig S, Stevenson K J, Tabener D. The determination of INR in stored whole blood.  J Clin Pathol. 1998;  51 360-363
  • 16 Adcock D M, Kressin D C, Marlar R A. Minimum specimen volume requirements for routine coagulation testing. Dependence on citrate concentration.  Am J Clin Pathol. 1998;  109 595-599
  • 17 Chuang J, Sadler M A, Witt D M. Impact of evacuated collection tube fill volume and mixing on routine coagulation testing using 2.5 mL (pediatric) tubes.  Chest. 2004;  126 1262-1266
  • 18 Lippi G, Montagnana M, Salvagno L, Guidi G S. Interference of blood cell lysis in routine coagulation testing.  Arch Pathol Lab Med. 2006;  130 181-184
  • 19 Marlar R A, Potts R M, Marlar A A. Effect on routine and special coagulation testing values of citrate anticoagulant adjustment in patients with high hematocrit values.  Am J Clin Pathol. 2006;  126 400-405
  • 20 Fitzmaurice D A, Gardiner C, Kitchen S, Mackie I, Murray E T, Machin S. An evidence based review and guidelines for patients self testing and management of oral anticoagulation.  Br J Haematol. 2005;  131 156-165
  • 21 Jennings I, Kitchen D P, Woods T AL, Kirtchen S, Walker I D. Emerging technologies and Quality assurance: the UK NEQAS perspective.  Semin Thromb Hemost. 2007;  33 243-249
  • 22 Cunningham M T, Brandt J T, Chandler W L et al.. Quality assurance in hemostasis: the perspective from the College of American Pathologists Proficiency Testing Programme.  Semin Thromb Hemost. 2007;  33 250-258

Dianne P KitchenF.I.B.M.S. 

Specialist Scientific Lead for Point of Care Programs, UK NEQAS for Blood Coagulation, Rutledge Mews

3 Southbourne Road, Sheffield S10 2QN, UK

Email: dianne.kitchen@coageqa.org.uk

    >