Semin Thromb Hemost 2009; 35(2): 139-149
DOI: 10.1055/s-0029-1220322
© Thieme Medical Publishers

Internal Quality Control and External Quality Assurance of Platelet Function Tests

Emmanuel J. Favaloro1
  • 1Department of Haematology, Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead, NSW, Australia
Further Information

Publication History

Publication Date:
30 April 2009 (online)

ABSTRACT

Internal quality control (IQC) and external quality assurance (EQA) are distinct processes that contribute to ensure the overall quality (i.e., correctness) of laboratory test procedures. This review summarizes the current position of IQC and EQA in platelet function testing. These processes are in their infancy for these tests, despite the many years in which these tests have been performed within diagnostic hemostasis laboratories. This is understandable, due to the many challenges imposed by the requirements of the tests themselves and of the IQC and EQA processes, namely the regular availability, and ongoing supply and transport, of fresh blood containing functional platelets for testing within a very short time frame. Nevertheless, recently published studies have shown that IQC and EQA are both feasible for platelet function testing, although these processes have typically been undertaken in some modified form compared with other tests of hemostasis. Several EQA organizations are currently involved in providing support to laboratories that perform platelet function testing. Initiatives to date include cross-laboratory challenges for PFA-100 testing, several patterns of practice surveys, and several other EQA challenges related to dense granules and light transmission aggregometry. EQA organizations may be best placed to act as facilitators to the process of improving diagnostic testing for platelet function, which supplements the role of expert organizations.

REFERENCES

  • 1 Cattaneo M. Light transmission aggregometry and ATP release for the diagnostic assessment of platelet function.  Semin Thromb Hemost. 2009;  35 158-167
  • 2 McGlasson D, Fritsma G. Whole blood platelet aggregometry and platelet function testing.  Semin Thromb Hemost. 2009;  35 168-180
  • 3 Harrison P, Mumford A. Screening tests of platelet function: update on their appropriate uses for diagnostic testing.  Semin Thromb Hemost. 2009;  35 150-157
  • 4 Favaloro E J. Clinical utility of the PFA-100.  Semin Thromb Hemost. 2008;  34 709-733
  • 5 Pereira J, Quiroga T, Mezzano D. Laboratory assessment of familial, nonthrombocytopenic mucocutaneous bleeding: a definitive diagnosis is often not possible.  Semin Thromb Hemost. 2008;  34 654-662
  • 6 Quiroga T, Goycoolea M, Panes O et al.. High prevalence of bleeders of unknown cause among patients with inherited mucocutaneous bleeding. A prospective study of 280 patients and 299 controls.  Haematologica. 2007;  92 357-365
  • 7 Favaloro E J. Investigating people with mucocutaneous bleeding suggestive of primary haemostatic defects: low likelihood of definitive diagnosis?.  Haematologica. 2007;  92 292-296
  • 8 Hayward C PM, Pai M, Liu Y et al.. Diagnostic utility of light transmission platelet aggregometry: results from a prospective study of individuals referred for bleeding disorder assessments.  J Thromb Haemost. 2009;  7 676-684
  • 9 Pai M, Hayward C. Diagnostic assessment of platelet disorders: what are the challenges to standardization?.  Semin Thromb Hemost. 2009;  35 131-138
  • 10 Favaloro E J, Lippi G, Adcock D M. Preanalytical and postanalytical variables: the leading causes of diagnostic error in hemostasis?.  Semin Thromb Hemost. 2008;  34 612-634
  • 11 Plebani M, Sanzari M C, Zardo L. Quality control in coagulation testing.  Semin Thromb Hemost. 2008;  34 642-646
  • 12 Available at: http://www.westgard.com/mltirule.htm Accessed January 3, 2009
  • 13 Olson J D, Preston F E, Nichols W L. External quality assurance in thrombosis and hemostasis: an international perspective.  Semin Thromb Hemost. 2007;  33 220-225
  • 14 Favaloro E J. Standardisation, regulation, quality assurance and emerging technologies in hemostasis: issues, controversies, benefits and limitations.  Semin Thromb Hemost. 2007;  33 290-297
  • 15 Moffat K A, Ledford-Kraemer M R, Plumhoff E A et al.. Are laboratories following published recommendations for lupus anticoagulant testing? An international evaluation of practices.  Thromb Haemost. 2009;  101 178-184
  • 16 Hayward C P, Eikelboom J. Platelet function testing: quality assurance.  Semin Thromb Hemost. 2007;  33 273-282
  • 17 Christie D J, Avari T, Carrington L R et al.. Platelet Function Testing by Aggregometry; Approved Guideline. CLSI document H58-A. Wayne, PA; Clinical and Laboratory Standards Institute (CLSI) 2008
  • 18 Hayward C P, Moffat K A, Pai M et al.. An evaluation of methods for determining reference intervals for light transmission platelet aggregation tests on samples with normal or reduced platelet counts.  Thromb Haemost. 2008;  100 134-145
  • 19 Hayward C, Moffat K, Black L, Heddle N. Application of Levey-Jennings plots to the quality monitoring of platelet aggregation tests.  Int J Lab Haem. 2008;  30(Suppl 1) 91 [abstract 308]
  • 20 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 program.  Semin Thromb Hemost. 2007;  33 250-258
  • 21 Moffat K A, Ledford-Kraemer M R, Nichols W L et al.. Variability in clinical laboratory practice in testing for disorders of platelet function: results of two surveys of the North American Specialized Coagulation Laboratory Association.  Thromb Haemost. 2005;  93 549-553
  • 22 Favaloro E J, Bonar R, Duncan E, Rodgers S, Marsden K. (on behalf of the RCPA QAP in Haematology). The utility of the PFA-100® as a screening test of platelet function: an audit of haemostasis laboratories in Australia and New Zealand.  Blood Coagul Fibrinolysis. 2007;  18 441-448
  • 23 Duncan E M, Bonar R, Rodgers S E et al.. Methodology and outcomes of platelet aggregation testing in Australia, New Zealand and the Asia-Pacific region: results of a survey from the Royal College of Pathologists of Australasia Haematology Quality Assurance Program.  Int J Lab Hematol. 2008;  , March 21 (Epub ahead of print)
  • 24 Jennings I, Woods T A, Kitchen S, Walker I D. Platelet function testing: practice among UK National External Quality Assessment Scheme for Blood Coagulation participants, 2006.  J Clin Pathol. 2008;  61 950-954
  • 25 Hayward C PM, Moffat K A, Spitzer E et al.. Results of an external proficiency testing exercise on platelet dense granule deficiency testing by whole mount electron microscopy.  Am J Clin Pathol. 2009;  131 671-675
  • 26 Hayward C P, Harrison P, Cattaneo M, Ortel T L, Rao A K. Platelet function analyzer (PFA)-100 closure time in the evaluation of platelet disorders and platelet function.  J Thromb Haemost. 2006;  4 312-319
  • 27 Michelson A D, Cattaneo M, Eikelboom J W et al.. Aspirin resistance: position paper of the Working Group on Aspirin Resistance.  J Thromb Haemost. 2005;  3 1309-1311
  • 28 Guidelines on platelet function testing. The British Society for Haematology BCSH Haemostasis and Thrombosis Task Force.  J Clin Pathol. 1988;  41 1322-1330

Dr. E.J. Favaloro

Department of Haematology, Institute of Clinical Pathology and Medical Research (ICPMR)

Westmead Hospital, SWAHS, Westmead, NSW, 2145, Australia

Email: emmanuel.favaloro@swahs.health.nsw.gov.au

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