External Quality Assessment Schemes in Coagulation in Germany: Between Regulatory Bodies and Patient Outcome

ABSTRACT

In the early 1980s, the first external quality assessment schemes (EQAS) regarding parameters of the coagulation laboratory were established in the daily routine of German laboratories. At present, the EQAS performed by INSTAND offers a wide range of global and single parameters of thrombosis and hemostasis. Only the participation in prothrombin time and activated partial thromboplastin time exercises is mandatory. However, devices applied for patient self-management of oral anticoagulation are not included. This article provides an overview of the EQA activities of INSTAND regarding different coagulation parameters. Problems in acquiring adequate sample material and strategies in establishing acceptability ranges are also discussed.

KEYWORDS

External quality assessment schemes (EQAS) - coagulation - sample material - acceptability criteria - self-management of oral anticoagulation

REFERENCES

• 1 Spannagl M, Haverkate F, Reinauer H, Meijer P. The performance of quantitative D-dimer assays in laboratory routine.  Blood Coagul Fibrinolysis. 2005;  16 439-443
• 2 Reinauer H. External quality assessment schemes for clinical chemistry in Germany.  Ann Ist Super Sanita. 1995;  31 77-86
• 3 Stockl D, Reinauer H. Development of criteria for the evaluation of reference method values.  Scand J Clin Lab Invest Suppl. 1993;  212 16-18
• 4 Committee European Normalization .Use of external quality assessment in the assessment of the performance of in vitro diagnostic examination procedures. Brussels, Belgium; Committee European Normalization (CEN) EN 14136 2004
• 5 Ansell J, Jacobson A, Levy J, Völler H, Hasenkam J M. Guidelines for implementation of patient self-testing and patient self-management of oral anticoagulation. International consensus guidelines prepared by International Self-Monitoring Association for Oral Anticoagulation.  Int J Cardiol. 2005;  99 37-45
• 6 Menendez-Jandula B, Souto J C, Oliver A, Montserrat I et al.. Comparing self-management of oral anticoagulant therapy with clinic management.  Ann Intern Med. 2005;  142 1-10
• 7 Heneghan C, Alonso-Coello P, Garcia-Alamino J M, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis.  Lancet. 2006;  367 404-411