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(1):35-40. doi: 10.1016/j.thromres.2004.01.009.

Abstract

Whole blood coagulation monitors are increasingly used for patient self-testing to control oral anticoagulation, but there are no comprehensive quality assurance (QA) programs to check their performance. We report on the experience with one of such programs applied in a field study where patients on prothrombin time (PT)-international normalized ratio (INR) self-testing were asked to bring their monitors to the anticoagulation clinic for checking. PT-INR testing was performed three times over 3 months with 14 patient's monitors and test strips on three recalcified QA plasmas by an experienced laboratory operator. Each patient was also asked to perform PT-INR self-testing (his/her own capillary blood) which was then compared to the laboratory PT-INR (plasma). Overall, the comparison between the observed and the consensus PT-INR on QA plasmas was acceptable with the majority of measurements lying within +/-15% or 20% of the consensus values. The comparison between the PT-INR self-testing and the laboratory method was also acceptable: overall, there was no statistical significant difference between the mean PT-INR values and the majority of paired measurements were less than 15% or 20% apart. In conclusion, our results show that the proposed QA scheme is feasible and may be implemented on a larger scale. Monitors should be recalled periodically to the clinic where they have been prescribed to the patient. During each visit, the clinic may check the monitors and patient self-testing performance as described. Such comprehensive QA system would make monitoring of oral anticoagulant treatment by self-testing safer and more effective.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Anticoagulants / administration & dosage*
  • Anticoagulants / pharmacology
  • Consensus
  • Female
  • Humans
  • International Normalized Ratio / instrumentation
  • International Normalized Ratio / standards*
  • Laboratories / standards
  • Male
  • Middle Aged
  • Monitoring, Ambulatory / instrumentation
  • Monitoring, Ambulatory / standards*
  • Point-of-Care Systems / standards*
  • Prothrombin Time / instrumentation
  • Prothrombin Time / standards*
  • Quality Assurance, Health Care*
  • Quality Control
  • Self Care / instrumentation*

Substances

  • Anticoagulants