POCT in coagulation

Summary

In the last years several point of care testing (POCT) systems used for coagulation parameters have been developed and became daily routine. As for other POCT applications (e. g. blood gas analysis) there is a need for user education and continous improvement of quality assurance.

For some POCT coagulation systems a comprehensive quality management has not been established yet. According to the feasibility and availability of control material and system self control each POCT coagulation method described in this article has a varying concept of quality management. Besides a high quality standard in manufacturing systems, devices and reagents the education of the user and the automatic self control of the instrument as well as the application of electronic and/ or liquid control samples contribute to the total quality assurance.

Even if a “like versus like” control material is not available a comprehensive quality management should be implemented in daily routine concerning pre-analytic as well as technical and post-analytic criteria.

Anyway to do nothing as the available control material seems to be not suitable is a bad decision.

Zusammenfassung

Das Gerätespektrum der patientennah in der Hämostasediagnostik eingesetzten Labor-methoden ist vielfältig. Die Anforderungen an die Nutzer sind höher als bei anderen POCTVerfahren (z. B. Glukose). Es bestehen hohe Anforderungen an Schulung und kontinuierliche Verbesserung.

Bei manchen Systemen ist eine umfassende Qualitätssicherung noch nicht implementiert. Insgesamt wird ein multimodales Konzept der Qualitätssicherung bei den vorgestellten Test-systemen angewandt. Präzise Kriterien der Herstellungskontrolle von Geräten und Verbrauchsmaterial sowie eine umfassende Schulung der Nutzer wird ergänzt durch auto-matische System-Selbstteste in Kombination mit nutzerabhängig einsetzbaren elektronischen- und/oder Flüssig-Kontrollen.

Als Konsequenz für die Praxis sollte, auch wenn Kontrollmaterial nicht „like vs. Like“ verfügbar ist, trotzdem ein umfassendes Qualitätsmanagement von der Präanalytik bis zur technischen Kontrolle implementiert und eingesetzt werden. Die Alternative, nichts zu ma-chen, da die Probe nicht stabil und zu komplex ist, ist schlecht.

Keywords

POCT - coagulation - platelet function testing - quality control - quality management

Schlüsselwörter

POCT-Gerinnung - Thrombozytenfunktions-test - Qualitätskontrolle - Qualitätsmanagement

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