Spannagl Michael, Dick A, Junker R
INSTAND e.V., Düsseldorf.
Hamostaseologie. 2010 May;30(2):82-90.
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 continuous 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.
在过去几年中，已经开发出几种用于凝血参数的即时检验（POCT）系统，并成为日常常规操作。与其他POCT应用（如血气分析）一样，需要对用户进行培训并持续改进质量保证。对于一些POCT凝血系统，尚未建立全面的质量管理体系。根据控制材料的可行性和可用性以及系统的自我控制，本文所述的每种POCT凝血方法都有不同的质量管理概念。除了在制造系统、设备和试剂方面有高质量标准外，用户培训、仪器的自动自我控制以及电子和/或液体控制样品的应用也有助于全面的质量保证。即使没有“同类”控制材料，在日常操作中也应针对分析前以及技术和分析后标准实施全面的质量管理。无论如何，因为现有的控制材料似乎不合适而什么都不做是一个糟糕的决定。
