Kuwa Katsuhiko
Rinsho Byori. 2015 Feb;63(2):224-31.
The quality management (QM) of POCT summarizes its internal quality control (IQC) and external quality assessment (EQA). For QM requirements in POCT, ISO 22870-Point-of-care testing (POCT) -Requirements for quality and competence and ISO 15189-Medical laboratories-Requirements for quality and competence, it is performed under the guidance of the QM committee. The role of the POC coordinator and/or medical technologist of the clinical laboratory is important. On measurement performance of POCT devices, it is necessary to confirm data on measurement performance from the manufacturer other than those in the inserted document. In the IQC program, the checking and control of measurement performance are the targets. On measurements of QC samples by the manufacturer, it is essential to check the function of devices. In addition, regarding the EQA program, in 2 neighboring facilities, there is an effect to confirm the current status of measurement and commutability assessment in these laboratories using whole blood along with residual blood samples from daily examinations in the clinical laboratory.
即时检验（POCT）的质量管理（QM）总结了其内部质量控制（IQC）和外部质量评估（EQA）。对于POCT中的质量管理要求，即ISO 22870-即时检验（POCT）-质量和能力要求以及ISO 15189-医学实验室-质量和能力要求，它是在质量管理委员会的指导下进行的。即时检验协调员和/或临床实验室医学技术人员的作用很重要。关于POCT设备的测量性能，除了插入文件中的数据外，有必要确认来自制造商的测量性能数据。在内部质量控制程序中，测量性能的检查和控制是目标。关于制造商对质量控制样品的测量，检查设备功能至关重要。此外，关于外部质量评估程序，在相邻的两个机构中，使用全血以及临床实验室日常检查中的残留血样来确认这些实验室的测量现状和互换性评估是有效果的。
