論我國定點照護檢驗（Point of Care Testing, POCT）執行人員之執行現況及其限制

The Point of Care Testing Implementation Status and Limitations of Personnel in Taiwan

定點照護檢驗（Point of Care Testing, POCT）因分析所需時間較短而漸為各醫療院所所使用。雖然該設備操作簡單，但其所衍生的問題並不亞於傳統實驗室所面臨，因此歐、美等國對該檢測項目訂定有專門之法律規範，但我國並未設有相關規定。因此各醫療機構不是自行採用他國的規範，就是擴大解釋我國法律的方式來執行，而讓臨床操作人員冒著違法的風險，甚至是影響病患就醫的權利與國民的健康權。本文將從美國FDA對醫療院所執行POCT項目之操作人員的相關規範中，來檢視我國執行檢驗POCT的相關規定與臨床實際執行狀態。

Point-of-care testing (POCT), providing a faster result, is gradually implemented by healthcare providers. The device is simple to operate, it presents challenges similar to the traditional laboratory. In adition to technology-based challenges in POCT, there are also regulatory challenges that must be considered. Therefore, the European Union and United States have guidelines or regulatory set for POCT, there is no any relevant statute in Taiwan. That’s why the healthcare providers either employ other country’s statutory provision or make an extensive interpretation of administrative rule of Taiwan. But this behavior will make all operating POCT personnel whoever not a medical technologist (or medical technician) be in dangers of breaking law. Moreover this could infringe patient’s health to right. So this article will review the relevant regulations and clinical implementation status of POCT in Taiwan comparing with the regulations of POCT enforced by U.S. FDA.