台灣地區醫療機構使用體外診斷醫療器材(IVD)的床邊檢驗(POCT)，應用在門診與住院病人有日益增加之趨勢。POCT有縮短檢驗作業時間(TAT)及簡化檢驗流程的優點，最主要提供醫師更快速的檢驗結果以輔助疾病診斷、動態監測與治療評估，對病人照護產生持續性影響，以上優點使得POCT的重要性與日俱增。衛生署醫院評鑑要求：檢驗項目必須制訂合適內部與外部的品管政策與程序，且內部與外部的品管結果異常時須有預防與矯正措施；儀器設備須有保養計畫與故障檢修等相關紀錄，並能定期檢討與持續改善。醫院評鑑條文並未明確制定POCT規範。國內醫學檢驗室大都以通過ISO 15189認證為主，ISO 15189亦無POCT條文要求。綜合上述評鑑規範發現國內的POCT都缺乏管理及技術要求，以致無法監控儀器功能、人員資格、品管結果、病人結果等。美國病理學會實驗室認證計畫(CAP-LAP)有專門的POCT認證規範，且獲得美國聯邦政府認可，凡通過POCT規範的醫學檢驗室，等同為國際級標準化醫學檢驗室。目前ISO國際規範組織已制定ISO 22870 (2016)為POCT標準規範，預期與ISO 15189合併應用，可導入國內有使用POCT的各級醫療院所及部分健康照護機構。因此，醫學檢驗室通過ISO 15189認可後，可再導入ISO 22870，以提升POCT檢驗品質及維護病人安全。

There is an increasing trend in Taiwan Domestic medical institutions use In Vitro Diagnostic (IVD)-Point-of-Care Testing (POCT) for outpatients and inpatients. POCT has the advantages of shortening the test around time (TAT) and simplifying the test process. The most important thing is to provide doctors with faster test results and diagnosis of diseases, dynamic monitoring and treatment evaluation, and have a continuous impact on patient care, all of these advantages are making POCT increasingly important. The requirements of hospital accreditation by Joint Commission of Taiwan: All test items in medical laboratory should have proper internal and external quality policy and process, when the test result is out of the control, should have corrective actions and preventive actions. All instruments should have maintenance plans and troubleshooting records, continuous review and improvements periodically. However, the hospital accreditation does not clearly formulate the POCT regulations. Domestic medical laboratory accreditation is mainly based on ISO 15189, but ISO 15189 also has no specific POCT requirements. Therefore, the domestic POCT lacks quality management and technical requirements; furthermore, it is impossible to monitor instrument functions, operator qualifications, quality control results, patient results, etc. College of American Pathological - Laboratory Accreditation Program (CAP-LAP) has a specific POCT accreditation checklist and is recognized by the United States Federal Government. Medical laboratory accredited by POCT checklist are equivalent to international standardized medical laboratories. The International Organization for Standardization (ISO) has ISO 22870 (2016) as a POCT standard, which is expected to be combined with ISO 15189 and can be introduced into domestic medical institutions and health care institutions that use POCT. Therefore, medical laboratories are accredited by ISO 15189, then comply with ISO 22870 for improving POCT quality and patient safety.