109年度捐血機構管理現況調查   全文下載

Investigating Blood Establishments in Taiwan, 2020

為維護國人用血的品質與安全，強化捐血機構功能與品質管理，食品藥物管理署（以下簡稱食藥署）依據血液製劑條例持續針對國內捐血機構定期每2至4年執行一次實地訪查，並追蹤訪查缺失的改善情況。最近一次實地訪查於109年執行，訪查團隊由具備血液管理、品質稽查、輸血醫學、檢驗醫學等經驗或專長之專家組成，採用符合我國、國際醫藥品稽查協約組織（Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme，簡稱PIC/S）及歐洲等捐血機構相關規範制定之查檢表進行訪查，訪查範圍涵蓋自採血至血品供應等14類查檢項目，訪查結果未發現影響用血安全的重大缺失，但仍有部分缺失事項及建議事項尚需改善，其中以捐血者相關缺失為大宗（28%），其次依序為廠房設施（21%）及人事（12%）。食藥署秉持著守護國人健康的使命，除定期訪查捐血機構外，亦持續藉追蹤訪查缺失之改善情形，確保有效監督捐血機構之品質系統運作，持續落實捐血機構品質管理的督導職責，以確保國人用血安全。

In order to maintain the quality and safety of blood components, and strengthen the quality management system and function of blood establishments, Taiwan Food and Drug Administration (Taiwan FDA) continuously conducts regular on-site inspections on blood establishments every 2 to 4 years in accordance with ''The Plasma Derivatives Act'', and follow-up the corrective and preventive actions (CAPAs). The latest inspection was carried out in 2020. The inspection team was composed of experts in fields on blood management, quality audit, blood transfusion, and medical laboratory science. A checklist in line with Taiwan, Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), and Europe standards was used for inspection, which covered 14 inspection items from blood collection to blood components supply. The results of the inspection did not find any major deficiencies affecting blood safety, but there were still some deficiencies and suggestion that needed to be improved. Among them, deficiencies related to blood donors were the major deficiency (28%), followed by plant facilities (21%) and personnel (12%). Taiwan FDA upholds the mission of protecting the health of Taiwanese. In addition to regular inspections on blood establishments, follow-up visits were made to keep track for the improvement. As all above, Taiwan FDA continues to implement the supervision responsibility for the quality management system of blood establishments to ensure the safety of blood use.