106年度捐血機構管理現況調查

Investigating Blood Establishments in Taiwan, 2017

為提升血液製劑之安全、品質及穩定供應，並加強對捐血機構之業務輔導，我國爰訂定「血液製劑條例」，以確保輸血品質及相關措施之執行，維護國人用血的安全性、可用性與供應的穩定性，最終達到國內血液及其製劑自給自足目標。有鑑於此，食品藥物管理署（以下簡稱食藥署）依據「血液製劑條例」所訂定之「血液製劑發展方案第三期計畫」，定期辦理捐血機構實地訪查，保障捐供血安全及病人的用血品質。為執行106年度的實地訪查，邀集各大醫院具備血庫管理或品質稽查專長及經驗之專家擔任訪查委員，共赴「台灣血液基金會」轄下之5家捐血中心及其所屬捐血站、捐血車與捐血室，針對捐血機構之捐供血等業務進行實地訪查與輔導。訪查標準則參照國際醫藥品稽查協約組織（Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, PIC／S）之血液機構指導文件（Guide for Blood Establishments），輔以我國『「醫療機構設置標準」–附表（八）：捐血機構設置標準表』、「捐血者健康標準」以及「歐洲血液機構稽查系統（EuBIS）」等文件，確保與國際間標準一致。訪查結果未發現影響血品安全之重大缺失，但仍有部分缺失事項及建議事項尚需改善，其中以人事相關缺失為大宗（20％），其次依序為廠房設施（16％）、捐血者篩選（13％）及血液成分製備（13％）等相關作業。本次查訪之缺失事項與前次（103年度）相比，缺失事項已由59項降低為45項。食藥署仍將持續秉持守護國人健康的使命，督導機構落實改善，提升捐血機構供血的品質與捐供血作業準則，進而確保國人用血安全。 For the purpose of preventing the transmission of blood borne diseases and ensuring the safety of blood transfusions, ＂The Plasma Derivatives Act＂ was enacted in Taiwan. This act was modeled in accordance to the resolutions made from the 28^(th) World Health Assembly: to promote voluntary non-remunerated blood donations, to provide a safe blood supply, and to achieve self-sufficiency in blood and its products. Under the act, the Taiwan Food and Drug Administration (TFDA) oversees the safety and quality of blood supply. Blood establishments involved in handling blood and its components for transfusions are subject to inspection per national and international standards and regulations. In 2017, blood establishments were inspected for quality by a committee composed of experts and professionals in the blood management field. During inspections, no critical violations were found. However, in certain cases, several issues for improvement were noted: particularly in the areas of human factors (20%), facility equipment (16%), blood donor selection (13%), and preparations(13%). To ensure blood quality and safety in Taiwan, TFDA is committed to safeguarding the nation’s health by conducting routine inspections of blood establishments.