開課講師｜鄭文誠
課程資訊｜2025.10.18-3
報名方式｜線上報名
課程介紹｜
中文摘要
馬偕紀念醫院自2010年規劃並建置人體器官保存庫（組織庫），發展羊膜、血管、周邊血液幹細胞、皮膚、眼及骨庫等多元保存項目。保存庫設於淡水院區恩典樓，採潔汙分流與分級無塵環境，並配置Air Shower、Pass Box以確保無菌作業。核心流程涵蓋採集、收受、篩檢、處理、儲存、配送、標示、追蹤與銷毀，搭配唯一條碼與資訊系統，全程可追溯。醫院定期舉行管理會議、年度內部稽核與管理審查，並進行設備校正、冷鏈監控與捐贈者感染篩檢，確保品質與符合法規。此管理模式搭配ISO文件架構、與風險控管，建立符合國際規範的高標準品質系統，提供臨床移植安全與永續發展基礎。
English abstracts
Since 2010, MacKay Memorial Hospital has established a comprehensive tissue banking system, covering amnion, vessels, peripheral blood stem cells, skin, eyes, and bone tissues. The facility, located at the Tamsui campus, operates with strict clean/dirty zoning, classified cleanroom standards, and environmental controls such as Air Showers and Pass Boxes to ensure aseptic procedures. Core processes include procurement, reception, donor screening, processing, storage, distribution, labeling, traceability, and disposal, all managed through unique barcoding and an integrated information system for full traceability. Quality assurance is reinforced through quarterly management meetings, annual internal audits, and management reviews, together with equipment calibration, cold chain monitoring, and donor infectious disease testing. The system integrates ISO-based documentation, and risk control mechanisms, aligning with international standards to ensure tissue safety, regulatory compliance, and sustainable clinical application. This model provides a robust framework for transplantation services and continuous improvement in quality management.
講師介紹｜
