血庫品質管理作業醫院血庫作業之管理目的醫院資材管理的目的便是於適當的時間 right time 在適當的地點

血庫品質管理作業

醫院血庫作業之管理目的：醫院資材管理的目的便是於適當的時間 (right time) ，在適當的地點 (right place)以適當的價格 (right price)及適當的品質 (right quality)供應適當數量 (right quantity)的資材給醫院各部門，使醫療服務作業順暢，保持一定水準的醫療服服務品質並降低醫院營運資材成本，以達成醫院永續經營的目標。 2 H. I. Chen

法規及規範國外 CAP (College of American Pathologists) AABB (American Association of Blood Bank) ISO-15189 國內捐血機構設置標準表 TAF ISO-15189 醫策會醫院評鑑

品質管理目標安全輸血訓練合格人員依標準流程執行核發血作業符合規範及認證要求有效正確使用血品

品質系統要素 (QSE, Quality system essentials) 組織文件及記錄人員事件處理設備內外部稽核供應品質改善流程管制設施與安衛

護理醫師血庫病人傳送輸血安全管理委員會捐血中心

輸血前組織與人員輸血安全管理委員會標準作業程序血品儲存設備 (溫度監控 ) WB, RBC (1~6℃) FFP (-18 ℃) Platelet (20~24 ℃, 震盪 ) 血品進銷存管理 (效期管控 ) 核發血檢驗三天內備血檢體 (雙重辨識 ) 血袋唯一標示 (Code 128) 血品運送管制 (溫度監控 ) 輸血同意書

輸血前檢驗病人 /適應症 Hgb (血色素 ) PT/a. PTT(凝血時間 ) Platelet(血小板 ) WBC(白血球 ) 血庫 /核發血病人及血袋 ABO, Rh血型不規則抗體篩檢大交叉試驗不規則抗體鑑定替代性血品核發電腦核血 (computer cross match)

輸血前檢驗之品管每日試劑品管細胞抗體溶液離心機：年度校正與確效檢體離心機血球洗滌機溫度：年度校正與確效溫度計冷藏、冷凍冰箱水浴箱溫箱分注器：年度校正與確效警報器之設定與測試

輸血中病人辨識血袋檢核確認血品、血型 (ABO, Rh)、血袋號、病歷號、姓名溫血標準程序溫血器確效及使用輸血技術訓練與監視輸血併用輸液之限制減白血品及過濾器之選用輸血反應觀察、處理與紀錄

輸血後品質指標備血檢體錯誤率逾時退血率 (> 30 min) 急 /普件核發血時效達成率 (急 < 30 min, 普 < 60 min) 血球 /血漿比率 (> 1) 不當用血案件檢討輸血紀錄回報率 (100%) 輸血反應提報率 (1~2%) 輸血病安事件檢討輸血反應調查與處理註記瑕疵血品之召回程序與記錄瑕疵血品輸注事件之調查

管理要求人員新進及年度教育訓練、考核、授權儀器設備年度校正維修計畫能力測試 (Proficiency test)執行與檢討內部稽核外部稽核文件年度審閱、修訂、管制試劑評估及允收

血液成分分離流程圖冷凍血漿 (Plasma) 採血 8小時後分離高重力離心血漿 (Plasma) ☆新鮮冷凍血漿 (Fresh Frozne Plasma) 採血 8小時內分離全血 Whole Blood 低重力離心冷凍冷凍血漿 (Frozne Plasma) 減除白血球之紅血球濃厚液 (Leukocyte Reduced RBC) 白血球過濾器血液壓板器 ☆富含血小板之血漿 (Platelet Riched Plasma, PRP) ☆必須在採血後 6 -8小時內製備 ☆冷凍沉澱品 (Cryoprecipitate) 洗滌紅血球 (Washed RBC) 紅血球洗滌機紅血球濃厚液 (Packed RBC) 解凍高重力離心冷凍血漿 (Frozne Plasma) buffy coat 高重力離心 ☆白血球濃厚液 (WBC concentrate) ☆血小板濃厚液 (Platelet concentrate) ☆新鮮冷凍血漿 (Fresh Frozne Plasma)

Receipt of Reagents Reagent Specificity Mnftr & Appearance Lot # Exp. Date A 1 cells A 2 cells B cells Ig. G coated cells Screen cell I Screen Cell III (Optional) Anti-A Anti-B Anti-A, B Anti-D Control for anti–D AHG Polyspecific Anti-Ig. G Anti-C 3 b Potentiator Date Received/ Checked by

Reagent Specificity A 1 cells A 2 cells B cells Anti-A Anti-B Anti-A, B Anti-D Control for –D AHG Polyspecific Anti-Ig. G Anti-C 3 b Ig. G coated cells Screen cell I Screen Cell III Potentiator______ Daily Quality Control of Reagents Week Range: ________ Mnftr & Exp. Date Reagent Appearance Lot # D 1 D 2 D 3 D 4 D 5 D 6 D 7 Quality Control Testing done by: All results reviewed and approved by:

捐輸血作業安全策略血品來源 a. 捐血中心部隊募血(比照捐血中心檢驗及愛滋道義基金) 1) 2) l 檢驗為CAP及ISO-15189雙重認證通過作業標準：AABB(美國血庫學會)及CAP(美國病理學會)規範血品庫存輸血教育 b. c. d. 1) 2) 3) 4) 5) 輸血適應症輸血用量監測使用成分血品輸血技術訓練捐血任務演訓

捐輸血作業安全策略核發血流程 e. 備血：病人手圈條碼辨識、備血專用標籤核血：血型檢驗雙重查核、電腦血型核對發血：雙人複核、時效內送達 1) 2) 3) 每季備血檢體退件率輸血流程 f. 血品收件：雙人複核 1) l 過期？破損？照光完成？血品輸注：雙人複核 2) l l 三查：病人手圈、輸血記錄單、血袋標示五對：姓名、病歷號、床號、血液成分、血型時效內送血達成率 g. 輸血反應回報與調查

血庫文件範例 Pre-analysis Guidelines Recipient Identification and Specimen Labelling Determining Specimen Suitability Recipient History Check Labelling of Test Tubes and Block Set Up For Compatibility Testing Cell Washing Automated and Manual Reading and Recording Hemagglutination Reactions Reading and Recording for Gel Technique Using MTS™ Columns

血庫文件範例 Routine Testing Guidelines ABO Grouping Rh Typing Weak D Typing Direct Antiglobulin Test Antibody Screen Group and Screen Immediate Spin Crossmatch Antiglobulin Crossmatch Rosette Test Investigation of Transfusion Complications Antibody Screen by Gel Technique Using MTS™ Columns

血庫文件範例 Complex Testing Guidelines Prewarm Technique Saline Replacement ABO Group Problem Solving Rh Typing Problem Solving Investigation of Positive Direct Antiglobulin Test (DAT) Antibody Identification of Cold Reactive Antibodies Antibody Identification of Warm Reactive Antibodies Exclusion and Confirmation of Antibodies Antigen Typing - Direct and Indirect Agglutination Acid Elution Antibody Identification by Gel Technique Using MTS™ Columns

血庫文件範例 Component Selection and Preparation Guidelines Selection of Blood Components for Transfusion Thawing Plasma Thawing and Pooling Cryoprecipitate Pooling Platelets Dividing Red Blood Cells (RBC)

血庫文件範例 Inventory Management Guidelines Standardized Nomenclature for Blood, Blood Components and Other Related Products Receiving Blood, Blood Components and Other Related Products Visual Inspection of Blood, Blood Components and Other Related Products Issuing Blood, Blood Components and Other Related Products Using the Issue/Transfusion Record Final Disposition of Blood, Blood Components and Other Related Products Not Suitable for Transfusion Packaging Blood, Blood Components and Other Related Products for Shipment of Blood Products Accompanying a Recipient Distribution and Reporting of Hepatitis B Immune Globulin (HBIG) to Public Health Units

Quality Control, Assurance and Improvement Guidelines Quality Control of Reagent Red Cells and Antisera Temperature Documentation of Blood Product Storage Equipment Maintenance of Blood Product Storage Refrigerators Maintenance of Blood Product Storage Freezers Maintenance of Platelet Incubators Temperature Calibration of Waterbaths and Heating Blocks Performance Testing and Functional Calibration of Automatic Cell Washers and Serological Centrifuges Functional Calibration of Thermometers Temperature and Alarm Check of Blood Warmers and Rapid Infusion Devices Temperature Check of Blood and Blood Components Hemagglutination Reading Skills Proficiency Testing Central Transfusion Registry (CTR) Reporting Process Pathologist Consultation Protocol

血庫品質管理作業 醫院血庫作業之管理 目的 醫院資材管理的目的便是於適當的時間 right time 在適當的地點

血庫品質管理作業醫院血庫作業之管理目的醫院資材管理的目的便是於適當的時間 right time 在適當的地點