血庫文件保存年限要求

依照 CAP 建議(翻譯僅供參考)

TYPE OF RECORD	RETENTION PERIOD
Donor Records捐血者記錄
●         Blood/component donor information, consent and collection(捐血者資料，同意書) ●         Donor blood testing(捐血者血液檢查) ●         Donor notification of significant findings       (捐血者特殊通知) ●         Component production (製造的血品成分) ●         Look back investigation/disease reporting       (疾病報告) ●         Final unit disposition(血品流向)	10 years(保存10年)
●         Indefinitely and permanently deferred donors       (停止捐血的捐血者) ●         Donors placed under surveillance (for recipient protection(被監控的捐血者)	Indefinitely(永久保存)
Patient Records病人記錄
●         Transfusion administration records (TRM.41450)        (輸血記錄) ●         Therapeutic phlebotomy/apheresis records        (治療性放血紀錄) ●         Final unit disposition (血品流向)	10 years(保存10年)
●         Patient pre-transfusion testing results/interpretation       (病人輸血前檢查的結果與解釋) ●         Immediate evaluation/interpretation of transfusion reactions (輸血反應的調查與解釋)	10 years(保存10年)
●         Transfusion problems such as transfusion reactions, unexpected antibodies, and special transfusion requirements. (輸血反應、不規則抗體、特殊血品需求)	Indefinitely(永久保存)
●         Employee signatures, initials, and identification codes (員工簽名及ID)	10 years(保存10年)
Quality Control Records*
●         Quality management reviews(品管審查) ●         Proficiency testing records(能力試驗紀錄) ●         Inspections of blood/critical materials        (特殊試劑與血液檢查) ●         Instrument/equipment quality control and maintenance       (儀器設備品管與保養) ●         Irradiation dose delivery(放射劑量) ●         Control systems for patient testing (病人檢查的管制系統) ●         Retyping of donor units(血袋血型重測) ●         Annual procedure review/procedure discontinued (年度審閱程序/已經停用的程序)	5 years(保存5年)
●         Control systems for donor testing (捐血者檢查的管制系統)	10 years(保存10年)
Tissue Records (including bone marrow and/or progenitor cells) (組織/骨髓/臍帶血)
●         Collection, transportation, processing, issuing, disposition (收集、運送、處理、發出及輸用)	10 yrs beyond tissue's disposition or expiration, whichever is longer (組織輸用或過期後10年，以年限較長者決定)
●         Daily temperature monitoring       (每日溫度記錄)	10 years(保存10年)