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1、侵入性檢查與治療說明書發展緣起,病人安全委員會,侵入性檢查與治療說明書發展緣起病人安全委員會,緣起：一個哨兵事件,一個UGI Bleeding急診病患在接受胃鏡檢查時心臟停止！雖然事先有解釋，但家屬說他們沒有簽同意書、因此不承認。後來發現胃鏡、TEE、Treadmill等等都不用簽同意書！,緣起：一個哨兵事件一個UGI Bleeding急診病患在接受,時代趨勢,時代趨勢,手術、麻醉同意書,醫院實施手術時，應取得病人或其配偶、親屬或關係人之同意，簽具手術同意書及麻醉同意書；在簽具之前，醫師應向其本人或配偶、親屬或關係人說明手術原因，手術成功率或可能能發生之併發症及危險，在其同意下，始得為之。但如
2、情況緊急，不在此限。 -醫療法第46條,手術、麻醉同意書醫院實施手術時，應取得病人或其配偶、親屬或關,侵入性治療與檢查同意書,醫療機構診治病人時，應向病人或其家屬告知其病情、治療方針及預後情形。-醫療法第58條醫師診治病人時，應向病人或其家屬 告知其病情、治療方針、處置、用藥、預後情形及可能之不良反應 -醫師法第十二條之一,侵入性治療與檢查同意書醫療機構診治病人時，應向病人或其家屬告,侵入性治療與檢查同意書,協助家屬了解侵入性治療與檢查之目的、可能併發症與風險協助醫師了解必要的解釋內容書面簽字證明醫師已盡到告知的義務手術麻醉同意書依衛生署最新規範情況緊急，不在此限。,侵入性治療與檢查同意書協助
3、家屬了解侵入性治療與檢查之目的、可,病人安全委員會,明定本院政策、確立權責單位建立標準流程規範、相關人員義務參考美國、澳洲等國做法參考國內各大醫學中心做法應用資訊化流程、簡化工作,病人安全委員會明定本院政策、確立權責單位,侵入性检查与治疗说明书发展缘起课件,侵入性检查与治疗说明书发展缘起课件,侵入性检查与治疗说明书发展缘起课件,侵入性检查与治疗说明书发展缘起课件,侵入性检查与治疗说明书发展缘起课件,政策(I),Written policies and procedures should be developed by each institutionConsent should be obta
4、ined for all major therapeutic and diagnostic procedures where disclosure of significant medical information, including major risks involved Harvard Risk Management Foundation,政策(I)Written policies and proc,政策(II),medical procedures and treatments for which informed consent is requiredpersons respon
5、sible for obtaining the consent of the patientmanner of documentation of consent, appropriate persons, other than the patient, from whom consent may be obtained Harvard Risk Management Foundation,政策(II)medical procedures and t,實施範圍(I),All surgical procedures performed under general/spinal anesthesia
6、 and selected procedures under local anesthesiaSelected biopsies and excisions (including bone marrow)Cardiac catheterization and angiographyAll major endoscopies Harvard Risk Management Foundation,實施範圍(I)All surgical procedures,實施範圍(II),Bronchograms, lymphangiograms, myelograms, pneumoencephalogram
7、s, splenograms, ventriculograms, and radiation therapyExtracorporeal and peritoneal dialysisCancer chemotherapy Electroconvulsive therapy Harvard Risk Management Foundation,實施範圍(II)Bronchograms, lymphang,實施範圍(III),Testing for HIVBlood and blood product use Major radiologic and/or imaging procedures
8、involving the use of contrast mediaMedications and/or other therapeutics with severe side effects Harvard Risk Management Foundation,實施範圍(III)Testing for HIV,相關人員義務,It is the physicians responsibility to obtain the informed consent, and to discuss sufficient medical information.Although the physicia
9、n is responsible for informing the patient, hospital personnel may assist in the completion of documentation. Harvard Risk Management Foundation,相關人員義務It is the physicians re,建立標準內容規範,Nature of patients condition and procedures to be performed Nature and probability of material risks involved Benefi
10、ts to be reasonably expected of the procedure Inability of the physician to predict results Irreversibility of the procedure, if that is the case The likely result of no treatment or procedure Available alternatives Harvard Risk Management Foundation,建立標準內容規範Nature of patients co,風險解釋(I),The type an
11、d the number of risks to be disclosed should depend on the significance the doctors patient would attach to such risks in deciding whether to consent to the procedure or treatment.The court recognizes that such disclosure does not apply to all remotely possibly risks of proposed treatment which may
12、be almost without limit. Harvard Risk Management Foundation,風險解釋(I)The type and the number,風險解釋(II),A specific listing of some of the more major material risks disclosed including, but not limited to, loss of life, loss of limb function, brain damage, paralysis, hemorrhage, allergic reactions, nerve
13、 injury and blood clots Harvard Risk Management Foundation,風險解釋(II) A specific listing of,本院現有流程,侵入性檢查/治療同意書及說明書格式範本侵入性檢查與治療填具同意書及說明書作業流程，於九十三年二月二日上線實施。運用此觀念建立高風險藥物同意說明書作業流程於九十三年九月二日上線實施。為確保說明書內容的適切性，94年12月訂定侵入性檢查與治療說明書內容審查作業流程 。,本院現有流程侵入性檢查/治療同意書及說明書格式範本,本院現有流程,為確保說明完整性，94年11月決議於放射線部針對高風險侵入性檢查於檢查前，放射科檢查醫師必須再次說明之流程。為確保中心靜脈導管處置安全性，建立CVP procedure Note核對流程。,本院現有流程為確保說明完整性，94年11月決議於放射線部針對,
