侵入性检查与治疗说明书发展缘起

1、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n一個UGI Bleeding急診病患在接受胃鏡檢查時心臟停止！n雖然事先有解釋，但家屬說他們沒有簽同意書、因此不承認。n後來發現胃鏡、TEE、Treadmill等等都不用簽同意書！時代趨勢手術、麻醉同意書n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；n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。但如情況緊急，不在此限。 -醫療法第46條侵入性治療與檢查同意書n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

2、預後情形。-醫療法第58條n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n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n協助醫師了解必要的解釋內容n書面簽字證明醫師已盡到告知的義務n手術麻醉同意書依衛生署最新規範n情況緊急，不在此限。病人安全委員會n明定本院政策、確立權責單位n建立標準流程規範、相關人員義務n參考美國、澳洲等國做法n參考國內各大醫學中心做法n應用資訊化流程、簡化工作政策(I)nWritten policies and procedures should be developed

3、by each institutionnConsent should be obtained for all major therapeutic and diagnostic procedures where disclosure of significant medical information, including major risks involved Harvard Risk Management Foundation政策(II)nmedical procedures and treatments for which informed consent is requirednper

4、sons responsible for obtaining the consent of the patientnmanner of documentation of consent, appropriate persons, other than the patient, from whom consent may be obtained Harvard Risk Management Foundation實施範圍(I)nAll surgical procedures performed under general/spinal anesthesia and selected proced

5、ures under local anesthesianSelected biopsies and excisions (including bone marrow)nCardiac catheterization and angiographynAll major endoscopies Harvard Risk Management Foundation實施範圍(II)nBronchograms, lymphangiograms, myelograms, pneumoencephalograms, splenograms, ventriculograms, and radiation th

6、erapynExtracorporeal and peritoneal dialysisnCancer chemotherapy nElectroconvulsive therapy Harvard Risk Management Foundation實施範圍(III)nTesting for HIVnBlood and blood product use nMajor radiologic and/or imaging procedures involving the use of contrast medianMedications and/or other therapeutics wi

7、th severe side effects Harvard Risk Management Foundation相關人員義務It is the physicians responsibility to obtain the informed consent, and to discuss sufficient medical information.Although the physician is responsible for informing the patient, hospital personnel may assist in the completion of documen

8、tation. Harvard Risk Management Foundation建立標準內容規範Nature of patients condition and procedures to be performed Nature and probability of material risks involved Benefits to be reasonably expected of the procedure Inability of the physician to predict results Irreversibility of the procedure, if that

9、is the case The likely result of no treatment or procedure Available alternatives Harvard Risk Management Foundation風險解釋(I)The type and 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

10、 or treatment.The court recognizes that such disclosure does not apply to all remotely possibly risks of proposed treatment which may be almost without limit. Harvard Risk Management Foundation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 injury and blood clots Harvard Risk Management Foundation本院現有流程n侵入性檢查/治療同意書及說明書格式範本n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。n運用此觀念建立高風險