某三级甲等综合性医院住院患者知情同意管理现状

Management of informed consent of inpatients in a grade Ⅲ general hospital

目的探讨某三级甲等综合性医院住院患者知情同意管理现状。方法收集2017年1-12月某三级甲等综合性医院的2 569份病历中的知情同意书进行回顾性调查分析。知情同意书包括手术同意书、麻醉同意书、特殊诊疗同意书、输血治疗同意书和血液制品同意书;并确定各类知情同意书的构成要素,如患者的基本情况、诊疗措施、替代方案、医疗风险、签名等。分析知情制度落实情况和规范情况。结果 2 569份病历中共需要签署各类同意书4 770份,知情同意制度落实的4 743份(99.43%),其中手术同意书1 284份(100.00%,1 284/1 284)、麻醉同意书1 152份(100.00%,1 152/1 152)、特殊诊疗同意书1 094份(99.27%,1 094/1 102)、输血治疗同意书574份(99.65%,574/576)、血液制品同意书639份(97.86%,639/653);知情同意未落实的27份(0.57%),其中无特殊诊疗同意书8份(0.73%,8/1 102)、无输血治疗同意书2份(0.35%,2/576)、无血液制品同意书14份(2.14%,14/653),同意书无患者或其家属签名3份。落实的4 743份知情同意书中,内容、格式完全符合医院规范的4 712份(99.35%),其中使用医院模板4 685份(99.43%,4 685/4 712),科室自设模板27份(0.57%,27/4 712);不符合医院规范的31份(0.65%),其中无医师签名12份(38.71%,12/31)、无替代方案8份(25.81%,8/31)、患者信息不全6份(19.35%,6/31)、名称为协议书5份(16.13%,5/31)。知情同意制度未落实的科室分布:外科17份(62.96%,17/27),内科8份(29.63%,8/27),医技科室2份(7.41%,2/27)。不规范同意书的科室分布:内科15份(48.39%,15/31),外科13份(41.94%,13/31),医技科室3份(9.68%,3/31)。结论医院知情告知管理比较规范,但要进一步规范知情告知项目管理、深化教育培训和加强监督管理,从而提高对知情同意书的管理水平。

Objective To explore the management status of informed consent of inpatients in a grade Ⅲ general hospital. Methods The fill-out of informed consent form of 2 569 medical records from January to December 2017 was retrospectively analyzed. Informed consent includes operation, anesthesia, special treatment, transfusion and blood products agreement. The components of informed consent, such as general information of patients, treatment measures, alternatives, medical risks, and signatures, were determined. The implementation and specification of the informed system were analyzed. Results Of the 2 569 medical records, 4 770 consents should be signed, 4 743(99.43%) were implemented, including 1 284(100.00%, 1 284/1 284) consents for surgery, 1 152(100.00%, 1 152/1 152) consents for anesthesia, 1 094(99.27%, 1 094/1 102) consents for special treatment, 574(99.65%, 574/576) consents for transfusion and 639(97.86%, 639/653) consents for blood products;27(0.57%) were not implemented, including 8(0.73%, 8/1 102) for special treatment, 2(0.35%, 2/576) for transfusion, 14(2.14%, 14/653) for blood products and 3 patient’s signatures. Among the 4 743 signed consent documents, 4 712(99.35%) were standard in content and format, including 4 685(99.43%,4 685/4 712) hospital templates and 27(0.57%,27/4 712) department templates;31(0.65%) were non-standard, including 12(38.71%,12/31) absence of doctor’s signature, 8(25.81%,8/31) absence of alternative plan, 6(19.35%,6/31) with incomplete patient information and 5(16.13%,5/31) with wrong name of the consent. Of the 27 unimplemented, 17(62.96%,17/27) were from surgery department, 8(29.63%,8/27) were from internal medicine department and 2(7.41%,2/27) were from department of medical technology. Of 31 non-standard consent forms, 15(48.39%,15/31) were from internal medicine department, 13(41.94%,13/31) were from surgery department, and 3(9.68%,3/31) were from department of medical technology. Conclusion The management of informed notification in hospitals is relatively standardized, but we should further standardize the content, emphasize education and training, and strengthen supervision and management, so as to improve the level of consent management.