【中英文对照版】医疗事故处理条例

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　 1 医疗事故处理条例 Regulation on the Handling of Medical Accidents 【中英文对照版】

　 发布部门：国务院

　发文字号：中华人民共和国国务院令第351号 发布日期：2002.04.04 实施日期：2002.09.01 效力级别：行政法规 法规类别：医疗事故 疫情防控 Area of Law ：

　Medical Malpractice Epidemic Prevention and Control Level of Authority ：

　Administrative Regulations Date Issued ：04-04-2002

　Effective Date ：09-01-2002

　Issuing Authority ：

　State Council

　 Order of the State Council 中华人民共和国国务院令

　 (Docket No. 351) （第 351 号）

　 The Regulation on the Handling of Medical Accidents has been passed at the fifty fifth executive meeting of the State Council on February 20, 2002, and is hereby promulgated for implementation as of September 1, 2002. 《医疗事故处理条例》已经2002 年 2 月 20 日国务院第55 次常务会议通过，现予公布，自 2002 年 9 月 1 日起施行。

　 Zhu Rongji, Premier of State Council 总理 朱镕基

　 April 4, 2002 二 00 二年四月四日

　 The Regulation on the Handling of Medical Accidents 医疗事故处理条例

　 Chapter I General Provisions 第一章 总则

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　 Article 1 The present Regulation has been enacted for the purpose of correctly handling medical accidents, protecting the lawful rights and interests of the patients, medical institutions and the staff members thereof, maintaining the medical order, safeguarding the security of medical treatment, and promoting the development of the medical science.

　 第一条 为了正确处理医疗事故，保护患者和医疗机构及其医务人员的合法权益，维护医疗秩序，保障医疗安全，促进医学科学的发展，制定本条例。

　 Article 2 The term “medical accident” as mentioned in the present Regulation shall refer to those that have caused personal injury to the patients negligently by the medical institutions or the staff members thereof in the activities of medical treatment by violating the laws, regulations, ministerial rules concerning medical treatment and health or the standards or conventions of medical treatment and nursing.

　 第二条 本条例所称医疗事故，是指医疗机构及其医务人员在医疗活动中，违反医疗卫生管理法律、行政法规、部门规章和诊疗护理规范、常规，过失造成患者人身损害的事故。

　 Article 3 In the handling of medial treatments, the people involved shall follow the principles of openness, fairness, justice, timeliness, and convenience, be practical and realistic so as to achieve the goal of clear fact finding, precise determination of the nature, clear determination of responsibilities and proper handling.

　 第三条 处理医疗事故，应当遵循公开、公平、公正、及时、便民的原则，坚持实事求是的科学态度，做到事实清楚、定性准确、责任明确、处理恰当。

　 Article 4 Medical accidents shall be classified, according to the seriousness of the injuries done to the body of the patient, into four categories:

　 第四条 根据对患者人身造成的损害程度，医疗事故分为四级：

　 Grade I medical accidents: those that have caused death or serious disability of patients; 一级医疗事故：造成患者死亡、重度残疾的；

　 3 Grade II medical accidents: those that have caused mid-level disability or injury to the organs which leads to serious functional obstacles; 二级医疗事故：造成患者中度残疾、器官组织损伤导致严重功能障碍的；

　 Grade III medical accidents: those that have caused mitigated disability or injury to the organs which leads to general functional obstacles; 三级医疗事故：造成患者轻度残疾、器官组织损伤导致一般功能障碍的；

　 Grade IV medical accidents: those that have caused obvious injury to the body of patients or other consequences. 四级医疗事故：造成患者明显人身损害的其他后果的。

　 The criteria for specific grades shall be formulated by the department of the State Council in charge of health. 具体分级标准由国务院卫生行政部门制定。

　 Chapter II Prevention and Handling of Medical Accidents 第二章 医疗事故的预防与处置

　 Article 5 Medical institutions and the staff members thereof shall, in the medical treatment activities, rigidly follow the laws, regulations, ministerial rules concerning medical treatment and health and the standards and conventions of medical treatment and nursing, and scrupulously abide by the professional ethics of medical treatment.

　 第五条 医疗机构及其医务人员在医疗活动中，必须严格遵守医疗卫生管理法律、行政法规、部门规章和诊疗护理规范、常规，恪守医疗服务职业道德。

　 Article 6 Medical institutions shall educate the staff members thereof in terms of the law, administrative regulations, ministerial rules concerning medical treatment and health, training of the standards and conventions of medical treatment and nursing, as well as professional ethics of medical services.

　 第六条 医疗机构应当对其医务人员进行医疗卫生管理法律、行政法规、部门规章和诊疗护理规范、常规的培训和医疗服务职业道德教育。

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　 Article 7 Medical institutions shall set up departments for the quality control of medical treatments or arrange for full-time or part-time persons to be responsible for supervising the medical treatment of the medical workers of the medical institution, inspecting the professional practice of the staff members, accept the complaints of patients concerning medical treatment, and provide consultation services.

　 第七条 医疗机构应当设置医疗服务质量监控部门或者配备专（兼）职人员，具体负责监督本医疗机构的医务人员的医疗服务工作，检查医务人员执业情况，接受患者对医疗服务的投诉，向其提供咨询服务。

　 Article 8 Medical institutions shall record and properly keep case history materials in conformity with the requirements of the department under the State Council in charge of health.

　 第八条 医疗机构应当按照国务院卫生行政部门规定的要求，书写并妥善保管病历资料。

　 In case any case history fails to be recorded due to the rescue of dangerous patients, relevant staff members concerned shall make up the record according to the facts within 6 hours after the rescue finishes, and shall a remark shall be made. 因抢救急危患者，未能及时书写病历的，有关医务人员应当在抢救结束后６小时内据实补记，并加以注明。

　 Article 9 It shall be prohibited to alter, fabricate, conceal, destroy or rob case history materials.

　 第九条 严禁涂改、伪造、隐匿、销毁或者抢夺病历资料。

　 Article 10 Any patient shall be entitled to photocopy or reproduce the outpatient case history, in-hospital records, temperature records, doctor"s advice, tests papers (testing reports), medical image examination materials, letters of consent to special examinations, letters of consent to medical operations, medical

　 第 十条 患者有权复印或者复制其门诊病历、住院志、体温单、医嘱单、化验单（检验报告）、医学影像检查资料、特殊检查同意书、手术同意书、手术及麻

　 5 operations and anaesthesia records, pathological materials, nursing records and other case history materials thereof as provided by the administrative department under the State Council in charge of health. 醉记录单、病理资料、护理记录以及国务院卫生行政部门规定的其他病历资料。

　 Where any patient demands to photocopy or reproduce case history materials according to the provisions of the preceding paragraph, the medical institutions shall provide photocopy or reproduction services, and shall attach seal to the photocopied or reproduced case history materials for proof purposes. In the process of photocopying or reproducing case history materials, the patient concerned shall be present at the scene. 患者依照前款规定要求复印或者复制病历资料的，医疗机构应当提供复印或者复制服务并在复印或者复制的病历资料上加盖证明印记。复印或者复制病历资料时，应当有患者在场。

　 The medical institutions may charge costs of production when photocopying or reproducing case history materials as per the requirement of patients. The specific rate of charge shall be formulated by the departments in charge of price affairs under the people"s government of the provinces, autonomous regions, and municipalities directly under the Central Government jointly together with the administrative departments of health. 医疗机构应患者的要求，为其复印或者复制病历资料，可以按照规定收取工本费。具体收费标准由省、自治区、直辖市人民政府价格主管部门会同同级卫生行政部门规定。

　 Article 11 In the activities of medical treatment, medical institutions and the staff members thereof shall inform the patients truthfully of the state of illness, measures of medical treatment, medical risks, etc., and shall give answers to their inquiries in a timely way unless, however, unfavorable consequences may happen to the patient concerned.

　 第十一条 在医疗活动中，医疗机构及其医务人员应当将患者的病情、医疗措施、医疗风险等如实告知患者，及时解答其咨询；但是，应当避免对患者产生不利后果。

　 Article 12 Medical institutions shall make preventive plans for avoiding and handling medical accidents so as to avoid the occurrence of medical accidents and mitigate the injuries of medical accidents.

　 第十二条 医疗机构应当制定防范、处理医疗事故的预案，预防医疗事故的发

　 6 生，减轻医疗事故的损害。

　 Article 13 Where any medical worker incurs or finds, in medical treatment activities, medical accidents or negligent medical acts that may lead to medical accidents or medical treatment disputes, he shall report to the person-in-charge of the section where he works immediately, and the person-in-charge shall report in turn to the department in charge of quality control or the full-time (or part-time) person of the medical institution in a timely way. The department in charge of quality control or the full-time (or part-time) person shall, after receiving the report, make immediate investigations and verifications, report the result truthfully to the person-in-charge of the medical institution, and inform explain to the patients concerned.

　 第十三条 医务人员在医疗活动中发生或者发现医疗事故、可能引起医疗事故的医疗过失行为或者发生医疗事故争议的，应当立即向所在科室负责人报告，科室负责人应当及时向本医疗机构负责医疗服务质量监控的部门或者专（兼）职人员报告；负责医疗服务质量监控的部门或者专（兼）职人员接到报告后，应当立即进行调查、核实，将有关情况如实向本医疗机构的负责人报告，并向患者通报、解释。

　 Article 14 In case any medical accident occurs, the medical institutions shall report to the local administrative department of health.

　 第十四条 发生医疗事故的，医疗机构应当按照规定向所在地卫生行政部门报告。

　 In case any of the following serious medical negligent acts occurs, the medical institution concerned shall report to the local administrative department of health within 12 hours: 发生下列重大医疗过失...