【中英文对照版】医疗事故处理条例.docx

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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：实施日期：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 ControlLevel of Authority : Administrative RegulationsDate Issued ： 04-04-2002Effective Date ： 09-01-2002Issuing Autho

2、rity : State CouncilOrder 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

3、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总理朱铭基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第一章总那么Government shall be responsible for further authentications.Where it is necessary, the All

4、-China Society of Medical Sciences may organize technical authentications for difficult or complicated medical disputes of national significance.必要时，中华医学会可以组 织疑难、复杂并在全国有重 大影响的医疗事故争议的技 术鉴定工作。Article 22 In case any party refuses to accept the conclusion of the initial authentication of medical acciden

5、ts, it may apply, within 15 days after receiving the conclusion of the initial authentication, to the local administrative department of health where the medical institution is located for a second one.第二十二条当事人对 首次医疔事故技术鉴定结论 不服的，可以自收到首次鉴 定结论之日起1 5日内向医 疗机构所在地卫生行政部门 提出再次鉴定的申请。Article 23 The societies

6、of medical sciences that are responsible for organizing authentications of medical accidents shall set up databases of experts.第二十三条负责组织 医疗事故技术鉴定工作的医 学会应当建立专家库QThe database of experts shall consist of medical professionals that satisfy the following conditions:专家库由具备以下条件的医 疗卫生专业技术人员组成：(1) Having goo

7、d professional knowledge and being of excellent professional ethics;（一）有良好的业务素质和 执业品德；(2) Being employed by a medical institution or institution of medical teaching or research and holding a senior professional title for three years or more;（二）受聘于医疗卫生机构 或者医学教学、科研机构并 担任相应专业高级技术职务 3年以上。Any legal medic

8、al expert who satisfies the conditions as provided in item (1) of the preceding paragraph and holds a senior professional title may be included in the符合前款第（一）项规定条 件并具备高级技术任职资格 的法医可以受聘进入专家database of experts.库。10负责组织医疗事故技术鉴定 工作的医学会依照本条例规 定聘请医疗卫生专业技术人 员和法医进入专家库，可以 不受行政区域的限制。第二十四条医疗事故 技术鉴定，由负责组织医疗 事故技术

9、鉴定工作的医学会 组织专家鉴定组进行。参加医疗事故技术鉴定的相 关专业的专家，由医患双方 在医学会主持下从专家库中 随机抽取。在特殊情况下， 医学会根据医疗事故技术鉴 定工作的需要，可以组织医 患双方在其他医学会建立的 专家库中随机抽取相关专业 的专家参加鉴定或者函件咨 询。符合本条例第二十三条规定 条件的医疗卫生专业技术人 员和法医有义务受聘进入专 家库，并承当医疗事故技术 鉴定工作。第二十五条专家鉴定 组进行医疗事故技术鉴定， 实行合议制。专家鉴定组人 数为单数，涉及的主要学科The societies of medical sciences that are responsible fo

10、r organizing authentications of medical disputes may invite medical professionals and legal medical expertwithoutto be included in the expert databases consideration of administrative jurisdictions.Article 24 Technical authentications of medical disputes shall be done by expert authentication groups

11、 organized by the societies of medical sciences that are responsible for organizing technical authentications of medical accidents.The experts of relevant majors that participate in the technical authentication of medical accidents shall be selected randomly by both parties to the medical dispute fr

12、om the expert database under the auspices of the society of medical sciences. However, under special circumstances, the society of medical sciences may, according to the need of technical authentication of medical accidents, arrange both parties select randomly experts of relevant majors from the ex

13、pert databases set up by other societies of medical sciences to participate in the authentication or to provide consultation services by mail.The medical professionals and legal medical experts that meet the conditions as provided in Article 23 of the present Regulation shall be obliged to be includ

14、ed in the databases of experts and to undertake technical authentications of medical accidents.Article 25 The collegiate system shall be practiced in the technical authentication of medical accidents by the groups of experts. The number of experts in the groups shall be in odd number, and, as a gene

15、ral rule,the experts of the dominating major involved shall not be less than one half of all the members of the groups. In the authentication of the cause of death or the grade of injury, legal medical experts shall be selected randomly from the database of experts to participate in the groups of ex

16、perts.的专家一般不得少于鉴定组 成员的二分之一；涉及死 因、伤残等级鉴定的，并应 当从专家库中随机抽取法医 参加专家鉴定组。Article 26 In any of the following circumstances, members of the groups of experts shall withdraw, and the parties concerned may plead their withdrawal in oral or written form:第二十六条专家鉴定 组成员有以下情形之一的， 应当回避，当事人也可以以 口头或者书面的方式申请其 回避：（一）是医疗事

17、故争议当事 人或者当事人的近亲属的；(2) Having interests in the medical dispute;（二）与医疗事故争议有利 害关系的；(1) Being a party or a close relative of the party to the medical dispute;（三）与医疗事故争议当事 人有其他关系，可能影响公 正鉴定的。第二十七条专家鉴定 组依照医疗卫生管理法律、 行政法规、部门规章和诊疗 护理规范、常规，运用医学 科学原理和专业知识，独立 进行医疗事故技术鉴定，对 医疗事故进行鉴别和判定， 为处理医疗事故争议提供医 学依据。任何单位或者个人不得

18、干扰 医疗事故技术鉴定工作，不(3) Having other relationship with the parties concerned that may affect the impartiality of authentication.Article 27 The groups of authentication experts shall authenticate the medical accidents independently by following the laws, regulations, ministerial rules concerning health an

19、d the standards or conventions of medical treatment and nursing, using medical principles and professional knowledge, make authentications and judgments of medical accidents and provide medical basis for the settlement of medical disputes.No entity or individual may disturb the authentication of med

20、ical accidents, or menace, lure by promise of12得威胁、利诱、辱骂、殴打 专家鉴定组成员。专家鉴定组成员不得接受双 方当事人的财物或者其他利 、乙 rm o第二十八条负责组织 医疗事故技术鉴定工作的医 学会应当自受理医疗事故技 术鉴定之日起5日内通知医 疗事故争议双方当事人提交 进行医疗事故技术鉴定所需 的材料。当事人应当自收到医学会的 通知之日起1 0日内提交有 关医疗事故技术鉴定的材料、书面陈述及辩论。医疗机构提交的有关医疗事故技 术鉴定的材料应当包括以下 内容：（一）住院患者的病程记 录、死亡病例讨论记录、疑 难病例讨论记录、会诊意 见、上级

21、医师查房记录等病 历资料原件；（二）住院患者的住院志、 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、手术及麻醉记 录单、病理资料、护理记录 等病历资料原件；gains, revile or batter any member of the authentication groups.No member of the authentication groups may accept any of the property or any other interest of any party concerned.Article 28 The society

22、 of medical sciences that is responsible for organizing technical authentications of medical accidents shall, within 5 days after accepting the application for technical authentication, inform both parties to the medical dispute to submit materials needed for the technical authentication.The parties

23、 concerned shall, within 10 days after receiving the notice of the society of medical sciences, submit the relevant materials of technical authentications, written statements and answers. The materials of technical authentication of medical accidents submitted by the medical institution concerned sh

24、all consist of the following:(1) The original case history materials, including the records of the course of diseases of the in-hospital patient, minutes of discussion of deaths, minutes of discussion of difficult or complicated cases, opinions of consultations, the records of looking over wards by

25、doctors at higher levels, etc.(2) The original case history materials, including in- hospital records of the patient, temperature records, doctors advice, tests papers (testing reports), medical image examination materials, letters of consent to special examinations, letters of consent to medical op

26、erations, medical operations and anaesthesia records, pathological materials, nursing records, etc.;13(3) The original case history materials made up during (三)抢救急危患者，在规 the prescribed time period for rescuing dangerous 定时间内补记的病历资料原patients;件;（四）封存保存的输液、注 射用物品和血液、药物等实 物，或者依法具有检验资格(4) The material ob

27、jects like fluid, injection tools, blood, medicines, etc. that have been sealed up for keeping, or testing reports issued by eligible testing institutions concerning the said tools and materials 的检验机构对这些物品、实objects;物作出的检验报告；(5) Other materials relating to the authentication of the medical accident.t

28、echnical （五）与医疗事故技术鉴定有关的其他材料。在医疗机构建有病历档案的 门诊、急诊患者，其病历资 料由医疗机构提供；没有在 医疗机构建立病历档案的， 由患者提供。The case history materials of the patients who has a case history archive in the medical institution shall be provided by the medical institution, those who do not have a case history archive in the medical instit

29、ution, the case history materials thereof shall be provided by the patient concerned.医患双方应当依照本条例的 规定提交相关材料。医疗机 构无正当理由未依照本条例 的规定如实提供相关材料，Both parties shall provide relevant materials in conformity with the provisions of the present Regulation. Any medical institution that fails to provide relevant ma

30、terials truthfully in conformity with the provisions of the present Regulation without导致医疗事故技术鉴定不能 进行的，应当承当责任。导致医疗事故技术鉴定不能 进行的，应当承当责任。第二十九条负责组织 医疗事故技术鉴定工作的医 学会应当自接到当事人提交 的有关医疗事故技术鉴定的 材料、书面陈述及辩论之日 起4 5日内组织鉴定并出具 医疗事故技术鉴定书。good reasons so that the technical authentication of the medical accident cannot

31、 be held shall be held to be responsible.Article 29 The society of medical sciences that is responsible for organizing the technical authentication shall, within 45 days after receiving the materials, written statements and answers relevant to the technical authentication of the medical accident sub

32、mitted by the parties concerned, organize an authentication and issue a conclusion of authentication.14负责组织医疗事故技术鉴定 工作的医学会可以向双方当 事人调查取证。负责组织医疗事故技术鉴定 工作的医学会可以向双方当 事人调查取证。The societies of medical sciences that are responsible for organizing technical authentications of medical accidents may conduct in

33、vestigations and gather evidences from the parties concerned.第三十条专家鉴定组 应当认真审查双方当事人提 交的材料，听取双方当事人 的陈述及辩论并进行核实。Article 30 The expert authentication group shall make a careful examination of the materials submitted by the parties concerned, listening to the statement and responses of both parties and m

34、aking verifications.双方当事人应当按照本条例 的规定如实提交进行医疗事 故技术鉴定所需要的材料， 并积极配合调查。当事人任 何一方不予配合，影响医疗 事故技术鉴定的，由不予配 合的一方承当责任。The parties concerned shall provide truthfully the materials needed for the technical authentication in conformity with the provisions of the present Regulation, and shall actively cooperate in

35、 the investigations. Any party that fails to give cooperation and thus affects the technical authentication shall be held to be responsible.第三H一条专家鉴定 组应当在事实清楚、证据确 凿的基础上，综合分析患者 的病情和个体差异，作出鉴 定结论，并制作医疗事故技 术鉴定书。鉴定结论以专家 鉴定组成员的过半数通过。 鉴定过程应当如实记载。医疗事故技术鉴定书应当包Article 31 The expert authentication group shall

36、make authentication conclusions on the basis of clearing fact findings and irrefutable evidences by making comprehensive analysis of the state of illness of the patient concerned and the differences between the individuals, and issue a letter of authentication of medical accidents. The authenticatio

37、n conclusion shall be passed by half of the members of the expert authentication group. The process of authentication shall also be truthfully recorded.The letter of authentication of medical accidents shall括以下主要内容:括以下主要内容:include the following major elements:(1) basic information about demands of t

38、he parties (一)双方当事人的基本情 concerned;况及要求；15(2) the materials submitted by the parties concerned and the investigation materials provided by the society of medical sciences that is responsible for organizing the technical authentication;（二）当事人提交的材料和 负责组织医疗事故技术鉴定 工作的医学会的调查材料；(3) a description of the aut

39、hentication process;（三）对鉴定过程的说明;(4) whether the medical treatment act has violated any of the laws, regulations, ministerial rules concerning medical treatment and health or any of the standards or conventions of medical treatment and nursing;（四）医疗行为是否违反医 疗卫生管理法律、行政法 规、部门规章和诊疗护理规 范、常规；(5) whether th

40、ere is a causal relationship between the negligent medical act and the consequence of personal injury;（五）医疗过失行为与人身 损害后果之间是否存在因果 关系；(6) the seriousness of the negligent medical act in the injury of medical accident;（六）医疗过失行为在医疗 事故损害后果中的责任程 度；(7) the grade of the medical accident;（七）医疗事故等级;(8) medical

41、 suggestions on the medical treatment and nursing to the patient involved in the medical dispute.（八）对医疗事故患者的医 疗护理医学建议。Article 32 The measures for the technical authentication of medical accidents shall be formulated by the administrative department under the State Council in charge of health.第三十二条医疗

42、事故 技术鉴定方法由国务院卫生 行政部门制定。Article 33 Any of the following circumstances shall not be deemed as a medical accident:第三十三条 有以下情 形之一的，不属于医疗事 故：(1) unfavorable consequences resulting from emergent（一）在紧急情况下为抢救16（二）在医疗活动中由于患 者病情异常或者患者体质特 殊而发生医疗意外的；（三）在现有医学科学技术 条件下，发生无法预料或者 不能防范的不良后果的；（四）无过错输血感染造成 不良后果的；（五）因患方

43、原因延误诊疗 导致不良后果的；medical measures taken under dangerous 垂危患者生命而采取紧急医 circumstances for rescuing the life of the patient; 学措施造成不 良后果的；medical emergencies resulting in the process of medical treatment from the unusual state of illness or the special physique of the patient;(2) unfavorable consequences t

44、hat cannot be predicted or prevented under the existing technical and medical conditions;unfavorable consequences caused by infections resulting from faultless blood transfusions;(3) unfavorable consequences caused by the delay of the patient in medical treatment;unfavorable consequences caused by f

45、orce (六)因不可抗力造成不良 majeure;后果的。第三十四条 医疗事故 技术鉴定，可以收取鉴定费 用。经鉴定，属于医疗事故 的，鉴定费用由医疗机构支 付；不属于医疗事故的，鉴 定费用由提出医疗事故处理 申请的一方支付。鉴定费用 标准由省、自治区、直辖市 人民政府价格主管部门会同 同级财政部门、卫生行政部 门规定。Article 34 Fees may be charged for technical authentications of medical accidents. If the authentication proves that the a medical acciden

46、t has occurred, the expenses of authentication shall be paid by the medical institution concerned; if the authentication proves that no medical accident has occurred, the authentication expenses shall be paid by the party that applies for settling the medical accident. The rates of authentication ex

47、penses to be charged shall be formulated by the department of the peoples government of the provinces, autonomous regions and municipalities directly under the Central Government in charge of price affairs in collaboration with the financial department and administrative department of health on the

48、same level.17Chapter IV Administrative Punishment and Supervision of Medical AccidentsThe administrative department of health shall give administrative punishments to the medical institutions and staff members thereof that have caused medical accidents in accordance with the present Regulation and other relevant laws, regulations or ministerial rules.Article 35 The administrative department of health shall, after re