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| 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 |
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| 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。 |
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| 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。 |
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| 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。 |
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| 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； |
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。 |
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| Chapter II Prevention and Handling of Medical Accidents | | 第二章 医疗事故的预防与处置 |
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| 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。 |
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| 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。 |
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| 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。 |
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| 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。 |
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| 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 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. | | 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。 |
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| 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。 |
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| 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，预防医疗事故的发生，减轻医疗事故的损害。 |
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| 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。 |
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| 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行为的，医疗机构应当在１２小时内向所在地卫生行政部门报告： |
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| (1) those that have incurred the death of patients or that may be a Grade II medical accident of above; | | （一）导致患者死亡或者可能为二级以上的医疗事故； |
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| (2) those that have incurred personal injury to three persons or more; | | （二）导致３人以上人身损害后果； |
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| (3) other circumstances as provided by the department under the State Council in charge of health or the administrative department of health under the people's government of the provinces, autonomous regions or municipalities directly under the Central Government. | | （三）国务院卫生行政部门和省、自治区、直辖市人民政府卫生行政部门规定的其他情形。 |
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| Article 15 In case any negligent medical act occurs or is found, the medical institution and the medical workers thereof shall take immediate and effective measures so as to avoid or mitigate the injuries done to the body of the patients and to prevent the deterioration of the injuries. | | 第十五条 发生或者发现医疗过失行为，医疗机构及其医务人员应当立即采取有效措施，避免或者减轻对患者身体健康的损害，防止损害扩大。 |
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| Article 16 In case any medical treatment dispute arises, the minutes of discussing deaths, minutes of discussing difficult and complicated cases, the records of looking over wards by doctors at higher levels, opinions of consultations, and the records of the course of diseases shall be sealed and opened when both parties to the dispute are present at the scene. The case history materials that are sealed may be photocopies, and shall be kept by the medical institution concerned. | | 第十六条 发生医疗事故争议时，死亡病例讨论记录、疑难病例讨论记录、上级医师查房记录、会诊意见、病程记录应当在医患双方在场的情况下封存和启封。封存的病历资料可以是复印件，由医疗机构保管。 |
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| Article 17 In case unfavorable consequences seem to be caused by fluid infusion, blood transfusion, injection, medicines, etc., both parties to the dispute shall seal up and open the material objects jointly at the scene, and the material objects shall be kept by the medical institution concerned. Where any test is needed, the test shall be done by the eligible testing institution that has been jointly designated by both parties. If both parties cannot make a joint designation, the administrative department of health shall designate the testing institution. | | 第十七条 疑似输液、输血、注射、药物等引起不良后果的，医患双方应当共同对现场实物进行封存和启封，封存的现场实物由医疗机构保管；需要检验的，应当由双方共同指定的、依法具有检验资格的检验机构进行检验；双方无法共同指定时，由卫生行政部门指定。 |
In case unfavorable consequences seem to be caused by blood transfusion and the blood needs to be sealed up for keeping, the medical institution shall inform the blood collecting and providing institution that has provided the blood to be present at the scene. | |
疑似输血引起不良后果，需要对血液进行封存保留的，医疗机构应当通知提供该血液的采供血机构派员到场。 |
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| Article 18 Where any patient dies, and both the medical institution and the relatives of the patient cannot determine the cause or they have different ideas about the cause, an autopsy shall be made within 48 hours after the patient dies. Where there are facilities for freezing the corpse, the time limit may be extended to seven days. The autopsy shall be subject to the consent of the close relative of the patient by way of affixing his or her signature. | | 第十八条 患者死亡，医患双方当事人不能确定死因或者对死因有异议的，应当在患者死亡后４８小时内进行尸检；具备尸体冻存条件的，可以延长至７日。尸检应当经死者近亲属同意并签字。 |
The autopsy shall be done by the institution that has obtained corresponding qualifications according to the relevant provisions of the State and the professionals majoring in pathological anatomy. The institution and professionals of pathological anatomy that make the autopsy shall be under the obligation of making autopsies. | |
尸检应当由按照国家有关规定取得相应资格的机构和病理解剖专业技术人员进行。承担尸检任务的机构和病理解剖专业技术人员有进行尸检的义务。 |
Both parties to a medical dispute may invite legal medical experts and pathological experts to participate in the autopsy; they may also delegate persons to observe the process of autopsy. Any one who refuses to make or delays the autopsy until the time limit expires and the determination of the cause of death is affected, the party that refuses or delays shall be held to be responsible. | |
医疗事故争议双方当事人可以请法医病理学人员参加尸检，也可以委派代表观察尸检过程。拒绝或者拖延尸检，超过规定时间，影响对死因判定的，由拒绝或者拖延的一方承担责任。 |
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| Article 19 If the patient dies within the medical institution, the corpse thereof shall be removed to the mortuary. As a general rule, the corpse may not be kept in the mortuary for more than two weeks. In case the corpse fails to be handled within the time limit, the medical institution shall, after obtaining the approval of the local administrative department of health and reporting to the department of public security at the same level for archivist purposes, handle the corpse according to relevant provisions. | | 第十九条 患者在医疗机构内死亡的，尸体应当立即移放太平间。死者尸体存放时间一般不得超过２周。逾期不处理的尸体，经医疗机构所在地卫生行政部门批准，并报经同级公安部门备案后，由医疗机构按照规定进行处理。 |
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| Chapter III Technical Authentication of Medical Accidents | | 第三章 医疗事故的技术鉴定 |
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| Article 20 Where the administrative department of health receives the report of any medical institution about any serious negligent medical acts or the application of the party to any medical dispute for handling and finds it necessary to make a technical authentication of the medical accident, it shall have the authentication done by the societies of medical sciences that are in charge of authenticating medical disputes. Where both parties agree to settle the medical dispute through mediation and a technical authentication is needed, the authentication shall be done by the society of medical sciences in charge upon the joint entrustment of both parties. | | 第二十条 卫生行政部门接到医疗机构关于重大医疗过失行为的报告或者医疗事故争议当事人要求处理医疗事故争议的申请后，对需要进行医疗事故技术鉴定的，应当交由负责医疗事故技术鉴定工作的医学会组织鉴定；医患双方协商解决医疗事故争议，需要进行医疗事故技术鉴定的，由双方当事人共同委托负责医疗事故技术鉴定工作的医学会组织鉴定。 |
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| Article 21 The local societies of medical sciences of the cities with districts and the local societies of medical sciences of the counties or cities that are under the direct jurisdiction of the provinces, autonomous regions or municipalities directly under the Central Government shall be responsible for making the initial authentication of medical accidents. The societies of medical sciences of the provinces, autonomous regions or municipalities directly under the Central Government shall be responsible for further authentications. | | 第二十一条 设区的市级地方医学会和省、自治区、直辖市直接管辖的县（市）地方医学会负责组织首次医疗事故技术鉴定工作。省、自治区、直辖市地方医学会负责组织再次鉴定工作。 |
Where it is necessary, the All-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。 |
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| Article 22 In case any party refuses to accept the conclusion of the initial authentication of medical accidents, 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 当事人对首次医疗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１５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。 |
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| Article 23 The societies 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。 |
The database of experts shall consist of medical professionals that satisfy the following conditions: | |
专家库由具备下列条件的医疗卫生专业技术人员组成： |
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| (1) Having good professional knowledge and being of excellent professional ethics; | | （一）有良好的业务素质和执业品德； |
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| (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 medical 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 database of experts. | |
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库。 |
The societies of medical sciences that are responsible for organizing authentications of medical disputes may invite medical professionals and legal medical expert to be included in the expert databases without consideration of administrative jurisdictions. | |
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。 |
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| Article 24 Technical authentications of medical disputes shall be done by expert authentication groups organized by the societies of medical sciences that are responsible for organizing technical authentications of medical accidents. | | 第二十四条 医疗事故技术鉴定，由负责组织医疗事故技术鉴定工作的医学会组织专家鉴定组进行。 |
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 from 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 expert databases set up by other societies of medical sciences to participate in the authentication or to provide consultation services by mail. | |
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。 |
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 included in the databases of experts and to undertake technical authentications of medical accidents. | |
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，并承担医疗事故技术鉴定工作。 |
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| 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 general 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 experts. | | 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。 |
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| 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 专家鉴定组成员有下列情形之一的，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： |
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| (1) Being a party or a close relative of the party to the medical dispute; | | （一）是医疗事故争议当事人或者当事人的近亲属的； |
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(2) Having interests in the medical dispute;
．．．．．． | | （二）与医疗事故争议有利害关系的；
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