8.249611E-02转载请声明出处2正2方2翻2译2网.2143458
上海市医疗机构管理办法（2002年修正）
Procedures of Shanghai Municipality on Administration Over Medical Institutions
上海市人民政府令第39号 颁布日期：19970302 实施日期：19970701 颁布单位：上海市人民政府
(Promulgated by Decree No. 39 of the Shanghai Municipal People''s Government on March 2, 1997)
第一章总则
Chapter I General Provisions
第一条（目的和依据）
Article 1 (Purpose and Basis)
为了加强医疗机构的管理，合理配置医疗资源，促进医疗卫生事业发展，保障公民健康，根据《医疗机构管理条例》的规定，结合本市实际情况，制定本办法。
For the purpose of strengthening the administration of medical institutions, rationally disposing medical resources, promoting the development of medical and public health services and ensuring citizens'' health; the present Procedures are formulated in accordance with the Regulations on Administration of Medical Institutions and in combination with the actual circumstances in Shanghai.
第二条（医疗机构的含义）
Article 2 (Implication of Medical Institutions)
本办法所称的医疗机构，是指从事医疗执业活动的医院、疗养院、妇幼保健院（所）、疾病防治院（所）、门诊部、诊所、护理院（站）、卫生所（站、室）、医务室、保健所、医疗急救中心（站）、临床检验中心等。
Medical institutions termed in the present Procedures refer to hospitals, sanatorium, women and children care center (station), disease prevention and cure center (station), out-patient department, clinic, nursing center (station), health center (station, post), medical room, health-care station, medical first-aid center (station), clinical laboratory, etc. which are engaged in medical business activities.
前款所称的医院，包括综合医院、中医医院、中西医结合医院、专科医院、康复医院、地段医院、乡（镇）卫生院。
The above mentioned hospitals include general hospital, hospital of traditional Chinese medicine, hospital which combines traditional Chinese medicine with Western medicine, special hospital, convalescence hospital, regional hospital and township (town) health hospital.
第三条（适用范围）
Article 3 (Scope of Application)
本办法适用于本市行政区域内医疗机构的设置、执业许可、医疗执业活动及其监督管理。
The present Procedures are applicable to the supervision and administration of medical institutions as well as their establishment, practice license and medical practising activities in the administrative areas of Shanghai.
第四条（管理部门）市卫生行政部门负责本市医疗机构的监督管理工作。区、县卫生行政部门负责本辖区内医疗机构的监督管理工作。
Article 4 (Administrative Authorities) The Municipal Public Health Administrative Department shall be responsible for the supervision and administration of municipal medical institutions while District (Country) Public Health Administrative Department shall be responsible for the supervision and administration of medical institutions within its jurisdiction.
卫生行政部门设立医疗执业监督员。医疗执业监督员承担医疗机构执业的监督管理工作。
Every public health administrative department shall nominate medical practice supervisors who shall undertake the supervisory and administrative work of medical practice of medical institutions.
公安、工商、规划、计划、物价等行政管理部门应当按照各自职责，协同卫生行政部门做好医疗执业活动的监督管理工作。
The administration departments of public security, of industry and commerce, programming, planning, and price control, and etc. shall help the Public Health Administrative Department to do a good job of supervision and administration over medical practising activities according to their respective duties.
第五条（职业宗旨和法律保护）
Article 5 (Professional Aim and Legal Protection)
医疗执业活动的宗旨是救死扶伤、防病治病，为公民健康提供服务。
The aim of medical practising activities is to heal the wounded and rescue the dying, to prevent and cure diseases and to render services for citizens'' health.
依法设置医疗机构和从事医疗执业活动，受法律保护。
Medical institutions established according to law and legal medical practising activities are all protected by law.
第六条（许可证制度）
Article 6 (The Practice License System)
本市对医疗机构实行执业许可证制度。
The practice license system is adopted in Shanghai for medical institutions.
未经许可，任何单位和个人不得从事医疗执业活动。
Any unit or individual person shall not be engaged in medical practising activities without getting a practice license.
第七条（医疗机构评审制度）
Article 7 (The Appraisal and Examination System for Medical Institutions)
各级卫生行政部门负责组织专家成立医疗机构评审委员会，评审委员会负责对医疗机构的执业情况进行评审。
Public Health Administrative Department at various levels shall be responsible for organizing experts to set up the appraisal committee for medical institutions. The appraisal committee shall take charge of the appraisal of the practising activities of medical institutions.
评审结论应当作为《医疗机构执业许可证》校验的重要依据之一。
The result of the appraisal shall be one of the important criteria for examining the "Practice License of Medical Institution".
医疗机构评审工作依照《医疗机构评审办法》的有关规定进行。
The appraisal and examination work of medical institutions shall be conducted according to the "Appraisal and Examination Rules for Medical Institutions".
第二章设置审批
Chapter II The Examination & Approval Procedures for the Establishment of Medical Institutions
第八条（设置规划）
Article 8 (The Establishment Planning)
市卫生行政部门应当根据国家医疗机构设置规划的指导原则，结合本市实际情况，编制本市医疗机构设置规划，经市规划管理部门综合平衡后，报市人民政府批准，并由市人民政府将该规划纳入全市卫生发展规划和城市总体规划。
The Municipal Public Health Administrative Department shall, under the guiding principle of the State Program of the Establishment of Medical Institutions and in combination with the actual circumstances in Shanghai, work out the Municipal Program for the Establishment of Medical Institutions which shall, after being comprehensively balanced by the Municipal Program Administrative Department, be submitted to Municipal People''s Government for approval, and then be incorporated into the Municipal Public Health Development Program and the Overall Urban Development Program.
区、县卫生行政部门应当依据本市医疗机构设置规划和本区、县的实际情况，会同规划管理部门编制本区、县医疗机构设置规划，经市卫生行政部门审核同意后，报区、县人民政府批准，并由区、县人民政府将该规划纳入本区、县卫生发展规划和地区详细规划。
District or County Public Health Administrative Department shall, according to the Municipal Program of the Establishment of Medical Institutions and in combination with its own actual circumstances, together with its Program Department, work out its own Program of the Establishment of Medical Institutions which shall, after being examined, verified, and approved by the Municipal Public Health Administrative Department, be submitted to the District or County People''s Government for approval, and then be incorporated into the District or County Public Health Development Program and the regional Detailed Program by the District or County People''s Government.
第九条（设置申请）
Article 9 (Application for Establishment)
设置医疗机构，应当向卫生行政部门提出申请，经卫生行政部门批准后，向其他部门办理有关手续。
For the establishment of a medical institution, an application must be submitted to the Public Health Administrative Department for approval. After being approved, the formalities for establishing the medical institution shall be handled with other authorities.
第十条（设置条件）
Article 10 (Requirements for the Establishment)
申请设置医疗机构，应当具备下列条件：
The application for the establishment of a medical institution shall meet the following requirements:
（一）符合本市医疗机构设置规划；
1. In conformity to the Municipal Program of the Establishment of Medical Institutions;
（二）符合国家规定的医疗机构基本标准；
2. In conformity to the Basic Standards for Medical Institutions stipulated by the State;
（三）有合适的场所；
3. With a suitable premise for establishing the medical institution; and
（四）有必要的资金。
4. With necessary fund.
第十一条（个体诊所、个体护理站的设置条件）
Article 11 (Requirements for the Establishment of a Private Clinic or a Private Nursing Station)
申请设置个体（包括合伙，下同）诊所或者个体护理站，除应当具备本办法第十条第二项至第四项规定的条件外，还应当同时具备下列条件：
In addition to the requirements stipulated in Item 2 of Article 10 to Item 4 of Article 10 in the present Procedures, the applicant for the establishment of a private clinic (including partnership. The same below) or a private nursing station shall also meet the following requirements at the same time:
（一）具有本市常住户口；
1. With permanent residential registration in Shanghai;
（二）根据申请执业范围取得相应的医师或者护士执业资格后，从事同一专业临床工作5年以上；
2. With the professional qualifications as a doctor or nurse in conformity with the practising scope applied for and a clinical experience of five years or more in the same profession; and
（三）非在职人员。
3. Non-in-service employee(s).
第十二条（申请限制条件）
Article 12 (Restrictive Terms for Application)
不能独立承担民事责任的组织，不得申请设置医疗机构。
Any organization, which is unable to bear civil liability independently, can not apply for the establishment of a medical institution.
有下列情形之一的人员，不得申请设置医疗机构：
No person in any one of the following cases is permitted to apply for the establishment of a medical institution:
（一）无民事行为能力或者限制民事行为能力的人员；
1. The person who is incapable of, or with restricted capacity of, doing a civil act;
（二）正在服刑或者劳动教养的人员；
2. The person who is serving a sentence liability or receiving reeducation through labour;
（三）在职人员；
3. In-service employee(s);
（四）发生二级以上医疗事故未满5年的直接责任人员；
4. The person who bears direct liability for a medical accident of Class II or above, which has not yet been five years;
（五）被吊销执业证书的医务人员；
5. The medical person whose certificate of practice is revoked;
（六）被吊销《医疗机构执业许可证》未满5年的医疗机构的原法定代表人或者主要负责人；
6. The original legal representative or the principal of a medical institution whose "Practice License of Medical Institution"has been revoked for less than five years;
（七）患传染病未愈或者其他健康原因不宜从事医疗执业活动的人员；
7. The person who is still suffering from an infections disease or other health problem, thus being unsuitable to be engaged in medical practising activities;
（八）被国家机关开除公职或者被医疗机构解除聘用合同未满5年的人员。
or 8. The person who has been dismissed from public office by the State organs or whose employment contract has been discharged by a medical institution for less than five years.
第十三条（申请材料的提交）
Article 13 (Application Documents to Be Submitted)
申请设置医疗机构，应当提交下列材料，但申请设置个体诊所或者个体护理站除外：
The following documents shall be submitted on application for the establishment of a medical institution, except for the application for establishing a private clinic or a private nursing station:
（一）设置申请书；
1. An application for establishment;
（二）选址报告和建筑设计平面图；
2. Site selection report and the drawings of architectural design;
（三）可行性研究报告；
3. The feasibility study report;
（四）设置申请人的资信证明；
4. The certificate of credit standing and respectability of the establishment applicant; and
（五）设置申请人的基本情况证明。
5. The certificate of the basic condition of the establishment applicant.
第十四条（申请设置个体诊所、个体护理站应当提交的材料）
Article 14 (Application Documents to Be Submitted for the Establishment of A Private Clinic or A Private Nursing Station)
申请设置个体诊所或者个体护理站，应当提交下列材料：
The following documents shall be submitted on application for the establishment of a private clinic or a private nursing station:
（一）设置申请书；
1. An application for establishment;
（二）房屋产权证明或者使用权证明；
2. The certificate of house property right or the certificate of house use rights; and
（三）设置申请人具备本办法第十条规定条件的相关证明。
3. All of the related certificates which fully prove that the establishment applicant meets the requirements stipulated in Article 10 of the present Procedures.
第十五条（医疗机构的分级）
Article 15 (Grading of Medical Institutions)
根据国家医疗机构基本标准的分级规定，本市医院（除康复医院外）、妇幼保健院（所）、疾病防治院（所）分为三级、二级和一级3个等级。
According to the national basic standards for grading medical institutions, hospitals (except convalescence hospital), women and children care center (station), and disease prevention and cure center (station) in Shanghai shall be graded into three grades-Grade III, Grade II and Grade I.
第十六条（设置审批权限）设置下列医疗机构，应当向市卫生行政部门提出申请：
Article 16 (Competence for Examining and Approving the Establishment) For the establishment of the following medical institutions, an application shall be submitted to the Municipal Public Health Administrative Department:
（一）三级医院、二级医院、康复医院；
1. Grade-III hospital, Grade-II hospital and convalescence hospital;
（二）疗养院、妇幼保健院（所）、疾病防治院（所）；
2. Sanatorium, women and children care center (station) and disease prevention and cure center (station);
（三）医疗急救中心（站）；
3. Medical first-aid center (station);
（四）临床检验中心；
4. Clinical laboratory; and
（五）市卫生行政部门规定的其他医疗机构。
5. Other medical institutions stipulated by the Municipal Public Health Administrative Department.
设置下列医疗机构，应当向设置地的区、县卫生行政部门提出申请：
For the establishment of the following medical institutions, an application shall be submitted to the District or County Public Health Administrative Department in the locality where the medical institution will be established:
（一）一级医院；
(1) Grade-I hospital;
（二）门诊部；
(2) Out-patient department;
（三）诊所；
(3) Clinic;
（四）护理院（站）；
(4) Nursing center (station); and
（五）卫生所（站、室）、保健所。
(5) Health center (station, post) and health-care station.
第十七条（设置审批原则和审批程序）
Article 17 (Principle and Procedure for Examining and Approving the Establishment)
卫生行政部门应当根据医疗机构设置规划、国家规定的医疗机构基本标准和本办法的有关规定，审批医疗机构的设置申请。
The Public Health Administrative Department shall, according to the Medical Institutions Establishment Program, the Basic Standard for Medical Institution stipulated by the State, and the related provisions of the present Procedures, examine and approve the application for establishing a medical institution.
卫生行政部门应当自收到医疗机构设置申请人提交的全部材料之日起30日内进行审查。对符合条件的，批准设置并发给《设置医疗机构批准书》；对不符合条件的，应当书面告知设置申请人。
The Public Health Administrative Department shall examine the application within 30 days after receipt of all the materials submitted by the applicant for establishing of a medical institution. The Public Health Administrative Department shall approve and issue an Approval Certificate for the Establishment of Medical Institution to the applicant if the application meets the requirements; or inform the applicant in writing if the application does not meet the requirements.
区、县卫生行政部门在核发《设置医疗机构批准书》之前，应当告知设置申请人向市卫生行政部门申请办理医疗机构名称核准手续，市卫生行政部门应当自收到核准名称的书面申请之日起10日内作出书面答复。核准名称期间，设置审批程序中止。
Before examining and issuing the Approval Certificate for the Establishment of Medical Institution, the District or County Public Health Administrative Department shall inform the applicant of going through the formalities for the Name Ratification of the medical institution with the Municipal Public Health Administrative Department; and the Municipal Public Health Administrative Department shall reply in writing within 10 days after receiving the written application for the Name Ratification. During the Name Ratification period, the procedure of examination and approval of the establishment shall be suspended.
区、县卫生行政部门应当自核发《设置医疗机构批准书》之日起15日内，报市卫生行政部门备案。对区、县卫生行政部门作出的不符合本办法规定的审批决定，市卫生行政部门有权纠正或者撤销。
The District or County Public Health Administrative Department shall submit the Approval Certificate for the Establishment of Medical Institution to the Municipal Public Health Administrative Department for record within 15 days after its issuance. The Municipal Public Health Administrative Department has the right to rectify or cancel the approval decision made by the District or County Public Health Administrative Department which does not conform to the stipulations of the present Procedures.
第十八条（批准书有效期）
Article 18 (The Validity Period of the Approval Certificate)
根据医疗机构的不同类别，《设置医疗机构批准书》的有效期限分别如下：
According to the different grades of medical institutions, the validity period of the "Approval Certificate for the Establishment of Medical Institution"shall respectively be as follows:
（一）医院、疗养院、妇幼保健院（所）、疾病防治院（所）、医疗急救中心、临床检验中心为２年；
1. Two years for hospitals, sanatorium, women and children care center (station), disease prevention and cure center (station), medical first-aid center and clinical laboratory;
（二）门诊部、医疗急救站、护理院为１年；
2. One year for outpatient department, medical first-aid station and nursing center; and
（三）诊所、护理站、卫生所（站、室）、保健所为6个月。
3. Six months for clinic, nursing station, health center (station, post), and health-care station.
第十九条（变更、重新设置审批和分支机构的审批）
Article 19 (Procedure for Examining and Approving the Alteration, Re-establishment, and for Examining and Approving the Establishment of Branches)
医疗机构执业登记前，其经核准的名称、诊疗科目发生变更的，应当申请办理变更审批手续。
Before the registration of practice of a medical institution, if the ratified name or medical subjects of diagnosis and treatment are changed, the institution shall apply for examination and approval for the change.
医疗机构执业登记前，其经核准的类别、床位、地点、设置申请人发生变更的，应当重新申请办理设置审批手续。
Before the registration of practice of a medical institution, if the ratified classification, number of sickbeds, address, or the establishment applicant is changed, the institution shall reapply for the establishment examination and approval.
医疗机构设置分支机构的，应当向原设置审批的卫生行政部门申请办理审批手续；
If a medical institution intends to establish a branch, it shall apply for examination and approval with the original Public Health Administrative Department which has examined and approved the establishment of the medical institution.
分支机构不在医疗机构所属的区、县内的，应当征得分支机构所在地的区、县卫生行政部门同意。
If the branch is not established in the district or county where the medical institution is located, the establishment of the branch shall obtain the consent from the District or County Public Health Administrative Department in the locality where the branch shall be established.
第二十条（建筑设计）
Article 20 (Architectural Design)
医疗机构的建筑设计，应当符合国家规定的医疗机构建筑规范、医疗机构设计标准以及国家其他有关规定和标准；设计方案、扩初设计经原设置审批的卫生行政部门审查同意，并取得规划部门核发的《建设工程规划许可证》后，方可施工。
The architectural design of medical institutions shall conform to the architectural specification, design standards and other relevant stipulations and standards for medical institutions stipulated by the State. The architectural project of medical institutions shall not be constructed until the design scheme and initial extension design are examined and approved by the original Public Health Administrative Department which has examined and approved the establishment of the medical institution and the "Planning Permit of the Construction Project"is issued by the Planning Department.
第三章执业登记
Chapter III Practice Registration
第二十一条（申请登记手续）
Article 21 (Process of Application for the Registration)
医疗机构从事医疗执业活动前，应当向原设置审批的卫生行政部门申请办理执业登记手续，领取《医疗机构执业许可证》。
Before being engaged in medical practising activities, a medical institution shall apply to the original Public Health Administrative Department which has examined and approved the establishment of the medical institution for the practice registration, and obtain the "Practice License of Medical Institution".
第二十二条（申请登记的条件）医疗机构申请办理执业登记手续，应当具备下列条件：
Article 22 (Requirements for the Registration Application) A medical institution shall meet the following requirements on application for the practice registration:
（一）有《设置医疗机构批准书》；
1. With the "Approval Certificate for the Establishment of Medical Institution";
（二）符合国家规定的医疗机构基本标准；
2. In conformity to the Basic Standards for Medical Institutions stipulated by the State;
（三）有符合规定的组织机构；
3. With an organizational structure conforming to the related stipulations;
（四）有与所开展的业务相适应并符合规定的资金、仪器设备、卫生技术人员以及通讯、供电、上下水道等必要设施；
4. With necessary fund, instruments and equipments, medical technical personnel and necessary facilities for communication, power supply, water supply and sewers, etc. to carry out its practice as well as to meet the prescribed requirements;
（五）有相应的规章制度；
5. With relevant rules and regulations; and
（六）能够独立承担民事责任。
6. Capable of undertaking civil liability independently.
第二十三条（申请登记应当提交的材料）
Article 23 (Materials to be Submitted with the Application for Registration)
医疗机构申请办理执业登记手续，应当提交下列材料：
A medical institution shall submit the following materials on application for the practice registration:
（一）《医疗机构申请执业登记注册书》；
1. "The Practice Registration Application for the Medical Institution";
（二）《设置医疗机构批准书》；
2. "The Approval Certificate for the Establishment of Medical Institution";
（三）房屋产权证明或者使用证明；
3. The certificate of house property right or the certificate of house use right;
（四）验资证明；
4. The fund verification certificate;
（五）医疗机构建筑设计平面图；
5. The drawing of the architectural design of the medical institution;
（六）医疗机构规章制度；
6. The rules and regulations of the medical institution; and
（七）医疗机构法定代表人或者主要负责人姓名及其资格证书或者执业证书。
7. The name and certificate of qualification or certificate of practice of the legal representative or the principal person in charge of the medical institution.
除前款规定外，新建、改建或者扩建的医疗机构，应当提交竣工验收的批准文件；
In addition to the above stipulations, the newly built or rebuilt or extended medical institution shall also submit the approval document of the project completion inspection.
共同设置的医疗机构，应当提交有关合同书或者协议书；诊所、护理站、卫生所（站、室）和保健所，应当提交卫生技术人员名单及其资格证书或者执业证书。
For the jointly established medical institution, the relevant contract or agreement shall be submitted. For a clinic, nursing station, health center (station, post) or healthcare station, it shall also submit the list of medical technical personnel and their certificates of qualification or their certificates of practice.
第二十四条（执业登记的审批）
Article 24 (Examination and Approval of the Practice Registration)
卫生行政部门应当自收到医疗机构执业登记申请人提交的全部材料之日起45日内进行审查核实。
The Public Health Administrative Department shall examine and verify the application for the practice registration within 45 days after receipt of all the materials submitted by the applicant for practice registration of the medical institution.
对符合条件的，予以登记并发给《医疗机构执业许可证》；对不符合条件的，应当书面告知执业登记申请人。
The Administrative Department shall approve the registration and issue the "Practice License of Medical Institution", if the application meets the requirements; if not, the Administrative Department shall inform the practice registration applicant in writing.
第二十五条（变更登记）
Article 25 (Alteration Registration)
医疗机构执业登记后，其经核准的名称、法定代表人或者主要负责人、诊疗科目、床位、类别、级别、地点、服务方式、服务对象发生变更的，应当向原执业登记的卫生行政部门申请办理变更登记手续。
After the practice registration of a medical institution, if the ratified name, the legal representative or the principal person in charge, medical subjects of diagnosis and treatment, number of sickbeds, classification, grade, address, mode of service or service target is changed, the medical institution shall apply for the alteration registration with the original Public Health Administrative Department which has approved its practice registration.
8.249611E-02转载请声明出处2正2方2翻2译2网.2143458 |
