AsianLII [Home] [Databases] [WorldLII] [Search] [Feedback]

Laws of the Shanghai Province

You are here:  AsianLII >> Databases >> Laws of the Shanghai Province >> Procedures of Shanghai Municipality on Administration Over Medical Institutions

[Database Search] [Name Search] [Noteup] [Help]

Procedures of Shanghai Municipality on Administration Over Medical Institutions

Procedures of Shanghai Municipality on Administration Over Medical Institutions
 
(Promulgated on March 2, 1997 by Decree No. 39 of the Shanghai Municipal People's Government)
    
     Chapter I General Provisions
     Article 1 (Purpose and Basis)
     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.
     Article 2 (Implication of Medical Institutions)
     Medical institutions termed in the present Procedures refer to hospitals, sanatorium, women and children care center (station), disease prevention and cure center (station), outª²patient department, clinic, nursing center (station), health center (station, post), medical room, healthª²care station, medical first-aid center (station), clinical laboratory, etc. which are engaged in medical business activities.
     The aboveª²mentioned 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.
     Article 3 (Scope of Application)
     The present Procedures are applicable to the supervision and administration of medical institutions as well as their establishment, practice license and medical practicing activities in the administrative areas of Shanghai.
     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.
     Every public health administrative department shall nominate medical practice supervisors who shall undertake the supervisory and administrative work of medical practice of medical institutions.
     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.
     Article 5 (Professional Aim and Legal Protection)
     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. Medical institutions established according to law and legal medical practising activities are all protected by law.
     Article 6 (The Practice License System)
     The practice license system is adopted in Shanghai for medical institutions. Any unit or individual person shall not be engaged in medical practising activities without getting a practice license.
     Article 7 (The Appraisal and Examination System for Medical Institutions)
     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. The result of the appraisal shall be one of the important criteria for examining the " Practice License of Medical Institution" .
     The appraisal and examination work of medical institutions shall be conducted according to the " Appraisal and Examination Rules for Medical Institutions" .
    
     Chapter II The Examination & Approval Procedures for the Establishment of Medical Institutions
     Article 8 (The Establishment Planning)
     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.
     District (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 (County) People's Government for approval, and then be incorporated into the District (County) Public Health Development Program and the regional Detailed Program by the District (County) People's Government.
     Article 9 (Application for Establishment)
     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.
     Article 10 (Requirements for the Establishment)
     The application for the establishment of a medical institution shall meet the following requirements:
     (1) In conformity to the Municipal Program of the Establishment of Medical Institutions;
     (2) In conformity to the Basic Standards for Medical Institutions stipulated by the State;
     (3) With a suitable premise for establishing the medical institution; and
     (4) With necessary fund.
     Article 11 (Requirements for the Establishment of a Private Clinic or a Private Nursing Station)
     In addition to the requirements stipulated in Article 10 (2) to Article 10 (4) 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:
     (1) With permanent residential registration in Shanghai;
     (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
     (3) Nonª²inª²service employee(s).
     Article 12 (Restrictive Terms for Application)
     Any organization, which is unable to bear civil liability independently, can not apply for the establishment of a medical institution.
     No person in any one of the following cases is permitted to apply for the establishment of a medical institution:
     (1) The person who is incapable of, or with restricted capacity of, doing a civil act;
     (2) The person who is serving a sentence liability or receiving reeducation through labour;
     (3) Inª²service employee(s);
     (4) The person who bears direct liability for a medical accident of Class II or above, which has not yet been five years;
     (5) The medical person whose certificate of practice is revoked;
     (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;
     (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; 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.
     Article 13 (Application Documents to Be Submitted)
     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:
     (1) An application for establishment;
     (2) Site selection report and the drawings of architectural design;
     (3) The feasibility study report;
     (4) The certificate of credit standing and respectability of the establishment applicant; and
     (5) The certificate of the basic condition of the establishment applicant.
     Article 14 (Application Documents to Be Submitted for the Establishment of A Private Clinic or A Private Nursing Station)
     The following documents shall be submitted on application for the establishment of a private clinic or a private nursing station:
     (1) An application for establishment;
     (2) The certificate of house property right or the certificate of house use rights; and
     (3) All of the related certificates which fully prove that the establishment applicant meets the requirements stipulated in Article 10 of the present Procedures.
     Article 15 (Grading of Medical Institutions)
     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.
     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:
     (1) Gradeª²III hospital, Gradeª²II hospital and convalescence hospital;
     (2) Sanatorium, women and children care center (station) and disease prevention and cure center (station);
     (3) Medical first-aid center (station);
     (4) Clinical laboratory; and
     (5) Other medical institutions stipulated by the Municipal Public Health Administrative Department.
     For the establishment of the following medical institutions, an application shall be submitted to the District (County) Public Health Administrative Department in the locality where the medical institution will be established:
     (1) Gradeª²I hospital;
     (2) Outª²patient department;
     (3) Clinic;
     (4) Nursing center (station); and
     (5) Health center (station, post) and healthª²care station.
     Article 17 (Principle and Procedure for Examining and Approving the Establishment)
     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.
     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.
     Before examining and issuing the " Approval Certificate for the Establishment of Medical Institution" , the District (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.
     The District (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 (County) Public Health Administrative Department which does not conform to the stipulations of the present Procedures.
     Article 18 (The Validity Period of the Approval Certificate)
     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:
     (1) Two years for hospitals, sanatorium, women and children care center (station), disease prevention and cure center (station), medical firstª²aid center and clinical laboratory;
     (2) One year for outª²patient department, medical firstª²aid station and nursing center; and
     (3) Six months for clinic, nursing station, health center (station, post), and healthª²care station.
     Article 19 (Procedure for Examining and Approving the Alteration, Reª²establishment, and for Examining and Approving the Establishment of Branches)
     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.
     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 reª²apply for the establishment examination and approval.
     If a medical institution intends to establish a branch, it shall apply for examination and approval with the original Public Health Administrative Department that has examined and approved the establishment of the medical institution. 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 (County) Public Health Administrative Department in the locality where the branch shall be established.
     Article 20 (Architectural Design)
     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.
    
     Chapter III Practice Registration
     Article 21 (Process of Application for the Registration)
     Before being engaged in medical practising activities, a medical institution shall apply to the original Public Health Administrative Department that has examined and approved the establishment of the medical institution for the practice registration, and obtain the " Practice License of Medical Institution" .
     Article 22 (Requirements for the Registration Application)
     A medical institution shall meet the following requirements on application for the practice registration:
     (1) With the " Approval Certificate for the Establishment of Medical Institution" ;
     (2) In conformity to the Basic Standards for Medical Institutions stipulated by the State;
     (3) With an organizational structure conforming to the related stipulations;
     (4) With necessary fund, instruments and equipment, 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;
     (5) With relevant rules and regulations; and
     (6) Capable of undertaking civil liability independently.
     Article 23 (Materials to be Submitted with the Application for Registration)
     A medical institution shall submit the following materials on application for the practice registration:
     (1) " The Practice Registration Application for the Medical Institution" ;
     (2) " The Approval Certificate for the Establishment of Medical Institution" ;
     (3) The certificate of house property right or the certificate of house use right;
     (4) The fund verification certificate;
     (5) The drawing of the architectural design of the medical institution;
     (6) The rules and regulations of the medical institution; and
     (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.
     In addition to the above stipulations, the newlyª²built or rebuilt or extended medical institution shall also submit the approval document of the project completion inspection. For the jointlyª²established medical institution, the relevant contract or agreement shall be submitted. For a clinic, nursing station, health center (station, post) or healthª²care station, it shall also submit the list of medical technical personnel and their certificates of qualification or their certificates of practice.
     Article 24 (Examination and Approval of the Practice Registration)
     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. 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.
     Article 25 (Alteration Registration)
     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.
     Article 26 (The Prescribed Intervals for Examination of Practice License)
     The " Practice License of Medical Institution" shall be examined at the prescribed intervals:
     (1) Once every three years for hospitals, sanatorium, women and children care center (station), disease prevention and cure center (station), medical firstª²aid center and clinical laboratory; and
     (2) Once every year for the outª²patient department, medical firstª²aid station, nursing center (station), clinic, health center (station, post) and healthª²care station.
     Article 27 (Examination of Practice License)
     A medical institution shall apply to the original Public Health Administrative Department, which has approved the practice registration, for handling the examination procedures for the " Practice License of Medical Institution" three months before the expiration of the examination interval by presenting the original and copy of the " Practice License of Medical Institution" and the inspection and assessment results for the previous year issued by the Public Health Administrative Department or the appraisal conclusion issued by the Appraisal Committee for Medical Institutions. The Public Health Administrative Department shall finish the examination within 30 days after receipt of all the documents submitted by the medical institution for the examination application. In case the medical institution does not pass the examination, its " Practice License of Medical Institution" shall be revoked.
     Article 28 (Reporting of the Registration Name List)
     District (County) Public Health Administrative Department shall report the practice registration name list of medical institutions in this District (County) for the previous year to the Municipal Public Health Administrative Department by the end of January every year.
     Article 29 (Stipulations for Terminating or Suspending the Practising Activities)
     A medical institution which terminates its medical practising activities shall go through the cancellation procedures for the " Practice License of Medical Institution" with the original public health administrative department which has approved its practice registration. In the event of the cancellation or merger of a regional hospital or a township (town) health hospital, the cancellation procedures shall not be handled until the cancellation is ratified by the Municipal Public Health Administrative Department.
     If a medical institution intends to suspend its practice temporarily or partly due to extension, or reconstruction, or other causes, it shall apply for the practice suspension procedures in advance with the original Public Health Administrative Department which has approved its practice registration.
     Article 30 (Forbidden Acts Relating to the Practice License)
     The " Practice License of Medical Institution" is unifiedly printed by the State Public Health Administrative Department, any unit or individual person shall not forge, alter, lease, lend or transfer it.
    
     Chapter IV Administration of Practice
     Article 31 (Scope of Practice)
     The medical practising activities of a medical institution shall be performed within the scope of practice specified in the " Practice License of Medical Institution" .
     Article 32 (Principle of Practice)
     Medical institutions, which are engaged in medical practising activities, shall abide by relevant laws, rules and regulations as well as medical technical specification and norms for professional ethics.
     Medical institutions shall carry out all rules and regulations, exercise the post responsibility system for various medical persons at all levels, strengthen medical quality control and ensure medical safety and the quality of services according to the State and Municipal medical quality control requirement.
     Article 33 (Use of the Name of a Medical Institution)
     A medical institution engaged in medical practising activities shall use the name ratified by the Municipal Public Health Administrative Department.
     The name of a medical institution to be used in the seal of a medical institution, its bank account, signboard, bills, medicine bags, labels for pharmaceutical preparations, medical record card, prescription pad, examination application, examination report, and in medical documents such as certificate of health examination, certificate of disease, birth certificate, death certificate, etc. shall be identical with the ratified name. If there are two or more ratified names, the first name shall be used.
     Any unit or individual person shall not buy, sell, transfer or fraudulently use the bills, medicine bags, labels for pharmaceutical preparations, and medical documents such as medical record card, prescription pad, examination application, examination report, certificate of health examination, certificate of disease, birth certificate, death certificate, etc.
     The regulations on the name using control of medical institutions shall be separately formulated by the Municipal Public Health Administrative Department.
     Article 34 (The Display System)
     A medical institution shall display the " Practice License of Medical Institution" , medical subjects of diagnosis and treatment, service timetable, layª²out of medical departments and service charge list in the conspicuous places.
     A medical institution shall exercise the system that every worker, when working at his/her post shall bear an identification card marked with his/her work number and job.
     Article 35 (The System of Ambulatory Treatment, Emergency Treatment and Hospitalization)
     A medical institution shall, according to the ratified mode of services, execute the relevant system of ambulatory treatment, emergency treatment and hospitalization, and carry out the medical practising activities.
     If no exact diagnosis can be made by the same doctor for three times under ambulatory treatment, the medical institution shall arrange for the patient to further consult a doctor of higher rank. In case the disease still cannot be exactly diagnosed through further consultation, a group consultation shall be organized or the patient shall be transferred to other hospital for further diagnosis.
     A medical institution with sickbeds shall have regular doctors to take charge of diagnosing and treating diseases of inª²patients and emergency patients staying for observation, carry out the system of wardª²touring by doctors of higher rank and the nursing responsibility system at different levels, and strictly execute the onª²duty system and the shiftª²rotating system. For a patient whose disease cannot be exactly diagnosed, the medical institution shall organize, or transfer the patient to other hospitals, for further diagnosis.
     A medical institution with an emergency room shall practise the round-the-clock reception system.
     Article 36 (Treatment of Patients in Serious Case)
     A medical institution shall organize emergency treatment at once to the patient who is seriously ill, and according to the development of the case issue a notice of critical illness to the patient's family member in time; or to the patient's unit if the patient has no family member or it is impossible to notify the patient's family member.
     If the reception doctor is unable to diagnose and treat a patient in critical illness due to his/her limited technical level, the medical institution shall assign a doctor of higher rank in time to diagnose and treat the patient. If the reception department is unable to diagnose and treat a patient in critical illness, the medical institution shall organize a group consultation in time.
     If the critical illness of a patient cannot be diagnosed and treated due to the limited medical apparatus or technical conditions, the medical institution shall organize a group consultation in time or transfer the patient to other medical institution escorted by medical personnel through arrangements for further diagnosis and treatment in time. But no such transfer shall be made, if the patient may die on the way.
     Article 37 (Preconditions for Performing Special Diagnosis and Treatment)
     When a medical institution intends to perform a surgical operation, special examination, blood transfusion or special treatment; it shall obtain the consent from the patient as well as the consent and signature of his/her family member or relative. In the event that the patient's opinion can not be obtained, or it is unadvisable to tell the patient the truth due to the adopting of a protective medical measure, it is necessary to obtain the consent and signature of his/her family member or relative. If it is impossible to get the patient's opinion and there is no family member or relative of the patient available, or in other special circumstances, the doctor in charge shall put forward a medical treatment plan and carry it out after the plan is ratified by the principal person in charge of the medical institution or the authorized responsible person of the medical institution.
     Article 38 (Control of Iatrogenic Infection)
     A medical institution shall strictly execute the systems of report on infectious diseases, of aseptic disinfecting and of isolation. Simultaneously, it shall adopt effective measures to dispose of sewage and wastes, and to prevent and control pathogenic infection.
     Article 39 (Control of Medical Record Cards)
     A medical institution shall record the ambulatory treatment, emergency treatment and hospitalization of patients timely, accurately, completely and clearly, and shall not alter, damage or destroy medical record cards with the exception that such amendment is permitted according to stipulations made by State or the Municipal Public Health Administrative Department.
     Any unit or individual person shall not read or ask for a medical record card without permission of the medical institution; and shall not alter, damage or destroy a medical record card.
     A medical institution shall properly keep the medical record cards of patients. The storage period of medical record cards of outª²patients shall not be less than fifteen years, except those selfª²kept by patients themselves as stipulated. The storage period of medical record cards of emergency patients staying for observation shall not be less than one year. And the storage period of medical record cards of inª²patients shall not be less than thirty years.
     Article 40 (Issuance of Medical Certificates)
     A medical institution shall not issue a diagnosis letter of disease, a health certificate or a death certificate or other documents without actual diagnosis and examination by a doctor of the medical institution. Likewise, it shall not issue a birth certificate or a deadª²birth report, if no obstetrician or midwife of the medical institution has delivered the baby.
     In the event that a medical institution issues a death certificate to a person who has died of an unknown cause without being treated in the medical institution, the certificate only certifies the death but not any diagnosis upon the cause of the death. In the event that the party concerned demands a diagnosis upon the cause of death, the medical instruction shall appoint doctors to perform the autopsy and laboratory tests; and then a diagnosis of the death cause can be made.
     Article 41 (Protective Medical Measure)
     A medical institution shall respect the patient's right to know the truth of his/her disease. However, when it is unadvisable to directly tell a patient the truth of his/her disease because protective medical measure is taken, the medical institution shall inform his/her family member of the truth, or inform his/her unit if the patient has no family or if his/her family member is not available.
     Article 42 (The Report System for Medical Disputes)
     In case that any medical accident or major medical dispute occurs, the medical institution shall promptly report it to the higher competent department and the Municipal Public Health Administrative Department. Simultaneously, it shall properly keep the relevant medical record cards and data, which shall not be altered, forged, hidden or destroyed. All the things, which have caused harmful consequences through injection, medicineª²taking, infusion of fluid, blood transfusion and use of apparatus, shall be sealed up for safekeeping temporarily for onª²theª²spot examination.
     Article 43 (Restrictions on Medical Practising Activities)
     Nonª²medical institution shall not organize medical persons to carry out medical practising activities without approval by the Municipal Public Health Administrative Department.
     If a medical institution intends to organize public health technical persons to carry out medical practising activities in any places outside the institution, it shall obtain approval from the Public Health Administrative Department. The detailed content of control shall be separately worked out by the Municipal Public Health Administrative Department.
     Article 44 (Medical Fees)
     A medical institution shall charge medical fees according to the standards stipulated by the Municipal Public Health Administrative Department and Price Control Bureau, and shall provide corresponding receipts.
     Any unit or individual person shall not refuse to pay medical fees.
     Article 45 (Duties of Disease Prevention and Healthª²Care)
     A medical institution shall undertake the corresponding work of disease prevention and healthª²care, execute the disease report system stipulated by the Municipal Public Health Administrative Department and fulfill the tasks of aiding the rural areas and instructing the medical and public health work of grassª²roots units as entrusted by Public Health Administrative Department at various levels in Shanghai.
     In case any grave disastrous accident, epidemic disease or other unforeseen events occur, a medical institution and its workers shall obey the assignment given by the Public Health Administrative Department at various levels.
     Article 46 (Forbidden or Restricted Acts)
     Medical institutions and their workers shall not commit the following offences in their medical practising activities:
     (1) Finding an excuse to refuse patients, or soliciting patients by improper means;
     (2) Opening the internal medical institution of a unit to the public without approval of the Public Health Administrative Department;
     (3) Employing nonª²public health technical persons or nonª²registered public health technical persons to carry out medical practising activities;
     (4) Introducing new medical technology and new projects from abroad, or being engaged in such special technical services for motherª²child healthª²care, such as medical examination before marriage, diagnosis on hereditary diseases, prenatal diagnosis, artificial insemination, etc. without approval of the State or Municipal Public Health Administrative Department;
     (5) Being engaged in such special technical services for motherª²baby healthª²care as suspension of pregnancy, birthª²control operation, midwife technique, etc. without approval of District (County) Public Health Administrative Department;
     (6) A private clinic or private nursing station employing an inª²service public health technical person or storing up medicines;
     (7) Taking advantages of one's professional position to accept others' money or things, or to gain other improper interests;
     (8) Using fake, inferior, expired, inefficacious or eliminated medicines;
     (9) Using unlicensed disinfectants, disinfecting apparatus or nonª²reusable medical and sanitary articles; and
     (10) Revealing private secrets of a patient known through medical practising activities.
     Article 47 (Guarantee of Medical Working Order)
     Any unit or individual person shall not, with any reason or in any way, disturb the normal order of medical institution, infringe upon personal safety of medical persons, or damage property and things; shall not do superstitious activities or sacrificial rites in any form inside the medical institution; or shall not interfere in or hinder the normal disposal of the corpse by the medical institution.
     Article 48 (Disposal of the Corpse)
     A medical institution shall place the corpse of a patient in the mortuary in time. The time limit for the corpse to be stored in the mortuary is not more than 2 days from June through September, and not more than 3 days in any other month. A medical institution has the right to demand that the family member of the deceased must transport the corpse to the funeral house for cremation within the above-regulated time limit. For any corpse which is stored beyond the above regulated time limit in the mortuary, the medical institution may transport it to the funeral house for cremation instead with approval of the public security organs in the locality where the medical institution is located; and all the related expenses shall be borne by the family member of the deceased.
     The corpse of a patient, who has died of infectious disease or whose death cause is in dispute, shall be disposed of according to relevant stipulations of the State.
    
     Chapter V Legal Liabilities
     Article 49 (Penalties on Unauthorized Practice)
     If a medical institution violates the present Procedures by doing any one of the following acts, the Public Health Administrative Department shall order the medical institution to suspend its practising activities, confiscate its illegal gains, medicines and apparatus, and may also impose a fine of 4,000 yuan up to no more than 10,000 yuan upon the medical institution according to the seriousness of the wrongdoing:
     (1) Being engaged in medical practising activities without the " Practice License of Medical Institution" , or the license being revoked or canceled;
     (2) The medical institution organizing medical persons to carry out medical practising activities at places outside the medical institution without approval of the Public Health Administrative Department;
     (3) The internal medical institution of a unit being opened to the public without approval of the Public Health Administrative Department; or
     (4) The medical institution changing its name, classification, numbers of sickbeds and address without going through the alteration registration procedures.
     Article 50 (Penalties on Not Having the Inspection Within the Time Limit)
     If a medical institution violates the provisions of the present Procedures, i. e. remains being engaged in medical practising activities without having the required inspection of the " Practice License of Medical Institution" within the time limit, the Public Health Administrative Department shall order it to make up the inspection within 10 days; if the makeª²up inspection is still not done after the deadline, the Public Health Administrative Department shall circulate a notice of criticism and give the principal person in charge of the medical institution an administrative disciplinary punishment.
     Article 51 (Penalties on Selling, Lending or Transferring Practice License)
     If a medical institution sell, lend or transfer the " Practice License of Medical Institution" , or borrow or fraudulently use the name of other medical institution to carry out medical practising activities in violation of the present Procedures; the Public Health Administrative Department shall confiscate its illegal gains and may impose a fine of 2,000 yuan up to no more than 5,000 yuan upon the medical institution; and may revoke its " Practice License of Medical Institution" in serious case.
     Article 52 (Penalties on Acts beyond the Registered Scope)
     If a medical institution commits one of the following acts in violation of the present Procedures, the Public Health Administrative Department shall order it to make rectification within the prescribed time limit, and impose a fine of 1,000 yuan up to no more than 3,000 yuan upon it; and may revoke its " Practice License of Medical Institution" in serious case:
     (1) Changing its medical subjects of diagnosis and treatment or mode of services without approval of the Public Health Administrative Department;
     (2) Importing new medical technology or new medical project from abroad without approval of the Municipal Public Health Administrative Department; or
     (3) A private clinic or a private nursing station employing inª²service public health technical persons or storing up medicines.
     Article 53 (Penalties on Employing Persons Without the Qualification Certificate of Public Health Technique)
     If a medical institution employs persons without the qualification certificate of public health technique to carry out the medical and health technique work in violation of the present Procedures, the Public Health Administrative Department shall order it to make rectification within the prescribed time limit, and impose a fine of 3,000 yuan up to no more than 5,000 yuan upon it; and may revoke its " Practice License of Medical Institution" in serious case.
     Article 54 (Penalties on Issuing False Certificates)
     If a medical institution issues a false diagnosis report on disease, health certificate, death certificate, birth certificate or deadª²birth report in violation of the present Procedures, the Public Health Administrative Department shall give it a disciplinary warning, and may impose a fine of no more than 500 yuan upon it. If the case has caused a harmful consequence, a fine of 500 yuan up to no more than 1,000 yuan may be imposed upon it, and simultaneously the direct responsible person(s) shall be given an administrative disciplinary punishment by the unit or by the higher authorities.
     Article 55 (Procedures of Penalties)
     When the Public Health Administrative Department gives an administrative disciplinary punishment, it shall issue a " Decision on Administrative Disciplinary Punishment" . It shall also provide a penalty receipt unifiedly printed by the Municipal Finance Bureau when a fine or the confiscated money is collected.
     All the penalized and confiscated money shall be turned over to the State Treasury according to stipulations.
     Article 56 (Reconsideration and Administrative Litigation)
     A party concerned, which (or who) disagrees with the concert administrative acts of the Public Health Administrative Department, may apply for an administrative reconsideration or bring an administrative action according to the " Regulations on Administrative Reconsideration" or the " Administrative Litigation Law of the People's Republic of China" .
     In case the party concerned does not apply for a reconsideration or to bring an administrative action within the legal time limit; nor does it fulfill the specific administrative acts; the Public Health Administrative Department that has done the specific administrative acts may apply to the People's Court for enforcement in accordance with the " Administrative Litigation Law of the People's Republic of China" .
     Article 57 (Penalties on Interference With Public Function)
     In case the public health law enforcement persons are refused or hindered from performing in accordance with law their official duties, penalties shall be imposed according to the " Regulations of the People's Republic of China on Public Security Administration and Imposition of Punishment" if no violence or duress is used. Those whose act constitutes a crime shall be prosecuted for their criminal liability.
     Article 58 (Penalties on Hindrance Against Medical Working Order)
     Any unit or individual, which (or who) has disturbed the normal order of a medical institution, shall be penalized in accordance with the " Regulations of the People's Republic of China on Public Security Administration and Imposition of Punishment" . Those whose act is serious enough to constitute a crime shall be prosecuted for their criminal liability by the judicial organs.
     Article 59 (Penalties on the Liable Persons)
     The principal person in charge of a medical institution and the directly liable person in violation of the present Procedures shall be given an administrative disciplinary punishment by its higher competent department. If the case is serious enough to constitute a crime, criminal liability shall be investigated by the judicial organs according to law.
    
     Chapter VI Supplementary Provisions
     Article 60 (Retroactive Practice Registration)
     All the medical institutions, which have been approved by the Public Health Administrative Department to carry out medical practising activities before the implementation of the present Procedures, shall handle a retroactive practising registration within six months after the implementation of the present Procedures according to stipulations, and receive the " Practice License of Medical Institution" .
     Article 61 (Definition of Related Terms)
     Definition of the following terms in the present Procedures:
     " Medical practising activities" refers to all the activities for diagnosing and curing diseases, mitigating the illness and alleviating patients' sufferings, improving physical functions, prolonging human life and helping patients recover from their illness by means of different kinds of examination, medicines, medical apparatus application and surgical operation;
     " Mode of services" refers to ambulatory treatment, emergency treatment, hospitalization, home sickbeds, mobile medical treatment and other services;
     " Service targets" refers to sources of patients from society, from the unit the medical institution belongs to, or from abroad;
     " Special examination" and " Special treatment" refer to the diagnosis and treatment activities in any of the following cases;
     (1) The examination and treatment which have a certain danger and may result in harmful consequences;
     (2) The examination and treatment which may result in harmful consequences and danger to the patient with special physical constitution or suffering from critical illness; or
     (3) Experimental clinical examination and treatment.
     " Public health technical persons" refers to those who have obtained the qualification or title of public health technicians according to the relevant State stipulations;
     " Medical technical specification" refers to the standardization documents concerning the technical standards, rules of operation, etc. for medical practising activities; as formulated by the Ministry of Public Health, State Administration of Traditional Chinese Material Medic and the Municipal Public Health Administrative Department.
     Article 62 (Other Applications)
     The present Procedures shall also be applicable to any army medical institution which is opened to the public.
     The Procedures for the establishment and practice registration of the internal outª²patient department, clinic, health station (post) or medical room of a government body, enterprise and institution for the purpose of serving their own employees shall be separately formulated by the Municipal Public Health Administrative Department in accordance with the present Procedures.
     Article 63 (Organ to Interpret the Application)
     The Municipal Public Health Administrative Department is responsible for the interpretation of specific problems in application of the present Procedures.
     Article 64 (Special Stipulations)
     The establishment of and administration of medical institutions of Sino-foreign joint ventures, Sino-foreign cooperative ventures, and solelyª²foreignª²owned enterprises shall be conducted in compliance with related State stipulations.
     Article 65 (Implementation and Annulment)
     The present Procedures shall become effective on July 1,1997.
     " The Procedures of Shanghai Municipality on Administration of Medical Personnel Engaged in Medical Practising Activities" promulgated on October 29, 1988 by the Shanghai Municipal People's Government shall be annulled at the same time.
    

AsianLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback
URL: http://www.asianlii.org/cn/legis/sh/laws/posmoaomi784