(Adopted at the 55th Executing Meeting of the State Council on February 20, 2002, promulgated by Decree No.351 of the State Council of the People's Republic of China on April 4, 2002, and effective as of September 1, 2002)
Chapter I General Provisions
Article 1These Regulations are formulated for the purposes of correctly handling medical accidents, protecting the lawful rights and interests of patients and medical institutions as well as their medical workers, maintaining the medical order, ensuring the medical safety and promoting the development of medical science.
Article 2For the purpose of these Regulations, "medical accident" means an accident caused by a medical institution or its medical workers resulting in personal injuries to a patient due to faults in medical activities as a result of violation of the laws, administrative regulations or departmental rules on medical and health administration, or of standards or procedures for diagnosis, cure and nursing.
Article 3In handling medical accidents, the principles of openness, equality, fairness, timeliness and convenience to the people shall be complied with, the scientific approach of seeking truth from facts shall be adhered to, the fact shall be thoroughly ascertained, the nature shall be accurately determined, the responsibility shall be clearly defined, and the handling shall be proper.
Article 4Medical accidents shall, according to the seriousness of personal injuries to patients, be classified into four grades:
Grade I medical accident: causing death or heavy disability of a patient;
Grade II medical accident: causing medium disability, or organ or tissue damage of a patient, thus resulting in severe dysfunction;
Grade III medical accident: causing minor disability, or organ or tissue damage of a patient, thus resulting in common dysfunction; and
Grade IV medical accident: causing other tangible personal injuries to a patient.
The specific grading standards shall be formulated by the health administration department of the State Council.
Chapter II Prevention and Disposition of Medical Accidents
Article 5Medical institutions and their medical workers must, in their medical activities, strictly comply with the laws, administrative regulations and departmental rules on medical and health administration, and the standards and procedures for diagnosis, cure and nursing, and abide by professional ethics of medical services.
Article 6Medical institutions shall train their medical workers in the laws, administrative regulations and departmental rules on medical and health administration, the standards and procedures for diagnosis, cure and nursing, and educate them in professional ethics of medical services as well.
Article 7Medical institutions shall set up medical service quality supervision departments or appoint full-time (or part-time) personnel that shall be specifically responsible for supervising medical service work of their medical workers, inspecting medical practice of their medical workers, accepting the complaints from patients about medical services and rendering consultation services to them.
Article 8Medical institutions shall write and properly preserve medical records as required by the health administration department of the State Council.
Medical workers concerned who fail to timely write medical records due to emergency treatment to fatal patients shall accurately make up the records and give an indication thereto within six hours after the emergency treatment.
Article 9Alteration, forgery, concealment, destruction or seizure of medical records shall be strictly forbidden.
Article 10Patients shall be entitled to duplicate or reproduce their clinical records, hospitalization records, body temperature records, doctor's advice records, laboratory test records (test reports), medical image examination records, special examination consent records, operation consent records, operation and anesthesia records, pathological records, nursing records and other medical records as specified by the health administration department of the State Council.
When patients request to duplicate or reproduce their medical records according to the provisions of the preceding paragraph, medical institutions shall render such duplication or reproduction services and affix the stamps for certification on the medical records so duplicated or reproduced. Patients shall be on the scene when duplicating or reproducing their medical records.
Medical institutions that duplicate or copy medical records upon the request of patients may collect prescribed costs therefor. The competent pricing departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government shall, together with the health administration departments at the corresponding levels, set forth the specific charging standards.
Article 11Medical institutions and their medical workers shall, in their medical activities, truthfully inform patients of the situations of their illness, cure measures, medical risks and other related matters, and timely answer patients' inquiries; however, they shall avoid the occurrence of any adverse effects to patients.
Article 12Medical institutions shall work out pre-scheme for prevention and disposition of medical accidents, so as to prevent the occurrence of medical accidents and reduce injuries caused by medical accidents.
Article 13A medical worker who, in medical activities, causes or discovers a medical accident or a medical fault that might result in a medical accident, or who causes a medical accident dispute, shall immediately report it to the responsible person of the section or office to which he belongs. The responsible person of the section or office shall promptly report it to the department or full-time (part-time) personnel that are responsible for supervising medical service quality in the medical institution. The medical service quality supervision department or full-time (part-time) personnel shall immediately investigate into and ascertain it after receipt of the report, truly report the relevant information to the responsible person of the medical institution, and inform and make an explanation to the patient concerned.
Article 14Where a medical accident occurs, the medical institution shall report it to the health administration department in the place where it is located according to the provisions.
Where any of the following serious medical faults occurs, the medical institution shall, within 12 hours, report it to the health administration department in the place where it is located:
(1) causing death of the patient or a medical accident that may be classified as Grade II or above;
(2) causing personal injuries to three patients or more; or
(3) other circumstances as specified by the health administration department of the State Council or the health administration department of the people's government of the province, autonomous region or municipality directly under the Central Government.
Article 15The medical institution and its medical workers shall, after the occurrence or discovery of a medical fault, immediately take effective measures to avoid or reduce the injury to the patient's physical health and to prevent the expansion of the injury.
Article 16Where a medical accident dispute arises, the death case discussion record, the difficult and complicated case discussion record, the superior doctor's rounds-making record, the group consultation record, and the illness history record shall be sealed and unsealed in the presence of both the medical institution side and the patient. The medical records so sealed may be duplicated copies and shall be deposited with the medical institution.
Article 17Where any adverse consequence is suspected of being caused by infusion, blood transfusion, injection or drug, things on the spot shall be sealed and unsealed by both the medical institution side and the patient. The things so sealed shall be deposited with the medical institution. If an inspection is needed, both parties shall jointly designate the inspection institution that has the inspection qualification according to law to carry out the inspection. If both parties can not make a joint designation, the health administration department shall designate an inspection institution.
Where blood is to be sealed up and preserved in case of suspicion of any adverse consequence of blood transfusion, the medical institution shall notify the blood-collecting-and-supplying institution which has supplied the blood in question to send a staff member to be present on the scene.
Article 18Where both the medical institution side and the patient can not determine, or have different opinions on, the cause of death of the patient, an autopsy shall be performed within 48 hours after the death of the patient. If the conditions for freezing and keeping the dead body are permissible, the period for the autopsy may be extended by seven days. The autopsy shall be performed with the consent and signature of the close relative of the dead.
The autopsy shall be performed by the institution and professionals of pathologic dissection having the qualifications therefor according to the relevant provisions of the State. The institution and professionals of pathologic dissection shouldering the task of autopsy shall have the obligation to perform the autopsy.
Both parties to the medical accident dispute may invite the professionals of forensic pathology to attend the autopsy, and may also appoint their representatives to oversee the autopsy. The party that refuses or delays an autopsy within the specified time period, thus affecting the determination of the cause of death, shall assume responsibility therefor.
Article 19Where the death of the patient occurs in the medical institution, the dead body shall be immediately moved to the mortuary. Generally, the period for preservation of the dead body may not exceed two weeks. The medical institution shall, upon approval by the local health administration department and after reporting for the record to the public security department at the same level, dispose of the dead body that has not been disposed of within the specified time period according to the provisions.
Chapter III Technical Identification of Medical Accidents
Article 20The health administration department shall, after it receives a report on any serious medical fault from a medical institution or an application for settling a medical accident dispute from the party to a dispute, transfer the report or application to the medical association responsible for technical identification of medical accidents to organize the technical identification which is needed for the medical accident; where both the medical institution side and the patient settle their medical accident dispute through consultation but require the technical identification of medical accident, they shall jointly invite the medical association responsible for technical identification of medical accidents to organize the identification.
Article 21Local medical associations at the level of cities divided into districts and local medical associations of the counties (cities) under the direct jurisdiction of provinces, autonomous regions or municipalities directly under the Central Government shall be responsible for organizing initial technical identification of medical accidents. Local medical associations of provinces, autonomous regions or municipalities directly under the Central Government shall be responsible for organizing re-identification.
When necessary, China Medical Association may organize technical identification of difficult and complicated medical accident disputes that have great impact in the country.
Article 22The party concerned who disagrees with the conclusion of the initial technical identification of a medical accident may, within 15 days from the date of receipt of the conclusion, make an application for re-identification to the health administration department in the place where the medical institution is located.
Article 23Medical associations responsible for organizing technical identification of medical accidents shall establish expert banks.
The expert bank shall be composed of the medical and health specialists who meet the following requirements:
(1) having good professional quality and ethics to practice; and
(2) being employed by medical or health institutions or medical education or scientific research institutions and holding superior technical positions of the corresponding profession for more than three years.
Forensic doctors who meet the requirements specified in Item (1) of the preceding paragraph and concurrently have the qualifications for superior technical positions may be invited as experts of expert banks.
Medical associations responsible for organizing technical identification of medical accidents shall not be restricted by administrative areas when they invite medical and health specialists and forensic doctors to be enrolled into expert banks according to the provisions of these Regulations.
Article 24Medical associations responsible for organizing technical identification of medical accidents shall organize expert groups to undertake the technical identification of medical accidents.
Under the presiding of the medical association, both the medical institution side and the patient shall, from the expert bank, select randomly experts in relevant fields to attend technical identification of medical accident. Under special circumstances, the medical association may, based on the need of technical identification of the medical accident, organize both the medical institution side and the patient to select randomly, from the expert banks established by other medical associations, the experts in relevant fields to attend the identification or to give advices by correspondence.
Medical and health specialists and forensic doctors who meet the requirements specified in Article 23 of these Regulations shall have the obligations to be invited as experts of the expert bank and to undertake technical identification of medical accidents.
Article 25Expert groups shall adopt the collegiate system in technical identification of medical accidents. The number of members of an expert group shall be odd. Generally, the number of the experts of the major branches of learning involved in may not be less than half of members of the expert group; forensic doctors shall be selected randomly from the expert bank to be enrolled into the expert group that undertakes the identification, where the cause of death or the degree of disability is involved.
Article 26A member of the expert group who is under any of the following circumstances shall recuse himself, and the party concerned may, orally or in writing, apply for the recusal of that member:
(1) being a party or a close relative of a party to the medical accident dispute;
(2) having an interest in the medical accident dispute; or
(3) having any other relations with a party to the medical accident dispute that might affect the impartial identification.
Article 27Expert groups shall, in accordance with the laws, administrative regulations and departmental rules on medical and health administration and the standards and procedures for diagnosis, cure and nursing, and by using the principles of medical science and professional knowledge, carry out the technical identification of medical accidents independently, identify and judge medical accidents, and provide the medical basis for settling medical accident disputes.
No unit or individual may interfere in technical identification of medical accidents, or threaten, seduce, insult or beat up members of expert groups.
No member of an expert group may take money, property or other benefits from any party concerned.
Article 28The medical association responsible for organizing technical identification of medical accidents shall, within five days from the date of acceptance of the application for technical identification of the medical accident, notify both parties to the medical accident dispute to submit materials needed for the identification.
Both parties concerned shall, within ten days from the date of receipt of the notification from the medical association, submit the materials relating to the identification of the medical accident, written statements and arguments. The materials relating to technical identification of the medical accident submitted by the medical institution shall include the following:
(1) original manuscripts of the medical records for the inpatient, such as the illness record, death case discussion record, difficult and complicated case discussion record, group consultation record, superior doctor's rounds-making record, etc.;
(2) original manuscripts of the medical records for the inpatient, such as the hospitalization record, body temperature record, doctor's advice record, laboratory test record (test report), medical image examination record, special examination consent record, operation consent record, operation and anesthesia record, pathological record, nursing record, etc.;
(3) original manuscripts of the medical records made up within the specified time period for emergency treatment to the fatal patient;
(4) things used in infusion and injection and material things of blood and drug that are sealed and preserved, or the report of inspection on these things issued by the inspection institution having the inspection qualification according to law; and
(5) other materials relevant to the technical identification of the medical accident.
The medical institution shall submit the medical records for the outpatients or emergency patients who have the illness history archives in the medical institution; otherwise, the patient shall submit his medical records.
Both the medical institution side and the patient shall submit the relevant materials according to the provisions of these Regulations. The medical institution that, without justified reasons, fails to truthfully submit the relevant materials according to the provisions of these Regulations, thus causing the incapability of technical identification of the medical accident, shall assume responsibility.
Article 29The medical association responsible for organizing technical identification of medical accidents shall, within 45 days from the date of receipt of materials relating to technical identification of the medical accident, written statements and arguments submitted by the parties concerned, organize identification and issue the report of technical identification of the medical accident.
The medical association responsible for organizing technical identification of medical accidents may inquire into and collect evidence from both parties concerned.
Article 30Expert groups shall carefully examine the materials submitted by both parties concerned, listen to the statements and arguments of both parties concerned and verify them.
Both parties concerned shall truthfully submit the materials needed for technical identification of the medical accident and actively cooperate with the investigation according to the provisions of these Regulations. Where either of them refuses to give such cooperation, thus affecting the technical identification of the medical accident, the party who fails to give cooperation shall assume responsibility.
Article 31Expert groups shall, on the basis of clear facts and conclusive evidence, comprehensively analyze the illness situation and personal difference of patients, make the identification conclusion and issue the report of technical identification of the medical accident. The identification conclusion shall be adopted by a simple majority of the members of the expert group. The identification process shall be truthfully recorded.
The report of technical identification of the medical accident shall contain the following major particulars:
(1) the basic information about both parties concerned and their claims;
(2) materials submitted by the parties concerned and investigation materials collected by the medical association responsible for organizing technical identification of the medical accident;
(3) the explanations on the identification process;
(4) whether the medical treatment violates the laws, administrative regulations or departmental rules on medical and health administration, and the standards and procedures for diagnosis, cure or nursing;
(5) the causality between the medical fault and the personal injury;
(6) the extent of responsibility of the medical fault for injury in the medical accident;
(7) the grade of the medical accident; and
(8) the medical and nursing advice for the patient of the medical accident.
Article 32The health administration department of the State Council shall formulate measures for technical identification of medical accidents.
Article 33Any of the following circumstances shall not be taken as a medical accident:
(1) adverse consequences caused by emergency medical measures taken to rescue the life of a fatal patient in an emergency;
(2) unforeseeable medical results arising from medical treatment activities due to the abnormal situation of the illness or the particular constitution of a patient;
(3) adverse consequences unforeseeable or unavoidable under current conditions of medical science and technology;
(4) adverse consequences caused by infection in the faultless blood transfusion;
(5) adverse consequences caused by the delay in diagnosis and treatment on the part of the patient; or
(6) adverse consequences caused by force majeure.
Article 34Identification fees may be collected for technical identification of medical accidents. If a medical accident is established upon identification, the medical institution concerned shall pay identification fees; if it is not a medical accident, the applicant for handling the medical accident shall pay identification fees. The competent pricing departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government shall, jointly with the finance departments and health administration departments at the corresponding levels, stipulate the standards for identification fees.
Chapter IV Administrative Disposition and Supervision for Medical Accidents
Article 35The health administration departments shall, in accordance with the provisions of these Regulations, relevant laws, administrative regulations and departmental rules, give administrative disposition to medical institutions and medical workers producing medical accidents.
Article 36Upon receiving the reports on the serious medical faults from medical institutions, the health administration departments shall, in addition to ordering medical institutions promptly to take necessary medical cure measures and to prevent the development of injury, organize investigation and ascertain whether they are medical accidents; where the health administration departments are incapable to ascertain whether there are medical accidents, they shall, according to the relevant provisions of these Regulations, transfer the cases to medical associations responsible for technical identification of medical accidents to organize identification.
Article 37Parties to medical accident disputes who apply for the settlement to the health administration departments shall submit their applications in writing. The written application shall contain the basic information about the applicant, relevant facts, claims in detail and reasons therefor, etc.
The party concerned may, within one year from the date when he knows or ought to know his bodily injury, submit an application for the settlement of the medical accident dispute to the health administration department.
Article 38Where a medical accident dispute arises and the parties concerned make an application for the settlement by the health administration department, the case shall be accepted by the health administration department of the people's government at the county level in the place where the medical institution is located. If the medical institution is located in a municipality directly under the Central Government, the health administration department of the people's government of the district or county in the place where the medical institution is located shall accept the application.
Under any of the following circumstances, the health administration department of the people's government at the county level shall, within seven days from the date of receipt of the report submitted by the medical institution or the application for the settlement of the medical accident dispute submitted by the party concerned, transfer the report or application to the health administration department of the people's government at the next higher level for the settlement:
(1) where the patient dies;
(2) where the medical accident might be classified as Grade II or above; or
(3)where other circumstances specified by the health administration department of the State Council or the health administration department of the people's government of the province, autonomous region or municipality directly under the Central Government occur.
Article 39The health administration department shall, within ten days from the date of receipt of an application for the settlement of a medical accident dispute, examine the application and decide whether to accept the application. The health administration department that decides to accept the application meeting the requirements of these Regulations and deems that the technical identification of medical accident is necessary shall, within five days from the date of decision of acceptance, transfer relevant materials to the medical association responsible for technical identification of medical accidents to organize identification and notify the applicant in writing; if it decides to reject the application not meeting the requirements of these Regulations, it shall notify the applicant and give the reasons in writing.
Where the party concerned disagrees with the conclusion of the initial technical identification of the medical accident and applies for re-identification, the health administration department shall, within seven days from the date of receipt of the application, transfer relevant materials to the local medical association of the province, autonomous region or municipality directly under the Central Government to organize re-identification.
Article 40If the party concerned submits his application for the settlement of a medical accident dispute to the health administration department and concurrently brings a lawsuit before the people's court, the health administration department shall not accept his application, or shall terminate the settlement if it has accepted.
Article 41The health administration department shall, after it receives the report of technical identification of a medical accident issued by the medical association responsible for organizing technical identification of medical accidents, examine the qualifications and professions of the persons who attend the identification and the identification process as well; when necessary, it may organize investigation and listen to the opinions of both parties to the medical accident dispute.
Article 42The health administration department shall take the conclusion of the technical identification that, upon its examination, is in conformity with the provisions of these Regulations, as the basis for giving administrative disposition to the medical institution and medical workers producing the medical accident and for making compensation and mediation for the medical accident; if, through examination, it discovers that the technical identification of the medical accident does not conform to the provisions of these Regulations, it shall demand another identification.
Article 43Where a medical accident dispute is settled through consultation by both parties concerned on their own, the medical institution shall, within seven days from the date of settlement through consultation, submit a written report, with the written agreement between them appended, to the health administration department in the place where it is located.
Article 44Where a medical accident dispute is settled through conciliation or ruling by the people's court, the medical institution shall, within seven days from the date of receipt of the effective written conciliation statement or judgment of the people's court, submit a written report, with the written conciliation statement or judgment appended, to the health administration department in the place where it is located.
Article 45Health administration departments of the people's governments at or above the county level shall, level by level, report medical accidents occurred in their respective areas and the administrative disposition given according to law to medical institutions and medical worker producing medical accidents to the health administration department of the State Council according to the provisions.
Chapter V Compensation for Medical Accidents
Article 46Both parties of the medical institution side and the patient may, through consultation, settle the disputes on civil liability such as the compensation for medical accidents; if they are unwilling or fail to make consultation, the parties concerned may apply for mediation to the health administration department, or may directly bring a civil lawsuit before the people's court.
Article 47Both parties concerned who, through consultation, settle the disputes on civil liabilities such as the compensation for medical accidents, shall prepare a written agreement. The written agreement shall contain the basic information about both parties concerned, cause of the medical accident, grade of the medical accident determined jointly by both parties concerned, amount of compensation that they determined through consultation and other matters, and shall be signed by both parties concerned.
Article 48Where a medical accident has been ascertained, the health administration department may, upon request of both parties to the medical accident dispute, mediate in the compensation for the medical accident. Such mediation shall be in compliance with the principle of voluntariness of both parties concerned, and the amount of compensation shall be computed according to the provisions of these Regulations.
Both parties concerned who reach an agreement on the amount of compensation through mediation shall prepare a written mediation statement and implement it. If the mediation fails or one of the parties concerned repents after the agreement is reached through mediation, the health administration department shall no longer make mediation.
Article 49The following factors shall be taken into account for determining the actual amount of compensation for a medical accident:
(1) the grade of the medical accident;
(2) the extent of responsibility of the medical fault for the injury in the medical accident; and
(3) the relationship between the injury in the medical accident and the old illness of the patient.
Medical institutions shall not be liable for compensation where there are not medical accidents.
Article 50The amount of compensation for a medical accident shall be computed according to the following items and standards:
(1) the medical expense shall be computed according to the costs incurred in medical treatment for the personal injury to the patient in the medical accident and paid against documents, but shall not include the costs incurred in medical treatment for the old illness. If the cure is needed indeed after the case is settled, it shall be paid according to the basic costs incurred in the medical treatment.
(2) the compensation for income loss of the patient who has fixed income shall be computed according to the reduction of his fixed income attributable to the medical accident. If the income of the patient is higher over three times annual average wage of the workers for the previous year in the place where the medical accident occurs, it shall be computed by three times. If the patient has no fixed income, the compensation shall be computed according to the amount of the annual wage of the workers for the previous year in the place where the medical accident occurs.
(3) the food allowance for hospitalization shall be computed according to the standard of food allowance for the business trip enjoyed by the ordinary staff member of the State organ in the place where the medical accident occurs.
(4) the expense for looking after the patient shall be computed according to the amount of the annual average wage of workers for the previous year in the place where the medical accident occurs, if a special person is needed to look after the patient in hospitalization.
(5) the living allowance for the disabled shall, depending on the degree of disability, be computed according to the amount of annual average living expense of residents in the place where the medical accident occurs. The period for the allowance shall be 30 years at longest from the month when the disability is determined. However, if the age of the disabled person is over 60 years, the period shall not exceed 15 years, and if the age of the disabled person is over 70 years, the period shall not exceed five years.
(6) the disability allowance for appliance shall, depending on the certification issued by the medical institution, be computed according to the price of the popular appliance, if the supporting appliance is needed due to disability.
(7) the funeral expense shall be computed according to the specified standard of the funeral expense in the place where the medical accident occurs.
(8) the living expense for the dependent shall, depending on the number of the persons who, without work ability, are actually supported by the deceased before he dies or by the disabled before he loses his work ability, be computed according to the minimum guaranteed living standard of the residents in the place where the dependent registers his residence or where he resides. If the dependent is under 16 years of age, he will be brought up till 16 years of age. If the dependent has reached 16 years of age but he has no work ability, he will be fostered for 20 years. However, if the age of the dependent is over 60 years old, the period shall not exceed 15 years, and if the dependent is over 70 years old, the period shall not exceed five years.
(9) the traffic allowance shall be computed according to the actual traffic expenses needed by the patient and paid against receipts.
(10) the lodging allowance shall be computed according to the standard of lodging for the business trip enjoyed by the ordinary staff member of the State organ in the place where the medical accident occurs and paid against receipts.
(11) the compensation for mental injury shall be computed according to the amount of annual average living expense of residents in the place where the medical accident occurs. In case of death of the patient, the period of compensation shall not exceed six years at longest, and in case of disability of the patient, the period shall not exceed three years at longest.
Article 51The traffic allowance, the compensation for income loss and lodging allowance of the close relatives of a patient who participate in the handling of the medical accident shall be computed by reference to the relevant provisions of Article 50 of these Regulations. In computation, the number of the relatives shall not exceed two.
If a medical accident causes the death of a patient, the traffic allowance, the compensation for income loss and lodging allowance of the patient's spouse and lineal relatives who attend the funeral activities shall be computed by reference to the relevant provisions of Article 50 of these Regulations. In computation, the number of such persons shall not exceed two.
Article 52The amount of compensation for a medical accident shall be cleared up once for all and paid by the medical institution that shall assume the responsibility for the medical accident.
Chapter VI Penalty Provisions
Article 53Where any staff member of the health administration department, in violation of the provisions of these Regulations and by taking advantage of his position in the handling of a medical accident, accepts money, property or other benefits, abuses his power, neglects his duty, or fails to investigate into and handle the illegal act discovered, thus causing a serious consequence, criminal liability shall, according to law, be investigated in accordance with the provisions of the criminal law on the crime of accepting a bribe, the crime of power abuse, the crime of neglect of duty or other relevant crimes; if it is not serious enough for criminal punishment, the administrative sanction of demotion or dismissal from office shall be given according to law.
Article 54Where the health administration department, in violation of the provisions of these Regulations, comes under any of the following circumstances, the health administration department at the higher level shall give a warning and order it to make corrections within the specified time limit; if the circumstances are serious, administrative sanctions shall be given to the person in charge who is responsible for such violation and other directly responsible persons according to law:
(1) failing to organize investigation immediately after receiving a report of the medical institution on the serious medical fault;
(2) within the specified time limit, failing to examine the application for the settlement of a medical accident dispute, or transfer it to the health administration department at the next higher level for disposition after receiving the application;
(3) failing to transfer the serious medical fault that shall be subject to technical identification of medical accident or the medical accident dispute to the medical association for identification;
(4) failing to report a medical accident occurred in its area and the circumstances about administrative disposition given according to law to the medical institution and medical workers producing the medical accident, level by level, to the superior authorities according to the provisions; or
(5) failing to examine the report of technical identification of a medical accident according to the provisions of these Regulations.
Article 55Where a medical institution produces a medical accident, the health administration department shall give a warning according to the grade and situation of the medical accident; if the circumstances are serious, the health administration department shall order the medical institution to suspend business for rectification within the specified time limit or the original license-issuing department shall revoke the license for practice, and the medical workers responsible therefor shall, according to law, be investigated for criminal liability in accordance with the provisions of the criminal law on the crime of medical accidents; if their acts are not serious enough for criminal punishment, administrative or disciplinary sanctions shall be given according to law.
In addition to the punishment imposed according to the preceding paragraph, the health administration department may concurrently order the medical workers who produce a medical accident to suspend their practicing activities for not less than six month but not more than one year; if the circumstances are serious, their certificates for practice shall be revoked.
Article 56Where a medical institution, in violation of the provisions of these Regulations, comes under any of the following circumstances, the health administration department shall order it to make corrections; if the circumstances are serious, administrative or disciplinary sanctions shall be given to the persons in charge who is responsible for such violation and other directly responsible persons according to law:
(1) failing to truthfully inform the patient of the illness situation, cure measures and medical risk;
(2) without justified reasons, refusing to offer the services of duplicating or reproducing medical records for the patient;
(3) failing to write or properly preserve medical records according to the requirements specified by the health administration department of the State Council;
(4) failing to make up medical records in emergency treatment within the specified time limit;
(5) failing to seal up, keep or unseal medical records or material things according to the provisions of these Regulations;
(6) failing to set up a department or appoint a full-time (part-time) person for the medical service quality supervision;
(7) failing to work out the pre-scheme for the prevention and disposition of medical accidents;
(8) failing to report the major medical fault to the health administration department within the specified time limit;
(9) failing to report a medical accident to the health administration department according to the provisions of these Regulations; or
(10) failing to perform autopsy or to keep or dispose of the dead body according to the provisions.
Article 57Where a person who attends the technical identification of a medical accident, in violation of the provisions of these Regulations, accepts money, property or other benefits from both or either of the parties who apply for identification, or issues a false report of technical identification of a medical accident, thus causing serious consequences, criminal liability shall, according to law, be investigated in accordance with the provisions of the criminal law on the crime of accepting a bribe; if it is not serious enough for criminal punishment, the original license-issuing department shall revoke his certificate for practice or certificate of qualifications.
Article 58Where a medical institution or other relevant institution, in violation of the provisions of these Regulations, comes under any of the following circumstances, the health administration department shall order it to make corrections, give a warning and give administrative or disciplinary sanctions to the person in charge who is responsible for such violation and other directly responsible persons according to law; if the circumstances are serious, the original license-granting department shall revoke their licenses for practice or certificates of qualifications:
(1) for an institution shouldering the task of autopsy, refusing to perform an autopsy without justified reasons; or
(2) altering, forging, concealing or destroying medical records.
Article 59Where an ignition of quarrels, seizure of medical records or disturbance of the normal medical order of a medical institution or the work of technical identification of medical accident is committed under the excuse of the medical accident, criminal liability shall, according to law, be investigated in accordance with the provisions of the criminal law on the crime of disturbance of social order; if it is not serious enough for criminal punishment, the penalty for violation of public order and security administration shall be given according to law.
Chapter VII Supplementary Provisions
Article 60The "medical institution" referred to in theses Regulations means an institution that obtains a Medical Institution License for Practice in accordance with the provisions of the Regulations on Administration of Medical Institutions.
Accidents in respect of technical services for family planning occurred in the institutions engaging in technical services for family planning of cities at or above the county level in their clinic medical services for family planning offered according to the provisions of the Regulations on Administration of Technical Services for Family Planning shall be handled according to the relevant provisions of these Regulations. Notwithstanding, if the accidents in respect of technical services for family planning occur in the institutions engaging in technical services for family planning of cities at or above the county level other than medical institutions, the family planning administration departments shall perform the functions which shall be performed by the health administration departments according to the relevant provisions of these Regulations, such functions as of accepting and transferring the accidents to the medical associations responsible for technical identification of medical accidents to organize identification, and making mediation for compensation; and shall, according to law, punish these institutions and persons responsible for the accidents in respect of technical services for family planning.
Article 61Personal injuries to patients caused by illegal medical practice shall not be defined as medical accidents. If the criminal law has been violated, criminal liability shall be investigated according to law. Victims may directly bring lawsuits for compensation before the people's courts.
Article 62The competent health department of the Chinese People's Liberation Army shall, together with the health administration department of the State Council, formulate measures for the handling of medical accidents in medical institutions of the Army according to these Regulations.
Article 63These Regulations shall be effective as of September 1, 2002. The Measures for the Handling of Medical Accidents promulgated by the State Council on June 29, 1987 shall be repealed simultaneously. Medical accident disputes that have already been settled prior to the entry into force of these Regulations shall not be re-handled.