Regulations on Handling Medical Accidents
Order of the State Council [2002] No. 351
April 4, 2002
The Regulations on Handling Medical Accidents, which was adopted at the 55th Executing Meeting of the State Council on February 20, 2002, is released hereby and shall take effect as of September 1, 2002.
Premier of the State Council Zhu Rongji
Appendix: Regulations on Handling Medical Accidents
Chapter I General Provisions
Article 1 These 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 2 For 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 3 In 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 4 Medical 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 5 Medical 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 6 Medical 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 7 Medical 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 8 Medical 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 9 Alteration, forgery, concealment, destruction or seizure of medical records shall be strictly forbidden.
Article 10 Patients 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 11 Medical 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 12 Medical 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 13 A 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 14 Where 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 15 The 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 16 Where 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 17 Where 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 18 Where 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.
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Order of the State Council [2002] No. 351
April 4, 2002
The Regulations on Handling Medical Accidents, which was adopted at the 55th Executing Meeting of the State Council on February 20, 2002, is released hereby and shall take effect as of September 1, 2002.
Premier of the State Council Zhu Rongji
Appendix: Regulations on Handling Medical Accidents
Chapter I General Provisions
Article 1 These 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 2 For 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 3 In 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 4 Medical 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 5 Medical 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 6 Medical 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 7 Medical 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 8 Medical 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 9 Alteration, forgery, concealment, destruction or seizure of medical records shall be strictly forbidden.
Article 10 Patients 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 11 Medical 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 12 Medical 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 13 A 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 14 Where 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 15 The 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 16 Where 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 17 Where 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 18 Where 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.
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