regulations on the treatment of medical negligence chapter I general provisions article 1 these regulations are formulated for the purpose of correctly handling medical accidents, protecting the legitimate rights and interests of patients, medical institutions and their medical staff, maintaining medical order, ensuring medical safety and promoting the development of medical science. Article 2 The term "medical accident" as mentioned in these Regulations refers to an accident in which a medical institution and its medical staff violate the laws, administrative regulations, departmental rules, medical treatment and nursing norms and practices in medical activities, resulting in personal injury to patients through negligence. Article 3 In handling medical accidents, we should follow the principles of openness, fairness, justice, timeliness and convenience, adhere to the scientific attitude of seeking truth from facts, and make the facts clear, the nature accurate, the responsibilities clear and the handling appropriate. Article 4 According to the degree of personal injury to patients, medical accidents are divided into four levels: first-class medical accidents: those that cause death or severe disability to patients; Secondary medical accident: causing moderate disability of patients and serious dysfunction due to organ and tissue damage; Third-class medical accident: causing slight disability of patients, organ and tissue damage leading to general dysfunction; Four-level medical accident: other consequences that cause obvious personal injury to patients. Specific grading standards shall be formulated by the health administrative department of the State Council. Chapter II Prevention and Disposal of Medical Accidents Article 5 In medical activities, medical institutions and their medical personnel must strictly abide by the laws, administrative regulations, departmental rules, norms and practices of diagnosis and treatment and nursing, and strictly abide by the professional ethics of medical services. Article 6 A medical institution shall provide its medical staff with medical and health management laws, administrative regulations, departmental rules, diagnostic and nursing standards, routine training and professional ethics education in medical services. Article 7 A medical institution shall set up a medical service quality monitoring department or be equipped with full-time (part-time) staff, who shall be specifically responsible for supervising the medical service work of the medical staff of the medical institution, checking the medical staff's practice, accepting patients' complaints about medical services and providing them with consulting services. Eighth medical institutions shall, in accordance with the requirements stipulated by the administrative department of health of the State Council, write and properly keep medical records. Due to the rescue of critically ill patients, medical records cannot be written in time, and the relevant medical personnel shall make up the facts within 6 hours after the rescue, and make a note. Article 9 It is strictly forbidden to alter, forge, conceal, destroy or rob medical records. Article 1 Patients have the right to copy or duplicate their outpatient medical records, hospitalization records, temperature sheets, doctor's orders, laboratory tests (inspection reports), medical imaging examination data, special examination consent, operation consent, operation and anesthesia records, pathological data, nursing records and other medical records specified by the health administrative department of the State Council. If a patient requests to copy or duplicate medical records in accordance with the provisions of the preceding paragraph, the medical institution shall provide copying or duplicating services and affix a certification mark on the copied or duplicated medical records. When copying or duplicating medical records, patients should be present. At the request of patients, medical institutions can copy or duplicate medical records for them, and can charge a fee according to regulations. The specific charging standards shall be formulated by the price departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in conjunction with the health administrative departments at the same level. Article 11 In medical activities, medical institutions and their medical staff shall truthfully inform patients of their illness, medical measures and medical risks, and answer their inquiries in time; However, adverse consequences for patients should be avoided. Twelfth medical institutions should formulate plans to prevent and deal with medical accidents, prevent the occurrence of medical accidents and reduce the damage of medical accidents. Article 13 Medical personnel who have or find medical accidents, medical negligence behaviors that may cause medical accidents or medical accident disputes in medical activities shall immediately report to the person in charge of the department where they belong, and the person in charge of the department shall promptly report to the department or full-time (part-time) personnel in charge of monitoring the quality of medical services in this medical institution; After receiving the report, the department or full-time (part-time) personnel in charge of monitoring the quality of medical services shall immediately investigate and verify, truthfully report the relevant situation to the person in charge of the medical institution, and inform and explain to the patients. Article 14 Where a medical accident occurs, the medical institution shall report to the local health administrative department in accordance with the regulations. In the event of the following major medical negligence, the medical institution shall report to the local health administrative department within 12 hours: (1) a medical accident that leads to the death of the patient or may be above the second level; (two) the consequences of personal injury to more than three people; (3) Other circumstances stipulated by the health administrative department of the State Council and the health administrative department of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. Fifteenth occurrence or discovery of medical negligence, medical institutions and their medical staff should immediately take effective measures to avoid or reduce the damage to the health of patients and prevent the damage from expanding. Article 16 When a medical malpractice dispute occurs, the discussion records of death cases, difficult cases, superior doctors' rounds, consultation opinions and course records shall be sealed and unsealed in the presence of both doctors and patients. Sealed medical records can be copies and kept by medical institutions. Seventeenth suspected infusion, blood transfusion, injection, drugs and other adverse consequences, both doctors and patients should * * * seal and unseal the on-site physical objects, and the sealed on-site physical objects shall be kept by medical institutions; Where inspection is required, the inspection shall be conducted by both parties together with the designated inspection agency with inspection qualification according to law; When both parties can't make the same appointment, it shall be appointed by the administrative department of health. If it is suspected that blood transfusion will cause adverse consequences and it is necessary to seal up the blood, the medical institution shall notify the blood collection and supply institution that provided the blood to send personnel to be present. Eighteenth patients died, doctors and patients can not determine the cause of death or have objections to the cause of death, it should be within 48 hours after the death of the patient; If the conditions for cryopreservation of corpses are met, it can be extended to 7 days. Autopsy shall be approved and signed by the close relatives of the deceased. Autopsy should be carried out by institutions and professional technicians of pathological anatomy who have obtained corresponding qualifications in accordance with relevant state regulations. Institutions undertaking autopsy tasks and professional technicians of pathological anatomy have the obligation to conduct autopsy. Both parties to a medical malpractice dispute may invite forensic pathologists to participate in the autopsy, or they may appoint representatives to observe the autopsy process. If the autopsy is refused or delayed for more than the specified time, which affects the determination of the cause of death, the party who refuses or delays shall bear the responsibility. Article 19 If a patient dies in a medical institution, the body shall be moved to the mortuary immediately. Generally, the storage time of the dead body shall not exceed 2 weeks. If the corpse is not disposed of within the time limit, it shall be disposed of by the medical institution in accordance with the regulations after being approved by the health administrative department where the medical institution is located and reported to the public security department at the same level for the record. Chapter III Technical Appraisal of Medical Malpractice Article 2 After receiving a report from a medical institution on major medical negligence or an application from a party to a medical malpractice dispute for handling medical malpractice disputes, the health administrative department shall submit the medical malpractice technical appraisal to the medical association in charge of medical malpractice technical appraisal. If medical malpractice disputes need to be identified through consultation between doctors and patients, both parties shall organize the identification with the medical association entrusted to be responsible for the technical identification of medical malpractice. Twenty-first municipal local medical associations with districts and county (city) local medical associations directly under the jurisdiction of provinces, autonomous regions and municipalities directly under the Central Government are responsible for organizing the first technical appraisal of medical accidents. The local medical associations of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for organizing the re-appraisal. When necessary, the Chinese Medical Association can organize technical appraisal of medical malpractice disputes that are difficult, complicated and have great influence in the whole country. Article 22 If a party refuses to accept the conclusion of the first technical appraisal of medical malpractice, he may, within 15 days from the date of receiving the conclusion of the first appraisal, apply to the health administrative department where the medical institution is located for re-appraisal. Twenty-third medical associations responsible for organizing the technical appraisal of medical accidents shall establish an expert database. The expert database consists of medical and health professionals who meet the following conditions: (1) having good professional quality and professional morality; (two) employed by medical and health institutions or medical teaching and scientific research institutions and held senior technical positions in the corresponding professions for more than 3 years. Forensic doctors who meet the requirements specified in Item (1) of the preceding paragraph and have senior technical qualifications may be employed to enter the expert database. The medical association responsible for organizing the technical appraisal of medical accidents may employ medical and health professionals and forensic doctors to enter the expert database in accordance with the provisions of these regulations, and may not be restricted by administrative regions. Twenty-fourth technical appraisal of medical accidents shall be organized by the medical association responsible for organizing the technical appraisal of medical accidents. Experts from related professions who participated in the technical appraisal of medical accidents were randomly selected from the expert database by both doctors and patients under the auspices of the Medical Association. Under special circumstances, the medical association may, according to the needs of the technical appraisal of medical accidents, organize both doctors and patients to randomly select experts from related professions from the expert database established by other medical associations to participate in appraisal or letter consultation. Medical and health professionals and forensic doctors who meet the conditions stipulated in Article 23 of these regulations have the obligation to be employed into the expert database and undertake the technical appraisal of medical accidents. Twenty-fifth expert appraisal group to carry out technical appraisal of medical accidents, the implementation of collegiate system. The number of experts in the expert appraisal group is odd, and the experts in the main disciplines involved shall generally not be less than half of the members of the expert appraisal group; Involving the cause of death, disability level identification, and should be randomly selected from the expert database to participate in the expert appraisal group. Article 26 A member of an expert appraisal team shall withdraw in any of the following circumstances, and the parties may also apply for his withdrawal orally or in writing: (1) He is a disputed party to a medical accident or a close relative of the party; (2) Having an interest in the dispute over medical malpractice; (3) Having other relations with the parties to the medical malpractice dispute, which may affect the impartial appraisal. Article 27 The expert appraisal team independently conducts technical appraisal of medical malpractice in accordance with medical and health management laws, administrative regulations, departmental rules, norms and practices of diagnosis and treatment and nursing, and uses medical scientific principles and professional knowledge to identify and judge medical malpractice, so as to provide medical basis for handling medical malpractice disputes. No unit or individual may interfere with the technical appraisal of medical accidents, and may not threaten, induce, abuse or beat members of the expert appraisal team. Members of the expert appraisal team shall not accept property or other interests of both parties. Article 28 The medical association responsible for organizing the technical appraisal of medical malpractice shall, within 5 days from the date of accepting the technical appraisal of medical malpractice, notify both parties to the medical malpractice dispute to submit the materials needed for the technical appraisal of medical malpractice. The parties concerned shall, within 1 days from the date of receiving the notice from the Medical Association, submit the materials, written statements and defense related to the technical appraisal of medical malpractice. The materials submitted by medical institutions for technical appraisal of medical accidents shall include the following contents: (1) The original medical records such as the course records of inpatients, the discussion records of death cases, the discussion records of difficult cases, the consultation opinions, and the records of superior doctors' rounds; (2) The original medical records of inpatients, such as hospitalization records, temperature sheets, doctor's orders, laboratory tests (inspection reports), medical imaging examination data, special examination consent, operation consent, operation and anesthesia records, pathological data and nursing records; (three) the original medical records of the emergency patients within the specified time; (4) Sealed and preserved articles for infusion and injection, blood, drugs and other physical objects, or inspection reports made by inspection institutions with inspection qualifications according to law on these articles and physical objects; (five) other materials related to the technical appraisal of medical accidents. Outpatients and emergency patients with medical records in medical institutions, whose medical records are provided by medical institutions; If medical records are not established in medical institutions, they shall be provided by patients. Both doctors and patients shall submit relevant materials in accordance with the provisions of these regulations. If a medical institution fails to provide relevant materials truthfully in accordance with the provisions of these regulations without justifiable reasons, which leads to the failure of technical appraisal of medical accidents, it shall bear the responsibility. Article 29 The medical association responsible for organizing the technical appraisal of medical malpractice shall organize the appraisal and issue the technical appraisal of medical malpractice within 45 days from the date of receiving the materials, written statements and defense submitted by the parties concerned. The medical association responsible for organizing the technical appraisal of medical accidents may investigate and collect evidence from both parties. Thirtieth expert appraisal group shall carefully review the materials submitted by both parties, listen to the statements and defenses of both parties and verify them. Both parties shall truthfully submit the materials needed for technical appraisal of medical accidents in accordance with the provisions of these regulations, and actively cooperate with the investigation. If either party refuses to cooperate, which affects the technical appraisal of medical accidents, the uncooperative party shall bear the responsibility. Thirty-first expert appraisal group shall, on the basis of clear facts and conclusive evidence, comprehensively analyze the patient's condition and individual differences, make an appraisal conclusion, and make a technical appraisal of medical accidents. The appraisal conclusion is passed by more than half of the members of the expert appraisal group. The appraisal process shall be truthfully recorded. The technical appraisal of medical malpractice shall include the following main contents: (1) the basic information and requirements of both parties; (two) the materials submitted by the parties and the investigation materials of the medical association responsible for organizing the technical appraisal of medical accidents; (3) A description of the appraisal process; (four) whether the medical behavior violates the medical and health management laws, administrative regulations, departmental rules and the norms and routines of diagnosis and treatment; (five) whether there is a causal relationship between medical negligence and the consequences of personal injury; (six) the degree of responsibility of medical negligence in the consequences of medical accident damage; (seven) the level of medical accidents; (eight) medical nursing medical advice for patients with medical accidents. Thirty-second measures for technical appraisal of medical accidents shall be formulated by the administrative department of health of the State Council. Article 33 Any of the following circumstances does not belong to a medical accident: (1) taking emergency medical measures to save the life of a dying patient in an emergency, which causes adverse consequences; (two) medical accidents occurred in medical activities due to the abnormal condition of the patient or the special physique of the patient; (3) Unforeseen or unforeseeable adverse consequences occur under the existing medical science and technology conditions; (four) no-fault blood transfusion infection caused adverse consequences; (five) due to the patient's delay in diagnosis and treatment, resulting in adverse consequences; (six) adverse consequences caused by force majeure. Thirty-fourth technical appraisal of medical accidents, appraisal fees can be charged. If it is identified as a medical accident, the appraisal fee shall be paid by the medical institution; If it does not belong to medical malpractice, the appraisal fee shall be paid by the party applying for medical malpractice treatment. The appraisal fee standard shall be formulated by the competent price department of the people's government of a province, autonomous region or municipality directly under the Central Government in conjunction with the finance department and the health administrative department at the same level. Chapter IV Administrative Handling and Supervision of Medical Accidents Article 35 The administrative department of health shall, in accordance with the provisions of these Regulations and relevant laws, administrative regulations and departmental rules, make administrative handling of medical institutions and medical personnel who have suffered medical accidents. Thirty-sixth health administrative departments after receiving the report of major medical negligence from medical institutions, in addition to ordering medical institutions to take necessary medical treatment in time.