(February 20, 2002 adopted by the 55th Executive meeting of the State Council on April 4, 2002 People's Republic of China promulgated as of September 1, 2002, promulgated by Decree No. 351) Chapter I General provisions article in order to correctly deal with medical incidents, protect the legitimate rights and interests of the patients and medical institution and its medical staff, maintain order, ensure medical safety, and promote the development of medical science, this Ordinance is enacted.     Second medical accidents referred to in these regulations refers to medical institutions and personnel in medical activities, violation of health laws, administrative regulations, departmental regulations, and medical care standards, General, patients personal injury accidents caused by negligence.     Article dealing with medical accident shall follow the principle of openness, fair, impartial, timely, and convenient, the scientific attitude of seeking truth from facts, the facts are clear, accurate, accountable, properly.     Fourth article according to on patients personal caused of damage degree, medical accident is divided into four level: level medical accident: caused patients death, and heavy degrees disability of; II level medical accident: caused patients in the degrees disability, and organ organization injury led to serious function obstacles of; three level medical accident: caused patients mild disability, and organ organization injury led to General function obstacles of; four level medical accident: caused patients obviously personal damage of other consequences of. 　　     Specific classification criteria formulated by the health Administrative Department under the State Council.     Chapter of medical accident preventing and dealing with the fifth medical institutions and medical personnel in medical activities, must be in strict compliance with medical and health management laws and administrative regulations, departmental regulations, and medical care standards, regular and abide by the professional ethics of medical services.     Sixth medical organizations should be of its medical personnel in health care management laws, administrative regulations, departmental rules and medical nursing standard, regular training and professional ethics education for medical services.     Seventh medical institutions shall set up medical services or quality control Department is equipped with spot (and) staff specifically responsible for monitoring work of the medical personnel of the medical service in medical institutions, check medical practice, accepts patients with complaints on medical services, to provide advisory services.     Eighth medical institutions shall, in accordance with the requirements prescribed by the health Administrative Department under the State Council, write and keep medical records.     For rescuing patients with acute diseases, failing to write medical records in a timely manner, relevant medical personnel should be completed within 6 hours after the end of the rescue, and annotated.     The Nineth no alteration, falsification, concealment, destruction or seizing medical records.     Tenth patients have the right to copy or replicate their outpatient medical records, hospital records, temperature, orders, orders, laboratory (analytical report), medical imaging information, special examination consent, consent, surgery and anaesthesia records, pathology, nursing records and other medical records of the health Administrative Department under the State Council. Patients in accordance with the provisions of the preceding paragraph require a copy or copies of medical records, medical institutions shall provide a copy or duplicate services and copy or copy stamped with proof marks on the medical records.     When you copy or copy medical records, patients should be present. Upon the request of patients in medical institutions, medical records for its copying or replication, you can charge fees in accordance with the regulations.     Specific rates by the provinces, autonomous regions and municipalities directly under the price administrative departments of health administration departments under the people's Government.     11th in medical practice, medical institutions and medical personnel should be the patient's condition, medical interventions, health risk, inform patients, answer their inquiries in a timely manner, however, one should not have an adverse effect on the patients.     12th medical institutions should be developed to prevent, plan for handling medical accidents, prevent the occurrence of medical accident, reducing medical malpractice damages. 13th article medical personnel in medical activities in the occurred or found medical accident, and may caused medical accident of medical fault behavior or occurred medical accident dispute of, should immediately to where Department head report, Department head should timely to this medical institutions is responsible for medical service quality monitoring of sector or designed (and) vocational personnel report; is responsible for medical service quality monitoring of sector or designed (and) vocational personnel received report Hou, should immediately for survey, and verified, will about situation truthfully to this medical institutions of head report     And communications, explained to the patient.     14th medical accident, medical agencies shall report to the local health authority in accordance with regulations.     Following major medical negligence occurred, the medical institution shall report to the local health administration department within 12 hours: (a) the causes of death or may be more than two medical malpractice, (ii) personal damage due to 3 or more; (c) the health Administrative Department under the State Council and provinces, autonomous regions, municipalities directly under other circumstances as prescribed by the Administrative Department of health under.     15th or find medical negligence, medical institution and its medical staff shall take immediate and effective measures to avoid or mitigate harm to patient health, prevent damage to expand. 16th medical accident disputes, proceedings of death cases, difficult cases discussion record, superior Ward records, consultation, course record should be in sealed and unsealed in the presence of both doctors and patients.     Copies of medical records can be sealed and kept by the medical institution.     The 17th suspected transfusion, blood transfusions, injections, medications and other adverse consequences, both doctors and patients should be common to the scene kind of sealed and unsealed, storage site kept by medical institutions in kind; needs testing, should be specified by both, according to inspection with inspection and testing qualification body; both sides when it is not common, designated by the Administrative Department of public health.     Suspected adverse consequences caused by blood transfusion, the blood needs to be sealed to retain, the medical institution shall notify the providing the blood the blood collection and supply agencies to the scene. 18th death, doctor-patient disagrees with the parties cannot determine the cause of death or the cause of death, shall, within 48 hours after death an autopsy; the body freezing conditions, can be extended to 7th.     Autopsies by close relatives of the deceased should be agreed and signed. Autopsies should be obtained in accordance with relevant regulations of the State eligible agencies and pathological anatomy of professional and technical personnel.     Assume control of autopsies of bodies and pathological anatomy of professional and technical personnel the obligation to have an autopsy. Medical dispute parties may participate at the forensic pathology at autopsy, may also appoint representatives to observe the autopsy process.     Refuse or delay the autopsy, exceeds the allotted time, impact on determining the cause of death, by refusing or delaying party responsibility. 19th patient deaths in medical institutions, the body should be immediately moved the morgue. Dead storage time should not exceed 2 weeks.     Fails to dispose of the bodies, and approved by the local health administrative departments of medical institutions, and reported to the public security departments at the same level after the filing, by medical institutions in accordance with the regulations for processing.     Third chapter medical accident of technology identification 20th article health administrative sector received medical institutions on major medical fault behavior of report or medical accident dispute party requirements processing medical accident dispute of application Hou, on need for medical accident technology identification of, should referred to the is responsible for medical accident technology identification work of medical will organization identification; medical patient both consultations solution medical accident dispute, need for medical accident technology identification of, by both party common delegate is responsible for medical accident technology identification work of medical will organization identification. 21st District, the municipal regional medical association of provinces, autonomous regions and municipalities directly under the jurisdiction of the County (City) local medical association is responsible for the Organization of medical accident technical appraisal work for the first time.     Provinces, autonomous regions and municipalities organize once again at the expense of the local medical association.     If necessary, the Chinese medical association can organize a difficult, complex and have major impact on the country's technical appraisal for medical accidents.     The 22nd party not satisfied with the conclusion of technical appraisal for medical accidents for the first time, since the date of receiving the conclusions for the first time in the 15th to local health administrative departments of medical institutions and retesting of applications.     23rd be responsible for the Organization of medical accident technical appraisal of medical experts should be established.     Experts made up of health professionals meet the following conditions: (a) have a good professional qualifications and practising virtue, (ii) employed by medical institutions or medical education, scientific research institutions and in senior professional positions for more than 3 years.     In line with the preceding paragraph (a) provides conditions and advanced technical qualifications of forensic experts could be recruited into the library.     Responsible for organizing the work of technical appraisal for medical accidents medical will in accordance with the provisions of this Ordinance to employ health professionals and forensic Access database can not be limited by administrative regions.     24th technical appraisal for medical accidents, responsible for the Organization of medical accident technical appraisal of medical organization expert team. Relevant professional experts in medical malpractice, by both doctors and patients in medical association under the auspices of randomly from the database.     In exceptional cases, medical association according to the needs of medical accident technical appraisal, organizations set up by both doctors and patients to other medical experts randomly selected relevant professional experts in identification or mail consultation.     Subject to this Ordinance, article 23rd conditions of health professionals and forensics have the obligation of employment into the experts database, and medical malpractice work. 25th medical malpractice expert group and collegiality.     Odd number of experts group, related to the subject of not less than one-second of the members of the Group of experts involved identification of the cause of death, disability scale, and should be randomly selected from an expert forensic participated in the expert group.     26th members of the experts group shall have any of the following circumstances shall withdraw, the party can also be made orally or in writing for its withdrawal: (I) is a medical accident disputes a party or a close relative of, (ii) and have a stake in medical malpractice and (iii) have other relationships with medical malpractice disputes the parties, may affect the impartiality of identification.     27th group of experts, in accordance with health care management laws, administrative regulations, departmental rules and medical nursing standard, conventional, using the principles of medical science and expertise, independent of technical appraisal for medical accidents, identification of medical accidents and found that providing medical basis for dealing with medical malpractice.     No unit or individual may interfere with medical malpractice, not threaten, cajole, abusing, beating members of the experts group.     Member of the experts group shall not accept property or other interests of the parties.     28th medical is responsible for the Organization of medical accident technical appraisal work will acceptance notice within the 5th days of technical appraisal for medical accidents medical malpractice disputes the parties submit materials required for medical malpractice. The Parties shall from the date of receipt of the notification of the Medical Association in the 10th on the medical malpractice materials, written statements and the respondent.     Medical institutions submitted of about medical accident technology identification of material should including following content: (a) hospital patients of course records, and death cases discussion records, and difficult cases discussion records, and consultation views, and superior physician rounds records, records information original; (ii) hospital patients of hospital records, and temperature single, and orders single, and laboratory single (test report), and medical image check information, and special check agreed book, and surgery agreed book, and surgery and the anesthesia records single, and pathology information, and nursing records, records information original;     (Iii) rescuing patients with acute diseases, missing the original medical records in the time allotted (iv) handling reserved goods and blood transfusion, injection, drugs and other physical, according to the inspection and testing qualification body for such items, physical examination reports; (v) related to medical malpractice and other materials.     Medical institutions built medical record of outpatient and emergency patients, their medical records provided by medical institutions without establishment of medical record in medical institutions, provided by the patient. Doctor and patient related materials shall be submitted in accordance with the provisions of this Ordinance.     Medical institutions without due cause fails to comply with these regulations provide relevant materials, medical malpractice cannot be carried out, shall be liable.     29th is responsible for the Organization of medical accident technical appraisal of Medical Association shall, upon receiving the party has submitted the medical malpractice materials, written statements and the respondent within 45 days of the date the organization identification and medical malpractice.     Responsible for the Organization of medical accident technical appraisal of medical investigation to the parties.     30th experts group should be carefully reviewed the material submitted by the parties, heard the parties ' representations and reply and verified. The Parties shall, in accordance with the provisions of this Ordinance, required materials submitted for medical malpractice, and cooperate with the investigation.     Either party fails to cooperate, influence of technical appraisal for medical accidents, by the responsible party fails to cooperate. 31st experts group should be based on clear facts and evidence, comprehensive analysis of the patient's illness and individual differences, make conclusions and make technical appraisal for medical accidents. Expert conclusions adopted by a majority of the members of the expert group.     Identification process should be the facts. Medical accident technology identification book should including following main content: (a) both party of basic situation and the requirements; (ii) party submitted of material and is responsible for organization medical accident technology identification work of medical will of survey material; (three) on identification process of description; (four) medical behavior whether violation medical health management legal, and administrative regulations, and sector regulations and clinic nursing specification, and General; (five) medical fault behavior and personal damage consequences Zhijian whether exists causal relationship; (six) medical fault behavior in medical accident     Damage in the aftermath of the degree of responsibility; (VII) medical accident levels; (VIII) medical care for patients of medical malpractice medical advice.     Article 32nd medical malpractice identification measures shall be formulated by the health Administrative Department under the State Council. 33rd article has following case one of of, not belongs to medical accident: (a) in emergency situation Xia for rescue dying patients life and take emergency medical measures caused bad consequences of; (ii) in medical activities in the due to patients illness exception or patients physique special and occurred medical accident of; (three) in existing medical science technology conditions Xia, occurred cannot expected or cannot prevention of bad consequences of; (four) no fault transfusion infection caused bad consequences of; (five) for patient party reasons delays clinic led to bad consequences of; (     F) adverse consequences caused by force majeure. 34th technical appraisal for medical accidents, appraisal cost can be charged. Identified, belong to medical malpractice, appraisal costs paid by the medical institution; not part of the medical malpractice, appraisal fees apply in the handling of medical accidents by the party.     Identification of cost standard by the provinces, autonomous regions and municipalities the price administrative departments, prescribed by the Administrative Department of health of the financial sector.     Fourth chapter of medical malpractice administrative processing and supervision article 35th health administrative departments shall, in accordance with this Ordinance and the provisions of the relevant laws, administrative regulations, departmental rules, medical institutions and medical personnel for medical incidents occurring in administrative processing.     36th public health Administrative Department receives reports on important medical negligence in medical institutions, in addition to order medical treatment medical institutions to take the necessary measures to prevent damage expansion of, should organize the investigation, determine whether the medical malpractice; cannot determine whether the medical malpractice, should be responsible in accordance with the relevant provisions of this Regulation referred to the identification of medical accident technical appraisal of medical organizations. 37th medical accident disputes, the Parties apply for administrative departments of public health, it shall submit a written application.     The application shall set forth the applicant's basic situation, relevant facts, specific requests and reasons.     Party knew or should have known that their physical health is within 1 year from the date of injury, may appeal to the administrative departments of public health medical malpractice disputes to process the request. Article 38th of medical accident disputes, the Parties apply for administrative departments of public health, by the Administrative Department of health under the county level, where the medical institutions accepted.     Medical institutions located in municipalities, by medical institutions in local district and county administrative departments of health under accepted.     Has following case one of of, County Government health administrative sector should since received medical institutions of report or party proposed medical accident dispute processing application of day up 7th within transferred Shang level government health administrative sector processing: (a) patients death; (ii) may for II level above of medical accident; (three) State health administrative sector and province, and autonomous regions, and municipalities Government health administrative sector provides of other case. 39th administrative departments for public health shall from the date of receiving the application for medical accident disputes within the 10th review, make a decision on whether to accept.     To comply with the provisions of this Ordinance, be entertained, need for medical malpractice, shall from the date of decision on admissibility the relevant material to within 5th is responsible for identification of medical accident technical appraisal of medical organizations and notify the applicant in writing; do not meet the provisions of this Ordinance, is inadmissible, it shall notify the applicant in writing and state the reasons.     The party disagrees with the conclusion of technical appraisal for medical accidents for the first time, apply for retesting, health administrative departments shall, from the date of receipt of the application referred to in the 7th of provinces, autonomous regions and municipalities directly under the local medical organizations and retesting.     40th parties both to the administrative departments of public health medical malpractice disputes the processing of applications, and initiate litigation to the people's Court, Administrative Department of public health was inadmissible; Administrative Department of public health has been accepted, shall be terminated.     41st health Administrative Department is responsible for the Organization of medical accident technical appraisal of technical appraisal for medical accidents issued by the Medical Association book, shall participate in the identification of the personnel qualification and professional category, identification procedures for auditing if necessary, may appoint an investigation, hearing the views of medical accident disputes the parties.     42nd health administrative departments audited, to comply with the provisions of this Ordinance the conclusion of technical appraisal for medical accidents, should serve as the medical incidents occurring in medical institutions and medical staff administrative and medical basis for accident compensation conciliation; audited found that medical malpractice does not comply with the provisions of this Ordinance, shall require recertification.     43rd medical malpractice disputes resolved by the parties themselves, the medical institution shall, from the date of negotiation in the 7th to local health administrative departments to provide a written report and attached with the letter of agreement.     44th medical malpractice judgment by the people's Court for mediation or solved by medical institutions shall receive the entry into force of court mediation books or judgements within 7th day of to provide a written report to local health administrative departments, and affix the conciliation statement or judgement.     Article 45th health administrative departments under local people's Governments at or above the county level shall step by step in accordance with regulations of local medical accidents and the law on medical incidents occurring in medical institutions and administrative processing of medical personnel, reported the health Administrative Department under the State Council.     Fifth chapter of medical malpractice compensation 46th civil liability for compensation of medical accident disputes between doctors and patients can be settled without consultation or negotiation, the parties may apply for mediation to the health administrative departments, civil action can also be directly to a people's Court. 47th parties consultation of civil liability for compensation of medical accident disputes, it shall make the agreement.     Agreement shall set forth the basic situation of the parties and the medical cause of the accident, the two sides jointly identified by the parties in medical malpractice and discussion to decide the amount of compensation, and when the agreement is signed by the parties. 48th article has been identified as medical malpractice, health administration medical malpractice disputes the parties request compensation for medical malpractice mediation.     When the mediation, parties should follow the principle of voluntariness and shall be calculated according to the provisions of this Ordinance the amount of compensation.     After mediation, the parties reached an agreement on the amount of compensation, and mediation, the Parties shall perform; after a conciliation agreement, the mediation fails or estoppel of a party, no longer mediate the health Administrative Department.     49th malpractice, you should consider the following factors, to determine the specific compensation amounts: (a) the medical accident, (ii) medical negligence in the medical consequences of the damage degree of responsibility; (c) the medical consequences of the damage and relationship between patients with existing disease.     Not part of the medical malpractice, medical institutions would not be liable. 50th malpractice Awards, and standards in accordance with the following items: (a) medical expenses: according to medical malpractice personal injury treatment to patients by medical costs, payment credentials, but does not include the primary diseases medical expenses.     Really need to continue therapy after closing, according to pay basic medical expenses.     (B) the delay compensation: patients with fixed income, in accordance with his or her loss of reduction of fixed income on income above the medical incidents on the ground, year 3 times more than the average wage of staff and workers in the previous year, calculated in accordance with 3 times; no fixed income, according to medical incidents on the ground, a calculated annual average wage of workers.     (C) the hospital food allowances: according to the medical staff of the State where the accident occurred on a business trip the food subsidy standards.     (D) the accompanying fee: patients need special care, according to medical incidents on the ground, a calculated annual average wage of workers.     (E) disability living allowance: according to grade, according to the resident medical incident occurs, the average annual cost of living calculations, custom residual maximum compensation of 30 years of the month; however, more than 60 years old, no more than 15 years; more than 70 years old, no more than 5 years.     (F) equipment costs of disability: disability compensation apparatus needs to be configured, with proof of medical institutions, in accordance with the costing of universal-type apparatus.     (G) the funeral expenses: funeral expenses allowances in accordance with medical incidents calculated. (H) the dependants living: to the deceased or disabled before the incapacity to actual maintenance and no able-bodied person limit, according to their domicile or residence resident's minimum living standard. Under 16 years of age, raised to 16 years of age.     To the age of 16 without the ability to work, to support 20 years; however, more than 60 years old, no more than 15 years; more than 70 years old, no more than 5 years.     (I) travelling expenses: in accordance with actual patients with necessary traffic costs, payment credentials.     (J) accommodation fee: according to the medical staff of the State where the accident occurred on a business trip accommodation allowances calculated payment credentials. (11) the mental injury compensation: according to the resident medical incident occurs, the average annual cost of living calculations.     Causing the death of the patient, oldest of compensation not to exceed 6 years; cause patients with disabilities, compensation period not longer than 3 years.     51st medical treatment required for close relatives of patients with transportation costs, time costs, accommodation costs, calculated with reference 50th of the relevant provisions of these regulations, costing no more than 2 people.     Deaths caused by medical malpractice, participate in funeral activities of patients ' spouses and immediate family required transportation, time, accommodation, reference to the 50th of the relevant provisions of this Ordinance, costing no more than 2 people.     52nd medical malpractice compensation cost, one-off settlement, paid for by the medical institutions bear responsibility for the accident.     Sixth chapter penalty is 53rd article health administrative sector of staff in processing medical accident process in the violation this Ordinance of provides, using positions Shang of convenience received others property or other interests, abuse, negligence, or found violations not investigation, caused serious consequences of, in accordance with criminal on bribery crime, and abuse crime, and negligence crime or other about crime of provides, law held criminal; is enough criminal punishment of, law give downgraded or dismissed of administrative sanctions.     54th article health administrative sector violation this Ordinance of provides, has following case one of of, by superior health administrative sector give warning and ordered deadline corrected; plot serious of, on has responsibility of competent personnel and other directly responsibility personnel law give administrative sanctions: (a) received medical institutions on major medical fault behavior of report Hou, not timely organization survey of; (ii) received medical accident dispute processing application Hou, not in provides time within review or transferred Shang level government health administrative sector processing of;     (C) should be carried out were not major medical malpractice medical negligence or Medical Association organized the transfer of medical malpractice identification (iv) failing to step by step the local medical accidents and the law on medical incidents occurring in medical institutions and medical staff administrative report (v) not in accordance with the provisions of this Ordinance the audit of technical appraisal for medical accidents.     55th medical accidents medical institutions, by the health Administrative Department under the medical level and circumstances of the accident, warning in serious cases, ordered closed until revoked by the original Licensing Department license to practice, on the responsibility of medical staff in accordance with the provisions of the criminal law on the crime of medical accident, criminal responsibility shall be investigated according to law; not serious enough for criminal punishment, shall be subject to administrative or disciplinary action.     Of medical incidents relating to medical personnel, in addition to penalties in accordance with the preceding paragraph, health administrative departments and can be ordered to suspend for more than 6 months 1 year practice in serious cases, revoke a practising certificate. 56th article medical institutions violation this Ordinance of provides, has following case one of of, by health administrative sector ordered corrected; plot serious of, on has responsibility of competent personnel and other directly responsibility personnel law give administrative sanctions or disciplinary: (a) not truthfully told patients illness, and medical measures and medical risk of; (ii) no due reason, refused to for patients provides copy or copy records information service of; (three) not according to State health administrative sector provides of requirements writing and properly custody records information of ; (Four) not in provides time within fill remember rescue work records content of; (five) not according to this Ordinance of provides sealed, and custody and unsealed records information and real of; (six) not set medical service quality monitoring sector or equipped with designed (and) vocational personnel of; (seven) not developed about medical accident prevention and processing plans of; (eight) not in provides time within health administrative sector report major medical fault behavior of; (nine) not according to this Ordinance of provides to health administrative sector report medical accident of; (ten     ) Is not in accordance with the provisions of the autopsy and preservation, disposal of carcasses.     57th medical accident technical appraisal work of personnel in violation of the provisions of the Ordinance, application for identification of the parties or a party's property or other interests, and issue false medical malpractice, resulting in serious consequences, in accordance with the provisions of the criminal law on the crime of bribery, criminal responsibility shall be investigated according to law; not serious enough for criminal punishment, by the original issuing authorities revoke a practising certificate or certificate.     58th article medical institutions or other about institutions violation this Ordinance of provides, has following case one of of, by health administrative sector ordered corrected, give warning; on has responsibility of competent personnel and other directly responsibility personnel law give administrative sanctions or disciplinary; plot serious of, by original sent card sector revoked its practice industry certificate or qualification certificate: (a) bear autopsy task of institutions no due reason, refused to for autopsy of; (ii) altered, and forged, and hidden, and destroyed records information of.     59th on the grounds of medical accident, cause trouble, Rob data, disrupt the normal order of medical institutions and medical malpractice, in accordance with the provisions of the criminal law on the crime of disturbing public order, criminal responsibility shall be investigated according to law; not serious enough for criminal punishment, they shall be given administrative penalties for public security. The seventh chapter by-laws 60th Medical institutions mentioned in these regulations refers in accordance with the provisions of the regulation of medical institutions having a medical license to practice agencies. County above city engaged in family planning technology service of institutions in accordance with family planning technology service management Ordinance of provides carried out and family planning about of clinical medical service, occurred of family planning technology service accident, in accordance with this Ordinance of about provides processing; but, which not belongs to medical institutions of County above city engaged in family planning technology service of institutions occurred of family planning technology service accident, by family planning administrative sector exercise in accordance with this Ordinance about provides by health administrative sector bear of accepted, and     Handed over to the medical organization in charge of technical appraisal for medical accidents identified the functions of mediation and compensation; family planning technical service accidents on the Agency and its responsibilities, and dealt with according to law.     61st unlawful medical practice, patients personal injury caused, not medical malpractice, violate the criminal law, criminal responsibility shall be investigated according to law; about compensation, directly by the victim initiate litigation to the people's Court.     62nd army medical services medical approach by Chinese health authorities and the Health Administration Department under the State Council in accordance with this Ordinance. 63rd these regulations come into force on September 1, 2002. The measures for the handling of medical accidents issued by the State Council on June 29, 1987 repealed simultaneously.  Prior to the implementation of this Ordinance have already dealt with the outcome of medical accident disputes, not reprocessed.