医疗事故处理条例 The Regulation on the Handling of Medical Accidents

　　Article 30 The expert authentication group shall make a careful examination of the materials submitted by the parties concerned， listening to the statement and responses of both parties and making verifications.

　　The parties concerned shall provide truthfully the ma

terials needed for the technical authentication in conformity with the provisions of the present Regulation， and shall actively cooperate in the investigations. Any party that fails to give cooperation and thus affects the technical authentication shall be held to be responsible.

　　Article 31 The expert authentication group shall make authentication conclusions on the basis of clearing fact findings and irrefutable evidences by making comprehensive analysis of the state of illness of the patient concerned and the differences between the individuals， and issue a letter of authentication of medical accidents. The authentication conclusion shall be passed by half of the members of the expert authentication group. The process of authentication shall also be truthfully recorded.

　　The letter of authentication of medical accidents shall include the following major elements：

　　（1） basic information about demands of the parties concerned；

　　（2） the materials submitted by the parties concerned and the investigation materials provided by the society of medical sciences that is responsible for organizing the technical authentication；

　　（3） a description of the authentication process；

　　（4） whether the medical treatment act has violated any of the laws， regulations， ministerial rules concerning medical treatment and health or any of the standards or conventions of medical treatment and nursing；

　　（5） whether there is a causal relationship between the negligent medical act and the consequence of personal injury；

　　（6） the seriousness of the negligent medical act in the injury of medical accident；

　　（7） the grade of the medical accident；

　　（8） medical suggestions on the medical treatment and nursing to the patient involved in the medical dispute.

　　Article 32 The measures for the technical authentication of medical accidents shall be formulated by the administrative department under the State Council in charge of health.

　　Article 33 Any of the following circumstances shall not be deemed as a medical accident：

　　（1） unfavorable consequences resulting from emergent medical measures taken under dangerous circumstances for rescuing the life of the patient；

　　（2） medical emergencies resulting in the process of medical treatment from the unusual state of illness or the special physique of the patient；

　　（3） unfavorable consequences that cannot be predicted or prevented under the existing technical and medical conditions；

　　（4） unfavorable consequences caused by infections resulting from faultless blood transfusions；

　　（5） unfavorable consequences caused by the delay of the patient in medical treatment；

　　（6） unfavorable consequences caused by force majeure；

　　Article 34 Fees may be charged for technical authentications of medical accidents. If the authentication proves that the a medical accident has occurred， the expenses of authentication shall be paid by the medical institution concerned； if the authentication proves that no medical accident has occurred， the authentication expenses shall be paid by the party that applies for settling the medical accident. The rates of authentication expenses to be charged shall be formulated by the department of the people‘s government of the provinces， autonomous regions and municipalities directly under the Central Government in charge of price affairs in collaboration with the financial department and administrative department of health on the same level.

　　Chapter IV Administrative Punishment and Supervision of Medical Accidents

　　Article 35 The administrative department of health shall give administrative punishments to the medical institutions and staff members thereof that have caused medical accidents in accordance with the present Regulation and other relevant laws， regulations or ministerial rules.

　　Article 36 The administra

tive department of health shall， after receiving a report of serious negligent medical act， not only order the medical institution concerned to take necessary measures of medical treatment so as to prevent the deterioration of the injury， but also arrange for investigations so as to decide whether a medical accident has really occurred. If it is impossible to decide whether the negligent act is a medical accident， it shall arrange for the societies of medical sciences that are responsible for making technical authentications to make authentications according to the relevant provisions of the present Regulation.

　　Article 37 Where any medical dispute arises and the parties concerned apply the administrative department of health for settlement， the application shall be filed in written form. The application shall clearly state the basic information about the applicants， relevant facts， specific demands and the reasons thereof， etc.

　　The parties concerned may apply to the administrative department of health for settling a medical dispute within one year after he has known or should have known that injury has been caused to his body.

　　Article 38 Where a medical dispute arises and an application is filed by the parties concerned to the administrative department of health for settlement， the application shall be accepted by the administrative department of health under the people‘s government of the county where the medical institution is located. If the place where the medical institution is located is a municipality directly under the Central Government， the application shall be accepted by the administrative department of health of the district or county where the medical institution is located.

　　In any of the following circumstances， the administrative department of health of the people‘s government of the county shall， within 7 days after receiving the report of the medical institution or the application of the parties concerned for settling medical disputes， transfer to the administrative department under the people’s government on the next higher level for settlement：

　　（1） The patient has died；

　　（2） The negligent medical act might be determined as a Grade II medical accident；

　　（3） Other circumstances as provided by the administrative department of health under the State Council or the department of health under the people‘s government of the provinces， autonomous regions and municipalities directly under the Central Government.

　　Article 39 The administrative department of health shall， within 10 days after receiving the application for settling medical disputes， make an examination and decide whether to accept or not. Where the application satisfies the requirements as mentioned in the present Regulation， it shall be accepted； where a technical authentication is found to be of necessity， the administrative department of health shall， within 5 days after deciding to accept the application， transfer the relevant materials to the society of medical sciences that is responsible for making technical authentications of medical accidents so as to arrange for an authentication and inform the applicant in writing. If the application does not satisfy the requirements as mentioned in the present Regulation， it shall not be accepted， and the applicant shall be informed in writing together with an account of the reasons.

　　In case any of the parties concerned refuses to accept the conclusion of the first authentication and pleads for a further one， the administrative department of health shall， within 7 days after receiving the application， arrange for the local society of medical sciences of the province， autonomous region or municipality directly under the Central Government for another authentication.

　　Article 40 Where the parties concerned apply to the administrative department of health for settling a medical dispute， and at the same time files a

suit at the people‘s court， the administrative department of health shall not accept the application. If the administrative department has already accepted， it shall terminate the settlement.

　　Article 41 The administrative department shall， after receiving the letter of authentication issued by the society of medical sciences that is responsible for organizing technical authentications， examine the qualifications and major of the persons to participate in the authentication as well as the procedures of authentication. If it is necessary， it may arrange for investigations so as to listen to the opinions of both parties to the medical dispute.

　　Article 42 If， upon examination of the administrative department of health， the authentication conclusion of a medical accident satisfies the requirements provided in the present Regulation， it shall be taken as a basis for giving administrative punishments to the medical institution and the staff members thereof that have caused the medical accident and for mediating the compensation for the medical accident. If， upon examination， the authentication conclusion is found to be inconsistent with the provisions of the present Regulation， the authentication shall be done anew.

　　Article 43 If a medical dispute is settled through negotiation between both parties， the medical institution shall， within 7 days after the dispute is settled through negotiation， report in written form to the administrative department of the place where it is located， attaching a copy of t

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