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

levant provisions of the State and the professionals majoring in pathological anatomy. The institution and professionals of pathological anatomy that make the autopsy shall be under the obligation of making autopsies.

　　Both parties to a medical dispute may invite legal medical experts and pathological experts to participate in the autopsy； they may also delegate persons to observe the process of autopsy. Any one who refuses to make or delays the autopsy until the time limit expires and the determination of the cause of death is affected， the party that refuses or delays shall be held to be responsible.

　　Article 19 If the patient dies within the medical institution， the corpse thereof shall be removed to the mortuary. As a general rule， the corpse may not be kept in the mortuary for more than two weeks. In case the corpse fails to be handled within the time limit， the medical institution shall， after obtaining the approval of the local administrative department of health and reporting to the department of public security at the same level for archivist purposes， handle the corpse according to relevant provisions.

　　Chapter III Technical Authentication of Medical Accidents

　　Article 20 Where the administrative department of health receives the report of any medical institution about any serious negligent medical acts or the application of the party to any medical dispute for handling and finds it necessary to make a technical authentication of the medical accident， it shall have the authentication done by the societies of medical sciences that are in charge of authenticating medical disputes. Where both parties agree to settle the medical dispute through mediation and a technical authentication is needed， the authentication shall be done by the society of medical sciences in charge upon the joint entrustment of both parties.

　　Article 21 The local societies of medical sciences of the cities with districts and the local societies of medical sciences of the counties or cities that are under the direct jurisdiction of the provinces， autonomous regions or municipalities directly unde

r the Central Government shall be responsible for making the initial authentication of medical accidents. The societies of medical sciences of the provinces， autonomous regions or municipalities directly under the Central Government shall be responsible for further authentications.

　　Where it is necessary， the All-China Society of Medical Sciences may organize technical authentications for difficult or complicated medical disputes of national significance.

　　Article 22 In case any party refuses to accept the conclusion of the initial authentication of medical accidents， it may apply， within 15 days after receiving the conclusion of the initial authentication， to the local administrative department of health where the medical institution is located for a second one.

　　Article 23 The societies of medical sciences that are responsible for organizing authentications of medical accidents shall set up databases of experts.

　　The database of experts shall consist of medical professionals that satisfy the following conditions：

　　（1） Having good professional knowledge and being of excellent professional ethics；

　　（2） Being employed by a medical institution or institution of medical teaching or research and holding a senior professional title for three years or more；

　　（3） Any legal medical expert who satisfies the conditions as provided in item （1） of the preceding paragraph and holds a senior professional title may be included in the database of experts.

　　The societies of medical sciences that are responsible for organizing authentications of medical disputes may invite medical professionals and legal medical expert to be included in the expert databases without consideration of administrative jurisdictions.

　　Article 24 Technical authentications of medical disputes shall be done by expert authentication groups organized by the societies of medical sciences that are responsible for organizing technical authentications of medical accidents.

　　The experts of relevant majors that participate in the technical authentication of medical accidents shall be selected randomly by both parties to the medical dispute from the expert database under the auspices of the society of medical sciences. However， under special circumstances， the society of medical sciences may， according to the need of technical authentication of medical accidents， arrange both parties select randomly experts of relevant majors from the expert databases set up by other societies of medical sciences to participate in the authentication or to provide consultation services by mail.

　　The medical professionals and legal medical experts that meet the conditions as provided in Article 23 of the present Regulation shall be obliged to be included in the databases of experts and to undertake technical authentications of medical accidents.

　　Article 25 The collegiate system shall be practiced in the technical authentication of medical accidents by the groups of experts. The number of experts in the groups shall be in odd number， and， as a general rule， the experts of the dominating major involved shall not be less than one half of all the members of the groups. In the authentication of the cause of death or the grade of injury， legal medical experts shall be selected randomly from the database of experts to participate in the groups of experts.

　　Article 26 In any of the following circumstances， members of the groups of experts shall withdraw， and the parties concerned may plead their withdrawal in oral or written form：

　　（1） Being a party or a close relative of the party to the medical dispute；

　　（2） Having interests in the medical dispute；

　　（3） Having other relationship with the parties concerned that may affect the impartiality of authentication.

　　Article 27 The groups of authentication experts shall authenticate the medical accidents indepen

dently by following the laws， regulations， ministerial rules concerning health and the standards or conventions of medical treatment and nursing， using medical principles and professional knowledge， make authentications and judgments of medical accidents and provide medical basis for the settlement of medical disputes.

　　No entity or individual may disturb the authentication of medical accidents， or menace， lure by promise of gains， revile or batter any member of the authentication groups.

　　No member of the authentication groups may accept any of the property or any other interest of any party concerned.

　　Article 28 The society of medical sciences that is responsible for organizing technical authentications of medical accidents shall， within 5 days after accepting the application for technical authentication， inform both parties to the medical dispute to submit materials needed for the technical authentication.

　　The parties concerned shall， within 10 days after receiving the notice of the society of medical sciences， submit the relevant materials of technical authentications， written statements and answers. The materials of technical authentication of medical accidents submitted by the medical institution concerned shall consist of the following：

　　（1） The original case history materials， including the records of the course of diseases of the in-hospital patient， minutes of discussion of deaths， minutes of discussion of difficult or complicated cases， opinions of consultations， the records of looking over wards by doctors at higher levels， etc.

　　（2） The original case history materials， including in-hospital records of the patient， temperature records， doctor‘s advice， tests papers （testing reports）， medical image examination materials， letters of consent to special examinations， letters of consent to medical operations， medical operations and anaesthesia records， pathological materials， nursing records， etc.；

　　（3） The original case history materials made up during the prescribed time period for rescuing dangerous patients；

　　（4） The material objects like fluid， injection tools， blood， medicines， etc. that have been sealed up for keeping， or testing reports issued by eligible testing institutions concerning the said tools and materials objects；

　　（5） Other materials relating to the technical authentication of the medical accident.

　　The case history materials of the patients who has a case history archive in the medical institution shall be provided by the medical institution， those who do not have a case history archive in the medical institution， the case history materials thereof shall be provided by the patient concerned.

　　Both parties shall provide relevant materials in conformity with the provisions of the present Regulation. Any medical institution that fails to provide relevant materials truthfully in conformity with the provisions of the present Regulation without good reasons so that the technical authentication of the medical accident cannot be held shall be held to be responsible.

　　Article 29 The society of medical sciences that is responsible for organizing the technical authentication shall， within 45 days after receiving the materials， written statements and answers relevant to the technical authentication of the medical accident submitted by the parties concerned， organize an authentication and issue a conclusion of authentication.

　　The societies of medical sciences that are responsible for organizing technical authentications of medical accidents may conduct investigations and gather evidences from the parties concerned.

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