The Regulation on the Handling of Medical Accidents has been passed at the fifty fifth executive meeting of the State Council on February 20, 2002, and is hereby promulgated for implementation as of September 1, 2002.
Zhu Rongji, Premier of State Council
The Regulation on the Handling of Medical Accidents
Chapter I General Provisions
Article 1 The present Regulation has been enacted for the purpose of correctly handling medical accidents, protecting the lawful rights and interests of the patients, medical institutions and the staff members thereof, maintaining the medical order, safeguarding the security of medical treatment, and promoting the development of the medical science.
Article 2 The term “medical accident” as mentioned in the present Regulation shall refer to those that have caused personal injury to the patients negligently by the medical institutions or the staff members thereof in the activities of medical treatment by violating the laws, regulations, ministerial rules concerning medical treatment and health or the standards or conventions of medical treatment and nursing.
Article 3 In the handling of medial treatments, the people involved shall follow the principles of openness, fairness, justice, timeliness, and convenience, be practical and realistic so as to achieve the goal of clear fact finding, precise determination of the nature, clear determination of responsibilities and proper handling.
Article 4 Medical accidents shall be classified, according to the seriousness of the injuries done to the body of the patient, into four categories:
Grade I medical accidents: those that have caused death or serious disability of patients;
Grade II medical accidents: those that have caused mid-level disability or injury to the organs which leads to serious functional obstacles;
Grade III medical accidents: those that have caused mitigated disability or injury to the organs which leads to general functional obstacles;
Grade IV medical accidents: those that have caused obvious injury to the body of patients or other consequences.
The criteria for specific grades shall be formulated by the department of the State Council in charge of health.
Chapter II Prevention and Handling of Medical Accidents
Article 5 Medical institutions and the staff members thereof shall, in the medical treatment activities, rigidly follow the laws, regulations, ministerial rules concerning medical treatment and health and the standards and conventions of medical treatment and nursing, and scrupulously abide by the professional ethics of medical treatment.
Article 6 Medical institutions shall educate the staff members thereof in terms of the law, administrative regulations, ministerial rules concerning medical treatment and health, training of the standards and conventions of medical treatment and nursing, as well as professional ethics of medical services.
Article 7 Medical institutions shall set up departments for the quality control of medical treatments or arrange for full-time or part-time persons to be responsible for supervising the medical treatment of the medical workers of the medical institution, inspecting the professional practice of the staff members, accept the complaints of patients concerning medical treatment, and provide consultation services.
Article 8 Medical institutions shall record and properly keep case history materials in conformity with the requirements of the department under the State Council in charge of health.
In case any case history fails to be recorded due to the rescue of dangerous patients, relevant staff members concerned shall make up the record according to the facts within 6 hours after the rescue finishes, and shall a remark shall be made.
Article 9 It shall be prohibited to alter, fabricate, conceal, destroy or rob case history materials.
Article 10 Any patient shall be entitled to photocopy or reproduce the outpatient case history, in-hospital records, 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 and other case history materials thereof as provided by the administrative department under the State Council in charge of health.
