Regulation on the Handling of Medical Accidents

Regulation on the Handling of Medical Accidents Order of the State Council (Docket No. 351) 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 April 4, 2002 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. Where any patient demands to photocopy or reproduce case history materials according to the provisions of the preceding paragraph, the medical institutions shall provide photocopy or reproduction services, and shall attach seal to the photocopied or reproduced case history materials for proof purposes. In the process of photocopying or reproducing case history materials, the patient concerned shall be present at the scene. The medical institutions may charge costs of production when photocopying or reproducing case history materials as per the requirement of patients. The specific rate of charge shall be formulated by the departments in charge of price affairs under the people's government of the provinces, autonomous regions, and municipalities directly under the Central Government jointly together with the administrative departments of health. Article 11 In the activities of medical treatment, medical institutions and the staff members thereof shall inform the patients truthfully of the state of illness, measures of medical treatment, medical risks, etc., and shall give answers to their inquiries in a timely way unless, however, unfavorable consequences may happen to the patient concerned. Article 12 Medical institutions shall make preventive plans for avoiding and handling medical accidents so as to avoid the occurrence of medical accidents and mitigate the injuries of medical accidents. Article 13 Where any medical worker incurs or finds, in medical treatment activities, medical accidents or negligent medical acts that may lead to medical accidents or medical treatment disputes, he shall report to the person-in-charge of the section where he works immediately, and the person-in-charge shall report in turn to the department in charge of quality control or the full-time (or part-time) person of the medical institution in a timely way. The department in charge of quality control or the full-time (or part-time) person shall, after receiving the report, make immediate investigations and verifications, report the result truthfully to the person-in-charge of the medical institution, and inform explain to the patients concerned. Article 14 In case any medical accident occurs, the medical institutions shall report to the local administrative department of health. In case any of the following serious medical negligent acts occurs, the medical institution concerned shall report to the local administrative department of health within 12 hours: (1) those that have incurred the death of patients or that may be a Grade II medical accident of above; (2) those that have incurred personal injury to three persons or more; (3) other circumstances as provided by the department under the State Council in charge of health or the administrative department of health under the people's government of the provinces, autonomous regions or municipalities directly under the Central Government. Article 15 In case any negligent medical act occurs or is found, the medical institution and the medical workers thereof shall take immediate and effective measures so as to avoid or mitigate the injuries done to the body of the patients and to prevent the deterioration of the injuries. Article 16 In case any medical treatment dispute arises, the minutes of discussing deaths, minutes of discussing difficult and complicated cases, the records of looking over wards by doctors at higher levels, opinions of consultations, and the records of the course of diseases shall be sealed and opened when both parties to the dispute are present at the scene. The case history materials that are sealed may be photocopies, and shall be kept by the medical institution concerned. Article 17 In case unfavorable consequences seem to be caused by fluid infusion, blood transfusion, injection, medicines, etc., both parties to the dispute shall seal up and open the material objects jointly at the scene, and the material objects shall be kept by the medical institution concerned. Where any test is needed, the test shall be done by the eligible testing institution that has been jointly designated by both parties. If both parties cannot make a joint designation, the administrative department of health shall designate the testing institution. In case unfavorable consequences seem to be caused by blood transfusion and the blood needs to be sealed up for keeping, the medical institution shall inform the blood collecting and providing institution that has provided the blood to be present at the scene. Article 18 Where any patient dies, and both the medical institution and the relatives of the patient cannot determine the cause or they have different ideas about the cause, an autopsy shall be made within 48 hours after the patient dies. Where there are facilities for freezing the corpse, the time limit may be extended to seven days. The autopsy shall be subject to the consent of the close relative of the patient by way of affixing his or her signature. The autopsy shall be done by the institution that has obtained corresponding qualifications according to the relevant 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 under 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; 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 medi......