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

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颁布日期:20020404  实施日期:20020901  颁布单位:国务院

  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.

  April 4, 2002

  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;

  (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 independently 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.

  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 materials 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 administrative 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 the agreement.

  Article 44 If a medical dispute is settled through the mediation the people‘s court or through judicial decision, the medical institution shall, within 7 days after receiving the letter of mediation or judgment of the people’s court that has come into force, report in written form to the administrative department of health where it is located, attaching a copy of the letter of mediation or judgment.

  Article 45 The administrative department of health under the people‘s government on the county level and above shall report the medical accidents and the administrative punishments given to the medical institutions and staff members thereof according to relevant provisions level-by-level to the administrative department under the State Council.

  Chapter V Compensations for Medical Accidents

  Article 46 Disputes of civil liabilities including compensations for medical accidents may be settled between both parties through negotiations. If the parties concerned refuse to or fail to settle the dispute through negotiations, the parties concerned may file an application to the administrative department of health for mediation or institute a civil action directly to the people‘s court.

  Article 47 Where both parties settle disputes of civil liabilities concerning a medical accident through negotiations, a letter of agreement shall be concluded. The letter of agreement shall clearly specify the basic information about the parties concerned, the causes of the medical accident, the grade of the medical accident consented to by both parties, and the sum of compensations decided through negotiations, and shall be signed by the parties concerned.

  Article 48 Where a medical accident is determined, the administrative department of health may, upon the request of the parties concerned to the medical dispute, make mediations concerning the compensations over the medical accident. In the process of mediation, the principle of voluntariness by the parties concerned shall be observed, and the sum of compensations shall be calculated according to the relevant provisions of the present Regulation.

  If, after mediation, the parties concerned reaches a consensus over the sum of compensation, a letter of mediation shall be concluded and be performed by the parties concerned. If the mediation fails or if any of the parties goes back on its words after reaching a consensus, the administrative department of health no longer makes any further mediation.

  Article 49 The following elements shall be taken into consideration in the determination of the specific sum of compensation for a medical accident:

  (1) The grade of the medical accident;

  (2) The seriousness of the negligent medical act in the consequences of the injury caused by the medical accident;

  (3) The relationship between the injury caused by the medical accident and the state of the original illness.

  If a medical accident is defied, the medical institution is not responsible for making any compensation.

  Article 50 The compensation for medical accidents shall be calculated according to the following items and rates:

  (1) Medical treatment expenses: to be calculated according to the expenses for curing the personal injury caused by the medical accident on the basis of vouchers, but not including the expenses for curing the original illness. Where it is necessary to continue the medical treatment, they shall be paid according to the basic expenses of medical treatment.

  (2) Charge for loss of working time: If the patient has fixed income, it shall be calculated according to the fixed income reduced due to loss of working time; if the income of the patient is three times higher than the average salary of the employees during the previous year of the place where the accident has occurred, it shall be calculated at three times; if the patient has no fixed income, it shall be calculated according to the average salary of the employees during the previous year of the place where the medical accident has occurred.

  (3) Subsidies to board wages: they shall be calculated according to the level of subsidies granted to the common workers of the state organs on business travels of the place where the medical accident has occurred.

  (4) Accompaniment nursing expenses: where the patient is in need of a special person for accompaniment and nursing during his stay at hospital, the accompaniment and nursing expenses shall be calculated according to the average salary of an employee during the previous year at the place where the medical accident has occurred.

  (5) Subsidies for the disabled life: they shall be calculated according to the grade of disability and to the average living expenses of the dwellers of the place the medical accident has occurred for a maximum term of 30 years, starting from the month when disability is affirmed. However, if the patient is 60 years old or above, the period for paying the subsidies shall be no more than 15 years; if the patient is 70 years old or above, the period shall be no more than 5 years.

  (6) Expenses for appliances of the disabled: if complementary appliances are needed due to disability, the expenses thereof shall be calculated according to the expenses for popular appliances on the basis of the certification of the medical institution concerned.

  (7) Funeral expenses: they shall be calculated according to the subsidies for funeral expenses as provided by the local authorities of the place where the medical accident has occurred.

  (8) Living expenses for the supported: they shall be calculated according to the number of persons who do not have the ability of work and who were indeed supported by the deceased before death or the disabled person before losing working abilities on the basis of the minimum living insurance of the dwellers of the place of their census register or their dwelling place. If the supported are younger than 16 years old, the expenses shall be paid until they are 16; if they are over 16 years but do not have working abilities, the expenses shall be paid for a term of 20 years; if they are 60 years old or above, for a term of 15 years; if 70 years old or above, for a term of 5 years.

  (9) Traffic expenses: shall be calculated on the basis of actual expenses incurred from the patient concerned and be paid on the basis of vouchers.

  (10) Accommodation expenses: shall be calculated according to the subsidies for accommodation to be paid to common employees of the state organs for business tours of the place where the medical accident has occurred.

  (11) Solatia for spiritual injury: shall be calculated according to the average annual living expenses of the dwellers of the place where the medical accident has occurred. Where the patient has died, the solatia shall be paid for no more than 6 years; where the patient is disabled, for more than 3 years.

  Article 51 The traffic expenses, expenses for loss of working time, accommodation expenses that are needed for the closes relatives of the patient to participate in the settlement of the medical dispute shall be calculated according to the relevant provisions of Article 50 of the present Regulation, but the number of persons whose expenses are to be included shall not exceed two.

  Where any patient dies as a result of the medical accident, the traffic expenses, expenses for loss of working time, and the accommodation expenses of the spouse and direct close relatives of the patient that participate in the funeral activities shall be calculated according to the relevant provisions of the present Regulation, but the number of persons whose expenses are to be included shall not exceed two.

  Article 52 The compensatory expenses for medical accidents shall be calculated once and for all, and shall be paid by the medical institution that is held to be responsible for the accident.

  Chapter VI Punishment Provisions

  Article 53 In case any of the staff members of the administrative department of health violates, in the process of settling any medical disputes, any of the provisions of the present Regulation, accepting the property of other people or any other interests by taking advantage of his position, abusing his power, neglecting his duties, or knows of any of the violations but fails to investigate so that serious consequences have resulted, he shall be subject to criminal liabilities according to the provisions of the criminal law concerning bribery, abusing power, neglecting duties or other relevant crimes. If the violation is not serious enough for taking criminal liabilities, he shall be given an administrative punishment of demotion or dismissal from post.

  Article 54 In case any administrative department of health violates the provisions of the present Regulation by committing any of the following acts, it shall be given a warning by the administrative department of health on the higher level and be ordered to make corrections during a prescribed time limit. If the circumstances are serious, the person-in-charge and other people who are held to be responsible shall be given an administrative punishment:

  (1) Receiving the report of any serious negligent medical act but failing to arrange for investigations;

  (2) Receiving the application for settling medical disputes but failing to examine it or transfer it to the administrative department of health under the people‘s government on the next higher level within the prescribed time limit;

  (3) Failing to arrange for the societies of medical sciences to make authentications to the serious negligent medical acts or medical disputes that should have been given technical authentications;

  (4) Failing to report level-by-level the medical accidents that have happened in the local place and the administrative punishments given to the medical institutions and the staff members thereof that have incurred medical accidents to the administrative departments of health of higher levels; or

  (5) Failing to examine the letters of technical authentication medical accidents according to the provisions of the present Regulation.

  Article 55 Where any medical accident is incurred by any medical institution, the administrative department of health shall take the grade and other circumstances into consideration and give a warning; where the circumstances are serious, it shall be ordered to make rectifications within a time limit or the license of business thereof could even be canceled by the authority that issued the license, and the staff members who are held to be responsible shall be subject to taking criminal liabilities according to the provisions of the criminal law concerning the crime of medical accidents; if the accident is not serious enough for criminal punishment, they shall be given administrative punishments or disciplinary punishments.

  Apart from the punishments given to the medical professionals that have incurred medical accidents as provided in the preceding paragraph, the administrative department of health may also order them to suspend business for a term of not less than 6 months but not more than a year; where the circumstances are serious, the licenses of practice thereof may be canceled.

  Article 56 In case any of the medical institutions violates the provisions of the present Regulation by doing any of the following, it shall be ordered by the administrative department of health to make corrections; if the circumstances are serious, the person-in-charge and other people that are held to be responsible shall be given administrative punishments or disciplinary punishments:

  (1) Failing to truthfully inform the patient of the state of his illness, the measures of medical treatment or medical risks;

  (2) Refusing to photocopy or reproduce the case history materials for the patients without good reasons;

  (3) Failing to write or properly keep the case history materials in accordance with the requirements of the administrative department of health under the State Council;

  (4) Failing to make up case history materials of rescue within the prescribed time limit;

  (5) Failing to seal up, keep and open the case history materials or material objects according to the requirements of the present Regulation;

  (6) Failing to set up a department to arrange for full-time (or part-time) persons for the quality control of medical treatment services;

  (7) Failing to formulate preliminary plans for the prevention and handling of medical accidents;

  (8) Failing to report serious negligent medical acts to the administrative departments of health within the prescribed time limit;

  (9) Failing to report medical accidents tot eh administrative departments of health according to the provisions of the present Regulation;

  (10) Failing to make autopsies or to keep or handle corpses according to the provisions of the present Regulation.

  Article 57 In case any of the professionals that participate in the technical authentications of medical accidents violates the provisions of the present Regulation by accepting any property or other interest of both or either party that applies for authentications, issuing false letters of technical authentication of medical accidents, and thus causing serious consequences, he shall be subject to undertaking criminal liabilities according to the provisions of the criminal law concerning the crime of taking bribes; if the offence is not serious enough for criminal liabilities, the license of practice or qualifications certificate thereof shall be canceled by the authority that granted it.

  Article 58 In case any of the medical institutions or other organizations violates the provisions of the present Regulation by doing any of the following, it shall be ordered by the administrative department of health for making corrections and shall be given a warning; the person-in-charge and other people that are held to be directly responsible shall be given administrative punishments or disciplinary punishments according to law; if the circumstances are serious, the license of practice or qualifications certificate thereof shall be withdrawn by the authority that granted it:

  (1) Any institution undertaking the task of making autopsies failing to do so without good reasons;

  (2) Altering, fabricating, concealing or destroying any of the case history materials.

  Article 59 Any who picks quarrels and stirs up trouble or robs case history materials under the pretext of medical accidents so that the normal order of medical treatment and technical authentication of medical accidents is handicapped shall be subject to undertaking criminal liabilities according to the provisions of the criminal law concerning the crime of disrupting the order of the society; if the offence is not serious enough for criminal liabilities, he shall be subject to subject to punishments in respect of management of public security and order.

  Chapter VII Supplementary Provisions

  Article 60 The term “medical institution” as mentioned in the present Regulation shall refer to an institution that has obtained a “License of Practice by Medical Institutions” according to the provisions of the Regulation on the Administration of Medical Institutions.

  The technical accidents of birth control caused by the institutions that are engaged in providing technical services in birth control in the cities on the county level and above according to the Regulation on the Administration of Technical Services in Birth Control shall be handled according to the relevant provisions of the present Regulation. However, as for the accidents of birth control caused by the institutions that are not medical institutions in the cities on the county level and above, the functions of accepting and arranging for societies of medical sciences that are responsible for making technical authentications of medical accidents and mediating compensations that are exercised by the administrative departments of health according to the relevant provisions of the present Regulation shall be exercised instead by the administrative department of birth control. The institutions and persons thereof that have caused any accident of birth control shall be handled according to law.

  Article 61 Illegal medical practices that cause personal injuries to the patients shall not be deemed as medical accidents; if the provisions of the criminal law have been violated, the offender shall be subject to taking criminal liabilities; if any compensations are involved, the victim therefrom shall institute actions directly at the people‘s court.

  Article 62 The measures for the handling of medical accidents of military medical institutions shall be formulated by the PLA department of health in collaboration with the administrative department of health under the State Council on the basis of the present Regulation.

  Article 63 The present Regulation shall come into force as of September 1, 2002. The Measures for the Handling of Medical Accidents which was promulgated by the State Council on June 29, 1987 shall be annulled concurrently. The disputes that have already been settled prior to the implementation of the present Regulation shall not be handled anew.

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