Prevention Vaccination Identification Approach

Original Language Title: 预防接种异常反应鉴定办法

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Prevention vaccination identification approach

    (September 11, 2008 Ministry of health promulgated as of December 1, 2008, 60th) Chapter I General provisions

    First to standardize the appraisal work of preventive vaccination, according to the management of vaccine circulation and inoculation regulations and the provisions of the regulation on the handling of medical accidents, developed this approach.

    Unusual reaction of vaccination in article, refers to the practice for qualified vaccine vaccination process or implementation specification after inoculation caused by damage to body tissues and organs, function, adverse drug reactions of the relevant parties without fault.

    Article type or guardians (hereinafter referred to as the kind of party), vaccination, vaccine manufacturers to investigate the preventive vaccination diagnosis disputed application for identification of preventive vaccination, these measures shall apply.

    Investigation diagnosis in accordance with the preventive vaccination the Ministry of Health's requirement and specification for the vaccination.

    Specification for vaccinations in violation of vaccination, immunization programs, vaccine guidelines, vaccination programmes and other reasons for the kinds of damage, need for medical malpractice, according to medical malpractice regulations.

    For quality reasons or vaccine results disputed, in accordance with the provisions of the drug control Act, apply to the pharmaceutical supervisory and administrative departments.

    Fourth article shall follow the identification of preventive vaccination open and impartial principle, adhere to scientific attitude of seeking truth from facts, and the facts are clear and accurate.

    Fifth preventive vaccination and identification by District municipal and Medical Association of provinces, autonomous regions and municipalities are responsible for.

    Chapter II expert Sixth of provinces, autonomous regions and municipalities directly under the Medical Association preventive vaccination expert organization established for provincial districts of the city-level medical preventive vaccination identification expert.

    Experts from the clinical, epidemiological, medical laboratory, pharmacy and related subjects such as forensic experts, and related disciplines and professional groups.

    Medical Association according to the actual conditions of preventive vaccination and identification, appropriate increase or decrease to the specialty group of experts, to adjust the expert library members.

    Article seventh following conditions database of medical professionals can be used as candidates:

    (A) have a good professional qualifications and practising virtue;

    (Ii) employed by the medical institution or medical and health education, and scientific research institutions and holding senior professional positions for more than 3 years;

    (C) epidemiological experts should have 3 years relevant working experience in immunization; medical experts should have 3 years relevant working experience in vaccine;

    (D) health competent appraisal work of preventive vaccination.

    In line with the preceding paragraph (a), (d) conditions and with forensic qualifications were employed in senior technology positions into the experts database.

    The provinces, autonomous regions and municipalities directly under the medical will in principle to employ experts to experts within their respective administrative regions when experts within their respective administrative regions do not meet established experts when needed, may engage outside the administrative database of experts.

    Eighth medical institutions or medical teaching and research institutions, health professional association shall, in accordance with medical requirements, database recommended candidates eligible individuals by the consent of the unit can also apply directly to the formation of expert medical association into the experts database. Medical experts candidates for membership will be reviewed.

    Examination, appointment, and sent letters and documents in the unified format of Chinese Medical Association. Nineth experts members employed for a period of 4 years.

    Recruitment occurs during any of the following circumstances, medicines will be adjusted according to the actual situation:

    (A) for health reasons is not competent for prevention of vaccination identification;

    (B) the change of employment or dismissal;

    (C) does not have full capacity for civil conduct;

    (D) subject to criminal punishment;

    (E) identification of violation of work discipline, and in serious cases;

    (Vi) health administration departments at or above the provincial level and other circumstances as prescribed by the pharmaceutical supervisory and administrative department.

    Expiry of the employment needs continue to employ, the original external medical review, employment.

    Chapter III application and acceptance

    Tenth levels of various medical institutions, disease control and prevention and vaccination units and duty personnel found that preventive vaccination, suspected preventive vaccination or to the related reporting shall promptly to the local county health departments, reported the drug regulatory agency. The 11th provincial, district and municipal-level and county-level disease prevention and control institutions shall establish a preventive vaccination survey diagnostic group, responsible for preventive vaccination investigation and diagnosis.

    Investigation diagnosis expert group made up of epidemiological, clinical, pharmaceutical, and other experts.

    County Administrative Department of public health, received the drug regulatory agency suspected after reports of preventive vaccination, and to investigate the needs of, referred to the experts on disease prevention and control institutions at the county level for investigation and diagnosis.

    Any of the following circumstances, it shall be divided into districts for municipal or provincial prevention for vaccination diagnosis expert group to investigate diagnostic investigations:

    (A) the kinds of deaths, severe disability;

    (B) the group suspected of preventive vaccination;

    (C) have a significant impact on the community suspected of preventive vaccination.

    12th preventive vaccination survey diagnostic group of experts should be based on laws, administrative regulations, departmental rules and technical specifications, based on clinical symptoms, medical examination results and vaccine quality test results, analyze and conduct the investigation concludes.

    Death investigation and diagnosis of autopsy results, such refusal or does not cooperate with the autopsy, assume responsibility for investigation and diagnosis cannot be made.

    Investigation diagnosis expert group to investigate in the 10th after diagnosis, investigation and diagnosis at the Administrative Department of public health and medicine supervision and Administration Department.

    Article 13th investigation suspected diagnosis suspected cause of preventive vaccination, vaccine quality, pharmaceutical supervisory and Administrative Department is responsible for organizing the relevant vaccine quality inspection, survey results report.

    Article 14th species, inoculation, vaccine manufacturers to investigate the preventive vaccination diagnosis when there is a dispute, you can receive preventive investigation for vaccination diagnosis vaccination unit, within 60 days from the date of the conclusion of city divided into districts, where identification would require preventive vaccination of medical, preventive vaccination and submit identification materials.

    15th concerning preventive vaccination and identification materials should include the following:

    (A) the preventive vaccination survey concludes;

    (B) the conditions of health, informed consent informed vaccination records such as medical advice;

    (C) related to the diagnosis and treatment of outpatient medical records, hospital records, body temperature, advice, laboratory (analytical report), pathology, nursing, medical imaging data records, such as medical records;

    (D) the vaccine receives, buys and storage temperature records;

    (E) the batch of vaccine related inspection or sampling inspection reports, importing vaccines should also be provided by wholesale enterprises import drugs tongguan files;

    (Vi) other materials related to the identification and preventive vaccination.

    Species, inoculation, vaccine production enterprise shall, according to requirements, provided by their own saved or available materials.

    Is responsible for identification of medical identification will need access to medical institutions who of course records, death records, consultation and other medical records.

    16th under any of the following circumstances, medical identification will not accept preventive vaccination:

    (A) no preventive vaccination survey concludes;

    (B) the proceedings have been brought before the people's Court (except commissioned by the people's Court, the public prosecutor's Office), or people's Court conciliation agreement or judgment;

    (C) species, inoculation, vaccine manufacturers did not submit supporting documents;

    (D) the material provided is not true;

    (V) does not pay the appraisal fee;

    (Vi) other circumstances as stipulated by the provincial health Administrative Department.

    Identification of inadmissible, medical reasons shall be in writing.

    Article 17th districts City Medical Association refuses to accept the conclusions of the May 15th from the date of receipt of the certificate of preventive vaccination, vaccination unit is located in provinces, autonomous regions and municipalities would require further medical evaluation. Section 18th for identification of preventive vaccination, from apply pre pay the appraisal fee. Certified belongs to a class of vaccine caused the preventive vaccination, identification of costs prescribed by the financial sector in accordance with the arrangement; two vaccines cause of preventive vaccination, identification of costs borne by the vaccine manufacturers. No abnormal reactions, identification of costs borne by the party that makes an application for identification of abnormal reaction.

    Identification of preventive vaccination fees in accordance with the relevant provisions of the State.

    The fourth chapter identification 19th is responsible for the identification of the Medical Association of preventive vaccination should be based on accepted identification of the disciplines involved, and determine the composition and size of the expert group. Expert Group for more than 5 people in the singular. Expert team of researchers by the kinds of experts in a random drawing. The kind of party for more staff, can be carried out by 1-2 kinds of elected representatives of people randomly selected members of the experts group.

    Selection does not appear, the medical society will be responsible for taking.

    20th member of the Group has one of the following should be avoided:

    (A) kind of a relative of the person;

    (B) the unit staff;

    (C) the preventive vaccination identified interested persons;

    (D) persons involved in vaccination adverse reaction investigation and diagnosis;

    (E) other personnel who could affect the impartial identification.

    Material 21st experts group should be carefully reviewed and, if necessary, can listen to the kind of statements, vaccination, vaccine production enterprise, the kinds of medical examinations. Is responsible for the identification of the medicine could be under investigation at the request of the expert group, for investigation shall be not less than 2. After the end of the investigation, investigators and participants shall sign the relevant instruments.

    Respondents refused to sign it, should be recorded.

    Organizational identification when requested by the medical kind, vaccinations, vaccine manufacturers must provide relevant materials, without assuming the related negative consequences.

    22nd experts group should be proper identification of materials, protection of privacy, keeping the secret.

    The 23rd head of the expert group elected by the members of the expert group, or preventive vaccination controversy involved mainly senior specialists in the discipline. 24th experts group based on need, and drew attention to the Medical Association to invite other experts to participate in the identification of preventive vaccination.

    Invited expert technical advice, can provide relevant information, but do not vote in the conclusion.

    Invited experts must not have 20th under these measures.

    25th article difficult, complex and have major impact on the national preventive vaccination and identification, the local medical association can ask the technical guidance and support from the Chinese Medical Association. 26th experts group should be carefully reviewed the relevant information in accordance with relevant regulations and technical standards, the use of scientific principles and knowledge, independent appraisal. In fact on the basis of clear, comprehensive analysis, conclusions, and testimonials.

    Certificate format developed by the unity of Chinese Medical Association. Conclusions shall be more than half of the consensus of the members of the expert group formation. Expert group members to sign the conclusions.

    Members of the experts group on the conclusions of the different views should be stated. Unusual reaction of vaccination in 27th testimonial issued by the head of the expert group.

    Special seal for certificate shall bear the identification of preventive vaccination.

    Medicine should be made in identification service of preventive vaccination and identification within the 10th applicant, and submitted to local health administrative departments at the same level and drug regulatory authorities.

    28th preventive vaccination certificate should include the following elements:

    (A) applicants for identification reasons;

    (B) the related personnel, investigation of the submitted materials and medical materials;

    (C) vaccination and diagnosis;

    (D) the description of the identification process;

    (V) determination and basis for preventive vaccination;

    (F) preventive vaccination damage rating.

    Certified no prophylactic vaccination, should be justified in a testimonial.

    29th medical will participate in the preventive vaccination of staff appraisal, the appraisal process should be recorded. 30th Medical Association shall receive the preventive vaccination and identification material within 45 days from the date of organization identification, preventive vaccination certificate of authenticity.

    Special circumstances may be extended to 90 days.

    31st health administration departments, pharmaceutical supervisory and Administrative Department and other departments concerned found that identification of violations of the relevant provisions of this approach may require medicine to regroup identification.

    32nd medical identification documents and related information should be archived, retained for periods of not less than 20 years.

    33rd of provinces, autonomous regions and municipalities directly under the Medical Association should be before April 30 in each year will be the identification of unusual reaction of vaccination in administrative regions last year, Chinese Medical Association, also reported to the health administration departments, pharmaceutical supervisory and administrative departments at the same level.

    City Medical Association should be divided into districts before March 31 in each year the administrative year preventive vaccination situation report on identification of provinces, autonomous regions and municipalities directly under the medical and health administration departments, pharmaceutical supervisory and administrative departments at the same level.

    The fifth chapter supplementary articles

    Article 34th prevent vaccination need to be compensated, in accordance with the vaccine circulation and inoculation regulations regulations of the 46th. 35th these measures shall come into force on December 1, 2008. On January 22, 1980, issued by the Ministry of health vaccination after the reaction of the trial measures for the handling of the accident and at the same time repealed.

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