In view of the formal implementation of the People's Republic of China (PRC) Vaccine Management Law on February 20 19, in order to implement the People's Republic of China (PRC) Vaccine Management Law and the Measures for the Identification of Abnormal Reaction to Vaccination, and further standardize the vaccination work in our province, the Regulations on the Administration of Vaccine Circulation and Vaccination issued by the State Council shall be abolished accordingly. Protect the rights and interests of the recipients, reasonably and legally solve the compensation for the abnormal reaction of vaccination, and ensure the normal implementation of immunization programs. According to the actual situation in our province, the Provincial Health and Health Commission, the Provincial Department of Finance and the Provincial Drug Administration revised the Measures for Compensation for Abnormal Reaction of Vaccination in Shaanxi Province issued on 20 14. The revised "Shaanxi Province vaccination abnormal reaction compensation measures" issued to you, please follow.
The Measures for Compensation for Abnormal Reaction of Vaccination in Shaanxi Province (No.313 [2065] of Shaanxi CDC) shall be abolished as of the date of issuance of these Measures.
Shaanxi Provincial Health and Wellness Committee
Shaanxi Provincial Department of Finance
Shaanxi Provincial Drug Administration
February 2022 14
Chapter I General Principles
Article 1 In order to standardize the administration of compensation for adverse reactions to vaccination, these Measures are formulated in accordance with the relevant provisions of the People's Republic of China (PRC) Vaccine Administration Law (hereinafter referred to as the Vaccine Administration Law) and the Measures for the Identification of Adverse Reactions to Vaccination (hereinafter referred to as the Appraisal Measures), combined with the actual situation in our province.
Article 2 These Measures shall apply to the compensation for cases of abnormal reaction to vaccination within the administrative area of this province. .
Article 3 The term "abnormal reaction to vaccination" refers to the adverse drug reaction that the qualified vaccine causes damage to the tissues, organs and functions of the recipients during or after the implementation of standardized vaccination, and all parties concerned are not at fault.
Article 4 The following situations do not belong to the abnormal reaction of vaccination:
(1) The general reaction after vaccination caused by the characteristics of the vaccine itself;
(two) the vaccine quality is not up to standard, which causes damage to the recipients;
(three) the vaccination unit violates the vaccination work norms, immunization procedures, vaccine use guidelines and vaccination programs, causing damage to the recipients;
(four) the recipient is in the incubation period or precursor period of a disease at the time of inoculation, and the disease is coupled after inoculation;
(5) The recipient has the vaccination contraindications specified in the vaccine instructions, and the recipient or his guardian fails to truthfully provide the health status and vaccination contraindications of the recipient before vaccination, and the original disease of the recipient has an acute recurrence or aggravation after vaccination;
(6) Psychogenic reactions of individuals or groups caused by psychological factors.
Article 5 The handling and compensation of abnormal reactions to vaccination shall follow the principles of openness, fairness, impartiality, timeliness, convenience and humanization, adhere to the scientific attitude of seeking truth from facts, and ensure clear facts, accurate qualitative determination, proper handling and reasonable compensation.
Article 6 These Measures shall apply to the compensation of abnormal reactions of immunization programs. Compensation for abnormal reaction of vaccination caused by non-immunization program vaccine can be implemented with reference to these measures, and the health department at the county level where the vaccination unit is located is responsible for the disposal of abnormal reaction of vaccination.
The measures referred to in immunization program vaccine, refers to the vaccine provided by the government to residents free of charge, residents should be vaccinated in accordance with government regulations, including the vaccine determined by the national immunization program, the vaccine added by the provincial people's government in the implementation of the national immunization program, and the vaccine used by the people's government at or above the county level or its health authorities to organize emergency vaccination or mass vaccination. Non-immunization program vaccine refers to other vaccines that residents voluntarily vaccinate at their own expense.
Article 7 The compensation for abnormal reaction of vaccination shall be one-off.
If it is necessary to compensate the recipients for the abnormal vaccination reaction caused by the immunization program vaccine, the compensation fee shall be paid in the special compensation fund for the abnormal vaccination reaction arranged by the financial department of the provincial people's government. If it is necessary to compensate the recipient for the abnormal reaction caused by the non-immune program vaccine, the compensation fee shall be borne by the holder of the relevant vaccine marketing license. If there is any objection to the compensation funds, the county health department where the vaccination unit is located may organize the parties, the vaccine marketing license holders and relevant units to mediate. If mediation fails, it shall promptly inform the parties to bring a lawsuit to the people's court according to law.
All levels of vaccination abnormal reaction investigation and diagnosis expert group work funds arranged by the financial department at the same level in the budget.
Eighth vaccine quality is not up to standard, in accordance with the relevant provisions of the "Drug Administration Law" of People's Republic of China (PRC) and the "Tort Liability Law" of People's Republic of China (PRC); Inoculation units or individuals who violate vaccination work norms, immunization procedures, guiding principles for vaccine use and vaccination programs shall be dealt with in accordance with the relevant provisions of the Regulations on Handling Medical Accidents and the Tort Liability Law of People's Republic of China (PRC).
Article 9 The beneficiary of compensation for abnormal reaction of vaccination shall be the recipient or his legal guardian or legal heir (hereinafter referred to as the recipient).
Tenth health departments at all levels are responsible for the specific implementation of these measures, daily compensation management matters and supervision and management.
Chapter II Diagnosis and Appraisal
Eleventh provincial, municipal and county-level disease prevention and control institutions set up an expert group to investigate and diagnose the abnormal reaction of vaccination, which is responsible for the investigation and diagnosis of the abnormal reaction of vaccination in this area. No other medical and health unit or individual may make a diagnosis of abnormal reaction to vaccination.
Twelfth county-level health departments and drug supervision and management departments need to investigate and diagnose after receiving the report of suspected abnormal reaction to vaccination, and organize experts to investigate and diagnose to the county-level disease prevention and control institutions.
In any of the following circumstances, county-level organizations and provincial and municipal expert groups for the investigation and diagnosis of abnormal reactions to vaccination shall participate in the investigation and diagnosis:
(1) The recipient is dead, severely disabled, moderately disabled, has organ loss, serious defect, serious deformity, serious dysfunction, may have special medical dependence, or can't take care of himself for most of his life (that is, the second-class B and above damages stipulated in Article 19 of these Measures);
(2) Group suspected abnormal reaction to vaccination;
(3) Suspected abnormal reaction to vaccination that has a significant impact on society;
(4) Related cases after polio vaccination;
(five) other circumstances stipulated by the national or provincial health department.
Health and drug supervision and management departments at all levels shall effectively supervise the work of the expert group on the investigation and diagnosis of abnormal reactions to vaccination at the corresponding level according to law.
Thirteenth recipients, vaccination units, vaccine marketing license holders, vaccine distribution units should cooperate with the investigation of the investigation and diagnosis expert group, including providing original and true materials, and cooperate with the further physical examination, inspection, detection and autopsy of the dead cases. The investigation and diagnosis expert group may ask medical institutions for medical records such as course records, death case discussion records and consultation opinions, and medical institutions may not refuse.
Article 14 The investigation and diagnosis expert group shall complete the investigation and diagnosis within 90 days after receiving the report, and form a Report on Investigation and Diagnosis of Abnormal Reaction to Vaccination and a Report on Investigation and Diagnosis of Abnormal Reaction to Vaccination. Within 10 days after the conclusion of investigation and diagnosis is made, it shall report to the competent health department and drug supervision and administration department at the same level. The health department at the county level shall inform the recipients of the investigation and diagnosis conclusion within 5 days, and deliver the investigation and diagnosis conclusion of abnormal reaction to vaccination to the recipients (Annex 1).
Fifteenth if there are special circumstances, the investigation and diagnosis expert group can not make a diagnosis conclusion within 90 days, and it needs to be reported to the competent health department at the same level and the drug supervision and administration department for approval, which can be extended for another 60 days.
Article 16 If the recipient, the inoculation entity and the vaccine marketing license holder are in dispute about the conclusion of the investigation and diagnosis of the abnormal reaction to vaccination, they can apply to the municipal medical association where the inoculation entity is located for the identification of the abnormal reaction to vaccination within 60 days from the date of receiving the conclusion of the investigation and diagnosis of the abnormal reaction to vaccination, and submit the materials needed for the identification of the abnormal reaction to vaccination. If you are dissatisfied with the appraisal conclusion of the municipal medical association with districts, you can apply to the provincial medical association for re-appraisal within 15 days from the date of receiving the appraisal of abnormal reaction to vaccination. Where an application for appraisal is made, the appraisal conclusion shall prevail.
Appraisal work should be carried out in accordance with the "Appraisal Measures" and relevant regulations.
Seventeenth because of vaccination program vaccine need to apply for abnormal reaction identification, identification of funds required by the financial department at the same level included in the budget, the recipient does not bear the relevant expenses. If it is necessary to apply for the identification of abnormal reaction of vaccination due to vaccination of non-immunization program vaccine, the identification fee shall be borne by the holder of the relevant vaccine marketing license, and the recipient shall not bear the relevant expenses.
Eighteenth seed death investigation and diagnosis need autopsy results, it should be in accordance with the provisions of the "Regulations" eighteenth autopsy. The legal guardian or legal heir of the donee shall cooperate. The funds required for autopsy related work shall be arranged by the financial department at the same level in the budget, and the donee shall not bear the related expenses. If the subject refuses or does not cooperate with the autopsy, he shall bear the responsibility of being unable to carry out investigation and diagnosis.
Chapter III Classification of Damage Degree and Compensation Standards
Nineteenth vaccination abnormal reaction damage rating by the provincial and municipal medical associations.
If the investigation and diagnosis conclusion of abnormal reaction to vaccination is confirmed as abnormal reaction to vaccination, the recipient shall apply to the municipal medical association with districts for damage assessment within 60 days. If the municipal medical association with districts refuses to accept the assessment of the damage degree of abnormal reaction to vaccination, it may apply to the provincial medical association for re-assessment within 30 days after the municipal medical association with districts issues the assessment conclusion of the damage degree of abnormal reaction to vaccination.
Anyone who applies for medical association to identify the abnormal reaction of vaccination, if the identification conclusion is confirmed as the abnormal reaction of vaccination, the medical association that accepts the identification will also evaluate the degree of damage.
Due to the abnormal reaction caused by immunization program vaccine, the cost of vaccination rate assessment shall be arranged by the financial department at the same level in the budget, and the recipients shall not bear the relevant expenses. The grading fee for preventing abnormal reactions caused by unplanned immunization vaccine shall be paid by the holder of the relevant vaccine marketing license.
Article 20 The grading standards for judging the damage degree of abnormal reaction to vaccination shall be implemented with reference to the Grading Standards for Medical Accidents (Trial) promulgated by the former Ministry of Health and divided into four levels:
(1) Level I: causing death and severe disability.
1.A level: death.
2. Class B: the function of important organs is completely lost, other organs can't be compensated, they have special medical dependence, and they can't take care of themselves completely.
(II) Grade II: Causing moderate disability and organ and tissue damage, resulting in serious dysfunction.
1.A grade: organ loss or complete loss of function, other organs can not be compensated, there may be special medical dependence, or most of the life can not take care of themselves.
2. Class B: organ loss, serious defect, serious deformity, serious dysfunction, possible special medical dependence, or inability to take care of themselves for most of life.
3. Class C: organ loss, serious defect, obvious deformity, serious dysfunction, possible special medical dependence, or inability to take care of oneself in part of life.
4.d and so on. There are organ loss, most defects, deformity, serious dysfunction, general medical dependence and self-care.
(3) Grade III: causing slight disability and organ and tissue damage, resulting in general dysfunction.
1.A grade: organ loss, most defects, deformity, severe dysfunction, general medical dependence, self-care.
2. Class B: Most of the organs are defective or deformed, with moderate dysfunction. They may have general medical dependence and can take care of themselves.
3. Class C: Most of the organs are defective or deformed, with mild dysfunction, and may have general medical dependence and can take care of themselves.
4.d and so on. : Partial organ defect or deformity, mild dysfunction, no medical dependence, self-care.
5. Grade E: partial organ defect or deformity, slight dysfunction, no medical dependence, self-care.
(4) Grade IV: Other consequences that cause obvious personal injury.
Twenty-first first-class and first-class (death) cases with abnormal reaction to vaccination shall be compensated at one time according to the following standards.
Calculated according to the per capita disposable income of urban residents in Shaanxi Province in the previous year. 6 years old (including 6 years old) death, compensation for 6 years; 6-18 years old (including 18 years old), compensation 10 years old; 18 years old died, compensation 15 years.
Twenty-second cases of abnormal reaction to vaccination are Grade B to Grade IV, and the one-time compensation amount shall be calculated according to the following items and standards.
(1) Medical expenses: calculated according to the basic medical expenses incurred in the designated medical institutions of provincial medical insurance or new rural cooperative medical system after the abnormal reaction of vaccination, mainly including registration fees, examination fees, laboratory fees, operation fees, treatment fees, hospitalization fees, medicine fees, etc. The medical expenses for continuing treatment after compensation for abnormal reaction of vaccination shall not be compensated, subject to the Effective Bill for Outpatient (Emergency) Consultation and Hospitalization Expenses of Medical Institutions (excluding some medical expenses reimbursed by the new rural cooperative medical system or urban residents' medical insurance).
(2) Lost time expenses: The lost time expenses of the family members of the seed recipients and the seed recipients with fixed income during hospitalization (limited to 1) are calculated according to the average annual salary standard of the employees in Shaanxi Province in the previous year, with the maximum calculation of 1 year.
If the recipient is younger than 16 years old or has no job, he shall be compensated for the lost time of 1 person; If the recipient 16 years of age or older (including 16 years of age) is employed, compensation will be paid for the lost time.
The hospitalization time shall be based on the hospitalization medical records or the certificate issued by the inpatient hospital.
Compensation amount for lost time = hospitalization time (days) * average annual salary of on-the-job workers in cities and towns in Shaanxi Province last year (yuan) /365 days * number of workers.
(3) Living allowance for the disabled: The allowance is graded according to the harm degree of abnormal reaction to vaccination, and calculated according to the per capita disposable income of urban residents in Shaanxi Province in the previous year of the application year. Maximum compensation 10 year.
Living allowance for each disabled person = per capita disposable income of urban residents in Shaanxi Province last year * 10 years * disability grade coefficient. The damage grade coefficient from grade Ⅰ B to grade Ⅲ E decreased from 1 to 0. 1, and the difference among the grades was 10%.
(4) Disability appliance fee: If the aided person needs to be equipped with compensation functional appliances due to disability, the compensation fee shall be based on the price of a single domestic ordinary wheelchair in the current year, with a maximum of 3,000 yuan. Replace it every five years, and the compensation is calculated as 20 years.
(5) Transportation expenses: the transportation expenses actually incurred by the seed and 1 accompanying personnel for medical treatment. Pay by car or train ticket voucher (soft sleeper by plane or train, hard sleeper by train ticket fare), and relevant vouchers should be consistent with the place, time, times and frequency of medical treatment. The maximum shall not exceed 1 1,000 yuan.
(six) other expenses that are not compensated.
Twenty-third Shaanxi Province, the upper limit of one-time compensation for cases of abnormal reaction to vaccination.
(1) The upper limit of the total amount of one-time and two-time compensation: 20 times of the per capita disposable income of urban residents in Shaanxi Province last year.
(2) Grade IIA to Grade III is ***9, and the upper limit of one-time compensation for each grade = upper limit of compensation for Grade IB * damage grade coefficient; From Ⅱ A to Ⅲ E, the damage grade coefficient decreased from 0.9 to 0. 1, and the difference of each grade was 10%.
1. secondary damage: the total compensation fee shall not exceed 90% of the upper limit of the total compensation for primary damage.
2. Second-class and second-class damages: The total amount of compensation expenses shall not exceed 80% of the upper limit of the total amount of first-class and second-class damages.
3. Second-and third-level damages: The total compensation expenses shall not exceed 70% of the upper limit of the total first-and second-level damages.
4. Class 4.II and Class D damages: The total amount of compensation shall not exceed 60% of the upper limit of the total amount of class I and B damages.
5. Grade III and Grade I damages: The total compensation expenses shall not exceed 50% of the upper limit of the total compensation for Grade I and Grade II damages.
6. Third-level and second-level damages: The total compensation expenses shall not exceed 40% of the upper limit of the total damages for first-level and second-level damages. '
7. Third-class and third-class damages: The total amount of compensation expenses shall not exceed 30% of the upper limit of the total amount of first-class and second-class damages.
8. Grade III and IV damages: The total compensation fee shall not exceed 20% of the upper limit of the total damages for Grade I and II.
9. Class III and Class V damages: The total compensation expenses shall not exceed 65,438+00% of the upper limit of the total damages for Class I and Class II.
(three) the four-level one-time compensation amount does not exceed the per capita disposable income of urban residents in Shaanxi Province in the previous year.
Twenty-fourth in the process of handling the abnormal reaction of vaccination, the medical expenses and other related expenses of the recipients shall be paid by the recipients in advance, and shall be handled in accordance with the relevant regulations after the conclusion of investigation, diagnosis or appraisal of the abnormal reaction of vaccination comes out.
Article 25 In addition to the compensation provided for in these Measures, the municipal and county (District) people's governments shall, in accordance with the principle of territorial management, implement relevant policies such as medical rehabilitation, life assistance, employment and disability care for abnormal reaction cases, give follow-up care and help, and strive to minimize the misfortune caused by abnormal reaction to cases and their families.
Twenty-sixth abnormal reactions to vaccination can not be ruled out by the final theoretical investigation, diagnosis or identification, and the provisions of these Measures shall be applied to make one-time compensation.
Chapter IV Acceptance and Compensation Procedures
Article 27 If a seed recipient is diagnosed or identified as an abnormal reaction to vaccination, he may, within 90 days from the date of receiving the diagnosis or identification conclusion of the abnormal reaction to vaccination and the conclusion of the classification of damage degree, submit a written application for economic compensation for the abnormal reaction to vaccination to the health department at the county level where the vaccination unit is located (Annex 2).
Article 28 When applying for economic compensation for abnormal reaction of vaccination, the recipient shall provide the following relevant materials to the local county-level health department:
(1) An application for compensation for abnormal reaction of vaccination;
(2) The original and photocopy of the payee's ID card and residence booklet, and the original and photocopy of the legal guardian's ID card;
(three) a copy of the course of treatment and medical records after the abnormal reaction of vaccination;
(four) the conclusion of the investigation, diagnosis or appraisal of the abnormal reaction to vaccination;
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