Decree No. 104/2016/ND-CP stipulates vaccination activities in Vietnam, including clauses on vaccine quality management, vaccination facility standards, training and certification for vaccinators, rights and responsibilities of parents or guardians of children in vaccination. The Decree also stipulates post-vaccination adverse event insurance and measures to handle violations.
Đối tượng áp dụng
This Decree applies to all vaccination facilities, healthcare organizations, parents or guardians of children, and other related parties involved in vaccination activities in Vietnam.
Các điểm cốt lõi
- Vaccine quality management
- Vaccination facility standards
- Training and certification for vaccinators
- Rights and responsibilities of parents or guardians of children in vaccination
- Post-vaccination adverse event insurance
- Handling violations
🌐 Tác động xã hội từ văn bản này
- Strengthening vaccine quality management
- Ensuring safety and effectiveness of vaccination activities
- Enhancing community awareness of the importance of vaccination
- Financial support for individuals experiencing post-vaccination adverse events
❓ Câu hỏi thường gặp
Which facilities can carry out vaccination activities?
Public and private healthcare facilities, commune health stations, ward health stations, and town health stations may carry out vaccination activities if they meet the prescribed standards under this Decree.
What certificate must a vaccinator have?
A vaccinator must be trained and certified according to the Ministry of Health's regulations on safe vaccination.
What are the responsibilities of parents or guardians of children in vaccination?
Parents or guardians of children are responsible for registering their children for vaccination, bringing them for vaccination according to the schedule, and following the guidance of healthcare staff.
How will individuals be supported if they experience a post-vaccination adverse event?
Individuals will be covered by post-vaccination adverse event insurance as stipulated in this Decree, including emergency care and treatment if necessary.
Toàn văn
|
THE GOVERNMENT |
SOCIALIST REPUBLIC OF VIET NAM |
|
Number: 104/2016/NĐ-CP |
Hanoi, July 1, 2016 |
DECREE
||| PROVISIONS ON VACCINATION ACTIVITIES
||| Pursuant to the Law on Organization of the Government dated June 19, 2015;
Based on the Law on Prevention and Control of Infectious Diseases dated November 21, 2007;
On the basis of the Investment Law dated November 26, 2014;
At the proposal of the Minister of Health;
The Government promulgates the Decree stipulating on vaccination activities.
PART I
GENERAL PROVISIONS
Article 1. Scope of Regulation
This Decree stipulates on vaccination safety and compensation when using vaccines.
Article 2. Scope of Application
1. This Decree applies to healthcare facilities implementing vaccination with vaccines in the Expanded Immunization Program and epidemic control vaccination.
2. Organizations and individuals engaged in vaccination services must meet the requirements: Ensuring vaccination safety as stipulated in this Decree, implementing reporting procedures as prescribed, and having plans to ensure sufficient vaccine supply for vaccination activities at their facilities.
Article 3. Explanation of Terms
1. Vaccination is the act of administering vaccines into the human body with the Purpose of creating the body's immune response to prevent diseases.
2. Epidemic control vaccination is free vaccination organized by the State for people at risk of contracting infectious diseases in epidemic areas, and those sent to epidemic areas by state authorities.
3. Cold chain equipment is a system of devices for storing, monitoring temperature, and transporting vaccines from manufacturers to vaccination Points.
4. Adverse events following immunization are unusual health phenomena including local and systemic reactions occurring after vaccination, not necessarily caused by the use of vaccines, including common post-vaccination reactions and severe adverse events following immunization.
6. A vaccination facility is a healthcare facility meeting the conditions and having announced its eligibility for vaccination according to this Decree.
Chapter II
Section 1. VACCINATION PROCEDURES
Section 1
VACCINATION PROCEDURES
1. The management of vaccination subjects includes:
a) Name, date of birth, and permanent address of the vaccination subject;
b) Name of father or mother or guardian in cases where the vaccination subject is a child;
c) Vaccination history and medical history related to vaccination indication.
The People's Committee of communes, wards, and towns is responsible for directing the Health Stations to investigate and compile lists of compulsory vaccination subjects as prescribed by the Law on Prevention and Control of Infectious Diseases and notify the subjects to participate in vaccination according to schedule and dosage.
2. The People's Committee of communes, wards, and towns is responsible for directing Health Stations to investigate and compile lists of individuals required to undergo mandatory vaccinations according to the Law on Prevention and Control of Infectious Diseases and notify these individuals to participate in vaccinations according to schedule and dosage.
a) Issuing and recording individual vaccination tracking books or electronic vaccination records;
b) Compiling lists of subjects vaccinated at the facility.
If the vaccinated person already has a citizen identification number, there is no need to collect information as prescribed in point a and point b of Clause 1 of this Article.
4. In cases where the vaccinated individual already has a citizen identification number, there is no need to collect the information specified in Points a and b of Clause 1 of this Article.
1. Vaccination must be carried out through the following steps:
a) Before vaccination: Conduct screening examination and counseling for the vaccination subject. In cases where the vaccination subject is a child, counseling should be conducted with the child's parents or guardian;
b) During vaccination: Administer the vaccine according to prescription, ensuring safety;
c) After vaccination: Monitor the vaccinated person for at least 30 minutes post-vaccination and guide the family or vaccination subject to continue monitoring for at least 24 hours post-vaccination.
2. When a severe adverse event following immunization occurs during vaccination implementation, the head of the vaccination facility is responsible for:
a) Immediately stopping the vaccination session;
b) Providing emergency treatment, diagnosing the cause of the severe adverse event following immunization; if beyond capacity, transfer the affected person to the nearest healthcare facility;
c) Fully documenting all relevant information about the severe adverse event according to the regulations of the Minister of Health and report to the Department of Health within 24 hours from the time of occurrence of the adverse event.
c) Fully record all relevant information regarding severe adverse events as prescribed by the Minister of Health and report to the Department of Health within 24 hours from the time of occurrence of the adverse event.
3. Healthcare facilities receiving cases of severe adverse events following vaccination must provide emergency care, treatment, and report to the Department of Health within 24 hours from the time of receiving the affected person.
4. In cases of severe adverse events following vaccination with vaccines outside the Expanded Program on Immunization and epidemic control vaccination, the facility where the severe adverse event occurred is responsible for reporting to the Department of Health located at the facility's headquarters as prescribed in Clause 2 of this Article and shall implement compensation according to civil law if there is fault causing the severe adverse event following vaccination.
Article 6. Investigation, Reporting, and Notification of Results of Investigation and Handling of Severe Adverse Events Following Vaccination
1. Within 24 hours from the occurrence of a severe adverse event following vaccination, the Department of Health is responsible for organizing the investigation, and within five working days from receiving the investigation report on severe adverse events following vaccination, the Department of Health must convene a meeting of the provincial specialized advisory board (hereinafter referred to as the provincial specialized advisory board) to:
b) Determine eligibility for compensation in accordance with Clause 6, Article 30 of the Law on Prevention and Control of Infectious Diseases and Clause 2, Article 15 of this Decree;
b) Determine cases eligible for compensation as prescribed in Clause 6 of Article 30 of the Law on Prevention and Control of Infectious Diseases and Clause 2 of Article 15 of this Decree;
2. Within twenty-four hours from the time the minutes of the provincial specialized advisory board meeting are recorded, the Director of the Department of Health shall be responsible for:
2. Within 24 hours from the time of recording the minutes of the provincial specialized advisory board meeting, the Director of the Department of Health is responsible for:
b) Informing the family of the person who suffered serious adverse events following immunization about the cause of the adverse event.
3. In cases where there is suspicion that the cause of serious adverse events following immunization is due to vaccine quality, the Director of the Department of Health must issue a decision to temporarily suspend the use of the related vaccine batch in the managed area after obtaining written approval from the Ministry of Health. When the provincial specialized advisory board concludes that the cause of serious adverse events is not related to vaccine quality, the Director of the Department of Health decides to resume the use of that vaccine batch and report to the Ministry of Health.
3. In cases where there is suspicion that the cause of severe adverse events following vaccination is due to vaccine quality, the Director of the Department of Health must issue a decision to temporarily suspend the use of the related vaccine batch in the managed area after obtaining written agreement from the Ministry of Health. When the provincial specialized advisory board concludes that the cause of the severe adverse event is unrelated to vaccine quality, the Director of the Department of Health decides to resume the use of the vaccine batch and report to the Ministry of Health.
5. The Minister of Health shall be responsible for detailing this provision.
Section 2. MANAGEMENT OF VACCINES
Section 2
VACCINE MANAGEMENT
1. Vaccines for immunization activities under the Expanded Immunization Program and epidemic control immunization programs shall be guaranteed in quantity and type suitable for annual needs and stored for six months by the State.
1. Vaccines used in the Expanded Program on Immunization and epidemic control vaccination, which are guaranteed by the State in quantity and type suitable for annual needs, are stored for six months.
4. When there is a shortage or surplus of vaccines at vaccination facilities, the Department of Health assists the Provincial People's Committee in directing the coordination of vaccines between facilities in the area to ensure adequate, timely, and continuous vaccine supply and reports to the Ministry of Health on the vaccine usage situation on a monthly basis.
5. When there is a shortage or surplus of vaccines in some provinces, the Minister of Health is responsible for directing relevant units to coordinate vaccines between provinces.
Article 8. Receiving, transporting, storing vaccines
1. Vaccines must be stored in cold chains from production until use and at temperatures appropriate for each type of vaccine as required by the manufacturer in the registration dossier with the Ministry of Health, specifically as follows:
a) Vaccine storage warehouses must comply with good storage practices for medicines;
b) Transporting vaccines from storage warehouses to vaccination Points must be done using refrigerated vehicles, cool boxes, or vaccine carriers;
c) Storing vaccines at vaccination Points using refrigerators, cool boxes, or coolers from the start of vaccination until the end of the session, and if vaccines need to be stored, temperature checks and records must be conducted at least twice daily;
đ) Having temperature monitoring equipment for vaccines during transportation, storage, and use, and fully documenting during transportation and delivery.
d) The Minister of Health shall provide guidance on receiving, transporting, and storing vaccines.
2. When receiving vaccines, the recipient has the responsibility to check the storage conditions and other information as prescribed by the Minister of Health.
Section 3
Article 9. PREREQUISITES FOR VACCINATION SITES
Article 9. Conditions for fixed vaccination facilities
1. Infrastructure:
a) The waiting area before vaccination must be equipped with sufficient seating for one vaccination session, ensuring protection from rain, sun, wind, and adequate ventilation;
b) The counseling and screening examination area must have a minimum area of 8 square meters;2;
c) The vaccination implementation area must have a minimum area of 8 square meters;2;
d) The observation and post-vaccination reaction management area must have a minimum area of 15 square meters;2;
e) For the Hepatitis B vaccine first-dose injection point at healthcare facilities with delivery rooms, the provisions of Points a, b, c, and d of this Clause shall not apply, but instead, the following requirements shall be met: Arrange a separate vaccination room or table, ensuring warmth for infants, having a screening examination area for infants, and providing counseling to mothers or guardians of children;
f) Ensure hygiene conditions, adequate lighting, and unidirectional layout principles in the areas specified in Points a, b, c, and d of this Clause;
2. Equipment:
a) Refrigerators, vaccine carriers, or cool boxes, and temperature monitoring devices at storage locations and during vaccine transportation;
b) Must have sufficient injection equipment, tools, chemicals for sterilization, and other necessary supplies;
c) Shock-resistant boxes and shock management protocols displayed at observation and post-vaccination reaction management areas as prescribed by the Minister of Health;
d) Must have medical waste containers as prescribed by the Minister of Health;
3. Personnel:
a) Number: At least three health professionals, including at least one with a level of expertise from a licensed practical nurse upwards; for vaccination sites in remote, mountainous, and extremely difficult areas, there must be at least two health professionals with a level of expertise from a diploma in nursing upwards, including at least one with a level of expertise from a licensed practical nurse upwards;
b) Healthcare personnel participating in vaccination activities must be trained in vaccination techniques. Personnel directly involved in screening examinations, counseling, monitoring, and managing post-vaccination reactions must have a level of expertise from a licensed practical nurse upwards; vaccination practitioners must have a level of expertise from a vocational school nurse upwards;
Article 10. REQUIREMENTS FOR MOBILE VACCINATION POINTS
1. Home-based vaccinations may only be conducted in communes located in remote, mountainous areas, or communes with particularly difficult socio-economic conditions when meeting the following requirements:
a) Only applicable to vaccination activities under the Expanded Immunization Program and epidemic control vaccination;
b) Must be carried out by a vaccination site that has been publicly announced as meeting the vaccination prerequisites stipulated in Article 11 of this Decree;
c) Must have vaccine carriers, sufficient vaccination equipment, and meet the requirements set forth in Points b, c, and d of Clause 2, Article 9 of this Decree;
d) Personnel must meet the requirements stipulated in Point d of Clause 2 of this Article;
2. Requirements for other mobile vaccination points:
a) Must be carried out by a vaccination site that has been publicly announced as meeting the vaccination prerequisites stipulated in Article 11 of this Decree;
b) Infrastructure: Must have counseling tables, screening examination tables, vaccination tables, observation areas, and post-vaccination reaction management areas, and must be arranged according to unidirectional principles. The vaccination point must ensure hygiene conditions, protection from rain and sun, windproofing, ventilation, and adequate lighting;
c) Equipment: Must have vaccine carriers or cold boxes, and meet the requirements set forth in Points b, c, and d of Clause 2, Article 9 of this Decree;
d) Personnel: Must have at least two health professionals, where personnel directly involved in screening examinations, counseling, monitoring, and managing post-vaccination reactions must meet the requirements stipulated in Point b of Clause 3, Article 9 of this Decree.
Article 11. Announcement of Vaccination Facilities Meeting Conditions
1. Prior to conducting vaccination activities, vaccination facilities must submit a notification document meeting vaccination conditions according to the model prescribed in the Appendix issued together with this Decree to the Department of Health where the vaccination facility is located.
2. Within ten days from the date of receipt of the notification meeting vaccination conditions, the Department of Health must publish information on the name, address, and head of the facility that has announced meeting vaccination conditions on the Department of Health's electronic information website (the date for publication is determined based on the receipt stamp of the Department of Health).
3. The facility may only conduct vaccination activities after completing the announcement of meeting vaccination conditions, and the head of the facility conducting vaccinations who self-declares meeting vaccination conditions shall be responsible under the law for their self-declaration.
4. During the inspection and examination of vaccination conditions at vaccination facilities, if it is found that the vaccination facility does not comply with the conditions stipulated in Articles 9 and 10 of this Decree, the inspection and examination team must prepare a temporary suspension record and recommend the competent authority to decide on handling according to the provisions of the law while sending one copy of the record to the Department of Health where the vaccination facility is located.
5. Within five working days from the date of receipt of the temporary suspension record specified in Clause 3 of this Article (the receipt date is determined based on the receipt stamp of the Department of Health), the Department of Health must remove the name of the facility from the list of self-declared facilities published on the Department of Health's electronic information website.
Section 4
VACCINATION CONDITIONS TO ENSURE VACCINATION WORK
Article 12. Vaccination Service Supply System
1. State health care facilities, according to their assigned functions and tasks, must carry out vaccination with vaccines under the Expanded Immunization Program, epidemic prevention vaccination, and ensure vaccination conditions as prescribed in this Decree.
2. State health care facilities other than those specified in Clause 1 of this Article; private health care facilities that have declared meeting vaccination conditions as prescribed in this Decree are permitted to register with the local Department of Health to conduct vaccination with vaccines under the Expanded Immunization Program and must organize epidemic prevention vaccination when requested by the competent state management agency.
Article 13. Vaccination Service Fee
1. The vaccination service fee is calculated based on the following factors:
a) Vaccine purchase price;
b) Transportation and storage costs for vaccines;
c) Vaccination service costs.
2. Vaccination service costs are calculated separately for each type of vaccine, number of doses, or oral administrations, and include the following direct and indirect cost factors:
a) Fees for screening, counseling, administration, and post-vaccination monitoring;
b) Consumable material costs;
c) Electricity, water, fuel, medical waste treatment, and environmental sanitation costs directly related to the provision of vaccination services;
d) Depreciation of fixed assets; interest payment costs under loan contracts, fundraising for investment and purchase of equipment to implement vaccination services (if applicable) are calculated and allocated to the cost of using these funds.
đ) Indirect departmental costs and other lawful costs necessary to ensure the operation of the vaccination facility.
3. Costs already guaranteed by the state budget for vaccination services under the Expanded Immunization Program and epidemic prevention vaccination are not included in the service price.
4. The Minister of Health shall specify the detailed vaccination service fees for vaccines in the Expanded Immunization Program and epidemic prevention vaccination.
Article 14. Sources of funds for vaccination activities
1. Sources of funds formed for vaccination activities:
a) State budget;
b) Sponsorship from organizations and individuals both within and outside the country;
c) The Health Insurance Fund;
d) Other lawful income sources as prescribed by law.
a) Using vaccines and medical products for the subjects specified in Clause 3 of Article 28 and Clause 4 of Article 29 of the Law on Prevention and Control of Infectious Diseases;
b) Investing in cold chain systems for the Expanded Immunization Program and Epidemic Vaccination Program;
c) Information, education, communication, inspection, and supervision of vaccination activities, training costs, research expenses to apply new techniques and methods in vaccination;
d) Compensation when using vaccines in the Expanded Immunization Program and epidemic prevention vaccination results in serious adverse events affecting health or causing loss of life to the vaccinated person.
Chapter III
COMPENSATION WHEN USING VACCINES IN THE EXPANDED IMMUNIZATION PROGRAM AND EPIDEMIC VACCINATION PROGRAM CAUSING SERIOUS HEALTH IMPACTS OR LOSS OF LIFE OF THE VACCINATED PERSON
Article 15. Cases eligible for compensation
1. When using vaccines in the Expanded Immunization Program and epidemic prevention vaccination, if serious adverse events occur that severely affect health or cause loss of life to the vaccinated person, the State shall be responsible for compensating the person suffering losses.
2. Cases eligible for State compensation include:
a) The vaccinated person suffers severe adverse events leaving permanent disabilities;
b) The vaccinated person dies.
Article 16. Damages, scope, and level of compensation
1. Losses due to residual effects leading to disability are compensated with thirty months' base salary and the costs specified in Clauses 3 and 4 of this Article.
2. Damage to life is supported as follows:
a) Costs specified in Clause 3 of this Article before death;
b) Funeral expenses equal to 10 months of the basic salary as prescribed by the State;
c) Compensation for mental distress is 100,000,000 VND for relatives of the person who has suffered losses;
d) Costs due to lost or reduced income as stipulated in Clause 4 of this Article.
3. Costs for medical examination and treatment at healthcare facilities:
a) In cases where the vaccinated person is compensated by the State and holds a health insurance card to examine and treat at healthcare facilities, the payment of examination and treatment costs, and rehabilitation services shall be carried out according to the laws on health insurance. The portion of costs that the insured individual must co-pay and additional services beyond the health insurance coverage shall be paid according to the invoice (maximum amount not exceeding the registered service fee level with the Ministry of Health).
b) In cases where the vaccinated person is compensated by the State but does not hold a health insurance card to examine and treat at healthcare facilities, the payment of examination and treatment costs, rehabilitation services, and patient transportation shall be carried out according to the current pricing regulations for public healthcare facilities and accompanied by an invoice.
c) In cases where the vaccinated person is compensated by the State and requires hospitalization for treatment, during treatment if other unrelated diseases are discovered, the individual must pay the examination and treatment costs for those diseases according to the laws on service fees for medical examination and treatment. If the person has a health insurance card, the payment of examination and treatment costs for those diseases shall be carried out according to the laws on health insurance.
4. Damage due to lost or reduced income:
a) Support for material losses for one person who must take leave without pay to care for a case being compensated by the State shall be supported according to actual income equivalent to the social insurance contribution rate of the previous month, specifically:
|
Support Amount = |
Social insurance contribution salary of the caregiver taking leave without pay |
x |
Actual number of days caring |
|
22 days |
b) If the caregiver for a case being compensated by the State cannot determine their actual income, the support level is determined as follows:
|
Support Amount = |
The minimum wage level in the region where the caregiver usually resides at the time of compensation settlement |
x |
Actual number of days caring |
|
22 days |
c) In cases where the vaccinated person being compensated by the State is a worker as defined by labor laws, they shall be supported for actual lost or reduced income during the period of treatment. The support level is similar to the support level for caregivers as stipulated in Points a and b of this Clause.
Article 17. Documents and Procedures for Determining Compensation Cases
1. Healthcare facilities where serious adverse events severely affecting health or causing loss of life to the vaccinated person occurred must prepare all relevant files and materials to assist the provincial expert advisory board in determining eligible compensation cases.
2. In case the vaccinated person or their relatives believe that they or their relatives fall under the circumstances stipulated in Clause 2, Article 15 of this Decree, they must prepare and submit to the Department of Health a dossier including the following documents and papers:
a) A request form to determine the cause of the adverse event and the extent of injury;
b) Vaccination confirmation forms and records related to the vaccine in question;
c) Discharge certificates, medical bills for examination, treatment, rehabilitation, and patient transportation costs (original or certified copies);
d) Death certificate (if applicable);
e) Other relevant documents proving the adverse event or other damages (if any).
3. Within five working days from the date of receipt of the application and valid documents, if it determines that the request falls within its responsibility, the Department of Health shall accept the case and notify the affected person or their relatives (hereinafter referred to as the affected person) in writing about the acceptance of the application. If the dossier is incomplete, the Department of Health shall issue a written instruction for the affected person to supplement.
4. Within fifteen days from the date of receipt of the affected person's application, the Department of Health must complete the determination of the cause of the adverse event, the extent of damage, and notify the applicant in writing while reporting to the Ministry of Health.
Article 18. Compensation Procedures
1. Within five working days from the date of receipt of the conclusion of the provincial specialized advisory board (the date of receipt is calculated based on the receipt stamp of the Department of Health), the Department of Health shall issue a decision on compensation for cases eligible for state compensation as prescribed in this Decree.
2. The compensation resolution decision must include the following main contents:
a) Name and address of the person being compensated;
b) Summary of reasons for compensation;
c) Amount of compensation;
d) Effectiveness of the compensation resolution decision.
3. The compensation resolution decision must be sent to the injured party, the person at fault, or the organization responsible for the damage (if any).
4. The compensation resolution decision becomes effective fifteen days after the injured party receives the decision, except in cases where the injured party disagrees and initiates a lawsuit.
Article 19. Procedures for Issuing and Paying Compensation Funds
1. Within five working days from the date the compensation resolution becomes legally effective, the Department of Health must send a document to the National Expanded Immunization Program requesting funding for compensation along with the legally effective compensation resolution.
2. Within ten days from the date of receipt of the document requesting funding for compensation, the National Expanded Immunization Program must provide funds to the Department of Health for payment to the affected person.
3. Within five working days from the date of receipt of the funds provided by the National Expanded Immunization Program, the Department of Health must implement the payment of compensation to the injured party.
The payment must be made in one lump sum in cash to the affected person or transferred according to the affected person's request. In case the affected person requests transfer, it shall be carried out according to the request and notified in writing to the affected person. If compensation is paid in cash, at least two days' notice must be given to the affected person. The receipt of compensation must be recorded in two copies, each party involved in the handover retains one copy.
Article 20. Procedures and Liability for Compensation
1. Within five working days from the date of the conclusion of the provincial specialized advisory board as prescribed in Point c, Clause 1, Article 6 of this Decree, the Department of Health shall issue a decision requiring reimbursement to the State.
a) Name and address of the organization or individual responsible for causing damage;
b) Summary of reasons for requesting compensation;
c) Amount of compensation;
d) Effectiveness of the decision requiring compensation.
3. The decision requiring compensation must be sent to the organization or individual responsible for causing damage.
3. The reimbursement decision must be sent to the organization or individual responsible for causing the damage.
4. The reimbursement decision becomes effective fifteen days after the organization or individual receives the decision, except in cases where the organization or individual disagrees and files a lawsuit.
5. Organizations or individuals responsible for causing damage as stipulated in Clause 2 of this Article are required to pay the reimbursement amount to the National Expanded Immunization Program and provide a receipt to the authority issuing the reimbursement decision.
3. Direct organizations to inspect, supervise, and handle violations related to immunization activities on its territory.
Chapter IV
RESPONSIBILITIES FOR IMPLEMENTATION
Article 22. Responsibilities of the Ministry of Health
1. Develop and implement annual plans for vaccine usage and immunization; develop short-term, medium-term, and long-term plans in the field of vaccines and immunization.
3. Direct organizations to inspect and supervise the use of vaccines nationwide.
4. Implement information technology applications in managing immunization activities.
Article 23. Responsibilities of Ministries and Sectors
1. The Ministry of Education and Training shall be responsible for:
a) Directing educational institutions to check the vaccination status of preschool and primary school students when enrolling, while promoting and encouraging parents and legal guardians
to implement vaccination work;
b) Inspect and supervise educational institutions in implementing vaccination work.
a) Direct educational institutions to check information on the vaccination status of preschool and primary school students upon enrollment, and promote and encourage parents or legal guardians of students to vaccinate those who have not been fully vaccinated, and cooperate with healthcare facilities to implement vaccination programs;
b) Inspect and supervise educational institutions in the implementation of vaccination activities.
2. The Ministry of National Defense shall be responsible for coordinating with the Ministry of Health to implement vaccination activities in remote areas, border regions, islands, and military and civilian hospitals.
4. Vietnam Television, Voice of Vietnam Radio, Vietnam News Agency, mass media organizations, and grassroots information agencies are responsible for organizing communication activities to promote the benefits of vaccination for disease prevention so that people can fully and timely get vaccinated.
5. Other ministries and sectors, in accordance with their assigned functions and tasks, are responsible for coordinating with the Ministry of Health to implement this Decree.
Article 24. Responsibilities of Vaccination Facilities
1. Vaccination facilities must ensure compliance with legal regulations, professional guidelines on vaccination safety, management of vaccinated individuals, and reporting as prescribed.
2. Maintain and manage documentation and records related to vaccinations and post-vaccination reactions as prescribed.
Article 25. Responsibilities of Vaccination Personnel
1. Provide comprehensive counseling to the person being vaccinated or the family of the child being vaccinated regarding the benefits and potential risks associated with vaccination.
2. Guide the person being vaccinated or the family of the child being vaccinated on how to monitor and handle post-vaccination reactions.
3. Adhere strictly to professional regulations during vaccination.
Article 26. Responsibilities of Parents or Guardians of Children and Individuals Receiving Vaccinations
1. Parents or guardians of children must register for vaccination for the child after birth or at the first vaccination visit and bring the child for vaccination as prescribed.
2. Individuals within the expanded immunization program must proactively register for vaccination with local healthcare facilities and complete all required vaccinations as prescribed.
3. Cooperate and strictly follow the guidance of health workers when implementing vaccinations and monitoring and managing post-vaccination reactions.
4. Report fully and truthfully all health information during the vaccination period and after vaccination.
5. Must undergo vaccination in cases where there is a professional indication.
6. Maintain and preserve personal vaccination records. Provide information on children's vaccinations to educational institutions specified in Point a, Clause 1, Article 23 of this Decree when requested.
Chapter V
IMPLEMENTING PROVISIONS
Article 27. Effective Date
This Decree takes effect from July 1, 2016.
Article 28. Transitional Provisions and Implementation Timeline
1. For vaccination facilities that have been issued a certificate of compliance with vaccination conditions before this Decree takes effect, they may continue to operate until the expiration date on the certificate and must complete the announcement of compliance with vaccination conditions as stipulated in Article 11 of this Decree before the certificate expires.
2. For vaccination facilities that submitted applications for certificates of compliance with vaccination conditions before this Decree takes effect but have not yet received such certificates, the Department of Health shall be responsible for guiding these facilities to comply with the announcement requirements set forth in Article 11 of this Decree within sixty days from the date this Decree takes effect.
Article 29. Responsibility for Implementation
1. Ministers, Heads of ministerial-level agencies, Heads of government agencies, Chairpersons of provincial People's Committees shall be responsible for implementing this Decree.
2. The Minister of Health, within the scope of their duties and authority, shall coordinate with relevant ministries and sectors to provide detailed regulations and guidance on the implementation of Articles and Clauses assigned in this Decree to meet state management requirements for vaccination activities./.
|
|
PRIME MINISTER |
ANNEX
Number: ……/….
(Attached to Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government)
………1………
………2………
------- SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness.
---------------No.: ……/….3….……. 4……, day…. month…. year….
NOTICE
Vaccination Facility Meeting Conditions
Respectfully submitted to: ...5………………………………
Contact Phone:… Email (if available): …
Address: …6....................................................
Based on Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government on vaccination activities, we respectfully request the relevant authorities to consider and publish the information as prescribed.
Name of the supervising agency proposing the announcement of qualification for vaccination
Name of the facility proposing the announcement of qualification for vaccination
Head of Unit
(Sign, write clearly their full name and stamp)
___________________
1 Name of Managing Authority of the Facility Requesting Announcement of Compliance with Vaccination Conditions
2 Name of Facility Requesting Announcement of Compliance with Vaccination Conditions
3 Abbreviation of Name of Facility Requesting Announcement of Compliance with Vaccination Conditions
4 Place name
5 Name of Agency Receiving Application for Announcement of Compliance with Vaccination Conditions
6 Specific Address of Facility Requesting Announcement of Compliance with Vaccination Conditions
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