What is the fine for health facilities failing to monitor vaccinees for at least 30 minutes after vaccination in Vietnam?

What is the fine for health facilities failing to monitor vaccinees for at least 30 minutes after vaccination in Vietnam? (Illustrative photo)

According to Article 9 of Decree 117/2020/ND-CP, the violations against regulations on use of vaccines and biologicals in Vietnam are as follows:

1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed for commission of one of the following violations:

- Failing to provide or obstructing children or pregnant women in using vaccines and biologicals compulsory for infectious diseases included in an expanded immunization program;

- Failing to provide counseling for vaccine recipients, parents, families or guardians of children getting vaccinated before vaccination; failing to provide counseling on benefits and risks related to vaccination;

- Failing to give instructions to vaccinees or families of children getting vaccinated on how to monitor and treat vaccine reactions;

- Failing to submit reports or submitting inadequate reports on vaccination as prescribed by law.

2. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

- Failing to use or obstructing the use of vaccines and biologicals for vaccine-preventable diseases for people susceptible to infectious diseases in epidemic zones or for people sent to epidemic zones at the request or according to guidelines of competent authorities;

- Failing to issue and keep physical or electronic personal vaccination records of people vaccinated at the vaccination clinic;

- Failing to compile the list of people vaccinated at the vaccination clinic;

- Failing to monitor vaccinees for at least 30 minutes after vaccination and instruct them or their facilities to monitor vaccine reactions for at least 24 hours later;

- Failing to prepare adequate relevant documents as requested to enable the provincial advisory council to verify the eligibility for compensation for a serious injury or death from vaccination;

- Failing to retain and manage documents concerning vaccination and post-vaccination reactions as prescribed by law.

3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

- Failing to provide pre-vaccination screening or insufficiently providing pre-vaccination screening for people getting vaccinated;

- Failing to strictly comply with regulations on receipt, transport and storage of vaccines;

- Failing to strictly comply with regulations of law and professional guidance on vaccine safety and vaccinee management;

- Failing to immediately stop the vaccination session in case of a serious injury occurring after vaccination;

- Failing to record adequate information on serious injuries in accordance with regulations of the Minister of Health and submit a report to the Provincial Department of Health within 24 hours from the occurrence of the injury;

- Failing to organize vaccination against epidemics at the request of competent authorities by a health facility that has registered with the provincial Department of Health for participation in the expanded immunization program;

- Including costs covered by state budget in vaccination prices under expanded immunization programs and vaccinations against epidemics;

- Selling vaccines and biologicals included in an expanded immunization program.

4. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

- Failing to follow prescriptions and ensure safety during vaccination;

- Failing to give emergency treatment and find the causes of a serious injury after vaccination;

- Failing to give the patient suffering from a serious injury after vaccination to the nearest health facility if the case is beyond the capacity of the vaccination clinic;

- Failing to give emergency and medical treatments to the patient suffering from a serious injury after vaccination, and submit a report to the Provincial Department of Health within 24 hours from the time of receipt of the patient;

- Failing to meet one of requirements for a fixed vaccination clinic after having made a declaration of eligibility for vaccination.

5. A fine ranging from VND 10,000,000 to VND 20,000,000 shall be imposed for commission of one of the following violations:

- Using vaccines and biologicals at a facility that fails to meet eligibility requirements;

- Giving vaccinations before completing procedures for declaration of eligibility for vaccination.

6. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for using vaccines which are not granted certificate of registration, expired vaccines or substandard vaccines.

More details can be found in Decree 117/2020/ND-CP, which comes into effect in Vietnam from November 15, 2020.

Thuy Tram

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