Decision 1273/QD-BYT in 2017 announcing the revised and supplemented administrative procedures in Decree 103/2016/ND-CP on biosafety assurance in laboratories and Decree 104/2016 /ND-CP on vaccination activities issued by the Minister of Health

MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No: 1273/QD-BYT

Hanoi, April 04, 2017

ON BEHALF OF THE MINISTER
DEPUTY MINISTER




Nguyen Thanh Long

No.

Name of procedure

Field

Implementing authorities

Notes

I. Administrative procedures of local authorities

I. Administrative procedures of local authorities

I. Administrative procedures of local authorities

I. Administrative procedures of local authorities

I. Administrative procedures of local authorities

1

Declaration of biosafety level I (BSL-1) and level II (BSL-2) laboratory

Preventive healthcare

Provincial Departments of Health

Procedure promulgated in accordance with Decree No. 103/2016/ND-CP

2

Declaration of eligibility for vaccine administrations

Preventive healthcare

Provincial Departments of Health

Procedure promulgated in accordance with Decree No. 104/2016/ND-CP

3

Identification of eligibility for compensation due to vaccine injuries

Preventive healthcare

Provincial Departments of Health

Procedure promulgated in accordance with Decree No. 104/2016/ND-CP

1- Procedure

Declaration of biosafety level I (BSL-1) and level II (BSL-2) laboratory

Implementation sequence

Implementation sequence

Step 1. The laboratory's legal representative sends the self-declaration of biosafety (form no. 8 in the Appendix under Decree No. 103/2016/ND-CP dated July 1, 2016) to the Department of Health.

Step 2. In three working days from the date the self-declaration of biosafety is received, the Department of Health must publish the list of laboratories which have submitted the self-declaration on the Department’s website.

Implementation methods

Implementation methods

Send by post or hand in directly.

Components and quantity of application

Components and quantity of application

I. Type of documents:

Self-declaration of biosafety (form no. 8 in the Appendix under Decree No. 103/2016/ND-CP dated July 1, 2016).

II. Quantity of documents: Not specified

Processing period

Processing period

Laboratories are allowed to carry out tests within their professional capacity after declaring biosafety.

Subjects of the administrative procedure

Subjects of the administrative procedure

Public and private laboratories.

Implementing authorities

Implementing authorities

Provincial Departments of Health.

Result of the administrative procedure

Result of the administrative procedure

List of laboratories which have submitted the self-declaration of biosafety, published on the Department of Health’s website.

Fees

Fees

None.

Forms (attached under this procedure)

Forms (attached under this procedure)

Form no. 1: Self-declaration of biosafety (form no. 8 in the Appendix under Decree No. 103/2016/ND-CP dated July 1, 2016).

Requirements

Requirements

Article 3 of Decree No. 103/2016/ND-CP.  Conditions applied to biosafety level I in laboratories

The area of the laboratory working on microorganisms that can cause communicable diseases in humans and specimen containing those microorganisms (hereinafter referred to as the testing area) must fulfill the following conditions:

1. Infrastructure requirements:

a) The floor, walls, lab table are flat, resistant to water, heat corrosive chemicals and easy to clean;

b) There are washing basins, emergency eye wash equipment, first aid box;

c) The electricity system is grounded and has backup power source;

d) There are clean water; the pipelines supplying water directly to the testing area have anti-backflow equipment to avoid contaminating the public water system;

e) There is fire safety equipment;

f) Lighting is sufficient for carrying out tests.

2. Equipment requirements:

a) The testing equipment must be technically appropriate for the specimens or microorganisms being tested on;

b) There are packages, tools and storage equipment for medical waste in accordance with regulations;

c) There are equipment for sterilization of tools and specimens;

d) Personal protective gear is appropriate for testing techniques carried out in biosafety-level-I laboratories

3. Personnel requirements:

a) Number of personnel: There are at least two testers. The testers who directly conduct tests on microorganisms (hereinafter referred to as testers) must have diplomas and certificates appropriate for the types of test carried out by that laboratory;

b) The laboratory must assign a person in charge of biosafety;

c) Testers and the one in charge of biosafety must be trained in biosafety level I or above;

d) Others working in the testing area must receive biosafety training that is appropriate for their tasks.

4. Practice regulations conditions:

a) There are regulations on testing area entry and exit;

b) There are regulations on reporting;

c) There is a document archive process;

d) There are testing processes which are technically appropriate for the specimens or microorganisms being tested on;

dd) There are instruction manuals for testing equipment;

e) Has decontamination and waste treatment processes;

g) There are regulations on health and medical surveillance.

Article 6 of Decree No. 103/2016/ND-CP.  Conditions applied to biosafety level II in laboratories

The testing area must fulfill the following conditions:

1. Infrastructure requirements:

a) Requirements specified in Clause 1, Article 5 of this Decree;

b) There are wastewater collection and processing system and processing equipment. Laboratories which are already in operation before this Decree comes into effect must have wastewater treatment test results in accordance with the national technical regulations on the environment before disposing wastewater into the common wastewater container;

c) The testing area is separated from the laboratory’s other rooms;

d) There is a biohazard sign on the testing area's door, as specified by Sample no. 1 in the Appendix under this Decree.

2. Equipment requirements:

a) Requirements specified in Points a and b, Clause 2, Article 5 of this Decree;

b) There is a biosafety cabinet;

c) There are moist heat or other sterilization equipment for medical waste carrying communicable diseases;

d) Personal protective gear is appropriate for testing techniques carried out in biosafety-level-II laboratories.

3. Personnel requirements:

a) Requirements specified in Points a, b and d, Clause 3, Article 5 of this Decree;

b) Testers and the one in charge of biosafety must be trained in biosafety level II or above;

4. Practice regulation requirements:

a) Requirements specified in Clause 4, Article 5 of this Decree;

b) There is a training plan for employees working in the testing area;

c) There are regulations on retention of specimens and communicable disease pathogens in the laboratory;

d) There are plans for assessment of biohazard risks, biohazard prevention and handling.

Legal basis of the administrative procedure

Legal basis of the administrative procedure

1. Law No. 03/2007/QH12 dated November 21, 2007 on Prevention of Infectious Diseases.

2. Law on Investment No. 67/2014/QH13 dated November 26, 2014.

3. Government’s Decree No. 103/2016/ND-CP dated July 1, 2016 on Biosafety in Laboratories.

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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
---------------

No:         /…[3]…

…….…[4]……., [month, day, year]

Head of unit
(Signature and stamp)

2- Procedure

Declaration of eligibility for vaccine administration

Implementation sequence

Implementation sequence

Step 1. Before carrying out vaccination, the vaccination center must declare its eligibility for vaccine administration to the local Department of Health in writing (form no. 1 in the Appendix under the Government’s Decree No. 104/2016/ND-CP dated July 1, 2016).

Step 2. In 10 days from the date the declaration of eligibility for vaccine administration is received, the Department of Health must publish the name, address and head of the aforementioned vaccination center on the Department’s website (the time limit’s starting date is based on the Department’s stamp of receipt).

Implementation methods

Implementation methods

Send by post or hand in directly.

Components and quantity of application

Components and quantity of application

I. Type of documents:

The declaration of eligibility for vaccine administration (form no. 1 in the Appendix under Decree No. 104/2016/ND-CP dated July 1, 2016.

II. Quantity of documents: Not specified

Processing period

Processing period

The vaccination center is allowed to administer vaccines after submitting the declaration of eligibility.

Subjects of the administrative procedure

Subjects of the administrative procedure

Public and private vaccination centers.

Implementing authorities

Implementing authorities

Provincial Departments of Health.

Result of the administrative procedure

Result of the administrative procedure

The name, address and head of the eligible vaccination center become available on the Department of Health's website.

Fees

Fees

None

Forms (attached under this procedure)

Forms (attached under this procedure)

Form no. 1: Declaration of eligibility for vaccine administration, as specified in the Appendix under Decree No. 104/2016/ND-CP dated July 1, 2016.

Requirements

Requirements

Article 9 of Decree No. 104/2016/ND-CP.  Conditions applied to stationary vaccination centers

1. Infrastructure:

a) The waiting area must have sufficient seats for one vaccination session, be shielded from rain, sunlight, wind and well-ventilated;

b) The consultation and screening area has the minimum area of 8 m2;

c) The vaccination area has the minimum area of 8 m2

d) The post-vaccination monitoring area has the minimum area of 15 m2;

dd) In the case of hepatitis-B vaccination for infants in medical facilities with maternity wards, the following conditions shall apply instead of those specified in Points a, b, c and d of this Clause: Separate vaccination room or table is available, the vaccination place must be able to keep the infants warm, a place for infant screening and consultation for mothers or guardians must be available;

e) Ensure the sanitation and lighting conditions are fulfilled, and the areas specified in Points a, b, c and d of this Article are placed in accordance with the one-way principle.

2. Equipment:

a) Has a refrigerator, insulated vaccine containers or chilled containers, temperature monitoring devices at the storage place and during vaccine transportation;

b) There are sufficient injection devices, tools and chemicals for antisepsis and other necessary materials;

c) There are anti-shock boxes and treatment regimens at post-vaccination monitoring in accordance with the Minister of Health's regulations;

d) There are tools for containing medical waste in accordance with the Minister of Health's regulations.

3. Personnel:

a) Number: There are a minimum of 3 health workers, at least one of whom has a medical assistant diploma or above; for vaccination centers in remote or disadvantaged regions, a minimum of 2 employees having associate degree in medicine is required, at least one of whom has a medical assistant diploma or above;

b) The health staff participating in vaccination activities must undergo professional training in vaccination beforehand. Employees directly carrying out screening, consultation, post-vaccination complication monitoring and handling must have professional capacities being physician or above; employees practicing vaccination must have at least associate degree in nursing or above.

Article 10 of Decree No. 104/2016/ND-CP.  Conditions applied to mobile vaccination clinics

1. At-home vaccinations shall only be carried out in remote, extremely disadvantaged communes when the following conditions are fulfilled:

a) Only applicable for the Expanded Program for Immunization or anti-epidemic immunization;

b) Must be carried out by vaccination centers which declared their eligibility vaccine administration as specified in Article 11 of this Decree;

c) There are insulated vaccine containers, sufficient vaccination tools which fulfill the conditions specified in Points b, c and d, Clause 2, Article 9 of this Decree;

d) The personnel meet the conditions specified in Point d, Clause 2 of this Article.

2. Conditions applied to other mobile vaccination clinics:

a) Must be carried out by vaccination centers which declared their eligibility for vaccine administration as specified in Article 11 of this Decree;

Infrastructure: There are consultation table, screening area, vaccination table, post-vaccination complication monitoring and handling place and all of them must be arranged in accordance with the one-way principle. The vaccination clinic has to ensure all sanitation conditions are fulfilled, be shielded from rain, sunlight and wind, well-ventilated and well-lit.

Equipment: c) Has insulated vaccine containers or chilled containers which fulfill the conditions specified in Points b, c and d, Clause 2, Article 9 of this Decree;

d) Personnel: Has at least 2 health workers, out of whom the one directly carrying out screening, consultation, post-vaccination monitoring must meet the conditions specified in Point b, Clause 3, Article 9 of this Decree.

Legal basis of the administrative procedure

Legal basis of the administrative procedure

1. Law No. 03/2007/QH12 dated November 21, 2007 on Prevention of Infectious Diseases.

2. Law on Investment No. 67/2014/QH13 dated November 26, 2014.

3. Government’s Decree No. 104/2016/ND-CP dated July 1, 2016 on Vaccination.

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……[2]..........
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
---------------

No:        /…[3]…

…….…[4]……., [month, day, year]

Head of unit
(Signature and stamp)

3- Procedure

Identification of eligibility for compensation due to vaccine injuries

Implementation sequence

Implementation sequence

Step 1. The person who believes that himself/herself or his/her family member suffers from serious vaccine injuries as specified in Clause 2, Article 15 of Decree No. 104/2016/ND-CP has to prepare the compensation claim and send it to the Department of Health.

Step 2. In 5 working days from the date the claim and valid documents are received, the Department of Health must receive the case and notify the claimant in writing. If the documents are insufficient, the Department of Health shall give instructions on amendments to the claimant.

Step 3. In 15 days from the date the claimant’s request form is received, the Department of Health must finish identifying the cause of injury, damage level and notify both the claimant and the Ministry of Health in writing.

Implementation methods

Implementation methods

Send by post or hand in directly.

Components and Quantity of application

Components and Quantity of application

I. Type of documents:

a) The request for identification of cause of injury and damage level;

b) Confirmation of immunization using the relevant vaccine;

c) Release from hospital confirmation, receipts for diagnosis, treatment, rehabilitation and transport of patient (original or certified copy);

d) Death certificate (in case of death);

dd) Other documents corroborating the injuries or other damages (if any)

II. Quantity of documents: Not specified

Processing period

Processing period

15 working days after receiving sufficient and valid documents.

Subjects of the administrative procedure

Subjects of the administrative procedure

The person receiving vaccination or their family members.

Implementing authorities

Implementing authorities

Departments of Health

Result of the administrative procedure

Result of the administrative procedure

Notification document

Fees

Fees

None

Forms

Forms

None

Requirements

Requirements

Legal basis of the administrative procedure

Legal basis of the administrative procedure

1. Law No. 03/2007/QH12 dated November 21, 2007 on Prevention of Infectious Diseases.

2. Law on Investment No. 67/2014/QH13 dated November 26, 2014.

3. Government’s Decree No. 104/2016/ND-CP dated July 1, 2016 on Vaccination.