Decision No. 3518/QD-BYT dated July 20, 2021 on safety criteria of COVID-19 immunization facilities

DECISION

SAFETY CRITERIA OF COVID-19 IMMUNIZATION FACILITIES

MINISTER OF HEALTH

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of Government on functions, tasks, powers, and organizational structure of Ministry of Health;

At request of Director of Vietnam Administration of Medical Services and Ministry of Health,

HEREBY DECIDES:

Article 1. The “Safety criteria for COVID-19 immunization facilities” are attached hereto.

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Article 3. Vietnam Administration of Medical Services is assigned to act as contact point and cooperate with Department of Preventive Medicine in directing, guiding, inspecting, monitoring, and supervising implementation and assessment of the criteria; consolidate assessment results of COVID-19 immunization facilities and report to Minister of Health.

Article 4. This Decision comes into effect from the day of signing.

Article 5. Director of Department of Medical Examination and Treatment, Director of Department of Preventive Medicine, Chief of the Ministry Office, Chief Ministry Inspector, directors of departments and agencies affiliated to Ministry of Health; directors of hospitals and facilities providing hospital beds affiliated to Ministry of Health; Directors of Departments of Health of provinces and central-affiliated cities, heads of relevant entities; heads of medical sector of ministries are responsible for implementation of this Decision. /.

PP. MINISTER
DEPUTY MINISTER




Nguyen Truong Son

SAFETY CRITERIA OF COVID-19 IMMUNIZATION FACILITIES

1. OBJECTIVES

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Improve safety of COVID-19 immunization on nationwide scale.

1.2. Specific objectives:

a. Provide a tool for immunization facilities to conduct self-inspection, assessment, review, and rectify all risks.

b. Provide a tool for supervisory agencies to produce list, inspection, assess, and supervise local immunization facilities and monitor implementation of immunization.

2. CRITERIA STRUCTURE

Safety criteria of immunization facilities consist of 3 parts. Part A is on administration information, Part B is on immunization results, and Part C is on assessment categories (9 categories in total). These criteria introduce requirements to be prepared prior to immunization, during immunization, and after immunization.

In order to conduct assessment conveniently, rapidly, and in a manner satisfactory to requirements of immunization campaign, only select fundamental contents that must be implemented by immunization facilities to ensure safety implementation (without taking into account everything related to immunization).

3. METHODS AND TIME OF ASSESSMENT

3.1. Methods of assessment

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Do note that criteria and sub-section marked with an asterisk (*) are required to be qualified. If any sub-section marked with an asterisk is unqualified, the immunization facility shall be classified unsafe and must immediately rectify prior to carrying out immunization.

3.2. Assessment time

Immunization facilities input figures of part A on the first assessment and update in case of any change.

Figures in part B shall be updated on a daily basis for every day on which immunization is carried out.

Immunization facilities shall conduct self-assessment based on 9 categories in part C on a weekly basis or prior to initiation of a new immunization; the facilities shall rectify unqualified sub-section and update information once rectification has been conducted.

A

ADMINISTRATION INFORMATION

Section filled in by the facility

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2

Type of immunization facility: (specify number)

1. Class I and special hospital

2. Class II hospital

3. Class III hospital

4. Class IV hospital

5. Private hospital

6. Ministry hospital

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8. Medical station of ward, town, townlet

9. Immunization facility in company, factory

10. Indoor immunization facility in head office, conference hall, cultural house, etc.

11. Mobile outdoor immunization facility

12. Other immunization facility (clarify)

3

Does immunization facility have intensive care unit?

1. Yes

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4

GPS location (for navigation on smart phone)

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Address of immunization facility

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Name of individual in charge of immunization facility

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Phone number

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Email address

B

IMMUNIZATION RESULT

(Immunization facility inputs on the software on a daily basis)

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1

Total number of immunization shot delivered

2

Number of cases with post-immunization allergic reaction(s)

3

Number of cases with second degree allergic reaction(s) or higher

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4

Number of cases requiring emergency medical aid

5

Number of mortality cases

Total results from initial date of immunization

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Total number of immunization shot delivered from initial date of immunization

7

Total number of cases with post-immunization allergic reaction(s)

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Total number of cases with second degree allergic reaction(s) or higher

9

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10

Total number of mortality cases

C. ASSESSMENT RESULTS

CATEGORY

ENTRY

Maximum score

Given score

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Infrastructure

5*

1.1

Have adequate space to allocate waiting space prior to immunization and monitor post immunization with 1 m of separation between 2 persons

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1.2

Establish route for receiving, providing screening examination, providing immunization, and conducting post-immunization monitor in a single-flow manner.

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1.3

Pathways in immunization facility are easily accessible and flat.

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1.4

Stay ready to power cold storage equipment and emergency medical aid equipment if necessary.

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Install sinks for medical personnel to wash their hands.

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Category 2

Equipment and tools serving immunization

13

Immunization facility is equipped with:

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2.1

Waiting room.

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2.2

- Seats for awaiting procedure follow-up and medical examination with adequate separation according to regulations on epidemic management applicable at the time of organizing immunization.

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- Screening examination table.

1*

2.4

- Immunization table.

1*

2.5

- It is advised to place at least 1 immunization table with curtains/partitions to ensure privacy for individuals who ask for privacy.

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2.6

- Immunization facility staying cool during the summer and avoiding breeze in the winter.

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2.7

- Seats for 30-minute post-immunization monitor must comply with separation requirements according to regulations and law on epidemic management at the time of immunization.

1*

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- Have at least 1 bed and 2 stretchers for monitor for every 100 immunization recipients.

1*

2.9

- Quality vaccine preservation and transportation equipment (cold storage, refrigerators, etc.)

1*

2.10

- Screening examination equipment: thermometer, sphygmomanometers, stethoscope.

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2.11

- Media: leaflets, posters.

1*

2.12

- Law compliant post-immunization waste collection equipment.

1*

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- Law compliant surface sterilizing equipment.

1*

Category 3

Information record

7

3.1

Print and place summarized vaccine instruction on immunization tables for the right vaccine in order to eliminate any confusion regarding dose and mixture of vaccine.

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3.2

Receive training and knowing how to fill in information on vaccine, preservation, use of drugs, materials, forms, documents as per the law

1*

3.3

List of immunization recipients must include personal identification information (Citizen Identity Card, health insurance, ID Card, etc.).

1*

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Personnel receive training and instruct immunization recipients to read and sign all proper documents as per the law.

1*

3.5

Receive training and knowing how to use immunization as per the law.

1

3.6

Apply information technology solutions, providing electronic forms for immunization recipients in advance

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3.7

Register immunization time, issuing number automatically

1

Category 4

Training for personnel providing immunization

5*

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Personnel providing immunization have received training regarding COVID-19 immunization (including pre-immunization screening examination, immunization organization, post-immunization monitor for adverse effect and emergency medical response).

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4.2

At least 1 employee who has received training regarding detecting and responding to allergic reactions must be present

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4.3

At least 1 employee who has received training for responding to circulation failure.

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4.4

All immunization personnel have watched the video guiding immunization steps: screening examination, standard immunization practice, post-immunization allergic-reaction response, etc.

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4.5

At least 1 employee with experience in emergency transport.

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Knowledge and practice of immunization screening examination

5*

5.1

Have knowledge and answering correctly methods of classifying immunization recipients by 4 groups.

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5.2

Have knowledge and knowing how to acknowledge history of allergy, chronic diseases, drug use, etc.

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5.3

Have knowledge and assessing general appearance of immunization recipients correctly.

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5.4

Have knowledge and complying with immunization direction.

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Receive training and recording information in screening form for all immunization recipients.

1

Category 6

Pre-immunization screening and classifying immunization recipients

3*

6.1

Cooperate with supervisory agency of immunization facility to conduct basic screening, classify and produce list of immunization recipients.

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6.2

Supervisory agency of immunization facility provides list of immunization recipients to match capacity of immunization facility.

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6.3

Provide immunization for individuals under assigned list.

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Basic medical aid

6*

7.1

Each immunization table is equipped with medicine containers for allergic reactions with adequate medicine as per the law and preserves 5 tubes of adrenaline.

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7.2

Each medicine container must have 1 adrenaline shot of 1 mg/1 ml ready (throughout immunization period).

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7.3

Have at least 2 liters (4 500 ml bottles) of NaCl 0.9% intravenous fluids and all infusion equipment.

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7.4

Oxygen and equipment for oxygen breathing.

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Ambu bag.

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7.6

Monitor machine, SpO₂ monitoring equipment.

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Category 8

Ready for medical emergency response

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8.1

Allergic reaction response regimen is ready and stick to the walls in visible spot or in containers for allergic reactions.

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8.2

Prepare response measures in case of allergic reactions.

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Having conducted post-immunization allergic reaction drills.

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8.4

If the immunization facility has intensive care unit

- Always assign personnel to stand-by for emergency medical response.

If the immunization facility does not have intensive care unit

- Have higher tier hospital in charge of the immunization facility, having ambulance (with all basic medical aid) stand-by in the hospital and ready to provide emergency response for patients in the immunization facility at earliest time possible.

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8.5

Having conducted transferring immunization recipients with emergency conditions to higher tier hospital.

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Category 9

Post-immunization monitor

3*

9.1

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9.2

All immunization recipients have countersigned to have read the “Post-immunization monitor form” and guaranteed to comply with the instruction.

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9.3

Providing hotline number, and phone number of hospital in charge of the immunization facility to provide emergency medical aid.

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TOTAL SCORE

52

The immunization facility is classified as safe if all criteria or all sub-sections marked with the * are qualified (total score of at least 45).

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          2. Not safe