Decision No. 478/QD-QLD 2021 on instructions for receipt, transportation, storage and use of COVID-19 vaccines

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Decision No. 478/QD-QLD dated August 10, 2021 of the Drug Administration of Vietnam on promulgation of instructions for receipt, transportation, storage and use of COVID-19 vaccines

Issuing body:		Effective date:	Known Please log in to a subscriber account to use this function. Don’t have an account? Register here
Official number:	478/QD-QLD	Signer:	Le Viet Dung
Type:	Decision	Expiry date:	Updating
Issuing date:	10/08/2021	Effect status:	Known Please log in to a subscriber account to use this function. Don’t have an account? Register here
Fields:	Medical - Health

SUMMARY

Instructions for receipt, transportation, storage and use of COVID-19 vaccines

The Drug Administration of Vietnam issues the Decision No. 478/QD-QLD on promulgation of instructions for receipt, transportation, storage and use of COVID-19 vaccines on August 10, 2021.

Specifically, upon receipt vaccines and solvents, staff must prepare refrigeration equipment, ensuring sufficient capacity to store vaccines before the receipt; check and prepare enough temperature monitoring devices for vaccine storage, which are suitable for each refrigeration equipment; Prepare a vaccine management book to record information upon receipt; Washing hands.

Besides, in case of storage of vaccines at ultra-cold temperatures in Pfizer’s insulated containers, it is necessary to store the insulated container in a room with temperatures between 15°C and 25°C to maintain the best capability of keeping ultra-cold temperatures. It is recommended to not open the thermal shipping container more than two times per day; not open the thermal shipping container for more than 3 minutes at a time; replenish dry ice in the thermal shipping container every 5 days. If the lid of the insulated container is opened multiple times a day, dry ice needs to be added more often, etc.

This Decision takes effect on the signing date.

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Effect status: Known

THE MINISTRY OF HEALTH

THE DRUG ADMINISTRATION

OF VIETNAM

^_________

No. 478/QD-QLD

THE SOCIALIST REPUBLIC OF VIETNAM

Independence – Freedom – Happiness

^{________________________}

Hanoi, August 10, 2021

DECISION

On promulgation of instructions for receipt, transportation, storage and use of COVID-19 vaccines

^____________

THE DIRECTOR

OF THE DRUG ADMINISTRATION OF VIETNAM

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

Pursuant to Decision No. 7868/QD-BYT dated December 28, 2018 of the Minister of Health, defining the functions, tasks, powers and organizational structure of the Drug Administration of Vietnam under the Ministry of Health;

Pursuant to Decision No. 3043/QD-BYT dated June 24, 2021 of the Minister of Health on the establishment of the Steering Committee for the National COVID-19 vaccination campaign;

Pursuant to Circular No. 03/2018/TT-BYT dated February 9, 2018 of the Minister of Health on the distribution of drugs and medicinal ingredients;

Pursuant to Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health on the storage of drugs and medicinal ingredients;

At the proposal of the Head of the Department of Pharmaceutical Business Management and the Head of the Department of Drug Quality Management.

DECIDES:

Article 1. To promulgate instructions for receipt, transportation, storage and use of COVID-19 vaccines in the National COVID-19 Vaccination Campaign in the Appendix to this Decision.

Article 2. Heads of relevant agencies shall promulgate professional processes applicable at their workplaces on the ground of these instructions.

Article 3. This Decision takes effect on the date of its signing.

Article 4. Chief of the Office, Heads of the Divisions of Pharmaceutical Business Management and Drug Quality Management under the Drug Administration of Vietnam, Director of the Central Institute of Hygiene and Epidemiology and heads of relevant agencies shall implement this Decision./.

P.P. THE DIRECTOR

THE DEPUTY DIRECTOR

(signed)

Le Viet Dung

APPENDIX

Instructions for receipt, transportation, storage and use of COVID-19 vaccines in the National COVID-19 vaccination campaign

(Promulgated with Decision No. 478/QD-QLD dated August 10, 2021 of the Director of the Drug Administration of Vietnam on promulgation of instructions for receipt, transportation, storage and use of COVID-19 vaccines)

^{________________________}

No.	Instructions
1	Receipt of vaccines
2	Storage of vaccines in refrigerators
3	Storage of solvents
4	Storage of vaccines in ultra-cold freezers
5	Storage of vaccines in insulated containers
6	Monitoring vaccine storage temperature
7	Freezing and defrosting ice packs
8	Packing vaccines into cold boxes
9	Transportation of vaccines by refrigerator trucks
10	Transportation of vaccines in cold boxes
11	Maintenance and repair of refrigerators and freezers
12	Handling of emergencies
13	Distribution of vaccines
14	Inventory of vaccines and solvents
15	Recall and separate storage of vaccines
16	Handling of transportation-related problems
17	Transportation of COVID-19 vaccines from airports to warehouses
18	Return of vaccine storage boxes to the manufacturers

INSTRUCTIONS FOR RECEIPT OF VACCINES AND SOLVENTS

1. Objectives

Those instructions aim to help staff involved in receipt of vaccines fully and synchronously implement the steps to receive vaccines and solvents to ensure safety for them and minimize impacts of the surrounding environment (temperature, light, etc.) on their quality as well as avoid confusion of them.

2. Relevant equipment and materials

Cold chain equipment and temperature monitoring instruments, including: refrigerators, cold boxes, ice packs, temperature monitoring devices.

Vaccine distribution documents, vaccine management books, receipts of vaccine delivery, etc.

3. Procedures

3.1. Preparation

3.1.1. Prepare refrigeration equipment, ensuring sufficient capacity to store vaccines before their receipt.

- Refrigerators: storing vaccines over a range of +2°C to +8°C.

- In case the refrigerators are currently storing other vaccines, warehouse-keepers shall rearrange those vaccines to ensure enough room and separation to avoid confusion with the new vaccines.

3.1.2. Check and prepare enough temperature monitoring devices for vaccine storage, which are suitable for each refrigeration equipment: Check the operation of temperature monitoring devices of each refrigerator, and automatic temperature recording devices.

3.1.3. Prepare a vaccine management book to record information upon receipt.

3.1.4. Hand washing: Staff must wash their hands before handling vaccine boxes and vials.

3.2. Steps

No.	Work contents	Assigned staff
1	Hand over relevant documents: warehouse release note/receipt of vaccine delivery, and vaccine lots release certificate.	Warehouse managers Vaccine receiving staff Vaccine delivery staff
2	Check the vaccine storage temperature upon receipt (temperature of refrigerator trucks and cold boxes). Record the temperature on the receipt of vaccine delivery.	Warehouse managers Vaccine receiving staff Vaccine delivery staff
3	Hand over vaccines: Check and compare each type of vaccine and solvent with the warehouse release note: * In terms of senses: Check the condition of transporting vehicles/refrigerators: external condition, cleanliness, arrangement. Check the condition of each vaccine box: integrity, contamination, etc. * In terms of details: Check with relevant records: - Name of vaccine/solvent - Consignment number, expiry date, - Number of vaccines of each consignment - Status of temperature monitoring devices - Temperature of each refrigerator - Time to receive (specific time, date, etc.) and time to open and inspect each vaccine storage refrigerator If there is anything unusual or incorrect with the warehouse release note (such as contaminated, torn or blurry packaging, or the number of vaccines, consignment number and expiry date), report to leaders for timely handling.	Warehouse managers Vaccine receiving staff Vaccine delivery staff
4	Arrange vaccines in refrigeration equipment in accordance with the Vaccine Storage Guide.	Warehouse managers
5	Arrange solvents on shelves in the warehouse.	Warehouse managers
6	Sign the receipt of vaccine delivery/warehouse release note and keep them in the vaccine/solvent receipt file.	Warehouse managers
7	Record information about vaccines and solvents in the "Receipt" section of the vaccine management book: name of delivery unit, type of vaccine and solvent, place of manufacture, quantity, consignment number, expiry date, temperature/vaccine vial monitor (if any), organoleptic status, etc.	Warehouse managers

INSTRUCTIONS FOR STORAGE OF VACCINES

IN REFRIGERATORS

1. Objectives

This document instructs warehouse managers and other staff involved in vaccine/solvent preservation activities on how to arrange and store vaccines/solvents safely in a refrigerator in accordance with regulations so as to minimize mistakes and impacts of temperature and light, etc. on their quality.

2. Relevant equipment and materials

- Refrigerators.

- Temperature monitoring devices: thermometer, automatic temperature recording device, electronic freeze indicator (if any).

- Daily temperature monitoring chart.

3. Procedures

3.1. General principles

- DO NOT keep medicines, chemicals, specimens, food and drinks in the refrigerator storing vaccines.

- DO NOT store expired vaccines or those with moldy labels in the refrigerator with other vaccines.

- DO NOT open the refrigerator door frequently and when not necessary, a list of stored vaccines should be posted on the outside of the refrigerator.

3.2. Hand washing: Staff must wash their hands before handling vaccine boxes and vials.

3.3. Steps

No	Work contents	Assigned staff
1	Place the vaccine boxes in baskets of the refrigerator. NEVER remove the baskets for extra storage space. Leave a space (2cm) between the vaccine boxes for cold air to circulate.	Warehouse managers Staff involved in arranging and storing vaccines
2	Arrange each vaccine separately, by consignment, by expiry date so that it can be easily dispensed for use according to the principles that the shortest expiration date comes first, and first received vaccines are prioritized for dispersion and use. In case different vaccines must be stored in the same refrigerator, there must be a physical separation. There must be also separation signs between boxes of different consignments of vaccines. In case later received vaccines expire sooner, they should be dispensed first according to their expiry date.	Warehouse managers Staff involved in arranging and storing vaccines
3	Place the temperature monitoring device with the vaccines in the indicated location.	Warehouse managers Staff involved in arranging and storing vaccines
4	Daily check and monitor the temperature of the refrigerator and record it on the temperature monitoring table according to the Instructions for monitoring and recording vaccine storage temperature.	Warehouse managers Staff involved in arranging and storing vaccines

INSTRUCTIONS FOR STORAGE OF SOLVENTS

1. Objectives

Solvents should be stored at an appropriate temperature, room temperature (≤25°C) or between +2°C and +8°C. This document guides warehouse managers and other staff involved in Solvent preservation activities on how to arrange and store solvents safely in accordance with regulations so as to minimize mistakes affecting their quality.

2. Relevant equipment and materials

- Refrigerator.

- Solvent storage rack/shelf.

- Daily temperature monitoring chart.

3. Procedures

3.1. General principles:

- Solvents need to be stored in a dry place, not in direct contact with surfaces that are at risk of moisture or mold.

- Solvents should be arranged on shelves or cabinets and DO NOT place them close to the wall or ground.

- Solvents can be stored at room temperature (≤25°C) and should be stored at +2°C to +8°C for 24 hours prior to vaccine reconstitution.

- DO NOT allow the solvents to freeze.

3.2. Hand washing: Staff must wash their hands before handling vaccine boxes and vials.

3.3. Store solvents at room temperature (≤25°C):

No	Work contents	Assigned staff
1	Place the solvent boxes on the shelf, leaving a space (2cm) between them for air to circulate. DO NOT place them close to the wall or ground. Odd solvent vials should be placed in small boxes or baskets and labeled to identify information about their name, number, and expiry date, and do not put odd solvent vials of different consignments in the same box or basket.	Warehouse managers Staff involved in arranging and storing vaccines
2	Arrange each solvent separately by consignments to avoid confusion and to facilitate their dispensing with vaccines. Do not put solvent containers of different consignments on the same shelf. In case they need to be placed on the same shelf, the shelf must have a physical separation and a clear sign.	Warehouse managers Staff involved in arranging and storing vaccines
3	Before vaccine reconstitution, the solvents should be stored at +2°C to +8°C for a minimum of 24 hours. During the time of storing solvents in the refrigerator, they must not be placed with vaccines. There must be separate and differentiating measures to prevent confusion.	Warehouse managers Staff involved in arranging and storing vaccines

INSTRUCTIONS FOR STORAGE OF VACCINES

IN ULTRA-COLD FREEZERS

1. Objectives

This document guides warehouse staff on how to store vaccines in ultra-cold freezers to ensure vaccines safety and minimize factors affecting their quality and ensure safety for warehouse keepers.

2. Relevant equipment and materials

- Protective equipment: isolation gown + medical cap, facemasks, anti-droplet goggles, waterproof insulated gloves, boots.

- Ultra-cold freezer.

3. Terminology - Acronyms

- FIFO: Principle of allocation "First In - First Out"

- FEFO: Principle of allocation "First Expiry - First Out"

- Safe areas: are locations in refrigerators and freezers with a guaranteed temperature between -80°C and -60°C, determined after assessing the temperature uniformity of each cold compartment.

4. Steps

4.1. Ensuring safety for staff:

+ At least 2 people are required when receiving, arranging and storing vaccines with the use of dry ice or ultra-cold freezers.

+ Before opening insulated containers to transport Pfizer vaccines with the use of dry ice (CO2) and an ultra-cold freezer, staff shall wear warm clothes, a mask, thick waterproof gloves, protective goggles, and boots.

+ Do not directly contact the dry ice and the trays/walls of the ultra-cold freezer.

+ Avoid breathing cold air from dry ice and ultra-cold freezers.

Safety precaution: First aid in case of accidents with dry ice:

• Inhaling CO₂: If you feel short of breath or have a headache, these could be signs that you have inhaled too much CO₂. Move immediately to a place with fresh air. Immediately call medical care/consultation (E.g. airway clearance, headrest, oxygenation, etc.)

• Ingestion: Rinse the mouth with clean water immediately if possible. Do not put anything into the unconscious person's mouth. Do not induce vomiting unless directed by medical personnel. Get first aid if there is physical damage.

• Eye contact: Rinse eyes thoroughly with plenty of water for at least 15 minutes and lift lower and upper eyelids to avoid contact. Get an ambulance immediately

• Skin contact: Remove contaminated clothing (if possible), and flush exposed area with large amounts of water to thaw. Soap can be used to wash, do not rub the affected area. Get an ambulance if there is a suspicion of physical injury.

4.2. Storing vaccines safely (For warehouse-keeper)

4.2.1. If vaccines arrive in ultra-cold condition (vaccines have not been thawed)

a. Immediately after opening the insulated containers for vaccine check-in, open the ultra-cold freezer door to place vaccine trays in the compartments of the freezer. Note that each time only arrange the received vaccines up to 3/4 of the total storage volume of the freezer.

b. Each time the ultra-cold freezer door opens for no more than 3 minutes or there should be an alarm when the freezer temperature rises to -60°C.

c. Sort vaccine boxes by consignment, by expiry date to facilitate monitoring, testing and dispensing (compliance with FIFO, FEFO principles and VVM display). Leave a vertical distance of 5-10 cm to distinguish between consignments/vaccines and for air circulation. Make sure the labels of the boxes are visible.

d. Attach a product classification tag to the shelf/box of each vaccine/solvent lot (according to the attached appendix).

e. The odd boxes/vials must be placed in the trays/baskets.

f. Remove vials/boxes of substandard vaccines (out of date) from the refrigerators and freezers and store them in the Containment area for destruction.

4.2.2. If vaccines arrive in cold condition between +2°C and +8°C (thawed vaccines): place them in refrigerators according to procedure.

4.3. Monitoring temperature control of vaccine storage (For warehouse-keeper)

- Daily check the temperature displayed on the control screen of the refrigerators and freezers, twice a day (in the morning at arrival and the afternoon at the leaving and 7 days/week.

- Record the temperature in the monitoring table (Appendix 1 Ultra-cold freezer temperature monitoring table).

- At the end of each week, record comments and put them in the archive file.

- Every month, plug the USB into the refrigerator storage drive to backup/print vaccine storage temperature data from the temperature monitoring device of each refrigerator and freezer.

4.4. Recording and keeping vaccine management documents (For warehouse-keeper)

- Each refrigerator and freezer must have a warehouse card stating the consignment, expiry date, time, place of receipt/distribution, quantity of import/export/inventory (using warehouse card form) and an outline of vaccines stored in the refrigerators and freezers (Appendix 4) to facilitate vaccine dispensing and avoid opening them to find vaccines.

- Record and manage information on stored and dispensed vaccines in the management book.

- Make a monthly inventory of vaccines and record them in minutes. Record the results of physical sensory inspection of each vaccine consignment in the minutes.

APPENDIX 1: TABLE MONITORING TEMPERATURE

OF ULTRA-COLD FREEZER

From ...../....../20... to ......./......./20...

Ultra-cold freezer No.:

Day
Temperature (°C)	M	A	M	A	M	A	M	A	M	A	M	A	M	A
-30
-40
-50
-55
-60
-61
-62
-63
-64
-65
-66
-67
-68
-69
-70
-71
-72
-73
-74
-75
-76
-77
-78
-79
-80
-82
-84
-86
-88
-90

Notes: M – Temperature recorded in the morning (from 8.00-9.00)

A – Temperature recorded in the afternoon (from 16.00-17.00)

COMMENTS

Time	Temperature changes	Remedy

Notes:

+ Record abnormal temperature changes, reasons and remedies

+ No abnormal temperature changes recorded: Write "The freezer is operating normally"

Unit:..........................

WAREHOUSE CARD

Vaccine brand name: ....................................................................................

Consignment No.: ...................................................................................

Expiry date: ...................................................................................................

From (date): ....................................... To (date): ..........................................

Time	Comment	Quantity (Dose)
Time	Comment	Import	Export	In stock

Supervisor Warehouse manager (his/her signature)

OUTLINE OF VACCINES STORED IN ULTRA-COLD TEMPERATURE NO….

From (date): ............................................... To (date): ...........................................

COMPARTMENT NO.	VACCINE BRAND NAME	CONSIGNMENT NO.	QUANTITY (Dose)
1
2
3
4

Warehouse manager (his/her signature)

INSTRUCTIONS FOR STORAGE OF VACCINES AT ULTRA-COLD TEMPERATURES IN PFIZER’S INSULATED CONTAINERS

. Objectives

This document guide the steps of replenishing dry ice to specialized insulated containers at ultra-cold temperature to preserve vaccines and ensure the safety of vaccines and people who are in charge.

2. Related equipment and materials

- Protective equipment: isolation gown + medical cap, facemask, safety goggles, waterproof insulated gloves, boots

- Dry ice sized 1*2cm: ordered 24 hours in advance to ensure sufficient dry ice for additional needs (about 10-15kg per container)

- Tool for shoveling dry ice: shovel/plastic ladle

- There are 2 types of specialized insulated containers for storing and transporting vaccines of Pfizer BioNTech: SOFTBOX and AEROSAFE.

3. Dry ice replenishment procedures when storing vaccines for a long time at ultra-cold temperatures with Pfizer specialized insulated container

IMPORTANT NOTES when using specialized insulated containers to store vaccines at ultra-cold temperatures:

- It is necessary to store the insulated container in a room with temperatures between 15°C and 25°C to maintain the best capability of keeping ULTRA-COLD temperatures.

- To maintain the amount of dry ice and ultra-cold temperatures of the vaccine, it is necessary to:

Ø 2x/day: Do not open the thermal shipping container more than two times per day

Ø 3 minutes: Do not open the thermal shipping container for more than 3 minutes at a time

Ø 5 days: Replenish dry ice in the thermal shipping container every 5 days

- If you have to open the lid of the insulated container multiple times a day, dry ice needs to be added more often.

- All supplies included in the insulated container should be carefully kept in the insulated container to be returned to the manufacturer for reuse.

3.1. Preparations when receiving/adding dry ice to the insulated container

- At least 2 people to perform the task.

- Those who contact with dry ice need to wear protective clothing, including long-sleeved clothes, boots, glasses, gloves and masks to avoid frostbite.

- Open the ventilation door/turn on the ventilation fan in the area for storage of the insulated container and replenishment of dry ice to avoid CO₂ asphyxiation.

- Place a warning sign at the position of adding dry ice: WARNING: KEEP SAFE DURING EXPOSURE TO DRY ICE.

3.2. Within the first 24 hours after receiving the vaccine: open the container, check and add dry ice to the insulated container of the vaccine

3.3. Dry ice replenishment process

3.3.1. Place the insulated container that needs to be replenished on the panet

When adding dry ice to any container, put it on the panet (do not let the container touch the warehouse floor).

3.3.2. Dry ice replenishment process for SOFTBOX insulated container

1. Memorize the components inside the insulated container for the quickest dry ice replenishment (within 3 minutes for each container) Insulated foam lid attached to the carton cover and fitted with a temperature monitoring device and heat probe wires. Box that holds the vaccine vial trays must be put back into the container after usage in order to return to the manufacturer.
2. Open the insulated container (E) by cutting the tape, put three fingers in the gap to lift the foam lid attached to the container (D). Avoid tearing the cover and the probe wire.
3. Use gloves to lift the dry ice pack (A) out and put it on the shelf
4. Shovel dry ice around the vaccine container compartment (C) so that the dry ice is only up to the top edge of the vaccine container
5. Place dry ice pack (A) back on top of the vaccine container, open pack (A) gently, add dry ice and spread them evenly (do not overfill).
6. Repack the dry ice pack (A) again to the original square shape, make sure the ice pack covers the container and levels with the top edge of the insulated foam container
7. Close the foam lid (D) and carton cover of the insulated container (E) and seal it with tape. Store the vaccine container in a well-ventilated place below 25°C

3.3.3. Dry ice replenishment process for AEROSAFE insulated container

1. Memorize the components inside the insulated container for the quickest dry ice replenishment within 3 minutes for each container The foam lid attached to the carton by a thin aluminum strip and fitted with a temperature monitoring device. Avoid tearing. The ice tray must be put back into the container when returned to the manufacturer
2. Open the insulated container (E) by cutting the tape then opening the carton cover. Wear gloves when lifting the insulated foam lid (D), avoid tearing the aluminum tape and breaking the probe wire
3. Wear insulated gloves to grab the belt and lift the dry ice tray (A), put it beside the container
4. Shovel dry ice into the compartment around the container so that the dry ice is up to the top edge of the vaccine compartment
5. Replace the dry ice tray (A) to fit the vaccine compartment, then fill the tray with dry ice (A), do not overfill.
6. Close the foam lid (D), carton cover of the insulated container (E) and seal with tape. Store the vaccine container in a well-ventilated place below 25°C.

Table tracking dry ice replenishment for insulated container No....

From .... /.... /20... to .... /.... /20...

No	Hour/minute	Day/month/year	Staff (His/her signature and full name)	Quantity of dry ice added (Estimated)	Supervisor (His/her signature)
1				..?.. kg
2
3
4
5
6

(Records kept at the unit’s warehouse)

INSTRUCTIONS FOR MONITORING AND RECORDING VACCINE STORAGE TEMPERATURE

1. Objectives:

As vaccines are sensitive to heat and freezing, they must be kept at the correct temperature. This document provides instructions on the work of and requirements for monitoring and recording the daily temperature during the storage of vaccines in order to promptly handle cases of out-of-range temperatures for the safety and quality of vaccines.

2. Relevant equipment and materials

- Daily temperature tracking chart.

- Temperature monitoring instruments: thermometer, electronic freeze indicator, temperature data logger.

3. Procedures

No		Work content	Assigned staff
1. Preparation	1.1	Place one automatic temperature recorder in each vaccine container. Place one electronic freeze indicator (if available) with freeze-sensitive vaccines. Do not store them in freezer compartment. Equipment must be encoded (numbered) according to the refrigerating appliances (refrigerator).	Warehouse manager Staff who is in charge of monitoring and storing vaccines
	1.1	Positions of temperature monitoring devices: - For thermometers and temperature date loggers: Placed with vaccines in a position that can be easily seen and likely to be affected by the temperature change when you close or open the refrigerator. - For electronic freeze indicators: Placed with freeze-sensitive vaccines9. Do not store them in freezer compartment.	Warehouse manager Staff who is in charge of monitoring and storing vaccines
	1.2	Specify the code number of each refrigerator on the daily temperature monitoring chart.	Warehouse manager
2. Every day	2.1	Check the temperature of the temperature data loggers and record it on the monitoring chart twice a day in the early morning (on arrival) and late afternoon (before leaving) for 7 days a week, including Saturday, Sunday and holidays.	Warehouse manager Staff who is in charge of monitoring and storing vaccines
	2.2	Check the temperature indicator for vaccines and freeze indicator (if there are any). In case of an abnormal situation, it must be reported to the leader/supervisor to handle following the incident handling procedure for vaccine storage.	Warehouse manager
	2.3	Check the daily temperature of the automatic temperature logger every 24 hours and record the highest and lowest temperatures on the temperature monitoring chart. The daily temperature monitored must remain within the acceptable temperature range.	Warehouse manager Staff who is in charge of monitoring and storing vaccines
	2.4	In case out-of-range temperatures occur, it must be reported to the leader/supervisor to handle following the incident handling procedure for vaccine storage.	Staff who is in charge of monitoring and storing vaccines Warehouse manager Professional warehouse staff
3. Every month	3.1	At the end of each month, the staff should evaluate and give comments on the monthly temperature condition of each refrigerator with the supervisor's signature on the monitoring chart.	Warehouse staff Professional warehouse staff
	3.2	The staff should replace the temperature tracking chart for every new month and store the previous month's tracking chart. Remember to fill in all information on the temperature monitoring chart (number of the refrigerator, the start date and the end date of monitoring...).	Warehouse staff
	3.3	Print/backup temperature data from the automatic temperature loggers for each refrigerator.	Warehouse staff
	3.4	In case the monthly refrigerator vaccine storage temperature is not stable, report the situation to the leader.	Warehouse staff Professional warehouse staff

INSTRUCTIONS FOR FREEZING AND DEFROSTING ICE PACKS

1. Objectives

This document provides instructions on how to freeze and defrost the ice pack properly for safe and effective vaccine storage. If the ice pack is not defrosted properly, the vaccine may be affected by exposure to freezing temperatures.

2. Relevant equipment and materials

- Ice-pack freezers or refrigerators with freezer compartment.

- Ice packs.

- Clean towel.

3. Procedures

No	Work contents	Assigned staff
1.	Calculate the demand for ice packs: - The number of needed ice packs should be calculated according to the plan for storing and transporting vaccines using cold boxes. The size of the ice pack must match the type of the cold box. - Calculate the time required to freeze the needed ice packs (Ice packs need at least 24 hours to freeze).	Warehouse manager
2.	Freeze the ice packs: - Pour clean water into the ice pack up to the specified line. Close the lid tightly. Hold the ice pack upside down and shake it to make sure it does not leak. - Put the ice packs upright or on their sides in the freezer for at least 24 hours to freeze solid the water inside the ice packs. - Take the frozen ice packs out of the freezer compartment and close the door.	Warehouse manager Assigned warehouse staff
3.	Defrost the ice packs: - Keep the ice packs at the ambient temperatures for about 15 to 30 minutes (depends on the temperatures outside) until part of the frozen ice inside melts into water. - Check to see if an ice pack has been conditioned by shaking it and listening for water. - Use clean towels to dry the defrosted ice packs before putting them into the cold box or vaccine carrier.	Warehouse manager

INSTRUCTIONS FOR PACKING VACCINES INTO COLD BOXES

1. Objectives:

This document provides instructions on how to pack the vaccines properly with defrosted ice packs to reduce the risk of temperature effects on vaccine quality during transport and storage.

2. Relevant equipment and materials

Cold boxes, ice packs and temperature monitoring devices.

3. Procedures

3.1 Preparation

3.1.1 Prepare the ice packs: following the process of freezing and defrosting ice packs (Process 6)

3.1.2. Prepare the cold boxes: The cold box needs to be clean and dry before packing the vaccine.

3.1.3. Wash hands: Staff must wash their hands before touching the vaccine containers and vials.

3.2 Pack the vaccines using cold boxes

No	Work contents	Assigned staff
1.	Put defrosted ice packs against each of the four sides of the cold box (the number of ice packs and the packing methods must follow the instructions for each type of cold box)	Warehouse manager and vaccine transporter Professional warehouse staff
2.	The vaccine vials and diluents must be packed in a container with a lid.	Warehouse manager and vaccine transporter
3.	Place the vaccine vials and diluents in the center of the cold box with the top of the vials facing up. Remember to pack the vaccines tightly in order to avoid collisions during transportation.	Warehouse manager and vaccine transporter
4.	Keep the temperature monitoring device near the vaccines. Avoid its direct contact with the ice packs	Warehouse manager and vaccine transporter
5.	Place the defrosted ice packs on the top of the cold box.	Warehouse manager and vaccine transporter
6.	Close the lid of the cold box and lock it.	Warehouse manager and vaccine transporter
7.	The cold box or vaccine carrier must always be protected against sunlight during transportation.	Vaccine transporter

INSTRUCTIONS FOR TRANSPORTATION OF VACCINES

BY REFRIGERATOR TRUCKS

1. Objectives

This document guides the use of refrigerator trucks for transporting vaccines from vaccine warehouses in military regions to warehouses of other units in order to minimize errors and other factors that impact vaccine quality during its transportation, ensuring that the routes are provided with safe and quality vaccines in a timely and complete manner.

2. Relevant equipment and materials

- Official dispatch/decision on vaccine distribution.

- Receipt of vaccine delivery, warehouse release note and vaccine release certificate. (Appendixes 1, 2 and 3)

- Temperature monitoring devices.

- Refrigerator trucks.

- Information of receiving units: Address, phone number of leaders or staff in charge of receiving warehouses

3. Procedure

Step 1: Formulating a plan on vaccine transportation

Warehouse management leaders or warehouse managers shall:

- Formulate a plan on the distribution and transportation of vaccines that specifies quantity, type, consignment number and estimated time of transportation to receiving warehouses. Inform the plan on transportation (estimated time of transportation, quantity and type of vaccines) to the receiving warehouses.

- Arrange trucks and drivers according to the set plan.

- Notify the drivers:

+ Estimated route, time, location of receipt, full name, phone number of receiving warehouse managers.

+ Technical conditions of vehicles (such as tires, brakes, gasoline, machinery, and cooling system) must be checked before the date of transportation.

+ About 1-2 hours before loading vaccines into trucks, their cooling system must be operated in order to keep the refrigerated compartment at a temperature of between +2 °C and +8°C.

+ Instructions for the handling of transportation-related problems are always available in refrigerator vehicles. (Procedure 15)

Step 2: Packing vaccines and solvents and prepare temperature monitoring devices

Warehouse managers, vaccine warehouse supporting staff or vaccine transporting staff shall:

- Prepare vaccine handover dossiers according to Procedure12: Distribution of vaccines.

- Inventory and compare each type of actual vaccines and solvents (quantity, consignment number and expiry date, etc.) with the warehouse release note. In cases where the actual quantity of vaccines left warehouses does not match the quantity according to consignment number/expiry date indicated on warehouse release notes, the warehouse-keepers shall report it to the leaders involved in warehouse management to modify and rewrite release notes/records.

- Before packing vaccines and solvents, check and record the state of storage temperature and vaccines (labels, mold and color) into the receipt of vaccine delivery (according to Appendix 1).

- Pack vaccines in turn and arrange vaccine boxes into cartons, in which each type shall be kept separate from others. Name of receiving units, type of vaccines, quantity, consignment number and expiry date must be clearly indicated on the outside of labeled bales/cartons. After packing vaccines, they must be re-inventoried according to release notes and sealed for each bale/carton of vaccines (warehouse managers shall be accountable for the number of packed vaccines).

- Install attached temperature monitoring devices.

Step 3: Arranging vaccines into refrigerator trucks for transportation

Warehouse managers, vaccine warehouse supporting staff or vaccine transporting staff, in coordination with drivers, shall perform the following activities:

- Check the temperature of the refrigerated compartment and only load vaccines into refrigerator trucks when the refrigerated compartment is kept at a temperature of between +2°C and +8°C.

- Quickly arrange vaccine bales/cartons of each vaccine receiving point into the refrigerated compartment of refrigerator trucks, ensuring that vaccine boxes must be kept at a certain distance for cold air circulation; do not place vaccines sensitive to freezing temperature near the vent of indoor unit (located at least 0.5m from the indoor unit); arrange vaccine boxes no higher than 2/3 of the truck height; arrange the boxes neatly and firmly to limit collisions and breakage and conveniently distribute to units according to the routes (the first receiving warehouse is at the outermost).

- Place temperature monitoring devices in the vaccine compartment of refrigerator trucks. Lock the vaccine compartment doors carefully and quickly transport vaccines to receiving units as scheduled.

- Sign the vaccine handover record (according to Appendix 2), vaccine warehouse managers shall hand over relevant dossiers (including release notes, receipt of vaccine delivery and release permit for each vaccine lot) and temperature monitoring devices to vaccine transporting staff.

Vaccine transporting staff and drivers shall perform the following activities:

- Upon transportation, the temperature of the refrigerated compartment must be regularly monitored (the temperature monitoring system in the truck cockpit), ensuring that it is kept at a temperature of between +2°C and +8°C. In cases where the temperature in the refrigerated compartment fails to remain at a temperature of between +2°C and +8°C, the handling of incidents shall comply with "Instructions for handing of transportation-related problems" (Procedure 15).

- Upon resting along the road, make sure the cooling system of refrigerator trucks is always running (starting the engine or plugging in the power). In cases of overnight stay, they must regularly monitor the temperature of the refrigerated compartment every 2-3 hours.

- About 45-60 minutes before arriving at vaccine delivery points, contact receiving warehouse managers to actively coordinate the delivery of vaccines as required.

Step 4: Handing over vaccines

- Upon arrival, vaccine transporting staff shall immediately hand over the vaccines and related dossiers (release notes, receipt of vaccine delivery and release permit) to staff involved in the receipt of vaccine delivery.

- Coordinate with receiving warehouse managers in checking and recording the temperature of refrigerated compartment and the temperature on temperature monitoring devices before recording the handover of vaccines into the receipt of vaccine delivery.

- Deliver the correct and complete number of cartons/bales of vaccines to the receiving warehouses.

- Coordinate with receiving warehouse managers in checking the quantity, consignment number, expiry date of distributed vaccines and solvents.

- In cases where there is anything incorrect regarding quantity, consignment or expiry date of vaccines/solvents, receiving warehouse managers shall immediately contact staff or leaders involved in distribution warehouse management for timely handling.

- Fill in all information about handover time, vaccine state, etc. in the handover minutes. Get the signature and seal of the leader in charge of receiving warehouse.

- Upon the receipt, if vaccines show any abnormal signs, the receiving warehouse may not accept the vaccines. Receiving warehouse managers shall make a record that clearly states the reasons for not receiving the vaccines and is confirmed by receiving warehouse leaders, and immediately notify distribution warehouse leaders for timely handling.

Step 5: Handing over equipment, dossiers and backing up vaccine storage temperature data during the transportation

- After returning to the distribution warehouses, the vaccine transporting staff shall be responsible for immediately handing over the receipt of vaccine delivery/warehouse release note of the shipment to staff in charge of thermometer warehouses.

- The staff in charge of distribution warehouses shall print and back up the temperature data recorded by vaccine transporting staff from the temperature monitoring devices on trucks and thermometers placed in the refrigerated compartment, and check the temperature data during the transportation. In cases where the vaccine storage temperature during the transportation does not meet the required temperature (beyond the range of between +2°C and +8°C), the vaccine transporting staff and staff in charge of warehouses must record the problem and report it for handling.

- At the end of the shipment, the staff in charge of warehouses shall send reports to the leaders of military regions.

Form:

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

^{________________________}

RECEIPT OF VACCINE DELIVERY

Vaccine deliverer:

- Full name of representative:................... Position:

- Full name of deliverer: ........................................................Position:

Vaccine consignee:

- Full name of representative:.................... Position:

- Full name of consignee: ......................................................Position:

Today, dd/mm/yyyy at......., the two parties conduct the vaccine delivery with the following contents:

Part I: Relevant dossiers and papers:

	Number of official dispatch on vaccine delivery	Date of signing	License of National Accreditation Institute	Warehouse release note
Before the receipt			Yeso Noo
After the receipt			Yeso Noo	Yeso Noo

Part II: Details of received vaccines and solvents:

Name of vaccines	Calculation unit	Quantity	Consignment No.	Expiry date	Manufacturer	Manufacturing country

Solvent	Calculation unit	Quantity	Consignment No.	Expiry date	Manufacturer	Manufacturing country

Part III. Conditions of temperature monitoring devices during the transportation

Total number of checked packages:

Vaccine temperature upon checking: °C

Temperature monitoring devices:

VVM □

(stages 1, 2, 3, 4)

Electronic freeze indicator

□ (write X or V)

Logtag temperature recorder

Yes □ No □

Part IV: General assessment on the state of consignments: (sanitation, packaging, labels, mold, etc.):

….(Location), dd/mm/yyyy…..

Representative of deliverer

Deliverer

Consignee

Representative of consignee

(signature, full name and seal)

Form:

VACCINE HANDOVER RECORD

Vaccines delivered to: .............................................................

1/ Refrigerator truck – License plate:...

2/ Date of handover: dd/mm/yyyy at..........

3/Temperature upon warehouse release: ......................................

4/ Packaging state upon warehouse release: .................................

5/ Relevant handover dossiers:

- Warehouse release certificate of inspection:	Yes	No
- Receipt of vaccine handover:	Yes	No
- Warehouse release note:	Yes	No

6/Packaging details:

No.	Type	Number of bales/cartons	Number of odd boxes (if any)	Number of doses	Note
1
2
3
4
5
6
7
8
9
10
11
12
13
14
	Total

Signature of driver/ transporting staff

Signature of vaccine warehouse-keeper

Form.

WAREHOUSE RELEASE NOTE

dd/mm/yyyy…

Name of consignee:

Reasons for release:

Release at the warehouse:

No.	Name, brand, quality specifications of materials	Calculation unit	Quantity	Unit price	Amount



	Total:

Total amount (in word):

dd/mm/yyyy..

Head of unit

Staff in charge of distribution warehouse

Staff formulating note

Consignee

Warehouse-keeper

INSTRUCTIONS FOR TRANSPORTATION OF VACCINES IN COLD BOXES

1. Objectives

This document guides the transportation of vaccines in cold boxes, ensuring that the vaccines are stored at an appropriate temperature.

2. Relevant equipment and materials

- Official dispatch/decision on vaccine distribution.

- Cold boxes, ice packs, thermometers.

- Means of transport: trucks...

- Receipt of vaccine delivery, warehouse release note and vaccine release certificate.

- Information of receiving units: Address, phone number of leaders or staff in charge of receiving warehouses

3. Procedure

Step 1: Formulating a plan on vaccine transportation

Warehouse management leaders or warehouse managers in military regions shall:

- Formulate plan on the distribution and transportation of vaccines that specifies quantity, type, consignment number and estimated time of transportation to the receiving warehouses. Inform the plan on transportation (estimated time of transportation, quantity and type of vaccines) to the receiving warehouses.

- Arrange trucks and drivers according to the set plan.

- Notify the drivers:

+ Estimated route, time, location of receipt, full name, phone number of receiving warehouse managers.

+ Technical conditions of vehicles (such as tires, brakes, gasoline, machinery, and cooling system) must be checked before the date of transportation.

Step 2: Packing vaccines and solvents and prepare temperature monitoring devices

Warehouse managers, vaccine warehouse supporting staff or vaccine transporting staff shall perform the following activities:

- Prepare vaccine handover dossiers according to Procedure12: Distribution of vaccines.

- Pack vaccines and solvents into cold boxes according to Procedure 07: Packing vaccines into cold boxes using ice packs.

Step 3: Arranging cold boxes into trucks for transportation

Warehouse managers, vaccine warehouse supporting staff or vaccine transporting staff, in coordination with drivers, shall perform the following activities:

- Quickly arrange cold boxes containing vaccines of each vaccine receiving point into the refrigerated compartment, arrange the cold boxes neatly and firmly to limit collisions and breakage and conveniently distribute to units according to the routes (the first receiving warehouse is at the outermost).

- Lock the vaccine compartment doors carefully and quickly transport vaccines to receiving warehouses as scheduled.

Upon the transportation, vaccine transporting staff and drivers shall perform the following activities:

- In cases where there is any problem arising upon the transportation, they must immediately report it to the leaders and managers of distribution warehouses according to the procedure for handling transportation-related problems.

- In cases where the truck breaks down and it takes a little time to repair the truck, they shall have the truck’s engine repaired to continue transporting the vaccines to the receiving points.

- In cases where it takes a long time to repair the truck or the trucks cannot be repaired, they shall contact the nearest receiving warehouse or the nearest military unit for help such as supporting equipment and machinery for repair or sending another vehicle to replace it to continue transporting the vaccines to the receiving points.

- About 45-60 minutes before arriving at vaccine delivery points, contact receiving warehouse managers to actively coordinate the delivery of vaccines as required.

Step 4: Handing over vaccines

- Coordinate with receiving warehouse managers in checking and recording the time of delivery and the temperature in cold boxes before recording the handover of vaccines into the receipt of vaccine delivery.

- Deliver the correct and complete number of vaccines to the receiving warehouses.

- Coordinate with receiving warehouse managers in checking the quantity, consignment number, expiry date of distributed vaccines and solvents.

- In cases where there is anything incorrect regarding quantity, consignment or expiry date of vaccines/solvents, receiving warehouse managers shall immediately contact staff or leaders in charge of warehouses in military regions for timely handling.

- Fill in all information about handover time, vaccine state, etc. in the handover minutes. Get the signature and seal of the leader in charge of receiving warehouse.

- Upon receipt, if vaccines show any abnormal signs, the receiving warehouses may not accept the vaccines. Receiving warehouse managers shall make a record that clearly states the reasons for not receiving the vaccines and is confirmed by the leaders in charge of receiving warehouses, and immediately notify the leaders in charge of warehouses in military regions for timely handling.

- Pending handling, vaccines must be stored separately and in a refrigerated container or refrigerator in accordance with storage requirements.

- Recover cold boxes and temperature monitoring devices, and return them to distribution warehouses.

Step 5: Handing over cold boxes, thermometers, dossiers and backing up vaccine storage temperature data during the transportation

- After returning to the distribution warehouses, the vaccine transporting staff shall be responsible for immediately handing over cold boxes, thermometers and receipt of vaccine delivery/warehouse release note of the shipment to staff in charge of thermometer warehouses.

- The staff in charge of distribution warehouses shall back up the vaccine storage temperature data in cold boxes during the transportation. In cases where the vaccine storage temperature during the transportation does not meet the required temperature (beyond the range of between +2°C and +8°C), the vaccine transporting staff and staff in charge of warehouses must record the problem and report it for handling.

- At the end of the shipment, the staff in charge of warehouses shall send reports to the leaders of military regions.

Form:

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

^{_______________________}

RECEIPT OF VACCINE DELIVERY

Vaccine deliverer:

- Full name of representative:................... Position:

- Full name of deliverer: ........................................................Position:

Vaccine consignee:

- Full name of representative:.................... Position:

- Full name of consignee: ......................................................Position:

Today, dd/mm/yyyy at......., the two parties conduct the vaccine delivery with the following contents:

Part I: Relevant dossiers and papers:

	Number of official dispatch on vaccine delivery	Date of signing	License of National Accreditation Institute	Warehouse release note
Before the receipt			Yeso Noo
After the receipt			Yeso Noo	Yeso Noo

Part II: Details of received vaccines and solvents:

Name of vaccines	Calculation unit	Quantity	Consignment No.	Expiry date	Manufacturer	Manufacturing country

Solvent	Calculation unit	Quantity	Consignment No.	Expiry date	Manufacturer	Manufacturing country

Part III. Conditions of temperature monitoring devices during the transportation

Total number of checked packages:

Vaccine temperature upon checking: °C

Temperature monitoring devices:

VVM □

(stages 1, 2, 3, 4)

Electronic freeze indicator

□ (write X or V)

Logtag temperature recorder

Yes □ No □

Part IV: General assessment on the state of consignments: (sanitation, packaging, labels, mold, etc.):

….(Location), dd/mm/yyyy…..

Representative of deliverer	Deliverer	Consignee	Representative of the consignee (signature, full name and seal)

Form:

VACCINE HANDOVER RECORD

Vaccines delivered to: .............................................................

1/ Refrigerator truck – License plate:...

2/ Date of handover: dd/mm/yyyy at..........

3/Temperature upon warehouse release: ......................................

4/ Packaging state upon warehouse release: .................................

5/ Relevant handover dossiers:

- Warehouse release certificate of inspection:	Yes	No
- Receipt of vaccine handover:	Yes	No
- Warehouse release note:	Yes	No

6/Packaging details:

No.	Type	Number of bales/cartons	Number of odd boxes (if any)	Number of doses	Note
1
2
3
4
5
6
7
8
9
10
11
12
13
14

	Total

Signature of driver

Signature of vaccine warehouse-keeper

Form.

WAREHOUSE RELEASE NOTE

dd/mm/yyyy…

No……

Name of consignee:

Reasons for release:

Release at the warehouse:

No.	Name, brand, quality specifications of materials	Calculation unit	Quantity	Unit price	Amount



	Total:

Total amount (in word):

dd/mm/yyyy….

Head of unit

Staff in charge of distribution warehouse

Staff formulating note

Consignee

Warehouse-keeper

INSTRUCTIONS FOR MAINTENANCE OF TCW 4000AC REFRIGERATORS

1. Objectives:

This document guides the daily and monthly maintenance of TCW 4000AC refrigerators for vaccine storage in order to minimize the risks that may affect the vaccine quality.

2. Relevant equipment and materials

- Necessary tools: soft brush, clean towel and tray.

- User manual for TCW 4000AC refrigerators

- Operation log book.

- Cold boxes with prepared ice packs

- The refrigerators that have been operated to the specified temperature for vaccine storage if they have to be temporarily moved to perform maintenance.

3. Procedure

3.1. Daily tasks

- Check the operation of refrigerators: electrical connection and automatic temperature monitoring devices attached.

- Clean the dust on the outside of refrigerators.

3.2. Weekly tasks

- Check condensate trays, in cases where there is a lot of condensation, the standing water shall be poured out while refrigerator compartments shall be checked for standing water. Unclog drain hoses if they are blocked.

- Check the tightness of refrigerator door gaskets and clean the compartment gaskets.

- Check for ice and frost and defrost if ice clings to indoor unit or wall of compartments >0.5cm. Defrosting/deicing shall be conducted by the following steps:

+ Step 1: Move vaccines and solvents in the refrigerator to a safe place: a cold box with ice packs OR another refrigerator.

+ Step 2: Turn off the power and unplug it from the outlet.

+ Step 3: Open the refrigerator door until the ice and frost on the inside melt. Do not use knives or other sharp objects to pry.

+ Step 5: Dry the refrigerator inside with a clean towel.

+ Step 6: Check the shelves and equipment inside the refrigerator.

+ Step 7: Close the refrigerator door.

+ Step 8: Turn on the power. Monitor the temperature in the refrigerator until the desired and stable temperature is reached (this level is often reached after 24 hours).

+ Step 9: Transfer vaccines and solvents back to the refrigerator.

3.3. Monthly tasks

a. Clean the refrigerator lids or doors with diluted soapy water.

b. Clean the TCW 4000AC refrigerator by the following these steps:

NOTE: Before cleaning the TCW 4000AC refrigerator, all vaccines must be taken out for temporary storage in a cold box with ice packs OR another refrigerator in good working status.

• Turn off the power switch and unplug it from the outlet.

• Prepare temporary storage devices and move vaccines out of the refrigerator to storage devices that ensure an appropriate temperature as prescribed.

• Remove the plastic cover of the container, and use a screwdriver to remove the temperature probe on the inside surface of container and the inner liner.

• Use warm water and neutral detergent to clean all inside and outside parts, refrigerator lids and lid gaskets. Then dry thoroughly.

• After cleaning the TCW 4000AC refrigerator, place the inner liner in the correct position and fix the temperature probe. Reattach the plastic cover of container. Close refrigerator lids.

• Check the cleanliness of the compressor and heat sink. The equipment will fail to operate correctly in cases where these parts are covered with dust. The compressor and heat sink shall be cleaned as follows:

+ Expose the refrigerator side where the hot rig and compressor compartment are located.

+ Use a screwdriver to open the screws in the compressor compartment and remove the protective cover.

+ Sweep all the dust on the heat sink and in the compressor compartment with a soft brush.

+ Close the protective cover and re-tighten the fixing screws.

• Plug in the power and turn on the switch for the TCW 4000AC refrigerator.

• Run the refrigerator and monitor the refrigerator temperature displayed on the screen and automatic temperature monitoring devices (Fridge-tag 2).

• Take vaccines from temporary storage devices back into the TCW 4000AC refrigerator only when the refrigerator has reached a temperature of between +2°C and +8°C.

c. The warehouse managers shall supervise the performance and the staff involved in maintenance shall record the date and contents of maintenance in the operation logbook, assess the operation process and the refrigerator state.

Form of operation logbook

MACHINERY DETAILS

AND OPERATION LOG BOOK

NAME OF EQUIPMENT:............................................

MACHINERY DETAILS

I. GENERAL INFORMATION

1. Manufacturer/Origin:........................................................................

2. Model and type of machine:..............................................................

3. Serial number:..................................................................................

4. Put-into-use date:.............................................................................

II. SPECIFICATIONS:

1. Voltage:

2. Capacity: .........................................................................................

3. Size:

4. Weight:

5. Other specifications:

.......................................................................................................................

Person in charge of unit:

III. INFORMATION ON SUPPLIER AND WARRANTY

1. Supplier:

Name of supplier:.................................................................................

Address:...............................................................................................

Phone number:......................................................................................

2. Warranty unit:

Name of warranty unit:.........................................................................

Address:...............................................................................................

Phone number:......................................................................................

IV.MANAGEMENT/REPAIR, REPLACEMENT/MAINTENANCE:

TIME	ASSIGNED STAFF	WORK CONTENTS	NOTE

INSTRUCTIONS FOR HANDLING OF EMERGENCIES REGARDING VACCINES STORED IN REFRIGERATORS

1. Objectives

This document guides the handling of emergencies (prolonged power outages, fires, natural disasters, floods and broken refrigerators, etc.) in order to ensure the safety of vaccines stored in refrigerators and the safety for people.

2. Relevant equipment and tools

- Backup generator and fuel.

- Standard fire-fighting orders mounted at warehouses and fire-fighting tools.

- Equipment operation logbook.

- List of names/phone numbers of staff for maintaining prompt communications in case of emergency: warehouse-keeper, warehouse specialist, leader of warehouse and leader of unit.

3. Procedure

Principle: In an emergency, the vaccine storage temperature should be maintained between 2°C and 8°C for all vaccines.

3.1. Scenario 1: PROLONGED POWER OUTAGES

When there is a prolonged power outage or a power failure without knowing when the power will be restored, which can affect the quality of vaccines, the following steps should be taken immediately:

No.	Contents	Assigned staff
1	Immediately notify the direct manager.	Detectors
2	Run a backup generator (if any) and make sure to reserve enough fuel for the generator. In cases where the unit does not have a backup generator, the handling of vaccines should comply with the same procedure as cases of broken refrigerators. Limit opening refrigerator doors during a power outage	Technical staff in charge
3	After the backup power is supplied, record the temperature of vaccine storage refrigerators at the time the warehouse resumes operation in the equipment operation logbook. Coordinate with technical staff to check the operating status of refrigerators. - In cases where the refrigerators are working properly, continue to store vaccines as usual. - In cases where the refrigerators fail to operate in a stable manner, notify persons in charge directly to handle and remedy.	Warehouse managers/technical staff
4	When the grid power is restored. Warehouse managers must check and monitor the operating status of all refrigerators to ensure their stable operation. Record the storage temperature of refrigerators (after the grid power is restored stably about 30 minutes and every 30 minutes within the first 2 hours to ensure their stable operation) and the operation status of refrigerators in the equipment operation logbook.	Warehouse managers/technical staff

3.2. Scenario 2: FIRES AND EXPLOSIONS IN REFRIGERATED WAREHOUSES

When fires occur in refrigerated warehouses, the following steps must be taken immediately:

No.	Contents	Assigned staff
1	Perform the tasks according to standard fire-fighting orders (alarm urgently, disconnect power, call 114, use fire-fighting means on-site, etc.)	Detectors
2	Move refrigerators to a safe area (if possible). Note: Do not open refrigerator doors.	All staff
3	After the fire-fighting is completed. - In cases where the refrigerators are able to work properly: operate the refrigerators again, inventory vaccines and check the temperature of refrigerators. - In cases where the refrigerators are unable to operate: + Transfer vaccines in damaged refrigerators to other refrigerated equipment and arrange them separately. + Inventory affected vaccines and report to leaders of units.	Warehouse manager/technical staff

3.3. Scenario 3: STORAGE TEMPERATURE OUT OF THE SAFETY RANGE DUE TO BROKEN REFRIGERATORS

When detecting that the refrigerator temperature is out of the safety range for vaccine storage (higher or lower than the required temperature), the following steps must be taken immediately:

No.	Contents	Assigned staff
1	Record the storage temperature of refrigerators at the time of detection in the equipment operation logbook.	Warehouse managers Warehouse specialists
2	Immediately notify persons in charge and technical staff on duty to remedy the damage in time.	Warehouse managers Warehouse specialists Technical staff
3	Coordinate in handling: - In cases where the refrigerator temperature remains lower than 2°C: open the refrigerator lid until the temperature indicates 7°C, then close it and monitor closely. In cases where vaccines are likely to be frozen, perform a “shake test” of freeze-sensitive vaccines. - In cases where the refrigerator temperature remains higher than 8°C: Put ice wrapped in a sealed plastic bag or a tray into the refrigerators and monitor the temperature every 30 minutes to ensure the temperature is maintained within the specified range of between 2 °C and 8°C - Transfer vaccines to other refrigerators or cold boxes (if any) for separate preservation according to the procedure for vaccine storage in the refrigerators and cold boxes. - In cases of transferring vaccines to cold boxes, the vaccines must be packed according to the procedure for packing vaccines into cold boxes - In cases where vaccines are transferred to refrigerators, the refrigerators must operate stably and reach the required temperature before transferring the vaccines into such refrigerators.	Warehouse managers Warehouse specialists
4	Report to the leader of the unit for handling	Warehouse specialists

3.4. Scenario 4: OTHER UNUSUAL SITUATIONS (uprooted trees, blown-off roofs, floods, etc.)

- Step 1: Alarm the whole unit

- Step 2: Check and evaluate the impacts on the refrigerator system in order to take appropriate on-site remedial solutions:

o In cases where the refrigerated warehouses are at risk of unsafety due to short circuits, fires or explosions, floods: Disconnect the power supply to the system of refrigerated warehouses.

o Use on-site vehicles to handle the incidents and coordinate in transporting vaccines from broken refrigerators to safe places: For example, move vaccines from the 1^st floor to the 2^nd floor (in cases of flooding) or cover the roof with tarpaulins (in cases of blown-off roofs) or handle cases of unstable refrigerator temperature according to instructions for scenario 3.

INSTRUCTIONS FOR DISTRIBUTION AND ALLOCATION OF VACCINES

1. Objectives

This document guides the allocation and distribution of vaccines at units to ensure adequate and timely supply of vaccines for vaccination activities and avoid redundancy/shortage of vaccines.

2. Relevant equipment and materials

- Vaccine distribution plan, vaccine management book, receipt of vaccine delivery/warehouse release note

- Cold boxes, ice packs, temperature monitoring devices.

- Procedures of packing vaccines into cold boxes.

3. Procedures

3.1 Prepare sufficient cold boxes, ice packs in quantity and capacity to store vaccines in each session: Warehouse manager or vaccine delivery/reception staff.

3.2 Handwashing: staff must wash their hands before handling vaccine vials/boxes.

3.3 The vaccine delivery/receipt area must be protected from the effects of weather: shady, avoid direct sunlight, rain, dust, etc..

3.4 Vaccines/solvents allocation

No	Work content	Assigned staff
1	Announce the time, quantity and type of vaccines to the receiving units in order to prepare a plan to receive vaccines.	Staff in charge of vaccine warehouse
2	Transfer the official dispatch/decision on the distribution of vaccines to the accounting department and the vaccine warehouse for the preparation of vaccine release and distribution notes.	Staff in charge of vaccine warehouse
3	Review the official dispatch/decision on distribution of vaccines and solvents: receiving unit and type, quantity, consignment and expiry date of vaccines.	Warehouse manager
4	Establish receipt of vaccine delivery.	Warehouse manager
5	Account for the number of cold boxes and ice packs for advanced preparation according to the Procedure for packing vaccines into cold boxes.	Warehouse manager Assistant
6	Check the temperature monitoring devices of refrigerators and freezers at the time of distribution. Record the temperature data on the warehouse release note/receipt of vaccine delivery.	Warehouse manager Vaccine delivery staff
7	Take out the required vaccines of the right type, quantity, and consignment from the refrigerator or freezers. Compare deliver/receive each type of vaccine according to the export note and pay attention to checking and comparing the consignment number and expiry date of the vaccines. Arrange and pack vaccines into cold boxes according to the Procedures of packing vaccines into cold boxes. Recording time of packing.	Warehouse manager Assistant
8	Sign the vaccine handover record and receipt of vaccine delivery/warehouse release note.	Warehouse manager Vaccine delivery staff
9	Record in the vaccine management book of the allocating unit: receiving unit, distributing quantity, temperature, time of allocation	Warehouse manager
10	Keep the allocation decision/dispatch, release note, and receipt of vaccine delivery	Warehouse manager

INSTRUCTIONS FOR INVENTORY OF VACCINES AND SOLVENTS

1. Objectives

The inventory of vaccines and solvents for accurate determination of quantity, consignment, expiry date and status of each vaccine and solvent stored in the warehouse helps to manage and coordinate vaccines more effectively, aiming to ensure adequate vaccines for timely distribution to the units and limit the situation for expired vaccines. Those procedures guide how to take inventory of the storage of vaccines and solvents quarterly or after each vaccine allocation.

2. Relevant equipment and materials

- Decision on the establishment of the Inventory Council (if necessary or during the inspection).

- Warehouse release/receipt note for vaccines and solvents.

- Receipt of vaccine and solvent delivery.

- Vaccine management accounting book (if any).

- Vaccine and solvent management book

- Previous inventory record.

3. Procedures

3.1. Making inventory of vaccines and solvents after their allocation

No	Work content	Assigned staff
1	Prepare documents: vaccine and solvent management book, vaccine release/receipt note, a record of vaccine delivery/receipt	Warehouse manager
2	Making inventory at the warehouse	Staff in charge of vaccine warehouse Warehouse manager Warehouse assistant
2.1	Review each type of vaccine and solvent: + Quantity. + Consignment number. + Expiry date. + Assess vaccine vial labels and the color and uniformity of vaccines and solvents + Indicators on the vaccine label (if any)
2.2	Compare data between vaccine and solvent management books with actual inventory
4	Record the data after inventory in the vaccine and solvent management book. In case of data mismatching with the management book, detect causes and work out solutions.	Staff in charge of vaccine warehouse Warehouse manager

3.2. Making inventory quarterly

No	Work content	Assigned staff
1	Announce the inventory plan, prepare inventory records.	Staff in charge of vaccine warehouse Warehouse manager
2	Prepare documents: vaccine and solvent management book, vaccine release/receipt note, receipt of vaccine delivery, previous inventory record.	Warehouse manager
3	Making inventory at the warehouse	Leaders of relevant agencies Staff in charge of vaccine warehouse Warehouse manager Relevant staff Assistants
3.1	Review each type of vaccine and solvent: + Quantity. + Consignment number. + Expiry date. + Assess vaccine vial labels and the color and uniformity of vaccines and solvents
3.2	Compare data between vaccine and solvent management books with actual inventory
4	Completing the Inventory record. In case of data mismatching with the management book, detect causes and work out a solution.	Staff in charge of vaccine warehouse Warehouse manager
4	Report the inventory to the leaders of the agency and keep them in the department.	Staff in charge of vaccine warehouse Warehouse manager

INSTRUCTION FOR RECALL AND SEPARATE STORAGE OF VACCINES

1. Objectives

This document shows how to fully recall and quarantine consignments of vaccines with doubt of quality/vaccine to be destroyed in order to avoid their distribution and ensure the effectiveness and safe uses of vaccines.

2. Relevant equipment and materials

- Decisions/documents of regulatory agencies (Ministry of Health) informing and guiding the suspension of use or withdrawal of a type or consignment of vaccines.

3. Procedures

- Arrange an area in the warehouse for the vaccines to be destroyed: lock or physically isolate it safely from unqualified vaccines.

- Arrange a refrigerator/or some positions in the refrigerator to store vaccines to be verified (waiting for inspection/ instructions from superiors)

- In case the position is in the same refrigerator as other vaccines, it is necessary to pack and seal separately and have physical separation measures and clear signs to avoid misdistribution.

No	Work content	Assigned staff
1.	After receiving the notice of recall/suspension of vaccine use, agencies in charge of recall must make statistics and send a notice detailing the recalled/suspended vaccines (lot number, expiry date, method of storage/transportation (in cold or normal temperature condition) and time to recall to relevant units.	Agencies in charge of recalling Relevant agencies
2.	Make statistics on the number of vaccines/solvents that need recalling or are temporarily suspended to report to leaders of relevant agencies.	Staff in charge of vaccine warehouse Warehouse manager
3.	Arrange a separate position in the warehouse or separate refrigerator with suitable cold volume for the storage of the vaccines to be suspended/recalled In the absence of a separate refrigerator, arrange a separate position in the refrigerator, with physical separation and clear identification, the vaccines must be sealed in isolation to avoid confusion.	Warehouse manager
4.	Vaccine recall: in case it is necessary to recollect vaccines from receiving units for storage at military zone warehouses, it is necessary to deliver/receive vaccines in accordance with Procedure 09 on transporting vaccines by cold boxes and Procedure 01 on receiving vaccines and solvents.	Warehouse manager Vaccine delivery staff Staff in charge of vaccine warehouse
5.	*Vaccine quarantine:* - In case vaccines are suspended for quarantine: + Store them in a refrigerator or a separate position in the refrigerator according to Procedure 02 on storing vaccines and solvents in the refrigerator until a treatment plan is available. + Put a yellow sign with black warning "vaccines to be quarantined" on the refrigerator or the area where they are stored. + The allocated vaccines recollected due to problems during transportation or delivery, need arranging in a separate position in the refrigerator after being verified and removed from the cold boxes or the refrigerator trucks. Pay attention to monitoring their quality and distribution. - In case of quarantined vaccines to be destroyed: + Take the vaccines to be destroyed outside the cold chain, move them to the quarantine area for destruction in the warehouse with a red sign with a black warning "Quarantined vaccines to be destroyed". + Pack and seal vaccines boxes and detail their information such as their name, quantity, consignment number, and expiry date on the box. + Carry out procedures to destroy vaccines according to regulations to ensure safety for people and the environment.	Staff managing warehouse Staff in charge of vaccine warehouse
6.	Carry out procedures to destroy vaccines according to regulations to ensure safety for people and the environment Report the recall, quarantine and destruction of vaccines to the leaders of the Military Region and the Campaign Steering Committee.	Staff in charge of vaccine warehouse Leaders of relevant agencies

INSTRUCTIONS FOR HANDLING OF

TRANSPORTATION-RELATED PROBLEMS

1. Objectives

This document shows how to solve problems during the transportation of vaccines by refrigerator trucks in order to minimize adverse factors affecting their quality and ensure they are stored between +2°C and +8°C during their delivery.

2. Relevant equipment and materials

- Mobile phones

- List of units in the vaccine transport route

- Procedures for handling problems related to storage of vaccines in the refrigerators and freezers

- Expenses for petrol and repairing

3. Procedures

No	Work content	Assigned staff
4.1.	In case of accidents on the road
1	Immediately inform the situation to leaders/Staff in charge of vaccine warehouse for solutions.	Driver/ Vaccine delivery staff
2	*a. For refrigerator truck: Immediately take necessary measures in the following cases: In case of car engine failure: - If the refrigerator truck is near the power source, operate the refrigeration system by electricity. - If the refrigerator truck is too far from the power source for the electrical refrigeration system to operate and the temperature of the cold compartment is higher than 8°C, buy ice along the way to maintain the vaccine storage temperature. Do not use dry ice as it can lower the temperature of the freezer compartment below 0°C and cause poisoning. - In case it takes little time to repair the truck, repair its engine to continue transporting the vaccine to the destination. - In case the truck repair takes a long time or cannot be repaired, the driver should contact the nearest unit for assistance. * In case of failure of the refrigeration system - If the compartment temperature is colder than 10°C, buy ice along the way to maintain the vaccine storage temperature. - If the refrigerator truck is near the warehouse, return to the warehouse, and notify its leader to plan to receive the vaccine. - In case the refrigerator truck is far away from the warehouse + Contact the nearest unit for help such as sending the vaccines to the local warehouse or asking for local refrigerator trucks to deliver the vaccines. In case the vaccines must be sent to the local warehouse, the driver must hand over the vaccines to the warehouse keeper and ask him/her to store them at the required temperature. + Contact the leader to send vehicles from the military zone to the forwarding area. - When transferring vaccines to another refrigerator truck, the accompanying temperature monitoring devices must be also transferred. - Repair the refrigeration system in order to continue transporting the vaccines to their destination (if possible). During the incident, the transporter/driver must continually contact Staff in charge of the vaccine warehouse for advice. * In case of damage of other parts: If the cold compartment system is still working properly, repair the damage to continue transporting the vaccine to the destination.	Driver/ Vaccine delivery staff Warehouse manager Staff in charge of vaccine warehouse Leaders of relevant agencies
3.	*b. For common truck*: Immediately take necessary measures in cases of automobile engine failure as follows: - In case it takes little time to repair the truck, repair its engine to continue transporting the vaccines to the destination. - In case the truck takes a long time to repair or cannot be repaired: + Contact the nearest unit in the province for help such as sending a local truck to deliver vaccines or contact the leader of the warehouse to send another one from the military region. + Check, if the temperature in the cold box is above +10°C, buy ice along the way to maintain the vaccine storage temperature between 2°C and 8°C (the ice needs to be put into plastic bags to avoid water causing the vaccine label to peel off)	Driver/ Vaccine delivery staff Warehouse manager Staff in charge of vaccine warehouse
4.2. On the way back
1	The driver must report the incident to the leader/staff in charge of the vaccine warehouse while transferring the records of vaccine delivery and temperature monitoring devices to the warehouse management team. In case the vaccine is returned to the warehouse, classify and handle the vaccines according to Procedure 11 on handling storage problems and Procedure 14 on recalling/quarantining the vaccines.	Driver/Vaccine delivery staff Warehouse manager Staff in charge of professional affairs Leaders of agencies
2	The vaccine warehouse management team shall record and review temperature monitoring devices and report to the leaders of the unit/military region and the Campaign Steering Committee.	Staff in charge of professional affairs Leaders of the Military Region

List of contacts in case of emergency (name/phone number);

+ Warehouse leader:

+ Staff in charge of vaccine warehouse:

+ Warehouse manager:

INSTRUCTIONS FOR TRANSPORTING COVID-19 VACCINES FROM AIRPORTS TO STORAGE FACILITIES

1. Objectives

The COVID-19 vaccines currently licensed for use in Vietnam have 3 recommended storage temperature ranges from 2°C to 8°C, from -25°C to -15°C, and at ultra-cold temperature. The time for storing vaccines with recommended temperature ranges is different. Vaccines storing in ultra-cold temperature conditions, after being thawed, are usually used for a maximum of 30-31 days. Therefore, speeding up the delivery of vaccines to vaccination sites is very important to ensure the effectiveness and safety of vaccination.

In order to meet the requirements of effective transportation and storage of vaccines, maximize the storage capacity of the warehouses and ensure the fastest delivery time of vaccines to vaccination sites, it is necessary to comply with the procedures on transporting COVID-19 vaccine with close coordination between units under the Ministry of National Defense and Ministry of Health in the 2021-2022 COVID-19 vaccination campaign.

2. Procedures

2.1. Vaccines stored at between 2°C and 8°C:

- The National Institute of Hygiene and Epidemiology shall complete the procedure for importing COVID-19 vaccines stored at temperatures between 2°C and 8°C from abroad, donors or Vietnamese distributors. Then, the vaccine will be transferred to the vaccine storage warehouse at the National Institute of Hygiene and Epidemiology and Ho Chi Minh City Pasteur Institute.

- After obtaining the Ministry of Health's factory certificate and decision to distribute vaccines to the military zones and provinces, the National Institute of Hygiene and Epidemiology shall notify the General Department of Logistics and Department of Military Medicine and Military Regions under the Ministry of National Defense of vaccine receipt and transportation including: contact list, time, type of vaccine, number of doses and number of packages, etc.

- Based on the above information, the General Department of Logistics directs relevant agencies to work out a plan to receive and transport vaccines by refrigerator trucks at the temperature between 2°C and 8°C from the vaccine storage warehouses of the National Institute of Hygiene and Epidemiology and Ho Chi Minh City Pasteur Institute to those of Military Zone.

- After receiving the vaccines, officers at Military Zone warehouses shall unload, consignment, count them and record in the reception report: vaccine type, consignment number, quantity, expiry date, condition, etc., then sent it to the National Institute of Hygiene and Epidemiology (Appendix 1).

- Vaccines will be stored at temperatures from 2°C to 8°C in refrigerators and freezers at Military Zone warehouses.

2.2. Vaccines stored at ultra-cold temperatures and/or between 2°C and 8°C:

- After the announcement of the receipt of the COVID-19 vaccine stored at an ultra-cold temperature from abroad, donors or Vietnamese distributors, the Ministry of Health shall promulgate decisions to distribute vaccines.

- After the National Institute of Hygiene and Epidemiology completes the procedure to receive the vaccines, based on the decision on vaccine allocation of the Ministry of Health, the supplier will transport the vaccine at ultra-cold temperature and hand them over to the Military Region warehouses.

- Military Region warehouse officers will unload, consign, count and record in the receipt report: type of vaccine, consignment number, quantity, expiry date, status upon receipt, etc. then send it to the National Institute of Hygiene and Epidemiology right after receiving it (Appendix 1).

- Return the shipping containers to the manufacturer (Appendix 2).

- Vaccines will be stored in ultra-cold freezers at Military Region warehouses and label "Undistributed vaccines to be verified".

- Sampling for testing: In case many vaccine consignments are different from those stored at the Institute of Hygiene and Epidemiology/Ho Chi Minh City Pasteur Institute:

+ After receiving reports on vaccine reception from Military Regions, the National Institute of Hygiene and Epidemiology shall notify the number of vaccine doses of each consignment to be sampled for testing.

+ Military Regions are responsible for transferring samples to the National Institute of Hygiene and Epidemiology, Ho Chi Minh City Pasteur Institute or the National Institute for Control of Vaccines and Biological within 02 days after receiving the notice. Vaccines to be sampled for testing should be stored between 2°C and 8°C during transportation.

- Only after obtaining the factory certificate, the Military Regions are allowed to allocate vaccines.

2.3. Vaccines stored at between -25°C and -15°C:

- The National Institute of Hygiene and Epidemiology (NIHE) will complete the import procedure for COVID-19 vaccines stored between -25°C and -15°C from abroad, donors or Vietnamese distributors. Then, the vaccines will be transferred to warehouses at the National Institute of Hygiene and Epidemiology and the Ho Chi Minh City Pasteur Institute for storing between -25°C and -15°C.

- After obtaining the factory certificate, the Ministry of Health shall promulgate a decision on vaccine allocation.

- The National Institute of Hygiene and Epidemiology shall notify the General Department of Logistics, Department of Military Medicine and Military Regions under the Ministry of National Defense of the vaccine reception and transportation, including: contact list, time, type of vaccine, number of doses, number of packages.

- Based on the above information, the General Department of Logistics directs relevant agencies to work out a plan to receive and transport vaccines by refrigerator trucks at temperatures between 2°C and 8°C from the warehouses of the National Institute of Hygiene and Epidemiology and Ho Chi Minh City Pasteur Institute to those of Military Regions.

After receiving the vaccines, officers at Military Zone warehouses shall unload, consign, count them and record in the reception report: vaccine type, consignment number, quantity, expiry date, condition, then sent it to the National Institute of Hygiene and Epidemiology (Appendix 1).

- Vaccines will be stored at temperatures from 2°C to 8°C in refrigerators and freezers at Military Zone warehouses.

INSTRUCTION FOR RETURN OF VACCINE STORAGE BOXES TO MANUFACTURERS

Step 1: Receive vaccine storage boxes from manufacturers

- - DHL express: Open the cardboard cover of the vaccine storage box, take out the purple instruction booklet and the returning label printed on the top of the box. Put the label in a plastic bag (a transparent plastic bag with glue) provided by the DHL (make sure the returning label goes with the box) along with the proforma invoice printed from an existing file.

- Switch off the Controlant logger temperature monitoring device by holding the Stop shipment button for 5 seconds, the device will flash 4 times then turn off, then leave your hand from the button.

Make sure the Controlant logger temperature monitoring device is repositioned inside the box where it was mounted at delivery.

Step 2: Take out all dry ice after removing vaccines from the box

Use a white label to cover the UN1845 dry ice mark & diamond number 9 as the box no longer contains dry ice.

Notice: Make sure all dangerous goods labels (including those of the express) are covered.

DO NOT COVER the UN3481 lithium battery label in the red frame.

Step 3: Stamp to cover the dry ice mark

The stamp covering the dry ice is peeled off from the back of the purple instruction booklet (paper with white glue) included in each box.

Note: DO NOT COVER the UN3481 lithium battery label in the red frame.

Step 4: Attach the plastic bag with the printed returning label and the proforma invoice on the upper left corner of the box (overlap the stamp covering the dry ice mark).

Step 5: Seal the lid of the box with clear tape. The box is ready to be returned to the manufacturer.

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Decision No. 478/QD-QLD 2021 on instructions for receipt, transportation, storage and use of COVID-19 vaccines

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