MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.:
1731/QD-BYT
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Hanoi, May 16,
2014
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DECISION
PROMULGATING GUIDELINES FOR ORGANIZATION OF IMMUNIZATION
SESSION
MINISTER OF HEALTH
Pursuant to the Government's Decree No.
63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and
organizational structure of the Ministry of Health;
Considering the suggestion of the Director of
National Institute of Hygiene and Epidemiology - Chairman of the Board of
Specialties for establishing vaccination guidelines at the Official Dispatch
No. 311/VSDTTU-TCQG dated March 24, 2014;
At the request of the Director General of the
General Department of Preventive Medicine - the Ministry of Health,
DECIDES:
Article 1. To promulgate under this Decision the Guidelines for
organization of immunization session.
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Article 3. This decision takes effect as of June 01, 2014.
Article 4. The Chief of Ministerial Office, Ministerial Chief
Inspector, Directors and Directors General of Departments, Bureaus and General
Departments directly under the Ministry of Health; Directors of medical
facilities directly under the Ministry of Health; Directors of Services of
Health of central-affiliated cities or provinces; Heads of medical agencies of
Ministries and sectors; Heads of relevant units shall implement this Decision./.
PP. MINISTER
DEPUTY MINISTER
Nguyen Thanh Long
GUIDELINES
FOR ORGANIZATION OF IMMUNIZATION SESSION
(Promulgated under the Decision No. 1731/QD-BYT dated May 16, 2014 of
the Minister of Health)
1. Preparation
before immunization session
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- Plan the immunization
session, in which, the number of vaccinees shall not exceed 50 persons/1
immunization site/ 1 immunization session (a vaccination facility may have many
immunization sites).
- Check the list of
vaccinees with each type of vaccine during the month to determine required
immunization sessions organized at each immunization site as follows: Total
organized immunization sessions = the number of vaccinees/(50 x the number of
immunization sites).
- At each immunization
site, each staff must be clearly assigned with specific tasks.
- Prepare materials and
equipment for the immunization session as regulated in Annex 1 herewith.
- Vaccination according
to the Expanded Program on Immunization (EPI):
+ Depending on the number of vaccinees, the
immunization sessions shall be continuously organized until all vaccinees have
been injected.
+ Determine and notice immunization time to each
group of vaccinees or each hamlet/village.
+ Arrange additional immunization session within
moth for cases that have been postponed from immunization.
1.2. Setting up a fixed immunization sites
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- Setting up the
immunization site according to one-direction process as follows:
Waiting seats before immunization à Table for
registration and instruction à Table for pre-vaccination screening examination
and consultancy à Immunization table à Table for recording and entering
information into immunization book à Seats for monitoring health after
vaccination.
- Have diagram guiding
one-direction process to facilitate vaccinees in complying with steps of the
process easily.
- Sites for injecting
Hepatitis B vaccine birth doses at medical facilities that have delivery rooms
shall comply with Point dd Clause 1 Article 5 of the Circular No.
12/2014/TT-BYT dated March 20, 2014 of the Minister of Health.
1.3. Setting up a mobile immunization sites
- Mobile immunization
sites shall comply with Article 6 of the Circular No. 12/2014/TT-BYT dated
March 20, 2014 of the Minister of Health.
1.4. Required documents at each immunization
site
- Have sufficient
professional documents and papers as regulated in Point c, Clause 2, Article 5
and Clause 1, Article 28 of the Circular No. 12/2014/TT-BYT dated March 20,
2014 of the Minister of Health.
- Posters and pamphlets
providing guidance for immunization steps and schedule, monitoring, caring and
taking actions against post-immunization reactions must be hang or stuck on the
wall where the immunization session is organized in order that health staffs
and mothers can see and read them.
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1.5. Preparing equipment, devices and
immunization forms
Equipment for carrying out the immunization
session shall comply with Clause 2, Article 5 of the Circular No.
12/2014/TT-BYT dated March 20, 2014 of the Minister of Health, including:
- Thermometer for
monitoring vaccine storage temperature.
- Syringes and needles:
types of 5ml, 0.1 ml, and 0.5ml auto-disable syringes.
- Cotton swabs, alcoholic
swabs, 70-degree alcohol, forceps, trays, metal file to open vaccine vials,
clean towel for covering immunization table.
- Safety boxes, container
for rubbish, bags or boxes for vaccine vials.
- Paper, pens/pencils,
tables, chairs and directional signs.
- Thermometers for
measuring body temperature and stethoscopes.
- Soap and hand wash.
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- Immunization books for
children/women, personal immunization sheets/books.
1.6. Setting up immunization table
- Principle: devices are
arranged in reach of health staffs to facilitate them in operations.
- Necessary equipment for
maintaining, injecting/taking vaccines orally such as vaccine carriers,
diluent, syringes and needles, metal file for opening vaccine vials, trays for
storing forceps, containers for cotton swabs and alcoholic swabs, AEFI kit, and
pens/pencils must be placed on the immunization table. Not place drugs or
devices for containing medical waste on the immunization table.
- Safety boxes, bags or
boxes for vaccine vials are placed under the table.
- Rubbish bin is also
placed under the table.
- Chairs for health staff
and vaccinee.
2. Process
during immunization session
2.1. Conducting screening examination and
determining immunization
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- As for adults, ask for
medical, allergy history, and vaccination history, observe general appearance
and ask for current health status.
2.2. Immunization consultancy
- Provide the vaccinee
or the child’s parent/guardian with type of vaccine which shall be given in
this immunization session, uses of such type of vaccine and required doses
(injections).
- Give advice to family/vaccinee
about uses and benefits received from vaccine and reactions that may occur
after immunization.
- Explain about
reactions occurring after immunization:
+ Common reactions: low-grade fever (temperature
from >37oC to <39ºC), pain and swelling at the site of
injection, etc.
+ Severe accident after the immunization such as
anaphylactic shock and other rare severe accidents that may result from a
certain type of vaccine.
- Provide guidance for
monitoring and caring after immunization:
+ Monitor health status of the vaccinee at home
at least 24 hours after the immunization according to the following signs:
general appearance, mind, eating, sleep, breath, hives, reactions occur at the
site of injection, etc.; if the vaccinee has a fever, take temperature and
closely monitor the vaccinee, take antipyretic as instructed by health staff.
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+ The vaccinee should be promptly led to the
hospital or medical facility if after the immunization, the following signs
occur: high fever (≥39oC), recurrent convulsions, the child burst
into loud wails, sniveled and cried for a long time, lethargy, poor feeding,
breast refusal, dyspnea, cyanosis, hives and other abnormal signs or common
reactions lasted over 1 day.
+ The parent who feels worry about health status
of their child after the immunization can lead the child to meet health staff
for examination and consultancy.
- Make appointment for
following date of injection.
3. Carrying
out the immunization
3.1. Vaccine dose and administration
Vaccine dose and administration routes shall
comply with Article 11 of the Circular No. 12/2014/TT-BYT dated March 20, 2014
of the Ministry of Health.
3.2. Reconstitution of freeze-dried vaccine
Freeze-dried vaccine must be reconstituted
before injection. The reconstitution of freeze-dried vaccine is carried out
only when the vaccinee has appeared and is ready for injection as stated in
Annex 2 herewith.
3.3. Procedures for giving a safe injection
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Step 2: Inspect the vial and ampoule of
vaccine: type of vaccine/diluent, status of vaccine vial/ ampoule, color,
label, vaccine vial monitor (VVM) and expiry date. Show the vaccine vial to the
vaccinee or the child’s parent/guardian before giving injection.
Step 3: Shake the vaccine vial. Don’t
touch the plastic cap.
Step 4: Open vaccine vial/ ampoule.
Step 5: Put the needle into the vial and
turn the vial upside down to take vaccine. Step 6: Take a sufficient
dose for each type of vaccine.
Step 7: Gently push the plunger just
enough to expel the air in the syringe through the tip of the needle.
Step 8: The injection must ensure 5
corrections (Correct vaccinee, correct vaccine, correct dose, correct rout of
administration and correct time) as regulated in the Circular No.
23/2011/TT-BYT dated June 10, 2011 of the Ministry of Health providing
directions for use of drugs in health facilities with beds for patients.
Request the vaccinee’s relative or the vaccinee
himself to press a clean dried cotton swab onto the injection site for a few
seconds if the injection site bled. Not to rub vigorously at the injection
site.
Orally-administrated vaccines: the vaccinee
needs to be given a full dose of vaccine by oral route of administration as
regulated.
Notes:
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- Don’t take the air into
the syringe before withdrawing vaccine into the syringe.
- Reconstituted vaccine
must be kept between +2ºC and +8ºC, and used within a given period according to
the manufacturer’s instruction.
- Use a sterile syringe and
needle for each reconstitution.
- When using auto-disable
syringe, don’t pull back the plunger to check for blood.
- Don’t take an overdose of
the same type of vaccine within the same period.
3.4. Taking several types of vaccines in the
same immunization session
- If giving several types
of vaccines to the same vaccinee in the same immunization session, vaccines
must be administrated at different injection sites, the injection should be not
taken at the same thigh or arm.
- If the interval between
the injections is longer than that stated in the immunization schedule, the following
injection must be taken according to the interval stated in the immunization
schedule without repeating from the first injection.
- If the first injection is
later than time stated in the immunization schedule, it’s still given to the
vaccinee with correct doses and correct interval between the injections as
stated in the immunization schedule or instructed by the manufacturer.
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- Write information in the
immunization sheet/book and return it to the child’s parent/the vaccinee and make
appointment for following immunization.
- Remind the child’s
parent/the vaccinee about safekeeping of the immunization sheet/book and taking
it with them when coming medical facility or hospital.
- Take notes of the
injection date for each type of vaccine given to the vaccinee into the
immunization register of medical facility.
5. Procedures
at the end of immunization session
5.1. Maintaining unused vaccines and diluent
The “Guidelines for vaccine storage” shall
apply.
5.2. Safe methods of removing injection
devices
- Put syringes and needles
into the safety boxes immediately after giving injection, don’t put the cap
back on the needle.
- Unused syringes and
needles shall be stored as regulated for the next use.
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Annex 1: PREPARING MATERIALS AND EQUIPMENT FOR THE
IMMUNIZATION SESSION
1. Preparing
vaccines:
Basing on the list of
vaccinees of each type of vaccine during the month, calculate the number of
vaccine vials needs to be prepared: The number of vaccine vials (rounded up) =
(the number of vaccinees x coefficient of utilization)/doses of each vial.
2.
Preparing syringes, needles and safety boxes:
- The
number of 0.5ml and 0.1ml syringes and needles = Total injections + 10%
- The
number of 5ml syringes and needles = Total vaccine vials requiring
reconstitution + 10%
- The
number of safety boxes = Total number of syringes and needles /100.
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Freeze-dried vaccine must be
reconstituted before use.
Step 1: Check the
label on the diluent and the vaccine to be sure that it is the diluent provided
by the manufacturer for that specific vaccine. Don’t use the diluent of this
type of vaccine to mix with another type of vaccine, and distilled water cannot
replace for diluent.
Step 2: Check to make sure
the expiry dates of diluent and vaccine have not passed. Diluent must be kept
between +2ºC and + 8°C before it is reconstituted.
Step 3: Open the
ampoule/vial of diluent and vaccine: Open the centre of the metal cap on the
ampoule/vial of vaccine or diluent where a small circle is located, or use the
metal file to open the ampoule/vial of vaccine or diluents.
Step 4: Use a sterile
syringe and needle (5ml) for each reconstitution. Draw the entire
contents of the diluent vial into the sterile syringe and then, empty the
entire contents of diluent into the vaccine vial or ampoule. Mix the contents
of diluent and the contents of vaccine by drawing them slowly into the syringe
and inject them back slowly into the vial or ampoule; repeat this mixing step several
times until all of the vaccine powder has dissolved. Don’t leave the needle in
the cap of vaccine vial. Discard the syringe and needle used for reconstitution
in a safety box.
Step 5: Place the
reconstituted vaccine into the cut of the foam pad in the vaccine carrier. Draw
vaccine by using the same auto-disable (AD) syringe that shall be used to
inject vaccine into the vaccinee.
Step 6: Discard the
entire reconstituted vaccine at the end of the immunization session or within 6
hours (if it’s measles vaccine) or 4 hours (if it’s BCG) or as instructed by
the manufacturer.
Annex 3. TECHNIQUES FOR INJECTION AND ORAL
ADMINISTRATION OF CERTAIN VACCINES IN THE EXPANDED PROGRAM ON IMMUNIZATION
(EPI)
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1. The mother shall hold the child in her arms
and show the child’s thigh area.
2. The child’s hand hugs the mother’s back.
3. The mother places the child’s head on her
hand and uses the palm of that hand to hold the child’s hand.
4. The other hand of the mother shall hold the
child's legs.
5. The health staff uses his thumb and
forefinger to softly stretch the thigh skin (mid upper outer thigh) at the
injection site of the child.
6. Swab skin at the injection site with
antiseptic solution.
7. Quickly pierce the skin at an angle of 90
degrees to the skin and the needle must reach the muscle layer. Slowly inject
the vaccine to minimise the child's pain.
II. BCG vaccine: intradermal
injection at the outer upper left arm.
1. The mother shall
carry her child in her arms; take the child’s dress off to show the child’s
left hand and shoulder.
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3. The health staff
shall hold the syringe with the needle bevel facing upwards.
4. Use the thumb and
forefinger to stretch the skin at the injection site.
5. Put the syringe and
needle lying almost along the child’s arm.
6. Insert the tip of the
needle just under the skin by inserting the bevel and a little bit more of the
needle into the skin.
7. The needle should be
almost parallel with the skin surface.
8. Don’t push the needle
too deeply and don’t move the point of the needle downwards because the needle
shall be inserted into fatty tissue below the skin and this is subcutaneous
injection instead of intradermal injection.
9. Hold the needle at
correct position, put the thumb on the tip of the syringe which is adjoined to
the needle but don’t touch the needle.
10. The barrel of the
syringe shall be kept by the forefinger and thumb. Use the right thumb to push
the plunger to inject vaccine.
11. Just inject 0.1ml of
vaccine and draw back the needle.
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1. The
mother shall carry the child in her arms and show the child’s arm.
2. The
child’s hand hugs the mother’s back.
3. The
mother places the child’s head on her hand and uses the palm of that hand to
hold the child’s arm where shall be injected.
4. The
other hand of the mother shall hold two legs of the child.
5. The
health staff shall hold the child’s arm from below, and pinch the skin with his
fingers.
6. Push
the needle a little way under the pinched-up skin, the tip of the need must
face toward the child’s shoulder.
7. Use
the thumb and forefinger to hold the tip of the syringe to direct the point of
the needle, don’t touch the needle.
IV. Oral administration of OPV
1. The mother holds the child
with the child’s head leaning back.
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3. Let two drops of the
vaccine fall from the dropper onto the child’s tongue. Don’t touch the child by
the dropper.
V. Giving vaccine against
tetanus for women
1. Ask the vaccinee to
sit down.
2. Show the shoulder
area and put her hands on the back or put her hands on her hip. Let the arm
muscles loose because it shall minimize the pain during the injection.
3. Hold the outer upper
arm of the woman by the thumb and fingers of the health staff, gently squeeze
the arm muscles of the vaccinee.
4. Insert the needle
swiftly and straight into the skin between the fingers grasping the vaccinee’s
arm. Insert the needle more deeply into the muscle at an angle of 90 degrees.
5. Use the thumb to push
the plunger to push vaccine into the muscle.
6. Draw the needle back
swiftly; if bleeding, request the vaccinee to press a sterile dried cotton swab
on the injection site.