Decision No. 1731/QD-BYT dated May 16, 2014, promulgating guidelines for organization of immunization session

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 >37^oC 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 (≥39^oC), 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.