Quyết định 4355/QĐ-BYT năm 2021 Hướng dẫn tạm thời khám sàng lọc trước tiêm chủng vắc xin phòng COVID-19 do Bộ trưởng Bộ Y tế ban hành

DECISION

PROVISIONAL GUIDELINES ON COVID-19 IMMUNIZATION SCREENING

MINISTER OF HEALTH

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

At request of the Specialized Council for development of guidelines for COVID-19 immunization screening established under Decision No. 2933/QD-BYT dated June 15, 2021 of Minister of Health;

At request of Director General of Vietnam Administration of Medical Services.

HEREBY DECIDES:

Article 1. The “Provisional guidelines on COVID-19 immunization screening” are attached hereto.

Article 2. The “Provisional guidelines on COVID-19 immunization screening” apply to all public and private medical examination and treatment establishments and immunization facilities.

Article 3. This Decision comes into effect from the day of signing. Annul Decision No. 3802/QD-BYT dated August 10, 2021 of Minister of Health on Provisional guidelines on COVID-19 immunization screening.

Article 4. Director of Department of Medical Examination and Treatment, Chief of the Ministry Office, Chief Ministry Inspector, directors of departments and agencies affiliated to Ministry of Health; directors of medical establishments affiliated to Ministry of Health; Directors of Departments of Health of provinces and central-affiliated cities, heads of relevant entities; heads of medical sector of ministries are responsible for implementation of this Decision. /.

PROVISIONAL GUIDELINES

COVID-19 IMMUNIZATION SCREENING
(Attached to Decision No. 4355/QD-BYT dated September 10, 2021)

I. Purpose of screening

Detect and classify individuals eligible for COVID-19 immunization to ensure safety.

II. Immunization beneficiary classification

1. Individuals eligible for immunization

Individuals within the age for immunization as per recommendation under use instruction of manufacturers and not too sensitive to active ingredients or any excipients of the vaccine.

2. Individuals that require attention in immunization

The following individuals must be screened carefully and thoroughly:

- Individuals who previously had allergic reactions to other allergens.

- Individuals who have underlying medical conditions or chronic diseases.

- Individuals who have lost their senses or behavioral capacity.

- Individuals who used to suffer from thrombocytopenia and/or coagulation disorders.

- Pregnant women ≥ 13 weeks.

- Individuals having irregular vital signs:

+ Temperature < 35.5 oC or > 37.5 oC.

+ Pulse: < 60 times/minute or > 100 times/minute.

+ Minimum blood pressure < 60 mmHg or > 90 mmHg and/or maximum blood pressure < 90 mmHg or > 140 mmHg or 30 mmHg more than daily blood pressure (for individuals with hypertension receiving treatment and having medical records).

+ Breathing rate > 25 times/minute.

3. Individuals whose immunization must be delayed

- Having history of COVID-19 infection in 6 months.

- Having chronic diseases.

- Pregnant women < 13 weeks.

4. Contraindications

- Previously having allergic reactions with the same COVID-19 vaccine.

- Having any contraindication as per publication of manufacturers.

III. Immunization screening

1. Asking about medical history

1.1. Current health conditions

Examine health for fever, any chronic disease, and any acute disease that are in progress, especially if the conditions suggest COVID-19.

1.2. History of COVID-19 immunization

Request information about the type of COVID-19 vaccine and time of vaccination.

1.3. History of allergic reactions

- Previously had allergic reactions to any allergen.

- Have history of severe allergic reactions, including anaphylaxis.

- Have history of allergic reactions with vaccine or any component of vaccine.

1.4. History of COVID-19 infection.

1.5. History of severe immunodeficiency, terminal cancer, receiving chemotherapy or radiotherapy.

1.6. History of coagulation disorders/hemostasis disorders or currently taking anticoagulant drugs.

1.7. Pregnant women (if any) or breastfeeding women:

- Pregnant women: Inquire about age of pregnancy. Explain risk/benefits, only consider COVID-19 immunization for pregnant women with ≥ 13 weeks of pregnancy when potential benefits are greater than any potential risks for mothers and children.

- Breastfeeding women: not recommended for Sputnik V vaccine.

2. Clinical evaluation

2.1. Detect any irregularity in vital signs:

- Measure body temperature of everyone arrives for immunization.

- Measure blood pressure of individuals having history of hypertension/hypotension, individuals having underlying medical conditions related to cardiovascular diseases, and individuals older than 65 years of age.

- Measure pulse, count breaths of individuals having history of heart failure or having any irregularity such as chest pain, dyspnea, etc.

2.2. Observe general appearance

- Assess level of senses by asking questions about the individuals arriving for immunization. Pay attention to individuals having severe underlying medical conditions that cause them to be bed ridden, lose senses, or lose behavioral capacity.

- Record any visual irregular symptoms in individuals arriving for vaccination in order to inquire about health record.

IV. Screening conclusion

- Recommend immunization for cases eligible for immunization.

- Delay immunization for cases where at least one factor demanding delay of immunization is present.

- Transfer to medical facilities capable of providing emergency care for allergic shock for cases with history of level 3 allergic shock regardless of causes.

- Pregnant women with ≥ 13 weeks of pregnancy after receiving explanation regarding risks/benefits and agreeing to be vaccinated should be transported for immunization in medical facilities capable of providing medical care in obstetrics.

- Do not recommend immunization for individuals who have contraindications for immunization.

V. Implementation

1. Screening personnel

Screening personnel must receive training regarding COVID-19 immunization screening and dealing with allergic shock as per Circular No. 51/2017/TT-BYT of Ministry of Health.

2. Equipment

- Thermometer, stethoscope, blood pressure meter.

- COVID-19 immunization screening schedule (attached under Annex).

- Medicine box for allergic shock and essential medical equipment for responding to allergic shock according to Annex V of Circular no. 51/2017/TT-BYT of Minister of Health.

- Prepare 1 Adrenaline 1 mg/1 ml syringe.

3. Recording of screening and documents

- Immunization beneficiaries shall receive physical examination, be advised, and sign immunization commitment.

- Record and store immunization data of beneficiaries, including cases of contraindications on software for managing population health record on http//hssk.kcb.vn as per applicable laws.

- Immunization screening form and immunization commitment shall be stored in immunization entities. Storage period shall be 15 days.

Other contents require compliance with immunization guidelines of Ministry of Health./.

ANNEX

(Attached to Decision No. 4355/QD-BYT dated September 10, 2021 of Minister of Health)

COVID-19 IMMUNIZATION SCREENING FORM

Full name: ……………………………………… Date of birth …………… Male □ Female □.

Citizen Identity Card: …………………………………… Phone number: ……………………

Occupation: ………………………………………………………………………………

Employer: …………………………………………………………………………………….

Address: ……………………………………………………………..…… ……………………

Received 1 shot of COVID-19 vaccine:

□ Not receive yet

□ Received, type of vaccine: ………………………………………………………………….

I. Screening

II. Conclusion:

* Breastfeeding women: not recommended for Sputnik V vaccine.

# For pregnant women with ≥ 13 weeks of pregnancy: Explain risk/benefits, require COVID-19 immunization commitment, and transfer to medical facilities providing obstetric care for vaccination.

** Measure blood pressure of individuals having history of hypertension/hypotension, individuals having underlying medical conditions related to cardiovascular diseases, and individuals older than 65 years of age.

*** Measure pulse, count breaths of individuals having history of heart failure or having any irregularity such as chest pain, dyspnea, etc.

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