Thông tư 34/2017/TT-BYT hướng dẫn sàng lọc trước sinh và sơ sinh

THE MINISTRY OF HEALTH

Circular No.34/2017/TT-BYT dated August 18, 2017 of the Ministry of Health guiding the prenatal and neonatal consultation, screening, diagnosis, and treatment

Pursuant to Clause 2 Article 97 of the Law on Marriage and Family dated June 19, 2014;

Pursuant to Clause 2 Article 84 of the Law on Children dated April 5, 2016;

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

At the request of Director of General Office for Population;

The Minister of Health promulgates a Circular on guidelines for prenatal and neonatal consultation, screening, diagnosis, and treatment.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of adjustment

This Circular sets forth guidelines for prenatal and neonatal consultation, screening, diagnosis, and treatment.

Article 2. Interpretation of terms

1.Birth defect(also known as congenital malformation or congenital disorder) refers to an abnormality of the structure or functions (including abnormality of metabolism) which occurs during the pregnancy period and may be found before, during, or after birth.

2.Prenatal screening testsrefer to a set of procedures that are performed during pregnancy to determine whether a baby is likely to have birth defects.

3.Neonatal screening testsrefer to a set of procedures that are performed to determine whether a newborn is likely to have congenital disorder, pathological signs relating to endocrine -metabolic-genetic disorder, but not clinically evident in the newborn period.

4.Prenatal diagnosisrefers to a set of procedures that are performed during pregnancy to diagnose whether a baby is likely to have birth defects that are found through prenatal screening tests.

5.Neonatal diagnosisrefers to a set of specific procedures that are performed during the newborn period to diagnose whether a newborn is likely to have congenital disorder, pathological signs relating to endocrine-metabolic-genetic disorder that are found through neonatal screening tests.

Article 3. Rules for prenatal and neonatal consultation, screening, diagnosis, and treatment

1. The prenatal and neonatal consultation, screening, diagnosis, and treatment is only allowed to be performed at health facilities obtaining proper operating licenses within their specialties

2. The prenatal and neonatal consultation, screening, diagnosis, and treatment will be performed on the voluntary basis. Particularly, prenatal screening, diagnosis, and treatment are compulsory for surrogate mothers for humanitarian purpose as prescribed in Clause 2 Article 97 of the Law on marriage and family.

3. The consultation must be performed before, during, and after prenatal and neonatal screening, diagnosis, and treatment.

Chapter II

PRENATAL AND NEONATAL CONSULTATION, SCREENING, DIAGNOSIS, AND TREATMENT

Article 4. Prenatal and neonatal screening tests

1. Pre-screening consultation:

A health worker will give a consultation about prenatal screening tests to a pregnant woman or give a consultation of neonatal screening tests to a newborn s parents or guardian as follows:

a) Provide purposes, meaning, benefits and possible risks during performance of screening procedures;

b) Instruct steps of screening procedures to be performed on a case-by-case basis.

2. Screening:

Health facilities shall perform screening procedures in accordance with guidelines promulgated by the Minister of Health.

3. Prenatal and post-screening consultation:

A health worker will give a consultation of prenatal screening tests to a pregnant woman as follows:

a) Inform and explain screening tests’ results;

b) Instruct the pregnant woman to choose methods of monitoring and caring the unborn baby or further specific diagnosis procedures;

c) Instruct and refer the pregnant woman to another proper health facility for monitoring and performing diagnosis procedures as deemed appropriate.

4. Neonatal and post-screening consultation:

The health worker will give a consultation of neonatal screening tests to the newborn’s parents or guardian as follows:

a) Inform and explain screening tests’ results;

b) Instruct the parents or guardian to refer the newborn to other proper health facilities so as to perform diagnosis procedures if the screening tests show that the baby is likely to have birth defects or pathological signs relating to endocrine-metabolic-genetic disorder.

Article 5. Prenatal and neonatal diagnosis

1. Pre-diagnosis consultation:

A health worker will give a consultation about prenatal screening tests to a pregnant woman or give a consultation of neonatal screening tests to a newborn s parents or guardian as follows:

a) Provide purposes, meaning, benefits and possible risks during performance of diagnosis procedures;

b) Instruct steps of diagnosis procedures to be performed on a case-by-case basis.

2. Diagnosis:

Health facilities shall perform diagnosis procedures in accordance with guidelines promulgated by the Minister of Health.

3. Prenatal and diagnosis consultation:

A health worker will give a consultation of prenatal diagnosis tests to a pregnant woman as follows:

a) Provide information about birth defects that have been found through prenatal diagnosis; risks and possible consequences of the continuation of pregnancy or abortion on a case-by-case basis;

b) Consult the pregnant woman to choose proper caring and treatment, including abortion due to birth defects as deemed appropriate.

4. Neonatal and post-diagnosis consultation:

The health worker will give a consultation of neonatal screening tests to the newborn’s parents or guardian as follows:

a) Provide information about the newborn’s pathological signs or defects found in the diagnosis; possible consequences if no timely treatment is performed on a case-by-case basis;

b) Give consultation of newborn monitoring, caring, and treatment on a case-by-case basis;

c) Instruct the parents or legal guardian to refer the newborn to another proper health facility for further management, monitoring, caring and treatment.

Article 6. Prenatal treatment

1. Pre-treatment consultation:

A health worker will give a consultation a pregnant woman and her husband (if any) as follows:

a) If the fetus is diagnosed normal or the pregnant woman decides to continue the pregnancy despite indication for abortion: Measures for monitoring and caring of pregnancy will be consulted;

b) If the fetus is diagnosed to have defects (with indication for abortion) and the pregnant woman decides the abortion: possible risks upon performance of abortion will be consulted;

c) Steps of abortion procedures to be performed on a case-by-case basis.

2. Treatment:

Health facilities shall perform prenatal treatment procedures in accordance with guidelines promulgated by the Minister of Health.

3. Regulations on abortion due to birth defects:

a) The abortion will only be considered upon serious abnormality of form and structure of the fetus; abnormality of chromosomes, fetus with molecular genetic disorders due to genetic mutations that no specific therapeutic method is found resulting in high risk of disability after birth.

b) The abortion due to birth defects will be considered upon the written consent of the pregnant woman who has received sufficient consultation from a health worker.

c) A health facility obtaining a property operating license within its specialties approved by the competent authority must hold a medical consultation with related specialties to consider whether to abort the pregnancy.

Medical consultation is composed of specialists with at least 5 years experience in the following areas of specialization: obstetrics, pediatrics, cardiovascular, medical imaging, testing and pathological anatomy. The medical consultation members may work for departments in the health facility or are invited from other health facilities.

d) The specialized head of the health facility shall consider whether to abort the pregnancy due to the birth defects according the medical consultation determinations.

Article 7. Neonatal treatment

1. Pre-treatment consultation:

A health worker will give a consultation of necessity and options of appropriate treatment to the newborn’s parents or guardian.

2. Treatment:

The health facility shall perform neonatal monitoring and treatment in accordance with guidelines promulgated by the Minister of Health on a case-by-case basis.

Chapter III

IMPLEMENTATION PROVISIONS

Article 8. Effect

This Circular takes effect on October 2, 2017.

To annul the Circular No. 34/2016/TT-BYT dated September 21, 2016 of the Minister of Health on physical examination, procedures for screening tests to discover and treat birth defects or congenital disorder from the effective date of this Circular.

Article 9. Implementation

Director of General Office for Population; Director of Department of Pediatric and Maternal Health; Director of Department of Examination and Treatment Management; heads of units affiliated to the Ministry of Health; Directors of Departments of Health  of provinces and central-affiliated cities shall implement this Circular.

Any difficulties arising in the course of  implementation of this Circular should be reported to General Office for Population affiliated to the Ministry of Health for consideration./.

For the Minister

The Deputy Minister

Nguyen Viet Tien