Circular No. 34/2017/TT-BYT guiding prenatal and neonatal counseling, screening, diagnosis, and treatment.

CIRCULAR

GUIDELINES FOR PRENATAL AND NEONATAL SCREENING, DIAGNOSIS, AND TREATMENT

Pursuant to Clause 2, Article 97 of the Marriage and Family Law enacted on 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/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director General of the General Office for Population and Family Planning;

The Minister of Health issues the Circular on Guidelines for Preconception, Prenatal, and Newborn Screening, Diagnosis, and Treatment.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates guidelines for prenatal and neonatal screening, diagnosis, and treatment.

Article 2. Interpretation of Terms

1. Fetal Anomaly (also known as congenital anomalies or birth defects) refers to structural or functional abnormalities (including metabolic disorders) occurring during the fetal period and can be detected before, during, or after birth.

2. Prenatal screening involves using techniques during pregnancy to detect the risk of fetal anomalies.

3. Newborn screening involves using techniques to identify newborns at risk of congenital anomalies and related endocrine, metabolic, and genetic disorders that have not yet manifested clinically in the neonatal period.

4. Prenatal Diagnosis involves using specific techniques during pregnancy to diagnose suspected cases of fetal anomalies identified through prenatal screening.

5. Neonatal Diagnosis involves using specific techniques during the neonatal period to diagnose cases at risk of congenital anomalies and related endocrine, metabolic, and genetic disorders identified through newborn screening.

Article 3. Principles of Prenatal and Neonatal Screening, Diagnosis, and Treatment

1. Prenatal and neonatal screening, diagnosis, and treatment shall only be conducted at healthcare facilities with valid operating licenses and appropriate technical expertise.

2. Prenatal and newborn screening, diagnosis, and treatment shall be conducted voluntarily. However, prenatal screening, diagnosis, and treatment for gestational surrogacy for humanitarian purposes as stipulated in Clause 2, Article 97 of the Marriage and Family Law must be mandatory.

3. Counseling shall be provided before, during, and after prenatal and neonatal screening, diagnosis, and treatment.

Chapter II
GUIDELINES FOR PRECONCEPTION, PREGNANCY SCREENING, DIAGNOSIS AND TREATMENT

Article 4. Prenatal and Neonatal Screening

1. Pre-screening counseling:

Healthcare staff provide counseling to pregnant women regarding prenatal screening; and to parents or guardians regarding neonatal screening on the following contents:

a) Purpose, significance, benefits, and potential risks that may occur when applying screening techniques;

b) Procedures for implementing screening techniques for each specific case.

2. Screening:

Healthcare facilities apply screening techniques according to the technical guidance of the Minister of Health.

3. Post-prenatal screening counseling:

Healthcare staff provide counseling to pregnant women after prenatal screening on the following contents:

a) Announcing and explaining the results of screening techniques;

b) Guiding pregnant women to choose methods for monitoring and caring for the fetus or continuing to implement specific diagnostic techniques;

c) Guiding and transferring pregnant women to suitable healthcare facilities for monitoring and implementing diagnostic techniques if necessary.

4. Post-neonatal screening counseling:

Healthcare staff provide counseling to parents or guardians after neonatal screening on the following contents:

a) Announcing and explaining the results of screening techniques;

b) Guide parents or guardians to bring newborns to appropriate healthcare facilities to perform diagnostic procedures if the newborn is at risk of congenital anomalies and related endocrine, metabolic, and genetic disorders based on screening results.

Article 5. Prenatal and Neonatal Diagnosis

1. Pre-diagnosis Counseling:

Healthcare staff provide counseling to pregnant women regarding prenatal screening; and to parents or guardians regarding neonatal screening on the following contents:

a) The purpose, significance, benefits, and potential risks that may occur when implementing diagnostic techniques;

b) The sequence of steps to perform diagnostic techniques for each specific case.

2. Diagnosis:

Medical examination and treatment facilities apply diagnostic techniques according to the technical guidance of the Minister of Health.

3. Post-prenatal diagnosis counseling:

Healthcare personnel provide pregnant women with post-prenatal diagnosis counseling on the following contents:

a) Providing information about prenatal fetal abnormalities diagnosed; risks and consequences that may arise from continuing pregnancy or terminating pregnancy for each specific case;

b) Advising pregnant women to choose appropriate care and management solutions, including terminating pregnancy due to fetal abnormalities if necessary.

4. Post-neonatal diagnosis counseling:

Healthcare staff provide counseling to parents or guardians after neonatal screening on the following contents:

a) Providing information about neonatal diseases and abnormalities after diagnosis; possible consequences if not treated for each specific case;

b) Advising on measures for monitoring, caring for, and treating neonates for each specific case;

c) Guiding parents or legal guardians to bring neonates to suitable medical examination and treatment facilities for management, monitoring, care, and treatment.

Article 6. Prenatal Treatment

1. Pre-treatment Counseling:

Healthcare personnel advise pregnant women and their husbands (if applicable) on the following contents:

a) In cases where the fetus is normal or the pregnant woman decides to continue the pregnancy despite a recommendation to terminate it: measures for monitoring and caring for the pregnancy;

b) In cases where the fetus has a confirmed diagnosis of malformation (with an indication to terminate pregnancy) and the pregnant woman decides to choose termination of pregnancy: the risks that may occur when applying termination techniques.

c) The procedure for performing termination techniques for each specific case.

2. Treatment:

Medical examination and treatment facilities apply prenatal treatment techniques according to the technical guidance of the Minister of Health.

3. Regulations on terminating pregnancy due to fetal abnormalities:

a) Termination of pregnancy shall only be considered when there is a serious abnormality in the morphology or structure of the fetus; chromosomal abnormalities, molecular genetic diseases due to gene mutations without specific treatment methods leading to high postnatal disability risk.

b) Termination of pregnancy due to fetal abnormalities will be considered when the pregnant woman consents in writing after being fully counseled by healthcare personnel.

c) Healthcare facilities with a permit and approved scope of technical activities by the competent authority for performing abortion techniques must organize multidisciplinary consultations to consider termination of pregnancy.

Participants in the consultation include specialists with at least five years of experience in obstetrics, pediatrics, cardiology, radiology, laboratory medicine, and pathology. Consultation participants may belong to departments or units within the healthcare facility or be invited from other healthcare facilities.

d) The person responsible for technical activities at the medical examination and treatment facility reviews and decides to terminate pregnancy due to fetal abnormalities based on the conclusion of the consultation.

Article 7. Neonatal Treatment

1. Pre-treatment Counseling:

Medical staff provide advice to parents or guardians of children regarding the necessity and appropriate treatment methods for them to choose.

2. Treatment

Healthcare facilities implement monitoring and neonatal treatment measures according to the specialized technical guidance of the Minister of Health for each specific case.

Chapter III
IMPLEMENTING PROVISIONS

Article 8. Effective Date

This Circular takes effect from October 2, 2017.

Circular No. 34/2016/TT-BYT dated September 21, 2016 of the Minister of Health regarding examination, screening procedures to detect, treat, and manage fetal abnormalities and malformations becomes invalid from the date this Circular takes effect.

Article 9. Responsibility for implementation

Director of the General Office of Population; Head of the Department of Maternal and Child Health; Director of the Department of Medical Examination and Treatment; Heads of units under and affiliated with the Ministry of Health; Directors of Provincial Health Departments directly under the central government are responsible for implementing this Circular.

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to promptly reflect these issues to the Ministry of Health (General Office of Population and Family Planning) for consideration and resolution./.