Decision No. 217/BYT-QD Issuing the Regulation on the Organization and Operation of Hospitals, Maternity Houses, Outpatient Clinics, Laboratories, Diagnostic Centers, and Private Health Services.

Pursuant to …;

ISSUING REGULATIONS ON THE ORGANIZATION AND OPERATIONS OF HOSPITALS, MATERNITY HOUSES, CLINICS, LABORATORIES, FUNCTIONAL DIAGNOSTIC ROOMS, AND PRIVATE HEALTH SERVICES. 

THE MINISTER OF HEALTH

Pursuant to Decree No. 153-CP dated October 5, 1961 of the Council of Ministers stipulating the tasks and powers of the Ministry of Health;

To legalize by law the operations of private health practice facilities;

At the proposal of the Director of the Health Management Department and the Head of the Office,

DECISION:

Article 1. - Now hereby promulgates with this Decision Regulations on the organization and operations of hospitals, maternity houses, clinics, laboratories, functional diagnostic rooms, and private health services collectively referred to as Regulations on Private Health Practice.

Article 2. - These Regulations shall take effect from the date of issuance of this Decision.

Article 3. - The Head of the Office, the Director of the Health Management Department of the Ministry of Health, the Directors of Provincial, Municipal, and Central Special Zone Health Departments, and the Health Departments of various sectors are responsible for guiding and supervising the implementation of these Regulations.

REGULATIONS

ON THE ORGANIZATION AND OPERATIONS OF HOSPITALS, MATERNITY HOUSES,

CLINICS, AND PRIVATE HEALTH SERVICES

(issued pursuant to Decision No. 217-BYT/QD dated April 29, 1989)

In order for private health services to operate in accordance with policy and law, ensuring safety, convenience, quality, and effectiveness to meet the healthcare needs of the people according to their preferences and economic capabilities, the Ministry of Health issues Regulations on the organization and operations of hospitals, maternity houses, clinics, laboratories, and private health services collectively referred to as Private Health Practice.

Chapter I SUBJECTS, STANDARDS, CONDITIONS, AND FORMS OF PRIVATE HEALTH PRACTICE

Article 1. - Subjects eligible for private health practice.

- Medical staff who have retired or left due to disability and meet the standards may be granted a license for private health practice according to their specialized diplomas.

- Currently serving medical staff are only permitted to engage in private health practice outside of working hours.

Article 2. - Standards for obtaining a license for private health practice.

- Having completed an internship period and worked for five years in state health facilities or holding a first-level specialized diploma. - Being reviewed by a specialized board for the standards of private health practice to ensure professional qualifications and medical ethics according to the diploma and work performed, thereby issuing a certificate of competence and moral character for private health practice. - Intermediate-level specialized technicians are not allowed to open private hospitals or clinics but can assist doctors in private medical activities. - The person registering to open a private hospital or clinic must be a general practitioner or specialist doctor. - The person registering to open a private maternity house must be an obstetrician or intermediate-level midwife. - The person registering to open a private laboratory or functional diagnostic room must be a specialist doctor. - The person registering to provide non-diagnostic and treatment health services must be a nurse or intermediate-level technician. - Foreign nationals (without Vietnamese citizenship) wishing to engage in private health practice in Vietnam must be reviewed and decided upon by the Ministry of Health of Vietnam.

Article 3. - Conditions for practicing private healthcare.

1. Private hospitals must meet the following conditions: A statement on infrastructure conditions, medical equipment, and operational plans. Attention should be paid to the following issues: - Infrastructure buildings must meet hygiene standards, water supply and drainage systems, waste treatment, and environmental pollution prevention. - Ensure sufficient medical equipment and tools as prescribed by the Ministry of Health. - Have conditions to organize living services for patients. - Enter into contracts with medical experts, institutes, and hospitals to provide technical support and assistance.

2. Private midwifery houses must meet the following conditions: - Have facilities that meet hygiene standards and sterile equipment conditions. - Ensure sufficient medical equipment for prenatal examinations, childbirth, and neonatal care, as well as facilities for the needs of pregnant women and newborns. - Enter into contracts with obstetric hospitals or obstetric departments of general hospitals for technical support when necessary.

3. Private clinics must meet the following conditions: - Infrastructure buildings must meet hygiene standards and technical requirements. - Equip appropriate medical devices and tools.

4. Private laboratories and functional diagnostic rooms must meet technical conditions regarding basic construction, chemicals, and corresponding equipment as registered for establishment.

Article 4. - Forms of private healthcare practice.

1. An individual may apply for registration and independently practice private healthcare. A group of people investing together to organize private healthcare practice must have a representative applying for registration.

2. The individual applying for registration to practice private healthcare must meet the criteria stipulated in Article 2 of this Regulation.

Article 2. - This regulation takes effect from the date of issuance of the Decision.

Chapter II RIGHTS AND RESPONSIBILITIES OF PRIVATE HEALTHCARE PRACTICE ESTABLISHMENTS

Article 5. - Rights of private healthcare practice establishments.

1. Private healthcare practice establishments have the right: - To be guaranteed equality in professional and technical matters by the health sector, including priority in purchasing quality medical equipment and supplies. - To enter into contracts for professional and technical support with state-owned healthcare establishments to ensure diagnosis and treatment quality based on mutual agreement and approval by authorized health authorities. - To establish clinical laboratories and functional diagnostic rooms to improve the quality of medical examination and treatment. - To have an emergency drug stock for immediate sale to patients if necessary. The quantity and components of the stock are determined by authorized health authorities. - To receive foreign sponsorship within the framework of the Law on Foreign Investment of the Socialist Republic of Vietnam. - To collect healthcare fees (the Provincial People's Committee, city, and centrally-administered municipality People's Committees shall determine the fee schedule for medical examination and treatment after consulting the provincial Department of Health and the local Price Control Committee).

2. Strictly prohibited for private healthcare practice establishments: - To prescribe and sell drugs simultaneously. Drug supply shall be handled by pharmacies. - To promote or advertise their disease treatment, examination, testing, and functional diagnostic capabilities inaccurately. Advertising content must be approved by authorized health authorities and comply with the regulations of the Ministry of Information.

Article 6. - Responsibilities of private healthcare establishments:

Private healthcare establishments shall be responsible for: - Adhering to state laws, professional technical regulations on healthcare issued by the Ministry of Health, and being subject to professional technical guidance from competent health authorities. - Participating in primary healthcare activities, publicizing and guiding the people to protect their health, prevent and treat diseases. - Unconditionally complying with mobilization orders from the main provincial health departments when natural disasters or epidemics occur locally. - Promptly reporting and coordinating with state healthcare establishments when outbreaks of infectious diseases, unusual diseases, or mass poisoning cases are discovered to quickly address the consequences. - Paying business fees and taxes as prescribed by the Ministry of Finance. - Maintaining records of professional activities and statistics as required by the state. - Regularly reporting to the main provincial health department about the professional and technical activities of the establishment.

Article 7. - Tasks of private healthcare establishments:

1. Private hospitals have the tasks: - Diagnosing illnesses, prescribing medications, treating diseases, and performing procedures according to regulations set by competent health authorities and the Professional Standards Review Board for private healthcare at the same level, based on staff capabilities and other material and technical conditions. - Must accept and handle all emergency or preliminary care cases and immediately transfer patients to the nearest state healthcare facilities.

2. Maternity homes have the tasks: - Inducing menstruation, delivering normal births for pregnant women without obstetric risks. - If a pregnant woman is found to have obstetric risks, she must be immediately transferred to the nearest state obstetric facility. - Managing pregnancies according to regulations. - Participating in activities to protect maternal and child health and family planning. - Operating continuously 24 hours a day.

3. Private clinics have the tasks: - Diagnosing illnesses, prescribing medications, and treating common diseases. - Organizing preliminary care for serious accident victims or patients and immediately transferring them to the nearest state healthcare facility. - The scope of activities is regulated by Circular No. 31-BYT/TT dated December 23, 1987, of the Ministry of Health.

4. Private laboratories or functional diagnostic centers: Only have the task of implementing requests from doctors diagnosing illnesses, except for functional tests within their own clinical specialties.

5. Private healthcare services have the tasks: Providing routine services such as patient care, injections, dressing changes, blood pressure monitoring, enemas, rehabilitation exercises guidance... at fixed facilities or at patients' homes.

Article 3. - The Director of the Office, Heads of the Health Management Department of the Ministry of Health, Directors of provincial and municipal health departments directly under the central government, and health departments of various sectors are responsible for guiding and inspecting the implementation of this Regulation.

Chapter III AUTHORITY AND PROCEDURES FOR REVIEWING REGISTRATION OF PRIVATE HEALTHCARE PRACTICE

Article 8. - Authority to review private healthcare practice:

1. Provincial and municipal health department directors directly under the central government have the authority to issue permits to practice after receiving a Certificate of Qualification for Practice issued by the Professional Standards Review Board for private healthcare at the same level and meeting the standards and conditions stipulated in Articles 2 and 3 of this Regulation.

2. The Professional Standards Review Board for private healthcare practice established by provincial and municipal health department directors directly under the central government has the authority to issue a "Certificate of Qualification for Practice" after assessing professional quality based on educational qualifications.

Article 9. - Procedures for reviewing registration of private medical practice:

The person applying for registration of private medical practice must complete the following procedures: - Application for practice. - Certificate of qualification for practice. - Personal curriculum vitae with confirmation from the People's Committee of the commune, ward, town where the applicant resides (for retired staff) or the managing agency (for current staff). - Description of the conditions of the facility, medical equipment, and operational plan.

Chapter IV INSPECTION, AUDIT AND HANDLING OF VIOLATIONS

Article 10. - Inspection and audit of private medical practice facilities.

1. Medical inspection officers (appointed by competent state health agencies) shall inspect compliance with professional and technical medical regulations at all private medical practice facilities. Private medical practice facilities must provide all favorable conditions for medical inspection officers to perform their duties effectively.

2. Provincial Health Departments have the responsibility to conduct regular or spot inspections of private medical practice facilities. Inspection records must be made in duplicate and stored separately at the Provincial Health Department and the inspected private medical practice facility.

Article 11. - Handling of violations.

Any individual engaging in private medical practice who violates the provisions of this Regulation or causes adverse effects on patients' health and lives due to negligence or lack of professional competence will be subject to administrative warnings, compensation for damages to patients, revocation of permission to practice, revocation of qualification certificates, temporary suspension, or permanent cessation of operations of the private medical practice facility, or criminal liability depending on the severity and nature of the violation.

Chapter V IMPLEMENTATION PROVISIONS

Article 12. -

1. Medical facilities and professional review boards at the same level should encourage the implementation of vaccination insurance and comprehensive health care contracts based on agreements, prioritizing and supporting home-based health management over opening private clinics.

2. All private medical practice facilities that were operating before the effective date of this Regulation must reapply for registration and review procedures and can only operate after receiving new permission to practice. Traditional medicine clinics will continue to follow the Decree on Practicing Medicine with Traditional Methods issued on May 6, 1975, and the Regulations of Traditional Medicine Clinics issued on May 6, 1974, by the Ministry of Health.

3. The Ministry of Health and Provincial Health Departments must have dedicated staff to monitor private medical practice activities and regularly or periodically (every six months or annually) report fully and accurately the list and operational status of private medical practice facilities under their jurisdiction to the Ministry and the Provincial People's Committees for monitoring and oversight.

4. This Regulation applies nationwide and takes effect from the date of issuance. During its implementation, the Ministry of Health will collect public opinions and feedback from facilities and localities to conduct a summary of experiences and supplement the Regulation after five years.