Circular No. 16/2000/TT-BYT guiding standards, conditions, scope of professional activities, files, procedures, and authority for establishing semi-public healthcare facilities

CIRCULAR

Guidelines for standards, conditions, scope of professional activities, files, procedures,

authority to establish semi-public healthcare facilities

__________________________

 Pursuant to the Private Medical Practice Law dated September 30, 1993.

Pursuant to Decree No. 73/1999/NĐ-CP dated August 19, 1999 of the Government on policies encouraging socialization in education, healthcare, culture, and sports sectors,

Pursuant to Circular No. 31/2000/TTLT-BTC-BYT dated April 25, 2000 jointly issued by the Ministry of Finance and the Ministry of Health on guidelines for establishing and financial management mechanisms for semi-public healthcare facilities,

The Ministry of Health guides standards, conditions, scope of professional activities, files, procedures, and authority to establish semi-public healthcare facilities.

I. GENERAL PROVISIONS

Article 1. Types of semi-public healthcare facilities:

1. Semi-public hospitals:

1.1 General semi-public hospitals.

1.2 Specialized semi-public hospitals.

2. Semi-public multi-specialty clinics.

3. Semi-public maternity homes.

4. Public hospitals with semi-public departments:

4.1 Semi-public department

4.2 Semi-public multi-specialty clinic

4.3 Semi-public specialized clinic

5. Public multi-specialty clinic with a semi-public department: Semi-public specialized clinic.

6. Public maternity home with a semi-public department

Article 2. Semi-public healthcare facilities must ensure the list of medical equipment according to the regulations of the Ministry of Health, encourage investment in modern medical equipment, staff must have sufficient professional qualifications, infrastructure must be appropriate for the approved scope of professional activities.

Article 3. Semi-public healthcare facilities are responsible for implementing the provisions in the "Hospital Regulations" issued together with Decision No. 1895/1997-BYT-QĐ dated September 19, 1997 and special allowances for particularly difficult professions like public healthcare facilities and other relevant laws.

Article 4. Semi-public healthcare facilities are responsible for managing finances according to Circular No. 31/2000/TTLT-BTC-BYT dated April 25, 2000 jointly issued by the Ministry of Finance and the Ministry of Health.

Article 5. Semi-public healthcare facilities may only operate after being authorized by the competent authority to establish and confirm that they meet the operating conditions.

Article 6. Semi-public healthcare facilities must comply with the scope of practice and approved outpatient fees set by the competent authority.

Article 7. Civil servants working at public healthcare facilities are permitted to provide medical services outside their regular hours at semi-public healthcare facilities, but must obtain written approval from the head of their agency.

Article 8. Semi-public healthcare facilities must pay the registration fee for assessing the establishment standards and conditions according to current regulations.

II. STANDARDS, CONDITIONS AND SCOPE OF PROFESSIONAL ACTIVITIES OF SEMI-PUBLIC HEALTHCARE FACILITIES

Article 9. Semi-public hospitals:

General semi-public hospitals and specialized semi-public hospitals have the function of inpatient and outpatient treatment.

1. Standards:

- The hospital director must be a general practitioner or specialist who has practiced for at least five years at a hospital.

- The head of the department must be a specialist who has practiced for five years at a legally recognized healthcare facility, including three years in their specialty.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

- The hospital must have at least 21 beds.

- The hospital must have the following departments:

+ Outpatient department.

+ Emergency department.

+ Treatment departments.

+ Ancillary departments.

- Must have adequate electricity, water, fire protection equipment, and waste disposal systems.

- Infrastructure and medical equipment must comply with the classification regulations of the Ministry of Health, encouraging investment in modern medical equipment and advanced techniques.

SCOPE OF ACTIVITY

Implement the approved technical directory and the provisions in the "Hospital Regulations" issued together with Decision No. 1895/1997-BYT-QĐ dated September 19, 1997.

Article 10. Semi-public multi-specialty clinics:

These are healthcare facilities comprising multiple specialty clinics under the supervision of a common clinic director.

1. Standards:

- The director of the multi-specialty clinic must be a general practitioner or specialist who has practiced for at least five years at a hospital.

- The head of the specialty clinic must be a specialist who has practiced for five years at a legally recognized healthcare facility, including three years in their specialty.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

Infrastructure: Must ensure sufficient area. Equipment must meet the standards and conditions of a multi-specialty clinic. In addition to specialty clinics, a multi-specialty clinic must have waiting rooms, emergency rooms, observation rooms (with no more than 10 beds and not exceeding 24-hour stays), adequate sanitary facilities, electricity, water, waste disposal, ensuring environmental hygiene.

SCOPE OF ACTIVITY

Operate within the approved scope of specialties based on the standards and conditions of specialty clinics.

Article 11. Internal clinics:

Includes the following types:

- General internal clinics (psychiatry, neurology, pediatrics, dermatology, etc.)

- Internal system clinics, Family Medicine Clinic

- Telemedicine consultation room.

1. Standards:

The physician in charge must be a general practitioner or specialist who has practiced for five years at a legally recognized healthcare facility.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

General internal clinics, internal system clinics, Family Medicine Clinic must have minimum specialized equipment, emergency and anti-shock kits, examination beds, work desks. The premises must be well ventilated, tidy, with adequate lighting, water, and sanitary facilities.

SCOPE OF ACTIVITY

General internal clinics, Family Medicine Clinic:

- Health counseling and family planning.

- Health management.

- First aid, emergency care, diagnosis, and treatment of common illnesses, without performing specialized procedures. Identify cases beyond their capacity and refer them to specialized clinics or higher levels.

- Outpatient surgery: initial fracture care without casting, no minor surgeries.

- Obstetric examination: Prenatal check-ups, pregnancy management, no delivery assistance.

- Dental examination: No tooth extraction.

- Eye examination: No minor surgery.

- Ear, nose, and throat examination: Otoscopy, rhinoscopy, no incision for middle ear inflammation.

- Simple laboratory tests using test strips.

- Collecting samples for testing, no biopsy, no puncture.

- Electrocardiogram, ultrasound, sigmoidoscopy, gastroscopy. No separate certification required, but must have professional training certificates and practical experience in these fields from legally recognized healthcare facilities, certified by the competent authority to include these activities in their scope of operations.

Internal system clinics: Diagnosis and treatment of diseases within their approved specialties.

Telemedicine consultation room: Physicians can only provide consultations in the specialties they have registered and trained in.

Article 12. Semi-public specialized surgical clinics:

1. Standards:

The responsible doctor is a specialist surgeon who has practiced for five years at a legally recognized medical facility, including at least three years in surgical specialization.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

In addition to equipment and facilities as stipulated for an internal medicine clinic, an external medicine clinic must have a minor surgery room, minor surgery tools, sterilization equipment for surgical instruments, with particular attention paid to anti-infection techniques.

SCOPE OF ACTIVITY

- Emergency first aid for external injuries.

- Examination and treatment of common wounds.

- Plastering small bone fractures.

- Removing plaster upon physician's instructions.

- Treating small hemorrhoids, excising small subcutaneous tumors, small superficial tumors, and draining small non-dangerous abscesses.

- Not to incise large spreading abscesses.

Article 13. Obstetrics and Gynecology Clinic, Family Planning Clinic.

1. Standards:

The responsible doctor is a specialist who has practiced for five years at a legally recognized medical facility, including at least three years in obstetric and gynecological specialization.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

- Examination table, obstetric and gynecological examination and procedure tools.

- Examination room, procedure room. Must have sufficient general emergency drugs, specialized emergency drugs, and sterilization equipment for examination and treatment tools.

SCOPE OF ACTIVITY

- Health education counseling, family planning counseling.

- Initial emergency care for obstetric and gynecological conditions.

- Prenatal examinations and pregnancy management.

- Routine gynecological examination and treatment.

- Inserting vaginal medication.

- Treating cervical erosion by cauterization.

- Performing cervical cytology tests.

- Insertion of intrauterine devices.

- Inducing abortion up to 15 days post-conception.

- Performing male sterilization without using a knife.

- Not performing induced abortion, removal of intrauterine devices, or female sterilization.

- Not to deliver babies at the clinic except in emergencies.

Article 14. Oral and Maxillofacial Surgery Clinic:

1. Standards:

The responsible doctor is a specialist in oral and maxillofacial surgery who has practiced for five years at a legally recognized medical facility, including at least three years in oral and maxillofacial surgery specialization.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

- Adequate dental and oral surgery equipment, including prosthodontic equipment if applicable.

- Adequate minor surgery rooms and suitable working spaces for the scope of practice.

SCOPE OF ACTIVITY

- Routine examination and treatment, emergency care for oral and maxillofacial injuries.

- Performing minor scar repair surgeries on facial wounds less than 2 cm in length.

- Correcting jaw misalignment.

- Surface laser treatment.

- Treating periodontal diseases.

- Incising and draining abscesses, scaling teeth, extracting common teeth.

- Dental work, making dentures, polishing teeth.

Article 15. Otolaryngology Clinic:

1. Standards:

The responsible doctor is a specialist in otolaryngology who has practiced at a legally recognized medical facility for five years, including at least three years in otolaryngology specialization.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

Adequate equipment and tools for otolaryngological examinations and procedures, including a minor surgery room.

SCOPE OF ACTIVITY

- Emergency otolaryngological care.

- Routine examination and treatment.

- Sinusitis, sinus puncture, cyst aspiration.

- Incising and draining acute middle ear infections.

- Incising and draining tonsillar abscesses.

- Simple polyp removal, benign cysts, small lipomas in the otolaryngological region.

- Stopping nosebleeds.

- Removing foreign bodies from the otolaryngological region. Not to remove foreign bodies from the trachea or esophagus.

- Thermal or laser throat cauterization.

- Suturing head and neck wounds up to 5 cm in length.

- Adenoidectomy.

Article 16. Eye Clinic:

1. Standards:

The responsible doctor is an ophthalmologist who has practiced at a legally recognized medical facility for five years, including at least three years in ophthalmology specialization.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

- Adequate examination and procedure tools.

- Adequate emergency eye medications.

- Minor surgery room.

SCOPE OF ACTIVITY

- Emergency and routine eye care.

- Subconjunctival injections, periocular injections, and retrobulbar injections.

- Removing foreign objects from the conjunctiva, treating styes, and performing cataract surgery.

- Lacrimal duct irrigation.

Article 17. Plastic Surgery Clinic:

1. Standards:

The responsible doctor is a specialist who has practiced at a legally recognized medical facility for five years, including at least three years in plastic surgery or aesthetic surgery specialization.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

- Must have appropriate equipment and facilities for the scope of practice.

- Facilities must ensure sterility, have minor surgery rooms, recovery rooms, and waiting rooms.

- If procedures alter appearance, they must be approved by the police department.

3. Scope of Practice.

- Tattooing lips and eyelids, acne extraction, and other blood-bleeding cosmetic services.

- Hair transplantation.

- Cheek augmentation and rhinoplasty.

- Facelift techniques.

- Treating upper and lower eyelid wrinkles, creating double eyelids from single eyelids.

Article 18. Rehabilitation and Functional Restoration Clinic:

1. Standards:

The responsible doctor is a specialist in rehabilitation and functional restoration who has practiced at a legally recognized medical facility for five years, including at least three years in rehabilitation and functional restoration specialization.

2. Conditions: In addition to the requirements for an internal medicine clinic, a rehabilitation and functional restoration clinic must have adequate rooms and equipment suitable for its scope of practice.

SCOPE OF ACTIVITY

- Caring for central and peripheral nervous system paralysis syndromes.

- Caring for chronic musculoskeletal diseases.

- Postoperative care requiring continued functional rehabilitation.

- Implementing techniques:

+ Massage, acupressure, acupuncture.

+ Approved physical therapy methods.

+ Physical therapy.

Article 19. Diagnostic Imaging Department:

A facility that assists in diagnosing diseases and monitoring treatment outcomes using X-ray, ultrasound, and endoscopy equipment.

1. Standards:

The head of the Diagnostic Imaging Department is a specialist who has practiced at a legally recognized medical facility for five years, including at least three years in diagnostic imaging specialization.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

- Encourages modern equipment, at minimum meeting the standards of a regional multi-specialty clinic radiology department.

- Adequate personal protective equipment.

- Infrastructure must ensure absolute safety; must comply with radiation safety laws.

- Must have waiting rooms, imaging rooms, film processing rooms, printing rooms, reading rooms, etc. Equipment rooms must be at least 3.5 meters high, with barium-coated walls, lead-lined doors, and raised floors.

SCOPE OF ACTIVITY

- Diagnose using conventional X-rays, CT scans, MRI.

- Ultrasound diagnosis.

- Not using intravenous contrast media.

- Not to perform ultrasound-guided biopsies, endoscopic surgery, bronchoscopy, or interventional radiology procedures involving bleeding.

Article 20. Laboratory:

A facility that aids in diagnosing and monitoring treatment: includes hematological, biochemical, microbiological, and histopathological (microscopic) tests.

1. Standards:

The head of the laboratory is a doctor or pharmacist, or a biological or biochemist who has practiced at a legally recognized medical facility for five years, including at least three years in laboratory specialization.

2. Conditions;

- Adequate equipment like a regional multi-specialty clinic laboratory.

- Infrastructure must meet laboratory standards, ensuring workplace safety and compliance with laboratory regulations.

- Adequate electricity and water supply.

- Fire prevention and firefighting equipment.

SCOPE OF ACTIVITY

Conduct hematological, biochemical, microbiological, parasitological, and histopathological (microscopic) tests.

Article 21. Semi-public Maternity Home:

1. Standards:

The responsible doctor is an obstetrician who has practiced for five years at a maternity facility, including at least three years in obstetric specialization.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

- Infrastructure includes delivery waiting rooms, delivery rooms, post-delivery rooms that are sterile and well-ventilated.

- Adequate equipment suitable for permitted scope of practice.

SCOPE OF ACTIVITY

- Prenatal examinations and pregnancy management.

- Emergency and first aid obstetric care.

- Tetanus vaccination.

- Urine protein testing.

- Normal delivery assistance.

- Removal of retained placenta after delivery or miscarriage.

- Not to perform abortions.

- Can handle difficult deliveries, vacuum extraction, suction abortion under 15 days, insertion of intrauterine devices, not removal of intrauterine devices, and level 1 obstetric procedures.

Article 22. State-owned hospitals have semi-private departments:

A. SEMI-PRIVATE DEPARTMENT

1. Standards:

The head of the department must be a specialist doctor with five years of practice at a legally recognized medical facility, including three years of specialized practice.

Military service personnel falling under the categories specified in Article 1 of this Circular may extend their age for active service if they meet all of the following conditions:

- Infrastructure: It should be located in a separate area within the state-owned hospital, equipped with sufficient sanitary facilities and waste treatment systems to ensure environmental hygiene.

- Professional activities must comply with the regulations set forth in the "Hospital Regulations" issued together with Decision No. 1895/1997-BYT-QD dated September 19, 1997.

- Modern equipment and advanced techniques must meet the needs for diagnosis and treatment.

SCOPE OF ACTIVITY

Specialized technical procedures shall be carried out according to the hospital classification by the Ministry of Health.

B. SEMI-PRIVATE MULTISPECIALTY CLINIC:

1. Standards and conditions: As stipulated in Article 10 of this Circular.

2. Scope of operation: Specialized technical procedures shall be carried out according to the hospital classification by the Ministry of Health.

C. SEMI-PRIVATE SPECIALTY CLINIC:

1. Standards and conditions: Depending on the specialty as specified in Articles 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 of this Circular.

2. Scope of operation: Specialized technical procedures shall be carried out according to the hospital classification by the Ministry of Health.

Article 23. A state-owned multispecialty clinic may have a semi-private specialty clinic:

1. Standards and conditions: Depending on the specialty as specified in Articles 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 of this Circular.

2. Scope of operation: Specialized technical procedures shall be carried out according to the hospital classification by the Ministry of Health.

Article 24. A public maternity home has a semi-private department: Specialty obstetrics clinic, Family planning clinic.

1. Standards and conditions: As stipulated in Article 13 of this Circular.

2. Scope of professional activities: Specialized technical procedures shall be carried out according to the regulations for public maternity homes.

III. DOCUMENTATION, PROCEDURES AND AUTHORITY FOR ESTABLISHING SEMI-PRIVATE MEDICAL FACILITIES.

Article 25. Documentation: (See Appendix 2)

Article 26. Procedures and authority for establishment:

1. New semi-private hospitals; Semi-private hospitals established based on state-owned hospitals and semi-private departments under the Ministry of Health:

- Documentation is submitted to the Ministry of Health (Treatment Department). The Ministry of Health will establish an Advisory Board to assist the Minister of Health in reviewing and deciding to establish semi-private hospitals within their authority or submitting it to the Prime Minister for review and decision.

- The Advisory Board is chaired by the Deputy Minister in charge of treatment, with the Director of the Treatment Department serving as the permanent vice-chairman, and members include representatives from the Vietnam Association of Medicine and Pharmacy and leaders from relevant Departments and Bureaus.

2. Semi-private hospitals established based on state-owned hospitals and semi-private departments within state-owned hospitals under local authorities:

Documentation is submitted to the Provincial Health Department (hereinafter referred to as the province). The People's Committee of the province will establish an Advisory Board to assist the Chairman of the People's Committee in reviewing and issuing decisions to establish. For the conversion of a public hospital to a semi-private hospital, written approval from the Minister of Health is required.

The Advisory Board is chaired by the leader of the People's Committee of the province, with the Director of the Provincial Health Department serving as the vice-chairman, and members include the Head of the Provincial Government Organization Department and leaders from relevant agencies.

3. Semi-private hospitals established based on state-owned hospitals and semi-private departments within state-owned hospitals under Ministries and Sectors:

Documentation is submitted to the Sectoral Health Department. The supervising Ministry or Sector will establish an Advisory Board to assist the leadership in reviewing and issuing decisions to establish. For the conversion of a public hospital to a semi-private hospital, written approval from the Minister of Health is required.

The Advisory Board is chaired by the leadership of the Ministry or Sector, with the leadership of the Sectoral Health Department serving as the permanent member or vice-chairman, and members include the Director of the Cadre and Civil Servant Organization Department and leaders from relevant Departments.

IV. DOCUMENTATION, PROCEDURES AND AUTHORITY FOR ISSUING CERTIFICATES OF MEETING STANDARDS AND CONDITIONS FOR PRACTICE

Article 27. Documentation: (See Appendix 2).

Article 28. Procedures:

After receiving the establishment decision, semi-private medical facilities complete all infrastructure construction, equipment procurement, personnel organization, and the establishment of the charter for semi-private medical facilities. The directors of semi-private medical facilities submit documentation to the Ministry of Health or the Provincial Health Department, Sectoral Health Department.

1. Procedures for certification of meeting standards and conditions for practice for semi-private medical facilities signed by the Minister of Health:

- Semi-private medical facilities under the Ministry of Health: Documentation is submitted to the Ministry of Health (Treatment Department).

- New semi-private hospitals, public hospitals converted to semi-private hospitals under provincial, sectoral, or ministry jurisdiction: After the review is completed, the Provincial Health Department or Sectoral Health Department sends a letter of request along with the review report and all documentation of the reviewed hospital to the Ministry of Health (Treatment Department). The Ministry of Health will conduct the review and issue the certificate.

2. Procedures for certification of meeting standards and conditions for practice for semi-private medical facilities signed by the Provincial Health Director or Sectoral Health Leadership:

- Documentation is submitted to the Provincial Health Department or Sectoral Health Leadership: The Provincial Health Department or Sectoral Health Leadership establishes a Review Team and conducts a direct review at the semi-private medical facility.

3. Contents of the review:

- Legal documents.

- Establishment documentation.

- Infrastructure and environmental hygiene conditions.

- Personnel organization.

- Medical equipment.

- Specific scope of practice.

- Hospital fees.

Article 29. Authority:

1. The Minister of Health issues certificates of meeting standards and conditions for practice for new semi-private hospitals; semi-private hospitals established based on public hospitals; semi-private departments in public hospitals under the Ministry of Health.

The Ministry of Health establishes an Advisory Board to assist the Minister in reviewing standards and conditions for issuing certificates. The Advisory Board is chaired by the Deputy Minister in charge of treatment, with the Director of the Treatment Department serving as the permanent vice-chairman, and members include representatives from the Vietnam Association of Medicine and Pharmacy and leaders from relevant Departments and Bureaus.

2. The Provincial Health Director or Sectoral Health Leadership issues certificates of meeting standards and conditions for practice for all other forms, except those specified in Clause 1 of this Article.

The Department of Health, the Ministry of Health, or the Sector shall establish an Advisory Board to assist leadership in reviewing standards and conditions for issuing Certificates. The Board shall be chaired by a leader from the Department or the Ministry of Health, Sector, with the head of the medical affairs department or the head of the organizational personnel department serving as vice-chairman, and other members. Specifically, the Advisory Board of the Department of Health must have a member representing the Provincial Association of Medicine and Pharmacy.

V. MANAGEMENT REGIME AND REPORTING.

Article 30.

1. Management and operation of semi-public healthcare facilities shall be carried out in accordance with the provisions of the Charter on organization and operation that has been approved.

2. The heads of public healthcare facilities with semi-public departments shall be responsible for comprehensively managing and directing such semi-public departments.

Article 31. Financial management within semi-public healthcare facilities shall be implemented in accordance with Circular No. 31/2000/TTLT-BTC-BYT dated April 25, 2000, jointly issued by the Ministry of Finance and the Ministry of Health.

Article 32. Semi-public healthcare facilities must comply with reporting requirements:

- In accordance with the Hospital Regulations promulgated together with Decision No. 1895/1997-BYT-QĐ dated September 19, 1997, of the Minister of Health.

- Periodic reports submitted by the Department of Health to the Ministry of Health (Treatment Department) must include local management of semi-public healthcare services.

- Each year, the Departments of Health must submit separate reports on semi-public healthcare services.

- Semi-public hospitals must submit periodic reports to the Ministry of Health (Treatment Department).

IV. INSPECTION AND AUDIT.

Article 33. Semi-public healthcare facilities must undergo regular or surprise inspections and audits by authorized health authorities.

- The Treatment Department shall coordinate with relevant functional departments and the Ministry of Health's Inspectorate to organize inspections and audits of semi-public healthcare facilities nationwide.

- The Department of Health shall be responsible for inspecting and auditing semi-public healthcare facilities within its jurisdiction.

VII. IMPLEMENTATION PROVISIONS

Article 34. The Ministry of Health shall assign the Director of the Treatment Department to collaborate with related functional departments to guide, monitor, and inspect the implementation of this Circular.

Article 35. Semi-public healthcare facilities shall be responsible for complying with the provisions of this Circular. Persons violating the provisions of this Circular shall be subject to disciplinary action, administrative penalties, or criminal prosecution, if damage is caused, they must compensate for damages in accordance with the law.

Article 36. This Circular shall take effect fifteen days from the date of issuance. Previous regulations inconsistent with this Circular shall be abolished.

During implementation, if there are difficulties, units and localities must report in writing to the Ministry (Treatment Department) for research and resolution.