Establish a specialized hospital in Vietnam

Along with the development of society, health issues are becoming more and more concern and focus. Therefore, many medical examination and treatment institutions were established to meet this necessary need. However, the establishment of these institutions must fully comply with the provisions of the law. In the article below, Viet An Law Firm will provide information Regarding the procedures to establish a specialized hospital in Vietnam.

Legal basis

• Law on Medical Examination and Treatment 2023;
• Decree 96/2023/ND-CP stipulating several articles of the Law on Medical Examination and Treatment;

What is a specialized hospital?

A specialized hospital is a hospital that focuses and specializes in one or several certain faculties. If it is several faculties, those faculties are often more or less related to each other. As for a general hospital, it is a hospital with many faculties, usually large hospitals that can test and treat most diseases.

General hospitals are often the priority choice when you want a general examination or have not specifically identified the type of disease or need emergency care, the general hospital will have full facilities to respond promptly. Once the type of disease has been determined or there is an indication, a specialized hospital will be the top choice because with specific specialties, a specialized hospital will satisfy more directly the patient’s needs.

Conditions for granting the operating license for a specialized hospital

In addition to the general regulations for medical examination and treatment institutions in Article 40 of Decree No. 96/2023/ND-CP, specific regulations for specialized hospitals need to be applied as follows:

Regarding the hospital scale

There must be a minimum of 20 beds (especially for specialized eye hospitals using high technology, there must be a minimum of 10 beds).

Regarding facilities

• Have a fixed location that meets legal regulations on load-bearing safety, fire prevention, and fighting, infection control, environmental protection, and radiation safety (if any); ensure enough electricity and water to serve the operations of medical examination and treatment institutions;
• Have signs, diagrams, and signs leading to faculties, departments, professional and administrative departments;
• Arrange specialized departments to suit the functions of each department, convenient for medical examination and treatment;
• Satisfy the requirement of construction in the law regulation: the floor’s square at least 50m²/ 01 bed; the Width front hospital’s at least 10m, ensure the path for emergencies going to the emergency area; the hospital’s clinic must be satisfied requirements Regarding the minimum square is equal to the square of the clinic specified in Article 43, 44, 45, 46, 47, 48, 49, 53 Decree No. 96/2023/ND-CP;
• In case a hospital has specialized departments that are not on the same campus, there must be a transportation infrastructure connection between the departments to ensure the safety of patients, patient’s families, and medical staff.

Regarding the medical equipment

• Have enough medical equipment and instruments appropriate to the hospital’s scope of professional activities;
• Have enough emergency vehicles inside and outside the hospital or must have a contract with a medical examination and treatment institution that has been granted an operating license with the scope of professional activities to provide emergency services to transport patients.

Professional departments

• The medical examination faculty: has a reception area, emergency room, storage room, examination room, and room for performing techniques and procedures (if performing techniques and procedures);
• The clinical faculty: a clinical faculty must be suited to the scope of professional activities for a specialized hospital;
• The paraclinical faculty: has at least one laboratory and one imaging diagnostics room. Particularly for specialized eye hospitals that do not have an imaging diagnostics department, they must have a professional support contract with a medical examination and treatment institution that has been granted the operating license and has an imaging diagnostics department;
• The pharmacy faculty;
• The nutrition faculty: opened in hospitals with 100 beds or more with at least 01 person/100 beds in charge of nutrition expertise. Clinical nutrition department or a person in charge of nutrition for hospitals with less than 100 beds;
• The infection control faculty: for hospitals with a scale of 150 beds or more and at least 01 infection control supervisor/150 beds. The infection control department for hospitals with a scale of less than 150 beds;
• Other specialized departments in the hospital must be appropriate to their scale and function.
• Have departments and divisions perform the functions of general planning, human resource organization, quality management, nursing, finance and accounting, information technology, medical equipment, and other necessary functions.

Regarding the human resource

• The number of full-time practitioners in each faculty must be accounted for at least 70% of the total number of practitioners in the faculty;
• Heads of specialized departments of the hospital must be full-time practitioners of the hospital have a practice license appropriate to the specialty of the specialized department assigned to perform, and have time to practice this specialty at least 36 months.
• Heads of other specialized departments not subject to grant the practicing license, they must have a university diploma with a major appropriate to the assigned work and must be a full-time practitioner at the hospital.
• People working in infection control must have a university degree or higher in the health sector, and have a certificate or diploma in infection control training.
• The person working in nutrition must have a bachelor of nutrition or a practitioner with the title of a doctor with a certificate of 6 months or more training in clinical nutrition or a nurse with a university degree and a training certificate of 06 months or more in clinical nutrition.

Note:

• The establishment of a specialized department in an inter-specialty form must meet the conditions for a practicing license. In case of not meeting the conditions to establish a faculty, units within a clinical faculty can be established; the person in charge of this unit must have the practicing license with a scope of practice appropriate to the specialty of that unit.
• Do not grant the operating license to specialized departments that are institutes, affiliated centers, and located on the hospital’s campus;
• Hospitals must provide inpatient treatment and organize professional duty 24 hours per day and every day.

A dossier to establish a specialized hospital in Vietnam

A dossier including the following document:

• An application for an operating license for a medical examination and treatment institution according to Form 02, Appendix II issued with Decree No. 96/2023/ND-CP;
• A valid copy of the establishment decision or document with the name of the medical examination and treatment institution issued by a competent state agency for state-owned or an enterprise registration certificate for private medical examination and treatment institutions or an investment certificate for foreign-invested medical examination and treatment institutions;
• A valid copy of the practicing certificate of the person in charge of technical expertise of the medical examination and treatment institution; the person in charge of the specialized department of the medical examination and treatment institution according to Form 11, Appendix I issued with Decree No. 96/2023/ND-CP (not applicable in cases where these documents have been linked, shared on the Information System on the management of medical examination and treatment activities or the national database of health);
• List of registration of practitioners at medical examination and treatment institutions (including registration of practitioners and people working in medical professions at the institution but not subject to be granted a practicing certificate) according to Form 01 Appendix II issued with Decree No. 96/2023/ND-CP;
• A declaration of facilities, medical equipment, organization, and personnel of the medical examination and treatment institution according to Form 08, Appendix II issued with Decree No. 96/2023/ND-CP;
• Documents proving that the medical examination and treatment institution meets the conditions for facilities, medical equipment, and personnel organization by the scope of professional activities of one in the organizational forms in accordance to Section 1 Chapter III Decree No. 96/2023/ND-CP;
• A chapter on the organization and operation of state hospitals is implemented according to the form prescribed by the Minister of Health; For private hospitals, follow Form 03, Appendix II issued with Decree No. 96/2023/ND-CP and the initial operation plan for the hospital;
• A valid copy of the patient transport contract for hospitals that do not have off-institution emergency transport vehicles;
• List of the technical expertise of a medical examination and treatment institution proposed according to the technical expertise list that is issued by the Minister of Health;
• In case of request the first grant for the operating license of humanitarian medical examination and treatment institutions or non-profit medical examination and treatment institutions, there must be documents proving the financial resources to ensure for humanitarian medical examination, treatment activities or non-profit medical examination, treatment activities.

Procedures for establishing a specialized hospital in Vietnam

Step 1: Submit the dossier for granting the operating license to the Ministry of Health.

Step 2: The Ministry of Health receives and sends the dossier receipt form according to Form 02 Appendix I issued with Decree No. 96/2023/ND-CP for requesters.

Step 3: Within 60 days from the date of fully receiving the dossier, the Ministry of Health will evaluate the dossier and appraise in the institution to grant the operating license:

• In case the dossier is not valid, within 10 working days from the date of submitting the dossier, the Ministry of Health must send an announcement writing for institutions that request a license to complete the dossier. The time of resolution of the procedures will start from the date of receiving the supplement dossier.
• In case the dossier is full and valid, the Ministry of Health will establish an appraisal council and perform an appraisal at medical examination and treatment institutions to grant the operating license.
• In case of not granting the operating license, the Ministry of Health must send a written response and state the reason.

Step 4: Send the operating license for institutions.

Implementing agencies

• Department of Medical Service Administration;
• Department of Traditional Medicine Administration.

Services of establishing the hospital of Viet An Law Firm

• Consulting on conditions and guiding on preparing necessary documents to establish a specialized hospital in Vietnam;
• Drafting the hospital establishment dossier;
• Representing customers to submit dossiers, monitor and resolve issues related to hospital establishment procedures at state agencies;
• Representing to carry out procedures for granting an Investment Registration Certificate, Enterprise Registration Certificate, Hospital Business License to customers;
• Comprehensive consulting on activities arising during the process of conducting business for customers.

If you need to establish a specialized hospital in Vietnam, please contact Viet An Law Firm for detailed support!