Chương V Nghị định 155/2018/NĐ-CP: Lĩnh vực khám bênh, chữa bệnh

Chapter V

MEDICAL EXAMINATION AND TREATMENT

Article 10. Annulment of the following regulations of the Government's Decree No. 109/2016/ND-CP dated July 01, 2016 on issuance of practice certificates to healthcare practitioners and operating licenses to the health facilities

1. Clause 1dd, Article 7.

2. Clause 17, 18 and 19 of Article 22.

3. Clause 3a, Article 23.

4. Clause 5b, 5c and 5k of Article 23.

5. Clause 2b and 2c, Article 24.

6. Clause 3, clause 5, Article 24.

7. Clause 2a, 2c and 2d, Article 25.

8. Clause 3a, Article 25.

9. Clause 4b, Clause 5, Article 25.

10. Clause 1a, 1d, 1dd and 1e of Article 26.

11. Sub-point 9, Clause 1c, Article 26.

12. Clause 2a, Article 26.

13. Clause 1a, 1d and 1dd, Article 27.

14. Second subpoint of Clause 2a, Clause 3a, Article 27.

15. Subpoints 10 and 11 of Clause 1a, Clause 1b and Clause 1c of Article 28.

16. Clause 3a and subpoint 3 of Clause 3b, Article 28.

17. Clause 1b and 1c of Article 29.

18. Clause 2, Article 29.

19. Clause 3a and 3b, Article 29.

20. Clause 1a, 1d and 1dd, Article 30.

21. Clause 2a, Article 30.

22. Clause 3a, Article 30.

23. Subpoints 2 and 3 of Clause 3b, Article 30.

24. Clause 4a, Article 31.

25. Clause 5, Article 31.

26. Clause 2b, Clause 3b and Clause 4a, Article 32.

27. Article 33, 34, 35, 36, 37 and 38.

28. Clause 1b and 1c, Clause 2a, Article 39.

Article 11. Amendments to some Articles of the Government’s Decree No. 109/2016/ND-CP dated July 01, 2016 on issuance of healthcare certificates to healthcare practitioners and operating licenses to health facilities

1. Clause 1b, Article 4 is amended as follows:

“b. Issuance of a modified practice certificate in case of change in contents of an issued practice certificate, including:

- Supplement the practice scope specified on the practice certificate when the practitioner applies for supplementation of a practice scope of a speciality different from the one specified in the practice certificate.

If the technical skills of one speciality are different from those of the speciality specified in the practice certificate, the practitioners may only practice these skills after receiving the certificate of training in practicing such technical skills. This certificate must be issued by a legal training institution. Also, these skills must be approved in writing by the chief physician of the health facility without the need to supplement the practice scope specified on the practice certificate.

- Supplement the practice scope specified on the practice certificate when the practitioner applies for a change of a speciality different from the one specified on the practice certificate.”

2. Article 7 is amended as follows:

“Article 7. Application documents for modification of practice certificates

1. An application for supplementation to the practice scope specified on the practice certificate shall contain:

a. An application form using form No. 05 in Appendix I hereto.

b. A valid copy of the issued practice certificate.

c. A valid of copy of a training qualification or a certificate issued by a legal training institution. The maximum training period is 6 months and must be conformable with the supplemented practice scope.

3. Article 22 is amended as follows:

"Article 22. Forms of organization of health facilities

The health facilities must be established in accordance with the law and must conform to one of the following forms of organization:

1. Hospital, including general hospital and specialized hospital.

2. Infirmaries of People's Public Security Forces.

3. Polyclinic.

4. Specialized clinic, including:

a. General medicine clinic.

b. Specialized clinic for internal medicine: cardiology, respiratory medicine, gastroenterology, pediatrics and other specialities in internal medicine.

c. Clinic providing healthcare consultancy or clinic providing healthcare consultancy by using information technology and telecommunications.

Specialized clinic, including:

dd. Antenatal clinic.

e. Clinic of andrology.

g. Clinic of odonto-stomatology.

h. Clinic of otolaryngology.

Clinic of ophthalmology.

k. Clinic of cosmetology.

l. Clinic of rehabilitation.

m. Clinic of psychiatry.

n. Clinic of oncology.

o. Clinic of dermatology.

p. Clinic of traditional medicine;

q. Clinic of dietetics.

r. Clinic of drug rehabilitation.

s. Clinic of HIV/AIIDS treatment.

t. Laboratory.

u. Image diagnosis clinic, X-ray room.

v. Opioid substitution treatment clinic which implements the regulations specified in the Government's Decree No. 90/2016/ND-CP dated July 01, 2016 on treatment for opioid substitution.

x. Preventive care clinic.

y. Occupational health clinic.

z. Other specialized clinics.

5. Family medicine facilities (or healthcare facilities operated in the principle of family medicine): pilot establishment as prescribed by the Minister of Health.

6. Maternity ward.

7. Medical service providers, including:

a. Injection, dressing change, pulse counting and temperature and blood pressure measurement service provider.

b. Home healthcare service provider.

c. Facilities providing emergency and patient transportation services in Vietnam or abroad.

d. Optical glasses service provider.

dd. Cosmetological service provider.

e. Other healthcare service providers.

8. Commune-level health stations, infirmaries.

9. Medical assessment facility and forensic examination facility providing medical examination and treatment shall be organized as a health facility specified in Clause 3 of this Article. Mental forensics examination facility providing medical examination and treatment shall be organized as a health facility specified in Clause 1 and Clause 3, or Clause 4m of this Article. Such facilities shall satisfy the applicable requirements.

10. Any medical facility affiliated to an agency, unit or organization which conducts healthcare must be operated in a form specified in Clause 3 or Clause 4a of this Article and must comply with the requirements applied to such form of organization.

11. Any medical center having a function of conducting medical examination and treatment shall be issued with a license to operate in form of a general hospital or a polyclinic and shall comply with the requirements applied to such form of organization. If the hospital is granted a license to operate in form of a general hospital, it shall be ranked as level IV, if it is granted a license to operate in form of a polyclinic, its rank shall correspond with its scale.

12. If the health facilities satisfy the requirements for healthcare service providers specified in this Decree, their scale and practice scope shall be supplemented accordingly.

4. Article 23a is added as follows:

“Article 23a. General requirements for issuance of operating licenses to healthcare facilities

1. Facility requirements:

a. The healthcare facility has a fixed location (unless it is a mobile healthcare clinic).

b. Radiation safety and fire safety are ensured in accordance with regulations of law.

c. There is a separated area for sterilizing reusable medical instruments, unless there are no reusable instruments or the healthcare facility has a contract with another healthcare facility for sterilization of reusable instruments.

2. Medical equipment:

a. Sufficient medical equipment must be provided and be suitable to the practice scope of the health facility.

b. An occupational health service provider must have at least a Biochemistry Laboratory Department.

c. Clinic providing healthcare consultancy or clinic providing healthcare consultancy by using information technology and telecommunications is not required to have the medical equipment specified in points a and b of this Clause. However, it must have sufficient information technology and telecommunications which are suitable to the registered practice scope.

3. Personnel:

a. Each health facility must have a chief physician. The chief physician and the deans of specialized departments of the health facility must:

- Be a doctor with a practicing certificate which is suitable to the practice scope of such facility.

- If the health facility has multiple departments, the chief physician must have a practicing certificate which is suitable to the practice scope of at least one of the registered clinical departments.

- Any chief physician of the following specialized clinics shall satisfy the corresponding conditions as follows:

+ Clinic of rehabilitation: being a doctor with a practice certificate relevant to physical therapy or rehabilitation.

+ Clinic for drug rehabilitation: being a psychiatric doctor or a general practitioner with a certificate of training in psychiatry or a traditional medicine practitioner with a certificate of training in drug rehabilitation using traditional medicine.

+ Clinic of HIV/AIDS treatment: being a doctor of infectious disease speciality or a general practitioner with a certificate of training in HIV/AIDS treatment.

+ Clinic of traditional medicine: Being a traditional medicine practitioner.

+ Traditional medicine facility: Being a herb doctor or a practitioner who is granted a certificate of traditional medicine prescription and treatment.

+ Clinic of dietetics: being a nutrition expert or a general practitioner with a certificate of training in dieting, or a preventive medicine doctor with a certificate of training in dieting or a bachelor in dieting; or a traditional medicine doctor with a certificate of training in dieting or a bachelor in dieting; or a physician with a certificate of training in dieting.

+ Clinic of cosmetic: Being a plastic surgeon or a Cosmetological doctor or a cosmetic surgeon.

+ Clinic of andrology: Being an adrological doctor or a general doctor with a certificate of training in andrology.

+ Clinic of occupational disease: being an occupational medicine doctor with a practice certificate or a general doctor with a practice certificate and a certificate of training in occupational disease.

+ Laboratory: Being a doctor or a physician specialized in testing with a bachelor degree or higher and a practice certificate for testing; or a chemical or biological bachelor, or a pharmacist with a bachelor degree. This requirement is applicable to those who are recruited to work in the laboratory before this Decree takes effect and are physicians who are granted practice certificates for testing.

+ Image diagnosis clinic, X-ray room: Being an image diagnosis doctor or have a bachelor’s degree of X-ray therapy or higher, or have a practice certificate.

- Have provided medical examination and treatment for at least 36 months after being granted a practice certificate, or have directly participated in providing medical examination and treatment for at least 54 months. The chief physician of the health facility must be assigned in writing to carry out the tasks.

- He/she must work on a full-time basis at the health facility.

b. Aside from the chief physician, other practitioners working in the health facility must have practice certificates and shall only provide medical examination and treatment within the assigned practice scope. The chief physician of the health facility shall assign the practitioners in writing to undertake the specialized tasks based on the practice scope, qualifications and certificates of training and the potential of such practitioners.

c. A testing physician with a bachelor degree is qualified for reading and signing the testing results. If the health facility does not have any general doctor who conducts the testing or a testing physician who has a bachelor degree, the doctor who recommends the testing must read and sign the testing results.

d. The bachelor who specializes in X-ray therapy is qualified to read and interpret medical images. If the health facility does not have an image diagnosis doctor or a radiologist, the doctor who recommends an imaging test must read and sign the image diagnostic results.

dd. Other entities that participate in the provision of medical examination and treatment but are not required to obtain practice certificates according to the Law on Medical Examination and Treatment must be allowed to perform the tasks assigned by the chief physician (medical physicists, radiation physicians, speech therapists, psychotherapists and other entities). Such entities must be assigned tasks which are suitable to their specialized qualifications.

4. Health facilities must satisfy the following requirements:

a. Be the health facilities which are granted operating licenses according to the law.

b. Have clinical and paraclinical departments, as well as sufficient personnel and equipment used for providing medical examination and detecting the health conditions of patients based on the health standards and medical forms which are enclosed with the documented guidelines on medical examination.

5. Cosmetological service providers are not required to obtain operating licenses but shall have a proof document proving their eligibility for providing Cosmetological services. Such document must be made by using the form specified in Appendix VIII hereto. They shall send this form to the Department of Health where their head office is located, at least 10 days before the operation.

Any Cosmetological service which involves the intervention of drugs, substances and equipment in human bodies (surgery, operation, injection, augmentation, ray emission, wave, firing and other types of intervention) that change the color of skin, shape, weight and shortcomings of human bodies (skin, nose, eyes, lips, face, breasts, belly, buttock and other body parts), or services of doing tattoos and microblading. Anesthetic is injected to the human bodies while providing the aforesaid services and is only used in hospitals having Cosmetological specialists or Cosmetological clinics or healthcare facilities with the practice scope in Cosmetological speciality approved by the competent authorities.”

5. Article 23 is amended as follows:

“Article 23. Requirements for issuance of the operating licenses to the hospitals

Aside from the requirements specified in Article 23a hereof, the hospitals must also satisfy the following requirements:

1. Scale of hospitals:

a. A general hospital must have at least 30 patient beds.

b. A specialized or traditional hospital must have at least 20 patient beds. Particularly, an ophthalmologic or a psychiatric hospital must have at least 10 patient beds.

2. Facilities:

Aside from the requirements specified in Article 23a hereof and depends on the scale of the hospital, a specialized or a general hospital must be designed and built in accordance with the following requirements:

a. Departments, rooms and hallways must be arranged conveniently for technique expertise under the interconnected and self-contained complex model within the hospital premises.

b. As for a general and a specialized hospital, there must be a minimum construction floor area of 50 m² per patient bed; the hospital façade must be at least 10m.

c. There must be a stand-by generator.

d. Requirements for medical waste treatment must be satisfied according to the regulations on environment.

3. Medical equipment: There must be sufficient emergency vehicles for transporting patients in and out of the hospital. If there are no emergency vehicles providing out-of-hospital treatment, a contract must be signed with a health facility which has been granted an operating license and its practice scope includes the provision of emergency transport services.

4. Organization:

a. Departments:

- There must be at least 02 of 04 departments of internal medicine, surgery, obstetrics and pediatrics, applicable to general hospitals, or an appropriate clinical department, applicable to specialized hospital.

- The medical examination department shall have a place for patient reception, emergency and patient stay rooms, consulting rooms and minor surgery rooms (if any minor surgery is carried out).

- The paraclinical department shall have at least one unit for testing and one unit for image diagnostic. Any ophthalmologic hospital having no image diagnostic unit must have a contract concluded with a healthcare facility having an operating license and with an image diagnostic unit.

- Pharmaceutical department.

- Other specialized departments and sections must be suitable to the scale, functions and tasks of the hospital.

b. There must be departments of general planning, organization and personnel, quality control, convalescence, finance and accounting and other necessary departments.

5. Personnel:

a. The number of full-time (tenured) practitioners in each department must account for at least 50% of the total number of practitioners in such department.

b. The deans of specialized departments of the hospital must have practice certificates which are suitable to such departments and must be the full-time practitioners at the hospital.

c. Deans of other departments who are not granted the practice certificates must have bachelor degrees in the specialities suitable to the assigned tasks. Also, they must be full-time practitioners at the hospital.

“Article 24. Requirements for issuance of operating licenses to infirmaries affiliated to People’s Police Force

Aside from the requirements specified in Article 23a hereof, the infirmaries affiliated to People’s Police Force must also satisfy the following requirements:

1. Scale:

a. Have at least 10 patient beds.

b. Have at least 02 departments specialized in internal medicine and surgery, including emergency rooms; patient rooms; and a paraclinical department.

2. Facilities: Have consulting rooms, emergency rooms, patient rooms and laboratories with an area sufficient for the use of means and instruments serving the medical examination and treatment."

7. Article 25 is amended as follows:

“Article 25. Requirements for issuance of the operating license to polyclinics

Aside from the requirements specified in Article 23a hereof, the polyclinics must also satisfy the following requirements:

1. Scale of a polyclinic:

a. Have 02 of 04 specialized departments of internal medicine, surgery, obstetrics and pediatrics.

b. Have a paraclinical department (units of testing and image diagnostic).

2. Facilities: Have emergency rooms, patient rooms, specialized consulting rooms and minor surgery rooms (if any minor surgery is carried out). The area of the rooms within the polyclinic must be sufficient for performing specialized techniques.

3. Have anti-shock first aid kits and sufficient specialized emergency drugs.

4. Personnel:

The number of full-time doctors must account for at least 50% of the total number of doctors of the polyclinic. The persons in charge of the specialized consulting rooms and the paraclinical department (units of testing and image diagnostic) which are affiliated to the polyclinic, must work on a full-time basis.

8. Article 26 is amended as follows:

“Article 26. Requirements for issuance of operating licenses to specialized clinics

Aside from the requirements specified in Article 23a hereof and except those applied to the chief physicians, the specialized clinics must also satisfy the following requirements:

1. Facilities:

a. If any operation is conducted, including implanting operation, acupuncture, massage or acupressure, the operation room must be located in a separate area. The area of the operation room must be sufficient for performing specialized techniques.

b. If the specialized clinic conducts both upper and lower gastro-endoscopic techniques, it must have 02 separate rooms.

c. There must be a biochemistry department for diagnosing and treating occupational diseases.

2. Medical equipment: Have anti-shock first aid kits and sufficient specialized emergency drugs.”

9. Article 30 is amended as follows:

“Article 30. Requirements for issuance of operating licenses to maternity wards

1. Aside from the requirements specified in Article 23a hereof, the maternity wards shall satisfy the following requirements:

a. Facilities:

- Functional rooms must be interconnected and convenient for emergency and medical examination and treatment.

- There must be rooms for pre-natal and gynecological checkup and for lying-in women. These rooms must have sufficient area for performing specialized techniques.

b. Medical equipment:

- Have sufficient vehicles for internal and external emergency transportation. Maternity wards having no vehicles for external emergency transportation must have transportation contracts signed with healthcare facilities which have operating licenses and are permitted to provide emergency transportation services.

- Have anti-shock first aid kits and sufficient specialized emergency drugs.

2. The chief physician of the maternity ward must:

a. Be a gynecological doctor or a midwife who has a bachelor degree and a practice certificate.

- Have conducted examination and treatment in gynecology for at least 36 months after being granted a practice certificate, or have participated directly in providing medical examination and treatment for at least 54 months. Such chief physician of the maternity ward must be assigned in writing to carry out the aforesaid tasks.

3. Any maternity ward eligible for providing pediatric healthcare services according to the regulations in Article 27 hereof or providing vaccines according to the law on immunization, may add such specialities to its practice scope.”

10. Article 33a is added as follows:

“Article 33. Requirements for issuance of operating licenses for healthcare service providers

1. Facilities must satisfy the requirements specified in Clause 1a, Article 23a hereof.

- If the healthcare service provider also provides optical glasses service, its area must be at least 15 m².

- A room for injection or dressing change must have an area of at least 10 m².

2. Medical equipment:

Aside from the requirements specified in Clause 2a, Article 23a hereof, if the healthcare service provider also provides:

a. Injection, dressing change, pulse counting and temperature and blood pressure measurement, then it must have anti-shock first aid-kits.

b. Emergency transportation, then it must have ambulances, anti-shock first aid kits and sufficient specialized emergency drugs. In case of registration for patient transportation abroad, such provider must have emergency transportation contracts signed with an aviation service company.

3. Personnel:

Aside from the requirements specified in Article 23a hereof and those applicable to the chief physician, if the healthcare service provider also provides:

a. Emergency transportation, the chief physician must satisfy the following requirements:

- Be a doctor with a practice certificate.

- Have specialized qualifications or certificates of recuperation and first aid.

b. Injection, dressing change, pulse counting, temperature and blood pressure measurement; and home nursing services, then the chief physician must have an intermediate or higher degree in medicine and a practice certificate. Also, he/she must have provided the aforesaid services for at least 45 months.

c. Optical glasses services, then the chief physician must have an intermediate or higher degree in medicine, a practice certificate and a certificate of training in ophthalmology or refractive eye defect.

d. Cosmetological services, then the person doing tattoos or embroidering pictures on the surface of the skin without use of anesthetics in injection form at a Cosmetological service provider, shall possess a certificate of study in the corresponding speciality lawfully issued by a training institution or a vocational training facility.

dd. If the home healthcare service providers also provide services including dressing change, suture removal, physical therapy, rehabilitation, mother and baby care, collection of blood samples for testing, result provision, care of patients with cancer and other home nursing services, then the chief physician must have an intermediate or higher degree in medicine and a practice certificate. Also, he/she must have provided medical examination and treatment for at least 45 months."

11. Article 45b is added as follows:

“Article 45b. Issuance, re-issuance and revocation of the certificates of traditional medicine prescription and treatment

1. Application documents for issuance or re-issuance of the Certificate of Traditional Medicine Prescription and Treatment (hereinafter referred to as “Certificate”):

a. Application for the new Certificate shall contain:

- An application form for the Certificate using form No. 01 in Appendix XV hereto.

- A written interpretation of the traditional medicine prescription and treatment, using form No. 02 in Appendix XV hereto.

- A medical certificate which is made within 06 months before the date of submission, using the set form.

- 2 color photos of 2 x 6 cm, with a white background. Such photos must be taken within 06 months before the date of submission.

b. Application documents

- An application form for re-issuance of the Certificate, using form No. 04 in Appendix XV hereto.

- A medical certificate which is made within 06 months, before the date of submission.

- 2 color photos of 2 x 6 cm, with a white background. Such photos must be taken within 06 months before the date of submission.

2. Procedures for issuance of the Certificate of Traditional Medicine Prescription and Treatment:

a. The applicant shall send 01 application dossier to the Department of Health of the same province. After receiving the application, the Department of Health shall issue the written confirmation to the applicant, using form No. 05 in Appendix XV hereto.

b. If the application is deemed unsatisfactory, within 05 working days from the date on which the application is received, the Department of Health shall send a written notification to the applicant to request for additional documents.

Within 60 days from the date on which the written notification is received, if the applicant does not provide additional documents, the application will be invalidated. If needed, the applicant shall submit a new application for issuance of the new Certificate.

c. If the application is deemed satisfactory, within 10 working days from the date on which the application is received, the Department of Health shall send such application to the Oriental Medicine Association of the same province or the same central-affiliated city for advices.

c. Within 30 days from the date on which the application from the Department of Health is received, the Oriental Medicine Association shall respond in writing, using form No. 03 in Appendix XV hereto.

d. After the written advice from the Oriental Medicine Association is received, the Department of Health shall organize a council meeting to appraise such application.

dd. Within 10 working days from the date on which the meeting minute of the Appraisal Council is received, the Department of Health shall issue the Certificate, using form No. 06 in Appendix XV hereto, or reject the application and provide explanations in writing.

3. The Director of the Department of Health shall issue, re–issue or revoke the Certificate.

4. Cases where the Certificate is revoked:

a. The Certificate is issued ultra vires.

b. The contents of the Certificate violate the law regulations.

c. The Appraisal Council established by the Department of Health concludes that the applicant makes serious mistakes that cause negative effects to the health and lives of patients.

d. The applicant who is granted the Certificate falls into the cases mentioned in clause 4, Article 18 of the Law on Medical Examination and Treatment."

12. Clause 5 is added to Article 50 as follows:

“The polyclinics within the areas where inpatients stay and are established and operated before this Decree takes effect shall implement the regulations hereof. This requirement also applies to those within the mountainous areas and remote and isolated areas and is approved in writing by the People’s Committees of provinces and Departments of Health.