Chương III Thông tư 41/2011/TT-BYT: Điều kiện hoạt động đối với cơ sở khám bệnh, chữa bệnh

Chapter III

CONDITIONS FOR OPERATION OF MEDICAL EXAMINATION AND TREATMENT FACILITIES

Section 1: SPECIFIC CONDITIONS FOR GRANTING OPERATION LICENSES FOR MEDICAL EXAMINATION AND TREATMENT FACILITIES OF DIFFERENT ORGANIZATIONAL FORMS

Article 23. Conditions for granting operation licenses for hospitals

1. Scale of hospitals:

a/ A general hospital must have at least 30 patient beds;

b/ A specialized or traditional medicine hospital must have at least 20 patient beds. Particularly, a high-tech ophthalmologic hospital must have at least 10 patient beds.

2. Physical foundation:

a/ A hospital must be designed and built according to Vietnam construction standard 365:2007. Particularly, the designing and building of emergency, intensive-care and anti-toxic, operation, image diagnosis and testing departments must strictly comply with the Minister of Health’s Decisions Nos. 32, 33 and 34/2005/QD-BYT of October 31, 2005, and No. 35/2005/QD-BYT of November 15, 2005.

A hospital planned to be built in a district of a centrally run city on a land area which is not large enough as required by Vietnam construction standard 365:2007, may be designed and built into a multi-storied block building satisfying the following conditions:

- Departments, rooms and hallways are arranged conveniently for technique expertise after the interconnected and self-contained complex model within the hospital premises; ensure aseptic and environmental sanitation conditions prescribed by law;

- A minimum construction floor area of 50 m2 per patient bed is ensured, the hospital façade is at least 10 m wide. Hospitals commencing their operation before January 1, 2012, may continue operating but must satisfy the condition of the façade width by January 1, 2016, at the latest.

b/ Satisfying the conditions of radiation safety, hospital waste management, fire prevention and fighting under law;

c/ Ensuring sufficient electricity and water supply and other conditions for patient care.

3. Medical equipment:

a/ Having sufficient medical equipment and instruments suitable to the scope of registered professional operation;

b/ Having sufficient vehicles for internal and external emergency transportation. Hospitals having no vehicles for external emergency transportation must have transportation contracts signed with facilities having such vehicles.

4. Organization:

a/ Departments:

- Having at least 2 of the 4 departments of internal medicine, surgery, obstetrics and pediatrics, for general hospitals, or an appropriate clinical department, for specialized hospitals;

- Medical examination department, which has a place for patient reception, first-aid and patient stay rooms, consulting room and minor operation room);

- Para-clinical department, which has at least two units for testing and image diagnosis. Particularly, an ophthalmologic hospital having no image diagnosis unit must have a contract signed with a medical examination and treatment facility having a licensed image diagnosis unit;

- Pharmaceutical department;

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

b/ Functional sections of general planning, organization and personnel, convalescence, finance and accounting.

5. Personnel:

a/ The number of full-time practitioners (official staff) in each department must account for at least 50% of the total number of practitioners in this department;

b/ Payroll limits, proportional structure of professional operation sections comply with Clauses 1, 2, 3 and 4, Section II of Joint Circular No.08/2007/TTLT-BYT-BNV of June 5, 2007, of the Ministry of Health and the Ministry of Home Affairs, guiding non-business payroll limits of state-owned health facilities;

c/ A person in charge of professional and technical activities of a hospital must satisfy the following conditions:

- Being a doctor with a practicing certificate relevant to at least one of medical specialties registered by the hospital;

- Having conducted medical examination and treatment for at least 54 months. The assignment or appointment of a person in charge of professional and technical activities of a hospital must be made in writing;

- Working on a full-time basis in the hospital.

d/ The head of the clinical department must satisfy the following conditions:

- Being a doctor with a practicing certificate relevant to this specialty;

- Having conducted medical examination and treatment for at least 36 months. The assignment or appointment of a department head must be made in writing;

- Working on a full-time basis in the hospital.

e/ The head of another department must satisfy the following conditions:

- Possessing a university degree and having worked in such department for at least 36 months, counting from the date of receiving the university degree to the date of being assigned or appointed as the department head. The assignment or appointment of a department head must be made in writing;

- Working on a full-time basis in the hospital;

f/ The head of the pharmaceutical department must be a person working on a full-time basis in the hospital and satisfying the conditions specified in Clause 1, Article 7 of the Minister of Health’s Circular No. 22/2011/TT- BYT of June 10, 2011, stipulating the organization and operation of pharmaceutical departments of hospitals;

g/ A surgeon must satisfy the following conditions:

- Being a doctor specialized in surgery or a general doctor possessing a certificate of training in surgery issued by a hospital at provincial or higher level or a medicine university or a training and direction center of a special- grade or grade-1 hospital attached to the Ministry of Health. A surgeon trained overseas must have a specialty certificate;

- Having a written permission for conducting surgery or surgical intervention issued by the hospital director at the request of the person in charge of professional and technical activities of the hospital.

h/ If wishing to conduct medical examination and treatment, persons other than those specified at Points c, d, e, f and g of this Clause working in a hospital must have a practicing certificate and may only conduct medical examination and treatment within the scope of assigned jobs. The assignment of jobs to these persons must be made in writing and suitable to the scope of technique expertise stated in their practicing certificates.

6. Scope of technique expertise:

Performing professional techniques in a list approved by the Minister of Health or the Department of Health of the province director.

Article 24. Conditions for grant of operation licenses for polyclinics

1. Scale of polyclinic:

A polyclinic must have at least the following:

a/ Two of the four specialized departments of internal medicine, surgery, obstetrics and pediatrics;

b/ A first-aid room;

c/ A minor operation room;

d/ A patient stay room;

e/ Para-clinical department, which consists of two units of testing and image diagnosis.

2. Physical foundation:

a/ A polyclinic must have a place for patient reception, a first-aid room, a patient stay room, specialized consulting rooms and a minor operation room. Rooms in a polyclinic must satisfy the following minimum area requirement:

- The first-aid room is at least 12 m2 large;

- The patient stay room is at least 15 m2 large and has at least 2 patient beds. If the patient stay room has 3 or more patient beds, the area for each bed is at least 5 m2;

- Specialized consulting rooms and the minor operation room are at least 10 m2 large each.

Particularly, state-owned regional polyclinics must conform to design standards provided in the Minister of Health’s Decision No.1327/2002/QD-BYT of April 18, 2002.

b/ Satisfying the conditions of radiation safety, hospital waste management and fire prevention and fighting under law;

c/ Having sufficient electricity and water supply and other conditions for patient care.

3. Medical equipment:

A polyclinic must have sufficient medical equipment and instruments suitable to the scope of its registered professional operation.

4. Organization and personnel:

a/ The number of full-time doctors (official staff) must account for at least 50% of the total number of doctors of the polyclinic;

b/ A person in charge of professional and technical activities of a polyclinic must satisfy the following conditions:

- Being a doctor with a practicing certificate relevant to at least one of medical specialties registered by the polyclinic;

- Having conducted medical examination and treatment for at least 54 months. The assignment or appointment of a person in charge of professional and technical activities of the polyclinic must be made in writing;

- Working on a full-time basis in the polyclinic.

c/ If wishing to conduct medical examination and treatment, persons other than the person in charge of professional and technical activities of a polyclinic working in the polyclinic must have a practicing certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of jobs to these persons must be suitable to the scope of technique expertise stated in their practicing certificates.

5. Scope of technique expertise:

Practicing within the scope of technique expertise approved by Department of Health of the province directors. Approval must be based on the provisions on scope of technique expertise of Articles 25, 26, 28, 29, 30, 32, 33 and 34 of this Circular.

Article 25. Conditions for grant of operation licenses for specialized clinics

1. Physical foundations:

a/ Construction and designing:

- A specialized clinic must be in a fixed location and separated from daily- life activities of surrounding households;

- A specialized clinic must be built firmly and well lit, and have dustproof ceilings, walls and floors made of easy-to-clean materials;

b/ A specialized clinic must have medical examination and treatment rooms which are at least 10 m2 large each and a place for patient reception, except rooms for medical examination consulting by phone and rooms for health care consulting via telematic media and medical equipment. Particularly, surgery or cosmetic surgery clinic must have also a patient stay room which is at least 12 m2 large; a functional rehabilitation clinic must have also a functional rehabilitation room which is at least 10 m2 large;

c/ In addition to the conditions specified at Point b, Clause 1 of this Article, depending on the scope of technique expertise, a clinic must additionally satisfy the following conditions:

- Having an operation room which is at least 10 m2 large in case the clinic performs operation, including dental implant technique;

- Having a functional probing room which is at least 10 m2 large in case the clinic performs functional probing;

- Having a gynecological examination room which is at least 10 m2 large in case the clinic performs gynecological examination or examination of sexually transmitted diseases;

- Having a room for performance of family planning techniques which is at least 10 m2 large in case the clinic performs family planning techniques;

- Having a room for kinetotherapy which is at least 40 m2 large in case the clinic provides kinetotherapy;

- For an orthodontic clinic having three or more dental chairs, the space for each dental chair must be at least 5 m2;

- Specialized clinics using radiation equipment (including also dental X-ray equipment mounted on dental chairs) must satisfy requirements on radiation safety.

d/ Ensuring medical waste treatment according to law and aseptic operation, implant and family planning rooms;

e/ Ensuring sufficient electricity and water supply and satisfy other conditions for patient care.

2. Medical equipment:

a/ Having sufficient medical equipment and instruments suitable to the scope of registered technique expertise;

b/ Having anti-shock medicine boxes and sufficient specialized first-aid medicines;

c/ Rooms for medical examination consulting by phone and rooms for health care consulting via telematic media and medical equipment are not required to have medical equipment and instruments specified at Points a and b, Clause 2 of this Article but must have sufficient telematic appliances and equipment suitable to registered consulting activities.

3. Personnel:

a/ A person in charge of professional and technical activities of a specialized clinic must be a doctor having a practicing certificate relevant to medical specialties registered by the clinic and having conducted medical examination and treatment for at least 54 months in such specialty.

b/ Apart from the person in charge of professional and technical activities of a specialized clinic, other persons working in this clinic and wishing to conduct medical examination and treatment must have a practicing certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of jobs must be suitable to the scope of technique expertise stated in their practicing certificates;

4. Scope of technique expertise:

a/ For general internal medicine clinics and family-doctor clinics:

- First-aid and examination and treatment of common adult diseases other than specialized operations;

- Performance of electrocardiographic, electroencephalographic, electromyographic, cerebral blood-flow measuring, ultrasonic, gastroscopic techniques, provided doctors directly performing these techniques have professional training certificates issued by a hospital at provincial or higher level. In case of performance of gastroscopic technique, a certificate of performance of practicing activities in the specialty for 18 months or more in a medical examination and treatment facility is also required.

Particularly, family-doctor clinics may conduct health care and medical examination and treatment at patients’ homes.

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

b/ For specialized clinics in the internal medicine system (cardiovascular system, respiratory system, digestive system, pediatrics and other specialties of internal medicine):

- First-aid, examination and treatment of diseases of internal medicine specialties;

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

c/ Rooms for medical examination and treatment consulting by phone and rooms for health care consulting via telematic appliances and medical equipment:

- Consulting rooms may provide counseling in their approved medical specialties;

- Practitioners may provide health care counseling relevant to their practicing certificates.

d/ For surgery clinics:

- Surgical first-aid and palliation;

- Examination and dressing of common wounds;

- Plaster cast and removal of plaster casts for minor bone fracture;

- Removal of sebaceous cysts and small superficial cysts;

- Non-lancing of big diffuse pyogenic abscess cavities.

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

e/ For obstetrics-gynecology - family planning clinics:

- Obstetrical and gynecological first-aid;

- Pre-natal checkup and pregnancy management;

- Examination and treatment of common gynecological diseases;

- Placement of vaginal suppositories;

- Cauterization of cervical uterine segment;

- Colposcopy and curettage for detection of precancerous cells;

- Obstetrical ultrasonic techniques, provided doctors directly performing ultrasonic techniques have professional training certificates issued by a hospital at the provincial or higher level and certificates of performance of practicing activities in the specialty for 18 months or more in a medical examination and treatment facility;

- Placement of intrauterine contraceptive devices;

- Internal vacuum extraction or abortion of fetuses which are up to 6 weeks old (between 36 and 42 days from the first date of the last menstruation), provided the conditions specified in the national standard for reproductive health care services promulgated by the Minister of Health are met;

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

f/ For dental clinics:

- Examination and treatment of common diseases and first-aid for maxillary and facial wounds;

- Minor operations to prevent scars of facial minor wounds of under 2 cm;

- Temporo-mandibular joint adjustment;

- Superficial laser treatment;

- Treatment of gum (alveolaris) diseases;

- Lancing of tooth abscesses, tartar removing and tooth extraction;

- Dental prosthesis;

- Dental orthopedics;

- Dental care and endodontological treatment;

- Simple implant of one or two teeth per time of manipulation (particularly for submandibular incisors, the maximum number per time of implant is four) provided doctors directly perform the implant technique have dental implant certificates granted by a medicine university or hospital at provincial or higher level. Dental clinics are not allowed to perform cuboid bone grafting for implant or perform implant for patients suffering progressive adult diseases which might affect implant quality;

- Dental minor operation;

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

g/ For otorhinolaryngologic clinics:

- Examination and treatment of common diseases and otorhinolaryngologic first-aid;

- Treatment of sinusitis, exploratomic sinusal puncture, draining of cystic mucus;

- Incision and lancing of acute otitis media;

- Incision and lancing of tonsillar abscesses;

- Excision of simple polyps, sebaceous cysts, benign cysts and adipoma in the ear, nose and throat;

- Nasal hemostasis;

- Removal of foreign objects from the ear, nose and throat, except those in larynx and esophagus;

- Heat or laser guttural cauterization;

- Adenoidectomy;

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

h/ For ophthalmologic clinics:

- Examination and treatment of common diseases, ophthalmologic first-aid;

- Subconjunctival and intraocular injection;

- Removal of foreign objects from conjunctiva or cornea, excision of eyelid cysts;

- Cleaning of lacrimal canals;

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

i/ Cosmetic surgery clinics:

- Creation of dimples, obliteration of supercillary arch tattoos, lifting of supercillary arch, formation of cheekbone, cleft chin or receding chin, reconditioning of facial and neck skin;

- Eyelid, nose, lip and ear re-shaping;

- Cosmetic surgery clinics are not allowed to perform plastic surgery operations of breast augmentation or implant, reduction of mammary areola and nipples; neatening of abdominal wall, buttock and thigh; tightening of facial, buttock and thigh skin; fat removal;

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

- Cosmetic surgery that would change identity features of persons indicated in their identity cards may be performed only after these persons have filed requests for permission of police departments that have issued their identity cards.

j/ For functional rehabilitation clinics:

- Functional rehabilitation for persons suffering central or peripheral neuroparalysis syndrome or chronic diseases or after undergoing operation;

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

k/ For mental clinics:

- First-aid, examination and outpatient treatment of mental diseases and epilepsy;

- Providing psychotherapy;

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

l/ For oncological clinics:

- Examination and early detection of common oncological diseases;

- Collection of swab samples for cytological or pathoanatomic tests of some types of cervical, rectal, vaginal, breast and nodular cancer. Results of cytological or pathoanatomic tests must be concluded by pathoanatomical - cytologic doctors;

- Examination and periodical monitoring of oncological diseases under treatment;

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

m/ For dermatological clinics:

- Examination and treatment of skin diseases, leprosy and sexually transmitted diseases;

- Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

Article 26. Conditions for grant of operation licenses for traditional medicine clinics

1. Physical foundations:

a/ A traditional medicine clinic must satisfy the conditions specified at Points a, d and e, Clause 1, Article 25 of this Circular;

b/ A diagnosis and treatment room must be at least 10 m2 large and have a place for patient reception;

c/ Depending on the scope of its registered technique expertise, a traditional medicine clinic must also satisfy the following conditions:

- If providing acupuncture, massage and acupressure, it must have a room or a place with beds for acupuncture, massage and acupressure, at least 5 m2 for each bed;

- If providing medicinal sauna (anemopathy), it must have a sauna chamber which is at least 2 m2 large, closed and well-lit;

- If preparing some pre-packaged medicines, it must obtain permission of the Department of Health of the province after appraisal.

2. Medical equipment:

a/ For clinics providing medical examination, giving prescriptions and medicinal herb recipes:

- They must have herb cabinets with medicinal herbs and substances contained in drawers and securely covered bottles or pots with labels showing names of medicinal herbs;

- They must have medicine scales and divide medicinal herbs according to recipes.

b/ For clinics providing acupuncture, massage and acupressure:

- They must have beds for acupuncture, massage and acupressure;

- They must have sufficient tools for acupuncture, massage and acupressure and infrared lamps;

- They must have sufficient tools for and guide the relief of over- acupuncture.

c/ Clinics providing medicinal sauna must have a medicinal steam system;

3. Personnel:

a/ Persons in charge of professional and technical activities of traditional medicine clinics must be doctors or assistant doctors specialized in traditional medicine or have galenic physician certificates granted by the Ministry of Health or Department of Health of the provinces or persons who have family remedies or treatment methods and traditional medical examination and treatment practicing certificates;

- Traditional medicine doctors must have conducted medical examination and treatment with traditional medicine for at least 54 months;

- Assistant doctors in traditional medicine must have conducted medical examination and treatment with traditional medicine for at least 48 months;

- Galenic physicians or persons who have handed-down family remedies or treatment methods must have conducted medical examination and treatment with traditional medicine for at least 36 months.

b/ In addition to the person in charge of professional and technical activities of a traditional medicine clinic, other persons working in the clinic and wishing to conduct medical examination and treatment must have a practicing certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of technique expertise stated in their practicing certificates.

4. Scope of technique expertise:

a/ Medical examination and treatment with traditional medicine (with or without medicinal herbs);

b/ Use of finished traditional medicines produced by other facilities which have circulation registrations granted by the Ministry of Health for use in medical examination and treatment;

c/ Preparation of medicinal raw materials into medicinal powders and slices and scaling of medicinal recipes for patients;

d/ Practitioners with handed down family remedies or treatment methods may conduct medical examination and treatment only with these remedies or methods;

e/ Before producing pre-packaged medicines (ointment, pill, pellet or powder) for use by their patients, traditional medicine clinics shall register these medicines with Department of Health of the provinces on their ingredients, production process (enclosed with a description of the physical foundations and equipment), effects, dosages, contraindications and labels. Department of Health of the provinces shall consider, appraise and recognize the satisfaction of all required conditions. These medicines may only be used by patients of traditional medicine clinics and may not be marketed as provided by the Pharmacy Law.

Article 27. Conditions for grant of operation licenses for medical assessment facilities

Medical assessment facilities that conduct medical examination and treatment shall apply one of the organizational forms specified in Articles 24 and 25 of this Circular.

Article 28. Conditions for grant of operation licenses for maternity homes

1. Physical foundations:

a/ Building and designing:

- A maternity home must be built firmly and have sufficient professional activity rooms which are well lit and have dustproof ceilings, and walls and floors made of easy-to-clean materials;

- Rooms of a maternity home must be interconnected and convenient for first-aid, medical examination and treatment.

b/ A maternity home must have rooms for pre-natal and gynecological checkup and family planning techniques, which are at least 10 m2 large each; a delivery room which is at least 16 m2 large; and a room for lying-in women which is at least 20 m2 large, to ensure at least 5 m2 for each bed;

c/ Rooms specified at Points a and b, Clause 1 of this Article must satisfy the requirements on work structure and designing specified at Point 5.4,Clause 5 of the Minister of Health’s Decision No. 2271/2002/QD-BYT of June 17, 2002, promulgating the design standard: Grassroots health stations

- sector standard;

d/ A maternity home must treat its medical wastes and satisfy the radiation safety conditions (if any) under law;

e/ A maternity home must have sufficient electricity and water supply and satisfy other conditions for patient care.

2. Medical equipment:

a/ A maternity home must have sufficient medical equipment and instruments suitable to the scope of its registered technique expertise;

b/ A maternity home must have vehicles for internal and external emergency transportation. A maternity home having no vehicles for internal and external emergency transportation shall sign contracts with facilities having such vehicles.

3. Organization and personnel:

a/ A maternity home must have an organizational apparatus suitable to the scope of its technique expertise registered in the dossier of application for operation license;

b/ A person in charge of professional and technical activities of a maternity home must satisfy the following conditions:

- Being a doctor or bachelor in midwifery (university graduate) and having a practicing certificate;

- Having conducted medical examination and treatment in gynecology and obstetrics for at least 54 months, for doctors, or at least 45 months, for midwifery bachelors (university graduates);

- Working on a full-time basis in the maternity home.

c/ Apart from the person in charge of professional and technical activities

of a maternity home, other persons working in such maternity home and wishing to conduct medical examination and treatment must have a practicing certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of technique expertise stated in their practicing certificates.

4. Scope of technique expertise:

a/ Pre-natal checkup and pregnancy management;

b/ Obstetrical first-aid;

c/ Tetanus vaccination;

d/ Urinary protein test;

e/ Midwifery;

f/ Manual removal (scaping) of post-natal or post-miscarriage retained placenta;

g/ Placement of intrauterine contraceptive devices;

h/ Internal vacuum extraction or abortion of fetuses up to 6 weeks old (between 36 and 42 days from the first day of the last menstruation), provided the conditions specified in the national standard for reproductive health care services promulgated by the Ministry of Health are satisfied;

i/ Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

Article 29. Conditions for grant of operation licenses for image diagnosis clinics

1. Physical foundation:

a/ Building and designing:

- An image diagnosis clinic must a fixed location separated from daily-life activities of surrounding households;

- An image diagnosis clinic must be built firmly and have dustproof ceiling and walls and floors made of easy-to-clean materials;

- X-ray, computed tomography (CT) scanner and magnetic resonance imaging (MRI) rooms must satisfy the radiation safety conditions specified by law;

- Ultrasonic and endoscopic diagnosis rooms must be independent and at least 10 m2 large each. Particularly for gastroendoscopy, if both upper and lower gastroendoscopic techniques are performed, there must be two separate rooms;

b/ An image diagnosis clinic must treat its medical wastes and satisfy the radiation safety conditions specified by law;

c/ An image diagnosis clinic must have sufficient electricity and water supply and satisfy other conditions for patient care.

2. Medical equipment:

a/ An image diagnosis clinic must have sufficient medical equipment and instruments suitable to its registered scope of technique expertise;

b/ An image diagnosis clinic must have personal protection devices required by the law on radiation safety.

3. Personnel:

a/ A person in charge of professional and technical activities of an image diagnosis clinic must be a doctor having a practicing certificate and having conducted medical examination and treatment in image diagnosis for at least 54 months;

b/ Apart from the person in charge of professional and technical activities of an image diagnosis clinic, other persons working in such clinic and wishing to conduct medical examination and treatment must have a practicing certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of technique expertise stated in their practicing certificates.

4. Scope of technique expertise:

a/ X-ray-, computed tomography- and ultrasonic resonance imaging-based diagnosis;

b/ Doppler ultrasonic, common ultrasonic and endoscopic diagnosis;

c/ Image diagnosis clinics may not use intravenous contrast agents;

d/ Image diagnosis clinics may not perform ultrasonic-guided probing, endoscopic operation, bronchial tube scopy and hemorrhagic X-ray interventions;

e/ X-ray bachelors (university graduates) may not make diagnostic conclusions;

f/ Other professional techniques as approved by Department of Health of the province directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundation of clinics.

Article 30. Conditions for grant of operation licenses for testing laboratories

1. Physical foundation:

a/ Building and designing:

- A testing laboratory must be located separately from daily-life activities of surrounding households;

- A testing laboratory must satisfy the requirements on architectural design and technical solutions specified in Sections 6 and 7 of the Minister of Health’s Decision No. 35/2005/QD-BYT of October 31, 2005, promulgating the design standard: testing departments of polyclinics - sector standard;

b/ In addition to the conditions specified at Point a, Clause 1 of this Article, a testing laboratory providing tests of microorganisms likely to cause infectious diseases in humans must satisfy the conditions specified in the Government’s Decree No. 92/2010/ND-CP of August 30, 2010, on assurance of bio-safety in laboratories;

c/ A testing laboratory must treat its medical wastes under law;

d/ A testing laboratory must have sufficient electricity and water supply and satisfy the conditions for patient care.

2. Medical equipment:

A testing laboratory must have sufficient testing devices and medical equipment for performing at least one of the six microbiological, biochemical, hematological, immunological, pathoanatomical and medico- genetic tests.

3. Personnel:

a/ A person in charge of professional and technical activities of a testing laboratory must satisfy the following conditions:

- Being a biological doctor or bachelor or a chemical bachelor or a university pharmacist or a testing technician (university graduate) and having a practicing certificate;

- Having conducted medical tests for at least 54 months, including the

period of postgraduate study in testing, from the date of starting to perform testing jobs (counting from the date of signing a labor contract or obtaining a recruitment decision) to the date of being assigned or appointed to act as the person in charge of professional and technical activities of a testing laboratory.

b/ Apart from the person in charge of professional and technical activities of a testing laboratory, other persons working in such testing laboratory and wishing to conduct medical examination and treatment must have a practicing certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of technique expertise stated in their practicing certificates.

4. Scope of technique expertise:

A testing laboratory may only perform tests suitable to its existing testing equipment and actual capacity of its practitioners.

Article 31. Conditions for grant of operation licenses for injection, dressing change, pulse counting, temperature and blood pressure measurement service facilities

1. Physical foundation:

a/ A service facility must be built firmly in a fixed location, well lit and separated from daily-life activities of surrounding households;

b/ A room for injection or dressing change must be at least 10 m2 large;

c/ A service facility must have sufficient electricity and water supply and satisfy other sanitation conditions for patient care.

2. Medical equipment:

a/ A service facility must have sufficient medical equipment and instruments suitable to the scope of its registered technique expertise;

b/ A service facility must have an anti-shock medicine box.

3. Personnel:

a/ A person in charge of professional and technical activities of an injection, dressing change, pulse counting, temperature and blood pressure measurement service providing must satisfy the following conditions:

- Having an intermediate or higher degree in medicine and a practicing certificate;

- Having conducted injection, dressing change, pulse counting, temperature and blood pressure measurement for at least 45 months.

b/ Apart from the person in charge of professional and technical activities specified at Point a of this Clause, other persons working in a service facility and wishing to conduct medical examination and treatment must have a practicing certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of technique expertise stated in their practicing certificates.

4. Scope of technique expertise:

a/ Injection and dressing change according to doctor prescriptions;

b/ Pulse counting and temperature and blood pressure measurement;

c/ Service facilities may not perform transfusion, medical examination and treatment and give prescriptions.

Article 32. Conditions for grant of operation licenses for denture prosthesis service facilities

1. Physical foundation:

a/ A dental and denture prosthesis room must be at least 10 m2 large;

b/ A denture prosthesis room must be at least 10 m2 large or is rent under a contract from another denture prosthesis facility;

c/ Having sufficient electricity and water supply and satisfying other sanitation conditions for patient care.

2. Medical equipment:

A denture prosthesis service facility must have sufficient medical equipment and instruments suitable to the scope of its registered technique expertise.

3. Personnel:

A person in charge of denture prosthesis must be a tooth implanter having practiced since 1980 or before at the age of full 18 or more and have a certificate thereof issued by the Department of Health of the  commune.

4. Scope of technique expertise:

a/ Making of onlay and inlay denture prosthesis;

b/ Particularly, dental implanters in Ho Chi Minh City, who have been licensed for practice since 1980 or before and attended the municipal Department of Health-organized professional training courses or passed a professional skill test (held in 1985 or 1986) and obtained a certificate of professional qualifications and wish to expand their scope of practice to filling teeth decayed at 1 or 2 level or extracting half-decayed teeth, must acquire additional relevant professional qualifications and have sufficient medical equipment and an anti-shock medicine box as required for these operations.

Article 33. Conditions for grant of operation licenses for home health care service facilities

1. Medical equipment:

A service facility must have sufficient medical equipment and instruments suitable to the scope of its registered technique expertise.

2. Personnel:

a/ A person in charge of professional and technical activities of a home health care service facility must possess an intermediate or higher degree in medicine and a practicing certificate and have conducted medical examination and treatment for at least 45 months;

b/ Apart from the person in charge of professional and technical activities of a home health care service facility, other persons working in such facility and wishing to conduct medical examination and treatment must have a practicing certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of technique expertise stated in their practicing certificates.

3. Scope of technique expertise:

a/ Home health care services according to doctor prescriptions;

b/ Home health care service facilities may not perform transfusion, medical examination and treatment and give prescriptions.

Article 34. Conditions for grant of operation licenses for optical glasses service facilities

1. Physical foundation:

a/ An optical glasses service facility must be built firmly in a fixed location, well lit and separated from daily-life activities of surrounding households;

b/ An optical glasses service facility must be at least 15 m2 large;

c/ An optical glasses service facility must have sufficient electricity and water supply and satisfy other sanitation conditions for patient care.

2. Medical equipment:

An optical glasses service facility must have sufficient medical equipment and instruments suitable to the scope of its registered technique expertise.

3. Personnel:

a/ A person in charge of professional and technical activities of an optical glasses service facility must possess an intermediate or higher degree in medicine and a practicing certificate and have conducted measurement, checking and diagnosis of refractive defects in an optical glasses service facility or a medical examination and treatment facility having an ophthalmological department for at least 45 months;

b/ An optical glasses service practitioner must have a practicing certificate or a certificate of expertise in medical equipment (equipment for measurement, checking and diagnosis of refractive defects) granted by a training facility designated by the Ministry of Health.

4. Scope of technique expertise:

a/ Measurement of refractive defects and counseling on use of optical glasses;

b/ Grinding and fitting of optical glasses according to doctor prescriptions and warranty for optical glasses.

Article 35. Conditions for grant of operation licenses for first-aid or patient transportation service facilities

1. Medical equipment and transportation vehicles:

a/ An facility must have sufficient transportation vehicles, medical equipment and instruments, anti-shock medicine boxes and first-aid medicines for keeping patients safe;

b/ An facility must have sufficient transportation vehicles ensuring environmental sanitation in the course of patient transportation.

2. Personnel:

a/ A person in charge of professional and technical activities of an facility providing first-aid or patient transportation services at home or abroad must satisfy the following conditions:

- Being a doctor with a practicing certificate;

- Having a certificate of study in the specialty of recuperation and first aid;

- Having conducted medical examination and treatment for at least 54 months.

b/ Apart from the person in charge of professional and technical activities specified at Point a of this Clause, other persons working in an facility providing first-aid or patient transportation services at home or abroad and wishing to conduct medical examination and treatment must have a practicing certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of technique expertise stated in their practicing certificates.

3. In case of registration for patient transportation abroad, a first-aid service and patient transportation facility must have a contract signed with an aviation service company.

4. Scope of technique expertise:

First-aid and transportation of patients at home and abroad.

Article 36. Conditions for grant of operation licenses for commune-level infirmaries and health stations

1. Physical foundation:

a/ A commune-level infirmary or health station must have a design under the Minister of Health’s Decision No. 2271/2002/QD-BYT of June 17, 2002, promulgating the design standard: Grassroots health station - sector standard.

b/ A commune-level infirmary or health station must satisfy the conditions of medical waste management and fire prevention and fighting under law;

c/ A commune-level infirmary or health station must have sufficient electricity and water supply and satisfy other conditions for patient care.

2. Medical equipment:

A commune-level infirmary or health station must have sufficient medical equipment and instruments suitable to the scope of its operational activities approved by the Department of Health of the province director.

3. Organization and personnel:

The number of practitioners of a commune-level health station must satisfy the condition specified in Section IV of Joint Circular No. 08/2007/TTLT- BYT-BNV of June 5, 2007, of the Ministry of Health and the Ministry of Home Affairs, guiding non-business payrolls limits of state-owned health facilities.

4. Scope of technique expertise:

a/ Commune-level infirmaries and health stations shall perform professional techniques on the list of techniques in medical examination and treatment promulgated by the Minister of Health, which are approved by Department of Health of the province directors;

b/ Village health workers shall provide primary health care according to assignment and professional direction by heads of commune-level health stations.

Article 37. Health facilities of agencies, units and organizations

1. Agencies, units and organizations that organize medical examination and treatment shall apply one of the organizational forms specified in Articles 24, 25 an 36 of this Circular.

2. For health facilities that conduct medical examination and treatment under the laws on drug, prostitution and HIV/AIDS prevention and control:

a/ In addition to the conditions specified by specialized laws, those commencing operation before January 1, 2012, must also satisfy the conditions specified in Article 25 of this Circular by January 1, 2016, at the latest;

b/ Those founded before January 1, 2012, must satisfy the conditions specified in Article 25 of this Circular in order to be granted operation licenses.

Section 2: COMPETENCE, DOSSIERS AND PROCEDURES FOR GRANT, RE- GRANT OR MODIFICATION OF OPERATION LICENSES FOR MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 38. Competence to grant, re-grant or modify operation licenses for medical examination and treatment facilities

1. The Minister of Health and Department of Health of the province directors may grant, re-grant or modify operation licenses for medical examination and treatment facilities under Clauses 1 and 2, Article 45 of the Law on Medical Examination and Treatment.

2. The Minister of Health may empower Department of Health of the province directors to approve a number of matters related to operations of private hospitals and hospitals of other ministries and sectors already licensed by the Minister of Health and to report in writing these matters to the Ministry of Health right after approval, specifically as follows:

a/ To appraise and permit in writing changes in the number of patient beds and organizational structure (facility of new departments or dissolution of existing departments or rooms), and to supplement the list of techniques under regulations;

b/ To permit in writing changes of hospital directors and persons in charge of professional and technical activities, department heads and other practitioners.

Article 39. Dossiers of application for grant, re-grant or modification of operation licenses for medical examination and treatment facilities

1. A dossier of application for grant, re-grant or modification of an operation license for a medical examination and treatment facility specified in Clause 1, Article 46 of the Law on Medical Examination and Treatment comprises:

a/ An application for an operation license, made according to the form provided in Appendix 13 to this Circular;

b/ A certified copy of the facility decision, for state-owned medical examination and treatment facilities, or of the business registration certificate, for private medical examination and treatment facilities, or of the investment certificate, for foreign-invested medical examination and treatment facilities;

c/ Certified copies of practicing certificates of all practitioners and a list of registered practitioners of the medical examination and treatment facility, made according to the form provided in Appendix 6 to this Circular;

d/ A declaration of physical foundation and medical equipment of the medical examination and treatment facility, made according to the form provided in Appendix 14 to this Circular;

e/ Personnel files of medical workers in the facility who are not required to acquire a practicing certificate.

f/ Documents evidencing that the medical examination and treatment facility satisfies the conditions of physical foundation, medical equipment, organization and personnel suitable to the scope of technique expertise of its organizational form as specified in Section 1, Chapter III of this Circular;

g/ An organization and operation regulation, for state-owned hospitals, made according to the Minister of Health’s Decision No. 5571/QD-BYT of December 29, 2006, promulgating the model organization and operation regulation of hospitals attached to the Ministry of Health; or made according to the form provided in Appendix 15 to this Circular, for private hospitals, and an initial operation plan of the hospital;

h/ A certified copy of the contract with an aviation service company for transportation of patients, for facilities providing first-aid and patient transportation abroad;

i/ A certified copy of the patient transportation contract, for hospitals having no emergency transportation vehicles;

j/ Projected scope of technique expertise: A medical examination and treatment facility shall propose the scope of its technique expertise and the list of techniques it plans to perform based on the list of professional techniques promulgated by the Minister of Health.

2. For a medical examination and treatment facility upon organizational transformation, splitting up, division, consolidation or merger, a dossier of application for an operation license complies with Clause 1 of this Article.

3. For a medical examination and treatment facility upon relocation, a dossier of application for an operation license complies with Points b, d, f, g and h, Clause 1 of this Article, together with an application made according to the form provided in Appendix 16 to this Circular.

4. For a medical examination and treatment facility upon renaming, a dossier of application for an operation license complies with Points b, f, g and h, Clause 1 of this Article, together with an application made according to the form provided in Appendix 17 to this Circular.

5. For a medical examination and treatment facility having its operation license lost, damaged or revoked, a dossier of application for re- grant of such operation license complies with Point a, Clause 1 of Article 48 of the Law on Medical Examination and Treatment, together with the damaged original license (if any) and an application made according to the form provided in Appendix 18 to this Circular.

6. For a medical examination and treatment facility having a change in the number of patient beds or organizational structure or scope of technique expertise, a dossier of application for modification of its operation license complies with Clause 3, Article 46 of the Law on Medical Examination and Treatment, together with a declaration of its physical foundation and medical equipment and personnel files suitable to the scale and scope of technique expertise it plans to change, and an application made according to the form provided in Appendix 19 to this Circular.

Article 40. Procedures for grant, re-grant and modification of operation licenses

1. A dossier of application for grant, re-grant and modification of an operation license for a medical examination and treatment facility specified in Article 39 shall be filed as follows:

a/ For medical examination and treatment facilities falling under the competence specified Clause 1, Article 45 of the Law on Medical Examination and Treatment, a dossier set shall be filed with the Department of Medical Service Administration of the Ministry of Health, except the cases specified in Clause 2, Article 38 of this Circular;

b/ For medical examination and treatment facilities falling under the competence specified Clause 2, Article 45 of the Law on Medical Examination and Treatment and the cases specified in Clause 2, Article 38 of this Circular, a dossier set shall be filed with the Department of Health of the province.

2. Procedures for considering the grant, re-grant or modification of operation licenses:

a/ After receiving a dossier of application for grant, re-grant or modification of an operation license, the Ministry of Health or the Department of Health of the province (below collectively referred to as the dossier-receiving agency) shall send to the applying medical examination and treatment facility a dossier receipt, made according to the form provided in Appendix 20 to this Circular;

b/ Within the time limit specified at Point b or c, Clause 1, Article 47 of the Law on Medical Examination and Treatment, counting from the date indicated in the dossier receipt, if no supplementation is needed, the dossier-receiving agency shall consider and grant, re-grant or modify the operation license. If refusal to grant, re-grant or modify the license, it shall reply in writing, clearly stating the reason;

c/ In case a dossier of application for grant, re-grant or modification of an operation license is invalid, within 10 working days after the date indicated in the dossier receipt, the dossier-receiving agency shall notify such in writing to the applying medical examination and treatment facility for completion of the dossier. A written notice must clearly state documents which must be added or contents which must be modified;

d/ Upon receiving a written notice requesting the completion of the dossier, the applying medical examination and treatment facility shall make supplementations or modifications as required in the notice and send the supplemented or modified dossier to the dossier-receiving agency. The date of receipt of the supplemented or modified dossier shall be indicated in the dossier receipt. Within 10 working days after the date of receipt of the supplemented or modified dossier, if the dossier-receiving agency makes no written request for supplementation or modification, it shall grant, re-grant or modify the operation license within the time limit specified at Point b or c, Clause 1, Article 47 of the Law on Medical Examination and Treatment. In case of refusal to grant, re-grant or modify the operation license, it shall reply in writing, clearly stating the reason;

e/ In case the applying medical examination and treatment facility has supplemented or modified its dossier but not up to requirements, the dossier-receiving agency shall request it to further supplement or modify its dossier under Points c and d, Clause 2 of this Article.

3. Operation licenses granted by the Minister of Health or Department of Health of the province directors are made according to the form provided in Appendix 21 to this Circular.

Section 3: ORGANIZATION OF GRANT, RE-GRANT AND MODIFICATION OF OPERATION LICENSES FOR MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 41. Organization of appraisal for grant, re-grant or modification of operation licenses for medical examination and treatment facilities

1. The Minister of Health shall form a team for appraisal for grant, re-grant or modification of an operation license for a medical examination and treatment facility attached to the Ministry, a private hospital or a hospital of another ministry or sector. Such a team is composed of:

a/ A representative of the leadership of the Department of Medical Service Administration as the team head;

b/ A representative of the leadership of the Legal Department as a team deputy head;

c/ A representative of the leadership of the Traditional Medicine and Pharmacy Department as a team deputy head (for appraisal of traditional medical examination and treatment facilities);

d/ A representative of the Medical Equipment and Work Department;

e/ A representative of the Department of Health of the province managing the medical examination and treatment facility in the locality;

f/ A representative medical expert of another hospital having departments similar to the scope of technique expertise that the applying medical examination and treatment facility registers;

g/ Other related persons (representatives of medical management agencies of ministries or sectors, when necessary, for medical examination and treatment facilities of other ministries or sectors);

h/ An expert of the Department of Medical Service Administration or an expert of the Traditional Medicine or Pharmacy Department (for appraisal of traditional medical examination and treatment facilities) as the team secretary.

2. The director of a Department of Health of the province shall form a team for appraisal for grant or modification of an operation license for a medical examination and treatment facility other than that specified in Clause 1 of this Article. Such a team is composed of:

a/ A representative of the leadership of the Department of Health of the province or a representative of the standing unit of the appraisal team as specified in Clause 3 of this Article, as the team head;

b/ A representative of the leadership of the practice management section or the medical professional operation section (for Department of Health of the provinces without the practice management section) as a team deputy head;

c/ A representative of the medical professional operation section (for Department of Health of the provinces with the practice management section) as a team deputy head;

d/ A representative of the organization and personnel section (for appraisal of state-owned medical examination and treatment facilities);

e/ A representative of another hospital having departments similar to the scope of technique expertise that the applying medical examination and treatment facility registers (when necessary);

f/ Other related persons, when necessary (representatives of medical management agencies of ministries or sectors, for medical examination and treatment facilities of other ministries or sectors);

g/ An expert of the practice management section or the medical professional operation section (for Department of Health of the provinces without the practice management section) as the team secretary.

3. The standing unit of an appraisal team specified in Clause 1 of this Article shall be based at the Department of Medical Service Administration of the Ministry of Health. The standing unit of an appraisal team specified in Clause 2 of this Article shall be based at the practice management section or the medical professional operation section (for Department of Health of the provinces without the practice management section) of the Department of Health of the province.

Article 42. Procedures for appraisal for grant, re-grant or modification of operation licenses for medical examination and treatment facilities

1. Procedures for appraisal for grant or modification of an operation license of a medical examination and treatment facility include:

a/ Examination of the legal dossier; inspection of conditions of the physical foundation, medical equipment and instruments, organization and personnel of the medical examination and treatment facility; appraisal of the scope of technique expertise;

b/ Making of a written record of appraisal according to the form provided in Appendix 22 to this Circular;

c/ A written record of appraisal of a medical examination and treatment facility under the management of the Minister of Health shall be made in three copies: One to be kept at the Ministry of Health, one to be kept at the Department of Health of the province of the locality in which the medical examination and treatment facility is located, and another to be kept at the appraised medical examination and treatment facility.

2. Procedures for appraisal for re-grant of an operation license of a medical examination and treatment facility include:

a/ Examination of the dossier subject to previous appraisal for grant of the operation license which is kept at the Ministry of Health or the provincial- level Department of Health or the damaged operation license (if any);

b/ Re-grant of the operation license according to the form provided in Appendix 21 to this Circular.

3. Management of operation licenses:

a/ Each medical examination and treatment facility may be granted only one operation license;

b/ Copies of operation licenses and dossiers of application for grant or re- grant of operation licenses shall be kept at licensing agencies;

c/ After granting an operation license to a medical examination and treatment facility:

- Within 30 days after the date of grant, re-grant, modification or revocation of the operation license, the Ministry of Health shall notify it in writing to the provincial-level People’s Committee and Department of Health of the locality in which the licensed medical examination and treatment facility is located;

- Within 30 days after the date of grant, re-grant, modification or revocation of the operation license, a Department of Health of the province shall notify it in writing to the People’s Committee of the district, town or provincial city in which the licensed medical examination and treatment facility is located.