Chapter 3.
CONDITIONS FOR MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS PERMITTED TO PERFORM MEDICAL EXAMINATION
Article 9. Conditions of personnel
1. The person performing clinical examination, preclinical examination must has the practicing certificate of medical examination and treatment as prescribed by Law on medical examination and treatment in line with speciality which such person is assigned task of examination. In case the person performing preclinical examination techniques that law not requires to have to have the practicing certificate of medical examination and treatment, he/she must have specialized degrees in line with the assigned job.
2. The conclusion person must meet the following conditions:
a. Being doctors possessing the practicing certificate of medical examination and treatment and having time of medical examination and treatment of at least 54 (fifty four) months;
b. Being assigned by competent persons of ME establishments so as to make health conclusions, to sign in the ME certificate and periodical ME book. The assignment must be performed in writing and affixed with a legal seal of ME&T establishments.
3. For ME establishments serving foreigners, Vietnamese persons residing in foreign country and Vietnamese persons going abroad for work under contract (hereinafter abbreviated to ME establishments involving foreign elements) apart from meeting provisions in clauses 1 and 2 this Article, they must meet additionally the following conditions:
a. The persons who perform clinical examination, the conclusion persons must be the specialized doctors at grade I or medical masters or higher.
b. When the person performed ME and the person performing ME is not fluent in the same language, a translator is required. The translator must have certificate of translation eligibility in medical examination and treatment as prescribed by Law on medical examination and treatment.
Article 10. Conditions on material facilities, equipment
1. Having rooms for clinical examination, preclinical examination of each speciality as prescribed by the Ministry of Health in line with content of ME.
2. Having sufficient material facilities and essential medical equipment as prescribed in Annex 4 promulgated together with this Circular.
Article 11. Conditions and scope of professional operation
1. Conditions for ME establishments not involving foreign elements: To perform the professional techniques in line with contents inscribed in ME certificate specified in Annexes 1, 2, 3 promulgated together with this Circular.
2. Conditions for ME establishments involving foreign elements, apart from meeting provisions in clause 1 this Article, they must be able to implement the following preclinical examination techniques:
a. Blood test: Blood formula, ABO blood, Rh blood, erythrocyte sedimentation rate, hemoglobin percentage, urea blood;
b. Searching malaria parasite in blood;
c. A, B, C, E hepatitis tests;
d. Syphilis serology;
dd. Test for affirming status of HIV infection (positive HIV);
e. Mantoux test;
d. Pregnancy test;
a. Drug test;
i. Stool test to search parasites;
k. Electrocardiogram (ECG);
l. Electroencephalogram (EEG);
m. Ultrasonic;
n. Test to diagnose leprosy.
If ME establishments involving foreign elements have not yet had conditions to implement techniques specified in point dd and n clause 2 this Article, they must sign contract for specialized support with ME&T establishments possessing operational license and permitted to implement those techniques.
3. Specialized scope:
a. ME&T establishments eligible as prescribed in clause 1, clause 2 Article 9, Article 10 and clause 1 Article 11 of this Circular may organize ME but not ME involving foreign element.
b. ME&T establishments eligible as prescribed in clause 3 Article 9, Article 10 and clause 2 Article 11 of this Circular may organize ME including ME involving foreign element.
Article 12. Dossiers of and procedures for announcing on medical examination
1. Dossier of announcing on eligibility for ME:
a. Written announcement on eligibility for ME made according to the set form in Annex 5 promulgated together with this Circular;
b. Authenticated copy of license for medical examination and treatment operation of establishments;
c. List of ME participants made according to the set form in Annex 6 promulgated together with this Circular (affixed with a seal on each page and an integrity seal between the pages);
d. List of material facilities and medical equipment as prescribed in Annex 4 promulgated together with this Circular.
dd. Report on specialized operation scope of ME establishments;
e. Authenticated copy of contract providing specialized support for case specified in clause 3 Article 11 of this Circular (if any).
2. Procedures for announcing on medical examination:
Before organizing initial ME, the ME&T establishments must send dossier of announcing ME as prescribed in clause 1 this Article to the state management agencies in health field, specified as follows:
a. For ME&T establishments attached the Ministry of Health: Dossier may send to the Department of medical examination and treatment management - the Ministry of Health;
b. For ME&T establishments under the management competence of the Ministry of National Defense, the dossier may send to the Army’s Health Department - the Ministry of National Defense; ME&T establishments under the management competence of the Ministry of Public Security, the dossier may send to the Health Department - the Ministry of Public Security; ME&T establishments under the management competence of the Ministry of Transport, the dossier may send to the Health Department - the Ministry of Transport;
c. For ME&T establishments under the management competence of the Departments of Health of central-affiliated cities and provinces (hereinafter abbreviated to as the provincial Department of Health); ME&T establishments with head offices locating in central-affiliated cities and provinces (except for ME&T establishments specified in point a, point b clause 2 this Article): Dossier may send to the provincial Department of Health where ME&T establishments locating their head offices.
Article 13. Duration and order for solving dossier of announcing eligibility for ME
1. Within 02 working days after receiving dossier of announcing eligibility for ME, the state management agencies in health field specified in clause 2 Article 12 of this Article (hereinafter abbreviated to agencies receiving dossiers) shall send a receipt slip of dossier to the ME&T establishments announcing eligibility (hereinafter abbreviated to establishments announcing eligibility) as prescribed in Annex 7 promulgated together with this Circular.
2. Within 10 working days after receiving dossier, the agencies receiving dossiers must appraise dossier.
If dossier is not valid, the agency receiving dossier must notify in writing the establishments announcing eligibility for completing dossier. The written notice must specify documents that must be supplemented and contents that must be revised. Establishments announcing eligibility must supplement, revise according to content of the written notice only. When receiving the written notice regarding invalid dossier, the establishments announcing eligibility must complete and send dossier for supplementation to the agency receiving dossier.
Within 02 working days after receiving supplemented dossier, the agencies receiving dossiers must send a receipt slip of supplemented dossier to the establishments announcing eligibility. If the establishments announcing eligibility has supplemented dossier but inconsistently with request, they must continue completing dossier according to the procedures specified in this clause until dossier meets request.
3. Within 20 working days after day of the receipt of dossier for valid dossier or day of the receipt of supplemented dossier for invalid dossier, if agencies receiving dossiers fail to have written reply, the establishments announcing eligibility for ME may carry out ME operation in proper with the specialized scope as announced.
Tìm kiếm
Thông tư 14/2013/TT-BYT (Bản Word)
Thông tư 14/2013/TT-BYT (Bản Pdf)
