THE MINISTRY OF HEALTH

Decision No.  1099/QD-BYT dated April 04, 2013 of the Ministry of Health promulgating conditions for implementation and quality management of T-CD4 cytometry tests
Pursuant to the Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health
At the proposal of the Director of the Vietnam Administration of HIV/AIDS Control,
DECIDES:
Article 1. To promulgate together with this Decision “Conditions for implementation and quality management of the T-CD4 cytometry tests”.
Article 2. This Decision takes effect on the signing date and replaces the Decision No. 3781/QD-BYT, of October 04, 2007 of the Minister of Health, on “Management and use of CD4-cytometry machine in serve for HIV/AIDS prevention and combating in Vietnam”.
Article 3. Mr., Mrs.: Chief of Ministerial Office, directors, general directors of departments, bureaus, general departments, heads of units affiliated the Ministry of Health, Directors of the provincial Departments of Health and heads of relevant units shall implement this Decision.
For the Minister of Health
Deputy Minister
Nguyen Thanh Long 
 
REGULATION
CONDITIONS FOR IMPLEMENTATION AND QUALITY MANAGEMENT OF THE T-CD4 CYTOMETRY TESTS
(Issued with the Decision No.1099/QD-BYT dated April 04, 2013 of the Ministry of Health)
Chapter 1.
CONDITIONS FOR IMPLEMENTATION OF THE T-CD4 CYTOMETRY TESTS
Article 1. Implementation of the T-CD4 cytometry tests using fixed machine
T-CD4 testing establishments must satisfy all criteria after carrying out the T-CD4 cytometry tests:
1. Personnel
There are at least 02 officers meeting the following conditions:
a. Officer taking main responsibility graduated from University or higher specialized in medical or biological sector. Officer conducting the testing activities graduated from professional high school or higher specialized in medical or biological sector;
b. Experienced for at least 01 year about conducting the activities of Serological tests or concerned tests;
c. Being trained on techniques and quality assurance for the T-CD4 cytometry tests and possessing certificates of training issued by units that are permitted by the Ministry of Health or certificates of training issued by the conformity international organizations that are recognized by the Ministry of Health;
d. Being assessed capability under periodical basis of 01 year/once about theory and practice by units that are appointed by the Ministry of Health.
2. Material facilities
a. T-CD4 cytometry machine must be placed on desk in the testing area in laboratory and be ensured for airiness, cleanness, anti-dust, anti-wetness and adequate light for implementation of the testing techniques in accordance with regulation, not placed together with other equipment that can cause vibration. Temperature in room always is maintained in about 18 – 25oC, humidity of 20 – 80 %. Walls are made by dado or painted by materials in conformity with laboratory, bright colors, easy for cleaning, with height of 160 cm or more;
b. The testing desk must be flat, firm, waterproof, heat resistant, resistant to chemical corrosion and resistant to electricity;
c. Having 02 sinks: One for washing the testing instruments and one for washing hands for staff;
d. Having the waste treatment system in accordance with the existing regulations;
dd. The power source is stable and conformable with equipment, prioritized or replaced when necessary.