This is one of requirements of the Ministry of Health at the Circular No. 15/2013/TT-BYT dated May 24, 2013 on quality assurance and HIV testing technique.
At this Circular, the Ministry of Health promulgates in details on personnel, infrastructure, equipment, requirements for testing quality control in laboratory providing screening serological tests, laboratory providing confirmatory serological tests, national serological reference laboratories (hereafter called HIV testing laboratory).
In particular, for the laboratory providing screening serological tests, personnel must have at least 02 laboratory technicians that hold intermediate qualifications in medicine, pharmacy, biology, or chemistry, or higher and hold certificates of training in HIV testing issued by the medical facilities appointed by the Minister of Health, or certificates of training in HIV testing issued by foreign authorities that are suitable for the testing techniques they use or have at least 01 counselor meets the requirements in Clause 3 Article 26 of the Law on HIV/AIDS Prevention if blood specimens are taken and results are given to the persons being tested.
For laboratory providing confirmatory serological tests, testing personnel of the confirmatory laboratory must have at least 01 year’s experience of HIV testing; have basic knowledge about HIV and HIV testing techniques, and able to analyze test results and be conversant with legislative documents relating to HIV testing.
For national serological reference laboratories, every National Laboratory for serological HIV testing shall have at least 08 employees, including two managers that hold bachelor’s degrees in medicine or biology and have at least 05 years’ experience of serological HIV testing. The employees in charge of testing quality control, formulating standards, and biosafety must hold bachelor’s degrees in medicine or biology and have at least 03 years’ experience of serological HIV testing. And other employees must have qualifications suitable for their tasks and have at least one year’s experience of such tasks. Besides, the Circular also provides documentation, procedure, and authority to accredit HIV testing laboratories.
This Circular takes effect on July 01, 2013 and replaces the Decision No. 3052/2000/QD-BYT dated August 29, 2000.