New regulation on the system of laboratory quality control at medical examination and treatment facilities in Vietnam

According to Article 3 of the Circular No. 01/2013/TT-BYT of the Ministry of Health of Vietnam, the system of laboratory quality control at medical examination and treatment facilities is prescribed as follows:

- The medical examination and treatment facility possessing laboratory shall implement test for testing samples; coordinate to implement affairs, plans with center of testing calibration that is decided and allowed for establishment and operation by the Ministry of Health in order to ensure the testing quality at its laboratory.

- The reference laboratory means laboratory of other medical examination and treatment facility or laboratory recognized by decision of the Ministry of Health, take responsibility for implementation of reference testing and supplying result of reference testing at the requests of the Ministry of Health, the provincial Departments of Health, center of testing calibration in affairs of calibration, based on scale, task and capacity of reference laboratory. During taking role of a reference laboratory, the laboratory shall be supervised on quality by the Ministry of Health and center of testing calibration. Every three years, the Ministry of Health shall make assessment to re-recognize the reference laboratories.

- Center of testing calibration keeps role as unit performing professional activities aiming to ensure the testing quality at laboratories of medical examination and treatment facilities (including reference laboratories). Based on the designed functions and tasks, the center of testing calibration shall perform: outer examination programs; quality control for laboratories; consult with specialists on calibration and quality control; use of reference testing results of reference laboratory as the basis for testing calibration.

- The Ministry of Health, the Departments of Health of provinces and centrally-run cities, Health sectors shall implement state management, direct, guide, examine, inspect implementation of regulation applicable to the medical examination and treatment facilities possessing laboratories and reference laboratories in the laboratory quality control; direct specialized activities of centers of testing calibration. The Ministry of Health shall assess and recognize a laboratory as a reference laboratory in respect of a or many types of testing.

View more details at the Circular No. 01/2013/TT-BYT of the Ministry of Health of Vietnam, effective from March 15, 2013.

Thu Ba

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