06 contents of laboratory quality control at medical examination and treatment facilities in Vietnam

According to current regulations, laboratory means testing departments, divisions or units at medical examination and treatment facilities that receive the testing sample taken from people and other relevant sources for the testing and information supply that directly serve for the medical examination and treatment, science study and education.

Specifically, according to Article 5 of the Circular No. 01/2013/TT-BYT of the Ministry of Health of Vietnam, the content of laboratory quality control at medical examination and treatment facilities are as follows:

- Having annual and 5-year plans on management of the testing quality approved by heads of medical examination and treatment facilities, that integrate with annual and 5-year plans of medical examination and treatment facilities.

- Having statement (commitment) of quality, quality target, quality plan, quality control, assurance of quality and improvement of testing quality.

- Conducting compilation, formulation of and complying with the quality handbook, including standard operating procedure (SOP) for all technical professional processes of laboratory. Reviewing, adjusting and improving (if necessary) the quality handbook once every year.

- Formulating and implementing the internal examination program approved by heads of medical examination and treatment facilities, having a system of recording, preservation, detecting breakdowns and measures to remedy, prevent breakdowns.

- Participating in outer examination programs under specialized sector, regulation on assigning to undertake specialized activities of testing calibration of the Ministry of Health and being encouraged to participate in international outer examination programs that have been recognized.

- Formulating the testing quality index set in conformity with conditions of laboratory and medical examination and treatment facilities:

+ The testing quality index set of unit that is used for striving to attain, assessment on continuously maintaining and improving quality is formulated in accordance with regulation in Annex promulgated together with this Circular;

+ At least once every year, conducting adjustment of the quality indexes.

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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