THE MINISTRY OF HEALTH
Circular No. 01/2013/TT-BYT dated January 11, 2013 of the Ministry of Finance guiding the laboratory quality control at medical examination and treatment places
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 Director of Medical Examination and Treatment Management Department;
The Minister of Health issues the Circular guiding the laboratory quality control at medical examination and treatment places.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation
This Circular guides the content of and responsibility for laboratory quality control at medical examination and treatment places possessing laboratory.
Article 2. Interpretation of terms
In this Circular, the following terms are construed as follows:
1. Laboratory includes testing departments, divisions or units at medical examination and treatment places 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.
2. Testing quality control means the coordinative activities of laboratory in order to orient and control on testing quality, including formulation of plans, control, assurance and improvement on testing quality.
3. Internal testing quality assessment mean activities of self-examination and assessment on testing quality that are organized and planned in laboratory with purpose of consideration by leaders for testing quality assessment, finding out unsuitable matters in order to set out measures for prevention, remedy and improvement.
4. The standard operating procedure (SOP) of testing means collection of compulsory and detailed guides in order to perform steps of a process.
5. The internal examination program means the system of quality examination in scope of a laboratory aiming to monitor and supervise all aspects of testing process in laboratory, ensuring for testing result to be enough reliability before returning them to customers and timely give out remedial measures if detecting errors; aiming to assess system of laboratory (method of measurement, reagent and chemicals, equipment, skill qualification of technicians).
