THE MINISTRY OF HEALTH
Decision No. 5530/QD-BYT dated December 25, 2015of the Ministry of Health guiding the development of standard practice procedure in laboratory quality management
Pursuant to the Law on examination and treatment No. 40/2009/QH12 issued in 2009;
Pursuant to the Decree No. 63/2012/ND-CP 31/8/2012 of the Government defining functions, duties, power and organizational structure of the Ministry of Health;
Considering the recommendation of the professional acceptance Council of Guidelines on development of standard practice procedure in management of laboratory quality;
At the request of the Director of Agency of Medical Services Administration;
Article 1. To issue with this Decision the “Guideline on development of standard practice procedure in management of laboratory quality” at medical facilities.
Article 2. The Guidelines on development of standard practice procedure in management of laboratory quality are applied at the medical facilities to gradually standardize the laboratory quality.
Article 3. This Decision takes effect on the signing date.
Article 4. Chief of Ministry Office, Director of Agency of Medical Services Administration, Director of hospitals directly under the Ministry of Health, Director of Department of Health of provinces and centrally-run cities, the medical units of Ministries, sectors, Director of laboratory quality control centers and Head of relevant units shall implement Decision./.
For the Minister
The Deputy Minister
Nguyen Thi Xuyen
DEVELOPMENT OF STANDARD PRACTICE PROCEDURE IN MANAGEMENT OF LABORATORY QUALITY
(Issued with Decision No. 5530/QD-BYT dated 25/12/2015 of the Minister of Health)
In recent years, the management of laboratory quality has received the special attention and steering from the Ministry of Health to improve the capacity of laboratory system, ensure the laboratory result is accurate, timely, avoid waste and save money for patients. In 2013, the Ministry of Health issued the Circular No. 01/2013/TT-BYT on “Guidelines on development of standard practice procedure in management of laboratory quality are applied at the medical facilities” specifying that all units must develop the standard practice procedure. This is one of the important tasks in management of laboratory quality to ensure the work is done consistently and the laboratory result is standardized and accurate.
For the time being, a lot of units have implemented the above Circular. The laboratory quality is constantly improved and better controlled. However, there are in fact laboratories at medical facilities with standard laboratory procedures but incomplete, inconsistent and without high efficiency; there are also laboratories having inadequate or no standard laboratory procedures in prescribed quality management. The above problems are due to many causes and one of them is that there are officers, managers and persons performing laboratory work not understand the role and importance of compliance with the standard laboratory procedures in management of laboratory quality.
Therefore, the requirement laid down is to standardize and provide complete, detailed and systematic guidelines in developing the standard laboratory procedures in management of laboratory quality, providing assistance in assessment and examination of laboratory results and monitoring in a objective manner to ensure the laboratory result. The issue of guidelines on compiling the standard practice procedure in management of laboratory quality is very necessary.
The content of the Guidelines includes 03 chapters and annex 1 and 2, specify name and sample examples on standard practice procedure in management of laboratory quality.
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