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Quality
Laboratory SOP Regulation
Laboratory SOP Regulation
DECISION
ISSUING THE GUIDELINES ON DEVELOPMENT OF STANDARD PRACTICE PROCEDURE IN MANAGEMENT OF LABORATORY QUALITY
MINISTER OF HEALTH
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;
DECIDES:
Article 1. Issuing 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 from its signing date for issue.
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 provincies and centrally-run cities, the medical units of Ministries, sectors, Director of laboratory quality control centers and Head of relevant units are liable to execute this Decision./.
GUIDELINES
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)
INTRODUCTION
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. 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 laborotories 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.
This is the first time there is a complete guideline on developing the standard practice procedure in the management of laboratory quality. Therefore, the shortcomings are inevitable. The Ministry of Health (Agency of Medical Services Administration) is looking forward to receiving the comments from the units, individuals and experts to so that this Guideline material is increasingly improved with better quality in order to contribute to the highest benefits for patients.
Chief editor
Assoc. Prof. Dr.. Nguyen Thi Xuyen
Co- Chief editor
Assoc. Prof. Dr. Luong Ngoc Khue
Editorial Board
MMed.. Nguyen Trong Khoa
MMed. Dao Nguyen Minh
Dr.. Bui Thu Hien
MMed. Do Thi Thu Thuy
Dr. Duong Ngoc Cuong
MMed. Le Sinh Quan
Assoc. Prof. Dr. Dang Thi Ngoc Dung
MMed. Truong Quan Thuy
Dr. Nguyen Hong Hanh
Dr.Vu Van Truong
Professional appraisal Council
Professional appraisal Council
1. Prof. Do Dinh Ho, former Chairman of Vietnam Association for Chemistry and Biology
Council Chairman
1. Prof. Do Dinh Ho, former Chairman of Vietnam Association for Chemistry and Biology
Council Chairman
1
2. MMed. Nguyen Trong Khoa, Deputy Director of Agency of Medical Services Administration – Ministry of Health
Council Deputy Chairman
2
3. Prof. Dr. Ta Thanh Van, Vice Rector of Hanoi Medical University, Director of Center for standardization and quality control in medical laboratory of Hanoi Medical University
Council Deputy Chairman
3
4. Mmed. Pham Tuan Duong, Deputy Director of National Institute of Hematology and Blood Transfusion
Member
4
5. Dr. Tran Huu Tam, Director of Center for standardization and quality control in medical laboratory of HCM City
Member
5
6. Dr. Le Thi Anh Hong, Head of microbiology department, Saint Paul Hospital
Member
6
7. Dr. Nguyen Van Hung, Head of microbiology and national standard lab tuberculosis department of National Lung Hospital
Member
7
8. MMed. Dao Nguyen Minh, Deputy Head of quality management Department, Agency of Medical Services Administration – Ministry of Health
Secretary
8
9. MMed. Le Sinh Quan, Agency of Medical Services Administration – Ministry of Health
Secretary
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ABBREVIATIONS
ABBREVIATIONS
Column 1
Column 2
Column 3
Column 1
Column 2
Column 3
1
Quy trình thực hành chuẩn
QTC
Standard Practice Procedure
2
Tổ chức Y tế Thế giới
WHO
World Health Organization
3
Kỹ thuật
KT
Techniques
4
Quản lý
QL
Management
5
Quy trình
QT
Procedure
6
Vi sinh
VS
Microbiology
7
Hóa sinh
HS
Biochemistry
There are no rows in this table
TABLE OF CONTENTS
Chapter I
GENERAL PROVISIONS
I. Purpose
II. Subjects of application
III. Explanation of terms
IV. Implementation principles
Chapter II
STEPS TO DEVELOP THE STANDARD PRACTICE PROCEDURE
1. Preparation for development plan
2. Review and modification
3. Approval and issue
4. Training and use
5. Modification, addition and storage
Chapter III
GUIDELINES ON DRAFTING OF STANDARD PRACTICE PROCEDURE
I. Requirements for presentation
II. Requirements for minimum contents of standard practice procedure
REFERENCES
ANNEXES
Chapter I: GENERAL PROVISIONS
I. Purpose
Guiding the drafting of standard practice procedure in management of laboratory quality (abbreviated as QTC), including the standard practice procedure on management and techniques in management of laboratory quality.
II. Subjects of application
1. Leadership of medical facilities;
2. Staff of laboratory;
3. Other relevant individuals and units in management of laboratory quality.
III. Interpretation of terms
The standard practice procedure (or standard operating procedure) in management of laboratory quality is a document guiding in detail and showing the way to conduct a specific work in management and technical skills to ensure the activities shall be done consistently with regulations.
IV. Implementation principles
1. Develop a standard practice procedure for all activities of management and technical skills.
2. The contents in this standard practice procedure must be written clearly, concisely, completely, understandable and comply with the guiding documents.
3. The standard practice procedure must be issued by the leadership of units or person having the authority to approve and issue each separate procedure.
4. The standard practice procedure must be annually reviewed and must be updated and re-approved in case of modification and in case of no modification, no approval is needed but the review must be documented.
5. The contents and presentation of standard practice procedure of each establishment can be adjusted accordingly but must ensure the requirements of such Guidelines.
Chapter II: STEPS TO DEVELOP THE STANDARD PRACTICE PROCEDURE
1. Preparation for development plan
- Making list of Standard Practice Procedure is based on the following main grounds:
+ The approved technical list of the units;
+ The work related to the quality management;
+ Classification of work to be done with priority at the laboratory.
- Assignment of person (or group of persons) drafting and person (or group of persons) making review.
- Performance of drafting as guided in Chapter III.
2. Review and modification
- The assigned persons are responsible for review and modification.
- The process of review and modification includes the following steps:
+ Send the draft to the reviewer;
+ Agree upon modified comments;
+ Modify the draft (if needed);
+ Send back the modified draft to the drafting group and request feedback at a definite time;
+ Summarize all comments to complete the Standard Practice Procedure (hold meeting to agree on the contents if necessary).
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