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Laboratory SOP Regulation

Decision No. 5530/QD-BYT development of standard practice procedure in management of laboratory quality (vanbanphapluat.co)⁠

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DECISION

ISSUING THE GUIDELINES ON DEVELOPMENT OF STANDARD PRACTICE PROCEDURE IN MANAGEMENT OF LABORATORY QUALITY

MINISTER OF HEALTH

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;

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.

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 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

2. MMed. Nguyen Trong Khoa, Deputy Director of Agency of Medical Services Administration – Ministry of Health

Council Deputy Chairman

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

4. Mmed. Pham Tuan Duong, Deputy Director of National Institute of Hematology and Blood Transfusion

Member

5. Dr. Tran Huu Tam, Director of Center for standardization and quality control in medical laboratory of HCM City

Member

6. Dr. Le Thi Anh Hong, Head of microbiology department, Saint Paul Hospital

Member

7. Dr. Nguyen Van Hung, Head of microbiology and national standard lab tuberculosis department of National Lung Hospital

Member

8. MMed. Dao Nguyen Minh, Deputy Head of quality management Department, Agency of Medical Services Administration – Ministry of Health

Secretary

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

Quy trình thực hành chuẩn

QTC

Standard Practice Procedure

Tổ chức Y tế Thế giới

WHO

World Health Organization

Kỹ thuật

Techniques

Quản lý

Management

Quy trình

Procedure

Vi sinh

Microbiology

Hóa sinh

Biochemistry

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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).

+ Control the format of Procedure and its contents with checklist before submission to the leadership for approval;

+ The writer and reviewer sign and specify the respective date and month;

Note: This modification process can be done many times until there is an agreement on content and form of the Procedure (the final draft).

3. Approval and issue

- The leadership or the competent person of the unit shall approve the Standard Practice Procedure.

- Announcing the approved Standard Practice Procedure.

- Distributing the copy of Standard Practice Procedure to all relevant staff and departments.

4. Training and use

- The training and use of Standard Practice Procedure for all relevant staff is done from 7 – 10 days after the issue of Standard Practice Procedure and documentation of dossier of persons involved in the training.

- Ensure the strict compliance with the issued Standard Practice Procedure and prepare dossier to record the remedial actions.

5. Modification, addition and storage

- It is necessary to modify or add the contents when there are modifications on regulations or policies of the units or when the Standard Practice Procedure is no longer consistent.

- Keep the original of Standard Practice Procedure as stipulated.

- Recover all issued old versions of Standard Practice Procedure upon issue of alternative procedure and keep it as stipulated.

Chapter III: GUIDELINES ON DRAFTING OF STANDARD PRACTICE PROCEDURE

I. Requirement for presentation

1. General presentation:

All Standard Practice Procedures are presented in the form as follows:

- Paper size: The Standard Practice Procedures are presented on paper with size A4 (210 mm x 297 mm).

- Type of presentation: with the portrait form of paper size A4. In case the Standard Practice Procedure has tables, the text can be presented with the landscape form of paper.

- Font: Times New Roman

- Encoding: Unicode

- Font size: 13-14

- Top margin: 2cm from the top edge

- Bottom margin: 2cm from the bottom edge

- Right margin: 2cm from the right edge

- Left margin: 3cm from the left edge

- Space between lines: 1.5 lines

2. Specific presentation:

2.1. The first page of Standard Practice Procedure includes the following

2.1.1. Name of body and department, logo (if any);

2.1.2. Name of standard procedure

2.1.3. Code of document: Each Standard Practice Procedure needs to be coded separately and uniquely, may be symbolized with the abbreviation of each department or by classification of Standard Practice Procedure (management procedure and technical procedure), for example:

The culture procedure of microbiology department is symbolized as QTKT-VSNC - 01, in which:

+ QT as abbreviation of procedure;

+ KT as abbreviation of technique;

+ VS as abbreviation of Microbiology Department;

+ NC as abbreviation of culture;

+ 01 is the first Standard Practice Procedure drafted by the microbiology department and numbered 01.

2.1.4. Version (order of issue): It is required to number in ascending order each time of issue of Standard Practice Procedure with Arabic number, for example:

When drafting the new procedure “Material control” in 2014, the first version is symbolized as 1.0. In 2015, there is the first modification, the new version is 1.1 or 2.0.

2.1.5. Effective date: Specify the effective date in the Standard Practice Procedure after it has been issued.

2.1.6. Full name, signature and position of the writers, verifier and approver.

2.1.7. Monitoring the modification of standard practice procedure: Specify information on modification/addition of content of standard practice procedure as guided in the following table:

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2.2. From the second page onward of the standard practice procedure, the presentation is done as follows:

The header and the footer will appear in each page of standard practice procedure, these parts include: name of standard practice procedure, code of document, version and ordinal number/total pages, for example:

The header is presented as follows:

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The footer is presented as follows:

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3. Way to number the levels of heading:

3.1. The main headings has bold Arabic number, ex: 1., 2., ...

3.2. The subordinate headings under the main heading are numbered in ascending order of the main heading as follows:

- Level 1: bold and italic, ex: 1.1., 1.2., ...

- Level 2: regular, ex: 1.1.1., 1.1.2., ...

- The following levels: regular, ex: 1.1.1.1., 1.1.1.2. ...

- The main ideas under the main or subordinate headings have the symbol (-).

- The minor ideas following the main ideas have symbol (+) and followed by (•).

For example

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II. Requirements for minimal content of standard practice procedure

1. The technical standard practice procedure includes the following contents:

1) Purpose;

2) Scope of application;

3) Responsibility;

4) Definition, terms and abbreviation;

5) Principle;

6) Equipment and material;

7) Quality control;

8) Safety;

9) Implementation content;

10) Interpretation of result and report;

11) Note (warning);

12) Dossier storage;

13) Relevant documents;

14) References.

2. The management standard practice procedure includes the following contents:

1) Purpose;

2) Scope of application;

3) Responsibility;

4) Definition, terms and abbreviation;

5) Implementation content;

6) Dossier storage;

7) Relevant documents;

8) References

Note: The content of one management standard practice procedure or technical standard practice procedure shall include the above items and specify not applicable for items which do not exist to ensure all standard practice procedures have uniform items.

3. Guidelines on drafting the contents of standard practice procedure

Guidelines on drafting the contents of standard practice procedure

Guidelines on drafting the contents of standard practice procedure

Content

Writing guidelines

1. Purpose

This procedure guides/describes the ways to do specific work in the laboratory Ex: For the intravenous blood collection for laboratory, the purpose part is written as follows: This procedure describes/guides the way to collect the intravenous blood to ensure the sample quality before laboratory.

2. Scope of application

- Specify location and time of application of procedure Ex: This procedure is applied at the biochemical laboratory department of XYZ hospital upon collecting the intravenous blood for patient.

3. Responsibility

- Define the person responsible for performing the procedure and the person monitoring the procedure compliance. Ex: - The employee assigned to collect the intravenous blood must comply with the procedure. - Department head of head nurse or….must monitor the compliance with procedure at department.

4. Definition, terms and abbreviation

- Specify the definition or terms (if needed) - Interpret all abbreviations used in the procedure in the alphabetical order from A to Z Ex: BVDK: Benh vien da khoa

5. Principle

- Brief the laboratory method and techniques. - Can interpret in the form of chart or images. Ex: Glass slide staining procedure Zielh-Neelsen staining is used for acid fast bacteria – AFB. The carbol fuchsin stain under the effect of temperature shall be organically linked to mycolic acid existing in the bacterial cell wall and will not disappear after being breached or stained with methylene blue giving the image of red or pink coloring of bacillus...

6. Equipment and material

6.1. Equipment: - List the equipment used in laboratory process. Specify the technical parameters and code of main equipment (if any). Ex: Centrifuge with 1000 RPM, code XY2-01 6.2. Material: - List necessary devices, chemical/ biological products and specimen. Note: The column “material” can be divided into sub-columns 6.2.1. Devices: List the name of all devices and specify type (Ex: 10ml glass pipette or 4-5ml plastic test tube). 6.2.2. Chemical/biological product: Specify name of chemical/biological product of the manufacturing unit. 6.2.3. Specimen: Specify the required specimen and volume (ex: 1ml serum)

7. Quality control

- Describe the methods of quality control including the standard operation of machine and internal control (ex: use of control sample, standard sample, quality controlling chart…). - In case of separate procedure on machine calibration, the detailed interpretation in this item is not required. Specify name and code of relevant procedure. - Specify the threshold limit on internal control and remedial action if the internal control fails.

8. Safety

Specify the safety issues to be noted upon implementation of procedure (if any).

9. Implementation content

9.1. Preparation (not applicable to standard practice procedure) - Specify the necessary preparation steps (preparation for biological product/chemical, machine operation, internal control…) which must be done before main steps. - These preparation steps can be integrated into the implementation process or separated into items. Note: If there is separate procedure for machine operation and calibration related to the standard practice procedure, the respective name of procedure and code of document can be referred. Ex: Operation and calibration of machine under the standard practice procedure with code XY-QTKTTB-03 9.2. Implementation steps: - Specify the order of main implementation steps, write specifically, concisely and easy to understand. - Number each implementation step in case of repeat to repeat the steps easily and avoid confusion. Ex: If the implementation steps are similar with the implementation of internal control, only write “similar with item 9.3....”.

10. Interpretation and result report

- Specify the obtained result - Specify the way to deal with incident in case of occurrence. - For the technical standard practice procedure, specify the additional information: + Specify the calculation formula and unit (if any) + Explanation of result for unusual cases. + Specify the limit of analysis system and the biological reference and alarming value (if any).

11. Note (warning)

Specify the difference which may occur or cause of result difference and limit of laboratory.

12. Dossier storage

Make record in book and forms related to the procedure and keep dossier.

13. Relevant documents

List the relevant standard practice procedure including the code of document

14. References

- List all references and professional guidelines during the drafting (Vietnamese documents first and followed by foreign documents). - For each reference, specify information in the order as follows: Name of author, name of document, edition, name of publisher/place of publication; year of publication; name of heading of reference; page of reference. Ex: The operation and laboratory procedure on machine FACSCount - 2009, 3rd publication – Hanoi, 2012, page 33-37.

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REFERENCES

Vietnamese language

1. Circular No.

01/2013/TT-BYT⁠

dated 11/01/2013 of the Minister of Health guiding the implementation of management of laboratory quality at medical facilities.

2. Decision No. 3701/QD-BYT issuing the “National action program on improvement of medical laboratory management capacity from now to 2020”.

3. National standard, 2014, medical laboratory – Requirements for quality and capacity (TCVN 7782:2014-ISO 15189:2012), Hanoi.

4. Circular No. 01/2011/TT-BNV dated 19/01/2011 of the Ministry of Interior guiding the formality and techniques for presentation of administration documents.

English language

1. World Health Organization, 1997. A WHO guide to Good Manufacturing Practice (GMP) requirement, Part 1: Standard Operation Procedure and master formulae, p12-111

2. Clinical and Laboratory Standards Institute, 2002. Clinical laboratory and technical procedure manuals; Approved guideline 4th Edition. GP2-A4 Appendix A. Suggested Contents of Laboratory Procedures. NCCLS: Wayne, Pennsylvania, p.19.

3. United States Environmental Protection Agency, 2007. Guidance for Preparing Standard Operation, 2007, p 6-60.