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:

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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./.

FOR THE MINISTER
DEPUTY MINISTER




Nguyen Thi Xuyen

GUIDELINES

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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.

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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

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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

1. Prof. Do Dinh Ho, former Chairman of Vietnam Association for Chemistry and Biology

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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

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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

ABBREVIATIONS

Quy trình thực hành chuẩn

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Standard Practice Procedure

Tổ chức Y tế Thế giới

WHO

World Health Organization

Kỹ thuật

KT

 Techniques

Quản lý

QL

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Quy trình

QT

 Procedure

Vi sinh

VS

Hóa sinh

HS

TABLE OF CONTENTS

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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

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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

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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.

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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:

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+ 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;

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+ 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.

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- 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

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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

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- 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;

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+ 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:

Version number

Modified place

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Date of review/modification

Reviewer/modifier

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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:

Guided drafting of standard practice procedure

Code of document: QLCL-01

The footer is presented as follows:

Version: 1.0

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Effective date:

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 (-).

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For example

1. Quality management system

Heading level 1

1.1. Requirements for document system

Heading level 2

1.1.1. Generalization

Heading level 3

1.1.2. Document control

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Heading level 4

- Quality handbook

Content level 1

- Regulation

- Procedure

+ Form

Content level 2

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Content level 3

• Vertical form

1.1.2.2. Control of outside documents

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;

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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;

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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;

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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

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

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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

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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:

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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…).

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- 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

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- 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)

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+ 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).

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Ex: The operation and laboratory procedure on machine FACSCount - 2009, 3^rd publication – Hanoi, 2012, page 33-37.

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.

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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.

4. World Health Organization, 2011. Laboratory Quality Management System - Handbook, Document and Record, p. 181.

5. World Health Organization, 2011. Laboratory Quality Standards and their Implementation-South-East Asia Region, Annex 5, p.39-45.

6. ISO 15189:2012, Medical laboratories - Particular requirements for quality and competence, 2012.

7. Clinical and Laboratory Standards Institute, 2013. Quality Management System - Development and Management of Laboratory Documents; Approved guideline 6th Edition, p.9-10.

ANNEX I

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1. Quality standard procedure in management

No.

NAME OF PROCEDURE

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Procedure for guidelines on drafting of standard practice procedure

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Procedure for document control

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Procedure for dossier control

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Procedure for personnel management and staff training

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Procedure for staff assessment

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Procedure for management of personnel dossier

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Procedure for management of equipment

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Procedure for management of biological products and consumable materials

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Procedure for management of nonconformity

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Procedure for assessment of customers’ satisfaction

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Procedure for settlement of complaints

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Procedure for supplier selection and assessment

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Procedure for information security

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Procedure for internal assessment

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Procedure for taking remedial actions

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Procedure for taking preventive actions

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Procedure for review meeting from the leadership

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Procedure for information exchange

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Procedure for selecting and assessing the laboratory transferring specimen

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Procedure for risk assessment

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Procedure for identification and monitoring of quality indicators

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Procedure for review of calibration result

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Procedure for continuous improvement

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Procedure for avoidance of interest conflict

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Procedure for specimen retention after laboratory

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Procedure for post-exposure treatment

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Procedure for summary and result report

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Procedure for training and assessment of effectiveness after training

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Procedure for goods quality control

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Procedure for response to urgent circumstances

2. Standard procedure for technical management

No.

NAME OF TECHNICAL PROCEDURE

1

Procedure for performance of tests (each test has a separate procedure. Ex: Procedure for testing the blood glucose level).

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Procedure for capillary blood collection (finger tip)

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Procedure for throat swab and nasal swab

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Procedure for cleaning and maintenance of equipment

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Procedure for waste treatment

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Procedure for preparing the agar and blood base

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Procedure for preparing the blood base

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Procedure for receiving, refusing and storing specimen

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Procedure for analysis of result of internal control

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Procedure for blood culture

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Procedure for stool culture

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Procedure for culture of respiratory specimen

ANNEX II- A

EXAMPLE OF SAMPLE OF STANDARD PRACTICE PROCEDURE FOR DOCUMENT CONTROL

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Logo (if any)

XYZ GENERAL HOSPITAL

XXX LABORATORY DEPARTMENT

Code: XX-QTQL-01

Version: 1.0

Issue date: 15/05/20xx

PROCEDURE

DOCUMENT CONTROL

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Writer

Reviewer

Approver

Full name

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Date

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MONITORING OF DOCUMENT MODIFICATION

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Modified place

Modified content

Modification date

Modifier

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Internal document

Procedure for document control

XX laboratory department

Version: 1.1

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1. Purpose

- Guide the regulations on management of internal documents and external documents of the quality system to ensure the staff in the department have the current regulations and procedures for implementation.

2. Scope of application

- To be applied in divisions of XX laboratory department – XXX General Hospital.

3. Responsibility

- All divisions of XX laboratory department must control documents as stipulated.

- The quality controller shall manage, guide and monitor the procedure implementation.

- The Head of department shall manage all documents in general.

4. Definition and abbreviation

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- Documents: the guiding documents (paper or electronic form) including the regulations, policies, procedures, forms, reports. The documents can be in the form of text or electronic form.

- Internal document: Quality handbook, management procedure, technical procedure, work, equipment and safe instructions and other applicable forms. Dossiers are out of this scope.

- External documents: are the ones written and issued by external organizations including legal normative documents, international standards, national standards, accreditation and certification documents, manual of manufacturer and guiding official letters.

- Obsolete documents: are the invalid ones or have new versions for replacement or invalidation by order.

4.2. Abbreviations

- BM                 Form

- PDF

- QLCL              Quản lý chất lượng/ Quality management

- QLKT              Quản lý kỹ thuật/ Technical management

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5. Content of procedure

5.1. Regulation on original and copy

5.1.1. Original document

- There are signatures in blue ink of the writer, reviewer and approver.

- There are red seals of “ORIGINAL” and “CONTROL DOCUMENT” on the first page with seals on remaining pages of document. The document is effective from its issuance date

5.1.2. Copied documents

- Are copied from the original so all signatures and seal “ORIGINAL” are in black ink.

- There must be a seal “CONTROLLED COPY” in red ink at the top center of each page. At the bottom of page, write the ordinal number of copy in blue ink.

- The documents with prescribed above features are the legal documents of the quality system.

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No.

Name of seal

Ink color of seal

Specification

Purpose of use

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ORIGINAL

Red

Rectangular frame - 35 x 12mm - with "ORIGINAL" in uppercase

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CONTROLLED COPY

Red

Rectangular frame -70 x 20mm – with “CONTROLLED COPY” in; “No:…..” in lowercase

Affixed on the copy of document distributed to the units.

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INVALIDITY

Red

Rectangular frame -49x17mm – with “INVALIDITY” in uppercase.

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5.3. Control of internal documents

5.3.1. Issue of document

- After the document is signed for approval, the quality controller shall:

+ Specify the validity date on each page of document;

+ Affix the seal “ORIGINAL” and “CONTROL DOCUMENT” on each page in the upper right corner;

+ Make copies and distribute documents in accordance with item 5.5.2;

+ Update the name of document in the “List of controlled internal documents” under the form with code No. XX-QTQL-01-BM01 and keep this list. This list only shows the current controlled document versions.

+ Keep the original in locked cabinet at room as stipulated under item 5.5.6;

+ Make training plan for staff on newly-issued documents.

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- Only the quality controller has the right to:

+ Make copy and provide documents of quality system as requested by other divisions in department;

+ Print the correct number of copies under the distribution list specified in the document and there must be the approval from the head of department in case of additional printing;

+ Affix the seal “CONTROLLED COPY” and write the ordinal number of copy on each page of copy;

+ Distribute the copies of document to the units/individuals named in the distribution list. When delivering documents, the person distributing documents must do an update in the “Document distribution/recovery monitoring book” under the form No. XX-QTQL-03-BM03.

+ The control documents can be distributed in the electronic form (PDF form) with sunken words “CONTROL COPY” from the email address of the quality controller or USB.

5.3.3. Periodical review

- At the beginning of each quarter, the quality controller shall make a list of documents to be reviewed in that quarter of the department and send a written notice so that the divisions in department can review the content of document in their divisions.

- All documents shall be reviewed 1year/time.

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- In case of modification, follow the document modification order specified in item 5.2.3.

5.3.4. Document modification and re-issue

- All staff can suggest modification of documents. The requester shall complete the “Document drafting/modification request sheet” under the form No. XX-QTQL-01-BM04.

- The modified contents shall be reviewed and approved by the competent person as follows:

No.

Type of document

Responsibility

Drafting

Review

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Quality handbook (STCL)

Quality management

Head of Department

Hospital leadership

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Management procedure (QTQL) 

Quality management

Head of Department

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Laboratory procedure (QTKT)

All staff

Technical management

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Safety handbook (STAT) 

Quality management

Head of Department

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All staff

Head of division

- The modifier shall update the modified information in the table “Monitoring of document modification” on the first page of document. The modified content in the document must be marked in the right margin.

- The modifier shall save the electronic files of modified documents in the different name (in accordance with naming regulation under item 5.3.1). Update the information in the excel file “Monitoring of document modification”.

- When issuing new documents, the quality controller shall recover the old documents as stipulated in item 5.2.5.

- The quality controller shall re-distribute the modified documents to the relevant units/individuals and do an update in the “List of controlled internal documents” under the form No. XX-QTQL-01-BM01 and the “Document distribution/recovery monitoring book” under the form No. XX-QTQL-4.3-BM03.

5.3.5. Use of documents

- The quality controller shall keep the original documents. The staff of department shall use the copy or electronic files only.

- As for the blank forms used for information completion, the quality controller shall print 01 copy for each type of form and affix the seal “CONTROL DOCUMENT” on the back of the blank forms and put them in the file folder for the relevant persons to use them. The users can make copies from such control form.

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- After being completed with information, the blank forms shall become dossier and be managed under the procedure “Dossier management” with code XX-QTQL-10.

5.3.6. Document recovery and destruction

- The invalid controlled documents, old versions of modified or unused documents must be recovered; do an updated in the “Document distribution/recovery monitoring book” under the form No. XX-QTQL-01-BM03.

Note: The Department shall not recover the uncontrolled copies.

- Affix the red seal “INVALIDITY” on the recovered document and write the date of invalidity.

Upon destruction of documents (text or electronic file), ensure they cannot be restored and only destroying them when there are new versions for replacement and the archiving time is in accordance with regulation.

- Update the information on document destruction in the “Document destruction sheet” under the form No. XX-QTQL-03-BM06.

- Keep one original in at least 3 years after destruction.

5.4. Control of electronic documents

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- The documents in the electronic form are named using the following rules: Document code – time of issue

- Ex:

+ The electronic file of procedure “Document control”, time of issue: 1.2. shall be saved with the following name: XX-QTQL-01_1.2.

+ The electronic file of form “Document destruction sheet”, time of issue: 2.2 shall be saved with the following name: XX-QTQL-01-BM06_2.2.

5.4.2. Document update and storage

- All electronic documents must be saved in the computer with appropriate forms of security (ex: password) to avoid any accidental / intentional change of content of document.

- These documents must be backed up into CD/external hard drive at least 3 months/time. Every time of backup, name the backup folder by year, month and date of backup. The CD/external hard drive must be placed in the locked cabinet under the quality controller’s management.

5.4.3. Document management and distribution

- All documents in electronic form upon distributed must be converted into “PDF” form.

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5.5. Control of external documents

5.5.1. Document identification

- When the external documents are transferred to the units, the quality controller shall do an update in the “List of external controlled documents” under the form No. XX-QTQL-01-BM02, affix the red seal “CONTROL DOCUMENT” on the first page of documents and deliver them to the relevant officer to handle, manage or submit them to the unit leadership for processing.

- With the external documents related to the system of quality management, the competent person must do an update and disseminate them to all staff under the procedure “Management organization and responsibility” code: XX-QTQL-05.

5.5.2. Document storage and management

- The document storage must follow their type and be put in separate folders with identifiable signs for search in case of necessity.

- The person in charge of document storage shall decide the permission of document copy.

- The documents which are expired, no longer necessary or superseded must be sealed “EXPIRED” with specified date.

- The procedure for recovery and destruction of documents is similar to item 5.2.5.

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- Are not the original or copy but without the red seal “COPY”.

- When distributing some uncontrolled documents, the form “Document distribution/recovery monitoring book” under the form No. XX-QTQL-01-BM03 if needed.

6. Dossier storage

Write all information in the following relevant forms:

- List of controlled internal documents

- List of controlled external documents

- Document distribution/recovery monitoring book

- Document drafting/modification request sheet

- Periodical document review sheet

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XX-QTQL-01-BM01

XX-QTQL-01-BM02

XX-QTQL-01-BM03

XX-QTQL-01-BM04

XX-QTQL-01-BM05

XX-QTQL-01-BM06

7. Relevant document

No.

Name of documents

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1

Dossier management

XX-QTQL-10

2

Management organization and responsibility

XX-QTQL-05

8. References

8.1. Vietnamese language

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

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- World Health Organization, 2011, Laboratory Quality Management System - Handbook, Document and Record, p.190-196.

http://whqlibdoc.who.int/publications/2011/9789241548274_eng.pdf

- ISO 15189:2012, Medical laboratories - Particular requirements for quality and competence, 2012./.

ANNEX II-B

EXAMPLE OF SAMPLE OF STANDARD PRACTICE PROCEDURE FOR DIRECT AFB STAIN

Logo (if any)

XYZ GENERAL HOSPITAL

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Code:: XX-QTKT-06

Version: 1.0

Issue date:: 15/10/2015

PROCEDURE FOR DIRECT AFB STAIN

Writer

Reviewer

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Full name

Signature

Date

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MONITORING OF DOCUMENT MODIFICATION

Code of document

Reviewed/modified contents

Modification date

Modifier

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Internal document

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Procedure for direct sputum testing for Acid Fast Bacilli (AFB) by Ziehl-Neelsen stain

XX Laboratory Department

Version 1.0

Document code: XX-QTKT-06

1. Purpose

- Describe and guide the way to do the direct sputum testing for Acid Fast Bacilli (AFB) by Ziehl-Neelsen stain.

2. Scope

- To be applied at XX Laboratory Department - XYZ General Hospital

3. Responsibility

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- The quality controller and professional team leader must monitor the compliance with procedure and assess the laboratory result.

4. Definition and abbreviation

AFB

Acid fast bacilli - Alcohol and acid resistant bacilli of Mycobacteriaceae family

BCĐN

Monocyte

ZN

Zeihl-Neelsen

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5. Principle

The Ziehl-Neelsen stain is the method using 02 staining chemicals as fuchsin red and methylene blue combined with decolorant (mixture of HCL acid and alcohol 96 °) for detection of AFB. This method is used to detect the microorganisms of Mycobacteriacae family as microorganisms with alcohol and acid resistant characteristics. They can survive in the environment with certain alcohol or acid content without losing their color when bleached with alcohol or acid

6. Equipment and material

6.1. Equipment

- Compound optical microscope with objective lens 100X, 10X

- Biosafety cabinet class 1

- Minute timer

6.2. Material

6.2.1. Devices

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- HB pencil

- Plastic cup for containing sputum

- Disposable sputum smear spatula

- Specimen stain rack

- Microscope cleaning tissue

6.2.2. Chemical

- Fuchsin solution 0,3%

- HCL alcohol solution 3%

- Methylen solution 0,3%.

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- Immersion oil

6.2.3. Specimen:

- Sputum contained in a sterile clean plastic tube with lid.

7. Safety

- Apply the general safety measures when processing and testing the specimen under the procedure for laboratory safety with code XX-QTQL-10.

8. Implementation procedure

8.1. Preparation

- Start up the biosafety cabinet at least 15 minutes before implementation.

- Arrange necessary devices in the biosafety cabinet.

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- Use HB pencil to write the code of specimen on the translucent head of glass slide.

- Arrange the sputum container and glass slide in order to avoid confusion.

Note: The testing number must be consistent between the testing number, testing slip, sputum container and glass slide.

8.2. Specimen spreading:

In the biosafety cabinet:

- Gently open the lid of sputum container, put the cap on its back on the stainless steel tray.

- Use the beveled head of spatula to smear the sputum and gently cut it by wiping the beveled side of spatula on the sputum container wall (note: use each spatula for each specimen)

- Close the sputum container.

- Put the spatula with specimen in the middle of slide and spread under the spirals from the inside out regularly and continuously to form an oval shape with size of 2 cm long and 1cm wide with the fineness and moderate thickness.

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Note: Only discarding the sputum container after returning the testing result.

8.3. Specimen drying

- Put the specimen on the glass tray and leave it dry completely at the room temperature (18-25°C).

Note: Do not dry the specimen with spirit lamp or in the sun light.

8.4. Specimen fixing:

- Do it outside the biosafety cabinet.

- Dry the specimen from side to side over the flame of spirit lamp for 3-4 times, 3 seconds for each time.

Note: Do not fix the specimen if it is not dry completely.

8.5. Staining

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- Cover Fuchsin solution 0,3% on the fixed specimen smear side.

- Dry it over the flame of spirit lamp until evaporation (do not leave it boil) for 1 time.

- Leave it cool naturally in 5 minutes.

- Rinse it under light running water.

8.6. Decoloring

- Cover HCL alcohol solution 3%

- Leave the specimen in 3 minutes.

- Rinse it under light running water.

Perform the 2^nd discoloring (1-3 minutes) if the specimen is still pink

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- Cover the Methylen solution 0,3% in 1 minute.

- Rinse it under light running water (note: do not put the specimen directly under strong running water).

- Leave it dry at room temperature.

8.8. Result reading:

- Examine the specimen with optical microscope with oil objective lens 100X as instructed in the manual for microscope with oil objective lens code XX.HD.03.

+ Positive: AFB is rod-shaped bacilli that are thin, somewhat curved, Fuchsin red absorbing, individually, in pairs or groups on blue background.

+ Negative: No AFB found

9. Quality control:

There are 06 standards as follows:

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- Observation: specimen has no mucus, saliva and blood at best.

- Standard upon microscopic examination:

+ There are 25 polymorphonuclear leukocytes (examination of objective lens 10X, eyepiece 10X).

+ There are 3-4 polymorphonuclear leukocytes/microscopic field (examination of objective lens 10X, eyepiece 10X).

+ Or there are macrophages.

9.2. Size of specimen on glass slide

- Oval shape in the center of glass slide.

- 1cm wide and 1cm long.

9.3. Fineness

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- Examination: The microscopic fields have the continuity and there are not many hollow microscopic fields, regular brightness.

9.4. Thickness

- The thickness of specimen is 0.04mm. Check by the way when the specimen is dry without staining, put a paper with letters 4-5 cm away from the specimen.

+ Satisfactory: if the words are fuzzy and readable.

+ Too thick: Illegible

+ Thin: Unclear

- Examine the depth of the specimen (bright blue microscopic field).

- If the specimen is too thick: Many layers, the microscopic field cannot be examined (dark blue microscopic field).

- If the specimen is too thin: Microscopic fields are sparse (light blue).

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- Examination under microscope: AFB absorb red color clearly on blue background.

- Unsatisfactory: The specimen is still red with naked eyes.

9.6. Cleaniness:

- No dirty residue, Fuchsin residue, crystal… upon examination under microscope.

- If there are dirty residues, the reasons are the stain is left long or dried too long during the staining.

9.7. Method of testing:

- Frequency of testing: daily or at least 1 week/1 time.

- Testing with a positive specimen to count the amount and color of AFB.

- Testing with a negative specimen to check if the stain and water source are infected with AFB.

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10. Result interpretation and report:

Amount of AFB

Result

Classification

No AFB/100 microscopic fields

Negative

With AFB > 10 AFB/ 1 microscopic field

(Examination of at least 20 microscopic fields)

Positive

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With 1-10 AFB/1 microscopic field

(Examination of at least 50 microscopic fields)

Positive

AFB 2 (+)

With from 10-99 AFB/100 microscopic fields

Positive

AFB 1 (+)

With from 1-9 AFB/100 microscopic fields

Positive

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Note: 01 line of glass slide is equivalent to 100 microscopic fields. Examine at least 3 lines.

11. Note:

- If AFB is light, it is because the discoloring was too long or the staining was not done sufficiently (time, heat).

- If AFB is dark, it is because the staining was too long.

- Each batch of stain should not contain 12 specimen which are placed at least 01 cm from each other.

12. Dossier storage

- Write the result in the result answer sheet and the sputum testing result book for AFB.

- Keep the forms of QC sheet in accordance with regulations of Department

13. Relevant documents:

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Code

1. Safety procedure for laboratory

XX-QTQL-10

2. Instructions on use of microscopy with oil objective lens

XX.HD.03

14. Reference:

- Ministry of Health, Guidelines on tuberculosis management, Medical Publishing House, 2009.

- Ministry of Health, National Tuberculosis Prevention Program, Guidelines on standard practice procedure for Tuberculosis bacteria testing.

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Quyết định 5530/QĐ-BYT năm 2015 hướng dẫn xây dựng quy trình thực hành chuẩn trong quản lý chất lượng xét nghiệm do Bộ trưởng Bộ Y tế ban hành