List of Vietnam Law
Decision No. 5530/QD-BYT dated December 25, 2015 of the Ministry of Health on issuing the guidelines on development of standard practice procedure in management of laboratory quality
Date: 12/25/2015
MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness --------------- |
No. 5530/QD-BYT
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Hanoi, 25 December 2015
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FOR THE MINISTER
DEPUTY MINISTER (Signed and sealed)
Nguyen Thi Xuyen |
(Issued with Decision No. 5530/QD-BYT dated 25/12/2015 of the Minister of Health)
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ON BEHALF OF DRAFTING COMMITTEE
(Signed and sealed) Luong Ngoc Khue |
1. Prof. Do Dinh Ho, former Chairman of Vietnam Association for Chemistry and Biology
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Council Chairman
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2. MMed. Nguyen Trong Khoa, Deputy Director of Agency of Medical Services Administration – Ministry of Health
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Council Deputy Chairman
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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
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Council Deputy Chairman
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4. Mmed. Pham Tuan Duong, Deputy Director of National Institute of Hematology and Blood Transfusion
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Member
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5. Dr. Tran Huu Tam, Director of Center for standardization and quality control in medical laboratory of HCM City
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Member
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6. Dr. Le Thi Anh Hong, Head of microbiology department, Saint Paul Hospital
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Member
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7. Dr. Nguyen Van Hung, Head of microbiology and national standard lab tuberculosis department of National Lung Hospital
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Member
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8. MMed. Dao Nguyen Minh, Deputy Head of quality management Department, Agency of Medical Services Administration – Ministry of Health
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Secretary
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9. MMed. Le Sinh Quan, Agency of Medical Services Administration – Ministry of Health
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Secretary
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Quy trình thực hành chuẩn
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QTC
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Standard Practice Procedure
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Tổ chức Y tế Thế giới
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WHO
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World Health Organization
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Kỹ thuật
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KT
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Techniques
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Quản lý
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QL
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Management
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Quy trình
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QT
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Procedure
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Vi sinh
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VS
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Microbiology
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Hóa sinh
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HS
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Biochemistry
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Version number
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Modified place
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Modified content
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Date of review/modification
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Reviewer/modifier
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Guided drafting of standard practice procedure
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Code of document: QLCL-01
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Version: 1.0
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Page: 2/5
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Effective date:
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1. Quality management system
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Heading level 1
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1.1. Requirements for document system
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Heading level 2
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1.1.1. Generalization
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Heading level 3
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1.1.2. Document control
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1.1.2.1. Internal document control
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Heading level 4
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- Quality handbook
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Content level 1
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- Regulation
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- Procedure
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+ Form
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Content level 2
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• Horizontal form
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Content level 3
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• Vertical form
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1.1.2.2. Control of outside documents
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Content
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Writing guidelines
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1. Purpose
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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.
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2. Scope of application
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- 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.
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3. Responsibility
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- 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.
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4. Definition, terms and abbreviation
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- 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
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5. Principle
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- 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 ofred or pink coloring of bacillus...
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6. Equipment and material
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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)
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7. Quality control
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- 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.
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8. Safety
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Specify the safety issues to be noted upon implementation of procedure (if any).
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9. Implementation content
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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....”.
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10. Interpretation and result report
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- 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).
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11. Note (warning)
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Specify the difference which may occur or cause of result difference and limit of laboratory.
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12. Dossier storage
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Make record in book and forms related to the procedure and keep dossier.
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13. Relevant documents
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List the relevant standard practice procedure including the code of document
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14. References
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- 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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No.
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NAME OF PROCEDURE
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1
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Procedure for guidelines on drafting of standard practice procedure
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2
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Procedure for document control
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3
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Procedure for dossier control
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4
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Procedure for personnel management and staff training
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5
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Procedure for staff assessment
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6
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Procedure for management of personnel dossier
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7
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Procedure for management of equipment
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8
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Procedure for management of biological products and consumable materials
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9
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Procedure for management of nonconformity
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10
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Procedure for assessment of customers’ satisfaction
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11
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Procedure for settlement of complaints
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12
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Procedure for supplier selection and assessment
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13
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Procedure for information security
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14
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Procedure for internal assessment
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15
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Procedure for taking remedial actions
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16
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Procedure for taking preventive actions
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17
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Procedure for review meeting from the leadership
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18
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Procedure for information exchange
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19
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Procedure for selecting and assessing the laboratory transferring specimen
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20
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Procedure for risk assessment
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21
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Procedure for identification and monitoring of quality indicators
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22
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Procedure for review of calibration result
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23
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Procedure for continuous improvement
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24
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Procedure for avoidance of interest conflict
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25
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Procedure for specimen retention after laboratory
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26
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Procedure for post-exposure treatment
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27
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Procedure for summary and result report
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28
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Procedure for training and assessment of effectiveness after training
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29
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Procedure for goods quality control
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30
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Procedure for response to urgent circumstances
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No.
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NAME OF TECHNICAL PROCEDURE
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1
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Procedure for performance of tests (each test has a separate procedure. Ex: Procedure for testing the blood glucose level).
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2
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Procedure for intravenous blood collection
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3
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Procedure for capillary blood collection (finger tip)
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4
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Procedure for throat swab and nasal swab
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5
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Procedure for cleaning and maintenance of equipment
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6
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Procedure for waste treatment
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7
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Procedure for packaging and transportation of specimen
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8
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Procedure for preparing the agar and blood base
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9
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Procedure for preparing the blood base
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10
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Procedure for receiving, refusing and storing specimen
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11
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Procedure for analysis of result of internal control
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12
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Procedure for storage of bacterial strain
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13
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Procedure for blood culture
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14
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Procedure for stool culture
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15
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Procedure for culture of respiratory specimen
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MONITORING OF DOCUMENT MODIFICATION
Internal document
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Procedure for document control
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XX laboratory department
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Version: 1.1
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Code: XX-QTQL-01
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No.
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Name of seal
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Ink color of seal
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Specification
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Purpose of use
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1
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ORIGINAL
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Red
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Rectangular frame - 35 x 12mm - with "ORIGINAL" in uppercase
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Affixed on the original of document
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2
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CONTROLLED COPY
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Red
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Rectangular frame -70 x 20mm – with “CONTROLLED COPY” in; “No:…..” in lowercase
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Affixed on the copy of document distributed to the units.
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3
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INVALIDITY
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Red
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Rectangular frame -49x17mm – with “INVALIDITY” in uppercase.
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Affixed on invalid or improper documents in case of new documents issued.
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No.
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Type of document
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Responsibility
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Drafting
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Review
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Approval
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1
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Quality handbook (STCL)
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Quality management
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Head of Department
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Hospital leadership
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2
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Management procedure (QTQL)
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Quality management
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Head of Department
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Hospital leadership
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3
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Laboratory procedure (QTKT)
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All staff
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Technical management
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Head of Department
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4
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Safety handbook (STAT)
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Quality management
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Head of Department
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Head of Department
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5
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Guidelines (HD), form (BM), notebook (SGC)
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All staff
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Head of division
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Head of Department
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- List of controlled internal documents
- List of controlled external documents
- Document distribution/recovery monitoring book
- Document drafting/modification request sheet
- Periodical document review sheet
- Document destruction 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
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No.
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Name of documents
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Code
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1
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Dossier management
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XX-QTQL-10
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2
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Management organization and responsibility
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XX-QTQL-05
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MONITORING OF DOCUMENT MODIFICATION
Internal document
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Procedure for direct sputum testing for Acid Fast Bacilli (AFB) by Ziehl-Neelsen stain
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XX Laboratory Department
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Version 1.0
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Document code: XX-QTKT-06
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AFB
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Acid fast bacilli - Alcohol and acid resistant bacilli of Mycobacteriaceae family
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BCĐN
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Monocyte
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ZN
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Zeihl-Neelsen
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…
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Amount of AFB
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Result
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Classification
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No AFB/100 microscopic fields
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Negative
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With AFB > 10 AFB/ 1 microscopic field
(Examination of at least 20 microscopic fields)
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Positive
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AFB 3 (+)
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With 1-10 AFB/1 microscopic field
(Examination of at least 50 microscopic fields)
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Positive
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AFB 2 (+)
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With from 10-99 AFB/100 microscopic fields
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Positive
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AFB 1 (+)
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With from 1-9 AFB/100 microscopic fields
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Positive
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Write the amount of AFB/100 microscopic fields
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Name of document
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Code
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1. Safety procedure for laboratory
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XX-QTQL-10
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2. Instructions on use of microscopy with oil objective lens
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XX.HD.03
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