Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health;
Pursuant to Decision No. 316/QD-TTg dated February 27, 2016 of the Prime Minister giving approval for the Scheme for improvement of quality management system of medical laboratories in 2016 – 2025 period;
At the request of Director of Administration of Medical Examination and Treatment,
HEREBY DECIDES:
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Article 2. The criteria for quality assessment of medical laboratories enclosed herein shall be adopted by health facilities that do tests to serve their medical examination and treatment works [hereinafter referred to as laboratories] to carry out the internal audit and make statement of quality of their laboratories, and also used by regulatory authorities to carry out external assessment and supervision and make statement of laboratories quality during the pilot period 2017-2018.
Article 3. The Administration of Medical Examination and Treatment shall take charge of and cooperate with relevant authorities in making inspection, assessment and statement of laboratories quality which shall be used as the basis for sharing and accreditation of testing results.
Article 4. This Decision comes into force as from the date on which it is signed.
Article 5. Chief of Ministry’s Office, Director of Administration of Medical Examination and Treatment, Ministry’s Chief Inspector, Directors/ General Directors of Departments/ Divisions and Directors of Hospitals affiliated to Ministry of Health, Directors of Departments of Health of provinces or central-affiliated cities, Heads of Ministries’ Health Units, Directors of Centers for Standardization and Quality Control in Medical Laboratories and heads of relevant units shall be responsible for implementing this Decision./.
PP MINISTER DEPUTY MINISTER
Nguyen Viet Tien
CRITERIA FOR QUALITY ASSESSMENT OF MEDICAL LABORATORIES
[Enclosed with Decision No. 2429/QD-BYT dated June 12, 2017 by Minister of Health on promulgation of Criteria for quality assessment of medical laboratories]
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LIST OF ABBREVIATIONS
PART I. GENEAL INSTRUCTIONS
PART II. ASSESSMENT CRITERIA
- LABORATORY PROFILE
- CONTENTS OF ASSESSMENT CRITERIA
CHAPTER I. LABORATORY ORGANIZATION AND MANAGEMENT
CHAPTER II. MANAGEMENT OF DOCUMENTS AND RECORDS
CHAPTER III: PERSONNEL MANAGEMENT
CHAPTER IV. CLIENT MANAGEMENT AND CUSTOMER SERVICE
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CHAPTER VI. INTERNAL QUALITY ASSESSMENT
CHAPTER VII. MANAGEMENT OF PURCHASING, EQUIPMENT, CONSUMMABLES, CHEMICALS AND BIOLOGICAL PRODUCTS
CHAPTER VIII. TESTING PROCESS CONTROL
CHAPTER IX. INFORMATION MANAGEMENT
CHAPTER X. DETERMINATION OF NONCONFORMITIES, CORRECTIVE AND PREVENTIVE ACTIONS
CHAPTER XI. CONTINUOUS QUALITY IMPROVEMENT
CHAPTER XII. FACILITIES AND SAFETY
NO.
Abbreviated words
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1.
ATSH
Biosafety
2.
BYT
Ministry of Health
3.
CLSI
Clinical and Laboratory Standards Institute
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EQA
External Quality Assessment
5.
HDKP
Corrective actions
6.
HDPN
Preventive actions
7.
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International Organization for Standardization
8.
PXN
Laboratory
9.
QLCL
Quality management
10.
QTQL
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11.
QTXN
Testing process
12.
SKPH
Nonconformity
13.
SI
Systeme International
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TTB
Equipment
15.
VTTH
Consumables
16.
XN
Testing
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1. Objectives
1.1. General objectives
- These criteria are adopted to assess the quality of medical laboratories [hereinafter referred to as laboratories] and used as tool by which a laboratory can assess its compliance with prevailing regulations on quality management and carry out acts of maintenance and continual improvement of laboratory quality.
- These criteria are also aimed to step by step improve the quality of medical tests in order to ensure the accuracy, punctuality and standardization of testing results which shall be used for sharing and accreditation of testing results, thereby minimizing inconveniences and expenses incurred by patients, saving social resources as well as integrating into regional and world networks of standardization and quality control in medical laboratories.
1.2. Specific objectives
- Provide tool for assessing the reality of quality of medical laboratories in health facilities;
- Classify quality levels of laboratories;
- Use as the basis for ensuring the reliability and sharing of testing results between laboratories;
- Assist laboratories in evaluating the status of their testing quality management and defining quality improvement duties;
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2. Scope of application
- These criteria shall be adopted by health facilities that do tests to serve their medical examination and treatment works [hereinafter referred to as laboratories] to carry out the internal assessment and make statement of quality of their laboratories, and also used by regulatory authorities to carry out external assessment and supervision and make statement of laboratories quality.
- These criteria are applied to officials and employees who are take charge of managing testing activities of Ministry of Health, Provincial Departments of Health, health agencies of ministries, hospitals, and other health facilities with testing function.
- Officials and employees who are take charge of carrying out assessment, supervision and providing assistance in quality management techniques of laboratories.
- Officials and employees working at biochemical, hematology, or microorganism laboratories and other laboratories treating human specimens.
3. Interpretation of terms used in the Criteria
- Assessment of quality management system of laboratory: refers to the inspection of operations, documents, arrangement and organization of a laboratory in order to define whether such laboratory conform to prevailing regulations on quality management or not.
- Quality indicator is used to measure and determine the degree of quality improved. c. Quality refers to a degree to which a set of inherent characteristics fulfills requirements.
- Interlaboratory comparison means organisation, performance and evaluation of measurements or tests on the same or similar test items by two or more laboratories in accordance with predetermined conditions.
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- Quality policy refers to overall intentions related to quality as formally expressed by holder of highest leading position of an agency or organization.
- Turnaround time is defined as the time between submitting or delivering a sample to the laboratory and returning test reports to the requesting customer [department/ ward, clinical doctor, nurse, patient or his/her relative, etc.].
- Referral laboratory refers to an external laboratory to which a sample is submitted by the assessed laboratory for examination.
- Process means a set of interrelated or interacting activities which transform inputs into outputs.
- Nonconformity means nonfulfilment of a requirement.
- Method validation refers to a confirmation, through provision of objective evidence, that the requirements for an intended specific application or use of test method or biological products or medical equipment have been fulfilled.
4. Assessment method
- Check documents, records and the way to arrange and organize activities of the assessed laboratory, including quality manual, standard operation procedures, other manuals, personnel records, records of internal and external quality control, internal audit, equipment and chemicals.
- Observe activities of the assessed laboratory and evaluate the compliance with pre-examination, examination and post-examination procedures.
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- Use open-ended questions in interviews, exchanges and discussions with officials and employees of the assessed laboratory, and relevant departments, including clinical doctors.
5. Legal grounds for establishing criteria
- The Government’s Decree No. 103/ND-CP dated July 01, 2016 by the Prime Minister providing for biosafety in laboratories
- Decision No. 316/QD-TTg dated February 27, 2016 of the Prime Minister giving approval for the Scheme for improvement of quality management system of medical laboratories in 2016 – 2025 period
- The Circular No. 01/2013/TT-BYT dated January 11, 2013 by Minister of Health providing guidance for assurance of testing quality in health facilities.
- The Checklist of Circular No. 01/TT-BYT dated January 11, 2013; SLIPTA Checklist developed by the World Health Organization/ CDC; TCVN ISO 15189:2014, and other relevant regulations and documents.
- The Circular No. 43/2011/TT-BYT dated December 05, 2011 by Minister of Health providing for management of infectious specimens.
- The Circular No. 19/2013/TT-BYT dated July 12, 2013 by Minister of Health providing guidance on quality management of health care services in hospitals.
- The Joint-Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015 providing for medical waste management.
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- Decision No. 6858/QD-BYT dated November 18, 2016 by Minister of Health on promulgation of criteria on hospital quality.
6. Structure of Criteria for quality assessment of medical laboratories
The Criteria for quality assessment of laboratories is comprised of 3 parts as follows:
- Laboratory profile
- Contents of assessment criteria
There are 12 chapters, 169 criterions and attached sub-items, including criteria on management and techniques. These are essential requirements of the quality management system. Officials and employees of the laboratory shall base on these criteria to formulate plan and conduct necessary actions of continual improvement of the laboratory quality.
- Summary of assessment results, precautions and recommendations for the quality improvement plan.
7. Scoring methods
Each criterion shall have a given scoring scale based on its importance in the quality management system.
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- Each criterion may be assessed according to the 4 following responses:
+ “Yes” [abbreviated as Y]; + “Partial” [abbreviated as P];
+ “No” [abbreviated as N];
+ Or “Not applicable” [abbreviated as N/A].
- If a criterion receives “Yes” response, it will be given the maximum point;
- If a criterion receives “No” response, 0 point shall be given to that criterion;
- If a criterion receives “Partial” response, a half of maximum score shall be given to that criterion. [A criterion receives “Partial” response if at least 50% of sub-items of that criterion receive “Yes” response. If less than 50% of sub-items of that criterion receive "Yes" response, "0" point shall be given to that criterion].
Notes:
- The “P” response is only given to a criterion with its sub-items specified.
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When marking “No” or “Partial” or “N/A”, reasons thereof must be specified in the comments field. Such comments will assist the laboratory to address areas of identified need following the assessment. Number of criteria and score:
No.
Contents
Total criteria
Maximum score
1.
Chapter I. Laboratory organization and management
15
23
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Chapter II. Management of documents and records
8
10
3.
Chapter III. Personnel management
17
21
4.
Chapter IV. Client management and customer service
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13
5.
Chapter V. Equipment management
19
30
6.
Chapter VI. Internal audit
9
13
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Chapter VII. Management of purchasing, equipment, consumables, chemicals and biological products
17
23
8.
Chapter VIII. Testing process control
27
57
9.
Chapter IX. Information management
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11
10.
Chapter X. Determination of nonconformities, corrective and preventive actions
6
14
11.
Chapter XI. Continual improvement
8
21
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Chapter XII. Facilities and safety
27
32
169
268
8. Rules for quality ranking
- Quality of a laboratory shall be ranked as follows: Not ranked, rank 1, rank 2, rank 3, rank 4 and rank 5 based on total points and percentage [%] to the maximum score given to the laboratory following the assessment.
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- Percentage [%] of total points given to the laboratory =
Total points given to the laboratory x 100%
Maximum total score
- With regard to each quality rank, the laboratory is required to achieve maximum score of certain predetermined criteria [criteria marked with "*"]. - Quality ranks of laboratory:
Not ranked
Rank 1
Rank 2
Rank 3
Rank 4
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