ASEMCONNECT VIETNAM

  List of Vietnam Law

Decision No.: 2429/QD-BYT dated June 12, 2017 of the Ministry of Health on promulgation of criteria for quality assessment of medical laboratories

Date: 6/12/2017

 

MINISTRY OF HEALTH
---------
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
---------------------
No.: 2429/QD-BYT
Hanoi, June 12, 2017
 
MINISTER OF HEALTH
Pursuant to the Law on Medical Examination and Treatment No. 40/2009/QH12, in 2009;
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:
 
PP MINISTER
DEPUTY MINISTER
(Signed and sealed)



Nguyen Viet Tien
 
 (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)
CONTENTS
LIST OF ABBREVIATIONS
PART I. GENEAL INSTRUCTIONS 
PART II. ASSESSMENT CRITERIA
A. LABORATORY PROFILE  
B. 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
CHAPTER V. EQUIPMENT MANAGEMENT
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
Explanation
1.
ATSH
Biosafety
2.
BYT
Ministry of Health
3.
CLSI
Clinical and Laboratory Standards Institute
4.
EQA
External Quality Assessment
5.
HDKP
Corrective actions
6.
HDPN
Preventive actions
7.
ISO
International Organization for Standardization
8.
PXN
Laboratory
9.
QLCL
Quality management
10.
QTQL
Management process
11.
QTXN
Testing process
12.
SKPH
Nonconformity
13.
SI
Systeme International
14.
TTB
Equipment
15.
VTTH
Consumables
16.
XN
Testing
 
PART I. GENEAL INSTRUCTIONS
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;
- Provide scientific grounds and data for executing investment, upgrade and development of laboratories.
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
a. 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.
b. Quality indicator is used to measure and determine the degree of quality improved. c. Qualityrefers to a degree to which a set of inherent characteristics fulfills requirements.
d. 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.
dd. Quality management system refers to the management system to control and direct an agency or an organization with regard to quality.
e. Quality policy refers to overall intentions related to quality as formally expressed by holder of highest leading position of an agency or organization.
g. 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.).
h. Referral laboratory refers to an external laboratory to which a sample is submitted by the assessed laboratory for examination.
i. Process means a set of interrelated or interacting activities which transform inputs into outputs.
k. Nonconformity means nonfulfilment of a requirement.
m. 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.
- Evaluate handling of test samples from the time the assessed laboratory receives such samples until it returns test results to its customers.
- 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.
- Decision No. 5530/QD-BYT dated December 25, 2015 by Minister of Health on promulgation of Guidelines on development of standard operation procedures in testing quality management.
- 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:
a) Laboratory profile
b) 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.
c) 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.
- Maximum total score of these criteria is 268 points.
- 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.
- The appropriate response for each criterion shall be marked with a tick and corresponding point is specified in the “Assessing point” column.
-
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
2.
Chapter II. Management of documents and records
8
10
3.
Chapter III. Personnel management
17
21
4.
Chapter IV. Client management and customer service
10
13
5.
Chapter V. Equipment management
19
30
6.
Chapter VI. Internal audit
9
13
7.
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
6
11
10.
Chapter X. Determination of nonconformities, corrective and preventive actions
6
14
11.
Chapter XI. Continual improvement
8
21
12.
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.
- Total points given the laboratory is the sum of points given to applicable criteria.
- 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
Rank 5
<20% of maximum total score or failure to achieve maximum score in compulsory criteria in the checklist with (*) mark
20% - <35% of maximum total score and the laboratory achieves maximum score in compulsory criteria in the checklist with (*) mark
35% - <65% of maximum total score and the laboratory achieves maximum score in compulsory criteria in the checklist with (*) mark
65% - <85% of maximum total score and the laboratory achieves maximum score in compulsory criteria for quality rank 3 in the checklist with (***) mark
85% - <95% of maximum total score and the laboratory achieves maximum score in compulsory criteria for quality rank 3 in the checklist with (***) mark
≥ 95% of maximum total score and the laboratory achieves maximum score in compulsory criteria for quality rank 3 in the checklist with (***) mark
The assessment team will consider and give suitable recommendations depending on each specific circumstance.
Corrective actions must be performed and reports thereof must be submitted to Ministry of Health, Provincial Department of Health and/or regulatory authority within a period of 06 months.
Corrective actions must be performed and reports thereof must be submitted to Ministry of Health, Provincial Department of Health and/or regulatory authority within a period of 03 months.
Testing activities will be maintained and the laboratory should remedy shortcomings.
Testing activities will be maintained and the laboratory should remedy shortcomings.
The laboratory remedies its shortcomings and is encouraged to follow ISO 15189
1. General information:
Name of assessed organization:
Address:
Full name of Director:
Date of assessment:
Name of Laboratory:
Head of Laboratory:
Telephone:                                                                                 Email:
Laboratory level (check only one)
□ National              □ Provincial
□ Regional                    □ District       □ Commune
Type of Laboratory
□ State-owned
□ Private
□ Other
Result of last assessment
Date of last assessment:
Assessed by:
□ Not assessed
□ Requirements for testing quality have been fulfilled
2. List of Assessors
No.
Names of affiliations of assessors
Names of assessors
1.
 
 
2.
 
 
3.
 
 
4.
 
 
5.
…
 
3. List of applicable testing methods:
Laboratory/ Testing Department
List of applicable testing methods
Testing methods with adopting internal quality control procedures
Testing methods with adopting external quality control or inter-laboratory comparison procedures
Average tests/ year
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4. Laboratory Staff
Qualification
Quantity
Physician
 
Pharmacist
 
Bachelor
 
- Bachelor of Medical Laboratory Science
 
- Bachelor of Biotechnology
 
- Bachelor of Science in Biology
 
- Chemical Engineer
 
Laboratory Technician
 
Nurse
 
Other, specify:
 
Total
 
5. List of Laboratory Equipment
No.
Name of equipment
Equipment Model
Quantity
Manufacturing year
Year of using such equipment
Origin (funded by state budget, private sector involvement, etc.)
Operating status (good, failed, etc.)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CHAPTER I. LABORATORY ORGANIZATION AND MANAGEMENT
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
 
 
 
 
 
 
 
 
Legal grounds
 
 
 
 
 
 
 
1.1. Does the Laboratory have the establishment decision (or the laboratory license) granted by a competent authority?
 
 
 
 
2
 
(*)
1.2. Does the Laboratory have the organizational chart which shows the relationships between the Laboratory and other departments/ divisions of the health facility?
 
 
 
 
1
 
 
1.3. Are the relationships between position holders and between expertise groups in the Laboratory clearly defined in the Laboratory’s organizational chart?
 
 
 
 
1
 
 
Establishment of quality objectives & plan
 
 
 
 
 
 
 
1.4. Does the Laboratory set up quality objectives which must be in conformity with its quality policy?
 
 
 
 
1
 
 
1.5. Does the Laboratory formulate annual plan for quality in order to achieve intended quality objectives?
 
 
 
 
1
 
 
1.6. Does the Laboratory implement the formulated plans for quality?
 
 
 
 
2
 
 
1.7. Does the Laboratory set up quality indicators for three examination periods in conformity with its established quality objectives?
 
 
 
 
1
 
 
Laboratory quality manual
 
 
 
 
 
 
 
1.8. The Laboratory quality manual includes the following contents:
 
 
 
 
5
 
 
a) Quality policy statement that includes scope of service, standard of service, objectives of the quality management system, and commitment to compliance by the leader of the governing body or the Laboratory Manager
 
 
 
 
 
 
 
b) Description of the structure of the quality management system and relationship of documentation used in the quality management system
 
 
 
 
 
 
 
c) Establishment of quality objectives and plans
 
 
 
 
 
 
 
d) Description of communication process
 
 
 
 
 
 
 
e) Guarantee on resource and capacity of Laboratory staff  
 
 
 
 
 
 
 
f) Regulations regarding quality management activities and testing methods of the Laboratory
 
 
 
 
 
 
 
g) Description of the roles and responsibilities of the Laboratory manager, quality manager, and other personnel, and referred documents
 
 
 
 
 
 
 
h) Regulation on the power to review and give approval for quality manual.
 
 
 
 
 
 
 
i) Reference to standard operation procedures in the Laboratory
 
 
 
 
 
 
 
1.9. Evidence that the quality manual contents have been communicated/ taught to all staff and relevant persons.
 
 
 
 
1
 
 
Implementation organization 
 
 
 
 
 
 
 
1.10. Does the Laboratory have the written assignment to each staff member
 
 
 
 
1
 
 
Review by management of the governing body
 
 
 
 
 
 
 
1.11. Does the Laboratory manager or authorized person annually perform a review meeting of the quality management system?
 
 
 
 
1
 
 
1.12. Does the review meeting include the following?
 
 
 
 
2
 
 
a) Follow-up of action items from previous management review meetings;
 
 
 
 
 
 
 
b) Review of requests for examination, and suitability of procedures and specimen requirements
 
 
 
 
 
 
 
c) Assessment of customer satisfaction and feedback;
 
 
 
 
 
 
 
d) Staff suggestions;
 
 
 
 
 
 
 
e) Internal audit;
 
 
 
 
 
 
 
f) Risk assessment
 
 
 
 
 
 
 
g) Application of quality indicators
 
 
 
 
 
 
 
h) Reviews by external organizations;
 
 
 
 
 
 
 
i) Internal quality control records across all test areas
 
 
 
 
 
 
 
j) Outcomes of external quality control programs or inter-laboratory comparisons or proficiency tests
 
 
 
 
 
 
 
k) Management and settlement of customer complaints
 
 
 
 
 
 
 
l) Evaluation of service quality of supplier;
 
 
 
 
 
 
 
m) Identification and control of nonconformities
 
 
 
 
 
 
 
n) Results of continual improvement, including current status of corrective actions and preventive actions;
 
 
 
 
 
 
 
o) Changes in the volume and scope of work, personnel, and premises that could affect the quality management system;
 
 
 
 
 
 
 
p) Recommendations for improvement, including technical requirements.
 
 
 
 
 
 
 
Results of management reviews  
 
 
 
 
 
 
 
1.13. Are the minutes of management review meetings, including findings and actions arising from management reviews retained by the Laboratory?
 
 
 
 
1
 
 
1.14. Are the actions arising from management reviews performed in conformity with the plans
 
 
 
 
2
 
 
1.15. Is the performance of actions worked out from management reviews exchanged and shared with the management of governing body and relevant personnel?
 
 
 
 
1
 
 
Total points of Chapter I
 
 
 
 
23
 
 
CHAPTER II. MANAGEMENT OF DOCUMENTS AND RECORDS
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
Document control
 
 
 
 
 
 
 
2.1. Does the Laboratory have internal and external document control procedures, including instructions for compilation of standard operation procedures, flow charts and forms?
 
 
 
 
2
 
 
2.2. Are all documents prepared by the Laboratory identified to include:
 
 
 
 
1
 
 
a) Title
 
 
 
 
 
 
 
b) Unique identifier on each page
 
 
 
 
 
 
 
c) The date of the current edition and edition number
 
 
 
 
 
 
 
d) Page number to total number of pages
 
 
 
 
 
 
 
e) Signature of person who takes charge of reviewing, giving approval and issue
 
 
 
 
 
 
 
2.3. Are all documents properly maintained and easily accessible?
 
 
 
 
1
 
 
2.4. Does the Laboratory strictly control documents in terms of:
 
 
 
 
2
 
***
a) Written requests for preparation, amendment, consideration and approval for documents
 
 
 
 
 
 
 
b) Records of distribution of documents
 
 
 
 
 
 
 
c) List of controlled internal and external documents
 
 
 
 
 
 
 
d) Changes to documents which are identified
 
 
 
 
 
 
 
e) Documents are periodically reviewed and updated at a frequency that ensures that they remain fit for purpose of use
 
 
 
 
 
 
 
f) Documents remain legible
 
 
 
 
 
 
 
g) Obsolete controlled documents are dated and marked as obsolete
 
 
 
 
 
 
 
h) At least one copy of an obsolete controlled document is retained for a specified time period of at least 12 months
 
 
 
 
 
 
 
2.5. Are summary procedures/ instructions controlled?
 
 
 
 
1
 
 
Record control
 
 
 
 
 
 
 
2.6. Does the Laboratory have documented procedures for identification, collection, indexing, access, storage, maintenance, amendment and safe disposal of records?
 
 
 
 
1
 
 
2.7. Does the Laboratory define the time period that the records are to be retained in conformity with national regulations or other relevant regulations 
 
 
 
 
1
 
 
2.8. Does the Laboratory provide a suitable environment for storage of records (hard copies or soft copies/ computerized records) to prevent damage, deterioration, loss or unauthorized access
 
 
 
 
1
 
 
Total points of Chapter II
 
 
 
 
10
 
 
CHAPTER III: PERSONNEL MANAGEMENT
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
3.1. Does the Laboratory set up requirements for professional level, qualification, training, experience and skills needed for each position in the Laboratory?
 
 
 
 
1
 
 
3.2. Does the Laboratory have job descriptions that describe responsibilities, authorities and tasks for all personnel?
 
 
 
 
1
 
 
3.3. Are all personnel of the Laboratory provided with training programs suitable for assigned tasks?
 
 
 
 
1
 
 
3.4. Does the Laboratory have procedures for personnel management and storage of personnel records?
 
 
 
 
1
 
 
3.5. Have the authorized person to confirm testing results meet competency requirements as prescribed by law?
 
 
 
 
2
 
*
3.6. Is there a decision on appointment of the Laboratory Manager available?
 
 
 
 
1
 
 
3.7. Does the Laboratory define specific duties and tasks of assigned/ appointed quality management personnel and technical managers?
 
 
 
 
1
 
 
3.8. Does the Laboratory have a program to direct/ introduce new staff to the organization with the following contents?
 
 
 
 
2
 
 
a) Introduction about the organization;
 
 
 
 
 
 
 
b) Introduction about the Laboratory;
 
 
 
 
 
 
 
c) Terms and conditions of employment;
 
 
 
 
 
 
 
d) Facilities;
 
 
 
 
 
 
 
e) Health and safety requirements in the Laboratory;
 
 
 
 
 
 
 
3.9. Does the Laboratory assess the competence of new staff following training?
 
 
 
 
1
 
 
3.10. Does the Laboratory have plan and implement the plan for supervising the performance of assigned tasks by new staff within a period of at least one year?
 
 
 
 
1
 
 
3.11. Does the Laboratory provide compulsory training program for its staff in the following areas:
 
 
 
 
2
 
 
a) The quality management system;
 
 
 
 
 
 
 
b) Assigned work processes and procedures;
 
 
 
 
 
 
 
c) The applicable laboratory information system;
 
 
 
 
 
 
 
d) Health and safety requirements in the Laboratory;
 
 
 
 
 
 
 
e) Confidentiality of patient information;
 
 
 
 
 
 
 
f) Professional ethics, including the prevention of conflicts of interest;
 
 
 
 
 
 
 
3.12. Does the Laboratory have procedure for assessing the competent of its personnel?  
 
 
 
 
1
 
 
3.13. Does the Laboratory annually assess the competence of its personnel?
 
 
 
 
1
 
***
3.14. Does the Laboratory periodically review its staff performance?
 
 
 
 
1
 
 
3.15. Does the Laboratory have plan for providing continuing education program to each staff?
 
 
 
 
1
 
 
3.16. Has all staff of the Laboratory participated in the continuing education program as required by current regulation?
 
 
 
 
1
 
 
3.17. Does the Laboratory store records of all staff with regard to the following contents?
 
 
 
 
2
 
 
a) Copy of qualification or certification;
 
 
 
 
 
 
 
b) Scientific CV;
 
 
 
 
 
 
 
c) Job descriptions;
 
 
 
 
 
 
 
d) Introduction of new staff to the laboratory environment (if any);
 
 
 
 
 
 
 
e) Records of training/ education;
 
 
 
 
 
 
 
f) Staff competency assessment;
 
 
 
 
 
 
 
g) Reports of accidents and exposure to occupational hazards;
 
 
 
 
 
 
 
h) Health examination record and immunization status related to assigned duties.
 
 
 
 
 
 
 
Total points of Chapter 3
 
 
 
 
21
 
 
CHAPTER IV. CLIENT MANAGEMENT AND CUSTOMER SERVICE
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
4.1. Does the Laboratory have procedures for client satisfaction survey?
 
 
 
 
1
 
 
4.2. Does the Laboratory have procedure for follow-up of complaints or feedback from clients, related parties and staff?
 
 
 
 
1
 
***
4.3. Is there a tool for regularly evaluating client satisfaction?
 
 
 
 
1
 
 
4.4. Does the Laboratory have records of client opinions?
 
 
 
 
1
 
 
4.5. Does the Laboratory assess the Service Agreements made with the Laboratory as well as review whether the ability to supply services meets quality requirements or not?
 
 
 
 
1
 
 
4.6. Does the Laboratory consider and resolve complaints/ feedbacks received from clients?
 
 
 
 
1
 
 
4.7. Does the Laboratory store records related to complaints and corrective actions taken?
 
 
 
 
1
 
 
Information for clients and users
 
 
 
 
 
 
 
4.8. Are there client service manual/ sampling manual available to relevant departments in the Laboratory?
 
 
 
 
2
 
*
4.9. Are copies of client service manual/ sampling manual readily accessed by Laboratory staff?
 
 
 
 
1
 
 
4.10. Shall the Laboratory have the following necessary information available for its clients?
 
 
 
 
3
 
 
a) The location of the Laboratory;
 
 
 
 
 
 
 
b) Types of clinical services offered by the Laboratory, including examinations referred to other laboratories;
 
 
 
 
 
 
 
c) Opening hours of the Laboratory;
 
 
 
 
 
 
 
d) The examinations offered by the Laboratory, consisting of: Information concerning samples required, primary sample volumes, special precautions, turnaround time, biological reference intervals, and clinical decision values (which may also be provided in general categories or for groups of examinations);
 
 
 
 
 
 
 
e) Instructions for completion of the request form;
 
 
 
 
 
 
 
f) Instruction for preparation of the patient;
 
 
 
 
 
 
 
g) Instructions for patient-collected samples;
 
 
 
 
 
 
 
h) Instructions for transportation of samples, including any special handling needs;
 
 
 
 
 
 
 
i) Any requirements for patients’ information confidentiality (e.g. consent to disclose clinical information and family history to relevant healthcare professionals, where referral is needed, etc.);  
 
 
 
 
 
 
 
j) The laboratory’s criteria for accepting and rejecting samples;
 
 
 
 
 
 
 
k) A list of factors known to significantly affect the performance of the examination or the interpretation of the results;
 
 
 
 
 
 
 
l) The availability of clinical advice on ordering of examinations and on interpretation of examination results;
 
 
 
 
 
 
 
m) The laboratory’s policy on protection of client’s personal information;
 
 
 
 
 
 
 
n)Instructions for complaint/ feedback procedure.
 
 
 
 
 
 
 
Total points of Chapter IV
 
 
 
 
13
 
 
CHAPTER V. EQUIPMENT MANAGEMENT
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
1.1. Does the Laboratory have procedure for management of equipment?
 
 
 
 
1
 
 
1.2. Is the Laboratory furnished with all equipment needed for its operations and in conformity with the list of techniques?
 
 
 
 
2
 
*
1.3. Has the Laboratory checked new equipment to ensure that the equipment is in good operating status before use?
 
 
 
 
1
 
 
1.4. Are there instructions on the use of equipment available in Vietnamese language?
 
 
 
 
1
 
 
1.5. Is direction for use of equipment placed at readily accessible place?
 
 
 
 
1
 
 
1.6. Is all equipment of the Laboratory uniquely labeled, marked or otherwise identified?
 
 
 
 
1
 
 
1.7. Is the equipment operated by trained personnel?
 
 
 
 
2
 
 
1.8. Does the Laboratory have the list and contact information of equipment suppliers and warranty providers?
 
 
 
 
1
 
 
1.9. Does the Laboratory have equipment usage log sheet?
 
 
 
 
1
 
 
1.10. Do procedures for management of equipment include procedures for safe handling, transport, storage and use of equipment to prevent its contamination and deterioration?
 
 
 
 
1
 
 
1.11. Does the Laboratory have plan and perform the verification/ calibration of equipment that may affects examination results in accordance with effective regulations of law/ of manufacturers?
 
 
 
 
3
 
***
1.12. Has the Laboratory carried out maintenance of equipment according to manufacturer's instructions?
 
 
 
 
3
 
*
1.13. Has the Laboratory take measures to decontaminate equipment before repair or decommissioning?
 
 
 
 
1
 
 
1.14. Whenever equipment is found to be defective/ or pending decommissioning, is it clearly labeled/ differentiated from others?
 
 
 
 
1
 
 
1.15. Do procedures for management of equipment include regulations on adverse incidents and accidents attributed to specific equipment which must be reported to the manufacturer or supplier and regulatory authorities and properly recorded?
 
 
 
 
1
 
 
1.16. Has the Laboratory verified and recorded the performance of equipment before use or after repair?
 
 
 
 
1
 
 
1.17. Does the Laboratory have back-up procedures for equipment failure?
 
 
 
 
2
 
 
1.18. Has the Laboratory provided uninterrupted testing services, with no disruptions due to equipment failure in the last year (or since the last assessment)?
 
 
 
 
3
 
 
1.19. Has the Laboratory retained all equipment records which include the following?
 
 
 
 
3
 
 
a) Identity of the equipment;
 
 
 
 
 
 
 
b) Manufacturer’s name, model and serial number or other unique identification;
 
 
 
 
 
 
 
c) Contact information for the supplier or the manufacturer;
 
 
 
 
 
 
 
d) Date of receiving and date of entering into service;
 
 
 
 
 
 
 
e) Location of equipment;
 
 
 
 
 
 
 
f) Condition when receiving the equipment (e.g. new, used or reconditioned);
 
 
 
 
 
 
 
g) Manufacturer’s instructions;
 
 
 
 
 
 
 
h) Records that confirmed the equipment’s initial acceptability for use when equipment is incorporated in the Laboratory;
 
 
 
 
 
 
 
i) Records of verifications/ calibrations, warranty, maintenance and equipment performance records;
 
 
 
 
 
 
 
j) Damage to, or malfunction, modification, or repair of the equipment.
 
 
 
 
 
 
 
Total points of Chapter V
 
 
 
 
30
 
 
CHAPTER VI. INTERNAL AUDIT
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
6.1. Does the Laboratory have procedures and plans for internal audits?
 
 
 
 
1
 
 
6.2. Are the audit criteria, scope, frequency and methods defined and documented in the audit program?
 
 
 
 
2
 
 
6.3. Has the Laboratory conducted internal audits at planned intervals?  
 
 
 
 
2
 
 
6.4. Have internal audits been conducted by persons who have been trained in quality management and are not involved in laboratory activities in the section being audited?
 
 
 
 
1
 
 
6.5. Have all activities in the quality management system been considered and audited in internal audits?
 
 
 
 
2
 
***
6.6. Are internal audit findings documented and retained by the Laboratory?
 
 
 
 
1
 
 
6.7. Are internal audit findings presented to the laboratory head/ manager and/or the management of health facility?
 
 
 
 
1
 
 
6.8. Are recommendations for corrective/preventive actions made based on internal audit findings?
 
 
 
 
1
 
 
6.9. Is corrective/preventive action plan developed with clear timelines and documented follow-up?
 
 
 
 
2
 
 
Total points of Chapter VI
 
 
 
 
13
 
 
CHAPTER VII. MANAGEMENT OF PURCHASING, EQUIPMENT, CONSUMMABLES, CHEMICALS AND BIOLOGICAL PRODUCTS
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
7.1. Does the Laboratory have a documented procedure for selection and purchasing of equipment, consumables, chemicals and biological products?
 
 
 
 
1
 
 
7.2. Has the Laboratory annually formulate the plan for needs for equipment, consumables, chemicals and biological products?
 
 
 
 
1
 
 
7.3. Has the Laboratory participated in determination of needs, selection of approved suppliers and acceptance of equipment, consumables, chemicals and biological products?
 
 
 
 
2
 
*
7.4. Is an up-to-date list of approved suppliers of equipment, consumables, chemicals and biological products available?
 
 
 
 
1
 
 
7.5. Has supplier performance been evaluated by the Laboratory?
 
 
 
 
1
 
 
7.6. Does the Laboratory have a documented procedure for the reception, storage, acceptance testing and inventory management of biological products and consumables?
 
 
 
 
1
 
 
7.7. Are storage areas/ warehouses of chemicals, biological products and consumables set up and monitored in an appropriate way that meets the following requirements?
 
 
 
 
3
 
 
a) The storage area is well-organized;
 
 
 
 
 
 
 
b) The storage area is clean and free of dust, rats and pests;
 
 
 
 
 
 
 
c) There are designated places labeled for all inventory items;
 
 
 
 
 
 
 
d) The storage in direct sunlight is avoided and the storage area is adequately ventilated;
 
 
 
 
 
 
 
e) The ambient temperature and humidity at the storage area are monitored daily;
 
 
 
 
 
 
 
f) The access to the warehouse/ storage areas is controlled.
 
 
 
 
 
 
 
7.8. If the Laboratory does not store chemicals, biological products and consumables at the Laboratory, does the Laboratory carry out an inspection of storage conditions and environment?
 
 
 
 
1
 
 
7.9. Is the quality of each test kit or shipment of chemicals and biological products verified by the Laboratory before use?
 
 
 
 
1
 
 
7.10. Are chemicals, biological products and consumables which are expired or whose quality does not meet prescribed quality requirements labeled and stored properly?
 
 
 
 
1
 
 
7.11. Area hazardous chemicals and biological products stored appropriately?
 
 
 
 
1
 
 
7.12. Are there instructions for use of chemicals, biological products and consumables, including manufacturer’s instructions, principles and safe handling, available in the Laboratory?
 
 
 
 
1
 
 
7.13. Is the FEFO principle (“First Expire/First Out", means chemicals and biological products that will expire first shall be placed and used in front of chemicals and biological products with a later expiry date) practiced at the Laboratory?
 
 
 
 
1
 
 
7.14. Are the following records of consumables, chemicals and biological products maintained by the Laboratory?
 
 
 
 
2
 
 
a) Identity of chemicals, biological products or consumables;
 
 
 
 
 
 
 
b) Manufacturer’s name and batch code or lot number;
 
 
 
 
 
 
 
c) Contact information for the supplier/ distributor or the manufacturer;
 
 
 
 
 
 
 
d) Date of receiving, the expiry date, date of entering into service and the date the material was taken out of service (if any);
 
 
 
 
 
 
 
e) Condition when received (e.g. acceptable or damaged);
 
 
 
 
 
 
 
f) Quality of chemicals, biological products and consumables before use;
 
 
 
 
 
 
 
g) Monitoring of quantity of chemicals, biological products and consumables (logbook of use of biological products/ stock cards).
 
 
 
 
 
 
 
7.15. Where the Laboratory uses chemicals, biological products/ mediums prepared or completed in-house, does the Laboratory s record, in addition to the relevant information above, information concerning the person or persons undertaking their preparation, expiry date and concentration (if any)?
 
 
 
 
1
 
 
7.16. Are chemicals, biological products and consumables which are expired or fail to meet quality requirements disposed of properly?
 
 
 
 
1
 
 
7.17. Has the Laboratory provided uninterrupted testing services, with no disruptions due to chemicals, biological products or consumables in the last year or since last audit?
 
 
 
 
3
 
***
Total points of Chapter VII
 
 
 
 
23
 
 
CHAPTER VIII: TESTING PROCESS CONTROL
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
Pre-examination processes
 
 
 
 
 
 
 
8.1. Are all samples accompanied by test request forms?
 
 
 
 
2
 
 
8.2. Does the test request form include all of the following information?
 
 
 
 
3
 
 
a) Patient identification, including: Full name, gender, date of birth, and the location/contact details of the patient, and a unique identifier;
 
 
 
 
 
 
 
b) Type of primary sample;
 
 
 
 
 
 
 
c) Examinations requested;
 
 
 
 
 
 
 
d) Clinically relevant information about the patient;
 
 
 
 
 
 
 
e) Date and time of specimen collection; name of person taking such samples;
 
 
 
 
 
 
 
f) Date and time of sample receipt; full name of the Laboratory’s staff receiving such samples;
 
 
 
 
 
 
 
g) Name and signature of doctor ordering examinations.
 
 
 
 
 
 
 
8.3. Are there documented procedures for sample collection, which include all of the following contents, available?
 
 
 
 
2
 
***
a) Determination of the identity of the patient from whom a specimen is collected;
 
 
 
 
 
 
 
b) Are received samples evaluated according to acceptance or rejection criteria?
 
 
 
 
 
 
 
c) Are samples logged appropriately upon receipt in the Laboratory (including date, time and name of receiving officer)?
 
 
 
 
 
 
 
d) When a primary sample is split, can the portions are traced back to the primary sample?
 
 
 
 
 
 
 
e) If it is not a 24-hour laboratory, is there a documented method for receiving and handling of samples after normal working hours?
 
 
 
 
 
 
 
f) Are samples delivered to the correction workstations in a timely manner?
 
 
 
 
 
 
 
g) Are specimens collected, transported and stored appropriately?
 
 
 
 
 
 
 
Examination processes
 
 
 
 
 
 
 
8.4. Has the Laboratory formulated and implemented examination procedures which include the following contents?
 
 
 
 
3
 
***
a) Purpose;
 
 
 
 
 
 
 
b) Scope of application;
 
 
 
 
 
 
 
c) Responsibility to implement;
 
 
 
 
 
 
 
d) Definition, terms and abbreviations;
 
 
 
 
 
 
 
e) Principles/ rules: Specify testing methods, examination rules and technical indicators
 
 
 
 
 
 
 
f) Equipment, materials and supplies (including types of specimens and chemicals used)
 
 
 
 
 
 
 
g) Quality control
 
 
 
 
 
 
 
h) Safety
 
 
 
 
 
 
 
i) Examination contents (including preparation of patient, chemicals, etc. and examination steps)
 
 
 
 
 
 
 
j) Interpretation and reporting of results (including principle of procedure for calculating quantitative results, where relevant; reference intervals of clinical decision values; reportable interval of examination results; instructions for determining quantitative results when a result is not within the measurement interval; alert/critical values; potential sources of variation; laboratory clinical interpretation;  
 
 
 
 
 
 
 
k) Precautions (including interferences (e.g. lipaemia, haemolysis, bilirubinemia, drugs) and cross reactions);
 
 
 
 
 
 
 
l) Document storage
 
 
 
 
 
 
 
m) Relevant documents
 
 
 
 
 
 
 
n) Reference documents
 
 
 
 
 
 
 
8.5. Has the Laboratory formulated and implemented the quality control procedures?
 
 
 
 
2
 
 
8.6. Does the Laboratory have a procedure to prevent the release of patient results in the event of internal quality control failure?
 
 
 
 
2
 
 
8.7. Has the Laboratory conducted internal quality control for 02 different values in quantitative tests?
 
 
 
 
3
 
*
8.8. Are positive and negative controls conducted for qualitative tests?
 
 
 
 
2
 
*
8.9. Are internal controls for semi-quantitative tests conducted in accompanied test kits or other internal control materials?
 
 
 
 
3
 
*
8.10. Are internal controls periodically conducted for other internal control samples in rapid tests, including positive and negative controls (if any)?
 
 
 
 
1
 
*
8.11. Are internal controls conducted at the same time or before testing patient samples?
 
 
 
 
3
 
*
8.12. If internal control results exceed the acceptable range, has the Laboratory identified causes and taken corrective actions, and then conducted tests after completion of such corrective actions?
 
 
 
 
3
 
***
8.13. Are internal control results periodically verified to discover factors that may adversely affect testing results and conduct corrective actions?
 
 
 
 
2
 
 
8.14. Are instructions for external quality control or interlaboratory comparison available?
 
 
 
 
1
 
 
8.15. Does the Laboratory participate in the external quality assessment or interlaboratory comparison programs (particularly, tests without EQA samples)? If the answer is yes, are the following criteria met?
 
 
 
 
3
 
*
a) Do EQA samples come from providers who are accredited or approved?
 
 
 
 
 
 
 
b) Are EQA samples tested by personnel who are authorized to conduct such test types?
 
 
 
 
 
 
 
c) Are all EQA results analyzed and corrective actions conducted in the event of unconformities?
 
 
 
 
 
 
 
d) Are EQA results exchanged with relevant personnel?
 
 
 
 
 
 
 
8.16. Are newly introduced equipment or biological products and methods validated/verified on-site and are records documenting validation available?
 
 
 
 
2
 
***
8.17. Has the Laboratory complied with the formulated examination procedures?
 
 
 
 
3
 
 
Post-examination processes
 
 
 
 
 
 
 
8.18. Does the Laboratory have procedures for review of examination results before releasing them to patients (specify personnel authorized to review examination results and factors to be reviewed, including internal and external quality control results, clinical information and previous examination results)?
 
 
 
 
2
 
***
8.19. Does the Laboratory adopt measures to ensure that examination results are reported accurately and clearly?
 
 
 
 
1
 
 
8.20. Are regulations on format and medium of the report of examination results available?
 
 
 
 
1
 
 
8.21. Does the report form include all of the following information?
 
 
 
 
3
 
 
a) Type of examination, including: examination procedure/ testing methods/ equipment;
 
 
 
 
 
 
 
b) The identification of the Laboratory that issued the report;
 
 
 
 
 
 
 
c) Identification of all examinations that have been performed by a referral laboratory;
 
 
 
 
 
 
 
d) Patient identification and patient location on each page of the report;
 
 
 
 
 
 
 
e) Name of the requester;
 
 
 
 
 
 
 
f) Date of primary sample collection (and time, when available);
 
 
 
 
 
 
 
g) Type of primary sample;
 
 
 
 
 
 
 
h) Measurement procedure, where appropriate;
 
 
 
 
 
 
 
i) Examination results reported in SI (International System) units, traceable to SI units, or other applicable units;
 
 
 
 
 
 
 
j) Biological reference intervals, clinical decision values, or diagrams/monograms’ supporting clinical decision values, where applicable;
 
 
 
 
 
 
 
k) Interpretation of results, where appropriate;
 
 
 
 
 
 
 
l) Other comments such as cautionary or explanatory notes;
 
 
 
 
 
 
 
m) Identification of the person(s) reviewing the results and authorizing the release of the report;
 
 
 
 
 
 
 
n) Date of the report, and time of release;
 
 
 
 
 
 
 
o) Page number to total number of pages;
 
 
 
 
 
 
 
p) The report includes space for interpretation or comments on results, if needed.
 
 
 
 
 
 
 
8.22. Does the Laboratory establish documented procedures for the release of examination results, including details of who may release results and to whom? Do such procedures ensure that the following conditions are met?
 
 
 
 
3
 
 
a) When the quality of the primary sample received is unsuitable for examination, or could have compromised the result, this is indicated in the report;
 
 
 
 
 
 
 
b) Examination results include “alert” or “critical” values;
 
 
 
 
 
 
 
c) Results are legible, without mistakes in transcription, and reported to persons authorized to receive and use the information;
 
 
 
 
 
 
 
d) When results are transmitted as an interim report, the final report is always forwarded to the requester;
 
 
 
 
 
 
 
e) Results that are distributed by telephone or electronic means must reach only authorized recipients;
 
 
 
 
 
 
 
f) Results which are provided orally shall be followed by a written report;
 
 
 
 
 
 
 
g) There shall be a record of all oral results provided.
 
 
 
 
 
 
 
8.23. Are there regulations on revision to reports available?
 
 
 
 
2
 
 
a) The revised report is clearly identified as a revision and includes reference to the date and patient’s identity in the original report;
 
 
 
 
 
 
 
b) The user is made aware of the revision;
 
 
 
 
 
 
 
c) The revised record shows the time and date of the change and the name of the person responsible for the change.
 
 
 
 
 
 
 
8.24. Are the original report entries remained in the record when revisions are made?
 
 
 
 
1
 
 
8.25. Does the Laboratory have procedures for identification, collection, retention, numbering, access, storage and safe disposal of tested specimens?
 
 
 
 
2
 
 
8.26. Are tested specimens stored appropriately?
 
 
 
 
1
 
 
8.27. Are specimens deposed of appropriately?
 
 
 
 
1
 
 
Total points of Chapter VIII
 
 
 
 
57
 
 
CHAPTER IX. INFORMATION MANAGEMENT
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
9.1. Are there regulations on security of information and examination results of patients available?
 
 
 
 
2
 
***
9.2. Are the authorities and responsibilities of all personnel, particularly the following, defined?
 
 
 
 
3
 
 
a) Access patient date and information;
 
 
 
 
 
 
 
b) Enter patient data and examination results;
 
 
 
 
 
 
 
c) Change patient data or examination results;
 
 
 
 
 
 
 
d) Authorize the release of examination results and reports.
 
 
 
 
 
 
 
9.3. Is the electronic information system protected from unauthorized access
 
 
 
 
2
 
 
9.4. Is the system maintained in a manner that ensures the integrity of the data and information?
 
 
 
 
1
 
 
9.5. Are system failures and the appropriate immediate and corrective actions recorded?
 
 
 
 
1
 
 
9.6. Does the Laboratory have documented contingency plans to maintain services in the event of failure or downtime in information systems?
 
 
 
 
2
 
 
Total points of Chapter IX
 
 
 
 
11
 
 
CHAPTER X. DETERMINATION OF NONCONFORMITIES, CORRECTIVE AND PREVENTIVE ACTIONS
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
Identification of nonconformities
 
 
 
 
 
 
 
10.1. Does the Laboratory have a documented procedure to identify and manage nonconformities? Are the following contents included in the procedure?
 
 
 
 
3
 
***
a) Identification of nonconformities in any aspect of the quality management system, including pre-examination, examination or post-examination processes;
 
 
 
 
 
 
 
b) Recording of information concerning the nonconformity (when such nonconformity occurs, causes of such nonconformity and involved lab personnel, etc.);
 
 
 
 
 
 
 
c) The responsibilities and authorities for handling nonconformities, including authorities and assignments for each handling step;
 
 
 
 
 
 
 
d) Definition of immediate actions (solutions) to be taken;
 
 
 
 
 
 
 
e) Determination of the extent of the nonconformity, and nonconformities need corrective actions;
 
 
 
 
 
 
 
f) Suspension of examinations and recall of released results, as necessary;
 
 
 
 
 
 
 
g) Notification to the requesting physician or authorized individual for using the results;
 
 
 
 
 
 
 
h) Appropriate identification and storage of the recalled results of nonconforming examinations;
 
 
 
 
 
 
 
i) Where/how nonconformities are recorded;
 
 
 
 
 
 
 
j) Determination of time-limit for resolution of nonconformities;
 
 
 
 
 
 
 
k) Ensuring the recall of the results of any nonconforming or potentially nonconforming examinations;
 
 
 
 
 
 
 
l) Release of results after corrective actions has been taken.
 
 
 
 
 
 
 
10.2. Have information concerning nonconformities been sufficiently recorded and appropriately stored in accordance with the Laboratory’s regulations?
 
 
 
 
2
 
 
Corrective actions
 
 
 
 
 
 
 
10.3. Does the Laboratory have a documented procedure for corrective actions which includes the following contents?
 
 
 
 
3
 
 
a) Determination of the root cause of nonconformities;
 
 
 
 
 
 
 
b) Implementation of correction actives;
 
 
 
 
 
 
 
c) Recording of the results of corrective actions taken;
 
 
 
 
 
 
 
d) Review and evaluation of the effectiveness of corrective actions taken;
 
 
 
 
 
 
 
e) Evaluation of the need for corrective actions to ensure that nonconformities do not recur.
 
 
 
 
 
 
 
10.4. Have information concerning corrective actions been sufficiently recorded and appropriately stored in accordance with regulations?
 
 
 
 
2
 
 
Preventive actions
 
 
 
 
 
 
 
10.5. Does the Laboratory have a documented procedure for preventive actions which includes the following contents?
 
 
 
 
2
 
 
a) Review of the Laboratory data and information to determine where potential nonconformities exist;
 
 
 
 
 
 
 
a) Determination of the root cause(s) of potential nonconformities;
 
 
 
 
 
 
 
c) Evaluation of the need for preventive actions to prevent the occurrence of nonconformities;
 
 
 
 
 
 
 
d) Determination and implementation of preventive actions needed;
 
 
 
 
 
 
 
e) Recording of the results of preventive actions taken;
 
 
 
 
 
 
 
j) Review of the effectiveness of the preventive actions taken.
 
 
 
 
 
 
 
10.6. Have information concerning preventive actions been sufficiently recorded and appropriately stored in accordance with regulations? Has the effectiveness of the preventive actions taken been considered and evaluated in terms of the following contents?
 
 
 
 
2
 
***
a) Review of the Laboratory data and information to determine where potential nonconformities exist;
 
 
 
 
 
 
 
b) Analysis of the root cause(s) of nonconformities;
 
 
 
 
 
 
 
c) Implementation and recording of preventive actions taken;
 
 
 
 
 
 
 
d) Review and evaluation of the effectiveness of preventive actions taken.
 
 
 
 
 
 
 
Total points of Chapter X
 
 
 
 
14
 
 
CHAPTER XI. CONTINUAL IMPROVEMENT
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
11.1. Does the Laboratory have a documented procedure for continual improvement activities which includes the following contents?
 
 
 
 
3
 
 
a) Determination of continual improvement activities in the quality management system;
 
 
 
 
 
 
 
b) Formulation of the action plan for improvement;
 
 
 
 
 
 
 
c) Recoding of information concerning the action plan for improvement;
 
 
 
 
 
 
 
d) Implementation of the action plan;
 
 
 
 
 
 
 
e) Communicating the action plan for improvement and related goals to the Laboratory personnel.
 
 
 
 
 
 
 
11.2. Does the Laboratory determine and implement continual improvement activities/ projects?
 
 
 
 
3
 
 
11.3. Does the Laboratory periodically organize meetings with the management of health facility or governing body to review applicable quality indicators and the need for continual improvement?
 
 
 
 
2
 
 
11.4. Are quality indicators tracked and reviewed regularly?
 
 
 
 
3
 
*
11.5. Are graphical tools (charts and graphs) used to communicate quality findings and identify trends (if any)?
 
 
 
 
2
 
 
11.6. Are the results of review and analysis of quality indicators used to identify potential quality improvement activities of the Laboratory?
 
 
 
 
2
 
 
11.7. Is the outcome of continual improvement activities reviewed and evaluated to determine the effectiveness of improved quality of laboratory performance?
 
 
 
 
3
 
***
11.8. Do the Laboratory personnel participate in quality improvement activities?
 
 
 
 
3
 
 
Total points of Chapter XI
 
 
 
 
21
 
 
CHAPTER XII. FACILITIES AND SAFETY
CONTENTS
Yes (Y)
Partial (P)
No (N)
Not applicable (N/A)
Score
Assessing point
Comments
12.1. Is the area or space of the Laboratory adequate as regulated and divided into specific functional sections?
 
 
 
 
2
 
*
12.2. Is a laboratory safety manual available, accessible and up-to-date?
 
 
 
 
1
 
***
12.3. Does the safety manual include guidelines on the following topics?
 
 
 
 
3
 
***
a) The Laboratory profile
 
 
 
 
 
 
 
b) Safety policies
 
 
 
 
 
 
 
c) Risk assessment
 
 
 
 
 
 
 
d) The laboratory safety management, including laboratory safety programs, responsibilities and duties of personnel in charge of laboratory safety, safety inspection programs, safety training programs and laboratory internal regulations.
 
 
 
 
 
 
 
e) Blood and body fluid precautions;
 
 
 
 
 
 
 
f) Hazardous waste treatment;
 
 
 
 
 
 
 
g) Hazardous chemicals/ materials;
 
 
 
 
 
 
 
h) MSDS sheets (Material Safety Data Sheet);
 
 
 
 
 
 
 
i) Personal protective equipment;
 
 
 
 
 
 
 
j) Vaccination;
 
 
 
 
 
 
 
k) Post-exposure prophylaxis;
 
 
 
 
 
 
 
l) Fire safety;
 
 
 
 
 
 
 
m) Electrical safety.
 
 
 
 
 
 
 
Office facilities
 
 
 
 
 
 
 
12.4. Does the Laboratory provide space for staff activities?
 
 
 
 
1
 
 
a) Washrooms;
 
 
 
 
 
 
 
b) Supply of drinking water;
 
 
 
 
 
 
 
c) Space for changing clothing or personal protective equipment.
 
 
 
 
 
 
 
Sample collection areas and facilities
 
 
 
 
 
 
 
12.5. Are there separate areas for collection of specimens?
 
 
 
 
1
 
*
a) Is the sample collection area appropriated equipped to ensure the patient privacy and comfort?
 
 
 
 
 
 
 
b) Washrooms;
 
 
 
 
 
 
 
c) Are there first aid kits available at the Laboratory for its personnel and patients at the sample collection area?
 
 
 
 
 
 
 
Laboratory areas
 
 
 
 
 
 
 
12.6. Is the access to the Laboratory’s areas functioned to conduct examinations properly controlled?
 
 
 
 
1
 
 
12.7. Is the physical work environment appropriate for testing?
 
 
 
 
2
 
 
a) Is there a backup power supply?
 
 
 
 
 
 
 
b) Is adequately lit?
 
 
 
 
 
 
 
c) Is adequately ventilated?
 
 
 
 
 
 
 
d) Is the noise controlled?
 
 
 
 
 
 
 
e) Is water supply adequately?
 
 
 
 
 
 
 
f) Are the chairs/stools at the workstations appropriate for bench height and the testing operations being performed?
 
 
 
 
 
 
 
g) Is the waste properly disposed of?
 
 
 
 
 
 
 
12.8. Is personal protective equipment appropriate and easily accessible at the Laboratory?
 
 
 
 
1
 
 
12.9. Is the safety equipment, including the following types, available and inspected regularly?
 
 
 
 
2
 
 
a) Biosafety cabinets;
 
 
 
 
 
 
 
b) Covers on centrifuge(s);
 
 
 
 
 
 
 
c) Hand-washing station;
 
 
 
 
 
 
 
d) Eyewash station/bottle(s) and showers where applicable;
 
 
 
 
 
 
 
e) Spill kits;
 
 
 
 
 
 
 
f) First aid kits.
 
 
 
 
 
 
 
12.10. Are disinfection procedures regularly conducted and documented at the Laboratory?
 
 
 
 
1
 
 
Storage facilities
 
 
 
 
 
 
 
12.11. Does the Laboratory provide a specific space for storage of the following materials?
 
 
 
 
1
 
 
a) Specimens;
 
 
 
 
 
 
 
b) Documents and records;
 
 
 
 
 
 
 
c) Equipment;
 
 
 
 
 
 
 
d) Biological products, chemicals and consumables.
 
 
 
 
 
 
 
12.12. Are measures taken at the storage areas to prevent cross contamination?
 
 
 
 
1
 
 
12.13. Are clinical specimens stored separately from biological products, chemicals and blood products?
 
 
 
 
1
 
 
12.14. Are hazardous materials stored, maintained and used in a safety manner as regulated?
 
 
 
 
1
 
 
Work areas and environmental conditions
 
 
 
 
 
 
 
12.15. Are work areas cleaned and well maintained with appropriate signage posted?
 
 
 
 
1
 
 
12.16. Are wires, cables and sockets properly located and protected from traffic?
 
 
 
 
1
 
 
12.17. Is there a backup power supply available to ensure the uninterrupted operation of equipment that may adversely affect examination results?
 
 
 
 
1
 
 
12.18. Is equipment placed appropriately (away from water hazards or hazardous chemicals, etc.)?
 
 
 
 
1
 
 
Waste management
 
 
 
 
 
 
 
12.19. Is infectious waste separated from non-infectious waste?
 
 
 
 
1
 
 
12.20. Has the infectious waste been treated properly by autoclaving or incineration?
 
 
 
 
1
 
 
12.21. Are hazardous chemicals/materials disposed or/ treated properly?
 
 
 
 
1
 
 
12.22. Are sharp instruments handled and disposed of properly in separate containers that are appropriately utilized?
 
 
 
 
1
 
 
12.23. Is fire safety included as part of the Laboratory’s overall safety programme?
 
 
 
 
1
 
 
a) Are appropriate fire extinguishers available, in working condition and routinely inspected?
 
 
 
 
 
 
 
b) Is an operational fire warning system in place in the laboratory, and are there periodic fire drills?
 
 
 
 
 
 
 
Laboratory safety
 
 
 
 
 
 
 
12.24. Are safety inspections documented and conducted regularly?
 
 
 
 
1
 
 
12.25. Is trained safety personnel designated to conduct safety inspections?
 
 
 
 
1
 
 
12.26. Are the outcomes of safety inspections documented and reported to an authorized individual?
 
 
 
 
1
 
 
12.27. Is a safety officer designated to supervise the implementation of safety programs?
 
 
 
 
1
 
***
Total points of Chapter 12
 
 
 
 
32
 
 
1. Total points
No.
Contents
Maximum score
Applied score
Assessing point
Percentage (%)
1.
Chapter I. Laboratory organization and management
23
 
 
 
2.
Chapter II. Documents and records
10
 
 
 
3.
Chapter III. Personnel management
21
 
 
 
4.
Chapter IV. Client management and customer services
13
 
 
 
5.
Chapter V. Equipment management
30
 
 
 
6.
Chapter VI. Internal audit
13
 
 
 
7.
Chapter VII. Management of purchasing, equipment, consumables, chemicals and biological products
23
 
 
 
8.
Chapter VIII. Testing process control
57
 
 
 
9.
Chapter IX. Information management
11
 
 
 
10.
Chapter X. Determination of nonconformities, corrective and preventive actions
14
 
 
 
11.
Chapter XI. Continual improvement
21
 
 
 
12.
Chapter XII. Facilities and safety
32
 
 
 
 
Total
268
 
 
 
2. Ranking and list of testing methods that meet quality requirements at corresponding rank
a) Laboratory quality rank:
b) List of testing methods that meet quality requirements (including testing methods that meet criteria requirements marked with “*” only).
c) Recommendations for the quality improvement plan./.
(This translation is for reference only)



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