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

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

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

- Percentage (%) of total points given to the laboratory =

Total points given to the laboratory x 100%

Maximum total score

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

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

No.

Names of affiliations of assessors

Names of assessors

1.

2.

3.

4.

5.

…

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

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

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.)

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

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

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

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

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

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

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

CONTENTS

Yes (Y)

Partial (P)

No (N)

Not applicable (N/A)

Score

Assessing point

Comments

Pre-examination processes