Circular No. 01/2013/TT-BYT guiding the implementation of quality management for laboratory testing at medical examination and treatment facilities

CIRCULAR

Guidelines for the Implementation of Quality Management of Laboratory Testing

at Medical Examination and Treatment Facilities

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Department of Medical Examination and Treatment;

The Minister of Health issues the Circular on Guidelines for the Implementation of Quality Management of Laboratory Testing at Medical Examination and Treatment Facilities.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular guides the contents and responsibilities for implementing quality management of laboratory testing at medical examination and treatment facilities with laboratories.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Laboratory refers to departments, rooms, or units conducting laboratory testing at medical examination and treatment facilities that accept samples from patients and related sources to perform tests, provide direct information to serve medical examination and treatment activities, scientific research, and training.

2. Quality Management of Laboratory Testing includes coordinated activities aimed at directing and controlling the quality of laboratory testing by the laboratory, including planning, monitoring, ensuring, and improving the quality of laboratory testing.

3. Internal Quality Assessment of Laboratory Testing involves organized and planned self-inspection and evaluation of laboratory testing quality within the laboratory with the aim of leadership review to assess the quality of test implementation, identify non-conformities, and propose preventive, corrective, and improvement measures.

4. Standard Operating Procedure (SOP) for Laboratory Testing consists of detailed mandatory guidelines for performing each step of a process.

5. Internal Quality Control Program is a system for quality control within a laboratory to monitor and supervise all aspects of the testing process, ensuring the reliability of test results before providing them to customers and taking timely corrective actions if errors occur; aiming to evaluate the laboratory system (measurement methods, reagents and chemicals, equipment, technical staff proficiency).

6. External Quality Control Program involves quality control, comparison, and benchmarking of laboratory test results against those from other laboratories using the same sample, comparing with reference laboratories both domestically and internationally to continuously improve test quality and contribute to providing evidence that the laboratory meets national or international standards.

7. Pre-analytical Process includes steps from receiving a testing request to the start of the analytical process, including patient preparation, test ordering, sample collection, storage, and transportation to the laboratory.

8. Analytical Process involves analyzing the test samples.

9. Post-analytical Process begins when the analytical process ends, including system checks, recording or interpreting test results, deciding to release test results, storing results and analyzed samples.

10. Customer is an organization or individual receiving laboratory test results or services, which may be internal or external clients of medical examination and treatment facilities.

Chapter II
CONTENTS OF QUALITY MANAGEMENT OF LABORATORY TESTING

Article 3. Quality Management System for Laboratory Testing

1. Medical examination and treatment facilities with laboratories conduct testing on samples; coordinate with standardization centers recognized by the Ministry of Health to implement tasks and plans to ensure the quality of laboratory testing at their facilities.

2. Reference laboratories are laboratories within medical examination and treatment facilities or other laboratories recognized by the Ministry of Health, responsible for conducting reference tests and providing reference test results upon request of the Ministry of Health, Provincial Health Departments, and standardization centers based on the scale of tasks and capabilities of reference laboratories. During their role as reference laboratories, they will be subject to quality supervision by the Ministry of Health and standardization centers. Every three years, the Ministry of Health will re-evaluate and recognize reference laboratories.

3. Standardization centers play a role in implementing specialized activities to ensure the quality of laboratory testing at laboratories within medical examination and treatment facilities (including reference laboratories). Based on assigned functions and tasks, standardization centers implement: external quality control programs; quality monitoring of laboratories; professional consultation on standardization and quality management; using reference test results from reference laboratories as a basis for standardization work.

4. The Ministry of Health, provincial health departments, and sectoral health authorities manage state administration, guide, inspect, and audit the implementation of regulations by medical examination and treatment facilities with laboratories and reference laboratories in quality management of laboratory testing; direct the professional activities of standardization centers. The Ministry of Health evaluates and recognizes laboratories as reference laboratories for one or more types of tests.

Article 4. Content of Quality Management for Laboratory Testing at Medical Examination and Treatment Facilities

1. Medical examination and treatment facilities shall implement quality management for laboratory testing in accordance with policies and laws, quality declarations (commitments), quality objectives, scale, and conditions of the medical examination and treatment facility and the laboratory.

2. Medical examination and treatment facilities shall develop plans and implementation schedules to achieve and maintain quality management for laboratory testing in compliance with national technical standards for laboratories after their promulgation by the Ministry of Health, encouraging attainment of national and international laboratory standards requirements.

3. Medical examination and treatment facilities must publicly disclose the calibration testing work of the unit for supervisory bodies, customers, and the community to be aware and monitor.

Article 5. Content of Quality Management for Laboratories

1. There shall be annual and five-year plans for implementing quality management for laboratory testing approved by the leadership of the medical examination and treatment facility, integrated into the annual and five-year plans of the medical examination and treatment facility.

2. There shall be quality declarations (commitments), quality objectives, quality plans, quality control, quality assurance, and quality improvement for laboratory testing.

3. Compile, establish, and implement a quality manual including standard operating procedures (SOPs) for all technical processes of the laboratory. Review, adjust, and improve (if necessary) the quality manual once a year.

4. Establish and implement internal quality control programs approved by the leadership of the medical examination and treatment facility, with a recording, storage, incident detection, and corrective action system to prevent incidents.

5. Participate in external quality control programs according to specialties, in accordance with the division of responsibilities for professional quality control activities of the Ministry of Health, and encouraged to participate in internationally recognized external quality control programs.

6. Develop quality indicators for laboratory testing suitable for the conditions of the laboratory and the medical examination and treatment facility:

a) A set of quality indicators for laboratory testing of the unit to strive to achieve, to evaluate the maintenance and continuous improvement of quality, established in accordance with the provisions in the Appendix issued together with this Circular;

b) Adjust quality indicators periodically at least once a year.

Article 6. Content of Ensuring Implementation of Quality Management for Laboratories

1. Implement organizational requirements:

a) Have an organizational chart, describe job duties, clearly state the roles and functions of each healthcare worker;

b) The laboratory retains personnel files of all healthcare workers (copies);

c) Healthcare workers in the laboratory have the responsibility to implement and effectively carry out quality management work for the laboratory.

2. Establish a documentation and quality management record system:

a) Establish a document and record management system, encourage the application of information technology in managing documents and records of the laboratory;

b) Implement document and record control procedures to help the document and record system be stored scientifically, facilitating control, tracking, retrieval, and use;

c) Ensure that the quality manual is easily accessible and usable, store all technical records.

3. Training:

a) Have a plan and conduct regular annual training on quality management for healthcare workers;

b) The laboratory participates in training activities on quality management within its field of expertise.

4. Monitoring and Evaluation:

a) Have a plan and conduct internal quality testing monitoring and evaluation, daily professional activities;

b) Have a plan and conduct post-training monitoring and evaluation for all healthcare workers;

c) Have a plan and conduct monitoring and evaluation to prevent potential incidents;

d) Monitor and evaluate the use, preservation, and maintenance of equipment and chemicals in testing;

e) Participate in building plans and conducting, monitoring, and evaluating inter-departmental or laboratory (if applicable).

Chapter III
RESPONSIBILITY FOR IMPLEMENTING QUALITY MANAGEMENT FOR LABORATORY TESTING

Article 7. Responsibilities of the leadership of medical examination and treatment facilities with laboratory departments

1. Direct the implementation and organization of the correct management of laboratory quality control content at the medical examination and treatment facility and within the laboratory department.

2. Establish an organizational system for developing and issuing quality management documents suitable to the actual conditions of their unit; develop a structure diagram for the laboratory quality management system parallel to the administrative and technical structure of the medical examination and treatment facility.

3. Approve the laboratory quality management plan of the unit.

4. Ensure appropriate resources for laboratory quality management, including: human resources, infrastructure, equipment, funding to implement the approved plan and regular funding comprising:

a) Implementing, maintaining, and improving laboratory testing quality;

b) Training laboratory personnel;

c) Ensuring laboratory quality;

d) Developing and approving regulations, guidance procedures, and organizing training for relevant staff;

e) Organizing the evaluation of the implementation of the laboratory quality management plan.

5. Assign at least one healthcare worker to manage laboratory quality at the laboratory department, depending on the scale and actual conditions of the medical examination and treatment facility and the laboratory department.

Article 8. Responsibilities of the Head of the Laboratory Department

1. Organize the implementation of laboratory quality management, fully perform the tasks and plans of the laboratory department regarding quality control, coordinate with the hospital's quality management department (or team), advise the leadership of the medical examination and treatment facility on all aspects of laboratory quality management.

2. Develop annual and five-year plans on laboratory quality management content to submit to the leadership of the medical examination and treatment facility for review and approval.

3. Directly lead and organize the implementation of the contents of the approved laboratory quality management plan. Review the implementation of the annual laboratory quality management plan every six months, proactively propose appropriate adjustments.

4. Direct and personally oversee monitoring, inspecting, and supervising laboratory testing quality; identify, propose solutions, and manage cases of errors or potential errors during laboratory quality management at the laboratory department.

5. Direct and develop a quality manual and standard operating procedures (SOPs) for the laboratory department to submit to the leadership of the medical examination and treatment facility for review and issuance.

6. Organize scientific research, develop, and submit to the leadership of the medical examination and treatment facility for approval plans for on-site training or sending laboratory healthcare workers and related departments for training on laboratory quality management.

7. Integrate laboratory quality management with other related department activities in scientific research and training for laboratory healthcare workers.

8. Receive information, process it, and advise the leadership of the medical examination and treatment facility to provide timely and appropriate feedback to clients using laboratory services.

Article 9. Responsibilities of Quality Management Staff at the Laboratory

1. Summarize and advise the laboratory director on the implementation of quality management contents for laboratory testing.

2. Develop plans and contents for laboratory quality management, submit to the laboratory director for review and decision-making, then present to the healthcare facility leadership for examination and approval.

3. Organize internal quality control programs and participate in external quality control programs to monitor, supervise, evaluate the quality of laboratory work, identify issues, and propose timely intervention solutions to manage errors and potential errors in testing procedures.

4. Collect, compile, analyze data, manage, and ensure the confidentiality of information related to laboratory activities.

5. Coordinate and support other departments in implementing laboratory quality management.

6. Summarize and report periodically monthly, quarterly, and annually on the activities and results of laboratory quality management to the laboratory director, the head of the quality management department (or team leader) of the hospital, and healthcare facility leadership.

7. Serve as the main advisor for implementing tasks related to organizations that assess and certify laboratories meeting national or international standards.

Article 10. Responsibilities of Clinical Departments

1. The department head is responsible overall, with the head nurse directing technical sample collection. Each department appoints a person responsible for sample collection, storage, transportation, and receiving test results.

2. Responsibilities of members within the department:

a) Assist the department leadership in fully implementing the department's laboratory quality management contents;

b) Participate in relevant training sessions and activities related to laboratory quality management.

Chapter IV
IMPLEMENTING PROVISIONS

Article 11. Effective Date

This Circular takes effect from March 15, 2013.

Article 12. Responsibility for Implementation

1. The Department of Medical Examination and Treatment shall be responsible for:

a) Being the lead unit organizing the implementation, inspection, and evaluation of this Circular at subordinate healthcare facilities and localities;

b) Performing other tasks related to laboratory quality management at healthcare facilities as assigned by the Minister of Health.

2. Provincial/Municipal Health Departments and Sector Health Departments shall be responsible for disseminating, directing, inspecting, evaluating the implementation of this Circular at subordinate healthcare facilities, and reporting to the Ministry of Health every six months.

During implementation, if there are difficulties or obstacles, units and individuals are advised to reflect these issues to the Ministry of Health (Department of Medical Examination and Treatment) for guidance, consideration, and resolution./.