Circular No. 49/2018/TT-BYT guiding diagnostic testing activities in medical examination and treatment

CIRCULAR

Guidelines for laboratory activities in medical examination and treatment

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

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

The Minister of Health issues this Circular to guide laboratory activities in medical examination and treatment.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Circular guides the management of laboratory activities and the duties of professional positions within laboratory activities in medical examination and treatment.

2. The types of laboratory tests in this Circular include hematological tests, blood transfusion tests, biochemical tests, microbiological tests, parasitological tests, histopathological tests, medical immunogenetic tests, molecular biological tests, endocrinological tests, allergological tests, oncological tests, cytological tests, and other types of laboratory tests (hereinafter referred to collectively as laboratory tests).

3. This Circular applies to medical examination and treatment facilities, healthcare facilities, and other entities that conduct laboratory tests for medical examination and treatment purposes.

Article 2. Interpretation of Terms

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

1. Point-of-Care testing (POCT) or Near-Patient Testing refers to laboratory tests conducted outside the laboratory department by healthcare staff, applied in emergency units, screening units, patient monitoring, and primary healthcare settings.

2. Rapid test (Quick Test) is a laboratory test that provides results within a short time after execution and is often used in point-of-care testing.

Article 3. Forms of organization for laboratory activities

1. Separate laboratory departments for each type of laboratory test.

2. Laboratory departments or centers for multiple types of laboratory tests.

3. Combined laboratory departments with other clinical auxiliary departments.

4. Independent laboratories licensed to operate in accordance with Article 28 of Decree No. 109/2016/NĐ-CP dated July 1, 2016, of the Government on issuing practice certificates for practitioners and licensing medical examination and treatment facilities.

5. Laboratory tests at commune health stations, ward health stations, town health stations, clinics, and other organizational forms as prescribed by law.

The forms of organization for laboratory activities specified in Clauses 1, 2, 3, and 4 of this Article are collectively referred to as laboratory departments.

Chapter II
MANAGEMENT OF LABORATORY ACTIVITIES

Article 4. Principles of managing laboratory activities

1. Ensuring accurate, reliable, and timely laboratory test results.

2. Ensuring laboratory safety.

3. Managing and using medical equipment for laboratory tests efficiently and economically.

4. Managing biomedical waste generated from laboratory activities in accordance with current laws.

5. Implementing quality management of laboratory tests in accordance with Circular No. 01/2013/TT-BYT dated January 11, 2013, of the Minister of Health on guiding the implementation of quality management of laboratory tests at medical examination and treatment facilities.

Article 5. Management of the laboratory testing process

1. Collection and reception of specimen samples

a) The collection and reception of specimen samples from patients must be based on the laboratory request form (paper or electronic version) containing all required fields according to the medical record format, signed by the prescribing physician;

b) The collection and reception of specimen samples are carried out in clinical departments, outpatient departments, laboratory departments, or at the patient's residence. In cases where the patient is in emergency care, primary care, or as directed by a physician, specimen samples are collected at the patient's bedside;

c) Nurses and technicians perform the collection and reception of specimen samples; certain specialized specimen collections are performed by physicians as required;

d) Medical equipment for specimen collection, preservation, and transportation must be fully equipped and properly maintained according to the specimen collection guidelines of the laboratory department;

đ) Managing the preparation of equipment, coordinating with outpatient and clinical departments to monitor and supervise the collection and reception of specimen samples in accordance with the professional guidelines of the Minister of Health;

e) Assigning personnel to receive and check specimen samples to meet requirements regarding quantity, quality, preservation, transportation conditions, and storage time;

2. Performing laboratory techniques

a) Physicians and technicians conduct laboratory tests according to the contents of the laboratory request form and follow technical procedures and quality management, prioritizing urgent and primary care tests;

b) Procedures and guidelines for performing laboratory tests must be approved by hospital leadership and available at the workplace;

3. Issuing laboratory test results

a) Reviewing laboratory test results and signing before issuing them to patients. If errors or doubts are detected during review, they must be cross-checked with clinical departments, and retesting may be necessary;

b) The laboratory department issues laboratory test results with clear information within the stipulated timeframe by the medical examination and treatment facility;

4. Archiving records and handling specimens post-testing

a) Laboratory records must contain complete information: name of the test, name of the person collecting the specimen sample, type of specimen sample, time of collection and reception of the specimen sample, testing method, result of quality control sample (if applicable), batch number and expiration date of the main reagent, name of the tester, test result, test conclusion, and signature of the person issuing the test result;

b) Specimen samples must be stored according to requirements for various types of tests, remaining specimens can only be disposed of after the test results have been signed.

Article 6. Management and use of medical equipment, chemicals, reagents, and consumables

1. Management and use of medical equipment shall be carried out in accordance with the provisions of Government Decree No. 36/2016/NĐ-CP dated May 15, 2016 on management of medical equipment and related guiding documents.

2. Hazardous, toxic, corrosive, flammable, and explosive chemicals and reagents must have safety instructions.

3. Chemicals, reagents, and consumables must be stored to ensure quality in compliance with the technical requirements of the manufacturer and complete records must be kept as required.

4. Medical equipment must be prepared and arranged neatly, orderly, and easily accessible for use.

Article 7. Ensuring laboratory testing safety and occupational hygiene

1. Compliance with the Law on Occupational Safety and Health and guiding documents for its implementation, Government Decree No. 103/2016/NĐ-CP dated July 1, 2016 on ensuring biosafety in laboratories, Government Decree No. 155/2018/NĐ-CP dated November 12, 2018 amending and supplementing certain regulations related to investment and business conditions under the Ministry of Health's jurisdiction, Circular No. 37/2017/TT-BYT dated September 25, 2017 of the Minister of Health on safe laboratory practices.

2. Maintain a laboratory safety manual and internal rules for labor protection.

3. Establish regulations on the management and use of chemicals, microbial strains, electrical equipment, and compressed gas cylinders at the facility.

4. Assign staff members responsible for laboratory safety to periodically inspect and supervise other staff members' compliance.

5. Implement occupational hygiene regulations and medical attire requirements before starting work, during working hours, and when leaving the laboratory area.

6. Laboratory personnel must meet the following requirements:

a) Be trained in laboratory safety and proficient in using assigned medical equipment, only use equipment after receiving training and obtaining department head approval;

b) Strictly comply with all regulations on preventing infection among staff, the environment, and the community;

c) Receive training and have adequate means to prevent and provide first aid in cases of caustic burns, acid burns, thermal burns, poisoning, electric shock, fire, and explosion.

Article 8. Management of medical waste

1. Comply with the provisions of Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015 of the Minister of Health and the Minister of Natural Resources and Environment on medical waste management.

2. Establish and implement procedures for storing, disposing of remaining specimens, chemicals, and reagents after testing, experimental animals, and sterilizing medical equipment as prescribed.

3. Classify and process medical waste, prevent risks before removing waste from the testing area.

4. Sanitize surfaces in the workplace.

Article 9. Management of HIV Testing Activities

The management of HIV testing activities must comply with the provisions of this Circular, Government Decree No. 109/2016/NĐ-CP dated July 1, 2016 on issuing practice certificates for practitioners and permits for healthcare facilities, Government Decree No. 155/2018/NĐ-CP dated November 12, 2018 amending and supplementing certain regulations related to investment and business conditions under the Ministry of Health's jurisdiction, Government Decree No. 75/2016/NĐ-CP dated July 1, 2016 on conditions for conducting HIV tests and other relevant regulations of the Ministry of Health regarding HIV testing.

Article 10. Conducting on-site tests at clinical departments of medical examination and treatment facilities

Clause 1. Rapid tests shall be conducted at clinical departments of medical examination and treatment facilities in emergency cases, screening, and patient monitoring.

Clause 2. Medical staff conducting rapid tests shall record in the medical file, and the physician ordering the test shall sign the test result.

Clause 3. Ensure quality control for on-site testing at the laboratory department of medical examination and treatment facilities.

Clause 4. Adhere to relevant regulations concerning on-site HIV testing.

Chapter III
DUTIES OF SPECIALIZED POSITIONS IN IMPLEMENTING TESTING ACTIVITIES

Article 11. Duties of the Head of the Laboratory Department

Clause 1. Direct and organize the activities of the department in accordance with the management content of testing activities.

Clause 2. Coordinate with clinical departments and outpatient clinics to organize sample collection and reception, round-the-clock testing work, and continuous disease prevention efforts 24 hours a day.

Clause 3. Develop and periodically update quality management procedures, technical procedures, and professional guidelines for issuance and application by the facility's head at the laboratory department.

Clause 4. Arrange the laboratory department workspace in a continuous, rational, and safe manner.

Clause 5. Coordinate with clinical departments, ancillary departments, and patients to receive and process feedback to improve the quality of testing services.

Clause 6. Develop plans for purchasing medical equipment, chemicals, and reagents for testing activities.

Clause 7. Participate in developing plans for selecting contractors for procurement and acceptance of medical equipment, chemicals, and reagents for testing activities of medical examination and treatment facilities within their field of expertise.

Clause 8. Sign requisition forms for chemicals, reagents, tools, and raw materials meeting testing requirements.

Clause 9. Serve as the point of contact for coordinating with clinical departments to monitor the quality of rapid tests and on-site testing.

Clause 10. Organize training, scientific research of the department, and evaluate employee capabilities.

Clause 11. Personally sign test results or delegate signing of test results to specialized physicians and laboratory technicians with bachelor’s degree or higher, as stipulated.

Clause 12. Participate in consultations and post-mortem reviews when requested.

Clause 13. For heads of laboratory departments that conduct pathological testing, they must also perform the following additional tasks:

Point a. Organize and conduct pathological and cytological tests.

Point b. Perform autopsy examinations and microscopic testing in accordance with legal regulations on handling deceased patients.

Point c. Store pathological specimens in accordance with regulations; provide pathological documentation upon request from the facility's head.

Point d. Designate and assign personnel for autopsies and reading of results.

Article 12. Duties of Specialized Physicians in Testing

Clause 1. Conduct assigned tests according to technical procedures and quality management procedures.

Clause 2. Sign test results within the scope of their assignment.

Clause 3. Review test results of laboratory technicians within the scope of their assignment.

Clause 4. Participate in on-call duties as assigned by the department head.

Clause 5. Provide consultation on testing.

Clause 6. Participate in technical support and quality management of testing for lower-level facilities.

Clause 7. Participate in consultations and post-mortem reviews when requested.

Clause 8. Participate in scientific research and disseminate information about testing as assigned.

Clause 9. Be subject to the direction and responsibility of the department head for assigned tasks, adhering to relevant professional regulations within the content of managing testing activities.

Clause 10. Perform other tasks as assigned by the department head.

Article 13. Duties of the Chief Technician

1. Organize the implementation of specialized techniques, supervise and urge technicians and other medical staff in the department to comply with regulations.

2. Receive and resolve patient complaints and their families' concerns, report to the head of the department for resolution.

3. Assign on-call duties within the department and participate in regular on-call shifts. Allocate tasks to technicians and other medical staff.

4. Manage administrative work, keep records, conduct statistics and reporting, develop work plans according to the head of the department's assignment.

5. Clock daily attendance, compile monthly attendance figures to submit to the head of the department for approval.

6. Participate in training for technicians, other medical staff in the department, and trainees studying under the head of the department's assignment.

7. Stockpile medical equipment, consumables, chemicals, and reagents used in the department to report to the head of the department.

8. Inspect the use, maintenance, and management of assets and materials in accordance with regulations, record repair forms for broken tools.

9. Inspect and urge the maintenance of environmental hygiene, infection control, and occupational safety in the department.

Article 14. Duties of Laboratory Technicians

1. Collect samples, perform assigned tests, and follow the prescribed technical procedures for testing.

2. Prepare reagents for testing and regularly check reagents according to guidelines.

3. Receive and store equipment and chemicals as assigned.

4. Prepare tools and consumables for laboratory activities.

5. Statistically record and archive test results; report abnormal or suspicious results to the head of the department.

6. Perform tasks as stipulated in Article 10 of Circular Joint No. 26/2015/TTLT-BYT-BNV dated October 7, 2015, issued by the Minister of Health and the Minister of Home Affairs regarding job code, qualification standards, appointment, and salary grading for nursing, midwifery, and medical technology professions.

7. Participate in on-call shifts according to the schedule assigned by the head of the department.

8. Perform other tasks as assigned by the head of the department and the chief technician.

9. For laboratory technicians holding a bachelor's degree or higher, perform additional tasks as follows:

a) Recheck test results within the assigned scope;

b) Sign off on test results within the assigned scope;

c) Participate in consultations and post-mortem reviews when requested;

d) Assist in technical support and quality management of laboratory testing for lower-level facilities.

Article 15. Duties of Nursing Staff in Laboratory Activities

1. Collect and receive sample specimens for testing.

2. Perform other tasks as stipulated in Article 17 of this Circular.

Article 16. Duties of Quality Management Personnel in Laboratory Testing

Implement quality management tasks as stipulated in Article 9 of Circular No. 01/2013/TT-BYT dated January 11, 2013, issued by the Minister of Health guiding the implementation of quality management in laboratory testing at healthcare facilities.

Article 17. Duties of Other Medical Staff in the Laboratory Department

1. Participate in preparing tools and sterile consumables for laboratory activities.

2. Participate in delivering test results.

3. Process tools after testing and biomedical waste in the department in accordance with regulations.

4. Maintain cleanliness in the laboratory department and restrooms in the testing area.

5. Perform other tasks as assigned by the head of the department and the chief technician.

Article 18. Duties of personnel conducting testing activities at commune health stations

1. Medical staff (doctors, medical assistants, nurses, technicians, midwives, pharmacists) shall perform rapid tests and record test results in patient records, outpatient books, and test result logs according to the assignment of the commune health station director.

2. Conduct tests or send specimen samples to healthcare facilities authorized by competent authorities to conduct tests within the permitted technical scope.

Chapter IV
IMPLEMENTING PROVISIONS

Article 19. Effective Date

1. This Circular takes effect from March 15, 2019.

2. Repeal Sections 17, 26, 39, 40, 41, 45, 56, and 69 of Decision No. 1895/1997/QĐ-BYT dated September 19, 1997 of the Minister of Health on the issuance of Hospital Regulations from the date this Circular takes effect.

Article 20. Cross-referencing Provisions

In cases where referenced documents in this Circular are replaced or amended, they shall be implemented according to the replaced or amended documents.

Article 21. Responsibility for Implementation

1. The Director of the Department of Medical Examination and Treatment shall be responsible for organizing the implementation, inspection, and supervision of this Circular nationwide.

2. Directors of provincial and municipal health departments shall be responsible for organizing the implementation, inspection, and supervision of this Circular within their jurisdiction.

3. Gentlemen and Ladies: Director of the Department of Medical Examination and Treatment, Head of the Ministry's Office, Head of the Ministry's Inspectorate, Heads of all Departments, Directors of all Departments under the Ministry of Health, Directors of hospitals under the Ministry of Health, Directors of provincial and centrally-administered city health departments, Directors of quality control laboratories, and heads of health sectors shall be responsible for implementing this Circular.

4. Heads of medical examination and treatment facilities, healthcare facilities, and testing facilities involved in medical testing activities shall be responsible for implementing this Circular at their respective facilities.

Any difficulties or issues encountered during implementation should be promptly reported to the Ministry of Health (Department of Medical Examination and Treatment) for guidance and resolution.