Thông tư 49/2018/TT-BYT hướng dẫn hoạt động xét nghiệm trong khám bệnh, chữa bệnh do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

GUIDELINES FOR MEDICAL TESTS

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, entitlements and organizational structure of the Ministry of Health;

At the request of the Director of the Vietnam Administration of Medical Services;

The Minister of Health hereby adopts a Circular to provide guidelines for medical tests.

Chapter I

GENERAL PROVISIONS

Article 1. Scope and regulated entities

1. This Circular provides guidelines for management of medical testing and tasks of positions involved in medical testing.

2. Tests mentioned in this Circular include tests on hematology, blood transfusion, biochemistry, microbiology, parasitology, anapathology, immunology, medical genetics, molecular biology, endocrinology, allergology, oncology, cytology and other tests (hereinafter referred to as “tests”).

3. This Circular applies to health facilities and other facilities involved in medical testing.

Article 2. Definitions

For the purposes of this Circular, the terms below shall be construed as follows:

1. “point of care testing or near patient testing” means a test carried out by a health worker outside a laboratory environment and applied at an emergency or screening facility to serve patient monitoring and primary healthcare.

2. “quick test or rapid test” means a test that gives results within a short period of time after it is done and is often used in point of care testing.

Article 3. Forms of organizations involved in testing

1. Laboratory departments in charge of each type of test.

2. Laboratory departments and centers in charge of various tests.

3. Laboratory departments in cooperation with other paraclinical departments.

4. Independent laboratories licensed to operate as prescribed in Article 28 of the Government’s Decree No. 109/2016/ND-CP dated July 01, 2016.

5. Medical stations of communes, clinics and other forms prescribed by law.

The forms mentioned in Clauses 1, 2, 3 and 4 of this Article are referred to as laboratory departments.

Chapter II

TESTING MANAGEMENT

Article 4. Principles of testing management

1. Provide test reports in an accurate, reliable and prompt manner.

2. Ensure laboratory safety.

3. Manage and use medical testing equipment in an effective and economical manner.

4. Manage medical waste generated from testing in accordance with applicable regulations.

5. Manage quality of tests as prescribed in the Circular No. 01/2013/TT-BYT dated January 11, 2013 of the Minister of Health.

Article 5. Management of testing process

1. Collect and receive pathological specimens.

a) Pathological specimens from patients shall be collected and received according to the laboratory test order (physical or electronic) that contains all sections of a medical record and bears the signature of the doctor;

b) Pathological specimens from patients shall be collected and received at clinical department, outpatient department or laboratory department or pathological specimens may be collected at the residence of the patient. In case the patient is being provided with emergency care or level 1 care or upon the recommendation of the doctor, pathological specimens shall be collected at the bed;

c) Nurses and technicians shall collect and receive pathological specimens. Some special tests require doctor to collect pathological specimens according to professional requirements;

d) There should be sufficient medical equipment for collection, storage and transport of pathological specimens. Such equipment should be used in a proper manner and under the laboratory department’s instructions for collection of pathological specimens.

dd) It is required to manage preparation of instruments and cooperate with outpatient department and clinical department to inspect and supervise the collection and receipt of pathological specimens under professional instructions of the Minister of Health;

e) It is required to assign personnel to receive and inspect pathological specimens, satisfying requirements for quantity, quality, storage, time and transport of pathological specimens.

2. Carry out tests

a) Doctors and technicians shall carry out a test according to the laboratory test order and comply with medical procedures and quality management procedures. Priority shall be given to the test serving emergency or level 1 care;

b) Testing procedures and instructions shall be approved and available in the workplace.

3. Deliver test report

a) Inspect the test report and append signature to it before returning it to patients. In case of any error or suspicion, it is required to carry out the test again.

b) The laboratory department shall return a clearly specified test report on the date prescribed by the health facility.

4. Retain documents and handle pathological specimens after the test

a) Test documents to be retained must contain the following information: name of the test, name of the pathological specimen collector, type of pathological specimen, date of collection and receipt of pathological specimen, test methods, results of quality inspection (if any), batch number and expiry date of the main reagent, name of the tester, test results and conclusion, person signing the test report;

b) Store pathological specimens used for each type of test. The remaining pathological specimens shall be only destroyed after the test report is signed.

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

1. Medical equipment shall be managed and used as prescribed in the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 and documents elaborating the Decree.

2. There shall be safety instructions for using dangerous, toxic, corrosive and flammable chemicals and reagents.

3. The storage of chemicals, reagents and lost supplies shall ensure quality and compliance with technical requirements laid down by the manufacturer and shall be recorded sufficiently and on schedule.

4. Medical equipment should be available for use, neatly arranged and easily accessible.

Article 7. Assurance of testing safety and occupational safety and hygiene

1. It is required to comply with the Law on Occupational Safety and Hygiene and documents elaborating the law, Government’s Decree No. 103/2016/ND-CP dated July 01, 2016, Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 and Circular No. 37/2017/TT-BYT dated September 25, 2017 of the Minister of Health.

2. There should be laboratory safety manual and labor protection rules.

3. There should be regulations on management and use of chemicals, microbial strains, electrical equipment and pressure vessels.

4. It is required to assign laboratory safety personnel to carry out periodic inspection and supervise other personnel.

5. Regulations on occupational hygiene and medical uniforms shall be complied with before work, during working hours and when leaving laboratory department.

6. Personnel in charge of testing must:

a) be provided with instructions for laboratory testing and expertly use medical equipment and only use equipment after receiving instructions and consent of the head of the department.

b) strictly comply with all regulations on prevention of contamination from personnel, environment and community;

c) be trained and have sufficient equipment to serve prevention and emergency in case of burns, acid burns, heat burns, poisoning, electric shock, fire or explosion.

Article 8. Management of medical waste

1. Regulations specified in the Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015 of the Minister of Health and Minister of Natural Resources and Environment shall be complied with.

2. There should be a procedure for storing and destroying pathological specimens, chemicals, reagents and animal carcasses left after a test is done and, and disinfecting medical equipment as prescribed.

3. Waste shall be classified and handled to preventing risks before removing waste out of the testing area.

4. Surface of work area shall be cleaned and disinfected.

Article 9. Management of HIV testing

HIV testing shall be managed in accordance with regulations of this Circular, Government’s Decree No. 109/2016/ND-CP dated July 01, 2016, Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 and Government’s Decree No. 75/2016/ND-CP dated July 01, 2016 and other relevant regulations of the Ministry of Health on HIV testing.

Article 10. Carrying out point of care testing at clinical departments of health facilities

1. Point of care testing shall be carried out at clinical departments of health facilities in case of emergency, screening and patient monitoring.

2. Health workers carrying out point of care testing shall keep records and the doctor who recommends the testing shall sign the test report.

3. Supervision of quality of point of care testing by clinical departments of health facilities is required.

4. Relevant regulations on point-of-care HIV testing shall be complied with.

Chapter III

TASKS OF POSITIONS INVOLVED IN TESTING

Article 11. Tasks of the head of the laboratory department

1. Provide guidance and organize activities of the department in accordance with regulations on testing management.

2. Cooperate with clinical departments and outpatient departments (clinics) in organizing the collection and receipt of pathological specimens, night shift work and 24-hour disease prevention.

3. Prepare and periodically update testing quality management procedure, medical procedure and professional instructions so that the head of the health facility promulgate and apply them at the laboratory department.

4. Working space of the laboratory shall be provided in an appropriate and safe manner.

5. Cooperate with clinical departments, paraclinical departments and patients in receiving and handling complaints in order to improve testing service quality.

6. Prepare a plan for procurement of medical equipment, chemicals and reagents to serve testing.

7. Act as a member that participates in preparing a plan for selection of suppliers of medical equipment, chemicals and reagents for testing by health facilities according to each specific field.

8. Sign the receipt for chemicals, reagents, instruments and raw materials that satisfy testing requirements.

9. Take charge of cooperating with clinical departments in supervising quality of point of care testing and rapid tests.

10. Organize provision of training and researches by the department and evaluate personnel’s competency.

11. Directly sign the test report or assign a general doctor who conducts the testing or a testing physician who obtains a bachelor’s degree to sign it.

12. Participate in medical consultations and mortality review upon request.

13. In addition to the aforementioned tasks, the head of the laboratory department that carries out pathology tests shall:

a) organize and carry out anapathology and cytology tests;

b) carry out post-mortem examinations and microbody tests in accordance with laws on handling of deceased patients;

c) store anapathological specimens in accordance with regulations; anapathology documents at the request of the head of the laboratory department;

d) appoint and assign personnel to carry out autopsies and read test results.

Article 12. Tasks of a general doctor who conducts tests

1. Conduct tests in compliance with medical procedure and quality management procedure.

2. Sign test reports within his/her jurisdiction.

3. Re-inspect test reports given by technicians within his/her jurisdiction.

4. Work night shifts as assigned by the head of the department.

5. Provide counseling on tests.

6. Provide assistance in testing techniques and quality management to lower-level health facilities.

7. Participate in medical consultations and mortality review upon request.

8. Participate in researches and notify scientific information about testing as assigned.

9. Follow the direction and take responsibility to the head of the department for assigned tasks, comply with relevant regulations on testing management.

10. Perform other tasks assigned by the head of the department.

Article 13. Tasks of a chief technician

1. Organize the implementation of medical techniques, inspect and request technicians and other health workers of the department to strictly comply with regulations.

2. Receive and handle complaints from patients and their family, and notify the head of the department thereof.

3. Work night shifts and assign other personnel to work night shifts. Assign tasks to technicians and other health workers.

4. Perform administrative management, manage documents, prepare statistical reports and work plans as assigned by the head of the department.

5. Do timekeeping on a daily basis, prepare monthly timesheets, and submit them to the head of the department for approval.

6. Provide training for technicians, other health workers and learners as assigned by the head of the department.

7. Stockpile medical equipment, lost supplies, chemicals and reagents used by the department and notify the head of the department of the stockpile.

8. Inspect the use, maintenance and management of assets and supplies as prescribed, make a note of repair of damaged instruments.

9. Inspect and expedite the environmental hygiene assurance, bacterial infection control and labor protection within the department.

Article 14. Tasks of a technician

1. Collect pathological specimens and conduct tests in compliance with medical procedures.

2. Prepare reagents for testing and regularly inspect reagents in compliance with instructions.

3. Receive and store instruments and chemicals as assigned.

4. Prepare instruments and lost supplies serving testing.

5. Consolidate and retain test reports. Regarding the tests that give unusual or suspicious results, it is required to notify the head of the department thereof.

6. Perform the tasks specified in Article 10 of the Joint Circular No. 26/2015/TTLT-BYT-BNV dated October 07, 2015 of the Minister of Health.

7. Work night shifts as assigned by the head of the department.

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

9. In addition to the aforementioned tasks, a technician that obtains at least a bachelor’s degree shall:

a) re-inspect test reports within his/her jurisdiction;

b) sign test reports within his/her jurisdiction;

c) Participate in medical consultations and mortality review upon request;

d) Provide assistance in testing techniques and quality management to lower-level health facilities.

Article 15. Tasks of a nurse involved in testing

1. Collect and receive pathological specimens for testing.

2. Perform other tasks specified in Article 17 of this Circular.

Article 16. Tasks of testing quality managers

Perform the tasks specified in Article 9 of the Circular No. 01/2013/TT-BYT dated January 11, 2013 of the Minister of Health.

Article 17. Tasks of other health workers of the laboratory department

1. Participate in preparing clean instruments and lost supplies serving testing.

2. Return test reports.

3. Handle post-test instruments and medical waste of the department as prescribed.

4. Clean laboratory department and toilets within testing areas.

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

Article 18. Tasks of persons conducting tests at medical stations of communes

1. Health workers (doctors, medical assistants, nurses, technicians, midwives, physicians) shall conduct rapid tests and write test results in medical records, medical report books and test result records as assigned by the head of the medical station of the commune.

2. They shall conduct tests or send pathological specimens to a health facility licensed to conduct tests by a competent authority in order to conduct tests according to the list of techniques allowed to be deployed.

Chapter IV

IMPLEMENTATION CLAUSE

Article 19. Effect

1. This Circular comes into force from March 15, 2019.

2. Sections 17, 26, 39, 40, 41, 45, 56 and 69 of the Decision No. 1895/1997/QD-BYT dated September 19, 1997 of the Minister of Health are null and void from the effective date of this Circular.

Article 20. Reference clause

In the cases where any of the documents referred to in this Circular is amended or replaced, the newest one shall apply.

Article 21. Responsibility for implementation

1. The Director of the Vietnam Administration of Medical Services shall organize and inspect the implementation of this Circular nationwide.

2. Directors of Departments of Health of provinces and cities shall organize and inspect the implementation of this Circular within the scope of management.

3. The Director of the Vietnam Administration of Medical Services, the Chief of the Ministry Office, the Chief Inspector of the Ministry, Directors of Departments affiliated to the Ministry of Health, directors of hospitals affiliated to the Ministry of Health, directors of Departments of Health of provinces and central-affiliated cities, directors of Quality Control Centers for Medical Laboratory and heads of health authorities are responsible for the implementation of this Circular.

4. Heads of health facilities and test facilities that conduct medical tests shall organize the implementation of this Circular at facilities under their management.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Vietnam Administration of Medical Services affiliated to the Ministry of Health for resolution./.