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.
Tìm kiếm
Thông tư 49/2018/TT-BYT (Bản Word)