Chapter III
MICROORGANISM TESTING ACTIVITIES, DUTIES AND POWERS OF TITLES IN DEPARTMENT OF MICROBIOLOGY
Article 6. Requirements on professional activities performed by Department of Microbiology
1. Department of Microbiology is arranged separately or within the testing area to facilitate its professional activities provided that the following requirements must be satisfied:
a) Department rooms must be suitably arranged according to one-way rule in order to ensure professional activities and biosafety as well as prevent the contamination;
b) Places for receiving patient specimens and disinfection must be available;
c) Restroom and bathroom must have enough clean water and hot water to serve the wash and disinfection of persons who work in department of microbiology before they leave there;
d) An area for receiving and performing emergency tests must be also available.
2. Laboratories must be designed and built in conformity with standards regulated in the Government's Decree No. 103/2016/ND-CP dated July 01, 2016 providing for biosafety in laboratories.
Article 7. Organizational structure of Department of Microbiology
1. The hospital shall, subject to its actual conditions, establish Department of Microbiology or Microorganism Testing Unit affiliated to Department of Testing, Department of Biochemistry and Microbiology, Department of Hematology and Microbiology, or Department of Microbiology and Immunology, and arrange appropriate personnel.
2. Department of Microbiology must be comprised of the following key sections:
a) A section in charge of producing biological products and chemicals serving tests and protecting test medium;
b) A section in charge of treating patient specimens, maintaining biological products and chemicals, steam sterilization and disinfection;
c) A section in charge of performing bacterial tests (receiving patient specimens, staining, culture and identification, antibiotic sensitivity testing, immunology, molecular biology and storage of strains of bacteria or patient specimens);
d) A section in charge of tests for viruses (receiving patient specimens, immunology, molecular biology and storage of strains of bacteria or patient specimens);
dd) A section in charge of tests for parasites (receiving patient specimens, staining, immunology, molecular biology and storage of strains of bacteria or patient specimens).
Article 8. Duties and powers of the Head of Department of Microbiology
1. Discharge and have general duties and powers of a Head of department in the hospital.
2. Organize activities of Department of Microbiology as regulated, ensure testing quality, and formulate regulations and procedures for bacterial contamination control and biosafety in laboratories.
3. Personally or make a letter of assignment to designate a qualified official in department to examine and sign testing result records before they are returned to clinical departments. Where the Department's Head is absent, he/she may not authorize anyone other than the Deputy Head of Department to fulfill the above-mentioned duties. The Department's Head shall assume responsibility before the Hospital’s Director for testing results.
4. Formulate and instruct standard operating procedures (SOPs) and regulations for performing activities of Department of Microbiology, including management procedure, systematic procedure and technical procedure in conformity with department’s activities, and laboratory biosafety manual.
5. Make plans for purchase of devices, machinery, medical consumables, equipment, chemicals, reagents, biological products, test medium for fulfilling assigned duties and serving the department’s scientific, technical and professional development.
6. Instruct the training for doctors, technicians, employees and students working at department of microbiology in management procedure, technical and professional procedures, biosafety, and use of testing machinery and equipment.
7. Inspect the compliance by department’s staff members with the hospital’s internal regulations.
8. Report to the Hospital’s Director immediately upon the discovery of any dangerous pathogens.
9. Instruct, monitor, supervise, evaluate, do research and make reports on drug-resistant organisms.
10. Send reports on drug-resistant organisms in the hospital to Ministry of Health (via Agency of Medical Services Administration) by applying WHONET Software on a periodical basis of once for every six months. Provide guide to WHONET software installation and instructions for use thereof according to Annex I to this Circular.
11. Participate in the Hospital’s Drug and Medical Treatment Council and Bacterial Contamination Control Council; participate in medical consultation, discussions about medical records and mortality review, if requested.
12. Provide advice and make reports to the hospital’s director on each assigned duty.
13. Discharge other duties as assigned by the Hospital’s Director.
Article 9. Duties and powers of laboratory physicians
A laboratory physician shall assume responsibility before the Head of Department of Microbiology for assigned works and have the following duties and rights:
1. Perform all professional works of a laboratory physician within the scope of his/her specialty.
2. Perform designated tests in conformity with microorganism testing techniques and procedure adopted in the hospital.
3. Examine and sign testing result records as assigned by the Head of Department of Microbiology.
4. Improve techniques on a periodical basis within the ambit of assigned duties.
5. Directly teach and provide instructions for practice to students working at the department and improve professional skills for test technicians and employees as assigned.
6. Participate in scientific researches and provide scientific information concerning microorganism as assigned by the Head of Department of Microbiology or the Hospital’s Director.
7. Take turn working night shifts as assigned by the Head of Department of Microbiology.
8. Participate in medical consultation with clinical departments and mortality review, if requested.
9. Instruct and provide technical assistance to lower-level health facilities as assigned in order to perform appropriate tests.
10. Strictly abide by regulations on labour protection and hygiene.
11. Discharge other duties as assigned by the Head of Department of Microbiology.
Article 10. Duties and powers of chief test technician
According to the assignment by the Head of Department of Microbiology, the chief test technician has the following duties and rights:
1. Perform professional techniques and inspect department’s test technicians or officials and medical orderlies for the compliance with Hospital Charter and microorganism testing techniques and procedure.
2. Manage records and books, and make reports and plans according to assigned duties. Assign tasks to test technicians and medical orderlies. Do daily timekeeping and aggregate and submit report on monthly working days to the Department's Head for approval.
3. Inventory and make regular reports on the use of chemicals, reagents, biological products and medical consumables according to forms 1, 2, 3 and 4 stated in Annex II enclosed to this Circular.
4. Take turn working night shifts in the department.
5. Receive and respond to requests of patients and their families, and report cases beyond the capacity of the chief test technician to the Department's Head for consideration.
6. Provide test technicians, medical orderlies and students working in the department for professional skills as assigned by the Department's Head.
7. Anticipate the amount of chemicals, biological products, reagents and medical consumables to be used by department of microbiology, and make records thereof by using the form stated in Annex III enclosed to this Circular. Examine the use, maintenance and management of medical equipment on a periodical basis as regulated. Make request for repair of medical equipment, if any.
8. Inspect hygienic activities and the compliance with the hospital’s regulation for antibacterials, biosafety and labour protection.
9. Perform tests, sign testing result records and participate in scientific researches as assigned by the Head of Department of Microbiology.
10. Discharge other duties as assigned by the Head of Department of Microbiology.
Article 11. Duties and powers of test technician
According to the assignment by the Head of Department of Microbiology and the chief test technician, a test technician has the following duties and rights:
1. Perform tests as assigned.
2. Make up chemicals, biological products and test medium, and examine reagents according to regulated standards.
3. Take patient specimens at beds of patients subject to level-1 care and in special tests.
4. Strictly abide by the hospital’s regulations and technical procedure and ensure the accuracy of testing results. Remaining patient specimens are destroyed upon the written approval by the department’s head.
5. Receive, dispense and maintain reagents, chemicals, biological products and medical devices as assigned and in accordance with regulations. Records of receiving reagents, chemicals, biological products and medical consumables follow the form stated in Annex IV enclosed to this Circular.
6. Record testing results in archives and send them to hospital's departments. Testing results must be promptly reported to the chief test technician and/or department's head if they are abnormal or suspect.
7. Provide students working at the department with instructions for practice as assigned by the Department's Head.
8. Take turn working night shifts and discharge other duties as assigned by the Head of Department of Microbiology and the chief test technician.
9. Monitor operating status of medical equipment and record daily operations into logbook.
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Thông tư 33/2016/TT-BYT (Bản Word)
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