Circular No. 33/2016/TT-BYT stipulates the organization and operation of microbiology testing in hospitals

CIRCULAR

REGULATIONS ON THE ORGANIZATION AND OPERATIONS OF MICROBIOLOGY TESTING IN HOSPITALS

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 this Circular to regulate the organization and operations of microbiology testing in hospitals.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Article 1. This Circular stipulates the organization and operations of microbiology testing, the functions and responsibilities of the Microbiology Department and the microbiology testing unit in hospitals.

Article 2. This Circular applies to state and private hospitals that have a Microbiology Department or a microbiology testing unit.

Article 2. Forms of organization for microbiology work in hospitals

The organization of microbiology testing in hospitals shall be carried out in one of the following forms:

1. Microbiology Department;

2. Microbiology testing unit under one of the following departments:

a) Laboratory Department;

b) Biochemistry-Microbiology Department;

c) Hematology-Microbiology Department;

d) Microbiology-Immunology Department.

Chapter II
FUNCTIONS AND RESPONSIBILITIES OF THE MICROBIOLOGY DEPARTMENT AND THE MICROBIOLOGY TESTING UNIT

AND THE MICROBIOLOGICAL TESTING DEPARTMENT

Article 3. Functions of the Microbiology Department

1. The Microbiology Department is a specialized department directly led by the Hospital Director. The Microbiology Department has the function of performing techniques to determine pathogenic microorganisms including bacteria, viruses, parasites according to the technical specialty lines and advising the Hospital Director on all microbiology testing activities in the hospital, contributing to improving diagnostic quality and monitoring treatment outcomes.

2. Participating in ensuring biosafety and biosecurity for members of the department, hospital environment, and surrounding areas.

Article 4. Responsibilities of the Microbiology Department

1. Developing and implementing microbiology testing procedures to meet the requirements of medical examination and treatment and disease prevention and control at the hospital and within the health sector when required.

2. Closely coordinating with clinical departments, other ancillary departments, and the infection control department to improve testing quality; participating in consultations, reviewing medical records, and advising on antibiotic usage.

3. Participating in monitoring, summarizing, evaluating, and reporting on issues related to antibiotic-resistant microorganisms and hospital infection control.

4. Planning and budgeting for the purchase of testing equipment, chemicals, reagents, and biological products to serve testing activities. Budgeting and equipping emergency drug and instrument reserves and spill containment equipment.

5. Monitoring, maintaining, and planning regular maintenance, calibration, and adjustment of testing equipment; regularly checking testing quality and updating testing procedures to ensure accurate and reliable testing results.

6. Monitoring, managing, and practicing testing according to appropriate biosafety levels for each testing technique: implementing monitoring, management, and storage of reagents, toxic chemicals, specimens, microbial strains according to technical requirements; carrying out sterilization work and handling waste safely to prevent contamination.

7. Continuously training healthcare staff on specimen collection, preservation, transportation, implementation of microbiological techniques, quality management, biosafety in laboratories, basic and advanced microbiology techniques at the unit and lower-level healthcare facilities.

8. Participating in scientific research, line guidance according to assigned functions and responsibilities, international cooperation on issues related to pathogen identification and antibiotic-resistant microorganisms.

9. Participating in disease prevention and control according to the division of labor by hospital leadership, the health sector, and local authorities when requested.

10. Advising and reporting to the hospital director on assigned fields and related issues.

Article 5. Functions and tasks of the microbiology testing unit

Depending on specific conditions of each unit, the microbiology testing unit shall perform functions, some tasks, or all tasks of the Microbiology Department as stipulated in Articles 3 and 4 of this Circular.

Chapter III
MICROBIOLOGY TESTING ACTIVITIES, TASKS

AND LIMITATIONS OF POSITIONS IN THE MICROBIOLOGY DEPARTMENT

Article 6. Requirements for professional activities of the Microbiology Department

1. The Microbiology Department may be arranged separately or within the laboratory area, facilitating professional activities and ensuring the following requirements:

a) Arranging rooms of the department in a continuous, unidirectional manner, reasonably to ensure professional work and biosafety, preventing contamination;

b) Having a place to receive specimens and a place for sterilization;

c) A bathroom with sufficient clean and hot water for staff to perform hygiene and sterilization before leaving;

d) Having a place for immediate reception and performance of emergency tests.

2. The design and construction of the laboratory must comply with standards as prescribed in Decree No. 103/2016/NĐ-CP dated July 1, 2016 of the Government on ensuring biosafety in laboratories.

Article 7. Organizational structure of the department

1. Depending on specific conditions, the Hospital establishes the Microbiology Department or the Microbiology Unit of the Laboratory Department, Biochemistry-Microbiology Department, Hematology-Microbiology Department, Microbiology-Immunology Department, and arranges appropriate personnel for assigned tasks.

2. The Microbiology Department must have the following main units:

a) Unit for production and storage of media, reagents, and chemicals for testing;

b) Unit for processing specimens, storing reagents and chemicals, autoclaving, and sterilization;

c) Bacterial testing unit (receiving specimens, staining and microscopy, culture, identification, antibiotic susceptibility testing, immunological methods, molecular biology techniques, maintaining bacterial strains or specimens);

d) Viral testing unit (receiving specimens, immunological methods, molecular biology techniques, maintaining viral strains or specimens);

e) Parasitic testing unit (receiving specimens, staining and microscopy, immunological methods, molecular biology techniques, maintaining parasitic strains or specimens).

Article 8. Tasks and authorities of the Head of the Microbiology Department

1. Implementing general duties and authorities of the Head of the Department in the hospital.

2. Organizing the operation of the Microbiology Department according to regulations, ensuring test quality, participating in building regulations and procedures for infection control and biosafety in the laboratory.

3. Directly checking test results and signing confirmation certificates before releasing results or assigning competent staff in the department to check test results and sign test reports before releasing them to clinical departments. In case the Head of the Department is absent, a delegation letter must be issued to the Deputy Head of the Department to perform these tasks and such delegation cannot be further delegated. The Head of the Department is responsible to the Hospital Director for the test results of the department.

4. Directing and developing standard operating procedures (SOPs) and regulations for activities in the Microbiology Department including management procedures, system procedures, and technical procedures suitable for the department's operations, and a laboratory biosafety manual.

5. Planning and budgeting for the purchase of equipment, machinery, consumable medical supplies, facilities, chemicals, reagents, biological materials, and media to fulfill assigned tasks and meet the development needs of scientific and technical expertise of the department.

6. Directing the organization of training, upgrading, and continuous education for doctors, technicians, and staff of the department and interns about management procedures, technical procedures, biosafety, and the use of laboratory equipment.

7. Inspecting compliance with internal rules and regulations of the hospital by members of the department.

8. Reporting to the Director immediately upon discovery of dangerous pathogens.

9. Directing, implementing, researching, monitoring, evaluating, and reporting on antimicrobial resistance situations in the unit.

10. Organizing the reporting of antimicrobial resistance situations in the unit to the Ministry of Health (Department of Medical Examination and Treatment) periodically (every six months) using the WHONET software template. Guidance on installing and using the WHONET software is provided in Appendix I attached to this Circular.

11. Participating in the Drug and Treatment Council, the Infection Control Council of the hospital; participating in consultations, reviewing medical records, and post-mortem reviews when requested.

12. Advising and reporting to the Hospital Director in each assigned field.

13. Performing other tasks as assigned by the Hospital Director.

Article 9. Duties and Authorities of Clinical Laboratory Physicians

Clinical laboratory physicians are responsible to the Department Head for the tasks assigned and have the following duties and authorities:

1. Perform clinical laboratory physician professional work within the scope of their expertise.

2. Conduct assigned laboratory tests according to the microbiology technical procedures implemented at the hospital.

3. Review and sign off on test result reports as assigned by the Department Head.

4. Regularly standardize techniques within the assigned scope.

5. Directly teach and guide practical training for students studying at the department and provide supplementary training for technicians and staff within the department as assigned.

6. Participate in scientific research activities and disseminate microbiological scientific information as assigned by the Department Head or Hospital Director.

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

8. Participate in consultations with clinical departments and post-mortem reviews when requested.

9. Participate in directing and providing technical support to lower levels as assigned to implement appropriate laboratory tests.

10. Strictly comply with hygiene and occupational safety regulations.

11. Perform other tasks as assigned by the Department Head.

Article 10. Duties and Authorities of Chief Laboratory Technicians

Under the direction and assignment of the Department Head, Chief Laboratory Technicians have the following duties and authorities:

1. Organize the implementation of specialized techniques, supervise and urge technicians, laboratory staff, and medical workers in the department to perform in accordance with the hospital's laboratory rules and microbiology technical procedures.

2. Manage records, statistical reporting, and plan work based on assigned plans. Assign tasks to technicians and medical workers. Record daily attendance, compile monthly attendance figures to submit to the Department Head for approval.

3. Inventory and report periodically on the usage of chemicals, reagents, biological products, and medical supplies according to models 1, 2, 3, and 4 stipulated in Appendix II issued together with this Circular.

4. Participate in regular duty shifts and assign duty shifts within the department.

5. Receive and resolve patient and family requests; if beyond their capability or authority, report to the Department Head for resolution.

6. Participate in training technicians and medical workers in the department and students studying as assigned by the Department Head.

7. Prepare budgets for chemicals, biological products, reagents, and consumable medical supplies for the department, maintain records of reagent, chemical, biological product, and medical supply inventory according to the model stipulated in Appendix III issued together with this Circular. Regularly inspect the use, maintenance, and management of equipment according to regulations. Write repair request forms for broken tools.

8. Supervise hygiene, hospital infection control protocols, biosafety, and occupational health and safety within the department.

9. Conduct assigned laboratory tests, sign off on test results, and participate in scientific research as assigned by the Department Head.

10. Perform other tasks as assigned by the Department Head.

Article 11. Duties and Authorities of Laboratory Technicians

Under the direction and assignment of the Department Head and Chief Laboratory Technician, Laboratory Technicians have the following duties:

1. Conduct assigned laboratory tests.

2. Prepare chemicals, biological products, media for testing, and regularly check reagents to meet specified standards.

3. Collect specimens from patients under primary care beds and special testing cases.

4. Strictly adhere to hospital rules and technical procedures to ensure accurate test results. Remaining specimens can only be disposed of after approval by the Department Head.

5. Receive, distribute, and store reagents, chemicals, biological products, and equipment as assigned and in accordance with regulations. Reagent, chemical, biological product, and medical supply requisition forms follow the model stipulated in Appendix IV issued together with this Circular.

6. Statistically record test results in storage logs and transfer test results to relevant departments. Report immediately to the Chief Laboratory Technician and Department Head in case of unusual test results or suspected issues.

7. Guide practical training for students and interns as assigned by the Department Head.

8. Participate in regular duty shifts and perform other tasks as assigned by the Department Head and Chief Laboratory Technician.

9. Monitor the operation status of medical equipment and keep daily activity logs.

Chapter IV
MAIN ACTIVITIES OF THE MICROBIOLOGY DEPARTMENT

Article 12. Activities of specimen collection, storage, transportation, and receipt in the Microbiology Department

1. Establish procedures and guidelines for collecting, storing, transporting, and receiving emergency and routine specimens according to standards for clinical departments and submit them for approval by the Hospital Director.

2. Organize the reception of specimens collected and stored by nurses and doctors from clinical departments according to the approved procedures. Specimens must be accompanied by test request forms containing all required information and signed by the treating physician. Transportation of specimens must ensure biosafety.

a) Suspected infectious specimens must be handled in accordance with Circular No. 43/2011/TT-BYT dated December 5, 2011, issued by the Minister of Health on the management regime for infectious disease samples.

b) In cases where special requirements exist for specimens, clinical departments must consult with the Microbiology Department to collect the specimens.

Article 13. Implementation of microbiological testing techniques and reporting results

1. Conduct tests according to technical procedures, prioritizing urgent cases and ensuring timely completion of tests with specific characteristics.

a) Ensure accuracy and reliability through technical implementation. Maintain logs of culture and bacterial isolation progress according to the model specified in Appendix V attached to this Circular.

b) Test results must be clearly and fully recorded on the test request form and the Microbiology Testing Logbook according to the model specified in Appendix VI attached to this Circular.

c) Basic microbiological testing techniques must be performed according to the model specified in Appendix VII attached to this Circular.

2. Before releasing test results, the Head of the Department or assigned staff must review and sign off on the results. Abnormal or questionable results must be immediately reported to the Chief Technician or the Head of the Department for verification against clinical data, and retesting may be necessary.

3. Provide complete test results within the prescribed time frame. The Microbiology Test Result Logbook must follow the model specified in Appendix VIII attached to this Circular.

4. Post-test specimen samples must be stored and disposed of according to regulations applicable to each type of specimen.

5. Emergency test results should be directly retrieved by nurses from the clinical department at the Microbiology Department or the Microbiology Laboratory.

6. Perform on-call duties as assigned.

Article 14. Storage and Use of Chemicals, Reagents, Biological Products, and Medical Equipment

1. Chemicals, Reagents, Biological Products:

a) Monitor, manage, and use chemicals, reagents, and biological products in compliance with drug usage regulations. Store hazardous, toxic, corrosive, flammable, and explosive chemicals according to laboratory safety regulations.

b) Proper storage of chemicals, reagents, and biological products must meet manufacturer requirements to avoid errors in test results.

2. Management of Instruments, Machinery, and Medical Equipment:

a) Maintain records and histories for each piece of equipment; establish handover, monitoring, and management logs for all equipment.

b) Post operational procedure guidelines for medical equipment at their respective locations.

c) Maintain usage, repair, and maintenance logs for equipment according to the model specified in Appendix IX attached to this Circular.

d) Doctors and technicians must use equipment and instruments for their intended purposes and according to technical procedures.

đ) Maintain daily usage and shift handover logs for medical equipment according to the model specified in Appendix X attached to this Circular.

3. Usage of Medical Supplies and Equipment:

a) Utilize all technical capabilities of installed equipment to achieve high efficiency, rationality, and cost-effectiveness.

b) Conduct safety checks on medical supplies and equipment as required, recording each check in a log for monitoring.

c) When equipment malfunctions, users must stop operation, report to the Head of the Department to document the incident, determine the cause, assign responsibility, and find repair solutions. Documentation of lost, damaged, or broken reagents, chemicals, biological products, medical supplies, and equipment must follow the model specified in Appendix XI attached to this Circular.

d) Strictly prohibit unauthorized use of medical equipment outside assigned responsibilities and unauthorized repairs.

đ) Disposal of non-repairable medical supplies and equipment must comply with legal regulations, with complete disposal documentation for reagents, chemicals, biological products, medical supplies, and equipment following the model specified in Appendix XII attached to this Circular.

Article 15. Implementation of infection control in departments

1. Establish regulations on the storage of reagents, chemicals, biological materials, and specimens; procedures for handling specimens after testing, disposal of experimental animal carcasses, and sterilization of contaminated equipment before transferring to the Infection Control Department.

2. Collect waste daily, autoclave equipment for sterilization, wash and prepare sterile equipment; disinfect floors with antiseptic solutions in microbiology laboratories.

3. Do not directly dispose of remaining specimens, tested slides into drains or through sinks at testing tables without prior treatment.

Article 16. Laboratory Safety

1. Ensure biosafety and biosecurity in accordance with Decree No. 103/2016/NĐ-CP dated July 1, 2016, of the Government on ensuring biosafety in laboratories.

2. Equip personal protective equipment for staff.

3. Train employees on the use and operation of machines and equipment to ensure safety.

4. Exercise caution when handling biological materials that can cause disease, strictly adhering to biosafety and hospital infection control regulations.

5. Conduct regular health checks for staff in accordance with regulations.

6. Staff must be trained on laboratory accident response: spills of specimens, chemicals, biological materials, and reagents during transportation and study, enhancing knowledge and skills to prevent and provide initial emergency treatment in case of accidental burns from alkali, acid, heat, poisoning, electric shock, fire, or explosion.

Chapter V
IMPLEMENTING PROVISIONS

Article 17. Effective Date

This Circular takes effect from November 3, 2016.

Decision No. 1895/1997/BYT-QĐ dated September 19, 1997 of the Minister of Health on the issuance of Hospital Regulations, concerning the "Head of Microbiology Department" (Item 42), shall cease to be effective from the date this Circular comes into force.

Article 18. Reference Provisions

In cases where the referenced documents in this Circular are replaced or amended, the replacement or amended documents shall apply.

Article 19. Responsibility for Implementation

The Permanent Deputy Minister of Health, Heads of Departments under the Ministry of Health, Inspectors General, Directors of Central Hospitals under the Ministry of Health, Directors of Health Services of provinces and centrally-administered cities, and Heads of Health Services of Ministries and Sectors are responsible for implementing this Circular.

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