Phụ lục XI Thông tư 33/2016/TT-BYT: Biên bản xác nhận thuốc thử/hóa chất/sinh phẩm/vật tư y tế/thiết bị mất/hỏng/vỡ

CIRCULAR

PROVIDING FOR ORGANIZATION AND PERFORMANCE OF MICROORGANISM TESTS IN HOSPITALS

Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of Minister of Health;

In consideration of the request of Director General of the Administration of Medical Examination & Treatment - the Ministry of Health;

Minister of Health promulgates this Circular to provide for the organization and performance of microorganism tests in hospitals.

Chapter I

GENERAL PROVISIONS

Article 1. Scope and regulated entities

1. This Circular provides for the organization and performance of microorganism tests, the role and duties of departments of microbiology and microorganism testing units in hospitals.

2. This Circular is applied to all public and private hospitals that have departments of microbiology or microorganism testing units established.

Article 2. Forms of organizing microbiological activities in hospitals

Microorganism tests in hospitals shall be performed according to any of the following forms:

1. Department of Microbiology;

2. Microorganism testing unit affiliated to any of the following departments:

a) Testing Department;

b) Department of Biochemistry and Microbiology;

c) Department of Hematology and Microbiology;

d) Department of Microbiology and Immunology.

Chapter II

ROLE AND DUTIES OF DEPARTMENTS OF MICROBIOLOGY AND MICROORGANISM TESTING UNITS

Article 3. Role of Department of Microbiology 

1. Department of Microbiology is a specialized department subject to the direct management of the Hospital’s Director.  Department of Microbiology is functioned to perform testing techniques to identify disease-causing organisms, including bacteria, viruses and parasites, according to specialty and technique-based assigned, and to provide advice to the Hospital’s Director about all microorganism testing activities performed in the hospital for the purposes of improving the quality of medical diagnosis and monitoring medical treatment results.

2. Department of Microbiology is responsible for ensuring biosafety and biosecurity for its staff within the department, hospital environment as well as the environment around the hospital.  

Article 4. Duties of Department of Microbiology

1. Formulate and perform microorganism testing techniques and procedure to meet requirements on medical examination and treatment, and disease control and prevention of the hospital and of health authorities, if requested.

2. Closely cooperate with clinical departments, other subclinical departments and bacterial contamination control department to improve the testing quality; participate in medical consultation and provide comments on medical records and professional advice on use of antibiotics.

3. Monitor, supervise, integrate, evaluate and make reports on drug-resistant organisms and bacterial contamination control in hospital.

4. Prepare plan for purchase of testing devices and equipment, chemicals, reagents and biological products to serve testing activities. Anticipate and provide adequate medicine, emergency devices and spill kits.  

5. Monitor, maintain and make plans for periodical maintenance, calibration and repair of testing equipment; conduct regular inspections of testing quality and adopt new testing techniques and procedure in order to obtain accurate and reliable testing results.

6. Monitor, manage and perform tests according to biosafety levels in conformity with testing techniques, consisting of: monitoring, managing and maintaining reagents, toxic chemicals, patient specimens and strains of microorganisms in conformity with technical requirements; carrying out the sterilization and waste treatment to ensure safety and prevent the contamination.

7. Provide regular training to medical staff in taking, maintaining and transporting patient specimens, performing microorganism techniques and procedure, managing testing quality and biosafety in laboratories, performing basic and advance microorganism testing techniques at the hospital and lower-level health facilities.

8. Participate in scientific researches and support for health facilities of lower levels within the ambit of assigned functions and duties, and carry out the international cooperation in issues related to the identification of disease-causing organisms and drug-resistant organisms.  

9. Participate in the disease control and prevention activities as designated by the hospital’s leader or as requested by health authorities and local governments. 

10. Provide advice and make reports to the hospital’s director on assigned duties and related issues.

Article 5. Role and duties of microorganism testing unit

A microorganism testing unit shall, subject to its specific conditions, perform functions and several or all duties which must be discharged by Department of Microbiology as referred to in Article 3 and Article 4 of this Circular.

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.

Chapter IV

MAIN ACTIVITIES OF DEPARTMENT OF MICROBIOLOGY 

Article 12. Department of Microbiology’s taking, storage, transport and receipt of patient specimens  

1. Formulate the procedure and instructions for taking, storing, transporting and receiving patient specimens in emergency and normal cases in accordance with technical specifications for clinical departments, and submit them to the hospital’s director for approval.

2. Receive and store patient specimens taken by nurses or doctors of clinical departments in accordance with the approved procedure.  Such patient specimens must be enclosed with written requests for testing, including required testing items and confirmation by attending physicians.  The transport of patient specimens must ensure biosafety.

a) Infectiousness-prone specimens must be treated in accordance with regulations in Circular No. 43/2011/TT-BYT dated December 05, 2011 by Ministry of Health providing for the management of infectious specimens; 

b) If a test requires special specimens, clinical department/ward should participate in medical consultation with the department of microbiology to take such specimens.

Article 13. Performance of testing techniques and returning microorganism testing results

1. Perform tests in conformity with techniques and procedure. Emergency tests and tests which must be performed in a timely manner shall be given priority.

a) The accuracy and reliability of testing techniques must be ensured. Logbook for culture and classification of bacteria must be prepared by using the form stated in Annex V to this Circular;

b) Testing results must be clearly and sufficiently specified in testing result records and the microorganism testing logbook according to the form stated in Annex VI to this Circular;

c) Basic microorganism testing techniques are recorded by using the form stated in Annex VII to this Circular.

2. Testing result records must be examined and signed by the department's head or authorized official before they are delivered to requesters. Abnormal or suspicious testing results must be reported to the chief test technician or the department’s head for comparing with clinical records or retesting, where necessary.  

3. Testing results must be delivered in full and within prescribed time. The record of delivering microorganism testing results shall be prepared by using the form stated in Annex VIII to this Circular.

4. Tested specimens shall be stored and destroyed in accordance with specific regulations for each type of specimen.

5. Nurses of clinical departments shall directly receive emergency testing results at department of microbiology or microorganism testing unit.

6. Take turn working night shifts as assigned.

Article 14. Storage and use of chemicals, reagents, biological products and medical equipment

1. Chemicals, reagents and biological product:

a) Monitor, manage and use chemicals, reagents and biological products in accordance with regulations on management and use of medicines. Hazardous, toxic, corrosive and flammable chemicals must be stored in conformity with regulations on safety of laboratories.

b) Chemicals, reagents and biological products must be stored in accordance with requirements by manufacturers thereof in order to avoid variation in testing results.

2. Management of medical devices, machinery and equipment:

a) Prepare records, including origin, of each type of medical equipment; prepare records of delivering, monitoring and managing medical equipment;

b) Post machinery operating procedure at the place where such medical machinery is located;

c) Logbook for use, repair and maintenance of medical equipment must be prepared by using the form stated in Annex IX to this Circular;

d) Medical devices and equipment must be properly used in accordance with their technical procedures;

dd) Written record for daily operations and hand-over of medical equipment between shifts must be prepared by using the form stated in Annex X to this Circular;

3. Use of medical equipment and supplies:

a) Technical specifications of installed equipment must be properly used in order to ensure operating efficiency;

b) Carry out the inspection of medical equipment as regulated for ensuring its safety during use and the result of such inspection must be recorded;

c) The operation of medical equipment must be stopped upon the occurrence of equipment failure which must be promptly reported to the department's head in order to make a written record of such failure, find causes thereof and adopt measures for repair. Records of lost, broken or damaged reagents, chemicals, biological products and medical equipment are prepared by using the form stated in Annex XI enclosed to this Circular;

d) The use of medical equipment for unauthorized purposes and self-repair are prohibited;

dd) The liquidation of irreparably damaged equipment must be carried out in accordance with the laws. The record of liquidation of reagents, chemicals, biological products and medical equipment must be prepared by using the form stated in Annex XII enclosed to this Circular.

Article 15. Bacterial contamination control

1. Formulate regulations for storage of reagents, chemicals, biological products and patient specimens; procedure for treatment of tested specimens, animal carcasses and sterilization of medical equipment before being delivered to bacterial contamination control department.

2. Collect wastes, steam disinfected devices, clean and prepare sterilized devices; clean the floors of microorganism laboratories by antiseptics.

3. Do not pour tested specimens which are not properly treated into sewer or wash-basin on the testing table.

Article 16. Safety in laboratories

1. Biosafety and biosecurity must be ensured in conformity with regulations in the Government's Decree No. 103/2016/ND-CP dated July 01, 2016 providing for biosafety in laboratories.

2. Personnel protective equipment must be sufficiently provided to persons working in laboratories.

3. Employees must be provided with training in the use and operation of medical machinery and equipment for ensuring safety.

4. Employees must be careful when contacting with biological products which are prone to communicate diseases, and strictly abide by regulations on biosafety and bacterial contamination control in hospital.

5. All employees working in department must go for periodical check-up.

6. Employees must be trained for response to laboratory accidents such as spill of specimens, chemicals, biological products or reagents during the transportation, and must attend training courses for prevention and first aids in case of acid burns, alkali burns, thermal burns, poisoning, electrocution, or explosion.    

Chapter V

IMPLEMENTATION

Article 17. Effect

This Circular takes effect as of November 03, 2016.

Section 42 “Head of Department of Microbiology” in Decision No. 1895/1997/BYT-QD dated September 19, 1997 by Minister of Health promulgating the Hospital Charter shall be out of force as of the entry into force of this Circular.

Article 18. Terms of reference

If documents referred to in this Circular are replaced or amended, the new ones shall be applied.

Article 19. Implementation

Chief of Ministry’s Office, Director of Agency of Medical Services Administration, Ministry’s Chief Inspector, General Directors/Directors of General Departments/Departments affiliated to Ministry of Health, Directors of hospitals directly under the Ministry of Health, Directors of Departments of Health of central-affiliated cities or provinces and heads of medical units affiliated to Ministries/regulatory bodies shall be responsible for implementing this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (via Agency of Medical Services Administration) for consideration./.

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