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Clinical Laboratory Biosafety

The application of knowledge, techniques and equipment to prevent a personal laboratory and environmental exposure to potentially infectious agents or biohazard is known as biosafety.
Biosafety defines the containment conditions under which infectious agents can be safely manipulated.
The objective of containment is to confine biohazard and to reduce the potential exposure of the laboratory worker, persons outside of the laboratory, and the environment to potentially infectious agents.

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Clinical Laboratory Biosafety

  1. 1. Tapeshwar Yadav (Lecturer) BMLT, DNHE, M.Sc. Medical Biochemistry Clinical Laboratory Biosafety
  2. 2. Introduction:  The application of knowledge, techniques and equipment to prevent a personal laboratory and environmental exposure to potentially infectious agents or biohazard is known as biosafety.  Biosafety defines the containment conditions under which infectious agents can be safely manipulated.  The objective of containment is to confine biohazard and to reduce the potential exposure of the laboratory worker, persons outside of the laboratory, and the environment to potentially infectious agents.
  3. 3. Contd…  The backbone of the practice of biosafety is risk assessment. While there are many tools available to assist in the assessment of risk for a given procedure or experiment, the most important component is professional judgment.  Risk assessment should be performed by the individual most familiar with the specific characteristics of the organisms.
  4. 4. Biological safety cabinet:  This equipment is designed for controlling aerosols and micro particles associated with managing potentially toxic or infectious biological material in laboratories.  Safety cabinets have been designed to protect the user, the environment and the sample manipulated using appropriate ventilation conditions.  They are also known as laminar air flow cabinets or biosafety cabinets.
  5. 5. Classification of infective micro organisms by risk group:  The following guidelines are recommended by the centers for disease control and prevention and the National Institutes of Health. Four biosafety levels ( BSLs) are described :  Risk group 1: No or low individual and community risk.  Risk group 2: Moderate individual risk, low community risk.  Risk group 3: High individual risk, low community risk.  Risk group 4: High individual and community
  6. 6. 1.Biosafety level 1:  Biosafety level 1 (BSL-1) is suitable for work involving agents of no known or minimal potential hazard to laboratory personnel and the environment.  The laboratory may be integral to general traffic patterns in the building.  Work may be conducted on open bench tops.  Special containment equipment is neither required nor generally used.  Laboratory personnel shall have specific training in procedures conducted in the laboratory.
  7. 7. Contd… Standard practices for BSL-1  The laboratory shall have an established policy for the safe handling of sharps.  Eating, drinking and applying cosmetics are not permitted.  Laboratory personnel shall wash their hands after they handle viable materials and animals and before leaving the laboratory.  Work surfaces shall be decontaminated once a day and after any spill of viable materials.
  8. 8. Contd… Safety equipment for BSL-1  It is recommended that laboratory coats, or uniforms be worn for prevention.  Gloves should be worn if skin is broken or afflicted by a rash. Laboratory facilities for BSL-1  The laboratory shall be designed so that it can be easily cleaned.  Bench top shall be impervious to water and resistant to acids, alkali and organic solvents and moderate heat.  Each laboratory shall contain a sink for hand
  9. 9. Biosafety Level 1 laboratory.
  10. 10. 2.Biosafety level 2: Biosafety level 2 is similar to level 1 and is suitable for work involving the agents of moderate potential hazards to personnel and the environment. It differs in that ;  Laboratory personnel are specifically trained to handle pathogenic agents.  Access to the laboratory is limited when work is being conducted.  Extreme precautions are taken with contaminated sharps items.
  11. 11. Contd… Special practices for BSL-2  Laboratory personnel receive appropriate immunization.  Receive appropriate training on the potential hazards associated.  A high degree of precaution must always be taken with any contaminated Sharp items.  Broken glassware must not be handled directly.  Containers of contaminated needles, sharp equipment, and the broken glass are decontaminated before disposal.  Cultures, tissues and specimens of body fluids are placed in a container that prevents leakage during collection, handling, processing, storage, transport.  Work surfaces should be decontaminated with an appropriate disinfectant.
  12. 12. Contd… Safety equipment for BSL-2  Properly maintained biological safety cabinets or other appropriate personal protective equipment or physical containment devices are used whenever necessary.  Face protection (goggle, mask, or other splatter guards) is used.  Personal protective coat, gowns are worn in the laboratory.
  13. 13. Contd… Laboratory facilities for BSL2  The laboratory is designed so that it can be easily cleaned.  An eyewash facility is readily available.  Biological safety cabinets shall be installed in such a manner that fluctuations of the room supply and exhaust air do not cause them to operate outside their parameters for containment.
  14. 14. Biosafety Level 2 laboratory
  15. 15. 3.Biosafety level 3:  The containment laboratory - Biosafety level 3 is designed and provided for work with Risk group 3 micro organisms and with large volumes or high concentration of Risk Group 2 micro organisms that pose an increased risk of aerosol spread.  Biosafety Level 3 containment requires the strengthening of the operational and safety programmes over and above those for basic laboratories -Biosafety Levels 1 and 2.
  16. 16. Contd… Special practices for BSL 3  The international biohazard warning symbol and sign displayed on laboratory access doors must identify the Biosafety level and indicates any special conditions for entry into the area ex: immunization  Front-buttoned standard laboratory coats and half sleeves that do not fully cover the forearms are unsuitable.  Open manipulation of all potentially infectious materials must be conducted within a biological safety cabinet.  Respiratory protective equipment are necessary laboratory procedures or working with animals infected with certain pathogens.
  17. 17. Contd… Laboratory design for BSL 3  The laboratory must be separated from the areas that are open to unrestricted traffic flow within the building.  Surfaces of walls, floors and ceiling should be water resistant and easy to clean.  The laboratory room must be sealable for decontamination.  There must be a controlled ventilation system that maintains a directional airflow into the laboratory room.
  18. 18. Contd… Laboratory facilities for BSL3 The objective of Health and medical surveillance programme for basic laboratories - Biosafety Levels 1 and 2 also apply to containment laboratories - Biosafety level 3, except where modified as follow :  Medical examination of all laboratory personnel who work in containment laboratories.  After a satisfactory clinical assessment, the examiner may be provided with a medical contact card stating that he / she is employed in a facility with a containment laboratory - Biosafety Level 3.
  19. 19. Biosafety Level 3 laboratory
  20. 20. 4.Biosafety level 4:  The maximum containment laboratory - Biosafety level 4 is designed to work with Risk Group 4 micro organisms.  Before constructing such laboratories and putting them into operation, intensive consultation should be done with institutions are experienced in operating similar laboratories.  Operation of maximum containment laboratories ‘Biosafety Level 4’ should be under the control of national or other authorized health authorities.
  21. 21. Contd… Special practices for BSL 4  Along with BSL 3 practices following codes must be exercised:  The two person rule should be applied, whereby no individual ever works alone.  A complete change of clothing and shoes is required prior to entering and upon exiting the laboratory.  Personnel must be trained in emergency extraction procedures in the event of injury or illness.
  22. 22. Contd… Laboratory design and facilities for BSL 4  Passage through a minimum of two doors prior to entering the rooms containing the class III biological safety cabinets is required.  A protective suit laboratory with self- contained breathing apparatus differs significantly in design and facility requirements from a Biosafety level 4 laboratory with class III biological safety cabinets.  The maximum containment laboratory - Biosafety Level 4 must be located in a separate building or in a clearly delineated zone within a secure building.  All effluents from the suit area, decontamination chamber, shower or class III biological safety cabinet must be decontaminated before final discharge.  Heat treatment is the preferred method.
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