1. Patient Safety Monitoring in International Laboratories (SMILE) 1 Biosafety in the Clinical Laboratory A SMILE Presentation

2. Patient Safety Monitoring in International Laboratories (SMILE) 2 Responsibility Safety is Everyone’s Responsibility Safety is Everyone’s Responsibility!

3. Patient Safety Monitoring in International Laboratories (SMILE) 3 Laboratory Responsibility To develop biosafety policies and procedures To advise personnel of special hazards To provide Personal Protective Equipment (PPE) To maintain safety equipment: fire extinguishers, blankets, eye wash stations To train employees to recognize potential hazards and proper handling procedures

4. Patient Safety Monitoring in International Laboratories (SMILE) 4 Staff Members When working with infectious agents or potentially infected materials: Must be aware of potential hazards; must read and follow required procedures; must be trained and proficient in practices and techniques required; must report unsafe conditions or incidents to the Laboratory Director.

5. The Laboratory Director is responsible for selecting additional safety practices in keeping with the hazards associated with the agents and procedures. Patient Safety Monitoring in International Laboratories (SMILE) 5

6. 6 Biosafety Program Objective: The containment of potentially harmful biological agents. Purpose: To reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents.

7. Patient Safety Monitoring in International Laboratories (SMILE) 7 BioSafety Containment = m ethods for managing infectious agents in the laboratory environment where they are being maintained or handled

8. The most important element of containment is: Strict adherence to standard microbiological practices and technique Patient Safety Monitoring in International Laboratories (SMILE) 8

9. 9 Biosafety Elements of containment: Laboratory practices and techniques Safety equipment Facility design

10. Patient Safety Monitoring in International Laboratories (SMILE) 10 Standard Microbiological Practices Policies must be enforced Handwashing No eating, drinking, chewing gum, smoking, or storing of food in laboratory areas No mouth pipetting Sharps handling policy Procedures to minimize splashes and aerosols

11. Patient Safety Monitoring in International Laboratories (SMILE) 11 Standard Microbiological Practices Decontamination of work surfaces Decontamination of cultures, stocks and infectious materials Sign posted with Universal Biohazard symbol when infectious agents are present Effective pest management program Appropriate training regarding duties

12. Hand Washing When to wash? What to use? Where to wash? How long? Why wash? Patient Safety Monitoring in International Laboratories (SMILE)

13. Decontamination When cleaning up surfaces use 5% freshly diluted bleach or another approved disinfectant Do an initial wipe up Spray and allow it to stand for ten minutes then wipe up Dispose of all wipes in biohazard containers PPE should be removed and disposed of in biohazard containers Patient Safety Monitoring in International Laboratories (SMILE)

14. 14 Biosafety Primary containment The protection of personnel and the immediate laboratory environment from exposure to infectious agents, is provided by good technique and the use of appropriate safety equipment.

15. Personal Protective Equipment (PPE) Anything that is used to protect a person from exposure Patient Safety Monitoring in International Laboratories (SMILE)

16. 16 Biosafety Personal Protective Equipment (PPE) Gloves/shoe covers/boots Safety glasses/Goggles/face shields/respirators Lab coats/gowns (should be fluid resistant) Clothing should provide protection to skin Closed toe shoes

17. Patient Safety Monitoring in International Laboratories (SMILE) 17 Biosafety How much PPE should you use? Wear as much or as little as you will need to prevent blood and other infectious materials from contact with your skin, mucus membranes and clothing. Used in combination with BSCs and other devices that contain the agent being handled.

18. PPE Rules to Remember Always check PPE for defects or tears before using If PPE becomes torn or defective, remove and get new Remove PPE before leaving a contaminated area Do not reuse disposable PPE Patient Safety Monitoring in International Laboratories (SMILE)

19. 19 Biosafety Safety equipment: BSCs Enclosed containers Other engineering controls

20. Patient Safety Monitoring in International Laboratories (SMILE) 20 Biosafety Biological Safety Cabinet (BSC) The principle device used to provide containment of infectious splashes or aerosols generated by microbiological procedures

21. Patient Safety Monitoring in International Laboratories (SMILE) 21 Biosafety Safety Centrifuge Cup An enclosed container designed to prevent aerosols from being released during centrifugation.

22. Patient Safety Monitoring in International Laboratories (SMILE) 22 Biosafety Secondary containment The protection of the external laboratory environment from exposure to infectious materials, is provided by a combination of facility design and operational practices.

23. Patient Safety Monitoring in International Laboratories (SMILE) 23 Biosafety Secondary Barriers: Doors for access control A sink for handwashing Laboratory design for easy cleaning- no carpets or rugs Furniture for laboratory use Windows fitted with screens

24. Patient Safety Monitoring in International Laboratories (SMILE) 24 Biosafety When the risk of infection by exposure to an infectious aerosol is present, higher levels of primary containment and multiple secondary barriers may be necessary to prevent infectious agents to escape into the environment.

25. Patient Safety Monitoring in International Laboratories (SMILE) 25 Biosafety These guidelines specify four biosafety levels (BSL) based on the potential hazard of the infectious microorganisms

26. Patient Safety Monitoring in International Laboratories (SMILE) 26 Biosafety BSL-1 Agents- not known to consistently cause disease in healthy adults Practices- Standard Microbiological practices Primary Barriers- Labcoats or gowns, gloves worn if broken skin or rash on hands, protective eyewear for possible splashes Secondary Barriers- Open bench top sink required

27. Patient Safety Monitoring in International Laboratories (SMILE) 27 Biosafety BSL-2 Agents- associated with human disease, hazard= percutaneous injury, ingestion, mucus membrane exposure Practices- BSL-1 plus limited access; hazard warning signs; sharps precautions; Biosafety manual Primary Barriers- Biological safety cabinet (BSC), PPE’s: labcoats, gloves, face protection is needed. Secondary Barriers- BSL-1 plus: Autoclave available

28. Patient Safety Monitoring in International Laboratories (SMILE) 28 Biosafety BSL-3 Agents- indigenous or exotic agents with potential for aerosol transmission; disease may have serious or lethal consequences. Hazard- autoinoculation, ingestion, and exposure to aerosols. Practices- BSL-2 plus controlled access; decontamination of all waste; decontamination of lab clothing before laundering; baseline serum Primary Barriers- Biological safety cabinet (BSC), PPE’s: protective lab clothing, gloves, respiratory protection as needed. Secondary Barriers- BSL-2 plus: Physical separation from access corridors; self closing double door access; exhausted air not re-circulated; negative airflow into lab

29. Patient Safety Monitoring in International Laboratories (SMILE) 29 Biosafety BSL-4- is applicable to working with dangerous and exotic agents which pose a high individual risk of life-threatening disease. This level is not applicable to the diagnostic laboratory.

30. Patient Safety Monitoring in International Laboratories (SMILE) 30 Biosafety Biological Safety Cabinets (BSC) used for Biosafety Levels 1,2,3 and 4 depending on the tasks are divided into 3 classes.

31. Patient Safety Monitoring in International Laboratories (SMILE) 31 Biosafety Class I BSC negative pressure with minimum face velocity of 75 linear feet per minute all of the air from the cabinet is exhausted through a HEPA filter either into the laboratory, or to the outside. provides protection of personnel and environmental but not product Class I BSCs are no longer being manufactured on a regular basis

32. Patient Safety Monitoring in International Laboratories (SMILE) 32 Biosafety Class II BSC Provides a face velocity of 75 – 100 linear feet per minute, HEPA-filtered vertical laminar airflow provides personnel, product and environmental protection All Class II cabinets are designed for work with BSL-1,2,and 3. not for use with volatile or toxic chemicals.

33. Patient Safety Monitoring in International Laboratories (SMILE) 33 Biosafety Class III BSC Is totally enclosed, ventilated cabinet of gas-tight construction highest degree of personnel and environmental protection from infectious aerosols, as well as protection of research materials from microbiological contamination. for work with hazardous agents that require Biosafety level 4 containment.

34. Patient Safety Monitoring in International Laboratories (SMILE) 34 Biosafety General suggestions: Effectiveness of the BSC is a function of directional air flow (Inward and downward) through a “high efficiency particulate air” (HEPA) filter. Anything such as rapidly moving your arms in and out of the BSC, doors opening, and people walking rapidly behind you, can disrupt the air flow which will reduce the cabinet’s effectiveness.

35. Patient Safety Monitoring in International Laboratories (SMILE) 35 Biosafety Operational suggestions: Do not place objects on or over front or rear air intake grilles Arrange materials to segregate contaminated and clean items Work should be performed at least six inches back from front grille Inside the BSC, always use discard pans containing appropriate disinfectant Clean up spills immediately. Wait 5 minutes before resuming work Do not use the BSC for storage

36. Patient Safety Monitoring in International Laboratories (SMILE) 36 Biosafety Questions and Comments

37. Patient Safety Monitoring in International Laboratories (SMILE) 37 Biosafety Reference: Biosafety in Microbiological and Biomedical Laboratories, 5 th Edition, US Government Printing Office found at http://www.cdc.gov/OD/ohs/pdffiles/bsl123.pdf http://www.cdc.gov/OD/ohs/pdffiles/bsl123.pdf