Selection of Safety Practices

Transcription

1 Selection of Safety Practices Andrew Cannons, Ph.D. Laboratory Director FL Bureau of Public Health Laboratories-Tampa Why We Are Here? Must be a Culture of Biosafety in the Laboratory Biosafety is Part of the Systemic Approach to Quality For Biosafety, Laboratories are Somewhat Self- Monitoring (Safety not a major component of CLIA, CAP) Laboratories Will Never be Risk Free USA Today Report (August 2014), 240 Incidents/Year Between US health agency blasted over lab safety violations (Nature, March ) 1

2 Why We Are Here? Change in Education and Training Shift from Traditional Microbiological Skills Emerging, Advancing Technologies Might Not Consider Safety Aspects Outline Biosafety Levels Which one do I use? Engineering Controls What do I need to have to be safe? Choice of Personal Protective Equipment What must I wear to be safe? Lab Practices Actions speak louder than words Biosafety Manual What must my Biosafety Manual cover? 2

3 SELECTING THE CORRECT BIOSAFETY LEVEL Biosafety Levels Biosafety does not equal Risk Group Risk group classifies microbiological agents based on their association with disease in humans Biosafety levels represent the conditions under which an agent can be handled safely Four biosafety levels that consider the agent, practices, equipment and facilities 3

4 Biosafety Levels BSL4 BSL3 BSL2 BSL1 Primary Barriers Safety Equipment BSC PPE Secondary Barriers Facility Design Biosafety Level 1 Basic Level Basic level of containment Standard microbiological practices No special primary or secondary barriers Training required Use of sink for hand washing Microorganisms not know to cause disease in healthy adult humans Bacillus thurengiensis, Escherichia coli Care when considering avirulent and attenuated strains 4

5 BSL-1 Standard Microbiological Practices Hand washing No eating drinking, smoking, applying cosmetics, food storage (human consumption) Mouth pipetting prohibited Safe handling of sharps Minimize aerosols and splashes Decontaminate work surfaces, cultures, stocks, spills, materials to be transported Biohazard sign posted, including biosafety level, contact information Integrated pest management program Primary Barriers -PPE X Lab coat Gloves Eye protection Secondary Barriers Access control Sink No carpets Chairs that can be cleaned/decontaminated Work surfaces impervious/heat resistant Biosafety Level 2 Typically applies to most laboratories, working with indigenous moderate-risk agents Appropriate for working with human-derived blood, other potentially infected material Specific training required Restricted access to laboratory Primary containment: Biological safety cabinets Aerosol containment PPE Microorganisms that pose moderate risk of disease in healthy adult humans Escherichia coli (O157:H7), Salmonella, Hepatitis B, HIV 5

6 BSL-2 Special Practices Staff understand the potential hazards Medical surveillance provided, including immunizations if available Base line serum? Biosafety manual in place and adopted All staff must demonstrate proficiency in working with BSL-2 agents Transport all infectious material in double containment Lab equipment decontaminated routinely and prior to repair/maintenance Spills contained and decontaminated per protocol All incidents involving exposure to infectious material reported immediately according to protocol No unnecessary animals/plants Any aerosol generating procedures performed in BSC/containment device BSL-2 Safety Equipment Primary Barriers BSC Certified, maintained Other containment devices Centrifuge safety cups, sealed centrifuge rotors PPE Lab coats (only worn in lab) Eye/face protection Gloves Selection based on risk assessment Removed before leaving lab Changed regularly, when contaminated/compromised Respiratory Protection 6

7 BSL-2 Safety Equipment, cont.. Secondary Barriers Self closing doors/locks (access control) Installed BSCs must operate correctly with room airflow Vacuum lines protected (traps) Unidirectional airflow into lab, no recirculation to non-lab areas if possible Autoclave available for decontaminating waste Biosafety Level 3 Applies to laboratories, working with indigenous or exotic agents with potential for respiratory transmission and may cause serious/potentially lethal infection Emphasis placed on protecting personnel in the lab area AND the community, environment from exposure as result of release/spill Mycobacterium, Bacillus anthracis, Yersinia pestis 7

8 BSL-3 Special Practices Specific training in BSL-3 agents and BSL-3 practices Medical surveillance provided, including immunizations if available Base line serum? Specific BSL-3 Biosafety manual in place and adopted Transport all infectious material in double containment Lab equipment decontaminated routinely and prior to repair/maintenance Spills contained and decontaminated per protocol All incidents involving exposure to infectious material reported immediately according to protocol All procedures where infectious material manipulated performed in BSC/containment device BSL-3 Safety Equipment Primary Barriers BSC (class II or III) Certified, maintained Other containment devices Centrifuge safety cups, sealed centrifuge rotors PPE Wrap around disposable gowns, coverall (only worn in lab) Disposable apron Eye/face protection Gloves Selection based on risk assessment Removed before leaving lab Changed regularly, when contaminated/compromised 2 pairs when appropriate Respiratory Protection 8

9 BSL-3 Safety Equipment, cont.. Secondary Barriers Self closing doors/locks (access control), including anteroom Hands free operated sink Easily cleaned floors, walls, ceilings (smooth, impervious, sealed) note procedure for decontaminating room Installed BSCs must operate correctly with room airflow Vacuum lines protected (traps, HEPA) Directional airflow into room out and through dedicated HEPA exhaust fans Dedicated autoclave (pass through if possible) Laboratory operations verified annually Biosafety Level 4 Highest Level of Containment Dangerous and exotic agents that cause lifethreatening disease Aerosol transmission No vaccine or treatment available Two main types Cabinet Laboratory All agents manipulated in a class III BSC Suit laboratory Personnel wear positive pressure supplied air protective suit Agents include Marburg, Ebola, Other VHF viruses 9

10 BSL-4 Special Practices Specific training in BSL-4 agents and BSL-4 practices Strict entry and exit procedures Medical surveillance provided, including immunizations if available Base line serum? Specific BSL-4 Biosafety manual in place and adopted Transport all infectious material in double containment, via dunk tank, can only be re-opened in a BSL-4 Lab equipment decontaminated routinely and prior to repair/maintenance Spills contained and decontaminated per protocol All incidents involving exposure to infectious material reported immediately according to protocol All procedures where infectious material manipulated performed in BSC class III/containment device ENGINEERING CONTROLS 10

11 Engineering Controls minimize risk for exposure Primary Containment: BSC Sharps Centrifuge Pipette Aids Secondary Containment Building design Sinks Door closing CHOICE OF PPE 11

12 Personal Protective Equipment Types Gloves Latex, nitrile Lab coats Coats, gowns, single use Eye goggles Face masks Suits Tyvek Sleeve covers Respiratory Protection N95, HEPA filtered Standards ASTM Coats, gloves ANSI Eye and face protection OSHA Use of PPE, hand protection FDA gloves Personal Protective Equipment some considerations Gloves Which type, check for integrity, shelf life Lab coats Laundered regularly (not at home) Disposable ones must be correctly disposed of Eye goggles/face Masks Used when splashes might occur. Eyeglasses, contact lenses are NOT PPE Respiratory Protection Annual FIT Testing and Training Filters changed regularly 12

13 LAB PRACTICES Lab Practices for Biosafety Specimen Receiving Specimen transport inside the facility Leaking containers Disinfection Waste management Inventory control Equipment maintenance (autoclave, BSC) Restricting aerosols Spill/emergency response Packaging & Shipping 13

14 BIOSAFETY MANUAL Biosafety Manual Elements Safety Policies Roles and responsibilities Regulations Routes of exposure Risk assessment and reporting incidents Biosafety practices Standard precautions SOPs 14

15 Biosafety Manual, cont. Elements Hazard communications Engineering controls PPE Use of the BSC Transport Emergency Procedures Decontamination Training Program Medical Surveillance Biosafety Manual Review/update Annually Policy changes After event/incident Who reads, when All staff using laboratory At beginning of tenure, annually, when updated Records of review kept for minimum of 3 years Training Annual Exercise, e.g. spill response 15

16 A Culture of Biosafety Establish and Enforce a Policy of Safety Identify Hazards Ahead of Time to Minimize Consider All Personnel in the Process Ensure Training is in Place Having a Biosafety Program is Ineffective if Staff Do Not Know it, Use it, Embrace it Work to Improve Biosafety Practices All Components of the Biosafety Program Must Be Operational Processes, Equipment, Barriers 16