Cannons Biosafety Selection of Safety Practices

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Analysis. Answers. Action. www.aphl.org

Selection of Safety PracticesAndrew 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 2009-2012

• US health agency blasted over lab safety violations (Nature, March 24 2015)

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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?

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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

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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

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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

• Lab coat• Gloves• Eye protection

• Secondary Barriers• Access control• Sink• No carpets• Chairs that can be cleaned/decontaminated• Work surfaces impervious/heat resistant

X


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

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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 EquipmentPrimary 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

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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

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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 EquipmentPrimary 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

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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 life-threatening 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

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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

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Engineering Controls –minimize risk for exposurePrimary Containment:

• BSC

• Sharps

• Centrifuge

• Pipette Aids

Secondary Containment

• Building design

• Sinks

• Door closing


CHOICE OF PPE

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Personal Protective Equipment

• Gloves• Latex, nitrile

• Lab coats• Coats, gowns, single use

• Eye goggles• Face masks• Suits

• Tyvek

• Sleeve covers• Respiratory Protection

• N95, HEPA filtered

• ASTM– Coats, gloves

• ANSI– Eye and face

protection

• OSHA– Use of PPE, hand

protection

• FDA– gloves

Types Standards


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

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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

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BIOSAFETY MANUAL


Biosafety Manual

Elements• Safety Policies

• Roles and responsibilities

• Regulations

• Routes of exposure

• Risk assessment and reporting incidents

• Biosafety practices

• Standard precautions

• SOPs

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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

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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

Cannons Biosafety Selection of Safety Practices

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