Pentella Biosafety Tools to Enhance BSBS - APHL · 2016. 5. 17. · 5/20/2015 1 Analysis. Answers....

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Analysis. Answers. Action. www.aphl.org

Tools to Enhance Laboratory Biosafety and Biosecurity

• Performing Risk Assessments

• Selection of Safety Practices

• Biosecurity in the Laboratory

• Safety Orientation and Training

• Biosafety Competencies

• Audits, Monitoring and Safety Committee


PERFORMING RISK ASSESSMENTS

Michael Pentella

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Risk Identification

LAI are under reported

Hospital labs

Research labs

Government labs

Veterinary labs


Culture of SafetyResearch, Clinical, & Teaching Labs

No labcoats

Two in a BSC

Staff should be trained in safe practices and their adherence to these practices should be monitored.

Bare arms, no gloves, hand touching mouth

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Building a culture of safety?

• Need a commitment from administration and lab leadership

• Have regular communication about safety issues


Biosafety Topics Are In the Forefront

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Definition of Biosafety (USA):

The development and implementation of administrative policies,

work practices, facility design, and safety equipment to prevent transmission of biohazardous agents to workers, other persons, and the environment.

(CDC/NIH, 1999)

Autoclave


Risk Assessment Goals:Balancing risk and work performance

Practices implemented to mitigate risk

Performance of work in an accurate and efficient manner.

Review Risk Assessments Annually

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Agent

Potential Hazards: Chain of Infection

Susceptible Host

Portal of Exit

Reservoir

Agent

Means of Spread

Risk is the probability that a health event will occur after an exposure to a specified amount of hazard


Estimate Risk based on Pathogen

• Infective dose

• Contagiousness

• Stability in the environment with regards to temperature, light, pH, desiccation, humidity, and life cycle

• Incubation period

• Infectious period

• Modes of transmission

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Analysis. Answers. Action. www.aphl.orgD. L. Sewell. 1995. Clinical Microbiology Reviews. 8: 389-405.

Analysis. Answers. Action. www.aphl.org12

PORTALS OF ENTRY : INFECTIOUS AGENTS

RESPIRATORY TRACT (LUNGS)RESPIRATORY TRACT (LUNGS)

GASTROINTESTINAL TRACTGASTROINTESTINAL TRACT

SKINSKIN

MUCOUS MEMBRANESMUCOUS MEMBRANESProtect from: Splash/splatter

Protect from: Aerosols

Protect from: Splash/splatter/ingestion

Protect from: Splash/splatter &Contact/Puncture

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Reservoirs lurking in the lab

Stability:Minutes to hours on surfaces (Measles virus)Days to weeks on surfaces (Hepatitis B virus)Weeks to months in hostile environment (Coxiella burnetii)

Analysis. Answers. Action. www.aphl.org14

Risk Mitigation

Containment Equipment

Lab Practices

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Risk can be defined as the probability that a health effect will occur after an individual has

been exposed to a specified amount of hazard.

Risk assessment is the process of gathering all available information on a hazardous substance and evaluating it to determine the possible risks associated with exposure. This is followed by determining the mitigation strategies necessary to provide protection.

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Benefits of a Risk Assessment

• Keeping the laboratorian, their families and the community safe

• Identification of training needs• Evaluation of procedural changes• Ensure compliance with regulatory

agencies• Justification for space and equipment

needs• Evaluation of emergency plans

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Who performs a risk assessment?• A knowledgeable risk assessor

– Knowledge of:• Safety principles

• The facility

• Hazards

• Modes of transmission

• Local, state and federal regulations

– Practical experience

– Problem solving skills

• Collaborative work with everyone engaged


Start with the Pathogens encountered

E. coli Staph. aureus

Common

Less common

Francisella tularensis H5N1 Avian

Influenza

Emerging

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When to perform the risk assessment?

• Before work begins

• Whenever there is a move or renovation

• New employees

• New infectious agent or reagent

• New equipment

• Repeat when changes are to made in agents, practice, employees or facilities


Four Parts to a Risk Assessment

• Hazard Identification – microbes?

• Hazard Evaluation or Dose-Response Assessment – pathogenicity?

• Exposure Assessment – LAI?

• Risk Characterization – exposures?

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Work plan to complete the risk assessment

Review assessment with staff and management

Evaluate staff competency and utilization of safety equipment

Determine appropriate biosafety level and risk mitigation steps

Identify lab procedure hazards through a protocol driven risk assessment

Create a risk assessment matrix for the agent, protocols and staff susceptibility to disease

Engage Everyone


RA - Predict and Identify Risk:Example – working with a bloodborne pathogen

Procedure Potential Hazards Control Comment

Preparation of blood specimen for testing

Breakage/Aerosolization/Splash/ Splatter

-Minimize number of staff handling specimen

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Predict, Identify, & Mitigate Risk:Example – working with a bloodborne pathogen

Procedure Potential Hazards Control Comment

Preparation of blood specimen for testing

Breakage/Aerosolization/Splash/ Splatter

-Use PPE: fluid resistant back-closing gown, double gloves, N95 respirator and goggles, or full face shield, (eyes and mucous membranes covered). -Perform work in the BSC.

-No exposed skin inside the BSC.Immediately change gloves if contamination is visible or suspected.-Bring all necessary material into the BSC before starting to work. -Do not enter and re-enter BSC once specimen processing begins.


RA - Predict and Identify Risk:Example – working with a blood culture bottles

Procedure PotentialHazards

Control Comment

Blood Cultures

Aerosolization/Splash/Splatter/Contact with Blood

-Use plastic bottles if available.

1990

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Predict, Identify, & Mitigate Risk:Example – working with a blood cultures


Control Comment

Blood Cultures

Aerosolization/Splash/Splatter/Contact with Blood

-Once received in the laboratory, all specimens should be opened inside a BSC.-Inspect for any signs of breakage. -Wipe the outside of the bottles with hospital approved disinfectant-Place the bottles into a rigid leak proof container and carry the container to the blood culture instrument.

-Use plastic bottles if available.


RA - Predict and Identify Risk:Example – Packaging and Shipping Specimens

Procedure Potential Hazard

Control Comment

Packaging &Shipping of Specimens

Breakage and Aerosolization

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Predict, Identify, & Mitigate Risk:Example – Packaging and Shipping Specimens

Procedure Potential Hazard

Control Comment

Packaging &Shipping of Specimens

Breakage and Aerosolization

-Specimens should be packaged and shipped without attempting to open collection tubes or aliquot specimens. -Specimens must be packaged based on the triple packaging system which consists of a tube in a sealable specimen bag with absorbent material (primary receptacle) placed in a watertight, leak-proof container (secondary receptacle).

Packaging and shipping of Infectious Substances or Biological Substances should only be performed by laboratory personnel who are trained and certified to do so.


RA - Predict and Identify Risk:Example – Stools Specimens

Procedure Potential Hazard Control Comment

Inoculation of Stool specimen for culture

Leaking containers, external contamination of container, Splash and Splatter

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RA - Predict and Identify Risk:Example – Stools Specimens


Inoculation of Stool specimen for culture


-Once received in the laboratory, all specimens should be opened inside a BSC.-Inspect for any signs of leakage. -Wipe the outside of container with hospital approved disinfectant.


RA - Predict and Identify Risk:Example – Sputum Specimens


Inoculation of Sputum specimen for culture


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RA - Predict and Identify Risk:Example – Sputum Specimens


Inoculation of Sputum specimen for culture


-Once received in the laboratory, all specimens should be opened inside a BSC.-Inspect for any signs of leakage. -Wipe the outside of container with hospital approved disinfectant.


Predict, Identify, & Mitigate Risk:Example – ebola


Control Further Needs Action

Centrifuging Aerosolization -Ensure o-ringmicrocentrifuge tube is tightly sealed.-Use sealed head rotor inside the BSC.-Must decontaminatespecimen before removing from BSC.

-Perform “mock” sample to practice technique

Supervisor to schedule

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Predict, Identify, & Mitigate Risk:Example – TB testing

ProcedurePotential Hazard(s)

Control Comment

M. tuberculosis SusceptibilityTest

• Aerosol generation; spill, leaks

• Personnel exposure while manipulating solid culture tubes: moderate risk

• Exposure to liquid culture: high risk

-PPE (double gloves, N-95 respirator, gown, and shoe covers) donned prior to entry to BSL-3 area-All the culture manipulation performed in BSC on disinfectant soaked pads-Dispose inoculation loops and transfer pipettes in rigid containers containing disinfectant

Pentella Biosafety Tools to Enhance BSBS - APHL · 2016. 5. 17. · 5/20/2015 1 Analysis. Answers....

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