Tools to Enhance Laboratory Biosafety and Biosecurity Performing Risk Assessments

Transcription

1 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 1

2 Risk Identification Hospital labs LAI are under reported Research labs Veterinary labs Government labs Culture of Safety Research, Clinical, & Teaching Labs Two in a BSC No labcoats Staff should be trained in safe practices and their adherence to these practices should be monitored. Bare arms, no gloves, hand touching mouth 2

3 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 3

4 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 Review Risk Assessments Annually Practices implemented to mitigate risk Performance of work in an accurate and efficient manner. 4

5 Potential Hazards: Chain of Infection Susceptible Host Agent Agent Risk is the probability that a health event will occur after an exposure to a specified amount of hazard Reservoir Portal of Exit Means of Spread 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 5

6 D. L. Sewell Clinical Microbiology Reviews. 8: PORTALS OF ENTRY : INFECTIOUS AGENTS MUCOUS MEMBRANES Protect from: Splash/splatter RESPIRATORY TRACT (LUNGS) Protect from: Aerosols GASTROINTESTINAL TRACT Protect from: Splash/splatter/ingestion SKIN Protect from: Splash/splatter & Contact/Puncture 12 6

7 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) Containment Equipment Lab Practices Risk Mitigation 14 7

8 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. 15 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 8

9 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 Common E. coli Staph. aureus Less common Emerging Francisella tularensis H5N1 Avian Influenza 9

10 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? 10

11 Work plan to complete the risk assessment Review assessment with Engage Everyone 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 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 11

12 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 Potential Hazards Control Comment Blood Cultures Aerosolization/ Splash/Splatter/ Contact with Blood -Use plastic bottles if available

13 Predict, Identify, & Mitigate Risk: Example working with a blood cultures Procedure Potential Hazards 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 13

14 Predict, Identify, & Mitigate Risk: Example Packaging and Shipping Specimens Procedure Packaging & Shipping of Specimens Potential Hazard Breakage and Aerosolization Control -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). Comment 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 14

15 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 -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 Procedure Potential Hazard Control Comment Inoculation of Sputum specimen for culture Leaking containers, external contamination of container, Splash and Splatter 15

16 RA - Predict and Identify Risk: Example Sputum Specimens Procedure Potential Hazard Control Comment Inoculation of Sputum specimen for culture Leaking containers, external contamination of container, Splash and Splatter -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 Procedure Potential Hazards Centrifuging Aerosolization -Ensure o-ring microcentrifuge tube is tightly sealed. -Use sealed head rotor inside the BSC. -Must decontaminate specimen before removing from BSC. Control Further Needs Action -Perform mock sample to practice technique Supervisor to schedule 16

17 Predict, Identify, & Mitigate Risk: Example TB testing Potential Procedure Hazard(s) M. tuberculosis Susceptibility Test Aerosol generation; spill, leaks Personnel exposure while manipulating solid culture tubes: moderate risk Exposure to liquid culture: high risk Control -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 Comment 17