Microorganism Risk Assessment Worksheet
Date Completed: ______
Completed By: ______
1. Bioagent/Microorganism Category
q Bacteria/chlamydia/ Ricketssia q Mycoplasm
q Virus q Prion
q Parasite q Other: Speciify______
2. Species Name:______
3. Strain Name: ______
4. Proposed Risk Group q 1 q 2 q 3
5. Is a PHAC or CFIA MSDS/PSDS available for your RG 2 or 3 biological agent(s)?
q Yes q No
IF No, Risk Group was determined according to:
q Human Pathogens and Toxins Act Schedules 2-4
q Risk Group definitions found in the PHAC Laboratory Biosafety Guidelines (3rd Edition)
q PI independent summary of Risk Factor Analysis as per Table below (based on PHAC LBG3rd classification criteria)
q ATCC or other vendor information
q ABSA table
q Published article: specify
q Best Guess
6. Host Range
q Human q Non-Human Primate q Plant
q Animal Specify all:______
7. Bioagent is
q wild type OR select from one of the options below
q attenuated q replication incompetent – if yes to either provide supporting evidence
q antibiotic resistance If yes, describe
q Other: describe the variation ______
8. Are toxins actively secreted? q Yes q No q Don’t Know If Yes what is the LD50? ______-
9. Micro-organism obtained From
q Commercial source: e.g. ATCC Company Name ______
q Catalogue Number ______
q Other Source: e.g. Dr. X at U of YZ, clinical isolate ______
If an MSDS is not available, you can document your risk assessment using the PHAC Risk Factor Group definitions and PHAC Risk Summary table (as found in the PHAC e-learning modules) in support of the final Risk Group determination. For Risk Group 2 and 3 biological agents, use this information to develop a PSDS if one is not available. A blank PSDS is available on the following web-site: http://umanitoba.ca/admin/vp_admin/risk_management/ehso/media/MSDS_blank_for_biological_agents.doc.
Risk Group Summary Table
Risk Factor / Risk Group / Risk Factor / Risk Group / Risk Factor / Risk GroupPathogenicity/Virulence / Environmental Stability / Availability of effective treatment or preventive measures
Mode of Transmission /Route of Infection / Host range / Vectors
Infectious Dose / Endemicty / rDNA?
Communicability / Economic impact of release into the environment/public / Overall Risk Group
Individual Risk Factor Risk Group definitions
Risk Factor / Risk Group 1 / Risk Group 2 / Risk Group 3 / Risk Group 4Pathogenicity & Virulence / Unlikely to cause disease, low individual and community risk / Mild or moderate disease, moderate individual risk, low community risk, any pathogen that can cause disease but under normal circumstances, is unlikely to be a serious hazard to a healthy laboratory worker, the community, livestock or the environment / Serious livestock, poultry or wildlife disease; high individual risk, low community risk: any pathogen that usually causes serious disease or can result in serious economic consequences or does not ordinarily spread by causal contact form one individual to another / Severe livestock, poultry or wildlife disease / high individual risk, high community risk, also causes human disease, any pathogen that usually produces very serious and often fatal disease, often untreatable and may be readily transmitted form one individual to another, or from animal to human or vice-versa, directly or indirectly, or by casual contact.
Mode of Transmission / Route of Infection / Not applicable (not known to cause disease) / Primary exposure hazards are through ingestion, inoculation and mucous membrane route (not generally through the airborne route) / May be transmitted through airborne route; direct contact; vectors / Readily transmitted, potential for aerosol transmission
Risk Factor / Risk Group 1 / Risk Group 2 / Risk Group 3 / Risk Group 4
Infectious Dose
/ Not applicable (not known to cause disease) / Variable or high (1,000-5,000 organisms or greater) / Medium (10 –1,000 organisms) / High (1-10 organisms)Ability to Spread / Transmission / Communicability / Not applicable (not known to cause disease) / Geographical risk of spread if released form the laboratory is limited, very limited or no transmission is relatively limited / Geographical risk of spread if released form the laboratory is moderate, direct animal to animal or human to human transmission occurs relatively easily – transmission between different animal species may readily occur / Geographical risk of spread if released form the laboratory is widespread
Environmental Stability / Not applicable / Short term survival (days); can survive under ideal conditions / Resistant (days to months) / Highly resistant (months to years) e.g. spores
Host Range / Not applicable (not known to cause disease) / Infects a limited number of species / Infects multiple species / Infects many species of animals
Endemicity / Enzootic / Generally enzootic (some low-risk exotics, or reportable diseases) / Exotic or enzootic but subject to official control / Exotic
Economic aspects of introduction and/or release into the environment of the Canadian public / No economic and /or clinical significance / Limited economic and/or clinical significance / Severe economic and/or clinical significance / Extremely severe economic and/or clinical significance
Availability of prophylactic and therapeutic treatments / Not applicable (not known to cause disease) / Effective treatment and preventive measures are available / Prophylactic and /or treatments may or may not be readily available (or of limited benefit) / Prophylactic and/or treatments are not usually available
Vectors / Not applicable (not known to cause disease) / Do not depend on vectors or intermediate hosts for transmission May depend on vectors or intermediate host for transmission / May depend on vectors or intermediate host for transmission / May depend on vectors or intermediate host for transmission
Recombinants- Refer also to rDNA risk assessment worksheet / The recombinant is a risk group 1 organism; modifications have not changed the risk / -The recombinant is a risk group 2 organism; modifications have not changed the risk
- DNA from risk group 2 or 3 organism is transferred into risk group 1 organism: but not the whole genome.
- DNA from risk group 4 organism is transferred into risk group 1 organism (only after demonstration of a totally and irreversible defective fraction of the organism genome is present in the recombinant.
- The recombinant is a risk group 3 or 4 organism, however, the modification has resulted in proven attenuation. / The recombinant is a RG3 organism and the modifications have not changed the risk
- the recombinant is based on a risk group 2 organism, however, the modifications have increased the risk group to a RG 3 organism;. / The recombinant is a risk group 4 organism; modifications have not changed the risk
- DNA from a risk group 4 organism is transferred into a risk group 1 organism in with an absence of demonstrations of a lack of virulence or pathogenicity.
Personnel Factors
10. Vaccine available? q Yes q No Name______
11. All personnel working with or near any of the above material in use have been:
q Offered any available vaccinations
q Offered any available vaccinations and the department has a record of vaccination being received OR being declined with counselling.
q Medical surveillance plan in place and documented.
Describe:
Refer also to the U of M Governance Procedure: Immunizations Standard
12. Personnel health assessment required? i.e. risks communicated for discussion with personal health care provider
q Immune status q allergen issues
13. Worker’s experience with agent
q Beginner q Intermediate q Advanced
14. Personnel Biosafety training completed
q Generic WHMIS
q Generic Biosafety
q New Lab Personnel Safety Checklist for site-specific/project specific procedures
q MSDS, and pertinent SWP read
q U of M Biosafety Guide read
q Autoclave use q Centrifuge use
q Specific equipment use: list-
q Technical proficiency in Procedures
q Emergency Procedures, Spill clean-up, fire, electrical failure/loss of power,
q 1st Aid, PEP, location of bandaids
q Other
15. PPE required when working with agent . Mark M-for mandatory
q CL1 – standard – lab coat, gloves, close-toed shoes – safety glasses as per procedure
q CL2 – standard – lab coat, gloves, close-toed shoes, covered legs – safety glasses as per procedure
q Face shield q safety glasses q N-95 q face mask
q back closing gown at BSC
16. Frequency of Contact with agent: q Routine/daily q Weekly q Random/monthly /yearly
17. Potential Routes of contact with Bioagent
q Sharps /puncture wounds /inoculation
q Ingestion from indirect contact
q Mucous membranes –eyes, mouth, nose,
q Broken skin, including facial blemishes
q Respiratory from aerosols
Assessment of Factors Associated with the Laboratory Operation
18. Will the agent be:
q cultured - Indicate typical concentrations and volumes in use:______
q concentrated – Specify method: q centrifuging q precipitation q freeze-drying
q filtration q other
19. Concentration/dose of potential exposure: ______
20. Largest single volume used: q < 1Litres q 1-10LItres q >10Litres
21. OR Typical Volumes, containers, concentrations used: ______
22. Will sharps be used? q Yes q No
If YES, are you using safety engineered sharps? If not, explain:
Potential for auto-inoculation?
If YES, do you have approved sharps containers (autoclavable, puncture resistant, secure lid, labelled) available for disposal? If not, explain sharps disposal procedure:
23. At what stage of the experiment is the infectious agent inactivated or lysed and how is this achieved ( what is the method of terminal inactivation?)
24. Is all work with the active agent done in a BSC?( not required for CL1 ) q Yes q No
25. Is the agent inactivated prior to manipulation on the open bench q Yes q No
If NO, indicate the type of procedures that will be done on the open bench. OR
List Aerosol/ droplet-Generating Procedures in Use :
List Aerosol/ droplet-Generating Equipment in Use:
-OR-
26. If bench work is done, identify procedures that would increase the hazard:
q Aerosol producing procedures including cell sorting, sonication, centrifuging in open
containers, shaking or vigorous mixing, vortexing, pipetting, blending, flaming loops, homogenizing, grinding, opening containers whose internal pressures may be different from ambient pressure?
q Procedures that create a splash, spill hazard
27. If bench work is done, describe measures to be used for the protection of personnel and the environment -OR -How will the hazards be mitigated? Or – How are the resulting aerosols controlled?
28. Will your experiments involve centrifugation? q Yes q No
29. If YES, are sealed rotors, or sealed centrifuge safety cups available for use? q Yes q No
If NO, do you only use screw –cap non-glass tubes? q Yes q No
30. Will you open the tubes in the BSC after centrifuging? q Yes q No
31. Disinfectants and decontaminants in use: ______How is efficacy of the above determined?
OR
32. Specify disinfectants and decontaminants and decontamination procedures in use.
33.
Surface DisinfectionList all decontaminants used in the laboratory to surface disinfect hard surfaces and laboratory gloves:
Disinfectant / Working Concentration / Contact Time (min) / Preparation Frequency / Used Against
Physical Waste
Check all practices that apply to the disposal of biohazardous waste generated by your research group:
qYes qNo qN/A / Solid waste contaminated with biohazardous material and all microbial and eukaryotic cell cultures, including broth cultures, will be treated by autoclaving at ______oC for at minimum ______of minutes.
qYes qNo qN/A / Needle and syringe assemblies will be placed into a puncture-resistant, autoclavable sharps container with a secure lid, without attempting to clip or recap the needle until being treated by autoclaving at ______oC for at minimum ______of minutes.
qYes qNo qN/A / Used glass and hard plastic pipettes and Pasteur pipettes will be immersed in a
solution of ______for a minimum of ______hours. After treatment items will be rinsed with water, placed into broken glass containers and picked up by Caretaking Services.
qYes qNo qN/A / A. Liquid waste contaminated with biohazardous material will be treated via autoclaving at _____oC for a minimum of ______minutes OR
qYes qNo qN/A / B. Liquid waste contaminated with biohazardous material will be treated chemically with ______for a minimum of ____ hours prior to pouring the material down the drain. Drain will be flushed with cold water for one minute to flush out sink trap.
qYes qNo qN/A / Other, specify:
Facility Design :
Refer to the U of M Biosafety Guide (2012), Section 7.1.2-7.1.3 and PHAC LBG and CFIA CSVF for pertinent facility design and operational requirements.
Summary
Risk Group q1 q2 q 3
Containment Level q1 q2 q 2+ q 2e q 3
Refer to the U of M Biosafety Guide (2012) Section 7.1 & 7.2 for definitions of the Containment Levels.
Lab or Project Specific Operational Practices -
Based upon the assessment of your pathogen risk factors, personnel and the specific laboratory operation or project, summarize the specific operational practices that may be required in addition to those outlined in the PHAC-LBG Section 3.1 Standard Operational Practices and the pertinent Containment level operational practises. Refer also to the U of M Biosafety Guide (2012) Section 8 U of M Biosafety- Operational Practices for additional resource information and specific U of M requirements. Suggested topics include:
Training-
Access Control- Entrance Signage or Biosecurity measures
Medical Surveillance-Immunizations, Medical Surveillance Statement or Post-Exposure Protocol
Personal Protective Equipment -
Disinfectants, Decontamination-
Spill Clean-up Protocol-
Operations or procedures that may only be done in the BSC-
Safety Procedure for work with sharps-
1
October 2012