MALDI-TOF Assays: (continued) Procedure Process Step Potential Hazards Initial Risk Control (Mitigation) Residual Level Risk Level Extraction after Add EtOH and vortex. Exposure to small Low Required: Low Centrifuge and pour off the volumes of chemicals. heat Follow written procedures. supernatant Minimal biological risk Wear appropriate PPE: (no respirator inactivation Use a fine tip pipettor to from production of necessary) lab coat, gloves and eye remove the remainder of EtOH aerosols after heat protection. (for Mycobacteria and air dry pellet for 5 inactivation. Follow chemical hygiene plan. minutes. and high risk Additional Protection Preferred: – Add silica beads and pathogens) Perform a viability to validate organisms acetonitrile. are non-viable after heat activation Use racking technique to mix. process as part of MALDI-TOF assay Vortex. validation. Add formic acid and vortex. Centrifuge. Comments: Spotting Low Required: Low Spot low risk pathogen growth Very little risk of directly onto MALDI target, or chemical exposure due organism onto Follow written procedures. extracted high risk pathogen to minimal amounts of Wear PPE: (no respirator necessary) lab coat target onto MALDI target and allow to chemicals. and gloves. air dry. Small risk of aerosol Follow chemical hygiene plan. Overlay with matrix. production when Additional Protection Preferred: – For extended direct spotting spotting target. Spot target in a BSC. only, overlay with formic acid. Wear additional eye protection. Additional Protection - Alternative: Wear a face shield or work behind a safety shield when spotting target. Comments: MALDI-TOF Assays: (continued) Procedure Process Step Potential Hazards Initial Risk Control (Mitigation) Residual Level Risk Level
MALDI-TOF Assays: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Extraction after heat inactivation (for Mycobacteria and high risk pathogens) Add EtOH and vortex. Centrifuge and pour off the supernatant Use a fine tip pipettor to remove the remainder of EtOH and air dry pellet for 5 minutes. Add silica beads and acetonitrile. Use racking technique to mix. Vortex. Add formic acid and vortex. Centrifuge. Exposure to small volumes of chemicals. Minimal biological risk from production of aerosols after heat inactivation. Low Required: Follow written procedures. Wear appropriate PPE: (no respirator necessary) lab coat, gloves and eye protection. Follow chemical hygiene plan. Additional Protection – Preferred: Perform a viability to validate organisms are non-viable after heat activation process as part of MALDI-TOF assay validation. Low Comments: Spotting organism onto target Spot low risk pathogen growth directly onto MALDI target, or extracted high risk pathogen onto MALDI target and allow to air dry. Overlay with matrix. For extended direct spotting only, overlay with formic acid. Very little risk of chemical exposure due to minimal amounts of chemicals. Small risk of aerosol production when spotting target. Low Required: Follow written procedures. Wear PPE: (no respirator necessary) lab coat and gloves. Follow chemical hygiene plan. Additional Protection – Preferred: Spot target in a BSC. Wear additional eye protection. Additional Protection - Alternative: Wear a face shield or work behind a safety shield when spotting target. Low Comments: MALDI-TOF Assays: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level
171025-Final-Revised-Risk-Assessment-Tool.docx