Luminex - Perform work outside of a BSC, but wear List your test specific process eye protection and work behind a Nanosphere steps safety shield or face shield. Genmark Cobas 4800 - HPV Other (Be specific) ______________ ______________ ______________ Comments: Molecular Assays: (continued) Procedure Process Step Potential Hazards Initial Risk Control (Mitigation) Residual Level Risk Level Manual or automated Moderate to Required: Low Follow Package insert. Outside of sample contaminated during extraction, High Wear appropriate PPE: lab coat, gloves, collection List your test specific process eye protection. amplification, steps Risk of spill when Follow written biosafety protocols. detection: transferring the primary Verigene specimen and inoculating Additional Protection Preferred: – the sample cartridge. Luminex xTag – Use Bio wipe/gauze cover when uncapping Risk of aerosol production Respiratory and tubes. during any pipetting or GI panels Perform specimen transfer in BSC as vortexing step. possible eSensor Puncture risk if sharps not Perform any manipulation of extract in a Laboratory disposed of in approved dead air box. sharps container Developed Test Additional Protection - Alternative: Risk of chemical exposure (LDT) PCR Perform work outside of a BSC, but wear Risk of burn or aerosol Other? eye protection and work behind a production if cap pops safety shield or face shield. open Risk of aerosol production from centrifuging specimen. Risk of sharps if tube breaks in centrifuge.
Luminex - Nanosphere Genmark Cobas 4800 - HPV Other (Be specific) ______________ ______________ ______________ List your test specific process steps Perform work outside of a BSC, but wear eye protection and work behind a safety shield or face shield. Comments: Molecular Assays: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Manual or automated extraction, amplification, detection: Verigene Luminex – xTag Respiratory and GI panels eSensor Laboratory Developed Test (LDT) PCR Other? Follow Package insert. List your test specific process steps Outside of sample contaminated during collection Risk of spill when transferring the primary specimen and inoculating the sample cartridge. Risk of aerosol production during any pipetting or vortexing step. Puncture risk if sharps not disposed of in approved sharps container Risk of chemical exposure Risk of burn or aerosol production if cap pops open Risk of aerosol production from centrifuging specimen. Risk of sharps if tube breaks in centrifuge. Moderate to High Required: Wear appropriate PPE: lab coat, gloves, eye protection. Follow written biosafety protocols. Additional Protection – Preferred: Use Bio wipe/gauze cover when uncapping tubes. Perform specimen transfer in BSC as possible Perform any manipulation of extract in a dead air box. Additional Protection - Alternative: Perform work outside of a BSC, but wear eye protection and work behind a safety shield or face shield. Low
171025-Final-Revised-Risk-Assessment-Tool.docx