Assists with Collection of Fine Needle Aspirations Confirm patient identification (2 identifiers). slides. Stain adequacy slides. Process/fix biopsy sections. Process/package samples. Needle stick with a clean or contaminated needle during specimen collection. Exposure to droplets/aerosols: During specimen collection process From the syringe needle splash or spray of specimen into mouth, mucous membrane or onto non-intact skin during collection, processing, packaging, or transport process. Moderate Required: Wear PPE: lab coat/gown, foot covers, gloves, mask, and face shield/eye protection. Wear additional PPE: N-95 respirator/PAPR if patient is known or suspected of having an infectious disease transmitted by aerosols, droplets (i.e. TB, MERS, SARS, Avian Influenza, mumps, measles, etc.). If CT-guided collection, wear additional lead gown, thyroid shield and radiation badge to monitor exposure. Additional Protection – Preferred: Obtain travel history (e.g. outside the USA in the past 30 days) prior to procedure. Low Comments: Specimen Collection and Transport: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Assists with Collection of Bone Marrow Aspirations Confirm patient identification (2 identifiers). Prepare/label slides. Prepare core touch preparations. Process/fix core and clot sections. Process/package samples. . Needle stick with a clean or contaminated needle during specimen collection. Exposure to droplets/aerosols: During specimen collection process From the syringe needle Spill, splash or spray of specimen into mouth, mucous membrane or onto non-intact skin during collection, processing, packaging, or transport process. Moderate Required: Wear PPE: lab coat/gown, gloves, and eye protection. Wear additional PPE: N-95 respirator/PAPR and disposable gown if patient is known or suspected of having an infectious disease transmitted by aerosols, droplets (i.e. TB, MERS, SARS, Avian Influenza, mumps, measles, etc.). If CT-guided collection, wear additional lead gown, thyroid shield and radiation badge to monitor exposure. Additional Protection - Preferred: Obtain travel history (e.g. outside the USA in the past 30 days) prior to procedure. Low
Specimen Processing and Handling: (Complete this section if your laboratory performs Specimen Processing and Handling. If your laboratory does not perform any Specimen Processing and Handling skip to Commercial Rapid Antigen Testing Assays.) Specimen Processing and Handling: Pathogen(s): There is a potential to be exposed to many pathogens during specimen handling dependent on the patient’s health, the specimen type, how the specimen was collected and transported, and the integrity of the specimen when it is received in the lab. Infectious Dose: Dependent on the pathogen. Routes of Transmission: Parenteral inoculation from a needle stick or other sharps Ingestion from spill or splash into mouth Contact from touching, or a spill or splash onto mucous membrane or non-intact skin Inhalation of infectious aerosol Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Use of Biosafety Cabinet (BSC) Turn on biosafety cabinet (BSC) for 4 minutes before using. airflow to make sure BSC is working properly before using. Make sure that no items in BSC are disrupting the airflow. Remove all equipment/supplies that will not be used. Use proper technique when working in BSC so as not to disrupt the airflow. Decontaminate before removing from the BSC. and disinfect BSC after use. Allow BSC to run for 4 minutes after completing all work before turning off. Airflow disruption caused by: Moving in and out of BSC too quickly Items placed on the air ducts Too many items in BSC Location of hood in busy traffic area BSC stops functioning properly while in use. Moderate Required: Follow written policy for use of BSC, cleaning/disinfection, and maintenance. Wear PPE: lab coat, gloves and additional eye protection when is a risk for a splash or spray. Check on air handling capabilities to determine if BSC needs to remain running at all times or can be turned off when not in use. Make sure that the BSC contains only the essential items necessary for the work being performed when working in the BSC. Additional Protection - Preferred: Audible sounds if BSC stops working correctly and airflow is not within the acceptable range. Low
Comments: Specimen Processing and Handling: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Use of Fume Hood Check airflow to make sure is working properly before using. Minimize clutter in fume hood to ensure proper airflow within the fume hood. Adjust fume hood sash to the proper position for working in the fume hood. Clean fume hood after use. Lower fume hood sash when done. Airflow disruption caused by: Improper sash position Too many items in fume hood Splash or spill of chemical Moderate Required: Follow written policy for use of fume hood. Wear PPE: lab coat, gloves and additional eye protection when there is a risk for a splash or spray. Laboratory chemical safety plan. Check on air handling capabilities to determine if fume hood needs to remain running at all times or can be turned off when not in use. Additional Protection – Preferred: Wear additional acid apron and gloves when working with strong acids or bases. Audible sounds if fume hood stops working correctly and air flow is not within the acceptable range. Low Comments: Perform Specimen Receipt Receive specimen into the laboratory Handling a leaking specimen Handling a syringe with an attached needle Low Required: Wear appropriate PPE: lab coat, glove and additional eye protection when there is a risk for a splash or spray. Low Comments:
Specimen Processing and Handling: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Perform Specimen Processing/ Handling specimen integrity and ensures that specimen is labeled properly with 2 patient identifiers. Follow specimen rejection policies as necessary. Process specimen, centrifuging or splitting specimen as necessary. Distribute specimen for in-house testing or packages specimen for shipment to testing reference lab. Store any remaining specimen appropriately. Specimen is not received in a biohazard bag. Specimen is leaking. Outside of specimen was contaminated during collection. Specimen is received in a syringe with an attached needle. Specimen tube breaks during centrifugation creating a spill and an aerosol risk. Specimen is spilled during processing. Specimen is splashed or sprayed into mouth, mucous membrane or onto non-intact skin during uncapping, or pouring, or pipetting aliquots to split the specimen. Moderate Required: Follow written Processing/Handling policy. Wear PPE: lab coat, gloves and additional eye protection when is a risk for a splash or spray. Specimens with a request for Mycobacteria or fungal culture are split or processed in a Class II BSC. Specimens with a request for Mycobacteria or fungal culture are centrifuged in covered cups/carriers and the centrifuged cups/carriers are opened in a Class II BSC. Additional Protection - Preferred: Process all specimens in a BSC. Use gauze or bio-wipe to cover cap when uncapping specimen. Wear additional PPE: N-95 respirator/PAPR and a disposable gown if patient is known or suspected of having an infectious disease transmitted by aerosols or droplets (i.e. TB, MERS, SARS, avian influenza, mumps, measles, etc.). Additional Protection - Alternative: Process specimens behind a safety shield/face shield and wear eye protection. Low Comments: Specimen Processing and Handling: (continued)
Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Perform Packaging and Shipping Classify specimen for shipping. Package Category A, Category B and exempt specimens according to regulations. Properly label the package and complete all documentation. Incorrectly packaged specimen may subject lab to monetary fines and legal action. Incorrectly packaged specimen breaks open exposing courier and community to possible pathogen. Moderate Required: Personnel are certified in Packaging and Shipping and have required documentation to prove it. Personnel who are certified in Packaging and Shipping receive documented refresher training and demonstrate competency every 2 years. Low Comments: Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Specimen Storage Store specimen at appropriate temperature for appropriate time. sealed specimens in racks, or boxes, or in sealed biohazard bags to prevent leaks and spills. Leak or during storage Low Required: Follow written procedure. Wear PPE: lab coat, gloves and additional eye protection when is a risk of a splash or spray. Wear additional freezer gloves if storing in ultra low (-70○ C) freezer. Low Comments: Specimen Processing and Handling: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Discarding Discard waste into appropriate double bagged biohazardous waste containers or biohazardous sharps container Leak or spill while discarding waste or while storing discarded waste. Possible poke through biohazard bag if sharps not disposed of properly Slight Required: Follow written procedure. Wear PPE: lab coat, gloves and additional eye protection when is a risk of a splash or spray. Double bag all biohazardous waste and use rigid biohazardous sharps container for sharps. Low
Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Perform: Parasitology examination Direct smear Concentrated smear Trichrome stained smear Other special smear (Be specific) __________________ The process steps will vary according to the microscopic exam being performed. List your test specific process steps here. An aerosol may be created during pipetting, cytocentrifuging, centrifuging, uncapping tubes, or preparing the slide Possible spill or splash of specimen Exposure to some hazardous chemicals during stool concentration or trichrome staining Moderate Required: Follow written procedures. Wear PPE: lab coat, gloves and additional eye protection when is a risk of a splash or spray. Additional Protection - Preferred: Prepare all smears in a BSC. Perform trichrome staining in a fume hood if using xylene. Additional Protection - Alternative: Work behind a full safety shield/face shield and wear eye protection. Low Comments: Specimen Storage Store specimen at appropriate temperature for appropriate time. sealed specimens in racks, or boxes, or in sealed biohazard bags to prevent leaks and spills. Store slides in rigid slide boxes to prevent slides from breaking. Leak or spill during storage Cut or abrasion from broken slide or coverslip Low Required: Follow written procedures. Wear PPE: lab coat, gloves and additional eye protection when there is a risk of a splash or spray. Wear additional freezer gloves if storing in ultra low (-70○ C) freezer. Low Comments: Direct Microscopic Exam: (continued) Procedure Process Step Potential Hazards Initial Risk Control (Mitigation) Residual Risk Level
Performs: Aerobic/anaerobic bacterial culture identification and susceptibility testing using manual methods: Kirby Bauer E-test Manual MIC Manual ID (e.g. API 20E, Rapid Ana ID, spot IDs, NF panels, etc.) Other (Be specific) ______________ _______________ _______________ Examine media for growth. Work up cultures as per laboratory policy based on specimen source. Perform AST as per laboratory policy based on specimen source. Prepare standardized inoculum. Inoculate Incubate Read Discard waste into appropriate container. List your test specific process steps here. Risk of aerosol production (See Table 1 for aerosol generating activities) Risk of contamination by touching growth Risk of spill or splash when handling liquid media Moderate High (possible high risk pathogens) Required: Follow written procedures. Wear PPE: lab coat, gloves and additional eye protection when there is a risk of a splash or spray. Do not touch your face, eyes, nose, or mouth without washing your hands first. Perform all aerosol-generating work in a Class II BSC when manipulating possible high risk pathogens using BSL-3 practices (controlled access to the area when working, decontamination of all waste, must wear a solid front gown with cuffed sleeves, gloves and N-95 respirator/PAPR). Additional Protection – Preferred: Wear gloves and additional eye protection when there is a risk of a splash or spray. If wear gloves when handling cultures, establish clean and dirty areas and be sure to remove gloves and wash hands before touching anything in a clean area (i.e. telephones, door handles, computer keyboards). Perform all aerosol-generating work in a Class II BSC. Do not use a flame to heat fix Gram stain slides, but allow to air dry, or dry on a heating block. Additional Protection - Alternative: Perform all aerosol-generating work behind a full safety shield/face shield and wear eye protection. Low Comments: Culture Work-up: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level
Performs: Fungal culture ID and Susceptibility Testing Examine media for growth. Work up cultures as per laboratory procedure based on specimen source. Perform AST as per laboratory procedure based on specimen source. List your test specific process steps here. Risk of aerosol production (See Table 1 for aerosol generating activities) Risk of contamination by touching growth Risk of spill or splash when handling liquid media Moderate High (Systemic molds) Required: Follow written procedures. Wear PPE: lab coat, gloves and additional eye protection when there is a risk of a splash or spray. Post a sign on the door warning others when working with possible systemic molds. Do not touch your face, eyes, nose, or mouth without washing your hands first. Inoculated plates for fungal culture must be shut or bagged. Perform work-up of mold isolates in a Class II or Class III BSC. When working with any possible systemic molds, use BSL-3 practices (controlled access to the area when working, decontamination of all waste, must wear a solid front gown with cuffed sleeves, gloves and N-95 respirator/PAPR). Low Comments: Culture Work-up: (continued) Procedure Process Step Potential Hazards Initial Risk Control (Mitigation) Residual Risk Level
Performs: Viral culture ID Examine media for growth. Work up cultures as per laboratory procedure based on specimen source. List your test specific process steps here. Risk of aerosol production (See Table 1 for aerosol generating activities) Risk of contamination by touching growth Risk of spill or splash when handling liquid media Moderate High (MERS, SARS, Avian influenza, etc.) Required: Follow written procedures. Wear PPE: lab coat, gloves and additional eye protection when there is a risk of a splash or spray. Do not touch your face, eyes, nose, or mouth without washing your hands first. Perform all work with open inoculated media for viral cultures in a Class II BSC. Perform all work with suspected or known highly pathogen viruses in a Class II BSC using BSL-3 practices (controlled access to the area when working, decontamination of all waste, must wear a solid front gown with cuffed sleeves, gloves and N-95 respirator/PAPR). Work with slides for immunofluorescence staining within a Class II BSC until they are fixed. Once slides are fixed, they may be stained outside the BSC on the bench top. Low Comments: Culture Work-up: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Isolate/ Specimen Retention Store completed culture media at appropriate temperature for appropriate time per procedure. Store isolates in racks, or boxes, or in sealed biohazard bags to prevent leaks and spills. Leak or spill during storage Low Required: Follow written procedure. Wear PPE: lab coat, gloves and additional eye protection when there is a risk of a splash or spray. Wear additional freezer gloves if storing in ultra low (-70○ C) freezer. Low
Inhalation of infectious aerosol Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Self-contained Sample to Answer: Panther Tigris Other (Be specific) ______________ ______________ ______________ Load sample onto instrument. Run sample. Remove sample from instrument and discard into Use bleach to clean instrument components and prevent List your test specific process steps Outside of sample contaminated during collection. Minimal risk of exposure to hazardous reagents when changing them. Minimal biological risk as sample doesn’t contain live organism. Exposure to 50% bleach during cleaning. Low Required: Wear appropriate PPE: lab coat, gloves, eye protection. Follow written biosafety protocols. Minimal Comments: Molecular Assays: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Sample diluent transfer and then self-contained Sample to Answer: GeneXpert BioFire BD Max Liat i Illumigene Simplexa Viper Transfer specimen to buffer/diluent. Vortex. Transfer to sample test cartridge. Load on instrument. Run sample. Remove sample from instrument and discard into waste. Use bleach or approved product to clean instrument components and prevent cross-contamination. 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. Moderate (but varies dependent on the suspect 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 Additional Protection - Alternative: Minimal
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
Comments: Molecular Assays: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Discarding Waste Dispose of waste in appropriate biohazardous waste. Leak or spill while discarding waste or while storing discarded waste. Possible poke through biohazard bag if sharps not disposed of properly in a rigid biohazard container. Low Required: Follow written procedure. Wear PPE: lab coat, gloves and additional eye protection when there is a risk of a splash or spray. Double bag all biohazardous waste or use rigid sharps container. Discard biohazardous sharps containers when 2/3 full. Cover partially filled biohazardous waste containers when not in use. Disinfect workspace and any spills with an appropriate disinfectant. Additional Protection – Preferred: Discard consumables into a rigid, puncture proof biohazardous waste container. Additional Protection - Alternative: Discard consumables into double bagged biohazardous waste. Low Comments: Specimen Storage Store specimen appropriately. Specimen spill in storage. Low Required: Follow written procedure. Wear PPE: lab coat, gloves and additional eye protection when there is a risk of a splash or spray. Store specimens in leak proof containers. Additional Protection – Preferred: Wear additional freezer gloves if storing in ultra low (-70○ C) freezer. Low
Comments: Assays: (continued) Procedure Process Step Potential Hazards Initial Risk Level Control (Mitigation) Residual Risk Level Reagent Preparation for tube extraction process (for Mycobacteria and other high risk pathogens) Prepare BTS, matrix: 70% formic acid solution 70% ethanol (target cleaning) 80% trifluoroacetic acid (target cleaning acetonitrile Risk of chemical exposure when aliquoting strong acids and organic solvents (Note: small volumes). Medium (Exposure to chemicals) Required: Follow written procedures. Wear appropriate PPE: (no respirator necessary), lab coat, gloves, eye protection. Follow Chemical Hygiene Plan. Additional Protection – Preferred: Perform work in a fume hood. Wear additional chemical resistant gloves. Additional Protection - Alternative: If perform work outside of a fume hood, wear eye protection and work behind a safety shield or face shield. Low Comments: Concentration and heat inactivation (for Mycobacteria and other high risk pathogens) Concentrate 3-6 ml specimen by centrifugation. Pour off supernatant. Add 1 ml water and vortex. Transfer to 1.5 ml tube and centrifuge again. Pour off supernatant. Add 300 ul of water. Make suspension from growth on solid media in 300 ul water and vortex. Heat for 30 minutes at 95-100C degrees. Risk of aerosols, splashes, and splatter when opening pouring off supernatant, vortexing and pipetting. High (MTBC) Low (NTM) Required: Follow written procedures. Post a sign on the door warning others when working with AFB cultures. Perform all work-up of AFB isolates in a II BSC using BSL-3 practices (controlled access to the area when working, decontamination of all waste, must wear a solid front gown with cuffed sleeves, gloves, eye protection and N-95 respirator/PAPR). Use centrifuge w/ sealed carriers. Use microcentrifuge with screw cap/gasket. Low Comments:
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
Analyze Target Carry target inside a plastic carrier to the MALDI-TOF analyzer. Place target in instrument. Analyze target. Very little risk of chemical exposure due to minimal amounts of chemicals. Small risk of aerosol production during ionization process. Low Required: Follow written procedures. Wear PPE: (no respirator necessary) lab coat and gloves. Follow chemical hygiene plan. Additional Protection – Preferred: Wear additional eye protection. Low Comments: Target Use 70% EtOH and 80% trifluoroacetic acid to clean MALDI plate. Moderate risk of exposure to chemicals. Moderate Required: Work in Fume hood. Wear PPE: (no respirator necessary) lab coat and gloves. Follow chemical hygiene plan. Additional Protection – Preferred: Wear additional chemical resistant gloves, apron. Low Comments: