ARE: Bloodborne Pathogens

What this is: A 30-minute annual compliance course covering Firefly Biologics' Bloodborne Pathogens (BBP) and Zoonotic Aerosol Transmissible Disease (ATD) Exposure Control Plan, built to satisfy 8 CCR 5193 and 8 CCR 5199.1 requirements. The course covers the regulatory basis, roles and responsibilities, the pathogens handled at Firefly Bio (lentiviral vectors, NHP tissues, HIV, HBV, Herpes B), exposure sources and routes, engineering and administrative controls, PPE, the Hepatitis B vaccination program, waste disposal, decontamination, spill response, and post-exposure reporting and recordkeeping.

Audience: All Firefly Biologics laboratory employees who may have occupational exposure to blood, other potentially infectious materials (OPIM), or aerosol transmissible diseases. This includes personnel who handle lentiviral vectors, non-human primate (NHP) tissues and cells, or human-derived biological materials. Training is mandatory and must be completed annually.

Outcome: Given a description of a workplace situation involving potential BBP or ATD exposure, the learner selects the correct control measure, reporting action, or disposal procedure consistent with Firefly Bio's Exposure Control Plan and the requirements of 8 CCR 5193 and 8 CCR 5199.1, with no critical steps omitted.

Targeted at ~30 minutes of seat time — the design is scoped to this.

• Regulatory basis: 8 CCR 5193 (Bloodborne Pathogens) and 8 CCR 5199.1 (Aerosol Transmissible Diseases, Zoonotic) require annual training for all personnel with potential occupational exposure.
• The Exposure Control Officer (ECO) at Firefly Bio is Marlon Castillo, Associate Director of Operations / Senior Lab Manager. Contact: mcastillo@fireflybiologics.com, 650.444.5081.
• ECO responsibilities include: implementing and annually updating the Exposure Control Plan, ensuring HBV vaccination offer and completion or declination, performing risk assessments for ATPs-L agents and procedures, recording safe practices in the ECP, conducting annual facility inspections and biosafety audits, and ensuring compliance supplies are available.
• HR responsibilities include: maintaining the training roster, scheduling training, and maintaining documentation of HBV vaccination or declination, training records, medical records, and exposure incidents.
• Employee responsibilities include: knowing which tasks carry exposure risk, attending BBP/ATD training, following work practice controls, practicing hand hygiene, reporting all exposure incidents, near misses, and unexplained illnesses to the ECO within 24 hours, completing HBV vaccination or signing a Declination Form, and following the Exposure Control Plan.
• BBP definition: pathogenic microorganisms present in human blood that can cause disease in humans. BBPs may also be present in non-human primate blood, body fluids, cell cultures, and OPIMs (semen, vaginal secretions, pleural or pericardial fluids, unfixed human tissues, any body fluid visibly contaminated with blood).
• All laboratory employees at Firefly Bio are required to be trained.
• Universal precautions: treat all sources as potentially infectious regardless of perceived risk; use all engineering controls, work practices, and PPE to minimize exposures.
• Firefly Bio handles the Lentivirus genus, which includes risk to HIV and simian immunodeficiency viruses (SIVs). High-risk lentiviral activities: centrifugation, sonication, vortexing, tube cap popping, handling sharps, and contact with exposed or broken skin.
• Working with NHP and human-derived tissues and cells presents risk of BBP exposure including bacterial, viral, parasitic, and fungal pathogens (e.g., measles, tuberculosis).
• HIV: affects T-cells; three CDC stages (A: asymptomatic/flu-like; B: weakened immune system; C: AIDS); no vaccine or cure, antiretroviral therapy extends life.
• HBV: incubation 4-26 weeks (average 12 weeks); 100 times more infectious than HIV; 50% of infected persons are asymptomatic; symptoms include loss of appetite, low-grade fever, joint pains, jaundice (late stage); vaccines and treatments available; 90-95% of personnel recover.
• Herpes B: common in NHPs (natural host), usually asymptomatic or mild in NHPs; can be fatal in other NHPs; more infectious in stressed or immunosuppressed NHPs; untreated human infection has approximately 80% mortality rate; no vaccine.
• Herpes B human symptoms: onset within one month (as little as three days); initial flu-like symptoms (fever, muscle aches, fatigue, headache); blisters at exposure site; shortness of breath, nausea, vomiting, abdominal pain; if disease progresses: numbness, pain, itching near wound, loss of muscle coordination, brain and CNS damage, death.
• Exposure sources: human blood and tissue, NHP blood and tissue, lentivirus; splash and aerosol hazards from centrifuges, vortex mixers, liquid transfers, shakers, blenders, sonicators; contaminated sharps (needles, syringes, scalpels, razor blades, broken glassware).
• Routes of infection: percutaneous; direct contact with mucous membranes (aerosol, splash, spatter); direct contact with abraded skin; any contaminated liquid or body fluid.
• Engineering controls: sharps containers for needles and blades, red step cans for biohazardous material, biosafety cabinets, centrifuge cups, handwashing stations, eyewash and shower units.
• BSC work practices: minimize disruption of inward directional airflow, minimize repeated arm insertion and withdrawal, proper placement and operation of materials in the work chamber, no brisk walking past BSC when in use.
• Biosafety levels defined: BSL1 (standard practices, minimal hazard, e.g., E. coli); BSL2 (moderate hazard, inoculation/ingestion/skin/mucous membrane exposure, e.g., HBV, blood, retroviral vectors); BSL3 (strong primary and secondary containment); BSL4 (complete isolation).
• All NHP work must be conducted in a BSL-2 environment per CDC/NIH BMBL guidance.
• BSL-2 general requirements: restricted lab access, durable leak-proof containers, lab coats and safety glasses, gloves when skin contact with infectious materials is possible, biohazardous waste treated as regulated Medical Waste disposed by licensed handler, aerosol-producing procedures in BSC, biohazard labeling, lab entrance signage, HBV vaccination program.
• BSL-2 standard microbiological practices include: restraining long hair and securing loose clothing and jewelry; wearing gloves (two pairs when appropriate); removing PPE to minimize self-contamination; washing hands after working with potentially infectious material and before leaving the lab; washing skin or flushing mucous membranes immediately after contact with blood or OPIM; minimizing splashing and droplet generation; prohibiting eating, drinking, smoking, cosmetics, contact lens handling, and food storage in work areas; prohibiting mouth pipetting and sniffing cultures; prohibiting washing or reusing disposable gloves; prohibiting benchtop lentiviral work outside BSC or centrifuge.
• Administrative controls: minimize aerosol generation, wear PPE, required handwashing, careful sharps handling, decontaminate work surfaces, dispose of biohazardous waste properly.
• Glove change and removal: change gloves frequently; remove before leaving the lab; wash hands immediately or as soon as feasible after removal.
• HBV vaccine: offered at new employee onboarding; three-shot series (initial, one month later, six months later); if declined, HBV Declination Form must be read and signed; post-incident vaccination available; coordinated through the EHS Administrator.
• PPE required: lab coat, disposable gloves, eye protection (safety glasses, goggles, or face shield); respiratory protection potentially required based on risk assessment. PPE is available at all lab entrances.
• Sharps injury prevention: keep exposed sharp in view; be aware of people nearby; avoid hand-passing sharps; stop if rushed or distracted; activate safety features immediately after use; user is responsible for their device; dispose in rigid sharps containers; do not overfill; place items into containers, never reach into containers; do not recap, bend, or break a used needle; pick up broken glassware with dustpan, brush, tongs, or forceps, never by hand; report improperly disposed sharps to manager.
• Needleless systems: substitute for needles when withdrawing bodily fluids after access is established, administering medications, or when alternatives are available.
• Decontamination: disinfection destroys resistant vegetative microbes or viruses but not spores; surface decontamination uses 10% bleach solution or 70% ethanol; if aerosol potential exists, wait 30 minutes before decontaminating; chemically disinfect reusable glassware and equipment; check reusable PPE for contamination and place dirty lab coats in designated containers.
• Solid biohazardous waste: red plastic bag meeting DOT specifications (ASTM D1709-D1 and ASTM 1922-00a), covered when not in use, in a leak-proof secondary container, securely tied, labeled with biohazard symbol and word 'Biohazard'. Vendor: Stericycle 1-866-738-7422. Spills and decontamination: Heritage 1-800-48-SPILL.
• Sharps waste: leak-proof, rigid, puncture-resistant, lidded containers labeled 'Biohazard' or 'Infectious Waste'; closed when three-quarters full; never overfill.
• Liquid biohazardous waste: collect in rigid leak-proof container, place in secondary containment, label as biohazardous, add 1:10 bleach/water solution with 30-minute contact time, dispose down sanitary sewer.
• Biohazard labeling required on: medical waste secondary containers (all visible sides), equipment used with or contaminated by these agents, storage areas (refrigerators/freezers), and labs where biohazards are present.
• Biological spill response materials: fresh 10% bleach solution, forceps/tongs/broom/dustpan, biohazard bag, sharps container, paper towels or absorbent, PPE (safety glasses or goggles, gloves, lab coat).
• Biological spill clean-up procedure: alert and evacuate immediate area; don PPE; cover area twice the spill size with absorbent, pour 1:10 bleach/water over it; allow 30-minute contact; use forceps/tongs/broom to pick up absorbent; place broken glass in sharps container or red bag; remove towels and re-clean with disinfectant; place all disposable contaminated supplies in biohazardous waste; decontaminate reusable items; inform lab personnel, ECO, and manager when complete.
• BSC spill procedure: keep cabinet running; clean per standard directions including back and side walls; follow up with 70% IPA to avoid corrosion; if catch basin is affected, add equal volume of disinfectant, wait 30 minutes, absorb with paper towels and place in red bag; allow cabinet to run at least 10 minutes before resuming work.
• Centrifuge spill procedure: shut off centrifuge and do not open lid for 30 minutes; don PPE; apply disinfectant to all contaminated surfaces minimizing splashing; allow 30-minute contact; clean chamber; use forceps or tongs for broken glass; remove buckets and rotors to nearest BSC and disinfect per manufacturer's instructions.
• Lentiviral spill outside containment: face away from spill, hold breath, quickly evacuate, notify nearby employees and manager/supervisor or ECO. Uncontrolled release outside the facility: evacuate, notify manager/supervisor or ECO; ECO reports to local health officers and regulators per 8 CCR Section 5199(f)(4)(J).
• Exposure incident reporting: notify manager, HR, and/or ECO. Occupational health: Concentra Urgent Care, 3 South Linden Ave, South San Francisco CA 94080, 650.238.1500, M-F 8AM-8PM, Sat 10AM-2PM. 24-hour emergency: Kaiser Medical Center ER, 1200 El Camino Real, South San Francisco CA 94080, 650.742.2000.
• Medical follow-up after exposure: document routes and circumstances of exposure; collect and store employee blood as soon as feasible with consent; make source individual test results available to employee per applicable laws; provide written medical opinion from healthcare provider within 15 days of post-exposure assessment; retain copy at Firefly Bio and give copy to affected employee.
• Medical recordkeeping (employee): kept by Firefly Bio HR; includes name and SSN, HBV vaccination status and dates, declination forms, examination and test results, healthcare professional's written opinion, and information provided to the healthcare professional.
• Medical recordkeeping (exposure incident): includes date of incident, names of employees in evaluation, disease or pathogen involved, name and job title of evaluator, date of medical evaluation, contact information of any other employer notified; records retained for duration of employment plus 30 years.
• Sharps injury log: completed within 14 days of incident report; includes date and time, type and brand of sharp, description of incident, whether sharp had engineered injury protection, and employee's opinion on whether controls could have prevented the injury.
• Training records: maintained by Firefly Bio; include dates of training, contents or summary, names and qualifications of trainers, names and job titles of attendees; retained for three years; available to employee, OSHA, Cal/OSHA, or other regulatory agencies on request.
• The Exposure Control Plan is available on the Firefly SharePoint site.
• The course is produced by BSI (Gary Wu, Consultant, gary.wu@bsigroup.com).

• The course will be built in Articulate Rise 360 using the standard block library plus Mighty Studio blocks where native Rise blocks cannot meet the requirement.
• Delivery is self-paced e-learning published to an LMS via SCORM 1.2, with completion tracked by a knowledge check pass rather than slide-view count, consistent with a compliance certification requirement.
• The target pass mark is 80%, which is a common threshold for Cal/OSHA-aligned BBP training; this will be confirmed in open questions.
• Learners complete the course individually on a desktop or laptop in a lab or office environment; mobile is a secondary consideration.
• The course will include a final knowledge check that generates a completion record; no branching scenario requiring Storyline embedding is assumed unless the client requests it, given the 30-minute seat-time constraint.
• All content is sourced exclusively from the supplied slides and PPTX. No additional SME content, job aids, or supplementary documents are available at this stage.
• The Firefly Bio contact details (Marlon Castillo, Concentra, Kaiser) are current and approved for inclusion in the published course.
• The course is California-specific (8 CCR 5193 and 8 CCR 5199.1); no other state or federal jurisdiction is in scope.
• Learners have basic familiarity with laboratory environments but may not know the specific Firefly Bio ECP requirements; the course is not designed for complete novices to laboratory work.
• The five-lesson structure will use one knowledge check per lesson (formative, unscored) plus a final summative check at the end of Lesson 5, consistent with the 30-minute seat-time budget.
• Voice-over narration will be included on all content blocks; AI TTS is assumed unless the client specifies a human voice artist.
• The slide notes in the source PPTX (e.g., references to BSC practices, sharps containers, PPE modifications) are SME annotations for the instructor, not learner-facing content; they will inform design decisions but will not be reproduced verbatim.
• Content from slides 26 and 27 (BSL-2 Standard Microbiological Practices, two slides) will be consolidated into a single lesson block set to stay within the content-block budget.
• The sharps injury prevention content (slides 33-37) will be consolidated into one lesson section covering safe handling, disposal, and needleless systems, rather than treated as five separate topics.
• Spill response content (slides 49-54) will be consolidated into one lesson section covering general biological spills, BSC spills, centrifuge spills, and lentiviral spills, with a process or accordion block rather than one block per slide.

1. Why This Training Exists — 8 CCR 5193 and 8 CCR 5199.1 requirements; definitions of BBP and OPIM; universal precautions; ECO, HR, and employee responsibilities. (~14 blocks)

2. Pathogens We Work With — Lentiviral vectors (HIV, SIV risk); NHP tissues and cells; HIV, HBV, and Herpes B: transmission, symptoms, and severity; exposure sources and routes of infection. (~14 blocks)

3. Controls That Protect You — Engineering controls; BSC work practices; biosafety levels 1 to 4; BSL-2 general and microbiological practice requirements; administrative controls; PPE selection and use; HBV vaccine program. (~14 blocks)

4. Sharps, Waste, and Decontamination — Sharps injury prevention and needleless systems; solid, sharps, and liquid biohazardous waste disposal; biohazard labeling requirements; surface and equipment decontamination. (~14 blocks)

5. When Something Goes Wrong — Biological spill response procedures; lentiviral spill protocol; exposure incident reporting contacts and timeline; medical follow-up; medical recordkeeping; sharps injury log; training records; summative knowledge check. (~14 blocks)