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Update: Application of Cal/OSHA Aerosol Transmissible Disease Standards in Laboratories. Deborah Gold, [email protected] Bob Nakamura, [email protected] October 2, 2009.

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update application of cal osha aerosol transmissible disease standards in laboratories

Update: Application of Cal/OSHA Aerosol Transmissible Disease Standards in Laboratories

Deborah Gold, [email protected]

Bob Nakamura, [email protected]

October 2, 2009

slide2

“Every Employer shall furnish employment and a place of employment that is safe and healthful for the employees therein.”

California Labor Code Section 6400

tuberculosis cases in california 1980 2008

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Tuberculosis Cases in California, 1980-2008

TB Incidence still well over national average; rate of decline has slowed.

CDPH

why an atd standard
Why an ATD standard
  • Existing aerosol transmissible diseases such as TB – health care workers still at increased risk
  • Experience of Canada and Asia with SARS
  • Planning for pandemic flu and other surge events
  • Incidents of laboratory transmission and near misses
  • Increased research on BSL 3 and above
four types of employers
Four Types of Employers
  • Hospitals, other work settings which perform:
    • evaluation, diagnosis, treatment, transport, housing or management of persons requiring airborne infection isolation;
    • high hazard procedures performed on suspect or confirmed cases;
    • decontamination or management of persons contaminated as a result of a release of biological agents;
    • autopsies or embalming procedures on human cadavers potentially infected with aerosol transmissible pathogens.
four types of employers cont
Four Types of Employers (cont)
  • Patients or clients are screened for airborne infectious diseases and referred if indicated (Referring Employers – subsection (c))
  • Laboratories (subsection (f))
  • Conditionally Exempt Employers – medical specialty practices, dentists that don’t treat ATDs, don’t perform high hazard procedures on those patients, and have screening and referral procedures;

Separate subsections allow people to focus on requirements that apply to them

laboratory subsection
Laboratory Subsection
  • Control of person to person transmission is different than laboratory aerosols.
  • Infectious organisms may become airborne in labs that are not naturally transmitted by that route.
  • Biosafety professionals have already established consensus guidelines, e.g. BMBL
  • We want to prevent an increase in laboratory risks due to increasing research on emerging pathogens and homeland security issues.
some recent lab exposures
Some Recent Lab Exposures
  • Brucellosis in clinical lab worker in southern California
  • Anthrax at research facility
  • TB conversions related to exposure chamber
  • Inadvertent distribution of H2N2 influenza virus
  • Tularemia
aerosol transmissible pathogens laboratory
Aerosol Transmissible Pathogens Laboratory
  • Listed in Appendix D
    • List derived from BMBL and HICPAC guidelines
  • BMBL recommends BSL 3 or above
  • Biosafety Officer recommends
  • Novel or Unknown Pathogen
novel or unknown pathogen
Novel or Unknown Pathogen
  • Causes serious human disease
  • Credible evidence that the pathogen is transmissible to humans by aerosols
  • The disease agent is:
    • (a) A newly recognized pathogen, or
    • (b) A newly recognized variant that differs significantly in virulence or transmissibility, or
    • (c) A recognized pathogen that has been recently introduced into the human population, or
    • (d) A not yet identified pathogen.
  • Pandemic flu strain is a novel pathogen, seasonal influenza is not
laboratories application
Laboratories -- Application
  • Laboratories that perform procedures that aerosolize ATPs-L
  • If employees have direct contact with infectious people (cases or suspected cases), other sections also apply.
  • The presence of ATPs-L requires the development of a biosafety plan (institutional risk assessment)
risk assessment
Risk Assessment
  • Done by a biosafety officer
  • Consistent with BMBL, Section II
  • For each agent and procedure
  • Record safe handling practices in biosafety plan
  • Trade secret info need not be recorded in plan
  • Control measures consistent with risk
zoonotics section 5199 1
Zoonotics – Section 5199.1
  • Applies to any place where employees are exposed to animals, or their products or wastes
  • Under normal circumstances address under IIPP (Section 3203)
  • Existing BBP regulation applies to animals infected with BBP
  • Existing respiratory protection standard (5144) applies to exposures to infectious aerosols.
risk assessment vivariums section 5199 1
Risk Assessment – VivariumsSection 5199.1
  • Applies to all vertebrate animal research facilities
  • Risk assessment and control consistent with BMBL
  • BMBL references NIH and ILAR guidelines for general conditions in anitmal facilities
  • Tissues and samples to comply with ATD standard, section 5199(f)
hierarchy of controls
Hierarchy of Controls
  • Engineering
    • Use alternative processes
    • Primary and secondary containment
  • Work Practices
  • Personal and Respiratory Protection, if necessary
  • Consistent with BMBL
biosafety officers are key
Biosafety Officers Are Key
  • Assess risk and specify control measures based on the specific pathogens and processes in the lab
  • Must have necessary knowledge, authority and responsibility
  • Audit and correct hazards
  • Review the plan
  • Be consulted regarding changes to facility that would effect biosafety
elements of biosafety plan 1
Elements of Biosafety Plan (1)
  • Lists of jobs, tasks, procedures, ATPs-L
  • Requirement to treat incoming materials as containing virulent pathogen until verify attenuated
  • Engineering controls (e.g. laboratory construction, biosafety cabinets)
  • Safe handling procedures
  • Decontamination and disinfection
  • PPE and Respirators if necessary
elements of biosafety plan 2
Elements of Biosafety Plan (2)
  • Emergency procedures, including report to local health officer
  • Medical services
  • Training
  • Employee involvement in review of plan
  • Inspection procedures and hazard correction
  • BSO to review design and construction plans for review of ATPs-L control
medical services
Medical Services
  • Vaccinations
  • Exposure incidents – notification and medical follow-up
  • LTBI surveillance – not required in research labs not working with materials reasonably anticipated to contain TB
  • Respirator evaluations, if applicable
  • Ensure confidentiality
vaccinations
Vaccinations
  • Health Care Workers – MMR, Tdap, Varicella, influenza (HBV per 5193)
  • Laboratory workers – pathogen/material/risk-benefit based on BMBL/ACIP recommendations
  • BMBL recommends medical consultation for employee’s at BSL 3 and above
  • Seasonal flu effective now
  • Other vaccination requirements effective September 1, 2010
recordkeeping
Recordkeeping
  • Medical records including vaccination, LTBI as applicable
  • Training
  • Plan review
  • Inspection and testing of engineering controls, such as ventilation systems and biosafety cabinets
  • Respiratory Protection per 5144
slide25
IIPP
  • Written health and safety program
  • Responsible person
  • System of compliance with safety rules
  • Hazard Identification/Evaluation and Correction
  • Communication
  • Accident/illness investigation
  • Training
  • Recordkeeping
zoonotics
Zoonotics
  • Subsection (c) applies to animals under quarantine order etc. from USDA, CDFA
  • Requires use of respirators and change rooms when entering enclosed areas.
  • Subsection (d) applies to eradication and clean up operations, disinfection of areas containing wastes from animals infected with zoonotic ATPs.
vertebrate animal research facilities absl 3 or above
Vertebrate Animal Research Facilities – ABSL 3 or above

MUST Comply with Subsection (d)

  • Written work plan, assessment of all risks (including chemical, physical and safety hazards) and control measures
  • Restricted areas
  • Contaminant reduction zone
  • Supervision
  • Recording of entry
vertebrate animal research facilities absl 3 or above cont
Vertebrate Animal Research Facilities – ABSL 3 or above (cont)
  • Respirators
  • Decontamination, disposal
  • Change facilities
  • Medical services
  • Procedures for access to drinking water and sanitation facilities
  • Training
  • Procedures for toxic or asphyxiant gases, if applicable
why is cal osha in my lab
Why is Cal/OSHA in My Lab?
  • Cal/OSHA is the agency designated by law to protect employees at work
  • Cal/OSHA provides a way for employees to get an independent review of safety issues at work, and to get hazards corrected in a timely manner
  • Cal/OSHA experience is that NIH guidelines and other audit programs do not prevent significant failures in occupational health and safety programs.
  • It’s our job.
slide30
H1N1
  • Laboratory capacity was overwhelmed in the first month
  • Reduction in testing recommendations
  • Reduction in laboratory precautions
interim biosafety guidance 2009 h1n1 influenza a virus cdc 8 15 09

Interim Biosafety Guidance 2009-H1N1 Influenza A Virus: CDC 8-15-09

Splash Protection for performing rapid immunoassay tests

Class II biosafety cabinet (BSC) in BSL-2 lab for more complex procedures (e.g., direct or indirect fluorescent antibody tests [DFA, IFA], culture, molecular assays), a Class II biosafety cabinet (BSC) in a biosafety level-2 (BSL-2) laboratory is required. 

BSL-3 practices are no longer required for viral isolation. 

Personal Protective Equipment -- lab coats and gloves

rapid tests lab or non lab settings
Rapid Tests: lab or non-lab settings
  • FDA-cleared rapid immunoassay tests require assessment of risks for generation of aerosols or contact with infectious material.
  • If they do not generate aerosols, they require splash protection: laboratory coat, gloves, eye protection, facemask
  • Procedures done outside a Class II BSC should be performed to minimize creation of splashes and/or aerosols.
  • Aerosol generating tests: BSL-2
procedures requiring bsl 2
Procedures Requiring BSL-2
  • Rapid tests involving steps that could generate aerosols (e.g. vortexing),
  • Direct or indirect fluorescent antibody tests (DFA, IFA) to detect viral antigens in clinical specimens,
  • Growth of virus in cell culture or embryonated eggs,
  • Molecular-based assays,
  • General laboratory research
  • Viral isolation and all sample manipulations with the potential for creating an aerosol in Class II BSC
occupational health
Occupational Health
  • Personnel who have had an occupational exposure to any infectious agent, including 2009-H1N1 influenza A (novel H1N1), should immediately inform their supervisor or manager.  Antiviral chemoprophylaxis is available and should be considered.  For additional information on antiviral treatment visit: Interim Guidance on Antiviral Recommendations for Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection and Close Contacts
benefits of lab section
Benefits of Lab Section
  • Supports the role of biosafety professionals in labs, including risk analysis
  • Establishes a baseline level of safety and works against cutting safety to compete for contracts etc.
  • Is structured to incorporate existing biosafety guidelines, procedures, plans
  • Provides notice to employers and employees regarding Cal/OSHA requirements – helps us all be on the same page
find cal osha on the web
Find Cal/OSHA on the Web
  • Cal/OSHA regulations:
    • http://www.dir.ca.gov/samples/search/query.htm
  • Standards Board Proposed Regulations:

http://www.dir.ca.gov/oshsb/atdapprvdtxt.pdf

  • Advisory committee webpage:
    • http://www.dir.ca.gov/dosh/DoshReg/advisory_committee.html
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