Title: Update: Application of Cal/OSHA Aerosol Transmissible Disease Standards in Laboratories
1Update Application of Cal/OSHA Aerosol
Transmissible Disease Standards in Laboratories
- Deborah Gold, dgold_at_dir.ca.gov
- Bob Nakamura, bnakamura_at_dir.ca.gov
- October 2, 2009
2Every Employer shall furnish employment and a
place of employment that is safe and healthful
for the employees therein. California Labor Code
Section 6400
3Tuberculosis Cases in California, 1980-2008
TB Incidence still well over national average
rate of decline has slowed.
CDPH
4Counties in CA with increased TB incidence
2007-2008
Source CDPH
5Why 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
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7Four 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.
8Four 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 dont treat
ATDs, dont 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
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10Laboratory 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.
11Some 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
12Aerosol 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
13Novel 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
14Laboratories -- 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)
15Risk 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
16Zoonotics 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.
17Risk 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)
18Hierarchy of Controls
- Engineering
- Use alternative processes
- Primary and secondary containment
- Work Practices
- Personal and Respiratory Protection, if necessary
- Consistent with BMBL
19Biosafety 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
20Elements 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
21Elements 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
22Medical 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
23Vaccinations
- Health Care Workers MMR, Tdap, Varicella,
influenza (HBV per 5193) - Laboratory workers pathogen/material/risk-benefi
t based on BMBL/ACIP recommendations - BMBL recommends medical consultation for
employees at BSL 3 and above - Seasonal flu effective now
- Other vaccination requirements effective
September 1, 2010
24Recordkeeping
- 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
25IIPP
- Written health and safety program
- Responsible person
- System of compliance with safety rules
- Hazard Identification/Evaluation and Correction
- Communication
- Accident/illness investigation
- Training
- Recordkeeping
26Zoonotics
- 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.
27Vertebrate 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
28Vertebrate 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
29Why 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. - Its our job.
30H1N1
- Laboratory capacity was overwhelmed in the first
month - Reduction in testing recommendations
- Reduction in laboratory precautions
31Interim 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
32Rapid 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
33Procedures 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
34Occupational 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
35Benefits 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
36Find 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_commit
tee.html