Presentation on theme: "Update: Application of Cal/OSHA Aerosol Transmissible Disease Standards in Laboratories Deborah Gold, Bob Nakamura,"— Presentation transcript:
Update: Application of Cal/OSHA Aerosol Transmissible Disease Standards in Laboratories Deborah Gold, Bob Nakamura, October 2, 2009
“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, TB Incidence still well over national average; rate of decline has slowed. CDPH
Counties in CA with increased TB incidence Source: CDPH
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 A. 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) B. Patients or clients are screened for airborne infectious diseases and referred if indicated (Referring Employers – subsection (c)) C. Laboratories (subsection (f)) D. 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 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 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 Listed in Appendix D –List derived from BMBL and HICPAC guidelines BMBL recommends BSL 3 or above Biosafety Officer recommends 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 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 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 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 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 Engineering –Use alternative processes –Primary and secondary containment Work Practices Personal and Respiratory Protection, if necessary Consistent with BMBL
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) 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) 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 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 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 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
IIPP Written health and safety program Responsible person System of compliance with safety rules Hazard Identification/Evaluation and Correction Communication Accident/illness investigation TrainingRecordkeeping
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 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) 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? 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.
H1N1 Laboratory capacity was overwhelmed in the first month Reduction in testing recommendations Reduction in laboratory precautions
Interim Biosafety Guidance H1N1 Influenza A Virus: CDC Splash Protection for performing rapid immunoassay tests 2. 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. 2. 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. 3. BSL-3 practices are no longer required for viral isolation. 3. BSL-3 practices are no longer required for viral isolation. 4. Personal Protective Equipment -- lab coats and gloves
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 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 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 : Interim Guidance on Antiviral Recommendations for Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection and Close Contacts: Interim Guidance on Antiviral Recommendations for Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection and Close Contacts
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 Cal/OSHA regulations: –http://www.dir.ca.gov/samples/search/query.htm Standards Board Proposed Regulations: Advisory committee webpage: –http://www.dir.ca.gov/dosh/DoshReg/advisory _committee.html