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1. Occupational Exposure to Tuberculosis (TB) John Furman
Division of Occupational Safety & Health
3. DOSH Enforcement
No OSHA/DOSH TB control rule
WRD 11.35 establishes enforcement of CDC TB control guidelines
Safe workplace standard
Hazard specific requirements
OSHA enforcement directive CPL 2.106
Currently enforcing 1994 CDC guidelines
2005 guidelines may be implemented without penalty
4. 1994 guidelines widely implemented in health-care facilities
Advisory Council for the Elimination of Tuberculosis (ACET) requested revision of 1994 guidelines based on decrease in TB incidence rates
New Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, [MMWR Vol. 54/No. RR-17]
Published December 30, 2005
Why revise the guidelines when 1994 guidelines widely implemented in healthcare settingsWhy revise the guidelines when 1994 guidelines widely implemented in healthcare settings
5. Why does OSHA/DOSH need to remain involved? TB remains a public health concern
Infection rates greater than US average in certain high risk populations
MDR-TB a growing concern
HCWs face increased exposure risks
10 HCWs diagnosed with TB disease in 2005
Recent cases of HCWs as exposure sources
6. WRD 11.35 Enforcement Procedures and Scheduling for Occupational Exposure to Tuberculosis, OSHA Instruction CPL 2.106, issued 1996
References CDC’s Guidelines for Preventing the Transmission of tuberculosis in Health-Care Facilities [MMWR Vol. 43/No. RR-13], 1994
Provides uniform inspection procedures
7. WRD 11.35, Applicability Scope of workplaces
Health Care Facilities
Correctional Institutions
Long-term Care Facilities for Elderly
Homeless Shelters
Drug Treatment Centers
8. Incidence of TB 2005 TB rates
US average rate was 4.9/100,000
Washington rate 4.0/100,000
# cases TB disease holding steady at ~253/yr
King (127), Pierce (27), & Snohomish (24) with most cases
3 cases of MDR-TB reported TB recordkeeping began in 1953, 2004 had the lowest rates ever since that timeTB recordkeeping began in 1953, 2004 had the lowest rates ever since that time
9. Risk Factors Foreign born
Unemployed
Homeless
Excess alcohol
HIV-AIDS positive
Injecting drug use
Other drug use
Health care worker
Previous diagnosis
Resident of correctional facility
Resident of long-term care facility
Migrant worker
10. HCW All paid and unpaid persons working in health care settings
WISHAct applies only to the employer, employee relationship
DOH, JCAHO, CMS et al expect that all HCWs are included in the TB medical surveillance program
11. 2005 GuidelinesSummary of Changes The scope of settings in which the guidelines apply has been broadened to include laboratories and additional outpatient and nontraditional facility based settings.
These recommendations generally apply to an entire health-care setting rather than areas within a setting.
The risk assessment process includes the assessment of additional aspects of infection control
12. Summary of Changes
A written TB control plan is required
Blood assay for M. tb, QuantiFERON®TB Gold, may be used instead of TST in TB screening programs for HCWs.
Criteria for serial screening of HCWs are more clearly defined. This may decrease the number of HCWs who need serial TB screening.
13. Summary of Changes New terms, airborne infection precautions, airborne infection isolation room (AII room), tuberculin skin testing (TST), are introduced.
Information on ultraviolet germicidal irradiation (UVGI) and room-air recirculation units has been expanded.
AFB specimens may be taken 8-24 hours apart with one being an early morning specimen.
[Change in criteria for serial testing; reduction in # of HCW required to be serial tested]
[Info added to UVGI and air circulation info}
[Change in criteria for serial testing; reduction in # of HCW required to be serial tested]
[Info added to UVGI and air circulation info}
14. Summary of Changes
Training recommendations have been expanded
Competency of those administering and reading TSTs
Recommendations for annual respirator training, initial respirator fit testing, and periodic respirator fit testing have been added.
The evidence of the need for respirator fit testing is summarized.
15. Expanded Scope New Terminology : Health-care-associated settings
used to broaden the potential places where guidelines apply
Inpatient settings
Patient rooms
Emergency depts.
Intensive care units
Surgical suites
Laboratories & Lab procedure areas
Bronchoscopy suites
Sputum induction or inhalation therapy rooms
Autopsy suites
Embalming rooms
16. Scope (cont.) Outpatient settings
TB treatment facilities
Medical offices
Ambulatory-care settings
Dialysis units
Dental care settings
Non-Traditional facility-based settings
Emergency Medical Services (EMS)
Long term care settings (hospices; skilled nursing facilities)
Settings in Correctional facilities (prisons, jails, detention centers)
Home-based healthcare & outreach settings
Homeless shelters Ambulatory care settings in old guidelines included TB treatment facilities & emergency departments; in these guidelines it is separate and part of “outpatient settings”; Dialysis units are included w/ recommendations to use AII rooms for patients w/ TB or transfer to a hospital w/ AII room that can perform dialysis & recommendation for use of N95 respirators for staff
In our old CPL we mention that “coverage of non-hospital healthcare settings(i.e., doctos’offices, clinics, etc.) includes only personell present during the performance of high hazard procedures on suspect or active TB patients.”
Medical offices and dental settings were included under the umbrella of “Other health cares settings”Ambulatory care settings in old guidelines included TB treatment facilities & emergency departments; in these guidelines it is separate and part of “outpatient settings”; Dialysis units are included w/ recommendations to use AII rooms for patients w/ TB or transfer to a hospital w/ AII room that can perform dialysis & recommendation for use of N95 respirators for staff
In our old CPL we mention that “coverage of non-hospital healthcare settings(i.e., doctos’offices, clinics, etc.) includes only personell present during the performance of high hazard procedures on suspect or active TB patients.”
Medical offices and dental settings were included under the umbrella of “Other health cares settings”
17. New TB Screening Blood Test D) QFT-G – Blood test
QuantiFERON®TB Gold test (QFT-G) (Cellestis Limited, Carnegie, Victoria, Australia)
A blood assay for M. tuberculosis (BAMT).
Whole-blood interferon gamma release assay (IGRA)
Might be used instead of TST in TB screening programs for HCWs
A Food and Drug Administration (FDA)--approved in-vitro assay This is the most recent blood test developed…the first was QFT which was Approved in 2001; QFT-G replaces QFT and uses syntehtic proteins as antigens instead of PPD (which is used by QFT)A Food and Drug Administration (FDA)--approved in-vitro assay This is the most recent blood test developed…the first was QFT which was Approved in 2001; QFT-G replaces QFT and uses syntehtic proteins as antigens instead of PPD (which is used by QFT)
18. QFT vs. TST Pros of using QFT-G (BAMT):
Cost effective alternative
Only 1 visit for blood draw
Results can be available in <24 hours after testing
Greater specificity for M. tuberculosis with BAMT
Antigens used are not present in most NTM or used for BCG
Can be used to screen persons vaccinated with BCG
Not subject to boosting effect
Not subject to placement and reading errors
Cons of using QFT-G (BAMT):
Possible errors in collecting or transporting blood specimens
Incubation must be done w/in 16 hours of collection
Lab-based errors in running or interpreting the assay
Cost prohibitive?
19. Appendix B – TB Risk Assessment Worksheet Elements considered in Risk Assessment Process:
Incidence of TB (community & facility)
Risk Classification
Screening of HCWs for M. TB infection
TB Infection-Control Program
Implementation of TB infection control plan based on review by infection control committee
Lab processing of TB related specimens, tests, & results based on laboratory
Environmental controls
Respiratory Protection Program
Reassessment of TB Risks Important questions on each of these elements of a risk assessment programs are written out in a Q&A format to facilitate review of program and determination of risk –
Ex. For risk classification : how many beds the facility has? How many TB patients encountered in previous year?
Separate questions to be considered by inpatient facilities than those to be considered by outpatient facilities or Nontraditional facilities Important questions on each of these elements of a risk assessment programs are written out in a Q&A format to facilitate review of program and determination of risk –
Ex. For risk classification : how many beds the facility has? How many TB patients encountered in previous year?
Separate questions to be considered by inpatient facilities than those to be considered by outpatient facilities or Nontraditional facilities
20. Risk Classification Low
<200 beds
<3 pts/yr
>200 beds
<6 pts/ yr
Outpatient, nontraditional facility-based
<3pts/yr
Medium
<200 beds
>3 pts/yr
>200 beds
>6 pts/ yr
Outpatient, nontraditional facility-based
>3 pts/yr
21. New Screening Frequency Recommendation Risk TB Screening Frequency
Classification
Low Baseline, further screening
is not necessary unless
unless exposure
Medium Baseline, annual screening
Potential Baseline, every screening
ongoing every 8-10 weeks
transmission
Decrease in freq of TB screening]
[Criteria to determine screening freq changed]
HCWs whose duties do not include contact with patients or TB specimens DO NOT NEED to be included in the serial TB screening program.
Decrease in freq of TB screening]
[Criteria to determine screening freq changed]
HCWs whose duties do not include contact with patients or TB specimens DO NOT NEED to be included in the serial TB screening program.
22. Special Notes on Risk Classifications Classification of medium risk might need to be assigned, even if a facility meets the low-risk criteria when:
Settings serve communities w/ high incidence of TB disease
Settings that treat populations at high risk (e.g., HIV patients)
Settings that treat patients w/ drug-resistant TB disease
A classification of potential ongoing transmission should be applied to a specific group of HCWs or to a specific area of the health-care setting in which evidence of ongoing transmission is apparent, if such a group or area can be identified.
Conduct investigation (screen workers every 8-10 wks until corrected)
Classification should be temporary
The setting should be reclassified as medium risk and recommended screening should be annual.
23. Criteria for HCW screening All HCW’s who “share the air” must be included in the medical surveillance program.
HCWs whose duties do not include contact with patients or TB specimens may not need to be included in the serial TB screening program
In certain settings, this change will decrease the number of HCWs who need serial TB screening
24. TST/BAMT Positive HCWs Remote infection
Initial and annual symptom screen
Additional evaluations as indicated
Education re: symptoms and duty to report
Baseline positive or conversion
Symptom screen and CXR
Additional evaluations as indicated
Consider prophylaxis
25. Airborne Infection Isolation (AII Room) New Terminology: AII Room
Airborne infection isolation room (AII room) is introduced instead of the term “negative pressure room” or “AFB Isolation room”
Another term used:
Airborne infection precautions - used instead of airborne precautions Negative pressure isolation rooms are now referred to throughout the document as AII roomsNegative pressure isolation rooms are now referred to throughout the document as AII rooms
26. AII Room (cont.) Use of other national consensus guidelines AIA, ASHRAE
6 ACH (existing); 12 ACH (new)
Minimum of 2 ACH of outdoor air
Monitoring devices
Differential air flow rates and leakage
Pressure differential from 0.001 to 0.01 in water
Maintenance schedules
27. Information on UVGI Information on ultraviolet germicidal irradiation (UVGI) and room-air recirculation units has been expanded.
Information on effectiveness of UVGI added
Discussion of studies conducted which examine:
Air mixing
Relative humidity
Ventilation rates
28. Respiratory Protection Expanded section on respiratory protection
Reference to OSHA Respiratory protection standard & requirement for Respiratory protection program
Selection criteria – CDC/NIOSH approved respirator
Medical screening/evaluation of those assigned respirators
Annual training recommended
29. Respiratory Protection WAC 296-842 applies to all respirator use at work.
OSHA not enforcing annual fit test requirements
DOSH will enforce 296-842 using state funds only
35. DOSH Inspection Focus Assignment of responsibility
Written TB control plan
TB risk assessment
Medical surveillance
Early detection and isolation
Engineering controls
Respiratory protection
HCW training and education
Respiratory etiquette
Coordination with local health department
36. Current Enforcement OSHA currently working on update to PCPL 2.106
Formally still enforcing 1994 CDC guidelines
Consult with DOSH ONC re: facilities who have implemented 2005 guidelines
Enforce DOSH Respirator rule re: bio-agents
37.
QUESTIONS?