CDC Draft TB Guidelines

1
CDC Draft TB Guidelines

• Do not make changes based solely on the Draft
  Guidelines

2
Comments

• Due on February 4, 2005
• APIC
• SHEA
• HICPAC
• AHA

3
Shift in focus---

• No longer hospital-based
• Emergency departments
• Urgent care centers
• Intensive care units
• Surgical suites ambulatory and inpatient
• TB treatment facilities
• Ambulatory care settings medical, dental
• Correctional medical settings

4
Workers

• Paid and unpaid
• Part-time, temporary and contract personnel
• Very broad job classification categories
• Why computer programmers? Food service staff?
• All locations where TB patients may visit
• Why Laundry? General stores? Kitchen?
• Maintenance shops?

5
TB Risk Assessment

• Settings with TB cases
• Initial and ongoing assessment
• Community TB profile
• Number of suspect or confirmed TB in last 5 years
• Number of actual TB cases in last year
• Determine if unrecognized TB cases in past year
• Purpose
• Determine AIIR needs
• Determine need for other environmental controls
• Determine which HCWs need TB screening
• Determine which HCWs to include in respiratory
  protection program
• Conduct periodic reassessments
• Recognize and correct lapses in infection control

6
TB Risk Assessment

• Settings without TB cases
• Community profile
• Number of suspect or confirmed TB cases in past 5
  years
• Number of actual TB cases in past year
• Unrecognized TB cases
• Determine need for TB screening
• Determine need for environmental controls
• Identify areas with potential risk
• Document procedures to identify cases, isolate
  and promptly transfer
• Periodic reassessments of risk level at least
  annually

7
Low Risk

• Inpatient settings with lt 200 beds
• lt 3 TB patients/year
• Inpatient settings with gt 200 beds
• lt 6 TB patients/year
• Outpatient or other facilities
• lt 3 TB patients/year
• TB treatment facilities
• LTBI not TB cases,
• No cough inducing procedures, and
• System to detect and triage if TB is suspected
• Laboratories
• Do not manipulate specimens that might contain
  M.tb

8
Medium Risk

• Inpatient settings with lt 200 beds
• gt 3 TB patients/year
• Inpatient settings with gt 200 beds
• gt 6 TB patients/year
• Outpatient or other facilities
• gt 3 TB patients/year
• TB treatment facilities
• TB cases are encountered
• Cough inducing procedures are performed
• System to detect and triage if TB is suspected
• Laboratories
• Specimens that might contain M.tb are manipulated

9
Potential Ongoing Transmission

• Any evidence of person-to-person transmission
  regardless of setting
• Increase or cluster of TB test conversions
• HCW with active TB disease
• Unrecognized TB disease in patients or HCWs
• Healthcare-associated transmission suspected by
  clustering of cases associated with a facility or
  fingerprinting of isolates
• Post-outbreak medium risk for at least one year

10
TB Screening

• Tuberculin Skin Testing
• TB conversion now gt 10 mm increase over a two
  year period regardless of age in a HCW with a
  two-step baseline or non-HCW with a negative in
  past two years
• QuantiFERON
• Draft based on 1st generation
• QFT conversion defined as going from negative to
  positive within a two year period
• Final will be based on QFT-Gold
• Conversion evidence of new infection

11
CDC Low Risk

• Baseline TB screening
• CDC states no need for annual
• NYS Codes, Rules and Regulations still require a
  minimum of annual testing if previously negative
• Your thoughts?

12
TB Screening HCWs with Baseline Positive

• Low-risk and Medium Risk
• After baseline chest radiograph, no need to
  repeat unless signs or symptoms of TB disease
  develop, or a clinician recommends a repeat chest
  radiograph, or as part of a contact
  investigation.
• This last phrase is not appropriate and,
  according to CDC, will be removed. We do not
  want to encourage unnecessary CXR examinations.

13
QuantiFERON

• 1st Generation
• Draft based on QFT
• 2nd Generation QuantiFERON-Gold
• Final revision will be based on QFT-Gold

14
QFT-Gold

• Whole blood assay
• Stimulate white cells
• Measure interferon gamma response
• Can distinguish between M. tuberculosis
• Mycobacterium bovis
• Bacille Calmette Guerin (BCG)
• Early literature is showing increased specificity
  and increased sensitivity

15
Specific Detection of TB Infection

• Mori T, Sakatani M, Yamagishi F et al.
• Am J Respir Crit Care Med Vol 170, pp59-64, 2004
• Specificity evaluated in 216 BCG-vaccinated
  Japanese student nurses at beginning of training
• 113 had TST 65 gt 10mm (specificity 35), 32 gt
  15mm (specificity 68)
• Specificity 98 percent with interferon-gamma
  assays
• Sensitivity evaluated in 118 culture-confirmed TB
  patients with less than 1 week of
  anti-tuberculosis treatment
• 76 had TST sensitivity was 66 using gt 5 mm
• CFP-10 and ESAT-6 combined 89 sensitivity

16
Comparison of TST and New Specific Blood Test in
TB Contacts

• Brock I, Weldingh K, Lillebaek T et al. Am J
  Respir Crit Care Med Vol 170 pp.65-69, 2004
• TST vs. QuantiFERON - TB Gold
• TB outbreak in a Danish High School
• 85 BCG-unvaccinated contacts of index case
• 40 BCG vaccinated no exposure with index case
• Excellent agreement between QFT and TST in
  BCG-unvaccinated contacts (94)
• QFT-Gold not confounded by BCG vaccination

17
QFT-Gold

• FDA approval announced on 12/3/04
• CDC guidelines will be developed
• Need to integrate into Guideline for Preventing
  the Transmission of Mycobacterium tuberculosis in
  Health-care Settings

18
Low Risk Settings Where TB patients are only
triaged

• No need for AIIR
• No need for respiratory protection program
• Mask patient
• Place in AIIR, if available, or separate room
  with door closed
• Triage to appropriate setting

19
Medium or On-going Transmission

• Need AIIR
• Triage areas
• ED
• Urgent Care
• Inpatient
• Need Respiratory Protection Program

20
OSHA Standard Interpretation

• 12/22/2004 - Tuberculosis and Respiratory
  Protection prohibition of enforcing annual fit
  testing requirements during 2005 fiscal year
• During FY 2005, employers may not be inspected or
  cited for the requirement to do annual fit
  testing of respirators for occupational exposure
  to tuberculosis
• If inspection activity regarding the annual fit
  testing of respirators for tuberculosis has
  already taken place, the Area Director shall
  ensure that no citations are issued and no
  penalties proposed

21
OSHA Standard Interpretations cont

• All requirements of the respiratory protection
  standard, including annual fit testing, may
  continue to be cited for respirator use against
  other hazards, such as Severe Acute Respiratory
  Syndrome (SARS) or other bioaerosols
• State Plan States and Consultation projects may
  not expend Federal or State matching funds to
  perform activities prohibited by the
  appropriations restriction