Tuberculosis Update Rachel L. Stricof, Epidemiologist New York State Department of Health rls01@health.state.ny.us

TB & MDR-TB - 2005 1,294 cases in NYS, a 4.9% decrease from 2004 > 72 percent decrease since 1992 > 51 of cases outside NYC are from Nassau, Suffolk and Westchester counties 27 MDR cases: 24 from NYC, 3 in rest of state Approximately, 70 percent of cases born outside U.S.

Key to Control Know the epidemiology of TB in the community you serve Changes can occur rapidly HIV epidemic MDR transmission Introduction of TB in homeless shelters, prisons, high risk populations, etc. e.g., Hmong Refugees Changes can have significant impact

What you don’t want to happen… Time 0 through day 5 45-year-old female admitted through ED 3 month history of productive cough, pleuritic chest pain, low grade temp and night sweats CXR examination revealed RLL infiltrate Past medical history – diabetes, smoking and asthma Discharged on oral Levaquin after clinical improvement on IV Levaquin

And the story continues…. Day 23 - ED Visit Fever, chills, productive cough CXR examination reveals RLL pneumonia Given prescription for 10 day course of Levaquin Day 37 - ED Visit Fever, chills, productive cough, chest pain Dx: resolving pneumonia and pleuritis Plan: Motrin and follow-up with PMD in 3 days

And the sad story continues…. Day 41 - 45 Patient admitted from ED Worsening shortness of breath, chest pain, cough, low grade fever Blood glucose = 592 CXR exam: RLL pneumonia Placed on Augmentin and develops pruritis and hives Switched to Ceclor and develops pruritis Discharged on Clindamycin and Zithromax

Is there no end……… Day 157 (5+ months) – Patient readmitted from the ED Blood glucose up to 609 CXR exam: RLL infiltrate, pleural effusion, LUL nodule CT exam: Cavitary lesions in LUL and RLL ID consultation obtained on 5th hospital day Noted weight loss (size 18 to 8) Orders TST, sputum for AFB, isolation Sputum: 4+ AFB, M. tuberculosis

Early Identification Most critical component As incidence goes down, so does index of suspicion As incidence goes down, public health infrastructure in jeopardy As incidence goes down, more difficult to maintain competency (lab, radiology, clinical acumen, etc.)

What’s New? Expanded scope – additional settings Criteria for moving into/out of isolation Revised risk assessment recommendations TB screening frequency modifications Respiratory fit testing and training wording Voluntary use of respirators by visitors QuantiFERON testing Frequently asked questions section added

Other Settings ERs Medical offices Ambulatory care units Bronchoscopy suites Autopsy suites Embalming rooms Operating suites Laboratories TB clinics Ambulatory care units Dialysis units Correctional facilities EMS Home healthcare Hospices LTCF

Frequency of Sputum Collection for TB Suspects Three consecutive negative sputum smears Taken 8 - 24 hours apart Previous guideline recommended 24 hour intervals between specimens At least one specimen obtained AM In most cases, collection will occur over 2 days

NYS NAA Testing *on AFB+ respiratory specimens – Not CDC Mycobacteriology Standard 8 ( to go into effect later this spring ): All respiratory specimens which test acid-fast smear positive and are from patients who have not previously been diagnosed with tuberculosis shall have nucleic acid amplification testing performed Guidance: Specimens from patients with a past history of NTM infection and without clinical suspicion of tuberculosis (e.g., cystic fibrosis patients) do not need nucleic acid amplification testing performed. If the laboratory does not have the capability to perform nucleic acid amplification testing, an additional respiratory specimen shall be immediately requested and sent to a New York State permitted laboratory that performs nucleic acid amplification. *Nucleic Acid Amplification: Gen-Probe AMPLIFIED Mycobacterium tuberculosis Direct (MTD) or Roche AMPLICOR Mycobacterium tuberculosis (MTB) test

Free MTD testing on AFB smear negative specimens: Wadsworth* All of the following criteria should be met: High clinical suspicion of TB, previously untreated or <7 days of treatment Respiratory specimen, or Non-respiratory specimens (request from the lab on a case by case basis if clinical suspicion is high) *For NYC specimens, Wadsworth or NYCPHL *not CDC

Discontinuing Isolation for Suspect or Rule-out TB Patients Infectious TB disease is unlikely AND Another etiology is identified OR Three consecutive negative sputum smears taken 8 - 24 hours apart Smear +, NAA-negative for M. tb

Discontinuing Isolation for Suspected/Confirmed TB Patients Remain in airborne isolation until: Three consecutive negative AFB sputum smear results collected 8 - 24 hours apart, with at least one being an early morning specimen On appropriate anti-TB treatment Usually a 4 drug regimen to start Usually for at least 2 weeks prior to discontinuing isolation Demonstrated clinical improvement

Airborne Infection Isolation Rooms (AIIRs) 6 ACH (existing); 12 ACH (new) Minimum of 2 outdoor air exchanges per hour Recommended minimum pressure differential has been increased from 0.001 to 0.01 w.g. (AIA Guidelines 2001) Monitoring is essential Direct exhaust to outside If must recirculate air to other areas, HEPA Proper installation and maintenance

High Efficiency Particulate Air HEPA Filter 99.97% @ 0.3 micron high air resistance may lose airflow leakage at seals special maintenance

Proper Installation and Maintenance Are Essential

Continuous Monitors vs. Smoke 189 New York State hospitals 172 (91%) had at least one AII room 117 rooms had a continuous-pressure monitoring device 25% had a discrepancy between smoke testing and continuous monitor Not associated with any particular type of device or manufacturer Discrepancies increased with increased verification w/smoke Recommend daily smoke test when room in use Pavelchak N, Cummings K, Stricof R et al. Infect Control Hosp Epidemiol 2001; 22(8):518–19

Smoke testing

Disruption of Ventilation Opening/closing windows or doors Movement of elevators Blocked air diffusers or exhaust grills Outdoor wind direction and speed Dirty filters Variable air volume (VAV) systems Changes in one area affect other areas

Ultraviolet Germicidal Irradiation (UVGI) Can be used as a supplement to ventilation Not a substitute for negative pressure Can substitute for HEPA filtration when recirculated into same AIIR Guidelines provide new emphasis on safety and maintenance Provide guidance on occupational exposure limits

CDC Guidelines - Respiratory Protection for Workers Determining need for a respiratory protection program for TB Suspect or confirmed TB patients Selection of respirators Fit testing Initial Periodic Annual training

Selection of Respirators Certified by CDC/NIOSH as a non-powered particulate filter respirator, including disposable respirators, or PAPRs with high efficiency filters Have the ability to adequately fit respirator wearers who are included in a respiratory-protection program Have the ability to fit the different facial sizes and characteristics of HCWs (This criterion can usually be met by making respirators available in different sizes and models.) Page 39

Fit Testing (Cut and Pasted) A fit test is used to determine which respirator fits the user adequately and to ensure that the user knows when the respirator fits properly. After a risk assessment is conducted to validate the need for respiratory protection, perform fit testing during the initial respiratory-protection program training and periodically thereafter in accordance with federal, state, and local regulations (http://www.osha.gov/SLTC/respiratory protection/index.html). Fit testing provides a means to determine which respirator model and size fits the wearer best and to confirm that the wearer can don the respirator properly to achieve a good fit. Periodic fit testing for respirators used in TB environments can serve as an effective training tool in conjunction with the content included in employee training and retraining. The frequency of periodic fit testing should be supplemented by the occurrence of 1) risk for transmission of M. tuberculosis, 2) facial features of the wearer, 3) medical condition that would affect respiratory function, 4) physical characteristics of respirator (despite the same model number), or 5) model or size of the assigned respirator (281). Page 39

Respiratory Protection for Visitors Visitors can use N-95’s – Why? Visitors may have much more intense and prolonged contact Minimizes confusion for employees and visitors No medical assessment or fit-testing is required for visitors Only necessary when mandated for workers OSHA standard Selecting a respirator with inherently good fit characteristics will benefit all

Note the Senator has his respirator on . . . They all have them around their necks The Senator also has his upside down!!! That’s why training is SO important!!!!

Depends on Facility Type And Specific Regulations Worker Screening Depends on Facility Type And Specific Regulations

TB Screening Prior to Employment Clinical signs and symptoms History of previous exposure, disease or treatment History of BCG, especially if born outside of the US Perform TB screening Evaluate based on results

Tuberculin Skin Test (TST) Intradermal (Mantoux) method 5 TU of PPD tuberculin Read by designated, trained personnel at 48-72 hours Read transverse diameter of induration Record mm of induration, not redness

Boosting Some people with TB infection may have a negative skin test when tested many years after infection The initial skin test may boost (stimulate) their ability to react to tuberculin Positive reactions on subsequent tests may be misinterpreted as new infection

Two-step Testing All newly employed HCWs with negative initial TST should be retested within 1-3 weeks Second reading should be recorded in mm induration This reading should serve as baseline

Tuberculin Screening: CDC vs. NYS CDC no longer recommends routine, periodic tuberculin skin testing ( or QFT) in low risk settings. [12/30/2005] NYSDOH still requires annual tuberculin screening in licensed healthcare facilities. May use Mantoux method tuberculin skin test or QuantiFERON TB Gold

QuantiFERON-TB Gold (QFT-G) December, 2004 FDA approval announced Whole blood assay Detects M. tuberculosis infection Detects immune responses to specific M. tb proteins

Advantages of QFT-G Higher specificity Not affected by prior exposure to BCG or most nontuberculous mycobacteria (exceptions: M. kansasii, M. marinum and M. szulgai ) Eliminates issues surrounding appropriate placement, tuberculin product, reading and interpretation Requires one visit, not multiple visits Results within 24 hours No need for 2-step baseline, does not induce boosting Can target follow-up resources on positives

Disadvantages of QFT-G Specimen must reach lab within 12 hours Reagents are more costly But, other costs need to be considered Results not directly comparable with TST HCWs move between different facilities Some may use QFT-G, others TST Implementation strategies may need to be developed Most labs are not offering QFT-G Not every laboratory will be able to reliably perform this test in a cost-effective manner

Disadvantages of TST Placement issues Reading issues Interpretation issues Elicits boosting Reagent issues Reproducibility issues Specificity poor

For more information on QuantiFERON-TB Gold…. Review CDC Guidelines on QuantiFERON-TB Gold http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5415a4.htm Review literature as it evolves Definitely more specific, may be more sensitive Although NYS regulations specify Mantoux method, QFT is acceptable alternative.

TB Prevention and Control in LTC Letter has been sent to long term care facilities http://www.health.state.ny.us/professionals/nursing_home_administrator/docs/dal_06-03_guidelines_for_tuberculosis_control.pdf Employee screening Baseline and annual Resident screening Baseline only No longer recommend routine, annual testing

Chest x-ray Examination After baseline chest radiograph, no need to repeat CXR unless signs or symptoms of TB disease develop or a clinician recommends a repeat chest radiograph.

CDC TB Guideline Reference CDC Guidelines for Preventing the Transmission of M. tb in Health-Care Settings, 2005 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm