Disclosure. Objectives

Transcription

1 Breaking the Chain of TB Airborne Isolation Regina McDade EdD, MPH, BSN, RN TB Clinical Care Coordinator Jackson Health System Department of Infection Prevention and Control David Ashkin, M.D. FCCP Medical Director, TB Program, Florida Department of Health Adjunct Assistant Professor, University of Florida College of Medicine Visiting Assistant Professor, Division of Pulmonary and Critical Care Medicine, University of Miami School of Medicine Co-Principal Investigator, Southeast National TB Center Disclosure I do not have (nor does any immediate family member have) a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation Objectives At the conclusion of the lecture, the participant will: 1. Understand the pathogenesis and epidemiology of TB in the US and Florida 2. Be familiar with new Recommendations concerning airborne isolation utilizing molecular diagnostic techniques 3. Be familiar with the impact that the new airborne isolation protocols have had at Jackson Memorial Hospital in Miami 1

2 TUBERCULOSIS GLOBAL USA Infected Cases 1.7 Billion 10 million (33% Population) (4% Population) Case Incidence Million/yr ~10,000/yr Case Prevalence Million 17 thousand Deaths 1.8 Million/yr 1,000-2,000/ 2,000/yr MDR (XDR) Up to 28% <1% (Former USSR, Ecuador, DR) Tuberculosis Rates by U.S. State United States, 2016* * Provisional National TB Surveillance System data as of February 17, Reported TB Cases United States, ,000 25,000 20,000 15,000 10,000 5, Data 9,287 Cases Rate 2.9/100, CDC.GovData are updated as of 2/17/17 and are provisional 2

3 1600 Tuberculosis Cases Florida, Number of Cases Year Sources: TIMS ( ) and HMS ( ) Tuberculosis Case Rates* Florida, Rate per 100,000 population Year Sources: TIMS ( ) and HMS ( ) Population estimates from Florida CHARTS. *2016 rate provisional and will become final when 2016 population is final. Data as of2/17/17 Florida DOH 4/3/17 3

4 Number of Cases TB Cases Among Foreign-born Persons Florida, % 62% 59% 56% 54% 49% 50% 50% 50% 46% 47% 47% 48% 44% 45% 42% 39% 36% 30% 31% 70% 60% 50% 40% 30% 20% 10% Percentage of Total Cases Year Total Cases Percentage of Total Cases 0% Sources: TIMS ( ) and HMS ( ) U.S. Born/Foreign Born TB among the highest morbidity counties, 2015 Florida DOH 4/25/16 Mycobacterium tuberculosis Mainly airborne disease caused by the bacterium Mycobacterium tuberculosis (M. tb) M. tbcomplex (M. ( tb, M. bovis,, M. africanum,, M. microti, M. canetti,, M. caprae,, M. pinnipedii,, and M. mungi) ) can cause TB disease Majority of TB cases caused by M. tb M. tb organisms also called tubercle bacilli 4

5 Transmission of Tuberculosis Factors Associated with Transmission Person factors The infectiousness of the presenting case Was the Person Able to Transmit Infection Contact Investigation Results Surrogate Markers Cough, AFB Smear, Cavities on CXR, PCR (+) New FDA indications for GenExpertto remove pts from AII Time factors The duration and frequency of exposure Place factors The characteristics of the environment 5

6 Pathogenesis of Tuberculosis Disease Progression Progression from infection to disease caused by an inability to contain infection 5-10% of all HIV(-) will progress from infection to disease Up to 8% per year of TST(+), HIV(+) patients will progress from infection to disease The average patient with active TB infects 30 other individuals Progression from Infection to Disease is Increased by... HIV infection X-ray evidence of old, untreated TB Substance abuse, injecting drug use Silicosis, diabetes Certain therapies Certain cancers Underweight by 10% or more Recent infection with M. tuberculosis 6

7 Diagnosis of Active TB Disease Key: THINK TB DIAGNOSIS OF TB-THINK TB!!!! Signs and Symptoms of TB Disease When you have a patient with epidemiologic risk factors (eg eghx hxof being born or lived in area with high rate of TB, congregate living settings, immunosuppression) and have symptoms of: Often of long duration General Fatigue, malaise, weight loss, fever, night sweats Pulmonary Prolonged cough, coughing up blood Extrapulmonary Depends on site 7

8 TST in Four Hospitals with MDR-TB Outbreak TESTED CONVERSION PERCENT MDR-TB in Healthcare Workers 11 were HIV-positive 8 were HIV-negative 9 have died 7 were HIV-positive 6 deaths related to MDR-TB 2 were HIV-positive deaths due to cancer and drug overdose Median Age 37 8

9 Negative air pressure is required for patient respiratory isolation rooms. It is created when the flow of air coming into the room from the regular source (blue)is less than the flow outward through vents and ducts (red).this allows air to come in from the corridor (purple). In-flow greater than outflow (not shown) creates positive pressure, which allows air to escape from the isolation room, increasing the danger of spread of infection Infection Control Think TB, isolate, and start meds Six to eight air exchanges/hour Negative pressure Doors closed All entering room wear N95 mask Traditionallykeep in isolation until three negative smears, If confirmed active disease, on medications for 2 weeks, responding clinically and 3 negative smears Problems with Isolation Patients are kept on average 5-7 days in isolation for TB Limited number of AII rooms in most facilities A systemic review showed patients in isolation tend to: Be seen less by HCWs Have an 8 fold increase in adverse effects Have a negative perspective of their care* Delay in getting the proper procedure performed Most people admitted into isolation DO NOT HAVE TB *Abad et. al. J of Hosp Infection 2010:97 9

10 Infectiousness of TB Not all patients with active TB are contagious Only about 20-50% of patients with TB are thought to be able to transmit disease (1-3) Those that are contagious can and at times do infect a lot of individuals- super transmitters Need to identify those that are contagious especially in congregate setting where the spread of TB may be even greater given the environment (especially in hospitals or other environments where there are immunosuppressed individuals) 1 Jones-Lopez et al AJRCCM 2013: Snider et al ARRD 1985:325 3 Riley et al ARRD 1962:511 Likelihood of Infectiousness Probably infectious Positive sputum smears with viable AFB Presence or induction of coughing Not treated or recently started Poor clinical or bacteriologic response to prescription Not infectious Receiving effective therapy and responding Three daily negative sputums Removing Patients from AII Traditionally used 3 sputum smears, at least one collected in the early morning Recommendation of 3 negative smears to remove from isolation not based on performance studiesbut historical data on risk of transmission from smear negative cases (30-50% of positive PPDs among smear (+) vs ~5% among smear (-)) as well as studies showing sensitivity of smears to diagnose TB (~50-60%) 1 1 Sepkowitz CID 1996:23:

11 FDA Approval of GenExpert for AII In February 2015, the U.S. Food & Drug Administration (FDA) approved a change in the package insert for the Xpertto reflect expanded claims related to AII. According to this change, negative results using this assay on either one or two sputum specimens can be used as an alternativeto examination of serial acid-fast stained sputum smears to aid in the decision to discontinue AII for patients with suspected pulmonary TB Its ability to detect other organisms rapidly in a Point of Care (POC) manner with minimal processing will give it greater penetration into the community making it more available especially if there was a wider application for this test for TB (eg AFB Airborne Isolation Decisions) 11

12 Specimen Collection Sputum quality is critical both for the diagnosis of pulmonary TB and for the performance of this assay. Sputum may be spontaneously expectorated after deep coughing, or induced following facility-approved procedures for sputum induction with deep inhalation of aerosolized saline and deep coughing to generate sputum. This often requires focused instruction and/or coaching of the patient by the respiratory therapist, nurse, or physician supervising the sputum collection. Specimen Collection At least 3 good quality sputum specimens should be obtained at least 8 hours apart (one of these obtained in the early morning, on rising) for AFB smear and culture. AFB smear and culture must be performed for growth detection/identification of M. tuberculosis complex, for antimicrobial susceptibility testing, for genotyping and to track response to treatment. When to Remove A Patient (With Medium to High Suspicion of TB) From AII If have 2 negative NAAs (eggenexpertor any NAA test that has been validated) and not high suspicion for TB Studies showing savings of $11,466/patient placed in AII when using this protocol (Cowan et. al. CID 2017;64(4):482 9) If high suspicion of TB (egnaa (+), Culture (+), Cavitary Disease on CXR) On TB meds for 2 weeks, known to be susceptible to rifampin, 3 negative AFB smears and clinically responding 12

13 TB Infection Control in the Home Patients can be sent home while still infectious if A follow-up plan has been made Patient is on standard treatment and DOT arranged No very young (under 5 years) or immunocompromised persons in household Patient willing to refrain from travel outside the home except for health-care visits Directly Observed Therapy (DOT) Health-care worker watches patient swallow each dose DOT is preferred management strategy for all patients Can reduce acquired drug resistance, treatment failure, and relapse Nearly all regimens can be intermittent if given as DOT DOT reduces total number of doses and encounters For drug-resistant resistant TB, use daily regimen and DOT Jackson Health System Experience with Change in Practice Using GeneXpert Regina McDade EdD, MPH, BSN, RN Jackson Memorial Hospital Department of Infection Prevention and Control 13

14 Background Current practice to rule out Tuberculosis (TB) and discontinue Airborne Infection Isolation (AII) requires three Acid Fast Bacilli (AFB) smear & culture, collected 8-24 hours apart, induced sputum as needed, with one early morning specimen. The process to rule out TB length of stay (LOS) can take from 4-7 days (Harmon & Roche, 1995). This process may lead unnecessary admissions and use of limited AII rooms, contribute to delayed diagnostic work up, and medical management for patients. A recent change in rule out TB practice initiated in September 2016 consists of an Information Technology (IT) created order bundle (RO TB Powerplan), which includes automatic order for AII, Respiratory Therapy to induce sputum, two AFB smears, cultures collected at least 8 hours apart, and two GeneXpert test. Change in Practice Meetings held with Infection Prevention & Control, Infectious Disease, Pulmonary, Microbiology Lab, IT, Nursing, Respiratory Therapy, and Department of Health TB Program Microbiology lab processes twice daily, Mon-Sun A.I.I. Policy change presented to Infection Control Committee, voted and approved IT order bundle A.I.I. Order sputum for AFB smear, culture, and GeneXpert X 2 Respiratory Therapy induce sputum RO TB Pulmonary TB AFB Powerplan went live on September 26, 2016 Electronic notification to Jackson Health System, including medical staff Jackson Health System Infection Control Committee RO Pulmonary TB AFB New Plan for TB can be found by searching TB, AFB, Pulmonary This plan can be found by searching using TB, AFB, Pulmonary or RO. All lab orders are required RO Pulmonary TB AFB Bronchoscopy Orders are linked. Choosing Mycobacterium Tuberculosis PCR will cause the Culture Acid Fast Bacilli order to be checked as well. 14

15 Case Presentation Inpatient A 60 year old Haitian female presented with a cough for 8 days and night sweats. Reported that at age 17 she was treated for TB in Haiti for 1 year, medication regimen unknown, physician told her she was cleared of disease. PMH: Hypertension, Hypothyroidism, Hyperlipidemia, Polymyalgia Rheumatica (diagnosed 1 year, on steroid therapy). Social History: Moved to US from Haiti 13 years ago. Lives with adult son and employed as a housekeeper. Abnormal CXR Orders for A.I.I., Sputum for AFB smear and culture X 3, culture (current practice) Sputum for AFB smear, culture and GenXpert X 2 ordered (change in practice) 1 st sputum AFB smear positive, GenXpert MTB complex not detected 2 nd sputum AFB smear positive, GenXpert MTB complex not detected A.I.I. discontinued Mycobacterium Fortuitum identified Case Presentation Correctional Health A 62 year old male inmate with cough for 2 weeks. Denies fever, night sweats, weight loss, other TB symptoms Abnormal CXR PMH: Arrest date 4/29/16, TST performed was positive. History of positive TST 8 years ago and stated he was treated with INH & Vit B6 while in prison. Admitted to A.I.I. cell to rule out TB Physician ordered two induced sputum for AFB smear, culture and GenXpert Specimen transported to JMH Microbiology lab 1 st sputum AFB smear negative- MTB complex not detected 2 nd sputum AFB smear negative- MTB complex not detected A.I.I. Discontinued Negative AFB cultures 15

16 Results Jackson Health System Average Length of Stay JHS 2015 JHS Alos Result (cont d) Preliminary data show a reduction of five days in overall hospital LOS since the rule out TB Powerplan was initiated. A larger scale study will be conducted to attempt to replicate the findings of this small scale study and evaluate the impact of this change in practice, appropriate use of AII rooms, LOS in AII rooms, TB exposure incidents, employee TB skin test conversions, frequency of GeneXpert use, avoidable ER admissions, and cost savings. Infection-Control Surveillance TB Control Pager Staff education Baseline employee TST testing Serial Employee TST testing based on risk assessment Serial screening for signs or symptoms of TB Respiratory Protection Program Biannual TB Control/ Employee Health Office Report to Infection Control Committee 16

17 Evaluation Appropriate A.I.I. bed utilization Decrease ER admission Decrease LOS Cost Effective Continue to monitor TB exposure incidents Continue to monitor employee TST Conversions Large scale study Summary and Key Learning Points Change in practice contributed to decreased length of stay in AII and potential for healthcare cost savings AII isolation is difficult for staff, patient and family Multidisciplinary team process effective Education and staff support (TB Control pager 24 hours/7 days coverage) Questions 17

18 References Centers for Disease Control and Prevention. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Healthcare Settings, MMWR 2005; 54(No. RR-17) Harmon, J. & Roche, J (1995). Development of a research-based protocol to rule out tuberculosis by means of continuous quality improvement techniques, American Journal of Infection Control 23(5), National Tuberculosis Controllers Association (2016). Consensus Statement on the use of Cepheid Xpert MTB/RIF Assay in Making Decisions to Discontinue Airborne Infection Isolation in Healthcare Settings, Atlanta, GA Take Home Points Molecular Diagnostic Techniques may improve our ability to remove patients from TB Airborne Infection Isolation (AII) in a more rapid and efficient manner May lead to significant cost savings More efficient use of limited AII rooms Patients diagnosed with TB may be sent home (if cleared by the Public Health Department) prior to being considered non infectious Think TB in any patient with risk factors for TB exposure who presents with prolonged symptoms c/w TB (egcough, fever, weight loss, hemoptysis)-place in AII and obtain CXR SNTC TB Hotline TB-INFO 18