1. WHO Policy on TB Infection Control in Healthcare Facilities, Congregate Settings and Households Michele L. Pearson, MD International Research and Programs Branch Division of TB Elimination New

2. Outline Global global TB trends and healthcare- associated TB transmission Process/methods used to develop WHO TB IC policy Summary of new TB IC recommendations and policy changes since previous document Recommended practices for biosafety

3. Rationale of TB IC Co-existing HIV pandemic Emergence of MDR/XDR-TB strains Documented TB transmission and outbreaks in healthcare settings Implementation of recommended TB infection control interventions terminated or reduced facility TB transmission

5. Wells, C et al. JID 2007;196:S86–S107

6. Importance of TB Infection Control Subcomponent of WHO’s updated Stop TB Strategy, contributing to health system strengthening Element of WHO’s 12 collaborative activities for TB and HIV control One of WHO’s “Three I’s for HIV/TB” Essential component of sound HIV control programs in countries with high HIV prevalence

7. Status of Global TB IC Efforts, 2008 66% (131/199) of WHO Member States reported having TB IC plan None reported data on implementation

8. WHO Policy on TB IC Objective: Provide member States with guidance on how to reduce TB transmission in healthcare facilities and how to prioritize TB IC measures Target audience: –Policy makers (national and subnational) –Managers of TB and HIV/AIDS programs –IC and quality assurance programs/personnel –Occupational health –Documented TB transmission and outbreaks in healthcare settings

9. What’s New Guidance on how to prioritize TB IC measures at National level, including national managerial activities Update on facility-level measures Considers facility-level managerial activities as a separate element, rather than a component of administrative controls Emphasis on appropriate administrative and environmental controls and personal protective equipment

10. What’s New? Special focus on building design and use of space Increased emphasis on certain activities: –Integration of TB IC with other healthcare system efforts –Greater involvement of civil society in design, development, implementation, and monitoring and evaluation of TB IC –Greater emphasis on selective administrative controls (e.g., reduction in time spent in healthcare facilities) –Provision of HIV prevention, treatment and care services for health workers

11. Policy Formulation Process

12. Systematic review panel reviewed science on efficacy and effectiveness of TB IC measures Collaborative effort of WHO Department for Epidemic and Pandemic Alert and Response, HIV/AIDS Department and the Patient Safety Programme Draft reviewed by various stakeholders, including systematic review panel, WHO regional office staff, TB IC sub-group of WHO TB/HIV working group, implementation working group of Stop TB Partnership Recommendations expected to remain valid until 2013

13. Recommendation Rankings Strong--desirable effects outweigh undesirable effects Conditional—desirable effects probably outweigh undesirable effects) Recommendations also informed by expert opinion, climatic, cultural, cost and programmatic factors

14. Factors that Influence Recommendation Rankings Quality of evidence Benefits Values and preferences Costs Feasibility

15. Other Outcomes of Systematic Review Identified gaps in science on efficacy and effectiveness of TB IC measures Need for scale-up in TB IC research Highlighted importance of simple indicators to monitor success in implementing TB IC programs/activities

16. WHO TB IC Policy for Healthcare Settings Policy complements: –General infection control efforts –Airborne infection control efforts Describes how to prioritize TB IC measures based on burdens of TB, HIV and MDR-TB Does not provide recommendations on laboratory biosafety Stresses importance of sustained political, institutional, and financial commitment and multidisciplinary involvement

17. National and Subnational Activities

18. National and Subnational TB IC Activities Describes six activities that provide the managerial framework for implementation of TB IC in healthcare settings Targeted to policy makers at national and subnational levels

19. National and Subnational TB IC Activities 1.Identify and strengthen a coordinating body for TB IC and develop comprehensive budgeted plan that includes necessary human resources for program implementation 2.Ensure appropriate facility design, construction, renovation and use 3.Conduct surveillance of TB among HCWs and conduct assessments at all levels of the healthcare delivery system 4.Address TB IC advocacy, communication, social mobilization (ACSM), including civil society engagement 5.Monitor and evaluate TB IC measures 6.Enable and conduct operational research

20. Reducing TB transmission in health-care facilities

21. Facility-level TB IC Measures Managerial Activities (Facility-level) –Identify and strengthen local coordinating bodies for TB IC and develop facility implementation plan (including human resources, and policies and procedures to ensure proper implementation of controls) –Conduct on-site surveillance of HCWs for TB disease and assess facility –Rethink use of available spaces and consider renovation of existing facilities or construction of new ones to optimize implementation of controls –Address advocacy, communication and social mobilization (ACSM) for HCWs, patients and visitors –Monitor and evaluate set of TB IC measures –Participate in research efforts

22. Facility-level TB IC Measures Administrative controls –Prompt detection of patients w/ TB sxs (triage), separation of infectious patients, cough etiquette and respiratory hygiene, minimize time in facility, decrease diagnostic delays (use of rapid diagnostics, decrease time for sputum testing and culture), prompt treatment –Package of prevention and care interventions for HCWs including HIV prevention, ART and IPT for HIV-positive HCWs Environmental controls –Use ventilation systems –Use UV germicidal irradiation (UVGI) fixtures, at least when adequate ventilation can not be achieved Personal protective equipment –Use particulate respirators

23. Administrative Controls: Strength of recommendation and Evidence Quality Promptly identify patients w/ TB symptoms STRONGLOW Separate infectious patients STRONGLOWTriage is crucial and TB suspects should be fast- tracked Control spread of pathogens (cough etiquette and respiratory hygiene) STRONGLOWMinimizes exposure of non-infected patients to infectious patients. Should be done irrespective of likely or known drug susceptibility patter Minimize time spent in facility STRONGLOWManage patients as outpatients where possible Recommendation Evidence Quality

24. Administrative Controls: Strength of recommendation and Evidence Quality Provide package of interventions for HCWs, including HIV prevention, ART, and IPT STRONG in HIV prevalence HIV areas CONDITIONAL in Low prevalence HIV areas HIGHAll HCWs should be given appropriate info and encouraged to undergo HIV testing and counseling. HIV-positive HCWs should not work with know or suspected TB patients and should be reassigned to areas/duties that pose lower risk of TB exposure. HIV-positive HCWs should receive regular screening for active TB and access to ART. Recommendation Evidence Quality

25. Environmental Controls: Strength of recommendation and Evidence Quality Use ventilation systems STRONGLOW Natural ventilationCONDITIONALLOWIn existing facilities, depending on climatic conditions, maximize use natural ventilation before considering other ventilation systems. Mechanical ventilation CONDITIONALLOWUseful when natural ventilation alone cannot provide sufficient rates. May be advisable in settings where natural or mixed-mode ventilation systems are inadequate given local conditions (e.g., building structure, climate, regulations, outdoor air-quality, costs UVGICONDITIONALLOWAdjunct to, not replacement for, ventilation. Upper UVGI devices potential hazardous if not properly designed, installed, used and maintained. Recommendation Evidence Quality

26. Personal Protective Equipment: Strength of recommendation and Evidence Quality Particulate respirators STRONG (in particular for MDR-TB and high- risk procedures) LOWShould be accompanied by a comprehensive training program for HCWs and, if possible, fit-testing. Recommendation Evidence Quality

27. Prioritizing Measures and Setting Targets for TB IC

28. Prioritization of TB IC Measures 1.Identify and strengthen a coordinating body for TB IC and develop comprehensive budgeted plan that includes necessary human resources for program implementation 2.Ensure appropriate facility design, construction, renovation and use 3.Conduct surveillance of TB among HCWs and conduct assessments at all levels of the healthcare delivery system 4.Address TB IC advocacy, communication, social mobilization (ACSM), including civil society engagement 5.Monitor and evaluate TB IC measures 6.Enable and conduct operational research

29. Suggested targets: Global-level implementation of TB IC By 2102 50% of countries have: National TB IC plan National surveillance of TB disease among HCWs TB IC assessments of major healthcare-facilities and congregate setting Reports on TB IC implementation By 2013 ALL countries: National TB IC plan National surveillance of TB disease among HCWs TB IC assessments of major healthcare-facilities and congregate setting Reports on TB IC implementation

30. Summary TB transmission in healthcare settings poses risk to patients and HCWs and undermines global TB control efforts WHO TB IC policy –provided evidence-based, cost-effective, feasible recommendations for TB IC –identified gaps in science on efficacy and effectiveness of TB IC measures –highlighted need for scale-up in TB IC research –stressed importance of simple indicators to monitor success in implementing TB IC programs/activities –prioritized TB IC efforts

31. Research Gaps Administrative controls –Impact of cough etiquette/respiratory hygiene on TB transmission –Rapid diagnostics to reduce time to diagnosis –Screening criteria for triaging TB suspects in different settings based on TB, HIV and MDR/XDR-TB burdens –Effect of physical separation based on smear results, HIV status and drug-susceptibility pattern –Methods for screening HCWs –Duration of preventive therapy

32. Research Gaps Environmental controls –Effectiveness of ventilation systems in different settings and climates and by design –Efficacy and effectiveness of UVGI Personal Protective Equipment –Impact of fit-testing on effectiveness –Re-use guidance

33. WHO Policy on TB Infection Control in Healthcare Facilities, Congregate Settings and Households

34. Muchas Gracias! mpearson@cdc.gov