Dr Mario Raviglione Director Stop TB Department World Health Organization

1. Retooling Task Force Meeting 15-16 January 2008 Role of WHO in promoting change and retooling Lesotho case study Dr Mario RaviglioneDirector Stop TB Department World Health Organization

2. WHO's functions in retooling – Two phases • Norms, standards and policies • From research and evidence into policy • Strategies, guidance towards implementation • From policy into practice

3. WHO's functions in retooling – Phase 1: policy development (1) • WHO Strategic and Technical Advisory Group (STAG-TB) • Before STAG, expert technical consultations • Selected STAG members and other experts • Evidence varies: new published, "grey" research or reviews; proof of principle; large-scale field trials • Recommendations made to WHO • Based on findings/recommendations, WHO prepares draft policies/guidelines for STAG review • STAG endorses • WHO issues final policies/guidelines

4. WHO's functions in retooling – Phase 1: policy development (2) • WHO recommendations disseminated via WHO channels to Member States (incl. WHA), via website, listserves etc. • WHO recommendations disseminated also to Global Fund, UNITAID, World Bank, other agencies and donors • New technology from research also needs review by national regulatory agencies and WHO may help • Operational research to further assess needed adaptations in different settings and scale-up issues • Iteration/revision of guidelines as needed

5. WHO's functions in retooling – Phase 2: from policy to practice • Production of Guidelines • Technical assistance to countries • Adaptation of guidelines • Human resource assessment • Capacity building and training tools • Adaptation of M&E • Operational research and guideline revision • Support for scale-up, resource mobilization, and partner coordination

6. WHO's functions in retooling • Example of liquid culture • Key point: focus is on technology, not on product!!

7. Example of liquid culturePhase 1: policy development • Process • Identification of need • Review of literature on test performance • Demonstration projects in different epidemiological and resource settings • Expert group meeting to review field data • Expert report used to prepare STAG proposal • STAG endorsement • WHO policy formulation and dissemination • Development of implementation checklist (RTF)

8. Example of liquid cultureFrom Phase 1 to Phase 2 • STAG recommendation on use of liquid culture, June 2007 • WHO policy announced, October 2007 • In parallel, implementation plan initiated with FIND, PIH/OSI working with MoH in Lesotho • Pilot country, small, resources available, readiness • Development of performance indicators • Implementation of external quality assurance programme with WHO Supranational Reference Laboratory, SAMRC • Appointment of country WHO Medical Officer

9. Example of liquid culture policy: Phase 2 (1) • Establishment of Central TB Laboratory, • Nov 2006 – November 2007 • Renovation & upgrade of laboratory and streamline of work-flow • Hire of additional technicians to conduct culture and DST • Installation of equipment procured already under GFATM • Use of external ‘Technical Assistance’ to upgrade and modernize the CTL • Securing of sufficient funding to avoid shortage of consumables and reagents • Country-widetraining and EQA for sputum microscopy • Phased approach: • Establish quality assured solid culture and DST • Establish liquid culture & DST, rapid speciation method • Implement rapid molecular methods to diagnose MDR-TB • Hire of consultant to reactivate the CTL as per established norms

10. Example of liquid culture policy: Phase 2 (2) • Working in partnership • FIND appointed a consultant for on-site supervision and technical expertise • FIND also provided MGIT culture and DST system, and Capilia TB • MoH&SW and PIH provided all logistics and financial support • WHO supported • SAMRC provided external quality assurance (DST proficiency testing)

11. Renovation of Central TB Laboratory, Maseru, Lesotho 3.25m 3.75m Cntfg BSC BSC Staining area Neg. Air Pressure Storage of chemicals, stains & inspissator MGIT 960, Fridge & Incubator 2.5 m 3 3m 6 BSC Culture room A/C Culture room 4 Autoclave Microscopy, centrifuge, Incubator Media room Insspi Sterilization room 2m Refrigerator 5 2 BSC Sink Sink Toilet Toilet Office of Microbiologist 7 Specimen receipt & Microscopy room 1 Hand-wash Entry 28thMay to 22ndJune AFTER Renovation BEFORE Renovation Primarily, smear microscopy Laboratory has been upgraded into Culture & DST setup for immediate needs

12. Safety cabinets Culture room Before After Anteroom

13. Office room shifted and converted into Microscopy room-work in progress

14. Glass partitioning & creation of a media room

15. Painting work & creation of anteroom

16. Microscopy room converted to sterilization room with on-site autoclave Before After After

17. Negative air pressure facility & monitoring HEPA Exhaust Magnehelic gauge HEPA In-flow

18. Example of liquid culture policy • Lessons learnt in Lesotho • Benefit of working in partnerships • Rapid introduction of new technology feasible in the poorest setting • Laboratory strengthening shown to be affordable

19. Example of liquid culture policy • Diagnostics retooling challenges • Extent of laboratory scale-up • Human resource mobilization • Laboratory biosafety • Regular laboratory quality assurance • Regulatory agency on Diagnostics • Laboratory recording and reporting systems linked with NTP • Sustainability • Funding

20. WHO's functions in retooling • Retooling of existing technologies • Examples: • Reduction in number of smears for case detection • Revised case definition (one positive smear)

21. Retooling Task Force Meeting 15-16 January 2008 Many thanks for listening Many thanks to Karin Weyer, Diana Weil, Véronique Vincent, Rachel Bauquerez who helped prepare this presentation. Many thanks to FIND and Paramasivan for providing photos and part of the text Dr Mario RaviglioneDirector Stop TB Department World Health Organization