Dr Mario Raviglione Director Stop TB Department World Health Organization Role of WHO in promoting change and retooling Lesotho case study Retooling Task Force Meeting January 2008

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

WHO's functions in retooling – Phase 1: policy development (1) 1.WHO Strategic and Technical Advisory Group (STAG- TB) 2.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 3.Based on findings/recommendations, WHO prepares draft policies/guidelines for STAG review 4.STAG endorses 5.WHO issues final policies/guidelines

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

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

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

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) Example of liquid culture Phase 1: policy development

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 Example of liquid culture From Phase 1 to Phase 2

Establishment of Central TB Laboratory, Nov 2006 – November Renovation & upgrade of laboratory and streamline of work-flow 2.Hire of additional technicians to conduct culture and DST 3.Installation of equipment procured already under GFATM 4.Use of external Technical Assistance to upgrade and modernize the CTL 5.Securing of sufficient funding to avoid shortage of consumables and reagents 6.Country-wide training and EQA for sputum microscopy 7.Phased approach: 1.Establish quality assured solid culture and DST 2.Establish liquid culture & DST, rapid speciation method 3.Implement rapid molecular methods to diagnose MDR-TB 8.Hire of consultant to reactivate the CTL as per established norms Example of liquid culture policy: Phase 2 (1)

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) Example of liquid culture policy: Phase 2 (2)

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

Before After Anteroom Safety cabinetsCulture room

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

Glass partitioning & creation of a media room

Painting work & creation of anteroom

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

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

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 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 Example of liquid culture policy

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

Dr Mario Raviglione Director Stop TB Department World Health Organization 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 Retooling Task Force Meeting January 2008