Dr Mario RaviglioneDirector

Stop TB DepartmentWorld Health Organization

Role of WHO inpromoting change and retooling

Lesotho case study

Retooling Task Force Meeting15-16 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 WHO3. Based on findings/recommendations, WHO prepares

draft policies/guidelines for STAG review 4. STAG endorses5. 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 culturePhase 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 cultureFrom Phase 1 to Phase 2

• Establishment of Central TB Laboratory, Nov 2006 – November 2007

1. 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)

04/10/23

Renovation of Central TB Laboratory, Maseru, Lesotho

BEFORE Renovation AFTER Renovation

Office of Microbiologist

Toilet

Microscopy, centrifuge, Incubator

Storage of chemicals, stains

& inspissator

Staining areaBSC

Refrigerator

Culture room

28thMay to 22ndJune

3m

MGIT 960, Fridge & Incubator

BSC

A/CBSC

Cntfg

3

5

2.5 m

2m

Neg. Air Pressure

Specimen receipt & Microscopy room

Sink

Sterilization room

Autoclave4

1

6

Sink

3.75m 3.25m

Culture room

7

Hand-wash

Toilet

InsspiMedia room

BSC2

Entry

Primarily, smear microscopy Laboratory has been upgraded into Culture & DST setup for immediate needs

Before After

Anteroom

Safety cabinets Culture 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 roomwith on-site autoclave

After

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 RaviglioneDirector

Stop TB DepartmentWorld 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 Meeting15-16 January 2008