1. Health Systems Strengthening: A Focus on Laboratories Wafaa El-Sadr, MD, MPH Track 1.0 Meeting Dar Es Salaam August 2009

2. Burden of Disease 2 Burden of Disease 2004, WHO

3. Leading Causes of Burden of Disease (DALYs in millions) GLOBAL BURDEN OF DISEASE Global Burden of Disease, WHO

4. nTraining & mentoring nAdherence & retention nLab systems nPharmacy systems nHMIS and M&E nLinkages & referrals nEquipment & supplies n Health policies n Strategic planning n Regulation / accreditation n Legislative frameworks “Collecting, pooling, and purchasing” Expanding financial resources for health Pre-paid risk pooling (e.g., mutuelles) Performance-based financing

5. Both HIV prevention and HIV treatment are chronic endeavors 5 Characteristics of HIV DiseaseRequirements Impact throughout lifecycleServices for adults (including pregnant women), infants, children, adolescents Asymptomatic periods, acute episodes of illness, chronic symptoms Health maintenance, continuity care, linkages Multiplicity of clinical & psychosocial needs Multidisciplinary teams, referral systems & partnerships Importance of adherence & retentionRelationship between patients & providers, outreach & tracking Need for clinical & laboratory monitoring, medications & other commodities Infrastructure, medical records/registers, laboratories, procurement systems Transmissible infectionCounseling, antenatal care, family planning and prevention methods

6. Health Systems in Crisis

7. ICAP In Africa

9. Number of sites Number of ICAP-supported sites by activity, March 2009 (n=839)

10. Proportion of ICAP-supported HIV care and treatment sites with access to laboratory assays (n=342) % sites

11. Proportion of ICAP-supported HIV sites with access to laboratory assays (n=336)

12. Approach to Lab Support Network approach –Standardized infrastructure and assays –Linkages: specimen transportation system –Capacity Number and skills of staff Training and Mentorship (laboratory & management) Integrate lab and clinical activities Strategic Planning

13. Laboratory Network

14. Tiered Laboratory Network Developing the lab network: define the number/level of labs in network –Based on # patients and geography of area define a standard minimum package for each tier: –Infrastructure and equipment –Testing menu for each level –Staffing –Training –SOPs, manuals and forms –Reagent/supply lists –Data management systems –QA/QC systems Lab support in not just about buying machines!

15. Infrastructure Enhancement

16. Standardized Renovations water and power supply work surface materials illumination of workspace equipment biosafety

17. TestReference LabProvincialDistrictHealth Center HIV SerologyEIA, Rapid Tests, WB EIA & Rapid TestsRapid Tests CD4 cell countFACSCaliburFACSCount FACSCount or Ref to Provincial LabRef to District Lab PCR /DBS for Infant DxRoche DNA PCRRefer to Ref Lab Viral LoadRoche RNA PCRRefer to Ref Lab Resistance TestingSelected sites/ReferralRefer to Ref Lab Chemistry Integra 400 Abbott c8000 Ortho-Clinical Vitros DT 60II; Visual BioMerioux Abbott c8000 Ortho-Clinical Vitros DT 60II; Visual BioMeriouxRoche Reflotron HematologyB. Coulter 5 diff B. Coulter 5 diff ; Sysmex K-21 (3 Diff)QBC Machine TBMicroscopy & CultureMicroscopy Syphilis TPHA, RPR TPHA, RPR, TPHA & RPRRPR OI Diagnosis Microscopy, Serology, culture, and PCR Microscopy & Serology Microscopy Parasitology Microscopy, Malaria smear UrinalysisTest Strip and ReaderStrip and ReaderTest Strip ICAP Lab Network: Standardized package by tier (Equipment listings should be considered as brand name equivalents and broadly representative of model, grade, and complexity.)

18. Goals of Clinical Systems Mentorship –Effective program implementation –High quality care –Sense of local ownership –Sustainability http://www.columbia-icap.org/

19. Goals of LSM Improve the quality of test results Build local capacity of lab systems Establish local ownership Integrate lab as part of clinical services

20. ICAP Lab indicator SOC

21. Shyira District Hospital, Rwanda SOC : All HIV-positive pregnant women should have CD4 testing done within first month of diagnosis

22. Laboratories: Serving Clinical Services Where is blood drawn? Where are assays done? How to transport specimens? How to transmit results? How to use results?

23. Where the test is done? ICAP-Ethiopia

24. Conclusions Enhancing laboratories is a clear contribution to health systems strengthening Laboratory support needs to conceptualize labs as part of the clinical services Laboratory support needs to also focus on durable effective systems responsive to patient needs Strong laboratory systems are critical to effective response to broad array of health threats

25. Vertical Funding Horizontal Implementation

26. Acknowledgements ICAP-NY Team Jessica Justman ICAP Lab Teamt –Amilcar Tanuri, Senior Regional Lab Advisor –Luis Felipe Gonzalaz, Regional Lab Advisor –Stephania Koblavi-Deme, Regional Lab Advisor –Allison Goldberg, ICAP-NY, GRA –Charon Gwynn, M&E Liaison for Lab Support ICAP in-country Lab Advisors –Rwanda Alaine Nyaruhirira –Cote D’Ivoire Dje Kouakou –Ethiopia Bereket Hailegiorgis –Kenya Kevin Omondi –South Africa Thabo Taleng –Tanzania Pierre Rugimbanya –Nigeria Juliet Iseniyi –Mozambique TBN