10 Years of Laboratory Capacity Building. September 6-11 th, 2015 Les Pensieres, Veyrier-du-Lac, France

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1 10 Years of Laboratory Capacity Building 6 th Advanced Course on Diagnostics September 6-11 th, 2015 Les Pensieres, Veyrier-du-Lac, France John N. Nkengasong, Ph.D Associate Director for Laboratory & Chief, International Laboratory Branch Division of Global HIV/AIDS Center for Global Health

2 Start with Conclusions - Resources matter - Coordination, partnerships, and relationships are key - Practical approaches to implement quality management are determinant - Global health development - not equity but driven by unknowns - Focus on known do nothing gaps

3 Decade of Increased Global Health Funding

4 Coordinate Efforts Through National Laboratory Strategic Plans to Develop Laboratory Networks

5 Development of National Laboratory Strategic Plan ( ) Mali Nigeria South Sudan Ethiopia Cameroon Uganda Kenya Rwanda DR Congo Tanzania Angola Zambia Mozambique Namibia Botswana Zimbabwe South Africa Lesotho Swaziland Partnerships and Coordination

6 Plan Improve Develop Quality Assurance Cycle Ensuring accurate patient results Corrective Actions Implement Monitor Practical Approaches for Continuous Quality Improvement: Embrace the Culture of Quality

7 Quality Matters: a Catalyst to a Tipping Point for Strengthening Laboratory Medicine? Insufficient Resources Under utilization of Laboratory Testing QUALITY MATTERS Unreliable Quality Results Clinician reticent attitude Less Optimal Laboratory Services Lack of Confidence

8 India s Story

9 Humble Beginning --- Before After Staining Area

10 The Journey Stepwise Approach (Genesis of SLIPTA and SLMTA) May 2008: NACO requested CDC to assess NRLs Develop Checklist Regional Workshops: Standardized assessor training and assessments (pre - to - post) Mentorship to labs (CDC, NACO, partners) July 2008: Initial NRL assessment First systematic assessment of HIV network Turning point for country ownership and action 1/13 NRLs scored > 80% standard

11 Systematic Approach Next Tier Level 2009: Initial SRL assessment two of 117 labs met 80% standard Response: TA strategy developed with increased commitment 2010: Re-assessment of NRLs One lab accredited 2011/2012: Re-assessment of SRLs

12 Number of Laboratories Achievements ISO Accreditation End of Year Accreditation Status March 2010 March March March March Present 18 additional Laboratories in accreditation cycle & will be accredited soon

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14 Share experiences and lessons learned Identify evidence based practices through consultative process Replicate and harmonize best practices

15 Vietnam Labs Accredited to International Standard TA Model Funding Only Bach Mai Hospital, Microbiology Lab National Pediatric Hospital, Hematology Laboratory HIV National Reference Laboratory National Pediatric Hospital, Biochemistry Laboratory HIV Regional Reference Laboratory Nat l TB Reference Lab: National Lung Hospital Microbiology Lab SLMTA-ISO TB Regional Reference Laboratory Phan Ngoc Thach Hospital Preventive Medicine Center-HCMC, Microbiology Lab Hai Duong Public Health Laboratory Children s Hospital Number 1, HCMC Children s Hospital Number 2, HCMC WHO HIV DR Pasteur Institute Nha Trang Hue Central Hospital HIV National Reference Laboratory HIV Regional Reference Laboratory SLMTA Labs Non-SLMTA Labs

16 Laboratories Accredited to International Standards in the Past 5 Years India (61) Bahamas Vietnam (10) Nigeria (1) Uganda (1) Kenya (4) Tanzania (6) Mozambique (1) Botswana (5) Zimbabwe (1) South Africa (1) SLMTA Labs Non-SLMTA Labs

17 Stepwise Laboratory Quality Improvement Process Towards Accreditation - SLIPTA Measures the level of quality using an ISO based audit checklist with 258 points Recognizes a lab s progression towards accreditation using a 0- to-5 star scale 4 Star 5 Star 2 Star 3 Star 95 % 1 Star % % 0 Star % % 17

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19 Spread of the SLMTA Program Guatemala Belize El Salvador Honduras Nicaragua Costa Rica Panama Colombia Peru Bahamas Jamaica Haiti Dominican Republic - St Kitts - Antigua - Dominica - St Lucia - St Vincent - Grenada Year when SLMTA was initiated: Sierra Leone Barbados Trinidad & Tobago Cote Ghana Suriname d Ivoire Nigeria Cameroon Democratic Republic of Congo Yao et al Angola Zambia Namibia South Africa Zimbabwe Botswana Ethiopia South Sudan Uganda Kenya Rwanda Burundi Tanzania Malawi Swaziland Lesotho Mozambique Vietnam Cambodia Total # countries 47 # labs enrolled 617 # people trained 1,923

20 Stars Baseline vs. Exit Audit Results (n=302) Baseline Exit 5 Stars 4 Stars 3 Stars 2 Stars 1 Star 0 Stars Average Score 39% 64% Note: Each square represents one laboratory 1 85% 0 30% Average Implementation Time = 16 months Source: Yao et al

21 Botswana Accredited Laboratories SLMTA Labs Non-SLMTA Labs

22 Nyangabgwe Referral Hospital Laboratory, Botswana

23 Tanzania Labs Accredited to International Standard Non-SLMTA Labs

24 Institute of Medicine Report on Evaluation Although challenges remain, the improvement of laboratories under PEPFAR support and guidance has been a signature achievement of the program ----During the committee s country visits, this was a theme emphasized with near universality

25 Strengthen Local and Regional Institutions

26 ASLM MISSION To advance professional laboratory medicine practice, science, systems and networks in Africa needed to support preventive medicine, quality care of patients and disease control through partnership with governments and relevant organizations. ADVANCING THE LABORATORY PROFESSION & NETWORK IN AFRICA

27 Quality Assurance and Proficiency testing

28 Disruptive Innovations Cheaper, Simpler, Reliable and More Convenient Laboratory Diagnostics and Services that meets the Needs of Public Health -----

29 Need for Reliable Point of Care Diagnostics

30 DTS PT Program DTS PT Panel Pack A set of DTS tubes with 5-6 coded specimens One vial of buffer (filtered PBS/Tween-20) Dropper pipette Instruction on how to rehydrate and test One blank report form All in a Ziplock bag with a label A1 to A6 Buffer

31 Malaria DTS

32 Syphilis DTS

33 Xpert MTB/RIF Proficiency Testing Panel Dried Tube Specimens (DTS) Based on HIV rapid test proficiency testing methodology Also used for viral load, syphilis, and malaria Advantages: Low biosafety requirements Specimens are stable at ambient temperature Developed for technology transfer to countries

34 Percentage Performances of Sites on HIV Proficiency Testing Improves Significantly Overtime VCT PITC Lab PMTCT 9,5 9,1 7,2 7,4 6,2 6,4 5,3 5,7 4,4 4,1 3,7 2,5 3 2,6 2,3 2,1 1,3 1,5 0,5 0,3 Round 7 Round 8 Round 9 Round 10 Round 11 Source: Kimani et al. Kenya

35 No. of testing sites PT Participation and Passing Rate, by Country Number of HIV rapid testing sites Number of sites passing PT (last round) Number of sites enrolled in PT program

36 Quality Assurance of Diagnostics for Point-of-Care Testing ASLM WHO AFRO CDC LSHTM Series of Regional Consultations South Africa East Africa West Africa 1.QA systems (regional and national) for CD4, EID and VL POCT 2.National QA models that can be adapted by countries 3.QA Toolkit as companion to the WHO CDC Handbook and SPI POCT Checklist

37 % Diagnosed % Linked to care and ART % VL suppressed Future: Improving the Diagnostic Cascade for Better Patient Outcomes Do Nothing Know Gaps

38 Making Diagnostics Count: Role of Clinicians Even when Xpert MTB/RIF is available, many patients treated empirically TB Diagnosis Xpert Clinical Xpert or AFB AFB Source: Cohen et al. JAIDS. 2014; 67(3).

39 Percent Xpert MTB/RIF Impact 49% increase in proportion with positive index test result No significant effect on: 6 month mortality Initial loss to follow-up TB treatment initiation within 6 months p = 0.05* Xpert Microscopy p = 0.61 p = 0.91 Index Test Positive Mortality Risk Initial Loss to Follow-up *p-values for adjusted ratio measures displayed p = 0.79 Treated for TB Mortality strongly associated with HIV-positivity in the absence of ART and unknown HIV status Source: Churchyard et al. Lancet Global Health

40 Even when routine viral load monitoring was in place, around 44% of patients with confirmed virological failure were not switched 22% of patients under routine viral load monitoring and 30% of those receiving targeted viral load monitoring switched regimen without any evidence of virological failure. Source:

41 Sensitive and Rapid Assays are Necessary but not Sufficient Symptom Identification Specimen Collection Specimen Referral/Transport Key opportunities for improving laboratory systems and linkage to treatment Diagnostic Testing Result Reporting TB and HIV Treatment Initiation Retention in Care and Treatment

42 Conclude with Start - Resources matter - Coordination, partnerships, and relationships are key - Practical approaches to implement quality management determinant - Global health development not equity but driven by unknowns - Focus on known do nothing gaps

43 Conclusions And Key Lessons Learned 1. Leadership and Commitment from Ministry and Partners 2. Strategic and Genuine Partnerships and Relationships

44 Thanks! The opinions in this presentation are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention.