1. Existing Challenges – POC Introduction Lab Technical Working Group Jason Williams, Principal Laboratory Advisor, SCMS January 20-21, 2013

2. PEPFAR Implementing Partner Overview Procurement perspective Continuum of impact Current CD4 situation Existing POC challenges Coordinated strategic response 2

3. PEPFAR Implementing Partner Procurement perspective Overarching challenges: Limited stakeholder coordination and communication regarding optimal use of diagnostic products Limited strategic and long term planning for the integration of new POC products coming to the market place Limited use of validated or accurate estimates of demand to inform deployment and work flow integration 3

4. PEPFAR Implementing Partner Continuum of impact Harmonized Lab Network Commodity Quantification Instrument Coverage Instrument Downtime ForecastPlanningProcurementDistribution Service Delivery Point Quality, Policy, & GuidelinesHealth System StrengtheningTrends, Models & Regulation Market Dynamics POC Integration Emerging Technologies Instrument validations Global Donors Ministry of Health Health Service Network Manufacturers Vendors Regulatory Agencies Supply Chain Optimization Stakeholders

5. PEPFAR Implementing Partner PFSCM spend on laboratory commodities delivered through June 2012

6. PEPFAR Implementing Partner Optimization to reduce CD4 costs Optimizing laboratory procurement Selecting and procuring the right product within the national tiered laboratory system, with an appropriate throughput and complexity, that is sustainable within it’s regional and local setting. Strategy Define the diagnostic coverage Compare actual demand to capacity Reduce instrument diversity Increase utilization to reduce costs Evidence based POC integration 6

7. PEPFAR Implementing Partner CD4: Finding the best cost / utilization FACSCount versus FACSCalibur utilization price per test Instrument Utilization Rate

8. PEPFAR Implementing Partner CD4 opportunities Greater efficiency may be established by maximizing CD4+ instrument utilization rates. Significant cost savings can be achieved by maximizing daily testing volumes per machine. Important to develop appropriate instrument placement strategies before procurement. Low-throughput point-of-care (POC) CD4+ testing platforms may contribute to lower costs per test. 8

9. PEPFAR Implementing Partner Existing POC Challenges Lengthy and unclear introduction/validation process Suboptimal instrument procurements and long term planning Optimizing existing lab infrastructure Evidence based POC integration Long term impact not clearly understood Instrument life span Maintenance strategy development Uptake – lessons learned 9

10. PEPFAR Implementing Partner Existing POC Challenges Limited government, donor, and technical coordination Competing priorities – treatment agenda (increased access) versus laboratory network development Vendor pressures (misleading) Logistics (SDP not lab) Procurement, quantification, distribution, and maintenance 10

11. PEPFAR Implementing Partner Country X: PIMA POC example Program expansion driven by PMTC programs No MOH laboratory involvement Existing warranties have expired Maintenance costs to be negotiated (currently at $1,200/machine) 11 Overall 2012 Total number of sites269 Sites with "0" consumption46 Sites with consumption ≤ 1/day 91 % of sites with 0 or consuming ≤1/day 34% % of sites with access to referral lab30%

12. PEPFAR Implementing Partner Stakeholder relationships 12 REGULATORY FDA WHO USAID CDC OGAC GF UNITAID SCMS UNICEF CHAI PRs/VPP ASLM ADVOCACY Governments and Local Partners TECHNICAL ASSISTANCE PROCUREMENT DONORS MSF