UNICEF SUPPLY DIVISION MEDICAL TECHNICAL TEAM “ HIV/AIDS: Where Are The Diagnostics ? “

UNICEF SUPPLY DIVISIONMEDICAL TECHNICAL TEAM“ HIV/AIDS: Where Are The Diagnostics ? “ Ludo Scheerlinck MSc, MBA, MPH

Planning & procurement of diagnostics in support of HIV/AIDS programmes • Rationale • Planning • Procurement • Yemen/MoH/NAP & GFATM financed HIV/AIDS project

Rationale • Widely recognised that availability & affordability of Dx modalities hamper fight against HIV/AIDS. • Price trend, seen with ARVs, so far not with Dx. • Dx will continue to consume large part of our available funds. Esp. for lab-based Tx monitoring.

Rationale, c’tnd • Too often assumed Dx will follow “automatically” when the ARVs are in place; overlooking that: • - Status depends on Dx. • - Tx initiation depends on Dx. • - Tx monitoring depends on Dx. • - Installing Dx is technically as complex as ARVs. • - Limited capacity/capabilities with sophisticated Dx. • Hence importance of professional planning of Dx at the earliest phases of programs/projects possible. • Share weaknesses most often observed, same time request to address them in your consultancy endeavors.

Diagnostics, what are we talking about ?

Planning (1) • Adults: • Office based (i.e.VCT): Simple/Rapid test • Laboratory, • Confirmatory test: ELISA • Tx initiation and monitoring: CD4, VL-PCR (QN) • Blood bank: ELISA

Planning (2) • Children (<18m, early diagnosis): • Test kits: No (mat. antibodies) • Laboratory, • Testing: VL-PCR (QL) • Tx initiation and monitoring: CD4%,VL-PCR (QN)

Planning (3) (i) Allocation should be carefully done based on geography and prevalence/incidence. (ii) Allocation to appropriate service providers: - CD4 from district level providers up. - VL only central level: ! consequences for children. (iii) Caution with perception “automatic”. Staff skills incl. device, procedures and technical aspects !

Planning (4) (iv) Draft generic specification include: test parameters, throughput, type and number of test per year. (v) Physical environment: - Dedicated lab rooms with specific requirements (sample contamination, safety, waste process, etc). - Supporting devices present & functioning.

Planning (5) • In-country logistics: • - Shelf-life of some reagents fairly short (ca. 45 days). • - Most of them need refrigerated transport & storage. • After sales service: focus on technical representation. • Last, check Dx services the private sector delivers.

Planning (6) (viii) Investment and recurrent cost indication, USD: - Rapid/Simple test: 0.5 to ± 1.5 - ELISA device: 12.000 reagents: ±1.0 per test - CD4 device: 25.000 reagents: ± 7.0 per test - VL device: 55.000 reagents: ± 30 per test P.S. To be added: – reruns – shelf life opened reagents – supporting devices – staff cost – admin and logistics of samples and test results.

Planning (7) Only when at least the above is identified, agreed, described and budgeted: “I have properly planned sustainable diagnostics support”. Procurement exercise without (too many) surprises can start.

Planning (8) Plenty info available about Dx from numerous of sources. No standard for “assessing needs” and subsequent “planning”. Approach case-by-case according country, goals and objectives, stakeholders involved, available budget and so on.

Procurement (1) Rapid/Simple Test: WHO specified & prequalified and tendered. List available online SD website. Analyzers: WHO prices and sources guidelines. If not standardized, public tendered. Generic specs submitted or developed in-house.

Procurement (2) We “refuse” to just procure & ship-out any BoQ submitted, when reveals inconsistencies vis-à-vis: needs addressed, completeness, or project goals and objectives. Able to add: (i) start-up reagents, (ii) training needs (user, technical, GLP), (iii) specificationssupporting devices, (iv) maintenance contract. With “post-planning” efforts increase risk of deviating from actual needs to be covered on site.

Procurement (3) To assist, to a certain extend, with planning and procurement SD develops a short planning brief, informing about: - Dx services to be provide at different levels. - Allocation of technology. - Supporting devices. - Sources to procure from. - Generic specifications (ELISA, CD4 and VL)

Background 1./ 2./ 3./ 4./ Request for CE prior to procurement equipment & supplies for (i) blood bank, and (ii) Tx initiation and monitoring. Different lists were inconsistent, poorly specified and budget indication way of the mark. Grant Agreement, Project Proposal or PSM from GFATM website provided necessary info neither. Three months of communication, no progress. UNICEF/CO/Yemen invited technical support from SD “to clarify the matter”.

Mission preparation 1./ 2./ 3./ • Desk research covering among others: • Prevalence, incidence, geographical distribution and other determinants of the epidemic. • Socio-economics of the country. • Health services delivery. • Public-private mix. • Health expenditure (pub and private). • Mission specific questionnaire as guideline for mission workshops. • Proposal for adjustments to BoQ & Specifications.

5 days mission (1) 1./ 2./ • With MoH/NAP weak link identified between: • Prevalence/distribution HIV/AIDS, and • Items requested in support - introduction Tx initiation and monitoring, and - strengthening screening services of blood banks. • Upon brief assessment of the situation the MoH/NAP recognised need to re-plan ALL commodities for both projects components.

5 days mission (2) 1./ 2./ • Re-planning exercise covered: • Prevalence and geographic distribution of HIV/AIDS: • Allowing calculation present and future national capacity for screening donated blood & testing/treatment monitoring. • Allowing allocating devices to service providers involved. • Consulting national Tx initiation and monitoring guidelines, i.e. frequency of testing, as this also guides the required capacity of the devices.

5 days mission (3) 3./ 4./ • Site visits hospitals & blood banks, focussing on: • present capacity and utilisation, • physical environment (incl. pre-installation requirements, supporting devices). • Training needs: • user, • technical, • procedures (GLP: emphasising sample collection, transportation, storage and preparation).

5 days mission (4), outcome 1./ 2./ 3./ A “new” final equipment list; items, specifications and their respective quantity. For budgeting and feasibility appraisal purposes (only) lump sum prices were produced (budget review USD 511.000 to 870.000). A time line/activities for issuance of cost estimate and subsequent procurement.

Conclusion and lessons learned (1) 1./ 2./ 3./ Context information about a project is essential. Capacity for basic planning (BoQ & Specs) of commodities in a project context limited with UNICEF/CO, MoH and Global Fund. Advanced planning issues s.a. (i) recurrent cost (= sustainability), (ii) training & installation, (iii) physical environment, (iv) in-country logistics (v) waste management unheard of.

Conclusion and lessons learned (2) 4./ 5./ Technical expertise should have been involved much earlier. Time waste trying to solve complex issues remotely. Project accumulated 5 months delay, seriously jeopardising Year 1 objectives (ARVs also delayed). Quality planning of diagnostics is vital for smooth PSM, but also for a successful sustainable project &program.

THANK YOU … FOR YOUR ATTENTION !

UNICEF SUPPLY DIVISION MEDICAL TECHNICAL TEAM “ HIV/AIDS: Where Are The Diagnostics ? “