2. Planning Laboratory Support for HIV, TB and Malaria Procurement and Supply Management Workshop for SEARO and WPRO Countries 25 – 30 July 2005 Bangkok, Thailand Anthony Louis Gomes World Health Organization Health Technologies WPRO-PNG

3. Specific Objectives To provide Guidance for strengthening laboratory support To provide technical information and guidance on selection criteria for lab supplies and equipment To provide guidance to conduct situation analysis and needs assessment

4. Laboratory service is essential WHY? No labs No diagnosis No treatment Will there be any meaningful programme without lab support? All due considerations should be given to improve the laboratory services

5. Planning Laboratory Services Strong commitment from decision makers Well defined/designed organizational structure Well designed physical structure at all levels Well trained and adequate human resources Proper procurement and supply management system in place

6. The issues Laboratory System/Network Human Resources Appropriate Technology – Affordable Price Supply Management - Quality supplies Capacity Building

7. Laboratory System/Network Integrated versus specialized services There must be a nationwide lab network Central – National Reference Laboratory Provincial – under the supervision of central Peripheral – often district/sub-district under the supervision of provincial level

8. Human Resources Well trained staff at all levels of lab services Skilled staffs with clear understanding on the test methodology including reporting, recording Knowledge on IQC, QA, QMS Supervisory skills for senior lab staff Necessary skills to perform routine calibration and maintenance of the lab equipment Adequate in number

9. Appropriate Technology – Affordable Price Assessment of technical capacity Choice of Cost Effective laboratory methods – WHO recommendations are available Careful selection of laboratory supplies and tests kits Nationwide uniformity in laboratory techniques WHO evaluation reports on equipment and tests kits

10. Supply Management - Quality Supplies Situation Analysis Resource inventory analysis (what is in hand) National Level Laboratory Level Needs assessment (additional requirements) Estimation/calculation of supply needs (based on prevalence/case notification etc) Includes HIV/TB/Malaria Consideration for buffer stock to avoid disruption (must consider shelf life) Spare parts/Additional instruments

11. Supply Management - Quality Supplies Selection criteria for supplies & Product/HIV Equipment must be reliable Service contracts Maintenance Repair Test Quality Must be high Should meet WHO criteria for Quality WHO Evaluations Review of Independent Evaluation Data and Certification Performance of Testing at WHO Collaborating Centers Data analysis and report dissemination

12. Supply Management - Quality Supplies/HIV Evaluation – Technical Aspects and Criteria for Quality: Serology (using the WHO Specimen Reference Panel) o Sensitivity >99% o Specificity > 98% o Inter-reader variability (if simple/rapid test) <5% etc

13. Supply Management - Quality Supplies/HIV Evaluation – Technical Aspects and Criteria for Quality: CD4 Enumeration and Viral Load -Compare to Gold Standard Methods Specificity/Sensitivity Linearity Subtype sensitivity (for viral Load) Reproducibility/Precision Others Inter/Intra Run Variability Technician Variability etc

14. Supply Management - Quality Supplies/HIV Other considerations for Rapid HIV test kits Ease of Use and interpretation the result Little or no equipment, electricity/water Specimen type Rapid Easy to store Refrigeration if possible even if labelled room temperature

15. Supply Management - Quality Supplies/TB Essentially DOTS Strategy Primarily Relies on Sputum Microcopy Microscopic diagnosis of TB - The Best Choice because: It is simple, inexpensive, easy to perform in limited settings, quick and results are accurate Microscope – The Most Important Equipment Description Binocular with light source, 220/240V, 50HZ Lenses – 100x, 40x, 10x and eyepieces 10x Concave Mirror for use with natural light source if electricity fails or not available Spare bulbs

16. Supply Management - Quality Supplies/TB Requirement will differ from one level to the other National Reference lab or lab that performs DST will require more sophisticated equipment Biological safety cabinet for Reference labs, should comply with international standard Common methodology will make it possible to make the results comparable countrywide

17. Supply Management - Quality Supplies/TB Supply needs should also address for: Sputum Microscopy Quality Assurance of Sputum Microscopy Surveillance of Drug Resistance (MDR study) etc Collection and transportation of specimens Reference: Laboratory Services in Tuberculosis Control, Part I.II & III, WHO-Geneva

18. Supply Management - Quality Supplies/Malaria Microscopic diagnosis still remains as the first choice Microscope – The Most Important Equipment Description Binocular with light source, 220/240V, 50HZ Lenses – 100x, 40x, 10x and eyepieces 10x Concave Mirror for use with natural light source if electricity fails or not available Spare bulbs Common methodology will make it possible to make the results comparable countrywide

19. Supply Management - Quality Supplies/Malaria Rapid Diagnostic Test - ICT (Immunochromatographic Test) available for Malaria diagnosis Easy to use, good for peripheral level Cost is high which makes it difficult for resource limited settings

20. Capacity Building Procurement and Supply Management Capacity Capacity to conduct Situation Analysis/Needs Assessment Capacity to estimate/calculate the laboratory requirements (HIV, TB and Malaria) Capacity to identify appropriate test kits and reagents Capacity to identify appropriate equipment using selection criteria Capacity to deliver the lab supplies to destinations Capacity for storage of test kits in appropriate temperature and conditions

21. WHO Bulk Procurement Scheme Low prices negotiated for WHO Member States and UN Agencies WebBuy e-catalogue – accessed at WHO Regional Offices via WHO intranet AMDS – Strengthening partnerships with other procurement agencies New Website www.who.int/diagnostics_laboratory Information Available: Sources and prices of selected medicines and diagnostics for people living with HIV/AIDS New addition available August 2005 via web

22. Thank You