Planning Laboratory SupportPlanning Laboratory Supportfor HIV, TB and Malariafor HIV, TB and Malaria
Procurement and Supply Management Workshop for SEARO and WPRO Countries
25 – 30 July 2005Bangkok, Thailand
Anthony Louis GomesWorld Health OrganizationHealth TechnologiesWPRO-PNG
Specific ObjectivesSpecific 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
Laboratory service is essentialLaboratory service is essentialWHY? 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
Planning Laboratory ServicesPlanning Laboratory Services
Strong commitment from decision makersWell defined/designed organizational
structureWell designed physical structure at all
levelsWell trained and adequate human resourcesProper procurement and supply
management system in place
The issuesThe issues
Laboratory System/Network
Human Resources
Appropriate Technology – Affordable Price
Supply Management - Quality supplies
Capacity Building
Laboratory System/Network Laboratory System/Network
Integrated versus specialized servicesThere 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
Human ResourcesHuman 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
Appropriate Technology – Appropriate Technology – Affordable PriceAffordable 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
Supply Management - Quality SuppliesSupply Management - Quality Supplies
Situation AnalysisSituation 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
Supply Management - Quality SuppliesSupply Management - Quality SuppliesSelection criteria for supplies & Product/HIVSelection 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
Supply Management - Quality Supplies/HIVSupply 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
Supply Management - Quality Supplies/HIVSupply 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
Supply Management - Quality Supplies/HIVSupply 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
Supply Management - Quality Supplies/TBSupply 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
Supply Management - Quality Supplies/TBSupply 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
Supply Management - Quality Supplies/TBSupply 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
Supply Management - Quality Supplies/MalariaSupply 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
Supply Management - Quality Supplies/MalariaSupply 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
Capacity BuildingCapacity 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
WHO Bulk Procurement SchemeWHO 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
Thank YouThank You