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