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Building TB Diagnostic Capacity in Quality-Assured
Laboratory Systems
Dr. John Ridderhof (CDC)Chair of Global Laboratory Initiative
April 3, 2009Beijing, China
Essential Elements for Laboratory Strengthening
• Infrastructure, biosafety and utilities• Human resource development (including training and retention)• Specimen referral, supply chain management and logistics• Equipment and maintenance• Technical procedures (disease-specific)• Quality assurance• Data management
Logistics and supplies
Human Resources
(Guidelines
Technology transfer)
Infrastructure Quality Assurance
Linked referral
systems and reporting
– Recognize and acknowledge the importance of laboratory systems in TB control and commit adequate human and financial resources.
Actions needed at the Country Level
Training MaterialTraining Material
GuidelinesGuidelinesPrograms/Programs/ReportsReports
Workshops/ConferencesWorkshops/Conferences
The US initiative in the 90The US initiative in the 90’’s to meet the challenge of MDRs to meet the challenge of MDR--TBTB““The Laboratory Makes a DifferenceThe Laboratory Makes a Difference””
National Laboratory Initiatives
– Set up a national mechanism to ensure coordination at all levels among departments responsible for laboratory services, disease-specific programmes, human resource development, and training
Actions needed at the Country Level (2)
Province Laboratories
District Laboratories
Health Centers
Ministry of Health
Global Programs
TB HIV Malaria Vaccine Prev Dis EPR
EPRVaccine Prev DisMalariaHIVTB
National Laboratory Infrastructure
National Institutes
National Reference Laboratory
Province Laboratories
District Laboratories
Health Centers
Ministry of Health
National Laboratory Infrastructure
Laboratory Division/Directorate
LaboratoryCoordinator/auditor
Quality Assurance
Training
– Ensure that health sector plans include adequately conceptualized and budgeted components for comprehensive laboratory capacity development.
Actions needed at the Country Level (3)
Planning, Constructing/Renovating Laboratories for MDRTB Diagnosis
Appropriate design and biosafety for culture and (integrated) molecular diagnostics
– Identify and remove barriers to laboratory staff career development, remuneration, staff retention, and sustainability of technical competency
Actions needed at the Country Level (4)
36% 32% 36%
77%
36%
Funding Infrastructure Equip & Sup Human Resources
EQA
Questionnaire results in 2006 among regional advisors from 75 countries:Major challenges are experienced in the area of….
Source: WHO
Laboratory Staff• laboratory’s greatest asset• critical to quality• partners in public health• qualified professionals
– Prepare a national inventory of donor and technical partner efforts in laboratory strengthening and identify synergies and opportunities for optimization of resources
Actions needed at the Country Level (5)
CROSS-CUTTING STREAMS
HIV
Immun-ization
INTEGRATED SERVICE DELIVERY
Linked Referral Services
Strengthen Laboratory Capacity
Training/Retention
Logistics and Commodities Management
Facility & Equipment Maintenance
TB
Malaria
INTEGRATED LABORATORY CAPACITY STRENGTHENING FOR DISEASES OF PUBLIC
HEALTH IMPORTANCE
Quality Assurance
Ref: GAP/CDC
– Formulate/modify policies and screening algorithms to facilitate scale-up of rapid diagnostics for MDR- and XDR-TB control
Actions needed at the Country Level (6)
WHO Guidance:Liquid culture and DST
Guidance on First and Second Line DSTLine Probe Assays for MDRTB
Country-specific Algorithms:Using LPA to replace culturefor SM (+) drug susceptible patients
SM + No result
MICROSCOPY
CULTURE
SM -
Solid Liquid
DST-FLD
No resultNegative Positive
Not MDR, res other drugs
DST-SLD
XDR No result
Solid Liquid
Not MDR, susc No result
Not XDR, res other drugs Not XDR, susc
MDR
Solid Liquid
LPA
– Engage private laboratories to improve access to TB diagnostic capacity, ensuring adequate support, training and quality assurance.
Actions needed at the Country Level (7)
•Laboratory Standards•External Quality Assessment (EQA)•Training•Accreditation•Surveillance•Referral
Making private laboratories part of the system
‘From unimaginable…to indispensable’
Strengthening TB laboratories