Laboratory Standardization:
4 years after Maputo
Carmit Keddem, Deputy Director, Health Logistics
June 19, 2012
Maputo Declaration on Strengthening of
Laboratory Systems (January 2008)
• Consensus among stakeholders
on strengthening of laboratory
systems to address challenges
that limit the scale up of services
for TB, malaria and HIV
• Two of three key meeting
objectives were focused on
standardization of laboratory
tests, equipment, and
commodities.
What is Standardization?
Standardization is the process of defining:
• Test menus,
• Test techniques,
• Operating procedures, and
• Laboratory equipment
……for each type of test at each level of the system
Broad Recognition of Benefits of Standardization
• Rational decision making in product selection,
forecasting, quantification and procurement
• Manageable supply chain by streamlining the number
of laboratory products
• Affordability through economies of scale
• Agile supply chain allowing redistribution of supplies
to reduce stock imbalances
• Efficiency in training and management of staff
• Quality assurance of testing by increasing reliability
and consistency of results
Country Experiences
• Cote D’Ivoire (2007)
• Ethiopia (2007)
• Ghana (2007)
• Kenya (2005)
• Malawi (2009)
• Uganda (2004)
• Zambia (2007)
Standardization Process
1. Assess existing test menus, techniques,
standard operating
procedures and equipment at
facilities from all levels
2. Hold consensus
building workshop with stakeholders
from all levels
3. Update laboratory policy documents with new standards
4. Determine timeframe for reviewing and
updating standards
5. Disseminate and implement standards at all facilities at all
levels
Progress with Standardization
• Identified as initial lab system
strengthening activity; often a pre-
requisite for system design &
quantification
• Variation in starting point across
countries
• Despite initial standardization
efforts, not all countries have
successfully standardized
– Procurement decisions useful in
enforcing standardization
– Time and resource intensive and
political process to see to fruition
Enablers and Challenges of Standardization
• Leadership & Ownership
– Reaching consensus among
stakeholders at standardization
workshop presents challenges,
given
• Vested interest
• Large number of existing tests,
equipment, techniques to
harmonize
– Changing behavior at all levels –
providers, implementers
– Who is in charge? Directorate of
Labs vs. program-specific
Enablers and Challenges of Standardization (2)
• The role of partners and donors
– Donated equipment reflects
standards of donors
– Variety of implementing
partners = variety of equipment
– Funding required for initial
consensus workshop, and to
update and disseminate
standards (and implement
transition plan)
Enablers and Challenges of Standardization (3)
• Global market & laboratory
technology
– Rapidly changing technology
makes equipment obsolete
more quickly
– Management of legacy
equipment and existing long-
term contracts with suppliers
– Major acquisitions of lab
technology firms
Summary
• General agreement
about importance of
standardization
• Lessons learned about
the enablers and
challenges
• Call for collective
participation in bringing
standardization process
to fruition
Thank you!
For more information about laboratory
logistics, please contact:
Abdourahmane Diallo
Director of Technical Services
USAID | DELIVER PROJECT
email: [email protected]
Website: www.deliver.jsi.com