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: adiallo@jsi.com

Website: www.deliver.jsi.com