Standardization and Harmonization of Laboratory Equipment: Selected Country Case Studies WHO Geneva AMDS Partners and Stakeholders Meeting March 22-24, 2010 Sherry Orloff Lead Public Health Advisor International Laboratory Branch Global AIDS Program CDC-Atlanta
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Standardization and Harmonization ofLaboratory Equipment: Selected Country
Case StudiesWHO Geneva AMDS Partners and Stakeholders Meeting
March 22-24, 2010
Sherry OrloffLead Public Health Advisor
International Laboratory BranchGlobal AIDS Program
CDC-Atlanta
2008 Tanzania Experience Assessment of laboratories Review of Guidelines Development of the Operational Plan
for the National Laboratory System tosupport HIV/AIDS Care and Treatment
Test Harmonization Equipment Standardization Implementation
Testing at tiered levels Health Center
Manual, low throughput equipment run by laboratorypersonnel with minimum certificate level of training.
District and Regional Medium throughput laboratory equipment run by at a
• A meeting sponsored by the National Care andTreatment MOH program and SCMS isscheduled for May 2010 to develop a nationaldocument for standardized equipment
• Lab accreditation: 20 Labs will be included in theprocess the first year ( with a focus on 3 centrallabs already engaged in the ISO15189accreditation). A TWG has been put in place andhave developed a draft national policy and theCOP10 work-plan
Nigeria HarmonizationExperience 2010
• Nigeria PEPFAR program works with 17laboratory partners in COP2010
• Harmonization of laboratory equipmenthas been done within implementingpartner programs
• At this time, Nigeria PEPFAR program isusing a phased approach to standardizeequipment across the country
Harvard Nigeria Program
Harvard Nigeria Major LaboratoryEquipment(Tertiary Level)
LEVELS(TERTIARY)
EQUIPMENT (Model) NUMBERINSTALLED
NUMBER INOPERATION
DRM AB 3130 Autosequencer 2 2
Viral Load 1. Roche (manual)2. Cobas/Roche (semi-
automated)
84
84
CD4 Count 1.Cyflow counter 1&22.Cyflow SL-3
615
615
Chemistry 1.Hitachi 902 2 2
Hematology 1.Sysmex KX-21N2.Mindray 3200
77
77
LEVELS(SECONDARY)
EQUIPMENT (Model) NUMBERINSTALLED
NUMBER INOPERATION
Viral Load - - -
CD4 Count 1.Cyflow counter 1&22.Cyflow SL-3
-21
-21
Chemistry Cobas-C111 18 18
Hematology 1.Sysmex KX-21N2.Mindray 3200
-17
-17
Harvard Nigeria Major LaboratoryEquipment (Secondary Level)
Institute Of Human VirologyNigeria
EXISTING LABORATORY MAJOR EQUIPMENT/ LABLEVEL-COP 09LEVELS EQUIPMENT