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Issues to consider in adopting new HIV point-of-care testing
Wednesday, June 29, 2011
Dennis Ellenberger
International Laboratory Branch
Division of Global HIV/AIDS
Centers for Disease Control and Prevention
Lessons learned from implementing Rapid HIV Testing
CDC-GAP-PMTCT
Challenges with Rapid HIV Diagnostic Testing
Human resources- Training, Competency, Turnover HIV Test Kit - Poor Quality, Inconsistent Lots Test Algorithm - None in place or not followed Patient and Specimen ID - No standards Reporting - Poor and inadequate records, logs and reports Quality Testing (QA/QC) – Neither done nor monitored Supply Chain - Stockouts, Expired reagents
What is necessary to implement new point-of-care assays?
CDC-GAP-PMTCT
Select Quality Assay (performance characteristics) Has it been evaluated by qualified agency or laboratory? Publish reports on quality
Appropriate Placement (which healthcare level?)InfrastructureNeed Health centersDistrict hospitalRegional/zone hospitalsNational referral hospitals
What is necessary to implement new point-of-care assays?
CDC-GAP-PMTCT
Who does the test?
Skilled staff: identified and retainedLaboratory scientists, counselors, nurses, or physicians?Who is available?Who is qualified?Where does it get embedded within the current workflow?
What is necessary to implement new point-of-care assays?
CDC-GAP-PMTCT
Quality Monitoring
Can the laboratory or testing site manage the monitoring of the quality of the assay?Are quality control material available?Can external quality monitoring be put in place and followed?Root cause analysisProficiency testing with feedback Site visits
What is necessary to implement new point-of-care assays?
CDC-GAP-PMTCT
Quality assurance
POC setting assumes responsibility for specimen collection and testing
adequate resources, appropriate training and the implementation of QA practices are critical
proper administration of test
correct interpretation of test result
What is necessary to implement new point-of-care assays?
CDC-GAP-PMTCT
AcceptabilityAssay characteristics, time-sensitive steps, read
times and configurationsAttachment – electronic medical recordWhole blood source (capillary vs venous)
Availabilityservice and maintenanceReagents, consumables and supplies
What is necessary to implement new point-of-care assays?
CDC-GAP-PMTCT
Program monitoring
Harmonization with country standards
Algorithm: need for confirmatory test (HIV +)
Post-marketing surveillanceAssay failure – reporting of problemLot-to-lot evaluation
Anticipated challenges
CDC-GAP-PMTCT
HR shortages; staff turnover and retentionHigh attrition rate of trained staff in hard-to-reach or remote areas
Disease burden and workforce mismatchPotential for capacity challengesWorkflow interruptionsHarmonization of equipmentWeak leadership and management capacityNo plans for implementing policy and strategyLine item in budget by MOH
Anticipated challenges
CDC-GAP-PMTCT
Ad hoc supply chain management including logistics and distribution of reagents and commodities
QA/QCProficiency testingRetestingQC materialsOversightExistence of monitoring and evaluation servicesMaintaining best practices
Conclusion: can it be done?
CDC-GAP-PMTCT
Development of national policy, manuals & standardsGovernment leadership and ownership will be critical for success
Guidance document for countriesSite selectionImplementation planNetworking testing facilitiesHarmonizing workflow at clinicOn-site mentoringTraining curriculumHow close to universal accessWhere does it fit into national algorithm
Conclusion: can it be done?
CDC-GAP-PMTCT
Establishment of regional or country facility to provide QA/QC materials
Implementation of best practices for quality systems management
FOCUS ON QUALITY
CDC-Global AIDS Program External Quality Assurance Programs
Available to all PEPFAR-supported countries for EID using DBS and viral load monitoring using DTS
Highly successful PT Programs: voluntary participation
** NO COST TO PARTICIPANTS**
Contact information: [email protected]
THANK YOU!
