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: gappt@cdc.gov

THANK YOU!