This document discusses the importance of quality systems and connectivity for decentralized HIV testing. It notes that point-of-care testing presents challenges for quality control compared to centralized laboratories due to harsher environments, less skilled operators, and fewer resources. However, connected diagnostic platforms can help by providing continuous quality monitoring, internal quality control, external quality assessment, and key performance/quality indicators. The document highlights a pilot project in Zimbabwe using an integrated laboratory network for automated quality monitoring and external quality assessment reporting. It concludes that connectivity is essential to ensure successful scale-up of testing and maximize return on investment as testing expands to more facilities.

1. Brad Cunningham
SystemOne, LLC
bcunningham@systemone.id
Importance of Quality Systems and
Connectivity
Decentralising HIV Early Infant Diagnosis and Viral Load Testing
to Achieve 90-90-90
Alere Session: ASLM Conference, Cape Town
7 December, 2016
© SystemOne LLC, 2016 All rights reserved.

2. © SystemOne, 2016 All rights reserved.
• Translating real-time data into real-time
actionTreatment
• Diagnostics moving further away from
centralized, well-controlled environmentsQuality
• Optimize utilization of instruments,
consumption of consumables, improve ROICost
Faster, better quality health
data leads to better patient
outcomes

3. Real-Time Results Quality
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Congratulations!
Your HIV test result has been completed
at your local clinic.
Your HIV Status is: Negative(ish)
# results being reported on
Connected platforms growing
at 16% per month.

4. Quality Systems
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• The successful implementation of POC for HIV & EID is ambitious,
but necessary
• If you cannot ensure the quality of a result, you cannot act on it
• Quality is much simpler to control in well-controlled, centralised
laboratories
Point of care
• Harsher environments (temperature, dust, power, surges…)
• Lower skill
• English is generally 2nd language (often 3rd or 4th)
• Less access to resources & support
• No training as a lab technician
• Low understanding of quality & quality systems
• No review process

5. Quality: Multi-Stakeholder Responsibility
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Result
Operator
Manufacturer
Clinical
Internal Quality Checks
Key Performance & Quality
Indicators
Monitoring & response
HIV: ?
Interpretation
Implementation
Follow-Up
Connected Diagnostics
Sample collection
Sample prep.
SOP
EQA
Performance monitoring
Training
Consumables
Sample logistics
…
Scale!

6. Quality Systems & Quality Assurance
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• QA is not a(n):
• Event
• Series of events
• Intervention
• Milestone
• QA is an ongoing process and (eco)system
• Continuous Quality Monitoring via
connectivity / connected diagnostics
Internal Quality Control
External Quality Assessment
Key Performance Indicators
Key Quality Indicators
Training
Screening
Algorithm Adherence
Consumables & inventory
Sample logistics & monitoring
Environmental conditions
Trends
Contamination clustering
Event-based triggers
Indicator-based monitoring
Calibration & maintenance
…

7. Zimbabwe Pilot: Integrated Laboratory Network
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• Pilot: Integrated laboratory network for Continuous Quality
Monitoring and Automated EQA reporting
EQA Provider
3rd Party
Patient Management
Daily Quality Monitoring
Operational
EQA samples: results from
testing at remote facility
to EQA provider system
within 40minutes

8. In Conclusion
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• Diagnostic landscape has progressed to the point where EID & VL
testing at POC is not only required, but feasible.
• Significant concerns about quality & impact of an incorrect result.
• Continuing innovation in connected diagnostic platform and the
consumption of data.
• Need to equip all stakeholders responsible for quality components
with the information ecosystem.
• POC testing in expensive – connectivity is required to ensure
successful translation in field and maximize ROI.
• Quality & operations are simple to manage for 3-4 central, well
coordinated laboratories.
• 50 facilities?
• 100 facilities?
• 1,000 facilities?

9. QUESTIONS?
© SystemOne LLC, 2016 All rights reserved.
Brad Cunningham
VP, Implementation
SystemOne LLC
(m): +27 61 487 4693
bcunningham@systemone.id
www.systemone.id