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
© SystemOne, 2016 All rights reserved.
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
© SystemOne, 2016 All rights reserved.
• 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
© SystemOne, 2016 All rights reserved.
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
© SystemOne, 2016 All rights reserved.
• 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
© SystemOne, 2016 All rights reserved.
• 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
© SystemOne, 2016 All rights reserved.
• 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