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Brad Cunningham
SystemOne, LLC
bcunningham@systemone.id
Importance of Quality Systems and
Connectivity
Decentralising HIV ...
© SystemOne, 2016 All rights reserved.
• Translating real-time data into real-time
actionTreatment
• Diagnostics moving fu...
Real-Time Results Quality
© SystemOne, 2016 All rights reserved.
Congratulations!
Your HIV test result has been completed
...
Quality Systems
© SystemOne, 2016 All rights reserved.
• The successful implementation of POC for HIV & EID is ambitious,
...
Quality: Multi-Stakeholder Responsibility
© SystemOne, 2016 All rights reserved.
Result
Operator
Manufacturer
Clinical
Int...
Quality Systems & Quality Assurance
© SystemOne, 2016 All rights reserved.
• QA is not a(n):
• Event
• Series of events
• ...
Zimbabwe Pilot: Integrated Laboratory Network
© SystemOne, 2016 All rights reserved.
• Pilot: Integrated laboratory networ...
In Conclusion
© SystemOne, 2016 All rights reserved.
• Diagnostic landscape has progressed to the point where EID & VL
tes...
QUESTIONS?
© SystemOne LLC, 2016 All rights reserved.
Brad Cunningham
VP, Implementation
SystemOne LLC
(m): +27 61 487 469...
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ASLM- Alere: Importance of Quality Systems

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Presentation given by Brad Cunningham, Vice President of Implementation at SystemOne from the 2016 ASLM Conference

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ASLM- Alere: Importance of Quality Systems

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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

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