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The role of site monitoring in quality assurance for point-of-care nucleic acid testing

This presentation discusses the role of site monitoring in quality assurance for point-of-care nucleic acid testing, with a focus on the process, tools, results, and lessons learned in Zimbabwe. It emphasizes the importance of monitoring, evaluating, and improving the quality of testing to ensure accurate and timely results. The presentation also highlights the common findings and conclusions drawn from site monitoring visits.

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The role of site monitoring in quality assurance for point-of-care nucleic acid testing

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  1. The role of site monitoring in quality assurance for point-of-care nucleic acid testing Dr. RaivaSimbi Deputy Director Laboratory Services Ministry of Health and Child Care, Zimbabwe IAS Satelite Session on Integrating POC NAT into Existing QA Programs in the AFRO Region July 2019, Mexico

  2. Outline • Background • Approaches to external quality assessment (EQA) for point-of-care testing • Site monitoring and mentoring in Zimbabwe: • Process and tools • Results and lessons learned • Conclusions

  3. Background • MOHCC has been supported by EGPAF and CHAI/UNICEF, with funding from Unitaid, to implement point-of-care early infant diagnosis (POC EID) in Zimbabwe since July 2015 • POC EID seeks to address: • Poor access to and delays in EID testing • Delays or no return of test result • Poor ART initiation of HIV-positive infants on treatment • MOHCC has rolled out POC EID to 77 testing sites and 230 spoke sites

  4. Background • Quality Assurance (QA) in point-of-care nucleic acid testing (POC NAT) is a major concern for MOHCC • A deliberate effort is needed to monitor, evaluate, assess, and ultimately improve the quality of POC testing • QA covers the entire testing cascade: • pre-analytical phase (sample collection, handling, packaging, transport, staff competency, etc.) • analytical phase (testing procedure, quality control) • post-analytical phases (reporting, recording, communication of results, waste disposal)

  5. Different approaches used in Zimbabwe for external quality assessment (EQA) of POC NAT • Site assessments and improvement plans/upgrades prior to enrolling a POC testing site • Competency assessments of platform operators • Frequent site monitoring and mentorship visits • Proficiency panels administered through the Zimbabwe National Quality Assurance Program (ZINQAP)

  6. Site monitoring and mentoring process • Joint teams conduct site monitoring and mentorship visits • EGPAF, CHAI and MOHCC district supervisors • Intervals for site monitoring post installation • 2 weeks, 6 weeks, 12 weeks, and quarterly thereafter • Two standardized checklists administered during the visits • testing site monitoring checklist • spoke site monitoring checklist • Inclusion of district MOHCC staff in monitoring team • To build capacity in anticipation for transition • Issues picked during monitoring visit addressed through mentoring during same visit

  7. Focus of site monitoring and mentoring visits • What is assessed during a visit? • Adherence to testing algorithms • Patient flow • Availability and use of SOPs, job aids, registers, tracking logs, and testing forms: • Training and competency of instrument operators/end-users • If possible, observation of operator(s)/end user(s) as they complete a test; • Instrument placement and performance; • Reagents and supply management; • Waste management • Linkage to care • Based on the results of the assessment, immediate mentoring and training are provided – and follow up actions are defined

  8. Experience and common findings of site monitoring and mentoring visits

  9. Experience and common findings of site monitoring and mentoring visits

  10. Experience and common findings of site monitoring and mentoring visits

  11. Experience and common findings of site monitoring and mentoring visits

  12. Experience and common findings of site monitoring and mentoring visits

  13. Experience and common findings of site monitoring and mentoring visits

  14. Experience and common findings of site monitoring and mentoring visits

  15. Experience and common findings of site monitoring and mentoring visits

  16. Experience and common findings of site monitoring and mentoring visits

  17. Experience and common findings of site monitoring and mentoring visits

  18. Conclusions • Site monitoring: • Is feasible and could be conducted with existing resources • Focuses on the right things including the three stages of the testing cascade • Pre-analytical, analytical and post analytical • Allows sites to overcome and resolve challenges efficiently and quickly • Supports the goal of quality assurance i.e. monitor, assess and ultimately improve the quality of POC testing

  19. Acknowledgements • MOHCC gratefully acknowledges: • Funding and support from Unitaid • Unitaid accelerates access to innovation so that critical health products can reach the people who most need them. • The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) • EGPAF is the global leader in the fight against pediatric HIV/AIDS, bringing dramatic change to the lives of millions of women, children, and families worldwide. • CHAI/UNICEF • The health care workers, mothers, children and families of Zimbabwe

  20. Thank You

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