AIDS Bureau, Ministry of Health and Long-Term Care

1. HIV Rapid Point of Care Testing Program Refresher Training 2013 AIDS Bureau, Ministry of Health and Long-Term Care

2. Quality Assurance & HIV POC • HIV tests normally performed highly regulated environment • Includes quality assurance and control (QA/QC) activities • Rapid Testing Sites are performing HIV screening tests • We have adapted QA/QC to POC setting • Essential to ensure “due diligence”, consistent and reliable test results

3. Quality Management System Quality Management System (QMS) System used to plan, create and deliver high quality products and services to the client Quality Assurance (QA) Systematic evaluation of products or services to ensure quality standards are being met Quality Control (QC) Activities to ensure adequate quality in product or service performance

4. Why is QA/QC necessary ? • Ensure accurate results • Monitor processes for inconsistencies • Ensure uniformity at all sites • Documentation provides work instructions and historical evidence

5. Quality Assurance • Quality Control • Parallel testing • External Quality Assessment • Documentation • Training and competency • Kit lot release • Kit lot validation • Kit lot monitoring • Inventory Control • Environmental monitoring

6. Training and Competency • New Staff Training • how to perform POC testing, QA/QC, counseling • Validation panels from Biolytical • Competency certificates from AIDS Bureau • Refresher training • Yearly (e.g. Testing Conference, Biolytical video) • After prolonged absences e.g. maternity leave • Documentation • Must be accurate and complete (worksheets, logs)

7. Kit Lot Validation • Each site tracks new kits/shipments • Logs lot number and expiry date • New kits are isolated until they have been tested with Pos and Neg control material • Log control results • IF OK, they can be put into use. • FIFO (First In, First Out) Inventory Control) Do not have more than one lot in use at a time.

8. Environmental Monitoring • Kit storage areas and testing areas must be monitored for temperature daily. • Min/max temperature monitor supplied to all sites.

9. Routine Quality Control • Run Neg and Pos controls for each box of tests (24 tests) • 1 Neg, 2 Pos (HIV1+, HIV2+) • Frequency depends on testing volume • Minimum - once weekly • Maximum – once daily • Record results in QC log • Supervisor must review regularly

10. Unacceptable QC Results • HIV1 or HIV2 Pos Control = Negative • Neg control = Positive • Sample Control = Negative • Indicates problem with process, material or device • Follow-up action required!

11. What to do aboutUnacceptable QC Results • Complete QC log and Incident Log • Retain devices (take photo if possible) • Repeat test with same QC material and new devices • If OK, consider cause of problem (control mix-up, skipped component) • If still unacceptable – test with new Pos and Neg controls • If OK, consider cause of problem with original Pos and Neg controls (eg may have been contaminated)…….

12. What to do aboutUnacceptable QC Results ……if consistently unacceptable • Situation is considered critical • Testing must stop and site must notify AIDS Bureau • Document all activities in the Incident Log

13. External Quality Assessment • External, objective comparison of performance with other sites; complements QC • IQMH prepares same EQA samples for all Ontario Labs and AIDS Bureau clinics • 4 samples, every 6 months, all sites • Up to 5 testers individually test and report results to QMPLS • Final results tabulated by QMPLS and expert committee • Errors are investigated by site and AIDS Bureau

14. QMPLS EQA Results

15. Root Cause Analysis Ask WHY 5 times • Systematically review process to identify problem • Review QC, repeat test, request additional material • List all potential causes • Determine root cause and appropriate corrective action • Develop action plan, implement and monitor

16. Possible EQA Errors • Pre Testing • Wrong Sample • Sample (deterioration, volume) • During Testing (QC OK?) • Reagents (deteriorate, volume) • Test performance (timing, sequence) • Result Interpretation • Post Testing • Transcription of result

17. POC and PHL Parallel Testing • To compare POC testing to lab based testing and monitor: • POC False Reactives (should not exceed 0.5%) • POC False Negatives • “Window Period” positives

18. Specificity – How many False Reactive POCs to expect? • BioLytical data: Specificity 99.5% • Up to 5 per 1000 HIV negative people may test POC reactive (likely fewer) • OHTN data: Specificity 99.9% • 20 false reactive results • 26015 HIV negative clients • Approx. 0.8 per 1000 HIV negative clients

19. Sensitivity – How many False Negative POCs to expect? • BioLytical data: Sensitivity 99.9 % • HIV Antibody test: Up to 1 per 1000 HIV positive people may test POC negative • OHTN data: • 0 False negative antibody results • 141HIV antibody positive clients • 4 P24 antigen positive clients

20. Window Period Samples • First 3 months following initial exposure • OHTN Data: • 467 Suspect Acute Seroconversion • 4 with P24 Antigen • 2 Inconclusive HIV Antibody • Suggests success with early testing/detection

21. Summary 2012 Quality Assurance activities demonstrate: • Improved completion of worksheets • Improved EQA performance • Improved test specificity • Parallel testing supports early HIV detection