HPV Workflow through the Cytology lab and Practical Dilemmas

1. HPV Workflow through the Cytology lab and Practical Dilemmas Kath Hunt Southmead Hospital Katherine.hunt@nbt.nhs.uk

2. History • Site for original trial in 2001 • Started testing as part of Sentinel Sites on the 2nd January 2008 • Triage cases and test of cure (TOC) on first follow up after treatment • Then brought in TOC on any specimen during the ten year follow up

3. Lab Requirements • Space – some more specialised • Storage space – kit sizes vary, consumables • Fridge Space • Freezer space (-18)

4. Space

5. Staffing • Majority of methods now automated and walk away • Band 4 graduate MLAs and BMSs prepare samples and run assay • Couple of ‘Superusers’ who troubleshoot

6. Lab Training • For most systems training is two to three days either on site or at HQs • Lead in period of gaining confidence • Validation run with samples provided by Edinburgh reference lab • Two staff suggested by NHSCSP, this will not be enough in reality

7. Sample Taker Training • For Sentinel sites we relied on Sample takers knowledge from previous trial • Four years on still some confusion • Repeat samples taken too soon • Brought up at every update day

8. Work Throughput- Triage • Primary screen – adds result code and screeners HPV code Borderline ‘H8, Mild ‘H3. • Checker verifies • Consultant (includes Con BMS) changes ‘H code to ‘TEST’ • This triggers the case to be picked up in search

9. Work Throughput - Triage • HPV result is returned to Consultant to be added to report and management added • In their absence another Consultant can add the result plus a Senior and Lead BMS have been trained to cover when necessary unless a complicated case

10. Work throughput - Triage • Important point – as the HPV result could be added by another Consultant the original result and any free text report must be added by the original Consultant who viewed the slide • Do not use HPV test to decide whether difficult cases are positive • Do not assume numerical values are truly quantitative – depends on cellular content

11. Work Throughput - TOC • Primary screener adds ‘H2 code to all TOC cases • Checker changes this to ‘TOC’ this triggers it to be picked up on the search • HPV result is returned to checker for adding to report and signing out. This includes Colp referrals for positive tests. • In their absence any checker can add result.

12. Twelve o’clock cut off for HPV requests unless urgent/breaching List is run from Ultra which picks up the ‘TEST’ and ‘TOC’ codes Vials retrieved from rack ‘Tubing up’ – hopefully a thing of the past! Samples run on QIASymphony, can be added all day if necessary in small batches Work Throughput and LEAN

13. Work Throughput and LEAN • Plate stored overnight in fridge or left on cooling tray in Symphony • In the morning the plate is put on the Rapid capture System • Results printed out at lunchtime and added to Ultra • Can both be run same day but results come off last thing

14. LEAN/ 14 day TAT • Does add at least 24 hours onto TAT • More if sending off site • Financially more sensible to batch if TATs short enough • Need reliable regular transport arriving at right time of day

15. IT • Platform to link to LIMs • Reliable IT link/secure e-mail for off site testing • Result codes and HPV codes for LIMs • Map codes to PCSA codes • Report wording • Patient letter wording

16. Other thoughts • Reprocessing – None of the platforms CE marked for Espostis samples. Recent paper shows that it works on HC2 • Potential other tests you might want to carry out (Chlamydia, GC?) • Fluctuating test numbers over first 2-3 years

17. Other thoughts • Colposcopy returning patient to routine recall – how is this communicated to the PCSA? • I’m more than happy to take phone calls or e-mails!

18. Any Questions?