1. Kay Ellis and Julie Russell The Sheffield Experience...... Lessons Learned

2. Areas to be covered What to be aware of Protocol Laboratory issues Sample taker training Screening office – recall agency Colposcopy Pathway manager The woman’s experience

3. What to be aware of? HPV triage and ‘Test of Cure’ Communication – never enough Involves the whole programme Sample taker updates NHSCSP documentation Colposcopy Don’t forget your own staff!

4. HPV Sentinel Sites 300,000 women (10% population) April 2008 - many protocols since Managed by the HPV Specialist Interest Group (HPVSIG) chaired by Professor Henry Kitchener

5. HPV Sentinel Sites Sheffield LiverpoolSurePath Manchester London Bristol ThinPrep Norwich Extended due to Laboratory mergers

6. HPV Triage of LG Samples Year 1 First Borderline or mild dyskaryosis HPV Test ReferRoutine recall +-

7. Borderline Nuclear Change (BNC) BNC - NOS Borderline in endocervical cells Borderline ? High grade cannot be excluded NOT borderline in endometrial cells

8. What is ‘Test of Cure’ (ToC)? Cytology test 6/12 after treatment for CIN (LLETZ/cold coagulation) Not for invasive or glandular lesions Abnormal cytology – rerefer for colposcopy Normal cytology – HPV test If HPV positive – rerefer for colposcopy HPV negative/cytology normal – 3 year recall

9. (a) BORDERLINE or MILD DYSKARYOSIS Moderate dyskaryosis or worse with treated CIN HPV -veHPV +ve COLPOSCOPY No repeat cytology BORDERLINE/MILD with negative colposcopy, no biopsy or biopsy with no CIN CIN1 CIN2/3 No treatmentTREATMENT (b) Cytology at 12 months with or without colposcopy (local preference) (c) Cytology at 6 months Normal, borderline, mild Moderate, severe Routine 3 or 5 year recall (depending on age <50 or ≥50) HPV –veHPV +ve (d) 3 year recall (e) COLPOSCOPY Treat or, if normal, cytology follow up according to national guidelines

10. Why HPV Test? Detection of high-grade CIN leading to earlier treatment and early discharge Early return of women with low-grade cytology and HR-HPV negative to routine recall Early return of women of women treated for CIN to routine recall who were cytology negative and HR-HPV negative.

11. Who is Eligible for HPV Testing? Women with low grade cervical disease will be offered HPV testing – routine call/recall Follow up after treatment at 6/12 Will be confirmed in the implementation guidance

12. HPV Test HPV testing is part of an enhanced screening service Sample taker to ensure woman understands about implications Consent to HPV test (like Cervical screening) implied by attendance

13. Laboratory Implications SOPs Training and dissemination of information to sample takers/staff Laboratory codes for transfer to Exeter and new letters need to be set up TAT Transfer of results from Manchester or other sites – data protection

14. Identifying women for ToC Nightmare trying to identify women who eligible Not able to set up rule in Apex Reliant on request forms, Open Exeter and looking up histories Some may get missed Call/recall may pick some up

15. Exeter/Open Exeter – Management Codes Cytological Pattern (Result code) B = BNC HR HPV tested M = Mild dysk HR HPV tested N = Negative HR HPV tested Infection Code Ø = HR HPV NOT detected 9 = HR HPV detected U = Inadequate HPV test – not on Exeter yet

16. Laboratory IT Issues Alpha codes in numerical areas e.g. B not 8 Need to map onto Exeter system Many combinations Need to run dummy patient tests Currently use NØR36 for women after treatment as first repeat in 3 years regardless of age i.e. over 50

17. Terminology HPV/koilocytosis (morphology changes) will no longer be mentioned in the final report HPV will refer only to the HR HPV test Avoid confusion

18. Terminology Borderline nuclear changes in squamous cells High risk HPV DETECTED Referral for colposcopy is recommended (Exeter Code B9S)

19. Terminology Mild dyskaryosis High risk HPV NOT DETECTED Routine recall is recommended (Exeter Code MØA)

20. HPV Testing In-house – space and capacity - VFM Training NEQAS scheme Access to Virology input for advice and trouble-shooting

21. HPV Testing Send away considerations Transport costs – DX SurePath lids for tubes and vials ThinPrep ? Invalid for HPV testing after glacial acetic acid treatment (on-going project) Eligibility of sample for HPV testing e.g. SP 28 days

22. Training Sample Takers Sheffield 2008 we hosted two evening events Aimed one person/practice Lectures and information packs distributed Excellent compliance

23. South Yorkshire and Bassetlaw Problems with time constraints/funds Information packs with FAQs distributed Any communications with GPs through PCT leads e.g. e bulletins, LMC newsletters Colposcopy – colp visits and training session More awareness Generally high acceptance

24. Procedure Amended invitation letter with HPV information and ‘The facts’ leaflet Original LBC sample tested if indicated – NO FURTHER SAMPLES REQUIRED Women under 25 excluded and over 65 All routine samples including GUM but not private samples HPV result included with cytology result and appropriate management i.e. combined

25. Documentation Training pack for each practice Poster Information CD Cervical Screening – The Facts Flow chart www.cancerscreening.nhs.uk

26. Translations Arabic Bengali Polish Punjabi Somali Urdu Top six languages above

27. Access to translations www.cancerscreening.nhs.uk NHS cervical screening programme HPV Other information about HPV and sentinel sites

28. Implications for Primary Care We cannot know when a woman became infected and from whom HR HPV does not cause genital warts and wart associated types do not cause CIN HPV vaccination only effective in the future before exposure

29. Role of Sample Takers You are expected to be informed about HPV testing so that you can advise and counsel women if they require an HPV test

30. What you should ask Has the woman read her letter and leaflet? Does she know that her test will be HPV tested if low grade abnormality found? Does she have any questions about the test or HPV? If positive referred for colposcopy HPV test after treatment Reassurance about the NPV

31. HPV What is it? How do you catch it? Has my partner been unfaithful? High risk types? Why test for HPV? Negative predictive value for HPV?

32. Screening Office Need to be involved at the start Plan for six weeks before go live date – invitations PCO need their HPV software enhancements activated by NHS Connecting for Health New set of standard invitation and result letters* Recommend action plan/check list * Some letters set up but not required currently e.g. Moderate dysk HPV +ve refer

33. Screening Office Practices that cover borders e.g. Sheffield/Derbyshire Set up additional districts for border practices Proposed rollout across different PCTs Exeter systems in different PCTs will not recognise HPV codes if software enhancement is not switched on ? Any GPs that send their own invitations

34. Screening Office Invitation letter, Screening – The Facts leaflet and HPV information leaflet* Enveloping machine capacity Outside agencies – capacity Need test runs between the lab and screening office - Ruby Whine * Possible incorporation into one leaflet

35. HPV Sentinel Sites – NHAIS (Exeter) System Date of issue: 26 October 2007 (Appendices revised April 2010) Document version: 1.4 FINAL Author: Andrea Pearson, NHSCSP http://www.cspnhs.org.uk/home.aspx?Menu=home

36. Examples of Letters to be Amended LetterTypePurpose/contentResultInfectA/C A-1InviteRoutine call/recallN/A A-2RemindRoutine call/recallN/A D-2ResultBNC HPV –ve routine recallBØA D-5ResultBNC HPV +ve refer for colpB9S E-2ResultMild dysk HPV –ve routineMØA E-5ResultMild dysk HPV +ve refer colpM9S J-2ResultNeg HPV +ve refer colpN9S

37. A1 – Invitation Letter Amendment Information about cervical screening and the recall processes are included in the enclosed leaflet ‘Cervical Screening – The Facts’ which you are advised to read before coming for the test. The second enclosed leaflet on HPV testing explains about another test that will be carried out on your screening sample if your screening result is mildly abnormal

38. J-2 Result Letter N9S The report from the laboratory showed that your cervical screening result appeared normal. The laboratory also tested your screening sample for the presence of the human papilloma virus (HPV) which can cause cervical abnormalities. The report showed some evidence of infection. This means that you may be at greater risk of developing cervical abnormalities in the future

39. Cytology Moderate or worse (no HPV test required) Colposcopy Referral 4S, 5S, 6S, 7S Screening test result Borderline/Mild Dyskaryosis HPV tested Negative Routine Recall 2A Moderate or worse or other indication for referral Colposcopy referral 1S, 2S, 3S, 4S, 5S, 6S, 7S, 8S HPV Negative Routine Recall BØA, MØA HPV Positive Colposcopy Referral B9S, M9S < CIN 1 Cytology Bord/Mild Routine Recall CIN 1/2/3 -> Treatment Invite for 6m test of cure < CIN 1 or Untreated CIN Cytology Follow-up or Recall Cytology abnormal (No HPV test) Colposcopy Referral 3S, 4S, 5S, 6S, 7S, 8S Cytology negative; HPV Positive Colposcopy Referral N9S Cytology negative; HPV Negative 3 Year Recall NØR36 Untreated CIN 1 Cytology Follow-up +/- Colposcopy KEY TO CODES & ABBREVIATIONS Aaction code: routine recall Raction code: early repeat Saction code: suspend from recall 1result code: inadequate 4 - 7result codes: NHSCSP standard abnormal results 2result code: negative (not HPV tested) Nresult code: negative (HPV tested) 3result code: mild dyskaryosis (not HPV tested) Mresult code: mild dyskaryosis (HPV tested) 8result code: borderline (not HPV tested) Bresult code: borderline (HPV tested) Ø (zero) infection code: HPV negative 9 (nine) infection code: HPV positive Uinfection code: HPV result unavailable/unreliable HPV test inadequate or unreliable Cytology = Borderline Repeat in 6m with HPV test only if Neg/Bord/Mild BUR(6) Inadequate Immediate repeat 1R(1-3) HPV test inadequate or unreliable Cytology = Mild dyskaryosis Colposcopy Referral MUS Cytology Neg/Bord/Mild; HPV Positive Colposcopy Referral N9S, B9S, M9S Cytology Neg/Bord/Mild; HPV Negative Routine Recall NØA, BØA, MØA Repeat test result NTDDNext Test Due Date BLUE indicates codes used on National Call and Recall Coding Test of cure Cytology negative; HPV test inadequate Immediate repeat NUR(1-3)

40. Activity Predictions/Modelling Laboratory currently refers on 2nd mild dysk and 3rd borderline – 128 additional colposcopies in 12 months/10 000 samples screened Laboratory currently refers on 1st mild dysk over 35, 2nd mild dysk under 35 and 3 rd BNC - 95 additional colposcopies in 12 months/10 000 samples screened

41. Activity Predictions/Modelling Laboratory currently refers on 1st mild dysk and 3rd BNC – 64 additional colposcopies in 12 months/10 000 samples screened

42. Colp Referral rates/quarter

43. Colp Referral Numbers/quarter

44. Sheffield HPV Testing ToC live from 1 st February 2008 Triage from 3 rd March 2008 Went well Masses of data collection

45. Future of HPV Testing It works – introduced nationally April 2011 Waiting national implementation guidance HPV testing done in cytology labs – centralisation 14 day TAT New HPV tests being evaluated – Sept 2011 Primary screening with HPV.........

46. Where do we go from here? NHSCSP Open Day National implementation guidance – on hold Pathway manager Bidding 35,000 samples/year Sign off PCT/QARC PASA agreement for HPV kits

47. Pathway Manager (PM) ? Central contact/lead Co-ordinates roll out across the patch Covers all aspects of the programme Funding comes through PM ? Who is best placed – HBPC?? Time – do not underestimate this

48. Why HPV test? From the woman’s point of view? Courtesy of Dr K Denton

49. Case1 Routine screen BNC HPV + Colp within 8 weeks CIN3, LLETZ ToC 6 months, negative Routine recall Patient pathway = 8 months Routine screen BNC Repeat 6 months, BNC Colp 14-18 months from original sample CIN3, LLETZ Annual F/U 10 years Patient pathway = 12 years

50. Case 2 Routine recall BNC HPV+ Colp SCC 1A1 LLETZ 10 years F/U Normal fertility and life expectancy Routine recall BNC Repeat at 6 months Colp referral delayed by 6 to 12 months SCC 1B+ Radical treatment Fertility and mortality affected

51. And finally ………… I HPV Testing