GP Clinical Governance Leads Meeting June 2008 Dr Fraser Mutch FRCPath

1. GP Clinical Governance Leads Meeting June 2008 Dr Fraser Mutch FRCPath

2. Issues in Cytology • Recent or Current Issues Direct referral to colposcopy Introduction of LBC New Screening intervals EQA in the laboratory

3. Issues in Cytology • Future Issues 14–Day Turnaround of reports HPV Triage Introduction of HPV vaccination

4. Issues in Cytology • Direct referral to colposcopy Introduced in 2007 Won Beds / Herts award for innovation Running for over 40 years in my previous post Widely accepted and working well

5. Issues in Cytology • Introduction of LBC Introduced in October 2007 Processing for Bedfordshire Extremely smooth implementation Issue around supply of vials Well liked by sample takers and lab staff Reduction in inadequate rates

6. Issues in Cytology • Routine Screening Intervals 25 – 49 every 3 years 50 – 65 every 5 years 65 + cancel recall if 2 negative samples in the last 10 years ** Laboratory not funded for samples taken outside these intervals

7. Routine Screening Intervals

8. Issues in Cytology • EQA in the laboratory Organised regionally by East of England QARC Minimum workloads for medical and non-medical staff Mandatory practical test every 6 months Action point reached if fall within bottom 2.5 percentile on two occasions or serious clinical error made Ultimately may be required to cease work

9. Issues in Cytology

10. Issues in Cytology • Future Issues 14–Day Turnaround of reports HPV Triage Introduction of HPV vaccination

11. Issues in Cytology • 14–Day Turnaround of reports 2005 General Election Manifesto Pledge - All women will receive their result in 7 days Subsequent option appraisal – unachievable without major financial investment 14 day TAT for 95% of women with minimal initial investment and 50% would get result in 7 days No central funding available to support this initiative

12. Issues in Cytology • 14–Day Turnaround of reports – advice issued April 2008 i. Limit processing of samples to only those women eligible within national standards ii. Implement an electronic link from the laboratory to the call and recall office iii. Despatch results letters by first class post on Monday, Tuesday and Wednesday mornings iv. Workforce redesign – training of Advanced Practitioners v. Merge workload from small laboratories (labs to report > 35000) Implemented by 2010

13. Issues in Cytology • What is HPV Triage? • All cervical samples with first BNC or mild dyskaryosis test result will be tested for HPV to distinguish between women who need referral to colposcopy and women who can be safely returned to routine recall. • Women who test positive for HPV will be referred to colposcopy. Women who are HPV negative will be returned to routine recall. www.cancerscreening.nhs.uk

14. Issues in Cytology • HPV Triage • There are over 100 subtypes of HPV. Most do not cause significant disease. • The high risk HPV subtypes are 16, 18, 31 & 33 – types 16 & 18 are found in 70% of cervical cancers. Non oncogenic types are 6 & 11, which cause visible genital warts. • Transient HPV is common especially in women under 35 years. • It persists in 20-30% of women putting them at increased risk of developing cervical cancer. • Women or their partners may have had HPV for many years without knowing it. • There is no reliable treatment to clear the virus.

15. Issues in Cytology • HPV Triage • MAVARIC is a randomised trial set up in August 2005 to compare two automated screening technologies with manual screening. • Women registered in the MAVARIC Trial already receive HPV triage. After 16th April 2007 all samples will be tested for HPV if the cytology result is first BNC or mild dyskaryosis. • Six cytology centres will soon become ‘sentinel sites’ for introducing HPV Triage into the cervical screening programme.

16. Issues in Cytology HPV Triage Pilot studies showed that: • HPV testing is acceptable to women because it reduces the number of early repeat tests that need to be done and speeds up referral to colposcopy where indicated. • 46% of women with (first) BNC changes were HPV positive. • 83% of women with (first) mild dyskaryosis were HPV positive. • Women who are high risk HPV negative are unlikely to develop cervical cancer. • HPV testing will result in some additional colposcopy referrals. Rana et al (2004) reported that in the long-term, 40% of women with BNC test results are eventually referred to colposcopy.

17. Issues in Cytology HPV Triage

18. Issues in Cytology • Test of Cure Protocol (Follow up of treated CIN) • HPV testing will be used following treatment for CIN. • Women who are cytology negative and HPV negative will proceed to a three year recall period – avoiding the need for 10 years of annual tests. • Untreated CIN1 will be followed up at colposcopists discretion. • Women who are cytology positive or HPV positive at 6 months post treatment will be colposcoped.

19. Issues in Cytology • Guidance on explaining HPV Triage to women • We cannot know when an individual woman became infected. • We cannot know from whom this infection was transmitted. • High risk HPV does not cause genital warts and wart associated types do not cause CIN. • HPV infection cannot be treated, only CIN. • HPV vaccination will help prevent HPV infection and CIN in the future.

20. Issues in Cytology • Introduction of HPV vaccination – issued May 2008 Schools-based programme Beginning of 2008/09 school year all 12-13 year old girls Catch-up campaign starting in 2009/10 for girls up to 18 3- dose course of HPV vaccine over about 6 months PCT’s to get £8.9 million to support implementation www.vaccination.nhs.uk

21. Contact details: Laboratory: 01234 792623 Myself: 01234 792325 fraser.mutch@nhs.net