GP Clinical Governance Leads Meeting June 2008 Dr Fraser Mutch FRCPath

GP Clinical

Governance Leads MeetingJune 2008

Dr Fraser Mutch FRCPath

Issues in CytologyIssues in Cytology

Recent or Current IssuesRecent or Current Issues

Direct referral to colposcopyDirect referral to colposcopy

Introduction of LBCIntroduction of LBC

New Screening intervalsNew Screening intervals

EQA in the laboratoryEQA in the laboratory


Future IssuesFuture Issues

14–Day Turnaround of 14–Day Turnaround of reportsreports

HPV TriageHPV Triage

Introduction of HPV Introduction of HPV vaccination vaccination


Direct referral to colposcopyDirect referral to colposcopy

Introduced in 2007Introduced in 2007

Won Beds / Herts award for Won Beds / Herts award for innovationinnovation

Running for over 40 years in my Running for over 40 years in my previous postprevious post

Widely accepted and working wellWidely accepted and working well


Introduction of LBCIntroduction of LBC

Introduced in October 2007Introduced in October 2007

Processing for BedfordshireProcessing for Bedfordshire

Extremely smooth implementationExtremely smooth implementation

Issue around supply of vialsIssue around supply of vials

Well liked by sample takers and lab staffWell liked by sample takers and lab staff

Reduction in inadequate ratesReduction in inadequate rates


Routine Screening IntervalsRoutine Screening Intervals

25 – 4925 – 49 every 3 yearsevery 3 years

50 – 6550 – 65 every 5 yearsevery 5 years

65 +65 + cancel recall if 2 cancel recall if 2 negativenegative

samples in the last 10 yearssamples in the last 10 years

** Laboratory not funded for samples taken outside these intervals** Laboratory not funded for samples taken outside these intervals

Routine Screening IntervalsRoutine Screening Intervals


EQA in the laboratoryEQA in the laboratory

Organised regionally by East of England QARCOrganised regionally by East of England QARC

Minimum workloads for medical and non-medical Minimum workloads for medical and non-medical staffstaff

Mandatory practical test every 6 monthsMandatory practical test every 6 months

Action point reached if fall within bottom 2.5 Action point reached if fall within bottom 2.5 percentilepercentile

on two occasions or serious clinical error madeon two occasions or serious clinical error made

Ultimately may be required to cease workUltimately may be required to cease work


Future IssuesFuture Issues

14–Day Turnaround of reports14–Day Turnaround of reports


Introduction of HPV Introduction of HPV vaccinationvaccination


14–Day Turnaround of reports 14–Day Turnaround of reports

2005 General Election Manifesto Pledge2005 General Election Manifesto Pledge- All women will receive their result in 7 days- All women will receive their result in 7 days

Subsequent option appraisal – Subsequent option appraisal – unachievableunachievable without major financial investmentwithout major financial investment

14 day TAT for 95% of women with minimal initial 14 day TAT for 95% of women with minimal initial investment and 50% would get result in 7 daysinvestment and 50% would get result in 7 days

No central funding available to support this No central funding available to support this initiativeinitiative


14–Day Turnaround of reports – advice issued April 200814–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 2010Implemented by 2010


What is HPV Triage?What is HPV Triage?

All cervical samples with first BNC or mild dyskaryosis test All cervical samples with first BNC or mild dyskaryosis test result will be tested for HPV to distinguish between women result will be tested for HPV to distinguish between women who need referral to colposcopy and women who can be who need referral to colposcopy and women who can be safely returned to routine recall.safely returned to routine recall.

Women who test positive for HPV will be referred to Women who test positive for HPV will be referred to colposcopy. Women who are HPV negative will be returned to colposcopy. Women who are HPV negative will be returned to routine recall.routine recall.

www.cancerscreening.nhs.ukwww.cancerscreening.nhs.uk



There are over 100 subtypes of HPV. Most do not cause There are over 100 subtypes of HPV. Most do not cause significant disease.significant disease.

The high risk HPV subtypes are 16, 18, 31 & 33 The high risk HPV subtypes are 16, 18, 31 & 33 – – types 16 & types 16 & 18 are found in 70% of cervical cancers. Non oncogenic 18 are found in 70% of cervical cancers. Non oncogenic types are 6 & 11, which cause visible genital warts.types are 6 & 11, which cause visible genital warts.

Transient HPV is common especially in women under 35 Transient HPV is common especially in women under 35 years.years.

It persists in 20-30% of women putting them at increased It persists in 20-30% of women putting them at increased risk of developing cervicalrisk of developing cervical c cancer.ancer.

Women or their partners may have had HPV for many years Women or their partners may have had HPV for many years without knowing it.without knowing it.

There is no reliable treatment to clear the virus.There is no reliable treatment to clear the virus.



MAVARIC is a randomised trial set up in August 2005 to MAVARIC is a randomised trial set up in August 2005 to compare two automated screening technologies with manual compare two automated screening technologies with manual screening.screening.

Women registered in the MAVARIC Trial already receive HPV Women registered in the MAVARIC Trial already receive HPV triage. After 16th April 2007 all samples will be tested for HPV triage. After 16th April 2007 all samples will be tested for HPV if the cytology result is first BNC or mild dyskaryosis.if the cytology result is first BNC or mild dyskaryosis.

Six cytology centres will soon become ‘sentinel sites’ for Six cytology centres will soon become ‘sentinel sites’ for introducing HPV Triage into the cervical screening programme. introducing HPV Triage into the cervical screening programme.

Issues in CytologyIssues in CytologyHPV TriageHPV Triage

Pilot studies showed that: Pilot studies showed that: HPV testing is acceptable to women because it reduces the number 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 of early repeat tests that need to be done and speeds up referral to colposcopy where indicated.colposcopy where indicated.

46% of women with (first) BNC changes were HPV positive.46% of women with (first) BNC changes were HPV positive. 83% of women with (first) mild dyskaryosis were HPV positive.83% of women with (first) mild dyskaryosis were HPV positive. Women who are high risk HPV negative are unlikely to develop Women who are high risk HPV negative are unlikely to develop

cervical cancer.cervical cancer. HPV testing will result in some additional colposcopy referrals.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 Rana et al (2004) reported that in the long-term, 40% of women with BNC test resultsresults

are eventually referred to colposcopy.are eventually referred to colposcopy.

Issues in CytologyIssues in CytologyHPV TriageHPV Triage


Test of Cure Protocol (Follow up of treated CIN)Test of Cure Protocol (Follow up of treated CIN)

HPV testing will be used following treatment for CIN.HPV testing will be used following treatment for CIN.

Women who are cytology negative and HPV negative Women who are cytology negative and HPV negative will proceed to a three year recall period will proceed to a three year recall period – – avoiding the avoiding the need for 10 years of annual tests.need for 10 years of annual tests.

Untreated CIN1 will be followed up at colposcopists Untreated CIN1 will be followed up at colposcopists discretion.discretion.

Women who are cytology positive or HPV positive at 6 Women who are cytology positive or HPV positive at 6 months post treatment will be colposcoped.months post treatment will be colposcoped.


Guidance on explaining HPV Triage to womenGuidance on explaining HPV Triage to women

We cannot know when an individual woman became infected.We cannot know when an individual woman became infected.

We cannot know from whom this infection was transmitted.We cannot know from whom this infection was transmitted.

High risk HPV does not cause genital warts and wart High risk HPV does not cause genital warts and wart associated types doassociated types do n notot c causeause C CIN.IN.

HPV infection cannot be treated, only CIN.HPV infection cannot be treated, only CIN.

HPV vaccination will help prevent HPV infection and CIN in HPV vaccination will help prevent HPV infection and CIN in the future.the future.


Introduction of HPV vaccination – issued May Introduction of HPV vaccination – issued May 20082008

Schools-based programmeSchools-based programme

Beginning of 2008/09 school year all 12-13 year old girlsBeginning of 2008/09 school year all 12-13 year old girls

Catch-up campaign starting in 2009/10 for girls up to 18Catch-up campaign starting in 2009/10 for girls up to 18

3- dose course of HPV vaccine over about 6 months3- dose course of HPV vaccine over about 6 months

PCT’s to get £8.9 million to support implementationPCT’s to get £8.9 million to support implementation

www.vaccination.nhs.ukwww.vaccination.nhs.uk

Contact details:Contact details:

Laboratory:Laboratory: 01234 79262301234 792623

Myself:Myself: 01234 79232501234 [email protected]@nhs.net

GP Clinical Governance Leads Meeting June 2008 Dr Fraser Mutch FRCPath

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