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GP Clinical Governance Leads Meeting June 2008 Dr Fraser Mutch FRCPath. Issues in Cytology. Recent or Current Issues Direct referral to colposcopy Introduction of LBC New Screening intervals EQA in the laboratory. Issues in Cytology. Future Issues - PowerPoint PPT Presentation
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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
Issues in CytologyIssues in Cytology
Future IssuesFuture Issues
14–Day Turnaround of 14–Day Turnaround of reportsreports
HPV TriageHPV Triage
Introduction of HPV Introduction of HPV vaccination vaccination
Issues in CytologyIssues in Cytology
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
Issues in CytologyIssues in Cytology
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
Issues in CytologyIssues in Cytology
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
Issues in CytologyIssues in Cytology
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
Issues in CytologyIssues in Cytology
Issues in CytologyIssues in Cytology
Future IssuesFuture Issues
14–Day Turnaround of reports14–Day Turnaround of reports
HPV TriageHPV Triage
Introduction of HPV Introduction of HPV vaccinationvaccination
Issues in CytologyIssues in Cytology
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
Issues in CytologyIssues in Cytology
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
Issues in CytologyIssues in Cytology
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
Issues in CytologyIssues in Cytology
HPV TriageHPV Triage
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.
Issues in CytologyIssues in Cytology
HPV TriageHPV Triage
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
Issues in CytologyIssues in Cytology
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.
Issues in CytologyIssues in Cytology
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.
Issues in CytologyIssues in Cytology
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