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Manual - North West Cervical Screening Quality Assurance Reference

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Manual - North West Cervical Screening Quality Assurance Reference Powered By Docstoc
					NORTH WEST CERVICAL SCREENING

Quality Assurance Reference Centre




                  AnnualReport
                     2007-2008
NORTH WEST CERVICAL SCREENING QUALITY ASSURANCE REFERENCE CENTRE


            Annual Report 2007-2008




                   The Liverpool Women‟s NHS Foundation Trust
                             Crown Street ● Liverpool
                                      L8 7SS
                      Tel 0151 702 4281 ● Fax 0151 702 4278
                            Email nw.csqarc@lwh.nhs.uk
                           Website www.nwcsqarc.org.uk
Ruth Stubbs

Primary Care Coordinator




Yvonne Browne

Project Manager / Coverage Officer




Millie Forde

HTA Study Research Coordinator / Audit Liaison Officer




Michael Wall

IT/Data Manager




 Jayne Williams

Acting Audit Liaison Officer
 Amy Trousdale

 Administrative Officer




Jan Perriton

HTA Study Administration & Clerical
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Table of Contents

CHAPTER                       1


THE CURRENT QA STRUCTURE ....................................................................................................................................................... 1
        Terms of Reference of the Executive Group .............................................................................................................................................. 2


MEMBERSHIP OF THE EXECUTIVE GROUP ..................................................................................................................................... 3


QARC MANAGEMENT STRUCTURE .................................................................................................................................................. 4


RELATIONSHIPS ................................................................................................................................................................................. 4


CHAPTER                       2


INFORMATION TECHNOLOGY – MICHAEL WALL ............................................................................................................................ 5


MULTIDISCIPLINARY QA SITE VISITS............................................................................................................................................... 5


DIRECT REFERRAL TO COLPOSCOPY............................................................................................................................................. 7


HPV SENTINEL SITE PROJECT ......................................................................................................................................................... 8


GUIDANCE FOR THE CONDUCT OF MDT/ DISCREPANCY MEETINGS .......................................................................................... 9


GUIDANCE FOR SATELLITE AND PRIMARY CARE-BASED COLPOSCOPY UNITS ..................................................................... 10


SCREENING OFFICE INITIATIVE...................................................................................................................................................... 11
 Issues Addressed ..................................................................................................................................................................................................... 13
 Improvements in Service Provision ......................................................................................................................................................................... 13


WORKFORCE AND WORKLOAD REVIEW AND QUALITY INITIATIVE........................................................................................... 13


SPECIALISED COMMISSIONING...................................................................................................................................................... 16


HOSPITAL BASED PROGRAMME COORDINATOR – ROLES AND RESPONSIBILITIES .............................................................. 17


REPORTING OF ORGANISMS / INFECTIONS IN CERVICAL SMEARS .......................................................................................... 19


CITY & GUILDS DIPLOMA IN CERVICAL CYTOLOGY .................................................................................................................... 20
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LIQUID BASED CYTOLOGY ............................................................................................................................................................. 21


LBC SPECIMEN ADEQUACY AND THE HTA ADEQUACY STUDY ................................................................................................. 21


HPV VACCINATION ........................................................................................................................................................................... 22


CEASED WOMEN AUDIT .................................................................................................................................................................. 23
 The North West Approach ...................................................................................................................................................................................... 24
 Data Extraction ....................................................................................................................................................................................................... 24
 Checks undertaken by each Screening Manager ...................................................................................................................................................... 25
 Women ceased due to Age ...................................................................................................................................................................................... 25
 Women ceased due to No Cervix ............................................................................................................................................................................ 25
 Women ceased due to Informed Choice .................................................................................................................................................................. 25
 Women ceased due to ‘Other’ reasons .................................................................................................................................................................... 25
 Women automatically ceased due to Age ................................................................................................................................................................ 25
 Women ceased – Reason Not Specified .................................................................................................................................................................. 26
 Result of the audit ................................................................................................................................................................................................... 26
 Summary ................................................................................................................................................................................................................. 26


REGIONAL CYTOLOGY TRAINING CENTRES ................................................................................................................................ 26


CHAPTER                       3


NUMBER OF UNITS, WORKLOAD AND STAFFING FIGURES ........................................................................................................ 27
 Workload ................................................................................................................................................................................................................ 27
 Turnaround Times ................................................................................................................................................................................................... 28
 CPA Accreditation Status........................................................................................................................................................................................ 29


PRIMARY SCREENING SENSITIVITIES ........................................................................................................................................... 29


KC61 DATA........................................................................................................................................................................................ 30


DERIVED PERFORMANCE DATA .................................................................................................................................................... 34
 Positive Predictive Value (PPV).............................................................................................................................................................................. 34
 Total Predictive Value (TPV) .................................................................................................................................................................................. 36
 Abnormal Predictive Value (APV) .......................................................................................................................................................................... 36
 Percentage Discordant Outcomes (PDO) ................................................................................................................................................................ 37
 Age-risk-interval PPV adjusted Moderate+ rate (ARI Mod+ PPV) ......................................................................................................................... 38
 Mean CIN Score...................................................................................................................................................................................................... 39
 Odds of false positive referral (OFP) ....................................................................................................................................................................... 40
 Referral-OUTcome (ROUT) diagram...................................................................................................................................................................... 40
 Treatable CIN Ratio ................................................................................................................................................................................................ 41


CONCLUSIONS ................................................................................................................................................................................. 42


SUMMARY OF GYNAECOLOGICAL AND TECHNICAL EQA SCHEMES - MILLIE FORDE AND JAYNE WILLIAMS..................... 42
 Gynaecological Cytopathology EQA ...................................................................................................................................................................... 42
 Technical EQA........................................................................................................................................................................................................ 43


CHAPTER                       4


COLPOSCOPY UNITS AND KC65 RETURNS .................................................................................................................................. 46


KC65 DATA........................................................................................................................................................................................ 46


CHAPTER                       5


COVERAGE OF CERVICAL SCREENING......................................................................................................................................... 52
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TIME SINCE LAST TEST ................................................................................................................................................................... 54


UPTAKE OF INVITATIONS ................................................................................................................................................................ 54


SMEAR TEST RESULTS ................................................................................................................................................................... 55


INVASIVE CERVICAL CANCERS...................................................................................................................................................... 57


COVERAGE REPORT – YVONNE BROWNE .................................................................................................................................... 59


PRIMARY CARE ACTIVITY – RUTH STUBBS .................................................................................................................................. 60


CHAPTER                       6


SPEEDING UP CERVICAL SCREENING .......................................................................................................................................... 62


SEMI-AUTOMATION AS AN ADJUNCTIVE QUALITY CONTROL MEASURE ................................................................................. 63


MOLECULAR MARKERS .................................................................................................................................................................. 64


REVISED TERMINOLOGY FOR CERVICAL CYTOLOGY ................................................................................................................. 64


KEY AREAS FOR ACTION ................................................................................................................................................................ 65


APPENDIX 1 – REGIONAL CYTOLOGY TRAINING CENTRES........................................................................................................ 66


LIVERPOOL CYTOLOGY TRAINING CENTRE .............................................................................................................................. 66
        NHS CSP NCCETC Accreditation .......................................................................................................................................................... 66
        Staffing of the Liverpool Cytology Training Centre ................................................................................................................................ 67
        Update on City & Guilds Diploma .......................................................................................................................................................... 68
        Proposed Changes in Training Activity ................................................................................................................................................... 69
        Training Centre Course Repertoire .......................................................................................................................................................... 70
        Future Funding Arrangements ................................................................................................................................................................. 72
        Changes to Facilities and other planned developments ............................................................................................................................ 73
             Semi-automated screening systems.................................................................................................................................................. 73
             Molecular Markers .......................................................................................................................................................................... 73
             Website and e-learning materials ..................................................................................................................................................... 73
        Course Material ....................................................................................................................................................................................... 73
        LBC Systems ........................................................................................................................................................................................... 74
        Future Directions and Business Strategy ................................................................................................................................................. 74


MANCHESTER CYTOLOGY TRAINING CENTRE .......................................................................................................................... 75
       Staffing .................................................................................................................................................................................................... 75
       Funding ................................................................................................................................................................................................... 76
       Course Information .................................................................................................................................................................................. 76
       LNR Regional LBC roll-out training ....................................................................................................................................................... 76
       Northern and Southern Ireland................................................................................................................................................................. 76
       Facilities and Equipment ......................................................................................................................................................................... 77
       Planned Developments for 2006-7........................................................................................................................................................... 78


APPENDIX 2 – PROTOCOLS FOR THE MANAGEMENT OF LOW SENSITIVITY ............................................................................ 79


APPENDIX 3 – TEMPLATE FOR HBPC ANNUAL REPORT ............................................................................................................. 81
    Annual Report Template ............................................................................................................................................................................... 81
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                           Foreword by the Author

Dear Colleague,


It gives me great pleasure in distributing the Annual Report 2007 – 2008 which
provides an overview of the accomplishments of the Cervical Screening
Programme in the North West last year.
This has been another busy year with further developments within the cervical
screening programme and more expected. The introduction of HPV vaccination
will mandate more fundamental change in the years to come, but in the interim it
is crucial that our adult population is made aware of the benefits of cervical
screening and is given every chance to readily access a service of the highest
possible quality.
It is appropriate therefore to thank all who participate in this programme either
by working within it, by providing data relating to it or by engaging in the many
QA activities which support its delivery. A special thank you also to the team at
the QARC and to the panel that travel widely within the region and provide
expert guidance and opinion to the QA Site visits.




Dr Lesley S Turnbull, QA Director
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                                  The Quality Assurance
                                  Reference Centre



                                  The Current QA Structure
                            The Executive Group is chaired by the QA Director and
has a strategic rather than operational function. Its membership includes all members
of the QARC and all lead professionals from the Specialty Action Groups, together
with additional members on an ad hoc basis. The current membership is listed below.
Members of these groups are tasked with specific responsibilities; with representing the
QARC on National QA Groups and with assisting in the process of communicating
with fellow professionals at grass-roots level. Facilitating and extending communication
throughout all components of the programme is again identified as a priority for all
who represent QA activities.

Over the course of the year there have been significant changes to the membership of
both the QARC and to Government Office North West, to which it responds. In
particular, Dr Mahmood Adil, previously Deputy Regional Director of Public Health,
left in September to take up a secondment to the Offcare Establishment Team. We
thank him for all his support in relation to cervical screening QA and wish him all
success in his new endeavours. We are sure that this role will be ably filled by Dr Judith
Richardson, Specialist in Public Health, who takes on responsibility for all screening
programmes, both cancer and non-cancer, across the North West.

In the QARC office, Mrs Deborah Jennings left for employment outwith the NHS and
has been replaced by Ms Amy Trousdale. Mrs Millie Forde commenced an 18-month
secondment as Research Coordinator to the HTA LBC Adequacy Study in September
2007 and will be assisted in this work by Mrs Jan Perriton. During the lifetime of the
study, Millie‟s role as Audit Liaison Officer will be undertaken by Mrs Jayne Williams.
We are greatly indebted to Millie who has agreed to provide expert cover to the unit in
addition to her HTA duties.




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          It is with regret that we announce the early retirement of Ms Helen Patrick on grounds
          of ill health. Helen has always been a passionate advocate of cervical screening and led
          the implementation of Technical EQA in the North West. We wish her all the best in
          retirement.


Terms of Reference of the Executive Group




                              To provide strategic direction to the Quality Assurance function of
                              the NHS CSP in the North West Region taking into account NHS
                              CSP guidance, the NHS Cancer Plan and other relevant national
                              documents.

                              To advise on the introduction and implementation of cervical
                              screening policies and procedures based on guidance from the NHS
                              CSP and professional bodies including Royal Colleges, the BSCC and
                              the BSCCP

                              To act as a vehicle to give all those who act on behalf of or who give
                              professional advice to the North West Cervical Screening Quality
                              Assurance Reference Centre (NWCSQARC) an overview of current
                              issues and new developments within the NHS CSP.

                              To provide a mechanism for information sharing and cross-
                              fertilisation between the various groups working within the structure
                              of the NWCSQARC. This would include the QARC itself, Specialty
                              Action Groups, EQA groups and ad hoc groups.

                              To act as a vehicle for the dissemination of information from grass
                              roots level, through the QARC to the National Office of Cancer
                              Screening Programmes and vice versa.

                              To overview the commissioning of time-limited task groups as
                              necessary to undertake specific pieces of work and to agree the terms
                              of reference and membership of such groups.

                              To overview the commissioning of specific projects or pieces of work
                              and to advise on the monitoring of their progress.




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Membership of the Executive Group
Dr Lesley Turnbull                  QA Director

Mrs Ruth Stubbs                     Primary Care Coordinator

Mrs Yvonne Browne                   Project Manager / Coverage Officer

Mr Michael Wall                     IT Manager / Data Coordinator

Mrs Millie Forde                    Audit Liaison Officer / HTA Study Research Coordinator

Mrs Jayne Williams                  Acting Audit Liaison Officer

Ms Amy Trousdale                    Administration & Clerical

Mrs Jan Perriton                    HTA Study Administration & Clerical

Mr Jonathan Herod                   Lead Colposcopist

Mr P Martin-Hirsch                  Lead Colposcopist

Mr Nabil Haddad                     Lead Colposcopist

Miss Nahid Gul                      Lead Colposcopist

Mr Derek Parkinson                  Lead Colposcopist

Mr David Semple                     Lead Colposcopist

Dr Jon Sheard                       Lead Pathologist

Dr David Bisset                     Lead Pathologist & Lead Gynaecological EQA

Dr Alistair Clark                   Lead Technical EQA

Mr Chris Evans                      Lead BMS

Mrs Julie Scanlon                   Lead BMS & Facilitator Technical EQA

Ms Alison Foley                     Lead BMS

Mr Mike Palmer                      Lead BMS

Dr Jane Rossini                     Lead Public Health

Dr Rebecca Wagstaff                 Lead Public Health

Mrs Elaine Jones                    Lead for Health Agencies

Dr Graham Allan                     Lead for General Practice

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    QARC Management Structure
    The current structure of the Quality Assurance Reference Centre is depicted below:




                                                    QA Director

                                              Dr Lesley Turnbull




Coverage Officer /                Primary Care                        IT Manager      Audit Liaison Officer /
 Project Manager                  Coordinator                                         HTA Study Coordinator
Mrs Yvonne Browne                Mrs Ruth Stubbs                    Mr Michael Wall     Mrs Millie Forde




                                 Acting Audit                      Administrative     HTA Administrative
                                Liaison Officer                       Officer              Officer
                               Mrs Jayne Williams                 Ms Amy Trousdale     Mrs Jan Perriton




    Relationships
    The QARC has close working relations with a wide range of professional groups and bodies.
    These include:

          Local Cervical Screening Working Parties / Steering Groups / PCTs

          Cancer Networks and Gynaecological Cancer Multi-disciplinary Teams

          Strategic Health Authority / Regional Government Office

          National Office of Cancer Screening Programmes

          National Cervical Screening QA Groups

          Other Regional QA Teams

          Royal College of Pathologists, British Society for Clinical Cytology, British Society for
          Colposcopy and Cervical Pathology

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                                  Programme-Wide Issues




                                  Information Technology – Michael
                                  Wall
                             The rolling program to assist in the installation of the
Cyres Pathology system continues across the region. Two sites remain to be installed,
but have been delayed by the implementation of Trust laboratory IT systems at
merging laboratories. A regional Cyres User Group has been proposed but has not as
yet met.

The NWCSQARC website is continually updated providing general information about
the activities of the unit and changes to the programme. The website attracts on
average over 6,200 visitors per month; an increase of 87% compared with last year.

Interactive applications for a variety of sources are available and are continually
updated. These have been developed to aid the rapid extraction of data in a number of
formats without requiring the user to have detailed IT knowledge. Sources include
KC61, KC65, the NHS CSP Statistical Bulletin and the North West Cancer Intelligence
Service – Incidence & Mortality for Cervical Cancer (C53).

Applications for Sample Takers and Practice Managers to obtain inadequate rates are
available and require the user to register with the site. These applications cover 12
months data and are updated quarterly.

Multidisciplinary QA Site Visits
Multidisciplinary QA site visits are an important and extremely useful component of the
quality assurance repertoire. It is clear that while the QA Reference Centre gathers a huge
array of workload and performance data, the site visits provide what is often a rather
different perspective on the functioning of the service. They are conducted in a supportive
rather than inspectorial manner and have provided a route by which communication can be

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expanded and acknowledged problems discussed in an open and fruitful medium. The
purpose of these visits is to:


                Assess the performance of the local screening programme against
                national and regional standards and establish reasons for any variation
                from these standards

                Establish whether there is good communication and co-operation
                between the various elements of the cervical screening programme in
                each area

                Support professionals working in the cervical screening programme in
                the North West to maintain and improve their service

                Provide a forum on which to report the quality of the services
                provided to the organisations involved, the Regional Director of
                Public Health and the National Office of Cancer Screening
                Programmes

                Identify areas of good practice that can be disseminated, through the
                regional structures, to the rest of the services within the North West


The visiting QA Team is selected from a panel of lead clinicians and professionals who work
in the main areas of professional activity provided by the Trust (pathology, colposcopy,
genitourinary medicine). The Regional QA Director leads the Team, supported by members
of the QARC who provide continuity between visits.

The date of the QA visit is usually agreed and confirmed many months in advance to avoid
coinciding with other accreditation visits and inspections. The Hospital-based Programme
Co-ordinator (HBPC) for the Trust helps to co-ordinate the visit and is provided with a
checklist of arrangements to be made. Questionnaires are sent to each discipline two months
prior to the visit, requesting information and statistics on which to base the visit. This data is
used to compile an information pack, which is sent to the Visiting Team members two
weeks in advance of the visit. If all services to be visited are on a single site then it is usually
possible to complete the visit within the day. If there are more sites to be visited then more
time may be necessary. The Lead Clinicians for Cytopathology and Colposcopy and the
Hospital-Based Programme Co-ordinator should be available throughout the visit.

The visiting team separates into its specialty areas to tour the Pathology laboratory, the
Colposcopy unit and Department of Genito-Urinary Medicine if appropriate. Meanwhile,
Primary Care and Public Health teams hold separate discussions regarding their own aspects
of the service. The visiting team then meets privately over lunch to discuss its findings.
Thereafter, the Lead Clinicians and all interested staff are invited to join the QA team for a
feedback session. This session aims to provide an assessment of professional performance,
programme management and compliance with national and regional standards, as well as
imparting good news, sharing good practice and providing advice where requested.



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In the final session, the QA Director meets with senior Trust staff usually including the
Chief Executive to give a brief verbal summary of the main findings and to seek clarification
of any professional or programme management issues.

A draft report, including a summary of findings and recommendations with timescales, is
sent to the Lead Clinicians and Hospital-Based Programme Co-ordinator for checking and
agreement. The final report is sent to the Trust Chief Executive, with copies to the PCT
Screening Commissioner, the Cancer Network, the Strategic Health Authority, the Regional
Director of Public Health and the National Co-ordinator of the NHS CSP. It is important to
note that changes made subsequent to the visit cannot be incorporated into the visit report,
but should form part of the local Steering Group action plan. Only changes of fact or
additional facts not available to the team on the day of the visit are admissible changes to the
documentation and are usually recorded as post scripts.

The second round of site visits commenced in November 2005 and will be completed
by May 2009. The scheduling has been devised such that those units which have been
unable to fulfil the previous action plan recommendations were visited at an early stage.
While following a similar format to the initial round, the second round visits have
higher expectations and place increased pressure on Trusts to address urgently areas of
non-compliance, particularly where these impact on service quality or patient safety.


Direct Referral to Colposcopy
The ability of laboratories to directly refer women for colposcopic assessment, without the
intervention of the general practitioner can significantly reduce colposcopy waiting times. As
a result, increasing numbers of screening units throughout the North West have
implemented or are considering implementing this method of referral. Conversely, some
Trusts which have implemented „Choose and Book‟ have experienced increasing waiting
times because patients have chosen clinic appointments outwith the target period.

However, direct referral is not without problems. The lack of a standardised protocol for
implementation has resulted in different systems being adopted and constitutes a potential
risk to the programme. Problems arise from two main sources. The first is where a single
laboratory serves two programmes, one wishing to use direct referral, the other „Choose and
Book‟. The laboratory can only operate one referral system. If it moves to a direct referral
system all GPs will receive electronic results stating that „this woman has been referred to
colposcopy‟ and there is a risk that some GPs operating within „Choose and Book‟ will not
refer women when they should. The second problem results from the use of different result
letters. Some ask the woman to ring a number to make an appointment with colposcopy;
others send a letter informing the woman that she will receive an appointment for
colposcopy by post. If different direct referral methods or a combination of direct referral
and „Choose and Book‟ are used by a single screening office using a single database some
women will inevitably receive misleading information resulting in a delay or worse a failure
to access the colposcopy service.

A pan-regional meeting involving colposcopists, pathologists, public health specialists and
screening managers was held in December 2007 to discuss these problems and to identify a
way forwards. Useful and informative presentations were given by a range of health

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professionals, outlining the relative strengths and weaknesses of various referral systems.
Elaine Jones, Head of Patient and Contractor Services, LaSCA explained how the Exeter
system could be used to establish „mini-districts‟, which would segment populations and
allow different referral options to co-exist within a single database. This was widely accepted
as the easiest and least disruptive solution which would facilitate the ongoing roll-out of
direct referral to those localities that wished to implement this pathway. At a more general
level, it was acknowledged that any change in referral practice should be agreed by screening
commissioners, screening offices, colposcopy units and laboratories and that all users of
laboratories and screening offices should be consulted when changes are made to systems or
letters, however small the numbers of women affected.

HPV Sentinel Site Project
In 2000-01 the Department of Health established a number of pilot sites to assess both
liquid based cytology (LBC) and HPV testing of women with borderline or mildly
dyskaryotic smear results. The findings in relation to LBC were published by NICE in
October 2003 and have led to nationwide implementation of this technology. The HPV
findings were published in the BMJ in 2006. The data showed that using HPV testing
to triage women with low-grade cytological abnormalities is more expensive but saves
slightly more lives. This gain in life expectancy is related both to referring women
earlier to colposcopy and to minimising loss to follow up after the initial smear result.
The authors made the point that the study was limited by the lack of data on the quality
of life implications and societal costs of using HPV testing compared with repeat
smears. There was a trade-off between the predicted potential gains in life expectancy
and reduction in surveillance smears (52-86%) using HPV testing and the negative
implications for women of increased lifetime colposcopies (64-138%). It was felt that
this deserved careful consideration and further work.
With this in mind the Advisory Committee for Cervical Screening determined that HPV
triage required further controlled implementation prior to proposing national roll-out. The
only triage setting was in Greater Manchester, where the MAVARIC Trial (HTA) started in
March 2006. This compares semi-automated cytology with manual reading and incorporates
the HPV triage of women with low-grade smear abnormalities. MAVARIC aims to enrol
approximately 100,000 screened women from a multi-ethnic inner city population. The
TOMBOLA trial, which examined the effectiveness and cost effectiveness of HPV triage, is
expected to report this year. It was therefore proposed that additional „sentinel sites‟ were set
up in other areas of England if possible, covering a population of 2-3M. Liverpool and
Manchester were selected as sentinel sites, together with Bristol, Norfolk and Norwich,
Liverpool, Sheffield and Northwick Park.

These sites commenced HPV testing between January and June of this year and will
examine the reflex use of HR-HPV testing both in the management of women with low-
grade abnormalities and as a „test of cure‟ following excisional treatment. It is anticipated that
the sentinel sites will effectively be early implementers and that national roll out will follow in
due course. This dual use of HR-HPV testing is expected to result in a further 10% decline
in cytology workloads.




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Guidance for the Conduct of MDT/ Discrepancy
Meetings
It is clear from QA Multidisciplinary Site Visits that there is huge variation in the conduct of
multidisciplinary / discrepancy meetings, both in terms of their frequency and organisation
and in the cases that are discussed. This guidance aims to bring some consistency to these
meetings by introducing a minimum quality standard. It is a distillate of discussions held
during the Quality Assurance Discussion Day on 31st July 2007 and sets out the minimum
standard for multidisciplinary meetings relating to cytology, histology and colposcopy. It is
not intended to be prescriptive and individual units may wish to do more than this minimum
standard. It is to be used as a supplement to the NHS CSP Publication No 20, 2004,
Colposcopy and Programme Management.

Within the Cervical Screening Programme, the purpose of multidisciplinary meetings is to
discuss difficult cases; cases which pose particular management issues and those where there
is significant discordance between the cytological, histological and colposcopic findings.
Current guidelines suggest that such meetings should be held at least twice a year (NHS CSP
Publication No 20, 2004, Colposcopy and Programme Management) but this is clearly out of line
with other cancer-focused MDTs and could result in long delays in cases being discussed. It
is recommended, therefore, that cervical cytology / histology / colposcopy MDT meetings
should be held every 2-4 weeks depending on the size of the unit and the number of cases to
be discussed. These may operate as separate cytology/histology/colposcopy discrepancy
meetings and gynaecological oncology meetings or as a combined meeting. Operational
meetings to discuss protocols, audits and teaching should be held every 3 months.

The meetings should be chaired by the HBPC, the Lead Cytologist or the Lead
Colposcopist and should include laboratory personnel, cytopathologists and
histopathologists, medical and nurse colposcopists, colposcopy nurses and colposcopy
administrators. Attendance should be noted in the minutes for audit purposes and all
members should aim to attend a minimum of 60% of meetings in a year. Where a unit
serves a number of peripheral MDTs attendance figures should relate to the parent MDT.

Formal minutes should be recorded. The patient notes should be available at the
meeting and a brief summary of cases should be circulated in advance. Action points
should be recorded in the patient notes as well as in the minutes. Letters should be sent
to the GP and to the Screening Office if a result is amended.

Cases for discussion should include the following categories:

       Discrepancy between smear and biopsy of two or more grades
       Glandular lesions
       Borderline glandular lesions
       Women under 25 years where treatment is contemplated or where there is 2 or
       more grade mismatch
       When a second LLETZ is contemplated

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       All cancer cases including microinvasive lesions
       Persistent low grade abnormalities (for 2-3 years or more) including in atrophic
       pattern smears
       Lesions at or close to the endocervical excision margin


Guidance for Satellite and Primary Care-Based
Colposcopy units
This guidance relates to Colposcopy Units which operate outwith the immediate Acute
Trust sector and should be used in conjunction with and as a supplement to NHS CSP
Publication No. 20, ‘Colposcopy and Programme Management’. It has been
produced by the NW QA Colposcopy Advisory Group in response to enquiries from
Primary Care. It aims to reinforce existing guidance and to clarify a number of areas not
directly covered by the above document. The units to which it refers include the
following:


       Satellite units operated by Acute Trust Colposcopy services and usually based
       in community hospitals and clinics at a distance from the main Acute Trust
       Hospital.

       Colposcopy units operated by Acute Trust Colposcopy services and based in a
       Primary Care setting.

       Colposcopy units operated by Primary Care in a Primary Care setting.


The unit must be in a private area with changing facilities and toilets. There must be a
permanent couch and colposcope, with appropriate recovery facilities; either a couch or
reclining chair. This may be situated either within the colposcopy room or in a separate
room. Intermittent nursing cover should be provided if the recovery area is separate
from the colposcopy room. It is unacceptable for the recovery area to be part of
the waiting area or for patients to be provided with only a standard waiting area
chair. Equipment for cold coagulation, cryocautery or loop excision, etc. should be
covered by regular service and maintenance contracts. Maintenance records should be
available for scrutiny. Adequate resuscitation equipment must be immediately available.

Written protocols must be available to cover the following:

       Chaperoning
       Informed consent - written consent is considered to be best practice but is
       not mandated at present. If verbal consent is obtained then the discussion
       must be documented in the case notes. Some units use an appropriate sticker
       which is then signed by the practitioner.
       Management and treatment of cervical abnormalities

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       Safe use of colposcopy and treatment equipment
       Resuscitation and emergency procedures
       Failsafe


All medical and nurse colposcopists must participate in regular Multidisciplinary Team
Meetings (MDTs) and / or discrepancy meetings. These should be held on at least a
monthly basis and it is expected that individuals would participate in at least 60% of
meetings. It is desirable although not mandatory for colposcopists also to have
colposcopy/gynaecology sessions in an Acute Trust. All practising colposcopists must
be able to demonstrate that they have received adequate training. All colposcopists
should be certified through the BSCCP/RCOG scheme and should comply with the
recertification process every three years. Colposcopists practising within the NHS CSP
should see at least 50 new abnormal cytology referrals per year. All colposcopists must
attend one colposcopy meeting recognised by the BSCCP every three years. All
colposcopists must ensure that regular audit of their service takes place to compare
practice with the local protocols and national targets. All colposcopy staff must
undergo regular resuscitation training.

Colposcopists who do not undertake either colposcopy or gynaecology sessions in an
Acute Trust should not accept patients referred with either severe ? invasive or
?glandular cytology reports. Patients deemed to be at increased risk of treatment-related
complications e.g. those on anticoagulants or with a bleeding disorder, should be
treated in secondary care. For diagnostic colposcopy, the colposcopist should be
assisted by a healthcare assistant and another trained nurse should be available on site.
For therapeutic colposcopy, the colposcopist should be assisted by a trained nurse and
a doctor should be available on site.

Each woman should be offered verbal and be sent written information before
colposcopy. All consultations must be recorded in full. Results and management plans
should be communicated to the referring practitioner within four weeks of the patient‟s
attendance at the clinic. There must be appropriate information technology equipment
and software to facilitate the collection of data for the BSCCP minimum dataset and
for the quarterly submission of the statutory KC65 return. Satellite units may be
included within the return from the parent unit. Independent colposcopy units must
complete an individual return.

Screening Office Initiative
The call/recall service is provided by PCTs, either directly, or indirectly as a delegated
function in which Agencies undertake the processing work. The call/recall programme and
the work of those screening staff have played a major part in the success of the cervical
screening programme. While acknowledging this achievement, it was announced at the NHS
Cervical Screening Programme Open Day at the end of 2005, that in the future the NHS
CSP would probably move towards centralised services, with a single screening office
covering a whole region. This concept has recently been reiterated in the Cancer Reform
Strategy and in the Options Appraisal and Review of the Administration of the NHS

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Cervical Screening Programme produced by Beaumont Colson Ltd. on behalf of the NHS
CSP. It seemed appropriate therefore that the North West takes a lead role in this
development, ensuring that the best model for the North West is implemented.

A meeting was held in summer 2006 with Directors of Public Health and (former) SHA
leads across the North West to alert them to the proposed changes and to seek their support
in taking this forward. Following this meeting the QA Director wrote to the Chief
Executives and Directors of Human Resources in every (former) PCT outlining the
proposed changes and highlighting the potential impact on staff. A further meeting was held
with screening managers from across the North West to ensure everybody was fully
informed and involved in the process.

In the North West the call/recall process for cervical screening was previously undertaken
by 10 (former) PCTs/Agencies working on 13 NHAIS systems. Organisational
arrangements varied considerably, from a single PCT operating its own system, to an agency
providing the call/recall services to 11 (former) PCTs. As might be expected this
arrangement resulted in different levels of service being provided to PCTs across the North
West.

Concerns have been expressed in the past around the administration of the screening
services provided by some PCTs and in particular around:


       Risks in service continuity due to inadequate staff cover
       Poor procedures and working practices
       Information provided for Public Health monitoring e.g. coverage rates
       Different levels of adaptability


Concerns have been further exacerbated over the last eighteen months by a series of serious
untoward events involving a number of screening offices across the North West. Most of
these have involved poor procedures and working practices or an apparent lack of
understanding of the implications of making changes to the configuration of the Exeter
system. To reduce risks in the administration of the cervical screening service, a project has
been set up with the Lancashire and South Cumbria Agency (LaSCA) which aims to:


       Develop standard procedures across the NW to ensure all PCTs follow best
       practice
       Test the delivery of the service through a central unit using remote access to
       systems, as opposed to staff processing locally.


The work undertaken over the past 2 years has been very successful and it has been proved
that all administrative tasks associated with the cervical screening call/recall can be
undertaken centrally using remote access to different NHAIS systems.



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Over the last year there has been significant consolidation of service with 6 PCTs opting to
move their cervical screening office to LaSCA. These include Ashton, Leigh & Wigan,
Bolton, East Cheshire, West Cheshire and Warrington. Stockport commenced a pilot
transfer in July of this year and Salford & Trafford PCT is due to move to LASCA in early
2009. To date the centralised service covers 4 NHAIS systems providing the call/recall
service to 13 PCTs (including Stockport and Salford & Trafford) with a population of over
3.67m which is just over 50% of the North West total.

Issues Addressed
The transfer of work has been relatively straightforward and the only real delays in planned
transfers have related to IT issues at some PCTs. Not all PCTs had IT staff who were fully
conversant with the NHAIS system and the need to use ftp to transfer files, etc. and some
problems were therefore encountered with firewall settings and ftp access. These were
overcome by staff from LaSCA working with the PCT staff and NHSCfH to fully resolve
issues.

There is still a need to transfer paper notifications between LaSCA and individual GP
practices. This is achieved by using a courier service to transfer the work to the PCT and the
PCT using their local courier arrangements to collect and deliver from practices. These
paper transfers should cease in early 2009 when PCTs will have implemented electronic
PNLs and further enhancements to the NHAIS system will also provide electronic
notification of non responder and ceasing cards.

Improvements in Service Provision
PCTs now served by LaSCA already benefit from improved information to public
health leads. Information on coverage etc is provided to the PCTs at both PCT and
individual practice level. All PCTs are able to see coverage rates at PCT level for all
PCTs using the centralised service and thus have access to benchmark data. Individual
PCTs are able to access the same information at practice level but this is restricted to
the practices within their own PCT. All information is made available electronically via
the LaSCA web site which has a password protected section for customer PCTs and
which is updated each month. After accessing the practice level information PCTs can
print the report in pdf format or at the click of a button download the information into
excel. In addition, improvements have been made on standardising services.


The workload, information technology, user impact, financial and human resource
implications of centralisation of service provision are currently being formally assessed by a
pilot between Stockport PCT and LaSCA. Given the importance of the outcomes of the
project in terms of reducing risks to patients and providing PCTs with high quality services
including comprehensive information for Directors of Public Health, it is hoped that the
project will be successful and will be used to inform decisions in respect of a move to a
centralised cervical screening office serving all of the North West.

Workforce and Workload Review and Quality Initiative
The successful implementation of Liquid Based Cytology (LBC); changes to the scheduling
of the cervical screening programme and declining coverage have together resulted in a drop
of 137,000 cervical samples per annum across the North West. Inevitably, this has had

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significant implications for individual laboratories some of which no longer have sufficient
work to ensure all screening staff meet national minimum workload requirements. Further
technological advances, including semi-automated scanning and HR-HPV testing (as
discussed above) are currently being trialled in the UK, and if adopted, will act as additional
drivers for change.

These issues were widely discussed with pathology modernisation leads in the Cancer and
Pathology networks and with screening staff across the programme. It was clear that the
current footprint of service delivery was not optimal and that a strategic review of the service
across the North West was urgently required to ensure the continuance of an equitable, high
quality screening service. As a result the North West Cervical Screening Quality Assurance
Centre commissioned a piece of work to address these concerns.

The review was undertaken by Ove Arup & Partners plc and overseen by an Executive
Group which includes representation from the SHA, Specialised Commissioning, PCTs,
Cancer Networks, Pathology Networks and Quality Assurance.

The original scope of the project was to undertake a high level strategic review with the
following aims:

        Undertake a comprehensive scoping exercise of the current cytology service
        provision across the North West

        Identify options for the future delivery of cervical cytology services to maximise use
        of all existing resources, including workforce, across the North West

        Carry out an option appraisal workshop to select up to a maximum of three
        potentially viable options for further consideration

        Fully involve key stakeholders, including laboratories and the wider health economy
        across the North West region in the review process

The project was driven by the desire to maintain and further increase the quality of service
within the North West. As a consequence the financial impact of any proposed changes was
specifically excluded, although it was agreed that it would be a key component of the next
stage of the change process.

A Project Executive Group was established, the purpose of which was to agree the project
process and approve documentation prior to its circulation to stakeholders. The
membership included:

        Lesley Turnbull

        Jon Develing, Chief Officer, North West Specialised Commissioning Team

        Mike Burrows, Chief Executive, Salford PCT and Chair of the Greater Manchester
        Pathology Network Board

        Chris Jeffries, Acting Director, Workforce and Education, NHS North West


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        Judith Richardson, Public Health Specialist, Screening Lead, NHS North West

        Neil Jenkinson, Network Director, Greater Manchester Pathology Network

        Les Martin, Network Manager, Cumbria and Lancashire Pathology Network

        Alison Williams, Network Manager, Merseyside and Cheshire Cancer Network

        Jennifer Johnson, Arup

        Pam Turpin, Arup

        Yvonne Browne, NW QARC

Stakeholder engagement and a proactive communication strategy were recognised as being
pivotal to the successful delivery of the project. Engagement with these key individuals was
therefore prioritised throughout the lifetime of the review, recognising and valuing their
skills and experience in an open and collaborative manner. To assist in the engagement
process the following were undertaken:

        A series of briefing papers was issued at key stages to update all stakeholders on
        progress. Clinicians and managers were encouraged to circulate the briefing papers
        and to seek feedback and discussion from all staff

        An inaugural meeting to introduce the project to key stakeholders was held on the
        2nd August 2007

        A member of the project team visited each laboratory site and met the cytology
        manager. This provided the opportunity for one-to-one discussion of the project
        and the detailed data requirements.

        During the option appraisal process information was issued to all stakeholders for
        consultation and feedback was encouraged via email and telephone.

        An interactive option appraisal workshop was held with medical and
        scientific/managerial leads of all cervical cytology laboratories in the North West.

A summary of the collated data is given in the final report issued by Arup. The data gathered
include workforce details by professional group, age profile of the workforce, estimated time
spent on cervical cytology tasks by individual staff members, workload by laboratory and
individual, CPA status, work station details and laboratory facilities, sickness and maternity
rates and turnaround times.

Once baseline information had been captured and analysed, an option appraisal process
took place. This followed NHS methodology, had clear objectives and was carried out with
a wide range of stakeholders, as agreed by the North West Project Executive Group. Two
stakeholders from each laboratory were invited to score. Subsequent analysis of the scores
showed a high degree of consistency for the three types of score (un-weighted, weighted and
adjusted weighted) with the ranking of all types being consistent for the top three scores.
The options to deliver the service from a managed network; to reduce the number of

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screening centres to 10; and to reduce the number of screening centres to 6 ranked
consistently first, second and third across all types of scoring process.

The option for a managed network was added at the request of stakeholders during the
appraisal meeting. This option had been discussed with pathology modernisation and cancer
network groups over the preceding two years but had attracted little support. Its late
inclusion within the appraisal process raised concerns that the real implications of a properly
organised managed network were ill understood and that it was perceived to be the option
of least change. Recent communications from Professor Julietta Patnick, Director NHS
Cancer Screening Programmes indicate that National Office „favours single site cytology
since moving cytology slides after processing introduces an extra step in the process without
any benefit to the patient‟. A recent networked bid for NHS Improvement Team support
was denied on the basis that the maintenance of reporting at three sites could be very costly
for the commissioners.

A commissioning framework document outlining the requirements of a cervical cytology
service was developed by the Project Executive Group and circulated widely for comment
prior to being finalised. Using this document, the project is now being taken forwards
through the three cancer networks / pathology modernisation groups who have been asked
to agree a single site reconfigured solution for service delivery. Commissioners have
indicated that failure to reach agreement may result in the service being put to tender.

Specialised Commissioning
Guidance was issued last year in respect of the collaborative commissioning of national
screening programmes. For the purpose of this guidance, the definition of commissioning
includes the full range of tasks involved in the commissioning cycle including strategic
planning, specifying outcomes and procuring services; and managing demand and
performance. Responsibility for commissioning screening programmes is not included
within Practice Based Commissioning.

National screening programmes usually have planning populations over one million and
therefore meet the statutory definition of a specialised service (as defined in S.I. 2375).
However, because there are significant differences between screening programme services
and other specialised services which Specialised Commissioning Groups (SCGs)
commission it was recognised that there should be flexibility for the PCTs who make up the
SCG to decide to adopt more localised collaborative arrangements where this is appropriate
to local circumstance. Such „sub SCG level‟ collaborations must cover several PCTs and will
have a planning population of at least 1 million, most likely larger.

SCGs have been asked to:

      Take the lead in ensuring strategic planning and development of an SHA wide
      commissioning framework for each screening programme

      Ensure there is agreement on the configuration of clinical and laboratory service
      providers appropriate to their area, with designation of service providers where relevant



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      Ensure there is clear documentation of who has responsibility for each stage of the
      commissioning cycle and each element of the screening pathway, including collaborative
      commissioning to be undertaken by smaller groups of PCTs at sub SCG level

      Ensure that the detailed work in the commissioning of each element of a screening
      pathway is brought together into an integrated package

      Produce an annual commissioning plan specifying the work to be undertaken for each
      national screening programme and an annual report on the achievement of the plan and
      its outcomes.

      Commissioners also have a vital role in supporting the overall programme delivery to
      QA standards and ensuring problems are solved.

Hospital Based Programme Coordinator – roles and
responsibilities
The role of Hospital Based Programme Coordinator (HBPC) was detailed in October 1997
in Cervical Screening: A Practical Guide for Health Authorities, NHS CSP Publication No 7. The
various responsibilities of this role included the coordination of cytology and histology
services and their linkage with colposcopy services; the preparation of an annual summary of
provider activity as a basis for contracting; agreeing a contract specification with the
screening commissioner; ensuring laboratory and colposcopy standards conform with NHS
CSP guidelines; ensuring a robust failsafe policy; ensuring information linkage and quality;
ensuring that appropriate, timely treatment is available for women with smear abnormalities;
linkage with regional initiatives on clinical quality; and the audit and registration of new cases
of invasive cervical cancer.

The guidance further suggested that the HBPC was likely to be a consultant cytopathologist
/histopathologist or an individual responding to this consultant who would coordinate
services outside his/her direct managerial control. In particular, the HBPC would seek to
integrate colposcopy into the programme. He/she would be provided with administrative
support amounting to approximately 2 person months per annum.

Most Acute Trusts in the North West have now implemented this guidance although few
fulfil all aspects of the specification given above. A small number of Trusts have still not
formalised or been prepared to fund this post despite recommendations from QA Site Visit
reports. This is of concern as the NHS CSP audit of newly diagnosed cervical cancers is
heavily dependent on the HBPC to identify cases and to administer the collation and
validation of data. Where this is the case, immediate recommendations are made during
Multidisciplinary Site Visits to establish or to strengthen this role.

It has become increasingly clear over the years that it is often unrealistic to expect a single
individual to undertake the role of HBPC for both pathology and colposcopy. Conforming
to standards and regional clinical quality initiatives are most easily achieved within discipline.
NWQARC now recommends that the function of HBPC is discipline-specific and that the
role is split between two individuals who each monitor their own area of expertise but who
work collaboratively to ensure all standards conform to NHS CSP guidelines.

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HBPCs from across the North West met on the 31st July 2007 to share experiences and to
agree roles and responsibilities, particularly in respect of the NHS CSP Audit of Invasive
Cervical Cancers. A template for the HBPC Annual Report has been produced as an aide
memoir and to facilitate this activity (Appendix 3). The main headings within this template are
given in Table1 below.
Table 1 - Key topics in template for Annual HBPC report


           Cytology/Histology                                              Colposcopy

                 CPA Accreditation

  Staffing levels – medical, non-medical, A&C                 Staffing levels – medical, nursing, A&C

       Equipment and working environment                       Equipment and working environment

            Programme Management                                      Programme Management
          Workload – total and individual                            Workload – total and individual
          Turnaround times – quarterly                                 Waiting times – quarterly
                   KC61 data                                                  KC65 data
          Primary screening sensitivities                                     DNA rates
                      PPVs

      External Quality Assurance – Gynae and                  QA & Cancer Peer Review inspections –
                     Technical                                     outcomes and action plan

       Failsafe arrangements and outcomes                          Failsafe arrangements and outcomes

                     Laboratory IT                                           Colposcopy IT

                 Serious Incidents                                         Serious Incidents

QA and CPA inspections – outcomes and action
                                                           Anticipated challenges and financial pressures
                   plan

 Anticipated challenges and financial pressures                          Points of good practice

               Points of good practice

                                       Multidisciplinary activities
                            Gynaecological MDTs and discrepancy meetings
                           Retaining documentary evidence of review findings
                         Communication of revised diagnoses to Screening Office
                             Participation in local Cervical Steering Group
                                 Management of Invasive Cancer Audit
                                Audits other than invasive cancers audit




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Reporting of Organisms / Infections in Cervical
Smears
The Quality Assurance Reference Centre convened a pan-regional meeting on the 16th
March 2007 to discuss issues relating to the reporting of infections detected in routine
cervical screening samples. These discussions were precipitated by the publication in
November 2006 of Circular 6 which advised that it is no longer considered good practice for
the presence of incidental infections noted in cervical samples to be reported by the
laboratory and for those then to be included in the result letters sent to women.

The National Screening Committee advised ‘that incidental infections are not relevant to
cervical screening and need not be reported by the laboratory. If by local agreement the laboratory
decides to report infections where present, this information should be sent to the sample taker for further
action as appropriate. References to infection should no longer be included in result letters.’

While all North West screening units had ceased to include the presence of an infection
in the results letters issued to women some years previously, all had continued to record
the presence of infections in the results issued to the smear taker. Unfortunately the
wording of Circular 6 was considered to be ambiguous and did not provide clear
guidance to stop the recording of organisms/infections in cervical samples. It was
deemed appropriate therefore to convene a meeting of all interested groups across the
North West.

The meeting was attended by 54 participants with representation from contraceptive
and sexual health medicine, colposcopy/gynaecology, public health, primary care and
laboratory services. There was wide ranging debate in which the following issues were
considered:
    The Facts leaflet is included with all cervical screening invitation letters and informs
    women about the process involved. The leaflet advises that the purpose of the test
    is to detect early cell changes which may lead to cancer and only refers to the
    presence of infections as a reason for an inadequate test result. The consent for
    cervical screening does not cover the reporting of infections.
    The Wilson & Junger screening principles advise that the chance of physical or
    psychological harm should be less than the chance of benefit. The reporting of
    many infections /organisms in cervical samples has no clinical benefit and can
    inflict substantial harm on the woman.
    Cervical cytology is only able to identify a limited spectrum of infective organisms
    and its use as a surrogate for microbiological investigation may prevent appropriate
    investigation and could result in the failure to detect significant infections such as
    Chlamydia, Gonorrhoea, etc.
    The specificity of reporting some infective agents is low. This is particularly true of
    Trichomonas where false positive rates approaching 40% are recorded in some
    studies.
    Some pathologists perceived that they have a duty of care to the patient to report
    all infections/organisms which they identify. However, it was pointed out that
    current practice already excludes the reporting of a range of non-neoplastic
    changes including non-specific bacterial overlay, inflammatory epithelial changes,
    tuboendometrioid metaplasia and lower uterine segment sampling.

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The meeting concluded with a formal vote in which the vast majority of participants
indicated that the reporting of Candida, Trichomonas, Actinomyces, Herpes simplex and
Human Papillomavirus should cease. In advance of such a move, the pathologists requested
that some form of indemnification be sought with respect to the non-reporting of
organisms/infections. The QA Director subsequently met with Sir Muir Gray, then Chair of
the National Screening Committee who agreed to liaise with the National Office of Cancer
Screening Programmes. The National Office has very recently indicated that the reporting of
infections is outwith their remit and they cannot therefore provide definitive guidance. It is
suggested that Cervical Steering Groups discuss the reporting of infections and reach local
agreement as to the way forward. A number of such groups have already ceased the
reporting of infections.

City & Guilds Diploma in Cervical Cytology
The relevant professional bodies and the NHS Cervical Screening Programme (NHS CSP)
through the National Cervical Cytology Education and Training Committee (NCCETC)
have long supported a drive to gain formal academic recognition for the current NHS CSP
Certificate in Cervical Cytology examination. The NHS CSP and a multi-professional expert
reference group worked with the City & Guilds of London Institute (City & Guilds) to
convert the examination into a national award. The award was matched to the appropriate
level on the National Qualifications Framework (NQF) and gained accreditation with the
Qualifications and Curriculum Authority (QCA) on 1st July 2007. Centre accreditation with
C&G was awarded at the end of last year.

Candidates who are new to training on or after 1st July 2007 are following the Diploma
route; candidates who commenced training prior to that date have the option to complete
the old Certificate or to transfer to the Diploma. Candidates who have gained a qualification
and experience in cervical screening outside the UK (and who are employed by a laboratory
which provides cervical screening services under contract to the NHS) also have to follow
the Diploma route. Individuals will not be exempt from any of the assignment tasks or the
screening test and written examination paper. They will, however, be encouraged to
complete the award at the earliest opportunity.

The Liverpool Cytology Training Centre ran a C&G Assessor Induction Course on 29th May
2007for laboratory training officers from across the region and a further event was held on
the 11th January 2008 at the Manchester Cytology Training Centre. These were intensive and
well attended courses which opened with a discussion of the new qualification, an overview
of VRQs, C&G approval requirements, policies and procedures. The terminology relating to
C&G qualifications was covered in detail together with the roles and responsibilities of all
individuals involved. Preparation for training was described as including learner induction,
initial agreement and foundation phases. The assignment structure proved a major
component of the day with discussion of the assignment units, assignment planning,
completing and marking assignments, presenting assignments and the external test. Record
keeping responsibilities and appeals procedures were also covered together with the role of
the internal verifier, the development of assessors and managing the quality of VRQ
delivery. Assessors/training officers have since been circulated with the following
documents:


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      C&G Centre Resource Pack containing the assignment tasks

      Marking and Grading criteria

      Supplementary Marking Guidance for Assessors

      Standard recording forms for Assessors

      Forms for assessment planning

Liquid Based Cytology
Most laboratories in the North West use the SurePath™ LBC system; three use the Cytyc
ThinPrep® system, two of those in combination with SurePath™. It is noted that inadequate
rates for ThinPrep® users remain higher than for SurePath™ with some users recording
higher inadequate rates than with conventional spread smears. This is disappointing and
reflects a number of inherent differences between the technologies. The ThinPrep® system
requires the broom head to be thoroughly rinsed before being discarded. If this process is
not conducted meticulously it is possible for material to remain on the bristles and to be lost.
Further, some cases will appear inadequate on the initial preparation but will be substantially
more cellular if treated prior to processing with glacial acetic acid. Indeed, in some cases the
repeat preparation will convert an inadequate sample into one in which abnormal cells are
detected. This additional preparatory step is time consuming and costly as each sample must
be treated individually. There are no national or company protocols currently in place to
indicate precisely which samples will benefit from such an intervention. At present pre-
processing rates of 5% are recorded but despite this 4-7% of cases remain inadequate.
Company representatives have offered additional support to primary care and are working
with laboratory staff to investigate the ongoing problems with sample processing.

LBC Specimen Adequacy and the HTA Adequacy
Study
The assessment of specimen adequacy is determined for both conventional spread smears
and LBC preparations by the total number of well-preserved and well-visualised squamous
epithelial cells. There is no additional requirement within the current BSCC Terminology
guidance for the recognition of endocervical cells or other transformation zone indicators.
Unfortunately, there are at present no national recommendations in respect of the total cell
count for a sample to be deemed adequate. The Scottish Cervical Screening Programme and
Cervical Screening Wales have independently set minimum cellularity values of 8,000 and
15,000 cells/slide respectively, but neither figure is evidence based. The difference in
cellularity requirements may reflect the use of different LBC systems. Cervical Screening
Wales uses only SurePath™; Scotland uses only ThinPrep®. It is clear from discussion with
units utilising both systems that SurePath™ preparations are generally more cellular than
those produced on ThinPrep®. The North West has opted pro tem for a minimum value of
15,000 cells/slide based on an average cell count over 10 high-power microscopy fields.

The Health Technology Assessment (HTA) invited bids in 2006 in respect of LBC
specimen adequacy. The bid requested two separate areas of investigation: to survey which
thresholds are used in current practice at laboratories using LBC and the reasons for their

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choice of threshold; and to establish a threshold of adequacy by carrying out multiple
analyses from individual samples to ascertain the number of cells necessary to ensure that
samples cannot wrongly be labelled as „negative‟ when they are inadequate.

Dr Gary Cook, Acting Deputy Regional Director of Public Health suggested that the QA
Director place a bid on behalf of the North West QARC. This bid was selected to go
forward to the second round of evaluations and subsequently merged with a bid from
Central Manchester. HTA funding was agreed following clarification of a number of areas
and some minor changes to the staffing infrastructure. Dr Turnbull is joint principal
investigator with Dr Mina Desai, Central Manchester representing the BSCC. The study is
likely to set the standards which will not only be adopted across the UK, but which will
influence working practice worldwide.

The study involves 56 sites across England, Scotland and Wales each of which have agreed
to provide details of their laboratory protocols for the reporting of inadequate slides and to
supply 110 archived slides; 55 of the 56 sites will undertake both cell counts and
morphological evaluations of anonymised slides. The study sites have been recruited and a
sub-study has been conducted to develop robust methodologies for cell counting for both
of the current LBC technologies. Slides are currently being circulated to the participating
laboratories for cell counting.

HPV Vaccination
The manufacturers Sanofi Pasteur MSD and GlaxoSmithKline have developed vaccines
against the predominant high risk HPV sub-types. The MSD vaccine was licensed for use by
the EMEA in September of 2006, approval for the GSK vaccine was awarded in summer
2007. The Sanofi Pasteur vaccine is a quadrivalent vaccine, adjuvanted with aluminium
hydroxyphosphate sulphate, which provides protection against types 6, 11 (linked to genital
warts), 16 and 18 (linked to cervical cancer). The GSK vaccine is a bivalent vaccine,
adjuvanted with aluminium hydroxide and 3-deacylated monophosphoryl lipid A (MPL) and
providing protection against types 16 and 18.

Both vaccines, as a three dose primary immunisation course, provide high initial antibody
levels that plateau out somewhere between 12-18 months. The vaccination schedule for the
GSK product is 0, 1 and 6 months. The Sanofi Pasteur product is 0, 2 and 6 months. GSK
also have data to show that there is a good immune response after a 2-dose immunisation
course. Continued vaccine efficacy has been shown for up to 6.5 years. It is reasonable to
assume protection for up to 10 years based on the experience of other vaccines.

High vaccine efficacy has been observed for the vaccines for those who were PCR negative
and seronegative on day 1 (used in per protocol and „intention to treat‟ analysis of the clinical
trials). There is protection in individuals PCR positive but seronegative. There is no
protection if the individual is PCR positive and seropositive (chronic infection). Those who
were PCR negative but seropositive (i.e. had cleared the infection) also had high vaccine
efficacy in preventing recurrence. If infected with one type at the time of vaccination, there
is evidence that individuals still gained a high level of protection to other HPV types in the
vaccine. There are some data to suggest that there may be some reduction in progression of
lesions in those who already have CIN but the confidence intervals are not significant for


                                                  22
N W   C S P   Q A   A N N U A L   R E P O R T   2 0 0 7 - 0 8




this group. Efficacy against type 6 and 11 related external genital lesions in women was
noted for the quadrivalent vaccine.

Some cross-protection data are available for the GSK product. Vaccine efficacy of 55%
against type 31 which is related to type 16, and 94% vaccine efficacy against type 45 which is
related to type 18 are reported.

It is forecast that the use of these vaccines could prevent approximately 75-80% of cervical
cancers. Rates of high grade CIN could be reduced by about 70% with a 20-30% reduction
in low-grade abnormalities.

In November 2007 the Secretary of State, the right honourable Alan Johnson announced
that an HPV vaccination programme would be introduced with effect from autumn 2008.
This would commence with the routine vaccination of girls aged 12-13 years (school year 8)
and would be followed by a catch-up programme starting in 2009 and running for 2 years.
Girls aged 16-18 (school years 12 and 13) would be vaccinated in autumn 2009; and girls
aged 15-17 (school years 11 and 12) would be vaccinated in autumn 2010. By the end of
catch-up all girls under 18 years would have been offered HPV vaccine.

The contract for the vaccination programme was recently awarded to GlaxoSmithKline and
the DH has accelerated the catch-up programme such that 17-18 year olds will be offered
the vaccine this autumn.

It is important to note that the cervical screening programme as currently delivered will not
be directly affected by the HPV vaccination programme for some 10-15 years. All women
beyond the age at which vaccination will be offered will still need to attend for routine
cervical screening under the current call/recall schedule. This public health message may
well need to be broadcast widely and in clear and unequivocal terms. It is already apparent
that the public perception of the vaccine is that of a panacea which will guard against all
cervical disease and which will remove the requirement for further screening. This is likely to
impact negatively on coverage rates.

Ceased Women Audit
QA Directors received a directive from the National Office of Cancer Screening
Programmes in August 2005 requesting a review of all women ceased from the
programme. The Quality Assurance function was asked to map those women ceased
from the programme to current ceasing guidance; to investigate those that did not
match; and to return inappropriately ceased women to call/recall arrangements. This
work commenced in September 2005 with a meeting of regional screening managers at
which a provisional protocol for this work devised. The work was led by Ms Elaine
Jones, Head of Contractor and Patient Services, LaSCA, who produced data extracts
for the other screening managers to review and audit.

The call and recall of women as part of the NHS Cervical Screening Programme is
managed by PCTs or Agencies on behalf of PCTs using the national NHAIS computer
system. Whilst all PCTs use the same computer system there are a number of reasons
why local protocols had been in place to deal with requests to cease recall. The
NHSCSP first published a document (NHSCSP Occasional Report 00/01 –„Consent to

                                                  23
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Cervical Screening‟) in 2000 which addressed the legal requirements for ceasing women
from recall at their own request. Prior to this it was possible that local protocols
resulted in women being ceased without all legal requirements being met. Until the
publication of NHSCSP Good Practice Guide No. 1 in 2004 there was a great deal of
uncertainty as to what constituted an acceptable reason for ceasing.

The new GMS contract which was introduced in 2004 provided for women to be
„excepted‟ from the percentage screened if they had declined an invitation. It further
stated that these women should be reinvited for screening within 5 years. It is possible
that misunderstandings around this may have led to some women being ceased from
recall when in fact they had only declined an invitation to attend at a particular time. In
addition to the above it is obviously possible that despite the best efforts of staff, errors
may have occurred which resulted in women being incorrectly ceased from recall.

The North West Approach
The North West QA Director held a meeting of both public health cervical screening
leads and PCT/Agency screening managers from across the North West to discuss the
proposed audit and to agree a standard protocol to be adopted. At this meeting it was
agreed that the initial data extraction would be undertaken by LaSCA on behalf of all
PCTs and that the files produced would be forwarded to screening managers together
with copies of standard letters which would be used when contacting GP practices. It
was further agreed that on completion of the audit the results would be aggregated to
provide details at PCT/ Practice and database level across the North West. Adoption of
                                                %age of    a standard approach across
                                     No. of
        Reason for
                         No. of
                                    women
                                                ceased     the North West would not
                        women                   women      only ensure consistency but
          Ceasing                 returned to
                       identified             returned to  would provide support for
                                     recall
                                                 recall
                                                           screening managers who did
        Due to Age        597           57       9.6%      not have the skills and
                                                           expertise in data extraction
         No Cervix      158,625       1,016      0.6%      and manipulation.

              Patient                                                  Data Extraction
                               5,151            421             8.2%
              choice
                                                                       Using the NHAIS web-based
              Other            2,070            154             7.5%   reporting facility, details of
                                                                       all women aged up to 65 and
        Automatically                                                  recorded as being ceased
        ceased due to          33,875           n/a                    from recall were extracted
             age                                                       from each NHAIS database
                                                                       in the North West. The data
         Reason not
          specified
                               14,147          4,365           30.9%   was then imported into
                                                                       spreadsheets to allow for
              Total           214,465          6,013            2.8%   further manipulation. This
                                                                       exercise identified details of
                                                                       214,465 women who were
Table 2 - All North West outcomes of ceased women audit
                                                                       ceased from recall.        The
                                                                       women were then split into


                                                         24
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different groups depending on the reasons recorded for them being ceased from recall.
Table 2 shows a breakdown of the number of women in each group.

A file was then created for each screening manager in the North West providing details
of the women registered on the screening managers NHAIS database. These files were
forwarded to the screening managers to allow checks to be carried out with each
woman‟s GP practice. A proforma was also provided for screening managers to record
counts by GP practice of the number of women who were returned to recall as a result
of the audit. Copies of the standard letters to be used when sending the lists to GP
practices were also provided. These standard letters included the fact that some of the
women included in the lists may have been ceased prior to the woman registering with
the practice.

Checks undertaken by each Screening Manager
It was agreed that all screening managers would take the actions detailed below:-

Women ceased due to Age
The vast majority of these related to women aged over 60 and in such cases no further
action was required. Details of any woman aged under 60 were highlighted and
screening managers were advised to return these women to recall and to notify the GP
practice.

Women ceased due to No Cervix
To allow a check to be made to ensure that none of these women had been ceased
incorrectly e.g. following a partial hysterectomy. Screening managers were advised to
forward the list of these women to each GP practice for checking. Practices were given
the option of either checking the list or producing a list from their own computer
system and forwarding it to the PCT for checking. Where practices submitted their
own lists, screening managers were advised to check this to ensure screening records
were correct. Any woman identified as still being eligible for recall was to be returned
to recall and included on a prior notification list when their next test was due.

Women ceased due to Informed Choice
To allow these to be checked and to ensure the GP was aware, screening managers
were again advised to forward the list of these women to each GP practice. The
covering letter pointed out the possible confusion between women declining a single
invitation and those who wished to be permanently excluded. Practices were advised
that they should notify the PCT if it was discovered that any of these women should be
returned to recall. The woman‟s name would then be returned to recall and included
on a prior notification list when her next test became due.

Women ceased due to ‘Other’ reasons
It was recommended that these be checked with the GP practice. If it was found that
any of these women should be returned to recall then the woman‟s name would be
included on a prior notification list when the next test became due.

Women automatically ceased due to Age
The women in this category would have been automatically ceased from recall by the
NHAIS computer system. The reason for this would be that the next test would have

                                                  25
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been due after their 65th birthday and their screening history showed that recall would
be ceased at age of 65. In view of this, no action was required by screening managers.

Women ceased – Reason Not Specified
These women would have been ceased from recall during or before year 2000. Prior to that
time it was not possible to record a reason for ceasing on the NHAIS system. To allow for
a check to be made screening managers were advised to forward the list of these women to
the GP practice. The covering letter provided valid reasons for ceasing recall and the GP
practice was asked to confirm the correct reason for ceasing. If it was discovered that the
women should be returned to recall then her name would be included in a prior notification
list when her next test became due. If no reply was received from the GP practice then the
women in this category would be returned to recall by the screening manager.

Result of the audit
Following checks with the GP practices, screening managers completed the pro-forma
provided giving details of the number of women returned to recall as a result of the
audit. This information was collated by LaSCA and showed that 6,013 women had been
returned to recall. This is summarised by reason for ceasing recorded prior to the audit
in Table 3. The results have also been collated at GP practice level and each PCT has
been provided with a copy of this report together with a further breakdown of the
results at GP practice level.

Summary
As detailed above 6,013 (2.8%) of women who were recorded as being ceased from
recall have been returned to the recall cycle as a result of this audit. The audit identified
significant differences between PCTs and NHAIS databases, some of which may be
attributed to differences in local protocols. Work is ongoing across the North West to
standardise working practices across all PCTs.

The audit also identified significant differences between individual GP practices within
a single PCT area. It is envisaged that PCTs will use the reports provided to investigate
further the reasons for any obvious differences.


Regional Cytology Training Centres
The QARC maintains close links with both the Liverpool and Manchester Cytology
Training Centres. Both are to be congratulated on the enormous amount of work
undertaken to train and continually update the wide range of staff involved in sample taking,
smear interpretation and patient treatment. Copies of their respective annual reports are
included as appendices.




                                                  26
                                                                          3
                                                                           Chapter
N W   C S P   Q A   A N N U A L   R E P O R T   2 0 0 7 - 0 8




                                  Cervical Screening
                                  Laboratories in the North
                                  West


                                  Number of Units, Workload and
                                  Staffing Figures
A total of 19 laboratories, working on 20 sites, now report cervical smears in the North West
Region. Eighteen of those report the full range of tests; the remaining laboratory is a „small
volume laboratory‟, which handles only diagnostic smears and reports no cases from GP or
NHS Community clinics.

A number of mergers have occurred since the last report and hence the data and charts are
not directly comparable. The three Pennine Acute Trust laboratories which participate in the
cervical screening programme (Bury, Oldham and Rochdale) have consolidated on purpose-
built accommodation at the Oldham site; the Burnley and Blackburn laboratories have
merged to form the East Lancashire Hospitals NHS Trust at the Burnley site; and the
Macclesfield Hospital cervical cytology service has merged with Leighton Hospital.

Workload
The workload data includes all full screens by primary screeners and checkers (excludes
rapid review and pre-view) and all smears reported by medical staff. Minimum and
maximum workload figures vary depending on the grade and function of the staff member,
but are not influenced by whether the individual is employed on a part-time or full-time
basis. Current workload standards for a 12-month period are as follows:


       Primary screener             >3,000 slides per 12-month period
                                    <7,500 slides per 12-month period

       Checker                      >750 slides per 12-month period

       Pathologist                  >750 slides per 12-month period


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Table 3 provides a breakdown of individuals and slides screened since 2004. It is interesting
to note that the number of individuals identified as primary screeners in the North West has
dropped from a previous high of 143 in 2004 to the current figure of 115. This is in line with
declining staff requirements consequent on the implementation of both LBC and the revised
scheduling of the call/recall system. Further reductions in cervical cytology staffing
requirements are anticipated as laboratory reconfigurations are agreed.

51.3% of the primary screener workforce fails to meet the national minimum workload
requirement and 33.0% are below the regional workload action point of 2,500 smears per
annum. The QARC contacts all laboratories where individuals fail to reach this target and
explanations for low relative workloads vary. Many relate to periods of prolonged sickness
or maternity leave; to trainees or new employees who have been in post for less than 12
months. There remains a small minority who work between histology and cytology and
whose time allocation for cytology is insufficient.
Table 3 - Breakdown of screening workload by individual for 2004-05, 2005-06, 2006-07 and 2007-08.

                                         Individual screeners – Number & Percentage
      Slides screened         2004-05              2005-06          2006-07              2007-08
           >3000              75 (52.4)            75 (58.1)       74 (61.7)             56 (48.7)
                            7           5.6     7            4.9
         3000-2500            29 (20.3)            22 (17.1)       25 (20.8)             21 (18.3)
         2499-2000          5 17 (11.9) 4.0         11 (8.5)         8 (6.7)              10 (8.7)
         1999-1500             5 (3.5)               8 (6.2)         6 (5.0)              11 (9.6)
         1499-1000             7 (4.9)               6 (4.7)         1 (0.8)              5 (4.3)
           <999               10 (7.0)               7 (5.4)         6 (5.0)             12 (10.4)



It should be noted however, that a further 62 individuals, while not identified as primary
screeners also undertake this function. These are usually more senior staff who undertake
both primary screening and checking. If all 177 staff who participate in primary screening are
considered, the percentage meeting the national minimum workload requirement drops to
32.2%. This means that many staff are not undertaking sufficient primary screening to
maintain competence and constitute a significant risk to the programme.

69 medical staff and advanced practitioners are involved in the reporting of cervical smears,
compared with 77 in the previous year. While the national minimum cervical workload for
medical staff is still set at 750, this is under review and it is likely that this arbitrary figure will
be dropped in favour of a single sessional allocation. At present 39% of those staff achieve
the minimum workload standard; a figure which has changed little over the preceding two
years. It is likely that the total number of medical staff reporting cervical smears will further
decrease as laboratories reconfigure and that a greater proportion of those remaining will
meet the workload target.

Turnaround Times
National guidelines recommend that 80% of women should receive their smear test result
within 4 weeks of the date of testing and all should receive their result within 6 weeks.
Compliance with these guidelines is dependent on staffing levels but has been complicated
this year by the impact of discussions round laboratory configuration which have had a
negative impact on morale and hence on productivity.

                                                   28
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All of the 18 current laboratory sites, which report population derived smears are within the
national target figure when an annual average turnaround time is considered (Table 4) and
increasing numbers of laboratories have little or no backlog. However, quarterly turnaround
times still show considerable variation throughout the year.

                       2006-07          2007-08         CPA Accreditation Status
                                                        Subsequent to EL (97)83, all
 Lancaster                13               14           laboratories participating in the cervical
 Carlisle                 15               10           screening programme are required to
 Blackpool                12               13           obtain accreditation with Clinical
 Chorley                   9                4           Pathology Accreditation (UK) Ltd. or
 East Lancs               14               20           another body accrediting to a similar
 Manchester               19               14           standard. This is a continuous, rolling
 Stepping Hill             9               16           process with laboratories being required
 Tameside                 54               28           to reaccredit on a four yearly basis.
 Bolton                   16                8
 Pennine Acute            36                0           At present 11 laboratories have full
 Liverpool                23               30           accreditation, 7 have conditional
 Aintree                  15               16           accreditation and 1 is awaiting
 Southport                16               21           assessment (Table 5). In comparison,
 Whiston                  19                0           during 2006 – 07 thirteen laboratories
 Warrington               19               21           had full accreditation, 5 conditional
 Arrowe Park              20                0           accreditation and 5 were registered
 Chester                  13                0           pending inspection or referred with no
 Leighton                 14                0           status.
 Average                  19               12
                                                   Inadequate levels of medical staff remains
                                                   the main reason for laboratories dropping
 Table 4 - Laboratory turnaround times (working to conditional status or being referred
 days) 2006-07 and 2007-08
                                                   with no status. A number of laboratories
                                                   have explored other strategies including
the employment of non-UK doctors or the establishment of Advanced Biomedical Scientist
Practitioner posts. The former avenue has met with only limited success, but the number of
Advanced Practitioner/ Consultant Biomedical Scientists appointments is gradually
increasing with six such individuals now being in post throughout the North West.

Primary Screening Sensitivities
The monitoring of screening sensitivity, as measured by rapid review, is one of the key
indicators of primary screener performance and may be determined for all grades of
abnormality and for moderate dyskaryosis and above. The latter is a more reliable indicator,
as all patients within this category will undergo biopsy confirmation. It is expected that all
staff participating in primary screening achieve a primary screening sensitivity in excess of
90% for all grades of abnormality and greater than 95% for high-grade abnormalities.

It is important to note that the sensitivity as determined by rapid review is different from the
overall laboratory sensitivity and is inevitably influenced by the quality of that rapid review
process. It is apparent that since moving to LBC increasing numbers of screeners are


                                                  29
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Network                                                         Accreditation Status
Lancs & S Cumbria            Lancaster                          Conditional
                             East Lancs                         Conditional
                             Blackpool Victoria                 Conditional
                             Carlisle                           Full
                             Chorley                            Full
M/chester & Cheshire         Tameside                           Conditional
                             Pennine Acute                      Not accredited
                             Manchester CC                      Full
                             Royal Bolton                       Full
                             Stepping Hill                      Full
                             Wigan                              Conditional
M/side & Cheshire            Arrowe Park                        Full
                             Royal Liverpool                    Conditional
                             Warrington                         Full
                             Whiston                            Full
                             Chester                            Conditional
                             Southport                          Full
                             Aintree                            Full
                             Leighton                           Full

Table 5 - Laboratory accreditation status

attaining values of 100% for moderate dyskaryosis and above. This calls into question the
effectiveness of rapid review in LBC and suggests that a move to an alternative form of
internal quality control, perhaps using semi-automated scanning, may be advisable.

KC61 Data
The KC61 workload data for 2002-03 to 2007-08 are given in Figure 1and Table 6. They
show the total number of smears processed from all sources, all ages and from GP and
NHS community clinics. Most laboratories have experienced a significant decline in total
workload over the five-year period. This in large part relates to the implementation of LBC
technologies and to changes to the scheduling of the programme, however, continued
declines in coverage have also had a noticeable effect. Data for 2007-08 show that one
laboratory now lies below the minimum quality standard of 15,000 smears per annum and a
further 3 laboratories are close to that figure. Across the region a fall of 178,882 smears per
annum or 27.3% of the annual workload is recorded over this 5-year period. Further
significant falls are anticipated in relation to the use of HPV testing in the triage of low-grade
abnormalities and as a „test of cure‟ and as a consequence of continued falls in programme
coverage. The new guidance on 14-day turnaround times issued in April of this year
recommends that „out of programme‟ smears are actively discouraged. These currently
comprise approximately 20.3% of the workload in the North West.

Figure 2 details the percentage of smears from GP and NHS Community Clinic smears
from women aged between 25 and 64 which were deemed inadequate for interpretation
during 2004-05, 2005-06, 2006-07 and 2007-08.

                                                  30
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                                                                                     Across the North
                                                                                     West an average
                                                                                     inadequate rate
                                                                                     of 2.7% was
                                                                                     recorded in 2007-
                                                                                     08      compared
                                                                                     with an average
                                                                                     value of 2.1% in
                                                                                     2006-07 and 3.4
                                                                                     % for 2005-06.
                                                                                     The comparable
                                                                                     figures         for
                                                                                               Greater
                                                                                     Manchester &
                                                                                              Cheshire,
                                                                                     Lancashire and
                                                                                     South Cumbria
                                                                                     and Merseyside
                                                                                     and Cheshire are
                                                                                     3.7%, 1.2% and
                                                                                                  3.2%
                                                                                     respectively. It is
                                                                                     pleasing to note
Figure 1 - Laboratory workloads, all sources for 2007-08, 2006-07, 20005-06, 2004-   that the average
05 and 2003-04.                                                                      inadequate rate in
                                                                                     the North West
remains below the all England average.

There are still significant differences in inadequate rates between laboratories with a range of
0.2 – 7.0%. This is likely to relate to two main factors: remaining problems with the Cytyc
ThinPrep system (the 2 laboratories in the North West with high inadequate rates both use
the ThinPrep LBC system for all or part of their workloads) and differences in the
assessment of LBC specimen adequacy, for which there are no nationally agreed criteria. It is
hoped that data from the HTA Adequacy study will allow a more standardised approach.

Inadequate rates also vary dramatically between individual smear takers. It is likely that
targeted, supplemental training may assist in further reducing inadequate rates.

Table 7 shows the KC61 data relating to low and high-grade smear abnormalities by Cancer
Network since 2003. In general, there have been slight declines in the reporting both of low-
and high-grade abnormalities but with a rise of approximately 10% in PPVs across the
North West since 2004. Numerically this increased accuracy of reporting represents
approximately 450 additional, histologically confirmed high-grade lesions over and above
that reported in 2004-05. This is a pleasing finding and is likely to reflect the improved
sensitivity and specificity expected with LBC technologies.




                                                   31
                               N W     C S P   Q A       A N N U A L   R E P O R T    2 0 0 7 - 0 8




                               Table 6 - Laboratory workloads, all sources and GP and NHS Community Clinics for 2007-08, 2006-07,
                               20005-06, 2004-05 and 2003-04.



                                                                           Workload – smears examined

            Laboratory                         2007-08              2006 - 2007           2005 - 2006           2004 - 2005            2003 - 04

            by Cancer
             Network                        All
                                                      GP &
                                                                   All
                                                                             GP &
                                                                                         All
                                                                                                   GP &
                                                                                                               All
                                                                                                                         GP &
                                                                                                                                     All
                                                                                                                                               GP &
                                                      NHS                    NHS                   NHS                   NHS                   NHS
                                         sources,               sources,              sources,              sources,              sources,
                                                     CC (20-                CC (20-               CC (20-               CC (20-               CC (20-
                                         all ages               all ages              all ages              all ages              all ages
                                                       64)                    64)                   64)                   64)                   64)



                           Carlisle      23,462      21,018      25,440     22,785    25.238       22,237   25,798      22,378    26,634      25,216
Lancs & S Cumbria




                          East Lancs     32,897      28,649      30,194     34,787    37,805       32,652   39,166      32,765    41,543      36,959

                          Blackpool      21,837      18,988      20,436     17,433    21,598       18,193   22,351      18,203    23,327      20,022

                           Chorley        22,166     18,998      23,399     19,783    25,535       21,872   25,926      20,609    28,321      24,350

                          Lancaster      18,206      16,303      17,944     15,829    22,012       19,231   22,079      18,141    22,387      19,815

                            Bolton       16,867      14,600      19,526     16,723    24,980       21,652   20,628      17,063    22,356      19,912
M/chester and Cheshire




                          Leighton       31,224      27,387      35,057     30,350    41,.467      36,077   41,787      35,151    40,572      35,809

                          M/chester      85,485      74,250      86,887     74,110    100,023      84,851   101,699     80,327    107,935     94,993

                           Oldham        40,628      33,722      44,560     36,640    48,869       39,647   48,102      37,630    52,954      44,362

                          Stepp/Hill     26,527      23,111      26,234     22,695    28,120       23,909   29,830      24,627    28,122      24,243

                          Tameside       16,134      13,921      15,994     13,804    16,140       13,812   16,539      13,525    17,617      15,824

                           Aintree       18,903      16,662      19,193     16,965    19,450       17,142   21,745      18,729    22,522      21,136

                           Arrowe         21,794     19,031      23,967     20,732    25,514       21,969   28,482      23,635    27,561      24,674
Merseyside and Cheshire




                           Chester       18,411      15,815      20,455     17,582    22,687       19,802   23,962      20,296    23,508      21,631

                          Liverpool      26,983      21,608      24,733     19,005    26,706       19,849   29,443      20,478    33,695      26,836

                          Southport      14,420      12,615      15,264     13,406    15,538       13,452   17,720      14,568    17,718      15,720

                          Warrington     21,784      18,936      24,883     21,186    31,143       26,597   26,215      21,371    26,799      23,681

                           Whiston       17,506      14,609      18,727     15,485    22,251       17,912   22,827      17,895    23,361      19,593




                                                                                         32
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Figure 2 - North West inadequate rates 2007-08, 2006-7, 2005-6 and 2004-5.

Indicator                                           10th – 90th percentile range
                                         2004-05             2005-06          2006-07          2007-08
 Inadequate as % all smears                         indicators not set at present
 Mild/borderline (% adequate smears)   3.2 – 7.2          3.4% - 7.0%        3.4% - 6.8%      3.6% - 7.4%
 Moderate + (% adequate smears)        0.8 – 1.3         0.7% - 1.4%         0.7% - 1.3%      0.7% - 1.4%
 PPV for CIN2 or worse                 65 – 87%          66.9 – 87.0%        70.5% - 86.4%   70.7% - 88.9%
                                                                          Source : Form KC61




The achievable standards for reporting of cervical samples are given above. Table 7 shows
that one laboratory is below the 10th percentiles for high-grade abnormalities and two lie
above the upper limit for low-grade abnormalities; one is substantially higher. This is likely to
reflect the over-reporting of smears as low-grade.



                                                        33
N W   C S P   Q A   A N N U A L   R E P O R T   2 0 0 7 - 0 8




Derived Performance Data
Earlier this year a document was provided to all laboratories undertaking cervical
cytology population screening in the North West with data for 2006-07 relating to a
number of performance indicators. This section of the report updates that work by
providing comparative data for 2007-08. Some of these indicators have been published
in peer-reviewed journals; others are currently under evaluation. These indicators have
been developed by Dr Roger Blanks, Cancer Screening Evaluation Unit who was
commissioned by the National Office of Cancer Screening Programmes to develop
epidemiological and statistical quality assurance measures from the screening data
currently collected.
                                                                   The KC61 return is the
                                                                   mandatory annual return
                                                                   from         cytopathology
                                                                   laboratories      to    the
                                                                   Department of Health.
                                                                   The KC61 part C
                                                                   provides information on
                                                                   the association between
                                                                   cytological        outcome
                                                                   leading to referral for
                                                                   colposcopy       and    the
                                                                   histological       outcome
                                                                   resulting     from     that
                                                                   referral. Prior to 2002/3
                                                                   the KC61 part C was
                                                                   completed for the 3
Figure 3 - North West laboratory PPVs 2006-07 and 2007-08. Target
values for 2007-08 are indicated in red.
                                                                  months from April to June
                                                                  at the beginning of each
screening year. From 2002/3 onwards the return has been modified to include an
additional table relating to the entire year prior to the screening year together with a
table for the first 3 months of the current year.

Positive Predictive Value (PPV)

The Positive Predictive Value is a traditional performance indicator which has been
used since the inception of the cervical screening programme. It forms one of four key
performance indicators which are set each year from the 10th and 90th percentiles of the
distributions of data for all England laboratories. The PPV is defined as the percentage
of moderate and severely dyskaryotic smears with a histological diagnosis of CIN2 or
worse. The PPV numerator is the number of moderate and severely dyskaryotic smears
with a histological diagnosis of CIN2 or worse. The denominator is the total of
moderate and severely dyskaryotic smears, excluding results not known, inadequate
biopsies and other cancers. The achievable range for all England for 2007-08 is 70.7% -
88.9%. Three laboratories in the North West (Figure 3) have PPVs above the upper
end of the achievable range; one is below the lower limit.



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                                                     Table 7 – KC61 Data by Network
Laboratory                               2003 2004 2005 2006 2007 2003 2004 2005 2006 2007 2003 2004 2005 2006 2007
                                                  borderline/mild (%)                           moderate/severe (%)                       PPV
Bolton                                     4.6       4.3         4.3   4.9    5.6         1.1    0.9    0.9   1.2     1.1   71.8   74.2   73.8   79.8   86.9
Bury                                       7.9       6.1         6.3                      1.1    0.8    1.1                 75.6   72.2   82.1
Manchester                                 7.0       5.2         5.6   5.8    5.1         1.2    0.8    1.0   1.5     0.9   73.9   77.7   80.6   80.6   67.9
Leighton                                   4.2       3.0         3.2   2.9    3.2         1.3    1.0    0.8   0.8     0.8   81.4   79.7   86.8   88.6   85.0
Oldham                                     8.5       5.1         4.0   6.5    4.8         1.5    0.7    1.0   1.1     1.0   68.7   65.8   78.9   76.5   77.3
Rochdale                                   4.9       6.2         5.9                      0.9    1.0    1.2                 69.5   70.1   73.6
Stepping Hill                             11.4       6.7         6.4    6.3   5.3         1.5    1.1    0.8   1.0     1.2   69.7   70.4   73.0   75.2   73.4
Tameside                                   5.6       5.9         8.4   14.3   7.3         0.9    0.8    1.2   0.8     0.6   78.7   85.9   69.2   71.5   75.7
Rochdale & Bury                                                         5.9                                   1.2
Average for M & Cheshire                  7.2       5.5      5.7       6.7    5.2     1.2        0.8    1.0   1.1     0.9                               77.7
Blackburn                                 4.7        4.9         4.8          5.8         1.1    0.7    0.9           0.7   75.9   71.0   59.9          79.0
Blackpool                                 5.6        4.2         4.6   6.5    5.4         1.6    1.1    1.1   1.7     1.1   79.9   77.6   83.4   85.1   83.0
Burnley                                   8.0        5.8         6.2                      1.2    0.5    0.8                 74.2   72.7   82.3
Chorley                                   4.2        4.0         5.0   6.4    6.9         1.0    0.8    1.0   1.4     1.1   75.1   74.6   80.8   82.1   83.3
Lancaster                                 9.8        6.1         5.0   5.9    6.5         1.6    1.4    0.8   0.8     1.0   66.6   67.9   71.9   79.0   73.7
Carlisle                                             5.6         6.1   6.5    5.8                1.2    1.0   1.1     1.0          85.4   82.3   90.9   86.7
Blackburn & Burnley                                                    5.6                                    0.7                                80.9
Average for Lancs & Cumbria               5.9       4.9      5.3       6.2    6.1     1.5        1.0    1.0   1.1     1.0                               81.1
Aintree                                   4.6        4.8         7.0   5.9    8.1         1.0    0.9    1.2   1.1     1.4   74.4   79.9   85.5   80.7   79.4
Arrowe                                    5.6        4.9         6.6   6.0    6.4         1.2    0.9    0.7   0.7     0.7   74.5   76.7   80.7   86.8   86.4
Chester                                   6.9        5.2         4.0   5.3    5.2         1.3    1.0    0.8   1.0     1.0   76.1   69.5   74.0   85.6   89.2
Liverpool                                 6.4        5.2         5.5   5.3    5.3         1.9    1.5    1.3   1.2     1.3   81.3   85.3   84.6   84.7   91.1
Macclesfield                              7.9        6.1         6.0   5.4                1.0    0.8    0.7   0.7           75.8   70.7   76.2   84.2
Southport                                 4.3        3.7         6.0   7.3    10.0        1.3    1.1    1.3   1.1     1.4   59.7   65.9   76.6   70.5   73.6
Warrington                                3.9        3.5         5.3   4.6     5.2        1.3    1.2    1.4   1.3     1.3   80.9   79.5   85.1   85.6   90.6
Whiston                                   7.3        4.7         4.8   5.5     5.7        1.5    1.0    1.0   1.0     0.8   78.7   77.1   81.7   78.9   82.8
Average for M/side & Cheshire             5.7       4.7      5.3       5.7    6.6     1.4        1.1    1.0   1.0     1.1                               84.7
Average for all North West                6.4       5.0      5.4       6.1    6.0     1.3        1.0    1.0   1.1     1.0          71.5   74.6   81.4   81.4
Laboratories


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Total Predictive Value (TPV)

The Total Predictive Value is defined as the percentage of referrals from borderline or
worse cytology with a histological diagnosis of CIN2 or worse. The TPV may prove to
be a useful indicator as it incorporates more data from the KC61 part C than the PPV
and consequently has greater statistical stability. For example, based on the all England
observed data for 2004-05, it could be suggested that to ensure a „reasonable‟
                                                                   specificity, at least 1 in
                                                                   3     referrals     from
                                                                   borderline or worse
                                                                   should have histology
                                                                   of CIN2 or above i.e.
                                                                   treatable disease and a
                                                                   TPV below 33%
                                                                   might           therefore
                                                                   warrant           further
                                                                   investigation. Prior to
                                                                   2004-05 the data
                                                                   quality               was
                                                                   insufficient to make
                                                                   such calculations, so it
                                                                   has only been possible
Figure 4 - North West laboratory TPVs 2006-07 and 2007-08. Target
                                                               to calculate the TPV
value in red.                                                  for the last four years
(2004-05, 2005-06, 2006-07and 2007-08). The all England data for 2004-05 show a
variation in the proportion of women referred to colposcopy from borderline or worse
smears with a diagnosis of CIN2 or worse of between 22% and 74%. In the North
West, data for 2006-07 showed a range of 32.8–52.7% extending to 22.7-54.5% in
                                                                 2007-08.      During
                                                                 2007-08         three
                                                                 laboratories    were
                                                                 below the 33%
                                                                 threshold compared
                                                                 with     only    one
                                                                 laboratory in 2006-
                                                                 07.

                                                                      Abnormal
                                                                      Predictive Value
                                                                      (APV)

                                                                   The        Abnormal
Figure 5 - North West laboratory APVs 2006-07 and 2007-08. Target  Predictive Value is
value in red.                                                      defined     as    the
                                                                   percentage         of
referrals from borderline and mildly dyskaryotic smears with a histological diagnosis of
CIN2 or worse. It is suggested that for most laboratories the APV will be below 20%.

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Nine of the 18 laboratories in the North West currently have APVs above the target
value.


Percentage Discordant Outcomes (PDO)

One of the simplest methods of examining the association between histology and
cytology is to examine concordant and discordant cells in the KC61 return. Concordant
                                                                cells are those where the
 Outcome        Inad    Bord  Mild   Mod   Sev    ?Inv   ?Gland
                                                                histology and cytology
 Stage 1b +             A     A      B     B      B      B
                                                                outcomes lead to the same
 Stage 1a               A     A      B     B      B      B      conclusion. In table 8 all
 Adeno                  A     A      B     B      B      B      women whose cytology and
 CIN 3                  A     A      B     B      B      B      histology results are in cells
 CIN2                   A     A      B     B      B      B      listed as A are those where
 CIN 1                  C     C      D     D      D      D      the cytology (borderline
 HPV only               C     C      D     D      D      D      and mild dyskaryosis) does
 No CIN/HPV             C     C      D     D      D      D      not correlate with histology
 Colp NAD               C     C      D     D      D      D      that requires treatment (i.e.
 Known                                                          CIN1 or less) and are
 Not known                                                      therefore discordant. Cells
 No outcome                                                     listed as B are where
 Inad biopsy                                                    cytology     of     moderate
 Non cervical                                                   dyskaryosis or worse has
 Total                                                          histology of CIN2 or worse
                                                                and       are       therefore
Table 8 - KC61 part C showing concordant and discordant cells   concordant. Results in B
                                                                and C cells are concordant;
results in cells of A and D types are discordant. The percentage of discordant outcomes
can therefore be calculated as follows:

                             PDO = 100 x (A+D) / (A+B+C+D)

Figure 6 shows that in the North West PDO values range from 12.8% to 23.1% with
most laboratories falling between 15 and 20%.

Care is required in the interpretation of these data as the percentage of borderline/mild
smears with CIN2+ may be affected by colposcopy referral patterns. For example,
laboratories that refer on one borderline or mildly dyskaryotic smear are likely to have
lower percentages in cell groups A than laboratories that refer after 3 borderline or 2
mildly dyskaryotic smears. Without knowledge of the detailed referral policy for each
laboratory it is impossible to examine this further.




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Age-risk-interval PPV adjusted Moderate+ rate (ARI Mod+ PPV)

                                                         Laboratories with either very low
                                                         or very high percentage mod+
                                                         rates may have extremes of
                                                         either sensitivity or specificity.
                                                         Laboratories do not however
                                                         examine smears from women
                                                         with the same underlying risk,
                                                         age distribution, etc. Some areas
                                                         have a much higher relative risk
                                                         of cervical disease than others
                                                         and laboratories in these areas
                                                         are therefore more likely to have
                                                         higher rates of cytological
                                                         abnormality than those in low
                                                         risk areas. This methodology
                                                         allows for some of those
                                                         confounding       variables and
 Figure 6 - North West laboratory PDO values 2006-07 and
 2007-08.
                                                         explains about 40% of the
                                                         variation       in       moderate
                                                         dyskaryosis or worse. It uses a
weighted multiple regression model to estimate the relative risk for each (old) PCT in
England. Variables include % Indian subcontinent population, % students, % working
in hotel and catering, % working in finance, % men working part time, % working in
health and social work, % single person households and % renting privately. Note that
negative coefficients (e.g. increasing mean age, increasing % Indian ethnic minority) will
decrease the estimated value and positive coefficients (e.g. increasing % in hotel and
catering) will increase the value.

It is clear from Figure 5 that despite this adjustment there is still considerable variation
in detection rates between
laboratories with a range of 0.43
– 1.10% for 2007-08. Substantial             Procedure for calculating ARI Mod+ PPV rate
variation was also noted when                Estimate % of smears arriving from contributing PCTs
these data were examined in                  Estimate relative risk of a moderate or worse smear for each
2005-06 and in 2006-07.                      PCT
However, while the rates between             Calculate a weighted relative risk based on percentage
years for some laboratories are              contribution from each PCT to each lab
very similar, others show either             Divide the labs observed moderate + rate (from the KC61) by
an increased or decreased                    the weighted relative risk to get the ARI mod + rate
detection rate. The reason for               Multiply the labs ARI mod + rate by the PPV to get the ARI
                                             adjusted mod + rate
these changes is unclear but may
reflect changes in population
demographics, coverage rates,
introduction         of        new
technologies, etc.


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Please note that caution is again required in the interpretation of these data. Limitations
in the methodology, possible outstanding data quality issues and other variables may be
in operation since the relative risk for each PCT was calculated (2005). It should be
stressed that laboratories with low ARI Mod+ PPV rates have most evidence of a
possible low sensitivity but do not necessarily have a low sensitivity. As noted above
this model only explains about 40% of the variation in moderate+ rates and there
                                                                   remains considerable
                                                                   potential for error. It is
                                                                   suggested that this
                                                                   parameter should be
                                                                   assessed               in
                                                                   conjunction with the
                                                                   many other indicators
                                                                   presented      in    this
                                                                   document before the
                                                                   evidence               of
                                                                        underperformance
                                                                   could be considered
                                                                   strong.

                                                                       Mean CIN Score

                                                                       The Mean CIN Score
                                                                (MCS) is defined as
Figure 7 - North West laboratory ARI Mod+ PPV rates for 2006-07 and
2007-08.                                                        the weighted average
                                                                CIN score. It can be
based on all grades of CIN (MCS123) or on CIN2 and CIN3 (MCS23). The MCS23 is
based on CIN2 or 3 as disease positive outcomes and is calculated as follows:

                                  MCS23 = (3 x CIN3) + (2 x CIN2)
                                             -----------------------
                                             (CIN3 + CIN2)

There is some suggestion from all England data that empirically an MCS 123 of between
2.1 and 2.2 may indicate an optimum range that balances the reduction in invasive
cancer with maintaining a high specificity. These data can be reformulated in terms of
CIN2 and CIN3 alone, when it can be shown that the invasive cancer rate increases
rapidly when the numbers of CIN2 lesions detected drop below 50% of the number of
CIN3 lesions. If this is causal then either some cases of CIN2 develop into invasive
cancer between screening tests or more likely a minimum of CIN2 is required to ensure
a high sensitivity for CIN3 and undetected CIN3 can become invasive cancer by the
next test.

An MCS123 of 2.2 corresponds to an MCS23 of about 2.66. An MCS23 greater than 2.5
indicates that more CIN3 is detected than CIN2. Conversely an MCS23 less than 2.5
indicates that more CIN2 is detected than CIN3. Figure 8 shows that one laboratory in
the North West has an MCS23 values in excess of 2.66. Note that the invasive cancer
rate does not continually decrease even for laboratories with very low MCS scores i.e.

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those detecting a lot of CIN1 and CIN2. It is important that screen-detected cancers
that are prevalent screens (1st invitation or 1st screen in previous non-attender) which
cannot be prevented and cancers from long term lapsed attenders (more than 10 years
since last test) are identified separately from incident screen detected cancers which are
potentially preventable. A rate of 2 per 10,000 may be largely the result of prevalent
and lapsed screen detected cancers i.e. the rate cannot be reduced to zero.

Odds of false positive referral (OFP)

If it is assumed that CIN2 and CIN3 represent disease positive outcomes then the
OFP23 is calculated as follows:

        OFP23 = (Colp NAD+No CIN/HPV+HPVonly+CIN1)

                                    (CIN2+CIN3)

                                                                       The MCS and OFP
                                                                       measures have both
                                                                       been corrected for
                                                                       inadequate referrals
                                                                       by           excluding
                                                                       inadequate outcomes
                                                                       from the totals. The
                                                                       exclusion is useful for
                                                                       laboratories     where
                                                                       many women are
                                                                       referred             to
                                                                       colposcopy        with
                                                                       repeated inadequate
                                                                       results as they will
                                                                       distort the OFP in
                                                                       particular.

                                                                       Referral-
 Figure 8 - ROUT diagram for North West laboratories 2007-08. Target   OUTcome (ROUT)
 values indicated in red.                                              diagram

Figure 8 shows a scattergram of MCS23 and OFP values for North West laboratories
for 2007-08. The majority of laboratories lie in the shadowed area in the lower left
quadrant of the graph where the MCS23 is below 2.66 and the OFP is below 2.0. These
findings correspond with all England data. It is likely that this area of the chart
corresponds to the optimal balance between sensitivity and specificity.

Laboratories with a low MCS123 and MCS23 have a high recall rate for mildly dyskaryotic
smears and the associated colposcopy clinics tend to see larger numbers of women
with CIN1, HPV only, No CIN/HPV and colposcopy NAD. There is a suggestion that
the threshold for referral could be reduced.


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Laboratories with a high MCS may be detecting insufficient CIN1 and CIN2 to ensure
a high sensitivity for the detection of CIN3. As a result the screen detected invasive
cancer rate may be increased. Note that this effect can only be seen by using the full
statistical power of national data. There is a suggestion therefore that the threshold for
referral could be increased.

Laboratories with a high MCS and a high OFP have the dual problem that they may be
detecting insufficient CIN1 and CIN2 to ensure a high sensitivity for the detection of
                                                                CIN3, and that those
                                                                cases reported as either
                          CIN2:3                 CIN1:3         CIN2 or CIN3 are less
               (43.4-100.8%)
                                                                likely to be confirmed
                  2004-07        2004-08 2004-07        2004-08
 East Lancs          85            84.5    187           192.7
                                                                histologically as high
 Chorley            49.2           52.8    78             83.6  grade disease.
 Carlisle             57.7          61.1          79             86.1
 Lancaster            67.9          67.7          87             86.2   Treatable CIN
 Blackpool             98           94.4          77             74.2
                                                                        Ratio
 Manchester           98.2          94.4          85             90.0
 Tameside             93.2         101.3          138           166.0
 Pennine Acute       115.7         106.6          125           As noted previously
                                                                119.0
 Bolton               56.4          55.3          56            there
                                                                 53.8      is      strong
 Stepping Hill        85.9          86.3          172           suggestive
                                                                162.9           evidence
 Liverpool            69.3          71.8          64            that
                                                                 61.5    the       screen
 Aintree              43.6          46.8          68             65.0
                                                                detected         invasive
 Warrington           76.8          72.0          64             59.6
 Whiston              68.4          66.7          104
                                                                cancer rate increases if
                                                                103.2
 Southport            77.6          80.1          102           the percentage of
                                                                115.3
 Chester               76           74.2          123           CIN2 detected relative
                                                                118.9
 Arrowe Park          33.9          42.0          47            to CIN3 (Treatable
                                                                 57.3
 Mid Cheshire         68.5          64.5          175           CIN Ratio (TCR)) falls
                                                                123.4
                                                                below 50%. At the
Table 9 - Ratios of CIN2:CIN3 and CIN1:CIN3 for all North West
                                                                other end of the
laboratories for 2004-07 and 2004-08.                          spectrum       there     is
                                                               evidence that the screen
                                                               detected cancer rate
does not continually decrease if the ratio rises above 85%. There is thus suggestive
evidence that the maximum efficiency of screening occurs where the TCR is between
50% and 85%.

The Treatable CIN Ratio (TCR) is calculated as follows:

TCR = 100 x CIN2/CIN3

Table 9 details the TCR for all North West laboratories for 2004-07 and for 2004-08.
The calculations use 3 and 4 years data respectively to achieve statistical stability and to
avoid the need for confidence limits. The mean of the suggested optimum range for
2004-07for all England laboratories (50-85%) is 67%, which corresponds closely with
the observed median TCR value of 69%. There is evidence therefore that over that
period the average laboratory may have the balance about right. However, nationally
there is a wide range from 27.7% to 147.2% with the 10th and 90th percentiles lying at

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43.4% and 100.8% respectively. A similar spread of results is seen in the North West as
is shown in Table 9. The individual laboratory data remain relatively stable when a
further 12 months data are added suggesting that reporting practices are also relatively
stable.

As always this type of calculation should be viewed with caution as there is variation in
histological reporting practice and the distinction between CIN2 and CIN3 is often not
easy. Indeed given that both lesions will be managed identically, some histopathologists
pay little time fine tuning this distinction. It is important therefore to look at this
measure in conjunction with other markers and at an epidemiological rather than
individual level. Given this proviso, it is interesting to note that there is a trend for
laboratories with low TCR values also to have low ratios of CIN1:CIN3(see Table 2).
Low TCR laboratories have a tendency to detect CIN at the CIN3 stage, whereas high
TCR laboratories have a tendency to detect more CIN1 than CIN3. It would appear
that laboratories operate different screening styles with the threshold for „disease‟ being
set at different levels.

Conclusions
This work is aimed to provide all laboratories in the North West with a raft of
conventional and derived performance data allowing direct comparison with the
regional peer group. Table 10 lists all of these indicators and gives the 10th and 90th
percentile values or other suggested guide values as appropriate.

It is important to note that many of these screening cytology indicators are influenced
by other activities e.g. colposcopy and histology, which may be outwith their control. In
addition, in some laboratories in the North West cytology and histology are reported by
different individuals in different departments; in others smears and biopsies are
reported by the same individuals. These varying working practices are acknowledged
but clearly none can be factored into the current calculations.

No one value should be taken in isolation, nor should any one value or a combination
thereof be taken as definitive evidence of underperformance. However, those
laboratories with a number of indicators substantially outwith the suggested range may
wish to work with QA to further examine their working practices. This would provide
additional information to all concerned regarding the use of these indicators and assist
in their further development.


Summary of Gynaecological and Technical EQA
Schemes - Millie Forde and Jayne Williams
Gynaecological Cytopathology EQA

The Fourth National Round was the third North West round, to be undertaken using
Liquid Based Cytology (LBC) Samples. As with previous rounds, staff based within the
two training schools (The Liverpool Cytology Training Centre and Manchester
Cytology Training Centre) who are able to report samples processed on both of the

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current LBC systems, are expected to alternate between the two Gynaecological
Cytopathology EQA schemes. Those staff, who participated last year using SurePath
slides, took part in this round using ThinPrep slides.

As there are insufficient medical staff within the North West to ensure a ThinPrep
round is statistically valid, (the facilitators handbook states that at least 25 people must
examine each set of 10 slides) a collaborative working agreement is in place between
three QA regions; East Midlands, West Midlands and the North West. Two slide sets
(one for technical staff and one for Pathologists / Advanced BMS Practitioners) were
used for the joint QA round. ThinPrep slides were delivered to the North West
laboratories so that staff could participate in their own workplace.

A total of 218 participants (excluding trainees and medical staff not yet reporting
smears) participated in the North West Region. This consisted of 101 Screeners, 54
Checkers, 57 Pathologists and 6 Advanced BMS Practitioners. There was a further
five staff members who did not participate in this round due to ill health or maternity
leave and one person who failed to participate for an in valid reason for non-
participation. There were also a number of staff who participated late (i.e. at the end of
the round after the slides had been in the laboratory for one week).

A total of 145 non-medical staff participated and their percentage scores ranged from
80.00% through to 100.00%. A total of 111 participants attained a score of 100%. The
2.5% figure was 88.89%. One participant scored 80.00% and so fell below the 2.5 th
percentile score for this round.

A total of 55 medical staff participated and their percentage scores ranged from 82.35%
through to 100.00%. A total of 28 participants attained a score of 100%. The 2.5%
figure was 85.29%. One participant scored 82.35% and so fell below the 2.5th percentile
score for this round.

No medical participants made a clinically serious error (CSE), which is where a slide
reaches 80%+ consensus as being high grade, but the participant reports the slide as
being either negative or inadequate. None of the participants who fell below the 2.5th
percentile or who made a „Clinically Serious Error‟ have any occurrences of
substandard performance in either of the last two rounds and no action was therefore
indicated.

Technical EQA

In accordance with NHS CSP Publication 19, four assessment sessions were scheduled
for 2007-08. As in the first two years of the scheme, the four rounds were scheduled to
alternate between the two cytology training schools, to allow for ease of travel to the
different venues. The Manchester Cytology Training Centre was used for the
assessments on Friday 9 June and Friday 8 December 2006. The Liverpool Cytology
Training School was used for the assessments on Monday 25 September 2006 and
Monday 5 March 2007.




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Slides were submitted from the following LBC processing laboratories: the Royal
Liverpool University Hospital, Arrowe Park Hospital, Royal Lancaster Infirmary,
Stepping Hill Hospital, Manchester Cytology Centre, Chorley and South Ribble DGH
and Royal Bolton Hospital.

Ratings of good, acceptable or marginal were recorded for all slides with the exception
of one of the original two slides submitted by laboratory „7‟ in round 3. These were
rated as substandard and precipitated the assessment of two further slides. These were
rated as “acceptable” and „good‟ and no further action was therefore indicated.




                                                  44
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                       Table 10 – Summary of derived performance indicators for all North West laboratories 2007- 08

                       Mod+
                                                                                                                    23          123
  Laboratory           rate        PPV          Mod+ PPV          ARI Mod+ PPV   PDO       APV      TPV      MCS         MCS          OFP      CIN2:3    CIN1:3
                       (0.7-       (70.7 –
                       1.4%)       88.9%)                                                  (<20%)   (>33%)   (<2.66)     <2.2         (<2.0)   2004-08   2004-08
  East Lancs           0.7         79.0         0.55              0.60           18        17.2     30.5     2.57        1.82         2.38     84.5      192.7

  Chorley              1.1         83.3         0.92              0.93           15.2      14.1     43.6     2.62        2.01         1.42     52.8      83.6

  Carlisle             1.0         86.7         0.87              0.92           17.8      21.2     49.2     2.58        1.96         1.14     61.1      86.1

  Lancaster            1.0         73.7         0.74              0.65           23.1      21.7     37.1     2.60        2.08         1.79     67.7      86.2

  Blackpool            1.1         83.0         0.91              0.75           12.3      8.7      41       2.54        2.14         1.47     94.4      74.2

  Manchester           0.9         67.9         0.61              0.54           17.8      14.9     33.1     2.54        1.99         2.14     94.4      90.0

  Tameside             0.6         75.7         0.45              0.43           14.7      12.9     22.7     2.45        1.70         3.57     101.3     166.0

  Pennine Acute        1.0         77.3         0.77              0.74           22.5      22.3     45       2.54        1.98         1.28     106.6     119.0

  Bolton               1.1         86.9         0.96              1.02           17.3      22.1     54.5     2.66        2.27         0.90     55.3      53.8

  Stepping Hill        1.2         73.4         0.88              0.82           22.2      19.5     39.7     2.53        1.91         1.63     86.3      162.9

  Liverpool            1.3         91.1         1.18              0.98           16.8      22.6     51.7     2.55        2.21         0.98     71.8      61.5

  Aintree              1.4         79.4         1.11              1.09           14.3      8.8      29.7     2.64        2.21         2.48     46.8      65.0

  Warrington           1.3         90.6         1.18              1.10           14.8      19.1     50.5     2.63        2.25         1.02     72.0      59.6

  Whiston              0.8         82.8         0.66              0.60           16.6      16.3     38.9     2.62        1.99         1.67     66.7      103.2

  Southport            1.4         73.6         1.03              1.06           18.4      13.7     35.9     2.53        1.87         1.88     80.1      115.3

  Chester              1.0         89.2         0.89              1.01           16.2      18.8     41.6     2.59        1.97         1.40     74.2      118.9

  Arrowe Park          0.7         86.4         0.60              0.65           16.3      17.2     34.7     2.69        2.18         1.96     42.0      57.3

  Mid Cheshire         0.8         84.9         0.68              0.76           19.3      22.2     47.4     2.66        2.02         1.18     64.5      123.4

                                                                                      45
                                                                         4
                                                                     Chapter
N W   C S P   Q A   A N N U A L   R E P O R T   2 0 0 7 - 0 8




                                  Colposcopy in the North
                                  West Region



                                  Colposcopy Units and KC65 Returns
                             A total of 36 colposcopy units now operate across the North
                             West. The KC65 quarterly return was introduced in April 2000
to collect information about referrals to colposcopy and subsequent treatments and
outcomes. Following a formal review, a revised KC65 with substantially enhanced data
requirements, came into use during 2003-04. Some units in the North West continue to
experience problems with the capture of these data but all submit a full return.

KC65 Data
The KC65 records details of all referrals to each clinic, regardless of whether or not the
woman attended her appointment. The North West generated 18,944 referrals to colposcopy
during 2007-08 and was second only to London region, which received 23,475 referrals. The
decline of 5.9% of workload almost certainly reflects the programmatic changes which have
also resulted in substantial decreases in the laboratory workloads. The implementation of
HPV testing in the triage of low grade abnormalities and as a „test of cure‟ are likely to
produce further declines as women are more rapidly returned to routine recall.

76.6% of those referrals in the North West were reported as originating from a screening
smear and 12% were clinically indicated. This compares with nationwide data of 80.4% and
16% respectively, and is only slightly lower than the previous years‟ figures of 79% and 12%.
Of women referred to colposcopy after a screening smear, 5% followed findings of
borderline changes or mild dyskaryosis; 11.0% followed a moderately dyskaryotic smear and
12.8% followed findings of severe dyskaryosis or worse. All regions reported roughly similar
proportions.




                                                   46
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          Figure 9 – All colposcopy referrals 2004-05, 2005-06, 2006-07 and 2007-08




                                                   47
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Clinics were asked to supply data on the time between the date on the woman‟s referral
letter and her first offered out-patient appointment, regardless of whether she attended
the appointment or not. Where direct referral systems are in operation, the referral date
was taken to be the date the smear was reported. In the North West 20.7% of women
were offered an appointment within 2 weeks; 61.4% within 4 weeks and 94.5% within 8
weeks (Table 11).

These figures are similar to those recorded for last year in which 20% of women were
offered an appointment within 2 weeks; 55% within 4 weeks and 93% within 8 weeks.
Comparative data for all England are given in Table 11. Women with more serious smear
results were offered earlier appointments. 80.9% of women with a smear result of
moderate dyskaryosis or above were offered an appointment within 4 weeks. This is
slightly lower than the national average figure of 83.2%.

Table 12 gives the percentage of all referrals seen within 2, 4, 8 and 12 weeks for 2007-08.
Table 13 gives the percentage of high-grade referrals seen within 4 weeks for each
colposcopy unit in the North West for 2003-04 to 2007-08. There is tremendous variation
in the ability of units to meet these targets. 78.9% of units now meet the national 90%
standard for all referrals but only 36.8% meet the standard for high-grade referrals.
Referral patterns and time to first offered appointment are influenced by a number of
factors including staffing levels, working practices, numbers of colposcopy sessions,
colposcopy rooms and colposcopes. These issues have been closely examined in all QA
                                                                             multi-disciplinary
 Referral indication                                                    site    visits     and
                     Waiting time     England        North West            recommendations
 All referrals                                                          made as appropriate.
                          ≤ 2 weeks        20.0                   20.7   The time from
                          ≤ 4 weeks        56.2                   61.4   referral to first
                          ≤ 8 weeks        93.3                   94.5                  offered
                         ≤ 12 weeks        98.6                   98.7
                                                                         appointment was
                                                                         over 12 weeks for
 Moderate or severe dyskaryosis                                          1.3% of women in
                          ≤ 4 weeks        83.2                   80.9   the North West and
 Severe / ? Invasive carcinoma                                           1.4%            across
                                                                         England.        These
                          ≤ 2 weeks        94.9                   80.0
                                                                         extended       waiting
 ? Glandular neoplasia                                                   times      are      on
                          ≤ 2 weeks        75.8                   65.1   occasion at the
                                                                         instigation of the
                                                                         patient who may
Table 11 - Women referred to colposcopy: Time from referral to first     wish to delay the
offered appointment, by referral indication and region 2007-08.
Percentage values                                                        appointment        for
                                                                         personal reasons but
should be avoided if possible.

Clinics were asked to supply details of all treatments undertaken at first attendance at the
colposcopy clinic. The data relates only to procedures undertaken the first time a woman
attends. In the case of a deferred treatment the woman will be recorded as having no

                                                     48
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treatment at her first attendance. The most common treatment or procedure at first
attendance was diagnostic biopsy. This was carried out in 49% of referrals for all grades of
abnormality and in 44% of high-grade referrals. Of women attending with a high-grade
abnormality 36% underwent excisional biopsy, whereas only 10% of those with all grades
abnormality underwent excision. It is likely that the majority of women presenting with
high-grade abnormalities who were reported as having no treatment or diagnostic biopsy
went on to definitive treatment at a later attendance.
Table 12 - Percentage of all colposcopy referrals seen within 2, 4, 8 and 12 weeks.

 Colposcopy Unit                  <2         <4          <8           <12          all non-
                                                                                      Of
                                  wks       wks          wks          wks
                                            weew                                    diagnostic
 University Hospital Aintree  20.6           58.8  99.8         99.9
                                            eeks                           biopsies taken in
 Countess of Chester Hospital 23.1           64.4  99.8         99.8
 Macclesfield District Gen    13.0           54.2  88.0         93.8       England in 2007-
 Hospital
 Cumberland House             10.2           54.2  98.3        100.0       08,          85.8%
 Liverpool Women's Hospital   18.0           55.7  99.2         99.9       showed evidence
 Leighton Hospital            17.3           60.5  98.8         99.4       of CIN. This
 Warrington                   26.5           84.9  98.7         99.6
 Royal Liverpool University
                                                                           figure       ranged
                              36.1           80.6  95.0         97.8
 Hospital
 Whiston Hospital             22.3           63.4  95.9         98.7
                                                                           from 90.2% in
 Southport & Formby           13.1           54.1  95.1         98.4       the North East
 Southport & Ormskirk         21.2           68.4  96.5         99.7       to 83.8% in the
 Arrowe Park Hospital         28.9           91.1  99.9        100.0       West Midlands.
 Queens Park Hospital,         9.8           40.8  89.1         97.5
 Blackburn                                                                 In the North
 Burnley General Hospital      6.4           44.4  95.7         98.7
 Blackpool Victoria Hospital  21.6           52.2  86.8         97.6
                                                                           West         85.3%
 Sharoe Green Hospital &      29.1           82.0  98.3         99.1       showed changes
 Chorley                                                                   of CIN. Part D
 Furness                      47.7           94.4 100.0        100.0
 Royal Lancaster Infirmary    10.5           54.8  98.4         99.3       of the KC65
 Westmorland                   9.4           56.5  98.6        100.0       shows, for each
 Cumberland Infirmary         10.9           36.5  79.6         97.7
 Royal Bolton Hospital        22.2           63.5  93.3         98.2
                                                                           biopsy taken, the
 Central Manchester           11.5           34.5  92.1         98.0       time       elapsing
 Palatine Centre              35.8           72.8 100.0        100.0       before           the
 North Manchester Hospital    30.4           78.7  97.9         98.9       woman              is
 Fairfield General Hospital   11.0           48.6  95.5         98.5       informed          in
 Royal Oldham Hospital        30.9           84.5  99.5         99.7
                                                                           writing of her
 Rochdale Infirmary           16.2           52.4  87.6         98.1
 Dawes Family Practice        22.6           84.7 100.0        100.0
                                                                           result.         The
 Monarch Medical Centre       11.1           33.3 100.0        100.0                   interval
 Hope Hospital                48.3           83.3  96.7         99.8       measured is the
 Withington                    9.3           27.0  70.2         97.2       time between the
 Wythenshawe                  21.2           54.5  96.6        100.0
                                                                           date on which
 Stepping Hill                11.9           47.4  86.6         94.3
 Tameside                     25.2           55.3  98.0         99.3
                                                                           the biopsy was
 Trafford General Hospital    14.4           29.5  46.1         93.0       taken and the
 Billinge Hospital            14.4           57.2  98.0         99.5       date on the letter
 University Hospital Aintree  20.6           58.8  99.8         99.9       that is sent to the
 Countess of Chester Hospital 23.1           64.4  99.8         99.8       patient informing
                                                                           her of her result.
In order to allow time for follow up of results, the return relates only to those biopsies
taken in the first month of each quarter. The data include all biopsies taken, not just those
from women on their first attendance. It is possible that more than one biopsy may be
taken from the same woman.

                                                    49
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Table 13 - Percentage of moderate + referrals seen within 4 weeks (standard 90%)

                                                                       Apr 07 -    Apr 06 -   Apr 05 -   Apr 04 -   Apr 03 -
        Colposcopy unit by Cancer Network
                                                                       Mar 08      Mar 07     Mar 06     Mar 05     Mar 04
                           Blackburn                                      69         63         65          43         49
  Lancs & S Cumbria

                           Blackpool                                      69         69         70          77         66
                           Burnley                                        64         69         70          50         32
                           Furness                                        98         98         98          93         95
                           Lancaster                                      81         81         82          54         94
                           Sharoe Green                                   88         85         86          90         95
                           Westmorland                                    74         78         79          22         44
                           Bolton                                         65         46         48          33         43
                           Bury                                           69         92         93          46         48
                           Central Manchester                             59         57         58          88         89
                           Cumberland House                               52         65         65          82         81
                           Dawes Family Practice**                        98         94         94          70         80
                           Hope Hospital                                  90         59         60          29         63
                           Leighton                                       84         84         85          97         86
  Manchester & Cheshire




                           Macclesfield                                   65         61         63          38         44
                           Monarch Medical Centre**                       76         67         67         100        100
                           North Manchester                               92         82         82          84         71
                           Oldham                                         98         97         98          97         92
                           Palatine Centre**                             100         98         98          75        100
                           Rochdale                                       55         63         64          53         46
                           Stepping Hill                                  64         51         51          16         23
                           Tameside                                      100         97         97          72         97
                           Trafford                                       42         71         70          28         48
                           Wigan                                          68         49         52          24         49
                           Withington                                     61         45         48          65         84
                           Wythenshawe                                    94         93         93          63         91
                           Aintree                                        96         97         97          91         66
                           Arrowe Park                                   100         99         99          85         96
  Merseyside & Cheshire




                           Chester                                        95         76         77          72         52
                           Liverpool                                      92         86         86          89         99
                           LWH                                            93         95         94          85         98
                           Southport & Formby                             82         76         76          26         39
                           Southport & Ormskirk                           88         82         82          40         49
                           Warrington                                     93         81         82          40         52
                           Whiston                                        77         65         66          96         81
                                                                          66         76         77          49         70
  N/ern




                           Cumberland Infirmary
                           West Cumberland                                 -          -          -          48         9

                           North West Regional Average                  79.4           76.3     77.0      62.4        68.1
                           ** GP based practices




                                                                          50
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Table 14 - Non-diagnostic biopsies taken at colposcopy by type, outcome and region (4 month
sample) 2007- 2008 (percentages)




                                                                                                            East of Eng




                                                                                                                                              East Coast
                                                                                            West Mids
                                                                                East Mids
                                                              & H/ber
                       England




                                                                                                                               London




                                                                                                                                                           Central
                                       North



                                                     North


                                                               Yorks




                                                                                                                                                South


                                                                                                                                                           South


                                                                                                                                                                         South
                                                     West




                                                                                                                                                                         West
                                       East
  Outcome


  No biopsies
  reported            15,407             1,152        2,143       1,440       1,764          1,856           1,774              2,240               955        388        1,695
  Bx with unknown
  result                     251                 -       93              6       32                     -                 11            51            51             6           1
  Bx with known
  result = 100%       15,156              1,152       2,050       1,434       1,732          1,856           1,763              2,189               904        382        1,694
  Cancer                         1.5           1.7      1.2             2.4     1.6                 1.6               1.7               1.1          0.7        1.8         1.7
  Adenoca in situ            2.2               3.0      2.1             3.2     3.9                 1.9               1.3               1.6          2.4        1.3         1.6
  CIN 3                   44.3            44.4         40.1        50.3        42.6             47.5              49.6            39.9             40.3       47.1         44.0
  CIN 2                   24.0            25.3         26.9        20.5        24.0             20.3              21.7            24.7             26.2       22.3         27.4
  CIN 1                    13.7           15.8         15.0             9.8    12.5             12.4              13.0            18.2             14.4       14.1         11.5
  HPV / Cervicitis
  only                       5.4               3.5      8.0             4.1     4.3                 8.0               2.4               6.2          7.4        4.7         4.2
  No CIN / No
  HPV                        8.5               6.2      6.4             9.6    11.0                 7.8           10.4                  8.0          8.4        8.1         8.7
  Inadequate /
  unsatis biopsy             0.3               0.2      0.4             0.1     0.2                 0.4                    -            0.3          0.2        0.5         0.9
  Total showing
  CIN or worse            85.8            90.2         85.3        86.1        84.5             83.8             87.2             85.5             84.0       86.6         86.2


Table 14 shows the histological outcomes of those women having non-diagnostic or
treatment biopsies taken at colposcopy by type, outcome and region during a four-month
period in 2007-08 for England and all regions. In the North West 15.0% showed CIN1,
                                                    26.9% showed CIN2 and 40.1%
                                                    showed CIN3. A further 8.0%
                                                    showed HPV related change without
                                                    dysplasia. 0.4% of biopsies were
                                                    unsuitable for diagnosis.

                                                       Figure 10 shows the waiting time
                                                       from colposcopy until the patient
                                                       was informed of her result for a 4-
                                                       month sample in 2007-2008. It
                                                       shows that in the North West 26.7%
                                                       of women were informed within 2
                                                       weeks; 35.3% of women were
                                                       notified between 2 to 4 weeks and
                                                       22.0% of women waited between 4
 Figure 10 – Waiting times for women to receive biopsy to 8 weeks. 6.5% of women waited
 results                                               between 8 to 12 weeks, and of that
                                                       9.5% of women had not had their
result within 12 weeks. Many of these delays are caused by a shortage of pathologists
available to report the material. As previously noted pathologist numbers are an ongoing
problem and it is anticipated that delays in the reporting will remain in the short to
medium term.


                                                                         51
                                                                            5
                                                                            Chapter
N W   C S P   Q A   A N N U A L   R E P O R T   2 0 0 7 - 0 8




                                  Public Health and
                                  Cervical Screening
                                  in the North West


                                  Coverage of cervical screening
In the year to end March 2008 1,370,100 women from an eligible population of 1,751,200
in the North West were recorded as being less than 5 years since their last screen that
resulted in an adequate test result. This represents coverage of 78.2% and is slightly lower
than the national average of 78.6%. In common with all other regions, it also represents a
further fall from 2006-07 and at a more rapid rate that that experienced by other regions.
                                                                       Table 16 gives the
                                                                       coverage data for
                                                                       the 24 PCTs in the
                                                                       North West for
                                                                       years       2005-06,
                                                                       2006-07 and 2007-
                                                                       08. 16 PCTs now
                                                                       have           overall
                                                                       coverage       figures
                                                                       below the national
                                                                       80%             target,
                                                                       compared with 12
                                                                       in 2006-07 and 9 in
                                                                       2005-06.

                                                               Coverage
Figure 11 - Cervical screening coverage by age, England 1999, 2004, 2007  values
and 2008; North West 2007 and 2008.                            range from 83.2%
                                                               in Central and
Eastern Cheshire PCT to 72.3% in Liverpool PCT. None of the North West PCTs now
achieves greater than 85% coverage and 4 PCTs fall below 75% coverage (Knowsley,
Liverpool, Manchester and Sefton).

All PCTs across the region have experienced a fall in coverage ranging from 0.3 – 1.4%
compared with 2006-07 with an average fall of 0.6%.

                                                   52
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Figure 11 shows all England coverage data for 1999, 2004, 2007 and 2008 with North West
data for 2007 and 2008. There is a consistent pattern of falling coverage both for all
England and for the North West region. However, while the North West coverage figure
for all ages is disappointing, Figure 11 shows coverage in the younger age groups (25-29,
30-34 and 35-39 years) is slightly higher than the national average. This advantage is lost
from 40 years onwards with regional coverage falling faster in the older age groups than the
national average. This is a trend which has been seen for some years and while welcome,
remains unexplained. However, despite performance which exceeds the national average in
the younger age groups, it is important to note that they have still experienced substantial
reductions in coverage over the last 12 months with losses of 2.5%, 0.6% and 0.5% in the
25-29, 30-34 and 35-39 year age groups respectively.




Figure 12 - Coverage for age groups 25-29, 30-34 and 35-39 years for North West PCTs.

Figure 12 provides details of coverage in the younger age groups for each of the North
West PCTs. There is considerable variation in performance with Warrington, Central &
Eastern Cheshire and Ashton, Leigh & Wigan achieving coverage of 72.7%, 72.4% and
72.3% respectively in the 25-29 years age group. Liverpool PCT has the lowest coverage in
this age group, recording a figure of only 60.3%.

The very low coverage in the 25-29 year group is of particular concern as this overlaps with
the peak age of severe dyskaryosis and early stage invasive cancer. It is critically important
to achieve high coverage rates in the early screening rounds to prevent high-grade
abnormalities remaining undetected and progressing to invasive disease.


                                                   53
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Increasing coverage, particularly in the central city PCTs remains a priority for the North
West QARC and the author is pleased to report that the NHS Improvement Foundation
has chosen Blackpool and Sefton as pilot sites for a new coverage initiative. Members of
the QA Team hope to work closely with these sites over the next year. It is unfortunate that
Liverpool PCT which has particularly low coverage was unable to offer the level of support
necessary to participate in this important piece of work.

Time since last test
                                                                  Figure 13 shows the length of
                                                                  time since a woman in the 25-
                                                                  64 age group was last tested.
                                                                  69.0% and 75.0% of women
                                                                  in the target age range were
                                                                  within 3 or 3.5 years
                                                                  respectively of their last
                                                                  smear.     85.0% of eligible
                                                                  women were less than 5 years
                                                                  from their last test and a
                                                                  further 10% and 3% were
                                                                  within 10 or 15 years. 2.0% of
                                                                  women were reported as
                                                                  having had at least one
                                                                  adequate smear, but not
Figure 13 - Length of time (years) since last smear across target
                                                                  within the last 15 years. 0.34%
population in North West
                                                                  had attended but never had
an adequate test, 0.95% had been called but had never attended for screening and 0.17% of
the target age group were reported as having no cytology record at all.

Uptake of Invitations
                                                                In the North West 527,700
                                                                women were invited for
                                                                cervical screening in 2007-
                                                                2008. For 10.5% of women in
                                                                the North West this was their
                                                                first ever invitation (call) and
                                                                for 64.4% a routine recall.
                                                                18.1% of invitations were early
                                                                recalls for surveillance, 4.3%
                                                                were early recalls following
                                                                persistent       low       grade
                                                                abnormalities and 2.8% were
                                                                recalls following inadequate
  Figure 14 - Uptake of smear invitations by category for
                                                                tests.    Figure     14     gives
  North West and all England                                    comparative data for all
                                                                England and the North West
                                                   54
N W   C S P   Q A   A N N U A L   R E P O R T   2 0 0 7 - 0 8




region in respect of the uptake of smear invitations. It shows that more women in the
North West are having early repeat tests to follow up previous abnormalities compared
with the rest of the country and the same percentage have repeat smears on the grounds of
a previous inadequate.

Smear Test Results
A total of 475,234 smear tests were performed in the North West during 2007-08, with
414,300 women in the 25-64 year age group being tested. Figure 15 shows that of those
225,600 (54.5%) followed a routine call/recall invitation from the screening programme. A
                                                                  further 76,300 tests were
                                                                  early      recalls    for
                                                                  surveillance, for the
                                                                  follow up of previous
                                                                  abnormalities or for
                                                                  inadequate tests. 84,200
                                                                  women had tests not
                                                                  prompted        by    the
                                                                  programme i.e. tests
                                                                  initiated by the sample
                                                                  taker or opportunistically
                                                                  by the woman, without
                                                                  her necessarily having
                                                                  been       invited.    In

Figure 15 - Smear tests by reason for test, North West and All  particular, some women
England                                                         are routinely called at an
                                                                earlier interval than that
agreed locally by the programme. Because women recorded as having a test not prompted
by the programme may nevertheless have been invited through a GP programme, it is not
                       Numbers within   %age of    possible to calculate the percentage
                       25-64 target age target age uptake of invitations from the
                                                   call/recall database. It is hoped that
   Negative
                            378,200         92.5   such local practices will cease
   Borderline                 15,200        3.7
                                                   following the recent national
                                                   amendments to the age and
   Mild                       10,200        2.5    frequency intervals of cervical
   Moderate                                        screening and that access to
                               2,400         .6
                                                   screening services will be more
   Severe                      2,500         .6    equitable in the future.
   Severe ?Invasive
                                  100               0      Across the region 2.8% of smears
   ?Glandular                                              were deemed „inadequate‟ i.e.
                                   300              0.1
                                                           unsuitable for diagnosis. This
                                                           represents a slight decrease over the
Table 15 - Smear test results, numbers in target range and equivalent figure for 2006-07 (3.1%)
percentage values                                          and is identical to the national
                                                           average. Table 15 shows the total
numbers in the North West of both negative and abnormal smears for those in the target age

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range of 25-64 years. 6.2% of all smears were reported as showing at least a low-grade
abnormality and 1.21% of smears were reported as showing a high-grade abnormality i.e.
moderate dyskaryosis and above.

                                                             Figure 16            shows
                                                             comparative data for both
                                                             low-grade (borderline and
                                                             mild dyskaryosis) and high-
                                                             grade        abnormalities
                                                             (moderate dyskaryosis and
                                                             above) for each of the
                                                             regions in England. The
                                                             North West ranks second
                                                             highest in its combined
                                                             abnormality rate with
                                                             London being the highest
                                                             and Yorkshire and Humber
Figure 16 - Comparative regional data for low and high-grade the lowest. The North
abnormalities 2007-08                                        West has a higher
                                                             proportion of low-grade
abnormalities and a lower proportion of high-grade abnormalities compared with all
England.

                                                                    Figure 17 compares the
                                                                    North West data with the
                                                                    national average for the
                                                                    various     grades      of
                                                                    abnormality detected. In
                                                                    the North West 3.7% of
                                                                    smears were reported as
                                                                    showing borderline nuclear
                                                                    change (national average
                                                                    3.4%); 2.5% as mild
                                                                    dyskaryosis      (national
                                                                    average 2.0%); 0.6% as
                                                                    moderate       dyskaryosis
                                                                    (national average 0.6%);
                                                                    and 0.6% as severe
Figure 17 - Comparative data for smears abnormalities, North West   dyskaryosis      (national
and All England                                                     average 0.6%).

Figure 18 shows the distribution of cervical smear abnormalities by age in the North West
region. Borderline nuclear change, mild, moderate and severe dyskaryosis now all peak in the
25-29 age group. These data are of course artificially skewed as women only enter the
programme at 25 years and women tested at an earlier age may not be representative. Mild
and moderate dyskaryosis decline sharply thereafter, but borderline changes persist at a
relatively high level throughout the screening age groups. This pattern is likely to reflect a
combination of true disease persistence, the diagnostic uncertainty seen with minimal
abnormalities and an increasingly legalistic reporting practice. It will be interesting to see

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whether this pattern of reporting changes with the use of HR-HPV testing in the triage of
low-grade abnormalities.

Severe dyskaryosis typically peaks approximately 10 years later than low-grade abnormalities
with the highest incidence in the 25-34 years age groups. Note that the peak of severe
dyskaryosis is seen in 25-29 year age group i.e. the first screening round. This is a source of
growing concern, particularly with falling coverage in the younger age groups. Screening
                                                                      sensitivities must be
                                                                      maintained or indeed
                                                                      increased to ensure that
                                                                      as many of the high-
                                                                      grade lesions as possible
                                                                      are detected at the first
                                                                      screening round.

                                                                           Figure 19 shows that
                                                                           smears reported as
                                                                           severe?invasive continue
                                                                           to display a roughly
Figure 18 - Distribution of smear abnormalities by age in North West.     bimodal        distribution
                                                                          with peaks in the 25-39
and 55-64 age groups. Note that the peak is now in the 30-34 year age group rather than
between 25-29 years. Numbers in these groups are relatively small and it is difficult to say
whether this shift reflects a true change in presentation or a delay in diagnosis. Further work
                                                                 is required to audit these cases
                                                                 and to determine their screening
                                                                 histories.

                                                                  Glandular abnormalities, or more
                                                                  correctly    category „6‟ reports
                                                                  show a more even distribution
                                                                  across the age groups but are a
                                                                  more heterogeneous group from
                                                                  a diagnostic viewpoint. Some of
                                                                  the cases recorded in this
                                                                  category are entirely spurious e.g.
                                                                  „endometrial cells out of phase‟.
Figure 19 - incidence of severe?invasive and ?glandular reports
for North West 2007-08.                                           Such cases should be recorded as
                                                                  national neoplasia code 2, but
some are still coded within the glandular neoplasia group.

Invasive Cervical Cancers
Figure 20 gives the numbers of newly diagnosed cervical cancers by age group for 2004,
2005, 2006 and 2007. There is some suggestion that total numbers are falling with 306,
354, 250 and 292 cases being registered for 2004, 2005, 2006 and 2007 respectively.
Similarly the percentage of cases within each of the age groupings appears fairly
constant from year to year.


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                                                     Table 16 – Coverage by PCT for 2005-06, 2006-07 and 2007-08.
                                                          2005-06                             2006-07                                                             2007-08
                                                            Coverage (less     Coverage (less                   Coverage (less    Coverage (less                 Coverage (less    Coverage (less
                                                             than 3.5 years      than 5 years                    than 3.5 years     than 5 years                  than 3.5 years     than 5 years
                                              Eligible           since last         since last       Eligible        since last        since last     Eligible        since last        since last
                                            population      adequate test)     adequate test)      population   adequate test)    adequate test)    population   adequate test)    adequate test)
                                               (000’s)                   %                  %         (000’s)                %                 %       (000’s)                %                 %

                      North West SHA              1,730.7             70.9               79.4         1,739.5             70.4              79.0        1751.2             69.4              78.2


Ashton, Leigh & Wigan PCT                           73.9               74.6               81.1           74.2              74.1              80.7         74.5              72.3              80.0
Blackburn with Darwen PCT                           37.4               70.4               77.9           37.7              69.3              77.3         38.1              67.3              76.0
Blackpool PCT                                       35.4               61.5               75.3           35.5              60.6              75.0         35.6              60.9              74.1
Bolton PCT                                          69.1               74.5               81.1           69.5              73.7              80.6         69.6              71.9              79.4
Bury PCT                                            46.6               76.4               82.4           46.9              75.1              82.0         47.2              73.5              81.3
Central & Eastern Cheshire PCT                     113.6               77.7               83.6          114.9              77.5              83.2        114.8              76.0              82.3
Central Lancashire PCT                                 ..                 ..                 ..         111.1              70.3              79.6        111.6              69.6              78.6
Cumbria PCT                                            ..                 ..                 ..         125.5              74.3              82.0        126.1              72.8              81.7
East Lancashire PCT                                    ..                 ..                 ..          92.1              72.4              80.0         92.5              71.2              79.0
Halton & St Helens PCT                              77.4               73.0               79.5           77.5              73.0              79.4         77.8              71.5              78.8
Heywood, Middleton & Rochdale PCT                   51.7               72.9               80.0           51.9              71.6              79.3         52.3              70.1              77.9
Knowsley PCT                                        38.3               66.5               74.8           38.3              66.2              74.5         38.4              65.4              74.0
Liverpool PCT                                      114.8               61.8               72.8          115.4              60.0              72.3        116.3              60.7              71.6
Manchester PCT                                     117.1               64.2               74.4          119.3              63.9              74.0        122.2              63.1              73.3
North Lancashire PCT                                   ..                 ..                 ..          76.1              66.1              79.2         76.4              66.3              78.5
Oldham PCT                                          55.2               73.4               80.7           55.4              72.7              80.2         55.7              71.2              79.1
Salford PCT                                         54.3               66.6               78.3           54.8              65.6              77.9         55.3              63.9              77.2
Sefton PCT                                          66.8               67.0               74.6           66.8              66.9              74.4         67.0              65.5              73.9
Stockport PCT                                       73.0               70.1               81.5           73.1              71.5              81.3         73.5              72.8              81.0
Tameside & Glossop PCT                              57.6               73.8               81.1           57.9              72.7              80.3         58.1              71.3              79.3
Trafford PCT                                        55.8               68.9               80.9           56.2              68.4              80.8         56.5              67.1              80.4
Warrington PCT                                      49.7               77.0               82.8           50.0              77.1              82.9         50.4              75.4              82.0
Western Cheshire PCT                                60.8               75.7               81.8           60.2              75.7              81.6         61.3              74.5              80.9
Wirral PCT                                          79.3               70.9               78.3           79.4              70.7              77.9         79.8              68.9              77.2
                                                                     70.8                79.1                            70.4              79.0                           69.3              78.2




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Figure 20 - Numbers of invasive cervical cancers by age for 2004, 2005, 2006 and 2007.

219 cases were submitted to CRUK national audit between 1st April and 31st December
2007. These showed an average age of 49 years with a mode of 36 years. The minimum age
was 23 years and maximum age 94 years. 194 cases had been screened at least once; 25 had
never been screened or had no screening history.

Histologically 157 were squamous carcinomas; 50 adenocarcinomas; 4 adenosquamous
carcinomas; 2 were undifferentiated; and 6 of other differentiation or undefined.

The majority of cases reported in the 25-29 year age group were stage 1 lesions, although
further work need to be done to separate the 1a1 from 1a2 lesions which were not
                                                           recordable on the early
                                                           version of the CRUK
                                                           database.

                                                                     Coverage Report
                                                                     – Yvonne Browne
                                                                     Despite      many       local
                                                                     initiatives   to    improve
                                                                     attendance rates for cervical
                                                                     screening,          coverage
                                                                     continues to fall both in the
                                                                     North West and across
                                                                     England. Coverage rates for
                                                                     cervical screening in the
Figure 21 - Coverage by Cancer Network 2007-08.                      North West remain below
                                                                     80% for the third year in a

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row.

Detailed coverage rates at local level highlight a number of practices falling well below
the 80% coverage target and this is particularly prevalent in the younger age groups.
Figure 21 shows current coverage rates by age band for the three cancer networks in
the North West region and highlights the problem of coverage in the younger age
groups.

The North West QARC continues to support and develop initiatives to improve
coverage rates. The coverage projects based in 7 of the regional PCTs within the region
have now completed the intervention stage and Professor Paola Dey, University of
Central Lancashire has produced an initial report of the findings. This shows a slight
increase in coverage for Manchester and East Lancashire; with the remaining sites
showing static or declining coverage. The full project evaluation is not due for
completion until 2008/09 when all comparative data on the various methodologies
used have been collected and analysed.

Initial findings suggest the need to develop educational packages to support primary
care reception staff who are often the first point of contact for women when booking a
smear test. QARC is developing a „toolkit‟ which outlines key issues and recent changes
to the cervical screening programme and highlights ways in which practices can support
and encourage women to come forward for regular screening. This will be rolled out to
PCTs during the coming year and will highlight „best practice‟ in those practices with
good coverage. A key element of this work will be to determine how the knowledge of
reception staff and their understanding of the cervical screening programme can
influence a woman‟s decision to attend for a test.

Further work looking at ways in which coverage can be improved is underway across
the North West. Cheshire & Merseyside Cancer Network has produced a „Cancer Early
Detection and Prevention Strategy‟ which incorporates cervical screening as a key
priority area and work is underway to develop action plans to take this forward.

Professor Dey is also working, in conjunction with QARC, to develop a pilot study
looking at the decline in coverage overall. This has been funded through the National
Office and work will begin on this study in 2008.


Primary Care Activity – Ruth Stubbs
The Primary Care guidance for good practice has proved to be a valuable resource to
sample takers in the North West. The document was widely circulated to Primary Care
and sample takers in the region. The publication features on most reading lists for
sample taker training courses and is regularly referred to on training events across the
North West. The document has been circulated to the primary care departments in
PCTs to provide a benchmark to assist in the Quality and Outcomes Framework visits
and assessments that take place annually. Many PCTs have adopted the regional guide
as their local screening policy.



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Training of sample takers continues to take place across the region. There are several
providers of the theoretical training within the region which include, Regional Cytology
Training Centres, Cumbria and Lancashire Public Health Network, PCTs and
Universities. In 2006/2007, 307 new sample takers undertook the novice sample taker
training on courses held by Regional Cytology Training Centres and Cumbria and
Lancashire Public Health.

Whilst there is a great deal of commitment from some training leads in PCTs to assist
with the training this is not uniform across the region, and some courses are run on
good will. Courses lacking a specified resourced lead are inevitably vulnerable. The
provision of the novice sample taker courses is vital to the quality and continuation of
the cervical screening programme in the region. This is an area that needs to be
addressed.

Mentors are provided by PCTs to support new sample takers in clinical practice. It is
essential that these mentors are kept up to date with clinical practice and developments
in the screening programme.           In September 2007 three Mentor update training
sessions were held across the region and eighty six mentors attended the events. These
training sessions evaluated very well. Demand for ongoing mentor updates is high and
it is intended that these events will be held annually and organised by QARC.

The NHSCSP recommends that sample takers should be updated every three years.
Update training events provide an opportunity to inform sample takers of the current
developments and clinical issues relating to the cervical screening programme. Sample
taker update training continues to be held across the region by PCTs without any
additional funding. The PCTs which have a designated cervical screening lead tend to
have a pro-active approach to organising this training.




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                                                                         6
                                                                          Chapter
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                                  Future
                                  Developments



                                  Speeding up Cervical Screening
                               Following the 2005 General Election Manifesto
commitment, the Prime Minister and Secretary of State announced in September of last
year that women can expect to receive the results of their cervical screening test within
14 days of it being taken. Subsequent advisory documents published in April of this
year provide guidance on achieving this target, which will be effective from the end of
2010. The „ScHARR Option Appraisal: Assessment of a seven-day turnaround for the reporting of
cervical smear results‟ recommended a number of options to assist the programme to meet
this target. These include:

      Limiting the processing of samples to only those women eligible within national
      standards
      Implementing an electronic links from the laboratory to the call/recall office
      Despatch result letters by first class post on Monday, Tuesday and Wednesday
      mornings
      Workforce redesign – training advanced practitioners
      Merging workload from small laboratories

The NHS Improvement, Pathology Service Improvement Team was invited to work
with a number of pilot sites across the country, using Lean improvement methodology,
to achieve or surpass the 14-day TAT. In the North West, the QARC and SHA
supported expressions of interest from Pennine Acute and Central Manchester sites
and both were selected for inclusion in the project. The cytology programme
commenced in October with a 2-day workshop in London to which all project sites and
core team members were invited. The QA Director has engaged actively with this
process and with members of the NHS Improvement Team to support the pilot sites
and to understand how this work can be rolled out more widely across the region.


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Semi-automation as an adjunctive quality control
measure
Automated scanning devices provide the ability to „predot‟ slides before human review
helping to prevent „omission‟ errors that frequently occur in the manual screening
process. The immediate identification of the „most abnormal‟ cells in a slide may lead to
more specific interpretation and will improve screening productivity as screeners will
not need to examine the entire slide to make a reliable negative interpretation on a
substantial number of cases.

Both of the currently available LBC systems have complementary system-specific semi-
automated scanning devices which achieve similar results, albeit through different
methodologies. The FocalPoint® GS which integrates with the SurePath LBC system
uses neural network technology to define classification algorithms; the ThinPrep®
Imager system uses near-stoichiometric staining to undertake a colorimetric
stratification of cell content. Both have been shown to improve screening sensitivity
and specificity. FocalPoint® differs from ThinPrep® Imager in that it ranks individual
slides relative to the probability that an abnormality is present, allowing up to 25% of
slides to be sorted into a „No Further Review‟ (NFR) category in which cases can be
authorised without manual intervention. This allows significant additional productivity
gains. The ThinPrep® system requires human review of all slides. A doubling of
productivity appears to be a realistic expectation for both systems.

The North West region was the first of all English regions to implement LBC and pre-
dated most of the other regions by several years. The expected advantages were quickly
accrued but were soon followed by new pressures and challenges to the service.
Declining workloads and increased productivity resulted in overcapacity and many staff
do not now achieve the minimum workload required to maintain competence. Quality
is further compromised by the relative failure of rapid review/rapid preview (RR/RP)
as the main quality control (QC) mechanism within the current screening pathway.
Data from the North West QARC show that RR/RP is detecting fewer additional
abnormalities in LBC samples compared with conventional spread smears.

The reconfiguration of the cervical cytology service (see page 13) while necessary and
inevitable has had a profoundly destabilising effect on screening staff and is likely to
result in increased error rates. Hence, the current drive to implement semi-automation
in the North West as an adjunctive quality control measure in advance of its proposed
use as a primary screening tool. A commissioning framework which incorporates the
use of semi-automation as a supplementary quality control measure was agreed by
Acute Trust and PCT Chief Executives at the beginning of this year.

The project aims to use semi-automation as a supplement to the current screening
pathway and as such would be entirely acceptable to the National Office of Cancer
Screening Programmes. It would be used to audit existing clinical practice and to
provide information which would underpin the likely national rollout of semi-
automation as a primary screening tool. Any increase in diagnostic accuracy would
benefit laboratories throughout the North West and the population they serve. All
laboratories throughout the North West will be invited to participate in this initiative
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which will run for a period of approximately two years and should therefore overlap the
publication of the MAVARIC trial data. It is hoped that as a result there could be a
seamless transition in the use of the scanners from a QC to primary screening tool.

Molecular Markers
A number of molecular assays are under evaluation which identifies the presence of
high-grade disease through the detection of a group of proteins specifically over-
expressed in cells showing moderate dyskaryosis and above. These abnormal cells are
detected through the specific reaction of monoclonal antibody reagents with disease-
specific proteins in an immunocytochemical test. During persistent infection with HPV
the continued expression of the two oncoproteins, E6 and E7, alter the integrity of the
cell cycle and disrupt the controlled processes of DNA repair, replication and
subsequent cell division. Ultimately, the disruption of the p53 and the Rb tumour
suppressor pathways leads to the loss of the G1/2 checkpoint, the G2/M checkpoint,
and the aberrant entry of the cell into the S-phase of the cell cycle. This in turn, results
in over-expression of those genes responsible for DNA synthesis and replication
including the genes for MCM-2, MCM-6, MCM-7, TOP2A and Cyclin E1. The assays
contain antibodies that recognise, for example, minichromosomal maintenance proteins
(MCM) proteins and topoisomerase11A (TOP2A). These assays may therefore be
capable of detecting high-grade disease within a cervical LBC sample. The detection of
high-grade disease rather than HPV infection has many attractions and might overcome
problems related to the relatively low specificity associated with HPV testing.

Studies are underway to establish the analytical performance of one such assay and to
obtain a preliminary indication of its potential clinical utility in the management of
cervical LBC samples assessed as showing either borderline nuclear change or mild
dyskaryosis.

Revised Terminology for Cervical Cytology
The BSCC has recently published revisions to the terminology for cervical cytology, which
will move reporting from a three-tier to a two-tier schedule. Koilocytic borderline
abnormalities and mild dyskaryosis are grouped into low-grade squamous dyskaryosis while
moderate and severe dyskaryosis and above form a high-grade squamous dyskaryosis
category. The existing category of borderline change remains and is sub-divided into
borderline? high-grade, borderline ?glandular and borderline not otherwise specified.
Glandular categories specify whether the abnormality is likely to be of endocervical or other
origin.

The proposed change in reporting practice for borderline koilocytic lesions may act
synergistically with the BSCCP guidance on referral and the implications of this to the
programme are still being investigated. Further consultation is on going with the National
Office and other professional bodies and acceptance of these changes will be dependent on
these ongoing discussions.




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Key areas for Action

      The reconfiguration of the laboratory service should be progressed as soon as
      possible to ensure the sustainability of the service; to prevent further deterioration of
      staff morale; and to avoid an impact on quality

      Semi-automated systems should be adopted as an adjunctive quality control measure
      to underpin service reliability


      Electronic links should be put in place in all laboratories and to all call/recall offices
      with which they communicate


      PCTs must be encouraged to prioritise cervical screening coverage; to monitor
      coverage at practice level; and to support poorly performing practices.


      Work relating to the establishment of a shared service for the management of the
      call/recall system should continue


      Colposcopy units should be encouraged to adopt „direct referral‟ to decrease waiting
      times

      PCTs should be encouraged to register all those who receive the HPV vaccine on the
      Exeter call/recall system

      PCTs should be encouraged to invest in cervical screening training and to support
      new and existing sample takers in practice




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           Appendix 1 – Regional Cytology Training Centres

           Liverpool Cytology Training Centre
           The role of the Liverpool Cytology Training Centre continues to evolve and grow in
           response to scientific and technical developments; to changing patterns of workforce
           planning and service delivery; and to enhancements in the configuration of other areas of
           diagnostic work. Hence, while retaining a strong focus in relation to the training of
           laboratory staff in cervical cytology, the scope of the Centre has widened considerably to
           encompass all disciplines and professional groups who are involved in the delivery of the
           Cervical Screening Programme in both primary and secondary care; and to non-
           professionals and lay workers tasked with increasing population coverage.

           Other cancer areas are also receiving increasing attention as site-specific Improving
           Outcomes Guidance is introduced which requires the delivery of high-quality pre-surgical
           diagnosis, often fine needle aspiration cytology. The relative lack of such services and hence
           of suitable material for training and updating has made non-gynaecological cytology courses
           particularly popular. Site-specific cytology courses are currently in development and are
           aimed particularly at consultant staff who deliver or who are planning to deliver rapid
           access/diagnostic services.

           The remit of the Centre has therefore changed over the last few years but especially in the
           last twelve months. It now offers a broad spectrum of training in cancer and cancer
           diagnosis both within cancer screening programmes and in the symptomatic setting. No
           other training establishment is in a position to offer both this breadth and depth of training
           and to have the flexibility and resource to meet changing conditions and regional/national
           needs at short notice. The Liverpool Cytology Training Centre delivers a „cancer training
           service‟ rather than a number of static courses. It monitors service needs and moves quickly
           to address areas of difficulty, changing clinical demands or changing workforce
           configurations. This new role must be fully acknowledged.

                                               The Training Centre underwent a second round
NHS CSP NCCETC Accreditation                   accreditation inspection by members of the National
                                               Cervical Cytology Education and Training Committee
                                               (NCCETC) in November of last year. Training Centre
         staff had put in considerable work over the preceding months to enhance the
         accommodation and facilities; replace training and course materials; and to update
         operational procedures. The inspectors were highly complimentary of the Training Centre
         facilities and equipment; of written course material, microscopy slide sets and lecture suites;
         and of the very strong team spirit displayed by Training Centre staff. They were particularly
         complimentary of feedback from course participants. The only area of concern related to the
         vacant Training Centre Technical Manager and Training Centre Deputy Manager posts, the
         funding for which awaited a decision from the North West Strategic Health Authority. As a
         result conditional accreditation was awarded pending the filling of these posts.

           Since then the Strategic Health Authority has agreed to fund the above posts for 18 months
           in anticipation of a wider review of service requirements and training delivery. The Training
           Centre Technical Manager post was filled in June of this year by Mr Christopher Evans,
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           Consultant Biomedical Scientist and Hospital Based Programme Coordinator, Royal
           Liverpool University Hospital. The Training Centre Deputy Manager post has recently
           received Agenda for Change banding and the post will be advertised shortly. This will fulfil
                                                       the requirements of NCCETC and allow
                                                       full accreditation to be reinstated.

Staffing of the Liverpool Cytology Training Centre                    The current staffing structure is shown in
                                                                      figure 1. The enhanced role undertaken
                                                                      by administrative/clerical staff and
           described in last year‟s report has been maintained since the appointment of the
           Technical Manager. Traditionally there has always been a split between those tasks
           which were assumed to be the sole province of biomedical scientists and those which
                                                                                 are usually undertaken by
                                          LCTC                                   administrative/clerical      staff.
                                         Director
                                       Dr Turnbull                               Increasing diversification and
                                                                                 the     loss    of    established
                                                                                 boundaries in employment
                    LCTC Manager
                     Mrs A Curran
                                                         Visiting ABSMPs
                                                         Ms S Montgomery
                                                                                 structures within the NHS have
                                                          Mrs V Beavers          provided the rationale to
                                      Technical Manager
                                                                                 maintain this structure and it has
                                         Mr C Evans                              proved extremely successful. In
                                                                                 practice, the Training Centre
                LCTC Administrator                                               Manager and Administrator
                  Mrs M Crane
                                                                                 have together taken on and
                                                          Visiting external
                                                              speakers           moved forward many of the
                                           Deputy
                                      Technical Manager                          duties of the previous Technical
                                                                                 Manager. This includes technical
                                                                                 duties such as the labelling and
             Figure 1 - LCTC staffing structure
                                                                                 cleaning of slide material; the
                                                                                 annotation and histological
           confirmation of slide collections; the setting up of microscopes and complex
           audiovisual equipment; and negotiating with consultants, laboratory managers and
           senior biomedical staff with regard to a range of training requirements. This allows
           senior scientific staff to concentrate their time and efforts on areas of work
           commensurate            with         their   AfC             banding.      Their     duties     include:

                         Assisting in the acquisition and assessment of new cytological material from
                         both current LBC systems (SurePath and Cytyc)
                         Assisting in the annual review of archived material as required by National
                         Cervical Cytology Education and Training Committee (NCCETC)
                         Developing new training materials in the form of notes, handouts,
                         photomicrographs, examination questions, e- and other distance learning
                         material, etc
                         Assisting in the development of a Liverpool Cytology Training Centre
                         website
                         Providing lectures, seminars and multiheaded microscopy discussion sessions
                         and individual tuition as required
                         Actively engaging in the evaluation and assimilation of new technologies to
                         allow the Training Centre to deliver training in novel areas
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                         Actively engaging in projects which will impact on the cervical screening
                         programme
                         Functioning as Internal Verifier in the City & Guilds Diploma in Cervical
                         Cytology
                         Liaising with North West Region Cytology Laboratory Training Officers and
                         with City & Guilds Assessors if these individuals are not also the Cytology
                         Laboratory Training Officers
                         By liaising with other educational establishments as appropriate
                         Participating in the training of staff in technical aspects of non-gynaecological
                         cytology
           The total time allocation for the Technical Manager is 0.25 WTE; substantially less than
           that of the previous incumbent who was employed by the Training Centre for 0.75
           WTE. The post of Deputy Technical Manager will also have an allocation of 0.25
           WTE. It is expected that these posts will complement each other and will allow cover
           both in terms of course delivery and the development of new slide material, workshops
           and other training innovations. A further training resource is also available from
           Visiting ABMSP lecturers, Ms Sandra Montgomery and Mrs Viv Beavers. Both are
           established Consultant Biomedical Scientist Practitioners working in Warrington and
           Blackpool respectively and continue to provide five half days each of training time. This
           staffing structure provides great flexibility and both routine and emergency cover for all
           aspects of training.

           Dr Turnbull continues to provide the majority of lectures and multi-headed microscopy
           sessions. While it is hoped that the Technical Manager and Deputy Manager will take
           on an increasing proportion of the training, she intends to continue to deliver the
           majority of update and medical courses, which require the highest level of professional
           input.

           Other outside speakers who have contributed to the lecture portfolio this year include
           Dr D Kinn, Dr Guy Hayhurst, Mrs V Beavers, Ms S Montgomery, Mrs B Malone, Mrs
           S Roseboro, Mrs R Stubbs, Mrs Y Browne, Mr M Wall, Mrs J Davies, Mr C Evans, Ms
           G Kinsela, Mrs B Brennan, Ms J Dillon and Ms D Zack-Williams.

                                             The relevant professional bodies and the NHS Cervical
Update on City & Guilds Diploma              Screening Programme (NHS CSP) through the
                                             National Cervical Cytology Education and Training
                                             Committee (NCCETC) have long supported a drive to
          gain formal academic recognition for the current NHS CSP Certificate in Cervical Cytology
          examination. The NHS CSP and a multi-professional expert reference group worked with
          the City & Guilds of London Institute (City & Guilds) to convert the current examination
          into a national award. The award was matched to the appropriate level on the National
          Qualifications Framework (NQF) and gained accreditation with the Qualifications and
          Curriculum Authority (QCA) on 1st July 2007. Centre accreditation with C&G is expected in
          the middle of November.

           Candidates who are new to training on or after 1st July will follow the Diploma route;
           candidates already in training have the option to complete the current Certificate or to
           transfer to the Diploma. Candidates who have gained a qualification and experience in

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          cervical screening outside the UK (and who are employed by a laboratory which provides
          cervical screening services under contract to the NHS) also have to follow the Diploma
          route. Individuals will not be exempt from any of the assignment tasks or the screening test
          and written examination paper. They will, however, be encouraged to complete the award at
          the earliest opportunity.

          The Liverpool Cytology Training Centre ran a C&G Assessor Induction Course on 29 May
          2007 for laboratory training officers from across the region. This was an intensive and well
          attended course which opened with a discussion of the new qualification, an overview of
          VRQs, C&G approval requirements, policies and procedures. The terminology relating to
          C&G qualifications was covered in detail together with the roles and responsibilities of all
          individuals involved. Preparation for training was described as including learner induction,
          initial agreement and foundation phases. The assignment structure proved a major
          component of the day with discussion of the assignment units, assignment planning,
          completing and marking assignments, presenting assignments and the external test. Record
          keeping responsibilities and appeals procedures were also covered together with the role of
          the internal verifier, the development of assessors and managing the quality of VRQ
          delivery. Assessors/training officers have since been circulated with the following
          documents:

                        C&G Centre Resource Pack containing the assignment tasks

                        Marking and Grading criteria

                        Supplementary Marking Guidance for Assessors

                        Standard recording forms for Assessors

                        Forms for assessment planning

          Candidates cannot be registered with C&G until Centre approval has been achieved. To
          ensure that candidates ready to start work on their assignments are not disadvantaged, an
          interim agreement has been negotiated with the C&G External Verifier. This allows any
          assignment tasks completed before Centre approval to be considered as APEL.

                                           Biomedical Scientists: The Institute for
Proposed Changes in Training Activity      Biomedical Science (IBMS) has introduced changes
                                           to its membership structure, which will have
                                           significant training implications. These changes are
          in line with the NHS Plan and the general move to modernise pay, jobs, learning and
          professional development and professional regulation and are underpinned by the
          following:

                        Agenda for Change
                        Knowledge and Skills Framework
                        National Occupational Standards for Healthcare Scientists
                        Healthcare Scientist Career Pathway



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           Nine stages are identified in the Healthcare Scientist Career Pathway, which are linked
           to Agenda for Change and have defined entry and access routes. The following new
           qualifications will be introduced:

                         Specialist Diploma
                         Higher Specialist Diploma
                         Extended and Expert Practice Diplomas
                         Advanced Specialist Diploma

           The Liverpool Cytology Training Centre has already introduced a course for the
           Advanced Specialist Diploma in Non-Gynaecological Cytology and awaits guidance
           from the IBMS as to the training implications for the lower ranked qualifications.

           Collaboration with Liverpool John Moores University: The Training Centre has recently
           agreed to collaborate with Liverpool John Moores University, School of Biomolecular
           Sciences in the delivery of „Diagnostic Applications in Biomedical Science‟ courses A and B.
           These courses provide support for students taking the IBMS Specialist Diploma as a route
           to Associate Membership of the IBMS, which can lead to promotion to Specialist
           Practitioner in Biomedical Science in the UK health services. This course can also form a
           module in preparation for an MSc in Biomedical Science. This is an exciting collaboration
           and is warmly welcomed.

           Improving Outcomes Guidance: As discussed above, a three-day course aimed
           specifically at the management of Head and Neck tumours is under development and will be
           held on 12 – 14 February 2008.

           Collaboration with Faculty of Family Planning and Reproductive Health: Dr
           Turnbull was recently approached and has agreed to act as a trainer for the Faculty of Family
           Planning and Reproductive Health.

                                                    The courses offered in relation to the cervical
Training Centre Course Repertoire                   cytology specification are as follows:

                                                     4-week Introductory course – An intensive
                 course aimed at novice cytology screeners. It covers a wide range of topics
                 including health and safety, principles of microscopy, theory and practice of
                 Papanicolaou staining, female genital tract anatomy, physiology, principles of
                 screening, cellular substructure, normal and abnormal histology, normal and
                 abnormal cytology, theories of neoplasia, development of cervical cancer,
                 principles of colposcopy, principles of treatment of CIN and cervical cancer,
                 principles of VaIN, VIN, MIN, PIN, basic endometrial and ovarian pathology.
                 The course gives structured practical tuition with both individual and
                 multiheaded microscopy sessions. There are written and practical assessments at
                 the end of each week.

                 Refresher course – A one-week course which reviews much of the ground
                 covered in the Introductory course but in greater detail. A mock Certificate in

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      Cervical Cytology examination is included on the final day.

      Certificate in Cervical Cytology Pre-Examination course – A four-day
      course providing a review of the overall syllabus with particular emphasis on
      examination format and technique. As a distance-learning exercise, students are
      provided with large numbers of sample examination questions prior to this
      course and detailed, individual feedback is provided for all work submitted.

      Update course – An intensive three-day course for experienced
      cytotechnologists and pathologists. The course content changes on a regular basis
      and is defined by current areas of interest or difficulty; changes to the NHS CSP;
      scientific developments and new technologies which may directly impact on
      cervical screening.

These four courses represent the minimum package which a Cytology Training
Centre must offer to be eligible for accreditation by the NCCETC. Other cervical
cytology courses offered to laboratory staff include the following:

      Advanced Biomedical Scientist Practitioner course – A mandatory one-week
      course for those experienced biomedical scientists who wish to sit the Advanced
      Specialist Diploma in Cervical Cytology. This high level course covers a wide
      range of issues relating to the reporting and management of cervical cytology
      samples, handling of discrepancies, clinical implications, management of critical
      incidents, role of hospital-based programme coordinator, role of quality
      assurance, organisation of the NHS CSP; and detailed case discussion. A mock
      Advanced Specialist Diploma in Cervical Cytology examination is offered on the
      final day.

      MRCPath Gynaecological Cytology course – A one-week course aimed at
      Pathology SpRs and often accessed prior to the final MRCPath examination. The
      course covers all aspects of both normal and abnormal cervical cytology and
      clinical management. The course gives structured practical tuition with both
      individual and multiheaded microscopy sessions.

      MRCPath Pre-Examination Course – An intensive four-day course using a
      format identical to that use in the RCPath examination. Students are provided
      with a total of 16 sets of slides which are reviewed in detail during multi-headed
      microscopy sessions.

      LBC Induction course – a mandatory three-day course aimed at trained
      cytotechnologists wishing to convert from conventional spread smears to Liquid
      Based Cytology.

      LBC Conversion course – a mandatory one-day course aimed at trained
      cytotechnologists wishing to convert from one LBC technology to the other.

      Novice Nurse Smear Takers: The course provides three days of theoretical
      training, an extended period of mentored practical training and a final day of
      reflection and evaluation.
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                 Nurse Smear Taker Mentors: A one-day course for nurse smear taker mentors
                 to provide update training and to advise mentors on the assessment of students
                 in their care.

                 Updates courses for Nurse Smear Takers: In compliance with “Taking
                 Samples for Cervical Screening” (NHS CSP Publication No 23, April 2006) a
                 one-day course is provided for trained nurse smear takers to provide an overview
                 of routine work and an update of topical issues.

                 Trainee Colposcopists: The Training Centre collaborates with the North West
                 Region Quality Assurance Reference Centre and Colposcopy units at Chorley
                 Hospital and The Liverpool Women‟s Hospital to provide a three-day
                 colposcopy course. One of these days is based entirely at the Training Centre and
                 provides novice colposcopists with training in histology, cytology, microscopy,
                 LBC sample preparation and laboratory procedures in compliance with BSCCP
                 accreditation requirements.


           The following non-gynaecological cytology courses are also offered by the Training
           Centre –

                 MRCPath Non-Gynaecological Cytology course - A one-week course aimed
                 at Pathology SpRs and often accessed prior to the final MRCPath examination.
                 The course covers a wide range of non-gynaecological exfoliative and aspiration
                 cytology. The course gives structured practical tuition with both individual and
                 multiheaded microscopy sessions.

                 Preparatory Course for Advanced Specialist Diploma in Non-
                 Gynaecological Cytology – a one-week course covering principles of neoplasia,
                 detailed histology and cytology of respiratory and urinary tracts and serous cavity
                 effusions. A mock Advanced Specialist Diploma in Non-Gynaecological cytology
                 examination is offered on the final day.

                 Non-Gynaecological Cytology update course for BMS staff - A one-week
                 course aimed at biomedical scientists covering a wide range of both exfoliative
                 and aspiration cytology. The course gives structured practical tuition with both
                 individual and multiheaded microscopy sessions.

                                             The current funding support to the Liverpool
Future Funding Arrangements                  Cytology Training Centre is provided by the North
                                             West Strategic Health Authority. It was
                                             recommended last year that funding be offered on
          individual items of service (covering only those courses required by NCCETC for
          Training Centre accreditation) rather than on the basis of a block contract. Costs would
          be based on full economic costing which would therefore entail a substantial increase to
          overall costs as by necessity capital charges, depreciation costs and proportionate
          overhead costs would be included. It was made clear, however, that the current training
          provision includes far more than that covered by NCCETC accreditation and that

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           essentially the same infrastructure can provide the many additional courses presently
           included in the Training Centre repertoire.

           Furthermore, it was pointed out that the capacity of the Training Centre is driven
           largely by the capacity of the multi-headed microscope which forms one of the most
           important components of training. Courses are increasingly dominated by such group
           discussions and they consistently evaluate extremely positively.

           The attempt at the end of last year to charge a commercial rate for courses was rapidly
           abandoned as neither the Acute Trusts nor the Post-Graduate deaneries had sufficient
           funds to meet these requirements. To have retained this policy would have
           disadvantaged students and would have compromised service delivery across the North
           West. As a Centre which is committed to underpinning excellence within the clinical
           areas it serves, this would have been contrary to our guiding principles.

                                                           Semi-automated screening systems:
Changes to Facilities and other planned developments       Semi-automated screening systems for
                                                           cervical cytology are currently being
                                                           trialled and there is a strong likelihood,
           given the data available worldwide, that these will be successful and will be adopted by
           the NHS CSP. In anticipation of this, the Training Centre has recently purchased a
           location guided screening system and 6 computer monitors to start to familiarise
           screening staff with this new technology. The monitors are situated within the footprint
           of the multiheaded microscope and closely simulate a semi-automated screening
           station. It is of paramount importance that the Training Centre maintains its position
           at the leading edge of knowledge and practice within this field.

           Molecular Markers: The Training Centre Director is currently undertaking a study to
           examine the use of a novel molecular marker for cytology, the ProEx C Cytology
           Assay. This is an exciting development for the Training Centre and provides further
           evidence of its determination to be at the forefront of cytology provision.

           Website and e-learning materials: The Training centre is planning to develop an
           interactive website to promote its activities as widely as possible. The site will provide
           information on courses, allow on-line booking, and will be a vehicle for e-learning to
           those registered with the Centre. The Director is already in negotiation with a developer
           of e-learning materials to ensure that the quality replicates as closely as possible that
           provided by conventional microscopy.

                                               The Training Centre constantly acquires new material
Course Material                                from the screening and diagnostic workloads handled
                                               through the Royal Liverpool University Hospital
                                               department. All cases are entered on a purpose-built,
          secure database which allows full annotation of the case to include:

                 Date of accessioning to database

                 Cytological diagnosis


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                    Histological confirmation

                    Workshop or collection to which case is allocated

                    Date of annual review

                    Date removed from database

            All databases are fully compliant with the Data Protection Act and Trust policies
            regarding security and confidentiality. All Training Centre staff attend the Data
            Protection, Information Security and Freedom of Information Update Session run by
            the Trust on an annual basis. All staff are fully compliant with PIAG Section 60
            requirements. All staff are compliant with agreed Standard Operating Procedures
            (SOPs) covering all aspect of the Training Centre this includes student registration,
            course information, generation of correspondence, databases and spreadsheets, etc.

            The Training Centre has retained a small amount of conventional spread material for
            examination and other purposes.

                                                At present there are two commercially available LBC
LBC Systems                                     systems, SurePath and ThinPrep. Both have been
                                                recommended by NICE for use in the NHS Cervical
                                                Screening Programme. The Centre is very clear that it
          should be able to support the education and training of all staff in the North West,
          whichever system the parent laboratory employs. However, this requires continued and
          regular exposure in a diagnostic setting to both preparations and hence a commitment to
          maintain both systems in-house at least for the immediate future. The PCT Commissioner
          has agreed to split the workload of the Royal Liverpool between the 2 systems, ensuring that
          approximately 15,000 samples are processed by each system annually. This level of
          throughput is required by the NCCETC to ensure competency.

            The Centre has continued to invest in new textbooks and journals as appropriate to ensure it
            is compliant with the requirements for national accreditation.

                                                 Liquid based cytology has imposed considerable change
Future Directions and Business Strategy          on the cervical screening programme. However, it
                                                 represents merely the first step in what is certain to be
                                                 an extended period of change. It is of fundamental
           importance that the Training Centre is fully cogniscent of these expected further changes
           and their implications and modifies its training schedules to meet the needs of the evolving
           service. These will include the adoption of semi-automated scanning devices; HPV testing
           used either as a primary screening modality or in reflex triage of low-grade abnormalities;
           and the incorporation of cell cycle and other molecular markers to the testing regime.

            The following proposals are submitted for consideration:

                  1. The renegotiation of the Training Centre contract in recognition of the changing
                     requirements of the service and the spectrum of staff trained therein.



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                 2. The acquisition of new technologies as appropriate to meet the changing needs of
                    the service



           Manchester Cytology Training Centre
           The Manchester Cytology Training Centre (MCTC) has continued in the path to
           completion of Regional LBC roll-out training during 2005

           The centre remains a popular venue for meetings and Training courses for the whole of
           the Directorate of Laboratory Medicine, and has been used for external meetings which
           have included Technical EQA. These events still include regular and popular courses
           organised by the Andrology Department . 2-3 times a week, the multi-head microscope
           is used for peer review discussions and occasional CPC meetings, ensuring regular use
           of the facilities.

           The Training Centre Director has remained a popular figurehead in the field of
           Cytopathology and has been extremely active in her role as Honorary Programme
           Secretary for the British Society for Clinical Cytology. She is a member of the Standing
           Committee on Academic Activities at the Royal College of Pathologists (RCPath), is
           responsible for organising annual scientific meetings for the BSCC and RCPath., and is
           also on the Editorial Board of various national and international Cytopathology
           journals. She has been invited to speak at various national and international cytology
           and papilloma virus meetings (including in the next 12 months Canada, Prague and the
           Netherlands)

           Together with other members of the National Cervical Cytology Education and
           Training Committee (NCCETC), the Training Centre Manager has been heavily
           involved in the development of the NHSCSP LBC Training Atlas, reviewing and
           replacing the slides in the NHSCSP Certificate in Cervical Cytology examination slide
           bank, and is a member of the Expert Reference group working towards the conversion
           of the existing Certificate examination into a City & Guilds Vocationally Recognised
           Qualification (VRQ). She also continues to be the Continuing Education Scheme
           Administrator for the National Association of Cytologists.


Staffing
                                              The Training Centre Manager and Director are
                                              supported by a full-time A&C 4 secretary, and other
           Consultant staff from the Manchester Cytology Centre (MCC). The LBC review
           sessions were shared between Dr Mina Desai and Dr Durgesh Rana, who were
           managing this around their routine workload, in spite of the MCC having 2 vacant
           consultant posts. This latter fact was exacerbated by the sudden and serious illness of
           one of the permanent Consultant Cytopathologists in July 2005. This meant that some
           of the plans we had for the Training Centre had to be put on hold. All staff had major
           concerns about this situation, but to our extreme relief and pleasure, the consultant in
           question recovered and returned to work in February 2006. Two locum Consultant


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           Pathologists were taken on during this time to ease the pressure, both of whom
           contributed to the Introductory course in March 2006.


Funding
                                             During the early part of 2006, concerns were raised
                                             about funding issues with Manchester Workforce
           Development Confederation, not least because of staff changes causing a poor transfer
           of information. This resulted in the income for 2005/6 being severely delayed.
           Following this, assurances have been given that this money will be formally identified
           for each year. Discussions also began about future arrangements given the plans for all
           three WDC‟s to merge into one large centre i.e. Cheshire & Mersey, Lancs & South
           Cumbria, and Manchester, and become NHS North West in July 2006. This could
           have major implications for both Training Centres in the Region which currently have
           completely separate, and successful, arrangements. There is a great need to keep two
           Centres due to the large geographical spread of the Region from South Manchester,
           East Cheshire and up to Carlisle. It is also advantageous to Regional staff to have a
           choice giving more variation in their update training. These discussions are still
           ongoing.


Course Information
                                             The success of the LBC training courses, and the
                                             reputation gained, resulted in many requests from
           external sources to carry out LBC conversion training courses. Wherever possible, this
           was done so that any remaining Regional and Departmental staff could be catered for:


LNR Regional LBC roll-out training
                                                In December 2005, the MCTC submitted a
                                                successful bid to train the Leicester, Northampton
           and Rutland region (LNR) which required its staff to convert to ThinPrep®
           morphology. This had been put out to tender due to their Regional Training Centre
           training in only Surepath™ morphology. This involved putting together a business
           case, training proposal, and a presentation to the LNR WDC, East-Midlands QA and
           Laboratory managers. The fact that we had completed the Regional Roll-out training at
           that time, and had experience of running LBC conversion courses since 2003, helped
           with the successful outcome. The training started in February 2006, and it is hoped to
           be completed, at the latest, by the end of October 2006.


Northern and Southern Ireland
                                               The Training Centre Director, through her contacts,
                                               was also approached to organise the training of staff
           in ThinPrep® morphology. This was accepted and extra training sets were prepared in
           order to carry out this task. This training was for all grades of staff from Cork, Galway
           and Altnagelvin laboratories. The reviews for the Irish staff were arranged in their host
           laboratories, but full training was only allowed at the Manchester site. In the time
           frame possible, assurances were sought about the quality of facilities available, including

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           equipment details, servicing and pictures of the area, before agreement was given to do
           the review off site. The ideal would have been on off-site visit, but due to the Training
           Centre manager‟s commitment with the Gynae Introductory course, this was not
           possible. Advise on this issue was sought from the NHSCSP examination office, and
           our proposal was deemed acceptable in the circumstances.

           The courses have been run in accordance with guidelines issued by the NHSCSP. This
           included a 3 day induction course (minimum 20 hours), followed by a consolidation
           phase of 200 slides (requirement before progression 95% sensitivity for High Grade
           abnormalities), an Interim test of 20 slides (pass mark 80%), and a Performance Review
           phase of a further 200 slides. Staff were invited back for a half day review session
           following completion of the Consolidation sets so that problems could be discussed
           before progressing to the Interim Test. Medical staff, and Advanced BMS Practitioner
           not doing any primary screening, could complete after the Interim test. Non-medical
           staff had to complete the Performance Review slides. Successful certification occurred
           if the “students” achieved 95% for High Grades in the combined Consolidation and
           Performance Review stages. Anyone not reaching the standard was asked to review
           another set of slides to bring the standard up.

           11 Courses were run in the 2005/6 financial year, largely due to the continuation of the
           LBC training, Consultant staffing levels, and the ongoing replacement of conventional
           teaching sets with LBC slides, which needed to be over and above those being used for
           the LBC training. In this particular year, there was no great need for formal update as
           Regional staff had just completed, or were still completing, their LBC conversion.
           However, the Centre still offered and ran Pre-Certificate courses and an Introductory
           Course, which began in March 2006. Preparation of teaching material for this latter
           course involved a huge amount of work in order to give the Trainees enough slides to
           cover their training needs. Extra slides were prepared form LBC samples and screened
           for suitability, but unfortunately not all slides proved to be good enough for the
           standard required for the Introductory course. The main priority was collection of
           Surepath™ material as that was the system requirement for the trainees on the course,
           but samples are also being collected for the ThinPrep® system as the Centre aims to be
           able to offer both. As both systems are in use in this Region.

           All courses are evaluated by use of an Exit Questionnaire to provide useful feedback
           for the Training Centre, and which are discussed at staff meetings.


Facilities and Equipment
                                            The Centre houses a 16 head teaching microscope
                                            (15+1), 15 ergonomic screening microscopes with
           recommended optics, an ergonomic microscope with camera for the Training Centre
           Manager, and 30 ergonomic chairs. These have been used in comfort since the transfer
           in September 2002. There is a dedicated lecture area, which may be screened off by a
           sound-proofing sliding panel, and a dedicated microscopy area with side benches for
           the 15 Olympus microscopes, and the table with the Multi-head microscope in the
           centre of this room. The Multi-head microscope capacity can be extended if necessary,
           using an adapter and video camera linked to a monitor, from which extra students can
           view the real time images. The lecture area also contains a microscope with video

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         camera, which can be used for large numbers of delegates to view real-time cytological
         images on 2 ceiling mounted monitors and on the projection screen. There is also an
         over head projector, and floor based points for the use of standard slide transparency
         projectors. All of this equipment is serviced annually.

         Consultant staff giving lectures on update courses continue to put together separate
         seminar sets to complement their sessions, and for discussion at the multi-head
         microscope.

         Ongoing plans to appoint a Deputy for the Training Centre Manager. The newly
         appointed training officer at the Manchester Cytology Centre may prove to be useful
         for cover in times of emergency, but would not suffice as an official deputy. The LNR
         tender was an outlet which was explored and included in the costing, but only the LBC
         training part of the tender was taken up and this would not, therefore, fund a member
         of staff in post. This avenue was not fully closed as at the end of March 2006.
         Following completion of LBC rollout training which has taken a priority, expansion of
         the course curriculum to include a greater volume and the development of shorter and
                                                specialist courses.

Planned Developments for 2006-7                 Links with the Liverpool Training Centre and
                                                QA Reference Centre and other external
                                                agencies that have a legitimate interest in the
         success of the Training Centre will continue to be fostered.

         The development of separate courses for medical and non-medical staff is being
         discussed.

         Continued revision and update of all training material, including replacement of all
         conventional training sets with slides from both LBC systems.

         Revision of study materials and schedules in line with the City and Guilds qualification

         Review of staffing structure and Training Officer links in line with City and Guilds
         requirements

         The offer of support to those wishing to study for the Certificate in Advanced Practice.

         To offer the facilities of the Training Centre as a host for the professional examinations
         in current practice.

         Re-introduction of Non-Gynae courses




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Appendix 2 – Protocols for the Management of Low
Sensitivity
The following protocols have been devised to provide guidance to laboratories in the
management of individuals whose performance in screening falls below the expected range.

Individuals achieving a sensitivity for moderate dyskaryosis and above of less than 95% on
two consecutive occasions will have their primary screening work rapidly reviewed by a
senior member of staff for a period of three month. Any discrepancies will be discussed in
full with the individual, preferably on a teaching microscope. During this period of time, it is
expected that the screener will attain/re-attain a sensitivity of 95%. It is also expected that
the screener will meet the minimum workload target (i.e. an annual workload of at least
3,000 smears). At the start of the three-month review period, it is expected that the screener
will be offered confidential counselling from a senior member of technical staff. It is
anticipated that in the main, screeners will acknowledge their misses, most of which are likely
to be detected by rapid review. However, in a small number of cases, the „false negative‟ may
result from the pathologist over-ruling the previous negative findings. If this is the case and
if the numbers suggest that this problem may have been a major contributory factor to the
low sensitivity, then these cases should be reviewed by the screening staff and the
pathologist, and the pathologist should mark those fields of the smear which he/she
considers to have been under-reported. On occasion, some of these positive reports may
have to be re-considered. Any such change should precipitate a recalculation of the
sensitivity. Pathologists are reminded that cervical smears should be reported independently
of any histological biopsy material, although subsequent correlation is clearly important.

If at the end of the 3-month review period the individual has attained the 95% target, then
that individual may be returned to normal working practice. If on the contrary the under-
performance is maintained, then the screener should be invited to participate in an
update/refresher course at the earliest opportunity. The monitoring process should continue
until the training is available.

Following the training episode, the individual should follow the regional protocol for
screeners returning to work after a prolonged period of absence. These require:

The first 300 smears screened on return to work are double screened in the following
manner:


                   First 100           100% rescreened

                   Second 100           50% rescreened

                   Third 100            25% rescreened


If performance is considered satisfactory during this period then the individual can
recommence signing out cervical smears. Unsatisfactory performance during this time would
include one high-grade miss or two low-grade misses. Should performance be unsatisfactory

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at any stage during this cycle of rescreening, then that stage of the rescreening exercise
should be repeated. Individual departments may feel that inadequate smears should be
monitored closely beyond the rescreening of the first 300 smears.

Performance during such an exercise must be recorded on the individual‟s screening records
and documentation must be retained. If the individual fails to complete the procedure within
a 3-month timescale, then the QA Director should be informed and a further individualised
action plan will be devised at that stage. In the event of a sensitivity of less than 85% being
achieved, it would be necessary for all work undertaken by that individual to be rescreened.
This action would only be taken after a detailed investigation of that individual‟s work and
when it was clear that the low sensitivity related to poor screening rather than any other
cause. No immediate action should be required in the event of a screener achieving less than
the required standard in the borderline and above category




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               Appendix 3 – Template for HBPC Annual Report



                                               … NHS Hospital Trust


                                   Hospital Based Programme Coordinator

                                                            for the

                                       NHS Cervical Screening Programme


                                               Annual Report Template




TRUST DETAILS

Name of Trust:


Address:




Name of Hospital Based Programme Coordinator:                Tel no:               Email:




Address of Pathology Department:


Name of Lead Histopathologist:


Name of Lead Cytopathologist:


Name of Technical Lead for Cytology:



Address of Colposcopy Department:


Name of Lead Colposcopist:


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Document Control

Circulation list:                                                                                    Date of issue:




Laboratory Data

CPA Status:                                      If conditional or referred please give reasons:
(Unconditional / Conditional / Referred)




QA Multidisciplinary Visit:                      If visit within previous 12 months give brief details of recommendations, action plan and action
                                                 achieved
Date of last visit:




Staffing levels ( number of WTE):                Comment on adequacy of staffing levels, difficulties in staff recruitment, long term sickness,
                                                 vacancies, etc.
Medical and consultant biomedical scientists:


Non-medical:


A&C:



Accommodation and Facilities: (please comment identifying areas of good practice or additional requirements)




Equipment: (please comment identifying recent acquisitions or current needs)




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Laboratory programme management

Total cervical                          Do all primary screeners meet                    YES / NO (If no give brief explanation)
cytology workload:                      national target figure:




                                        Do all medical / consultant biomedical staff      YES / NO (If no give brief explanation)
                                        meet national target figure:




Turnaround Times over          1st quarter                     2nd quarter                     3rd quarter                    4th quarter
last year (in working days):

Please comment as
appropriate



KC61 Data for 2006/07: (Please comment as appropriate)




Primary screening sensitivities: Please comment on overall performance of unit




Positive predictive Values (PPVs): Please comment on overall performance of unit




EQA Schemes participation:                          Gynaecological Cytology YES / NO                         Technical   YES / NO

Please comment as appropriate



Failsafe arrangements and outcomes: Give brief details with percentage of cases with no outcome at 12 months




Serious Incidents: Please give brief details of any serious incidents which have occurred in last 12 months with results of investigation, reasons for
incident and outcomes, actions taken




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Anticipated challenges and financial pressures:




Points of good practice:




Colposcopy data

Cancer Peer Review Visit:                         If visit within previous 12 months give brief details of recommendations, action plan and action
                                                  achieved
Date of last visit:




QA Multidisciplinary Visit:                       If visit within previous 12 months give brief details of recommendations, action plan and action
                                                  achieved
Date of last visit:




Staffing levels ( number of WTE):                 Comment on adequacy of staffing levels, difficulties in staff recruitment, long term sickness,
                                                  vacancies, etc.
Medical and Nurse Colposcopist:


Colposcopy nurses:


A&C:



Accommodation and Facilities: (please comment identifying areas of good practice or additional requirements)




Equipment: (please comment identifying recent acquisitions or current needs)




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Colposcopy programme management

Total Colposcopy workload:              Do all staff meet                                   YES / NO (If no give brief explanation)
                                        BSCCP minimum figure:




Waiting times over last        1st quarter                     2nd quarter                     3rd quarter                    4th quarter
year (in working days):

Please comment as
appropriate



KC65 Data for 2006/07: (Please comment as appropriate)




DNA rates: Please give figures for new and repeat appointments




Failsafe arrangements and outcomes: Give brief details with percentage of cases with no outcome at 12 months




Serious Incidents: Please give brief details of any serious incidents which have occurred in last 12 months with results of investigation, reasons for
incident and outcomes, actions taken




Anticipated challenges and financial pressures:




Points of good practice:




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General comment on performance of NHS Cervical Screening Programme within Trust:




Signature of HBPC:                                              Date:




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