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					     MODERNISING THE NHS CERVICAL SCREENING PROGRAMME

          NICE Appraisal on Liquid Based Cytology published
                          22nd October 2003

                         ADVICE TO THE SERVICE

Issue
1.    NICE’s appraisal on the introduction of Liquid Based Cytology (LBC)
      across the NHS Cervical Screening Programme (NHSCSP) in England
      and Wales was published on 22nd October 2003. The appraisal
      recommends that LBC techniques be introduced across the NHSCSP.
      The implementation of the NICE appraisal is mandatory, but the normal
      3 Month Direction has been waivered as it is expected that it will take
      up to 5 years to complete roll-out of LBC across the NHSCSP in
      England.

2.    On the advice of the Cancer Taskforce, the Advisory Committee on
      Cervical Screening (ACCS) and SHA Cancer Leads, Ministers have
      agreed that the introduction of LBC presents an opportunity to
      modernise the NHSCSP: it is suggested that the best outcome for
      women and the NHS will be achieved through a comprehensive
      implementation approach that takes account of 4 strands:

      •   Implementation of LBC
      •   Frequency of cervical screening – new research evidence offers an
          opportunity for rationalising this to common national standards
      •   Workforce – skill mix development, in particular recruiting and
          training more Advanced Biomedical Scientist Practitioners
      •   Pathology Modernisation

3.    This paper gives advice on the key implementation issues for SHAs,
      PCTs and Cancer Networks, based on the advice of a specially set up
      Implementation Group. Background, key implementation issues and
      contact details for further advice on each of the 4 strands of the
      modernisation programme is at Annexes A to E.

4.    The timescale of implementation of LBC will be determined by the need
      to retrain all laboratory staff involved with cervical cytology, all primary
      care sample takers, and the installation of equipment in laboratories.
      We anticipate this will take up to 5 years to complete nationally. Once
      fully implemented, there will be clear benefits from LBC. These
      include:

     • The public – around 300,000 women a year will not have to have a
       repeat test due to inadequate samples, with all the associated anxiety
       and inconvenience.
     • The NHS – around 300,000 fewer tests to undertake, quicker
       throughput through laboratories leading to clearing of backlogs, and
       associated cost savings. Waiting times for results will be lower as
       laboratories clear their backlogs
     • Screening staff – morale will be raised by training in the latest
       techniques, the reduction in backlogs of work, and the knowledge that
       a more efficient service is being provided. In the pilot LBC was
       welcomed in both laboratories and in primary care

5.    The above benefits will create room for manoeuvre to help optimise
      screening frequency in those areas where the current interval is five
      years, thus reducing inequalities. It will make sense to plan training
      programmes to support the future shape and skill mix of pathology
      services.

Commissioning
6.  PCTs are responsible for the commissioning of cervical screening
    services. However, as not all PCTs have a cervical screening
    laboratory and there is only a small network of NHSCSP training
    schools, therefore it is suggested that SHAs lead on the modernisation
    work in their areas, in close collaboration with PCTs, particularly PCT
    Directors of Public Health. It is suggested that in order to develop the
    modernisation strategy for their local populations, SHAs should work
    very closely with Regional Quality Assurance Directors and involve
    Regional Directors of Public Health and, where appropriate, Cancer
    Networks as key stakeholders.

7.    In order to develop these local strategies, it is suggested that SHAs put
      in place local arrangements covering the roll-out of LBC. These will not
      have to be submitted centrally, but should be shared with SHAs in the
      same Quality Assurance area and served by the same training school
      ensure regional coherence of roll-out. It may also be worth discussing
      the way forward with other local SHAs before developing local
      arranagements.

8.    SHAs and PCTs may wish to use this opportunity to rationalise
      laboratory services in their local areas. This may include the
      centralisation of processing and the rationalisation of pathology
      services.

9.    Clinical governance is key to national roll-out, and SHA strategies
      should ensure that modernisation is sensible, equitable and safe.

Funding
10.  Central funds will be made available in 2003/4 and 2004/5 as pump
     priming for the national roll-out of LBC. These are as follows:

                    REVENUE
                    £m
      2003/4            1.2

      2004/5               6
11.   PCT baseline funding for 2005/6 takes account of the costs of
      completing roll-out. The funding for 2002/3 and 2003/4 will be
      allocated to SHA areas on an eligible population basis via NHS Cancer
      Screening Programmes. SHAs will need to nominate a PCT in their
      area to receive the funding. SHAs will wish to consider pooling this
      funding to ensure the training school in their area is adequately funded
      to begin retraining and then training of other staff.

12.   It is envisaged that the central funds in 2003/4 and 2004/5 may be
      used to cover:

      •     Year one equipment financing
      •     Year one consumables and maintenance costs
      •     Double running of the programme during conversion (including
            sending slides away if necessary)
      •     Sending material away during conversion process to prevent
            histopathology backlogs
      •     Physical changes to the laboratory if necessary (eg the supply of
            cupboards etc for vials)
      •     Training of laboratory staff
      •     Training of primary care staff
      •     For training centres only, monies to build up sufficient new
            training materials (to replace stocks produced in the
            conventional way over many years) and the provision of multi
            headed microscopes, where necessary, in order to support the
            training programme
                                                                        Annex A
Implementation of LBC
1.   Liquid Based Cytology (LBC) techniques offer a new way to prepare
     cervical material for cytological examination. The sample is collected in
     a similar fashion to the standard Pap smear test, using a plastic “broom”
     type spatula. Rather than “smearing” the material on to a slide in the
     conventional way, the head of the spatula is broken off or rinsed into a
     vial of preservative fluid without the loss of any material in the original
     sample. The sample is then transported to the laboratory, where it is
     processed to remove unwanted material. A thin layer of the resultant
     cell suspension is transferred to a slide and stained. The slide is then
     examined in the usual way.

2.   NICE was asked to consider the evidence and advise on whether LBC
     would offer worthwhile benefits to the NHSCSP. The NICE appraisal
     was received in May 2000, and although it stated that there was
     insufficient evidence to support the introduction of LBC at the time, a
     pilot study was recommended. The LBC pilot was designed to evaluate
     all the effects, costs and practical implications of introducing LBC
     technology into the cervical screening programme. Three pilot sites
     were selected (North Bristol, Newcastle, and Norfolk and Norwich), and
     the pilot began from April 2001.

Pilot results
3.     The independent evaluation report of the pilot was sent to NICE in March
       2003. The summary of the evaluation report concluded that:
       •    LBC resulted in a clear reduction in the reported rate of inadequate
            tests (from 9% to 1-2%). Nationally this would result in a reduction
            in workload from 4.2 million slides a year to 3.9 million. This will
            also be of considerable benefit to women in terms of reducing
            anxiety, uncertainty and the need for repeat tests
       •    The productivity of laboratories increased with LBC because 9%
            more slides could be primary screened per hour
       •    LBC resulted in a reduction in the backlog of tests at laboratories
            and hence in reporting times of tests

4.   NICE issued its Appraisal Consultation Document on LBC in April, which
     concluded that LBC should be rolled out across the NHS. NICE issued
     the Final Appraisal Determination on LBC on 22nd October 2003.

Implementation Issues
5.   SHAs need to take the following issues into accounting when
     considering implementation of LBC in their local programmes:
      • Training – around 3,000 laboratory staff currently read cervical
         screening tests. All will need to be retrained, along with all 40,000
         primary care sample takers. It is envisaged that the network of
         approved cytology training centres will be retrained first (ie train the
         trainers). It will then be important for SHAs to plan retraining of
         their local programmes in a sensible way to avoid “bottle necks”.
         SHAs will also have to consider how their local programmes will
          continue while retraining takes place as well as linking with other
          SHAs which use the same cytology training school to ensure a
          coherent and implementable re-training programme. Options may
          include subcontracting of test reporting

Details of the approved cytology training centres are as follows:

BIRMINGHAM CYTOLOGY TRAINING CENTRE
 Cytology Department           Ms Linda Grosvenor 0121-627 2722
 Birmingham Women’s Hospital   Dr Chris Waddell (Director)
 Metchley Park Road
 Edgbaston
 Birmingham B15 2TG

SOUTH WEST REGIONAL CYTOLOGY TRAINING CENTRE
 Cellular Pathology            Mrs Helen Burrell    0117-959 5649
 Southmead Hospital            Dr Karin Denton (Director)
 Westbury-on-Trym
 Bristol BS10 5NB

SOUTH WEST THAMES CYTOLOGY TRAINING CENTRE
 Pathology Department          Mrs Barbara Sayer 01483 571122
 Royal Surrey County Hospital  Dr Louise Daborn (Director)
 Egerton Road
 Guildford GU2 5XX

NORTHERN & YORKSHIRE CYTOLOGY TRAINING CENTRE
 Cytopathology Department               Mrs. Diana Mera      0113-392 7836
 United Leeds Teaching Hospitals NHS Trust (Acting Manager)
 Britannia House,                       Dr Jonathan Sutton (Director)
 Britannia Road
 Morley
 Leeds SL27 0BT

LIVERPOOL CYTOLOGY TRAINING CENTRE
  Pathology Department                     Mrs Irene Turner      0151-706 4580
  6th Floor, Duncan Building               Dr. Lesley Turnbull (Director)
  Royal Liverpool University Hospitals NHS Trust
  Daulby Street
  Liverpool L69 3GA

MANCHESTER CYTOLOGY TRAINING CENTRE
 Ground Floor, Clinical Sciences Building 2 Mrs. Jenny Davies     0161-276 5114
 Manchester Royal Infirmary                 Dr. Mina Desai (Director)
 Oxford Road
 Manchester M13 9WL

LONDON REGIONAL CYTOLOGY TRAINING CENTRE
 Cellular Pathology                      Mr. David Smith       0208-869 3314
 Northwick Park & St Mark’s Hospitals NHS Trust Dr. Tanya Levine (Director)
 Harrow
 Middlesex HA1 3UJ
SHEFFIELD CYTOLOGY TRAINING CENTRE
 Northern General Hospital      Mr. Nick Dudding      0114-271 5864
 Herries Road                   Dr. John Smith (Director)
 Sheffield S5 7AU

EASTERN REGION CYTOLOGY TRAINING CENTRE
 Histopathology Department     Mr. Ian Munro        01223 216749
 Box 235                       Dr. Anne Warren (Director)
 Addenbrooke’s Hospital
 Hills Road
 Cambridge CB2 2QQ

For further information on training issues, please see the NHSCSP contacts
and the list of Quality Assurance Directors at Annex E.

Co-ordination of Procurement
      • Equipment, Consumables and Maintenance – there were two
         suppliers of LBC utilised in the NICE evaluation, each using slightly
         different methodologies. In addition there are further suppliers, all
         of whom will be required to meet minimum technical requirements,
         as per the NHSCSP guidelines on Technical Aspects of LBC for
         Cervical Cytology, in order to be considered for use within the
         NHSCSP

      •   SHAs need to consider carefullywith their local laboratories and
          other key stakeholders which system to adopt; SHAs with a
          cytology training school will need to consider whether the training
          school should have more than one system. In addition SHAs may
          wish to consider the implications and opportunities for
          reconfiguration of cytology services.

      •   NHS Purchasing and Supply Agency (PaSA) will co-ordinate
          purchasing and supply issues on behalf of the NHS, including the
          negotiation of appropriate purchasing arrangements for LBC and
          multi-headed microscopes to support training, in addition to
          providing guidance and support to the NHS on purchasing and
          supply issues

      •   As LBC is an emerging and developing technology , local services
          should consider alternative methods of acquisition (eg Capital,
          Lease, Rentals and Private Sector Solution)

      SHAs are advised to liase with the PaSA contacts below when
      developing local arrangements in order to take advantage of a co-
      ordinated approach to procurement activity across the NHS.

      For further information and advice on purchasing and supply issues,
      please contact:

      James Richards, NHS PaSA (James.Richards@pasa.nhs.uk, Tel: 01244
      586717)
       Alan Woodworth, NHS PaSA (Alan.Woodworth@pasa.nhs.uk, Tel: 01244
       371472)

Communications
• LBC will have clear benefits for the general public, the NHS and NHS staff,
  but SHAs and PCTs should be realistic about why roll-out will take so long
  and why there may be delays in local screening services while training
  takes place. Also, in areas where women’s samples continue to be sent
  for conventional screening, reassurances will have to be given that this is
  acceptable, if less efficient.

•   The conversion to LBC offers PCTs the opportunity to promote the
    screening programme and address uptake issues afresh.
                                                                      Annex B

Frequency of Cervical Screening

1.     For historical reasons, there has been a longstanding inequality in the
       NHS Cervical Screening Programme regarding the frequency of
       invitations for screening. Some local programmes invite women every
       three years, some every five years, and some a combination of the
       two. Thus women living only miles apart may have a variable risk
       reduction for cervical cancer.

2.     The Advisory Committee on Cervical Screening has always kept this
       issue under review, and commissioned research in order to find out the
       optimum screening interval. This research, by Sasieni et al, was
       published in the British Journal of Cancer on 1 st July 2003. The
       research recommends:

       •   Women aged under 25 should not be screened as their risk is so
           low and there may be more harm than good
       •   Women aged 25 to 49 should be screened every three years
       •   Women aged 50 to 64 should be screened every five years

3.     The Advisory Committee on Cervical Screening considered the
       research at its meeting on 14th July. The committee advised that the
       recommendations in the research be adopted across the NHSCSP.

4.     Implications for the NHSCSP are as follows:
       • Local programmes that currently screen women every three years
          will screen fewer women
       • Programmes that screen every five years will have to screen more
          women, but this will be offset by not screening women aged under
          25 and by the benefits of implementing LBC
       • Programmes that currently operate a combination of the two will
          have a similar workload
       • SHAs will need to consider the impact of changes in workload in
          assessing the options for equipment selection, service configuration
          and re-training requirements

Contacts for further information are listed in Annex E.
                                                                         Annex C

Workforce
1.   In December 2001, a working party was established by the Royal
     College of Pathologists (RCPath) in conjunction with the Institute of
     Biomedical Science (IBMS), British Society for Clinical Cytology
     (BSCC), Association of Clinical Pathologist (ACP), National Association
     of Cytologists (NAC), Clinical Pathology Accreditation (CPA) UK
     Limited, NHS Cervical Screening Programme (NHSCSP) and the
     Department of Health.

2.    The remit of the working party was to define the role of biomedical
      scientists in the reporting of abnormal cervical samples.

3.    The introduction of this new role would enable some of the burden of
      reporting to be taken from pathologists, releasing clinical time and
      reducing service pressures.

4.    This initiative introduced a four tier approach within the programme for
      staff involved in the reporting of cervical samples.

      Tier 1 -      non state registered practitioners - cytology screeners
      Tier 2 -      state registered practitioners – biomedical scientists
      Tier 3 -      state registered practitioners with additional skills,
                    qualifications and experience - advanced biomedical
                    scientist practitioners
      Tier 4 -      consultant practitioners

5.    This clearly offers improved career opportunities for BMS staff. An
      examination run by a conjoint board of the Royal College of Pathologist
      and the Institute of Biomedical Science has been introduced. Training
      is provided largely in the workplace but with an intensive background
      course being provided at several NHSCSP training centres.

6.    Since the introduction of this role there have been 99 entries to the
      examination, 43 individuals have passed and this has resulted in
      approximately 25 advanced biomedical scientist practitioners taking up
      formal appointments around the country as at summer 2003.

7.    SHAs are advised to encourage and develop this skill mix initiative with
      hospital trusts hosting laboratories participating in the NHS Cervical
      Screening Programme. This could be done through the local
      performance management framework, or in discussion with Workforce
      Development Confederations.

Details of the Advanced Practitioner role were given in ADVANCE LETTER
(PTB) 2/2001: PROFESSIONAL AND TECHNICAL STAFFS B (PTB)
WHITLEY COUNCIL ADVANCED BIOMEDICAL SCIENTIST
PRACTITIONER IN CERVICAL CYTOLOGY
For further information, please contact the professional bodies concerned or
the NHSCSP/Workforce Development Confederation names listed in Annex
E.
                                                                         Annex D

Pathology Modernisation

1.   Pathology services are an essential part of healthcare provision and
     have considerable impact on patient welfare. 60%-70% of all
     diagnoses in NHS patients depend on laboratory tests and NHS
     pathology services are essential to the delivery of evidence-based care
     of patients and key national commitments. However, they also face
     particular challenges, including:
     • workforce pressures
     • the impact of the EU Working Time Directive
     • new scientific and technical developments
     • growing demand, especially from primary care
     • changing clinical practice
     • growing development of new and expensive diagnostic technologies
     • the need for more sophisticated information technology systems
     • changing public perceptions and expectations of pathology services
     • the effect of several recent reports on post mortems and organ
         retention and use
     • new guidance on consent to treatment and use of tissue
     • planned legislation and regulation on the taking and use of tissue.

2.   As part of its pathology modernisation programme, the Department
     shall shortly be publishing a document on modernising pathology
     services. The key focus of the document will be how service design can
     help build the pathology capacity required to deliver the targets set out
     in Investment, Expansion and Reform: the next three years. The
     document suggests that pathology services take a whole systems view
     and implement change based on system redesign which:
     • adopts new technologies
     • increases standardisation of information and guidelines
     • implements new strategies to increase workforce capacity and
         capability
     • is supported by modern information management and technologies
     • tracks progress.

3.   The national introduction of liquid based cytology (LBC) fits in well with
     the direction of travel suggested by the document, by:
     • making best use of new technology
     • extending roles for pathology staff and making best use of their
        skills
     • making an important contribution to driving up quality standards and
        clinical governance arrangements.

4.   It will be important that the roll-out of LBC be fully integrated into local
     pathology service developments.
For further information and advice on pathology modernisation, please
contact:

Deirdre Feehan, Department of Health ( Deirdre.Feehan@doh.gsi.gov.uk, Tel: 020
7972 4789)
Paul Clegg, Department of Health ( Paul.Clegg@doh.gsi.gov.uk, Tel: 020 7972 4302)

5.    The emerging Modernising Pathology Services guidance sets clear
      objectives for NHS pathology services as part of the Department of
      Health’s wider work to modernise diagnostic services. The Diagnostics
      agenda offers a unified approach for the NHS to co-ordinate and build
      on existing initiatives in the priority areas of pathology, imaging,
      endoscopy and other diagnostic services. Through successful
      examples of managed networks, workforce initiatives and technological
      support the Pathology Modernisation Programme illusatrates how
      national support can enable diagnostics to be improved locally.

For further information on Diagnostic Services, please contact:

Keith Smith, Department of Health (Keith.Smith@doh.gsi.gov.uk, Tel: 0113 254
6636)
Marisa Logan, Department of Health (Marisa.Logan@doh.gsi.gov.uk, Tel: 0113 254
5274)
                                                                               Annex E

             USEFUL CONTACTS FOR FURTHER INFORMATION

NHS Cancer Screening Programmes
Julietta Patnick, Director ( Julietta.Patnick@sheffield-ha.nhs.uk, Tel: 0114 2711060)
Richard Winder, Deputy Director ( Richard.Winder@sheffield-ha.nhs.uk, Tel: 0114
2711060)

Department of Health
Tim Elliott, Team Leader: Cancer Screening (Tim.Elliott@doh.gsi.gov.uk, Tel: 0207
9724194)

Workforce Development Confederation
Barry Muir, Project Lead, Pathology Modernisation and National Cancer
Workforce (Barry.Muir@nelwdc.nhs.uk, Tel: 0207 655 6651

Quality Assurance Directors
NORTHERN & YORKSHIRE
Dr K Faulkner
Director of Quality Assurance
Newcastle General Hospital
Westgate Road
Newcastle Upon Tyne
NE4 6BE
Tel: 01912563882
Email: keith2@faulkner54.freeserve.co.uk

EAST OF ENGLAND
Dr Sue Halliday
Quality Assurance Director
East of England Cancer Screening QA Programmes
Compass House
Chivers Way
Vision Park
Histon
Cambridge
CB4 9AD
Tel; 01223 253651
Email: sue.halliday@esqa.nhs.uk

SOUTH EAST (West)
Dr M Roche
Quality Assurance Director
Oxford Cancer Intelligence Unit
Old Road
Headington
Oxford OX3 7LF
Tel: 01865 227040
Email: Monica.Roche@phru.nhs.uk
SOUTH EAST (East)
Dr L Garvican
Quality Assurance Director
Cervical Screening
Kent,Surrey & Sussex Cancer Network
36-38 Friars Walk
Lewes
E Sussex
BN7 2PB
Tel: 01273 403604
Email: linda.garvican@scn.nhs.uk

WEST MIDLANDS
Dr G Lawrence
Quality Assurance Director
West Midlands Cancer Registry
The Public Health Building
University of Birmingham
Birmingham
B15 2TT
Tel: 0121 414 7713
Email: gill.lawrence@wmciu.thenhs.com

LONDON
Dr K Binysh
QA Director - London
NHS Executive London QA Reference Centre
Room 58
40 Eastbourne Terrace
London W2 3QR
Tel: 020 7725 5429
Email: qarc@doh.gsi.gov.uk

NORTH WEST
Dr L S Turnbull
Consultant Clinical Cytopathologist
Royal Liverpool University HospitaL NHS Trust
Duncan Building Cytology Dept                6th Floor
PO Box 147
Liverpool L69 3BX
Tel: 0151 706 4447
Email: lesley.turnbull@rlbuh-tr.nwest.nhs.uk
EAST MIDLANDS
Dr D Slater
Director of Quality Assurance
The Royal Hallamshire Hospital
Department of Histopathology
Floor "E"
Glossop Road
Sheffield
S10 2JF
Tel: 0114 271 3378
Email: david.slater@sth.nhs.uk

SOUTH WEST
Dr K Denton
Quality Assurance Director
SW Cytology Training School
Southmead Hospital
Bristol
BS10 5NB
Tel: 0117 959 5645
Email: denton_k@southmead.swest.nhs.uk

				
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