Docstoc

District Policy for The Cervical Screening Programme

Document Sample
District Policy for The Cervical Screening Programme Powered By Docstoc
					                  District Policy
                        for
        The Cervical Screening Programme




Reference No:                               PH001
Version:                                    2
Ratified by:                                Screening Commissioning Board/ Trust Board
Date ratified:                              April 2008/ April 2008
Name of originator/author:                  Cervical Screening Co-ordinating Group
Name of responsible committee/individual:   Cervical Screening Co-ordinating Group
Date issued:                                April 2008
Review date:                                April 2010
Target audience:                            All NHS Lincolnshire Staff & Primary Care
Distributed via:                            myMail Email
                                            Website and Practice Managers
                                  NHS Lincolnshire


           District-Policy for the Cervical Screening Programme

                               Version Control Sheet

 Version    Date            Author             Status                 Comment
 1          March 2008      Cervical
                            Screening Co-
                            ordinating Group
 2          April 2009      Cervical                                  Group membership
                            Screening Co-                             added in Appendix
                            ordinating Group                          One and references
                                                                      and name change to
                                                                      NHS Lincolnshire.
 3
 4
 5
 6
 7
 8
 9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20




Improving Health, Improving Services           Lincolnshire Teaching Primary Care Trust
2 of 71
                                            NHS Lincolnshire

                 District-Policy for the Cervical Screening Programme

                                                Contents

     i.          Version control sheet
     ii.         Policy statement

1.         Introduction                                                                     6
           1.1      The Cervical Screening Programme in Lincolnshire                        6
           1.2      Commissioning Screening Board & Co-ordinating Group
                    Terms of Reference                                                      6
2.         Purpose                                                                          6
           2.1      Function                                                                6
           2.2      Guiding Principles                                                      7
3.         Responsibility for the Cervical Screening Programme                              7
4.         The Screening Programme                                                          8
           4.1      Role of Primary Care Trusts                                             8
           4.2      Role of the Call/Recall Agency                                          8
           4.3      Role of the Hospital Based Programme Coordinator                        9
           4.4      Role of the Cytology Laboratory                                         9
           4.5      Role of General Practitioners Providing Cervical Screening Services     9
           4.6      Role of Other Clinicians Responsible for Cervical Screening Tests      10
           4.7      Role of Colposcopy Clinic                                              11
           4.8      Role of Health Promotion and Cervical Screening                        11
5.         The Population to be Screened                                                   12
           5.1      Eligible Screening Population                                          12
           5.2      Deferring Call or Recall                                               12
           5.3      Ceasing from the Screening Programme                                   13
           5.4      Increasing Uptake of Cervical Screening                                14
6.         Appropriate Cervical Screening                                                  15
7.         Women with sprecial Requirements                                                15
           7.1      Learning Disabilities                                                  15
           7.2      Physical Disabilities                                                  16
           7.3      Ethnic Minorities                                                      16
           7.4      Armed services                                                         17
           7.5      Prison Health                                                          17

Improving Health, Improving Services                  Lincolnshire Teaching Primary Care Trust
3 of 71
8.        Call/Recall Cycle                                                               17
9.        Consent and Confidentiality                                                     18
          9.1    Consent                                                                  18
          9.2    Confidentiality                                                          19
10.       Taking the Sample for Cervical Screening                                        19
          10.1   Where is the sample taken                                                19
          10.2   Practical Consideration                                                  19
          10.3   Consumables used in Cervical Screening                                   20
          10.4   Decontamination of Instruments                                           20
11.       Training Requirements                                                           20
          11.1   Qualification of Trainers                                                20
          11.2   Procedure for Student Experience                                         21
          11.3   Monitoring                                                               21
          11.4   Update Training                                                          22
12.       Management of Inadequate & Abnormal Results                                     22
13.       Failsafe Mechanisms                                                             22
14.       Evaluation, Monitoring and Clinical Governance                                  22
15.       Invasive Cancer Audit                                                           25


Appendices


Appendix 1       Membership                                                               27
Appendix 2       Terms of Reference                                                       31
Appendix 3       Lincolnshire Cervical Cytology Screening Programme Failsafe Protocol     35
Appendix 4       Disclaimer Form and Letter                                               42
Appendix 5       Exclusion Form                                                           44
Appendix 6       Guidelines for Ceasing Women with Learning Disabilities                  45
Appendix 7       Cervical Screening Publications for Women                                48
Appendix 8       Screening Programmes Manager Annual Report Format                        50
Appendix 9       Quality Assurance Primary Care Questionnaire                             51
Appendix 10 GMS/PMS Quality and Outcome Framework                                         58
Appendix 11 Path Links Cytology REcall Policy                                             59
Appendix 12 Glossary                                                                      68
Appendix 13 GP Patient Advisory Letter Template                                           69




Improving Health, Improving Services                 Lincolnshire Teaching Primary Care Trust
4 of 71
                                  NHS Lincolnshire

           District Policy for the Cervical Screening Programme

                                  Policy Statement


Background                 The purpose of this Policy is to ensure a co-ordinated and
                           uniform approach to the Cervical Screening Programme.


Statement                  This Policy is comprehensive, formally approved and ratified,
                           disseminated through approved channels and implemented.


Responsibilities           Compliance with the policy will be the responsibility of all NHS
                           Lincolnshire staff.
                           The Cervical Screening Co-ordination Group has undertaken
                           appropriate consultation during the development of this Policy.


Training                   The Cervical Screening Co-ordination Group is responsible for
                           the management and development of this Policy.


Dissemination              Website
                           Via Postmaster Email
                           Identified in the NHS Lincolnshire staff newsletter
                           To GP Practices


Resource implication       This Policy has been developed in line with the NHS Litigation
                           Authority guidelines to provide a framework for staff within NHS
                           Organisations to ensure the appropriate production,
                           management and review of organisation wide policies.




Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
5 of 71
1         Introduction

          The aim of the cervical screening programme is to decrease the incidence of invasive
          cervical cancers. This will be achieved by preventing the development of invasive
          cervical cancers through cytological testing of women at regular intervals and by
          treating asymptomatic pre-invasive disease diagnosed.

          Research findings published in 2004 recognise the huge contribution of the NHS
          Cervical Screening Programme (NHSCSP) to saving lives. According to the research
          up to 4,500 lives are saved every year in England, demonstrating the importance of
                                                         1
          regular screening in preventing cervical cancer (Page 26).

1.1       The Cervical Screening Programme in Lincolnshire

          1.1.1   This document relates to the cervical screening programme that operates
                  across the Lincolnshire area. Future policy and development of the service as a
                  whole is directed by the multidisciplinary Lincolnshire Screening Commissioning
                  Board. The Cervical Screening Co-ordinating Group provides expert advice on
                  the management and development of cervical screening and informs and
                  reports to the Board. Current membership of the Lincolnshire Screening
                  Commissioning Board and Cervical Screening Co-ordinating group is provided
                  in appendix 1.

          1.1.2   The cervical screening programme is not a stand alone programme; it is
                  complex relying upon a co-ordinated effort by health care professionals working
                  in partnership to provide a seamless service. The Cervical Screening
                  Programme in Lincolnshire is provided by a number of organisations, including:

                  United Lincolnshire Hospitals NHS Trust (ULHT)
                  NHS Lincolnshire
                  Screening Office: NHS Lincolnshire
                  Path Links.
                                               2
          1.1.3   As outlined by the NHSCSP (Page 26), the Programme for the Lincolnshire
                  area has nominated a Screening Programmes Manager who is part of the
                  Strategic Planning and Health Outcomes Directorate, and a Hospital Based Co-
                  ordinator who is part of Path Links (appendix 1).

1.2       Commissioning Screening Board & Co-ordinating Group Terms of Reference (appendix
          2)

2 Purpose

          The purpose of the Cervical Screening Co-ordinating Group is to ensure that the
          delivery of the screening programme is in accordance with the NHSCSP and Quality
          Assurance guidelines and standards (appendix 3).

      2.1 Function




Improving Health, Improving Services                Lincolnshire Teaching Primary Care Trust
6 of 71
          2.1.1   To ensure that the day to day operational problems are managed as near to the
                  point of delivery of the screening programme as is practicable.

          2.1.2   To monitor performance across all aspects of the local Cervical Screening
                  Programme against nationally determined targets and performance indicators.

          2.1.3   To find solutions to issues considered by the co-ordinating committee.

          2.1.4   To ensure the service provided is safe and acceptable to all users.

          2.1.5   To ensure that all interested parties are advised of any risks and cost
                  implications associated with the delivery of the screening programme or
                  decisions made by the co-ordinating committee.

2.2       Guiding Principles

          2.2.1   The main guiding principles for the cervical screening programme as outlined by
                               2
                  the NHSCSP (Page 26) are similar to those for delivery of other types of
                  healthcare namely:

                     Screening should be integrated among different providers.
                     Screening should be appropriate.
                     There should be equity in the level of screening provided.
                     Screening should be effective and should minimise adverse events.
                     Screening should be accessible without geographical, cultural, linguistic or
                      organisational barriers.
                     Screening should be provided efficiently.
                     Screening should be acceptable and should be tailored to an individual's
                      needs. Women should be treated with courtesy, respect and understanding
                      of their needs.
                     Screening should follow national guidelines.

          2.2.2   Different component parts of the cervical screening programme will be guided
                  by these principles in all dealings with the women who use the service. They
                  must also ensure that the organisational arrangements do not interfere with the
                  implementation of these principles.

3 Responsibility for the Cervical Screening Programme

3.1       NHS Lincolnshire and United Lincolnshire Hospitals Trust will be accountable for
          delivery of parts of the programme that it directly provides. The responsibility rests with
          the Board of each organisation and the accountable officer is the Chief Executive (HSC
                     3
          2001/024) (Page 26). NHS Lincolnshire is responsible for ensuring that:

           Women are invited for cervical screening tests at the appropriate ages and intervals.
           Women are provided with the necessary information to make an informed decision
            about whether to participate in the programme or not.
           Arrangements are in place for taking samples for cervical cytology.
           Arrangements are in place for reporting the screening samples.




Improving Health, Improving Services                 Lincolnshire Teaching Primary Care Trust
7 of 71
           Women are informed in writing of their test results.
           Test results are recorded in the woman’s screening history.
           Failsafe systems are in place to ensure that test results are followed up
            appropriately.
           The woman’s GP is notified if the woman does not respond to an invitation for a
            cervical test.

4 The Screening Programme

4.1       Role of Primary Care Trusts (NHS Lincolnshire) known as NHS Lincolnshire

          4.1.1   NHS Lincolnshire will appoint or nominate a named individual to be the
                  Screening Programme Manager (appendix 1), to oversee the co-ordination,
                  quality and effectiveness of the cervical screening programme for the resident
                  population of women. The Manager will sit within the Directorate of Strategy and
                  Health Outcomes and liaise regularly with the Public Health screening lead.
                  Below is outlined the role of the Screening Programme Manager in relation to
                                             2, 5
                  cervical cytology screening (Page 26).

          4.1.2   To ensure overall co-ordination of the cervical screening programme in line with
                  the District Policy.

          4.1.3   To prepare screening specification covering all elements of the programme.

          4.1.4   To monitor the quality, activity and cost of the programme.

          4.1.5   To monitor the effectiveness of the failsafe mechanisms.

          4.1.6   To ensure the provision of efficient and effective call/recall services, maintain an
                  up to date register of eligible women and ensure appropriate and timely
                  communication with women and GPs.

          4.1.7   To work with GP practices ensure systems are in place to support the Quality
                  and outcomes Framework of the General Medical Services Contract.

          4.1.8   To produce an annual report on the cervical screening programme for NHS
                  Lincolnshire’s Board.

4.2       Role of the Call Recall Agency

          4.2.1   NHS Lincolnshire undertakes the role of the Call/Recall Agency for the
                  Lincolnshire area. The call and recall system is administered using the NHS
                                                              6
                  Information Authority system (Exeter system) (Page 26). The system provides a
                  means of:

                   Inviting women for cervical screening tests at the appropriate interval.
                   Sending women information to assist them in making an informed choice
                    about whether to participate in the screening programme or not.
                   Informing women of inadequate test results as part of the re-invitation
                    process.
                   Recording and informing women of their test results.
                   Notifying GPs if women do not respond to invitations for cervical screening
                    tests (via non-responder cards).


Improving Health, Improving Services                  Lincolnshire Teaching Primary Care Trust
8 of 71
                   Operating a failsafe system that ensures that women are invited for
                    screening again, even if no other action is taken.

4.3       Role of the Hospital based Programme Coordinator

          Any hospital Trust providing cytology services should nominate or appoint a named
          individual to oversee the co-ordination, quality and effectiveness of the screening
          programme linked to that laboratory (appendix 1). Below is the role of this Hospital
                                                                    2
          Based Programme Co-ordinator as outlined by the NHSCSP (Page 26).

           To ensure the quality of services provided is of the standard outlined by the
            NHSCSP7.
           To provide timely information to the call/recall register.
           To provide information to the trust management to negotiate the screening contract.
           To implement the requirements of the screening specification covering cytology and
            histology services.
           To co-ordinate the implementation of the screening specification for colposcopy
            services.
           To provide quarterly activity, quality and monitoring information for the PCT
            screening commissioner. To collate laboratory data for an annual summary for the
            screening programme in a timely fashion.

4.4       Role of Cytology Laboratory

          The cytology laboratory should be accredited by Clinical Pathology Accreditation CPA
          (UK) Ltd, comply with national guidance and provide a comprehensive cytopathology
          service, in Lincolnshire this is provided by Path Links. A named consultant should be in
          charge with designated sessions and also be responsible for the cytology service (see
                                                                         2, 7
          appendix 1). The main functions of the cytology laboratory are (Page 26):

           To analyse the cervical samples sent to the laboratory (see appendix 3).
           To monitor the inadequate result rates advising on appropriate action to keep these
            to a minimum.
           To send results to the test taker and GP (if different) and call/recall register.
           To make cervical screening test results available at colposcopy, make cytology slide
            available to histopathologist and link test results with colposcopy.
           To produce quarterly activity reports for the PCT Screening Programme Manager.
           To monitor Performance Indicator ranges.
           To provide a Form KC61 return for the Department of Health annually.
           To ensure that activity conforms to “Quality Assurance Standards” set out by the
                                                   8
            NHS Cervical Screening Programme (Page 26).
           To operate failsafe procedures for women who require referral to colposcopy (see
          appendix 4).

4.5       Role of General Practice Providing Cervical Screening Services

          4.5.1   Only professionally registered practitioners should sample cells from the cervix.
                  Doctors may delegate medical care to nurses and other health care staff. They
                  must however be satisfied that the person is competent to undertake the
                  procedure involved by fulfilling the minimum training requirements
                  recommended by NHS Lincolnshire and outlined in section 11. The doctor will
                                                                     9
                  still be responsible for managing the woman’s care (Page 26).



Improving Health, Improving Services                 Lincolnshire Teaching Primary Care Trust
9 of 71
       4.5.2    Nurses as sample takers should abide by the Nursing and Midwifery Council
                                                          10
                (NMC) Code of Professional Conduct (Page 26). Which states “to practice
                competently, you must possess the knowledge, skills and abilities required for
                lawful, safe and effective practice without direct supervision. Nurses must
                acknowledge the limits of their professional competence and only undertake
                practice and accept responsibilities for activities in which they are competent.”
                                                                                               2,
       4.5.3    The role of the sample taker in the NHS Cervical Screening Programme is
                11
                  (Page 26):

                 To make arrangements for taking cervical screening samples.
                 To ensure that the woman is provided with the necessary information and
                  advice to assist her in making an informed choice about whether to
                  participate in the screening programme.
                 To improve the accessibility of screening for women in socially excluded and
                  minority groups.
                 To ensure that women give informed consent attempting to provide health
                  advocacy if needed because of language, mental or physical disability (see
                  section 6).
                 To complete all of the documentation relating to the cervical screening test
                  during the consultation prior to the test being taken.
                 To ensure that when a woman requests further information/support in relation
                  to the result of her cervical screening, this is undertaken in a timely manner.
                 To support the follow up of non-responders to call/recall, including the
                  opportunistic screening of women who have not been screened.
                 To ensure each woman is informed of the direct referral process for
                  colposcopy and that one possible outcome following the test result is that
                  they might subsequently receive a letter directly from the hospital should
                  there be need for an appointment in Colposcopy.
                 To update information on the call/recall register lists including checking:
                 All reports for cervical screening tests have been received
                 Prior Notification Lists (weekly)
                 Amending the non-responder card (as appropriate)
                 To achieve 80% coverage of the eligible women registered with the GP
                  practice.
                 To operate the correct failsafe mechanisms for the follow up of women with
                  abnormal or inadequate cervical screening results and those other than
                  routine recall (appendix 4). Failure to respond to enquiries should be
                  considered a clinical governance issue.
                 To ensure the practice meets the standards of the Quality and Outcome
                  Framework (see appendix 11).

4.6    Role of Other Clinicians Responsible for Cervical Screening Tests

       4.6.1    Cervical screening services may be provided in other settings, including
                community clinics and Genito Urinary Clinics (GUM). Clinicians responsible for
                                                                       4
                requesting cervical screening tests are responsible for (Page 26):

                Ensuring the woman is provided with necessary information and advice to
                 assist her in making an informed choice about whether to participate or not.
                Making arrangements for taking a cervical screening sample.
                Arranging for the woman to be informed of her test result (unless a woman
                 attending a GUM clinic has requested anonymity).

Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
10 of 71
                Completing all of the documentation relating to the cervical screening test
                 during the consultation prior to the test being taken.
                Agreeing with the woman on an appropriate arrangement for her to collect her
                 test result if a woman has requested ‘no correspondence’.
                Ensuring the test result is followed up appropriately. In Lincolnshire, Path Links
                 operate a system of direct referral for colposcopy, it is therefore important that
                 each woman is informed of the direct referral process for colposcopy and that
                 one possible outcome following the test result is that they might subsequently
                 receive a letter directly from the hospital should there be need for an
                 appointment in colposcopy.
                Co-operating with failsafe enquiries about a woman who requires further
                 investigation or treatment. Failure to respond to enquiries should be
                 considered a clinical governance issue.
                Co-operation in invasive cancer audit enquiries from the hospital based
                 programme co-ordinator

4.7    Role of Colposcopy Clinic

       4.7.1    Within the Lincolnshire area the cytology, histology and colposcopy services
                take place in close geographical proximity, which facilitates a close clinical
                relationship between disciplines. All colposcopy services provided in the area
                                                                                            12,
                covered by this policy must meet the standards defined by the NHSCSP
                13
                  (Page 26).

       4.7.2    Individual colposcopists should be accredited by the British Society for
                Colposcopy and Cervical Pathology (BSCCP).

       4.7.3    Provide a colposcopic service enabling diagnosis for women with abnormal
                cervical screening results.

       4.7.4    Inform women in writing of the results of any biopsy taken during the
                colposcopy.

       4.7.5    The colposcopist has responsibility for informing women of cervical screening
                results of samples taken in clinic.

       4.7.6    Ensure that results are linked to screening histories and cancer surveillance
                databases.

       4.7.7    Inform the GP of the results of the test.

       4.7.8    Initiate further treatment if required.

       4.7.9    Provide a Form KC65 return for the Department of Health quarterly.

       4.7.10 Monitor performance through KC65 data.

       4.7.11 Ensure that the colposcopy service operates within the parameters set out by
                           12, 13
              the NHSCSP         (Page 26).

4.8    Role of Health Promotion and Cervical Screening

       4.8.1    Health promotion activities should be undertaken in an appropriate cultural
                                      1
                context for all women (Page 26). There will be different health promotion

Improving Health, Improving Services                  Lincolnshire Teaching Primary Care Trust
11 of 71
               activities for each of the groups specified below, some of whom will require
               particular interest:

                Women who are registered with a GP but who have not responded to the
                 call/recall letters.
                Women who are not registered with a GP.
                Women registered with GPs who have a low uptake rate.
                Improve accessibility of screening for women in socially excluded and
                 minority groups.
                Women attending family planning clinics.
                Women attending GPs surgeries.

5 The Population to be Screened

5.1    Eligible Screening Population
                                                 14
       5.1.1   In line with NHSCSP Guidance           (Page 26) the age range and interval for
               Cervical Screening is:

                  Women aged 25 - 49 years invited for cervical screening every three years.
                  Women aged 50 - 64 years invited for cervical screening every five years.

       5.1.2   Details of women who are due for call or recall are extracted from the Exeter
               database and printed on the Prior Notification List (PNL) monthly.

       5.1.3   The PNL is sent to the GP for checking and amendment to show:

                Any women who should not be called or recalled at the present time.
                Women for who recall should be permanently cancelled.
                The date of any recent test, together with the result and taker of the last test
                 if known.
                Any amendments to the woman’s registration details such as change of
                 name, address etc.

       5.1.4   The PNL is returned to the Screening Office, which updates the computer
               record. PNLs should be returned within one month of receipt. If the PNL is not
               returned to the Screening Office by the date stated, it will be assumed the
               information it contains is correct and invitations will be issued.

       5.1.5   Current NHSCSP Screening targets require 80% of eligible women within the
               age range 25-65 years to be screened.

5.2    Deferring Call or Recall

       5.2.1   ‘Postpone’ category is used in situations where the test is delayed, including any
               situation where the GP wishes to defer recall (e.g. pregnancy, woman’s wish,
               under treatment, etc.) and should always include the date the test has been
               postponed to.

       5.2.2   ‘Suspend’ category is now only used for women who are being followed up by
               colposcopy after an abnormal result.

       5.2.3   Women undergoing investigations or treatment for pre-malignant disease, or
               cervical neoplasia, are treated and followed up according to the Path Links

Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
12 of 71
                                                                                         13
               Cytology Recall Policy, which is based upon NHSCSP guidelines                  (Page
               26)(see appendix 3).

5.3    Ceasing a Woman from the Cervical Screening Programme

       5.3.1   Ceasing a woman from the Cervical Screening programme has the effect of
               stopping all invitations being sent to a woman and removing her name
               permanently from Prior Notification Lists (PNL). Women should only be ceased
                                                                                     14
               from the cervical screening programme call/recall register as follows (Page
               26).

       5.3.2   Following the first test after her 60th birthday if the last three consecutive
               cervical screening tests have a negative result.

       5.3.3   Persistent non-responders should be ceased on their 65th birthday. However
               these women may be screened opportunistically if appropriate or if they later
               request a test.

       5.3.4   Women who have undergone radiotherapy for cervical cancer.

       5.3.5   The absence of cervix marker is used for:

                  Women with a total hysterectomy
                  Male to female transsexuals
                  Congenital absence of the cervix

       5.3.6   Women who have no cervix will be removed from call/recall and if follow up of
               cancer then it is the responsibility of the clinician/GP.

       5.3.7   If the GP/practice nurse advises permanent cancellation of recall due to
               hysterectomy the words total abdominal or vaginal hysterectomy and the date of
               the operation should be clearly documented on the PNL.

       5.3.8   For all of the above indications the NHSCSP advise that a GP or practice
               nurse’s attention should be drawn to any instance of ceasing before the Prior
               Notification List (PNL) is “signed off” for anything other than routine changes of
                        12
               address (Page 26).

       5.3.9   The following women should not automatically be ceased from the cervical
                                              14
               screening Programme call/recall (Page 26):

                  Women who have never had sex with a man.
                  Women who are terminally ill.
                  Women who have been circumcised.
                  Women with physical disabilities (including severe arthritis and obesity).
                  Women with learning disabilities
                  When ‘clinical’ or ‘medical’ reasons alone are cited.

       5.3.10 For all of the above indications the NHSCSP advise that the woman’s GP must
              approve the request to cease the woman from the NHSCSP. This is a clinical
              decision and requires the GP to complete and sign the NHSCSP Exclusion
                                 14
              Form (appendix 6) (Page 26).



Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
13 of 71
       5.3.11 The NHSCSP guidance states that NHS Lincolnshire and Patient Data Services
              should not act when ‘clinical’ or ‘medical’ reasons alone are cited as a reason to
              cease a woman from the call/recall for the cervical screening programme,
                                                     14
              unless further explanation is provided (Page 26).

       5.3.12 Women over the age of 65 years who do not meet the criteria for automatic
              removal from the programme will be removed if the GP considers that she is low
              risk. This is a clinical decision and requires the GP to complete and sign the
              NHSCSP exclusion form (appendix 6).

       5.3.13 Women must be ceased from call/recall if they make an informed choice that
              this is what they want and if they sign a written request that this should happen
              14
                (Page 26). If this is the case the process is as follows:

               Women who do not wish to be invited for future cervical screening tests
                should be highlighted on the Prior Notification List (PNL), none responder
                card or by letter to patient data services.
               The woman will be sent a letter with a disclaimer form and the information
                leaflet ‘Cervical Screening the Facts’ explaining the risks and benefits of
                cervical screening and the risks of non-participation (see appendix 5). The
                National Cancer Screening Programmes in consultation with their legal team
                and the Department of Health have produced the format of both the letter
                                      15
                and disclaimer form (Page 26).
               When the Call/Recall Office receives the completed disclaimer form (the
                woman’s written instructions are required for data protection and consent
                purposes), the woman’s name will be removed from the call/recall register.
               The woman’s GP will be sent a copy of the disclaimer form to be filed in the
                woman’s records.

       5.3.14 Please note women who elect to be removed from call/recall will continue to be
              included in the eligible screening population of the GP practice, for the purpose
              of national coverage statistics. The GMS/PMS Quality and Outcome
              Framework, exception reporting is a separate issue. This will be monitored by
              NHS Lincolnshire.

       5.3.15 Women’s names can be restored to the call/recall register at any time, and a
              woman can be screened at any time on request by contacting her GP.

       5.3.16 Practices will be asked to review women who have been ceased from the
              Cervical Screening Programme at least every five years, this is part of the
              Quality and Outcomes Framework of the General Medical Services and
              Personal Medical Services Contract.

5.4    Increasing Uptake of Cervical Screening

       There is evidence that uptake of the cervical screening programme can be improved
       by:

        Offering women the opportunity of being screened by a woman (whether a nurse or
         a doctor).
        Offering a specific appointment time.
        Making sure screening is available at times convenient to women.
        Offering screening at a clinic (e.g. family planning or community clinic) instead of by
         their GP.

Improving Health, Improving Services             Lincolnshire Teaching Primary Care Trust
14 of 71
        Taking an opportunistic approach.

6 Appropriate Cervical Screening

6.1    Some cervical screening tests are taken outside of the screening programme
       parameters, they do not benefit the women for whom they are taken, and can result in
       unnecessary anxiety, discomfort and treatment. The NHS Cervical Screening
       Programme is designed to screen women for pre-cancerous changes of the cervix.
       Cervical screening is not a diagnostic test for cancer. There are clear guidelines of best
                                                                                         2
       practice within the screening programme describing the policies to be followed (Page
       26).

6.2    The objective of the NHSCSP is that all eligible women receive a cervical screening
       test every three or five years (dependent upon age), to achieve this target recall
                                                                                       2
       invitations must be issued no later than one month before the next test due date (Page
       26). Opportunistic screening is only appropriate for women who have not attended
       routine screening invitations, but not in other circumstances.

6.3    Screening maybe advised more frequently following the detection of a cervical
       abnormality and a repeat sample will be necessary after an inadequate sample as per
       Path Links Cytology Recall Policy (see appendix 12).

6.4    Screening is not appropriate for women who are symptomatic or where a diagnosis is
       sought. Cervical screening tests are a screening not a diagnostic tool. Symptomatic
       women should be referred for a specialist opinion regardless of their last cervical
       screening result and referral should not wait for a screening result.

6.5    If a woman has had cervical screening within the previous three or five years
       (dependent upon age), an additional screening test is not indicated in any of the
       following circumstances:

          On taking or starting to take an oral contraceptive.
          On insertion of an IUCD.
          On taking or starting to take hormone replacement therapy.
          In association with pregnancy; antenatally, postnatally, or post termination.
          In women with genital warts.
          In women with vaginal discharge.
          In women who have had multiple sexual partners.
          In women who are heavy cigarette smokers.

7. Women with Special Requirements

7.1    Learning Disabilities

       7.1.1   The cervical screening programme has a clear duty to include women with
               learning disabilities in their activities. Current evidence suggests that a
               significantly smaller proportion of women with learning disabilities are accessing
               the cervical screening programme than the normal eligible population. It is
               common for women with a learning disability not to be offered routine cervical
               screening tests on the assumption that they have never had sexual intercourse.
               However it may not be possible to be sure that someone has never been
               sexually active. Women with learning disabilities may experience sexual abuse
               that goes unrecognised, and are therefore at risk of developing cervical
                       16
               cancer (Page 26).

Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
15 of 71
       7.1.2   It is advisable that women with learning disabilities are given more support and
               preparation in order to access the screening programme. Where women live in
               the community the general practice team, and, if appropriate the carers, who
               have a knowledge and understanding of the extent and nature of the disability
               will be in a position to advise on what suitable provision and care should be
               arranged. Where women are resident in a care facility, it is essential that carers
               be informed about the screening procedure in order to advise on the provision
               and care to be provided and to help to communicate effectively with the women.

       7.1.3   The NHS Cancer Screening Programmes have produced “Equal Access to
               Breast and Cervical Screening for Disabled Women” that provides full advice
               that meets the requirements of the Disability Discrimination Act 1995. A full copy
               can be found at http://www.cancerscreening.nhs.uk/publications/cs2.pdf or
               ordered from:

               Department of Health Publications Orderline
               Quoting NHS Cancer Screening Series No 2
               Tel: 08701 555455
               Fax: 01623 724524
               Email: doh@prolog.uk.com

       7.1.4   The agreed guidelines for Lincolnshire area on ceasing women with learning
               disability can be seen in appendix 6 and 7.

7.2    Physical Disabilities

       Health care professionals should consider whether there is adequate access to the
       venue, the height of the couch, the possible need for assistance, a domiciliary visit and
       perhaps contacting a specialist group or individual for advice. The national leaflet
       "Cervical Screening: The Facts" is also available in Braille and audio format for women
       with visual or hearing impairment (see appendix 8). A copy of this can be borrowed by
       contacting the Screening Programme Manager.

7.3    Ethnic Minorities

       7.3.1   It is important that smear takers are aware of the customs and health beliefs of
               local ethnic groups and take these into account when obtaining consent from
               women for cervical screening. This may include reinforcing the availability of a
               female smear taker, providing information in a suitable language or in picture
               form or arranging access to a trained interpreter if possible.

       7.3.2   Some ways in which low uptake of cervical screening in these groups can be
               improved are by the opportunistic screening of women who have not had a
               cervical screening test previously or by identifying which sections of the
               community are not attending for screening and targeting them directly. This
               could be done by putting information in areas important to that community e.g.
               religious meeting areas (if appropriate), halls used regularly for community
               events or specific shops. The national leaflet "Cervical Screening: The Facts" is
               available in different languages (see appendix 8).




Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
16 of 71
7.4    Armed Services

       Warwickshire screening office deals with the call/recall for all women who work in the
       armed forces. These arrangements should, however be clarified with each individual
       woman. Noting the service number of the woman or her partner (if they are serving in
       the armed forces) may help with follow up of these women if necessary.

7.5    Prison Health

       Women serving prison sentences who require follow up for abnormal cervical screening
       results can be traced by contacting:

       Steve Tyman
       Healthcare Consultant and Programme Director Women’s Team and Juvenile Group
       Units 1&2 Faraday Court
       Centrum 100
       Burton Upon Trent
       Staffordshire, DE14 2WX

       Tel: 01283 524500        Fax: 01283 566392
       Email: stev.tymanoowp@hhps.gsi.gov.uk

8 Call/Recall Cycle

8.1    The policy in Lincolnshire is to invite women within the age range 25–64 years
       inclusive, to attend for cervical screening, routinely on a three or five yearly recall basis
                             2, 17.
       dependent upon age          (Page 26)

8.2    This is carried out by the Lincolnshire Shared Services, for women resident in
       Lincolnshire.

8.3    Those residents outside of Lincolnshire will be called for by the Screening Office in their
       area of residence

8.4    Details of women who are due for call or recall are extracted from the Exeter database
       and printed on the Prior Notification List (PNL) once a month. These categorise women
       as:

        Call - women who have never had a smear test.
        Recall - normal routine recall.
        Repeat Advised - women due for a repeat test earlier than routine recall.
        Suspended Recall - women due for recall following a previous gynaecological
         referral.
        Inadequate - women due for a repeat test after an inadequate result. (Only affects
         women due for a repeat in more than 3 months).

85     Invitation Letters

       Invitation letters are issued three months after the PNLs have been sent to the GP
       practices; all appropriate letters are printed and sent directly to the women. Letters are
       thus sent out six weeks prior to the due date.




Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
17 of 71
8.6    Invitation reminder Letters

       Sent approximately 12 weeks after the first letter.

8.7    1st Non Responder Cards Sent approximately 8 weeks after the reminder letter

8.8    Final Non Responder Cards

       Sent approximately 8 weeks after the 1st non responder card
       NB: Following this a woman will revert to 12 months if previous result was not routine,
       otherwise the next test date will be 3 or 5 years in the future.

8.9    Result Letters

       The majority of results are received electronically from Path Links laboratories on a
       daily basis. A small quantity are received on paper.

        Result letters are sent from the Call/Recall agency on a daily basis by 1st class post,
         except Friday letters are sent by 2nd class post.
        NB: Result letters for result codes 5S and 6S are direct referrals from Coloposcopy.
        Please also note - In the case of cervical samples being reported as severe,
         invasive or glandular neoplasm, it is the responsibility of the smear takers to inform
         the women of her result. A letter will not be issued from NHS Lincolnshire.

8.10   Women who have been removed from the NHSIA Exeter database

       Patients are removed from the Exeter database due to transfer to another area, death
       embarkation etc. An analysis job is therefore run each day by the Screening Section, to
       ensure that any screening history is sent to the new area. The information is sent
       electronically to the new area, which confirms receipt. Screening history for deaths etc.
       is filed in the medical records.

8.11   Patients requiring follow up who have transferred in to NHS Lincolnshire area from
       another part of the country.

        History received from other areas electronically and women’s screens updated.
        Copy of the history forwarded to local laboratories.
        Urgent action required cards are forwarded to the GP.

9 Consent and Confidentiality

9.1    Consent

       Issues of consent have become increasingly important regarding the cervical screening
       programme. The new national leaflet "Cervical Screening the Facts" (NHSCSP) is
       included with every invitation to attend for a cervical screening test. The same
       information should be reinforced by the clinician taking the test and on attending an
                                                                          11, 15
       appointment for a cervical sample test every woman should be told        (Page 26):

        The purpose of cervical screening.
        The likelihood of a normal screening result (about 90%).
        The meaning of a normal screening result (low risk not no risk).



Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
18 of 71
        Several cytological patterns are not easy to recognise and may lead to false
         negative reports. Similarly false positives can occur. Women should be made aware
         of these possibilities.
        The likelihood of an inadequate screening result (approx 1% since LBC
         implementation).
        The meaning of being recalled following an abnormal screening result.
        That certain results may require attendance at the colposcopy clinic and within
         Lincolnshire referral will happen automatically. Information should be given to
         women that the hospital will inform them by letter should a colposcopy be necessary.
        That in most cases results will be made available in writing, with telephone results
         from the sample taker in some cases.
        The importance of always reporting any abnormal bleeding or discharge.
        That the consultation and cervical screening results are confidential.
        That cervical screening samples are retained by the laboratory.

       Consent issues for women with learning disabilities are outlined in section 7.1 and the
       district guidelines are included in appendix 7.

9.2    Confidentiality

       The NHSCSP place a very high importance on the confidentiality of information
       maintained and processed on behalf of NHS patients. All aspects of the NHSCSP deal
       with personal and sensitive data about individual women. They have been given
       exemption under section 60 of the Health and Social Care Act 2001 on an interim basis
       to allow transfer of patient identifiable data within and between organisations. Staff at
       all levels within the programme need to be fully informed of good practice in
       confidentiality and data security as laid out in the NHS Cancer Screening Programme
                                              18, 19
       Confidentiality and Disclosure Policy        (Page 26).

10 Taking Cervical Screening Samples

10.1   Venues for Cervical Screening

       Routinely cervical screening samples are taken in GP surgeries as this is the focus for
       primary care. For the harder to reach population alternative arrangements for screening
       can be agreed.

10.2   Practical considerations

       As outlined above cervical screening samples may be submitted to the laboratory from
       a variety of sources, however, the essential requirements do not vary, they are:

       10.2.1 A carefully completed Path Links cervical cytology request form or order comms
              form, should accompany every cervical sample. This should be completed, by
              the clinician at the time the test is taken, using a ball point pen. The information
              at the bottom of the invitation letter is intended to ensure the laboratory will have
              identical information to the screening office. If no letter is available the following
              information should be clearly marked on form HMR101:

                 Full name
                 Any previous name
                 Current address
                 Date of birth
                 NHS number

Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
19 of 71
       10.2.2 For temporary residents the resident town of registration and name of GP (if
              known) should be obtained.

       10.2.3 If the woman requests “no correspondence home” this must be marked clearly
              (preferably in red) on the request form.

       The clinician should enter their individual test taker code on the request form.

       10.2.4 Ensure the correct equipment and facilities that ensure privacy are available.
              Ensuring the cervix is fully visualised. (The sample will be considered
              inadequate if this is not seen). A liquid based sample is taken using a cervix
              brush which should be rotated on the cervix 360º, five times in a clockwise
              direction. The brush head is then placed in the vial of fluid. Correct sampling
              should be confirmed on the request form.

       10.2.5 Identify the specimen vial with the woman’s full name, date of birth and NHS
              number. Ensure the lid of the vial is tightly closed to prevent leaking and thus an
              inadequate sample.

       10.2.6 The use of request form with attached specimen bags provided by the
              laboratory is required. The form and specimen being placed in separate
              compartments to avoid contamination in the case of specimen leakage.

10.3   Consumables used in cervical screening sampling

       10.3.1 The laboratory will provide LBC lab kits on request which contain:

                 Instructions
                 25 request forms with attached specimen bag
                 25 cervix brushes
                 25 vials containing fixing fluid
                 28 labels

       10.3.2 Supplies can be ordered from the laboratory using the Path Links order form,
              allowing at least one week for delivery.

10.4   Decontamination of Instruments used in Cervical Screening

       The infection risk associated with the use of reusable vaginal speculum is high
                                                          20, 21
       therefore this policy advocates single use specula       (Page 26).

11 Training Requirements

       The NHSCSP developed minimum requirements for the training and updating of all
       health professionals who take cervical screening samples in primary care, family
       planning clinics colposcopy clinics and departments of sexual health. The aim of this
       was to introduce consistency within the cervical screening programme and to provide
                                  11
       learning to a minimum level (Page 26).

11.1   Qualification of Trainers

       Those who train health professionals to take cervical screening samples should:


Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
20 of 71
          Demonstrate continuing competence in cervical sampling with particular reference
           to:
            transformation zone sampling
            technique
            audit of results including inadequacy rate
          Demonstrate good communication skills.
          Undertake regular update training.
          Maintain awareness of developments in the cervical screening programme.

11.2   Procedure for student to gain practical experience

       For the first practical session/s the student must be accompanied by the
       Trainer/Advisor and must:

          Identify training needs in discussion with the Trainer/Advisor.
          Observe at least one cervical screening sample being taken.
          Undertake a minimum of five cervical screening samples under supervision.

       The Trainer/Advisor and student then decide whether the student may proceed without
                  11
       supervision (Page 26).

       The student should then undertake and document a minimum of 20 cervical screening
       samples with easy access to a trained colleague.

       Both student and trainer will be expected to maintain regular contact and to discuss:

        Progress towards meeting identified training needs
        Any problems.

       As part of the course the student should visit both:

        The cytology Laboratory.
        The colposcopy clinic.
        The above visits should be supported by the employer as they serve to develop a full
         understanding of the different aspects that combine to provide the local cervical
         screening process. These visits should be documented in the record book.

       Before the final evaluation session, the student must have completed a minimum of 20
       cytologically adequate cervical screening samples.

       Final evaluation must include a final clinical assessment.

       Training must be completed within a nine month period.

11.3   Monitoring

       NHSCSP guidance states to ensure continuing safe practice, the clinician will conduct
                                11
       annual self evaluation by (Page 26):

        Auditing and reflecting on a minimum of 20 consecutive cervical screening samples
         including the inadequacy rate.
        Documenting these in a record book.



Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
21 of 71
11.4   Update training

       All health professionals who take cervical screening tests are required by the NHSCSP
       to undertake update training for a minimum of one half day session every three
             11
       years (26):

       Update training must address the following issues

          Current developments in the cervical screening programme nationally and locally.
          Recent literature relevant to smear taking, sampling devices and women's needs.
          Changes to local policies and procedures.
          Personal learning needs.
          A qualitative assessment of 20 recent consecutive cervical screening samples.

       Within NHS Lincolnshire update training is organised by work force development to
       NHSCSP requirements.

12 Management of Inadequate and Abnormal Results

12.1   In accordance with NHSCSP guidance, women with a cervical screening test result that
       has an action code of R will have an early repeat test; the interval is specified in the
       Path Links Cytology Recall Policy (appendix 12). The call/recall system sets the
       woman’s next test date to the screening interval specified by the laboratory. The
       woman is included on a PNL and is sent an invitation letter at the appropriate time.

12.2   Women with an inadequate test result can have the test repeated immediately, it is not
       necessary to wait for an invitation letter to be generated.

12.3   Women with an abnormal test result that has an action code of S will be suspended
       from the call/recall system for the duration of investigation, treatment and follow up by
       the colposcopy service. The recommended recall intervals and referral action is
       outlined in the Path Links Cytology Recall Policy (appendix 12). Failsafe actions for the
       follow up of women who do not attend for colposcopy are outlined in appendix 4.

13 Failsafe Mechanisms

       A series of failsafe mechanisms are in place at each stage of the programme to ensure
       that all women, and especially those with abnormal cervical cytology results, are
                                                                                 4
       included in the programme and offered all necessary care and management (Page 26).
       The Failsafe Procedures in the cervical screening programme are attached to this
       policy document (appendix 4).

13     Failsafe Mechanisms

       A series of failsafe mechanisms are in place at each stage of the programme to ensure
       that all women, and especially those with abnormal cervical cytology results, are
                                                                                  4
       included in the programme and offered all necessary care and management (Page 26)
       The Failsafe Procedures in the cervical screening programme are attached to this
       policy document (appendix 4).

14     Evaluation, monitoring and clinical governance

14.1   The effectiveness of the screening programme cannot be properly evaluated unless
       there is commitment to audit as a natural part of the programme’s activities. It is quite

Improving Health, Improving Services             Lincolnshire Teaching Primary Care Trust
22 of 71
       clear that one of the key objectives of the screening programme is to demonstrate to
       women within the target population invited for screening that the programme is of high
       quality and is effective in reducing mortality from invasive cancer of the cervix.

14.2   The role of audit, at all levels, within the NHSCSP is the process whereby standards
       are maintained and improved in the screening programme. Whilst it is recognised that
       individual unidisciplinary audit has an important role to play in self education in a non-
       threatening environment, the nature of the screening programme dictates that
       multidisciplinary audit across professional boundaries is vital to the provision and
       maintenance of a high quality screening programme.

14.3   Nationally
       The monitoring of the numbers of invasive cancers developing per 100,000 women
       annually gives an idea of the effectiveness of the screening programme.

14.4   At a district level
       The Quality Assurance Reference Centre (QARC) has an established system of
       programme inspection which covers all aspects of the local Cervical Screening
       Programme. A detailed inspection takes place every three years and covers Patient
       Data Services (Screening office function), district organisation, pathology laboratory
       and colposcopy services. In the near future this inspection will also include primary care
       facilities (appendix 10). Any problems or deficiencies within local programmes are
       highlighted along with a clearly defined timescale for implementation of any
       recommendations.

14.5   Monitoring is done using the KC53, KC61 and KC65 returns giving the following
       information:

        KC53 Returns: are annual statistical returns provided by the Screening Office. It is a
         complex report providing information about screening trends across the screening
         office area. This includes screening uptake rates (> 80% of the eligible screening
         population) and classification of smears into invited and opportunistic.

        KC61 Returns: are annual statistical returns providing an over view of participating
         laboratories, for Lincolnshire this will be Path Links. This provides information
         around important quality indicators:

            Workload – NHSCSP recommend that individual laboratories have a minimum
             workload of 15,000 smears per year.
            Workload broken down by source and age range monitors smears, which fall
             outside of the screening programme (e.g. from women under 25 years).
            Reporting rates - the various percentages of unsatisfactory smears,
             borderline/mild dyskaryosis and high grade dyskaryosis are recorded and
             expected to fall within nationally defined ranges.
            Positive Predictive Value (PPV) – comparison of laboratory reports and eventual
             diagnosis are used to calculate the PPV for each laboratory – this should be in
             excess of 65%.

        KC65 Return: is a three monthly monitoring report from the colposcopy units and
         covers the work performed within a single hospital trust or colposcopy provider.
         Information includes:

            Workload.
            Comparison of laboratory’s cytological grading of smears and eventual outcome.

Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
23 of 71
            Waiting times between referral smear and colposcopic assessment.
            Histological outcome of all biopsies collected at colposcopy.
            Interval between cervical biopsy being taken and informing the woman of her
             result in writing.

        At a local and personal level

            Completion of an annual audit of the standards for commissioning the NHSCSP
             in Lincolnshire will be responsibility of the Screening Programme Manager
             (appendix 9).
            Laboratories have a particular role in providing information to smear takers on
             the quality of their smears, which includes satisfactory form completion and
             sample labelling.

14.6   Audit of the NHSIA Exeter Database

       An annual audit of the NHSIA Exeter database is carried out and an audit report is
       produced. Any observations or recommendations are noted and changes are made as
       necessary.

14.7   Auditing the Adequacy of Cervical Screening Tests:

       14.7.1 Health professionals need to have an annual record of the number of adequate
              and inadequate Cervical Screening tests they have taken. As per NHSCSP
              guidance health professionals will undertake an annual audit of a minimum of
              twenty cervical screening tests taken by themselves, including the inadequacy
                   8
              rates (26). Evidence of this will be required for the Quality Assurance audit of
              premises and facilities in the future (appendix 10). The results of the personal
              audit can be compared with previous audits or with other health professionals
                                          11
              within the same practice (Page 26). This is now one of the GMS/PMS
              standards (see appendix 11).

       14.7.2 Laboratories will supply individual practices with information regarding
              inadequate rates.

       14.7.3 Health professionals need to know the percentage of cervical screening tests
              reported as inadequate by their local laboratory. These statistics are collected
              annually by all laboratories for the completion of the national KC61 forms in May
                       6
              or June (Page 26) and can be found in the NHSCSP Annual Statistical Bulletin
              or at http://www.cancerscreening.nhs.uk/

       14.7.4 It is the responsibility of the health professional to ensure that the whole of the
              transformation zone has been covered when taking a cervical screening
              sample. Thus, the cervix must be visualised at the time the sample is taken. It is
              not possible for the laboratory to be certain that the full circumference of cervix
              has been sampled, whatever the cellularity or cell content of the sample. A
              cervical screening sample taken from half of the cervix would look to the
              cytologist the same as one from the whole circumference.

       14.7.5 If a health professional’s rate of inadequate cervical samples is significantly out
              of line with the national standard for reporting of inadequate samples or with the
              national standard for cervical screening, the reasons given by the laboratory for
              the samples being classified as inadequate should be analysed. Appropriate


Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
24 of 71
              advice should be sought from a trainer/advisor, a gynaecologist and/or the
              laboratory.

15 Invasive Cervical Cancer Audit

15.1   Women who develop invasive cervical cancer despite participating in the programme
       often wish to know why this has happened. Audit of their personal history can yield
       such information and can provide valuable information on population and operational
       aspects of the programme. Review of events and specimens from previous years can
       highlight valuable learning points for the health professionals. The results of such
       activity nationwide, collected over several years, will yield a great deal of information
       about the effectiveness of cervical screening.

15.2   As required by the NHS Cervical screening Programme, every case of cervical cancer
       diagnosed since 1st April 2007 will have all aspects of the programme audited
       (including cervical cytology, histology, colposcopy and GP records if relevant). This is in
       order to monitor the effectiveness of the screening programme and to identify any
       areas of good practice and where improvements can be made. The protocol for the
       Invasive Cervical Cancer Audit is documented in NHSCSP publication 28.

15.3   The audit looks at the previous ten years of screening history for any patient that has
       developed cervical cancer. Biopsies and cervical cytology specimens reported within
       the ten year period will be reviewed. Hospital records will be reviewed by colposcopists
       when there have been previous colposcopic episodes. The call/recall history will be
       reviewed and, where there are significant gaps in the screening history primary care will
       be contacted in order to gain information on what actions were taken to encourage
       attendance for cervical cytology and also what other factors may have impacted on
       attendance. Primary care may also be contacted to see if there is evidence of previous
       symptoms during the ten year review period. An example of the letter sent to primary
       care is shown below. The national audit for G is attached. If preferred, a letter listing
       the findings of the review of the patient notes can be sent.

15.4   At the end of the audit process a report is produced and sent to the relevant clinician.
       The patient is informed that the audit has taken place and asked if they wish to know
       the results of the audit. A meeting is arranged and an outline of what is discussed is
       included in a letter to the GP.

15.5   The audit is co-ordinated by Kathryn Snee, Consultant Healthcare Scientist and Mrs
       Lyn Boon, Audit and Failsafe Coordinator. Both are based at PathLinks Cytology
       Department.




Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
25 of 71
                                       REFERENCES

   1.      A Practical Guide for Health Authorities. Sheffield NHS Cervical Screening
           Programme, 1997 (NHSPB Publication No 7)
   2.      Department of Health 2001 A Protocol for the Decontamination of Surgical
           Instruments.
   3.      Achievable Standards, Benchmarks for Reporting and Criteria for Evaluating
           Cervical Cytopathology. Sheffield NHS Cervical Screening Programme, 1997
           (NHSCSP Publication No1).
   4.      Ceasing Women from the NHS Cervical Screening Programme. Sheffield, NHS
           Cervical Screening Programme, 2004 (NHSCSP Publication No.1).
   5.      Cervical Screening Reference Manual. NHS Information Authority (available from
           www.nhsia.nhs.uk/nhais/pages/download)
   6.      Code of Professional Conduct. London: Nursing and Midwifery Council 2002.
   7.      Colposcopy and Programme Management. Sheffield NHS Cervical Screening
           Programme 2004 (NHSCSP Publication No 20).
   8.      Consent to Cervical Screening. NHS Cervical Screening Programme 2000.
   9.      Duties of a Doctor: Guidance from the General Medical Council. London, General
           Medical Council, 1995.
   10.     Good Practice in Breast and Cervical Screening for Women with Learning
           Disabilities. Sheffield NHS Cervical Screening Programme, 2000 (NHSCSP
           Publication No13).
   11.     Guidelines on Failsafe Actions for the Follow-up of Cervical Cytology Reports. 2004
           (NHSCSP Publication No. 21).
   12.     Guidelines For Practice and Programme Management. Sheffield, NHS Cervical
           Screening Programme, 1997 (NHSCSP Publication No 8).
   13.     Health Service Circular (6 Dec 2001) Health Authority Revenue Resource Limits
           2002/03. (HSC 2001/024) Department of Health.
   14.     Histopathology Reporting in Cervical Screening. Sheffield NHS Cervical Screening
           Programme, 1999 (NHSCSP Publication No 10).
   15.     NHSCSP Confidentiality and Disclosure Policy. NHS Cancer Screening
           Programmes 2003.
   16.     NHSCSP Information Security Policy. NHSCSP, September 2003.
   17.     Peto J. et al “The Cervical Cancer Epidemic that Screening has prevented in the
           UK.” Lancet (2004), 364 (9430) 249-56.
   18.     Resource Pack for Training Smear Takers. Sheffield NHS Cervical Screening
           Programme, 1998.
   19.     Standards and Quality in Colposcopy. Sheffield NHS Cervical Screening
           Programme 1992 (NHSCSP Publication No 2).
   20.     Department of Health 2003 Winning Ways-Working together to reduce health care
           associated infection in England. DOH Publications London.
   21.     www.cancerscreening.nhs.uk




Improving Health, Improving Services             Lincolnshire Teaching Primary Care Trust
26 of 71
Appendix 1

       Lincolnshire Screening Commissioning Board Membership
Name             Title                               Contact Details
Andrew Rix       Lead Manager for Specialised        Boston Locality Office
(Chair)          Commissioning                       Boston West Business Park
                                                     Sleaford Road, Boston
                                                     PE21 8EG
                                                     Tel: 01205 318051
                                                     Email: Andrew.rix@lpct.nhs.uk
Ann Ellis        Health Improvement Principle        Orchard House
                                                     Greylees, Sleaford, NG34 8PP
                                                     Tel: 01529 416090 ext 6023
                                                     Email: ann.ellis@lpct.nhs.uk
Sara Brine       Senior Contracts Manager            Orchard House
                                                     Greylees, Sleaford, NG34 8PP
                                                     Tel: 01529 416000 ext 6215
                                                     Email: sara.brine@lpct.nhs.uk
Richard          Head of Performance                 Bracebridge Heath
Woolsey                                              Cross O Cliff
                                                     Lincoln
                                                     LN4 2HN
                                                     Tel: 01522 513355
                                                     Email: Richard.woolsey@lpct.nhs.uk
Lisa Creed       Service Manager - Screening         Lincoln county hospital
                                                     Greetwell Road
                                                     Lincolnshire NHS Shared Services
                                                     LN2 4AX
                                                     Tel 01522 512512
                                                     Email: lisa.creed@ulh.nhs.uk
Zoe Crawford     Screening Programmes Manager        Orchard House
                                                     Greylees, Sleaford
                                                     NG34 8PP
                                                     Tel: 01529 416000
                                                     Email: Zoe.crawford@lpct.nhs.uk




Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
27 of 71
Cervical Screening Co-ordinating Group Membership
Name / title                            Main                   Contact details
                                        responsibility
                                        within the
                                        programme
Zoe Crawford                            District screening     Orchard House
Screening Programmes Manager            and programme          Greylees, Sleaford
                                        management             NG34 8PP
                                                               Tel: 01529 416000
                                                               Email: Zoe.crawford@lpct.nhs.uk
Miss Kathryn Snee                       Co-ordinating          Path Links
Path Links Cytology Manager,            Hospital and Path      Cytology Department
                                        Lab function           Lincoln County Hospital
                                                               Greetwell Road
                                                               Lincoln
                                                               LN2 5QY
                                                               Tel: 01522 512512 ext 2752
                                                               Fax:01225 573708
                                                               Email: Kathy.Snee@ulh.nhs.uk
Dr Pat Parsons                          Cytology               Path Links, Histopathology
Lead Consultant for Cervical Cytology                          Lincoln County Hospital
Hospital Based Programme                                       Greetwell Road
Coordinator                                                    Lincoln, LN2 50Y
                                                               Tel: 01522 572572 ext. 2702
                                                               Fax: 01522 573708
                                                               Email: Pat.parsons@ulh.nhs.uk
Mr M Lamb                               Colposcopy             Lincoln County Hospital
Consultant Gynaecologist                                       Greetwell Road
                                                               Lincoln
                                                               LN2 5QY
                                                               Tel: 01522 573295
                                                               Fax: 01522 573419
                                                               Email: Martin.lamb@ulh.nhs.uk
Dr Elizabeth Devonald                   Colposcopy             Lincoln County Hospital
Associate Specialist                                           Greetwell Road
                                                               Lincoln
                                                               LN2 5QY
                                                               Tel: 01522 512512
                                                               Fax: 01522 573419
                                                               Email:
                                                               Elizabeth.devonauld@ulh.nhs.uk
Mr Adeyemi                              Colposcopy             Pilgrim Hospital
Consultant Gynaecologist                                       Sibsey Road
                                                               Boston
                                                               Lincolnshire
                                                               PE21 9QS
                                                               Tel: 01205 445579
                                                               Fax: 01205 354395
                                                               Email:
                                                               Adeyemi.oluwole@ulh.nhs.uk




Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
28 of 71
Name / title                           Main                 Contact details
                                       responsibility
                                       within the
                                       programme
Mr Husemeyer                           Colposcopy           Grantham & District Hospital
Consultant Gynaecologist                                    101 Manthorpe Road
                                                            Grantham
                                                            Lincolnshire
                                                            NG31 8DG
                                                            Tel: 01476 464356
                                                            Fax: 01476 590441
                                                            Email: Roy.husemeyer@ulh.nhs.uk
Pam Aspland                            Call/Recall          Cross O Cliff
Senior Screening Officer               Services             Bracebridge Heath
                                                            Cross O Cliff
                                                            Lincoln
                                                            LN4 2HN
                                                            Tel: 01522 515329
                                                            Fax:01522 515389
                                                            Email: pam.aspland@lpct.nhs.uk
Mrs Bonita McCarthy                    Call/Recall          Cross O Cliff
Patient Data Manager                   Services             Bracebridge Heath
                                                            Cross O Cliff
                                                            Lincoln
                                                            LN4 2HN
                                                            Tel: 01522 515332
                                                            Fax:01522 515389
                                                            Email:
                                                            bonita.mccarthy@lpct.nhs.uk
Ellen Ewer                             Colposcopy           Lincoln County Hospital
Nurse colposcopist                                          Greetwell Road
                                                            Lincoln
                                                            LN2 5QY
                                                            Tel: 01522 512512 ext 3552
                                                            Fax: 01522 573419
                                                            ellen.ewer@ulh.nhs.uk
Ann Ellis (Chair)                      Public Health        Orchard House
Health Improvement Principle           Screening Lead       Greylees Sleaford
                                                            NG34 8PP
                                                            Tel: 01529 416090 ext 6023
                                                            Fax: 01529 416030
                                                            Email: ann.ellis@lpct.nhs.uk




Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
29 of 71
Name / title                           Main                 Contact details
                                       responsibility
                                       within the
                                       programme
Richard French                         Quality Assurance    NHS Cervical Screening
Deputy Director                        Reference Centre     Programme
(Cervical Screening)                                        East Midlands Region
Quality Assurance Reference Centre                          Quality Assurance Reference
                                                            Centre
                                                            Sheffield Teaching Hospitals NHS
                                                            Trust
                                                            Northern General Hospital
                                                            Herries Road
                                                            Sheffield
                                                            S5 7AU
                                                            Tel: 0114 2715500
                                                            Fax: 0114 2714395
                                                            Email: ehewer@dial.pipex.com
Mrs Bonita McCarthy                    Call/Recall          Cross O Cliff
Patient Data Manager                   Services             Bracebridge Heath
                                                            Cross O Cliff
                                                            Lincoln
                                                            LN4 2HN
                                                            Tel: 01522 515329
                                                            Fax:01522 515389
                                                            Email:
                                                            bonita.mccarthy@lpct.nhs.uk




Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
30 of 71
Appendix 2


                 Lincolnshire Screening Commissioning Board
                              Terms of Reference
Objectives

Plan, shape and lead the development of screening programmes across Lincolnshire

Ensure the delivery of high quality, consistent, comprehensive and equitable screening
services

Roles/Tasks

   Ensure that a vision/common understanding of screening programmes is established for
    Lincolnshire in line with national direction

   Ensure that strategic direction is provided and key tasks are identified for each
    programme

   Ensure individual multidisciplinary screening groups to address each national programme
    are established and monitored (e.g. Breast, Cervical, Chlamydia, Colon, antenatal,
    diabetic retinopathy, etc)

   Confirm in collaboration with the individual programme groups if any ad hoc or project
    groups are required to fulfil key tasks, and agree parameters for their work.

   Ensure the utilisation of resources is effective and equitable

   Ensure that the patient screening pathways are used to inform the commissioning
    process

   Ensure that an investment programme is prepared and implications for primary care and
    acute Trusts considered

   Working closely with the cancer network on ensuring robust screening services are/will
    be in place.

   Ensure that, in collaboration with the Regional QA Directors, Reference Centres and
    standing clinical subgroups ensure that:

     o       Local policies and protocols are drafted/implemented in accordance with national
             guidance

     o       There is a robust and consistent communication strategy

     o       Mechanisms are in place to monitor the delivery of programmes against national
             standards and guidance. (e.g. that NHS Lincolnshire is able to report population
             coverage for cancer screening programmes).

     o       Systems are in place to address potential deviation from required standards


Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
31 of 71
   Alert the SHA, and QA Director to any deviation in standard of care and oversee the
    management of such exceptions

   Act as a focal point for the system to raise and consider issues about screening
    programmes and work through individual clinical subgroups to ensure that such issues
    are resolved

   Ensure the coordinated involvement of clinicians and managers from all organisations in
    delivering the various components of a screening programme.

   Support the Government Office in performing their QA function

   Ensure that the concept of supportive learning and sharing of good practice is
    established.


Membership

Public Health Screening Lead

Programme Screening Manager

Planning and Health Outcomes Lead

Performance Lead

Ad Hoc Chair of standing clinical subgroups when necessary

Clinical/GP representation

Patient representation


Frequency of meetings

Four times a year




Review Date: December 2009




Improving Health, Improving Services           Lincolnshire Teaching Primary Care Trust
32 of 71
                         Lincolnshire Cervical Screening
                              Co-ordinating Group
                               Terms of Reference
Objectives

To lead the development and implementation of the cervical screening programme across
Lincolnshire

To ensure the delivery of a high quality, consistent, comprehensive and equitable screening
programme

Roles/Tasks

      Support the Lincs Screening Commissioning Group (LSCG) in their strategic role

      Support the screening lead and commissioner in their local roles

      Identify, in conjunction with the screening commissioning group, other ‘ad hoc’ or
       project groups required to fulfil key tasks and set parameters for their work

      Ensure that the there is a mechanism in place for investing in the cervical screening
       programme by developing a prioritised investment plan cervical screening

      Identify the implications for primary care and acute trusts of any investment plan
       (including the consequences to the diagnostic and treatment services)

      Ensure that patient pathways are used to inform the commissioning process

      Agree in liaison with QA reference centre and LSCG:

            Local policies, protocols and service specifications for component parts of the
             programme – e.g. ensure robust population registers exist and that appropriate
             arrangements are in place with local information strategies to maintain them
            A robust and consistent communication strategy
            Partake in liaison with QA reference centre in:

               Arrangements to monitor the delivery of programme against national
                standards and guidance – e.g. that NHS Lincolnshire is able to report
                population coverage for the cervical screening programme
               Arrangements to monitor the implementation of the investment plan and its
                consequences

      Alert the LSCG and QA Director to any deviation in standards of care and participate
       in the resolution of such exceptions

      Coordinate the involvement of clinicians and managers from all organisations in
       delivering the various components of the screening programme

      Produce an annual report on the delivery and performance of the screening
       programme

      Ensure service continuity by:
Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
33 of 71
      Overseeing the development of a skilled workforce

      Ensuring that an education and training programme is provided to underpin the
       delivery of the screening programme across Lincolnshire.

      Work in collaboration with the respective Regional QA Director and QA Reference
       Centre

      Develop mechanisms to share good practice and expertise.


Membership

Chair – To be decided by the Group

Clinicians – lead clinician for the programme

Other professional leads (as identified by the screening programme, e.g. colposcopists,
radiologists)

QA manager

Commissioning representation

Public Health Lead for screening programmes

Hospital Trust representative


Accountability

Accountable to the Lincolnshire Screening Commissioning Group


Frequency of meetings

Minimum 3 times per annum in January, May & September. The Cervical Screening Group
may redefine their schedule depending on the business which needs to be undertaken.




Review Date: December 2009




Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
34 of 71
Appendix 3


            Lincolnshire Cervical Cytology Screening Programme
                              Failsafe Protocol
INTRODUCTION

It is essential that there are systems in place to ensure women attend colposcopy when
referral is advised as a result of an abnormal smear. The ultimate responsibility for the follow
up of an individual woman with an abnormal smear lies with the smear taker (Health Circular
DHSS HC (88)1/HC (FP)2 and NHSCSP, 1992). However, Primary Care Trusts have overall
responsibility for the failsafe system (as having overall responsibility for the programme),
although laboratories and colposcopy clinics have an important role to play. The cytology
laboratories within Path Links must liaise closely with all other parties involved in the NHSCSP
including smear takers, Colposcopy Clinics, Screening Offices and Public Health Cervical
Screening Co-ordinators (See Lincolnshire NHSCSP Failsafe Protocol and North and North
east Lincolnshire Area NHSCSP Failsafe Protocol

The failsafe staff on Grimsby site will perform the laboratory failsafe function for the Path Links
cervical cytology service. These staff members will be managed directly by the Cytology
Manager but feed failsafe information directly to Hospital Based Programme Co-ordinators for
both Northern Lincolnshire and Goole NHS Trust and United Lincolnshire Hospitals NHS Trust.

A failsafe system is a "mechanism to ensure that a process reverts to a danger free condition
in the event of breakdown".

PRINCIPLE OF THE METHOD

The purpose of laboratory failsafe is to confirm that a referral for colposcopy has been made
and a clinic appointment has been sent to the woman. If the woman does not attend,
responsibility for taking any further action rests with the GP (or responsible clinician) who has
knowledge of the woman's individual circumstances.

Although women are referred directly from the laboratory to colposcopy laboratory fail safe
letters are sent to the GP as they may be able to encourage attendance at colposcopy.

Quality Control

The proportion of women with unknown outcome after 12 months should be less than 5%.

PROCEDURE

Urgent Referrals

          A record is kept of all referrals on the laboratory database.
          Four weeks after the date of authorisation a list is generated by the laboratory
           database. This list is run weekly.
          The failsafe office checks that a smear or biopsy or a letter has been received from
           colposcopy clinic. Diagnosis is recorded for audit purposes.
          A letter is sent to the woman’s GP/smear taker when the woman is four months
           overdue for referral. A questionnaire is also sent to obtain information on the action
           taken. This includes:-

Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
35 of 71
              Referral for colposcopy has been made
              Referral for colposcopy has been delayed
              Referral for colposcopy has not been made

The register is updated with the information provided.

          If no follow-up has been received the failsafe office contact colposcopy to check if
           urgent referral has occurred
          If referral has not taken place then the GP/responsible clinician is contacted by letter
           with questionnaire by the Failsafe co-ordinator or the Laboratory Manager
          Six weeks after the date of authorisation of the test a further list is generated. The list
           is generated weekly If no follow-up has been received then a second letter with
           questionnaire is generated to send to the GP/responsible clinician
          The GP/responsible clinician is sent a closure letter when laboratory failsafe actions
           are closed) 6 weeks after the second letter has been generated.
          If the woman is known to have moved, is no longer registered with the GP or has
           failed to attend colposcopy, the laboratory should inform the Screening Commissioner
           that no further action will be taken by the laboratory.

Non-urgent Referrals

         A record is kept of all such referrals on the laboratory database.
         Four months after the date of authorisation of the report a list is generated by the
          laboratory database. This list is run weekly.
         The failsafe office checks that a smear or biopsy or a letter has been received from
          colposcopy clinic. Diagnosis is recorded for audit purposes
         A letter is sent to the woman’s GP/smear taker when the woman is four months
          overdue for referral. A questionnaire is also sent to obtain information on the action
          taken. This includes:-

             Referral for colposcopy has been made
             Referral for colposcopy has been delayed
             Referral for colposcopy has not been made

The register is updated with the information provided

         The GP(or responsible clinician) is sent a closure letter when laboratory failsafe actions
          are closed three months after reminder letter was generated.
         If the woman is known to have moved, is no longer registered with the GP or has failed
          to attend for colposcopy, the laboratory should inform the screening commissioner that
          no further failsafe action will be taken by the laboratory
         Enquiries should be continued for a period of 12 months form the date of the test. If no
          outcome can be established in that time then the Hospital Based Programme Co-
          ordinator should inform the GP in writing that the laboratory failsafe is closed
         Women new to the area who require referral will be added to the register
         The failsafe co-ordinator will notify the screening commissioner of women where
          colposcopy attendance and outcome cannot be established

Additional Notes

         All letters generated at colposcopy clinics across Lincolnshire are copied to the failsafe
          co-ordinator so that a complete patient record can be achieved. Observations,


Improving Health, Improving Services                 Lincolnshire Teaching Primary Care Trust
36 of 71
           treatment and recommended follow-up are recorded on the laboratory database . The
           laboratory database recall date is also updated
          Occasionally patient demographics or General practitioner may change between the
           authorisation of the cytology report and the generation of the failsafe letter. This is
           updated.
          Occasionally a patient may elect to have treatment outside the UK. A letter will be
           issued to the sample taker in order that the record can be closed when treatment has
           been confirmed.


    Failsafe Action for Urgent Referrals
                 Smear reported as severe/invasive or glandular neoplasia



Senior BMS telephones                                             Call and recall office
result to GP/ responsible                                         informed in usual way
clinician                                                         (electronic link )


Standard letter proforma                                  Result telephoned to appropriate colposcopy
filled in and sent to                                     clinic and advised that urgent clinic
GP/responsible clinician.                                 appointment will be required

               Four weeks after authorisation date list of patients
                generated by laboratory database list is run weekly
               Failsafe office checks if smear/biopsy or colposcopy
                letter received


                       NO                        YES

    Telephone colposcopy to check                 Record diagnosis for audit purposes
     urgent referral made                          Failsafe closed.
    IF not, then contact GP/responsible
     clinician by letter/questionnaire


                                      YES
    6 weeks after authorisation date list generated by laboratory database
    check woman has been to colposcopy

 NO
 Generate standard letter/questionnaire for GP/responsible                    Failsafe Closed
  clinician                                                                    Closure letter sent
                                                                                                nd
 Agree_______
          further action                                                       (6 weeks after 2
                                                                               letter)


    Please note – In the case of cervical samples being reported as severe/? Invasive or ?
    glandular neoplasia it is the responsibility of the smear taker to inform the women of the result.
    A letter is not sent from NHS Lincolnshire

    Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
    37 of 71
    Failsafe Action for Non Urgent Referrals


                  Smear reported with advice to refer woman to
                  colposcopy. Direct referral from laboratory to colposcopy




    4 months after the authorisation date a list of patients is generated by the
     laboratory database
    Failsafe office checks if smear/biopsy or Colposcopy letter received
                                               Woman attended colposcopy
                                               Outcome recorded

No response received
PCT clinical governance lead
                                               Woman has not attended colposcopy
and HBPC informed
                                               Contact GP/responsible clinician by
                                               letter. A questionnaire is included



                                             Referral delayed (pregnant/temporarily
                                             away from home/undergoing other
                                             treatment)
                                             Failsafe date advanced on laboratory
                                             database further letter sent in 'X' months


                                             Referral not made              Inform PCT
                                             Patient moved away             commissioner &
                                             or no longer registered        HBPC



                                             Referral not made                      Failsafe Closed
                                             Other treatment                        Closure letter sent
                                             Death
                                             Declined




    Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
    38 of 71
RETENTION

On the advice of Regional Quality Assurance Team all paper records are kept for five years.

RESPONSIBILITIES OF HOSPITAL BASED PROGRAMME COORDINATOR

The role of the Hospital based Programme Co-ordinator is not necessarily held within the
laboratory. Currently United Lincolnshire Hospitals Coordinator is Dr Pat Parsons(Lead
Consultant Histopathologist for PathLinks Cervical Cytology) and Northern Lincolnshire and
Goole Co-ordinator is Kathryn Snee (PathLinks Cytology Manager).

Their role is as follows:-

     Arrangements are in place to transfer test results and recommendations for
      management to the call and recall system, and to notify sample takers and GPs or
      responsible clinicians
     Histology results are collated with cytology results
     Arrangements are in place to initiate failsafe enquiries about women who require
      further investigation and treatment

Colposcopy clinics

Responsibility for referring a woman for colposcopy rests with the GP/responsible clinician
unless there are direct referral arrangements with the laboratory.

NB: Local arrangements are in place in Lincolnshire for Path Links to make direct
colposcopy referral.

If a woman attends for colposcopy the colposcopist to whom she is referred becomes
responsible for her treatment, arranging further follow up and informing the laboratory and the
GP/responsible clinician of the outcome.

Colposcopy clinics must have a system for notifying laboratories and GPs/responsible
clinicians of colposcopy attendance and results

Colposcopy clinics must have a system for sending reminder letters to women who do not
attend either for a first appointment or for follow up appointments for colposcopy, they must:

     Send a reminder letter or second invitation to all women who do not attend for their first
      appointment
     Send a non responder notification to the GP/responsible clinician and the laboratory if a
      woman does not attend a first appointment for colposcopy
     Send a non responder notification to the GP/responsible clinician and the laboratory if a
      woman does not attend a follow up appointment for colposcopy
     Respond to failsafe enquiries by laboratories
     The failure to respond to laboratory failsafe enquiries should be addressed by the
      hospital based programme coordinator as a clinical governance issue.

Primary Care

On behalf of the Primary Care Trust the Screening Programmes Manager will:

     Operate a failsafe system for all test results that require suspension from recall
     Coordinate laboratory, screening office and colposcopy failsafe

Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
39 of 71
     Require notification by the laboratory of women for whom a colposcopy outcome
      cannot be established
     Audit failsafe systems annually
     Satisfy themselves that all reasonable steps are taken to contact women who are
      subject of laboratory failsafe enquiries

The failure of a GP/responsible clinician to respond to a laboratory failsafe enquiry
should be dealt with as a clinical governance issue.

GPs and other clinicians responsible for requesting tests must:

     Maintain a register of tests taken
     Make arrangements for women who fall outside the call and recall system to be given
      their test results (e.g. temporary residents, women not GP registered, women
      requesting no correspondence)
     Ensure that a test result has been received from the laboratory for every sample taken
     Act on non responder notifications for women who have not responded to invitations for
      an early repeat test
     Give a woman her test result on a personal basis that is appropriate when urgent
      referral is required
     Refer a woman for colposcopy if required
     Act on the non responder notifications from the colposcopy clinic for women who have
      not attended for colposcopy
     Respond to failsafe enquiries by laboratories

Failsafe responsibilities when taking a cervical screening sample must include:

       Correct labelling of samples
       Accurate completion of forms
       Correct storage and transportation of samples
       Full explanation of the purpose, risks and potential outcomes of cervical screening




Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
40 of 71
Table 1 - Failsafe Summary

Action               Screening Office              Laboratory            General        Colposcopist
                                                                         Practice
Initial invitation   1 month after PNL sent
to woman             to GP
Reminder letter      3 months after initial
to woman             invitation
1st non              3 months after reminder
responder card       letter
to GP
Final non            3 months after 1st non
responder card       responder card – Revert
to GP                to 12 month recall
Urgent referral                                    Notify GP by          Personally
required                                           phone/fax and         notify woman
                                                   letter as soon as     as soon as
                                                   possible              possible
                                                   Contact GP at 4
                                                   and 6 weeks if
                                                   woman does not
                                                   attend
Colposcopy                                         Directly refer to
required                                           colposcopist
Woman seen                                         Confirm outcome                      Arrange further
for colposcopy                                     with colposcopist                    follow up as required
                                                   after 6 weeks                        and notify laboratory
                                                                                        and GP
Woman does                                                                              Send a reminder
not attend for                                                                          letter to woman
colposcopy                                                                              Send a first non
                                                                                        responder card to
                                                                                        GP
                                                                                        Send a final non
                                                                                        responder card to
                                                                                        GP
Early repeat         Send a reminder letter to
test required        woman. (Early repeats
                     appear on the PNL 3
                     months before due and
                     then follow timings for all
                     letters)
                     Send a first non
                     responder card to GP
                     Send a final non
                     responder card to GP
                     Revert to 12 month
                     recall
Colposcopy                                         Enquire to GP at
outcome not                                        3-6 months (letter
known by                                           and questionnaire)
laboratory                                         Enquire to
                                                   colposcopist at 3-6
                                                   months




Improving Health, Improving Services                        Lincolnshire Teaching Primary Care Trust
41 of 71
Appendix 4

                              Disclaimer Form and Letter


                                                          Public Health Cervical Screening Lead
                                                      Directorate of Public Health & Partnerships
                                                                                  Orchard House
                                                                                        Greylees
                                                                                         Sleaford
                                                                                     Lincolnshire
                                                                                      NG34 8PP

Strictly Private and Confidential


Dear

Women are invited for cervical screening examinations every three to five years. Cervical
cancer can be significantly reduced by having routine screening.

I understand that you do not wish to be invited for future cervical screening for which you are
eligible as part of the NHS Cervical Screening Programme. I enclose for your information a
leaflet explaining the risks and benefits of cervical screening and the risks of non-participation.
If you are still unsure as to the risks and benefits and require further information, please do not
hesitate to contact your General Practitioner.

In order to allow us to remove your name from the list of eligible women, your written
instructions are needed to ensure that there is no misunderstanding. I would be grateful,
therefore, if you could sign and return the attached form confirming that you wish to have your
name removed and receive no further information.

You may have your name restored to the list at any time and may be screened at any time on
request by contacting your General Practitioner.



Yours sincerely



XXXXXXXXXXXXXXXX
Public Health Cervical Screening Lead




Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
42 of 71
       Consent To Remove Name From The Cervical Screening Programme

                               Personal Disclaimer Form



CONSENT TO REMOVE NAME FROM THE CERVICAL SCREENING PROGRAMME

To: Public Health Cervical Screening Lead, Orchard House , Sleaford, Lincolnshire

I do not wish to attend for a cervical screening test, as part of the NHS Cervical Screening
Programme. I assume full responsibility for this decision and confirm that I have read and
understood the statement about the risks and benefits and the importance of screening in
reducing cervical cancer deaths.

I understand that my name can be restored to the list of eligible women at any time, at my
request to my General Practitioner


NAME

ADDRESS

NHS NUMBER

DOB

SIGNED ……………………………………………………….. DATE ………………………………..

Please return this form to:


Public Health Cervical Screening Lead
Directorate of Public Health & Partnerships
Orchard House
Greylees
Sleaford
Lincolnshire
NG34 8PP




Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
43 of 71
Appendix 5


              Exclusion From The NHS Cervical Screening Programme


To: Lincolnshire Public Health Cervical Screening Lead



MS: ________________________________DOB____________________


Screening No._______________________NHS No.__________________


General Practitioner:         …………………………………………………
Address:                      …………………………………………………
                              …………………………………………………
                              …………………………………………………
                              …………………………………………………

Ms………………………………….recently came for cervical screening. She found compliance
with the procedure difficult and/or distressing.
(other reason please state)
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………

I do not consider her as having a particularly high risk, therefore I advise she should be
excluded from the screening programme in future.

Yours sincerely

General Practitioner

Please return this form to:

Public Health Cervical Screening Lead
Directorate of Public Health & Partnerships
Orchard House
Greylees
Sleaford
Lincolnshire
NG34 8PP


A copy of this form should be kept with the woman’s medical records.




Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
44 of 71
Appendix 6

               Cervical Screening for Women with Learning Disabilities

The cervical screening programme has a clear duty to include women with learning disabilities
in their activities. Current evidence suggests that a significantly smaller proportion of women
with learning disabilities are accessing the cervical screening programme than the normal
eligible population. It is common for women with a learning disability not to be offered a routine
smear test on the assumption that they have never had sexual intercourse1. However it may
not be possible to be sure that someone has never been sexually active. Women with learning
disabilities may experience sexual abuse that goes unrecognised, and are therefore at risk of
developing cervical cancer2.

It is advisable that women with learning disabilities are given more support and preparation in
order to access the screening programme. Where women live in the community it is preferable
that the general practitioner, the learning disability team and if appropriate the carers, who
have a knowledge and understanding of the extent and nature of the disability, advise on what
suitable provision and care should be arranged. Where women are resident in a care facility, it
is essential that carers are informed about the screening procedure in order to advise on the
provision and care to be provided and to help to communicate effectively with the women.

The Prior Notification List (PNL) gives the GP the opportunity to identify any women with a
known learning disability and to consider whether they should be invited for a smear test. It is
important to seek advice on what different or additional preparations may be needed to make
screening more acceptable and accessible to these women. Information needs to be
accessible and understandable. The NHS Cancer Screening Programme has formulated good
practice guidance for professionals involved in the cervical screening programme around the
issues of cervical screening for women with learning disabilities and promoting access to the
service by these women3. Material has also been prepared for women and their carers in order
to improve the information available to them and enable women with learning disabilities to
make informed choices about participating in the cervical screening programme (see details on
following page to obtain copies).

Capacity to consent to cervical screening
The following points have been identified by the NHS Cancer Screening Programme and
should be considered when assessing a woman’s capacity to consent to cervical screening3:

1.   Does the woman have a basic understanding of what cervical screening is, what it is for
     and why she has been invited?
2.   Does she understand that the smear test does not always find if something is wrong?
3.   Does she understand that an abnormal smear result means having more tests?
4.   Is she able to retain information for long enough to make an affective decision?
5.   Is she able to make free choice (i.e. free from pressure from supporters or health
     professionals)?

Some woman with severe learning disabilities may not have the capacity to make their own
choice about cervical screening, even after careful preparation. If a woman does not have the
capacity to consent, then the health professionals must act in the best interests of the woman.
The following points should be taken into consideration:

1.   What are the woman’s known wishes?
2.   Involve the woman in discussions?
3.   Seek the views of others who know the woman well?
4.   Is there any other action that would be better for the individual?

Improving Health, Improving Services                Lincolnshire Teaching Primary Care Trust
45 of 71
The decision may be taken by the GP to cease the woman from the cervical screening
programme (see section on ceasing).

                                         Key Points

   Women with learning disabilities have the same right of access to cervical screening as
    other women.

   Women with learning disabilities cannot be assumed to be sexually inactive.

   Women with learning disabilities are entitled to information to make their own decision
    about cervical screening.

   The PNL and non responder notification can be used as a prompt to give women the
    picture leaflet about screening.


Ceasing women with learning disabilities

A few women with learning disabilities are unable to understand and comply with the
procedures of having a cervical smear taken, which they may also find distressing. In law no
one can consent for another adult other than the person themselves. HC(90)22 on consent,
remains current
      34
policy .

In such cases health professionals must act in accordance with reasonable practice. Ultimately
the decision on whether to attempt cervical screening must be made by the care team
including the lead clinician, learning disability team and family/carers, who act in the best
interests of the woman. It is therefore recommended that the care team involved with the
individual woman weigh up the risks and benefits for each woman and that they document
their decision accordingly. The process for the Lincolnshire area is as follows:

   Indicate on the PNL that the GP wishes the woman to be ceased due to severe learning
    disability.

   Screening Commissioner will write to the GP enclosing a copy of the NHSCSP guidance
    and exclusion form (District Policy appendix 6).

   A copy of the completed form should be retained by the GP, in the woman’s records.

   The original form should be forwarded to the Screening Commissioner, the woman will be
    ceased from call/recall on receipt of the completed form.




Improving Health, Improving Services             Lincolnshire Teaching Primary Care Trust
46 of 71
Improving Health, Improving Services   Lincolnshire Teaching Primary Care Trust
47 of 71
Appendix 7

                 Cervical Screening Information Available For Women

Addresses of where to obtain these leaflets are given


LEAFLET NAME                                         AVAILABLE FROM

Cervical Screening the Facts                         DH Publications Orderline
(available in Braille or audio format and in other   PO Box 777
languages)                                           London SE1 6XH
What your abnormal result means
The colposcopy examination                           Tel: 08701 555455
(available in other languages)                       Fax: 01623 724542
                                                     Email: dh@prolog.uk.com
Audio cassette of the above leaflets – other         Talking Magazines for the visually impaired
languages                                            Cathedral Centre
                                                     Captain Street
                                                     BRADFORD
                                                     BD1 4AH
                                                     Tel: 01274 308707
Having a Smear Test                                  DH Publications Orderline
(leaflet in picture form for women with learning     PO Box 777
disabilities)                                        London SE1 6XH

                                             Tel: 08701 555455
                                             Fax: 01623 724542
                                             Email: dh@prolog.uk.com
Keeping Healthy Down Below                   Price £10.00 inc p&p
(designed to be used by women with learning Book Sales
disabilities and those who support them)     Royal College of Psychiatrists
                                             Tel: 020 7235 2351 ext 146
Cervical Health for Women – tape and leaflet Birmingham Health Authority
(available in other languages)               Fazeley House
                                             Aston Cross
                                             50 Rocky Lane
                                             Aston
                                             BIRMINGHAM
                                             B6 5RQ
A simple check - video                       Healthcare Production Ltd
                                             Unit 301
                                             Blackfriars Foundry
                                             156 Blackfriars Road
                                             LONDON
                                             SE1 8EN
                                             Tel: 0207 721 7150
Woman to woman (for use with women from Rotherham Health Promotion Department
minority ethnic groups)                      220 Badsley Moor Lane
                                             ROTHERHAM
                                             South Yorkshire
                                             S65 2QU
                                             Tel: 01709 820020


Improving Health, Improving Services                 Lincolnshire Teaching Primary Care Trust
48 of 71
LEAFLET NAME                                   AVAILABLE FROM

Mrs Malik goes for a cervical smear – video Films Ltd
(available in other languages)                   78 Holyhead Road
                                                 Handsworth
                                                 BIRMINGHAM
                                                 B21 0LH
Information is also available on the internet at www.cancerscreening.nhs.uk
the following sites:                             www.nhsdirect.nhs.uk




Improving Health, Improving Services          Lincolnshire Teaching Primary Care Trust
49 of 71
Appendix 8

                  Screening Programmes Manager Annual Report Format

1. Summary

2. Contents

3. Introduction

4. Programme Overview

5. Screening test uptake

  a) by Cluster and GP
  b) by age and socioeconomic group
  c) call and recall

6. Reading and Reporting

  a) Laboratory
      i) workload
    ii) quality control
   iii) inadequate rates
   iv) negative rates as a percentage of adequates
    v) failsafe
   vi) referred for colposcopy

  b) Colposcopy
      i) mortality rates
    ii) new registration and death rates
   iii) clinical audit
   iv) disease stage at presentation

7. Conclusion

8. Recommendations

9. References




Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
50 of 71
Appendix 9




             NHS CERVICAL SCREENING PROGRAMME
              LINCOLNSHIRE QUALITY ASSURANCE
                PRIMARY CARE QUESTIONNAIRE

  Practice Manager          .………………………………………………………..................

   Practice Name            .…………………………………………………………………….

  Practice Address         ……………………………………………………………………

                            ……………………………………………………………………

GUIDELINES FOR COMPLETION OF THE QUESTIONNAIRE


Part A to be completed by the lead clinician for cervical screening within the practice in
consultation with the relevant professionals

Part B to be completed by ALL individuals within the practice who take cervical
smears (SEVERAL COPIES OF PART B ARE ENCLOSED BUT PLEASE PHOTO
COPY MORE IF YOU DO NOT HAVE ENOUGH FOR THE NUMBER OF
SMEARTAKERS)

Please complete both sections in full and if not relevant or applicable please state this

Please return the completed questionnaire (including all part B’s) to:

xxxxxxxxxxx
Screening Programmes Manager
   XXXXXXXXX
   XXXXXXXXXX
   XXXXXXXXXX

If you have any queries concerning this questionnaire please do not hesitate to contact
me on XXXXX XXXXXXX




Improving Health, Improving Services           Lincolnshire Teaching Primary Care Trust
51 of 71
PART A:      To be completed by the lead clinician for cervical screening within
the practice and in consultation with the relevant professionals

PRACTICE DETAILS



 Practice Name ………………………………………………………………………………

 Name of Clinical Lead for cervical screening ……………………………………………

 Post held within the practice …………………………………….………………………….

 Number of General Practitioners who take cervical screening samples ………………

 Number of Practice Nurses who take smears               …………………

 Please indicate the practice coverage rate              …………………

 Name of person responsible for checking PNL’s ………………………………………
                                  (prior notification lists)

 Their grade or title ……………………………………….


APPOINTMENTS

Please indicate below when appointments are available in your practice:

Day and evening                         Day only                        Evening only

How much time is allotted for each appointment?                    (minutes)

                                                                            Yes           No

Are women given the opportunity to request a female sample taker?

Do you have access for the disabled?

INFORMATION / COMMUNICATION

                                                                               Yes        No
Does the practice send out routine invitation letters?

Does the practice send out routine result letters?


Please enclose copies of all routine letters sent



Improving Health, Improving Services           Lincolnshire Teaching Primary Care Trust
52 of 71
Is there a supply of the following leaflets?

                                                                        Yes          No
Cervical Screening the Facts

The Colposcopy Examination

What your Abnormal Result Means

Keeping Healthy "Down Below"


                                                                              Yes          No
Is a record kept of smears sent to the laboratory and results returned?

Do you have a practice protocol?

If yes, does it include a failsafe mechanism?


                                                                Month               Year
Please indicate when your protocol was last reviewed?


                                                                 Yes                No
Do you have a protocol or policy for cervical screening?

If so, does any aspect of it cause you difficulty?

If yes, please give details ………………………………………………………………………

………………………………………………………………………………………………….

TRAINING

                                                                        Yes         No

Is basic training expected of smeartakers within the practice?


If yes, what training is expected? …………………………………………………………


What update training is available?         …………………………………………………

…………………………………………………………………………………………………

Who would you access for support or advice outside the practice?………………………

……………………………………………………………………………………………………..

Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
53 of 71
                                                                                                           Yes              No

Are GP trainees required to provide evidence of supervised
and audited smears before they are assessed to be competent?

If yes, please give details …………………………………………………………………..

......................................................................................................................................

…………………………………………………………………………………………………..

…………………………………………………………………………………………………..


INFECTION CONTROL

Please indicate the type of steriliser used in your unit?

a) Little Sisters 2                                             d) Century

b) Little Sisters 3                                             e) SES

c) Eschmann                                                     f) Other

If other (please give details) ………………………………

                                          Day Month Year
Date of last service?


                                                                                                                Yes                No
Do you have a logbook for the steriliser?

Do you record daily testing of the steriliser?

Do you have a designated covered receptacle
for used non-disposable speculae?

Are there yellow bags for disposal of waste?

Do you use disposable sheets?

If no, is a freshly laundered sheet used for each patient?




Improving Health, Improving Services                                    Lincolnshire Teaching Primary Care Trust
54 of 71
OTHER

Please indicate below if there are there any areas of innovation, good practice or
achievement over and above the general guidelines for your professional area that you
wish to highlight?

…………………………………………………………………………………………………

…………………………………………………………………………………………………...

Please indicate below what initiatives you have employed in order to improve
coverage?

Contacting the patient by telephone                   During consultation

Contacting the patient by letter                      Health visitor visiting home

Other (please specify below)

………………………………………………………………………………………………..


Please feel free to add any comments or suggestions on how this questionnaire might
be improved.

…………………………………………………………………………………………………..

…………………………………………………………………………………………………..

…………………………………………………………………………………………………..

…………………………………………………………………………………………………..

…………………………………………………………………………………………………..

…………………………………………………………………………………………………..

…………………………………………………………………………………………………..



Thank you very much for taking the time to complete this questionnaire
Your comments and feedback will be greatly appreciated




Improving Health, Improving Services        Lincolnshire Teaching Primary Care Trust
55 of 71
PART B         A Separate Form to be Completed by Each Individual Cervical Sample Taker




 Name and title of smeartaker                 …………………………………………………

 Smeartaker code (If used) ………………………………………………………..

 Name of practice …………………………………………………………………..




PLEASE PROVIDE THE FOLLOWING INFORMATION ON CERVICAL SAMPLE TAKING



 How many smears did you take in -------                        ……………….

 How many of those were inadequate?                             ……………….




EDUCATION



 What basic cervical sample taker training have you undertaken? ..................................

 …………………………………………………………………………………………..

 When and where did you undertake this training? ..........................................................

 ………………………………………………………………………………………….

 When did you last receive update training?              ---------------- ------------------
                                                            Month                   Year




PLEASE COMPLETE SECTIONS OVERLEAF




Improving Health, Improving Services                         Lincolnshire Teaching Primary Care Trust
56 of 71
SCREENING ENVIRONMENT

This section provides information on the place you usually take smears.
Please answer even if others also take smears here.
                                                                   Yes                   No

Do you have a designated area for taking smears?

Please describe this area …………………………………………………………………….

…………………………………………………………………… ……………………………….

                                                                         Yes          No

Is there a lockable door?

Does a screen separate the couch from the rest of the room?

Are there hand-washing facilities in all of the smear taker areas?

Do you supply modesty sheets?

Is the modesty sheet disposable?

Is there any other place where you sometimes take smears?

Do you have any concerns about smeartaking facilities in this place?

Please describe this area ………………………………………………………………………

EQUIPMENT
                                                                     Yes         No
Is the light source adjustable?

Do you use latex gloves?

Do you have different sizes of speculae?

Are the speculae disposable?

Please indicate which of the following are available:

LBC Broom                                LBC Endo cervix
                                         Sampling device

                 Please return this completed questionnaire to
          the clinical lead for cervical screening within your practice
     Thank you very much for taking the time to complete the questionnaire
           Your comments and feedback will be greatly appreciated


Improving Health, Improving Services          Lincolnshire Teaching Primary Care Trust
57 of 71
Appendix 10


     GMS/PMS Quality and Outcomes Framework Relating to Cervical Screening


CS             Additional – Cervical Screening

CS1            The percentage of patients aged 25 – 64 years whose notes record that a
               cervical smear has been performed in the last three to five years.
11 points      Standard: 80%


CS2            The practice has a system to ensure inadequate/abnormal smears are
3 points       followed up.


CS3            The practice has a policy on how to identify and follow up cervical smear
               defaulters.
2 points
               Patients may opt for exclusion from the cervical cytology register by
               completing a written statement, which is filed in the patient record (exception
               reporting).


CS4            Women who have opted for exclusion from the cervical cytology recall register
               must be offered the opportunity to change their decision at least every five
2 points       years.


CS 5           The practice has a system for informing all women of the results of cervical
               smears.
2 points


CS 6           The practice has a policy for auditing its cervical screening service, and
               performs an audit of inadequate cervical smears in relation to individual smear
2 points       takers at least every two years.




Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
58 of 71
Appendix 11




                              Cytology
                             Recall policy
                    Guidance Notes for Primary Care

This document sets out the Path Links Cytology Services guidelines for Primary Care for the
correct recall and referral of patients.

The Cytology department follows National Guidelines for reporting and recall. This guide sets
out both the recommended recall intervals for the national programme and referral action
where required.

1      Recall

Table 1.
       Smear result                                Recommended      FHSA
                                                   recall           Code
       Inadequate                                  Repeat           R3
                                                   Immediately
       Negative, age 25-49 - no abnormal           Routine 3 yr     A
       history                                     recall
       Negative, age 50-64 - no abnormal           Routine 5 yr     A
       history                                     recall
       Borderline squamous cells                   Repeat in 6      R6
                                                   months
       Borderline squamous cells- second           Repeat in 6      R6
                                                   months
       Borderline endocervical cells               Refer            S
       Borderline - suspicious of high grade       Refer            S
       dyskaryosis
       First Mild dyskaryosis                      Repeat in 6      R6
                                                   months
       Mild smear followed by borderline           Repeat in 6      R6
                                                   months
       Inadequate - third                          Refer            S
       Borderline sample followed by mild          Refer            S
       Borderline squamous cells -third            Refer            S
       Mild dyskaryosis - second                   Refer            S
       Third low grade smear in 10 years           Refer            S
       Moderate dyskaryosis                        Refer            S
       Severe dyskaryosis                          Refer            S
       Severe/invasive                             Refer            S
       Glandular neoplasia                         Refer            S



Improving Health, Improving Services            Lincolnshire Teaching Primary Care Trust
59 of 71
2      Direct Referral to Colposcopy

       Grimsby, Scunthorpe, Goole, Lincoln, Louth, Grantham and Boston colposcopy
       services operate a direct referral policy i.e. the laboratory notifies the colposcopy clinic
       directly of all women where referral is advised. It is important to inform the patient at the
       time of taking the sample that she may be contacted by the colposcopy unit.

3      Referral for Inadequate smears

       Women will be referred to colposcopy following three consecutive inadequate cervical
       cytology samples. If no abnormalities are found colposcopically a repeat sample will
       often be taken. The colposcopy staff will mark the form 'Colposcopy NAD'. If this
       sample is reported as negative routine recall will be advised. If the sample is
       considered suboptimal it will be reported as negative and given routine recall and the
       following statement will be added to the report. 'Smear sub-optimal for the purposes of
       screening but taken in conjunction with colposcopic examination can be considered
       negative'

4      Recall for low grade abnormalities

       A borderline sample following a mildly dyskaryotic sample will be given a recall date of
       6 months (R6).

       Where a mildly dyskaryotic sample follows a borderline sample referral for colposcopic
       assessment will be recommended.

       Women should be referred for colposcopy after three borderline tests without being
       returned to routine recall.

       Women should be referred for colposcopy after two samples show mild dyskaryosis.

       Women will be referred for colposcopic assessment if they have had three tests
       reported as abnormal, at any grade, in a ten year period, even if they have returned to
       routine recall on one or more occasions.

       Samples reported as Borderline changes in Endocervical cells will be referred.

       Samples reported as Borderline changes suspicious of high grade dyskaryosis will be
       referred to coloposcopy.

       NHSCSP Document No1 recommends that women who have low grade abnormalities
       on cervical cytology samples have three negative smears at least 6 months apart.
       Follow up after borderline or mild cervical samples will therefore be two samples taken
       at six month intervals and a sample at twelve months (R6x2, R12)




Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
60 of 71
5      Recall post biopsy/colposcopic assessment (see FIG 1.)

       Follow-up should start no later than eight months after treatment and may take place in
       the primary care sector.

       Women treated for low grade disease require repeat cervical cytology samples at 6, 12
       and 24 months after treatment (R6x2, R12). They should then return to routine
       screening (Low risk follow up)

       Women referred with mild dyskaryosis or less that have a satisfactory and normal
       colposcopy examination and or biopsy should have a cervical sample taken six months
       after examination, followed by two further samples at 12 months and 24 months from
       treatment (R6x2, R12). If these samples are negative the woman should be returned to
       routine recall. If a follow-up sample is borderline it should be repeated in a further six
       months. If a follow-up sample shows mild dyskaryosis or worse, colposcopy will be
       recommended.

       Where high grade CIN (2-3) is found on biopsy following a borderline and mildly
       dyskaryotic cytology samples high risk follow-up is required (R6x2, R12x9)

6      Recall for high grade dyskaryosis

       All cervical cytology samples reported as high grade dyskaryosis or glandular neoplasia
       will be referred to colposcopy.

7      Recall Post-Colposcopic Assessment (see FIG 2.)

             Post LLETZ

       Histologically confirmed and treated CIN2/3 or microinvasive cancer should be followed
       up by two cervical cytology samples taken at 6 monthly intervals followed by 9 annual
       smears (R6x2, R12x9). (High risk follow up)

       If the histological findings are negative or low grade Cervical Intraepthelial Neoplasia
       (CIN 1) two samples should be taken at 6 months interval followed by an annual
       smear .(R6x2, R12 Low risk follow up)

             Post Cervical Biopsy Only

       Women referred with moderate dyskaryosis or worse cytological abnormality which is
       histologically confirmed as CIN1 or less on biopsy should have close colposcopic and
       cytological follow up. (R6x2, R12)

8      Recall for Glandular Neoplasia (see FIG 3.)

       After treatment for Cervical Glandular Intraepithelial Neoplasia (CGIN) or Endocervical
       Glandular Neoplasia two smears should be taken at 6 month intervals followed by 9
       annual smears (R6x2, R12x9). All smears taken in the follow up period will be reported
       as inadequate if endocervical cells are absent.

       If the histological findings are negative or CIN1 two repeat smears should be taken at 6
       months followed by an annual smear (R6x2, R12). If the histological findings are of high
       grade CIN then the recall should be as for these findings (R6x2, R12x9)


Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
61 of 71
9      Correlation of Cytology and Histology

       All cases of significant non-correlation between cytology and histology grading will be
       reviewed at a multiheaded microscope session. The results of this review will be
       discussed with the relevant gynaecologist/colposcopist at the local colposcopy
       correlation meeting. Any resultant change in patient management plan will be
       discussed and fed back to patient and GP in the letter from colposcopy.

10     Return to Routine Recall

       Women will be returned to routine recall of 36 or 60 months dependant on age once
       the follow up period has finished for points 2 - 5 above.

       In cases of High Risk follow up, if after ten years there have been less than ten cervical
       cytology samples but more than five (because of poor attendance) routine recall can
       be advised assuming the samples were negative (advice from BSCC).

11     Abnormal Smears During Follow Up Period

       Smears taken in the follow up period of CIN/CGIN (low or high grade) will be repeated
       in 6 months if borderline changes are observed and re-referred to colposcopy if mild
       dyskaryosis, borderline changes in endocervical cells or worse, is identified.

12     Follow up After Hysterectomies (see FIG 4.)

       A woman who has a total hysterectomy for benign reasons with no CIN will be ceased
       from the NHSCSP. This will be done in primary care by using the 'prior notification list'.
       Inappropriate samples will be returned to sender unread.

       Where a hysterectomy has been performed for the treatment of CIN (whether CIN is
       found in the hysterectomy sample or not) Then a vault sample should be taken 6 and
       18 months after surgery. No further cytological follow up is required if both samples are
       negative. (R6, R12). Borderline smears in the follow-up period should be given a six
       month recall (R6), however, any abnormal sample of higher grade should have referral
       for colposcopy recommended. Cytological surveillance of the vaginal vault is NOT
       recommended and colposcopic examination is the preferred method of surveillance
       when necessary

       In the case of incomplete or uncertain excision of CIN, follow up should be conducted
       as if the cervix were still in situ (i.e. as low or high risk follow up as above, point 3 and
       4)

       Follow up in women who have had hysterectomy for invasive disease of the cervix (of
       any type) will be according to the advice of the clinician.

13     Women with invasive disease who have been treated with Radiotherapy

       The discharge advice of the clinician will be followed. Further smears are not
       recommended. Recall will be ceased.




Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
62 of 71
14     Smears taken at Gynaecology

       Cervical cytology samples should only be taken where there is cytological indication or
       those who have not been screened in the previous routine screening interval.

       Samples taken at gynaecology will be given recall status according to the smear result
       and the patient history. The FHSA standard action code of 'S' will not be used routinely.

15     Cervical cytology samples taken at Colposcopy

       Samples taken at colposcopy will count towards the required number of follow up
       cytology samples. The suspend category will be used for all smears taken at
       colposcopy with the exception of those women referred for persistent inadequate
       samples (see above). However, recall advice will also be given according to the above
       policy.

16     Cervical cytology samples taken at Genito-Urinary Medicine

       Samples should only be taken where there is cytological indication or those who have
       not been screened in the previous routine screening interval.

       Recall will be given as for known patient history and smear pattern. If the
       Patient’s history is not known and the smear is negative the woman will be placed on
       routine recall and the following comment added to the report. 'Insufficient patient
       information to provide management recommendations'.

       Cervical cytology samples are discouraged from women attending GUM. The patient
       name should be put on the sample where possible in order that follow up and failsafe
       can be correctly managed.

17     Cervical cytology samples taken in Private Practice

       These samples will be given a recall status according to the woman's cervical cytology
       history and the appearance of the current sample. A FHSA code of H will be used
       where a negative sample follows a normal history.

       Women who have private samples will be included in the laboratory failsafe system.

18     Women who are immunosuppressed.

       This includes women on immunosuppressing medication, transplant recipients and
       other forms of immunosuppression.

       a)      Women with renal failure requiring dialysis. All women aged 25-65 years
       with renal failure requiring dialysis must have cervical cytology performed at, or shortly
       after, diagnosis. Any cytological abnormality should be treated as a high grade
       abnormality requiring prompt colposcopic referral. All women about to undergo renal
       transplantation should have had a cervical cytology sample within one year. Co-existing
       CIN should be managed according to national guidelines.

       b)      Women taking maintenance immunosuppression medication post
       transplantation. Where there is no history of CIN the woman should be screened as
       per national guidelines. Any abnormal result should prompt colposcopic referral. Follow


Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
63 of 71
       up for CIN should be as recommended for the immunocompetent population. Annual
       smears are not required for transplant patients.

       c)      Women receiving cytotoxic drugs for rheumatological disorders.
       Screening should be as per national guidelines. If the screening history is incomplete at
       commencement of cytotoxic drugs then a cervical cytology should be taken with referral
       to colposcopy for any cytological abnormality.

       d)      Other women who are immunosuppressed. There is no indication for extra
       surveillance for women receiving cytotoxic chemotherapy for non-genital cancers, for
       women receiving long term steroids or those receiving oestrogen antagonists such as
       tamoxifen. Such women should have cytological screening in accordance with national
       guidelines.

       e)     HIV positive women. All women newly diagnosed with HIV should have
       cytological surveillance performed by, or in conjunction with, the medical team
       managing the HIV infection. Annual cytology should be performed. The age range
       screened should be the same as for HIV negative women.

19     Women age 65 and over.

       Women who have reached the age of 65 and have had three consecutive negative
       cervical cytology samples should be ceased from the NHSCSP via 'prior notification
       lists'.

       Women over 65 should only be screened if they have not been screened since the age
       of 50 or if they have had recent abnormal tests and are still within the follow up period.

       Before recall is ceased for reasons of age, recall should be continued as appropriate
       for women with previous abnormal smears or CIN on biopsy.

20     Teenagers

       Cervical cytology samples received from teenagers will be returned to sender unread.

21     Women Aged 20 - 25

       Women will be eligible for cervical screening from the age of 25. The age of first smear
       was increased from 20 to 25 in 2005. Some women in this age bracket will have
       already had a smear and so will receive a recall letter. Only these women in this age
       range should have a cervical cytology sample taken.

22     Frequency of screening

       Age Group (years)            Frequency of screening
       25                          First invitation
       25-49                       Three Yearly
       50-64                       Five Yearly




Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
64 of 71
23     Clinically indicated samples

       Only routine cervical cytology samples or samples taken for the follow up of previous
       dyskaryosis or CIN should be taken in Primary Care. There are NO clinical indications
       for a cervical cytology sample to be taken in Primary Care. Please talk to Dr Hunt or Dr
       Parsons if you wish to take a smear from a woman who is not due for a routine/ follow-
       up cervical sample but in whom you feel it is necessary to take a cervical sample.

       Women with an abnormal cervix, post coital bleeding in the over 40's, intermenstrual
       bleeding and persistent vaginal discharge should be referred for gynaecological
       examination and onward referral for colposcopy if cancer is suspected. Referral of
       younger women with post coital bleeding to sexual health (GUM) should be considered.

       Contact bleeding at the time of taking the cytology sample is not an indication for
       referral.

       All unexplained bleeding should be referred to a gynaecologist.

       All patients with Herpes should be referred to sexual health (GUM).

24     Urgent Referral

       When an invasive squamous dyskaryosis or glandular neoplasia is reported the result
       is telephoned by the laboratory to the GP and colposcopy clinic so that urgent referral
       can be achieved.

25     Ceasing

       Ceasing a woman from the NHSCSP has the effect of stopping all invitations being
       sent to a woman and removing her name permanently from the prior notification lists
       (PNLs). There are two clear categories where this takes place (age and no cervix), but
       there are a number of other reasons why a woman may be ceased.

       Women should be ceased where
       Following the first test after the 60th birthday if last three consecutive cervical cytology
       samples are negative.

       Persistent non-responders should be ceased on their 65th birthday

       Women who have undergone radiotherapy for cervical cancer

       The 'absence of cervix' marker can be used to cease women who have had a total
       hysterectomy, male to female transsexuals and where there is congenital absence of
       cervix.

26     Infections

       Cervical cytology must not be used for the diagnosis of infection

       Women with Actinomyces-like organisms (ALOs) should be assessed as per
       guidelines. Repeat cytology is not required unless the smear was graded
       inadequate/abnormal.

27     Cervical Screening undertaken in Foreign Countries

Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
65 of 71
       Where the results of overseas cervical cytology samples are recorded by the call/recall
       office they should be treated in the same way as private smears with code H used for
       negative or inadequate results and codes R or S for all others.

       References

       NHSCSP publication No 8. Dec 1997. Guidelines for Clinical Practice and Programme
       Management. 2nd Edition. Editor Dr I Duncan.

       NHSCSP publication No 1 May 2000. Achievable standards, Benchmarks for reporting
       and Criteria for Evaluating Cervical Cytopathology. 2nd Edition. Editors Dr J Johnson, J
       Patnick.

       NHSCSP publication No 20. April 2004. Colposcopy and Programme Management
       Guidelines for the NHS Cervical Screening Programme.
       Editors D Luesley, S Leeson.

       NHSCSP Good Practice Guide No1 Feb 2004. Ceasing Women from the NHS Cervical
       Screening Programme




Improving Health, Improving Services             Lincolnshire Teaching Primary Care Trust
66 of 71
                                           FIG 3. FOLLOW-UP OF
                                               ?GLANDULAR
                                              NEOPLASIA OF
                                             ENDOCERVICAL
                                                   ORIGIN




 NO ENDOCERVICALS SEEN    WOMAN HAS NOT BEEN TO             WOMAN HAS BEEN TO           WOMAN HAS BEEN TO
    IN ANY FOLLOW UP          COLPOSCOPY                     COLPOSCOPY, BUT              COLPOSCOPY AND
   CYTOLOGY SAMPLES                                        OUTCOME NEGATIVE OR          OUTCOME WAS HIGH
                                                              LOW GRADE CIN              GRADE CIN OR CGIN




                            HIGH RISK FOLLOW UP             LOW RISK FOLLOW UP          HIGH RISK FOLLOW UP
 REPORT AS INADEQUATE        2 X R6 THEN R12 X 9              2 X R6 THEN R12            2 X R6 THEN 9 X R12




                                            FIG 4.VAGINAL VAULT
                                              SAMPLES AFTER A
                                               HYSTERECTOMY




  TOTAL ABDOMINAL              TOTAL ABDOMINAL               INCOMPLETE OR              HYSTERECTOMY FOR
  HYSTERECTOMY FOR           HYSTERECTOMY FOR CIN         UNCERTAIN EXCISION OF          INVASIVE DISEASE
                            (NO CIN IN HISTOLOGY OR
   BENIGN REASONS             COMPLETE EXCISION)                  CIN




      CYTOLOGY                       R6                    FOLLOW UP ACCORDING TO       ACCORDING TO THE
         NOT                        THEN                     THE GRADE OF CIN i.e.        ADVICE OF THE
      REQUIRED                       R12                    LOW RISK 2 X R6 THEN R12        CLINICIAN

                                                           HIGH RISK 2 X R6 THEN   9X
                                                                      R12




Improving Health, Improving Services                  Lincolnshire Teaching Primary Care Trust
67 of 71
Appendix 12

                                       GLOSSARY
Aetiology                   The science of causes and causality.

Call/Recall Scheme          The invitation and follow up of women for routine smears.

Cervical Sample             Sample of cervical cells scraped from the transformation zone
                            with a spatula or brush transferred to a vial of preservative fluid.

Cervix                      The part of the uterus below the internal os.

Colposcopy                  Method of examining the cervix using a colposcope (x10
                            binocular microscope). Abnormal epithelium has a characteristic
                            appearance.

Cone Biopsy                 A cone of tissue (point inwards) cut out around the external
                            cervical os, using knife or laser.

Cytology                    The study of cells, in this case cervical cells.

Dyspareunia                 Pain on sexual intercourse. Can be superficial or deep.

Dysuria                     Pain when passing urine.

Fail Safe                   The follow up of women with abnormal and inadequate cervical
                            cytology samples.

Incidence                   The number of instances of illness commencing or of persons
                            falling ill during a given period in a specified population.

Intermenstrual Bleeding     Bleeding in-between normal periods.

IUCD                        Intra-uterine contraceptive device.

LBC                         Liquid Based Cytology

Quality Assurance           System of procedures, checks, audits and corrective actions to
                            ensure that all testing and analysis and other technical and
                            reporting activities are of the highest achievable quality.

Squamocolumnar Junction     Transformation zone between the endocervical canal, lined with
                            mucous columnar epithelium, and the vaginal cervix, lined with
                            squamous epithelium. This area is predisposed to malignant
                            change.

Subtotal Hysterectomy       Removal of the body of the uterus and fallopian tubes but not
                            removal of the cervix.

Total Hysterectomy          Removal of the uterus, fallopian tubes and cervix.

Vault                       The top of the vagina left after a total hysterectomy.


Improving Health, Improving Services             Lincolnshire Teaching Primary Care Trust
68 of 71
Appendix 13




CYTOLOGY MANAGER:                                   PATHOLOGY SERVICES
Kathryn Snee (01522 512512 ext 2476)                Grimsby Site
ksnee@nhs.net                                       Cytology Department
                                                    Diana, Princess of Wales Hospital
AUDIT CO-ORDINATOR:                                 Scartho Road
Lyn Boon (01472 875266 fax 01472 875333             Grimsby
lyn.boon@nhs.net                                    NE Lincolnshire. DN33 2BA

2009

STRICTLY PRIVATE AND CONFIDENTIAL

To practice manager

Dear

The following patient who registered with your practice has been diagnosed with invasive
cervical cancer.

The current details of this patient are:

NAME:
NHS no:
DOB:
DATE OF DIAGNOSIS:
ADDRESS:
DATE WHEN
REGISTERED WITH
CURRENT GP:
STUDY ID NO:

In line with the NHS Cervical Screening Programme (NHSCSP) Publication Number 28 “Audit
of Invasive Cervical Cancers” this woman’s cervical screening history, incorporating primary
care data, call and recall, cytology, histology and colposcopy, is being reviewed. Your patient
has been informed of the review and, if she wishes to know the results, they will be reported to
her by her diagnosing/treating gynaecologist or oncologist. If she does not wish to know the
results but changes her mind in the future she can be re-referred to her consultant who will
provide the results. Further details on the audit and related policies can be found at the end of
this letter.

The NHSCSP has approval to carry out the exchange of this confidential patient data between
the relevant organisations under Section 60 and the Health and Social Care Act via approval
by the Patient Information Advisory Group. Women invited for screening receive a leaflet
which explains how their data may be used in auditing the NHSCSP and ensuring that women
are cared for appropriately. By attending for screening women are consenting to their
information being used in these activities.



Improving Health, Improving Services              Lincolnshire Teaching Primary Care Trust
69 of 71
In order to carry out a full review for this woman it is essential that all information recorded on
paper and electronically regarding the cervical screening history and any relevant
gynaecological symptoms are obtained.

Due to the importance of obtaining a complete screening history for each woman we would
appreciate it if you could arrange for completion and return of the attached form. Guidance
notes are enclosed as an aid to completing the form. In addition please find enclosed a copy
of the cytology screening history from which you will note that this patient (enter relevant
history of pt).   Please contact Kathy Snee on the above telephone number or email address
if you wish to discuss the audit in general or a particular patient.

As this document contains confidential patient identifiable information please double wrap the
completed form in two envelopes, both fully addressed to Lyn Boon at the above address,
marked ‘private and confidential for the addressee only’, with a return address on the back of
the envelope.

Please return by (date approx 1/12 forward).

Yours sincerely




Kathryn Snee                                     Dr P Parsons
PathLinks Cytology Manager                       Consultant Histopathologist
Hospital Based Programme Co-ordinator            Hospital Based Programme Co-ordinator
for Northern Lincolnshire & Goole                for United Lincolnshire Hospitals NHS Trust
NHS Foundation Trust

Further information is available at:
Cervical screening invitation leaflet
http://www.cancerscreening.nhs.uk/cervical/publications/nhscsp-the-facts-english-2006.pdf

National invasive cervical cancer audit
http://www.cancerscreening.nhs.uk/cervical/publications/nhscsp28.html

National guidance on the disclosure of results
http://www.cancerscreening.nhs.uk/publications/cs3.pdf




Improving Health, Improving Services               Lincolnshire Teaching Primary Care Trust
70 of 71
Improving Health, Improving Services   Lincolnshire Teaching Primary Care Trust
71 of 71

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:12
posted:6/11/2011
language:English
pages:71