The One Stop Cervical Assessment Clinic: Clinical Guideline - V1.0 March 2021 - RCHT

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The One Stop Cervical Assessment
              Clinic:
        Clinical Guideline

              V1.0

          March 2021
Summary: The “One-Stop” Cervical Assessment Clinic

                            Referral for Cervical Assessment
                                           from:
                              Community / Internal Referral
                                             on
                                2WW or 18 week pathway

                                      Booking Office

                  Book directly onto “One-Stop” Cervical Assessment Clinic
                  Standard letter and Patient Information Leaflet sent to patient

                        “One-Stop” Cervical Assessment Clinic

                  Clinic Database pre-populated by clinic nurse
                  History taken by clinician
                  Further assessment as indicated
              

    Clinical Examination       Colposcopy          Ultrasound Scan          Hysteroscopy

                                      Clinic Database
                  Details of assessment to be completed by clinician
                  Clinic letter generated for patient and GP
                  Letter uploaded into MAXIMS by admin staff

                                      Clinic Outcome

  Immediate Discharge          Investigations                             Onward Referral

        Reassurance           Clinician to contact patient
        Advice                with results and plan

              The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
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1. Aim/Purpose of this Guideline
     1.1. This guideline applies to all patients referred to for assessment of their
          uterine cervix, and the staff involved in their healthcare. The provision of a
          dedicated clinic for patients with possible abnormalities of the cervix (some
          of which may represent serious pathology such as cervical cancer) ensures
          that all patients are seen within two weeks of referral, achieving equality of
          access for all, regardless of the route of referral. Ensuring that patients are
          seen by clinicians with an appropriate skill set means that consultations are
          responsive to patients’ concerns and needs. The one-stop model reduces
          fragmentation of care and delay, whilst promoting efficiency and protecting
          scare healthcare resource.

Data Protection Act 2018 (General Data Protection Regulation – GDPR)
Legislation
The Trust has a duty under the DPA18 to ensure that there is a valid legal basis to
process personal and sensitive data. The legal basis for processing must be identified
and documented before the processing begins. In many cases we may need consent;
this must be explicit, informed and documented. We cannot rely on opt out, it must be
opt in.
DPA18 is applicable to all staff; this includes those working as contractors and providers
of services.
For more information about your obligations under the DPA18 please see the
Information Use Framework Policy or contact the Information Governance Team
rch-tr.infogov@nhs.net

2. The Guidance
     2.1. Nationally, it is recommended that in individuals presenting with symptoms
          of cervical cancer (for example post-coital bleeding or persistent vaginal
          discharge that cannot be explained by infection or other causes), once “the
          common causes of these symptoms have been excluded … the individual
          must be referred for examination by a gynaecologist experienced in the
          management of cervical disease”.

     2.2. Patients may be referred for an assessment of their uterine cervix for a
          variety of reasons. Referrals may be made on the two-week wait cancer
          pathway, or on routine 18 week pathway. Referrals may or may not be in
          line with existing local referral guidance, however it is recommended that all
          referrals are accepted and processed swiftly in order to facilitate early
          diagnosis of significant pathology such as cervical cancer. The patient’s
          cervix may or may not have been clearly visualized by the referring
          practitioner, and may or may not have been noted to be macroscopically
          abnormal at the time.

                 The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
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2.3. The cervical assessment service at RCHT follows a “one-stop” model, with
     the expectation that patients will not be followed-up in the cervical
     assessment clinic, although they may require referral to another clinic after
     initial investigation. Sufficient clinic provision allows all patients to be seen
     within 2 weeks of referral.

2.4. The clinic is intended for two-week wait referrals for patients with suspected
     cervical cancer and all “non-urgent” referrals to colposcopy clinic. The clinic
     is not intended for patients referred from the cervical screening programme.
     These referrals do not require vetting by a consultant or nurse colposcopist,
     they should be booked directly by the booking office, and sent the standard
     introductory letter and patient information leaflet (Appendix 3). This applies
     to both referrals from the community and internal referrals via MAXIMS.

2.5. Each “One-Stop Cervical Assessment Clinic” has 2 “two-week wait” slots
     and 6 “non-urgent/18 week pathway slots”. Two-week wait patients can be
     booked into “non-urgent” slots as required to meet the two-week target.
     Ideally, patients on a “non-urgent/18 week pathway” should be booked
     within two weeks of referral, but it is acceptable to book their first
     appointment up to 6 weeks from referral if required. Issues with clinic
     capacity should be directed to the Lead Colposcopist / Lead Colposcopy
     Nurse in the first instance. It is accepted that clinics may not always be “fully
     booked” as this allows time for multi-modal “one-stop” assessment when
     required.

2.6. The clinic database (currently Viewpoint) will be pre-populated by the clinic
     nurse with the patient’s demographic information and the reason for the
     referral by the clinic nurse prior to the clinic starting.

2.7. Reasons for referral may include:

           Post-Coital Bleeding (PCB). The local RMS guidance suggests that
            patients with “PCB only” should be referred for a cervical assessment,
            and an up to date Chlamydia swab be taken as part of their initial
            investigations. It is accepted that evidence for the positive predictive
            value of PCB as a symptom of cervical cancer is poor. Local
            guidelines suggest that patients with a “mixed picture of abnormal
            bleeding” such as PCB with intermenstrual bleeding (IMB) should be
            seen in the Menstrual Disorders Clinic (MDC). Often patients in the
            latter group are referred for cervical assessment, rather than to the
            MDC.

           “Abnormal Cervix” on examination. The speculum examination may
            have been undertaken for a variety of reasons e.g. routine cervical
            screening, insertion/removal of IUCD or for symptoms such as
            unscheduled/unexpected vaginal bleeding. The majority of the time,
            the findings on cervical assessment will not be of concern, or
            physiological in nature. The patient’s original health concern may
            therefore still need to be addressed after their cervix has been fully
            assessed.

            The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
                                    Page 4 of 14
2.8. Causes of PCB and “Abnormal Cervix”

           Vulval, vaginal, cervical, endometrial cancer; rarely ovarian and non
            gynaecological malignancies

           Infective causes e.g. Chlamydia

           Physiological e.g. cervical ectropion, Nabothian cysts

           Iatrogenic e.g. scarring following previous LLETZ treatment

           Local cervical cause e.g. benign cervical polyp

           Menstrual disorders

           Contraceptive problems

2.9. It may be helpful to conduct a quick “briefing session” before the clinic
     starts. Staff may consider reviewing the referral letters to see what each
     patient is likely to need in terms to outpatient procedures in order to ensure
     that the clinic runs as smoothly as possible.

2.10.At the cervical assessment clinic the clinician will take a history to include
     details of presenting symptoms, a menstrual history, obstetric history,
     contraceptive history to include the patient’s desire for future fertility and a
     cervical screening history.

2.11.The chlamydia swab result will be checked, and if it is not available,
     consideration should be given to repeating the test.

2.12.A urinary pregnancy test should be considered if indicated from the history.

2.13.The clinician will undertake a physical examination to include inspection of
     the vulva, vagina and cervix and proceed as clinically indicated. Bimanual
     examination can be helpful in assessing patients with symptoms of
     bleeding, pain or pressure.

2.14.Colposcopy is not routinely indicated if the cervix is obviously
     macroscopically normal, or there are obvious benign lesions such as an
     obvious ectropion, Nabothian cysts, or a benign cervical polyp.

2.15.Formal colposcopy with application of acetic acid may be required for
     confirmation of some lesions e.g. large ectropions. A biopsy should only be
     performed if there is a strong clinical suspicion of pathology, and not to
     confirm a clinically benign entity (e.g. an ectropion).

2.16.Benign cervical polyps can usually be treated by avulsion, or excised with
     loop diathermy if they have an especially large/broad base.

2.17.A cervical ectropion usually does not usually require treatment. An
     explanation backed up with written patient information and reassurance is
     sufficient in the majority of cases. In selected patients it may be appropriate
            The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
                                    Page 5 of 14
to offer ablative treatment with silver nitrate, cold cautery, diathermy or
     shallow LLETZ, provided patients have an up to date cervical screening
     history and no evidence of CIN at colposcopy.

2.18.It may be necessary for cervical screening tests to be taken in the clinic.
     These should be designated on the request form as having originated from
     an “NHS Hospital” in order to allow for CSP “failsafe mechanisms” to
     operate correctly. The appropriate referral will be made to the colposcopy
     clinic by the laboratory if indicated. As with all investigations, it remains the
     responsibility of the clinician to ensure that test results have been checked
     and actioned as appropriate.

2.19.Patients who have biopsies taken in the clinic which show CIN should be
     referred on to the colposcopy clinic for their ongoing management.

2.20.If a cervical malignancy is identified:

           Multiple cervical punch or wedge biopsies of non-necrotic tissue
            should be sent for 48 hour histology

           The patient should be informed of the likely diagnosis

           The patient should have the opportunity to meet the gynaeoncology
            CNS team during the clinic if possible. If this is not possible on the
            day, then verbal consent should be sought from the patient for CNS
            contact, and they will make contact by telephone on the next working
            day. The patient should be sent home with the contact details for the
            gynaeoncology team

           An MRI Pelvis and whole body PET-CT scan should be requested as
            a two-week wait

           The MDT coordinator, lead consultant for the MDT and the CNS team
            should be informed of the patient details and the plan by email

           The patient should be advised that follow-up will be arranged after the
            MDT meeting

2.21.If the referral has been made in the context of a menstrual disorder, and
     there are no concerns about cervical pathology after assessment, then the
     patient can be offered immediate outpatient hysteroscopy, biopsy/treatment
     of focal lesions as appropriate, and/or insertion of Mirena IUS if that is their
     preference. Patients may prefer other medical treatments, in which case
     they should advised about the different options. Patients are asked to see
     their GP for follow-up if the treatment is subsequently ineffective. It is usual
     practice at RCHT for patients with menstrual disorders to be offered a
     transvaginal ultrasound scan. This can be undertaken at the time of the
     consultation, or arranged in the radiology department and the patient
     contacted with the results. If the scan demonstrates pathology requiring
     follow-up, then the patient should be referred to the most appropriate team
     for ongoing management.

            The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
                                    Page 6 of 14
2.22.If after assessment the symptoms appear to be secondary to a
     contraceptive problem, then appropriate advice backed up with the relevant
     patient information leaflet should be offered. The patient should be
     encouraged to seek follow-up with their primary care team. Patients wishing
     to have an IUCD fitted may have this done during their clinic attendance,
     with follow-up in primary care to be arranged by the patient.

2.23.Post-menopausal patients with PCB, by definition also have post-
     menopausal bleeding (PMB). These patients should be assessed in the
     clinic and examined to look for a lower genital tract cause for their
     symptoms, as per the referrer’s request. They also require a transvaginal
     scan for endometrial thickness. This can be performed in the clinic, or
     requested under the auspices of the “PMB Service” as a two-week wait.
     Vaginal pessaries should be removed in the clinic (in patients who are
     unable to remove their own) to facilitate the scan. An internal referral to the
     PMB Service should be made on MAXIMS. The patient should be offered
     RCHT leaflet 1797 “Post-menopausal Bleeding”. The patient will be
     reviewed on the Virtual PMB clinic on the Friday morning in the week that
     they have their scan, and advised of the outcome of the review by post.

2.24.Clinic correspondence to the patient and GP will be usually be generated
     from the clinic database (currently viewpoint). It may be more appropriate on
     some occasions to dictate a more detailed letter, at the discretion of the
     clinician.

2.25.Clinic letters will be uploaded in MAXIMS by administration staff.

2.26.Checking investigation results and informing patients/referrers about results
     and ongoing management plans is the responsibility of individual clinicians.
     The results will not be checked by the administration team.

            The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
                                    Page 7 of 14
3. Monitoring compliance and effectiveness
Element to be        Numbers of referrals will be monitored monthly to ensure that clinic
monitored            provision meets demand to allow patients to be assessed within 2 weeks
                     of referral.
                     Clinic processes in terms of investigations undertaken and likely
                     diagnosis will be monitored through the clinic database (currently
                     viewpoint)
                     Cervical cancer diagnoses will continue to be monitored through the
                     existing “Cervical Cancer Audit”
Lead                 Miss S Julian
                     Lead Colposcopist
                     Consultant Gynecological Oncologist
                     &
                     Ms L Russ
                     Lead Nurse Colposcopist
Tool                 Process and outcome data will be recorded for every patient on the clinic
                     database (currently viewpoint). Data summaries are provided quarterly as
                     part of the NHS-CSP KC65 return to PHE.

Frequency            As above

Reporting            As above
arrangements
Acting on            Miss S Julian
recommendations      Lead Colposcopist
and Lead(s)          Consultant Gynecological Oncologist
                     &
                     Ms L Russ
                     Lead Nurse Colposcopist
Change in            Required changes to practice will be identified and actioned within 3
practice and         months, immediately if required. A lead member of the team will be
lessons to be        identified to take each change forward where appropriate. Lessons will be
shared               shared with all the relevant staff/stakeholders.

4. Equality and Diversity
       4.1. This document complies with the Royal Cornwall Hospitals NHS Trust
            service Equality and Diversity statement which can be found in the 'Equality,
            Inclusion & Human Rights Policy' or the Equality and Diversity website.

       4.1. Equality Impact Assessment

            The Initial Equality Impact Assessment Screening Form is at Appendix 2.

                   The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
                                           Page 8 of 14
Appendix 1. Governance Information
                                     The One Stop Cervical Assessment Clinic: Clinical
Document Title
                                     Guideline V1.0
This document replaces
(exact title of previous             New Document
version):
Date Issued/Approved:                March 2021

Date Valid From:                     March 2021

Date Valid To:                       March 2024
                                     Miss S Julian, Consultant Gynaecological Oncologist
Directorate / Department
                                     & Lead Colposcopist, Gynaecology Dept., Women’s
responsible (author/owner):
                                     & Children’s.
Contact details:                     Secretary Nadia Francis (01872)252729
                                     This guideline applies to all patients referred to for
                                     assessment of their uterine cervix, and the staff
                                     involved in their healthcare. The provision of a
                                     dedicated clinic for patients with possible
                                     abnormalities of the cervix (some of which may
                                     represent serious pathology such as cervical cancer)
                                     ensures that all patients are seen within two weeks
                                     of referral, achieving equality of access for all,
Brief summary of contents
                                     regardless of the route of referral. Ensuring that
                                     patients are seen by clinicians with an appropriate
                                     skill set means that consultations are responsive to
                                     patients’ concerns and needs. The one-stop model
                                     reduces fragmentation of care and delay, whilst
                                     promoting efficiency and protecting scare healthcare
                                     resource.

                                     Abnormal Cervix
                                     Post-coital Bleeding
                                     One-Stop Cervical Assessment
Suggested Keywords:
                                     Colposcopy
                                     Rapid Access Clinic
                                     Two-week Wait Clinic
                                          RCHT             CFT                      KCCG
Target Audience
                                             
Executive Director                   Medical Director
responsible for Policy:
Approval route for                   Obs and Gynae Specialty Meeting
consultation and ratification:

General Manager confirming
                                     Mary Baulch
approval processes

                 The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
                                         Page 9 of 14
Name of Governance Lead
confirming approval by
                                      Caroline Amukusana
specialty and care group
management meetings
Links to key external                 https://www.gov.uk/government/publications/cervical-
standards                             screening-programme-and-colposcopy-management
Related Documents:                    None
Training Need Identified?             No
Publication Location (refer to
Policy on Policies –                  Internet & Intranet                 Intranet Only
Approvals and Ratification):
Document Library Folder/Sub
                                      Clinical/Gynaecology
Folder

Version Control Table

              Version                                                           Changes Made by
   Date                              Summary of Changes
                No                                                             (Name and Job Title)

 06/02/2021   V1.0      Initial version                                         Sophia Julian

All or part of this document can be released under the Freedom of Information
                                   Act 2000

     This document is to be retained for 10 years from the date of expiry.
             This document is only valid on the day of printing

                             Controlled Document
This document has been created following the Royal Cornwall Hospitals NHS Trust
 Policy for the Development and Management of Knowledge, Procedural and Web
Documents (The Policy on Policies). It should not be altered in any way without the
               express permission of the author or their Line Manager.

                 The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
                                         Page 10 of 14
Appendix 2. Initial Equality Impact Assessment Form
         Name of the strategy / policy /proposal / service function to be assessed

                The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
         Directorate and service area:                       New or existing document:
              WCSH, Gynaecology                                           New
Name of individual completing assessment:                            Telephone:
                   Sophia Julian                                       Ext 2729
 1. Policy Aim
 Who is the
                         All patients referred to for assessment of their uterine cervix, and the
 strategy / policy /
                         staff involved in their healthcare.
 proposal / service
 function aimed at?

 2. Policy Objectives     The provision of a dedicated clinic for patients with possible
                          abnormalities of the cervix (some of which may represent serious
                          pathology such as cervical cancer) ensures that all patients are
                          seen within two weeks of referral, achieving equality of access for
                          all, regardless of the route of referral. Ensuring that patients are
                          seen by clinicians with an appropriate skill set means that
                          consultations are responsive to patients’ concerns and needs. The
                          one-stop model reduces fragmentation of care and delay, whilst
                          promoting efficiency and protecting scare healthcare resource.

 3. Policy
 Intended                 To meet the mandated NHS “28 days faster diagnosis” target which came
 Outcomes                 into force in April 2020.

 4. How will
 you measure              See section 3 - Monitoring compliance and effectiveness
 the outcome?

 5. Who is intended
 to benefit from the      Patients referred to for assessment of their uterine cervix
 policy?
6a Who did you                                           Local           External
                          Workforce       Patients                                     Other
consult with                                             groups          organisations
                                x

b). Please identify the
groups who have           The RCHT Colposcopy Team
been consulted about
this procedure.
What was the              Guideline approved
outcome of the
consultation?

                  The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
                                          Page 11 of 14
7. The Impact
Please complete the following table. If you are unsure/don’t know if there is a negative impact
you need to repeat the consultation step.
Are there concerns that the policy could have a positive/negative impact on:
Protected
                          Yes No        Unsure           Rationale for Assessment / Existing Evidence
Characteristic
 Age
                                   X             The policy applies to all adult patients with a cervix
 Sex (male, female
 non-binary, asexual                   X               The policy applies to all adult patients with a cervix
 etc.)

 Gender
 reassignment                          X               The policy applies to all adult patients with a cervix

 Race/ethnic
                                                       Any information provided will be in an accessible format for
 communities                           X               the patient’s needs – i.e. available in different languages if
 /groups                                               required/access to an interpreter if required
 Disability
 (learning disability,
 physical disability,                                  Those patients with any identified additional needs will be
                                                       referred for additional support as appropriate - i.e. to the
 sensory impairment,
                                       X               liaison team or for specialist equipment.
 mental health                                         Information will be provided in a format to meet the patient’s
 problems and some                                     needs e.g. easy read, audio etc.
 long term health
 conditions)
 Religion/                                             The policy applies to all adult patients with a cervix
 other beliefs                         X

 Marriage and civil                                    The policy applies to all adult patients with a cervix
 partnership                           X

 Pregnancy and                                         The policy applies to all adult patients with a cervix
 maternity                             X

 Sexual orientation                                    The policy applies to all adult patients with a cervix
 (bisexual, gay,                       X
 heterosexual, lesbian)
 If all characteristics are ticked ‘no’, and this is not a major working or service
 change, you can end the assessment here as long as you have a robust rationale
 in place.
         I am confident that section 2 of this EIA does not need completing as there are no highlighted
         risks of negative impact occurring because of this policy.

Name of person confirming result of initial                 Miss S Julian, Consultant Gynaecological
impact assessment:                                          Oncologist & Lead Colposcopist
If you have ticked ‘yes’ to any characteristic above OR this is a major working or
service change, you will need to complete section 2 of the EIA form available here:
Section 2. Full Equality Analysis

For guidance please refer to the Equality Impact Assessments Policy (available
from the document library) or contact the Human Rights, Equality and Inclusion
Lead debby.lewis@nhs.net

                          The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
                                                  Page 12 of 14
Appendix 3: Introductory Clinic Letter
To be sent to the patient with the clinic appointment

Dear Patient,

You have been referred to us for a check-up of your cervix (the neck of the womb). Usually this is
because you have had some vaginal bleeding, or something has been noticed on your cervix when
you were examined.

The vast majority of the time, it turns out that there is nothing serious wrong and patients can be
reassured that all is well. In a very small number of cases, cervical cancer is the cause of the
symptoms/cervical appearance. Because of this we offer all patients an appointment on an urgent
basis. The quicker you are seen, the quicker we can reassure you.

Please find enclosed a booklet about what to expect during your appointment. If you have any
questions, please contact the Colposcopy Team on (08172) 252360.

Yours sincerely,

Miss S Julian
Consultant Gynaecological Oncologist / Lead Colposcopist

Enc: Patient Information Booklet “The One-Stop Cervical Assessment Clinic”

                   The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
                                           Page 13 of 14
Appendix 4: List of Abbreviations
CIN      Cervical intra-Epithelial Neoplasia
CNS      Clinical Nurse Specialist
CSP      Cervical Screening Programme
IMB      Intermenstrual Bleeding
IUCD     Intrauterine Contraceptive Device
LLETZ    Large Loop Excision of the Transformation Zone
MDC      Menstrual Disorders Clinic
MDT      Multidisciplinary Team Meeting
MRI      Magnetic Resonance Imaging
PCB      Post-coital Bleeding
PET-CT   Positron Emission Tomography and Computed Tomography
PMB      Post-menopausal Bleeding
2WW      Two-week Wait

             The One Stop Cervical Assessment Clinic: Clinical Guideline V1.0
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