Generation of Invasive Cervical Cancer Audit Reports and their use in Feedback to Patients - Protocol for the

Publication: 19/05/2016  
Next review: 14/12/2025  
Clinical Protocol
CURRENT 
ID: 4650 
Approved By: Trust Clinical Guidelines Group 
Copyright© Leeds Teaching Hospitals NHS Trust 2022  

 

This Clinical Protocol is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

Protocol for the Generation of Invasive Cervical Cancer Audit Reports and their use in Feedback to Patients

Introduction

This policy has been developed to ensure compliance with national guidance for the conduct of the invasive cervical cancers audit 1, 2, 3   and in line with Leeds Teaching Hospitals open and honest approach to openness through "Duty of Candour"

In drawing together all of these various disparate elements of policy and recommendation, it is hoped to provide a single clear resource which defines the process of data collection, report generation, identification of patients requiring feedback, conduct of feedback sessions, notification of risks identified and integrating lessons learned into the clinical governance framework. In this way the audit process can contribute to risk management.

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Aims and objectives

This policy is intended to provide a reference guide to staff involved in providing feedback to patients diagnosed with cervical carcinoma. The intention is that this policy outlines the whole of the procedure from data collection though to conducting the feedback interview, recording the outcomes and ensuring any lessons learned are recorded and information disseminated.

The objectives for this process include: -

  • Ensuring that all information gathered is as accurate as possible.
  • Where appropriate, meeting with team members from other disciplines prior to disclosure to ensure any difficult issues are clearly understood. Team members required might include: -
    • Histopathologist
    • Cytopathologist
    • Primary care / GP representative
  • When disclosure is requested by the patient ensuring the legal services department is informed of any errors made prior to the feedback. Such errors might include: -
    • False negative pathology tests
    • False negative colposcopy
    • Delays in diagnosis or treatment
  • Ensuring the legal services department is informed of adverse reactions to feedback following its delivery. This includes a formal complaint or expression by the patient that they will seek legal advice.
  • Ensuring that problems identified are discussed in the relevant forums and appropriate actions planned. The forums involved might include: -
    • Pathology Clinical Governance
    • Women’s Clinical Governance
    • Colposcopy MDT

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Scope of policy

This policy covers the provision of disclosure to all patients diagnosed with cervical carcinoma within Leeds Teaching Hospitals including microinvasive carcinoma (early stromal invasion) and must be read by anyone who may take part in disclosure and feedback to patients within the Trust. This applies equally to patients diagnosed in colposcopy or any other clinic.

All colposcopists and consultant gynaecologists should have access to this policy as should consultant pathologists and Biomedical Scientists

Policies must be adhered to by all Trust staff, including those on temporary or honorary contracts, secondments, agency staff and students.

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Accountability

  • Has responsibility for ensuring an appropriate policy is in place to detail the creation of invasive cervical cancers audit reports and the manner of presenting and recording feedback.

Hospital Based Cervical Screening Programme Co-ordinator (HBPC)

  • Is responsible for creating and updating the policy.
  • Is jointly responsible for monitoring effectiveness of this policy.
  • Is responsible for creating individual feedback reports.
  • Is responsible for informing legal services of any errors identified should a case proceed to formal disclosure.
  • Is responsible for discussing identified errors with relevant clinical leads.
  • May be required to participate in feedback sessions as required.

Clinical leads for Gynaecology and Lead colposcopist (or their appointed deputies)

  • Are responsible for ensuring the policy is adhered to.
  • Are jointly responsible for monitoring effectiveness of this policy with the HBPC.
  • Are responsible for participating in feedback and report production.
  • Are responsible for ensuring any lessons learned from the invasive cancers audit are disseminated within their own practice area.

Clinical leads for Histopathology and Cytopathology

  • Are responsible for participating in feedback report production.
  • Are responsible for ensuring any lessons learned from the invasive cancers audit are disseminated within their own practice area.

Clinical Risk management Team

  • Responsibility for approval / ratification of this policy
  • Responsible for coordinating the dissemination, implementation and review of the documentation

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Implementation and dissemination

This policy will, following ratification by the Clinical Risk management team be disseminated to staff via the Trust intranet. A link to the new policy will, on implementation, be sent via e-mail to all colposcopy and gynaecological oncology staff.

Engagement of those responsible for implementing this policy has been ensured by their inclusion as stakeholders in the development process.

In addition to the intranet this policy will be disseminated through the joint colposcopy MDT and by discussion with gynaecological oncology staff. Inclusion of awareness of this policy in induction/ orientation training will be arranged by training leads within both Colposcopy and Gynaecology to ensure that all new starters are aware of it.

All staff involved in breaking bad news should have evidence of participation in training specific to the task.

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Monitoring compliance and effectiveness

The HBPC and lead colposcopist will be responsible for the auditing the process, which must as a minimum record the number of cases where feedback has been given and any issues identified which might lead to service improvement. To assist with audit each feedback session must be recorded on an audit form (appendix 2, page12) and a copy sent to the HBPC.

As part of the audit process, this policy will be reviewed and amended where necessary.

All those involved in the feedback of audit outcomes to patients have a responsibility to identify any weaknesses in the policy, audit procedures. Issues with administrative or clinical practice should be raised via the clinical incident reporting system as appropriate. Any comments or concerns should also be raised with the HBPC.

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Associated documentation

The following documents are linked to these topics but were not referenced directly in this version.

  • Audit of invasive cervical cancers: colposcopy review 2013-14. Addendum 1 to NHSCSP PUBLICATION No 28, September 2012
  • Protocol changes to the audit of invasive cervical cancers: to be implemented April 2013. Addendum 2 to NHSCSP PUBLICATION No 28, March 2013.
  • Coding guide for the audit of invasive cancers (April 2013 protocol). Addendum 3 to NHSCSP PUBLICATION No 28, March 2013.

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Appendix 1 – Process Details

The Hospital Based Cervical Screening Programme Coordinator (HBPC) is responsible for identifying newly diagnosed cases of cervical cancer1, reporting these to the Screening Quality Assurance Service (SQAS) and instigating the audit review process required.

The lead clinician in colposcopy, histology and cytology are responsible for ensuring that all enquiries are responded to and completed questionnaires returned to the HBPC in a timely manner. The review process covers all relevant histology, cytology and colposcopy episodes within 10 years of the date of diagnosis. In certain cases information may be requested from the patients GP.

The HBPC must complete the Cancer Research UK workbook using the submitted information and return this to the QARC once all of the reviews are available. If the patient asks for disclosure of the screening history results the HBPC will compile a report for the physician giving feedback. It is this report which will be used to form the basis of the feedback session, it is therefore essential that it is reviewed and agreed before being issued to the patient or anyone else. This is to ensure that all patient notes and events have been interpreted correctly.

If there are learning points that arise following the reviews then discussion of the case and any learning outcomes will take place at the colposcopy MDT meetings.

In cases where the patient requests a formal review and disclosure the HBPC must write to the Head of Legal Services (HLS) to inform them of any errors or mistakes in patient diagnosis or treatment have been identified. This must be done before feedback is given. The HLS may ask for further information or offer advice as needed.

The colposcopist/gynaecologist responsible for diagnosing the patient should ensure that the patient is aware that the audit of invasive cancers will be undertaken and at a time they deem to be appropriate. They must ensure that the patient receives a copy of the patient information leaflet (see appendix 3) and clarify that they understand the process of asking to receive feedback about the outcomes. Whoever receives this information should ensure that the HBPC is informed so that they can, if necessary, prioritise the reports for patients wishing to receive feedback.

The HBPC should discuss the reports generated with the lead colposcopist to ensure accuracy and correct interpretation of data as noted above.

Where a patient has requested feedback, the diagnosing clinician should be contacted by the Lead Colposcopist, Unit Cancer Lead or Deputy (if diagnosed through a non colposcopy clinic) as soon as the final report is available.  They should agree who is appropriate to give feedback and then that clinician should arrange a date for the feedback interview to take place.  It may be appropriate for Lead colposcopist to see the patient alongside or instead of the diagnosing clinician.  The term clinician includes colposcopy nurse. The HBPC should be informed of this date in writing.

Before the feedback interview, in line with best practice, the person conducting the feedback should meet briefly with the HBPC and other clinical leads to discuss the contents of the report, seeking clarification and advice as necessary.

The feedback interview must be recorded in the patient’s notes.

After the interview, the clinician conducting the interview should write to the patients GP with details of what was discussed and the patient reactions. A copy of this letter should be offered to the patient. Completing a feedback audit form as shown in appendix X and copying this to the HBPC will allow audit of the feedback process.

It is possible that some of the staff involved may find the process stressful and they may wish to seek help or advice form relevant professionals within the trust. Advice on this procedure can be found through "Care- Safe" Advice, information and counselling service.

Appendix 2 - Audit form for disclosure

Appendix 2 - Audit form for disclosure

Appendix 3 - Patient information leaflet

Appendix 3 - Patient information leaflet

Provenance

Record: 4650
Objective:
  • Ensuring that all information gathered is as accurate as possible.
  • Where appropriate, meeting with team members from other disciplines prior to disclosure to ensure any difficult issues are clearly understood. Team members required might include: -
    • Histopathologist
    • Cytopathologist
    • Primary care / GP representative
  • When disclosure is requested by the patient ensuring the legal services department is informed of any errors made prior to the feedback. Such errors might include: -
    • False negative pathology tests
    • False negative colposcopy
    • Delays in diagnosis or treatment
  • Ensuring the legal services department is informed of adverse reactions to feedback following its delivery. This includes a formal complaint or expression by the patient that they will seek legal advice.
  • Ensuring that problems identified are discussed in the relevant forums and appropriate actions planned. The forums involved might include: -
    • Pathology Clinical Governance
    • Women’s Clinical Governance
    • Colposcopy MDT
Clinical condition:

Cancer of the Cervix

Target patient group:
Target professional group(s): Secondary Care Doctors
Adapted from:

Evidence base

  • Audit of invasive cervical cancers. NHSCSP Publication Number 28.
    December 2006.
  • Audit of invasive cervical cancers: protocol changes for 2012-13. NHSCSP Publication Number 28.
    May 2012.
  • Disclosure of Audit Results in Cancer Screening: NHSCSP Cancer Screening Series Number 3.
    April 2006.

Approved By

Trust Clinical Guidelines Group

Document history

LHP version 1.0

Related information

Not supplied

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