DISCLOSURE OF CERVICAL CANCER SCREENING AUDIT RESULTS POLICY

Document Title: DISCLOSURE OF CERVICAL CANCER SCREENING AUDIT RESULTS POLICY Document Reference/ Register no: 18015 Version Number: 1.0 Document type: Policy To be followed by: Cervical Screening Provider Lead Lead Consultant in Gynaecology Pathology Lead Consultant in Colposcopy Lead Gynaecological Cancer Consultant Lead Nurse Colposcopist Oncology CNS All Colposcopists All Gynaecologists All other staff involved with the review and disclosure of invasive cancer audit results. Ratification Issue Date: 10 th July 2018 Review Date: May 2021 Developed in response to: Issuing Division/Directorate: Author/Contact: Hospital Sites: NHSCSP Disclosure Policy SQAS recommendations Women s and Children s Mark Howard, Cervical Screening Provider Lead X MEHT BTUH SUH Professionally Approved by: Mr Colin Partington, Consultant Gynaecologist and Cervical Screening Lead Date: July 2018 Ratification Group: DRAG Chairmans Action Date: 6.7.18 Issue Date 10th July 2018 Page 1 of 17

Consulted With: Post/ Approval Committee/ Date: Group: Patient Safety & Quality Group Mark Howard Cancer Service Provider Lead 27/06/18 Mr Colin Partington Consultant Gynaecologist and 29/06/18 Cervical Screening Lead Susanna Cotter Lead Nurse Colposcopist 27/06/18 Eimear McComish Oncology CNS 27/06/18 Anne Powell Lead Matron for Gynaecology 27/06/18 Consultant Gynaecologists 29/06/18 Colposcopists 26/06/18 Related Trust Policies 04071 Standard Infection Prevention 04072 Hand Hygiene 08026 Colposcopy Operational Document 04086 - Access to Records Policy Document Review History: Version Authored/Reviewer: Summary of amendments: Issue Date: : 1.0 Mark Howard Creation of Policy 6 th July 2018 Page 2 of 17

Contents 1 Introduction... 4 2 Scope... 4 3 Definitions... 5 4 Roles and Resposibilities..6 5 Cervical Cancer Audit Screening Process... 6 6 Training Requirements... 8 7 Monitoring and Audit... 8 8 Approval and Implementation... 9 9 References... 9 10 Equality Impact Assessment... 9 11 Review... 10 Appendix 1: Interim Statement... 11 Appendix 2: Disclosure Process Flow Chart... 12 Appendix 3: Checklist for Procedural Document... 13 Appendix 4: Equality Impact Assessment... 15 Appendix 5: Privacy Impact Assessment Screening...16 Page 3 of 17

1.0 Introduction 1.1 This document outlines the Mid Essex Hospital NHS Trust policy for providing information about the audit of cases of cervical cancer to the individuals concerned. It does not cover the review of the clinical material which is covered in the following NHS Cancer Screening Programme (NHSCSP) publications: NHSCSP publication 28 (December 2006) - Audit of Invasive Cervical Cancers NHSCSP publication 28 (December 2014) Audit of Invasive Cervical Cancers Protocol Changes 2012/13 Addendum 1 to NHSCSP publication 28 - Colposcopy Review (September 2012) Addendum 2 to NHSCSP publication 28 - Audit Protocol Changes (March 2013) Addendum 3 to NHSCSP publication 28 - Audit Coding Guide (March 2013) 1.2 This policy is based on the advice provided by the NHSCSP in their publication Disclosure of audit results in cancer screening (2006) and existing local policies and good practice highlighted during Cervical Screening Quality Assurance Team visits until further guidance is issued by Public Health England (refer to the interim statement in Appendix 1) 2.0 Scope 2.1 This Policy and Procedures document applies equally to all members of staff either permanent or temporary, and to those working within, or for, the Trust under a contract for services. 2.2 This Policy and Procedures document complies with the Trust s equality policies. 2.3 It is the responsibility of staff to ensure that all women diagnosed as having cervical cancer are given the option of being informed of the results of a review on all clinical material reported by cytology and histology laboratories. This includes assessments undertaken by the colposcopy service(s) at individual Trusts 2.4 This policy and procedures document may also include clinical materials held at other trusts including supplemental information obtained from the patients general practice records. 2.5 This policy and procedures document is to be adhered to for all patients who are initially diagnosed with cervical cancer at Mid Essex Hospital Trust irrespective of route of diagnosis, stage or type. 2.6 The policy and procedures document does not include patients with recurrent disease or metastatic disease. These patients are not to be offered disclosure. Page 4 of 17

3.0 Definitions 3.1 TERM NHSCSP CSPL SQAS PHE CNS NICE PALS DEFINITION National Health Service Cervical Screening Programme Cervical Screening Provider Lead Screening Quality Assurance Service Public Health England Clinical Nurse Specialist National Institute of Clinical Excellence Patient Advisory Liaison Service 4.0 Roles and Responsibilities 4.1 Chief Executive 4.1.1 The Chief Executive, as Accountable Officer, has overall responsibility for ensuring that the Trust operates effective disclosure, meeting all statutory requirements and adhering to guidance issued by the NHSCSP and PHE. 4.2 Site Medical Director 4.2.1 The Site Medical Director is accountable to the Chief Executive and the Board for the delivery of the Trusts Disclosure of Audit Results in Cervical Cancer Screening Policy. 4.2.2 The Site Medical Director has lead responsibility for National Clinical guidance/nice guidance and Medical Staff education. 4.2.3 The Site Medical Director is has lead responsibility for all disclosures and ensures effective management of these and the CSPL via the appraisal process. 4.3 Cervical Screening Provider Lead (CSPL) 4.3.1 The CSPL is accountable to the Site Medical Director and has responsibility for performing the Cervical Screening Disclosure Audits and providing evidential feedback to the Site Medical Director and Trust Colposcopy Leads. 4.3.2 THE CSPL is responsible for the annual review of the Policy for the Disclosure of Audit Results in Cervical Cancer Screening and ensuring it aligns with guidance provided by the NHSCSP, SQAS and PHE. 4.3.3 The CSPL is responsible for the dissemination of the Policy for the Disclosure of Audit Results in Cervical Cancer Screening. 4.4 Lead Colposcopist 4.4.1 The Lead Colposcopist is responsible for the discussion and disclosure of the cervical Cancer audit review process to patients that this policy affects. Page 5 of 17

4.4.2 The Lead Colposcopist is responsible for ensuring the disclosure of the audit process to affected patients is accurately recorded within the guidelines of the enclosed policy and complies with the Trusts Information Governance Policy. 4.4.3 The Lead Colposcopist is responsible for the Colposcopists and CNS s and ensuring that they are accurately following the Policy for the Disclosure of Audit Results in Cervical Cancer Screening. 5.0 Cervical Cancer Audit Screening Process 5.1 All women diagnosed at MEHT as having cervical cancer will have an audit of their screening histories performed as per NHSCSP publication 28 guidelines. This is carried out by the CSPL. 5.2 All patients are to be offered the results of the review of their screening history unless they have no previous screening history or their most recent history is more than 10 years prior to diagnosis, in which case old samples will have been destroyed. In other situations, for example if the woman is terminally ill and unlikely to cope with the information, appropriate judgement is to be exercised and the reason for not offering the audit results documented clearly in the patient notes. 5.3 The initial consultation when results of diagnosis are given is not an appropriate occasion to discuss audit and review. 5.4 Two weeks after diagnosis, and after MDT discussion, the patient will be sent the audit leaflet with consent form in the post explaining that the review of her screening history will be taking place and she has an option to know the result of the audit review. New records for each patient is started within the cervical cancer audit disclosure excel form by the CNS for gynaecology oncology and all dates of this process is recorded. 5.5 If the patient does not respond after one month the audit leaflet and consent form are resent and this is recorded in the excel form. 5.6 If the patient does not respond to this second attempt to offer disclosure, a recorded is to be noted in the excel document. further attempts are to be made to offer disclosure to the patient. 5.7 If at any time in the future the patient requests the review result, the audit leaflet and consent form are given/posted to her and the process followed as below. 5.8 If at any time during this process the patient dies it must be stopped forthwith and recorded in the excel spreadsheet. 5.9 Where patients express a wish not to receive the results from the review of their screening history, they will be informed that they can change their mind at any point and can subsequently choose to know the results by contacting their consultant. If the patient has been previously discharged, they can access their results through their General Practitioner. Page 6 of 17

5.10 A record of the patient s decision on disclosure is to be made in the excel spreadsheet and within the patient s notes to safeguard against inadvertent disclosure. 5.11 The GP will be informed of their decision and the process to follow; i.e. to notify the Trust in order that the review results can be communicated by the diagnosing clinician, should the patient change their mind in future. Should the GP wish to receive the result of the review, it must be reiterated that the patient does not wish not to receive the results from the review. 5.12 The Trusts Access to Records Policy (register number: 04086) is to be adhered to and as such, access to audit results cannot be disclosed to the relatives of patients whilst the patient is alive and competent to refuse consent. 5.13 Where the patients express a wish to be informed of the results of their personal screening history review, the protocol in appendix 2 is to be followed. It is to be explained to the patient that the review can take many months to complete and that she will be written to when the review is complete to offer her an audit disclosure appointment at MEHT. 5.14 A Consultant Colposcopist or Lead Nurse Colposcopist, together with a gynaecology oncology CNS nurse will carry out the disclosure appointment/interview. 5.15 In the case of an under reported cervical cytology or histology report or under treatment in colposcopy, the Trust s Duty of candour protocol is followed. Should any issues come to light during reviews that could indicate a potential screening incident, the SQAS is to be informed immediately so that appropriate advice can be given in line with NHSCSP guidelines on the management of potential screening incidents. This includes situations where it is considered that litigation is very likely, then the Trust policy on incident reporting and litigation is to be followed. 5.16 In the event of 5.15, the following checks are to be carried out: Has the patient consented to receive cancer audit review findings? Check the patients understanding of why she has asked for the information; Ascertain how much the patient wishes to know; Discuss the relevant reports and implications; Invite the patient to voice her comments and concerns before moving on to provide reassurance; Help the patient understand the reason for any missed abnormality or potential under treatment; Refer to the effectiveness and limitations of the screening programme as described in the information leaflet; Give apologies and explanations, as opposed to admissions of liability; Assure the patient of a right to have the issue investigated further should she so wish; Patients who say they wish to complain are to be given contact details of the Trust PALS process and provided with eth contact details; Page 7 of 17

After the interview, the clinician will write up the discussion which is filed in patient notes and send an outline of the discussion to the patient s GP and copied to the CSPL. 6.0 Training Requirements 6.1 The CSPL is to ensure they are up to date with all guidance and training supplied by the NHSCSP, SQAS and PHE relevant to this policy and procedures document. 6.2 The CSPL is responsible for ensuring that all relevant staff are aware of changes in guidance and processes. 6.3 Colposcopists and CNS s are required attend duty of candour training. 6.4 All staff are to be compliant with the Trust s mandatory Information Governance Training 7.0 Monitoring and Audit 7.1 An annual audit of compliance with this policy is to be undertaken by the CSPL to ensure that all women diagnosed with cervical cancer have been offered the results of their cervical screening review where appropriate and to identify any trends. Aspect of compliance or effectiveness being monitored Monitoring method Individual department responsible for the monitoring Frequency of the monitoring activity Group/committee/ forum which will receive the findings/ monitoring report Committee/ individual responsible for ensuring the actions are completed Audit cancer cases for evidence disclosure of audit findings has been offered and when audit results available patient has attended for disclosure Look at patient notes for consent form and recorded information disclosure appointment. Interrogate audit disclosure excel. Colposcopists should cascade information and report to CSPL. CSPL will include this in the annual CSPL report. Annually Cervical Screening Group Colp-path MDT Lead Gynaecology Consultant Clinical Director Medical Director PS&Q forum Lead Gynaecologist/Consu ltant Colposcopists/Lead Nurse Colposcopist /CSPL Lead Gynaecologist, Colposcopists/ Lead nurse Colposcopist /CSPL Page 8 of 17

8.0 Approval and Implementation 8.1 The Disclosure of Cervical Cancer Screening Audit Results Policy is to be approved by the Patient Safety and Quality Group with ratification through the Document Ratification Group. 8.2 The Policy for Disclosure of Audits Results in Cervical Cancer Screening is to be disseminated and made available to: 8.2.1 Internally All stakeholders highlighted within this document and made available in the Trust Intranet. 8.2.2 Externally This Policy and Procedure document is to be freely available on request. 8.3 Amendments to this Policy and Procedure document are to be communicated to all stakeholders as and when they occur. 9.0 References Disclosure of Audit results in Cancer Screening, NHSCSP; April 2006 SOP - LP 710 068 Audit of invasive cancers Audit of Invasive Cervical Cancers, NHSCSP 28, Jan 2007 NHSCSP publication 28 Audit of Invasive Cervical Cancers Protocol Changes 2012 Addendum 1 to NHSCSP publication 28(CS28 addendum1) - colposcopy review Sept 12 Addendum 2 to NHSCSP publication 28(CS28 addendum2) - Audit Protocol Changes Mar 13 Addendum 3 to NHSCSP publication 28(CS28 addendum3) - Audit Coding Guide Mar 13 https://www.gov.uk/government/publications/cervical-screening-role-of-the-cervicalscreening-provider-lead/nhs-cervical-screening-programme-the-role-of-the-cervicalscreening-provider-lead 10.0 Equality Impact Assessment 10.1 As part of its development, this policy and its impact on equality have been reviewed in line with the Trust s Equality Scheme. 10.2 The purpose of the assessment is to minimise and, if possible, remove any disproportionate impact on employees on the grounds of race, sex, disability, age, sexual orientation or religious belief. detriment was identified. Page 9 of 17

10.3 Refer to Appendix 4 for Equality Impact Assessment Page 10 of 17

11.0 Review 11.1 This Policy will be reviewed annually or sooner if circumstances dictate. Page 11 of 17

Appendix 1: Interim Statement 12 August 2015 Public Health England (PHE) has met with the Care Quality Commission (CQC) to discuss the implication and interpretation of Duty of Candour as applied to national screening programs. CQC and PHE have agreed to produce guidance on an appropriate response to potentially adverse events, such as interval cancers, false negative and false positive results. Until guidance is issued, trusts providing screening programs are advised to follow best practice including ensuring compliance with Disclosure of Audit Guidance. The purpose of audit in a cancer screening programme is to monitor the effectiveness of the programme and to identify areas of good practice and areas for improvement. Audit of personal screening histories may help to identify why an invasive cancer has occurred, despite the individual having previously participated in that screening programme. Some individuals may wish to be informed of the outcome of this audit while others may not. For the purposes of clarity, a screening history review covers a retrospective review, in full knowledge of the final cancer diagnosis, of cytology, histology and colposcopy specimens and assessments. Primary care information may also be used to supplement the review where appropriate, for example in instances where there may be a gap in the cervical cytology history, to confirm whether relevant symptoms were reported by the patient and to verify previous screening invitations and results via Open Exeter although this is no longer a mandatory requirement of the national audit process. The Trust is committed to treating people with dignity and respect in accordance with the Equality Act 2010 and Human rights Act 1998. Throughout the production of this policy due regard has been given to the elimination of unlawful discrimination, harassment and victimisation (as cited in the Equality Act 2010). Page 12 of 17

Appendix 2: Disclosure Process Flow Chart t less than 2 weeks after diagnosis (and after MDT) Audit information leaflet with consent form is posted to the patient. If consent form is not returned within 4 weeks the Audit information leaflet with consent form is posted again to the patient. If consent form is not returned after a further 4 weeks no further attempts are made to offer disclosure. Patient wishes to know the review result Patient completes and signs the consent form Patient declines offers of disclosure OR Patient fails to respond to offers of disclosure Patient wishes to know review result at later time CSPL completes audit review and sends it to the Lead Colposcopist Attempt(s) to offer disclosure must be recorded in patient notes along with the returned signed consent form to indicate patients wish NOT to receive feedback of review; the GP is kept informed of the patient s desire to this effect Disclosure appointment Colposcopist with CNS conducts an honest and open discussion with patient regarding results of audit review. In cases of underreported cytology/histology or under treatment by colposcopy, the trusts Duty of Candour process is be followed. Safeguard against inadvertent disclosure using a note on front of records and in Electronic patient record Access to records by relatives of patient cannot be given whilst patient is alive and competent to refuse consent to disclosure Clinician writes up discussion and sends an outline of discussion to patient s GP. and to the CSPL A copy is kept in patient notes Page 13 of 17

Appendix 3: Checklist for Procedural Documents To be completed by the author and attached to any document which guides practice when submitted to the appropriate committee for consideration and approval / ratification. Document Title and Version. Disclosure of Cervical Cancer Screening Audit Results Policy v. 1 // Unsure Comments 1. Title Is the title clear and unambiguous? Is it clear whether the document is a guideline, policy, protocol or standard? 2. Rationale Are reasons for development of the document stated? 3. Development Process 4. Content Is the method described in brief? Are individuals involved in the development identified? Do you feel a reasonable attempt has been made to ensure relevant expertise has been used? Is there evidence of consultation with stakeholders and users? Is the objective of the document clear? Is the target population clear and unambiguous? Are the intended outcomes described? Are the statements clear and unambiguous? 5. Evidence Base Is the type of evidence to support the document identified explicitly? Are key references cited? Are the references cited in full? Page 14 of 17

// Unsure Comments Are local/organisational supporting documents referenced? 6. Approval Does the document identify which committee/group will approve it? If appropriate, have the joint Human Resources/staff side committee (or equivalent) approved the document? 7. Dissemination and Implementation Is there an outline/plan to identify how this will be done? Does the plan include the necessary training/support to ensure compliance? 8. Document Control Does the document identify where it will be held? Have archiving arrangements for superseded documents been addressed? 9. Process for Monitoring Compliance Are there measurable standards or KPIs to support monitoring compliance of the document? Is there a plan to review or audit compliance with the document? 10. Review Date Is the review date identified? Is the frequency of review identified? If so, is it acceptable? 11. Overall Responsibility for the Document Is it clear who will be responsible for coordinating the dissemination, implementation and review of the documentation? Completed by Name Mark Howard Date 04/07/18 Job Title Cervical Screening Provider Lead Page 15 of 17

Appendix 4: Equality Impact Assessment The organisation aims to design and implement services, policies and measures that meet the diverse needs of our service, population and workforce, ensuring that none are placed at a disadvantage over others. The Equality Impact Assessment Tool is designed to help you consider the needs and assess the impact of your policy. Name of Document: Completed by: Cervical Cancer Audit Disclosure Policy Mark Howard Job Title: Cervical Screening Provider Lead Date: 04/07/18 / 1. 2. 3. 4. Does the document/guidance affect one group less or more favourably than another on the basis of: Race Ethnic origins (including gypsies and travellers) Nationality Gender (including gender reassignment) Culture Religion or belief Sexual orientation Age Disability - learning disabilities, physical disability, sensory impairment and mental health problems Is there any evidence that some groups are affected differently? If you have identified potential discrimination, are there any exceptions valid, legal and/or justifiable? Is the impact of the document/guidance likely to be negative? 5. 6. 7. If so, can the impact be avoided? What alternative is there to achieving the document/guidance without the impact? Can we reduce the impact by taking different action? N/A N/A N/A Completed by Name Mark Howard Date 04/07/18 Job Title Cervical Screening Provider Lead Page 16 of 17

Appendix 5: Privacy Impact Assessment Screening Privacy impact assessment (PIAs) is a tool which can help organisations identify the most effective way to comply with their data protection obligations and meet individual s expectations of privacy. The first step in the PIA process is identifying the need for an assessment. The following screening questions will help decide whether a PIA is necessary. Answering yes to any of these questions is an indication that a PIA would be a useful exercise and requires senior management support, at this stage the Information Governance Manager must be involved. Name of Document: Completed by: Cervical Cancer Audit Disclosure Policy Mark Howard Job title Cervical Screening Provider Lead Date 04/07/18 1. Will the process described in the document involve the collection of new information about individuals? This is information in excess of what is required to carry out the process described within the document. 2. Will the process described in the document compel individuals to provide information about themselves? This is information in excess of what is required to carry out the process described within the document. 3. Will information about individuals be disclosed to organisations or people who have not previously had routine access to the information? 4. Are you using information about individuals for a purpose it is not currently used for, or in a way it is not currently used? 5. Does the process involve the use of new technology which might be perceived as being privacy intrusive? For example, the use of biometrics. 6. Will the process result in decisions being made or action taken against individuals in ways which can have a significant impact on them? 7. Is the information about individuals of a kind particularly likely to raise privacy concerns or expectations? For examples, health records, criminal records or other information that people would consider to be particularly private. 8. Will the process require you to contact individuals in ways which they may find intrusive? or If the answer to any of these questions is please contact the Information Governance Manager. In this case, ratification of a procedural document will not take place until approved by the Information Governance Manager. IG Manager approval Name: Date of approval t Required N/A Page 17 of 17