POLICY FOR CLINICAL AUDIT OF NEW CASES OF INVASIVE CERVICAL CANCER AND DISCLOSURE OF RESULTS

POLICY FOR CLINICAL AUDIT OF NEW CASES OF INVASIVE CERVICAL CANCER AND DISCLOSURE OF RESULTS Reference Number Version: Status Author: Alison Cropper CL-CP/2009/010 V3 Final Job Title: Hospital Based Programme Coordinator (HBPC) for the Cervical Screening Programme Version / Amendment History Version Date Author Reason 1 2004 Alison Cropper Original version 2 Feb 2009 Alison Cropper Reviewed and amended. Reformatted to NHSLA standard. 3 Sept. 2015 Alison Cropper Consultant BMS & Hospital Based Programme Coordinator Cytology Dept Royal Derby Hospital Reviewed following revised national guidelines in 2012 and QA visit recommendations 2014 Intended Recipients: Cervical Screening Hospital Based Programme Coordinator, Gynaecology Clinicians and other staff involved in cervical screening. Training and Dissemination: The HBPC has received training in this process. Dissemination will be via the Gynaecology operational meetings, MDT and Intranet. To be read in conjunction with: NHS Cancer Screening Programmes Audit of Invasive Cervical Cancers, protocol changes May 2012 In consultation with and Date: Consultant Gynaecology Oncologists & MDT EIRA stage One Completed Yes Stage Two Completed No Procedural Documentation Review Group 10 th September 2015

Assurance and Date Approving Body and Date Approved Gynae Oncology MDT, Legal services, Governance and Patient Safety group. Date of Issue October 2015 Review Date and Frequency 2018 Contact for Review Hospital Based Programme Coordinator for Cervical Screening Executive Lead Signature Director of Nursing Approving Executive Signature Director of Nursing Clinical Audit of new cases of cervical Cancer Page 2 of 18

POLICY FOR CLINICAL AUDIT OF NEW CASES OF INVASIVE CERVICAL CANCER AND DISCLOSURE OF RESULTS Contents Section Page Summary Audit & Disclosure Pathway Flowchart 4 1 Introduction 5 2 Purpose & Outcomes 5 3 Definitions 6 4 Key Responsibilities 7 5 Management of the Audit of New Cases of Invasive Cervical Cancer 5.1 Notification of cases 7 5.2 Study ID numbers 8 5.3 Cytology slide review 8 5.4 Histology Slide review 8 5.5 Review of colposcopy and gynaecological management 8 6 Reporting Audit Findings 9 7 Audit & Disclosure Pathway 9 8 Disclosure of results 10 9 Monitoring compliance and effectiveness 11 10 References 12 Appendices Appendix A MDT Notification Form 13 Appendix B Case Review Summary 15 Appendix C Audit disclosure record sheet 16 Appendix D Patient leaflet 17 7 Clinical Audit of new cases of cervical Cancer Page 3 of 18

Cervical Cancer Audit & Disclosure Pathway Cervical Cancer diagnosed within DHFT HBPC notified (MDT minutes) Woman given leaflet (Reviewing your cervical screening history) at first appointment following surgery/treatment HBPC notifies QA of new case QA assign study I.D. number and inform HBPC First follow up appointment confirm woman has had leaflet and aware an audit is being undertaken. No untoward findings HBPC co-ordinates audit Audit results discussed at MDT Patient informed Significant Incident policy and Duty of Candour policies to be followed Incident YES DATIX Notify Divisional Clinical Governance facilitator MDT discussion Re: contacting patient Audit reveals treatment/care should have been different HBPC contacts QA to ascertain incident status Incident - NO HBPC to discuss with Divisional Clinical Governance facilitator regarding next steps Woman makes appointment disclosure given No appointment made no disclosure given N.B :- All above steps to be documented both in patient notes and on audit record sheet, which when complete is sent to HBPC for annual audit of disclosure. Clinical Audit of new cases of cervical Cancer Page 4 of 18

TRUST POLICY FOR CLINICAL AUDIT OF NEW CASES OF INVASIVE CERVICAL CANCER AND DISCLOSURE OF RESULTS 1. Introduction The aim of the NHS Cervical Screening Programme (NHSCSP) is to reduce the incidence of and mortality from, invasive cervical cancer. This is achieved by offering regular cervical screening to eligible women so that conditions which otherwise might develop into cancer can be detected and treated before cancer develops. All women who develop cervical cancer must have their screening history audited which includes a review of the events and specimens in the ten years prior to diagnosis. The purpose of the audit review is to monitor the effectiveness of the screening programme and to understand reasons why cervical cancers occur despite the existence of an excellent cervical screening programme in the UK. The audit is run on a national level by Cancer Research UK on behalf of the NHSCSP. Every Trust is obligated to feedback the audit results to the patient - CEM/CMO/2001/06 states that whenever a woman is diagnosed with invasive cervical cancer her consultant will explain that her screening history will be reviewed and offer to discuss with her the outcome of that clinical audit. NHSCSP publication No 28 ( Audit of Invasive Cancers, 2006) formalised details of how the audits should be performed. The document was revised in 2012 to include protocol changes. The Disclosure of Audit Results in Cancer Screening document was also published in 2006 (Cancer Screening Publication No.3, 2006), advising on best practice for passing on information about the results of the audit to the woman concerned. 2. Purpose and Outcomes All health services should regularly review their performance and the quality of care that they provide and clinical audit is one component of this. Within the NHS Cervical Screening Programme this includes an audit of the screening history of every woman who is diagnosed with invasive cervical cancer, whether she has been previously screened or not. Part of the case audit involves reviewing any cervical cytology screening tests from the 10 years prior to diagnosis, along with any Colposcopy attendances and histology samples. A summary report on the results of the audit of each case is produced by the Hospital Based Programme Coordinator (HBPC) and information contained in this report can be used for disclosure to any patient wishing to know the results of the audit. The purpose of this local Trust policy is to provide a clear and consistent process by which all newly diagnosed cases of invasive cervical cancer are audited, and the results disclosed to the individual women concerned, in line with NHSCSP guidelines. Clinical Audit of new cases of cervical Cancer Page 5 of 18

3. Definitions Used Invasive Cervical Cancer: NHS Cervical Screening Programme (NHSCSP) Conventional Cervical Smear: A histologically proven invasive tumour of the uterine cervix. Aims to reduce the incidence of and mortality from, cervical cancer. This is achieved by regular screening of all women at risk; to detect early changes in the cervix, which if left untreated may develop into invasive disease. The Liquid Based Cytology (LBC) sample is the screening test currently used. Cells collected from the cervix and spread onto a glass slide by the smear taker, for processing and examination under a microscope in the cytology laboratory technique no longer in use in Derby since 2005/06. LBC Sample: Liquid Based Cytology sample - cells collected from the cervix into liquid medium, for processing onto a glass slide in the cytology laboratory, ready for examination under a microscope. Open Exeter System: HBPC: MDT: QARC: CTC: The national database and software used by screening offices to operate the call/recall system for inviting women for cervical screening when due, and generating result letters to women screened. The Hospital Based Programme Co-ordinator is the individual responsible for co-ordinating all aspects of the cervical screening programme carried out within the Trust. Multi Disciplinary Team meeting for case discussions in Gynaecological Oncology and Colposcopy Quality Assurance Reference Centre Cytology Training Centre Clinical Audit of new cases of cervical Cancer Page 6 of 18

4. Key Responsibilities / Duties Hospital Based Programme Co-ordinator (HBPC) The Hospital Based Programme Co-ordinator is responsible for ensuring all newly diagnosed cases of invasive cervical cancer are audited in line with NHSCSP guidance. Notification of new cases to the HBPC is via minutes of the Gynaecological Oncology MDT. When a new case of invasive cancer is identified the HBPC is responsible for triggering the audit process and notifying the QARC. The HBPC is then responsible for managing the audit process of any Cytology, Histology and Colposcopy reviews undertaken, and ensuring that the audit results are uploaded onto the QARC database. The HBPC is responsible for obtaining reviews of any slides from other Trusts that may be needed for the audit. Results of these reviews must be included in the audit report, as must any reviews done externally to the Trust. A summary report of the case audit is produced by the HBPC and sent to the relevant Consultant Gynaecologist and lead Colposcopist, for discussion at the Gynaecology Oncology and/or Colposcopy MDT prior to any disclosure being made. The HBPC also annually audits that disclosure to all relevant women has been offered. Lead Colposcopist Undertakes audit of colposcopy appointments, or arranges for another accredited Colposcopist to undertake the audit if they were involved in the original appointments. Consultant Gynaecologist/Oncologist The Consultant Gynaecologist is responsible for informing the woman that the audit review will be carried out, and for subsequent disclosure of the audit information, to be carried out within the framework of the Trust s clinical governance protocols. It should be noted that the audit report constitutes an NHSCSP audit and although it can form the basis of information for disclosure it is NOT a legal case review. Once treatment is completed the Consultant in charge of the case should also write to the screening office to remove the woman from the call/recall system as further management is outside the scope of the cervical screening programme. Regional Quality Assurance Reference Centre (QARC) QARC are responsible for collating all regional cases on their database and submitting annually to the Cancer Research UK national database. 5. Management of the Audit of New Cases of Invasive Cervical Cancer 5.1 Notification of Cases All cases of invasive cervical cancer identified on a histology specimen are discussed at the weekly Gynaecology Oncology MDT meeting. The minutes of this MDT act as notification of new cases to the HBPC who then commences the audit process in accordance with NHSCSP document No. 28 Audit of Invasive Cervical Cancers and regional QA protocol. See Appendix A - MDT Notification Form Clinical Audit of new cases of cervical Cancer Page 7 of 18

5.2 Study ID numbers The HBPC notifies QARC of the new case. QARC assign a national study ID number to each case and send an audit dataset template back to the to the HBPC for completion and return to the QARC when the audit is complete. See attachment 1 for national audit dataset template. 5.3 Cytology Slide Review The screening history for each case is obtained from the Open Exeter system. Any previous slides requiring review will be retrieved from archives, where available. In cases where slides were reported elsewhere, the HBPC will request the originating laboratory to review the slides and send the results to the HBPC, or to send the slides for review in the Derby laboratory. A primary screener, a checker and a Consultant Pathologist/Biomedical Scientist will independently review the slides, and then review on the multi-header microscope any slide that does not reach consensus agreement. Only the opinion of Consultant is recorded on the audit dataset section E. Some slides will require external review, as per the criteria in Document No.28: All slides taken within 2 years of diagnosis that were originally reported as negative or inadequate, irrespective of the review diagnosis All slides reported as negative or inadequate that were subsequently upgraded at local review to moderate dyskaryosis or worse, irrespective of when they were taken Any slides originally reported as borderline or mild dyskaryosis that were subsequently upgraded at local review to severe dyskaryosis, glandular neoplasia, or invasive carcinoma Slides for external review are sent by the HBPC to the regional Cytology Training Centre (CTC) for review by the CTC Director or Manager. External review results are returned to the HBPC for inclusion on the national audit dataset. 5.4 Histology Slide Review A record of histology results from the 10 years preceding diagnosis is collated. The diagnostic sample does not need to be reviewed but any relevant samples prior to diagnosis must be reviewed by a Consultant Pathologist (not the same person who originally reported the sample) and the findings documented on the audit dataset section F. 5.5 Review of Colposcopy and Gynaecological Management This is undertaken by the lead Consultant Colposcopist, or another accredited Colposcopist if the lead participated in the management of the woman. Notes from all Colposcopy examinations* that pre-date the index cytology sample by up to 5 years are reviewed and results collated on the audit dataset forms section C. Clinical Audit of new cases of cervical Cancer Page 8 of 18

If local review indicates that previous management was inappropriate then the case should be reviewed by the QA Colposcopy lead, or another Colposcopy lead if the case is the QA lead s own case. (* any Colposcopy examination(s) associated with the index sample and made within 18 months of a subsequent cancer diagnosis do NOT require review) 6. Reporting Audit Findings The HBPC will upload a completed national dataset on each case to QARC, who will then complete the national data return to Cancer Research UK for further analysis. A summary of the audit findings is sent to the patient s Gynaecologist by the HBPC for discussion at both the Colposcopy MDT and the Gynae-Oncology MDT. At the Gynae-Oncology MDT any cases where a false negative result is identified in the slide review (i.e. originally called normal or technically inadequate but on review considered to be a high grade abnormality), and agreed so by the MDT, are then notified by the HBPC to QA, who will advise as to whether or not the false negative screening test constitutes a clinical incident. If considered by QA to be an incident then the incident will be recorded on Datix by the HBPC, notified to the Divisional Clinical Governance Facilitator, and the Trust s incident management policy will then be triggered. The audit findings and further action required are recorded by the Gynaecologist on the Cervical Cancer Audit Disclosure record sheet and in the patient s notes see Appendix C 7. Audit & Disclosure pathway Upon diagnosis, a Cervical Cancer Audit Disclosure record sheet is started and filed in the patient s notes see Appendix C. When the patient attends her first appointment following surgery/treatment she must be given the Trust leaflet Reviewing your cervical screening history if she has been previously screened. This leaflet explains that an audit is being undertaken, and why. It also explains that when the results of the audit are available she will be offered the results of the audit if she wishes to know see Appendix D. It must be recorded on the Audit Disclosure record sheet that the leaflet has been given. At her next appointment, usually three months later, the patient must be asked if she has read the leaflet and is aware that a review has been done. Confirmation of this discussion must be documented in the patient s notes and on the audit record sheet. Once the audit results are complete they are discussed by the MDT and the disclosure pathway agreed, either Where there are no untoward findings the patient will be written to or told this at her next appointment with her Consultant. Confirmation of this letter / discussion must be documented in the patient s notes and on the audit record sheet. or Where the audit shows that her care / treatment should have been different then she must be written to, saying that the results of the audit are now available and Clinical Audit of new cases of cervical Cancer Page 9 of 18

to make an appointment to come in and discuss with her Consultant if she wishes to know. If she makes an appointment to discuss, disclosure must be given by the Consultant (see section 8 disclosure of audit results) and confirmation that this has happened documented in the patient notes and on the audit record sheet. The GP must be written to, explaining what has been said in the disclosure interview. For both scenarios, once the disclosure record sheet is fully completed a copy is sent to the HBPC for filing with the case review records. An annual audit is then undertaken by the HBPC to monitor compliance with the policy - that all women have been offered the results of their screening history review and that disclosure has occurred in all cases where this was requested by the patient. 8. Disclosure of audit results The results of the audit must be given by the patients Consultant, and given carefully to ensure good understanding by the patient.* If the review finds that there has been a possible under-reported cervical cytology or histology result, or a similar occurrence during colposcopy appointments, then the conversation giving the patient that information should be treated as a bad news interview in accordance with Trust protocols. The interview should follow the process below: Check the patient s understanding of why she has asked for the results of her review Ascertain how much information she wishes to know Discuss the relevant reports and implications Invite her to voice any concerns or ask any questions The patient must be helped to understand the reasons for any missed abnormality and the limitations of the screening programme. It must be emphasised that any reporting discrepancies found on review do not imply that the same findings should have been made under routine conditions and, importantly, why this is so. The quality of the explanation is vital. Lack of empathy in discussing results, especially if a false negative result has been identified in the audit, often gives rise to complaints and claims. If the patient perceives that the process leading up to being given the results has been open and transparent, and that they receive an apology or expression of sympathy for their present position, they are less likely to make a complaint or claim. Following the disclosure interview, which must be documented in the patient s notes, the patient and her GP should be written to, outlining what has been discussed. Patients often consult their GP after a bad news interview and it is therefore important that the GP understands what has been said. * see NHSCSP Cancer Screening Document No.3 Disclosure of Audit Results in Cancer Screening (2006) for details of what is considered to be best practice for when and how to inform the patient about audit results. Clinical Audit of new cases of cervical Cancer Page 10 of 18

9. Monitoring Compliance and Effectiveness The review findings constitute an NHS audit review, not a legal review, and as such must be carefully discussed in this light. Data collected as part of the case audit can also be used for disclosure, but it does not constitute disclosure in itself. Monitoring Requirement : Monitoring Method: Report Prepared by: Monitoring Report presented to: Frequency of Report Audit data from every case reviewed is submitted to the regional QARC for submission to the national database held by Cancer Research UK. Audit and disclosure record sheet (appendix D) to be completed for every cervical cancer patient. A summary of each audit undertaken will be sent by the HBPC to the woman s Consultant Gynaecologist, for discussion at the Gynaecology MDT if considered appropriate. Any untoward findings relating to audit results (e.g. false negative smear cytology results) must be discussed at the MDT meeting prior to disclosure. Issues must also be escalated via the appropriate Divisional Quality meetings Completed disclosure record sheets will be audited annually by the HBPC to monitor compliance with offering of results to all women. Hospital Based Programme Coordinator Data on cancer case audits is reported in the HBPCs Cervical Screening Programme Annual Report and is also reported in the Business Unit annual audit programme to the Trust Audit Committee and at DMB. Annual report summary presented to Clinical Audit and Effectiveness group. Annually Clinical Audit of new cases of cervical Cancer Page 11 of 18

10. References Source of data NHSCSP Publication N o Cancers 28 Audit of Cervical Date of publication/issue December 2006 Revised May 2012 Audit of invasive cervical cancers: colposcopy review; addendum 1 to NHSCSP no.28 Protocol changes to the audit of invasive cervical cancers: to be implemented April 2013; addendum 2 to NHSCSP No.28 September 2012 March 2013 Coding guide for the audit of invasive cancers (April 2013 protocol); addendum 3 to NHSCSP No.28 March 2013 Cancer Screening Programme Series N o 3 April 2006 Disclosure of audit results in cancer screening Guidance for the Disclosure of Audit Results in Cancer Screening September 2014 East & West Midlands Cervical Screening Quality Assurance Reference Centre Clinical Audit of new cases of cervical Cancer Page 12 of 18

APPENDIX A DERBY TEACHING HOSPITALS NHS FOUNDATION TRUST GYNAE ONCOLOGY MULTI DISCIPLINARY TEAM MEETING MDT DATE: Name: Referral Route: Hosp No: First Discussion: DoB: Age: First Treatment: Cons: Recurrence: NHS Number:. First Def. Treatment by: PRESENTING SYMPTOMS AND HISTORY: INVESTIGATIONS AND RESULTS: DATE OF DIAGNOSIS: Clinical Audit of new cases of cervical Cancer Page 13 of 18

CANCER SITE: Pre Treatment Staging: Post Treatment Staging: TRIALS CONSIDERED: MDT OUTCOME/PLAN OF ACTION: NEXT OPA & CONS: SIGNED: DATE: KEYWORKER: KEYWORKER(2): CONTACT No: CONTACT No: Name: Hospital No: DOB: Cons: NHS No: Clinical Audit of new cases of cervical Cancer Page 14 of 18

APPENDIX B AUDIT OF NEW CERVICAL CANCER CASE - REVIEW SUMMARY PATIENTS NAME:. DOB:. NHS NUMBER:. HISTOLOGY: Squamous Carcinoma PRESENTATION: Screening Endocervical Adenoca Symptomatic Other type* *Please specify: Stage:... Treatment:.. CYTOLOGY REVIEW: SLIDE NUMBER ORIGINAL REPORT INTERNAL REVIEW FINDINGS EXTERNAL REVIEW FINDINGS (if applicable) HISTOLOGY REVIEW COMMENTS: COLPOSCOPY REVIEW COMMENTS: SUMMARY / ADDITIONAL COMMENTS: MDT DISCUSSION OUTCOME: HBPC SIGNATURE: REVIEW DATE: Please note that this review is not a medico-legal review and is carried out by NHS staff for educational purposes. This report constitutes an NHSCSP audit review, not a legal review, and as such must be carefully discussed in this light. Clinical Audit of new cases of cervical Cancer Page 15 of 18

APPENDIX C CERVICAL CANCER AUDIT / DISCLOSURE RECORD SHEET (To be kept in patient notes and a copy sent to HBPC when complete) PATIENTS NAME: DOB: NHS NUMBER:.. HISTOLOGY: Squamous Carcinoma PRESENTATION: Screening Endocervical Adenoca Symptomatic Other type* *Please specify: Stage: Treatment:.. 1. First appointment after surgery / treatment Leaflet Reviewing your cervical screening history given on. (Date) By: Name..Signature.. 2. First follow-up appointment Is the patient aware an audit is being undertaken and why? YES NO Does she want to be informed of the review outcome? YES NO Discussed by: Name..Signature Date. 3. MDT action agreed: a) Audit has revealed nothing untoward patient to be written to / told at next appointment b) Patient written to - results of review available and to make an appointment to discuss with Consultant if she wishes to know the audit results Letter sent: By: Name..Signature Date. 4. Summary of Disclosure given to be completed by Consultant Gynaecologist: Patient and GP written to, confirming what was discussed in disclosure interview. Name..Signature Date. PLEASE SEND A COPY OF THIS COMPLETED FORM TO THE HOSPITAL BASED COORDINATOR Clinical Audit of new cases of cervical Cancer Page 16 of 18

Appendix D Reviewing your Cervical Screening History We know that this is a difficult time for you and naturally you will be concerned about your treatment and future health. However, you may also be wondering why you have developed cervical cancer, especially if you have had screening tests (often known as smear tests) in the past. Cervical screening reduces the risk of developing cervical cancer. Regular screening is by far the best way to detect changes to the cervix early on, but like other screening tests, it is not perfect. The cervical screening process involves many different steps which aim to identify and treat abnormal cells on the cervix to prevent cervical cancer. It may be that all steps have been followed efficiently and that a cervical cancer has developed despite the screening programme working properly. Or, it could be that at one or more of these steps, something may not have worked as well as it should. Reviewing your case history and previous tests will help identify what has happened in your case and if anything should have been done differently. Reviews are an essential part of every high-quality screening programme and are a routine part of the cervical screening process. Information we gather from individual cases helps to improve the programme and also helps us to learn more about how cancers develop and how they are diagnosed. Once we have completed the review we will contact you and invite you to arrange a convenient time for you to come and discuss the results with your doctor if you wish to do so. What does the review involve? We review all records connected to the letters inviting you to come for screening, your cervical screening tests, result letters and any previous medical investigations you have had related to cervical screening. A group of professionals will look again at your previous tests, your medical notes related to cervical screening, and also examine whether your screening history meets national guidance. What will the review show? In most cases, the review will show that the correct procedures have been followed and that you received appropriate care. Occasionally, the review may find that one or more steps in the process have not worked as well as they should and may highlight where we could make improvements. Could my cancer have been found earlier? In most cases the cancer will have been detected at the earliest possible stage. Although cervical screening prevents about 75% of cervical cancers, it cannot prevent all of them. The review process aims to highlight any possible areas of weakness so we can make improvements for everyone. Some examples are given below: Screening cannot always identify abnormal cells on a cervical sample slide because: sometimes the cells do not look much different from normal cells there may be very few abnormal cells on the slide consequently, the person reading the slide may miss the abnormality (this happens occasionally, no matter how experienced the reader is). Colposcopy (a visual examination of the cervix) cannot always identify abnormal areas of the cervix because: Clinical Audit of new cases of cervical Cancer Page 17 of 18

the abnormal area might not be visible during the examination the abnormal area might not be taken as a sample in a biopsy as it did not appear to be abnormal on Colposcopy the abnormal cells might be hidden higher up inside the cervix some types of abnormality are simply not easy to identify on colposcopy How will I find out the results of the review? Your doctor will let you know when the outcome is available, and invite you to make an appointment to come in and discuss the results, if you wish to do so. What if I don t want to know the results of the review? It is completely up to you to decide whether or not you want to know the results of the review. It will not make any difference to your care. What if I don t want to know the results of the review now, but change my mind later? We understand this is a difficult time and you may not want to receive the results of the review now. If you decide that you do want to know the results in the future, please contact your hospital doctor who will discuss the review with you. Can my family ask for the results if I don t want to know? No, unless you give permission; we cannot give your relatives access to any details of your medical records. What happens to the information collected for my review? We collect screening information as part of an ongoing process. Your information (without your name) goes towards improving the systems of the programme, and to help discover more about how cancers develop and how they are diagnosed and treated. This is done whether or not you want to know the results of the review. Your notes or questions Please write down any questions you have and bring them with you to your next appointment. More information If you have any more questions about your referral, treatment or the review process, please phone the Gynaecology Clinical Nurse Specialists on 01332 785925 If you have any questions about the review process, please contact PALS (Patient Advice and Liaison service) on 01332 785156 or Freephone 0800 783 7691 or e-mail PALS at dhft.contactpals@nhs.net Clinical Audit of new cases of cervical Cancer Page 18 of 18