Document filename: SCCI2026 Implementation Plan Cross Government Programme Project FGM Prevention Programme Project Manager Richard Steele Status Final Owner Richard Steele Version 1.0 Author Sam Sibeko Version issue date 01 Oct 2014 Directorate / Programme Document Reference FGM Enhanced Dataset Implementation Plan Copyright ©2014 Health and Social Care Information Centre Document Management Revision History Version 0.1 Date 18th Sept 2014 Summary of Changes Initial Draft 1.0 01 Oct 2014 Final version incorporating early CAP testing in November 2014 Reviewers This document must be reviewed by the following people: author to indicate reviewers Reviewer name Title / Responsibility Date Richard Steele HSCIC FGMP Programme Manager 18/09/2014 Version 0.1 Approved by This document must be approved by the following people: author to indicate approvers Name Astrid Fairclough Page 2 of 30 Signature Title Date DH FGMP Programme Manager 30/09/2013 Version 1.0 Copyright ©2014 Health and Social Care Information Centre Glossary of Terms Term / Abbreviation What it stands for DH Department of Health FGM Female Genital Mutilation FGMP Female Genital Mutilation Prevention (Programme) HSCIC Health and Social Care Information Centre (new name for NHS Connecting for Health as from April 1st 2013) ICD International Statistical Classification of Diseases and Related Health Problems Read Codes Standard clinical terminology system used in general practice SNOMED CT Classification of medical terms providing codes, terms, synonyms and definitions used. WHO World Health Organisation Document Control: The controlled copy of this document is maintained in the HSCIC corporate network. Any copies of this document held outside of that area, in whatever format (e.g. paper, email attachment), are considered to have passed out of control and should be checked for currency and validity. Page 3 of 30 Copyright ©2014 Health and Social Care Information Centre Contents 1 Contacts 5 2 Background 6 3 Purpose 7 4 Scope 8 5 Strategic Assumptions 11 6 Change Required 12 6.1 Current Situation 12 6.2 Success Criteria 12 7 Implementation Strategy 13 7.1 Implementation Approach 13 7.1 Pilot 15 7.2 Full Implementation 16 Project work streams 20 8 8.1 Governance 20 8.2 Communications and support 20 8.3 Conformance monitoring 21 Roles and responsibilities 22 9 9.1 Department of Health 22 9.2 HSCIC 22 10 Funding 23 11 Information governance and Clinical safety 24 12 Measuring Conformance 25 13 FGM Enhanced Dataset Adoption 27 14 Implementation Timetable 28 14.1 FGM Enhanced Dataset Pilot Test Plan 15 Maintenance and Review Page 4 of 30 29 30 Copyright ©2014 Health and Social Care Information Centre 1 Contacts For information on the dataset please contact Sam Sibeko FGM Enhanced Dataset Developer Name Sam Sibeko Organisation HSCIC Email Address Sam.sibeko@hscic.gov.uk Sponsor Name Flora Goldhill Organisation Department of Health Email Address Flora.goldhill@dh.gsi.gov.uk Copyright ©2014 Health and Social Care Information Centre 2 Background Currently there is the FGM Prevalence dataset which is being collected at a national level across all Acute Trusts (Foundation and non-Foundation) across England. The FGM Prevalence dataset will be retired from April 2015, and as such the FGM Enhanced dataset will be implemented from April 2015 to ensure; A continuation of FGM information being collected nationally within England The provision of more detailed FGM information regarding a patient, to better support; a. Identification of commissioned FGM services where required b. Identifiy risk of FGM occurring to young girls and vulnerable women Successful implementation is based on the following elements: 1. Data Recording: a standard approach to recording FGM information when this is identified and ensuring that this information is appropriately shared locally a standard and consistent approach to submit FGM information centrally to HSCIC 2. Data Collection and Flow: routine collection and recording of the Enhanced dataset in all NHS Acute Trusts (Foundation and Non Foundation), Mental Health Trusts and General Practices, in order to extract this information and submit this to the HSCIC on a monthly basis 3. Analysis and Intelligence: processing and analysis of the data to transform it into intelligence and then exploitatiing that intelligence to help inform the capability to identify potential FGM services, development of improved care pathways and the improvement in safeguarding approaches 4. FGM Enhanced Dataset Publication: using the intelligence identified to publish the findings (at an aggregate level only), and sharing this intelligence with other government agencies, to support safeguarding practices and increase prosecutions against FGM These elements must be underpinned by recognition of the shared goal of reducing FGM by all healthcare workers where FGM is identified and the establishment of routine working relationships and governance to sustain this with the DH. Achieving this requires action at a national level. Page 6 of 30 Copyright ©2014 Health and Social Care Information Centre 3 Purpose This document aims to set out the plans to implement the FGM Enhanced Dataset as across all Acute Trusts (Foundation and non-Foundation), Mental Health Trusts and GP Practices in England. These plans include all the activities required to support all applicable organisations, to implement the FGM Enhanced dataset, and the governance structures that will be required to ensure that the appropriate steps are clearly defined in order to support the implementation locally. The purpose of the FGM Enhanced dataset is to build on the FGM Prevalence Dataset, providing more detailed FGM information at the patient level, when FGM is identified by clinical staff, and subsequently return this to HSCIC on a monthly basis. In addition to the FGM Enhanced dataset, clinical engagement with Trusts will ensure that there is consistent communication about identifying FGM and its impacts on health to the patient, in conjunction with how this should be recorded within clinical notes locally to support monthly submissions to the HSCIC. This will further be supported by the work undertaken by the Department of Health’s FGM Prevention Programme of work. Limited knowledge of FGM for health professionals is a known issue, however, the introduction of the FGM Prevalence dataset, has laid the foundations for increasing that knowledge locally and provide a blue print for; How FGM information should be recorded How FGM information can be collected How FGM information can be submitted The full FGM Enhanced dataset suite, will continue to direct readers to the multiagency guidelines which are the current and best resource available. Page 7 of 30 Copyright ©2014 Health and Social Care Information Centre 4 Scope This information standard mandates the recording of FGM information when it is identified, to better support local processes in raising the awareness of the potential risks of FGM occurring to young girls and vulnerable women. In addition to this, the central flow of administrative and clinical information will be used for secondary uses purposes. The standard defines the data items to be recorded and extracted from existing clinical systems, and also additional information identified as part of any consultation, clinical diagnosis or clinical procedure. The scope includes all activity undertaken by all clinical settings funded, and/ or provided by the NHS. In summary, this includes the following organisations which MUST return the FGM Enhanced dataset; NHS Hospital Trusts (Foundation and Non Foundation NHS Trusts) NHS Mental Health Trusts General Practitioners o All NHS funded providers are required to conform to this standard For clarity the FGM Enhanced Dataset is outlined in full below; Standard Standard Number SCCI2026 Standard Title Female Genital Mutilation (FGM) Enhanced Dataset Description The FGM Enhanced Dataset requires organisations to record collect and return more detailed information about FGM within the patient population, as treated by the NHS in England. Female Genital Mutilation (FGM) is illegal in the UK, as is taking a child abroad to undergo FGM, as legislated in the 2003 Female Genital Mutilation Act. FGM is medically unnecessary, extremely painful and has serious health consequences both at the time when the mutilation is carried out and in later life. Whilst there have been no prosecutions, it is believed that the practice continues both in the UK and that girls are taken abroad for the purpose of FGM. FGM must also be treated as child abuse. There are UK government multi-agency guidelines: https://www.gov.uk/government/publications/female-genital-mutilation-guidelines Particular note should be given to guidelines for health professionals. The NHS is in a unique position to identify detailed information about women where FGM has been undertaken, including family history information to help identify potential risks of occurring to girls and vulnerable women. There are multiagency guidelines in place detailing what to do but there is recognition that this is not happening in all cases. Further to this is the existing FGM Prevalence dataset, which mandates that FGM must be recorded within all clinical settings. This standard builds upon the 1610 FGM Prevalence Dataset. There is a programme of work, led by the Department of Health, to improve the NHS response to FGM, and subsequent management of women and safeguarding for girls at risk. This standard introduces additional requirements to that of the FGM Prevalence dataset about information that must be captured and must be centrally returned. Page 8 of 30 Copyright ©2014 Health and Social Care Information Centre Recording FGM Information The FGM information captured is needed to help provide a consistent approach to sharing FGM information locally and specifically includes the following; 1. All clinicians, regardless of organisation type, to record in clinical notes when FGM is identified, and what type it is following clinical examination, using the FGM clinical codes, published in April 2014 (also detailed later in this document). This builds upon the FGM Prevalence dataset, but clinical terminology MUST be used to record the FGM information within all settings. 2. All Maternity Discharges, must include relevant FGM information identified, prior to and post-delivery of baby, informing the GP and Health Visitor of the FGM identified during the provision of care. 3. All babies born to a mother with FGM, must have the relevant FGM information recorded in the babies patient healthcare record to help identify the potential risk of FGM facing the young girl Where FGM is identified, all referrals made by General Practitioners MUST include FGM information when referring to relevant services where FGM may be applicable e.g.; Urology, Paediatric Urology, Paediatric Dermatology, Dermatology, Genitourinary Medicine, Obstetrics, Gynaecology, Gynaecology Oncology, Midwifery Service or Psychiatric Services – this list is not exhaustive 4. When FGM is identified this MUST be included within screening returns, immunisation notes and also included within the Red Book following the birth of a child. When FGM is identified health promotion MUST also be provided. Submitting FGM Information The FGM Enhanced dataset collection will specifically require the stated organisations to return the FGM information for each patient. The collection and submission of this information aims to support improvements in; the identification of FGM and the wider social issues that impact upon the victim and thus improve public awareness and inform the development of training for clinicians data quality by promoting more detailed recording of FGM when it is identified; and provide better evidence for potential prosecutions of those who carry out FGM supporting the sharing of women’s information to other referred services aligning prevention (through risk identification) and support for the women, identifying where support is needed most. provide secondary use data to support aggregated studies on the prevalence of FGM in detail informing local and cross government organisations to the prevalence of FGM and therefore support the ability to target specific areas for the commissioning of appropriate services, and training needs a more informed collection of the risk of FGM to young girls and vulnerable women, resulting in improved safeguards against FGM, including early intervention by relevant organisations to reduce and work towards the eradication of FGM opportunities to facilitate greater and more comprehensive academic research, including the potential to support the identification of community education programmes Applies to Page 9 of 30 Recording FGM information – all NHS funded providers Returning FGM information – all Acute (Foundation and Non-Foundation Trusts), Mental Health Trusts and GP Practices Copyright ©2014 Health and Social Care Information Centre Release Release Number SCCI2026 Release Title FGM Enhanced Dataset Description The recording and submission of detailed FGM information when this is identified from within Acute, Mental Health and GP Practices Voluntary Implementation Date 1 April 2015 to submit FGM information to HSCIC 1 April 2015 to Record and Share FGM information locally when identified Mandatory Implementation Date Page 10 of 30 1 Aug 2015 to Record the FGM Enhanced dataset items 1 Oct 2015 to Submit FGM information to HSCIC. (This will require the FGM Enhanced dataset information to be Recorded locally from 1st August 2015) Copyright ©2014 Health and Social Care Information Centre 5 Strategic Assumptions All applicable health organisations, will be collecting the dataset and submitting this with HSCIC on a monthly basis Most Trusts will require some support to implement the dataset to the specified standard The priority for this release is to ensure the standard and the more detailed FGM information can build on, and implement, the data collection and flow mechanisms. Governance for implementation and beyond will be provided by the HSCIC Once the standard has been implemented, the DH will have strategic oversight and provide governance for future developments including periodic review of the standard, changes and future development of the standard and eventual withdrawal of the standard; Future developments might include: o The standardisation of flow mechanisms and data formats o Changes to the data items o The migration of the audit function (currently the responsibility of DH) to NHS England Trusts are already expected to follow the FGM multi-agency guidelines in relation to recording FGM in clinical records. Acute Trusts (Foundation and non Foundation) are already submitting monthly FGM information Page 11 of 30 Copyright ©2014 Health and Social Care Information Centre 6 Change Required 6.1 Current Situation Whilst Acute Trusts (Foundation and non-Foundation), are currently collecting FGM Prevalence information, this collection does not go far enough to support specific risks of FGM and in addition, not only where FGM is identified, but where patients are currently residing (which can be used to better to support the need for FGM services across various regions). There are some organisations which have a particular interest in the identification and treatment of FGM, and with the FGM Prevalence dataset, awareness of FGM is growing, in addition to understanding the appropriate clinical pathways to follow. 6.2 Success Criteria All applicable organisations recording FGM on patient records when identified in accordance with the FGM multi-agency guidelines. All applicable healthcare organisations sharing FGM information locally, included alongside existing referral and discharge information All applicable healthcare organisations understand the benefits of collecting and sharing the FGM Enhanced dataset information All applicable healthcare organisations are collecting the FGM Enhanced dataset on a monthly basis, with a high level of data quality and are submitting this via the Clinical Audit Platform tool A sufficient level of quality data is being collated in order to; o continue with the collection of FGM prevalence information nationally o identify where additional FGM support services may be required o develop improved safeguarding processes based on the information identified Page 12 of 30 Copyright ©2014 Health and Social Care Information Centre 7 Implementation Strategy 7.1 Implementation Approach The technical aspects of implementing the FGM enhanced dataset are expected to be minimal. Whilst it would be welcome for the NHS to develop automated capture of the FGM Enhanced dataset, this is by no means anticipated to have been developed nationally, by April 2015 The FGM implementation guidance will specifically include the following and will be further updated and detailed accordingly. This will specifically include clinical, with wider input required from Dept of Health in agreement with various Royal College approvals as part of the wider FGM Prevention Programme of work. It is anticipated that the FGM Enhanced dataset implementation guidance will specifically include the following information which will be developed further in following further stakeholder consultation and CAP development; 1. Trust Readines & Communication Guidance outlining that it will be essential for clinicians and information teams (GPs and Practice Managers), communicate locally, and ideally have implementation plans in place to support; o Awareness of the FGM Enhanced dataset information standard implementation and submission timescales o Which mechanisms will be used by which clinicians within the organisaton o How the information will be collected by the Information Teams or GP Practice managers, e.g. manual spreadsheet collections or code queries Page 13 of 30 Overview on the schedules for submission, including; o The date periods with which FGM information is to be recorded by clinicians o The associated collection period and when this needs to be made available to the Information Team or GP Practice managers o The time period to collect this information locally o The data quality and confirmation of complete information locally o The submission period to HSCIC via CAP Provision of the FGMP Upload too, which will require the following agreement locally; o Confirmation locally of how this can be accessed, by whom and when Copyright ©2014 Health and Social Care Information Centre 2. Clinical Guidance This will be outlined and expanded to specifically support the different clinical groups; General Practitioners o Guidance on the FGM codes to be used and when o Guidance to help determine who will be responsible within the GP Practice for submitting the monthly return to HSCIC o Guidance on how to ask questions about FGM – this will be provided by Department of Health Midwives, FGM specialist clinicians, all other clinicians o Guidance on the FGM codes to be used and when o The mechanisms available to record the FGM information o Guidance to support the data dictionary model content o Guidance about what FGM is and the provision of links to wider FGM documentation 3. Information Teams and Practice Managers Overview of the CAP Registration process for Acute and Mental Health Trusts Overview of the CAP Implementation Guidance for Acute and Mental Health Trusts The mechanism used to submit the FGM information to HSCIC Guidance to about the storage of patient lists locally, whilst adhering to existing protocols around patient data and the safe and secure storage of the information Specific guidance outlining how the FGM information recorded by clinicians can be recorded within CAP, specifically the options to; o Run FGM code queries against local patient databases to extact the relevant FGM information o Use of spreadsheets and how this will be stored, accessed and who they will be available to Data quality requirements o Avoidance of duplications o Confirmation of returns within the organisation from all relevant clinicians and departments o Where clinicians have direct access to CAP and where FGMP Upload tools are also used, to ensure that all records are complete locally o Assessment of newly identified records for that recording period o Assessment of active cases locally that have been previously submitted and have ongoing care needs Page 14 of 30 Copyright ©2014 Health and Social Care Information Centre 4. HSCIC Support Guidance Support on how to retrieve the FGM information for each Trust Support on how to retrieve and create the relevant FGM reporting capability o Whilst it is anticipated that the FGM information will result in the production of Official Statistics, it is not known at this time, the detail of this information Support and guidance in analysing the data received Identification of trends as a result of the FGM information received Guidance on ensuring the quality of the data is fit for purpose and that any anomalies are appropriately identified, with the appropriate checks in place to help determine the accuracy of the information. Provision of Trust contacts as part of the registration process to ensure a contacts list is available to analysts. 7.1 Pilot A short pilot will be run, prior to the Implemention date in April 2015. This is expected to be undertaken in Dec 2014, lasting a month to allow for early submission to the SCCI Committee. The Test Strategy is outlined further within the FGM Enhanced Dataset Draft Requirements Specification. The pilot will have the following aims: 1. 2. 3. 4. Introduce the new FGM enhanced processes and collection tools to the Trusts, leading to a higher uptake of the standard at the earliest possible dates. Prolonged review of support materials. Learning and preparation for the project team in anticipation of the publication of the standard Feb 2015. Early exposure to the reporting cycle will improve the preparedness for the full publication. Early identification of any key issues. Any advance warning of complications will be highly beneficial. The outcome of the pilot will be provided to SCCI in Jan 2015. Page 15 of 30 Copyright ©2014 Health and Social Care Information Centre 7.2 Full Implementation Patient identifiable information when FGM has been identified will be submitted to HSCIC via the Clinical Audit Platform tool, the clinical audit collection tool, owned and supported by the HSCIC. The CAP system can be accessed following registration to the service, providing opportunity for it to be determined locally who will require access to the submission tool. The CAP tool is already used within Trusts, although guidance will be required to detail the specific FGM information to be uploaded on a monthly basis. The FGM Enhanced dataset will be collected and submitted 2 months following collection, on the 5th working day of the following 2 months. This will allow time for the appropriate information to be collected locally, for appropriate data quality activity to be undertaken. This will also be required where no FGM has been identified by the Trust within a reporting period. The high level dates outlined in the table below, outline when the FGM Enhanced dataset MAY and MUST be implemented, for both the recording of FGM information and sharing this locally, and also the central submission of FGM information to HSCIC; Voluntary Implementation Date 1 April 2015 to Submit FGM information to HSCIC Mandatory Implementation Date 1 April 2015 to Record FGM information locally 1 Oct 2015 to submit FGM information to HSCIC Current Expected End Date 31st Mar 2020 Copyright ©2014 Health and Social Care Information Centre The following collection schedule outlines the responsibility, activity and dates for the Submission of the FGM Enhanced dataset from all applicable organisations, including the responsibility for Recording, Collecting, Analysing and Submitting the FGM Enhanced information. The Highlighted sections outline when it will be Mandatory for the FGM Enhanced dataset to be undertaken. Month Clinicians & GPs Information Team Analysts & Practice Managers Information Team Analysts & Practice Managers HSCIC HSCIC Local Identification and Recording (Between) Local Collecting and Compiling of Data (Completed Between) Local Submission of Enhanced Dataset (Submitted Between) Receipt of FGM Enhanced Dataset (Received By) Quality Review, Analysis & Data Preparation (Completed By) Apr 2015 1st Apr – 30th Apr May 2015 1st May – 31st May 1st May – 31st May (Apr data) Jun 2015 1st Jun – 30th Jun 1st Jun – 30th Jun (May data) 1st – 5th Jun 2015 (Apr data) 5th Jun 2015 (Apr data) 30th June 2015 (Apr data) Jul 2015 1st Jul – 31st Jul 1st Jul – 31st Jul (Jun data) 1st – 7th Jul 2015 (May data) 7th Jul 2015 (May data) 31st July 2015 (May data) 7th 31st 1st Aug – Aug (Jul data) 31st 3rd – Aug 2015 (Jun data) 7th Aug 2015 (Jun data) Aug 2015 (Jun data) Aug 2015 1st Aug – 31st Aug Sept 2015 1st Sept – 30th Sept 1st Sept – 30th Sept (Aug data) 1st – 7th Sept 2015 (Jul data) 7th Sept 2015 (Jul data) 30st Sept 2015 (Jul data) Oct 2015 1st Oct – 31st Oct 1st Oct – 31st Oct (Sept data) 1st – 7th Oct 2015 (Aug data) 7th Oct 2015 (Aug data) 31st Oct 2015 (Aug data) Nov 2015 1st Nov – 30th Nov 1st Nov – 30th Nov (Oct data) 2nd – 6th Nov 2015 (Sept data) 6th Nov 2015 (Sept data) 30th Nov 2015 (Sept data) Dec 2015 1st Dec – 31st Dec 1st Dec – 31st Dec (Nov data) 1st – 7th Dec 2015 (Oct data) 7th Dec 2015 (Oct data) 31st Dec 2015 (Oct data) HSCIC Official Statistics Publication (Released On) Voluntary Submission Period: Internal Management Reports 1st October 2015; (Q1:1st Apr – 30th Jun Data) Copyright ©2014 Health and Social Care Information Centre Jan 2016 1st Jan – 31st Jan 1st Jan – 31st Jan (Dec data) 4th – 8th Jan 2016 (Nov data) 8th Jan 2016 (Nov data) 31st Jan 2016 (Nov data) Feb 2016 1st Feb - 29th Feb 1st Feb – 29th Feb (Jan data) 1st – 5th Feb 2016 (Dec data) 5th Feb 2016 (Dec data) 29th Feb 2016 (Dec data) Mar 2016 1st Mar – 31st Mar 1st Mar – 31st Mar (Feb data) 1st – 7th Mar 2016 (Jan data) 7th Mar 2016 (Jan data) 31st Mar 2016 (Jan data) Apr 2016 1st Apr – 30th Apr 1st Apr – 30th Apr (Mar data) 1st – 7th Apr 2016 (Feb data) 7th Apr 2016 (Feb data) 30th Apr 2016 (Feb data) May 2016 1st May – 31st May 1st May – 31st May (Apr data) 2nd – 6th May 2016 (Mar data) 6th May 2016 (Mar data) 31st May 2016 (Mar data) Jun 2016 1st Jun – 30th Jun 1st Jun – 30th Jun (May data) 1st – 7th Jun 2016 (Apr data) 7th Jun 2016 (Apr data) 30th Jun 2016 (Apr data) Jul 2016 1st Jul – 31st Jul 1st Jul – 31st Jul (Jun data) 1st – 7th Jul 2016 (May data) 7th Jul 2016 (May data) 31st Jul 2016 (May data) Aug 2016 1st Aug – 31st Aug 1st Aug – 31st Aug (Jul data) 1st – 5th Aug 2016 (Jun data) 5th Aug 2016 (Jun data) 31st Aug 2016 (Jun data) Sept 2016 1st Sept – 30th Sept 1st Sept – 30th Sept (Aug data) 1st – 7th Sept 2016 (Jul data) 7th Sept 2016 (Jul data) 30th Sept 2016 (Jul data) Oct 2016 1st Oct – 31st Oct 1st Oct – 31st Oct (Sept data) 3rd – 7th Oct 2016 (Aug data) 7th Oct 2016 (Aug data) 31st Oct 2016 (Aug data) Nov 2016 1st Nov – 30th Nov 1st Nov – 30th Nov (Oct data) 1st – 7th Nov 2016 (Sept data) 7th Nov 2016 (Sept data) 30th Nov 2016 (Sept data) Dec 2016 1st Dec – 31st Dec 1st Dec – 31st Dec (Nov data) 1st – 7th Dec 2016 (Oct data) 7th Dec 2016 (Oct data) 31st Dec 2016 (Oct data) Page 18 of 30 Copyright ©2014 Health and Social Care Information Centre 1st Jan 2016 including; (Q2: 1st Jul – Sept 30th Data) 1st April 2016 including; (Q3: 1st Oct – 31st Dec Data) 1st Jul 2016 including; (Q4: 1st Jan – 30th Mar Data) 1st Oct 2016 including; (Q1: 1st Apr – 30th Jun Data) The bulk of the work lies in: Ensuring that the Trusts are communicated to effectively in order to understand what needs to be captured and when Informing the NHS staff about the FGM Enhanced dataset and how this differs to the FGM Prevalence dataset collection approach Developing the necessary working relationships and networks locally to sustain the flow of information and underpin data quality The implementation methodology is focused on: Communications to get the key messages to the right people via the most appropriate channels Provision of guidance and support documentation to propagate best practice including use of the FGM multi-agency guidelines [ref 1] pages 27 – 29. Establishment of local working relationships and feeding back intelligence on the progress of implementation and any blockages The mobilisation of the formal levers available to help ensure successful implementation Audit processes to gauge success and inform future development. Building on the pilot implementation there will be an initial focus on the Trusts with an interest in FGM to help support through the implementation phases of the first few months. Page 19 of 30 Copyright ©2014 Health and Social Care Information Centre 8 Project work streams The main project work streams are set out below. 8.1 Governance Robust governance and project management is required to ensure the objectives outlined above are realised. The Department of Health will continue to have the overarching lead role, with a programme board directing the programme, reflecting the partnership between DH, NHS England and HSCIC. The DH will monitor progress and act as the point of escalation for any risks and issues that may threaten the collection of data. Once the standard has been implemented, the DH will lead on the successful outcome of the implementation and make decisions about future directions. 8.2 Communications and support This work stream addresses the existing risk that clinical staff are following the latest existing FGM multi-agency guidelines, in relation to recording details of FGM in clinical notes. The effort takes into account the plan for a significant training and awareness campaign to begin in October 2014. The intention therefore is to enable all well intentioned Trusts to be able to adhere to the standard with the least possible burden, therefore ensuring efficiency. By introducing simple measures, this exercise will inform the future work of the programme through targeting and raising awareness. Copyright ©2014 Health and Social Care Information Centre 8.3 Conformance monitoring DH will remain responsible for conformance monitoring with 2 audits to be undertaken: Initial Trusts submitting – following the initial submission period July 2015 Initial Stage Audit – at the end of the initial mandatory submission period Nov 2015 These audits will review and identify which Trusts have been submitting information and help determine how successful the implementation plan has been in practice. It will collect enough information to determine whether additional implementation activity is required beyond the end of the SCCI approved window. In addition, the following will be monitored to ensure the successful implementation of the standard. # Criteria 1 All components of the FGM Enhanced dataset MUST be collected as specified. 2 The FGM Enhanced dataset MUST be input into the Clinical Audit Platform (CAP) as made available to each applicable organisation for the specified reporting periods. 3 Centrally issued guidance and FAQs SHOULD be used to steer decisions. 4 Providers MUST apply data validation processes to assure the quality and completeness of the data prior to submission to HSCIC. 5 Quality assurance MUST be undertaken by Information Teams to ensure that a patient is not counted twice within a submission, and therefore avoid duplicate recording of information. Page 21 of 30 Copyright ©2014 Health and Social Care Information Centre 9 Roles and responsibilities 9.1 Department of Health Provide governance, setting up the necessary representation to oversee implementation, maintenance and strategic development Provision of funding to support the implementation, collection, analysis and publication of FGM information received from the applicable healthcare organisations. 9.2 HSCIC Business analyst, to support the development of the FGM Enhanced Dataset Audit Manager support to provide the relevant resource to analyse submissions received, undertake quality assurance, develop publications Project team to lead the implementation plan and support of the FGM Enhanced Dataset with applicable healthcare organisations. Page 22 of 30 Copyright ©2014 Health and Social Care Information Centre 10 Funding Most of the implementation activity described will be absorbed within the business as usual activities of the organisations involved. There will be no specific funding made available to NHS Trusts to support the implementation of the standard. A small budget has been secured to support the central Implementation work, and Department of Health are aware of the ongoing costs to support the development of CAP, the collection, analysis and publication of FGM information. Whilst these costs are not fully detailed at this time, as further development is undertaken in this area, DH will be funding this. . Page 23 of 30 Copyright ©2014 Health and Social Care Information Centre 11 Information governance and Clinical safety There are no clinical safety issues identified with the FGM Enhanced Dataset collection following clinicical safey initial asssessment. With regards to the local collection of patient’s FGM information, this will be patient identifiable information in order to ensure; Data quality and avoid the duplication of counting patients twice Data linkage with information extracted from General Practitioners Support transition of this dataset into the existing Maternity, Child and Adolescent Mental Health Services and Children and Young People’s datasets To support the collection of this patient identifiable information, patient consent will be required to support the sharing of this information. Whilst implied consent will be obtained, to support the recording of FGM information locally with other clinicians to support the provision of care, following the consultation with the clinician, when this information is to be shared with HSCIC, this will require patient consent in order to do so, and this must be explicitly recorded The collection and storage of FGM information, will need to adhere to a Trust’s existing patient information security principles, namely Confidentiality: NHS Codes of Practice policy, built in conjunction with the existing 3 principles around information security; Information must be secured against unauthorised access - confidentiality Information must be safeguarded against unauthorised modification - integrity Information must be accessible to authorised users at times when they require it - availability Page 24 of 30 Copyright ©2014 Health and Social Care Information Centre 12 Measuring Conformance In order to measure conformance to the FGM Enhanced dataset and as outlined as part of the FGM Enhanced Dataset Data Quality criteria, the following will be expected; Conformance Criteria The threshold on the coverage of organisations submitting the FGM Enhanced dataset is still to be determined, but initial expectations are that; 95% of all FGM specialist clinics will submit data 70% of all remaining Trusts will submit data It still to be determined what the percentage of GPs will be required to support the usability of the FGM information received The threshold on the completeness of initial submissions from organisations is still to be determined. It is expected that all mandatory FGM Enhanced dataset items will be 100% validated, when manually entering the data into the FGMP Collection Tool. It is expected that all mandatory FGM Enhanced dataset items will be 100% validated, when clinician’s directly enter the data into CAP. It is expected that all NHS numbers will be 100% validated, when clinician’s manually record data in the FGMP CollectionTool, or, directly record data within CAP, as a result of the modulus 11 check undertaken within the FGMP collection tool. It is acknowledged that Required data items will not have the same validation restrictions to ensure completeness, but analysis will be undertaken within HSCIC to help identify, where the same submitting organisation omits any Required or Optional FGM information. Whilst it will be legitimate to submit non mandatory FGM dataset items, continual omission of this information ‘could’ provide an indication to non compliance of the dataset. The threshold on the omission of Required and Optional dataset items is still to be determined. The FGM Enhanced dataset will be provided by all Acute (Foundation and Non Foundation) Trusts, Mental Health Trusts and General Practices, on a monthly basis. Where no FGM information was identified locally, it will still be mandatory to provide a Nil return. Initial analysis of FGM Type Unknowns being received within the dataset, will provide a baseline figure, used to help identify where additional training and FGM awareness may be required. Further to this, the initial baseline will be used to confirm the improvements in training, although the threshold on the expected reduction in the number of FGM Type Unknown is still to be determined. Page 25 of 30 Copyright ©2014 Health and Social Care Information Centre Page 26 of 30 Copyright ©2014 Health and Social Care Information Centre 13 FGM Enhanced Dataset Adoption The adoption process will vary depending on the state of development of the FGM process in each specific locality. However, a high level generic approach will be: 1. Assessment of the applicable health organisations data collection, recording, extraction and transmission process against the published standards documentation 2. Assessment of the setup and governance arrangements against the implementation guidance 3. Development of an implementation plan locally that includes as a minimum: o The establishment of routine governance arrangements o Agreement on the data format and transmission mechanisms to be used locally o Agreement and communication on the timetable for delivery of data and the receiving organisation Page 27 of 30 Copyright ©2014 Health and Social Care Information Centre 14 Implementation Timetable The proposed timetable for implementing the FGM Enhanced dataset and establishing the support arrangements are set out below. Task Responsible Due by Communications & Support Particular Interest sites (pilot) early engagement and communication DH Sept - 2014 On-going public consultation via existing Patient, Survivor and Victim Groups in conjunction with DH engagement DH Oct - 2014 Clinical guidance preparation (All applicable healthcare organisations) DH Nov - 2014 Information Team analyst guidance preparation (All applicable healthcare organisations) DH Nov - 2014 Engagement with Royal Colleges DH Nov - 2014 Circulation to all stakeholders in DH FGM network DH Nov - 2014 Guidance to NHS Trusts published DH Mar - 2015 FGM Enhanced dataset communication (All applicable healthcare organisations) DH Apr - 2015 Circulation via Royal Colleges to professionals DH Apr - 2015 Recording: FGM Enhanced dataset – Mandatory NHS Organisations Apr - 2015 Submitting: FGM Enhanced dataset – Voluntary (this will require the collection of FGM information from Mar 2015) NHS Organisations Apr - 2015 Submitting: FGM Enhanced dataset – Mandatory (this will require the collection of FGM information from Aug 2015) NHS Organisations Aug - 2015 Trusts initially submitting identification DH June - 2015 Trusts not submitting identification DH Oct - 2015 HSCIC Oct - 2015 Conformance Monitoring FGM Enhanced dataset Official Statistic publication Page 28 of 30 Copyright ©2014 Health and Social Care Information Centre 14.1 FGM Enhanced Dataset Pilot Test Plan The table below outlines the high level plan for the Piloting of the FGM Enhanced dataset. Task Responsible Due by Clinical Audit Platform development to begin; (including FGMP Upload Tool and FGMP Collection Tool) HSCIC Oct -2014 Identification of FGM Enhanced dataset Pilot Sites, including named contacts HSCIC Oct -2014 Pilot site confirmation (including; clinicians and information team analysts) HSCIC Early Nov - 2014 Circulate FGM Enhanced dataset Pilot documentation; (Overview, Objectives, Approach, Timescales, Test Criteria & Questionnaire/ Survey) HSCIC Late Nov - 2014 Clinical Audit Platform development completed HSCIC Mid Nov - 2014 FGM Enhanced dataset pilot start HSCIC Late Nov - 2014 FGM Enhanced dataset pilot end HSCIC Late Dec – 2014 Submission of Pilot Test Report HSCIC Late Dec - 2014 FGM Enhanced dataset extended pilot review HSCIC Feb – 2015 Testing and Piloting If there is any delay in the development of CAP and piloting of the dataset by Dec 2014, then the contingency will include; - Provision of the test report without the findings, outlining acceptance of all known risks and issues and confirmation of acceptance from DH. - Provision of a statement, rather than the inclusion of the complete report findings with regards to the testing outcome. Further to this however, will be consideration of the following if and where applicable; o Reduction in the Pilot testing time frame o Re-prioritise development of CAP to support direct entry by clinicians. If direct entry by clinicians is still not possible for 1st April 2015, communications will be provided to remove this method of submission from 1st April 2015 to 1st October 2015. Dependent on the outstanding issues, to proceed with the Implementation Date of 1 st April 2015 with acceptable issues to DH and the FGMP Programme Page 29 of 30 Copyright ©2014 Health and Social Care Information Centre 15 Maintenance and Review Department of Health will have the operational ownership of the Standard and manage any future development work, including: Changes to data items either to include additional data or redact specific fields Changes to the recommended extraction and transfer schedule Introduction of standardised flow mechanisms including data formats Introduction of alternative data collection mechanisms (e.g. collection by Primary Care or Community Health teams) Withdrawal of the standard when it is no longer required. No changes to the standard will be made without the explicit approval of DH. Copyright ©2014 Health and Social Care Information Centre