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Cancer Outcomes and Services Dataset Sponsor Department of Health Version Number 1.1 Developer National Datasets Service Version Date 18.01.2010 Cancer Outcomes and Services Data Set Requirement Operational Information Standard Amendment History: Version Date Amendment History 0.1 03.11.2009 Circulated to Project Board and A. Casey ISB for review 0.2 23.11.2009 Elaboration of section 2.5, additions to other sections to address ISB comments. Circulated to Project Board and A. Casey for review. 0.3 27.11.2009 Amendments to reflect feed back from Project Board members. Circulated to Project Board for approval. 1.0 03.12.2009 Approved version submitted to ISB 1.1 18.01.2010 Revisions to address ISB appraisal disposition Related Documents: These documents will provide additional information. Reference Number Title Version Appendix C Project Initiation Document v1.0 1.0 Approval: This document must be approved by Project Board member Version Date Chris Carrigan (Project Executive) 1.1 18.01.2010 Ally Butler (Senior Supplier) 1.1 18.01.2010 Distribution: Cancer Outcomes and Services Data Set Project Board Document Status: This is a controlled document. Whilst this document may be printed, the electronic version maintained internally by the owning department is the controlled copy. Any printed copies of the document are not controlled. ISB Submission Template v 11 (13th May 2008) and Toolkit Version 3.0 (29th May 2008) have been used for this submission. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 2 of 30 Table of Contents 1. Standard Demographics ..........................................................................................................4 1.1. Name of Standard ...................................................................................................................4 1.2. Sponsors .................................................................................................................................4 1.3. Developers ..............................................................................................................................4 1.4. Commercial Issues .................................................................................................................4 1.5. Customer Need .......................................................................................................................4 2. Purpose and Scope ...................................................................................................................6 2.1. Standard Overview..................................................................................................................6 2.2. Purpose ...................................................................................................................................6 2.3. Scope .......................................................................................................................................7 2.3.1. What will the proposed standard be used for? .............................................................7 2.3.2. Who is the subject? ........................................................................................................7 2.3.3. Who will use it? ...............................................................................................................7 2.3.4. How will it be used in routine existing working practices? ..........................................8 2.3.5. Where will it be used? .....................................................................................................9 2.4. Out of Scope..........................................................................................................................10 2.5. Performance Characteristics ...............................................................................................10 3. Business Justificat ion ...........................................................................................................12 3.1. Strategic Fit ...........................................................................................................................12 3.1.1. Criteria under which the proposed information standard is submitted ....................12 3.1.2. Business justification ...................................................................................................12 3.1.3. When are the NHS and/or social care organisations required to adhere to the proposed information by? ............................................................................................................13 3.1.4. Review of Central Returns (ROCR) Submission Plan (NHS only) / Strategic Information Group for Adult Social Care (SIGASC) Submission Plan (Social Care only) ........13 3.2. Relationship to the National Programme for IT (NPfIT) ......................................................13 3.3. Operational Fit.......................................................................................................................14 3.3.1. Concept of Operation ....................................................................................................14 3.4. Impact and Implications .......................................................................................................18 3.4.1. Implications to stakeholders ........................................................................................18 3.4.2. Analysis of replacement of existing standards ...........................................................18 3.5. Known Standards..................................................................................................................19 3.5.1. Existing standards with a related purpose and scope ...............................................19 3.5.2. Assessment to include or eliminate.............................................................................19 3.6. Interdependencies ................................................................................................................20 3.6.1. Existing or planned standards .....................................................................................20 3.6.2. Projects, programmes or organisations ......................................................................21 3.7. Consultation and Support ....................................................................................................21 4. Devel opment and I mplementation ......................................................................................23 4.1. Timelines ...............................................................................................................................23 4.2. Provisional Testing Approach..............................................................................................24 4.3. Implementation Plans ...........................................................................................................25 4.4. Governance Issues ...............................................................................................................26 4.5. Migration Issues ....................................................................................................................26 4.6. Costs and Funding................................................................................................................26 4.7. Safety .....................................................................................................................................27 4.8. Maintenance ..........................................................................................................................27 4.9. Conformance .........................................................................................................................28 4.10. Evaluation..............................................................................................................................28 APPENDIX A ......................................................................................................................................29 Sponsor Statement(s) .......................................................................................................................29 APPENDIX B ......................................................................................................................................30 NHS Connecting for Health - Technology Office Statement ..........................................................30 Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 3 of 30 1. 1.1. Standard Demographics Name of Standard Cancer Outcomes and Services Data Set 1.2. Sponsors Gerard Hetherington Director Clinical Policy & Strategy Division Department of Health Wellington House, 133-155 Waterloo Road London SE1 8UG [email protected] 1.3. Developers National Datasets Service The NHS Information Centre for health and social care 1 Trevelyan Square Boar Lane Leeds LS1 6AE Tel: 0845 300 6016 Project Manager: Alison Roe The National Datasets Service is a recognised standards developer and will also be responsible for the ongoing maintenance of the standard. 1.4. Commercial Issues The intellectual property rights of SNOMED CT lie with the International Health Terminology Standards Development Organisation (IHTSDO). NHS Suppliers require a license from NHS Connecting for Health for this to be implemented in systems. There are no other commercial, licensing or Intellectual Property Rights issues relating to the use of this standard within the NHS. 1.5. Customer Need This standard development is to provide a new operational information standard for Cancer services in England. It is will replace the existing National Cancer Data Set and associated collections to provide an up to date collection that supports the current policy and strategy for Cancer services. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 4 of 30 The Cancer Reform Strategy (2007) 1 sets out a clear direction for cancer services through to 2012, building upon the progress achieved since publication of the NHS Cancer Plan (2000). The Cancer Reform Strategy (‘the strategy’) sets out a programme of action in ten areas, six relating to action to improve cancer outcomes and four that relate to action to ensure delivery. The strategy states that “defined data sets of clinical outcomes information” will be collected as part of the national model contract and that this work will be co-ordinated by the National Cancer Intelligence Network (NCIN). The network has been established to build, maintain and quality assure a new national repository of cancer data. The National Datasets Service carried out the development of cancer data sets following publication of the NHS Cancer Plan (2000) and has been commissioned to work with NCIN to carry out a review of the cancer data sets to ensure that they are fit for purpose and relevant to the requirements of current cancer services and the Cancer Reform Strategy. The approval status of the existing cancer data sets is mixed, as is the implementation within services. Both the National Datasets Service and the Information Standards Board for Health and Social Care (ISB) have carried out reviews of these existing data sets and both reports 2 3 provide evidence of the need to revise and update the National Cancer Data set in line with current service and policy requirements. This submission is the first stage in that process. The key customers and beneficiaries of the standard will include; NHS provider and commissioner organisations Cancer Registries Department of Health and the National Cancer Intelligence Network Strategic Health Authorities Clinical and administrative system suppliers Royal Colleges and audit groups National Cancer Research Institute and other research groups (Section 2.3.3. contains more detail of who will use the information standard.) Indirectly, patients will be beneficiaries of the standard as the information produced will be used to support the delivery of service improvements and increased patient choice. This new standard will use clinically recorded data to derive the secondary uses information to report on delivery of the Cancer Reform Strategy objectives. This will address the existing issues of relevance, variation of definitions between collections and low completion rates, as documented in the ISB report, by aligning collection to one consistent set of data item definitions. 1 Cancer Reform Strategy, Department of Health 2007 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_081006 2 National Cancer Datasets Review, Interim Stage Report. 2007 A Butler, National Datasets Service National Cancer Dataset Review August – October 2008 S Forsey, K Lloyd, Information Standards Board for Health & Social Care http://www.isb.nhs.uk/about-isib/isb-publications/ISBHaSC-NCDS.pdf 3 Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 5 of 30 2. 2.1. Purpose and Scope Standard Overview The standard will specify the secondary uses information required by the Department of Health for the purposes of assessing implementation of the Cancer Reform Strategy (CRS). It will support local and national comparisons of performance and service activity which will enable local organisations to assess their progress towards implementation of the CRS. Additionally the output will support commissioning and service development through provision of relevant information on service delivery and outcomes. The standard will cover neoplasms coded within ICD-10 diagnosis codes range C00 – C97 and D00 – D48 (as per the national cancer registration system) and will comprise the data set with definition of data items, values and purpose; business and information requirements to evidence the need for the standard; guidance for users, organisations and system suppliers on implementing the standard including matters to consider in migrating from existing standards and an assessment of the impact of the change; detail of a maintenance process and how users can request changes to the standard. consideration of the development of existing schemas in use within cancer registries for data collection to support migration towards use of XML Detail of all these aspects will be provided in the documents and plans to be produced to accompany the submission at Draft Standard stage. 2.2. Purpose The purpose of the standard is to support the delivery of the Cancer Reform Strategy objectives and the requirement for high quality, useable and relevant information. Chapter 8 (paragraph 8.1) of the Cancer Reform Strategy sets out that “Collecting and using improved information on different aspects of cancer services is central to delivering this strategy. Virtually all the improvements we expect to see over the next five years will rely on the availability of high quality, usable and relevant information. Provision of high quality information will: Empower patients in making important decisions about their care; Strengthen commissioning, as highlighted by the world class commissioning competencies; Enable providers to identify areas where they can make improvements; Facilitate greater understanding of inequalities in cancer; and Encourage informed national and local scrutiny of performance.” It will do so by providing definitions of data items which will be derived from clinical records in cancer services. These definitions will enable service providers to extract consistent, person based data to be used for reporting and analysis at both local and national levels. Consistent definitions are fundamental to enabling meaningful comparisons of data across and between services. This standard also addresses the findings of the ISB review of cancer data sets which reported that Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 6 of 30 “It has been established that there is a keen interest in revising the NCDS, even amongst those with limited knowledge of its current content and use. The majority view from those familiar with the NCDS is that a radical overhaul is required.” 2.3. Scope 2.3.1. What will the proposed standard be used for? The data set will be used at both local and national levels to generate ‘secondary uses’ information to assist in achieving, supporting and monitoring the CRS and provide quality data to support service development and commissioning. The data set business and information requirements have been identified predominantly from the CRS, with some additional requirements identified in the Standard NHS Contract for acute hospitals4. The business and information requirements will be presented as part of the Draft Stage submission. As part of the user guidance, the developer will also provide information to map the data to the patient pathway. 2.3.2. Who is the subject? The data set relates to all cancer patients, both adult and paediatric, in acute inpatient and outpatient settings. The trigger for data collection is when a diagnosis, or suspected diagnosis of cancer is confirmed, primarily this diagnosis takes place within secondary care. Whilst not covering specific episodes of radiotherapy or chemotherapy, which are the subject of separate standards (existing and forthcoming), the data set does cover all other aspects of cancer care leading up to and following on from radiotherapy or chemotherapy. 2.3.3. Who will use it? The data set is intended to define secondary uses information for use by health organisations. It is not for use in direct patient care but will be derived from patient care records. At a national level: the Department of Health, the National Cancer Intelligence Network and other appropriate national information, research and service planning organisations, e.g. The NHS Information Centre (NHS IC), National Cancer Action Team, CRS Advisory Board, Care Quality Commission, Monitor, Public Health Observatories, NHS Improvement, will use the information generated using the standard to monitor the achievement and the delivery of CRS objectives. These bodies may also use the information to monitor other quality agendas for example the NHS Next Stage Review5. At a local level: The regional Cancer Networks and Cancer Registries, Strategic Health Authorities (SHA), Primary Care Trusts (PCT) and NHS Trusts will have data on cancer services based on this national standard. Managers, commissioners, service and workforce planners, and clinical staff can analyse the information obtained from the data. This information will also support commissioning, performance management, planning of services, clinical audit and research, and will aid continuous improvement to cancer services to meet local needs. The following table summarises who will use the data and for what purpose; 4 Standard NHS Contract for acute hospitals, Department of Health, December 2008 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_091451 5 High Quality Care for All: NHS Next Stage Review final report, Department of Health, June 2008 http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/DH_085825 Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 7 of 30 Who will use the data set? NHS Cancer care providers (clinicians, administrators) Clinical systems suppliers 8 Regional Cancer Registries and the specialist children’s registry Cancer Networks Strategic Health Authorities Primary Care Trusts Royal Colleges Cancer Reform Strategy Advisory Board National Cancer Action Team (NCAT) National Cancer Intelligence Network (NCIN) National Cancer Research Institute (NCRI) Department of Health (DH) NHS Information Centre (NHSIC) National Cancer Services Analysis Team (NatCanSAT) NHS Improvement Care Quality Commission Monitor Public Health Observatories Clinical Audit teams How will they use the data set? Data set completion and local level analysis To support systems specification Local and national level analysis Local level analysis Local level analysis Local level analysis National level analysis National level analysis National level analysis National level analysis National level analysis National level analysis National level analysis National level analysis National level analysis National level analysis National level analysis National level analysis National level analysis As a Secondary Uses data set, this standard does not define record level data to be used in the delivery of care. Patient identifiable records for the purpose of care management are outside the scope of this standard although we would expect the dataset and the definitions of the data items to be taken account of during the development of such electronic healthcare record application. 2.3.4. How will it be used in routine existing working practices? The information standard is not for use in clinical practice, and as such will be invisible to a clinician recording their activities and care. It will help to inform the development of operational systems by defining the data items and values required for information purposes that should be able to be extracted from those systems. Aggregate, non patient identifiable data will provide the output from the data set and will enable reporting and analysis by NHS organisations including PCTs, SHA, Cancer Registries and Cancer Networks as well as the DH to assess their delivery against the relevant policies. Examples of how the information from the data set will be used for reporting and analysis come from the information requirements drawn out of the CRS as part of the data set review process. These information requirements are the high level questions on which analysis will be carried out. Examples of information requirements6 from the CRS include: Measures to ensure faster referral and diagnosis for people where cancer is suspected will help those who may be less informed about cancer signs and symptoms. (IR 1.40) PCTs, working with cancer networks, should give high priority to: Reviewing current bed utilisation by both tumour group and elective/emergency split against national benchmarks; 6 Cancer Outcomes and Services Dataset Information Requirements v0.01, National Datasets Service, 2009 Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 8 of 30 Ensuring that providers take up opportunities to participate in cancer inpatient management programmes; Developing local strategies to tackle the key causes of avoidable admissions and long lengths of stay; Considering establishing ambulatory facilities and models of care; and Using commissioning levers to drive change and get best value for money. (IR 1.58) Multi Disciplinary Team (MDT) working, as specified by NICE guidance, will remain the core model for cancer service delivery in the future. Commissioners will be expected to take account of the findings from their local peer review and to decide whether all of their current MDTs are viable and can deliver the quality of care that patients should reasonably expect. (IR 1.59) Robust data on levels of awareness of risk factors and symptoms is needed to highlight groups in whom awareness raising initiatives are likely to be of greatest benefit. (IR 1.60) An example of an information requirement from the Standard NHS Contract for acute hospitals is: To achieve the goals of this strategy, PCTs will need to work in closer partnership with other PCTs and their supporting practice based commissioning and specialised commissioning arrangements, taking strategic decisions to shape how and where care is best delivered. They will need to secure comprehensive services for cancer for their population, that are coordinated across the care pathway, including health promotion, social services, preventative and other services provided jointly with local authorities. (IR 1.70) The reference numbers shown in parentheses after the requirements (IR1.xx) relate to the business and information requirement documents which will be provided as part of the Draft Standard Submission, once they have been signed off by the Project Board. The Royal College of Pathologists has an extensive data set that comprises core and non core data items which are collected and coded by the Cancer Registries, transcribing details from text based pathology reports into SNOMED CT coded clinical data items. SNOMED CT is used to achieve as much uniformity as possible from different cancer centres and to facilitate reliable cancer registration “The College's Standards and Datasets for Histopathology Reporting on Cancers and Tissue Pathways have been written to help pathologists work towards a consistent approach for the reporting of the more common cancers and to define the range of acceptable practice in handling pathology specimens.” http://www.rcpath.org/index.asp?PageID=254 The Royal College of Pathology (RC Path) data sets cover the items of pathological information that are most important for patient management. Given the extent of coverage of the RC Path data sets, the Project Board overseeing this development work have decided that these data sets should form the basis of the Cancer Outcomes and Services Data Set for pathology. Section 3.5 of this submission includes detail of these data sets and their inclusion in this project. 2.3.5. Where will it be used? The standard will be used to inform the development of systems to facilitate the consistent derivation or extraction from clinical records of the data that will be used for secondary purposes. NB This is only a subset of all data that will need to be recorded for the care of cancer patients. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 9 of 30 It will also be used by information analysts to understand the meaning of the data extracted and the purposes for which it can be used. Users of secondary information reporting will have access to standardised reports and have the facilities to run ad hoc reports. Cancer services data are collected at contacts in acute and specialist hospital settings within inpatient and outpatient services, palliative and end of life care. It is generated from clinical and administrative records, including histopathology reports and other diagnostic services. The data set will need to be extracted or derived from systems supporting inpatient and outpatient services, screening, pathology and laboratory testing. The standard may also be used in the future development of outcome-based Cancer Peer Review measures. As part of the user guidance to be developed for Draft and Full stages, the developer will make use of the concept of mapping the data to the patient pathway to help define how and where the data will be collected that will be used for the secondary reporting purposes. 2.4. Out of Scope Radiotherapy; this is subject to an existing standard, the National Radiotherapy Data set (DSCN 22 / 2008) Cancer waiting times; these are the subject of the existing Cancer Waiting Times standard, (DSCN 20 / 2008) Chemotherapy – is the subject of a separate development which will be submitted to the ISB for assurance. General Practice – developments in the extraction of data from general practice systems are the subject of other work by the NHS IC, specifically the General Practice Extraction Service (GPES). Care record content and the Logical Record Architecture are out of scope of this standard. 2.5. Performance Characteristics As this is a review project, the data set will continue to run on existing systems and be transmitted via the existing methods. We will work with a range of trusts and registries to ensure that the standard continues to be safe, fit for purpose and interoperable across their existing systems and delivers the output data that ensures the standard operates as it is intended to do. This will be assessed through pilot work and end to end testing to ensure that data collected at sites holds the same meaning when extracted and reported. Our development work will include assessment of the capacity and capability of the existing systems. This will ensure that any changes or new items included in the data set are developed in line with these capabilities and that the proposals are fit for purpose. It will be necessary to validate flows of existing, unchanged data items and to evidence the collection and flow of both changed and new data items. Existing formats and transmission methods used by the Cancer Registries will continue to be used and new data items will be tested by addition into this mechanism, given due risk assessment. The Registries already have criteria for these data flows and these will be adhered to. There is support within the Registries to extend the existing schema to enable the flow of new and changed data items. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 10 of 30 Cancer registries receive data from trusts in a mixture of formats, in some registries the process is completely electronic, in others a mixture of paper and electronic records are received from trusts. These records are drawn from a mixture of systems including the PAS, the multi disciplinary team system and other sources including pathology reports. Work is in progress to complete this process electronically, in line with the target set in the NHS Standard Contract registration records to be completely electronic by March 2011. The registries complete the registration process from these records. An example of the process in one cancer registry is given below. Example of a Regional Cancer Registry validation mechanism Eastern Cancer Registry and Information Centre (ECRIC) receives cancer death notifications electronically every week and processes them every week. ECRIC also receives Pathology reports and extracts from Patient Administration System (PAS) on a monthly basis from approximately 20 hospitals. The registry is also now receiving data from Multi Disciplinary Teams in cancer care centres although the processing of this new data is in the early stages. The content and format of these data sources with the exception of cancer deaths have been negotiated between ERCIC and the hospitals with the aim of finding as close a match as possible between what ECRIC wants and what the hospital are actually able to produce. As a result of this the data arrive in a variety of different formats and layouts. Each data source has to undergo a stage of pre-processing in order to fit it into a common structured format so that it can be handled by the ECRIC main system. Generally, pathology and PAS extracts arrive monthly. The pathology extract for the previous month will arrive during the first half of the next month (Octobers arrives by mid-November) and PAS early the month after (October PAS early December). One of the early stages in the processing is post coding and tracing. Where an address is present but there is no postcode for that address, the system attempts to add a postcode from ECRIC’s post code and address database software. Where this is not possible, a human operator will fill in the postcode. Once all records have been post coded (if possible) the data are sent for tracing via the Demographics Batch Service. The returned file is used either to add NHS numbers to the original record if it was missing, or is used to confirm the address, GP data etc. The data are now matched by the system to the ECRIC main database. Matching is done on a patient basis – attempting to identify if a patient in the received data are already present on the main database or if they are a new patient. Matching is done using a combination of surname, forename, date of birth, sex, NHS number and post code. The matching algorithm has weightings associated with it. The output of this is that patients are partitioned into definite matches, not matched (new patients) and possible matches. The latter category is where the system has identified more than one patient on the main database which could match a patient in the data and where the degree of certainty is too low to be sure which if any of them the patient matches. For probable matches, the next phase of processing is for an operator to review the data and make the decision to match the patient in the data to one of the possible matches, or to none of them – there by declaring the patient to be a new patient. This process is / will be pretty much the same for any data source either in use now or in the near future. The next stage of processing is that an operator will review each record in a batch (e.g. a months worth of pathology or PAS records from a single hospital). Usually a single operator is given responsibility for processing the data from one or more hospitals and so when the pathology or PAS from last month arrives it will be processed as a batch by a single operator. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 11 of 30 The operator generally processes all the “new” patients first. The data received for each patient will be inspected on screen. The operator will determine if the diagnostic information provided indicates that the patient has a cancer that is registerable. If the patient does, then the operator uses the system to record the demographic information about the patient, their diagnosis, a proxy (to be confirmed or modified by other information received later) date of diagnosis, information about the hospital they have visited and clinicians seen and any relevant treatment they have received in terms of OPCS codes and the dates of those treatments. Not all of this information is available from every source of data – it depends upon the type of data and the hospital system from which it was extracted. For the existing patients, the operator is able to see the new data provided and the data already held on the main database for that patient. The operator will compare the diagnostic information provided with the diagnosis already held to determine if this is a new or existing tumour. If it is an existing tumour, the operator checks to see if the new data has anything to add to what is already held, e.g. is there additional treatment to be recorded, has a more specific diagnosis now been made ? If it is a new tumour, then the operator will create a new tumour record for the patient and record as much information as possible as with a new patient but without creating a new patient record. If the data provided is not for a registerable tumour, or the information does not add anything new to what is already held, then the record will be discarded. 3. Business Justification 3.1. Strategic Fit 3.1.1. Criteria under which the proposed information standard is submitted The information standard will be used by the Department of Health as part of public scrutiny of NHS services. This activity will be able to be described in terms of a structure, process and expected outcomes. 3.1.2. Business justification This information standard is integral to the delivery of the Cancer Reform Strategy which requires robust data to enable the delivery of the required objectives in the following areas: Actions to improve cancer outcomes Preventing cancer Diagnosing cancer earlier Ensuring better treatment Living with and beyond cancer Reducing cancer inequalities Delivering care in the appropriate setting Drivers for Delivery Using information to improve quality and choice Stronger commissioning Building for the future The reviews of the existing cancer information standards, as referenced in section 1.5 also provide the justification for this work. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 12 of 30 3.1.3. When are the NHS and/or social care organisations required to adhere to the proposed information by? The NHS will be required to adhere to this information standard from April 2012. Details of when the NHS may use the standard will be given in the Advance Notification. Subject to the project plan remaining on schedule, it is envisaged that trusts and system suppliers may use the standard for the purposes of planning or specifying new systems from November 2010, after the ISB has reviewed the Draft Standard submission. The project development timescales have been estimated given experience of developing and testing other clinical standards. The impact of the new standard on systems suppliers and NHS trusts will be assessed during the testing of the data set. The assessment of systems capacity and the required changes to support implementation will be reported on at Draft and Full stages. If the date for implementation needs to be adjusted as a result of this impact assessment, this will be confirmed as part of those submissions. This standard does not apply to social care organisations. 3.1.4. Review of Central Returns (ROCR) Submission Plan (NHS only) / Strategic Information Group for Adult Social Care (SIGASC) Submission Plan (Social Care only) In line with all data set implementation plans, appropriate and required forms will be completed to seek confirmation of assessment of burden and approval from ROCR prior to implementation, based on feedback from piloting. As this standard relates only to health services, SIGASC is not relevant. 3.2. Relationship to the National Programme for IT (NPfIT) This standard conforms to the aims of the NPfIT by enabling the secondary use of data which is recorded during the delivery of care to patients. It will make use of data recorded in clinical systems, and the associated record keeping standards which are part of the NPfIT delivery via the NHS CFH Clinical Content Assurance programme. Understanding cancer services and the information which is recorded during the delivery of care allows the developer to identify how the data can be used appropriately for secondary uses without creating additional burden in the clinical setting. Enabling this type of information to be generated consistently to support service development and planning aligns to the NPfIT objectives for secondary uses by making best use of the information collected during the course of patient care to enable commissioners and providers to assess outcomes, planning, monitoring and benchmarking for example. A statement of support from the Director of Business Requirements, NHS CFH has been requested in support of this submission and will be requested for the subsequent stages of ISB assurance. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 13 of 30 3.3. Operational Fit 3.3.1. Concept of Operation The Cancer Outcomes and Services Data Set will replace the current Office of National Statistics Cancer Registration Dataset information flows and provide a better working solution to National Cancer Information for Regional Cancer Registries. This is part of the commitment made within the CRS to improve information and which is supported by from the Department of Health. The development of a new national cancer repository, described in the future data flow scenario in the following pages is a funded commitment within the National Cancer Intelligence Network delivery plan, as set out in the Impact Assessment of the Cancer Reform Strategy7. The repository will be in place to receive data to be collected as part of this standard. Funding set out in Option 3 of the Impact Assessment includes allocation for “Data (including NCIN)” which is split to provide a funding stream to NCIN and for data collection in NHS services, particularly within the Multi Disciplinary Teams. The funding allocation and split is as follows: £6.3m in 2008/09 (split £1.4m to NCIN and £4.9m for data collection) £12.6m in 2009/10, (split £2.8m to NCIN and £9.8m for data collection) £18.8 in 2010/11 (split £4.2m to NCIN and £14.6m for data collection) and each year there after to 2017/18. Both the current and planned national data standard concepts are detailed below; Office of National Statistics Cancer Registration Data Set (ONS CRDS) The eight regional cancer registries and the specialist children’s registry collect and collate data on cancers resident in their area, and submit a standard data set on these registrations to the National Cancer Bureau at National Statistics. The National Cancer Intelligence Centre (NCIC) at National Statistics coordinates the national collation of cancer registration data and carries out a wide range of secondary analysis and research. To fulfil these objectives, cancer registries need to collate data on individual patients from multiple sources and over long time periods. These sources include district general hospitals, cancer centres, hospices, private hospitals, cancer screening programmes, other cancer registers, primary care, nursing homes and death certificates. The ONS Cancer Registration data set is completed by Regional Cancer Registries, some cancer care providers submit data to their Regional Cancer Registry from many disparate cancer information sources and other cancer care providers have integrated cancer information systems with their patient administration system, and are able to complete and send the full ONS Cancer Registration Data Set to their Regional Cancer Registry. The following examples are for information, though not necessarily representative of all trusts: Some cancer care providers submit data to their Regional Cancer Registry separately from their patient administration system/medical records such as patient demographics, admission and discharge data and death details. This information is then combined by the Regional Cancer Registry with information contained in disparate cancer databases around cancer waiting times and referrals, cancer diagnosis, staging, MDT care plan, palliative care, clinical trials, chemotherapy and radiotherapy and cancer drugs. Finally the cancer registration data set is completed with data from the information contained in the Pathology reports sent to the Regional Cancer Registry from multiple care providers. 7 Impact Assessment of the Cancer Reform Strategy, http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_080977.pdf Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 14 of 30 The other way the ONS Cancer registration data set is completed is by providers having a fully integrated cancer information system linked to their patient administration system. The cancer information system will have patient cancer information around waiting times, referrals, diagnosis, staging, cancer treatment and pathology recorded as the patient progresses along the cancer care pathway. The data can then be extracted from the information system and combined with the patient administration system data around patient demographics, admission, discharge and death data to complete the ONS Cancer Registration data set. Office of National Statistics Cancer Registration Dataset – Flow of Information ONS National Cancer Bureau ONS Cancer Registration Dataset Downloaded Nationally linked Cancer Registration Data Hospital Episode Statistics Cancer Waiting Times Regional Cancer Registry 8 Cancer Regional Registries and the specialist children’s registry in England ONS Death Certificates Separate care provider information submissions ONS Cancer Registration Dataset Hospital/ Cancer Centre Hospital/ Cancer Centre Pathology Departments Cancer Information System Medical Records Cancer Treatment Databases Patient Administration System Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Patient Administration System Page 15 of 30 Cancer Outcomes and Services Data Set (COSDS) The Data Standard (Cancer Outcomes and Services Data Set) will enable the accurate flow of clinical cancer information from Cancer Care Centres (hospitals and other providers of cancer care) to a Central Cancer Data Repository via the care centre’s Regional Cancer Registry. The diagram below details how the data set will be completed by Hospital/Cancer Care Centres, from data compiled from different information sources, and sent to their Regional Cancer Registry. The COSDS will then be forwarded by the Regional Cancer Registry to the National Cancer Data Repository, where the data will be housed and linked with other information flows covering Hospital Episode Statistics (HES), Death Certificates, Cancer Waiting times, Radiotherapy and Chemotherapy data sets and National Clinical Audit Support Programme (NCASP) Cancer Audits. This linkage of different Cancer Information Sources will provide a clear national insight into Cancer services and treatment outcomes across Cancer Networks, Primary Care Trusts and Cancer Treatment Centres. This information is then available to be accessed by each of the eight regional registries and the children’s registry to download and store in order to fulfil their Business and Information Requirements. The development of a new national repository of cancer data is a CRS commitment. discussion between the NCIN and NHS IC that is making positive progress which has support of the key stakeholders, including the Department of Health. Consideration is being creation of the repository as part of the suite of federated secondary uses services, which further analysis alongside the use of data sources such as HES. It is under in principle given to the will support Work is also ongoing by NCIN with the regional cancer registries to consider a move from the current, different models of working towards alignment on a common architecture and processes. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 16 of 30 Cancer Outcomes and Services Dataset – Flow of Information Radiotherapy and Chemotherapy Datasets ONS Death Certificates Hospital Episode Statistics NCASP Cancer Audits National Cancer Data Repository Cancer Waiting Times Cancer Outcomes and Services Dataset (COSDS) 8 Cancer Regional Registries and the specialist children’s registry in England Downloaded Nationally linked Cancer Information Regional Cancer Registry Cancer Outcomes and Services Dataset (COSDS) Hospital/ Cancer Centre Hospital/ Cancer Centre Pathology Departments Cancer Information System Medical Records Cancer Treatment Databases Patient Administration System Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Patient Administration System Page 17 of 30 3.4. Impact and Implications 3.4.1. Implications to stakeholders The implications to stakeholders of the proposed standard proceeding are assessed as: The Department of Health and NCIN will benefit from consistent data for reporting and analysis to support further policy development and the implementation of the Cancer Reform Strategy. Among other objectives, this will inform and empower patients in making choices about their care. The NHS will benefit from consistent data collection which will bring benefits at both local and national levels including comparative reporting on processes and outcomes. NHS trusts and system suppliers will need to include the new and changed data items into their systems. These organisations and the Cancer Registries will need to amend their transmission methods to enable the new and changed data items to flow and be centrally collated. There may be training implications for staff given changes to data item definitions or the implementation of new data items. The implications to stakeholders of the proposed standard not proceeding are assessed as: The Department of Health will not receive the improved information to support the objectives of the Cancer Reform Strategy, which include empowering patients (as set out in section 2.2 of this submission). The NHS will not benefit from consistent data collection and there will be an opportunity cost to both local and national services of this failure. Inconsistent and incomplete data collection will not be addressed Definitions will continue to diverge, to the detriment of the service and the objectives set out in the Cancer Reform Strategy. 3.4.2. Analysis of replacement of existing standards Once approved, this standard will replace the National Cancer Data set as covered by the following Data Set Change Notices: DSCN 53/2002 National Cancer data set core items DSCN 54/2002 National Cancer data set additional site specific data items, covering seven types of cancer: Breast, Colorectal, Lung, Head & Neck, Urological, Upper Gastro-Intestinal and Gynaecological. DSCN 11/2004 National Cancer data set (revision) Cancer Registration data set, mandated via Standard NHS Contract for acute hospitals. The developers note that users (including researchers) have a requirement for data items to remain comparable over time. This will be considered through out this development, in consultation with the clinical reference groups, in order to retain items for longitudinal use where they remain fit for purpose. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 18 of 30 3.5. Known Standards 3.5.1. Existing standards with a related purpose and scope National Cancer Waiting Times Minimum Data Set DSCN 20/2008 (includes Going Forward on Cancer Waits); National Radiotherapy Data set DSCN 22/2008 The Royal College of Pathologists has an extensive data set that comprises core and non core data items. “The College's Standards and Datasets for Histopathology Reporting on Cancers and Tissue Pathways have been written to help pathologists work towards a consistent approach for the reporting of the more common cancers and to define the range of acceptable practice in handling pathology specimens.” http://www.rcpath.org/index.asp?PageID=254 NHS Scotland’s Information Services Division runs the Scottish Cancer Information Programme which has comparable and relevant information standards. These will be assessed as part of this development and are included as part of the work with the NCIN which is a UK wide organisation. http://www.isdscotland.org/isd/183.html Similarly, the equivalent services in Wales and Northern Ireland have their standards which will also be considered, for example, the All Wales Core Cancer Data Set http://howis.wales.nhs.uk/sites3/Documents/299/CLINICAL%20DATA%20SET%20CATALOGUE.mht caBIG® Cancer Biomedical Informatics Grid of the National Cancer Institute, USA; This programme of work includes the development of standard rules to facilitate the sharing of information through an interoperable infrastructure. https://cabig.nci.nih.gov/ The details of this work and relevance to this standard will be assessed during the development process. Other national and international standards will be considered during the development and fully documented at draft and full stages. Examples of such standards already under consideration as part of this review work are the Scottish Bed Days analysis and use of the Adult Co-morbidity Evaluation-27 (ACE-27) in Washington State, USA, both as mechanisms for assessing comorbidity. 3.5.2. Assessment to include or eliminate The Cancer Waiting Times and Going Forward on Cancer Waits standards are relevant to this development and will be used where appropriate within this standard. The National Radiotherapy Data set standard may have items relevant to this standard; the developer will ensure consistency between the new standard and these existing standards. As referenced above, the Royal College of Pathology (RC Path) data sets cover the items of pathological information that are most important for patient management, as described in the following information: “Introduction to datasets The datasets have been developed by pathologists who have extensive experience of the Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 19 of 30 demands of current clinical practice and have been subject to consultation with relevant subspecialty pathology groups and societies, with general pathologists, cancer registries and with national medical and surgical stakeholders in order to obtain the broadest possible consensus. The datasets are evidence-based and highlight the core items of pathological information that are most important for patient management. The core items are those that will be recorded by Cancer Registries and will include core data for the National Cancer Dataset. Other (non-core) data items may be recorded to improve the clarity of reports, because of particular local interest, for monitoring clinical trials or for research. As far as possible, the datasets conform to a standard format. They include a proforma and, for some cancers, a synoptic reporting form that are intended to act as an aide memoire when reporting specific tumours. The data in the proforma may be presented as, or supplemented by, free text but the use of proformas in histopathology reporting is recommended as they are effective in ensuring that all necessary data are consistently provided.” http://www.rcpath.org/index.asp?PageID=254 Given the extent of coverage of the RC Path data sets, the Project Board overseeing this development work have decided that the RC Path data sets should form the basis of the Cancer Outcomes and Services Data Set. The developer will work with the RC Path data sets working group to manage the change process that will be required for on going maintenance of these data items once incorporated into a nationally mandated information standard. The developer will consider how to address the minority of rare cancers that are not currently covered by RC Path data sets during the development process. 3.6. Interdependencies 3.6.1. Existing or planned standards In addition to the known standards detailed above, the developers note the inter dependency between this standard and the Chemotherapy data set that is being developed by the National Cancer Action Team (NCAT) and NCIN. It is understood that NCAT plan to submit a requirement for the Chemotherapy data set during 2010. To ensure alignment between these standards, representatives from the National Datasets Service are members of the expert working group for the Chemotherapy data set and both standards have considerable input from the NCIN team. Systematised Nomenclature of Medicine Clinical Terms (SNOMED CT); this information standard will be required to work alongside or be used with SNOMED CT. The developer is working with the Terminology team within NHS CFH Data Standards and Products to ensure that this is achievable. This information standard will also be required to be used with International Classification of Diseases for Oncology, version 3 (ICD-O-3). This includes morphology classification which has been adopted by SNOMED. RC Path data sets are existing standards which are included within the scope of this project. Other professional standards relevant to the development work will be reviewed at the relevant point in the development phase. The definitions for the Cancer specialised services are under revision, due to be published in spring 2010; this will be reviewed once available. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 20 of 30 http://www.specialisedservices.nhs.uk/index.php/key-documents/specialised-services-nationaldefinitions-set/ NHS CFH Clinical Content programme are carrying out development work relating to the record keeping standards in cancer care. Their development team and the team for this information standard are in on going liaison to ensure alignment between these two standards. 3.6.2. Projects, programmes or organisations Chemotherapy data set development: the developers of this standard are members of the working group for the development of the Chemotherapy data set. The developer of the Chemotherapy data set is the National Cancer Action Team and NCIN, who also have representatives on the working groups supporting this standard. Plans for the development of a revised mechanism for the processing and construction of a national cancer data repository are under discussion by NCIN, ONS and the NHS IC. These plans are also related to the work to provide a replacement of the ONS National Cancer Intelligence Centre system. The following points summarise the process, which is currently subject to detailed scoping work; 1. The NCIN having ownership of the programme of work, providing oversight and being responsible for requirements specification. 2. The NHS IC providing a central data management service which will act as the prime sourcing agency into the cancer registration process. 3. Cancer Registries will continue to provide designated information moving from their current processes of cancer registration which links to ONS, to the end point of a new system linking to the NHS IC’s central data management service 4. The ONS data processing function will need to be migrated in a controlled manner with a potential effect on staffing levels and roles and responsibilities. The developer will also consider other related standards such as the NHS CFH Common User Interface (CUI) development and demographic data items being assured by ISB to assess whether they have an impact on this project. 3.7. Consultation and Support The standard has the support of the Department of Health and the NCIN. Twelve site specific clinical reference groups (SSCRG) have been established by the NCIN and tasked with reviewing the data items for each cancer site. These SSCRG have representatives from the various clinical and professional groups across the UK. Through these groups and other forums such as the Cancer Network Development Programme, we have sought and will continue to seek the involvement of all interested parties. A specific engagement and consultation exercise is being planned for clinical system suppliers. A formal period of consultation is also planned for early summer 2010, as shown in the project timescales in section 4.1. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 21 of 30 Each of the SSCRG includes representatives of relevant charity, voluntary and patient organisations, for example Breakthrough Breast Cancer The Roy Castle Lung Cancer Foundation Ovacome, the ovarian cancer support network UK Myeloma forum Sarcoma UK Brain Tumour Research Campaign – Way Ahead A full list will be provided as part of the consultation report at draft stage. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 22 of 30 4. Development and Implementation 4.1. Timelines The following timescales for development of the standard are taken from the PID Outline Plan Tasks Project initiation Business & Information Requirements Data item definition Requirement Standard Submission Definitional Testing Consultation Data Dictionary Draft Standard Submission Draft Standard Operational Testing8 Full Standard Submission ISB Full Standard approval sub task / requirements scope project PID set up project board ID sponsor and implementation mechanisms Business requirements analysis Information requirements analysis consultation / sign off Core / Registration data items - consult with registries/ networks/ users to review required items Site Specific data items reference groups consideration of required items Submission document Sponsor statements Business Requirements Identify sites and contacts Arrange visits Carry out visits to review data items with range of staff Write up evidence report Prepare & agree consultation papers with Project Board Post documents on website Publicise consultation period Collate responses and write up report Dictionary modelling & change paper Submission document Appraisal by ISB Identify sites, contacts and system suppliers Submission document Appraisal of Standard lapse time from start of to end of 2 months Apr-09 May-09 4 months Apr-09 Jul-09 6 months Jun-09 Dec-09 4 months Oct-09 Jan-10 4 months Jan-10 Apr-10 2 months May-10 Jun-10 12 months Apr-10 Apr-11 3 months Jul-10 Sept-10 2 months Sept-10 Oct – 10 Jul-10 Apr -11 3 months May-11 Jul-11 2 months Aug-11 Sept-11 10 months ‘Operational Testing’ includes implementation of data collection within NHS trusts for a pilot period, evaluation and writing up lessons learned 8 Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 23 of 30 4.2. Provisional Testing Approach Before the Draft Standard Stage, the data set will be subject to Definitional Testing. This is a ‘desk top’ exercise at a number of relevant sites to establish that the data set is fit for purpose in respect of its terms and value sets. Whilst this data set project is a review of existing items, the developers have found the Definitional Testing exercise to be a valuable exercise in the development and refinement of other data sets; as it has proved to be a valuable exercise in other standard developments, we will use the same method to review the data elements, whether existing or new, identified to be part of the Cancer Outcomes and Services Data set. A report of this exercise will be provided with the Draft Operational Standard stage submission. For the Full Standard Stage, the data set will be tested in a number of sites, piloting live data collection for a period of time. A Testing Plan describing the methods, objectives and measures of Operational Testing will be developed for inclusion with the Draft Standard Submission. The principles of the testing work during the project will be to ensure that; i) Existing data items without changes are validated as fit for purpose ii) Existing data items with changes to values and/or definitions are tested and proven to be fit for purpose iii) New data items are tested to ensure that the definitions and values are fit for purpose. Work will be undertaken with NHS CFH Data Standards and Products to ensure that the data items are interoperable with the terminology, clinical recording standards and Data Dictionary standards for use across the NHS. The Clinical Content Programme are also working on standards relating to record keeping in cancer services and the developers of this standard will liaise closely with them during the respective developments, to ensure alignment between the developments and to address matters raised in the ISB National Cancer Data Set Review. A representative group of pilot sites will be sought, to reflect different organisations, systems and localities. This will include the Cancer Networks and Registries in addition to NHS trusts. The operational testing will be carried out in a safe and controlled manner with the objective of ensuring the implementability of the data set and its associated guidance documentation. This review project is addressing the recommendations of the ISB National Cancer Data Set Review in the following ways; Co-morbidity (ISB review paragraph 9.6) The NCIN held a workshop to discuss co-morbidity measures and options for implementation, which included consideration of other national and international uses of co-morbidity scoring methods. As a result of this they are recommending the adoption of a summary co-morbidity score (none, mild, moderate, severe) in the short term, with optional collection of underlying scoring data. This will be tested as part of the development of this information standard. Revision of Guidance (paragraph 6.5) Development of the standard will include production of the human behavioural, organisation and technical guidance to support users, organisations and systems suppliers to implement the standard. The existing cancer data set manuals will be reviewed and revised in accordance with the changes to the data set. Validation of data set content (paragraph 6.4) Definitional testing, consultation and piloting of the data set are all processes that are used to ensure that we engage a wide range of stakeholders in the development of the standard. By doing this we Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 24 of 30 ensure that the standard reflects business needs and both the size and content of the data set are validated. This should address issues such as the data set being unnecessarily large or a ‘wish list’ which were some of the criticisms highlighted in the ISB review. Size and design (paragraph 7.1) As described, the testing and consultation to be undertaken as part of the development will help to ensure that the aims of the data set are clear and that the outputs are defined. Priority areas for change (paragraph 7.3) Diagnosis; The inclusion of the RC Path data sets in this review will help to address this area. Stage; This review is picking up details of the staging requirements for each site specific area. The existing RCPath data set items allow for coding by specific cancer site, stage classifications e.g. FIGO for gynaecological cancers or TNM. Co-morbidity; See details above Cancer Registration Data Set; It was seen as ‘critical to retain’ the CRDS and it is the central component of this data set review. The CRDS items have been mapped to the project business and information requirements but they are also subject to review by stakeholders to ensure that the data items remain relevant and fit for purpose. Part of our work will be to identify the key items that are required in this standard for registration and other collections such as Cancer Waiting Times, Radiotherapy and RC Path which must be kept in alignment. This project will address the ISB report recommendation that “it would be logical to remove the distinction between the NCDS and CRDS and go forward with an improved, single data set”. 4.3. Implementation Plans As stated in section 4.2, the data set will be tested in a number of sites. We will work with NHS Trusts to identify a range of sites that represent different service delivery arrangements and the use of different clinical and administrative systems. System suppliers will be specifically engaged in the development, as part of the consultation activities (as stated in section 3.7) and in the operational testing work with NHS Trusts. At present it is planned that the data will continue to flow to the regional cancer registries. As set out in section 3.3, Concept of Operation, the NCIN have plans for the development of a national data repository, this may be provided by NCIN and/or the NHS IC, subject to agreements. This development would be funded by the NCIN, supported by the Department of Health, as sponsor of this standard. These plans are subject to agreement, and more detail will be provided at Draft and Full Stages as the developments progress. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 25 of 30 4.4. Governance Issues Guidance and technical support for data and information sharing at both an operational level and for secondary uses exists already, for example The NHS Confidentiality Code of Practice (2003) and the Caldicott Report (1997)9. The Ethics and Confidentiality Committee of the National Information Governance Board for health and social care (NIGB)10 considers ethical issues relating to the processing of patient data. The standard developers will be guided by NIGB and their principles and objectives for the collection, flow, storage and reporting of data for this data set. Issues of Information Governance will continue to be investigated and any concerns and reassurances will be reported in Draft and Full Standard Submissions. 4.5. Migration Issues The developer acknowledges that there will be migration issues to consider for the following groups of users of the information standard; staff inputting data at Trust level staff providing data extracts at Trust level recipients of data extracts at Registries suppliers of clinical and administrative systems end users of data for reporting from the national repository all users with respect to the maintenance of the standard once approved and mandated As referenced in section 3.5.2, the developer will work with the RC Path data sets working group to include their data items in the maintenance process of the information standard. The National Datasets Service has an agreed and established process for the maintenance of information standards. It is possible that either this or the RC Path process may need to be amended to manage the maintenance of the RC Path data items in the nationally mandated information standard. Communication of the agreed process and adherence to the process will be critical, to ensure that the standards remain aligned and consistent. Consideration of these issues will be reported on at draft and full stages, as the processes of consultation and testing will inform these areas. 4.6. Costs and Funding As described in section 4.2, the testing of the data set will cover validation of existing and changed data items and testing of new data items. As the data set is currently under development, the proportion of data items within each of these three categories is unknown. These proportions will influence the cost of implementation, as this will determine the extent of systems change required, both within clinical or administrative systems to capture the data and registry systems to receive the data. Changes to existing data items and the addition of new items will also require changes to the transmission mechanism to ensure that the data can flow. Costs and impact will be assessed as part of the development work and testing. These will be reported on as part of the Draft and Full Stage submissions. 9 Both documents available from http://www.dh.gov.uk/en/Managingyourorganisation/Informationpolicy/Patientconfidentialityandcaldicottguardians/DH_40841 81 10 National Information Governance Board website at http://www.nigb.nhs.uk/ Cancer Outcomes and Services Dataset | Requirement | Operational Page 26 of 30 Version 1.1 | 18.01.2010 As set out in section 3.3, Concept of Operation, the NCIN have plans for the development of a national data repository, this may be provided by NCIN and/or the NHS IC, subject to agreements, but is a funded commitment in the NCIN delivery plan. 4.7. Safety Operational testing of the Cancer Outcomes and Services Data set will take place at nominated sites within England. The developer will carry out a risk assessment before commencing operational testing which will include; Hazard assessment - an assessment of the hazards and the associated risk for each hazard (i.e. impact versus likelihood) which might occur were this standard approved and implemented; Risk management plan for publication with the standard in order that end users can be advised and manage risks appropriately. We will provide details of the assessment and report on safety at the Draft and Full standard stages in relation to the activities carried out during and planned for each stage. The standard is not for clinical practice or direct patient care; therefore, we do not envisage any patient safety risk arising from this standard. The output of the standard will be the secondary use of routinely gathered clinical information. Working with the NHS services, the developer will ensure that the data to be used for secondary purposes is derived from data that is clinically relevant in the delivery of care to patients. It is acknowledged by the SSCRG involved in the development of this standard, that data that is of clinical relevance is the data that will have the highest quality associated with it. The developer notes the DSCN 14/2009 and 18/2009 relating to the application of patient safety risk management in the manufacture and deployment of health software and will assess the implications for this project. Basing our standard on data that is clinically relevant will give the best assurance that the secondary uses data is of high quality and can therefore be meaningfully used for analysis. The secondary use analysis may lead to changes in service protocols or arrangements; it is crucial that such changes are made based on the highest quality data to make meaningful improvements for the benefit of patients. 4.8. Maintenance Following approval of the Full Operational Standard, the data set will be transferred into the Datasets Maintenance Service. This has a responsibility to ensure requests for change and periodic reviews are addressed, ensuring that data sets remain fit for purpose. The scope of the maintenance process covers: Management of change requests from users and stakeholders; Specification of changes to the data set in response to changes in policy, practice, coding and classifications; The process for authorisation and approval of changes to data set items, including obtaining ISB Standard Change Approval. Dissemination of approved changes to data set users and stakeholders, once approved, will be issued in the form of DSCN by ISB. A Maintenance Plan will be submitted with the Full Operational Standard Submission. Where further amendments are to be made over time, a service will be provided to support the implementation and maintenance of the data set. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 27 of 30 4.9. Conformance Conformance between the proposed standard and recording systems will be investigated during definitional and operational testing. Any changes recommended as a result of the testing will be reported as outcomes of that process and will form part of the supporting documents for the Draft and Full Stage submissions. Criteria for monitoring conformance once the information standard is implemented will form part of the Full Operational Standard Submission. Issues raised by users during use of the standard once approved, will be managed through the maintenance process. 4.10. Evaluation During the lifecycle of the development, full sign-off of any created products or outputs is required by the various bodies involved. These include the following: Cancer Outcomes and Services Data Set Project Board (composition of this group is detailed in the PID) Site Specific Clinical Reference Groups Informatics Data Standards Programme Board; NHS CFH Technical Office; NHS CFH Data Standards. Please refer to the PID (Appendix C) for details of which groups sign off specific products. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 28 of 30 APPENDIX A Sponsor Statement(s) (Insert copy of statement from sponsor(s) here) Statement provided by Gerard Hetherington, Director of Clinical Policy and Strategy, Department of Health. See attached PDF file Appendix A Cancer outcomes data set_requirement.pdf G:\DS\ICDS010 Cancer Datasets Review\Working\ISB\Appendix A Cancer outcomes data set_requirement.pdf Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 29 of 30 APPENDIX B NHS Connecting for Health - Technology Office Statement (Insert copy of statement from NHS CFH - Technology Office here) Requested from Jeremy Thorp. Cancer Outcomes and Services Dataset | Requirement | Operational Version 1.1 | 18.01.2010 Page 30 of 30