Download 1. Standard Demographics

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.
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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
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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.
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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
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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
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“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
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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
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

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.
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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.
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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.
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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.
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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.
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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
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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
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Patient
Administration
System
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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.
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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
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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.
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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
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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.
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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.
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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.
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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
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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
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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.
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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/
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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.
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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.
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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
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APPENDIX B
NHS Connecting for Health - Technology Office Statement
(Insert copy of statement from NHS CFH - Technology Office here)
Requested from Jeremy Thorp.
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