SCCI Development Framework

Transcription

1 Document filename: SCCI Development Framework Directorate / Programme SCCI Project Development Support Service Document Reference <insert> Project Manager [Manager] Status Approved Interim Owner Gwen Smith Version 1.0 Author Gwen Smith Version issue date 24/11/2014 SCCI Development Framework

2 Document Management Revision History Version Date Summary of Changes /08/2014 First Draft /10/2014 Second draft following limited review /10/2014 Final Draft for submission to SCCI following SMG review /11/2014 Accepted by SCCI as interim pending review following NIB Framework and Standards Chapter publication Reviewers This document must be reviewed by the following people: author to indicate reviewers Reviewer name Title / Responsibility Date Version SCCI Development Support Team Operational team 0.1 SCCI Service Management Group Operational management of SCCI services 0.2 SCCI membership Approvers of final draft 0.2 ISAS Independent Standards Appraisal Service 0.2 Approved by This document must be approved by the following people: author to indicate approvers Name Signature Title Date Version Standardisation Committee for Care Information Standardisation Committee for Care Information 29/10/ Glossary of Terms The glossary is accurate at the time this document was published; for more up to date information use the links provided in section 6 Sources of Information. Term / Abbreviation ALB BAAS What is stands for Arm s Length Bodies Burden Advice and Assessment Service Page 2 of 72

3 Term / Abbreviation BIS BPG Business Lead CEO Collection Concordat CQC Developer DH Direction DTR DTU EC98/34 EU Extraction FOMI HRA What is stands for Department of Business, Innovation and Skills Business Planning Group The Programme/Project Lead within an organisation who is directly responsible for delivery and maintenance of an ISCE; the business lead can be from any organisation and occasionally will be within HSCIC Caldicott Guardian Chief Executive Officer Where information is collected and distributed to the centre or requesting body to conform to the information request, either specifically as a result of the data request, or as a by-product of another process (e.g. operational systems, data sets An agreement between the partner organisation that constitute the membership of NIB to work collaboratively towards all information and data flowing to HSCIC; either as primary or secondary flow Care Quality Commission The individual/s who is designated as the developer of an ISCE or a component part of it Department of Health A direction to HSCIC as defined in section 254 of the Health and Social Care Act 2012 Draft Technical Regulation Draft for Trial Use European Commission Technical Standards and Regulations Directive 98/34 European Union Extraction is the term given to a customer request and refers to the act of obtaining information from general practice systems with the aim of improving patient care False or Misleading Information Health Research Authority HSCA 2012 Health and Social Care Act 2012 HSCIC IAP I2N Information Health and Social Care Information Centre Impact Assessment Panel Idea to Need Information Standard as defined within the Health and Social Page 3 of 72

4 Term / Abbreviation What is stands for Standard Care Act 2012 ISAS ISB ISCE ISCEG ISCG MHRA Major Mandatory Request Minor Monitor N2R NHS NHS Confederation NHS DD NIB NICE NTPS PbR PfC PHE PRSB Project/Programme Lead Request ROCR Independent Standards Assurance Service Information Standards Board for Health and Social Care Information Standards Collections (including Extractions) Information Standards Collections and Extraction Group (working name of SCCI) Informatics Services Commissioning Group, former name of NIB Medicines and Healthcare Products Regulatory Agency A categorisation of a change submission which is defined by a set criteria as laid out in the change categorisation tool A request to HSCIC to collect data which is mandatory as defined in section 255 of the Health and Social Care Act 2012 A categorisation of a change submission which is defined by a set criteria as laid out in the change categorisation tool As the sector regulator for health services in England, Monitor s job is to make the health sector work better for patients. Need to Requirement National Health Service The NHS Confederation is the membership body for all organisations that commission and provide NHS services NHS Data Model and Dictionary National Information Board National Institute for Health and Care Excellence National Tariff Payment System (new name for PbR) Payment by Results Proposal for Change Public Health England Professional Record Standards Body The role of the Project/Programme Lead is to support the SRO in their work with the developer organisation and is referred to as Business Lead throughout this document. A request to HSCIC to collect data which is not mandatory as defined in section 255 of the Health and Social Care Act 2012 Review of Central Returns replaced by the Burden Advice and Assessment Service Page 4 of 72

5 Term / Abbreviation SCCI SCCI Front Door SME SoN SoS Sponsor SRO Submitter Survey techuk SPNS Within Tolerance What is stands for Standardisation Committee for Care Information The terminology used where all ideas are submitted to, also known as Idea to Need (I2N) Subject Matter Expert Statement of Need Secretary of State The Sponsor is the individual that takes on responsibility for an ISCE including funding Senior Responsible Owner The individual or organisation who has proposed an idea or a request for change to an existing ISCE A collection of data in the form of a request for answers to questions designed to gather information to support programmes of work and health and care initiatives techuk provides a collective voice for its members and drives connections with government and business to create a commercial environment Single Publication and Notification Service A ISCE change pathway. The pathway is used where a change can be identified as being within the defined tolerance levels that do not require a change to the approved ISCE. The tolerance levels must be defined within a maintenance plan which was approved as part of the ISCE. Document Control: The controlled copy of this document is maintained in the HSCIC corporate network. Any copies of this document held outside of that area, in whatever format (e.g. paper, attachment), are considered to have passed out of control and should be checked for currency and validity. Page 5 of 72

6 Contents 1 Introduction Purpose of Document Background Document Scope Audience 9 2 SCCI Support Services 10 3 Process Overview Process Scope High Level Process Review process Impact Assessment and Prioritisation Collections Publishing Roles & Responsibilities Workload management Issue resolution 36 4 Stages Idea to Need Need to Requirement Requirement to Draft Draft to Full Review Retire 49 5 Product Descriptions Product Pathway Matrix Product Descriptions 55 6 Sources of Information 59 Appendix A. SCCI Support Services Structure Scope Idea Development Development Support Independent Standards Assurance 65 Page 6 of 72

7 7.6 Publication and Knowledge Management Service Secretariat 70 Appendix B. Change Categorisation tool 72 Page 7 of 72

8 1 Introduction 1.1 Purpose of Document This document defines the Development Framework for Information Standards and Collections including Extractions (ISCE) to support the Standardisation Committee for Care Information (SCCI). It is intended to provide help and guidance to anyone wishing to submit ideas or changes into the process to obtain approval to publish as a Standard as described within the Health and Social Care Act 2012 ( or publication as an assessed and accepted collection. Additionally it provides an overall framework within which the Health and Social Care Information Centre (HSCIC) teams who support the SCCI operate. The aim is to provide a framework that: encourages the development of efficient and justified improvements in the information needed for Health and Care delivery, enables understanding how the system supports individuals enables understanding of how the system is performing at national level enables services which are focussed on supporting the submitter, developer and business leads. 1.2 Background The SCCI Lifecycle has been described in The ISCE Process and is depicted as a Tube Map which is recreated in Figure 1. Note that the tube map describes a development lifecycle and is not intended to detail a process. Page 8 of 72

9 Initial Idea Received S Development and maintenance Draft a proposal Appraisal and assurance service Implementation and benefits realisation Need accepted 0 EU Directive 98/34 Applies to s.250 & 259 standards only Requirement elaborated Requirement accepted 1 Retirement E Retire Design Design Accepted Redesign Build Initial test 2 Draft Technical Regulation Released Deprecate Implementation test Notify BIS BIS notify EU and member states Consultation 4 Review Member state detailed opinion Consider detailed opinion EU decide to legislate Technical Regulation Published 3 Initiate Routine maintenance Systemic Adoption Live deployment Benefits realisation Education & Training Support Title: Standards & Collections Lifecycle Status: Draft Version: 0.6 Date: 10 th September 2013 Figure 1 Information Standard and Collection life and assurance cycles To support this lifecycle a number of services have been established; each service operates within the boundaries of this framework and their defined processes and procedures. 1.3 Document Scope This document provides a high level description of the activities and processes to support SCCI acceptance and approval; it does not provide granular detail of individual processes and procedures, this detailed information can be found by following the links in section 6 Sources of Information. The document specifically provides guidance in relation to submissions listed as being in scope. 1.4 Audience The audience of this document is: Submitters of ideas Developers of Information Standards, Collections and Extractions SCCI Support Teams members General public with an interest Page 9 of 72

10 2 SCCI Support Services A number of services have been established to support SCCI and the development, assurance, approval and publication of ISCE as they flow through the system. The support services include teams which have specific focus on the following areas: Idea Development - Provides a front door for ISCE ideas for improvement. A nominated member of the team will work with the submitter of an idea to introduce a new ISCE or change an existing one, to establish and document the national need. This short step includes, obtaining relevant HSCIC subject matter expert (SME) input to ensure that consideration is given to existing standards and resource impacts. Development Support Provides an overall planning, management help and advice service for anyone submitting (or intending to submit) an ISCE. The team will work with the submitter the business lead and other SCCI services to support them in achieving the best outcome. The team will engage with other services across HSCIC and the Health and Social Care system as required to ensure progression of the ISCE through the process where possible, including looking at impact on existing ISCE. The team additionally provides management reporting and information across the whole process. Independent Standards Appraisal Service (ISAS) Provides an independent critical appraisal service to support SCCI in their decision making. The team will liaise with Development Support to appraise and assure submissions before they are passed to SCCI. The team will manage the appraisal process undertaken by independent external appraisers and prepare a recommendation report which will be submitted alongside other documentation to SCCI. To ensure the objectivity appraisers are independent of development. Publication and Knowledge Management Provides a publication and knowledge management service. The team will work with NHS England, HSCIC Board and others to obtain appropriate approval letters and ensure the publication of Information Standards Notices. The team additionally provides a knowledge management and consultation service across SCCI support services and to submitters. Secretariat - Provides the management and organisation of SCCI meetings including the recording and notification of discussions and decisions. This service is currently hosted by NHS England Burden Advice and Assessment Service (BAAS) Provides advice on the burden across Health and Care of all submissions and produces burden assessment reports. Requests for burden assessment and advice would normally come through the single SCCI front door ; the team however, has additional responsibilities outside the SCCI process; it is not a SCCI only service although the team provides input on all submissions. Full details of the SCCI Support Services are provided in Appendix A. In addition to the dedicated SCCI Support Services a number of other teams within the HSCIC will have to be engaged through the process for example to ensure that the proposal is compliant with other standards. These additional services need to be engaged dependant on the nature of the submission; examples are given below but it is not an exhaustive list: Technical Architecture Team NHS Data Dictionary Team Clinical or Pharmacy Terminology Team Information Governance Team Page 10 of 72

11 Indicator Assurance Team Page 11 of 72

12 3 Process Overview 3.1 Process Scope The SCCI development process provides a mechanism to progress ISCE at various stages of their development and from any source, including initial ideas. It is assumed that not all submissions into the process will be fully worked up and resources to progress may not be in place as an idea is submitted. The process starts when an idea is submitted and ends when the idea is published as an approved ISCE under the Health and Social Care Act Submissions will broadly fall into one of the following categories: Information standard idea:- a business requirement for an information standard Collection / Extraction idea:- a business requirement for a national or cross organisation collection or extraction of data Information standards change:- a business requirement and or proposal to change an approved ISB or SCCI standard Collection / Extraction change:- a business requirement to change an approved ISB, ROCR or SCCI Collection / Extraction Please note this is not an exhaustive list and other types of submissions may be accepted. Should you require information or advice please contact the Development Support team via (SCCIDSupport@hscic.gov.uk) 3.2 High Level Process The process is split into a number of logical stages: Idea to Need develop an idea into a justified need for consideration by SCCI. Need to Requirement develop an accepted idea and document the individual unique requirements which will meet the need. Requirement to Draft design a solution which meets the requirements and considers existing standards; build the solution and test that it can be implemented; plan consultation, implementation, how it will be maintained and understand the benefits. Draft to Full undertake European consultation if appropriate; understand the results of the consultation and adjust the solution and implementation plans as needed. First of type implementation could also be undertaken within this stage. Generally first of type (if appropriate) will be performed in requirement to draft. Benefits Realisation Review after implementation gather feedback from the implementation; understand any changes which may be required and the benefits which have been realised. Retire understand the reasons to retire, consult and plan retirement. New ISCE which have not previously been through the process (or approved under the old Information Standards Board for Health and Social Care or ROCR regime) would be expected to follow the full process and pass through each of the logical stages. The process provides consistent quality assurance and ensures that appropriate consideration is given to alignment with other standards; legal and confidentiality obligations in respect of the ISCE and implementation. Stages may be combined where it is appropriate: this could be in order to meet implementation deadlines or where the tasks and documentation is largely completed when submitted. Combining stages provides less opportunity for progress and documentation to be assured and to receive feedback from SCCI; this in turn increases the risk of not meeting the expectations of SCCI and requiring rework. A wish to move rapidly Page 12 of 72

13 through the process must be balanced with the risk of doing so without formal assurance of work being undertaken. Combining stages would only be recommended where the risk is low and is accepted by the Senior Responsible Owner (SRO). The developing team must also have the capacity to complete all tasks within a potentially shortened timeframe Full process activities New ISCE or changes which are major and impact other standards will normally be expected to proceed through each stage in turn. The figure below provides a simple view of activities which are undertaken within each stage and the progression through stages. Idea to Need Idea Submitted Statement of Need Produced (10 working days) SCCI presentation / Need accepted Need to Requirement Readiness/ impact/priority Assessment burden assessment Requirement documented ISAS Appraisal (10 working days) SCCI presentation / Requirement accepted Requirement to draft Requirement Elaborated design solution, consult and test plan implementatio n ISAS Appraisal (10 working days) SCCI presentation / accepted as draft standard Publication Draft to Full European Consultation (only if required) identify and undertake any re work ISAS (10 working days)appraisal SCCI presentation / accepted as full standard Publication Review Post implementation report benefits realisation analysis Change analysis Change documentation and implementation Retire Consult Plan retirement Communicate deprecation / retirement plan Publication Page 13 of 72

14 Figure 2 Stage Activity overview Figure 2 above provides a high level overview of the full end to end lifecycle activities. Actual time taken to complete the stage is dependent on the capacity of the business to complete the tasks and may be longer than those shown above in some instances. Dependency on things outside the SCCI process may additionally cause delays e.g. ministerial decision. More detail of each of the stages is provided in the section below Stages. At the end of each stage a presentation of documentary evidence is made to SCCI who will provide confirmation that the submission remains on track and is acceptable to progress to the next stage with any caveats. With the exception of Idea to Need, all documentary evidence undergoes appraisal by the ISAS in advance of being presented to SCCI. ISAS provides additional advice to SCCI in the form of a recommendation report. The recommendation report will be considered by SCCI alongside all other documentary evidence; SCCI will determine the outcome based on evidence presented. The stages above, with the exception of Idea to Need, may be combined in some instances where this is appropriate. Combining stages will be considered in conjunction with the SRO where there is confidence that documentary evidence; testing and communication requirements for multiple stages can be met without risk to the quality of the standard, public safety and or burden across the Health and Care system. The scope and scale of the submission will also be considered; combining stages will normally be agreed as an exception where there is strong justification and need to shorten the overall time to approval. It should be noted that where stages are combined, all evidence for each stage will be appraised and presented to SCCI at one meeting; by agreeing to a combined stage submission the SRO is accepting the risk that work on a subsequent stage is undertaken without knowledge or feedback from SCCI. This may lead to a greater level of rework being needed and risks unforeseen delays in progress to full approval Change Categorisation Change categorisation takes place alongside prioritisation and impact assessment and is undertaken by the Impact Assessment Panel (IAP). A link to additional information about IAP and its terms of reference can be found in section 6 Sources of Information. Changes are categorised by using the change categorisation tool; Appendix B. Categorisation takes account of: any outstanding conditions set at previous approval fitness for purpose of the ISCE following the specified change scale of change is it a change or a correction any agreed maintenance plan and if the change is within tolerance of the plan the impact of the identified change in the following areas o scale of burden cost either in currency or days effort o information governance o implementation timelines / impact on suppliers o impact on other existing standards Change Categorisation Criteria The Change pathways are described in section below. To be categorised as a particular type of change the following criteria must be true. Note: Page 14 of 72

15 Changes that do not fit into any of the categories below will be subject to the full process due to their scope, complexity and impact. Changes that require EU consultation will have an additional submission to SCCI to enable the review of any feedback received. Data Dictionary Change Notice: A change to the Data Dictionary No impact on an existing ISCE or systems across Health and Care It is a cosmetic change to the Data Dictionary only Corrigendum: A correction to publication documents for an ISCE. No impact on burden, No impact on benefits No impact on other ISCE No impact on implementation. This could include publication of a correction before implementation that may impact implementation if it were published later Within Tolerance: A change which falls within the scope of what has been defined and approved by SCCI as part of a business as usual maintenance plan when originally submitted and approved Minor Single Submission: Not a DDCN, Corrigendum or within Tolerance change Burden impact less than 70,000 across the Health and Care system Burden effort less than 1 year across the Health and Social care system No Information Governance Issues or any governance issues have been resolved No impact on implementation timelines where the ISCE has not yet been implemented Effort to implement all required changes to a system less than six months No impact on other ISCE Major Single Submission: Not a DDCN, Corrigendum or within Tolerance change Not a Minor change Fails two or less of the following criteria: o Burden impact less than 70,000 across the Health and Care system o Burden effort less than 1 year across the Health and Social Care system o No Information Governance Issues or any governance issues have been resolved o No impact on implementation timelines where the ISCE has not yet been implemented o Effort to implement all required changes to a system less than six months No impact on other ISCE Major Two Stage Submission: Not a DDCN, Corrigendum or within Tolerance change Not a Minor or Major Single Stage change Impacts other ISCE Page 15 of 72

16 Fails two or less of the following criteria: o Burden impact less than 70,000 across the Health and Care system o Burden effort less than 1 year across the Health and Social Care system o No Information Governance Issues or any governance issues have been resolved o No impact on implementation timelines where the ISCE has not yet been implemented o Effort to implement all required changes to a system less than six months Change Pathway activities Changes will normally follow a process which integrates stages dependent on the scale, scope and burden of the change. This enables minor or major single stage (due to low risk) category of changes to be accepted through a fast track method. There are 5 basic paths which are determined based on the category of change: Major Two Stage submission categorised as a major change but able to be compressed into 2 stages. Will be reviewed by SCCI as a requirement and as a full standard. Major One Stage submission categorised as a major change but the risk and scope of the change is small enough to enable it to be compressed into a single stage. Will be presented to SCCI for acceptance to publish as a full standard Minor One Stage submission categorised as a minor change which is low risk, scope and burden. Will be presented to SCCI for information and acceptance to publish as a full standard. Corrigendum categorised as being the correction of an error in a published standard. The correction must have no material impact on the standard or its implementation. Will be presented to SCCI for information and acceptance to publish the corrigendum. Data Dictionary Change Notice not strictly a change to a standard but will follow the same categorisation process to establish that there are no impacts to any standards. Will be presented to SCCI for information only. Within Tolerance Change categorised as a change that is within tolerance of an approved maintenance plan. Will be presented to SCCI for information only. Major 2 stage submission: Page 16 of 72

17 Idea to Need (0 working days) Logged and passed to Change process Change process Impact assessment, categorisation and prioritisation Impact assessment & categorisation Burden Assessment Prioritisation Determine Path Requirement Elaborate proposal for Change Document Requirement Plan implementation ISAS appraisal (10 working days) SCCI presentation and acceptence Full Design solution, consult and test ISAS appraisal (10 working days) SCCI presentation and acceptence Publication Figure 3 Major 2 stage submission activities Change single stage submission: Idea to Need (0 working days) Logged and passed to Change process Change process Impact assessment, categorisation and prioritisation Impact assessment & categorisation Burden Assessment Prioritisation Determine Path I to publish to Need (0 working days) Figure 4 Minor & single stage major change submission activities Corrigendum submission: : Elaborate proposal for Change Document Requirement Plan implementation Full Design solution, consult and test ISAS appraisal (10 working days) SCCI presentation for information and acceptence Publication Page 17 of 72

18 Idea to Need (0 working days) Logged and passed to Change process Change process Impact assessment, categorisation and prioritisation (15 working days) Impact assessment & categorisation Burden Assessment Prioritisation Determine Path Corrigendum Document Corrigendum Produce Corrigendum publication documents ISAS appraisal (5 working days) SCCI presentation for information and acceptence to publish Publication Figure 5 Corrigendum Activities Data Dictionary Change Notice: Change process Impact assessment, categorisation and prioritisation (15 working days) Impact assessment & categorisation Prioritisation Determine Path Data Dictionary Change Document Data Dictionary Change Notice ISAS appraisal (4 working days) Publication SCCI presentation for information Figure 6 Data Dictionary Change Notice Page 18 of 72

19 Figures 3, 4, 5 and 6 above provide a high level overview of the change process activities for changes to ISCE. Actual time taken to complete the stage is dependent on the capacity of the developer to complete the tasks and may be longer than those shown above in some instances. Dependency on things outside the SCCI process may additionally cause delays e.g. ministerial decision. Please note that if EU consultation is necessary then an additional 120 working days will be required to complete the EU consultation process; it is not expected that Data Dictionary Change Notice will require EU consultation Review process As part of acceptance a benefits realisation review date for any ISCE is agreed by SCCI; to enable the committee to understand how well it has been implemented and if the expected outcome has been achieved. This review of an approved ISCE is considered in addition to the three year review of all approved collections which is undertaken by the BAAS team. An ISCE review will be aligned with the three year review where it coincides with it. As the review date is approaching the business lead responsible for maintenance will be contacted by the Development Support Service to start the process Purpose The purpose of the review is to understand: How successful was implementation? Are benefits being realised? What has been achieved since acceptance? Is the standard still relevant and fit for purpose? Is the standard meeting its specific need/requirement? Are there any changes needed as a result of lessons learned from implementation? It should be noted that following the implementation of the SCCI process in April 2014,the first review of standards which were approved under the old Information Standards Board (ISB) regime will additionally look to understand: What additional work is required to uplift the standard to comply with the Health and Social Care Act 2012? Can this work be undertaken as part of the review; or agree the timescales for uplift? Review process scope The scope of the review process is all ISCE which have been accepted by SCCI or its predecessor the ISB Overview The review process is split into two potential stages: Standard Review review implementation; understand any benefits and any changes which may be necessary. Standard Uplift review work necessary to uplift to a Health and Social Care Act published standard, plan and potentially undertake the uplift (only for first review of standards approved by ISB). Please note that the review will be presented to SCCI at each stage Review Pathway activities Standard stage activities: Page 19 of 72

20 Idea to Need (0 working days) Review activation (6 months in advance of SCCI presentation) Logged and passed to review process Standard Review Review imlementatio n Review burden / benefits / achievement s Review relevance / fitness for purpose Plan and document changes Plan any uplift (optional) ISAS appraisal (10 working days) SCCI presentation for acceptance Publication Optional Standard uplift review work needed to uplift Document necessary changes Uplift documentation ISAS appraisal (10 working days) SCCI presentation for acceptence to publish Publication Figure 7 SCCI review process activities Figure 7 above provides a high level overview of the activities of the review process. The standard uplift process is optional (it will only be completed where an ISCE needs to be uplifted to become ACT compliant; where uplift is needed then the review of work required to uplift will be undertaken within the timescales of the standard review. The work required and plan for uplift will be presented to SCCI at the standard review stage. In exceptional circumstances where the uplift is possible within the standard review timeframe the uplifted documentation will also be presented at the standard review stage. 3.4 Impact Assessment and Prioritisation Impact Assessment and Prioritisation is conducted by the IAP and takes place either following an idea or change being submitted. The assessment takes place alongside the change categorisation process (changes only), collection categorisation process (collections only) and subject matter expert input request for new ideas; the following outputs are produced: A prioritisation score which can be used to compare relative priorities of work A change categorisation as described in section (changes only) A collection categorisation as described in section (collections only) An IAP outcome which will be in the form of a categorisation, a statement from each panel member and a general statement from the IAP as follows: o support the work in its current proposed form, no caveats o support the work in its current proposed form, caveats and delivery recommendations applied (e.g. wider engagement and interdependencies to be addressed) Page 20 of 72

21 o panel statement: support the work; caveats to one or more areas, conditions and risks being added to the risk register o any Impacts and Risks Note: IAP does not reject, but they may provide advice that the SRO and business lead reconsider their submission in line with caveats and recommendations of the panel; they additionally may request advice from SCCI in exceptional circumstances Prioritisation and impact assessment takes account of: Impact o Inter-dependencies o strategic considerations o risks including but not limited to: reputational damage and visibility o caveats o burden o Clinical safety o information governance o technology and architecture o compliance to existing standards Expected benefits o to individuals o to care providers o to service management Ease of delivery in respect of o funding o resource o technical o commercial o appetite within the health and care system o business change o business leadership The IAP outcome is updated throughout the process and is part of any submission to SCCI Prioritisation report Prioritisation scores will be recorded within a report for publication and presentation to SCCI each month which provides a relative comparison of all active items in the SCCI process. This will inform any decisions SCCI are required to make in respect of prioritising one submission over another when scheduling conflicts occur. 3.5 Collections All national collections are in scope of SCCI regardless of whether they are part of Information Standards. Local collections are not in scope unless they are for national implementation. The need for collections can happen quickly and it may not be practical to take them through the full SCCI process; an amended process will be applied to submissions for collections. There are a number of different categories of collection in scope of the SCCI process. Each category has different levels of impact and risk across the health and social care system; it is the level of impact and risk which is used to determine the path that a request will take, this in turn dictates the level of scrutiny and assurance required to gain SCCI acceptance. The broad categories (which are not mutually exclusive) are described below: A mandatory national collection which is part of an information standard. Page 21 of 72

22 A mandatory national collection which is not part of an information standard. A voluntary ongoing collection which is part of an information standard. A voluntary ongoing collection which is not part of an information standard. A voluntary one-off collection which is not part of an information standard. A one-off survey (please note this will be treated in the same way as a collection). A recurring survey (please note this will be treated in the same way as a collection) The terms collection and information standard is used within the context of the definitions provided within the glossary Details of all collections approved through the SCCI process are currently published on the Burden Advice and Assessment Service website. [DN add link to BAAS published collections] Impact and Risk Assessment In order to determine the category of a collection and therefore its development pathway, an impact and risk assessment is undertaken managed by the SCCI support services. This assessment takes into account: Frequency of collection is it one-off or a regular collection Burden of collection what is the cost to the service of collection in terms of financial and time effort. The scale and coverage of the collection is considered as part of the burden assessment. Please note that the full methodology for burden assessment is published here.[dn link to burden methodology to be added] Information Governance implications does the data being collected create information governance issues and / or pose a risk to patients, public or the collecting organisation which have not been resolved. Does the collection include patient identifiable or confidential information and how will this be addressed to ensure confidentiality remains secure? Is the same data being collected elsewhere or within a previous collection? Previous submission where it is a re-submission of a one-off collection Legal basis for the flow of information (if required). Voluntary or mandatory nature of the collection. Any requirement for EU consultation. Impact on existing standards or collections. Compliance to existing ISCE. The impact and risk assessment decision will be in the form of a collection summary report stating an agreed pathway and may include some conditions to be met as part of acceptance. This decision will be documented and the IAP Secretariat will send a formal notification to the submitter Collection pathway activities Collections will generally follow a process which combines stages and potentially reduces the documentation requirement dependent on the risk and impact assessment. This enables small low risk and low burden collections to be accepted through a fast track method where it is not appropriate or practical to bring such collections through the full SCCI process. There are 4 basic pathways which are determined based on the level of impact and risk: Page 22 of 72

23 Light impact categorised as low impact, low burden and low risk collections. Will follow a light touch process; will be presented to SCCI for information and acceptance Low impact categorised as low burden, low or medium impact but medium risk. Will follow a light touch process; will be presented to SCCI for acceptance. Medium impact categorised as up to medium impact and burden but high risk. Will follow a single stage submission process; will be assured by ISAS with a reduced documentation requirement and presented to SCCI for acceptance. High impact categorised as high impact and burden and high risk. Will follow a two stage submission process; both stages will be assured by ISAS with a reduced documentation requirement appropriate to collections and presented to SCCI for acceptance. Light and Low collections may be accepted by SCCI through Chairs action outside of a formal meeting where it is urgent. Light impact Idea to Need (0 working days) Logged and passed to Collection process Collection process Impact assessment, categorisation and prioritisation Impact assessment & categorisation Prioritisation Determine Path Light impact Burden assessment consultation Burden assessment report Produce Collection Summary report SCCI SMB verification SCCI presentation for information and acceptance to publish Publication Figure 8 - Light impact collection activities Figure 8 above provides a high level overview of the light impact activities; timings provided are estimated and may vary. Activities within the light impact pathway will run in parallel and assuming that required documents are received it is expected not to take longer than 7 weeks to gain approval. Low impact Page 23 of 72

24 Idea to Need (0 working days) Logged and passed to Collection process Collection process Impact assessment, categorisation and prioritisation (15 working days) Impact assessment & categorisation Prioritisation Determine Path Low impact Burden assessment consultation Burden assessment report Produce Collection Summary report SCCI SMB verification SCCI presentation for acceptence Publication Figure 9 Low impact collection activities Figure 8 above provides a high level overview of the low impact activities; timings provided are estimated and may vary. Activities within the low impact pathway will run in parallel; in this instance however submission to SCCI is required to gain approval and it is not expected to take longer than 11 weeks. Medium impact Page 24 of 72

25 Idea to Need (0 working days) Logged and passed to Collection process Collection process Impact assessment, categorisation and prioritisation (15 working days) Impact assessment & categorisation Prioritisation Determine Path Medium impact Burden assessment consultation Burden assessment report Produce Collection Summary report Produce specification Produce implementati on guidance ISAS appraisal (10 working days) SCCI presentation for acceptance Publication Figure 10 Medium impact activities Figure 10 above provides a high level overview of the medium impact activities; timings provided are estimated and may vary dependent on available resource to complete work required. Activities within the medium impact pathway will run in parallel; in this instance however ISAS appraisal followed by submission to SCCI is required to gain approval and it is expected not to take longer than 18 weeks. High impact Page 25 of 72

26 Idea to Need (0 working days) Logged and passed to Collection process Collection process Impact assessment, categorisation and prioritisation Impact assessment & categorisation Prioritisation Determine Path High impact requirement Burden Assessment consultation Burden assessment report Produce Collection Summary report ISAS appraisal (10 working days) High impact full Update Collection Summary report Produce specification Produce implementation guidance ISAS appraisal (10 working days) SCCI presentation for accepaence Publication Figure 11 High impact collection activities Figure 11 above provides a high level overview of the high impact activities; timings provided are estimated and may vary dependent on available resource to complete work required. Activities within the high impact pathway will run in parallel where this is possible; in this instance however submission to ISAS and SCCI for acceptance is required at two stages. The first submission is to gain acceptance of the requirement before completion of the specification and implementation guidance and submission for full approval. It is expected not to take longer than 18 weeks Collection Categorisation criteria To be determined to be within a particular category all criteria as defined below must be met; if one or more criteria is not met it will be tested against the next level up until categorised as high impact. All changes to existing collections will be categorised to ensure that the category is unaffected by the change. Light impact: One-off or voluntary collection (without the need for a standard) if it additionally meets the following criteria: The burden is less than 70k (such collections will still be subject to a burden assessment) There are no Information Governance (IG) implications, or any IG issues have been addressed Page 26 of 72

27 The collection is concordat 1 compliant or not applicable (i.e. it is already being collected by the HSCIC; plans are already in place to do so, or it is not practical to flow the data through the HSCIC) There is a statement which details what is being collected and how Low impact A one-off / ongoing / or voluntary collection (without the need for a standard) if it additionally meets the following criteria: The burden is less than 150k (such collections will still be subject to a burden assessment) (Note: in the case of Social Care the minimum burden figure is 100,000) There are no Information Governance (IG) implications, or any IG issues have been addressed The collection is concordat compliant or not applicable (i.e. it is already being collected by the HSCIC; plans are already in place to do so, or it is not practical to flow the data through the HSCIC) The collection and submission method is in existence and proven The collection considers the use of existing standards where this is appropriate The collection has a legal basis There is a statement which details what is being collected and how There is evidence that funding is in place to ensure the development, maintenance and collection of the data The collection complies with existing standards or plans are in place to work towards compliance where appropriate (it may not be appropriate for a one-off collection). Medium impact An on-going collection (with an associated standard) if it additionally meets the following criteria: The burden is between k (such collections will still be subject to a burden assessment) There are no Information Governance (IG) implications, or any IG issues have been addressed The collection is concordat compliant or not applicable (i.e. it is already being collected by the HSCIC; plans are already in place to do so, or it is not practical to flow the data through the HSCIC) The collection and submission methods are in existence and proven The collection considers the use of existing standards where this is appropriate The collection has a legal basis There is no impact or overlap with other collections and or standards which has not been addressed within the standard 1 An agreement between the partner organisation that constitute the membership of NIB to work collaboratively towards all information and data flowing to HSCIC; either as primary or secondary flow Page 27 of 72

28 There is a statement which details what is being collected and how That appropriate consultation has taken place and any issues raised through the consultation have been addressed There is evidence of funding and resource to ensure on-going management of the standard The collection complies with existing standards or plans are in place to work towards compliance. High impact An on-going collection (with an associated standard) if it additionally meets the following criteria: The burden is greater than 250k (such collections will still be subject to a burden assessment) There are no Information Governance (IG) implications, or any IG issues have been addressed The collection is concordat compliant or not applicable (i.e. it is already being collected by the HSCIC; plans are already in place to do so, or it is not practical to flow the data through the HSCIC) The collection and submission methods can be demonstrated to work The collection considers the use of existing standards where this is appropriate The collection has a legal basis There is impact or overlap with other collections and or standards There is a statement which details what is being collected and how That appropriate consultation has taken place and any issues raised through the consultation have been addressed There is evidence of funding and resource to ensure on-going management of the standard The collection complies with existing standards or plans are in place to work towards compliance Review All collections will have a review date set 12 months after implementation. The review will be coordinated with the three year review of approved collections which is undertaken by BAAS where they coincide. Development Support will contact the business lead responsible for the collection in advance of the review date to initiate. As part of the review the following will be considered by SCCI: A report on the data which has been collected A statement of the benefits realised in relation to those which were expected Continued need of the collection (excluding one-off collections) Publication Publication of collections will be in the form of a formal Information Standards Notice (ISN) and inclusion within the approved assessed collections list. Information Standards Notice Page 28 of 72

29 The ISN will include confirmation of the collection details, its nature (mandated or voluntary), the legal or contractual basis upon which the data is being requested and key contacts. It will additionally include any links to associated information and guidance. Collections that have an associated Standard will be published through an ISN, alongside documentation which details the items which are being collected and the method of collection. This documentation must additionally provide advice on any information governance issues. Assessed Collections List All accepted collections will be published within the assessed collections list which details what is being collected and how. 3.6 Publishing On acceptance of an ISCE by SCCI, a decision is made as to the urgency of publication of the ISN. There are two points of publication: 1. A monthly publication date, three weeks after the date of acceptance (i.e. the SCCI meeting). 2. An expedited publication date, taking place as soon as possible after the date of approval. Post acceptance, SCCI Secretariat has to notify DH, NHS England and the HSCIC of the action and request formal approval of the ISCE for publication as f: an information standard under the Health and Social Care Act 2012 a data collection included with the HSCIC Assessed Collections list. No publication can take place until formal approval has been received. The three weeks duration has been determined to allow time for SCCI Secretariat to issue the acceptance letter and for the appropriate SCCI representative to request the approval letter be issued. SCCI will consider a request for expedited publication as part of the Developer s submission. Such a request should reflect extraordinary circumstances, e.g. ministerial commitment. If no request is made, publication is scheduled for the next monthly publication date Pre-publication checks Once the final set of documents is received by the SPNS, ISAS is instructed to undertake a pre-publication review to provide assurance that the documents are ready for publication. Any issues with the documents are passed back to the Development Support Manager for resolution. On return from ISAS, a final inspection of the documents is undertaken by the SPNS to insert any URLs and to convert the documents to PDF format, prior to uploading to the HSCIC website. NB. There is a period of transition from use of the ISB website to the HSCIC website. However the HSCIC website will point users to the most up-to-date version of the ISCE. Page 29 of 72