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The Cataract National Data set
NHS Connecting for
Health Office of the Chief Version Number 0.4
Connecting for Health
Clinical Officer and Royal Royal College of
Version Date 7 April 2010
CFH National Clinical
Lead for Ophthalmology
The Cataract National Data set
Inherited Information Standard
Version Date Amendment History 0.1 8 January 2010 First draft for comment 0.2 15 January 2010 Comments on first draft from Anne Casey 0.3 5 February 2010 Revised draft addressing issues raised by Anne Casey 0.4 7 April 2010 Revised submission addressing issues raised by appraisers Paul Budgen, Ian Shepherd, Nick Strong and Elizabeth Hunter
These documents will provide additional information.
Reference Number Title Version Appendix 1 2010.04.07 Cataract National Data set v3.1.xls Appendix 2 Cataract Data Set Hazard Log v0.1.xls See also embedded documents The Cataract National Data set | Inherited Information Standard Page 2 of 29 Version 0.3 | 3 February 2010 Table of Contents
1. Standard Demographics
1.1. Name of Standard
1.4. Commercial Issues
1.5. Background and Customer Need
2. Purpose and Scope
2.1. Standard Overview – describe the standard and refer to specification
2.3.1. What is the proposed standard to be used for?
2.3.2. Who is the subject?
2.3.3. Who uses it?
2.3.4. How is it used in routine existing working practices? Scenarios for use by different user groups
2.3.5. Where is it used? (locations)
2.4. Out of Scope
2.5. Performance Characteristics – measurable criteria against which the standard can be judged as safe, interoperable, implementable and fit for purpose
3. Business Justificat ion
3.1. Strategic Fit
3.1.1. Criteria under which the proposed information standard is submitted
3.2. Implementation Architecture
3.3. Operational Fit
3.3.1. Concept of Operation. Paper / systems / scenarios for use in different technical contexts.
3.4. Impact and Implications
3.4.1. Implications to stakeholders of the standard being approved / not approved...........18 3.4.2. Analysis of replacement of existing standards
3.5. Known Standards
3.5.1. Existing standards with a related purpose and scope (originally and since development)
3.5.2. Assessment to include or eliminate – if relevant
3.6.1. Existing or planned standards
3.6.2. Projects, programmes or organisations
3.7. Consultation and Support – initial development and ongoing (may be related to governance in 3.9.1 below
3.8. Standard Specification – refer to standard specification document
3.9.1 Of the standard and its maintenance
3.9.2 Information governance considerations
4. Devel opment and I mplementation
4.1. Summary of Approach to Development and Implementation to date
4.2. Implementation Evaluation Report – how extensive; issues and lessons
4.3. Implementation Roll Out Plans – if relevant
4.4. Migration Plans – if relevant
4.5. Human Behavioural, Organisational and Technical User Implementation Guidance........24
4.6. Safety – what risks accompany the use of the standard and how are these monitored / mitigated?
4.7. Maintenance and Update Process Plans
4.8. Conformance Test Specification – what checks are done / should be done to demonstrate that the standard has been deployed as intended?
The Cataract National Data set | Inherited Information Standard Page 3 of 29 Version 0.3 | 3 February 2010 APPENDIX A
Failed attempts to interest other suppliers including VersaSuite, Cerner Millennium & I-Soft Lorenzo:
Email strings to suppliers.rtf APPENDIX B
NHS Connecting for Health - Technology Office Statement
1.1. Name of Standard The Cataract National Data Set
1.2. Sponsors Departmental Connecting for Health
John Sparrow Connecting for Health (CFH) National Clinical Lead for Ophthalmology New Kings Beam House 22 Upper Ground London SE1 9BW John.Sparrow@nhs.net Tel: +44 (0) 77 7330 6370 Content Royal College of Ophthalmologists
Kathy Evans, Chief Executive Officer The Royal College of Ophthalmologists 17 Cornwall Terrace London NW1 4QW Kathy.Evans@rcophth.ac.uk Tel: +44 (0) 20 7935 0702 Fax: +44 (0) 20 7935 9838
1.3. Developers Responsible for producing the standard Connecting for Health
John Sparrow, CFH National Clinical Lead for Ophthalmology New Kings Beam House 22 Upper Ground London SE1 9BW John.Sparrow@nhs.net Tel: +44 (0) 77 7330 6370 (Previously CFH Do Once And Share (DOAS) Cataract Team) Ongoing owner of the standard Jointly owned by the sponsors identified in 1.2 above.
The Cataract National Data set | Inherited Information Standard Page 5 of 29 Version 0.3 | 3 February 2010
1.4. Commercial Issues There are no commercial, licensing or Intellectual Property Rights issues relating to the use of this standard within the NHS.
In future, the standard will include SNOMED-CT coding - 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.
1.5. Background and Customer Need
Cataract surgery is the most frequently performed surgical procedure in the NHS with over 300,000 operations annually in England alone. Clinical systems to support the management of patients undergoing cataract surgery are in place or in development but there is no approved standard for the data that is recorded to support the cataract care pathway and provide data for secondary purposes. The cataract national data set has already been implemented in an electronic cataract care record (Medisoft) which is in use in ~40% of NHS cataract units in England. Given this extent of implementation, the data set is proposed as the national information standard. A second specialty system developer, (OpenEyes – an open source developer wishing to enter the market) has expressed an interest in the data set although the CFH LSP‟s (Cerner Millennium and I-Soft Lorenzo) and a third specific developer, VersaSuit, have thus far failed to express any interest despite repeated attempts at establishing a dialogue with each of them. The existing system at Moorfields Eye Hospital (E-Patient) is no longer supported though has been used to collect largely compliant data for around a decade in that hospital (see embedded report in the form of a poster presentation under 2.5 below).
Customers for / beneficiaries of the proposed standard are:
Patients with cataract requiring assessment and treatment Cataract surgical units which deliver cataract care.
Healthcare professionals delivering care to cataract patients.
Surgeons for quality assurance: audit, appraisal, revalidation.
Commissioners to support quality based purchasing.
Acute trust managers and Care Quality Commission (CQC) for quality accounts.
DH to support 18 week pathway and for quality indicators for cataract services.
System developers to deliver cataract care records.
Royal College of Ophthalmologists in setting benchmark standards for surgical practice.
Royal College of Anaesthetists in setting benchmark standards for anaesthetic practice.
Royal College of Nursing in setting benchmark standards for cataract care.
College of Optometrists in setting benchmark standards for cataract care.
Clinical and epidemiological researchers.
2.1. Standard Overview – describe the standard and refer to specification The proposed standard defines data elements and values to meet information needs for the management of patients undergoing cataract surgery. This covers the full care pathway, from referral to discharge. All information items necessary for cataract assessment and treatment are included.
The cataract national data set specification covers all aspects of the care pathway and is available as Appendix 1 formatted as an Excel workbook. Separate sheets cover patient details and demographics, preoperative assessment, ocular biometry, anaesthesia, surgery and follow up (Excel workbook also embedded at 3.8).
A „gap analysis‟ has also been undertaken by CFH which deals with the requirements for cataract care and maps these against those specified in the supplier Outline Base Specification (OBS).
2.2. Purpose The primary purpose is to provide a data set to cater for the information needs of health care professionals caring for patients with cataract. The full cataract care pathway is covered, including information required at referral (level of vision, co-morbidity, medications), ophthalmological clinical assessment (details of ocular examination), preoperative assessment (ocular biometry, fitness for anaesthesia, fitness for surgery), anaesthesia (type of anaesthetic), surgery (details of procedure, any complications), postoperative treatments and recovery (eye drops, postoperative events) and visual rehabilitation (refractive and visual outcomes).
Indirect benefits will accrue due to the ability of electronic systems to automatically analyse the routinely collected data to risk assess individual patients in terms of the likelihood of a surgical complication. This risk stratification process will facilitate the process whereby the most complex and highest risk surgery is performed by the most experienced surgeons, a strategy which can minimise the absolute numbers of patients who experience a surgical complication.
Standardisation of the data items collected will ensure that information acquired by different centres is recorded consistently and hence is fit to be employed for the secondary purposes.
Service quality and professional benefits arise from the use of large volumes of electronically collected data for benchmarking, research and revalidation.
2.3.1. What is the proposed standard to be used for?
Cataract care from referral into secondary care to discharge back to primary care. The data set is a by product of the clinical process but the richness of the contained data will support a variety of secondary uses.
Steps in the cataract pathway include: Initial optometric assessment with referral information for the hospital eye service, general practitioner information on general health and medications (in future some of this information may be derived from the summary care record), initial outpatient assessment and pre-operative assessment for those for whom it is appropriate to proceed to surgery, on the day preparation for surgery, anaesthesia and surgery, post-operative follow-up The Cataract National Data set | Inherited Information Standard Page 7 of 29 Version 0.3 | 3 February 2010 and outcome assessment. Knowledge support within software will allow pre-operative case mix stratification for surgical risk to ensure that surgery is delivered by the most skilled surgeons when the complication risk is highest.
Secondary uses for the standard will include benchmarking of outcomes for services as a whole and for individual surgeons. These form important clinical governance components in terms of quality assurance at institutional and surgeon levels. Future „Trust Quality Accounts‟ and revalidation for surgeons would be greatly facilitated by standardised data being collected routinely as a by product of clinical care.
Organisations designing and deploying electronic care record systems for cataract units. Other supplier organisations may use elements of the data set, for example, to support referral from primary care. Certain software products e.g. Choose & Book are „customisable‟ with features which may be adjusted locally for improvement of referrals to secondary care.
Health care providers:
Carers of patients with cataract would directly collect, enter and use the information contained in the data set. Such individuals who are involved in direct clinical care consist of clinicians and support staff: ophthalmologists, general practitioners, nurses, optometrists, health care assistants, service managers, administrative staff.
The data set will support quality assurance (clinical governance, clinical audit, benchmarking), commissioning, appraisal and revalidation of professionals, managers responsible for running services, local and national aggregation of data, clinical and epidemiological researchers. Overall these activities will serve to drive up standards of clinical care by informing and empowering users.
2.3.4. How is it used in routine existing working practices? Scenarios for use by different user groups The data set is currently collected in a variety of ways and cataract units vary from being fully electronic (in house) to fully paper based. From the perspective of the care pathway as a whole no settings are fully electronic because information transferred between GP‟s, optometrists and secondary care rely to a greater or lesser extent on paper based systems.