NHS Digital Data Release Register - reformatted

National Institute For Cardiovascular Outcomes Research projects

424 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

🚩 National Institute For Cardiovascular Outcomes Research was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. National Institute For Cardiovascular Outcomes Research may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

National Cardiac Audit Programme / Transcatheter Aortic Valve Implantation (TAVI) Registry - Welsh mortality data — DARS-NIC-717493-V2R4K

Opt outs honoured: (Excuses: Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2023-08 – 2026-07

Access method: Ongoing

Data-controller type: DIGITAL HEALTH AND CARE WALES

Sublicensing allowed: No

Datasets:

  1. Civil Registrations of Death
  2. Demographics

Type of data: Identifiable

Objectives:

Digital Health and Care Wales (DHCW) requires access to NHS England data for the purpose of the six national cardiovascular audits (named below) and the UK Transcatheter Aortic Valve Implantation (TAVI).

The cardiovascular audits and TAVI registry are based on prospectively collected, patient-level data on patients in all NHS providers in England and Wales. The audits included in NCAP are:

• Myocardial Ischaemia National Audit Project (MINAP- heart attack) - Includes all adult patients with acute coronary syndromes (any condition resulting from the sudden reduction of blood flow to the heart, which leads to shortness of breath and sudden chest pain), collecting information on the management of patients admitted with a diagnosis of myocardial infarction (heart attack) and other acute coronary syndromes.

• National Heart Failure Audit (NHFA): Includes all patients with an unscheduled admission to hospital with heart failure, collecting data on patients discharged from acute hospitals with a primary diagnosis of heart failure

• National Congenital Heart Disease Audit (NCHDA): Includes cardiac (relating to the heart) or intrathoracic (within the chest) great vessel procedures carried out in patients under the age of 16 years, and all adult congenital cardiac procedures performed for a cardiac defect present from birth

• National Adult Cardiac Surgery Audit (NACSA): Includes all adult patients undergoing major heart surgery

• National Audit for Cardiac Rhythm Management (NACRM): Includes all adult patients with implanted devices or receiving interventional procedures for the management of cardiac rhythm disorders

• National Audit for Percutaneous Coronary Interventions (NAPCI): Includes all adult patients on whom a percutaneous cardiovascular intervention (PCI) procedure (a non-surgical method used to open narrowed arteries that supply the heart muscle with blood) is performed

• The UK TAVI registry: Includes all patients who have undergone a procedure to implant a TAVI device (a percutaneous method to implant a new aortic valve)

The aim of these audits/ registries is to measure and report delivery of care against defined guidance standards and to enable the improvement of the quality of care and outcomes of patients with a range of cardiac conditions.

The following NHS England data will be accessed:
• Civil Registration Mortality and Demographics – necessary to provide high quality comparative information of the clinical practice/processes and patient outcomes in these clinical areas. For example, it enables the comparison of disease and treatment options and outcome by Trust, hospital, unit and in some audits by consultant (NACSA and NAPCI).

The level of the data will be identifiable – necessary to evaluate the success of the data linkage.

The data will be minimised as follows:
- Limited to data for a cohort supplied by National Institute for Cardiovascular Outcomes Research (NICOR – hosted at NHS Arden & Greater East Midlands (GEM) Commissioning Support Unit (CSU)), including any individual meeting the inclusion criteria for one or more of the aforementioned clinical audits/ the TAVI registry.

The NCAP audits and TAVI registry are commissioned by NHS England.

NHS England are controllers for the English aspect of the registry. All data flows for this aspect are reflected under DARS-NIC-359940-W1R7B.

Digital Health and Care Wales (DHCW) are the controller for Welsh data in the NCAP audits and TAVI registry, including from the Civil Registration (Deaths) and Demographics data released under DARS-NIC-359940-W1R7B. The permissions for the flow of the Welsh mortality data are represented under DARS-NIC-717493-V2R4K.

The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(i) – processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy.

The processing is in the public interest because the audits and registries aim to drive improvements in the quality and safety of care and to improve outcomes for all patients.

NHS Arden & GEM CSU is a processor acting under the instructions of DHCW. NHS Arden & GEM CSU’s role is limited to managing the NCAP audits and TAVI registry.

Redcentric PLC provide server housing facilities to NHS Arden & GEM CSU. Redcentric PLC are not able to access the data stored on NICOR servers managed by NHS Arden & GEM CSU.

Yielded Benefits:

NICOR’s harmonisation of the six national clinical cardiovascular audits into a national cardiac audit programme with 6 separate specialist audit domains, led to a standardised approach to methodology (data collection, data completeness, data quality, analysis and reporting). As part of this harmonisation process an annual report for the benefits of the patients and the public has been produced each year using lay terminology, written by patients and non-clinician staff. These reports have been used by patients extensively, enhancing patient choice and understanding, informing patients about what they can expect when going into hospital for their procedure, and provision of other useful sources of information. Another benefit is that NICOR has used audit data linked with Civil Registrations data for developing risk adjustment models for Heart Failure and MINAP. These models are now in their final stages of implementation (validation). These will ensure that the reports produced for these domains are reliable and that the data are being interpreted accurately and meaningfully. This should impact patient care as well as health service delivery. Use of HES data for case ascertainment and the development of risk models has been beneficial for enhancing the integrity of the NICOR’s clinical audits. NICOR has used the HES APC data to supplement the dataset variables which have not been part of the dataset for very long and allows verification and completeness of demographic and clinical data. In the Heart Failure audit, data on types of cardiomyopathy have only recently been collected. Use of the HES APC data to understand co-morbidities supplements the data collected through the audit and enhances our ability to identify key outcomes and disease progression. Linkage of the NCAP data to HES and ONS data was essential for a range of outputs performed by NICOR and academic colleagues to assess the early impact of the COVID-19 pandemic on cardiovascular services. The on-going VICORI research project led by the University of Leicester holds a Data Sharing Agreement for linked patient level death data and HES data, allowing researchers to better understand the relationship between cancer and cardiovascular diseases. A number of analyses are demonstrating the marked regional variance of the prevalence of cardiovascular disease in subsets of patients with specific cancers; this is highly likely to impact treatment choices and outcomes. Some examples of key benefits realised from the audits are: 1) National Congenital Heart Disease Audit (NHCDA): • The use of linked NCHDA data with Civil Registration Mortality data to calculate expected treatment outcomes using the PRAiS2 (risk model) to report centre level differences in case-mix adjustment for paediatric congenital heart disease patients undergoing cardiac surgery. These linked data are used to recalibrate the risk adjustment model. The results show high survival rates, just under 98%, at 30 days following paediatric cardiac surgery which compare very favourably to results reported in similar developed countries in Europe and North America. • The PRAiS2 risk model for paediatric surgery was updated using NCHDA data. The software was updated in July 2016, such that PRAiS2 is the most up-to-date model, reflecting recent national outcomes (2009-15). Work is on-going to perform a further re-calibration using more recent data. o The NCHDA now includes rates of significant complications after paediatric surgical intervention and provides comparative data for individual hospitals to consider. o A risk-adjustment model has also been applied to patients undergoing surgical or percutaneous interventions in older patients and has been able to provide assurance on the quality of care. • Antenatal diagnosis continues to improve to now over 50% of those requiring an intervention in infancy. This is hugely important for mothers and families and for their care services in planning treatment and also the necessary advisory and support services required. 2) National Audit for Percutaneous Coronary Interventions (NAPCI): • Year-on-year improvements in various processes of care (known to be associated with improved outcomes) have been achieved (e.g., primary PCI (PPCI) is now the default treatment for patients with ST-elevation myocardial infarction (big heart attacks), use of radial procedures, use of drug-eluting stents). • The standards for “door to needle” and “door to balloon” times continue to be met although increased times with inter-hospital transfer were observed • There has been a reduction in the use of thrombectomy devices in PPCI procedures, reducing costs without impacting on outcomes. • However, the NICOR data reveal continuing issues with a number of processes of care including the overall time taken for patients to receive treatment for ST-elevation MI (“call-to-balloon” times) which have initiated a national debate and a work programme within NHS England to address this. • Similarly, systems reviews are needed to address the issue of timely treatment for patients with non-ST-elevation myocardial infarction [smaller heart attacks] and for all heart attack patients requiring an inter-hospital transfer. • The implementation of a risk adjustment model has enabled a comparison of outcomes of individual hospitals and operators, adjusting for case mix. 3) National Heart Failure Audit (NHFA): • In spite of fears that outcomes would be worse during the COVID-19 pandemic, this did not prove to be the case. However, there was a dramatic fall-off of admissions to hospital with heart failure. • Best outcomes, in terms of processes of care and outcomes, are seen in those patients who are managed by specialist cardiac care. • The prescription of key disease-modifying medicines for patients with heart failure and a reduced left ventricular ejection fraction (HF-REF) continues to increase. These treatments are both life-saving and inexpensive. However, there is still evidence that too many patients are being discharged with some of these drugs, but not all the indicated medications they should have received. • On-going analysis is investigating the prescription of newer classes of drugs that impact favourably on outcomes. • The Heart Failure audit data are used to support Best Practice Tariff – a quality improvement initiative to reward hospitals that provide a high standard of care. 4) MINAP: • As with NHFA, the outcomes of patients admitted to hospital during the COVID-19 pandemic were not significantly altered and processes of care were, largely, maintained or improved. • As per the NAPCI findings, there is a national concern about the deteriorating call-to-balloon times for patients with ST-elevation myocardial infarction (large heart attacks) and the on-going delays associated with inter-hospital transfers for treatment for patients with all forms of heart attack. • During the COVID-19 pandemic, patients requiring angiography following presentation with non-ST-elevation myocardial infarction (smaller heart attack) received the investigation and subsequent treatment faster than seen in previous years and more received treatment within the guideline-recommended 72 hours from admission. This related to a reduction in the number of admissions and greater access to the catheter laboratories whilst elective work was postponed. • There are improvements in the number of patients being assessed with in-patient echocardiography prior to discharge. This helps direct which additional treatments they should receive. • The proportion of patients receiving secondary prevention medications has been maintained at a high level. • There has been a gradual improvement in the number of patients being referred for cardiac rehabilitation following a heart attack. • MINAP data are used to support Best Practice Tariff – a quality improvement initiative to reward hospitals that provide a high standard of care. 5) National Audit for Cardiac Rhythm Management • Procedure numbers, especially for elective ablation procedures fell dramatically during the early part of the COVID-19 pandemic. • The audit has identified quite significant regional variations in rates of device implants and ablation methods for control of arrhythmias. • The number of hospitals performing fewer than the recommended minimum number of procedures has been falling progressively. • Although there is overall high compliance with national standards, documentation of indications for procedures varies and some hospitals need to improve. • There is a significant variation in the need for second treatments during follow-up after an initial procedure. 6) National Adult Cardiac Surgery Audit: • There was a significant fall in all types of elective cardiac surgery during the early part of the COVID-19 pandemic. • Analysis has demonstrated the likely increased mortality for patients with aortic valve disease during this period. • Waits for cardiac surgery had been falling but increased again during the COVID-19 pandemic. • There has been an overall reduction in complications following surgery with a reduction in the variation between hospitals. • The development and implementation of the risk model for cardiac surgery has been an essential part of quality assurance in the NHS. There is considerable use of the cardiac national data which has become a valuable source of data for commissioners, the Department of Health, patients, clinicians, and managers. The audit data, linked to HES and/or mortality data, has and will continue to be used to: • Improve standards of care • Facilitate completeness of data • Inform Patient choice • Inform effective commissioning • Inform regulatory and monitoring bodies (e.g. CQC) • Provide new evidence

Expected Benefits:

A number of future benefits are expected to be applicable to all the audits. For example:

• Investigating cumulative missed opportunities for patient care and major cardiovascular and cerebrovascular events. Patients tend to benefit from national clinical audits as the audit process assesses the quality of care provided by different specialist units to patients with cardiovascular heart disease and the treatment outcomes. Care providing units are benchmarked against others nationally. This enables patients to see which units / clinicians are better care providers than others which also facilitates patient choice when they are referred for hospital specialist care.

• Determining case ascertainment rates and under-reporting of procedures and patient admissions. The information analysed by NICOR on the treatment outcomes and benchmarking of specialist units and clinicians is used by hospitals for service planning and quality improvement. The hospitals are able to use the Information and Communications Technology reporting tools that NICOR has provided to the hospital units submitting data to NICOR (e.g. comparison of unit’s performance with the national average or with the top 10 hospitals in the country) for planning and quality improvement purposes. Similarly the audit information outputs developed by NICOR are also used by the regulators for example the Care Quality Commission (CQC) to monitor the performance of the individual units. This is expected to be a major public/health service benefit as it leads to safe care being provided by hospitals.

The other expected benefits of NHS England linked data with national cardiac audit programme data are that the specialised commissioners, regulators (e.g. CQC, Medicines and Healthcare products Regulatory Agency) and other stakeholders should find the outcomes data useful for ensuring they are purchasing high quality of services, and that the cardiac services received by patients are of high/consistent quality. This is made more relevant to the key stakeholders by NICOR standardising and harmonising the approach to conducting the 6 clinical domains of NCAP in terms of methodology, data collection, data completeness, data quality, statistical methodology for analysis and reporting, thus making the NCAP reports truly relevant and useful for all key stakeholders, commissioners, trusts, patients and the public and clinicians, which will lead to improvements in the quality of care provided to patients.

The use of the information provided by NICOR could:
• help the system to better understand the health and care needs of populations.
• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
• advance understanding of regional and national trends in health and social care needs.
• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
• inform decisions on how to effectively allocate and evaluate funding according to health needs.
• provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.
• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The audits are continuously evolving and developing. Selected examples of some of the future specific expected measurable benefits/developments for the audits include:
• National Congenital Heart Disease Audit:
o Developing additional outcome measures other than life status. This is particularly important for this cohort of patients undertaking complex procedures at a very young age – often neonates.
o Developing a risk model for adult congenital cases to measure the safety of patient services. Without the audit data this would not be possible.

• National Audit for Percutaneous Coronary Interventions:
o Data used to develop clinical service quality markers for heart attack services - an expected benefit for health services.

• National Heart Failure Audit (NHFA):
o Use of audit data to develop a heart failure risk adjustment model for ensuring that variations in patient types/casemix are accounted for
o Use of audit data to develop Clinical Service Quality Measures (CSQM) which should benefit the health services
o Data used by hospitals in the NHS to support best practise tariff (BpT) – a quality improvement initiative to reward hospitals that provide a high standard of care. Improving efficiency and good use of limited resources would be beneficial for both patients and the system.

• MINAP:
o Development of a risk model that reflects the complexity of the heart attack care pathway. Audit data is crucial to this work due to the complexity of the pathways within England and Wales.
o Publication of risk adjusted survival rates is both a patient benefit as it improves patient choice as well as a system benefit.

• National Audit for Cardiac Rhythm Management:
o Provide commissioning level reports which should benefit both patients with improved levels of commissioning, and the health services.
o reporting one year re-intervention rates for first-time pacemaker and complex implants at each centre. This is an important index of major complications.

• National Adult Cardiac Surgery Audit:
o Develop methods for rapid analysis of local and national data for individual consultant performance and unit level reporting. A national “pre-alert” system will be introduced to anticipate and prevent deviation from agreed performance standards (alerts and alarms) which is of expected benefit to patients and health services.

Outputs:

NICOR anticipate producing the NCAP 2023 Annual Aggregate Report along with the Summary Domain Reports as well as the NCAP Patients' Report to be published in 2023.

The aim is to publish annual National Cardiac Audit Programme (NCAP) reports based on 2021/22 data in each of the domains of NCAP during 2023. NHS England information is essential to be able to provide appropriate case ascertainment and mortality outcome for these publications. Without such data the essential analysis and core reporting and subsequent quality improvement cannot be done.

The intended audience are clinicians, healthcare professionals, Medical Directors, Chief Executives, audit managers, commissioners, NHS England, public and patients. Trusts will use the outcomes in the annual reports to assess their care against national standards and benchmark against other trusts, and make improvements which in turn will benefit patients. The Audit is able to identify and report the following year whether improvements have been made. The outputs will show whether the trusts are meeting national guidance and whether there is any variation in the provision of care.

• Each audit domain will produce and publish a summary report alongside the main NCAP Annual Report and the Annual Report for Patients and the Public.

• The National Adult Cardiac Surgery Audit and the National Audit for Percutaneous Coronary Interventions domains may publish consultant level outcomes on the professional society websites in 2023. Consultant-level outcomes likely to be reported are volume of operations and risk-adjusted in-hospital survival rate (adult cardiac surgery) and number of procedures, data completeness, freedom form major adverse events, survival 30-days post-procedure and proportion of patients treated using radial artery access (NAPCI): This is to provide transparency, quality assurance and to assist in patient choice.

• The process creates a single cardiovascular dataset in which patients can be tracked as they develop cardiac conditions, present with clinical complications and receive cardiovascular treatments. The NCHDA (Congenital) audit is hoping to develop a programme to track outcomes for specific patient groups over the next 2-3 years.

• The dataset provides additional insight into outcomes (especially adverse reactions such as stroke, bleeding or renal failure) which NICOR can then include in annual reports used to inform quality improvement work. Several NCAP domains are actively looking at how to utilise the linked data over the next 2-3 years to develop new outputs to support these aims.

• The linkages make it possible to investigate and publish outcomes beyond survival in each of the audits. These could include other post-procedure/care pathway complications, longer-term outcome or process measures. For example, both the disease-based and procedure-based domains are investigating analytical plans to explore the number of and reason for readmissions.

• The linkages enable the development and implementation of new clearly defined audit-specific quality improvement questions and plans.

• Linkages will enhance plans in the NACRM (arrhythmia management) audit to publish pacemaker and complex procedure numbers by implanter and by responsible consultant, but including follow-up outcomes such as requirements for additional procedures. In addition, analytical plans are considering how many patients in the disease-specific domains (MINAP and NHFA) receive appropriate treatment with implantable device therapy.

• The enhanced analytical platform enables the publication of results, where appropriate, in peer-reviewed journals which allows greater discussion of the strengths and weaknesses of the results and will provide the benefit of peer-review of the work from third parties. The work is highly relevant to current clinical practice and publication will allow NICOR to disseminate the findings widely amongst health professionals.

• All reports and outputs will be made available on the NICOR website, and websites of the associated professional societies to make them further accessible by healthcare professionals and patients and the public.

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The NCAP 2022 Annual Aggregate Report, the six Summary Domain Reports and the NCAP Report for Patients and the Public were published in June 2022: https://www.nicor.org.uk/2022/06/09/nicor-publishes-national-cardiac-audit-programme-ncap-annual-report-2022/
The 2022 Reports (https://www.hqip.org.uk/resource/national-cardiac-audit-programme-2022-report-the-heart-in-lockdown/#.Y8Z6_JjP2Uk) and earlier annual reports are also available to view on the Healthcare Quality Improvement Partnership's website.

Processing:

Under DARS-NIC-359940-W1R7B, NHS Arden & GEM CSU will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Surname, Forename, Date of Birth, Postcode, Gender and a unique person ID) for the cohort to be linked with NHS England data.

NHS England data will provide the relevant records from the Civil Registrations (Deaths) and Demographics datasets to NHS Arden & GEM CSU. The data will contain directly identifying data items including NHS Number which is required to link the data at record level with data already held by the recipient.

The data will be stored on National Institute for Cardiovascular Outcomes Research (NICOR) servers managed by NHS Arden & GEM CSU. Servers are housed and maintained by Redcentric PLC. Redcentric PLC is not permitted to access the data.

The data will be accessed onsite at the premises of NHS Arden & GEM CSU, or by authorised personnel via remote access. The data will remain on the servers at NHS Arden & GEM CSU at all times.

The data will not leave England and Wales at any time.

Access is restricted to employees of NHS Arden & GEM CSU.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The data will not be transferred to any other locations.

The data will be linked at person record level with other data collected for the purposes of the respective audits. After validation of the linkage, all health data is stored in a pseudonymised format.

The identifying details will be stored in a separate database to the linked dataset used for analysis.

NICOR at NHS Arden & GEM CSU analyse the linked audit outcomes to produce statistical analyses and identify NHS organisations whose performance is an outlier of expected outcomes, in order to identify and exploit improvement opportunities.

National Audit for Percutaneous Coronary Interventions (Angioplasty) - HES Tabulation data — DARS-NIC-318886-M1B9L

Opt outs honoured: No - data flow is not identifiable, No (Excuses: Does not include the flow of confidential data, Internal flow of aggregate tables only)

Legal basis: Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Internal flow of aggregate tables only

Purposes: No, This data sharing agreement is not an intended legal document, it is a reference document to evidence data flows.  The agreement will not be signed as a legal document.  It will instead be signed by internal NHS England colleagues. NHS England has commissioned NHS Arden and Greater East Midland Commissioning Support Unit (Arden and GEM) to host the National Institute for Cardiovascular Outcomes Research (NICOR) to continue to manage the six national cardiovascular audits: • Myocardial Ischaemia National Audit Project (MINAP-– concerning heart attacks or other acute coronary syndromes) • National Heart Failure Audit (NHFA) • National Adult Percutaneous Interventions Audit (NAPCI- relating to a non-surgical method used to open narrowed arteries that supply the heart muscle with blood) • National Congenital Heart Disease Audit (NCHDA- relating to procedures performed for a cardiac defect present from birth) • National Adult Cardiac Surgery Audit • National Cardiac Rhythm Management Audit As of 24 June 2022, NHS England is the data controller, commissioner and funder for all NICOR's audits and registries. The audits are based on prospectively collected data on patients in all NHS and independent healthcare providers in England and Wales. NICOR is the delivery arm of Arden and GEM (formal processor) for managing the audits and data processing. NICOR's national audit programme comprises of two types of audits: two specialist domains that are concerned with the disease processes (heart attacks and heart failure) and four that cover delivery of specific services (procedures for patients with congenital heart disease, percutaneous coronary intervention, cardiac surgery and the management of cardiac rhythm abnormalities). The aim of these NICOR audits is to measure and report delivery of care against defined guidance standards and to enable the improvement of the quality of care and outcomes of patients with a range of cardiac conditions. Individuals who are already included in NICOR’s six national cardiovascular audit databases have their hospital and mortality outcomes reported under DARS-NIC-359940-W1R7B. This Data Sharing Agreement concerns The National Audit for Percutaneous Coronary Interventions (NAPCI) which is one of the six focal areas for audit within the National Cardiac Audit Programme (NCAP) that contains information about the care provided to patients who are admitted to hospital for percutaneous coronary interventions (PCIs). The audit's findings have been made public for many years through its annual reports published on the NICOR website. NAPCI aims to capture data on clinical indicators which have a proven link to improved outcomes, and to encourage the increased use of clinically recommended diagnostic tools, disease modifying interventions/treatments and referral pathways. The NAPCI aspires to include complete information about the care of every patient admitted to hospital with coronary disease requiring percutaneous coronary intervention / angioplasty. By so doing there can be greater confidence in the reliability of subsequent analyses and in the validity of comparisons between participating hospitals. The audit must publish case ascertainment at Trust and hospital level to ensure it is capturing all relevant cases. This aspect of data quality is fed back to participating centres, to NHS England and regulatory bodies. The data supplied by NHS England will be used to produce participation tables for audit purposes and to determine whether hospitals are fully participating in the audit. Aggregate HES APC data at hospital level will be compared to the number of records submitted to the audit by each Trust and hospital, to measure case ascertainment. The hospital level HES tabulation data requested is the minimum level of data required for case ascertainment purposes. NICOR only receive data concerning the number of patients who received care by individual hospitals. The HES tabulation data will be used to determine whether hospitals are fully participating in the audit. Aggregate HES data at Trust (and component hospital) level will be compared to the number of records submitted to the audit and expressed (in tabular format) as case ascertainment rates for participating centres. This is a key quality indicator. There are no alternative less intrusive ways of achieving the purpose. The HES Tabulation data is only required once a year for case ascertainment purposes. Once the audit data has been analysed and the annual reports have been published, the HES tabulation data is destroyed. NICOR is hosted by Arden and GEM which as the sole data processor only processes the data for the purposes described in this agreement. For NICOR’s annual reports, the HES Tabulation data requires all small numbers to be unsuppressed, because otherwise when comparing HES figures with the number of records that hospitals have submitted to the audit, NICOR’S numbers will be inaccurate. If 300 cells are suppressed (with each suppressed cell representing up to 7) that is up to 2100 admissions excluded from the total, which is quite a significant amount. The data with small numbers not suppressed will allow the comparison of the number of cases a hospital has submitted to the audit with the actual number the hospital has treated as recorded in the HES data. To address the GDPR principle of Data Minimisation, NICOR request that the data received is restricted to patients who have been discharged from hospital (with hospital code) with a diagnosis of percutaneous coronary intervention (PCI)/angioplasty. NHS England relies on the Article 6(1)(e) legal basis under UK GDPR – “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller”. The processing activities described within this agreement can be deemed to be in the public interest because processing may result in improvements in the quality of care for people undergoing Percutaneous Coronary Interventions. NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance., This data sharing agreement is not an intended legal document, it is a reference document to evidence data flows. The agreement will not be signed as a legal document. It will instead be signed by internal NHS England colleagues. NHS England has commissioned NHS Arden and Greater East Midland Commissioning Support Unit (Arden and GEM) to host the National Institute for Cardiovascular Outcomes Research (NICOR) to continue to manage the six national cardiovascular audits: • Myocardial Ischaemia National Audit Project (MINAP-– concerning heart attacks or other acute coronary syndromes) • National Heart Failure Audit (NHFA) • National Adult Percutaneous Interventions Audit (NAPCI- relating to a non-surgical method used to open narrowed arteries that supply the heart muscle with blood) • National Congenital Heart Disease Audit (NCHDA- relating to procedures performed for a cardiac defect present from birth) • National Adult Cardiac Surgery Audit • National Cardiac Rhythm Management Audit As of 24 June 2022, NHS England is the data controller, commissioner and funder for all NICOR's audits and registries. The audits are based on prospectively collected data on patients in all NHS and independent healthcare providers in England and Wales. NICOR is the delivery arm of Arden and GEM (formal processor) for managing the audits and data processing. NICOR's national audit programme comprises of two types of audits: two specialist domains that are concerned with the disease processes (heart attacks and heart failure) and four that cover delivery of specific services (procedures for patients with congenital heart disease, percutaneous coronary intervention, cardiac surgery and the management of cardiac rhythm abnormalities). The aim of these NICOR audits is to measure and report delivery of care against defined guidance standards and to enable the improvement of the quality of care and outcomes of patients with a range of cardiac conditions. Individuals who are already included in NICOR’s six national cardiovascular audit databases have their hospital and mortality outcomes reported under DARS-NIC-359940-W1R7B. This Data Sharing Agreement concerns The National Audit for Percutaneous Coronary Interventions (NAPCI) which is one of the six focal areas for audit within the National Cardiac Audit Programme (NCAP) that contains information about the care provided to patients who are admitted to hospital for percutaneous coronary interventions (PCIs). The audit's findings have been made public for many years through its annual reports published on the NICOR website. NAPCI aims to capture data on clinical indicators which have a proven link to improved outcomes, and to encourage the increased use of clinically recommended diagnostic tools, disease modifying interventions/treatments and referral pathways. The NAPCI aspires to include complete information about the care of every patient admitted to hospital with coronary disease requiring percutaneous coronary intervention / angioplasty. By so doing there can be greater confidence in the reliability of subsequent analyses and in the validity of comparisons between participating hospitals. The audit must publish case ascertainment at Trust and hospital level to ensure it is capturing all relevant cases. This aspect of data quality is fed back to participating centres, to NHS England and regulatory bodies. The data supplied by NHS England will be used to produce participation tables for audit purposes and to determine whether hospitals are fully participating in the audit. Aggregate HES APC data at hospital level will be compared to the number of records submitted to the audit by each Trust and hospital, to measure case ascertainment. The hospital level HES tabulation data requested is the minimum level of data required for case ascertainment purposes. NICOR only receive data concerning the number of patients who received care by individual hospitals. The HES tabulation data will be used to determine whether hospitals are fully participating in the audit. Aggregate HES data at Trust (and component hospital) level will be compared to the number of records submitted to the audit and expressed (in tabular format) as case ascertainment rates for participating centres. This is a key quality indicator. There are no alternative less intrusive ways of achieving the purpose. The HES Tabulation data is only required once a year for case ascertainment purposes. Once the audit data has been analysed and the annual reports have been published, the HES tabulation data is destroyed. NICOR is hosted by Arden and GEM which as the sole data processor only processes the data for the purposes described in this agreement. For NICOR’s annual reports, the HES Tabulation data requires all small numbers to be unsuppressed, because otherwise when comparing HES figures with the number of records that hospitals have submitted to the audit, NICOR’S numbers will be inaccurate. If 300 cells are suppressed (with each suppressed cell representing up to 7) that is up to 2100 admissions excluded from the total, which is quite a significant amount. The data with small numbers not suppressed will allow the comparison of the number of cases a hospital has submitted to the audit with the actual number the hospital has treated as recorded in the HES data. To address the GDPR principle of Data Minimisation, NICOR request that the data received is restricted to patients who have been discharged from hospital (with hospital code) with a diagnosis of percutaneous coronary intervention (PCI)/angioplasty. NHS England relies on the Article 6(1)(e) legal basis under UK GDPR – “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller”. The processing activities described within this agreement can be deemed to be in the public interest because processing may result in improvements in the quality of care for people undergoing Percutaneous Coronary Interventions. NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance. (Academic, internal NHS transfer)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2020-03 – 2021-03 2021.04 — 2025.04.

Access method: One-Off

Data-controller type: HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), NHS ENGLAND (QUARRY HOUSE), NHS ENGLAND (QUARRY HOUSE)

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)

Type of data: Anonymised - ICO Code Compliant, Aggregated, Pseudonymised

Objectives:

The Healthcare Quality Improvement Partnership (HQIP) has commissioned, on behalf of NHS England as part of the National Clinical Audit and Patient Outcomes Programme (NACPOP), six national cardiovascular audits which are managed by the National Institute for Cardiovascular Outcomes Research (NICOR) based within Barts Health NHS Trust.
• Myocardial Ischaemia National Audit Project (MINAP)
• National Heart Failure Audit (NHFA)
• National Congenital Heart Disease Audit
• National Adult Cardiac Surgery Audit
• National Cardiac Rhythm Management Audit
• National Adult Percutaneous Interventions Audit (NAPCI)

National Institute of Cardiovascular Outcomes Research (NICOR) conducts the national cardiac audit programme (NCAP) of which NAPCI is one of six domains. NICOR is hosted by Barts Health NHS Foundation Trust, and the Trust also holds funding for NCAP, as such Barts Health NHS Foundation Trust process the data for the purposes described in this agreement. However, as NICOR monitor’s all hospitals (including Barts Health’s) performance through national clinical audit this work has to be kept at an arms’ length from Barts Health.

The six audits, collectively termed the National Cardiac Audit Programme (NCAP) audits, are based on prospectively collected, patient-level data on patients in all NHS providers in England and Wales. NCAP is managed by NICOR, and their funding contract for the National Cardiac Audit Programme runs until June 2022.

NCAP collects data from two domains that are concerned with particular disease processes (heart attacks and heart failure) and four that cover delivery of specific services (procedures for patients with congenital heart disease, percutaneous coronary intervention, cardiac surgery and the management of cardiac rhythm abnormalities). The aim of these NCAP audits is to measure and report delivery of care against defined guidance standards and to enable the improvement of the quality of care and outcomes of patients with a range of cardiac conditions.

The National Audit for Percutaneous Coronary Interventions (NAPCI) is one of the six focal areas for audit within the NCAP that contains information about the care provided to patients who are admitted to hospital for percutaneous coronary interventions (PCIs). The audit's findings have been made public for many years through its annual reports published on the NICOR website.

NAPCI aims to capture data on clinical indicators which have a proven link to improved outcomes, and to encourage the increased use of clinically recommended diagnostic tools, disease modifying interventions/treatments and referral pathways. The NAPCI aspires to include complete information about the care of every patient admitted to hospital with coronary disease requiring percutaneous coronary intervention / angioplasty. By so doing there can be greater confidence in the reliability of subsequent analyses and in the validity of comparisons between participating hospitals. The audit must publish case ascertainment at Trust and hospital level to ensure it is capturing all relevant cases. This aspect of data quality is fed back to participating centres, to NHS England and regulatory bodies.

The data supplied by NHS Digital will be used to produce participation tables for audit purposes and to determine whether hospitals are fully participating in the audit. Aggregate HES APC data at hospital level will be compared to the number of records submitted to the audit by each Trust and Health Board, to measure case ascertainment. The hospital level HES tabulation data requested is the minimum level of data required for case ascertainment purposes. Barts Health NHS Trust only receive data concerning number of patients who received care by individual hospitals.

For the purpose of this report NICOR cannot allow for any small numbers to be suppressed, because otherwise when comparing HES figures with the number of records that hospitals have submitted to the audit, NICOR’S numbers will be inaccurate. If 300 cells are suppressed (with each suppressed cell representing up to 7) that is up to 2100 admissions excluded from the total, which is quite a significant amount. The data with small numbers not suppressed will allow the comparison of the number of cases a hospital has submitted to the audit with the actual number the hospital has treated as recorded in the HES data. Small number suppression will be applied to the audit outputs.

With appropriate IG and other permissions the NAPCI data is also used for research purposes, to investigate further the causes, treatment and management of heart disease requiring PCI.

To address the GDPR principle of Data Minimisation, NICOR request that the data received is restricted to patients who have been discharged from hospital (with hospital code) with a diagnosis of percutaneous coronary intervention (PCI)/angioplasty.

NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs.

NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties.

Therefore, both HQIP and NHS England are Data Controllers. GDPR Legal Basis for data dissemination for HQIP is the General Data Protection Regulation Article 6(1)(e) and Article 9(2)(i) and for NHS England is the General Data Protection Regulation Article 6(1)(e) and Article 9(2)(h). The processing activities described within this agreement can be deemed to be in the public interest because processing may result in improvements in the quality of care for people being treated for people undergoing Percutaneous Coronary Interventions.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract - i.e. employees, agents and contractors of the Data Recipient who may have access to that data).

Yielded Benefits:

The NAPCI audit has allowed NICOR to identify centres that are consistently falling below national benchmarks. Letter are sent from the British Cardiovasular Intervention Society (BCIS) clinical standards group to any centre whose total PCI numbers fall below 200 for 3 successive years. Regional commissioners may need to discuss with local providers. The audit has indicated that a focus is needed to reverse the deterioration in ambulance response times for patients with ST-elevation myocardial infarction. In addition, although the overall Door-To-Balloon times are good, there is still considerable variation between hospitals. Improvement in the slower centres is therefore also needed to improve patient care. These centres have been advised to contact hospitals that perform well to see what lessons can be learned. This report highlighted that it is important that many centres improve the rapidity of Non-ST-Myocardial Infarction (NSTEMI) patient access to invasive cardiology investigation and treatment for patients. As a result of the NAPCI reports there has been a substantial shift in practice to the use of radial access for PCI of which the UK can be proud. The few operators who have yet to change their practice have been be encouraged to make use of the educational resources available in the UK and, given the high percentages of the large majority, are very likely to have colleagues who can help support their shift in practice. NICOR have advised that trusts should introduce day case procedures for patients undergoing elective PCI, hospitals should seek to modify their pathways and ward structures to reduce unnecessary overnight stays for patients. Based on the findings of the NAPCI report, NICOR have advised that the hospitals not meeting the standards for the use of drug-eluting stents during primary PCI should review their cases to see where improvements can be made.

Expected Benefits:

The primary benefit of this work is in the calculation (and presentation) of case ascertainment rates for participating centres.

Case ascertainment is an important aspect of data quality and provides an estimate as to what proportion of patients with the clinical condition under study are submitted to the audit. The publication of case ascertainment rates encourages participating centres to include as many patients as possible. This minimises the risk of hospitals͚ 'cherry picking' patients for the audit and enables the audit to measure like with like and provide national comparative data.

A secondary benefit is in an understanding of the coding practices of participating hospitals with respect to similar cardiac conditions.

Improved data quality: Publication and comparison of case ascertainment will identify poorer performing hospitals and encourage such hospitals to improve the quality of the data they submit. At the same time higher performing hospitals can receive credit.

Confidence in the implications (and generalisability) of national audit: Access to HES trusts level data is crucial for establishing case ascertainment and ensuring the quality of patient care and patient outcomes is being monitored for all patients. Case ascertainment is key to measuring equity of access and care. This will lead to:
(a) Improvements in patient care, as the NCAP supports both quality assurance and quality improvement initiatives both locally and nationally;
(b) Understanding differences in hospital coding practices: Variation in cases ascertainment may also point to differences in HES coding practices between hospitals.

Outputs:

NICOR must deliver to HQIP and NHS England the NCAP Annual Report - as a contracted deliverable. Following formal sign off by NHSE and HQIP the NCAP 2021 Annual Report and the NAPCI Summary Report will be published. After which there will be some individual discussions and presentations of the report e.g. at conferences. These presentations may not necessarily include the HES tabulation data, but the publication and any presentations would be based on the NCAP Annual Report (which uses HES tabulation data for case ascertainment purposes).

These annual reports will be distributed electronically to Trust chief executives, clinicians, British Cardiovascular Society and to other stakeholders. These reports are also publicly available online on the HQIP on its webpages on the NICOR website: https://www.nicor.org.uk/national-cardiac-audit-programme/

Both the NCAP 2021 Annual Report and the domain-specific NAPCI Summary Annual Report will be distributed electronically to Trust chief executives, clinicians, British Cardiovascular Society and to other stakeholders. These reports are also publicly available online on the HQIP webpages on the NICOR website: https://www.nicor.org.uk/national-cardiac-audit-programme/.

Analyses from NAPCI and NCAP Reports appear in Quality Accounts and are made available to CQC visiting teams.

The NAPCI audit publishes case ascertainment and clinical practice analysis at Trust and hospital level, and feeds back on this to NHS England and the Care Quality Commission. The hospital level HES tabulation data requested is the minimum level of data required for case ascertainment purposes, which basically means that it’s a check for verifying the number of patients submitted to NICOR with the number of patients’ coded by the hospitals for HES. The data received is number of patients who received care by individual hospitals (with a hospital code).

The NAPCI data is used in a number of ways to drive improvement in PCI (angioplasty) services and patient outcomes. Primarily, data is fed back to individual hospitals to report on their clinical practice and outcomes over time.

NICOR recently published the NAPCI 2020 Annual Report (released December 2020) which presents case ascertainment rates for participating Trusts in Hospital Episode Statistics (HES) tabulated data provided by NHS Digital in England to the number of cases submitted to NAPCI.

The audit provides participation rates, and hospital level data, to organisations such as the Care Quality Commission's Quality and Risk Profiles, the NHS Choices website and data.gov.uk. Case Ascertainment is also presented within annual public reports.

Additionally NICOR are mandated by HQIP to maintain and improve 'Data Quality'. Markers of data quality include:
• Timeliness of reporting - how soon after, and how often during, the relevant period of reporting are reports made available?
• Accuracy/validity of submitted data - are the data submitted to the audit a true reflection of the care provided?
• Data completeness - for each case, how many of the data fields are completed?
• Case ascertainment - what proportion of the entire 'population' of patients with the clinical condition of interest is submitted to the National Audit?
Following receipt of previous HES data, NAPCI has been able to report on this last aspect of data quality - case ascertainment.

Processing:

There will be no flow of data into NHS Digital. NHS Digital will flow tabulated HES APC data to Bart’s Health NHS Trust. There will be no subsequent flow of data.

All who will be processing NHS Digital data are substantive employees of Bart's Health NHS Trust.

The NAPCI audit aims to drive up the quality of the diagnosis, treatment and management of PCI by collecting, analysing and disseminating data, measuring improvements in participation in the NAPCI; eventually to improve mortality and morbidity outcomes for patients receiving PCI procedures.

The HES tabulation data will be used to determine whether hospitals are fully participating in the audit. Aggregate HES data at Trust (and component hospital) level will be compared to the number of records submitted to the national audit and expressed (in tabular format) as case ascertainment rates for participating centres. This is a key quality indicator. The NAPCI audit publishes case ascertainment and clinical practice analysis at Trust and hospital level and provides feedback on this to NHS England and the Care Quality Commission. For the purpose of the NAPCI Annual Report, NICOR cannot allow for any small numbers to be suppressed.

The tabulated HES data is stored on the NICOR shared drive only accessible to NICOR staff. Once the reports have been published the data is destroyed.

To protect patient confidentiality, when presenting results calculated from HES data, outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide. When publishing HES data, it must be ensured that cell values from 1 to 7 are suppressed at a local level to prevent possible identification of individuals from small counts within the table. Zeros (0) do not need to be suppressed. All other counts will be rounded to the nearest 5.

The data from NHS Digital will not be used for any other purpose other than that outlined in this agreement. It will also not be linked to any other data sets. There will be no attempt to re-identify the data. Onward sharing of data which is not aggregated with small number suppression is not permitted.

Upon instruction from NHS Digital, a Certificate of Data Destruction must be completed by the Data Controller confirming the data has been appropriately disposed of following use.

Barts Health NICOR NCAP (Previously known as CCAD - Central Cardiac Audit Database - MR1233) — DARS-NIC-359940-W1R7B

Opt outs honoured: Yes - patient objections upheld, Yes, No (Excuses: Section 251, Section 251 NHS Act 2006)

Legal basis: Section 251 approval is in place for the flow of identifiable data, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012, Health and Social Care Act 2012 – s261(7), National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261 - 'Other dissemination of information'; National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No, This data sharing agreement is not an intended legal document, it is a reference document to evidence data flows. The agreement will not be signed as a legal document. It will instead be signed by internal NHS England colleagues. The six national cardiovascular audits (named below) and the UK Transcatheter Aortic Valve Implantation (TAVI) registry are managed by the National Institute for Cardiovascular Outcomes Research (NICOR) which is hosted at NHS Arden and Greater East Midland Commissioning Support Unit (Arden and GEM CSU). The data processing work carried out by NICOR transferred to Arden and GEM from Barts Health NHS Trust on 23 June 2022. The NICOR audits and TAVI registry are based on prospectively collected, patient-level data on patients in all NHS providers in England and Wales. These audits, collectively termed the National Cardiac Audit Programme (NCAP) audits, are commissioned by NHS England (NHSE). Arden and GEM will hold the funding and data* for all NICOR Audits and Registries including NCAP (*the data is technically held on NICOR servers housed at a Redcentric data centre under the control of NICOR staff). The audits included in NCAP are: • Myocardial Ischaemia National Audit Project (MINAP- heart attack) - Includes all adult patients with acute coronary syndromes (any condition resulting from the sudden reduction of blood flow to the heart, which leads to shortness of breath and sudden chest pain), collecting information on the management of patients admitted with a diagnosis of myocardial infarction (heart attack) and other acute coronary syndromes. • National Heart Failure Audit (NHFA): Includes all patients with an unscheduled admission to hospital with heart failure, collecting data on patients discharged from acute hospitals with a primary diagnosis of heart failure • National Congenital Heart Disease Audit (NCHDA): Includes cardiac (relating to the heart) or intrathoracic (within the chest) great vessel procedures carried out in patients under the age of 16 years, and all adult congenital cardiac procedures performed for a cardiac defect present from birth • National Adult Cardiac Surgery Audit (NACSA): Includes all adult patients undergoing major heart surgery • National Audit for Cardiac Rhythm Management (NACRM): Includes all adult patients with implanted devices or receiving interventional procedures for the management of cardiac rhythm disorders. • National Audit for Percutaneous Coronary Interventions (NAPCI): Includes all adult patients on whom a percutaneous cardiovascular intervention (PCI) procedure (a non-surgical method used to open narrowed arteries that supply the heart muscle with blood) is performed. • The UK TAVI registry: Includes all patients who have undergone a procedure to implant a TAVI device (a percutaneous method to implant a new aortic valve). The aim of these audits/ registries is to measure and report delivery of care against defined guidance standards and to enable the improvement of the quality of care and outcomes of patients with a range of cardiac conditions. The care pathways for these patients are complex and thus the data collected within the audits, combined with Hospital Episode Statistics (HES) and/or Civil Registration mortality data, provide high quality comparative information of the clinical practice/processes and patient outcomes in these clinical areas. For example, it enables the comparison of disease and treatment options and outcome by Trust, hospital, unit and in some audits by consultant (NACSA and NAPCI). Where the data indicates performance is an ‘outlier’ of expected outcomes, NICOR (at Arden & GEM) work to NHSE-defined processes and standards, and with NHS organisations to explore this further and recommend quality improvement work, if required. All results are made available on public facing websites and on the websites of the audit associated Professional Societies. The NICOR website highlights the latest reports but allows access to previously published reports. National Data Opt-Outs (NDOs) have been historically applied to the data disseminated under this agreement following support from the Confidentiality Advisory Group (CAG). The National Data Opt-Out (NDO) enables patients to opt-out from the use of their confidential patient information for research and planning purposes where the data flows rely upon Regulation 5 of the Health Service COPI (Control of Patient Information) Regulations 2002. It is a standard condition of support under Regulation 5 of the COPI Regulations 2002 that patient wishes are respected. In line with the National Data Opt-Out Operational Policy the Confidentiality Advisory Group (CAG) may exceptionally advise the decision-maker that the NDO should not apply to a specific data flow supported under Regulation 5 of the COPI Regulations 2002. In the case of the NCAP and TAVI registry, this has been supported. The justification to not apply the NDOs are as below: The NCAP and TAVI registry have direct implications for changes in clinical care pathways at local, regional and national level. The audits and registry aim for 100% inclusivity and case ascertainment figures are either very high or increasing annually. The audits/ registry collect data on all-comer patients with varying risk profiles; collection of the highest risk groups is essential for these programmes. The opt-out figures have increased significantly but with high variance between regions; this non-random variation is extremely problematic for monitoring of public health and healthcare delivery. Civil Registration data Death data (death status and date of death) will be linked to the NCAP and TAVI registry data to provide short-term and long-term survival outcomes. Demographic data will be used to facilitate this. HES Admitted Patient Care (APC) Data NICOR's annual report will include the details of comorbidities and complications which are collected in the audit/ registry data. However, in some cases HES APC data is needed to supplement the audit/ registry data. Linkage to the full HES dataset would allow further exploration of the geographic, socio-economic and organisational data of patients more detail. This could lead to a better understanding of commissioning patterns within the UK. In addition, the HES dataset collects information on augmented care and the patient care pathway, and covers readmissions which are an important requirement for outcomes analysis. The level of data will be identifiable in order to validate the success of the data linkage. The data will be minimised as follows: - Limited to data for a cohort supplied by NICOR, including any individual meeting the inclusion criteria for one or more of the aforementioned clinical audits/ the TAVI registry. In late 2022, there were ~40,000 individuals on the TAVI registry. - Limited to data between 2000 and the latest available year of data, in order to be able to conduct longitudinal analyses for the audits/ registry and the VICORI programme. The primary reason for which NICOR uses Civil Registration data/HES APC linked data is to work out the treatment outcomes for the patients treated by the hospitals and clinicians. A key part of the reason for conducting the National Cardiovascular Audit Programme (NCAP) is to be able to benchmark each hospital against other hospitals in terms of the number of patients that died following treatment/care provided by the hospitals. Up until and including current practice, the key criteria for bench-marking hospitals and individual clinicians for the Clinical Outcomes Publication (COP) reports is the mortality rate (or reverse of this - survival rate). This can only be worked out by using Civil Registration linked data. Although the NACSA domain of NCAP uses hospital reported mortality data for bench-marking purposes, not all domains of NCAP have accurate hospital reported mortality data, e.g. the national congenital heart disease domain requires the Civil Registration data for the risk adjustment model. The outcomes data (NICOR audit linked data to civil registrations) is also being used by the NHS to support Best Practice Tariff - particularly for the National Heart Failure Audit and Myocardial Ischaemia National Audit Project (MINAP) – a quality improvement initiative to reward hospitals that provide a high standard of care. Only the minimum amount of data fields required for audit purposes is requested. HES Tabulation Data Hospital level HES Tabulation data (small numbers unsuppressed) is required for case ascertainment purposes. The Data Sharing Agreements DARS-NIC-318886-M1B9L, DARS-NIC-42272-S9J3L and DARS-NIC-64572-X0Q4D cover these purposes. The tabulated data is released under these Agreements. VICORI NCAP data linked with tracked mortality data and patient level HES APC data is required for the Virtual Cardio-Oncology Research Institute (VICORI) programme run by The University of Leicester, NHS England and NICOR. This body of work is divided into several different work packages. These are detailed further in Data Sharing Agreement DARS-NIC-143888-H0W2N. DATA CONTROLLERSHIP NHS England (NHSE) is the controller for this Agreement, representing the English NCAP audit and TAVI registry data. Digital Health and Care Wales (DHCW) are the controller for Welsh data in the NCAP audits and TAVI registry, including from the Civil Registration (Deaths) and Demographics data released under this Agreement. The permissions for the flow of the Welsh mortality data are represented under DARS-NIC-717493-V2R4K. As data controller and commissioner, NHSE is responsible for determining which projects/topics are included, for project specification development, procurement and extension activities, contract management, authorising data sharing requests, and the publication of project outputs. The NCAP project specifications developed by NHSE set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHSE are part of the NICOR data access request approvals process which authorises data sharing applications from third parties. The data shared with any third parties is only NICOR data. NHS England’s data is not onward shared with anyone unless they have a specific current NHS England approved Data Sharing Agreement in place. LEGAL BASIS JUSTIFICATION: NHS England relies on the Article 6(1)(e) legal basis under UK GDPR - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services. NHS England rely on Article 9(2)(i) of the UK GDPR as the legal basis for processing. “Processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy”. This is justified as the NHSE commissioned audits and registries aim to drive improvements in the quality and safety of care and to improve outcomes for all patients., This Data Sharing Agreement is not an intended legal document, it is a reference document to evidence data flows. The Agreement will not be signed as a legal document. It will instead be signed by internal NHS England colleagues. The six national cardiovascular audits (named below) and the UK Transcatheter Aortic Valve Implantation (TAVI) registry are managed by the National Institute for Cardiovascular Outcomes Research (NICOR) which is hosted at NHS Arden and Greater East Midland Commissioning Support Unit (Arden and GEM CSU). The data processing work carried out by NICOR transferred to Arden and GEM from Barts Health NHS Trust on 23 June 2022. The NICOR audits and TAVI registry are based on prospectively collected, patient-level data on patients in all NHS providers in England and Wales. These audits and registry, collectively termed the National Cardiac Audit Programme (NCAP), are commissioned by NHS England (NHSE). Arden and GEM holds the funding and data* for the NCAP (*the data is technically held on NICOR servers housed at a Redcentric data centre under the control of NICOR staff). The NCAP is now considered as one national database which comprises of following10 intra-linked specialist domains: • Myocardial Ischaemia National Audit Project (MINAP- heart attack) - Includes all adult patients with acute coronary syndromes (any condition resulting from the sudden reduction of blood flow to the heart, which leads to shortness of breath and sudden chest pain), collecting information on the management of patients admitted with a diagnosis of myocardial infarction (heart attack) and other acute coronary syndromes. • National Heart Failure Audit (NHFA): Includes all patients with an unscheduled admission to hospital with heart failure, collecting data on patients discharged from acute hospitals with a primary diagnosis of heart failure • National Congenital Heart Disease Audit (NCHDA): Includes cardiac (relating to the heart) or intrathoracic (within the chest) great vessel procedures carried out in patients under the age of 16 years, and all adult congenital cardiac procedures performed for a cardiac defect present from birth • National Adult Cardiac Surgery Audit (NACSA): Includes all adult patients undergoing major heart surgery • National Audit for Cardiac Rhythm Management (NACRM): Includes all adult patients with implanted devices or receiving interventional procedures for the management of cardiac rhythm disorders. • National Audit for Percutaneous Coronary Interventions (NAPCI): Includes all adult patients on whom a percutaneous cardiovascular intervention (PCI) procedure (a non-surgical method used to open narrowed arteries that supply the heart muscle with blood) is performed. • The UK TAVI registry: Includes all patients who have undergone a procedure to implant a TAVI device (a percutaneous method to implant a new aortic valve). This amendment seeks the addition of 3 new structural heart intervention (SHI) registries (as part of NCAP) which are established to collect data for the same procedures as in the former Commissioning through Evaluation (CtE) registries: Left Atrial Appendage Occlusion (LAAO) Patent Foramen Ovale Closure in Adults (PFOC) Transcatheter Mitral and Tricuspid Valve (TMTV) - previously called Percutaneous Mitral Valve Repair. The aim of NCAP is to measure and report delivery of care against defined guidance standards and to enable the improvement of the quality of care and outcomes of patients with a range of cardiac conditions. The care pathways for these patients are complex and thus the data collected within the audits, combined with Hospital Episode Statistics (HES) and/or Civil Registration data, provide high quality comparative information of the clinical practice/processes and patient outcomes in these clinical areas. For example, it enables the comparison of disease and treatment options and outcome by Trust, hospital, unit and in some audits by consultant (NACSA and NAPCI). Where the data indicates performance is an ‘outlier’ of expected outcomes, NICOR works to NHSE-defined processes and standards, and with NHS organisations to explore this further and recommend quality improvement work, as required. All results are made available on public facing websites and on the websites of the audit associated Professional Societies. The NICOR website highlights the latest reports but allows access to previously published reports. National Data Opt-Out Policy (NDOP) is not applied to the agreement following the support from the Confidentiality Advisory Group (CAG). The National Data Opt-Out (NDO) enables patients to opt-out from the use of their confidential patient information for research and planning purposes where the data flows rely upon Regulation 5 of the Health Service COPI (Control of Patient Information) Regulations 2002. It is a standard condition of support under Regulation 5 of the COPI Regulations 2002 that patient wishes are respected. In line with the National Data Opt-Out Operational Policy the Confidentiality Advisory Group (CAG) may exceptionally advise the decision-maker that the NDO should not apply to a specific data flow supported under Regulation 5 of the COPI Regulations 2002. In the case of the NCAP and TAVI registry, this has been supported. The justification to not apply the NDOs are as below: The NCAP have direct implications for changes in clinical care pathways at local, regional and national level. The NCAP aims for 100% inclusivity and case ascertainment figures which are either very high or increasing annually. The audits/ registry collect data on all-comer patients with varying risk profiles; collection of the highest risk groups is essential for these programmes. The NDO figures have increased significantly but with high variance between regions; this non-random variation is extremely problematic for monitoring of public health and healthcare delivery. Civil Registration data Death data (death status and date of death) will be linked to the NCAP and TAVI registry data to provide short-term and long-term survival outcomes. Demographic data will be used to facilitate this. HES Admitted Patient Care (APC) Data NICOR's annual report will include the details of comorbidities and complications which are collected in the audit/ registry data. However, in some cases HES APC data is needed to supplement the audit/ registry data. Linkage to the full HES dataset would allow further exploration of the geographic, socio-economic and organisational data of patients more detail. This could lead to a better understanding of commissioning patterns within the UK. In addition, the HES dataset collects information on augmented care and the patient care pathway, and covers readmissions which are an important requirement for outcomes analysis. The level of data will be identifiable in order to validate the success of the data linkage. The data will be minimised as follows: - Limited to data for a cohort supplied by NICOR, including any individual meeting the inclusion criteria for one or more of the aforementioned clinical audits/ the TAVI registry. In late 2022, there were ~40,000 individuals on the TAVI registry. - Limited to data between 2000 and the latest available year of data, in order to be able to conduct longitudinal analyses for the audits/ registry and the VICORI programme. The primary reason for which NICOR uses Civil Registration data/HES APC linked data is to work out the treatment outcomes for the patients treated by the hospitals and clinicians. A key part of the reason for conducting the National Cardiovascular Audit Programme (NCAP) is to be able to benchmark each hospital against other hospitals in terms of the number of patients that died following treatment/care provided by the hospitals. Up until and including current practice, the key criteria for bench-marking hospitals and individual clinicians for the Clinical Outcomes Publication (COP) reports is the mortality rate (or reverse of this - survival rate). This can only be worked out by using Civil Registration linked data. Although the NACSA domain of NCAP uses hospital reported mortality data for bench-marking purposes, not all domains of NCAP have accurate hospital reported mortality data, e.g. the national congenital heart disease domain requires the Civil Registration data for the risk adjustment model. The outcomes data (NICOR audit linked data to civil registrations) is also being used by the NHS to support Best Practice Tariff - particularly for the National Heart Failure Audit and Myocardial Ischaemia National Audit Project (MINAP) – a quality improvement initiative to reward hospitals that provide a high standard of care. Only the minimum amount of data fields required for audit purposes is requested. HES Tabulation Data Hospital level HES Tabulation data (small numbers unsuppressed) is required for case ascertainment purposes. The Data Sharing Agreements DARS-NIC-318886-M1B9L, DARS-NIC-42272-S9J3L and DARS-NIC-64572-X0Q4D cover these purposes. The tabulated data is released under these Agreements. VICORI NCAP data linked with tracked mortality data and patient level HES APC data was required for the Virtual Cardio-Oncology Research Institute (VICORI) programme run by The University of Leicester, NHS England and NICOR. This project (now complete) was divided into several different work packages detailed in Data Sharing Agreement DARS-NIC-143888-H0W2N. DATA CONTROLLERSHIP NHS England (NHSE) is the controller for this Agreement, representing the English NCAP audit and TAVI registry data. Digital Health and Care Wales (DHCW) are the controller for Welsh data in the NCAP audits and TAVI registry, including from the Civil Registration (Deaths) and Demographics data released under this Agreement. The permissions for the flow of the Welsh mortality data are represented under DARS-NIC-717493-V2R4K. As data controller and commissioner, NHSE is responsible for determining which projects/topics are included, for project specification development, procurement and extension activities, contract management, authorising data sharing requests, and the publication of project outputs. The NCAP project specifications developed by NHSE set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHSE are part of the NICOR data access request approvals process which authorises data sharing applications from third parties. The data shared with any third parties is only NICOR data. NHS England’s data is not onward shared with anyone unless they have a specific current NHS England approved Data Sharing Agreement in place. LEGAL BASIS JUSTIFICATION: NHS England relies on the Article 6(1)(e) legal basis under UK GDPR - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services. NHS England rely on Article 9(2)(i) of the UK GDPR as the legal basis for processing. “Processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy”. This is justified as the NHSE commissioned audits and registries aim to drive improvements in the quality and safety of care and to improve outcomes for all patients. (Academic, internal NHS transfer)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2019-04 – 2020-07 2017.06 — 2025.04.

Access method: One-Off, Ongoing

Data-controller type: HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), NHS ENGLAND (QUARRY HOUSE), NHS ENGLAND (QUARRY HOUSE)

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Office for National Statistics Mortality Data
  3. Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics
  4. Civil Registration - Deaths
  5. MRIS - Members and Postings Report
  6. Demographics
  7. MRIS - Cause of Death Report
  8. MRIS - Scottish NHS / Registration
  9. MRIS - Flagging Current Status Report
  10. Civil Registration (Deaths) - Secondary Care Cut
  11. HES:Civil Registration (Deaths) bridge
  12. MRIS - Cohort Event Notification Report
  13. HES-ID to MPS-ID HES Admitted Patient Care
  14. Civil Registrations of Death - Secondary Care Cut
  15. Hospital Episode Statistics Admitted Patient Care (HES APC)
  16. Civil Registrations of Death

Type of data: Identifiable, Anonymised - ICO Code Compliant

Objectives:

The processing is to enable NICOR to undertake its HQIP contracted audit work - reports and aggregate table reports at the unit or consultant level. Specifically to enable the delivery, by NICOR staff, of the National Cardiovascular Audit Programme the 6 audits

• Myocardial Ischaemia National Audit (MINAP)
• Adult Cardiac Surgery Audit
• National Heart Failure Audit
• Congenital Heart Disease Audit,
• Cardiac Rhythm Management Audit
• Adult Cardiac Interventions Audit
as contracted between NICOR and HQIP.

The data may also be used to enable the delivery of additional audit analysis, with the approval of HQIP and as requested by those being audited (NHS Units and associated Consultants).

Yielded Benefits:

The audit data is being used by the NHS to support Best Practice Tarrif - particularly for Heart Failure and MINAP - a quality improvement initiative to reward hospitals that provide a high standard of care. This year, NICOR have harmonised the six national clinical cardiovascular audits into a national cardiac audit programme with 6 separate domains. This means that NICOR are standardising the approach in terms of (methodology, data collection, data completeness and data quality) conducting the audits. This will be reported back to all key stakeholders, commissioners, trusts, patients and public and clinicians data in a relevant and meaningful way which will lead to improvements in the quality of care provided. NICOR are using the audit data for developing risk adjustment models for Heart Failure and MINAP - to ensure that the reports are reliable and are being interpreted accurately and meaningfully.

Expected Benefits:

There are a number of expected benefits for example;
1. The ability to look at cardiovascular admissions which may be related to, and impacted on by, the medical management of a patient’s heart failure. This will provide a much more detailed and complex picture of readmissions, and help us to determine the full impact that good and poor management of specific cardiac conditions has on readmission rates and mortality outcomes.
2. The ability to utilise readmission for reasons other than, but connected to, major cardiac surgery as an outcome measure would be extremely beneficial in terms of assessing the long term effects on patients undergoing the various cardiac surgical procedures, and what effect different variables have on these outcomes.
3. Provide additional insight into outcomes (especially adverse reactions such as stroke) which we can then include these in our annual reports used to inform quality improvement work. Linkage to the full HES dataset would allow further exploration of the geographic, socio-economic and organisational data of patients more detail. This could lead to a better understanding of commissioning patterns within the UK. In addition, the HES dataset collects information on augmented care and the patient care pathway.
4. The ability to investigate cumulative missed opportunities for patient care and major cardiovascular and cerebrovascular events.
5. The ability to determine case ascertainment rates and underreporting of procedures and patient admissions.
These types of outputs will be included in the various publications NICOR produces including annual and other public reports (in various formats) for the key stakeholders such as clinicians, trusts, commissioners and patients. The information in the reports will be useful for Quality Improvement purposes.

Outputs:

The outputs will be audit reports (in various formats) which will be published throughout 2016/17.

Processing:

Processing by NHS Digital of the cardiovascular audit data is required with both HES and ONS Mortality data, as done previously. Both HES and ONS data will be linked systematically by NHS Digital to the patient records submitted by hospitals/units, for each of the 6 audits using a number of variables (NHS Number, ID Number, Surname, Forename, Date of Birth, Gender, Postcode). NICOR will provide these patient identifiers to NHS Digital for linkage purposes.
NHS Digital return to NICOR the linked HES and ONS data (fields detailed elsewhere).
Before the linked data is used NICOR remove all patient identifiable fields so that the final dataset will be pseudonymised before the audit work is undertaken. No variables which might identify individuals (PID) will ever be published, reported or shared with a third party. Such analysis will only contain aggregated small numbers suppressed data in line with the HES Analysis guide.

Myocardial Ischaemia National Audit Project (MINAP) Annual Report — DARS-NIC-64572-X0Q4D

Opt outs honoured: No - data flow is not identifiable, No (Excuses: Does not include the flow of confidential data, , , Internal flow of aggregate tables only)

Legal basis: Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Internal flow of aggregate tables only

Purposes: No, This data sharing agreement is not an intended legal document, it is a reference document to evidence data flows. The agreement will not be signed as a legal document. It will instead be signed by internal NHS England colleagues. NHS England has commissioned NHS Arden and Greater East Midland Commissioning Support Unit (Arden and GEM) to host the National Institute for Cardiovascular Outcomes Research (NICOR) to continue to manage the six national cardiovascular audits: • Myocardial Ischaemia National Audit Project (MINAP – concerning heart attacks or other acute coronary syndromes) • National Heart Failure Audit (NHFA) • National Audit for Percutaneous Coronary Interventions (NAPCI – relating to a non-surgical method used to open narrowed arteries that supply the heart muscle with blood) • National Congenital Heart Disease Audit (NCHDA – relating to procedures performed for a cardiac defect present from birth) • National Adult Cardiac Surgery Audit (NACSA) • National Audit of Cardiac Rhythm Management (NACRM) NICOR's national audit programme comprises of two types of audits: two specialist domains that are concerned with the disease processes (MINAP and NHFA) and four that cover delivery of specific services (procedures for patients with congenital heart disease, percutaneous coronary intervention, cardiac surgery and the management of cardiac rhythm abnormalities). The aim of these NICOR audits is to measure and report delivery of care against defined guidance standards and to enable the improvement of the quality of care and outcomes of patients with a range of cardiac conditions. Individuals who are already included in NICOR’s six national cardiovascular audit databases have their hospital and mortality outcomes reported under DARS-NIC-359940-W1R7B. As of 24 June 2022, NHS England is the data controller, commissioner and funder for all NICOR's audits and registries. The audits are based on prospectively collected data on patients in all NHS and independent healthcare providers in England and Wales. NICOR is the delivery arm of Arden and GEM (formal processor) for managing the audits and data processing. This Data Sharing Agreement concerns the MINAP which contains information about the care provided to patients who are admitted to hospital with acute coronary syndromes (heart attack). Its findings have been made public since 2003 via annual public reports. MINAP aspires to include complete information about the care of every patient admitted to hospital with heart attack. By so doing there can be greater confidence in the reliability of subsequent analyses and in the validity of comparisons between participating hospitals. The audit must publish case ascertainment at Trust and hospital level to ensure it is capturing all relevant cases. Pseudonymised hospital provider codes are required for this reason. This aspect of data quality is fed back to participating centres, to NHS England and regulatory bodies such as the Care Quality Commission (CQC). The tabulated HES Admitted Patient Care data requested under this Data Sharing Agreement is the minimum level of data required for case ascertainment purposes. NICOR (Arden and GEM) only receive data concerning the number of patients who received care by individual hospitals and trusts. This data allows NICOR to complete a comparison of HES-recorded acute coronary syndrome with MINAP-recorded acute coronary syndrome admissions. There are no alternative less intrusive ways of achieving the purpose. The HES APC data supplied by NHS England will be used to produce ‘participation’ tables for audit purposes, to determine whether hospitals are fully participating in the audit. This will confirm the validity of the numbers that are reported by the hospitals to other NHS databases e.g., HES data and Best Practice Tariff. Aggregate HES data at Trust (and component hospital) level will be compared to the number of records submitted to the audit by each Trust and Health Board, to measure case ascertainment for participating centres. This is a key quality indicator. NICOR requires small numbers unsuppressed for the Annual Reports. If numbers were suppressed, comparison to HES figures with the number of records that hospitals have submitted would result in the NICOR numbers being inaccurate. i.e. if 300 cells are suppressed with each cell representing up to 7, that is up to 2100 admissions excluded from the total, which is a significant amount. To address the GDPR principle of Data Minimisation, NICOR request that the data received is restricted to patients who have been discharged from hospital with a diagnosis of ST segment elevation Myocardial infarction (STEMI) and Non-ST-elevation myocardial infarction (NSTEMI). NICOR only use the latest annual HES data year to analyse case ascertainment. Once the analysis is complete and the annual reports have been published, NICOR destroy the previous year’s data request. NICOR is hosted by Arden and GEM which as the sole data processor only processes the data for the purposes described in this agreement. NHS England relies on the Article 6(1)(e) legal basis for processing personal data under UK GDPR - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services. NHS England rely on Article 9(2)(h) of the UK GDPR as the legal basis for processing special category data. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". This is justified as NHS England are responsible for provision of health and social care, and management of systems and compliance. (Academic, internal NHS transfer)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2018-01 – 2021-01 2021.05 — 2024.09.

Access method: One-Off

Data-controller type: HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), NHS ENGLAND (QUARRY HOUSE), NHS ENGLAND (QUARRY HOUSE)

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)

Type of data: Anonymised - ICO Code Compliant, Aggregated, Pseudonymised

Objectives:

The Healthcare Quality Improvement Partnership (HQIP) have commissioned, on behalf of NHS England as part of the National Clinical Audit and Patient Outcomes Programme (NACPOP), six national cardiovascular audits which are managed by the National Institute for Cardiovascular Outcomes Research (NICOR) hosted by Barts Health NHS Trust.

The six audits, collectively termed the National Cardiac Audit Programme (NCAP) audits, are based on prospectively collected, data on patients in all NHS providers in England and Wales. NCAP is managed by NICOR, and their funding contract for the National Cardiac Audit Programme runs until June 2022.

NCAP collects data from two domains that are concerned with particular disease processes (heart attacks and heart failure) and four that cover delivery of specific services (procedures for patients with congenital heart disease, percutaneous coronary intervention, cardiac surgery and the management of cardiac rhythm abnormalities). The aim of these NCAP audits is to measure and report delivery of care against defined guidance standards and to enable the improvement of the quality of care and outcomes of patients with a range of cardiac conditions.

The Myocardial Ischaemia National Audit Project (MINAP) is one of the six focal areas for audit within the NCAP that contains information about the care provided to patients who are admitted to hospital with acute coronary syndromes (heart attack). Its findings have been made public since 2003 via annual public reports.

MINAP aspires to include complete information about the care of every patient admitted to hospital with heart attack. By so doing there can be greater confidence in the reliability of subsequent analyses and in the validity of comparisons between participating hospitals. The audit must publish case ascertainment at Trust and hospital level to ensure it is capturing all relevant cases. This aspect of data quality is fed back to participating centres, to NHS England and regulatory bodies.

Hospital Provider codes (pseudonymised) are now required as MINAP must publish an audit case ascertainment at Trust AND hospital level to ensure it is capturing all relevant cases for feeding back to NHS England and the Care Quality Commission.

The tabulated HES Admitted Patient Care data requested is necessary for the performance of a task carried out in the public interest, namely improving the quality of care for people being treated for heart attack – Myocardial Ischaemia.

There are no alternative, less intrusive ways of achieving the purpose.

This agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England.

NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs.

NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties.

NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs.

NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties.

NICOR is hosted by Bars Health NHS Trust, as such Barts Health NHS Trust is the sole data processor, and only processes the data for the purposes described in this agreement.

Legal Basis Justification:
HQIP and NHS England both rely on the Article 6 (1) (e) legal basis under GDPR - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services.

HQIP rely on Article 9 (2) (i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients.

NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance.

Yielded Benefits:

MINAP presented case ascertainment rates for participating Trusts – expressed as the ratio of the number of cases coded as myocardial infarction (in Hospital Episode Statistics (HES) data provided by NHS Digital for England to the number of cases submitted to MINAP – for the first time in 2017. This has repeated annually since. Analysis revealed wide variation in case ascertainment. Some hospitals submit significantly fewer cases to MINAP than would be expected based upon the corresponding HES codes; others submit many more cases to MINAP than appear in HES. This latter point – a greater than expected number of cases submitted to MINAP – appears counterintuitive. It is likely to represent differences in hospital coding practices. So, for example, in 2018 while the median case ascertainment rate for English Trusts is 99%, there are 11 Trusts that have rates above 150% (implying substantially greater MINAP submissions than coded discharges) and 11 Trusts that have rates below 50% (implying inadequate case finding). Given the documented variation, MINAP will work with participating centres to better understand existing coding practice. This will lead to a request for additional ICD codes in HES returns. Additionally NICOR are mandated by HQIP to maintain and improve 'Data Quality'. Markers of data quality include: • Timeliness of reporting - how soon after, and how often during, the relevant period of reporting are reports made available? • Accuracy/validity of submitted data - are the data submitted to the audit a true reflection of the care provided? • Data completeness - for each case, how many of the data fields are completed? • Case ascertainment - what proportion of the entire 'population' of patients with the clinical condition of interest is submitted to the National Audit? Following receipt of previous HES data, MINAP has been able to report on this last aspect of data quality - case ascertainment. The audit publishes case ascertainment and clinical practice analysis at Trust and hospital level, and feeds back on this to NHS England and the Care Quality Commission. The hospital level HES tabulation data requested is the minimum level of data required for case ascertainment purposes, which basically means that it’s a check for verifying the number of patients submitted to NICOR with the number of patients’ coded by the hospitals for HES. The data we receive is number of patients who received care by individual hospitals. So the hospital level HES tabulation data is NOT at patient level. We do not consider this to be “intrusive” however, there are no other ‘less intrusive’ ways of achieving this purpose. The data supplied by NHS Digital will be used to produce ‘participation’ tables for audit purposes, to determine whether hospitals are fully participating in the audit. This will confirm the validity of the numbers that are reported by the hospitals to other NHS databases e.g. HES data and Best Practice Tariff. The CQC also use our data for monitoring the performance of hospitals. For this case ascertainment process provides them with the required quality assurance.

Expected Benefits:

The primary benefit is in the calculation (and presentation) of case ascertainment rates for participating centres.

Case ascertainment is an important aspect of data quality and provides an estimate as to what proportion of patients with the clinical condition under study are submitted to the audit. The publication of case ascertainment rates encourages participating centres to include as many patients as possible. This minimises the risk of hospitals ‘cherry picking’ patients for the audit and enables the audit to measure like with like and provide national comparative data.

A secondary benefit is in an understanding of the coding practices of participating hospitals with respect to similar cardiac conditions

Transparency with respect to degree of participation in mandated clinical audit: The audit provides participation rates, and hospital level data, to organisations such as the Care Quality Commission’s Quality and Risk Profiles, the NHS Choices website and data.gov.uk. Case Ascertainment is also presented within annual public reports.

Improved data quality: Publication and comparison of case ascertainment will identify poorer performing hospitals and encourage such hospitals to improve the quality of the data they submit. At the same time higher performing hospitals can receive credit.

Confidence in the implications (and generalizability) of national audit: Access to HES trusts level data is crucial for establishing case ascertainment and ensuring the quality of patient care and patient outcomes is being monitored for all patients. Case ascertainment is key to measuring equity of access and care. This will lead to:
(a) Improvements in patient care, as the NCAP supports both quality assurance and quality improvement initiatives both locally and nationally.
(b) Understanding differences in hospital coding practices: Variation in cases ascertainment may also point to differences in HES coding practices between hospitals.

Outputs:

The MINAP audit publishes case ascertainment and clinical practice analysis at Trust and hospital level, and feeds back on this to NHS England and the Care Quality Commission.

NICOR must deliver to HQIP and NHS England the NCAP Annual Report - as a contracted deliverable. Following the formal sign off and publication of the NCAP 2020 Annual Report there will be some individual discussions and presentations of the report e.g. at conferences. These presentations may not necessarily include the HES tabulation data, but the publication and any presentations would be based on the NCAP Annual Report (which uses HES tabulation data for case ascertainment purposes).

Both the National Cardiac Audit Programme (NCAP) 2020 Annual Report and the domain-specific Summary MINAP Annual Report will be distributed electronically to Trust chief executives, clinicians, British Cardiovascular Society and to other stakeholders. These reports are also publicly available online on the HQIP webpages and on the NICOR website: https://www.nicor.org.uk/national-cardiac-audit-programme/. Analyses from NCAP appear in Quality Accounts and are made available to CQC visiting teams.

All outputs will be restricted to aggregate data with small number suppressed in line with the HES analysis guide.

Processing:

All those with access to the data are substantive employees of Bart's Health NHS Trust. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

There will be no flow of data into NHS Digital. NHS Digital will flow tabulated HES APC data to Barts Health NHS Trust. There will be no subsequent flow of data.

The data from NHS Digital will not be used for any other purpose other than those outlined in this agreement. The data received from NHS Digital will not be linked to other available datasets.

The HES tabulation data will be used to determine whether hospitals are fully participating in the audit. Aggregate HES data at Trust (and component hospital) level will be compared to the number of records submitted to the audit and expressed (in tabular format) as case ascertainment rates for participating centres. This is a key quality indicator.

For the purpose of the MINAP annual report, NICOR cannot allow for any small numbers to be suppressed. If numbers were supressed, comparison to HES figures with the number of records that hospitals have submitted would result in NICOR numbers being inaccurate. I.e. If 300 cells are suppressed, that is up to 1500 admissions excluded from the total, which is a significant amount.

The tabulated HES data is stored on a shared drive only accessible to NICOR staff. Once the annual reports have been published, the data for that year is destroyed is destroyed.

Upon instruction from NHS Digital, a Certificate of Data Destruction must be completed by the Data Controller confirming the data has been appropriately disposed of following use.

National Heart Failure Audit 2016-17 Report — DARS-NIC-42272-S9J3L

Opt outs honoured: No - data flow is not identifiable, No (Excuses: Does not include the flow of confidential data, Internal flow of aggregate tables only)

Legal basis: Health and Social Care Act 2012, Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Internal flow of aggregate tables only

Purposes: No, This data sharing agreement is not an intended legal document, it is a reference document to evidence data flows. The agreement will not be signed as a legal document. It will instead be signed by internal NHS England colleagues. NHS England has commissioned NHS Arden and Greater East Midland Commissioning Support Unit (Arden and GEM) to host the National Institute for Cardiovascular Outcomes Research (NICOR) to continue to manage the six national cardiovascular audits: • Myocardial Ischaemia National Audit Project (MINAP – concerning heart attacks or other acute coronary syndromes) • National Heart Failure Audit (NHFA) • National Audit for Percutaneous Coronary Interventions (NAPCI – relating to a non-surgical method used to open narrowed arteries that supply the heart muscle with blood) • National Congenital Heart Disease Audit (NCHDA – relating to procedures performed for a cardiac defect present from birth) • National Adult Cardiac Surgery Audit (NACSA) • National Audit of Cardiac Rhythm Management (NACRM) NICOR's national audit programme comprises of two types of audits: two specialist domains that are concerned with the disease processes (MINAP and NHFA) and four that cover delivery of specific services (procedures for patients with congenital heart disease, percutaneous coronary intervention, cardiac surgery and the management of cardiac rhythm abnormalities). The aim of these NICOR audits is to measure and report delivery of care against defined guidance standards and to enable the improvement of the quality of care and outcomes of patients with a range of cardiac conditions. Individuals who are already included in NICOR’s six national cardiovascular audit databases have their hospital and mortality outcomes reported under DARS-NIC-359940-W1R7B. As of 24 June 2022, NHS England is the data controller, commissioner and funder for all NICOR's audits and registries. The audits are based on prospectively collected data on patients in all NHS and independent healthcare providers in England and Wales. NICOR is the delivery arm of Arden and GEM (formal processor) for managing the audits and data processing. This Data Sharing Agreement concerns the NHFA which is a national clinical audit which monitors the care and treatment of hospitalised heart failure patients in England and Wales. The audit collects data on patients with an unscheduled admission to hospital in England and Wales, who are discharged with a primary diagnosis of heart failure. It was established in 2007 and has collected over 580,000 records of heart failure-coded hospital episodes. The audit aims to capture data on clinical indicators which have a proven link to improved outcomes for heart failure patients, and to encourage the increased use of clinically recommended diagnostic tools, disease modifying treatments and referral pathways. The audit publishes case ascertainment and clinical practice analysis at Trust and hospital level, and feeds back on this to NHS England and the Care Quality Commission (CQC). The hospital level HES Admitted Patient Care (APC) tabulation data requested under this Data Sharing Agreement is the minimum level of data required for case ascertainment purposes. NICOR (Arden and GEM) only receive data concerning the number of patients who received care by individual hospitals and trusts. This data allows NICOR to complete a comparison of HES-recorded heart failure admissions with National Heart Failure Audit-recorded heart failure admissions. There is no alternative, or less intrusive way of achieving the purpose stated within this Agreement. The HES APC data supplied by NHS England will be used to produce ‘participation’ tables for audit purposes, to determine whether hospitals are fully participating in the audit. This will confirm the validity of the numbers that are reported by the hospitals to other NHS databases e.g., HES data and Best Practice Tariff. The CQC also use data from NHFA for monitoring the performance of hospitals, this case ascertainment process provides them with the required quality assurance. Aggregate HES data at Trust (and component hospital) level will be compared to the number of records submitted to the audit by each Trust and Health Board, to measure case ascertainment for participating centres. This is a key quality indicator. NICOR requires small numbers unsuppressed for their NHFA Annual Report. If numbers were suppressed, comparison to HES figures with the number of records that hospitals have submitted would result in NICOR numbers being inaccurate. i.e. If 300 cells are suppressed with each cell representing up to 7, that is up to 2100 admissions excluded from the total, which is a significant amount. To address the GDPR principle of Data Minimisation, NICOR request that the data received is restricted to patients who have been discharged from hospital (with hospital code) with a diagnosis of heart failure. NICOR only use the latest annual HES data year to analyse case ascertainment. Once the analysis is complete, NICOR destroy the previous year’s data request. NICOR is hosted by Arden and GEM which as the sole data processor only processes the data for the purposes described in this Agreement. NHS England relies on the Article 6(1)(e) legal basis for processing personal data under UK GDPR - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services. NHS England rely on Article 9(2)(h) of the UK GDPR as the legal basis for processing special category data. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". This is justified as NHS England are responsible for provision of health and social care, and management of systems and compliance. (Academic, internal NHS transfer)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2019-01 – 2020-01 2016.09 — 2024.09.

Access method: One-Off

Data-controller type: HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), NHS ENGLAND (QUARRY HOUSE), NHS ENGLAND (QUARRY HOUSE)

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)

Type of data: Anonymised - ICO Code Compliant, Aggregated

Objectives:

The National Heart Failure Audit is a national clinical audit which monitors the care and treatment of hospitalised heart failure patients in England and Wales and collects data on patients with an unscheduled admission to hospital in England and Wales who are discharged with a primary diagnosis of heart failure. It was established in 2007 and has now collected over 200,000 records of heart failure-coded hospital episodes.

The audit aims to capture data on clinical indicators which have a proven link to improved outcomes for heart failure patients, and to encourage the increased use of clinically recommended diagnostic tools, disease modifying treatments and referral pathways. The audit publishes case ascertainment and clinical practice analysis at Trust and hospital level, and feeds back on this to NHS England and the Care Quality Commission.

The data supplied by NHS Digital (formerly known as Health and Social Care Information Centre) will be used to produce ‘participation’ tables for audit purposes, to determine whether hospitals are fully participating in the audit. Aggregate HES data at Trust level will be compared to the number of records submitted to the audit by each Trust and Health Board, to measure case ascertainment.

For the purpose of the heart failure national report NICOR cannot allow for any small numbers to be suppressed, because otherwise when comparing HES figures with the number of records that hospitals have submitted to the audit, NICOR’S numbers will be inaccurate. If 300 cells are suppressed, that is up to 1500 admissions excluded from the total, which is quite a significant amount.

The data is required for a national clinical audit so the data needs to be as accurate as possible. Over 200 hospitals in England and Wales are assessed against the data NICOR publish in reports in Quality Accounts and by the CQC.

Yielded Benefits:

The Heart Failure audit is used by NHS England to support the Best Practice Tariff (BPT), a model that was created to incentivise care that is high quality and cost effective with the aim to reduce unexplained variation in the quality of care. The heart failure BPT was introduced in April 2015, to be an incentive to delivering specialist input in to the care of heart failure patients admitted to secondary care as an emergency as outlined in the NICE clinical guidelines 108 ‘Chronic heart failure: Management of chronic heart failure in adults in primary and secondary care’ and the clinical guideline 187 ‘Acute heart failure: diagnosing and managing acute heart failure in adults’ and the chronic heart failure quality standard (QS9). This feeds into the findings of the Heart Failure audit report year highlighting that outcomes are better for patients that access specialist care, overall improving mortality. For Chief Executives, Medical and Clinical Directors The Heart Failure audit is now comprehensive. Trusts and Health Boards should be aware that there is considerable variation in the quality of care delivered by different hospitals, and in different wards within a hospital. For Multidisciplinary Heart Failure Teams and Heart Failure leads and networks Recommendations on how to encourage and support quality improvement work targeted at improving limitations in care of people with acute heart failure. For Commissioners Ensure that the commissioners understand their local Heart Failure team and that it is properly constituted and fully commissioned along with use of the audit report to understand how the Heart Failure team commissioned by them compares with other Trusts and understanding service gaps and limitations in local Heart Failure care and work with the Trust to address gaps in service.

Expected Benefits:

The audit aims to drive up the quality of the diagnosis, treatment and management of heart failure by collecting, analysing and disseminating data, measuring improvements in participation in the National Heart Failure Audit; eventually to improve mortality and morbidity outcomes for heart failure patients.

Audit data is used in a number of ways to drive improvement in heart failure services and patient outcomes. Primarily, data is fed back to individual hospitals to report on their clinical practice and outcomes over time.

The audit provides participation rates, and hospital level data to organisations such as the Care Quality Commission’s Quality and Risk Profiles, the NHS Choices website and data.gov.uk. In addition to this, the audit produces an annual report, which is publically available: an archive of National Heart Failure Audit Reports can be found on the Annual reports webpage.

There are future plans to provide anonymised National Heart Failure Audit data, by hospital, to Cardiac Networks and Clinical Commissioning Groups.

Audit data is also used for research purposes, to investigate further the causes, treatment and management of heart failure. More information about the research use of National Heart Failure Audit and NICOR data can be found on the Research section the NICOR website: - http://www.ucl.ac.uk/nicor/audits/heartfailure/research

Outputs:

Past Outputs
NICOR UCL published the National Heart Failure Audit Report 2013/14 on the 20 October 2015.

The seventh annual report for the National Heart Failure Audit presents findings and recommendations based on patients with an unscheduled admission to hospital, who were discharged or died with a primary diagnosis of heart failure between 1 April 2013 and 31 March 2014. The report covers all NHS Trusts in England and Health Boards in Wales that admit patients with acute heart failure.

The report is aimed at all those involved in collecting data for the National Heart Failure Audit, including those involved in collecting data for the National Heart Failure Audit, as well as clinicians, hospital chief executives, managers, clinical governance leads commissioners, patient groups and many others. The report includes clinical findings at national and local levels and patient outcomes. Participation tables are produced and published every year in the report.

Future outputs
NICOR will use aggregate HES data with small numbers suppressed at Trust level to produce ‘participation tables’ in the National Heart Failure Audit Annual Report each year with publication to be confirmed. Participation tables are produced and published every year in the report.

The publication will be distributed in hard copy to all Trust Chief Executives, and clinicians in the heart failure community, and also made publically available on the NICOR website. It will also be published by HQIP on its PARCAR (participation and case ascertainment) webpages.

Processing:

Comparison of HES-recorded heart failure admissions with National Heart Failure Audit-recorded heart failure admissions to determine case ascertainment rate.

HSCIC supply tabulated HES APC data for the year only specified in this agreement for ICD 10 codes for heart disease. Data is broken down at provider level.

NICOR (UCL) will publish aggregated data with small number suppression within the National Heart Failure Audit Annual Report for the current financial year in hard copy to all Trust Chief Executives and clinicians in the heart failure community; also made publically available on NICOR website

HQIP will publish aggregated data with small number suppression in-line with the HES analysis guide within the National Heart Failure Audit Annual Report for the current financial year; made publically available on PARCAR (participation and case ascertainment) webpages. For clarity, no record level data will be shared with any third party; all individuals with access to the record level data are employed by the data processor. No data will be transferred outside the EEA.