Barts Health NICOR NCAP (Previously known as CCAD - Central Cardiac Audit Database - MR1233)

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Civil Registrations of Death; + HES-ID to MPS-ID HES Admitted Patient Care

Objective for processing

The six national cardiovascular audits (named below) are, commissioned by the Healthcare [9 words unchanged] National Institute for Cardiovascular Outcomes Research (NICOR) at Barts Health NHS Trust. The work carried out by NICOR transferred to Barts Health NHS Trust from UCL on 1st July 2017. • Myocardial Ischaemia National Audit Project (MINAP - (MINAP- heart attack) • National Heart Failure Audit (NHFA) [3 paragraphs unchanged] • National Adult Percutaneous Interventions Audit (NAPCI) [6 paragraphs unchanged] • National Adult Percutaneous Interventions Audit: Includes all adult patients on whom a percutaneous cardiovascular intervention (PCI) procedure is performed performed. The aim of these audits is to measure and report delivery of [122 words unchanged] improvement work, if required. All results are made available on public facing websites- NICOR at Barts transferred from UCL on the 1st July 2017, websites e.g. NHSChoices, MyNHS as well as on the websites of the audit associated Professional Societies. The Barts: Barts NICOR website highlights the latest reports but allows access to previous reports [8 words unchanged] live portal lists the sources of where HQIP audit data is published. Death data All data received under this agreement relates to individuals who meet the inclusion criteria for one or more of the aforementioned clinical audits. Death data (death status and date of death) will be linked to the NCAP data to provide short-term and long-term survival outcomes. The demographic data will be used for this purpose. Civil Registry data Date of death and cause of death are not provided by the trusts, as it is recognised that a more thorough and comprehensive record of death is available through Civil Registration data (demographic data). Death data (death status and date of death) will be linked to the NCAP data to provide short-term and long-term survival outcomes. Demographic data will be used to facilitate this. Barts Health NHS Trust require this data from NHS Digital because Date of death and cause of death are not provided by the trusts, as it is recognised that a more thorough and comprehensive record of death is available through Civil Registration data. [1 paragraph unchanged] a) HES data is currently required for the heart failure and MINAP audits. This is for case ascertainment at Trust level (aggregate data). For the first time NICOR have agreed with NHSE and HQIP that the NCAP 2020 annual [6 words unchanged] comorbidities and complications. This can only be obtained from HES APC data. b) NCAP data linked with tracked mortality data and HES patient level (HES APC) data is required for VICORI [ref DSA DARS-NIC-143888-H0W2N]. 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, Public Health England and Barts Health NHS Trust. This body of work is divided into several different work packages, these are detailed further in DSA DARS-NIC-143888-H0W2N. [10 paragraphs unchanged]

Processing activities

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 [27 words unchanged] contractors of the Data Recipient who may have access to that data). Data disseminated under this application can only be used for different purposes after those different purposes have been approved by NHS Digital under separate DSAs and a live DSA is in place. All those with access to the data are substantive employees of Bart's Health NHS Trust. All outputs will be restricted to aggregate data with small number suppressed in line with the HES analysis guide unless in relation guide, with the exception of data that is shared to a separate DSA as above. support the VICORI programme. [6 paragraphs unchanged] 3. HES data is securely returned to NICOR via the secure web based file repository Secure Electronic File Transfer (SEFT)repository provided by NHS Digital. 4. Death data is securely returned to NICOR via the secure web based file SEFT repository provided by NHS Digital. [3 paragraphs unchanged] Data disseminated under this application can only be used for different purposes after those different purposes have been approved by NHS Digital under separate applications and a live DSA is in place NICOR will transfer the record level HES and Death data to third parties who also hold a Data Sharing Agreement (DSA) with NHS Digital. One such named project in this Agreement is VICORI project (led by University of Leicester in collaboration with Public Health England and NICOR) under DSA DARS-NIC-143888-H0W2N. NICOR will onward share the record level HES and Death data - as per agreement of our DSA with NHS Digital with third parties who also hold a DSA with NHS Digital. One such named project in our DSA application is VICORI project (led by Leicester University in collaboration with Public Health England and NICOR) [See SD9 for details of DSA DARS-NIC-143888-H0W2N - University of Leicester (VICORI) - Active]. Data disseminated under this Agreement can only be used for a novel purpose after those purposes have been approved by NHS Digital under separate DSAs and a live DSA is in place.

Expected output

[1 paragraph unchanged] Data disseminated under this application can only be used for different purposes after those different purposes have been approved by NHS Digital under separate DSAs and a live DSA is in place. [1 paragraph unchanged] NICOR anticipate producing the NCAP 2019 2020 Annual Aggregate Report along with the Summary 2019 2020 Domain Reports as well as the NCAP 2019 2020 Patients' Report (containing 2017/18 2019/20 data) to be published in 2020. 2021. The aim is to publish annual National Cardiac Audit Programme (NCAP) reports based on 2018/19 2019/20 data in each of the domains of NCAP by late 2020. 2021. NHS Digital information is essential to be able to provide appropriate case [11 words unchanged] essential analysis and core reporting and subsequent quality improvement cannot be done. [2 paragraphs unchanged] • Adult cardiac surgery and the PCI domains will publish consultant level outcomes on NHS Choices and on the professional society websites in 2020. 2021. Consultant-level outcomes likely to be reported are volume of operations and risk-adjusted [32 words unchanged] is to provide transparency, quality assurance and to assist in patient choice. [1 paragraph unchanged] • All reports and outputs will be made available on a Barts Health:NICOR website Health’s NICOR website, and websites of the associated professional societies to make them further accessible by healthcare professionals and patients and the public. The NCAP 2019 Annual Aggregate Report and the Summary 2019 Domain Reports for each of the NCAP domains are to be was published in 2020: https://www.nicor.org.uk/national-cardiac-audit-programme/ Death Data and patient level HES data will be onward shared with VICORI (led by Leicester University in collaboration with NICOR and PHE) and other third parties who already have a DSA in place with NHS Digital. PHE).

Expected measurable benefits

Some examples of key benefits realised from the 2015/16 audits are: A number of additional expected future benefits are applicable to all the audits. For example: • Congenital audit: o Overall outcomes continue to show high survival rates just under 98% at 30 days following paediatric cardiac surgery which compare very favourably to similar developed countries in Europe and North America. o 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) o Antenatal diagnosis continues to improve to now over 50% of those requiring an intervention in infancy. The audit has extended to include fetal screening. This includes maternal and fetal data, enabling the tracking of outcomes for a set of 10 key heart anomalies from the time of antenatal diagnosis through to infancy and beyond, whether procedures are undertaken or not. • PCI audit: o The standards for “door to needle” and “door to balloon” times continue to be met although increased times with inter-hospital transfer were observed o There has been a progressive uptake of radial access procedures, associated with better outcomes, and a fall in the use of thrombectomy devices, reducing costs • Heart failure audit: o The mortality of patients hospitalised with heart failure is significantly lower in 2015/16 at 8.9% compared to 9.6% in the previous year. 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. The Heart Failure audit data used to support Best Practice Tariff – a quality improvement initiative to reward hospitals that provide a high standard of care. • MINAP o Audit data identified areas with scope for improvement. For example, only 56.5% of nSTEMI* patients are admitted to a cardiac unit and only 55.8% of nSTEMI* patients had an angiogram within the recommended 72 hours of admission to hospital. [*NSTEMI is a type of heart attack. NSTEMI stands for Non-ST-elevation myocardial infarction. Sometimes an NSTEMI is known as a non-STEMI. A myocardial infarction is the medical term for a heart attack. ST refers to the ST segment, which is part of the EKG heart tracing used to diagnose a heart attack.] o MINAP data used to support Best Practice Tariff – a quality improvement initiative to reward hospitals that provide a high standard of care. • Cardiac rhythm management o Audit data identified areas with scope for improvement. For example, a) the audit has identified variation in implant rates across the country that have not improved in the last 2 years and b) while nearly all centres meet NICE guidance for ICD implantation in patients who have suffered life-threatening arrhythmias (secondary prevention), in cases where they are implanted purely because of the risk of arrhythmias (primary prevention), documented adherence to these NICE guidance is not as good. o Occasional practice has reduced and the number of adult NHS hospitals implanting small numbers of pacemakers (below the recommended minimum) has approximately halved in the last year. There is considerable use of the cardiac national data which has become a valuable source of data for commissioners, the Departments of Health, patients, clinicians, and managers. Both previously, and in the future, the audit data and that linked to HES and/or Civil Registration data will 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 Furthermore, there are a number of additional expected future benefits that are applicable to all the audits. For example: [25 paragraphs unchanged]

Benefits reported

The audit data is being used by the NHS to support Best Practice Tariff - particularly for Heart Failure and Myocardial Ischaemia National Audit Project (MINAP (MINAP) - a quality improvement initiative to reward hospitals that provide a high standard of care. In the year 2017-18 (the first year of the HQIP contract), NICOR have harmonised the six national clinical cardiovascular audits into a national cardiac audit [30 words unchanged] reported back to all key stakeholders, commissioners, trusts, patients and public and clinicians clinician’s 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. The primary reason for which NICOR uses Civil Registration data/HES 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 Clinical 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 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 national adult cardiac surgery audit 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. Often the hospital reported children’s death are not accurate due to the need for the coroner to investigate the reasons of death which could take many months. Hence, the NHS Digital Civil Registrations data is more reliable for being able to compare performance between hospitals, particularly where there are small number of deaths involved in the congenital domain. Some outcomes may be measured by mortality data. The outcomes data (our audit linked data to civil registrations) is also being used by the NHS to support Best Practice Tariff - particularly for Heart Failure and MINAP – a quality improvement initiative to reward hospitals that provide a high standard of care. The primary reason for which NICOR uses Civil Registration data/HES 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 Clinical 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 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 national adult cardiac surgery audit 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. Often the hospital reported children’s death are not accurate due to the need for the coroner to investigate the reasons of death which could take many months. Hence the NHS Digital Civil Registrations data is more reliable for being able to compare performance between hospitals, particularly where there are small number of deaths involved in the congenital domain. Some outcomes may be measured by mortality data. The outcomes data (our audit linked data to civil registrations) is also being used by the NHS to support Best Practice Tariff - particularly for Heart Failure and MINAP – a quality improvement initiative to reward hospitals that provide a high standard of care. The other benefits of NHS Digital linked data with national cardiac audit programme data are that the specialised commissioners, regulators (e.g. CQC, MHRA) and other stakeholders will 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 other benefits of NHS Digital linked data with national cardiac audit programme data is that the specialised commissioners, regulators (e.g. CQC, MHRA) and other stakeholders will 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. [1 paragraph unchanged] In terms of benefits yielded by use of HES data NICOR have [38 words unchanged] enrich their audit data. Hence this application for patient level HES data. Also VICORI research project led by Leicester University (Dr David Adlam) holds a DSA for linked patient level death data and HES data. NICOR is required to onward share linked death and HES patient level data with VICORI. Also, the VICORI research project led by Leicester University holds a DSA for linked patient level death data and HES data, allowing researchers to better understand the relationship between cancer and ischemic heart diseases. NICOR is required to onward share linked death and HES patient level data with VICORI. Some examples of key benefits realised from the audits are: • Congenital audit: o Overall outcomes continue to show high survival rates just under 98% at 30 days following paediatric cardiac surgery which compare very favourably to similar developed countries in Europe and North America. o 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) o Antenatal diagnosis continues to improve to now over 50% of those requiring an intervention in infancy. The audit has extended to include fetal screening. This includes maternal and fetal data, enabling the tracking of outcomes for a set of 10 key heart anomalies from the time of antenatal diagnosis through to infancy and beyond, whether procedures are undertaken or not. • PCI audit: o The standards for “door to needle” and “door to balloon” times continue to be met although increased times with inter-hospital transfer were observed o There has been a progressive uptake of radial access procedures, associated with better outcomes, and a fall in the use of thrombectomy devices, reducing costs • Heart failure audit: o The mortality of patients hospitalised with heart failure is significantly lower in 2015/16 at 8.9% compared to 9.6% in the previous year. 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. The Heart Failure audit data used to support Best Practice Tariff – a quality improvement initiative to reward hospitals that provide a high standard of care. • MINAP o Audit data identified areas with scope for improvement. For example, only 56.5% of nSTEMI* patients are admitted to a cardiac unit and only 55.8% of nSTEMI* patients had an angiogram within the recommended 72 hours of admission to hospital. [*NSTEMI is a type of heart attack. NSTEMI stands for Non-ST-elevation myocardial infarction. Sometimes an NSTEMI is known as a non-STEMI. A myocardial infarction is the medical term for a heart attack. ST refers to the ST segment, which is part of the EKG heart tracing used to diagnose a heart attack.] o MINAP data used to support Best Practice Tariff – a quality improvement initiative to reward hospitals that provide a high standard of care. • Cardiac rhythm management o Audit data identified areas with scope for improvement. For example, a) the audit has identified variation in implant rates across the country that have not improved in the last 2 years and b) while nearly all centres meet NICE guidance for ICD implantation in patients who have suffered life-threatening arrhythmias (secondary prevention), in cases where they are implanted purely because of the risk of arrhythmias (primary prevention), documented adherence to these NICE guidance is not as good. o Occasional practice has reduced and the number of adult NHS hospitals implanting small numbers of pacemakers (below the recommended minimum) has approximately halved in the last year. There is considerable use of the cardiac national data which has become a valuable source of data for commissioners, the Departments of Health, patients, clinicians, and managers. Both previously, and in the future, the audit data and that linked to HES and/or Civil Registration data will 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

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Data controllers: + NHS ENGLAND

Datasets: + Demographics · − MRIS - Scottish NHS / Registration

Objective for processing

[16 paragraphs unchanged] Death data (death status and date of death) will be linked to the NCAP data to provide short-term and long-term survival outcomes. The demographic data will be used for this purpose. Date of death and cause of death are not provided by the [7 words unchanged] more thorough and comprehensive record of death is available through Civil Registration data. data (demographic data). [2 paragraphs unchanged] b) NCAP data linked with tracked mortality data (ONS) and HES patient level (HES APC) data is required for VICORI [ref DSA DARS-NIC-143888-H0W2N]. Legal Basis: DATA CONTROLLERSHIP Article 6 (1)(e) - NHS England are a public authority. NHS England contract HQIP to commission the NCAPOP and the NHS standard contract with NHS providers of services to participate within the National Clinical Audit and Patient Outcomes Programme (NCAPOP). This agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. Article 9(2)(i) 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. The data is required for audit purposes - for improvement and ensuring high standards and quality/safe care. 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. There are three purposes to this agreement: 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. Purpose 1: Extension to hold previously obtained HES data 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. Purpose 2: Refresh Civil Registration (Deaths) Data and refresh HES APC data Legal Basis Justification: Purpose 3: To amend the agreement to allow onward sharing of data once this purpose has been recommended for approval under a separate data sharing agreement. 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. Each purpose is covered by Section 251 CAG approval. 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.

Processing activities

[3 paragraphs unchanged] Redcentric PLC [also known as Redcentric Managed Solutions, and Redcentric Solutions Limited [36 words unchanged] the secure facility (bricks and mortar) with power and internet connectivity for us NICOR to house our the servers. Servers are in a secure locked environment which Redcentric do not [34 words unchanged] Health NHS Trust staff have access to the data via remote access. [12 paragraphs unchanged]

Expected output

[3 paragraphs unchanged] NICOR anticipate producing the NCAP 2019 Annual Aggregate Report along with the [7 words unchanged] the NCAP 2019 Patients' Report (containing 2017/18 data) to be published in late 2019. 2020. The aim is to publish annual National Cardiac Audit Programme (NCAP) reports based on 2018/19 data in each of the domains of NCAP by June late 2020. NHS Digital information is essential to be able to provide appropriate [12 words unchanged] essential analysis and core reporting and subsequent quality improvement cannot be done. [2 paragraphs unchanged] • Adult cardiac surgery and the PCI domains will publish consultant level outcomes on NHS Choices and on the professional society websites in May/June 2020. Consultant-level outcomes likely to be reported are volume of operations and [33 words unchanged] is to provide transparency, quality assurance and to assist in patient choice. [2 paragraphs unchanged] The NCAP 2019 Annual Aggregate Report and the Summary 2019 Domain Reports for each of the NCAP domains are to be published in September 2019: 2020: https://www.nicor.org.uk/national-cardiac-audit-programme/ [1 paragraph unchanged]

Unchanged: Expected measurable benefits, Benefits reported.